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Review
. 2017 Aug;13(2):68-72.
doi: 10.17925/EE.2017.13.02.68. Epub 2017 Aug 22.

Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance

Chantal Mathieu  1 , Plamen Kozlovski  2 , Päivi M Paldánius  2 , James E Foley  3 , Vikas Modgill  2 , Marc Evans  4 , Carmen Serban  2
Affiliations
Review

Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance

Chantal Mathieu et al. Eur Endocrinol. 2017 Aug.

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: Dipeptidyl peptidase-4 (DPP-4) inhibitors; post-marketing surveillance; safety; vildagliptin.

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Conflict of interest statement

Disclosure: 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.

Figures

Figure 1:
Figure 1:. Incidence and risk ratios for adjudicated composite endpoint of major adverse cardiovascular events and its individual components with vildagliptin (50 mg once daily/twice daily) versus comparators (placebo and active comparators)
CI = confidence interval; CV = cardiovascular; MACE = major adverse CV events consisting of myocardial infarction, stroke and CV death; MHRR = Mantel-Haenszel risk ratio.
See this image and copyright information in PMC

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