Cardiovascular safety of vildagliptin in patients with type 2 diabetes: a European multi-database, non-interventional post-authorization safety study

Abstract

This non-interventional, multi-database, analytical cohort study assessed the cardiovascular (CV) safety of vildagliptin vs. other non-insulin antidiabetic drugs (NIADs) using real-world data from five European electronic healthcare databases. Patients with type 2 diabetes aged ≥18 years on NIAD treatment were enrolled. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (95% CIs) for the outcomes of interest (myocardial infarction [MI], acute coronary syndrome [ACS], stroke, congestive heart failure [CHF], individually and as a composite) were estimated using negative binomial regression. Approximately 2.8% of the enrolled patients (n = 738,054) used vildagliptin at any time during the study with an average follow-up time of 1.4 years, resulting in a cumulative current vildagliptin exposure of 28,330 person-years. The adjusted IRRs (vildagliptin [± other NIADs] vs. other NIADs) were in the range of 0.61-0.97 (MI), 0.55-1.60 (ACS), 0.02-0.77 (stroke), 0.49-1.03 (CHF), and 0.22-1.02 (composite CV outcomes). The IRRs and their 95% CIs were close to 1, demonstrating no increased risk of adverse CV events, including the risk of CHF, with vildagliptin vs. other NIADs under real-world conditions.