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Vildagliptin

Classification: A

Drug products: Eucreas®, Galvus®

ATC code: A10BD08, A10BH02

Substances: vildagliptin

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 the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2014-08-28

References

  1. GALVUS (vildagliptin). Summary of Product Characteristics. European Medicines Agency (EMA); 2014.
  2. 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
  3. 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
  4. 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
  5. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson