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Cardiovascular and heart failure safety profile of vildagliptin: a meta‐analysis of 17 000 patients
Author(s) -
McInnes G.,
Evans M.,
Del Prato S.,
Stumvoll M.,
Schweizer A.,
Lukashevich V.,
Shao Q.,
Kothny W.
Publication year - 2015
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12548
Subject(s) - vildagliptin , medicine , mace , myocardial infarction , heart failure , clinical endpoint , relative risk , adverse effect , diabetes mellitus , stroke (engine) , placebo , confidence interval , body mass index , type 2 diabetes , cardiology , randomized controlled trial , endocrinology , percutaneous coronary intervention , mechanical engineering , alternative medicine , pathology , engineering
Aims To report the cardiovascular ( CV ) safety profile and heart failure ( HF ) risk of vildagliptin from a large pool of studies, including trials in high‐risk patients with type 2 diabetes mellitus ( T2DM ), such as those with congestive HF and/or moderate/severe renal impairment. Methods We conducted a retrospective meta‐analysis of prospectively adjudicated CV events. Patient‐level data were pooled from 40 double‐blind, randomized controlled phase III and IV vildagliptin studies. The primary endpoint was occurrence of major adverse CV events ( MACEs ; myocardial infarction, stroke and CV death). Assessments of the individual MACE components and HF events (requiring hospitalization or new onset) were secondary endpoints. The risk ratio ( RR ) of vildagliptin (50 mg once‐ and twice‐daily combined) versus comparators (placebo and all non‐vildagliptin treatments) was calculated using the M antel– H aenszel ( M–H ) method. Results Of the 17 446 patients, 9599 received vildagliptin (9251.4 subject‐years of exposure) and 7847 received comparators (7317.0 subject‐years of exposure). The mean age of the patients was 57 years, body mass index 30.5 kg/m 2 (nearly 50% obese), glycated haemoglobin concentration 8.1% and T2DM duration 5.5 years. A MACE occurred in 83 (0.86%) vildagliptin‐treated patients and 85 (1.20%) comparator‐treated patients, with an M‐H RR of 0.82 [95% confidence interval ( CI ) 0.61–1.11]. Similar RRs were observed for the individual events. Confirmed HF events were reported in 41 (0.43%) vildagliptin‐treated patients and 32 (0.45%) comparator‐treated patients, with an M–H RR 1.08 (95% CI 0.68–1.70). Conclusions This large meta‐analysis indicates that vildagliptin is not associated with an increased risk of adjudicated MACEs relative to comparators. Moreover, this analysis did not find a significant increased risk of HF in vildagliptin‐treated patients.