Drug products: Forxiga, Xigduo
ATC code: A10BD15, A10BK01
Substances: dapagliflozin, dapagliflozin propanediol monohydrate
Dapagliflozin in monotherapy or in combination treatment reduces HbA1c-levels equally in men and women. Clinical studies have shown urinal infection and genital infection to be more common in women than in men on dapagliflozin treatment.
A randomized placebo-controlled study has shown that men loose more weight than women treated with dapagliflozin.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
Pooled data from clinical pharmacology studies (349 men, 89 women) showed that women had a greater mean dapagliflozin AUC of 23%, even though Cmax was not increased . In a population pharmacokinetic model (634 men, 619 women), mean dapagliflozin AUC at steady state was 22% higher in women than in men . Despite differences described in AUC between men and women, this does not have any substantially clinically relevant impact and no dose adjustment has been considered necessary according to sex .
According to clinical studies done by the original manufacturer, treatment with dapagliflozin as monotherapy and in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin reduced HbA1c at week 24 compared to control in both men and women . Pooled data from several phase III studies show minimal differences in efficacy between men and women (data not shown) .
Data from randomized placebo-controlled clinical trials [3-7] report a higher frequency of genital infections and urinary tract infections in women than men treated with dapagliflozin. Genital infections incidence rates vary from 4.3-4.5% in women and 2.0-2.1% in men. Urinary tract infections incidence rates vary from 2.8-11.9% in women and 2.0-3.5% in men. The incidence of infections was not dose-related [3-7].
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
An international randomized, double-blind, placebo-controlled Phase III study (100 men, 80 women) showed a greater decrease in total body weight in men (-2.8 kg) at 24 weeks with dapagliflozin compared to women (-1.2 kg) .
Date of litterature search: 2014-08-29
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson