Drug products: Janumet®, Januvia®
ATC code: A10BD07, A10BH01
Substances: sitagliptin, sitagliptin phosphate, sitagliptin phosphate monohydrate
Controlled studies on differences between men and women in effect of sitagliptin are lacking. No pharmacokinetic differences have been found.
A clinical study has shown that women had more hypoglycemia than men.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
Clinical studies have shown no pharmacokinetic differences between men and women of single- or multiple-dose sitagliptin [1, 2]. According to the original manufacturer, no clinically relevant pharmacokinetic sex differences have been shown .
In a Japanese retrospective cohort study (in total 87 678 patients), dose levels of sitagliptin were compared before and after the safety alert on the risk of serious hypoglycemic events with the combination sitagliptin and high-dose sulfonylureas. Women were prescribed lower mean daily doses of sitagliptin both before and after the safety alert (before; women : 59.6 ± 21.8 mg, men: 63.4 ± 24.4 mg, after; women: 57.2 ± 20.1 mg, men: 61.6 ± 23.7 mg) . However, the original manufacturer do not recommend any dose adjustment based on sex .
No studies with a clinically relevant sex analysis regarding the effects of sitagliptin have been found.
A study evaluated the relative risk of hypoglycemic events in patients (691 men, 481 women) treated with sitagliptin or glipizide after adjustning for the most recently measured HbA1c value. The adjusted hazard ratio for women on either of the two studied drugs was 2.05, indicating that women had a twofold increase in risk of experiencing confirmed hypoglycemia relative to men. In multivariate analysis, female sex was one of the factors associated with a higher risk of hypoglycemia .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2014-08-19
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson