Association between vildagliptin and risk of angioedema, foot ulcers, skin lesions, hepatic toxicity, and serious infections in patients with type 2 diabetes mellitus: A European multidatabase, noninterventional, postauthorization safety study

Abstract

Objectives This noninterventional, multidatabase, analytical cohort study explored whether vildagliptin is associated with an increased risk of specific safety events of interest, namely angioedema, foot ulcers, or skin lesions, adverse hepatic events, or serious infections compared with other noninsulin antidiabetic drugs (NIADs) using real‐world data from five European electronic healthcare databases. Design Patients with type 2 diabetes mellitus aged ≥18 years on NIAD treatment were included between January 2005 and June 2014. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for the outcomes of interest were estimated using negative binomial regression. Patients Approximately 2.8% of the included patients (n = 738 054) used vildagliptin at any time during the study, with an average follow‐up time of 1.4 years. Results The adjusted IRRs (vildagliptin vs. other NIADs) were in the range of 0.87‐3.71 (angioedema), 0.73‐1.19 (foot ulcers), 0.37‐1.18 (skin lesions), 0.24‐1.14 (composite of foot ulcer or skin lesions), 0.29‐0.55 (serious hepatic events), and 0.59‐1.04 (serious infections), with no lower bound of the 95% CIs > 1. Conclusions Overall, there was no increased risk of the events of interest in association with vildagliptin use compared with other NIADs.

Risk of sepsis and pneumonia in patients initiated on SGLT2 inhibitors and DPP-4 inhibitors

“…Similarly, studies on DPP-4 inhibitors, another class of frequently prescribed hypoglycemic agent, have shown conflicting results. DPP-4 inhibitors were associated with an increased risk of infections in some studies, especially higher in the risk of upper respiratory tract infection [12] and aspiration pneumonia [13], but, were not associated with increased serious infections in some others [12,15,30]. Notably, there are no sizable head-to-head clinical trials or observational studies comparing the effect of SGLT2 inhibitors with DPP-4 inhibitors on infections to-date, despite both being common second line hypoglycemic agents.…”

Angioedema associated with dipeptidyl peptidase-IV inhibitors

“…A noninterventional cohort study explored the association of vildagliptin use with the risk of specific safety events of interest, including angioedema, compared with other noninsulin antidiabetic drugs using real-world data from five European electronic healthcare databases [ 30 ]. Patients with a previous angioedema event were not included in the analysis.…”