Key result
Vildagliptin was not associated with an increased risk of major adverse cardiovascular events compared to non-vildagliptin treatments (0.86% vs 1.20%; RR 0.82; 95% CI 0.61-1.11).
Why the study?
Does vildagliptin increase the risk of major adverse cardiovascular events or heart failure compared to placebo or active comparators in patients with type 2 diabetes mellitus?
Meta-Analysis (n=17,446)
Double-blind
randomized
Yes
Does vildagliptin increase the risk of major adverse cardiovascular events or heart failure compared to placebo or active comparators in patients with type 2 diabetes mellitus?
Relative Risk: 0.82 (95% CI 0.61–1.11)
Absolute Event Rate: 0.86% vs 1.2%
This large meta-analysis demonstrates that vildagliptin is not associated with an increased risk of major adverse cardiovascular events or heart failure in patients with type 2 diabetes mellitus.
Supports vildagliptin as a cardiovascular-safe option in type 2 diabetes; confirms neutrality across DPP-4 inhibitor meta-analyses.
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 Mantel-Haenszel (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.
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McInnes et al. (2015) conducted a meta-analysis in Type 2 diabetes mellitus (T2DM) (n=17,446). Vildagliptin vs. Placebo and all non-vildagliptin treatments was evaluated on Occurrence of major adverse CV events (MACEs; myocardial infarction, stroke and CV death) (RR 0.82, 95% CI 0.61-1.11). Vildagliptin was not associated with an increased risk of major adverse cardiovascular events compared to non-vildagliptin treatments (0.86% vs 1.20%; RR 0.82; 95% CI 0.61-1.11).
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