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Cardiovascular safety of empagliflozin in patients with type 2 diabetes: a meta‐analysis of data from randomized placebo‐controlled trials
Author(s) -
Salsali A.,
Kim G.,
Woerle H. J.,
Broedl U. C.,
Hantel S.
Publication year - 2016
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.12734
Subject(s) - empagliflozin , mace , placebo , medicine , hazard ratio , clinical endpoint , randomized controlled trial , myocardial infarction , type 2 diabetes , diabetes mellitus , confidence interval , conventional pci , endocrinology , alternative medicine , pathology
Aim To assess the effect of empagliflozin on cardiovascular ( CV ) risk in patients with type 2 diabetes ( T2DM ) through a meta‐analysis of data from eight placebo‐controlled trials. Methods Data were analysed from eight randomized placebo‐controlled trials undertaken to investigate the efficacy and safety of empagliflozin 10 and 25 mg once daily in patients with T2DM , comprising patients at low/medium and high CV risk. Suspected CV events were prospectively adjudicated. The empagliflozin 10 and 25 mg groups were pooled for the primary analysis. The primary endpoint was a composite of CV death, non‐fatal myocardial infarction ( MI ), non‐fatal stroke and hospitalization for unstable angina [4‐point major adverse CV events ( MACE )]. The secondary endpoint was a composite of CV death, non‐fatal MI and non‐fatal stroke (3‐point MACE ). Risk estimates were calculated using C ox regression analysis. Results A total of 3835 patients received placebo and 7457 received empagliflozin. Total exposure was 7448.3 years for placebo and 15482.1 years for empagliflozin. Four‐point MACE occurred in 365 (9.5%) patients receiving placebo and 635 (8.5%) patients receiving empagliflozin [hazard ratio for empagliflozin vs. placebo 0.86 (95% CI 0.76, 0.98)]. Three‐point MACE occurred in 307 (8.0%) patients receiving placebo and 522 (7.0%) patients receiving empagliflozin [hazard ratio for empagliflozin vs. placebo 0.84 (95% CI 0.73, 0.96)]. Conclusions In a meta‐analysis of data from eight randomized trials involving 11 292 patients with T2DM at low/medium or high CV risk, empagliflozin was associated with a reduced risk of 4‐point MACE and 3‐point MACE compared with placebo.