Clinical Safety and Tolerability of Vildagliptin – Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance
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.
Dipeptidyl peptidase-4 (DPP-4) inhibitors, postmarketing
surveillance, safety, vildagliptin
Chantal Mathieu serves or has served on the advisory panel for
AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company,
Intrexon, Janssen Pharmaceuticals, Hanmi Pharmaceuticals, Mannkind, Medtronic,
Merck Sharp & Dohme Corp., Novartis, Novo Nordisk, Pfizer, Sanofi, Roche
Diagnostics and UCB. Chantal Mathieu serves or has served on the speaker’s bureau
for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Merck Sharp & Dohme
Corp., Novartis, Novo Nordisk and Sanofi. Katholieke Universiteit Leuven has received
research support for Chantal Mathieu from Abbott, Eli Lilly and Company, Intrexon,
Merck Sharp & Dohme Corp., Novartis, Novo Nordisk, Roche Diagnostics and
Sanofi. Plamen Kozlovski, Päivi M Paldánius, Vikas Modgill and Carmen Serban are
employees and shareholders of Novartis Pharma AG. James E Foley is an employee
and shareholder of Novartis Pharmaceuticals Corporation. Marc Evans received
financial support for consulting from Novartis, Merck Sharp & Dohme Corp. and
Novo Nordisk and has served on speaker’s bureau for Novartis, Eli Lilly, Boehringer
Ingelheim, Merck Sharp & Dohme Corp., Novo Nordisk, Janssen and Takeda.
Chantal Mathieu, Department of Clinical and
Experimental Medicine, Katholieke Universiteit Leuven, UZ Herestraat
49, Leuven 3000, Belgium. E: email@example.com
The publication of this article was supported by Novartis Pharma AG.
This article is published under the Creative Commons
Attribution Noncommercial License, which permits any noncommercial
use, distribution, adaptation and reproduction provided
the original author(s) and source are given appropriate credit.
Medical writing assistance was provided by Amit Kumar
Garg and Lakshmi Deepa of Novartis Healthcare Private Limited, Hyderabad, India.
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