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Current Practice of Stress Ulcer Prophylaxis in Surgical Departments in Mecklenburg Western Pomerania, Germany. Healthcare (Basel) 2021; 9:healthcare9111490. [PMID: 34828536 PMCID: PMC8625761 DOI: 10.3390/healthcare9111490] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/07/2021] [Revised: 10/31/2021] [Accepted: 10/31/2021] [Indexed: 11/20/2022] Open
Abstract
Background: Despite the growing concern over its potentially severe side effects and considerable economic burden, stress ulcer prophylaxis (SUP) is still frequently prescribed to patients in medical non-intensive care units. Recent data indicate that the situation is similar in surgical departments. Currently, data on the concepts within and regulation of routine SUP practice in surgical departments are sparse. The present study was designed to examine the current practice of SUP in Mecklenburg West Pomerania, Germany, and to identify possible reasons for the dissociation of medical literature and clinical practice. Methods: A questionnaire-based survey was conducted to elucidate current SUP practices in surgical departments of acute care hospitals in Mecklenburg Western Pomerania, Germany. Results: In most surgical departments (68%), a standard operating procedure (SOP) for SUP had not been developed. In departments with an existing SOP, 47.6% of responding medical staff members (MSM) with prescribing authority did not know of its existence. Of the MSMs aware of the existence of an SUP-SOP, only 42.9% indicated that they were familiar with its content. Critical re-evaluation of SUP indications upon transfer from the intensive care unit (ICU) to the general hospital ward (GHW) and before hospital discharge was performed frequently or systematically by only about half of the responding MSMs. Discussion: In the face of continued massive over-prescription of SUP in the perioperative routine, the development of easy-to-use local guidelines and their strict implementation in the clinical routine, as well as intensified medial education on this subject, may be effective tools to reduce acid-suppressive medication (ASM) associated side effects and economic burden.
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Mehta P, Nahass RG, Brunetti L. Acid Suppression Medications During Hospitalization as a Risk Factor for Recurrence of Clostridioides difficile Infection: Systematic Review and Meta-analysis. Clin Infect Dis 2021; 73:e62-e68. [PMID: 32386313 DOI: 10.1093/cid/ciaa545] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/01/2020] [Accepted: 05/05/2020] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Studies have had conflicting results regarding the influence of acid-suppression medications (ASMs) during hospitalization on the recurrence of Clostridioides difficile infection (CDI). METHODS A systematic review and meta-analysis investigating the association between recurrent CDI and ASM use in inpatients was performed. Relevant literature was identified using Medline, Google Scholar, and Web of Science. All human studies were considered regardless of publication date. Case-control and cohort studies and clinical trials were included if they contained the necessary information to calculate appropriate statistics related to the objective of this study. Review articles, meta-analyses, and commentaries were excluded; however, their references were searched to identify any studies missed. The random-effects model was selected since significant heterogeneity in study design was identified. To evaluate the sensitivity of the analysis various subgroup analyses were performed. RESULTS Our search identified 9 studies involving 5668 patients of whom 1003 (17.7%) developed recurrent CDI. Patients on ASM were 64% more likely to develop recurrent CDI than patients not on ASM (OR, 1.64; 95% CI, 1.13-2.38; P = .009; I2 = 79.54%). Proton pump inhibitor (PPI) use was associated with an 84% increased risk of recurrent CDI versus no ASM (OR, 1.84; 95% CI, 1.18-2.85; P = .007; I2 = 83.4%). CONCLUSIONS ASM use during hospitalization was associated with a 64% increase in recurrent CDI. The association was greater with PPI use. Due to significant heterogeneity in the analyses, additional studies are essential to further elucidate iatrogenic effects of ASM. Unnecessary PPI use should be discontinued.
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Affiliation(s)
- Palna Mehta
- Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey; Piscataway, New Jersey, USA
| | - Ronald G Nahass
- Department of Infection Prevention, Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, USA.,ID Care, Hillsborough, New Jersey, USA
| | - Luigi Brunetti
- Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey; Piscataway, New Jersey, USA.,Center of Excellence in Pharmaceutical Translational Research and Education, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, New Jersey, USA
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Meriggi F. Controversial link between proton pump inhibitors and anticancer agents: review of the literature. TUMORI JOURNAL 2021; 108:204-212. [PMID: 34159850 DOI: 10.1177/03008916211025091] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/27/2022]
Abstract
Drug-drug interactions represent a topic of great interest, not only due to the risk of unexpected adverse events but also due to the possibility of altering the effectiveness of a specific treatment. Inappropriate or concomitant use of drugs can often lead to changes in the bioavailability of various compounds, resulting in pharmacokinetic alterations. A recent example is the concomitant administration of proton pump inhibitors (PPIs) and anticancer agents. PPIs are overused beyond their classic indications, resulting in a high risk of interactions with other drugs, such as anticancer agents, both PO and intravenous. However, the real clinical impact of concomitant acid suppression therapy and anticancer therapies remains controversial and is not yet fully understood. Certainly, the gut microbiota plays a key role in regulating the response of the immune system, and PPIs can significantly alter the gut microbiome, resulting in gut dysbiosis. Indeed, while the link sometimes appears to lead to negative outcomes, as in the case of immunotherapy, oral capecitabine, or tyrosine kinase inhibitors, in other cases, it seems to enhance the effectiveness of intravenous chemotherapy. In this review, I analyse the possible drug interactions between PPIs and the main classes of anticancer drugs.
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Affiliation(s)
- Fausto Meriggi
- Oncology Department, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
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Liu Y, Li D, Wen A. Pharmacologic Prophylaxis of Stress Ulcer in Non-ICU Patients: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials. Clin Ther 2020; 42:488-498.e8. [PMID: 32046894 DOI: 10.1016/j.clinthera.2020.01.008] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2019] [Revised: 01/07/2020] [Accepted: 01/14/2020] [Indexed: 02/07/2023]
Abstract
PURPOSE Acid-suppressive medications are widely used in non-intensive care unit (non-ICU) patients for stress ulcer (SU) prophylaxis. However, SU prophylaxis in this population is still controversial. The purpose of this study was to systematically evaluate the efficacy and tolerability of these agents for SU prophylaxis in non-ICU patients. METHODS Electronic databases including Cochrane, ClinicalTrials.gov, Ovid-Medline, Embase, Chinese CNKI, and Wanfang Data were systematically searched on July 10, 2019, for randomized controlled trials (RCTs) that evaluated acid-suppressive medications in non-ICU patients. Network meta-analysis and pairwise meta-analysis were performed to calculate odds ratios (ORs) and 95% CIs. A random-effects model was used for generating pooled estimates. The primary outcome was occurrence of SU bleeding, and the adverse drug events (ADEs) were described as the secondary outcome. FINDINGS A total of 17 RCTs involving 1985 patients were eligible. Meta-analysis results indicated that the occurrence of SU bleeding was significantly decreased with all acid-suppressive medications compared with placebos (gastric mucosa protectants, OR = 0.29 [95% CI, 0.14-0.61]; H2-receptor antagonists, OR = 0.3 [95% CI, 0.18-0.50]; proton pump inhibitors [PPIs]: OR = 0.08 [95% CI, 0.04-0.16]). The occurrence of SU bleeding was significantly decreased with PPIs compared with gastric mucosa protectants (OR = 0.29; 95% CI, 0.12-0.72) and H2-receptor antagonists (OR = 0.28; 95% CI, 0.16-0.48). There was no significant difference between any 2 classes of PPIs on SU bleeding or any 2 acid-suppressive medications on ADEs. IMPLICATIONS PPIs could significantly decrease SU bleeding risk without increasing ADEs than other acid-suppressive medications for SU prophylaxis in non-ICU patients. However, RCTs of high quality were required to confirm the findings of this investigation.
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Affiliation(s)
- Yi Liu
- Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China
| | - Dandan Li
- Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China
| | - Aiping Wen
- Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
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Abstract
GOAL The goal of this study was to reduce the percentage of inappropriately prescribed proton pump inhibitors (PPIs) in patients aged 50 and older from 80% (baseline) to 60% within 12 months in an academic, internal medicine clinic. BACKGROUND The use of PPIs has increased drastically worldwide. Internal medicine clinic patients had inappropriate use of PPIs for an average of 4 to 5 years. STUDY A multidisciplinary quality improvement team used the Plan-Do-Study-Act Model of health care improvement and performed a root cause analysis to identify barriers to inappropriate use of PPIs. The outcome measure was the percentage of patients inappropriately prescribed PPI. Process measures were completion rates of PPI risk assessment and esophagogastroduodenoscopy. Interventions included the creation of customized electronic health record templates and education to providers and patients. Analysis was performed using monthly statistical process control charts. RESULTS The average rate of PPI discontinuation was 51.1% (n=92/180), which corresponds to 30.0% inappropriate PPI usage within 12 months. The mean PPI discontinuation rate in the 1-year prestudy, study and 6 months poststudy period was 2.0%, 32.0%, and 49.7%, respectively. The mean esophagogastroduodenoscopy completion rate was 49.8% from the baseline of <30%. CONCLUSIONS We achieved a statistically significant and sustainable reduction of inappropriate PPI use to 30% from the baseline rates of 80% and surpassed our goal within 12 months. This quality improvement was unique as no pharmacy personnel was utilized in this process. The multifaceted strategies in a safety-net internal medicine clinic resulted in successful deprescribing of PPI and can be replicated in other setting.
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Proton-Pump Inhibitors and Hypomagnesaemia in Kidney Transplant Recipients. J Clin Med 2019; 8:jcm8122162. [PMID: 31817776 PMCID: PMC6947083 DOI: 10.3390/jcm8122162] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2019] [Revised: 12/01/2019] [Accepted: 12/04/2019] [Indexed: 02/06/2023] Open
Abstract
Proton-pump inhibitors (PPIs) are commonly used after kidney transplantation and there is rarely an incentive to discontinue treatment. In the general population, PPI use has been associated with hypomagnesaemia. We aimed to investigate whether PPI use is associated with plasma magnesium, 24-h urinary magnesium excretion and hypomagnesaemia, in kidney transplant recipients (KTR). Plasma magnesium and 24-h urinary magnesium excretion were measured in 686 stable outpatient KTR with a functioning allograft for ≥1 year from the TransplantLines Food and Nutrition Biobank and Cohort-Study (NCT02811835). PPIs were used by 389 KTR (56.6%). In multivariable linear regression analyses, PPI use was associated with lower plasma magnesium (β: −0.02, P = 0.02) and lower 24-h urinary magnesium excretion (β: −0.82, P < 0.001). Moreover, PPI users had a higher risk of hypomagnesaemia (plasma magnesium <0.70 mmol/L), compared with non-users (Odds Ratio (OR): 2.12; 95% confidence interval (CI) 1.43–3.15, P < 0.001). This risk tended to be highest among KTR taking high PPI dosages (>20 mg omeprazole Eq/day) and was independent of adjustment for potential confounders (OR: 2.46; 95% CI 1.32–4.57, P < 0.005). No interaction was observed between PPI use and the use of loop diuretics, thiazide diuretics, tacrolimus, or diabetes (Pinteraction > 0.05). These results demonstrate that PPI use is independently associated with lower magnesium status and hypomagnesaemia in KTR. The concomitant decrease in urinary magnesium excretion indicates that this likely is the consequence of reduced intestinal magnesium absorption. Based on these results, it might be of benefit to monitor magnesium status periodically in KTR on chronic PPI therapy.
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The Phylogeny and Biological Function of Gastric Juice-Microbiological Consequences of Removing Gastric Acid. Int J Mol Sci 2019; 20:ijms20236031. [PMID: 31795477 PMCID: PMC6928904 DOI: 10.3390/ijms20236031] [Citation(s) in RCA: 47] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/03/2019] [Revised: 11/24/2019] [Accepted: 11/25/2019] [Indexed: 12/15/2022] Open
Abstract
Gastric juice is a unique combination of hydrochloric acid (HCl), lipase, and pepsin. Acidic gastric juice is found in all vertebrates, and its main function is to inactivate microorganisms. The phylogenetic preservation of this energy-consuming and, at times, hazardous function (acid-related diseases) reflects its biological importance. Proton pump inhibitors (PPIs) are one of the most widely used drugs in the world. Due to the reduced prevalence of Helicobacter pylori infection as well as the increased use of inhibitors of gastric acid secretion, the latter has become the most important cause of gastric hypoacidity. In the present manuscript, we review the microbiological consequences of removing gastric acidity. The resulting susceptibility to infections has not been studied extensively, and focus has mainly been restricted to bacterial and parasitic agents only. The strongest evidence concerning the relationship between hypochlorhydria and predisposition to infections relates to bacterial infections affecting the gastrointestinal tract. However, several other clinical settings with increased susceptibility to infections due to inhibited gastric acidity are discussed. We also discuss the impact of hypochlorhydria on the gut microbiome.
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Cardiovascular and non-cardiovascular concerns with proton pump inhibitors: Are they safe? Trends Cardiovasc Med 2019; 29:353-360. [DOI: 10.1016/j.tcm.2018.10.008] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/16/2018] [Revised: 10/09/2018] [Accepted: 10/16/2018] [Indexed: 12/11/2022]
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Adverse outcomes of long-term use of proton pump inhibitors: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2018; 30:1395-1405. [PMID: 30028775 DOI: 10.1097/meg.0000000000001198] [Citation(s) in RCA: 60] [Impact Index Per Article: 8.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
The association between the long-term use of proton pump inhibitors (PPIs) and the risks of various diseases remains controversial. Therefore, the primary objective of this study was to quantify the associations as presented in the literature and to also provide this information to healthcare professionals and patients about their potentially adverse effects. In July 2016, we searched through Medline (PubMed), Embase, and the Cochrane Library from inception using common keywords. We included observational studies that provided risk estimates on the long-term use of PPIs and their adverse effects. Overall, 43 studies were included in the systematic review, of which 28 studies were also included in the random effect meta-analysis. Odds of community-acquired pneumonia, hip fracture, and colorectal cancer were 67% [odds ratio (OR)=1.67; 95% confidence interval (CI): 1.04-2.67], 42% (OR=1.42; 95% CI: 1.33-1.53), and 55% (OR=1.55; 95% CI: 0.88-2.73) higher in patients with long-term PPIs use compared with patients who did not use PPIs. Although the use of PPIs provides short-term health benefits, their prolonged use is associated with minor and also potentially major adverse health outcomes. Hence, we strongly recommend that the prescription of PPIs should be done with caution to improve the medication's efficacy and patients' safety.
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10
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Jaynes M, Kumar AB. The risks of long-term use of proton pump inhibitors: a critical review. Ther Adv Drug Saf 2018; 10:2042098618809927. [PMID: 31019676 PMCID: PMC6463334 DOI: 10.1177/2042098618809927] [Citation(s) in RCA: 138] [Impact Index Per Article: 19.7] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2018] [Accepted: 09/28/2018] [Indexed: 12/17/2022] Open
Abstract
Proton pump inhibitors (PPIs) are among the most frequently prescribed
medications. Their use is likely even higher than estimated due to an increase
in the number of PPIs available without a prescription. Appropriate indications
for PPI use include Helicobacter pylori infection, erosive
esophagitis, gastric ulcers, and stress ulcer prevention in high-risk critically
ill patients. Unfortunately, PPIs are often used off-label for extended periods
of time. This increase in PPI usage over the past two decades has called into
question the long-term effects of these medications. The association between PPI
use and infection, particularly Clostridium difficile and
pneumonia, has been the subject of several studies. It’s proposed that
the alteration in gastrointestinal microflora by PPIs produces an environment
conducive to development of these types of infections. At least one study has
suggested that long-term PPI use increases the risk of dementia. Drug
interactions are an important and often overlooked consideration when
prescribing any medication. The potential interaction between PPIs and
antiplatelet agents has been the subject of multiple studies. One of the more
recent concerns with PPI use is their role in the development or progression of
chronic kidney disease. There is also some literature suggesting that PPIs
contribute to the development of various micronutrient deficiencies. Most of the
literature examining the potential adverse effects of PPI use is composed of
retrospective, observation studies. There is a need for higher quality studies
exploring this relationship.
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Affiliation(s)
- Megan Jaynes
- Division of Critical Care, Department of Pharmacy, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Avinash B Kumar
- Division of Critical Care, Department of Anesthesiology, Vanderbilt University, Nashville, TN 37212, USA
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11
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Schultz K, Sickbert-Bennett E, Marx A, Weber DJ, DiBiase LM, Campbell-Bright S, Bode LE, Baker M, Belhorn T, Buchanan M, Goldbach S, Harden J, Hoke E, Huenniger B, Juliano JJ, Langston M, Ritchie H, Rutala WA, Smith J, Summerlin-Long S, Teal L, Gilligan P. Preventable Patient Harm: a Multidisciplinary, Bundled Approach to Reducing Clostridium difficile Infections While Using a Glutamate Dehydrogenase/Toxin Immunochromatographic Assay/Nucleic Acid Amplification Test Diagnostic Algorithm. J Clin Microbiol 2018; 56:e00625-18. [PMID: 29997201 PMCID: PMC6113472 DOI: 10.1128/jcm.00625-18] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/16/2018] [Accepted: 07/05/2018] [Indexed: 12/18/2022] Open
Abstract
Health care facility-onset Clostridium difficile infections (HO-CDI) are an important national problem, causing increased morbidity and mortality. HO-CDI is an important metric for the Center for Medicare and Medicaid Service's (CMS) performance measures. Hospitals that fall into the worst-performing quartile in preventing hospital-acquired infections, including HO-CDI, may lose millions of dollars in reimbursement. Under pressure to reduce CDI and without a clear optimal method for C. difficile detection, health care facilities are questioning how best to use highly sensitive nucleic acid amplification tests (NAATs) to aid in the diagnosis of CDI. Our institution has used a two-step glutamate dehydrogenase (GDH)/toxin immunochromatographic assay/NAAT algorithm since 2009. In 2016, our institution set an organizational goal to reduce our CDI rates by 10% by July 2017. We achieved a statistically significant reduction of 42.7% in our HO-CDI rate by forming a multidisciplinary group to implement and monitor eight key categories of infection prevention interventions over a period of 13 months. Notably, we achieved this reduction without modifying our laboratory algorithm. Significant reductions in CDI rates can be achieved without altering sensitive laboratory testing methods.
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Affiliation(s)
- Katherine Schultz
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | | | - Ashley Marx
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - David J Weber
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
- Division of Adult Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
| | - Lauren M DiBiase
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Stacy Campbell-Bright
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
- Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA
| | - Lauren E Bode
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Mike Baker
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Tom Belhorn
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Mark Buchanan
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Sherie Goldbach
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Jacci Harden
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Emily Hoke
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Beth Huenniger
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Jonathan J Juliano
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
- Division of Adult Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
| | - Michael Langston
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Heather Ritchie
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - William A Rutala
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Jason Smith
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | | | - Lisa Teal
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
| | - Peter Gilligan
- University of North Carolina Medical Center, Chapel Hill, North Carolina, USA
- Clinical Microbiology-Immunology Laboratories, UNC Health Care, Chapel Hill, North Carolina, USA
- Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
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Savarino V, Dulbecco P, de Bortoli N, Ottonello A, Savarino E. The appropriate use of proton pump inhibitors (PPIs): Need for a reappraisal. Eur J Intern Med 2017; 37:19-24. [PMID: 27784575 DOI: 10.1016/j.ejim.2016.10.007] [Citation(s) in RCA: 190] [Impact Index Per Article: 23.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2016] [Accepted: 10/10/2016] [Indexed: 12/12/2022]
Abstract
The advent of powerful acid-suppressive drugs, such as proton pump inhibitors (PPIs), has revolutionized the management of acid-related diseases and has minimized the role of surgery. The major and universally recognized indications for their use are represented by treatment of gastro-esophageal reflux disease, eradication of Helicobacter pylori infection in combination with antibiotics, therapy of H. pylori-negative peptic ulcers, healing and prophylaxis of non-steroidal anti-inflammatory drug-associated gastric ulcers and control of several acid hypersecretory conditions. However, in the last decade, we have witnessed an almost continuous growth of their use and this phenomenon cannot be only explained by the simple substitution of the previous H2-receptor antagonists, but also by an inappropriate prescription of these drugs. This endless increase of PPI utilization has created an important problem for many regulatory authorities in terms of increased costs and greater potential risk of adverse events. The main reasons for this overuse of PPIs are the prevention of gastro-duodenal ulcers in low-risk patients or the stress ulcer prophylaxis in non-intensive care units, steroid therapy alone, anticoagulant treatment without risk factors for gastro-duodenal injury, the overtreatment of functional dyspepsia and a wrong diagnosis of acid-related disorder. The cost for this inappropriate use of PPIs has become alarming and requires to be controlled. We believe that gastroenterologists together with the scientific societies and the regulatory authorities should plan educational initiatives to guide both primary care physicians and specialists to the correct use of PPIs in their daily clinical practice, according to the worldwide published guidelines.
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Affiliation(s)
- Vincenzo Savarino
- Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy.
| | - Pietro Dulbecco
- Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy
| | - Nicola de Bortoli
- Department of Translational Research and New Technology in Medicine and Surgery, Division of Gastroenterology, University of Pisa, Cisanello Hospital, Pisa, Italy
| | - Andrea Ottonello
- Department of Surgical and Diagnostic Integrated Sciences, University of Genoa, Genoa, Italy
| | - Edoardo Savarino
- Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy
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Daure E, Ross L, Webster CRL. Gastroduodenal Ulceration in Small Animals: Part 2. Proton Pump Inhibitors and Histamine-2 Receptor Antagonists. J Am Anim Hosp Assoc 2016; 53:11-23. [PMID: 27841679 DOI: 10.5326/jaaha-ms-6634] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
In the first part of this review, we discussed the pathophysiology and epidemiology of gastric acid secretion and the epidemiology of gastroduodenal ulceration in dogs and cats. In this section, we discuss the pharmacology and evidence-based clinical use of histamine-2 receptor antagonists and proton pump inhibitors.
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Affiliation(s)
- Evence Daure
- From the Centre Vétérinaire Daubigny, Quebec, Canada (E.D.); and the Department of Clinical Sciences, Cummings School of Veterinary Medicine at Tufts University, North Grafton, Massachusetts (L.R., C.R.L.W.)
| | - Linda Ross
- From the Centre Vétérinaire Daubigny, Quebec, Canada (E.D.); and the Department of Clinical Sciences, Cummings School of Veterinary Medicine at Tufts University, North Grafton, Massachusetts (L.R., C.R.L.W.)
| | - Cynthia R L Webster
- From the Centre Vétérinaire Daubigny, Quebec, Canada (E.D.); and the Department of Clinical Sciences, Cummings School of Veterinary Medicine at Tufts University, North Grafton, Massachusetts (L.R., C.R.L.W.)
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14
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Agee C, Coulter L, Hudson J. Effects of pharmacy resident led education on resident physician prescribing habits associated with stress ulcer prophylaxis in non-intensive care unit patients. Am J Health Syst Pharm 2016; 72:S48-52. [PMID: 25991596 DOI: 10.2146/sp150013] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
OBJECTIVE Overutilization of stress ulcer prophylaxis in both critically and noncritically ill patients poses significant health risks and increases healthcare costs. The purpose of this study was to assess the impact of education for appropriate stress ulcer prophylaxis prescribing by Family Medicine Resident Physicians. METHODS The study evaluated the SUP prescribing and continuation or discontinuation of acid suppressive therapy upon discharge. Patients admitted to the Family Medicine Residency team at Washington Regional Medical Center were retrospectively assessed from September through November 2011. In January 2012, an educational seminar describing appropriate stress ulcer prophylaxis indications, the associated risks and costs of acid suppressive therapy, and initial findings was provided. After the educational intervention, patients admitted to the Family Medicine Residency team were retrospectively followed from February through April 2012 to assess the impact of the educational intervention. RESULTS Post education analysis demonstrated a decrease in inappropriate stress ulcer prophylaxis prescribing from 55.5% to 30.5% (p < 0.0001). There was no statistically significant difference between the pre-intervention (5.5%) and post-intervention (8.3%) groups in regards to patients discharged on AST inappropriately (p = 0.627). CONCLUSION Pharmacist led educational sessions improved appropriateness of stress ulcer prophylaxis prescribing by Family Practice Resident Physicians, leading to patient risk avoidance and cost savings..
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Affiliation(s)
- Christina Agee
- PGY-1 Pharmacy Practice Resident, University of Arkansas for Medical Sciences Northwest, Fayetteville, AR
| | - Lois Coulter
- Associate Professor, Residency Program Director, University of Arkansas for Medical Sciences Northwest, Fayetteville, AR
| | - Jonell Hudson
- Assistant Professor University of Arkansas for Medical Sciences Northwest, Fayetteville, AR
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15
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Schepisi R, Fusco S, Sganga F, Falcone B, Vetrano DL, Abbatecola A, Corica F, Maggio M, Ruggiero C, Fabbietti P, Corsonello A, Onder G, Lattanzio F. Inappropriate Use of Proton Pump Inhibitors in Elderly Patients Discharged from Acute Care Hospitals. J Nutr Health Aging 2016; 20:665-70. [PMID: 27273358 DOI: 10.1007/s12603-015-0642-5] [Citation(s) in RCA: 39] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Proton-pump inhibitors (PPI) are extensively prescribed in older patients. However, little information is available on factors associated to PPI prescribing patterns among older patients discharged from hospital. OBJECTIVE To evaluate the appropriateness and clinical correlates of PPI prescription at discharge in a population of 1081 older patients discharged from acute care Italian hospitals. DESIGN We used data from the CRiteria to Assess Appropriate Medication Use among Elderly Complex Patients (CRIME) study, a multicenter observational study. The appropriateness of PPI prescriptions was defined according to the Italian Medicines Agency (AIFA) rules. Correlates of overprescribing (i.e prescribing without recognized AIFA indications) and underprescribing (i.e. not prescribing despite the presence of recognized AIFA indications) were investigated by logistic regression analysis. RESULTS Overprescribing was observed in 30% of patients receiving PPIs at discharge. Underprescribing was observed in 11% of patients not receiving PPIs at discharge. Overprescribing of PPIs at discharge was negatively associated with age (OR=0.88, 95%CI=0.85-0.91), depression (OR=0.58, 95%CI=0.35-0.96), use of aspirin (OR=0.03, 95%CI=0.02-0.06) and systemic corticosteroids (OR=0.02, 95%CI=0.01-0.04). The negative association with number of medications (OR=0.95, 95%CI=0.88-1.03) and overall comorbidities (OR=0.92, 95%CI=0.83-1.02) was nearly significant. Conversely, older age (OR=1.09, 95%CI=1.04-1.14), use of aspirin (OR=24.0, 95%CI=11.5-49.8) and systemic corticosteroids (OR=19.3, 95%CI=11.5-49.8) and overall comorbidities (OR=1.22, 95%CI=1.04-1.42) were independent correlates of underprescribing. CONCLUSION Overprescribing of PPIs is more frequent in younger patients with lower burden of depression, whilst underprescribing is characterized by older age and greater burden of comorbidity and polypharmacy. Hospitalization should be considered as a clue to identify inappropriate use of PPIs and improve appropriateness of prescribing.
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Affiliation(s)
- R Schepisi
- Sergio Fusco, MD, Unit of Geriatric Pharmacopidemiology, Italian National Research Centre on Aging, Cosenza, Italy, C. da Muoio Piccolo, 87100 Cosenza, Italy, Phone +39 0984682050, Fax +39 0984682343, E-mail:
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Chia CTW, Lim WP, Vu CKF. Inappropriate use of proton pump inhibitors in a local setting. Singapore Med J 2015; 55:363-6. [PMID: 25091884 DOI: 10.11622/smedj.2014087] [Citation(s) in RCA: 41] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
Abstract
INTRODUCTION There are growing concerns that the use of proton pump inhibitors (PPIs) may be inappropriate in instances that do not conform to evidence-based indications. This point-prevalence study aimed to investigate the frequency, indications and appropriateness of use of PPIs in hospitalised patients on a randomly chosen day. METHODS On a randomly chosen day, all inpatients were documented, and those on any form of PPIs on that day were determined. Indications for maintaining these patients on PPIs were obtained from the electronic medical records, which were then recorded and cross-referenced against a list of accepted indications adapted from the US Food and Drug Administration (FDA)-approved list. RESULTS In all, 1,025 inpatients were documented. Of the 477 (46.5%) inpatients using PPIs, only 219 (45.9%) fulfilled the FDA-approved indications, while the majority (n = 258, 54.1%) did not. Overall, PPIs were not strictly indicated for use in 206 (43.2%) inpatients, according to FDA criteria. Of the 477 inpatients on PPIs, 52 (10.9%) had borderline indications based on expert consensus/guidelines other than FDA criteria. CONCLUSION Although the use of PPIs is prevalent in hospitals, less than half of the hospitalised patients using PPIs in our study had evidence-based indications that supported such use. The overuse of PPIs has a negative impact on healthcare costs and may lead to adverse effects. Steps to curb the inappropriate use of PPIs should address factors such as indications for the initiation of PPIs, and reassessment of the need for ongoing PPI use in inpatients upon discharge and during outpatient reviews.
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Affiliation(s)
- Christopher Tze Wei Chia
- Department of Gastroenterology and Hepatology, Tan Tock Seng Hospital, 11 Jalan Tan Tock Seng, Singapore 308433.
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Multimorbidities and Overprescription of Proton Pump Inhibitors in Older Patients. PLoS One 2015; 10:e0141779. [PMID: 26535585 PMCID: PMC4633104 DOI: 10.1371/journal.pone.0141779] [Citation(s) in RCA: 34] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2015] [Accepted: 10/13/2015] [Indexed: 12/11/2022] Open
Abstract
OBJECTIVES To determine whether there is an association between overprescription of proton pump inhibitors (PPIs) and multimorbidities in older patients. DESIGN Multicenter prospective study. SETTING Acute geriatric medicine at the University Hospital of Nantes and the Hospital of Saint-Nazaire. PARTICIPANTS Older patients aged 75 and over hospitalized in acute geriatric medicine. MEASUREMENTS Older patients in acute geriatric medicine who received proton pump inhibitors. Variables studied were individual multimorbidities, the burden of multimorbidity evaluated by the Cumulative Illness Rating Scale, age, sex, type of residence (living in nursing home or not), functional abilities (Lawton and Katz scales), nutritional status (Body Mass Index), and the type of concomitant medications (antiaggregant, corticosteroids', or anticoagulants). RESULTS Overprescription of proton pump inhibitors was found in 73.9% older patients. In the full model, cardiac diseases (odds ratio [OR] = 4.17, p = 0.010), metabolic diseases (OR = 2.14, p = 0.042) and corticosteroids (OR = 5.39, p = 0.028) were significantly associated with overprescription of proton pump inhibitors. Esogastric diseases (OR = 0.49, p = 0.033) were negatively associated with overprescription of proton pump inhibitors. CONCLUSION Cardiac diseases and metabolic diseases were significantly associated with overprescription of proton pump inhibitors.
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Ho SW, Hsieh MJ, Yang SF, Yeh YT, Wang YH, Yeh CB. Risk of Stroke-Associated Pneumonia With Acid-Suppressive Drugs: A Population-Based Cohort Study. Medicine (Baltimore) 2015. [PMID: 26200649 PMCID: PMC4603020 DOI: 10.1097/md.0000000000001227] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/15/2023] Open
Abstract
Acid-suppressive drugs, including histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), are common medications used for treating upper gastrointestinal tract disorders. However, acid-suppressive drugs have been reported to increase the risk of pneumonia in numerous disease populations. However, the relationship between acid-suppressive drugs and stroke-associated pneumonia (SAP) remains controversial. The purpose of this study was to investigate the association between acid-suppressive drug usage and pneumonia among patients with stroke by using a nationwide data set. A population-based cohort study was conducted using a data set from the Taiwanese National Health Insurance Research Database. Data on patients with new-onset stroke from 2010 to 2011 were collected. Patients with and without acid-suppressive drug usage were followed up to identify the occurrence of any type of pneumonia. We estimated the adjusted hazard ratios (HRs) by using the Cox proportional hazards model. The study cohort comprised 7965 patients with new-onset stroke. The incidence of pneumonia was 6.9% (552/7965) and more than 40% (225/552) of patients developed pneumonia within 3 months after an acute stroke. Acid-suppressive drug usage was an independent risk factor of pneumonia. The adjusted HR for the risk of pneumonia in patients with new-onset stroke using acid-suppressive drugs was 1.44 (95% confidence interval [CI] = 1.18-1.75, P < 0.01). Only PPI usage increased risk of chronic SAP (adjusted HR = 1.46, 95% CI = 1.04-2.05). Acid-suppressive drug usage was associated with a slightly increased risk of SAP. Physicians should exercise caution when prescribing acid-suppressive drugs to patients with stroke, particularly at the chronic stage.
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Affiliation(s)
- Sai-Wai Ho
- From the Department of Emergency Medicine, School of Medicine, Chung Shan Medical University (S-WH, C-BY); Department of Emergency Medicine, Chung Shan Medical University Hospital, Taichung (S-WH, C-BY); Cancer Research Center, Changhua Christian Hospital, Changhua (M-JH); Institute of Medicine, Chung Shan Medical University (M-JH, S-FY); Department of Medical Research, Chung Shan Medical University Hospital (SF-Y, Y-HW); School of Dentistry, Chung Shan Medical University (Y-TY); Department of Dentistry, Chung Shan Medical University Hospital, Taichung, Taiwan (Y-TY)
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Martín de Argila de Prados C, Aguilera Castro L, Rodríguez de Santiago E. PPIs: Between overuse and underprescription when really necessary. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2015; 107:649-51. [DOI: 10.17235/reed.2015.4022/2015] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
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Garcia-Martinez I, Francés R, Zapater P, Giménez P, Gómez-Hurtado I, Moratalla A, Lozano-Ruiz B, Bellot P, González-Navajas JM, Such J. Use of proton pump inhibitors decrease cellular oxidative burst in patients with decompensated cirrhosis. J Gastroenterol Hepatol 2015; 30:147-54. [PMID: 25039465 DOI: 10.1111/jgh.12667] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 05/21/2014] [Indexed: 12/25/2022]
Abstract
BACKGROUND AND AIMS Proton pump inhibitors (PPIs) are commonly used antisecretory drugs and have been linked to an increased risk of bacterial infections in cirrhosis. We investigated whether the treatment with PPIs in cirrhosis affects the oxidative burst activity of granulocytes and monocytes and its possible interference with serum norfloxacin (Nflx) levels in these patients. METHODS 70 patients with cirrhosis and ascitic fluid and 24 healthy controls were included in the study and distributed into groups according to the regular use of PPIs and/or norfloxacin. The blood granulocyte and monocyte's phagocytic activity and oxidative burst were evaluated by flow cytometry. Blood levels of norfloxacin were measured by HPLC and bacterial translocation was evaluated by detection of bacterial DNA in blood. RESULTS Use of PPIs was associated with a decreased granulocyte and monocyte oxidative burst, but not of phagocytic activity, as compared with patients not receiving PPIs. PPIs use did not affect serum norfloxacin levels in patients. A not significant trend to an increased bacterial DNA translocation was observed in patients receiving PPIs, including patients simultaneously receiving norfloxacin. CONCLUSIONS PPIs significantly decrease cellular oxidative burst in cirrhosis. This fact may provide a pathogenic explanation to the reported high rates of bacterial infections in this setting, and strongly suggests that PPIs should only be used in patients with cirrhosis when clinically indicated.
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Herzig SJ, Doughty C, Lahoti S, Marchina S, Sanan N, Feng W, Kumar S. Acid-suppressive medication use in acute stroke and hospital-acquired pneumonia. Ann Neurol 2014; 76:712-8. [PMID: 25164323 DOI: 10.1002/ana.24262] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/11/2014] [Revised: 07/24/2014] [Accepted: 08/22/2014] [Indexed: 01/09/2023]
Abstract
OBJECTIVE Pneumonia is a morbid complication of stroke, but evidence-based strategies for its prevention are lacking. Acid-suppressive medications have been associated with increased risk for nosocomial pneumonia in hospitalized patients. It is unclear whether these results can be extrapolated to stroke patients, where other factors strongly modulate pneumonia risk. We investigated the association between acid-suppressive medication and hospital-acquired pneumonia in patients with acute stroke. METHODS All patients hospitalized with acute ischemic stroke or intracerebral hemorrhage in a large, urban academic medical center in Boston, Massachusetts from June 2000 to June 2010 who were ≥18 years of age and hospitalized for ≥2 days were eligible for inclusion. Acid-suppressive medication use was defined as any pharmacy charge for a proton-pump inhibitor or histamine-2 receptor antagonist. Multivariate logistic regression was used to control for confounders. The main outcome measure was hospital-acquired pneumonia, defined via International Classification of Diseases, Ninth Revision, Clinical Modification codes. RESULTS The cohort comprised 1,676 admissions. Acid-suppressive medication was ordered in 1,340 (80%) and hospital-acquired pneumonia occurred in 289 (17.2%). The unadjusted incidence of hospital-acquired pneumonia was higher in the group exposed to acid-suppressive medication compared to those unexposed (20.7% vs 3.6%, odds ratio [OR] = 7.0, 95% confidence interval [CI] = 3.9-12.7). After adjustment, the OR of hospital-acquired pneumonia in the exposed group was 2.3 (95% CI = 1.2-4.6). The association was significant for proton-pump inhibitors (OR = 2.7, 95% CI = 1.4-5.4), but not for histamine-2 receptor antagonists (OR = 1.6, 95% CI = 0.8-3.4). INTERPRETATION In this large hospital-based cohort of patients presenting with acute stroke, acid-suppressive medication use was associated with increased odds of hospital-acquired pneumonia.
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Affiliation(s)
- Shoshana J Herzig
- Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA
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Owen C, Panesar P, Marks DJB, Banks M. The dangers of proton pump inhibitor therapy. Br J Hosp Med (Lond) 2014; 75:C108-12. [DOI: 10.12968/hmed.2014.75.sup7.c108] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/25/2023]
Affiliation(s)
| | | | - Daniel JB Marks
- Specialty Registrar in Clinical Pharmacology and Therapeutics
| | - Matthew Banks
- Consultant Gastroenterologist, University College London Hospital NHS Foundation Trust, London NW1 2BU
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Ladd AM, Panagopoulos G, Cohen J, Mar N, Graham R. Potential costs of inappropriate use of proton pump inhibitors. Am J Med Sci 2014; 347:446-451. [PMID: 24270078 DOI: 10.1097/maj.0b013e31829f87d5] [Citation(s) in RCA: 39] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND Proton pump inhibitors (PPIs) are commonly overused in hospitalized patients. The objectives of this study were to determine the extent of their inappropriate initiation in patients with low risk for gastrointestinal hemorrhage, factors associated with their continuation on discharge and potential cost of this trend. METHODS Retrospective examination of patients with low risk for gastrointestinal hemorrhage admitted to a tertiary-care teaching hospital over a 3-month period who received esomeprazole. The following information was collected: age, gender, PPI status (de novo or continued) and admitting diagnoses. Additional information collected from the de novo subgroup included indication for PPI, number of days on PPI and continuation of the drug on discharge. The cost of the medication was obtained from pharmacy records. RESULTS Four hundred nine patients were admitted during the study period and 204 (49.9%) received PPI de novo. Among these, 155 patients (76%) had an inappropriate indication for PPI. Of these, 62 (40%) patients were continued on PPI on discharge. Older age was a significant predictor of continuation of PPI at discharge. The estimated cost of the inpatient and outpatient inappropriate use of PPI was $12,272 and $59,272, respectively. CONCLUSIONS PPIs are overused in the majority of hospitalized patients with low risk for gastrointestinal bleeding and this practice gets perpetuated at discharge, especially in older patients. The cost of this phenomenon is alarming.
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Affiliation(s)
- Antonio Mendoza Ladd
- Division of Gastroenterology (AML), Department of Medicine (JC, NM, RG), Department of Internal Medicine, Lenox Hill Hospital (GP), New York, New York
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Concomitant proton pump inhibitors with mycophenolate mofetil and the risk of rejection in kidney transplant recipients. Transplantation 2014; 97:518-24. [PMID: 24162246 DOI: 10.1097/01.tp.0000436100.65983.10] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
BACKGROUND Recent pharmacokinetic studies have demonstrated that proton pump inhibitors (PPI) reduce exposure of mycophenolic acid. However, the clinical significance of this drug-drug interaction on transplantation outcomes has not been determined. METHODS This was a retrospective cohort study in kidney transplant recipients who were prescribed rabbit antithymocyte globulin, calcineurin inhibitor, mycophenolate mofetil, and steroids. We evaluated the impact of PPI use on the 1-year rates of biopsy-proven acute rejection (BPAR). RESULTS Two hundred thirteen patients who were prescribed PPI were compared with 384 patients who were on standard acid-suppressive therapy with ranitidine. BPAR occurred in similar rates in both groups (15% vs. 12%; P=0.31). In a multivariable analysis, black race was associated with a higher risk of rejection (risk ratio [RR], 2.38; 95% confidence interval [CI], 1.41-4.03). While controlling for rejection risk factors, PPI exposure was associated with an increased risk of rejection in black patients (RR, 1.93; 95% CI, 1.18-3.16) but not in non-black patients (RR, 0.54; 95% CI, 0.19-1.49). At 1 year, BPAR type, BPAR grade, patient and graft survival, graft function, and time to BPAR were not associated with PPI exposure. CONCLUSION In this retrospective study, PPI use in the first transplant year was associated with an increased risk for BPAR in black patients but not in non-black patients. It is possible that a reduction in mycophenolic acid exposure contributed to the increased risk.
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Ramírez E, Cabañas R, Laserna LS, Fiandor A, Tong H, Prior N, Calderón O, Medrano N, Bobolea I, Frías J, Quirce S. Proton pump inhibitors are associated with hypersensitivity reactions to drugs in hospitalized patients: a nested case-control in a retrospective cohort study. Clin Exp Allergy 2013; 43:344-52. [PMID: 23414543 DOI: 10.1111/cea.12034] [Citation(s) in RCA: 31] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2012] [Revised: 08/27/2012] [Accepted: 08/29/2012] [Indexed: 11/30/2022]
Abstract
BACKGROUND Previous research has shown that gastric acid suppression by antacid drugs can promote allergic reactions to acid-labile food proteins. No data are available about whether antacid drugs can promote drug hypersensitivity reactions. The most potent and longer lasting inhibition of gastric secretion is provided by proton pump inhibitors (PPIs). We hypothesized that gastric acid suppression by proton pump inhibitors could be causative of drug hypersensitivity reactions during hospitalization. OBJECTIVE To estimate the risk of developing drug hypersensitivity reactions during the hospitalization of patients treated with proton pump inhibitors, and other associated factors. METHODS A nested case-control in a retrospective cohort study of hospitalized patients from September 2008 to December 2010 (70 771 admissions) was conducted using the registry of cases of interconsultations to the Allergy Department (161 confirmed cases of drug hypersensitivity reactions). A total of 318 controls were matched by first drug suspected in the hypersensitivity reaction, time of admission, age, gender and hospitalization wards. RESULTS The relative risk of drug hypersensitivity reaction occurrence during hospitalization of patients treated with PPIs compared with those not treated in the period of study was significant (RR: 3.97; 95% CI: 1.97-8.29). After controlling for confounders in the nested case-control cohort, the use of PPIs persists as a predisposing factor (OR: 4.35; 95% CI: 2-9.45). Personal history of drug allergy and a long hospitalization time were other predisposing factors of drug hypersensitivity reactions (DHRs). The hazard that a DHR has occurred during PPI treatment was 3.7% per day. The hazard for immediate or accelerated reactions was 1.706 (P = 0.003) times that of delayed reactions. CONCLUSION AND CLINICAL RELEVANCE In hospitalized patients, the use of proton pump inhibitors was associated with a significant increase risk of drug hypersensitivity reactions along with a personal history of drug allergies and long hospitalization time.
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Affiliation(s)
- E Ramírez
- Department of Clinical Pharmacology, Hospital La Paz Health Research Institute (IdiPAZ), School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
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Pareek A, Chandurkar N. Comparison of gastrointestinal safety and tolerability of aceclofenac with diclofenac: a multicenter, randomized, double-blind study in patients with knee osteoarthritis. Curr Med Res Opin 2013; 29:849-59. [PMID: 23581533 DOI: 10.1185/03007995.2013.795139] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
OBJECTIVE To compare the gastrointestinal (GI) tolerability and efficacy of aceclofenac with diclofenac in patients with knee osteoarthritis (OA). METHODS In this randomized, double-blind, double-dummy, multicentric, comparative study, post 7 day placebo washout, patients were randomly allocated to receive either aceclofenac 100 mg b.i.d. or diclofenac 50 mg t.i.d. and were followed up for the next 6 weeks. The GI tolerability was evaluated based on the incidence and severity of predefined GI adverse events (AEs), number of gastroprotective agents (GPAs) consumed by patients, and discontinuation from the study due to GI AEs. The secondary outcome included assessment of pain intensity using a visual analogue scale (VAS), Western Ontario and McMaster Universities (WOMAC) score, pain relief score, and investigators' and patients' overall assessments of response to study drugs. RESULTS A total of 591 (aceclofenac group: 297; diclofenac group: 294) patients were enrolled. The cumulative incidence of GI AEs for dyspepsia (28.1% versus 37.9%; p = 0.014), abdominal pain (19% versus 26.3%; p = 0.037), overall incidence of predefined GI AEs (57.3% versus 73.6%; p < 0.001) and number of patients reporting GI AEs (28.9% versus 36.5%; p = 0.053) were significantly less in the aceclofenac group compared to the diclofenac group throughout the study. All the AEs were mild to moderate in intensity. Fewer patients from the aceclofenac group required GPAs compared to the diclofenac group (28.17% versus 33.68%; p = 0.155). During first 7 days of therapy, >90% of patients from aceclofenac group did not require GPAs. There were no differences between the study groups in the various pain assessment scales when measured during the study period. CONCLUSION Aceclofenac was better tolerated in terms of incidence and severity of GI AEs and GPA requirement and was as efficacious as diclofenac. The need for GPAs increased with the increase in duration of treatment with NSAIDs. Hence, it could be concluded that usual practice of co-prescription of GPAs with aceclofenac could be avoided to improve patient compliance and reduce cost of treatment. However, long term trials with endoscopic evaluation in the wider population are required to assess the GI tolerability of aceclofenac and diclofenac in detail.
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Koczka CP, Geraldino-Pardilla LB, Goodman AJ. Physicians' opinions of stress ulcer prophylaxis: survey results from a large urban medical center. Dig Dis Sci 2013; 58:777-81. [PMID: 23065088 DOI: 10.1007/s10620-012-2423-x] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/06/2012] [Accepted: 09/19/2012] [Indexed: 12/20/2022]
Abstract
BACKGROUND Stress ulcer prophylaxis (SUP) has been increasingly prescribed for patients admitted to medical wards. The knowledge, attitudes, and practices of those in the healthcare profession regarding use of SUP in medical wards are understudied. METHODS A survey consisting of closed-ended questions and multiple-choice queries was handed out during grand rounds. RESULTS One hundred people (39 attending physicians, 61 residents) completed the survey. More attending physicians (41 vs. 30 %) believed SUP was indicated for patients treated in a non-intensive-care medical ward (P = 0.2357). All residents preferred a proton-pump inhibitor (PPI) for SUP compared with 85 % of attending physicians (P < 0.05). Despite equal agreement that PPIs were not harmless, more attending physicians than residents agreed that using PPIs increased the risk of community-acquired pneumonia (P < 0.05). More residents than attending physicians agreed on the use of SUP for patients suffering from major burns and for those with liver failure. In situations of respiratory distress not requiring intubation and in cases of steroid treatment for a chronic obstructive pulmonary disease flare, more attending physicians than residents felt SUP was required. Approaching a statistically significant difference, more attending physicians than residents felt that being too busy to question SUP indication and the perception of PPIs as harmless affected decision making. CONCLUSION Despite the publication of guidelines, misuse of gastric acid suppressants continues to occur, even by attending physicians. More complete understanding of the need and occasion for SUP use should result in more cautious use.
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Affiliation(s)
- Charles P Koczka
- Department of Gastroenterology and Hepatology, SUNY Downstate Medical Center, 450 Clarkson Avenue, Brooklyn, NY 11203, USA.
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Salmasian H, Freedberg DE, Abrams JA, Friedman C. An automated tool for detecting medication overuse based on the electronic health records. Pharmacoepidemiol Drug Saf 2013; 22:183-9. [PMID: 23233423 PMCID: PMC3566345 DOI: 10.1002/pds.3387] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2012] [Revised: 10/30/2012] [Accepted: 11/10/2012] [Indexed: 01/17/2023]
Abstract
PURPOSE Medication overuse is a serious concern in healthcare as it leads to increased expenditures, side effects, and morbidities. Identifying overuse is only possible through excluding appropriate indications that are primarily mentioned in unstructured notes. We developed a framework for automatic identification of medication overuse and applied it to proton pump inhibitors (PPIs). METHODS We first created an indications knowledge base using data from drug labels, clinical guidelines, expert opinion, and other sources. We also obtained the list of current problems for 200 randomly selected inpatients who received PPIs using a natural language processing system and the discharge summaries of those patients. These problems were checked against the indications knowledge base to identify overuse candidates. Two gastroenterologists manually reviewed the notes and identified cases of overuse. Results from the automated framework were compared with the manual review. RESULTS Reviewers had high interrater reliability in finding indications (agreement = 92.1%, Cohen's κ = 0.773). In 137 notes included in the final analysis, our system identified indications with a sensitivity of 74% (95%CI = 59-86) and specificity of 95% (95%CI = 87-98). In cases of appropriate use where the automated system also found one or more indications, it always included the correct indication. CONCLUSIONS We created an automated system that can identify established indications of medication use in electronic health records with high accuracy. It can provide clinical decision support for identifying potential overuse of PPIs and could be useful for reducing overuse and encouraging better documentation of indications.
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Affiliation(s)
- Hojjat Salmasian
- Department of Biomedical Informatics, Columbia University, 622 West 168th Street, New York, NY 10032, USA.
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Kleiman DA, Sporn MJ, Beninato T, Metz Y, Crawford C, Fahey TJ, Zarnegar R. Early referral for 24-h esophageal pH monitoring may prevent unnecessary treatment with acid-reducing medications. Surg Endosc 2012; 27:1302-9. [PMID: 23232999 DOI: 10.1007/s00464-012-2602-z] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/30/2012] [Accepted: 09/16/2012] [Indexed: 02/06/2023]
Abstract
BACKGROUND Gastroesophageal reflux disease (GERD) affects nearly 25 % of adults; however, an objective diagnosis is rarely established. We hypothesized that patients' symptoms and response to acid-reducing therapy are poor predictors of the outcome of 24-h esophageal pH monitoring. METHODS A review of 24-h esophageal pH monitoring studies performed at an ambulatory tertiary care center between 2004 and 2011 was performed. Demographics, type of GERD symptoms, and duration and response to acid-reducing medications before referral for pH monitoring were collected. DeMeester score, symptom sensitivity index (SSI), and symptom index (SI) were tabulated and compared with the patients' symptoms and response to medical therapy. RESULTS One hundred patients were included. Of all reported symptoms, only heartburn was more common in patients with positive DeMeester scores, but there were no correlations between any symptoms and SSI or SI scores. Sixty-nine percent of patients with esophageal symptoms had a positive DeMeester score compared with only 29 % of patients with extraesophageal symptoms (P < 0.01). Esophageal symptoms and endoscopic evidence of GERD significantly increased the likelihood of having a positive DeMeester score, but they had no influence on SSI or SI scores. There was no correlation between response to acid-reducing medications and DeMeester, SSI, or SI scores. A total of 536 person-years of acid-reducing medications were prescribed to the study population, of which 151 (28 %) were prescribed to patients who had a negative pH study. CONCLUSIONS Extraesophageal symptoms and response to empiric trials of acid-reducing medications are poor predictors of the presence of GERD and the DeMeester score is more likely to identify GERD in patients who met other empiric diagnostic criteria than SSI or SI. Early referral for 24-h esophageal pH monitoring may avoid lengthy periods of unnecessary medical therapy.
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Affiliation(s)
- David A Kleiman
- Division of Endocrine and Minimally Invasive Surgery, Department of Surgery, New York Presbyterian Hospital - Weill Cornell Medical College, 525 East 68th Street, F-2024, New York, NY 10065, USA.
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Issa IA, Soubra O, Nakkash H, Soubra L. Variables associated with stress ulcer prophylaxis misuse: a retrospective analysis. Dig Dis Sci 2012; 57:2633-2641. [PMID: 22427129 DOI: 10.1007/s10620-012-2104-9] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/02/2011] [Accepted: 02/21/2012] [Indexed: 01/12/2023]
Abstract
BACKGROUND Stress ulcer prophylaxis (SUP) is commonly used in hospitals. Although its indications are better delineated for intensive care unit (ICU) patients, its use in non-ICU settings is somewhat arbitrary and based on judgment. OBJECTIVE We attempted to assess the extent of SUP overuse in our hospital. We also carefully collected and analyzed several variables to detect associations governing this flawed behavior and its financial burden on the hospital's budget. MATERIALS AND METHODS We retrospectively analyzed charts of patients admitted to the medical floor of a tertiary referral university hospital over a 1 year period. All adult patients admitted to the medical ward who received at least one dose of SUP were included and reviewed for a multitude of variables in addition to the appropriateness of acid suppression therapy (AST). RESULTS We included 320 charts and found that 92% of patients admitted during that period were not eligible for SUP. The total inappropriateness of SUP was noted to be 58% (p = 0.015). Increasing age and male gender were found to be significant variables in AST misuse (p = 0.045 and p = 0.010), much like duration of hospital stay (p = 0.008). Comorbidities was also found to be a defining variable for AST overuse (odds ratio [OR] = 3.27). Patients with two or more minor risk factors were also subjected more to SUP inappropriately (OR = 3.53), in addition to patients of certain specialties (Neurology, Infectious Diseases, etc.). Our calculated financial burden was more than $23,000 per year for the medical floor. CONCLUSION This retrospective study confirmed the growing suspicion that SUP misuse is evident on the medical floors. We also delineated several factors and variables associated with and affecting SUP overuse.
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Affiliation(s)
- Iyad A Issa
- Department of Internal Medicine, Division of Gastroenterology, Rafik Hariri University Hospital, Specialty Clinics Center, 4B Hamra, Beirut 2034-7304, Lebanon.
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Ahrens D, Behrens G, Himmel W, Kochen MM, Chenot JF. Appropriateness of proton pump inhibitor recommendations at hospital discharge and continuation in primary care. Int J Clin Pract 2012; 66:767-773. [PMID: 22805269 DOI: 10.1111/j.1742-1241.2012.02973.x] [Citation(s) in RCA: 68] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
Background: Inappropriate prescriptions of proton pump inhibitors (PPI) in hospital and primary care have been widely reported. Recommendations from hospital have been implicated as one reason for inappropriate prescriptions of PPI in primary care. Objective: To quantify the amount of appropriate PPI recommendations in hospital discharge letters and the influence of these recommendations on general practitioners' (GPs') PPI-prescriptions. Materials and Methods: This is an observational study in 31 primary care practices. We identified patients discharged from hospital with PPI recommendation between 2006 and 2007 and assessed practice records and PPI prescription six months prior and after hospital admission. Hospital recommendation for continuous PPI-treatment and continuation by GPs was classified as appropriate, inappropriate or uncertain. Logistic regression analysis was used to calculate factors associated with indicated and non-indicated PPI continuation. Results: In 263 (58%) out of 506 patients discharged from 35 hospitals with a PPI recommendation no indication could be found. Non-indicated PPIs were continued by GPs in 58% for at least 1 month. Indicated PPIs were discontinued in 33%. Two thirds of non-indicated PPIs were initiated in hospital. The strongest factor associated with non-indicated continuation was a PPI-prescription prior to hospital admission [OR: 3.0; 95% confidence interval (CI): 1.7-5.4]. This was also the strongest factor for continuation of an indicated PPI medication (OR: 3.2; 95% CI: 1.4-7.5). Conclusions: We found a strong influence of hospital recommendations and previous prescriptions on PPI prescriptions after discharge. Hospitals should critically review their practice of recommending PPI and document indications. GPs should carefully assess hospital recommendations and their medication prior to admission to avoid over- and under-prescribing.
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Affiliation(s)
- D Ahrens
- Department of Family Practice, Göttingen University Medical Center, Göttingen, Germany Department of Family Practice, University Medicine Greifswald, Institute for Community Medicine, Greifswald, Germany
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Heidelbaugh JJ, Metz DC, Yang YX. Proton pump inhibitors: are they overutilised in clinical practice and do they pose significant risk? Int J Clin Pract 2012; 66:582-91. [PMID: 22607510 DOI: 10.1111/j.1742-1241.2012.02921.x] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022] Open
Abstract
Proton pump inhibitors are highly effective acid suppressants with decades of use highlighting positive outcomes in millions of patients worldwide, and they offer minimal risk of adverse events. PPIs are considered overutilised when prescribed without an appropriate indication, when patients are left on them 'indefinitely' without appropriate indications and when they are continued after being utilised for most cases of hospital SUP. While several adverse outcomes have been linked to PPI therapy, most data are from retrospective observational studies that may be subject to confounding and bias.
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Affiliation(s)
- J J Heidelbaugh
- Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
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Abstract
Proton pump inhibitors (PPIs) are the drugs of choice in the therapy of acid-related disorders. PPIs are as a class remarkably safe. Serious adverse events such as acute interstitial nephritis are extremely rare. Some reports in recent years have placed some concern on the long-term use of PPIs. Long-term therapy with PPIs can cause hypochlorhydria, hypergastrinemia and has interactions on hepatic cytochrome P450 enzymes which might increase the risk of infectious complications, nutritional deficiencies and drug-drug interactions. The vast majority of data came from retrospective case-control or cohort studies which are prone to confounders. At the moment we cannot conclude that long-term PPI use causes anemia, osteoporosis and bone fractures, increases the risk for pulmonary or enteric infections, has an effect on GUT mucosa, polyp or tumor formation, or that PPI use increases the risk of cardiovascular events in patients on PPIs and clopidogrel. We need prospective randomized trials to be able to definitely answer the questions raised in epidemiologic studies. Maintenance therapy with PPIs should be started only if strict indications for that therapy are fulfilled.
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Zeitoun A, Zeineddine M, Dimassi H. Stress ulcer prophylaxis guidelines: Are they being implemented in Lebanese health care centers? World J Gastrointest Pharmacol Ther 2011; 2:27-35. [PMID: 21860840 PMCID: PMC3158880 DOI: 10.4292/wjgpt.v2.i4.27] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/23/2011] [Revised: 07/11/2011] [Accepted: 07/18/2011] [Indexed: 02/06/2023] Open
Abstract
AIM To evaluate the current practice of stress ulcer prophylaxis (SUP) in Lebanese Health care centers. METHODS A multi-center prospective chart review study was conducted over 8 mo. A questionnaire was distributed to pharmacy students who collected data on demographics, SUP medications, dose, route, duration and associated risk factors. The appropriateness of SUP use was determined as per American Society of Health-System Pharmacists guidelines. Institutional review board approval was obtained from each hospital center. RESULTS A total of 1004 patients were included. 67% of the patients who received prophylaxis did not have an indication for SUP. The majority (71.6%) of the patients who were administered parenteral drugs can tolerate oral medications. Overall, the regimen of acid-suppressant drugs was suboptimal in 87.6% of the sample. This misuse was mainly observed in non-teaching hospitals. CONCLUSION This study highlighted the need, in Lebanese hospitals, to establish clinical practice guidelines for the use of SUP; mainly in non-critical care settings.
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Affiliation(s)
- Abeer Zeitoun
- Abeer Zeitoun, Maya Zeineddine, Hani Dimassi, Department of Pharmacy Practice, School of Pharmacy, Lebanese American University, PO Box 36, Byblos, Lebanon
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Hughes GJ, Belgeri MT, Perry HM. The Impact of Pharmacist Interventions on the Inappropriate Use of Acid-Suppression Therapy. ACTA ACUST UNITED AC 2011; 26:485-90. [DOI: 10.4140/tcp.n.2011.485] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022]
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Fohl AL, Regal RE. Proton pump inhibitor-associated pneumonia: Not a breath of fresh air after all? World J Gastrointest Pharmacol Ther 2011; 2:17-26. [PMID: 21731913 PMCID: PMC3124633 DOI: 10.4292/wjgpt.v2.i3.17] [Citation(s) in RCA: 59] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/15/2011] [Revised: 05/25/2011] [Accepted: 06/02/2011] [Indexed: 02/06/2023] Open
Abstract
Over the past two decades, proton pump inhibitors (PPIs) have emerged as highly effective and relatively safe agents for the treatment of a variety of gastrointestinal disorders. Unfortunately, this desirable pharmacological profile has also contributed to superfluous and widespread use in both the inpatient and outpatient settings. While generally well-tolerated, research published over the last decade has associated these agents with increased risks of Clostridium difficile disease, fractures likely due to calcium malabsorption and both community-acquired (CAP) and hospital-acquired pneumonias (HAP). The mechanism behind PPI-associated pneumonia may be multifactorial, but is thought to stem from compromising the stomach’s “acid mantle” against gastric colonization of acid-labile pathogenic bacteria which then may be aspirated. A secondary postulate is that PPIs, through their inhibition of extra-gastric H+/K+-ATPase enzymes, may reduce the acidity of the upper aerodigestive tract, thus resulting in increased bacterial colonization of the larynx, esophagus and lungs. To date, several retrospective case control studies have been published looking at the association between PPI use and CAP. Some studies found a temporal relationship between PPI exposure and the incidence of pneumonia, but only two could define a dose-response relationship. Furthermore, other studies found an inverse correlation between duration of PPI use and risk of CAP. In terms of HAP, we reviewed two retrospective cohort studies and one prospective study. One retrospective study in a medical ICU found no increased association of HAP in PPI-exposed patients compared to no acid-lowering therapy, while the other in cardiothoracic surgery patients showed a markedly increased risk compared to those receiving H2RAs. The one prospective study in ICU patients showed an increased risk of HAP with PPIs, but not with H2RAs. In conclusion, the current literature shows a slight trend toward an association between PPI use and pneumonia and an increased risk with PPIs over H2RAs, but the findings are not consistent across all studies. Larger controlled trials still need to be done to better identify the risk that PPIs impart towards patients contracting CAP or HAP. Until these are completed, we will have to continue to extrapolate across smaller controlled trials to predict the associated risks in our respective patient populations. In the interim, it appears prudent to limit the use of PPIs to situations where they are clinically indicated and, in such cases, use them at the lowest effective dose. In the case of prescribing for stress ulcer prophylaxis in ICU patients, perhaps H2RAs should be used as the preferred agents over PPIs.
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Affiliation(s)
- Alexander L Fohl
- Alexander L Fohl, University of Michigan Hospitals and College of Pharmacy, Ann Arbor, MI 48109-5008,, United States
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Abstract
BACKGROUND Little is known about why physicians prescribe inappropriate stress ulcer prophylaxis (SUP) among nonintensive care unit (ICU) hospitalized patients without supporting evidence. This study seeks to understand which factors influence physician prescribing behavior regarding SUP. DESIGN We designed a cross sectional web-based survey to assess physicians' knowledge, beliefs, and behavior surrounding the prescribing of SUP for non-ICU patients. The survey was emailed to internal medicine residents and hospitalists at a university-affiliated tertiary care hospital. Clinically relevant bivariable associations were examined in logistic regression to determine whether these associations remained after adjustment for potential confounding factors. RESULTS Sixty-nine percent of physicians reported prescribing SUP to ≥25% of patients. In multivariable analyses, the following factors were associated with higher level of prescribing (≥25%) of SUP: fear of gastrointestinal bleeding (OR = 2.7, 95% CI 1.07, 7.28) and of the legal repercussions of not prescribing SUP (OR = 3.02, 95% CI 1.07, 8.56), whereas knowledge of SUP indications (OR = 0.39, 95% CI 0.20, 0.74) and concern about side effects (OR = 0.24, 95% CI 0.09, 0.61) were associated with low prescribing behavior. Level of training was not associated with prescribing rate. Less than half of respondents were able to identify a single side effect of proton pump inhibitor therapy. CONCLUSION Fear of legal repercussions and ignorance of the side effects of acid suppressive therapy were strongly associated with inappropriate prescribing of SUP. Educating physicians about the adverse effects of acid suppression therapy and about existing national guidelines might reduce inappropriate prescribing.
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Amaral MC, Favas C, Alves JD, Riso N, Riscado MV. Stress-related mucosal disease: incidence of bleeding and the role of omeprazole in its prophylaxis. Eur J Intern Med 2010; 21:386-8. [PMID: 20816590 DOI: 10.1016/j.ejim.2010.06.010] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/19/2010] [Revised: 06/12/2010] [Accepted: 06/17/2010] [Indexed: 11/18/2022]
Abstract
BACKGROUND Upper gastrointestinal bleeding is the severe complication of stress-related mucosal disease in hospitalized patients. In intensive care units (ICU), risk factors are well defined and only mechanical ventilation and coagulopathy proved to be relevant for significant bleeding. On the contrary, in non-ICU settings there is no consensus about this issue. Nevertheless, omeprazole is still widely used in prophylaxis of bleeding. The objective of our study was to evaluate the relevance of stress-related mucosal disease bleeding in patients admitted to an internal medicine ward, and the role of omeprazole in its prophylaxis. METHODS We conducted a retrospective study in which we analysed consecutive patients who were admitted to our ward over a year. We recorded demographic characteristics of the patients, potential risk factors for stress-related mucosal disease (clinical data, laboratory, and medication), administration of prophylactic omeprazole, and total cost of this prophylaxis. Patients with active gastrointestinal bleeding on the admission were excluded. We recorded every upper gastrointestinal bleeding event with clinical relevance. RESULTS Five hundred and thirty-five patients, mean age 70 years, mean length of stay 9.6+/-7.7 days; 140 (26.2%) patients were treated with 40 mg of omeprazole intravenously, 193 (36.1%) with 20mg of omeprazole orally, and 202 (37.8%) patients had no prophylaxis. There was only one episode (0.2%) of clinically relevant bleeding. CONCLUSION In patients admitted to an internal medicine ward, incidence of upper gastrointestinal bleeding as a complication of stress-related mucosal disease is low. We found that there is no advantage in prophylaxis with omeprazole.
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Affiliation(s)
- Marta C Amaral
- Department of Medicine II, Curry Cabral Hospital, and Pharmacology Department, Faculty of Medical Sciences, New University of Lisbon, Campo Mártires da Pátria 130, Lisbon, Portugal.
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Kanwal F, Barkun A, Gralnek IM, Asch SM, Kuipers EJ, Bardou M, Sung J, Enns R, Agreus L, Armstrong D, Spiegel BMR. Measuring quality of care in patients with nonvariceal upper gastrointestinal hemorrhage: development of an explicit quality indicator set. Am J Gastroenterol 2010; 105:1710-8. [PMID: 20686458 DOI: 10.1038/ajg.2010.180] [Citation(s) in RCA: 29] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES With an increasing emphasis on quality in health care and recognition of inconsistencies in the management of patients with nonvariceal upper gastrointestinal hemorrhage (NVUGIH), it is critical to establish a set of explicit quality indicators (QIs) in NVUGIH. METHODS We conducted a nine-member, multidisciplinary expert panel and followed modified Delphi methods to systematically identify a set of QIs for NVUGIH. The panel performed independent ratings of each candidate QI using a nine-point RAND appropriateness scale, then met in person and re-voted using an iterative process of discussion. The final set comprised QIs with a median RAND Appropriateness Score >or=7 and no disagreement among experts. RESULTS Among 116 candidate QIs, the panel rated 26 as valid measures of quality care. The selected QIs cover pre-endoscopy, endoscopy, and post-endoscopy care, including diagnosis, early resuscitation, risk stratification, endoscopic care, Helicobacter pylori management, and proton pump inhibitor therapy. CONCLUSIONS We have developed an explicit set of evidence-based QIs in NVUGIH, providing physicians and institutions with a tool to identify processes amenable to quality improvement. This tool is intended to be applicable in all institutions providing care for NVUGIH patients.
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Affiliation(s)
- Fasiha Kanwal
- Saint Louis Veterans Administration (VA) and Saint Louis University, Saint Louis, Missouri, USA
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Dublin S, Walker RL, Jackson ML, Nelson JC, Weiss NS, Jackson LA. Use of proton pump inhibitors and H2 blockers and risk of pneumonia in older adults: a population-based case-control study. Pharmacoepidemiol Drug Saf 2010; 19:792-802. [PMID: 20623507 PMCID: PMC2938739 DOI: 10.1002/pds.1978] [Citation(s) in RCA: 54] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
PURPOSE To examine whether use of proton pump inhibitors (PPIs) and H2 blockers is associated with increased pneumonia risk. METHODS We conducted a population-based, nested case-control study within Group Health, an integrated healthcare delivery system. Among community-dwelling, immunocompetent adults aged 65-94, we identified presumptive cases of ambulatory and hospitalized community-acquired pneumonia in 2000-2003 from ICD-9 codes and validated them by medical record review (N = 1125). Controls were selected, matched to cases on age, sex, and calendar year (N = 2235). Current PPI or H2 blocker use was ascertained from computerized pharmacy records. Comorbid illnesses and other characteristics were ascertained by medical record review. Multivariable conditional logistic regression was used to examine the association between medication use and pneumonia risk. We conducted sensitivity analyses using only administrative and pharmacy data to assess how these results differed from our primary results. RESULTS The prevalence of PPI or H2 blocker use was 21% (241/1125) for pneumonia cases and 16% (350/2235) for controls (adjusted odds ratio [OR] 1.03, 95% CI 0.86-1.24, compared to nonuse). No increased risk was seen for recent initiation. The prevalence of PPI use was 12% (132/1125) for cases and 7% (160/2235) for controls (adjusted OR 1.13, 95% CI 0.88-1.44). Analyses using only administrative and pharmacy data yielded risk estimates farther from the null (adjusted OR 1.32, 95% CI 1.17-1.49, for current PPI use versus nonuse). CONCLUSIONS Use of PPIs and H2 blockers is not associated with increased pneumonia risk in older adults. The increased risk observed in some prior studies may reflect confounding.
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Affiliation(s)
- Sascha Dublin
- Group Health Research Institute, Seattle, Washington 98101-1448, USA.
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Dyspeptic symptom development after discontinuation of a proton pump inhibitor: a double-blind placebo-controlled trial. Am J Gastroenterol 2010; 105:1531-7. [PMID: 20332770 DOI: 10.1038/ajg.2010.81] [Citation(s) in RCA: 95] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Conflicting data exist on whether discontinuation of proton pump inhibitors (PPIs) is associated with rebound secretion of gastric acid. METHODS A total of 48 healthy Helicobacter pylori-negative volunteers (24 females) were randomized in a double-blinded manner to treatment with either pantoprazole 40 mg or placebo once daily for 28 days. Dyspeptic symptoms were registered daily using the Glasgow dyspepsia score (GDS) 2 weeks before, during, and 6 weeks after treatment. Plasma levels of gastrin and serum levels of chromogranin-A levels were measured before, during, and after treatment. RESULTS During the 2 weeks before treatment, the placebo group had a mean GDS of 0.20 + or - 0.7 compared with the pantoprazole group score of 0.54 + or - 1.3 (NS). No significant differences between the symptom severity scores of the two groups were shown during the treatment period. During the first week after discontinuation of treatment, the pantoprazole group had a mean symptom score of 5.7 + or - 11.7 vs. 0.74 + or - 2.6 in the placebo group (P<0.01). A total of 11 out of 25 (44%) subjects in the pantoprazole group developed dyspepsia compared with 2 out of 23 (9%) in the placebo group (P<0.01). During the second week of follow-up, the pantoprazole group had a mean symptom score of 1.6 + or - 3.4 compared with 0 + or - 0 in the placebo group (P<0.05). There were no significant differences in the mean symptom score for the pantoprazole group (1.1 + or - 0.6) compared with the placebo group (0.4 + or - 0.3) during the third week of follow-up. Symptom scores during the first week after treatment correlated with basal (P<0.01) and meal-stimulated (P<0.01) gastrin levels at the end of treatment. CONCLUSIONS A 4-week course of pantoprazole seems to induce dyspeptic symptoms in previously asymptomatic healthy H. pylori-negative subjects. The correlation between symptom score and gastrin levels suggests that these symptoms are due to acid rebound hypersecretion and seem to be related to the degree of acid inhibition.
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Acid Suppression Therapy: Overused and Difficult to Control. South Med J 2010; 103:713-4. [DOI: 10.1097/smj.0b013e3181e0b9c1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Pillai L, Burnett BP, Levy RM. GOAL: multicenter, open-label, post-marketing study of flavocoxid, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin. Curr Med Res Opin 2010; 26:1055-63. [PMID: 20225990 DOI: 10.1185/03007991003694522] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
OBJECTIVES GOAL (Gauging Osteoarthritis [OA] with Limbrel*), an open-label, post-marketing study was performed to determine the overall efficacy and gastrointestinal (GI) tolerability of flavocoxid, a novel, plant-based, anti-inflammatory medication, in a 'real world' clinical practice setting. To this end, the study enrolled several unique patient types including nonsteroidal anti-inflammatory drug (NSAID) naïve patients, those who had used NSAIDs in the past, regardless of outcome (positive or negative), and those who had previously taken a gastroprotective medication to improve GI tolerability or continued to take it as a precautionary measure to prevent NSAID-associated GI damage. METHODS A total of 1067 individuals at 41 rheumatology practices were enrolled and prescribed flavocoxid, 500 mg b.i.d., for 60 days. The Physician Global Assessment of Disease (PGAD) visual analog scale (VAS) was used as a global measure to assess the signs and symptoms of OA, including joint discomfort, functional stiffness, functional mobility and quality of life. In addition, overall tolerability and upper GI tolerability were assessed by individual questions scored on a 5-part Likert scale. The physicians also monitored any interruption in, or cessation of use of flavocoxid due to a GI issue as well as changes in the use of gastroprotective medications. Adverse event (AE) monitoring was also conducted. RESULTS Of the 1005 patients who completed all follow-up visits, physicians recorded an average improvement in VAS scores from 60.1 +/- 18.8 at baseline to 42.5 +/- 21.9 at 8 weeks (p < 0.001) in 65.8% of patients. The PGAD VAS noted the most significant improvement in those patients with moderate to severe OA (baseline VAS [0 = least severe, 100 = most severe]: 0-25 mm, -3.5 +/- 6.9; 26-50 mm, -10.1 +/- 17.0; 51-75 mm, -19.3 +/- 19.5; 76-100 mm, -29.6 +/- 23.6; p < 0.001) and in those patients who were historically non-responders to NSAIDs (40.3 +/- 21.1 vs. 66.3 +/- 17.7 at baseline; p < 0.001). Patients who had previously responded well to NSAIDs had VAS scores of 42.6 +/- 19.8 vs. 58.0 +/- 18.0 (p < 0.001) and NSAID naïve subjects showed improvement in VAS scores from 60.5 +/- 18.0 at baseline to 46.3 +/- 23.7 (p < 0.001). The study recorded a low incidence ( approximately 10%) of AEs reported to physicians and good overall tolerability to flavocoxid. Flavocoxid showed improved upper GI tolerability in almost 50% of previous NSAID users (p < 0.001) and reduced therapy interruption in approximately 90% of previous NSAID users with a history of GI-related therapy interruptions (p < 0.0001). Finally, the use of flavocoxid resulted in a >30% reduction in or cessation of the use of gastroprotective medications such as proton pump inhibitors (PPI) or histamine-2 receptor antagonists (H2s) in subjects (p < 0.001). CONCLUSIONS Within a 'real world' clinical rheumatology practice setting, flavocoxid demonstrated significant efficacy in the management of OA in multiple patient types and displayed significant potential for reducing the possibility of adverse GI side-effects and use of gastroprotective agents associated with more traditional OA medications. A limitation of this study was that it was open-label and not rigorously controlled. The large population may compensate for this lack of control.
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Turco R, Martinelli M, Miele E, Roscetto E, Del Pezzo M, Greco L, Staiano A. Proton pump inhibitors as a risk factor for paediatric Clostridium difficile infection. Aliment Pharmacol Ther 2010; 31:754-759. [PMID: 20047577 DOI: 10.1111/j.1365-2036.2009.04229.x] [Citation(s) in RCA: 78] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND Proton pump inhibitors (PPIs) and H(2) receptor antagonists (H(2)RAs) may play an important role on the onset of Clostridium difficile-associated disease (CDAD) in adults. The impact of Clostridium difficile on children treated with gastric acid-suppressing agents remains unknown. AIM To investigate the relationship between CDAD and exposure to acid suppressive therapy in hospitalized paediatric patients. METHODS We reviewed the medical records of children, with a diagnosis of protracted diarrhoea and abdominal pain, whose stool was analysed for C. difficile toxins. We identified 68 patients with CDAD. For each patient, we randomly selected one control subjects with stool analysis negative for C. difficile. Comorbid illnesses, previous hospitalizations, antibiotics, corticosteroids, immunosuppressants and gastric acid suppressing exposures were recorded. RESULTS The use of PPI was significantly higher in C. difficile positive group compared with C. difficile negative group [odds ratio (OR): = 4.5; 95% confidence interval (CI) = 1.4-14.4]. We also found a trend for the use of H(2)RAs in patients infected by C. difficile compared with C. difficile negative comparison group (OR: = 3.8; 95% CI = 0.7-18.9). CONCLUSIONS Children exposed to PPIs therapy seem to be at higher risk for the development of Clostridium difficile-associated disease.
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Affiliation(s)
- R Turco
- Department of Pediatrics, University of Naples Federico II, Naples, Italy
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47
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Palkovic LB, Coley KC, Sokos DR. Factors associated with inappropriate inpatient prescribing of acid-suppressive therapy. INTERNATIONAL JOURNAL OF PHARMACY PRACTICE 2010; 17:73-5. [PMID: 20218033 DOI: 10.1211/ijpp.17.1.0011] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/31/2022]
Abstract
OBJECTIVES Acid-suppressive therapy is used for 54-70% of inpatients, and is frequently prescribed for inappropriate indications. The objective of this study was to identify characteristics associated with inappropriate prescribing of acid-suppressive therapy. METHODS A random sample of adult internal medicine inpatients admitted between 1 July 2005 and 30 June 2006 was screened for acid-suppressive therapy. Patients receiving such therapy without an accepted indication and those not prescribed acid-suppressive therapy were included in group 1 and group 2, respectively. Significant characteristics from separate univariate regression models were entered into a multivariate logistic regression to determine characteristics associated with inappropriate use. The setting was internal medicine units at a tertiary care academic medical centre. KEY FINDINGS There were 108 patients in group 1 and 134 patients in group 2. Group 1 patients were older, had a longer median length of stay, a greater number of comorbidities, a greater median number of medications upon admission, and a higher rate of cirrhosis. Factors associated with use of acid-suppressive therapy without an accepted indication were use of a proton-pump inhibitor (odds ratio, 15.3; 95% confidence interval, 4.1-56.3) or histamine2 receptor antagonist (14.5; 2.8-74.8) prior to admission, cirrhosis (6.4; 1.02-39.5), use of inpatient anticoagulants (2.7; 1.4-5.2) and length of stay (1.1; 1.1-1.3). CONCLUSIONS The strongest factors associated with use of acid-suppressive therapy without an accepted indication were use of a proton-pump inhibitor or histamine2 receptor antagonist prior to admission, a diagnosis of cirrhosis and use of inpatient anticoagulants.
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Affiliation(s)
- Lindsay B Palkovic
- Department of Pharmacy Practice and Pharmacy Administration, University of the Sciences in Philadelphia-Philadelphia College of Pharmacy, Philadelphia, Pennsylvania 19104, USA.
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Gupta R, Garg P, Kottoor R, Munoz JC, Jamal MM, Lambiase LR, Vega KJ. Overuse of Acid Suppression Therapy in Hospitalized Patients. South Med J 2010; 103:207-11. [DOI: 10.1097/smj.0b013e3181ce0e7a] [Citation(s) in RCA: 47] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Eid SM, Boueiz A, Paranji S, Mativo C, Landis R, Abougergi MS. Patterns and predictors of proton pump inhibitor overuse among academic and non-academic hospitalists. Intern Med 2010; 49:2561-8. [PMID: 21139293 DOI: 10.2169/internalmedicine.49.4064] [Citation(s) in RCA: 68] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/06/2022] Open
Abstract
OBJECTIVE In the hospital setting, several studies have reported proton pump inhibitor (PPI) overuse, a majority of which is continued after discharge. In addition to being expensive, PPIs are associated with an increased risk of infections, osteoporosis and serious drug interactions. We examined the trends and predictors of PPI guidelines non-compliance among academic and non-academic hospitalists in USA. METHODS AND PATIENTS Oral PPI prescriptions initiated by 2 academic and 2 non-academic hospitalist groups were reviewed. Prescription indications were recorded when explicitly stated in the chart. Otherwise, qualified physicians reviewed the chart to make such determination. Indications were then compared to the published guidelines. Several variables were tested to determine independent predictors of initiation and post discharge continuation of guideline non-compliant prescriptions. RESULTS Of the 400 PPI prescriptions 39% were guideline compliant. Academic hospitalists were significantly more compliant with PPI prescription guidelines (50 vs 29%). Gastrointestinal ulcer bleeding prophylaxis (GIP) for low risk patients was the most common indication for non-compliant prescriptions, while that of guideline compliant prescriptions was dyspepsia treatment. Independent predictors of the initiation of guideline non-compliant prescriptions were non-academic hospitalist group, PPI indication not documented in the chart, and GIP as part of the admission orderset. The latter was an independent predictor of those prescriptions continuation post-discharge (protective) in addition to non-academic hospitalists group. CONCLUSION Hospitalists overprescribe PPI to a level comparable to that of the non-hospitalist providers in the literature. Understanding the determinants of increased compliance among academic groups is instrumental to design interventions aimed at increasing PPI prescription compliance.
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Affiliation(s)
- Shaker M Eid
- Department of Internal Medicine, Johns Hopkins School of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, USA
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50
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Kim YS. Respiratory Review of 2010: Pneumonia. Tuberc Respir Dis (Seoul) 2010. [DOI: 10.4046/trd.2010.68.6.319] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/24/2022] Open
Affiliation(s)
- Yun Seong Kim
- Department of Internal Medicine, Pusan National University School of Medicine, Yangsan, Korea
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