Brief Articles
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World J Diabetes. Nov 15, 2010; 1(5): 153-160
Published online Nov 15, 2010. doi: 10.4239/wjd.v1.i5.153
Efficacy and safety of vildagliptin/pioglitazone combination therapy in Korean patients with diabetes
Sun-Woo Kim, Sei Hyun Baik, Kun Ho Yoon, Hyoung Woo Lee, Claudia Filozof
Sun-Woo Kim, Kangbuk Samsung Hospital, Seoul 110-746, South Korea
Sei Hyun Baik, Korea University Guro Hospital, Seoul 152-703, South Korea
Kun Ho Yoon, Catholic University Medical Center, Kangnam St. Mary’s Hospital, Seoul 137-701, South Korea
Hyoung Woo Lee, YeungNam University Medical Center, Daegu 705-030, South Korea
Claudia Filozof, Novartis Pharma AG, Postfach, Basel, CH-4002 Switzerland
Author contributions: Kim SW, Baik SH, Yoon KH, and Lee HW have authored this paper on behalf of the following study investigators: Moon Kyu Lee, Bong Soo Cha, Jeong Taek Woo, In Ju Kim, Jeong Hyun Park, Dong Seop Choi, Sung Woo Park, Kyung Soo Ko, In Kyu Lee, Tae Sun Park, and Hak Chul Jang; and Filozof C has authored this paper on behalf of many individuals at Novartis who have contributed to the design, implementation, analysis and reporting of the data, including Jia Y, Amiour Y, Couturier A and Kothny W.
Supported by the Novartis Pharmaceuticals Corporation
Correspondence to: Claudia Filozof, MD, PhD, Principal Medical Scientific Expert, Novartis Pharma AG, Postfach, Basel, CH-4002, Switzerland. claudia.filozof@novartis.com
Telephone: +41-61-3242987 Fax: +41-61-3247921
Received: March 6, 2010
Revised: August 30, 2010
Accepted: September 6, 2010
Published online: November 15, 2010
Abstract

AIM: To assess the efficacy and safety of vildagliptin/pioglitazone combination therapy in Korean patients with type 2 diabetes mellitus (T2DM).

METHODS: This was a post hoc analysis in Korean patients, from a 24-wk, randomized, active-controlled, double-blind, parallel-group, multicenter study. Eligible patients were aged between 18 and 80 years, drug naive, and had been diagnosed with T2DM [hemoglobin A1c (HbA1c): 7.5%-11.0% and fasting plasma glucose (FPG): < 270 mg/dL (< 15 mmol/L)]. Patients were randomized (1:1:1:1) to receive the vildagliptin/pioglitazone combination at 100/30 mg q.d. (high-dose) or 50/15 mg q.d. (low-dose), vildagliptin 100 mg q.d., or pioglitazone 30 mg q.d. monotherapies. The primary outcome measure was change in HbA1c from baseline to endpoint.

RESULTS: The distribution of baseline demographic and clinical parameters was well balanced between treatment groups. The overall mean age, body mass index, HbA1c, FPG, and duration of disease were 50.8 years, 24.6 kg/m2, 8.6%, 10.1 mmol/L, and 2.2 years, respectively. Adjusted mean changes (± standard error) in HbA1c from baseline (~8.7%) to week 24 endpoint were -2.03% ± 0.16% (high-dose, N = 34), -1.88% ± 0.15% (low-dose, N = 34), -1.31% ± 0.21% (vildagliptin, N = 36), and -1.52% ± 0.16% (pioglitazone, N = 36). The high-dose combination therapy demonstrated greater efficacy than monotherapies [vildagliptin (P = 0.029) and pioglitazone (P = 0.027)]. Percentage of patients achieving HbA1c < 7% and ≤ 6.5% was the highest in the high-dose group (76% and 68%) followed by low-dose (58% and 47%), vildagliptin (59% and 37%), and pioglitazone (53% and 28%) groups. The overall incidence of adverse events was comparable.

CONCLUSION: In Korean patients, first-line treatment with high-dose combination therapy improved glycemic control compared to pioglitazone and vildagliptin monotherapies, consistent with results published for the overall study population.

Keywords: Type 2 diabetes mellitus; Vildagliptin; Pioglitazone