Clinical Safety and Tolerability of Vildagliptin – Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance
Open Access
- 1 January 2017
- journal article
- review article
- Published by Touch Medical Media, Ltd. in touchREVIEWS in Endocrinology
- Vol. 13 (2), 68-72
- https://doi.org/10.17925/ee.2017.13.02.68
Abstract
Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit–risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.Keywords
This publication has 51 references indexed in Scilit:
- Intraclass differences in the risk of hospitalization for heart failure among patients with type 2 diabetes initiating a dipeptidyl peptidase‐4 inhibitor or a sulphonylurea: Results from the OsMed Health‐DB registryDiabetes, Obesity and Metabolism, 2017
- Bullous pemphigoid and dipeptidyl peptidase IV inhibitors: a case-noncase study in the French Pharmacovigilance DatabaseBritish Journal of Dermatology, 2016
- Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment: a randomised clinical trial.Diabetologia, 2015
- Efficacy and Safety of Vildagliptin in New-Onset Diabetes After Kidney Transplantation—A Randomized, Double-Blind, Placebo-Controlled TrialAmerican Journal of Transplantation, 2014
- Pharmacokinetics of vildagliptin in patients with varying degrees of renal impairmentInt. Journal of Clinical Pharmacology and Therapeutics, 2013
- Experience with Vildagliptin in Patients ≥75 Years with Type 2 Diabetes and Moderate or Severe Renal ImpairmentDiabetes Therapy, 2013
- One‐year safety, tolerability and efficacy of vildagliptin in patients with type 2 diabetes and moderate or severe renal impairmentDiabetes, Obesity and Metabolism, 2012
- Diabetes and cancer (1): evaluating the temporal relationship between type 2 diabetes and cancer incidenceDiabetologia, 2012
- Dipeptidyl peptidase inhibitors, an emerging drug class for inflammatory disease?Trends in Pharmacological Sciences, 2009
- Dipeptidyl-peptidase IV (CD26)-role in the inactivation of regulatory peptidesRegulatory Peptides, 1999