Vildagliptin
Classification: AATC code: A10BD08, A10BH02
Summary
The effect of vildagliptin on the enzyme dipeptidyl-peptidase-4 (DDP-4) is similar in men and women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
Additional information
Pharmacokinetics and dosing
In an open, parallel-group, clinical study, young and elderly healthy volunteers (20 men, 20 women) received a single dose of 100 mg vildagliptin. No clinically relevant differences in pharmacokinetic parameters were observed between men and women [1-3]. No dose adjustment based on sex is necessary [4].
Effects
Vildagliptin inhibits the enzyme dipeptidyl-peptidase-4 (DDP-4), which increases endogenous levels of incretin hormones, resulting in improved glucose-dependent insulin secretion. Inhibition of DDP-4 by vildagliptin is not affected by sex [1, 2]. No clinically relevant outcome studies have been found.
Adverse effects
A large meta-analysis (7458 men, 6112 women) reported that vildagliptin was not associated with an increased risk of cardiovascular or cerebrovascular events, neither in men nor in women, relative to comparative drugs [4].
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Updated: 2020-08-28
Date of litterature search: 2014-08-28
References
- GALVUS (vildagliptin). Summary of Product Characteristics. European Medicines Agency (EMA); 2014.
- He YL, Sabo R, Campestrini J, Wang Y, Riviere GJ, Nielsen JC et al. The effect of age, gender, and body mass index on the pharmacokinetics and pharmacodynamics of vildagliptin in healthy volunteers. Br J Clin Pharmacol. 2008;65:338-46. PubMed
- He YL, Sadler BM, Sabo R, Balez S, Wang Y, Campestrini J et al. The absolute oral bioavailability and population-based pharmacokinetic modelling of a novel dipeptidylpeptidase-IV inhibitor, vildagliptin, in healthy volunteers. Clin Pharmacokinet. 2007;46:787-802. PubMed
- Schweizer A, Dejager S, Foley JE, Couturier A, Ligueros-Saylan M, Kothny W. Assessing the cardio-cerebrovascular safety of vildagliptin: meta-analysis of adjudicated events from a large Phase III type 2 diabetes population. Diabetes Obes Metab. 2010;12:485-94. PubMed
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson