Association between peripheral arterial disease and diabetic foot ulcers in patients with diabetes mellitus type 2

M.Á. Tresierra-Ayala, A. García Rojas
2017 Medicina Universitaria  
This is an open access article under the terms of the Creat ive Commo ns Attri butio n-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. 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,
more » ... s, 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. K E Y W O R D S angioedema, dipeptidyl peptidase-4 inhibitors, foot ulcers, hepatic toxicity, serious infections, skin lesions, type 2 diabetes mellitus, vildagliptin S U PP O RTI N G I N FO R M ATI O N Additional supporting information may be found online in the Supporting Information section at the end of the article. How to cite this article: Williams R, Kothny W, Serban C, Lopez-Leon S, de Vries F, Schlienger R. 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. Endocrinol
doi:10.1016/j.rmu.2017.07.002 fatcat:ilpufephrfgtrb7ndtiksaqdhi