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Kha R, Min H, Marschner S, Mahendran S, Thiagalingam A, Poulter R, Redfern J, Brieger D, Thompson PL, Hillis GS, Collins N, Shetty P, McGrady M, Hamilton-Craig C, Kangaharan N, Atherton J, Maiorana A, Klimis H, Juergens C, Chow CK. Determinants of medication adherence in patients with acute coronary syndrome: a secondary analysis of a randomised clinical trial. Heart 2025; 111:462-470. [PMID: 39819620 DOI: 10.1136/heartjnl-2024-325144] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/25/2024] [Accepted: 12/25/2024] [Indexed: 01/19/2025] Open
Abstract
BACKGROUND Coronary heart disease (CHD) remains a leading cause of mortality and disability worldwide. Approximately half of the patients who have had a prior hospital admission for CHD will have a recurrent coronary event, with the majority of these occurring within 12 months. Despite well-established evidence-based therapies, medication non-adherence is highly prevalent and reasons for medication non-adherence are poorly understood. This study evaluates factors influencing adherence to secondary prevention medications in people with acute coronary syndrome (ACS). METHODS We performed a secondary analysis of TEXT messages to improve MEDication adherence and Secondary prevention after ACS (TEXTMEDS), a single-blind randomised clinical trial of 1424 patients with ACS from 18 hospitals across Australia. The primary outcome was self-reported medication adherence to each of up to five classes of guideline-recommended cardioprotective medications indicated for secondary prevention after ACS. Patients were followed up at 6-month and 12-month time points and were defined as adherent if at both time points, the proportion of indicated medications taken was >80% (>24/30 days in the preceding 1 month) for all five classes if not otherwise contraindicated. Logistic regression analysis and the Least Absolute Shrinkage and Selection Operator regularisation technique were used to assess the effect of sociodemographic and clinical factors on medication adherence. RESULTS The analyses included 1379 participants with complete adherence data (mean age 58.5±10.7 years; 1095 (79.4%) men). The following variables were associated with adherence to cardiovascular medications at both 6 and 12 months: greater number of total medications taken (OR: 1.33; 95% CI: 1.25 to 1.42) and attending a cardiac rehabilitation programme (1.47; 95% CI: 1.17 to 1.86). In contrast, female sex (0.67; 95% CI: 0.50 to 0.90) and physical disability (0.43; 95% CI: 0.23 to 0.77) were associated with lower likelihood of medication adherence. CONCLUSIONS Sociodemographic and clinical factors may influence medication adherence. Greater awareness, discussion and monitoring of these factors during patient follow-up may help improve medication adherence. TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364448; registration number: ACTRN12613000793718.
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Affiliation(s)
- Richard Kha
- Westmead Applied Research Centre, The University of Sydney, Westmead, New South Wales, Australia
| | - Haeri Min
- Westmead Applied Research Centre, The University of Sydney, Westmead, New South Wales, Australia
| | - Simone Marschner
- Westmead Applied Research Centre, The University of Sydney, Westmead, New South Wales, Australia
| | - Shehane Mahendran
- Westmead Applied Research Centre, The University of Sydney, Westmead, New South Wales, Australia
| | - Aravinda Thiagalingam
- Westmead Applied Research Centre, The University of Sydney, Westmead, New South Wales, Australia
| | - Rohan Poulter
- Department of Cardiology, Sunshine Coast University Hospital, Sunshine Coast, Queensland, Australia
| | - Julie Redfern
- Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
| | - David Brieger
- Department of Cardiology, Concord Repatriation General Hospital, Concord, New South Wales, Australia
| | - Peter L Thompson
- Department of Cardiovascular Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
| | - Graham S Hillis
- Department of Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia
| | - Nicholas Collins
- Department of Cardiology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia
| | - Pratap Shetty
- Department of Cardiology, Wollongong Hospital, Wollongong, New South Wales, Australia
| | - Michele McGrady
- Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
| | | | - Nadarajah Kangaharan
- Department of Cardiology, Alice Springs Hospital, Alice Springs, Northern Territory, Australia
| | - John Atherton
- Department of Cardiology, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
| | - Andrew Maiorana
- Fiona Stanley Hospital, Murdoch, Western Australia, Australia
| | - Harry Klimis
- Westmead Applied Research Centre, The University of Sydney, Westmead, New South Wales, Australia
| | - Craig Juergens
- University of New South Wales, Sydney, New South Wales, Australia
| | - Clara K Chow
- Westmead Applied Research Centre, The University of Sydney, Westmead, New South Wales, Australia
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Malhotra S, Lijnse T, Cearbhaill EO, Brayden DJ. Devices to overcome the buccal mucosal barrier to administer therapeutic peptides. Adv Drug Deliv Rev 2025; 220:115572. [PMID: 40174726 DOI: 10.1016/j.addr.2025.115572] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2024] [Revised: 03/21/2025] [Accepted: 03/24/2025] [Indexed: 04/04/2025]
Abstract
Peptide therapeutics are important in healthcare owing to their high target specificity, therapeutic efficacy, and relatively low side effect profile. Injections of these agents have improved thetreatment of chronic diseases including autoimmune, metabolic disorders, and cancer. However, their administration via injections can prove a barrier to patient acceptability of treatments. While oral delivery of these molecules is preferable, oral peptide formulations are associated with limited bioavailability due to degradation in the intestine and low epithelial permeability. Buccal administration of peptides is a potential alternative to injections and oral formulations. Similar to the oral route, the buccal route can promote better patient adherence to dosing regimens, along with the added advantages of not requiring restriction on food or drink consumption before and after administration, as well as avoidance of the liver first-pass metabolism. However, like oral, effective buccal absorption of peptides is still challenging due to the high epithelial permeability barrier. We present a multidisciplinary approach to understanding the buccal physiological barrier to macromolecule permeation and discuss how engineered devices may overcome it. Selected examples of buccal devices can facilitate fast and efficient macromolecule absorption through multiple mechanisms including physical disruption of epithelia, convection-based mass transfer, and a combination of physicochemical strategies. Importantly, minimally invasive devices can be self-applied and are associated with the maintenance of the barrier after exposure. We analysed the critical attributes that are required forthe clinical translation of buccal peptide administration devices. These include performance-driven device development, manufacturing features, patient acceptability, and commercial viability.
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Affiliation(s)
- Sahil Malhotra
- UCD School of Medicine, University College Dublin (UCD), -Belfield, Dublin 4, Ireland; Research Ireland-CÚRAM Centre for Medical Devices, UCD, Ireland; UCD Conway Institute of Biomolecular and Biomedical Research, UCD-Belfield, Dublin 4, Ireland
| | - Thomas Lijnse
- Research Ireland-CÚRAM Centre for Medical Devices, UCD, Ireland; School of Mechanical and Materials Engineering, UCD, Ireland; UCD Conway Institute of Biomolecular and Biomedical Research, UCD-Belfield, Dublin 4, Ireland
| | - Eoin O' Cearbhaill
- Research Ireland-CÚRAM Centre for Medical Devices, UCD, Ireland; School of Mechanical and Materials Engineering, UCD, Ireland; UCD Conway Institute of Biomolecular and Biomedical Research, UCD-Belfield, Dublin 4, Ireland
| | - David J Brayden
- Research Ireland-CÚRAM Centre for Medical Devices, UCD, Ireland; UCD School of Veterinary Medicine, Ireland; UCD Conway Institute of Biomolecular and Biomedical Research, UCD-Belfield, Dublin 4, Ireland.
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Wang C, Liu X, Lv W, Kuang X, Wu F, Fan X, Pang Y. Long-lasting comfort ocular surface drug delivery by in situ formation of an adhesive lubricative Janus nanocoating. SCIENCE ADVANCES 2025; 11:eads0282. [PMID: 40053587 PMCID: PMC11887845 DOI: 10.1126/sciadv.ads0282] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/26/2024] [Accepted: 02/03/2025] [Indexed: 03/09/2025]
Abstract
Topical drug delivery on ocular surface always suffers from frequent administration and low bioavailability due to short drug residence. Despite advances of different adhesive ophthalmic drugs in extending release, cornea and eyelid nonselective adhesion inevitably causes ocular discomfort and even damage. Here, we describe in situ formation of an adhesive lubricative Janus nanocoating (ALJN) to enable long-lasting comfort drug delivery. By iron complexation, an asymmetric ALJN is formed on ocular surface via facile sequential instillation. The adhesive polyphenol inner layer binding with ocular surface enables drug loading and sustained release, while the lubricative zwitterionic polymer outer layer prevents eyelid adhesion to ensure comfort. Following instillation, ALJN retains on ocular surface over 24 hours and reduces blinking frequency to normal level. Moreover, ALJN demonstrates remarkable therapeutic potential in mouse and rabbit models of corneal contusion and alkali burn. This work proposes a comfortable long-lasting topical delivery platform for treating various ocular diseases.
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Affiliation(s)
- Chuhan Wang
- Department of Ophthalmology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200011, China
- Shanghai Key Laboratory of Orbital Diseases and Ocular Oncology, Center for Basic Medical Research and Innovation in Visual System Diseases, Ministry of Education, Shanghai 200011, China
| | - Xiaobing Liu
- College of Chemistry and Materials Science, Shanghai Normal University, Shanghai 200234, China
- Shanghai Key Laboratory for Nucleic Acid Chemistry and Nanomedicine, Institute of Molecular Medicine, State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Wenyan Lv
- College of Chemistry and Materials Science, Shanghai Normal University, Shanghai 200234, China
- Shanghai Key Laboratory for Nucleic Acid Chemistry and Nanomedicine, Institute of Molecular Medicine, State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Xiao Kuang
- Shanghai Key Laboratory for Nucleic Acid Chemistry and Nanomedicine, Institute of Molecular Medicine, State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Feng Wu
- Shanghai Key Laboratory for Nucleic Acid Chemistry and Nanomedicine, Institute of Molecular Medicine, State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
| | - Xianqun Fan
- Department of Ophthalmology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200011, China
- Shanghai Key Laboratory of Orbital Diseases and Ocular Oncology, Center for Basic Medical Research and Innovation in Visual System Diseases, Ministry of Education, Shanghai 200011, China
| | - Yan Pang
- Department of Ophthalmology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200011, China
- Shanghai Key Laboratory of Orbital Diseases and Ocular Oncology, Center for Basic Medical Research and Innovation in Visual System Diseases, Ministry of Education, Shanghai 200011, China
- Shanghai Frontiers Science Center of Drug Target Identification and Delivery, School of Pharmaceutical Sciences, Shanghai Jiao Tong University, Shanghai 200240, China
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Qiao T, Wen XH. Exploring gut microbiota as a novel therapeutic target in Crohn's disease: Insights and emerging strategies. World J Gastroenterol 2025; 31:100827. [PMID: 39811502 PMCID: PMC11684203 DOI: 10.3748/wjg.v31.i2.100827] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/28/2024] [Revised: 09/30/2024] [Accepted: 11/15/2024] [Indexed: 12/18/2024] Open
Abstract
Extensive research has investigated the etiology of Crohn's disease (CD), encompassing genetic predisposition, lifestyle factors, and environmental triggers. Recently, the gut microbiome, recognized as the human body's second-largest gene pool, has garnered significant attention for its crucial role in the pathogenesis of CD. This paper investigates the mechanisms underlying CD, focusing on the role of 'creeping fat' in disease progression and exploring emerging therapeutic strategies, including fecal microbiota transplantation, enteral nutrition, and therapeutic diets. Creeping fat has been identified as a unique pathological feature of CD and has recently been found to be associated with dysbiosis of the gut microbiome. We characterize this dysbiotic state by identifying key microbiome-bacteria, fungi, viruses, and archaea, and their contributions to CD pathogenesis. Additionally, this paper reviews contemporary therapies, emphasizing the potential of biological therapies like fecal microbiota transplantation and dietary interventions. By elucidating the complex interactions between host-microbiome dynamics and CD pathology, this article aims to advance our understanding of the disease and guide the development of more effective therapeutic strategies for managing CD.
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Affiliation(s)
- Tong Qiao
- Department of Clinical Medicine, Jinan University, Guangzhou 510632, Guangdong Province, China
| | - Xian-Hui Wen
- College of Life Science and Technology, Jinan University, Guangzhou 510632, Guangdong Province, China
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Abe T, Takeda Y, Sakuma I, Okada M, Kurigaki A, Bessho R, Sato M, Kitsunai H, Takiyama Y, Sakurai M. Efficacy of Alogliptin/Metformin Fixed-Dose Combination Tablets and Vildagliptin/Metformin Fixed-Dose Combination Tablets on Glycemic Control in Real-World Clinical Practice for the Patients with Type 2 Diabetes: A Multicenter, Open-Label, Randomized, Parallel Group, Comparative Trial. Metab Syndr Relat Disord 2024; 22:651-660. [PMID: 39421912 DOI: 10.1089/met.2024.0127] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2024] Open
Abstract
Background: This study was aimed to compare the efficacy of two combination tablets of dipeptidyl peptidase-4 (DPP-4) inhibitors and metformin with different dosages, alogliptin/metformin (AM) and vildagliptin/metformin (VM), on glycemic control in patients with type 2 diabetes (T2D). Methods: This was a prospective, multicenter, open-label, randomized, parallel group, comparative trial. After a run-in period of treatment with metformin alone, a total of 59 Japanese outpatients with T2D, aged 20-79 years with glycated hemoglobin (HbA1c) levels of 6.5%-10% were randomly assigned to 12-week AM treatment, alogliptin 25 mg/metformin 500 mg combination tablet orally once a day, or VM treatment, vildagliptin 50 mg/metformin 250 mg combination tablet orally twice a day. The primary endpoints were the changes in HbA1c and fasting plasma glucose (FPG) levels from baseline to week 12 between the two groups. Blinded intermittently scanned continuous glucose monitoring (isCGM) was performed between weeks 10 and 12. The incidence of adverse events during the study was also evaluated. Results: In all, 52 participants were analyzed. Significant decreases in HbA1c and FPG levels from baseline to week 12 were observed in both treatment groups. However, there were no significant differences between the AM and VM groups in the change in HbA1c level (-0.3% and -0.4%, P = 0.309) or the FPG level (-9.0 and -15.0 mg/dL, P = 0.789). The isCGM revealed that both treatments achieved the recommended glycemic target range. No adverse events, such as severe hypoglycemia, were observed in either group. Conclusions: We concluded that there were no significant differences in the efficacy of two combination tablets of DPP-4 inhibitors and metformin with different dosages on glycemic control in patients with T2D.
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Affiliation(s)
- Tomoe Abe
- Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan
- Sapporo Diabetes and Thyroid Clinic, Sapporo, Japan
| | - Yasutaka Takeda
- Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan
- Department of Diabetology and Endocrinology, Kanazawa Medical University, Uchinada, Japan
| | - Ichiro Sakuma
- Caress Sapporo Hokko Memorial Clinic, Sapporo, Japan
| | | | - Ayaka Kurigaki
- Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan
| | - Ryoichi Bessho
- Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan
| | - Mao Sato
- Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan
| | - Hiroya Kitsunai
- Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan
| | - Yumi Takiyama
- Department of Internal Medicine, Asahikawa Medical University, Asahikawa, Japan
| | - Masaru Sakurai
- Department of Social and Environmental Medicine, Kanazawa Medical University, Uchinada, Japan
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Boonpattharatthiti K, Songkla PN, Chantara J, Koomsri C, Krass I, Chaiyakunapruk N, Dhippayom T. Prevalence of adherence to oral antidiabetic drugs in patients with type 2 diabetes: A systematic review and meta-analysis. J Diabetes Investig 2024; 15:1614-1625. [PMID: 39133204 PMCID: PMC11527837 DOI: 10.1111/jdi.14285] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/04/2024] [Revised: 07/06/2024] [Accepted: 07/25/2024] [Indexed: 08/13/2024] Open
Abstract
INTRODUCTION The treatment of type 2 diabetes requires multidimensional management, with medication adherence a crucial aspect of diabetes control. However, recent rigorous estimates of adherence to oral antidiabetic drugs (OAD) are lacking. The objective of this study is to determine the prevalence of adherence to OAD in type 2 diabetes patients. METHODS A systematic search was performed in PubMed, EMBASE, PsycINFO, and CINAHL from July 2013 to April 2023. Cross-sectional studies published in English were included if they met the following criteria: (1) reported the adherence to OAD using a validated measure; and (2) had a sample size of at least 385 patients with type 2 diabetes. The Joanna Briggs Institute critical appraisal for studies reporting prevalence data was used to assess the quality of the included studies. Pooled estimates of the prevalence of adherence to OAD were calculated as a percentage together with 95% confidence interval (95% CI) using a random-effect model. All analyses were conducted using STATA 17.0; PROSPERO (CRD42023414264). RESULTS Twenty-six studies involving a total of 69,366 patients met the selection criteria and were included in the meta-analysis. The overall estimated prevalence of adherence to OAD was 55.53% (95%CI: 44.22%-66.85%). Among the included studies, nine were deemed to be of high quality. A sensitivity analysis conducted using only the high-quality studies revealed a prevalence of adherence to OAD at 52.24% (95% CI: 39.63%-64.85%). CONCLUSIONS The overall prevalence of adherence to OAD was remarkably low among type 2 diabetes patients worldwide. Healthcare practitioners and policy makers should employ appropriate approaches to improve adherence to OAD.
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Affiliation(s)
- Kansak Boonpattharatthiti
- Faculty of Pharmaceutical SciencesBurapha UniversityChon buriThailand
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical SciencesNaresuan UniversityPhitsanulokThailand
| | - Pirune Na Songkla
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical SciencesNaresuan UniversityPhitsanulokThailand
- Department of Clinical PharmacySiriraj Piyamaharajkarun HospitalBangkokThailand
| | - Junpen Chantara
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical SciencesNaresuan UniversityPhitsanulokThailand
- Department of PharmacyNakornmaesot International HospitalTakThailand
| | - Chanchanok Koomsri
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical SciencesNaresuan UniversityPhitsanulokThailand
- Department of Clinical PharmacyChonburi HospitalChon buriThailand
| | - Ines Krass
- School of PharmacyThe University of SydneySydneyNew South WalesAustralia
| | - Nathorn Chaiyakunapruk
- Department of Pharmacotherapy, College of PharmacyUniversity of UtahSalt Lake CityUtahUSA
- IDEAS CenterVeterans Affairs Salt Lake City Healthcare SystemSalt Lake CityUtahUSA
| | - Teerapon Dhippayom
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical SciencesNaresuan UniversityPhitsanulokThailand
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Nam M, Lee JW, Cha GD. Biomedical Application of Enzymatically Crosslinked Injectable Hydrogels. Gels 2024; 10:640. [PMID: 39451293 PMCID: PMC11507637 DOI: 10.3390/gels10100640] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2024] [Revised: 09/28/2024] [Accepted: 10/04/2024] [Indexed: 10/26/2024] Open
Abstract
Hydrogels have garnered significant interest in the biomedical field owing to their tissue-like properties and capability to incorporate various fillers. Among these, injectable hydrogels have been highlighted for their unique advantages, especially their minimally invasive administration mode for implantable use. These injectable hydrogels can be utilized in their pristine forms or as composites by integrating them with therapeutic filler materials. Given their primary application in implantable platforms, enzymatically crosslinked injectable hydrogels have been actively explored due to their excellent biocompatibility and easily controllable mechanical properties for the desired use. This review introduces the crosslinking mechanisms of such hydrogels, focusing on those mediated by horseradish peroxidase (HRP), transglutaminase (TG), and tyrosinase. Furthermore, several parameters and their relationships with the intrinsic properties of hydrogels are investigated. Subsequently, the representative biomedical applications of enzymatically crosslinked-injectable hydrogels are presented, including those for wound healing, preventing post-operative adhesion (POA), and hemostasis. Furthermore, hydrogel composites containing filler materials, such as therapeutic cells, proteins, and drugs, are analyzed. In conclusion, we examine the scientific challenges and directions for future developments in the field of enzymatically crosslinked-injectable hydrogels, focusing on material selection, intrinsic properties, and filler integration.
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Affiliation(s)
| | | | - Gi Doo Cha
- Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Republic of Korea; (M.N.); (J.W.L.)
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Naser YA, Vora LK, Tekko IA, Peng K, Volpe-Zanutto F, Greer B, Paredes A, McCarthy HO, Donnelly RF. Atorvastatin-Loaded Dissolving Microarray Patches for Long-Acting Microdepot Delivery: Comparison of Nanoparticle and Microparticle Drug Formulations. ACS APPLIED MATERIALS & INTERFACES 2024; 16. [PMID: 39356645 PMCID: PMC11492242 DOI: 10.1021/acsami.4c05517] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/04/2024] [Revised: 08/28/2024] [Accepted: 09/01/2024] [Indexed: 10/04/2024]
Abstract
The increasing popularity of prolonged-release dosage forms, owing to their ability to provide continuous drug release after administration, has significantly improved patient compliance and overall quality of life. However, achieving prolonged release beyond 24 h frequently requires the use of invasive methods, including injections or implants, which may prove challenging for people suffering from needle phobia. This study introduces atorvastatin (ATR) microparticles (MPs) or nanocrystal (NCs) dissolving microarray patches (D-MAPs) as a noninvasive alternative for intradermal drug delivery over a two-week period for the management of hyperlipidemia. The MP-loaded D-MAPs exhibited an average drug loading of 5.15 ± 0.4 mg of ATR per patch, surpassing the 2.4 ± 0.11 mg/patch observed with NC-loaded D-MAPs. Skin deposition studies demonstrated the superior performance of MP D-MAPs, which delivered 2.0 ± 0.33 mg of ATR per 0.75 cm2 patch within 24 h, representing 38.76% of the initial amount of drug loaded. In contrast, NC D-MAPs delivered approximately 0.89 ± 0.12 mg of ATR per 0.75 cm2 patch at 24 h, equivalent to 38.42 ± 5.13% of the initial ATR loaded. Due to their favorable results, MP D-MAPs were chosen for an in vivo study using Sprague-Dawley rats. The findings demonstrated the capacity of D-MAPs to deliver and attain therapeutically relevant ATR concentrations (>20 ng/mL) for 14 days after a single 24-h application. This study is the first to successfully demonstrate the long-acting transdermal delivery of ATR using MP-loaded D-MAPs after a 24-h single-dose application. The innovative D-MAP system, particularly when loaded with MP, arises as a promising, minimally invasive, long-acting substitute for ATR delivery. This technology has the potential to improve patient compliance and therapeutic outcomes while also significantly advancing the field of transdermal drug delivery.
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Affiliation(s)
- Yara A. Naser
- School
of Pharmacy, Queen’s University Belfast,
Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, U.K.
| | - Lalitkumar K. Vora
- School
of Pharmacy, Queen’s University Belfast,
Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, U.K.
| | - Ismaiel A. Tekko
- School
of Pharmacy, Queen’s University Belfast,
Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, U.K.
- Department
of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Aleppo University, Aleppo 00 963, Syria
| | - Ke Peng
- School
of Pharmacy, Queen’s University Belfast,
Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, U.K.
| | - Fabiana Volpe-Zanutto
- School
of Pharmacy, Queen’s University Belfast,
Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, U.K.
- School
of Biomedical Sciences, Ulster University, Cromore Road, Coleraine BT52 1SA, Northern Ireland, U.K.
| | - Brett Greer
- Institute
for Global Food Security, School of Biological Science, Queen’s University Belfast, 19 Chlorine Gardens, Belfast BT9 5DL, Northern Ireland, U.K.
| | - Alejandro Paredes
- School
of Pharmacy, Queen’s University Belfast,
Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, U.K.
| | - Helen O. McCarthy
- School
of Pharmacy, Queen’s University Belfast,
Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, U.K.
| | - Ryan F. Donnelly
- School
of Pharmacy, Queen’s University Belfast,
Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, U.K.
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Manickavasagam M, Vakil A, Singh E, Roy H, Lal N, Patel RG, Mishra R, Gudibanda S, Shah S. Real-World Evidence of Dydrogesterone 20 mg and 30 mg SR Usage in Pregnancy. Cureus 2024; 16:e72016. [PMID: 39569237 PMCID: PMC11577976 DOI: 10.7759/cureus.72016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/21/2024] [Indexed: 11/22/2024] Open
Abstract
Background Dydrogesterone, an oral selective progesterone receptor agonist with high bioavailability, has been used since the 1960s to treat various conditions arising due to the deficiency of progesterone. Patients are expected to have additional compliance and reduced pill burden with dydrogesterone 20 mg and 30 mg SR once a day (OD) for conditions requiring 10 mg twice a day (BID) or thrice a day (TID). Methodology A real-world analysis was conducted using the HealthPlix electronic medical records (EMR) database to understand the demography, indications, and prescription patterns of dydrogesterone 20 mg and 30 mg SR, including co-prescriptions. Results The mean age of the female patients prescribed dydrogesterone 20 mg SR was 27.23 ± 4.79 years while those prescribed 30 mg SR had a mean age of 28.56 ± 5.17 years. Common indications for the prescription of dydrogesterone 20 mg SR were pregnancy, infertility, and abortion/miscarriage. Pregnancy, infertility, and amenorrhea were the common conditions for dydrogesterone 30 mg SR prescription. The average duration of prescription of dydrogesterone 20 mg and 30 mg SR was 55.50 ± 31.33 and 79.66 ± 68.38 days, respectively. OD regimen was the preferred regimen for dydrogesterone 20 mg SR (89.48%) and dydrogesterone 30 mg SR (64.06%). Conclusions This analysis suggests dydrogesterone 20 mg and 30 mg SR are being prescribed for various indications in the real world with significant variation in the prescription patterns.
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Affiliation(s)
| | - Ashish Vakil
- Obstetrics and Gynaecology, Vatsalya Hospital and Asha IVF Centre, Una, IND
| | - Ekika Singh
- Obstetrics and Gynaecology, Sharda Narayan Health Care Pvt. Ltd., Mau, IND
| | - Himanshu Roy
- Obstetrics and Gynaecology, Srijan Fertility Clinic Pvt. Ltd., Patna, IND
| | - Nitin Lal
- Obstetrics and Gynaecology, Manan Institute For Fertility and Test Tube Baby Centre Pvt. Ltd., Rajkot, IND
| | - R G Patel
- Obstetrics and Gynaecology, Sunflower Hospital, Infertility and IVF Center, Ahmedabad, IND
| | - Rashi Mishra
- Obstetrics and Gynaecology, Shivani Hospital and IVF Center, Kanpur, IND
| | | | - Snehal Shah
- Manager Insights, HealthPlix Technologies, Bengaluru, IND
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Hirai T, Hanaoka S, Terakado Y, Seki T, Watanabe F. Investigating the effect of prescribing status and patient characteristics on the therapeutic outcomes in patients with diabetes using a leftover drug adjustment protocol. JOURNAL OF PHARMACY & PHARMACEUTICAL SCIENCES : A PUBLICATION OF THE CANADIAN SOCIETY FOR PHARMACEUTICAL SCIENCES, SOCIETE CANADIENNE DES SCIENCES PHARMACEUTIQUES 2024; 27:12886. [PMID: 38915418 PMCID: PMC11195439 DOI: 10.3389/jpps.2024.12886] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 02/22/2024] [Accepted: 05/16/2024] [Indexed: 06/26/2024]
Abstract
Treatment for diabetes includes anti-diabetic medication in addition to lifestyle improvements through diet and exercise. In Japan, protocol-based pharmacotherapy management allows drug treatment to be provided through cooperation between physicians and pharmacists, based on a protocol that is prepared and agreed upon in advance. However, there are no studies to clarify the relationship between patient characteristics and therapeutic effects after pharmacist intervention in protocol-based pharmacotherapy management for patients with diabetes. Therefore, this study aimed to use protocol-based reports from pharmacies to understand the status of outpatient diabetes medication compliance. We classified patients with diabetes on the basis of patient characteristics that can be collected in pharmacies and investigated the characteristics that impacted diabetes treatment. Patients were prescribed oral anti-diabetic drugs at outpatient clinics of Hitachinaka General Hospital, Hitachi, Ltd., from April 2016 to March 2021. Survey items included patient characteristics (sex, age, number of drugs used, observed number of years of anti-diabetic drug prescription, number of anti-diabetic drug prescription days, and presence or absence of leftover anti-diabetic drugs) and HbA1c levels. Graphical analyses indicated the relationship between each categorised patient characteristic using multiple correspondence analyses. Subsequently, the patients were clustered using K-means cluster analysis based on the coordinates obtained for each patient. Patient characteristics and HbA1c values were compared between the groups for each cluster. A total of 1,910 patients were included and classified into three clusters, with clusters 1, 2, and 3 containing 625, 703, and 582 patients, respectively. Patient characteristics strongly associated with Cluster 1 were ages between 65 and 74 years, use of three or more anti-diabetic drugs, use of 3 years or more of anti-diabetic drugs, and leftover anti-diabetic drugs. Furthermore, Cluster 1 had the highest number of patients with worsening HbA1c levels compared with other clusters. Using the leftover drug adjustment protocol, we clarified the patient characteristics that affected the treatment course. We anticipate that through targeted interventions in patients exhibiting these characteristics, we can identify those who are irresponsibly continuing with drug treatment, are not responding well to therapy, or both. This could substantially improve the efficacy of their anti-diabetic care.
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Affiliation(s)
- Toshiyuki Hirai
- Department of Pharmacy, Hitachi, Ltd. Hitachinaka General Hospital, Ibaraki, Japan
| | - Shunsuke Hanaoka
- Laboratory of Pharmacotherapy, School of Pharmacy, Nihon University, Chiba, Japan
| | - Yuusuke Terakado
- Department of Pharmacy, Hitachi, Ltd. Hitachinaka General Hospital, Ibaraki, Japan
| | - Toshiichi Seki
- Department of Pharmacy, Hitachi, Ltd. Hitachinaka General Hospital, Ibaraki, Japan
| | - Fumiyuki Watanabe
- Laboratory of Pharmacy Practice in Primary Care, School of Pharmacy, Nihon University, Chiba, Japan
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Jairoun AA, Al-Hemyari SS, Shahwan M, Jairoun SA, Alorfi NM, Zyoud SH, Suliman AA, Shahwan MK, Alnuaimi G, Shahwan M, Al-Qirim T, El-Dahiyat F. Current Perspectives, Practices, and Barriers Faced by Community Pharmacists Regarding Pharmaceutical Care Services for Diabetes Mellitus in the United Arab Emirates. J Multidiscip Healthc 2024; 17:2563-2576. [PMID: 38803617 PMCID: PMC11129742 DOI: 10.2147/jmdh.s447450] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2023] [Accepted: 03/04/2024] [Indexed: 05/29/2024] Open
Abstract
BACKGROUND Providing accurate and sufficient information is a crucial requirement for delivering effective diabetes care, making it essential for community pharmacists to possess adequate knowledge of diabetes mellitus (DM) and its management. OBJECTIVE To investigate community pharmacists' level of expertise and engagement in providing counseling and health promotion services for individuals with DM in the United Arab Emirates (UAE). METHODS A cross-sectional study design was used. The community Pharmacies were chosen via random sampling and researchers then conducted face-to-face interviews with them using the structured questionnaire. The questionnaire included demographic data, 14 questions on the knowledge and 9 questions about the practice concerning pharmaceutical care for Diabetes Mellitus. RESULTS The average age ± SD was 31 ± 6.3. Of the total 516 community pharmacists recruited in the study, 37.2% (n=192) were male and 62.8% (n=324) were female. The average knowledge score about DM prevention and management was 9.7 with a 95% confidence interval (CI) [9.5, 9.9] and the average practice score about DM prevention and management was 7.1 with a 95% confidence interval (CI) [6.9, 7.2]. Better knowledge scores were observed in chief pharmacists (OR 1.29; 95% CI 1.08-1.56), pharmacists with 6-10 Years of experience (OR 6.92; 95% CI 3.43-8.86), pharmacist with > 10 years of experience (OR 1.99; 95% CI 1.67-2.36), when the number of patients the pharmacist serve is 5-10 (OR 1.27; 95% CI 1.06-1.53) and being trained on DM prevention and management (OR 2.18; 95% CI 1.92-2.47). Similarly, better practice scores were observed in older participants (OR1.02; 95% CI 1.001-1.03), chain pharmacies (OR 1.42; 95% CI 1.20-1.68), chief pharmacists (OR 1.56; 95% CI 1.18-2.06), when the number of patients the pharmacists serve was 5-10 (OR 12.26; 95% CI 7.26-16.19), when the number of patients the pharmacists serve was 11-20 (OR 4.23; 95% CI 3.54-5.06) and being trained on DM prevention and management (OR 1.33; 95% CI 1.11-1.59). The most commonly reported barriers to providing counseling and health promotion services for diabetes mellitus (DM) in community pharmacies include a lack of coordination with other healthcare professionals (77%) and insufficient knowledge or clinical skills (68.7%). CONCLUSION Our study revealed that community pharmacy staff members displayed a noteworthy level of involvement in providing pharmaceutical care services for patients with diabetes mellitus. Based on these findings, it is recommended to enhance pharmacy education by incorporating more advanced, evidence-based training and curricula focusing on disease management and appropriate therapies, particularly for diabetes.
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Affiliation(s)
- Ammar Abdulrahman Jairoun
- Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM), Pulau Pinang, 11500, Malaysia
- Health and Safety Department, Dubai Municipality, Dubai, United Arab Emirates
| | - Sabaa Saleh Al-Hemyari
- Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM), Pulau Pinang, 11500, Malaysia
- Pharmacy Department, Emirates Health Services, Dubai, United Arab Emirates
| | - Moyad Shahwan
- College of Pharmacy and Health Sciences, Ajman University, Ajman, 346, United Arab Emirates
- Centre of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab Emirates
| | - Sumaya Abdulrahman Jairoun
- Department of Clinical Pharmacy & Pharmacotherapeutics, Dubai Pharmacy College for Girls, Al Mizhar Dubai, United Arab Emirates
| | - Nasser M Alorfi
- Pharmacology and Toxicology Department, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia
| | - Sa’ed H Zyoud
- Department of Clinical and Community Pharmacy, College of Medicine and Health Sciences, An-Najah National University, Nablus, 44839, Palestine
- Clinical Research Centre, An-Najah National University Hospital, Nablus, 44839, Palestine
| | - Abdulhaq A Suliman
- Centre of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab Emirates
- College of Dentistry, Ajman University, Ajman, United Arab Emirates
| | - Manar Khalil Shahwan
- College of Pharmacy and Health Sciences, Ajman University, Ajman, 346, United Arab Emirates
- Centre of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab Emirates
| | - Ghala Alnuaimi
- College of Pharmacy and Health Sciences, Ajman University, Ajman, 346, United Arab Emirates
| | - Monzer Shahwan
- Diabetes Clinic, AL-Swity Center for Dermatology and Chronic Diseases, Ramallah, 972, Palestine
| | - Tariq Al-Qirim
- Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, 11733, Jordan
| | - Faris El-Dahiyat
- Clinical Pharmacy Program, College of Pharmacy, Al Ain University, Al Ain, 64141, United Arab Emirates
- AAU Health and Biomedical Research Center, Al Ain University, Abu Dhabi, 112612, United Arab Emirates
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Rocholl C, Zablotski Y, Schulz B. Online-Assisted Survey on Antibiotic Use by Pet Owners in Dogs and Cats. Antibiotics (Basel) 2024; 13:382. [PMID: 38786111 PMCID: PMC11117295 DOI: 10.3390/antibiotics13050382] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2024] [Revised: 04/19/2024] [Accepted: 04/22/2024] [Indexed: 05/25/2024] Open
Abstract
The aim of the study was two-fold: first, to collect data on the use of antibiotics in Germany for dogs and cats and, second, their owners' experiences and opinions. Using an anonymous online survey, dog and cat owners were asked about the last antibiotic administration in their pet. The inclusion criterion was any antibiotic administration within the last year. A total of 708 questionnaires from 463 dogs and 245 cats could be evaluated. Diarrhea was reported as the most common reason for antibiotic administration in dogs (18.4%). Wound infection/abscess/bite injury was the second most common reason in dogs (16.0%). In cats wound infection/abscess/bite injury was the most common reason (23.3%), followed by dental treatment (21.2%) and upper respiratory tract infections (16.7%). The most common antibiotics used systemically in both species were amoxicillin/clavulanic acid (32.5%), amoxicillin (14.8%), metronidazole (6.9%), and doxycycline (6.8%). While efficacy (99.9%) and tolerability (94.8%) were rated as most important for the choice of antibiotics, costs (51.6%) were cited as predominantly unimportant. First-line antibiotics were used significantly more often than critically important antibiotics. The majority of animal owners show awareness for avoidance of antibiotic resistance and the use of critically important antibiotics.
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Affiliation(s)
- Clara Rocholl
- Clinic of Small Animal Medicine, Centre for Clinical Veterinary Medicine, Ludwig Maximilian University of Munich, 80539 Munich, Germany
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Shiomi M, Takada T, Otori K, Shibuya K. Frequency of missed doses and its effects on the regulation of glucose levels in patients with type 2 diabetes: A retrospective analysis. Medicine (Baltimore) 2024; 103:e37711. [PMID: 38608082 PMCID: PMC11018172 DOI: 10.1097/md.0000000000037711] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2023] [Accepted: 03/04/2024] [Indexed: 04/14/2024] Open
Abstract
This study aimed to investigate the association between medication adherence to oral hypoglycemic agents (OHAs) and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) for more than 48 weeks, as well as the factors affecting long-term adherence to OHAs. This retrospective study included 83 patients who had been receiving OHAs for T2DM for ≥48 weeks. Medication adherence values (MAVs) were calculated using the following formula: (total prescription days - prescription days of OHAs brought at admission)/(days from the initiation of OHAs to hospitalization). We assessed the association between HbA1c and MAVs using the Jonckheere-Terpstra test. Furthermore, we examined the association between patient- and medication-related factors and MAVs affecting HbA1c levels. Based on the results, MAVs were categorized as MAV ≤0.86 and MAV >0.86, and factors affecting MAVs were analyzed. Logistic regression analysis revealed that the total number of medications, the number of nonhypoglycemic agents, and a family history of diabetes were independent determinants of MAV ≤0.86 (P < .05). Multiple regression analyses indicated that the number of dosages per day and the timing of OHA administration at lunch were independent determinants of lower MAVs (P < .05). Our findings suggest that poor medication adherence is associated with elevated HbA1c levels in T2DM patients. Independent factors contributing to poor adherence include a lower number of prescribed medications, fewer nonhypoglycemic agents, no family history, a higher daily dosage frequency, and the administration of OHAs at lunch.
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Affiliation(s)
- Megumi Shiomi
- Department of Clinical Pharmacy, School of Pharmacy, Kitasato University, Tokyo, Japan
- Department of Pharmacy, Kitasato University Medical Center, Kitamoto, Japan
| | - Tesshu Takada
- Department of Endocrinology, Diabetes, and Metabolism, School of Medicine, Kitasato University, Sagamihara, Japan
| | - Katsuya Otori
- Department of Clinical Pharmacy, School of Pharmacy, Kitasato University, Tokyo, Japan
- Department of Pharmacy, Kitasato University Medical Center, Kitamoto, Japan
| | - Kiyoshi Shibuya
- Department of Clinical Pharmacy, School of Pharmacy, Kitasato University, Tokyo, Japan
- Department of Pharmacy, Kitasato University Medical Center, Kitamoto, Japan
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Smalls BL, Kruse-Diehr A, Ortz CL, Douthitt K, McLouth C, Shelton R, Taylor Z, Williams E. Older adults using social support to improve self-care (OASIS): Adaptation, implementation and feasibility of peer support for older adults with T2D in appalachia: A feasibility study protocol. PLoS One 2024; 19:e0300196. [PMID: 38498512 PMCID: PMC10947915 DOI: 10.1371/journal.pone.0300196] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2024] [Accepted: 02/21/2024] [Indexed: 03/20/2024] Open
Abstract
INTRODUCTION The prevalence of type 2 diabetes (T2D) is 17% higher in rural dwellers compared to their urban counterparts, and it increases with age, with an estimated 25% of older adults (≥ 65 years) diagnosed. Appropriate self-care is necessary for optimal clinical outcomes. Overall, T2D self-care is consistently poor among the general population but is even worse in rural-dwellers and older adults. In rural Kentucky, up to 23% of adults in Appalachian communities have been diagnosed with T2D and, of those, 26.8% are older adults. To attain optimal clinical outcomes, social environmental factors, including social support, are vital when promoting T2D self-care. Specifically, peer support has shown to be efficacious in improving T2D self-care behaviors and clinical and psychosocial outcomes related to T2D; however, literature also suggests self-selected social support can be obstructive when engaging in healthful activities. Currently available evidence-based interventions (EBIs) using peer support have not been used to prioritize older adults, especially those living in rural communities. METHOD To address this gap, we conducted formative research with stakeholders, and collaboratively identified an acceptable and feasible peer support EBI-peer health coaching (PHC)-that has resulted in improved clinical and psychosocial T2D-related outcomes among participants who did not reside in rural communities nor were ≥65 years. The goal of the proposed study is to use a 2x2 factorial design to test the adapted PHC components and determine their preliminary effectiveness to promote self-care behaviors and improve glycemic control among older adults living in Appalachian Kentucky. Testing the PHC components of the peer support intervention will be instrumental in promoting care for older adults in Appalachia, as it will allow for a larger scale intervention, which if effective, could be disseminated to community partners in Appalachia. TRIAL REGISTRATION This study was registered at www.clinicaltrials.gov (NCT06003634) in August 2023.
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Affiliation(s)
- Brittany L. Smalls
- Department of Family and Community Medicine, College of Medicine, University of Kentucky, Lexington, KY, United States of America
| | - Aaron Kruse-Diehr
- Department of Family and Community Medicine, College of Medicine, University of Kentucky, Lexington, KY, United States of America
| | - Courtney L. Ortz
- Department of Family and Community Medicine, College of Medicine, University of Kentucky, Lexington, KY, United States of America
| | - Key Douthitt
- Department of Family and Community Medicine, College of Medicine, University of Kentucky, Lexington, KY, United States of America
| | - Christopher McLouth
- Department of Biostatistics, College of Public Health, University of Kentucky, Lexington, KY, United States of America
| | - Rachel Shelton
- Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, United States of America
| | - Zoe Taylor
- Department of Family and Community Medicine, College of Medicine, University of Kentucky, Lexington, KY, United States of America
| | - Edith Williams
- Center for Community Health and Prevention, School of Medicine and Dentistry, University of Rochester, Rochester, NY, United States of America
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Boonpattharatthiti K, Saensook T, Neelapaijit N, Sakunrag I, Krass I, Dhippayom T. The prevalence of adherence to insulin therapy in patients with diabetes: A systematic review and meta-analysis. Res Social Adm Pharm 2024; 20:255-295. [PMID: 38104019 DOI: 10.1016/j.sapharm.2023.11.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2023] [Revised: 11/14/2023] [Accepted: 11/29/2023] [Indexed: 12/19/2023]
Abstract
BACKGROUND Adherence to insulin therapy is crucial to achieving good glycemic control for patients with type 1 diabetes (T1D) or type 2 diabetes (T2D). A comprehensive estimation of adherence to insulin therapy in patients with diabetes is currently lacking. OBJECTIVE To explore the prevalence of adherence to insulin therapy in patients with both T1D and T2D. METHODS A systematic search was performed using the following databases: PubMed, EMBASE, Cochrane CENTRAL, and ProQuest Dissertation and Theses from the inception of each database to August 2023. Cross-sectional studies were included if they met the following criteria: (1) conducted in patients with T1D or T2D; (2) reported adherence to insulin therapy. The Joanna Briggs Institute (JBI) critical appraisal checklist for studies reporting prevalence data was used to assess the quality of included studies. Pooled estimates of the prevalence of adherence to insulin were calculated as a percentage together with a 95 % confidence interval (95%CI) using a random-effect model. All analyses were conducted using STATA 15 (College Station, Texas, United States); PROSPERO (CRD42022322323). RESULTS Search results yielded 14,914 articles, of these 57 studies with a total of 125,241 patients met the inclusion criteria. The overall estimated prevalence of adherence to insulin therapy in both types of diabetes was 55.37 % (95%CI: 48.55 %-62.19 %). The adherence for T1D was 52.63 % (95 % CI: 37.37 %-67.87 %), whereas the adherence for T2D was 52.55 % (95 % CI: 43.08 %-62.01 %). The prevalence of adherence in lower middle-income countries was 56.79 % (95 % CI: 27.85 %-85.74 %). CONCLUSIONS The overall prevalence of adherence to insulin therapy was remarkably low. This requires attention from healthcare practitioners and policymakers to implement appropriate strategic approaches to improve adherence to insulin therapy.
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Affiliation(s)
- Kansak Boonpattharatthiti
- Faculty of Pharmaceutical Sciences, Burapha University, Chon Buri, Thailand; The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
| | - Thitinan Saensook
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; Department of Pharmacy, Navamin 9 Hospital, Bangkok, Thailand.
| | - Nipaporn Neelapaijit
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; Department of Pharmacy, Navamin 9 Hospital, Bangkok, Thailand.
| | - Itsarawan Sakunrag
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
| | - Ines Krass
- School of Pharmacy, University of Sydney, Sydney, NSW, Australia.
| | - Teerapon Dhippayom
- The Research Unit of Evidence Synthesis (TRUES), Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
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Kim JH, Lee Y, Kim DY, Kim S, Seo SS, Kang S, Park SY, Lim MC. Adherence of PARP inhibitor for frontline maintenance therapy in primary epithelial ovarian cancer: a cross-sectional survey. J Gynecol Oncol 2024; 35:e3. [PMID: 37681357 PMCID: PMC10792206 DOI: 10.3802/jgo.2024.35.e3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2023] [Revised: 05/22/2023] [Accepted: 08/13/2023] [Indexed: 09/09/2023] Open
Abstract
OBJECTIVE To identify the adherence rate to poly (ADP-ribose) polymerase (PARP) inhibitors and identify factors contributing to the deterioration of adherence at our institution. METHODS The adherence rate to PARP inhibitors was calculated using self-reported Adherence to Refills and Medications Scale questionnaires from a cross-sectional survey. Multivariable logistic regression analysis was performed to identify the factors that affected adherence. RESULTS Of the 131 respondents, 32 (24.4%) showed non-adherence to PARP inhibitors. In the multivariable logistic regression analysis, unemployed or retired status (odds ratio [OR]=4.878; 95% confidence interval [CI]=1.528-15.572; p=0.008), patients receiving niraparib (OR=3.387; 95% CI=1.283-8.940; p=0.014), and a lower score on the quality-of-life assessment (EORTC-QLQ-OV28), which reflects a better quality of life (QOC) with a lower symptom burden (OR=1.056; 95% CI=1.027-1.086; p<0.001) were associated with high adherence to PARP inhibitors. CONCLUSION Approximately one-fourth of patients with ovarian cancer are non-adherent to PARP inhibitors as maintenance treatment for newly diagnosed advanced ovarian cancer. The occupational status, type of PARP inhibitor, and QOC may affect adherence to PARP inhibitors.
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Affiliation(s)
- Ji Hyun Kim
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
| | - Yumi Lee
- Department of Nursing, Pukyong National University, Busan, Korea
| | - Da-Young Kim
- Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea
| | - Sinae Kim
- Biostatistics Collaboration Team, Research Core Center, National Cancer Center, Goyang, Korea
| | - Sang-Soo Seo
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
| | - Sokbom Kang
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
| | - Sang-Yoon Park
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
| | - Myong Cheol Lim
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
- Rare & Pediatric Cancer Branch and Immuno-oncology Branch, Division of Rare and Refractory Cancer, Research Institute, National Cancer Center, Goyang, Korea
- Center for Clinical Trial, Hospital, National Cancer Center, Goyang, Korea.
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Builes-Montaño C, Wandurraga E, Ramírez A, Ordóñez JE. Simplification of Complex Insulin Regimens with IdegLira in People with Type 2 Diabetes: Literature Review and Clinical Recommendations. Diabetes Ther 2023; 14:1959-1976. [PMID: 37736786 PMCID: PMC10570232 DOI: 10.1007/s13300-023-01471-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/21/2023] [Accepted: 08/31/2023] [Indexed: 09/23/2023] Open
Abstract
INTRODUCTION This study developed a simple algorithm based on clinical results described in medical literature and which allows one to simplify complex insulin regimes with IdegLira to avoid adverse events related to the complexity of some insulin treatments. METHODS We conducted a systematic review of the literature that allowed us to identify studies that evaluated the clinical result of simplifying complex insulin regimes. The authors reviewed the common factors these simpler regimes had, including the type of patients who used them. RESULTS We found nine clinical studies published between 2017 and 2022, eight performed in Europe and one in Latin America. The monitoring time of the studies ranged between 3 and 18 months. The size of the study populations was between 61 and 611 patients (the latter was in five countries). In all studies, HbA1c decreased by 0.6-1.7% and the weight decreased by 0.1-3.11 kg. CONCLUSIONS On the basis of the findings of these studies, we made some recommendations for clinical practice to simplify treatment. The results of these studies support an algorithm that simplifies the treatment of complex insulin regimens.
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Affiliation(s)
- C Builes-Montaño
- University of Antioquia Faculty of Medicine, Medellin, Colombia
- Hospital Pablo Tobón Uribe, Medellín, Antioquia, Colombia
| | - E Wandurraga
- Universidad Autónoma de Bucaramanga, Bucaramanga, Colombia
| | - A Ramírez
- Universidad Pontificia Bolivariana, Medellín, Antioquia, Colombia
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Gowen R, Gamal A, Di Martino L, McCormick TS, Ghannoum MA. Modulating the Microbiome for Crohn's Disease Treatment. Gastroenterology 2023; 164:828-840. [PMID: 36702360 PMCID: PMC10152883 DOI: 10.1053/j.gastro.2023.01.017] [Citation(s) in RCA: 24] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/28/2022] [Revised: 12/12/2022] [Accepted: 01/06/2023] [Indexed: 01/28/2023]
Abstract
The central role of the gut microbiota in the regulation of health and disease has been convincingly demonstrated. Polymicrobial interkingdom interactions between bacterial (the bacteriome) and fungal (the mycobiome) communities of the gut have become a prominent focus for development of potential therapeutic approaches. In addition to polymicrobial interactions, the complex gut ecosystem also mediates interactions between the host and the microbiota. These interactions are complex and bidirectional; microbiota composition can be influenced by host immune response, disease-specific therapeutics, antimicrobial drugs, and overall ecosystems. However, the gut microbiota also influences host immune response to a drug or therapy by potentially transforming the drug's structure and altering bioavailability, activity, or toxicity. This is especially true in cases where the gut microbiota has produced a biofilm. The negative ramifications of biofilm formation include alteration of gut permeability, enhanced antimicrobial resistance, and alteration of host immune response effectiveness. Natural modulation of the gut microbiota, using probiotic and prebiotic approaches, may also be used to affect the host microbiome, a type of "natural" modulation of the host microbiota composition. In this review, we discuss potential bidirectional interactions between microbes and host, and we describe the changes in gut microbiota induced by probiotic and prebiotic approaches as well as their potential clinical consequences, including biofilm formation. We outline a systematic approach to designing probiotics capable of altering the host microbiota in disease states, using Crohn's disease as a model chronic disease. Understanding how the effective changes in the microbiome may enhance treatment efficacy may unlock the possibility of modulating the gut microbiome to improve treatment using a natural approach.
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Affiliation(s)
- Rachael Gowen
- Department of Dermatology, Case Western Reserve University, Cleveland, Ohio; University Hospitals Cleveland Medical Center, Cleveland, Ohio
| | - Ahmed Gamal
- Department of Dermatology, Case Western Reserve University, Cleveland, Ohio; University Hospitals Cleveland Medical Center, Cleveland, Ohio
| | - Luca Di Martino
- University Hospitals Cleveland Medical Center, Cleveland, Ohio; Department of Medicine, Case Western Reserve University, Cleveland, Ohio; Case Digestive Health Research Institute, Case Western Reserve University, Cleveland Ohio
| | - Thomas S McCormick
- Department of Dermatology, Case Western Reserve University, Cleveland, Ohio; University Hospitals Cleveland Medical Center, Cleveland, Ohio
| | - Mahmoud A Ghannoum
- Department of Dermatology, Case Western Reserve University, Cleveland, Ohio; University Hospitals Cleveland Medical Center, Cleveland, Ohio.
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Naser YA, Tekko IA, Vora LK, Peng K, Anjani QK, Greer B, Elliott C, McCarthy HO, Donnelly RF. Hydrogel-forming microarray patches with solid dispersion reservoirs for transdermal long-acting microdepot delivery of a hydrophobic drug. J Control Release 2023; 356:416-433. [PMID: 36878320 DOI: 10.1016/j.jconrel.2023.03.003] [Citation(s) in RCA: 33] [Impact Index Per Article: 16.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2022] [Revised: 02/24/2023] [Accepted: 03/02/2023] [Indexed: 03/08/2023]
Abstract
Hydrogel-forming microarray patches (HF-MAPs) are used to circumvent the skin barrier and facilitate the noninvasive transdermal delivery of many hydrophilic substances. However, their use in the delivery of hydrophobic agents is a challenging task. This work demonstrates, for the first time, the successful transdermal long-acting delivery of the hydrophobic atorvastatin (ATR) via HF-MAPs using poly(ethylene)glycol (PEG)-based solid dispersion (SD) reservoirs. PEG-based SDs of ATR were able to completely dissolve within 90 s in vitro. Ex vivo results showed that 2.05 ± 0.23 mg of ATR/0.5 cm2 patch was delivered to the receiver compartment of Franz cells after 24 h. The in vivo study, conducted using Sprague Dawley rats, proved the versatility of HF-MAPs in delivering and maintaining therapeutically-relevant concentrations (> 20 ng·mL-1) of ATR over 14 days, following a single HF-MAP application for 24 h. The long-acting delivery of ATR suggests the successful formation of hydrophobic microdepots within the skin, allowing for the subsequent sustained delivery as they gradually dissolve over time, as shown in this work. When compared to the oral group, the use of the HF-MAP formulation improved the overall pharmacokinetics profile of ATR in plasma, where significantly higher AUC values resulting in ∼10-fold higher systemic exposure levels were obtained. This novel system offers a promising, minimally-invasive, long-acting alternative delivery system for ATR that is capable of enhancing patient compliance and therapeutic outcomes. It also proposes a unique promising platform for the long-acting transdermal delivery of other hydrophobic agents.
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Affiliation(s)
- Yara A Naser
- School of Pharmacy, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, UK
| | - Ismaiel A Tekko
- School of Pharmacy, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, UK; Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Aleppo University, Aleppo, Syria
| | - Lalitkumar K Vora
- School of Pharmacy, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, UK
| | - Ke Peng
- School of Pharmacy, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, UK
| | - Qonita K Anjani
- School of Pharmacy, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, UK
| | - Brett Greer
- Institute for Global Food Security, School of Biological Science, Queen's University Belfast, 19 Chlorine Gardens, Belfast BT9 5DL, UK
| | - Christopher Elliott
- Institute for Global Food Security, School of Biological Science, Queen's University Belfast, 19 Chlorine Gardens, Belfast BT9 5DL, UK
| | - Helen O McCarthy
- School of Pharmacy, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, UK
| | - Ryan F Donnelly
- School of Pharmacy, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast BT9 7BL, UK.
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20
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Emonena H, Ojo O. The Efficacy of Tele-Monitoring in Maintaining Glycated Haemoglobin Levels in Patients with Type 2 Diabetes Mellitus: A Systematic Review. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2022; 19:16722. [PMID: 36554601 PMCID: PMC9779018 DOI: 10.3390/ijerph192416722] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 11/15/2022] [Revised: 12/08/2022] [Accepted: 12/11/2022] [Indexed: 06/17/2023]
Abstract
BACKGROUND It is well documented that telemedicine offers effective accessibility and consistency which are useful in overcoming the barriers associated with the traditional delivery of chronic disease management. Furthermore, home-based telemonitoring approach for managing chronic disease conditions has been shown to break geographical barriers and facilitate provider-to-patient communication. However, the efficacy of telemedicine in reducing HbA1c is debatable. AIM This systematic review aims to evaluate the effect of telemedicine on glycaemic control in patients with type 2 diabetes. METHOD This systematic review has been conducted in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. Searches were primarily conducted using the EBSCOhost database. Other search engines such as Cochrane Library and Google scholar were also used and search of grey literature was performed using google, NHS.uk website, WHO websites, and gov.uk website. Nine articles were included in this review. RESULTS Three themes were identified in this review including diabetes education/telemonitoring technology and glycaemic control, the attitude of participants, and cost effectiveness of tele-medicine. While three studies reported improved glycaemic control with statistically significant improvement in HbA1c compared to the control group, three other studies did not find significant improvement in glycaemic control. In addition, the findings suggest that participants' positive attitude to self-care can lead to an improved HbA1c, and finally, several of the selected studies found that telemonitoring is not cost-effective. CONCLUSION The findings of this review show that telemedicine may be effective in managing blood glucose in patients with type 2 diabetes. However, factors such as educational level of patients, attitude and costs may limit its application in primary care. More studies are required to fully establish the effectiveness of Telemonitoring in managing patients with type 2 diabetes.
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Affiliation(s)
- Hope Emonena
- Woodlands Health Centre, 4, Edwin Hall Place, Hither Green Lane, London SE13 6RN, UK
| | - Omorogieva Ojo
- School of Health Sciences, Avery Hill Campus, University of Greenwich, Avery Hill Road, London SE9 2UG, UK
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21
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Physician influence on medication adherence, evidence from a population-based cohort. PLoS One 2022; 17:e0278470. [PMID: 36454907 PMCID: PMC9714848 DOI: 10.1371/journal.pone.0278470] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2022] [Accepted: 11/16/2022] [Indexed: 12/03/2022] Open
Abstract
BACKGROUND The overall impact of physician prescribers on population-level adherence rates are unknown. We aimed to quantify the influence of general practitioner (GP) physician prescribers on the outcome of optimal statin medication adherence. METHODS We conducted a retrospective cohort study using health administrative databases from Saskatchewan, Canada. Participants included physician prescribers and their patients beginning a new statin medication between January 1, 2012 and December 31, 2017. We grouped prescribers based on the prevalence of optimal adherence (i.e., proportion of days covered ≥ 80%) within their patient group. Also, we constructed multivariable logistic regression analyses on optimal statin adherence using two-level non-linear mixed-effects models containing patient and prescriber-level characteristics. An intraclass correlation coefficient was used to estimate the physician effect. RESULTS We identified 1,562 GPs prescribing to 51,874 new statin users. The median percentage of optimal statin adherence across GPs was 52.4% (inter-quartile range: 35.7% to 65.5%). GP prescribers with the highest patient adherence (versus the lowest) had patients who were older (median age 61.0 vs 55.0, p<0.0001) and sicker (prior hospitalization 39.4% vs 16.4%, p<0.001). After accounting for patient-level factors, only 6.4% of the observed variance in optimal adherence between patients could be attributed to GP prescribers (p<0.001). The majority of GP prescriber influence (5.2% out of 6.4%) was attributed to the variance unexplained by patient and prescriber variables. INTERPRETATION The overall impact of GP prescribers on statin adherence appears to be very limited. Even "high-performing" physicians face significant levels of sub-optimal adherence among their patients.
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22
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Tekale S, Varma A, Tekale S, Kumbhare U. A Review on Newer Interventions for the Prevention of Diabetic Foot Disease. Cureus 2022; 14:e30591. [PMID: 36426316 PMCID: PMC9682366 DOI: 10.7759/cureus.30591] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/01/2022] [Accepted: 10/22/2022] [Indexed: 11/05/2022] Open
Abstract
Diabetic foot disease (DFD), which includes ulcers on the foot, infections, and gangrene of the foot, is one of the leading causes of disability worldwide. About half of diabetic foot disease (DFD) patients have a recurrence in less than a year. To alleviate the burden of DFD globally, it is essential to give long-term medication to reduce the likelihood of recurrence. The effectiveness of telemedicine, wearable technologies, and sensors in DFD prevention is discussed in this review. Offloading footwear helps to cure and prevent ulcerated diabetic foot by distributing physical stress away from bony prominences. Sensors and wearables can record the temperatures of the foot, blood pressure (BP), and blood sugar levels and estimate lipid profile. These technologies have offered a practical means of reaching individuals in rural areas with a heightened risk of developing DFD. There is less need for in-person consultations with this strategy. This methodology is simple to operate and lessens reliance on patients. The benefits of adopting these remote monitoring approaches have been demonstrated in some studies with DFD-at-risk individuals. It is required to do more analysis to ascertain the effectiveness and value of incorporating different remote monitoring systems as part of an all-encompassing strategy to prevent DFD.
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Affiliation(s)
- Sanket Tekale
- Department of Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences (Deemed to be University), Wardha, IND
| | - Anuj Varma
- Department of Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences (Deemed to be University), Wardha, IND
| | - Shubhangi Tekale
- Department of Pathology, Dr. Ulhas Patil Medical College and Hospital, Jalgaon, IND
| | - Unnati Kumbhare
- Department of Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences (Deemed to be University), Wardha, IND
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23
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Rice JD, Johnson BA, Strawderman RL. Screening for chronic diseases: optimizing lead time through balancing prescribed frequency and individual adherence. LIFETIME DATA ANALYSIS 2022; 28:605-636. [PMID: 35739436 DOI: 10.1007/s10985-022-09563-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/06/2021] [Accepted: 06/07/2022] [Indexed: 06/15/2023]
Abstract
Screening for chronic diseases, such as cancer, is an important public health priority, but traditionally only the frequency or rate of screening has received attention. In this work, we study the importance of adhering to recommended screening policies and develop new methodology to better optimize screening policies when adherence is imperfect. We consider a progressive disease model with four states (healthy, undetectable preclinical, detectable preclinical, clinical), and overlay this with a stochastic screening-behavior model using the theory of renewal processes that allows us to capture imperfect adherence to screening programs in a transparent way. We show that decreased adherence leads to reduced efficacy of screening programs, quantified here using elements of the lead time distribution (i.e., the time between screening diagnosis and when diagnosis would have occurred clinically in the absence of screening). Under the assumption of an inverse relationship between prescribed screening frequency and individual adherence, we show that the optimal screening frequency generally decreases with increasing levels of non-adherence. We apply this model to an example in breast cancer screening, demonstrating how accounting for imperfect adherence affects the recommended screening frequency.
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Affiliation(s)
- John D Rice
- Department of Biostatistics and Informatics, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA
| | - Brent A Johnson
- Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA
| | - Robert L Strawderman
- Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.
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24
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Al-Qahtani KM, Aldeeri IA, Alshaibi AM, Alshabib NS, Barghouthi RM, Alyusuf EY, Jammah AA. Optimal Timing of Thyroid Hormone Replacement During Ramadan Fasting: A Randomized Controlled Trial in Patients with Prior Total Thyroidectomy. Thyroid 2022; 32:1029-1036. [PMID: 35708106 DOI: 10.1089/thy.2022.0110] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
Background: Fasting during Ramadan may be challenging for patients on levothyroxine (LT4), as the drug has a narrow therapeutic index and is administered on an empty stomach. The majority of Muslims who fast in Ramadan have two meals per day, iftar immediately after sunset and suhoor just before dawn. This study aimed at evaluating the impact of LT4 timing during Ramadan on thyrotropin (TSH) levels in patients who underwent total thyroidectomy to determine the best timing for intake and identify the predictors of TSH level changes. Methods: We conducted a parallel, double-blind, randomized controlled trial on Saudi patients diagnosed with hypothyroidism who underwent total thyroidectomy. Patients were required to have stable thyroid function for 6 months before the study period and fast ≥20 days of Ramadan. Participants were randomized to one of three times for LT4 administration: Group A, 30 minutes pre-iftar (n = 48); Group B, 3 hours post-iftar (n = 47); or Group C, 1 hour pre-suhoor (n = 47). The number of participants in the final analysis (excluding patients who dropped out) was as follows: Group A, (n = 31); Group B, (n = 34); and Group C, (n = 22). The changes in TSH and free thyroxine (fT4) levels two weeks before and after Ramadan were compared. Factors associated with a change in TSH levels were examined through multivariable analysis. Results: The TSH levels significantly increased in Group B (1.7 ± 1.8 mU/L vs. 3.1 ± 3.9 mU/L, p = 0.003) and Group C (2 ± 1.7 mU/L vs. 5.5 ± 10 mU/L, p = 0.011), but not Group A (1.8 ± 1.6 mU/L vs. 3.3 ± 4.2 mU/L, p = 0.158). The change in fT4 levels was comparable among the groups: Group A, 16.5 ± 2.7 mcg/dL vs. 15.9 ± 3.2 mcg/dL, p = 0.144; Group B, 15.8 ± 3.8 mcg/dL vs. 16.3 ± 3.6 mcg/dL, p = 0.620; and Group C, 17.5 ± 2.8 mcg/dL vs. 17.3 ± 3.9 mcg/dL, p = 0.770. In multivariable linear regression analysis, the following variables were significantly independently associated with TSH level change: age, weight gain, and the number of nonadherence days to LT4, where β = -0.2, p = 0.026; β = + 0.2, p = 0.026; and β = + 0.5, p < 0.0001, respectively. Conclusions: Fasting patients who took LT4 pre-iftar did not experience significant changes in TSH, whereas those who took LT4 post-iftar or pre-suhoor did. The TSH changes during Ramadan may be associated with age (inverse association), weight gain, and the number of non-adherence to LT4 days. Trial Registration: SCTR Application no. 21122002.
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Affiliation(s)
| | | | - Amal M Alshaibi
- College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | | | - Rakan M Barghouthi
- Department of Family Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Ebtihal Y Alyusuf
- Division of Endocrinology, Department of Internal Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Anwar Ali Jammah
- Division of Endocrinology, Department of Internal Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia
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25
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Yamazaki S, Takano T, Tachibana K, Takeda S, Terauchi Y. Comparison of the Effectiveness of Once-Daily Alogliptin/Metformin and Twice-Daily Anagliptin/Metformin Combination Tablet in a Randomized, Parallel-Group, Open-Label Trial in Japanese Patients with Type 2 Diabetes. Diabetes Ther 2022; 13:1559-1569. [PMID: 35793047 PMCID: PMC9309109 DOI: 10.1007/s13300-022-01292-2] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2022] [Accepted: 06/20/2022] [Indexed: 11/28/2022] Open
Abstract
INTRODUCTION The combination tablets of dipeptidyl peptidase-4 (DPP-4) inhibitors and metformin are used for both once-daily and twice-daily agents in Japan. If there is no difference in effectiveness between the once-daily and twice-daily DPP-4 inhibitor/metformin combination tablets, the once-daily agent is advantageous in terms of frequency of administration. The aim of this study was to compare the effectiveness of once-daily alogliptin/metformin combination tablet (alogliptin 25 mg/metformin 500 mg) and twice-daily anagliptin/metformin combination tablet low dose (LD) (anagliptin 100 mg/metformin 250 mg). METHODS Forty-eight Japanese patients with type 2 diabetes whose metformin administration of 250 mg twice daily had remained unchanged for at least 8 weeks, except when using DPP-4 inhibitors, glucagon-like peptide-1 receptor agonists, or insulin, were randomized to either the once-daily alogliptin/metformin combination tablet group or the twice-daily anagliptin/metformin combination tablet LD group. The primary endpoint was the difference in glycosylated hemoglobin (HbA1c) levels from baseline to week 12 of administration, whereas the secondary endpoints were fasting blood glucose, body mass index (BMI), and adherence. RESULTS Forty-four patients completed the study, and intention-to-treat analyses were performed. The adjusted mean value (standard error) for the change in HbA1c from week 0 to 12, was - 0.75 (0.109)% for the once-daily alogliptin/metformin combination tablet group and - 0.65 (0.109)% for the twice-daily anagliptin/metformin combination tablet LD group, with an intergroup difference of - 0.10% (95% confidence interval, CI - 0.407, 0.215). The upper limit of the bilateral 95% CI was 0.215%, below the 0.40% pre-defined as the non-inferiority margin. Fasting blood glucose, BMI, and adherence were not significantly different between the groups. CONCLUSIONS The once-daily alogliptin/metformin combination tablet was non-inferior to the twice-daily anagliptin/metformin combination tablet LD in Japanese patients with type 2 diabetes. TRIAL REGISTRATION University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR) (registration number: UMIN000034951).
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Affiliation(s)
- Shunsuke Yamazaki
- Department of Diabetes and Endocrinology, Fujisawa City Hospital, Fujisawa, Japan.
- Fujisawa Ekimae Diabetes and Thyroid Clinic, Shotoen Bldg 1F, 600, Fujisawa, Fujisawa-shi, Kanagawa, 251-0052, Japan.
- Department of Endocrinology and Metabolism, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
| | - Tatsuro Takano
- Department of Diabetes and Endocrinology, Fujisawa City Hospital, Fujisawa, Japan
| | - Koji Tachibana
- Department of Diabetes and Endocrinology, Fujisawa City Hospital, Fujisawa, Japan
| | - Soichiro Takeda
- Department of Diabetes and Endocrinology, Fujisawa City Hospital, Fujisawa, Japan
| | - Yasuo Terauchi
- Department of Endocrinology and Metabolism, Yokohama City University Graduate School of Medicine, Yokohama, Japan
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Mamoon R, Mamoon MY, Hermanstyne D, Sachmechi I. Anti-hyperglycemic Medication Compliance: A Quality Assurance Project. Cureus 2022; 14:e24421. [PMID: 35619860 PMCID: PMC9126438 DOI: 10.7759/cureus.24421] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/22/2022] [Indexed: 11/13/2022] Open
Abstract
In order to determine the prevalence of adherence among diabetes patients treated at Queens Hospital Center's Diabetes Clinic and to determine barriers preventing adherence, 50 patients were asked a series of questions regarding their medication intake. The majority of patients reported that they understood the self-management steps that were necessary in order to control their diabetes. However, 30% of the interviewed patients with type 1 or type 2 diabetes reported that they missed a dose of their diabetes medication on at least one day in the last month. Forgetting and lifestyle inconveniences were the two most frequently reported reasons for non-adherence. Side effects and problems with the pharmacy or insurance were also significant reasons for non-adherence. Adherence can potentially be increased by combining new forms of treatment and increasing educational reinforcement.
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27
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Jacquelet E, Poujois A, Pheulpin MC, Demain A, Tinant N, Gastellier N, Woimant F. Adherence to treatment, a challenge even in treatable metabolic rare diseases: A cross sectional study of Wilson's disease. J Inherit Metab Dis 2021; 44:1481-1488. [PMID: 34480375 DOI: 10.1002/jimd.12430] [Citation(s) in RCA: 27] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/06/2021] [Revised: 08/26/2021] [Accepted: 09/01/2021] [Indexed: 11/09/2022]
Abstract
Wilson's disease (WD), a rare genetic disorder responsible for copper accumulation in the body, is fatal if left untreated. Although there are effective treatments, adherence to treatment tends to be low. We evaluated the medication adherence of 139 patients using the Morisky scale. Adherence was correlated with age at diagnosis and at inclusion in the study, the form of the disease, the treatment, the duration of treatment, delivery and storage problems, depression, anxiety, the level of education, and the biological data. 32.4% of the patients had low adherence; their levels of exchangeable copper were significantly higher than those of the patients with high or medium adherence (P = .049). The average age of the patients at the time of the study was significantly higher in those with high adherence than in those with medium or low adherence (P = .043). 75.9% of the patients with high adherence had a neurological form and 26.7% of the patients with low adherence were asymptomatic (P = .0090). The duration of treatment was significantly longer in the patients with high adherence than in those with medium or low adherence (P = .0192). The type of treatment (chelators or zinc) had no impact on the level of adherence. Forty-four percent of the patients experienced problems dispensing and storing medications. Despite the availability of effective treatments for this rare disease, adherence problems occur with Wilson's disease in particular in asymptomatic patients. Although different factors are involved, sustained multidisciplinary management on a case-by-case basis is necessary.
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Affiliation(s)
- Elodie Jacquelet
- Department of Neurology, Lariboisière University Hospital, AP-HP, Paris, France
- Department of Neurology, National Reference Centre for Wilson's Disease, Hôpital Fondation Adolphe de Rothschild, Paris, France
| | - Aurelia Poujois
- Department of Neurology, National Reference Centre for Wilson's Disease, Hôpital Fondation Adolphe de Rothschild, Paris, France
- Department of Neurology, Rothschild Foundation Hospital, Paris, France
| | | | - Adèle Demain
- Department of Neurology, Lariboisière University Hospital, AP-HP, Paris, France
- Department of Neurology, National Reference Centre for Wilson's Disease, Hôpital Fondation Adolphe de Rothschild, Paris, France
| | - Nadège Tinant
- Department of Neurology, Lariboisière University Hospital, AP-HP, Paris, France
- Department of Neurology, National Reference Centre for Wilson's Disease, Hôpital Fondation Adolphe de Rothschild, Paris, France
| | - Nathalie Gastellier
- Department of Neurology, Lariboisière University Hospital, AP-HP, Paris, France
| | - France Woimant
- Department of Neurology, Lariboisière University Hospital, AP-HP, Paris, France
- Department of Neurology, National Reference Centre for Wilson's Disease, Hôpital Fondation Adolphe de Rothschild, Paris, France
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Than T, Morettin CE, Harthan JS, Hartwick ATE, Huecker JB, Johnson SD, Migneco MK, Shorter E, Whiteside M, Olson CK, Alferez CS, van Zyl T, Rodic-Polic B, Storch GA, Gordon MO. Efficacy of a Single Administration of 5% Povidone-Iodine in the Treatment of Adenoviral Conjunctivitis. Am J Ophthalmol 2021; 231:28-38. [PMID: 34102153 PMCID: PMC11460794 DOI: 10.1016/j.ajo.2021.05.018] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2021] [Revised: 05/20/2021] [Accepted: 05/27/2021] [Indexed: 10/21/2022]
Abstract
PURPOSE To evaluate the safety and efficacy of a single, in-office administration of 5% povidone-iodine (PVP-I) compared to artificial tears (AT) for adenoviral conjunctivitis (Ad-Cs). DESIGN Double-masked pilot randomized trial. METHODS Patients presenting with presumed adenoviral conjunctivitis were screened at 9 U.S. clinics. INCLUSION CRITERIA ≥18 years of age, symptoms ≤4 days, and a positive AdenoPlus test. EXCLUSION CRITERIA thyroid disease, iodine allergy, recent ocular surgery, and ocular findings inconsistent with early-stage Ad-Cs. Randomization was to a single administration of 5% PVP-I or AT in 1 eye and examinations on days 1-2, 4, 7, 14, and 21 with conjunctival swabs taken at each visit for quantitative polymerase chain reaction. Primary outcome was percent reduction from peak viral load. Secondary outcomes were improvement in clinical signs and symptoms. RESULTS Of 56 patients randomized, 28 had detectable viral titers at baseline. Day 4 posttreatment, viral titers in the 5% PVP-I and AT groups were 2.5% ± 2.7% and 14.4% ± 10.5% of peak, respectively (P = .020). Severity of participant-reported tearing, lid swelling, and redness as well as clinician-graded mucoid discharge, bulbar redness, and bulbar edema were lower in the 5% PVP-I group than AT group on day 4 (P < .05). After day 4, viral titers and severity of signs and symptoms decreased markedly in both groups and no differences between groups were detected. CONCLUSIONS Pilot data suggest a single, in-office administration of 5% PVP-I could reduce viral load and hasten improvement of clinical signs and symptoms in patients with Ad-Cs.
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Wang Y, Huang W, Wang N, Ouyang D, Xiao L, Zhang S, Ou X, He T, Yu R, Song L. Development of Arteannuin B Sustained-Release Microspheres for Anti-Tumor Therapy by Integrated Experimental and Molecular Modeling Approaches. Pharmaceutics 2021; 13:1236. [PMID: 34452197 PMCID: PMC8399913 DOI: 10.3390/pharmaceutics13081236] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2021] [Revised: 07/30/2021] [Accepted: 08/06/2021] [Indexed: 11/26/2022] Open
Abstract
Arteannuin B (AB) has been found to demonstrate obvious anti-tumor activity. However, AB is not available for clinical use due to its very low solubility and very short half-life. This study aimed to develop AB long sustained-release microspheres (ABMs) to improve the feasibility of clinical applications. Firstly, AB-polylactic-co-glycolic acid (PLGA) microspheres were prepared by a single emulsification method. In vitro characterization studies showed that ABMs had a low burst release and stable in vitro release for up to one week. The particle size of microspheres was 69.10 μm (D50). The drug loading is 37.8%, and the encapsulation rate is 85%. Moreover, molecular dynamics modeling was firstly used to simulate the preparation process of microspheres, which clearly indicated the molecular image of microspheres and provided in-depth insights for understanding several key preparation parameters. Next, in vivo pharmacokinetics (PK) study was carried out to evaluate its sustained release effect in Sprague-Dawley (SD) rats. Subsequently, the methyl thiazolyl tetrazolium (MTT) method with human lung cancer cells (A549) was used to evaluate the in vitro efficacy of ABMs, which showed the IC50 of ABMs (3.82 μM) to be lower than that of AB (16.03 μM) at day four. Finally, in vivo anti-tumor activity and basic toxicity studies were performed on BALB/c nude mice by subcutaneous injection once a week, four times in total. The relative tumor proliferation rate T/C of AMBs was lower than 40% and lasted for 21 days after administration. The organ index, organ staining, and tumor cell staining indicated the excellent safety of ABMs than Cis-platinum. In summary, the ABMs were successfully developed and evaluated with a low burst release and a stable release within a week. Molecular dynamics modeling was firstly applied to investigate the molecular mechanism of the microsphere preparation. Moreover, the ABMs possess excellent in vitro and in vivo anti-tumor activity and low toxicity, showing great potential for clinical applications.
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Affiliation(s)
- Yanqing Wang
- Biotechnological Institute of Chinese Materia Medica, Jinan University, Guangzhou 510632, China; (Y.W.); (S.Z.)
| | - Weijuan Huang
- Department of Pharmacology, College of Pharmacy, Jinan University, Guangzhou 510632, China; (W.H.); (X.O.); (T.H.)
| | - Nannan Wang
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences (ICMS), University of Macau, Macau, China; (N.W.); (D.O.)
| | - Defang Ouyang
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences (ICMS), University of Macau, Macau, China; (N.W.); (D.O.)
| | - Lifeng Xiao
- Zhuhai Livzon Microsphere Technology Co., Ltd., Zhuhai 519090, China;
| | - Sirui Zhang
- Biotechnological Institute of Chinese Materia Medica, Jinan University, Guangzhou 510632, China; (Y.W.); (S.Z.)
| | - Xiaozheng Ou
- Department of Pharmacology, College of Pharmacy, Jinan University, Guangzhou 510632, China; (W.H.); (X.O.); (T.H.)
| | - Tingsha He
- Department of Pharmacology, College of Pharmacy, Jinan University, Guangzhou 510632, China; (W.H.); (X.O.); (T.H.)
| | - Rongmin Yu
- Biotechnological Institute of Chinese Materia Medica, Jinan University, Guangzhou 510632, China; (Y.W.); (S.Z.)
| | - Liyan Song
- Department of Pharmacology, College of Pharmacy, Jinan University, Guangzhou 510632, China; (W.H.); (X.O.); (T.H.)
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Aluzaite K, Braund R, Seeley L, Amiesimaka OI, Schultz M. Adherence to Inflammatory Bowel Disease Medications in Southern New Zealand. CROHN'S & COLITIS 360 2021; 3:otab056. [PMID: 36776660 PMCID: PMC9802163 DOI: 10.1093/crocol/otab056] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/25/2021] [Indexed: 11/12/2022] Open
Abstract
Background Inflammatory bowel diseases (IBDs) require continuous clinical management; poor medication adherence may result in worse disease outcomes and increased healthcare costs. This study investigated medication adherence and associated risk factors in IBD patients. Methods Otago (New Zealand) IBD patients were mailed questionnaires on demographics, medication-taking behavior, and a validated Probabilistic Medication Adherence Scale (ProMAS). Results The response rate was 29.7% (n = 174/590). The study sample was mean (SD) 50.5 (16.9) years old, 57.9% female, 49.4% had Crohn's disease, and 43.9% ulcerative colitis, with median of 9.5 years (interquartile range: 5.0-22.0) of IBD duration. About 31.1% scored below medium adherence according to ProMAS. About 11.9%, 24.7%, and 23.1% reported failing to renew, purposely not taking, and stopping taking medications, respectively; 27.2% of those who reported having no issues taking medication scored below medium on the ProMAS. Older age was associated with higher ProMAS adherence score (Pearson's r = .25; P = .0014). There were no differences in medication adherence between the types of IBDs (P = .87), disease activity status (P = .70), or gender (P = .27). There was no correlation between the number of medications and level of adherence (Pearson's r = .09; P = .27). About 18.7%, 10.1%, and 5.0% of patients reported forgetting to take medications when traveling, when out of routine, and when busy, respectively. The most used strategies to remember medications included utilizing specific routines (40.1%) and keeping medications in specific locations (21.1%). Conclusions A third of IBD patients had below medium medication adherence. There were discrepancies between self-reported and tool-assessed medication adherence scores with over one-third of patients underestimating/overestimating their adherence.
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Affiliation(s)
- Kristina Aluzaite
- Gastroenterology Research Unit, Department of Medicine, DSM, University of Otago, Dunedin, New Zealand
| | - Rhiannon Braund
- Department of Preventive and Social Medicine, New Zealand Pharmacovigilance Centre, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
| | - Liam Seeley
- Gastroenterology Research Unit, Department of Medicine, DSM, University of Otago, Dunedin, New Zealand
| | | | - Michael Schultz
- Gastroenterology Research Unit, Department of Medicine, DSM, University of Otago, Dunedin, New Zealand,Gastroenterology Unit, Dunedin Hospital, Southern District Health Board, Dunedin, New Zealand,Address correspondence to: Michael Schultz, MD, PhD, FRACP, Department of Medicine, Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin 9054, New Zealand ()
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Shiomi M, Kurobuchi M, Tanaka Y, Takada T, Otori K. Pill Counting in the Determination of Factors Affecting Medication Adherence in Patients with Type 2 Diabetes: A Retrospective Observational Study. Diabetes Ther 2021; 12:1993-2005. [PMID: 34120302 PMCID: PMC8266921 DOI: 10.1007/s13300-021-01091-1] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/22/2021] [Accepted: 05/27/2021] [Indexed: 11/05/2022] Open
Abstract
INTRODUCTION For medication adherence, pill counting has higher accuracy in objective assessment. However, previous reports have shown that factors such as psychological bias and other people's involvement in managing and helping patients take their medications may influence the outcomes. In Japan, all prescription medicines of patients are checked by medical reconciliation, and a pill count is performed during hospitalization. This study investigated factors affecting the medication adherence of patients with type 2 diabetes mellitus (T2DM), including patient- and medication-related factors, by pill counting using medical reconciliation in a situation where the patient's psychological bias is low. METHODS This study included 103 patients with T2DM who had been treated with oral hypoglycemic agents (OHAs) for at least 24 weeks. Patients whose OHAs were managed by another person were excluded. We calculated medication adherence values (MAVs) according to the following formula: MAV = (total prescription days - prescription days of OHAs brought when admitted)/(days from the start of OHAs to hospitalization). The relationship between MAVs and patient- and medication-related factors was analyzed. RESULTS On multiple linear regression analysis of patient-related factors with P < 0.10 in the univariate analysis as explanatory variables, a lower number of chronic diseases (β = 0.017; P < 0.001) and higher number of OHAs (β = - 0.021; P = 0.04) were independent factors for lower MAV. Medication-related factors were not found to be independent factors. CONCLUSIONS Our findings suggest that poor adherence was independently associated with lower number of chronic diseases and higher number of OHAs in patients with T2DM.
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Affiliation(s)
- Megumi Shiomi
- Department of Clinical Pharmacy, School of Pharmacy, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.
- Department of Pharmacy, Kitasato University Medical Center, 6-100 Arai, Kitamoto, Saitama, 364-8501, Japan.
| | - Momoka Kurobuchi
- Department of Clinical Pharmacy, School of Pharmacy, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan
| | - Yoichi Tanaka
- Department of Clinical Pharmacy, School of Pharmacy, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan
| | - Tesshu Takada
- Department of Endocrinology, Diabetes, and Metabolism, School of Medicine, Kitasato University, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
| | - Katsuya Otori
- Department of Clinical Pharmacy, School of Pharmacy, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan
- Department of Pharmacy, Kitasato University Medical Center, 6-100 Arai, Kitamoto, Saitama, 364-8501, Japan
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Lee WK, Lee J. Evaluation and improvement of adherence to medication. JOURNAL OF THE KOREAN MEDICAL ASSOCIATION 2021. [DOI: 10.5124/jkma.2021.64.2.130] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/02/2023] Open
Abstract
Medication adherence refers to the extent to which a patient takes medication according to prescription. In many cases, adherence to medication is defined as the proportion of prescribed drugs taken as prescribed over a certain period. However, there is no satisfactory level of adherence that can be applied uniformly to all diseases and medications. Patients with poor adherence experience worsening of conditions, complications, and increased risk for death, which increases medical expenses. Therefore, to improve medication adherence, healthcare providers should try to identify poor adherence, adjust prescriptions to optimize treatment according to the patient’s lifestyle, and educate patients to help them understand the value of medical treatment and the effects of adherence. The most practical way to identify poor adherence during clinical visits is by asking patients about their medication adherence in a non-judgmental manner. Reducing the number of doses is more effective than reducing the number of tablets to increase compliance. It is necessary to adopt innovative methods based on information technology in our healthcare system because of the labor-intensive nature of educational intervention to improve adherence.
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Ailincai D, Porzio W, Marin L. Hydrogels Based on Imino-Chitosan Amphiphiles as a Matrix for Drug Delivery Systems. Polymers (Basel) 2020; 12:E2687. [PMID: 33202586 PMCID: PMC7696980 DOI: 10.3390/polym12112687] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2020] [Revised: 11/03/2020] [Accepted: 11/12/2020] [Indexed: 12/13/2022] Open
Abstract
This paper reports new formulations based on chitosan, citral, and diclofenac sodium salt (DCF). The central idea was to encapsulate an anionic drug into a polycationic hydrogel matrix in order to increase the intermolecular forces between them and thus to ensure slower drug release, while citral was used as a penetration enhancer to assure efficient delivery of the drug. Hydrogels without drug were also synthesized and used as a reference. The structure, morphology, and supramolecular architecture of the drug delivery systems were evaluated by FTIR spectroscopy, scanning electron microscopy, polarized optical microscopy, and wide-angle X-ray diffraction. The drug release kinetics was monitored in vitro by UV-VIS spectroscopy, in physiological conditions, while the enzymatic and hydrolytic degradability of the hydrogels were evaluated in the presence of lysozyme and phosphate buffer saline (PBS), at 37 °C. All of the data revealed that the anionic DCF was strongly anchored into the polycationic matrix and the drug was slowly released over 7 days. Moreover, the release rate can be controlled by simple variation of the molar ratio between the polycationic chitosan and lipophilic citral.
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Affiliation(s)
- Daniela Ailincai
- “Petru Poni” Institute of Macromolecular Chemistry, 400487 Iasi, Romania;
| | - William Porzio
- Institute of Chemical Sciences and Technologies, “G. Natta“ Consiglio Nazionale delle Ricerche (SCI-TEC) via A. Corti, 12 20133 Milano, Italy;
| | - Luminita Marin
- “Petru Poni” Institute of Macromolecular Chemistry, 400487 Iasi, Romania;
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Patient adherence to multivitamin supplementation after bariatric surgery: a narrative review. J Nutr Sci 2020; 9:e46. [PMID: 33101663 PMCID: PMC7550964 DOI: 10.1017/jns.2020.41] [Citation(s) in RCA: 36] [Impact Index Per Article: 7.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2020] [Revised: 09/04/2020] [Accepted: 09/07/2020] [Indexed: 02/07/2023] Open
Abstract
Morbid obesity is a growing problem worldwide and has subsequently resulted in a wide application of bariatric surgery to achieve long-term weight loss and improvement of obesity-related co-morbidities. In spite of these clinical benefits, vitamin deficiencies are common after bariatric surgery; therefore, lifelong multivitamin supplementation (MVS) is recommended. However, patient adherence to MVS intake is generally poor. The aim of this narrative review is to analyse which factors influence the adherence of MVS intake after bariatric surgery. To provide an extensive overview, we will discuss the different factors that influence MVS use in patients who underwent bariatric surgery, but also review the literature on MVS in other patient groups.
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Gholizadeh-Hashjin A, Shabani M, Monajjemzadeh F. Evaluation of Pharmaceutical Compatibility between Acarbose and Common Excipients Used in the Development of Controlled Release Formulations. PHARMACEUTICAL SCIENCES 2020. [DOI: 10.34172/ps.2020.67] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022] Open
Abstract
Background: Excipients are used in the formulation of pharmaceutical dosage forms, but mayinteract with active pharmaceutical ingredients (APIs). Some of these interactions could alterthe physicochemical properties of the APIs which can affect the therapeutic efficacy and safety.Acarbose is an anti-diabetic drug used in this study as an API to investigate its compatibility withcommon excipients in order to development of pharmaceutical controlled release formulations. Methods: For this purpose, 15 different excipients were selected. Binary mixtures of drug witheach of the excipients (1:1 mass ratio) were prepared. Mixtures were analyzed immediately aftermixing and also after incubation at stress conditions (adding 20% water and incubated at 40°Cfor 2 months). The thermal analytical investigation like differential scanning calorimetry (DSC),Fourier transform infra-red spectroscopy (FTIR) and high-performance liquid chromatography(HPLC) were employed for physicochemical evaluations of the possible incompatibility.Photodiode-array (PDA) and mass studies were performed to ensure the peak purity of theHPLC peaks of API in stressed samples. Results: Incompatible excipients with acarbose were determined as EC (ethyl cellulose),Carbopol 934, Hydroxypropyl cellulose, PEG2000 (Polyethylene Glycol 2000), Mg Stearate, NaAlginate and Poloxamer. Conclusion: Results of this study would be used for the development of controlled releaseformulation of acarbose. It is recommended to avoid the use of incompatible excipients.
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Affiliation(s)
- Aiesheh Gholizadeh-Hashjin
- Department of Pharmaceutical and Food Control, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
- Student Research Committee, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
| | - Mohammad Shabani
- Student Research Committee, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
| | - Farnaz Monajjemzadeh
- Food and Drug Safety Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
- National Institute for Medical Research Development (NIMAD), Tehran, Iran
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Zero-order drug delivery: State of the art and future prospects. J Control Release 2020; 327:834-856. [PMID: 32931897 DOI: 10.1016/j.jconrel.2020.09.020] [Citation(s) in RCA: 165] [Impact Index Per Article: 33.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2020] [Revised: 09/07/2020] [Accepted: 09/08/2020] [Indexed: 01/21/2023]
Abstract
Pharmaceutical drugs are an important part of the global healthcare system, with some estimates suggesting over 50% of the world's population takes at least one medication per day. Most drugs are delivered as immediate-release formulations that lead to a rapid increase in systemic drug concentration. Although these formulations have historically played an important role, they can be limited by poor patient compliance, adverse side effects, low bioavailability, or undesirable pharmacokinetics. Drug delivery systems featuring first-order release kinetics have been able to improve pharmacokinetics but are not ideal for drugs with short biological half-lives or small therapeutic windows. Zero-order drug delivery systems have the potential to overcome the issues facing immediate-release and first-order systems by releasing drug at a constant rate, thereby maintaining drug concentrations within the therapeutic window for an extended period of time. This release profile can be used to limit adverse side effects, reduce dosing frequency, and potentially improve patient compliance. This review covers strategies being employed to attain zero-order release or alter traditionally first-order release kinetics to achieve more consistent release before discussing opportunities for improving device performance based on emerging materials and fabrication methods.
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Golledge J, Fernando M, Lazzarini P, Najafi B, G. Armstrong D. The Potential Role of Sensors, Wearables and Telehealth in the Remote Management of Diabetes-Related Foot Disease. SENSORS (BASEL, SWITZERLAND) 2020; 20:E4527. [PMID: 32823514 PMCID: PMC7491197 DOI: 10.3390/s20164527] [Citation(s) in RCA: 37] [Impact Index Per Article: 7.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/14/2020] [Revised: 07/29/2020] [Accepted: 08/12/2020] [Indexed: 12/18/2022]
Abstract
Diabetes-related foot disease (DFD), which includes foot ulcers, infection and gangrene, is a leading cause of the global disability burden. About half of people who develop DFD experience a recurrence within one year. Long-term medical management to reduce the risk of recurrence is therefore important to reduce the global DFD burden. This review describes research assessing the value of sensors, wearables and telehealth in preventing DFD. Sensors and wearables have been developed to monitor foot temperature, plantar pressures, glucose, blood pressure and lipids. The monitoring of these risk factors along with telehealth consultations has promise as a method for remotely managing people who are at risk of DFD. This approach can potentially avoid or reduce the need for face-to-face consultations. Home foot temperature monitoring, continuous glucose monitoring and telehealth consultations are the approaches for which the most highly developed and user-friendly technology has been developed. A number of clinical studies in people at risk of DFD have demonstrated benefits when using one of these remote monitoring methods. Further development and evidence are needed for some of the other approaches, such as home plantar pressure and footwear adherence monitoring. As yet, no composite remote management program incorporating remote monitoring and the management of all the key risk factors for DFD has been developed and implemented. Further research assessing the feasibility and value of combining these remote monitoring approaches as a holistic way of preventing DFD is needed.
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Affiliation(s)
- Jonathan Golledge
- Ulcer and wound Healing consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland 4811, Australia;
- The Department of Vascular and Endovascular Surgery, Townsville University Hospital, Townsville, Queensland 4814, Australia
| | - Malindu Fernando
- Ulcer and wound Healing consortium (UHEAL), Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland 4811, Australia;
| | - Peter Lazzarini
- School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland 4000, Australia;
- Allied Health Research Collaborative, Metro North Hospital and Health Service, Brisbane, Queensland 4006, Australia
| | - Bijan Najafi
- Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX 77030, USA;
| | - David G. Armstrong
- Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, CA 90089, USA;
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Schmidt SJ, Wurmbach VS, Lampert A, Bernard S, Haefeli WE, Seidling HM, Thürmann PA. Individual factors increasing complexity of drug treatment-a narrative review. Eur J Clin Pharmacol 2020; 76:745-754. [PMID: 32239242 PMCID: PMC7239823 DOI: 10.1007/s00228-019-02818-7] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/16/2019] [Accepted: 12/08/2019] [Indexed: 12/11/2022]
Abstract
Purpose Complexity of drug treatment is known to be a risk factor for administration errors and nonadherence promoting higher healthcare costs, hospital admissions and increased mortality. Number of drugs and dose frequency are parameters often used to assess complexity related to the medication regimen. However, factors resulting from complex processes of care or arising from patient characteristics are only sporadically analyzed. Hence, the objective of this review is to give a comprehensive overview of relevant, patient-centered factors influencing complexity of drug treatment. Methods A purposeful literature search was performed in MEDLINE to identify potential complexity factors relating to the prescribed drug (i.e. dosage forms or other product characteristics), the specific medication regimen (i.e. dosage schemes or additional instructions), specific patient characteristics and process characteristics. Factors were included if they were associated to administration errors, nonadherence and related adverse drug events detected in community dwelling adult patients. Results Ninety-one influencing factors were identified: fourteen in “dosage forms”, five in “product characteristics”, twelve in “dosage schemes”, nine in “additional instructions”, thirty-one in “patient characteristics” and twenty in “process characteristics”. Conclusions Although the findings are limited by the non-systematic search process and the heterogeneous results, the search shows the influence of many factors on the complexity of drug treatment. However, to evaluate their relevance for individual patients, prospective studies are necessary. Electronic supplementary material The online version of this article (10.1007/s00228-019-02818-7) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Steffen J Schmidt
- Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448, Witten, Germany
| | - Viktoria S Wurmbach
- Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.,Cooperation Unit Clinical Pharmacy, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany
| | - Anette Lampert
- Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.,Cooperation Unit Clinical Pharmacy, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany
| | - Simone Bernard
- Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448, Witten, Germany
| | | | - Walter E Haefeli
- Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.,Cooperation Unit Clinical Pharmacy, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany
| | - Hanna M Seidling
- Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany. .,Cooperation Unit Clinical Pharmacy, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
| | - Petra A Thürmann
- Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448, Witten, Germany.,Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Heusnerstraße 40, 42283, Wuppertal, Germany
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3D printing for oral drug delivery: a new tool to customize drug delivery. Drug Deliv Transl Res 2020; 10:986-1001. [DOI: 10.1007/s13346-020-00737-0] [Citation(s) in RCA: 66] [Impact Index Per Article: 13.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
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Meguro S, Matsui S, Itoh H. Treatment preference for weekly versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: outcomes from the TRINITY trial. Curr Med Res Opin 2019; 35:2071-2078. [PMID: 31366262 DOI: 10.1080/03007995.2019.1651130] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/02/2023]
Abstract
Objective: To examine patient preference for treatment with the oral once-weekly dipeptidyl peptidase-4 inhibitor (DPP-4i), trelagliptin, and oral once-daily DPP-4i, alogliptin, administered for 8 weeks each in patients with type 2 diabetes mellitus prescribed a daily DPP-4i.Methods: In this randomized, open-label, two-way crossover study, patients received trelagliptin followed by alogliptin (T-A group) or alogliptin followed by trelagliptin (A-T group), for 8 weeks each (NCT03231709, JapicCTI-173662). Treatment preference was assessed using a standardized questionnaire in the overall population and by baseline characteristics. Other outcomes included patient satisfaction with diabetes treatment (assessed using the Diabetes Treatment Satisfaction Questionnaire [DTSQ]), hemoglobin A1c (HbA1c) levels after 8 weeks of treatment with each agent, and safety.Results: Sixty patients from two clinical sites were randomized 1:1 to T-A and A-T groups (each n = 30); baseline characteristics were similar between groups. After 16 weeks of treatment, 51.7% of patients preferred treatment with alogliptin compared with 30.0% selecting trelagliptin (p = .014); preference for alogliptin was consistently greater than for trelagliptin in the secondary analyses by baseline characteristics. DTSQ score and HbA1c levels were similar between treatments after 8 weeks of therapy. Both treatments demonstrated favorable safety and tolerability profiles.Conclusions: Patients expressed a significantly greater treatment preference for once-daily alogliptin than once-weekly trelagliptin, although patient satisfaction and HbA1c levels were similar across treatments. The decision to administer a once-weekly or once-daily DPP-4i is likely to depend on patient preference, patient-physician discussions, and treatment practices of the prescribing physician.
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Affiliation(s)
- Shu Meguro
- Department of Nephrology, Endocrinology and Metabolism, Keio University School of Medicine, Tokyo, Japan
| | - Shingo Matsui
- Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan
| | - Hiroshi Itoh
- Department of Nephrology, Endocrinology and Metabolism, Keio University School of Medicine, Tokyo, Japan
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Hayashi A, Kubo T, Okuyama K, Tokita S, Kamei M. Adherence to Oral Antihyperglycemic Agents (Dipeptidyl Peptidase-4 Inhibitors and Biguanides) and Its Associated Factors in Patients with Type 2 Diabetes. YAKUGAKU ZASSHI 2019; 139:1569-1581. [DOI: 10.1248/yakushi.18-00197] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022]
Affiliation(s)
| | | | | | | | - Miwako Kamei
- Laboratory of Social and Administrative Pharmacy Science, School of Pharmacy, Nihon University
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Wang X, Chang Y, He Y, Lyu C, Li H, Zhu J, Liu K, Hu Y, Huang K, Pan S. Glimepiride and glibenclamide have comparable efficacy in treating acute ischemic stroke in mice. Neuropharmacology 2019; 162:107845. [PMID: 31704276 DOI: 10.1016/j.neuropharm.2019.107845] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/15/2019] [Revised: 10/27/2019] [Accepted: 11/04/2019] [Indexed: 12/20/2022]
Abstract
Glibenclamide protects against ischemic injury in both preclinical and clinical studies, presumably by blocking the de novo assembled sulfonylurea receptor 1-transient receptor potential M4 (Sur1-Trpm4) channel induced by ischemia. However, glibenclamide may cause unexpected serious hypoglycemia. Here, we tested whether glimepiride, another sulfonylurea with better safety, has comparable efficacy with glibenclamide and whether gene deletion of Trpm4 (Trpm4-/-) exerts similar effect. Wild-type (WT) mice subjected to temporary middle cerebral artery occlusion (tMCAO) were randomized to receive glibenclamide (an initial dose of 10 μg/kg and additional doses of 1.2 μg every 8 h), three different doses of glimepiride (10 μg/kg, 100 μg/kg and 1 mg/kg) or vehicle after ischemia, while tMCAO-treated Trpm4-/- mice were randomized to receive vehicle or glimepiride. Neurological function, infarct volume, edema formation, the integrity of blood-brain barrier and inflammatory reaction were evaluated at 24 h after ischemia. In tMCAO-treated WT mice, 10 μg/kg and 100 μg/kg glimepiride had comparable efficacy with glibenclamide in improving longa score and grip test score, reducing infarct volume, mitigating brain edema, lessening extravasation of Evans blue dye and IgG, restoring tight junction protein expression as well as suppressing inflammatory cytokines. Compared with WT mice, Trpm4-/- mice showed less neurological deficit, smaller cerebral infarction, lighter brain edema and more integrity of blood-brain barrier. As expected, glimepiride did not provide additional neuroprotection compared with vehicle in the tMCAO-treated Trpm4-/- mice. Glimepiride shows comparable efficacy with glibenclamide in alleviating brain injury after ischemic stroke in mice, possibly via targeting the Sur1-Trpm4 channel.
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Affiliation(s)
- Xiaoqiang Wang
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Yuan Chang
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Yihua He
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Chenfei Lyu
- Interdisciplinary Institute of Neuroscience and Technology, Zhejiang University School of Medicine, Hangzhou, China
| | - Hua Li
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Juan Zhu
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Kewei Liu
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Yafang Hu
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Kaibin Huang
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
| | - Suyue Pan
- Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
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Yu HM, Kim SJ, Chun SW, Park KY, Lim DM, Lee JM, Hong JH, Park KS. A comparison study on efficacy, insulin sensitivity and safety of Glimepiride/Metformin fixed dose combination versus glimepiride single therapy on type 2 diabetes mellitus patients with basal insulin therapy. Diabetes Res Clin Pract 2019; 155:107796. [PMID: 31326458 DOI: 10.1016/j.diabres.2019.107796] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/13/2018] [Revised: 06/15/2019] [Accepted: 07/10/2019] [Indexed: 12/17/2022]
Abstract
AIM The aim of this study was to analyze the efficacy, insulin sensitivity and safety in the event of administering sulfonylurea-based drugs and metformin in combination with basal insulin. METHODS A randomized, open-label, parallel, 16-week trial was conducted across four study centers. The 97 type 2 diabetic patients were selected and randomized into two groups, the insulin glargine plus fixed-dose combination glimepiride 1 mg and metformin 500 mg twice daily group (the G/M group) and the insulin glargine plus glimepiride 4 mg once daily group (the G group). The primary endpoint evaluated was change in HbA1c. The secondary endpoints evaluated were changes in fasting blood glucose (FPG), 2-h post prandial glucose (PPG 2 h), insulin, and C-peptide levels. RESULTS The G/M group was found to have experienced a significantly greater decrease in HbA1c, as well as PPG 2 h compared to the G group. While no significant intergroup difference was found regarding FPG in the ITT, the G/M group in the PP set experienced a significantly greater decrease in FPG. CONCLUSION Comparison of combined therapy consisting of either the G/M group or the G group indicated that both forms of therapy are relatively safe but that the former more effectively decreases blood glucose levels.
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Affiliation(s)
- Hea Min Yu
- Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Seoul, Republic of Korea
| | - Sang Jin Kim
- Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea
| | - Sung Wan Chun
- Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea
| | - Keun Young Park
- Department of Internal Medicine, Konyang University Hospital, Daejeon, Republic of Korea
| | - Dong Mee Lim
- Department of Internal Medicine, Konyang University Hospital, Daejeon, Republic of Korea
| | - Jong Min Lee
- Department of Internal Medicine, The Catholic University of Korea, Daejeon ST.Mary's Hospital, Daejeon, Republic of Korea
| | - Jun Hwa Hong
- Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Seoul, Republic of Korea
| | - Kang Seo Park
- Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Seoul, Republic of Korea.
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Easthall C. Medication Nonadherence as a Complex Health Behavior: There Is More to It Than Just Missed Doses. J Am Geriatr Soc 2019; 67:2439-2440. [PMID: 31437311 DOI: 10.1111/jgs.16143] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/05/2019] [Revised: 08/01/2019] [Accepted: 08/03/2019] [Indexed: 11/29/2022]
Affiliation(s)
- Claire Easthall
- School of Healthcare, University of Leeds, Leeds, United Kingdom
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Ishii H, Suzaki Y, Miyata Y, Matsui S. Randomized Multicenter Evaluation of Quality of Life and Treatment Satisfaction in Type 2 Diabetes Patients Receiving Once-Weekly Trelagliptin Versus a Daily Dipeptidyl Peptidase-4 Inhibitor. Diabetes Ther 2019; 10:1369-1380. [PMID: 31214997 PMCID: PMC6612345 DOI: 10.1007/s13300-019-0643-1] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2019] [Indexed: 11/25/2022] Open
Abstract
INTRODUCTION Dipeptidyl peptidase-4 (DPP-4) inhibitors are an established treatment in type 2 diabetes mellitus (T2DM). The objective of this study was to investigate differences in quality of life (QOL) and treatment satisfaction among treatment-naïve T2DM patients receiving once-weekly trelagliptin or a daily DPP-4 inhibitor. METHODS In this multicenter, randomized, open-label, parallel-group, phase IV study conducted in Japan, 218 patients were randomized to trelagliptin 100 mg once weekly or a once- or twice-daily DPP-4 inhibitor for 12 weeks (NCT03014479; JapicCTI-173482). QOL and treatment satisfaction were assessed using the Diabetes Therapy-Related QOL (DTR-QOL) Questionnaire and Diabetes Treatment Satisfaction Questionnaire (DTSQ), respectively. The primary endpoint was change from baseline in DTR-QOL total score at week 12. Secondary endpoints included further analysis of the DTR-QOL and DTSQ components. Other endpoints included glycemic control, treatment adherence, and safety. RESULTS The between-group difference in the change from baseline to week 12 in DTR-QOL total score was 2.418 (95% confidence interval - 1.546, 6.382; P = 0.2305). Analysis of the DTR-QOL and DTSQ results by subscales and stratification generally showed a numerical improvement with trelagliptin over daily DPP-4 inhibitors. QOL and treatment satisfaction improved with a reduction in frequency of concurrent and study drug dosing. Treatment adherence was > 97% for both groups. The effect of trelagliptin on glycemic control was similar to that seen with daily DPP-4 inhibitors. Trelagliptin and daily DPP-4 inhibitors were well-tolerated and demonstrated similar safety profiles. CONCLUSIONS Once-weekly trelagliptin 100 mg administered for 12 weeks resulted in a numerically, but not statistically, greater improvement in QOL and treatment satisfaction versus daily DPP-4 inhibitors. The decision to administer once-weekly or daily DPP-4 inhibitor treatment is likely to depend on patient preferences and the treatment policies of physicians. TRIAL REGISTRATION ClinicalTrials.gov (NCT03014479) and JAPIC (JapicCTI-173482). FUNDING Takeda Pharmaceutical Company Ltd.
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Affiliation(s)
- Hitoshi Ishii
- Department of Diabetology, Nara Medical University, Nara, Japan
| | - Yuki Suzaki
- Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan
| | - Yuko Miyata
- Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan
| | - Shingo Matsui
- Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
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Heck DW, Davis-Stober CP. Multinomial Models with Linear Inequality Constraints: Overview and Improvements of Computational Methods for Bayesian Inference. JOURNAL OF MATHEMATICAL PSYCHOLOGY 2019; 91:70-87. [PMID: 30956351 PMCID: PMC6448806 DOI: 10.1016/j.jmp.2019.03.004] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/07/2023]
Abstract
Many psychological theories can be operationalized as linear inequality constraints on the parameters of multinomial distributions (e.g., discrete choice analysis). These constraints can be described in two equivalent ways: Either as the solution set to a system of linear inequalities or as the convex hull of a set of extremal points (vertices). For both representations, we describe a general Gibbs sampler for drawing posterior samples in order to carry out Bayesian analyses. We also summarize alternative sampling methods for estimating Bayes factors for these model representations using the encompassing Bayes factor method. We introduce the R package multinomineq, which provides an easily-accessible interface to a computationally efficient implementation of these techniques.
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Wentz SM, Price F, Harris A, Siesky B, Ciulla T. Efficacy and safety of bromfenac 0.075% formulated in DuraSite for pain and inflammation in cataract surgery. Expert Opin Pharmacother 2019; 20:1703-1709. [DOI: 10.1080/14656566.2019.1645834] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Affiliation(s)
- Scott M Wentz
- Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA
| | | | - Alon Harris
- Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA
| | - Brent Siesky
- Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA
| | - Thomas Ciulla
- Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA
- Midwest Eye Institute, Indianapolis, IN, USA
- Clearside Biomedical, Alpharetta, GA, USA
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Ito H, Ando S, Tsugami E, Araki R, Kusano E, Matsumoto S, Uemura K, Nishio S, Antoku S, Yamasaki T, Mori T, Togane M. Changes in medication adherence and unused drugs after switching from daily dipeptidyl peptidase-4 inhibitors to once-weekly trelagliptin in patients with type 2 diabetes. Diabetes Res Clin Pract 2019; 153:41-48. [PMID: 31150724 DOI: 10.1016/j.diabres.2019.05.025] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/01/2019] [Revised: 05/15/2019] [Accepted: 05/22/2019] [Indexed: 11/25/2022]
Abstract
AIMS The changes in patients' satisfaction with the treatment, medication adherence and unused drugs before and after switching from daily DPP-4 inhibitors to once-weekly trelagliptin administration were prospectively investigated in patients with type 2 diabetes. METHODS After excluding 46 patients who declined to switch from daily DPP-4 inhibitors, 79 subjects were included in the present study. The clinical parameters and results of questionnaire surveys regarding satisfaction with treatment as well as impressions of the amount of medicine/number of doses, medication adherence, and unused drug were examined at the baseline and 3 months after switching from daily DPP-4 inhibitors to trelagliptin in 75 patients with type 2 diabetes. RESULTS Although the value of HbA1c did not change (7.0% ± 0.5% to 7.0% ± 0.6%), the scores representing satisfaction with the treatment (25.2 ± 6.4 to 26.4 ± 6.0), impression of the amount of medicine (-0.3 ± 1.0 to 0.3 ± 1.0) and number of doses (0.3 ± 1.0 to 0.8 ± 0.6), and medication adherence (0.8 ± 0.4 to 0.9 ± 0.3) as assessed by the questionnaire surveys were significantly improved after switching from DPP-4 inhibitors. The self-reported amount of unused drugs was significantly reduced after switching. CONCLUSIONS Switching from daily DPP-4 inhibitors to once-weekly trelagliptin improved the satisfaction with the treatment, impression of the prescribed medicine and medication adherence in the type 2 diabetic patients who expresses a desire to reduce their prescription medicines. In such patients, improvements in the glycemic control and long-term prognosis might be expected through the reduction of unused drugs.
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Affiliation(s)
- Hiroyuki Ito
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan.
| | | | | | - Rie Araki
- Department of Pharmacy, Edogawa Hospital, Japan
| | - Eiji Kusano
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan
| | - Suzuko Matsumoto
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan
| | - Kosuke Uemura
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan
| | - Shinya Nishio
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan
| | - Shinichi Antoku
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan
| | - Tomoko Yamasaki
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan
| | - Toshiko Mori
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan
| | - Michiko Togane
- Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Japan
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du Pon E, El Azzati S, van Dooren A, Kleefstra N, Heerdink E, van Dulmen S. Effects of a Proactive Interdisciplinary Self-Management (PRISMA) program on medication adherence in patients with type 2 diabetes in primary care: a randomized controlled trial. Patient Prefer Adherence 2019; 13:749-759. [PMID: 31190757 PMCID: PMC6512791 DOI: 10.2147/ppa.s188703] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
PURPOSE The present study aims to investigate the effect of the group-based Proactive Interdisciplinary Self-Management (PRISMA) training program on medication adherence in patients with type 2 diabetes (T2DM) treated in primary care. PATIENTS AND METHODS The current study is a two-arm, parallel group, randomized, open label trial (1:1) of 6-month duration with a 6-month extension period in which both groups received the intervention (wait-list control). People 18 years old or older who were diagnosed with T2DM were included. The intervention consisted of two group meetings about T2DM guided by care providers. The control group received usual care only (visits at the general practice). The primary outcome was adherence based on pharmacy refill data and was measured using medication possession ratio (MPR). The secondary outcomes were the number of drug holidays and self-reported adherence, measured by the 5-item Medication Adherence Rating Scale (MARS-5). RESULTS Of the total sample (n=108), 66.6% were male. The mean age was 69.3 years (SD=9.1). In the 6-month period, patients were more adherent in the intervention group (n=56) (median MPR =100.0 [51.1-100.0]) than in the control group (n=52) (median MPR =97.7 [54.1-100.0]) (U=1,042, z=-2.783, P=0.005). The intervention group had less drug holidays than the control group (relative risk 0.55, 95% CI, 0.37-0.80). The sum scores of the MARS did not differ between the intervention group (median =23.98, SD=0.91) and the control group (median =24.00, SD=1.54). CONCLUSION The PRISMA program resulted in a small improvement in MPR and fewer drug holidays, while no improvement has been found in self-reported adherence. However, health care providers and policy makers could take into account that adherence might be influenced by PRISMA.
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Affiliation(s)
- Esther du Pon
- Research Group Process Innovations in Pharmaceutical Care, Utrecht University of Applied Sciences, Utrecht, the Netherlands,
- Diabetes Centre, Isala Clinics, Zwolle, the Netherlands,
| | - Siham El Azzati
- Research Group Process Innovations in Pharmaceutical Care, Utrecht University of Applied Sciences, Utrecht, the Netherlands,
| | - Ad van Dooren
- Research Group Process Innovations in Pharmaceutical Care, Utrecht University of Applied Sciences, Utrecht, the Netherlands,
| | - Nanne Kleefstra
- Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
- Medical Research Group, Langerhans, Ommen, the Netherlands
| | - Eibert Heerdink
- Research Group Process Innovations in Pharmaceutical Care, Utrecht University of Applied Sciences, Utrecht, the Netherlands,
- Department of Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands
| | - Sandra van Dulmen
- NIVEL (Netherlands Institute for Health Services Research), Department of Communication in Healthcare, Utrecht, the Netherlands
- Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Primary and Community care, Nijmegen, the Netherlands
- Faculty of Health and Social Sciences, University of Southeast Norway, Drammen, Norway
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Settineri S, Frisone F, Merlo EM, Geraci D, Martino G. Compliance, adherence, concordance, empowerment, and self-management: five words to manifest a relational maladjustment in diabetes. J Multidiscip Healthc 2019; 12:299-314. [PMID: 31118655 PMCID: PMC6499139 DOI: 10.2147/jmdh.s193752] [Citation(s) in RCA: 34] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2018] [Accepted: 01/23/2019] [Indexed: 12/15/2022] Open
Abstract
Background: The pathological reality of diabetes and the incidents in following the prescribed therapies have been considered and are still a serious and relevant problem in the health sector. Objective: This review aims at highlighting the importance of clinical psychological phenomena that underlie the notion of therapies. Methods: The review was conducted through search engines such as PubMed, Medline, Web of Science and Google Scholar. The articles related to compliance, adherence, concordance, empowerment and the self-management of diabetes were included, in order to highlight the possible similarities and differences that these terms bring with them in them management of diabetes. Results: Starting from 252 initial publications, 101 articles were selected that highlighted the practical implications that each term has compared to the others. Conclusion: The review can represent a bridge between the medical approach and clinical psychology, in which integration can suggest paths aiming at improving patients' existential conditions and adaptation.
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Affiliation(s)
- Salvatore Settineri
- Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
| | - Fabio Frisone
- Department of Cognitive Sciences, Psychology, Educational and Cultural Studies (COSPECS), University of Messina, Messina, Italy
| | - Emanuele Maria Merlo
- Department of Cognitive Sciences, Psychology, Educational and Cultural Studies (COSPECS), University of Messina, Messina, Italy
| | - Daniele Geraci
- Department of Clinical and Experimental Medicine, University of Messina, Italy
| | - Gabriella Martino
- Department of Clinical and Experimental Medicine, University of Messina, Italy
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