Drug products: Jardiance, Synjardy
ATC code: A10BD20, A10BK03
The effect of empagliflozin on cardiovascular death, hospitalization for heart failure and incident or worsening nephropathy is similar in men and women. The incidence of genital infections increases in both men and women on empagliflozin treatment.
In our opinion, the present evidence does not motivate differentiation in dosing or treatment between men and women.
A population pharmacokinetic analysis of empagliflozin was performed from phase I, II and III studies in 2761 persons with type 2 diabetes mellitus. Compared to men, women had 11% lower clearance and approximately 10-15% higher AUC of empagliflozin .
Pooled data from five randomized Phase I and II clinical trials (574 men, 400 women), four were included in the population pharmacokinetic analysis mentioned above, and showed that women had a 5% smaller apparent central volume of distribution (V2/F) than men .
A secondary analysis of the placebo-controlled EMPA-REG OUTCOME trial (5016 men, 2004 women) showed that empagliflozin reduced cardiovascular death, non-fatal stroke and non-fatal myocardial infarction to a similar degree in men and women. No sex differences in cardiovascular death, hospitalization for heart failure, or incident or worsening nephropathy were observed .
A population exposure-response analysis of empagliflozin plasma concentrations from Phase I, II and III studies in persons with type 2 diabetes mellitus (2217 men, 1848 women) showed that the maximum reduction of fasting plasma glucose (Gmax) was 11% lower in women than in men . Contrary to these findings, a covariate analysis of five randomized Phase I and II clinical trials in persons with type 2 diabetes (232 men, 63 women) showed that women had 12% higher Gmax than men. No clinically relevant difference between men and women was noted in urinary glucose excretion .
No differences in body weight, waist circumference, index of central obesity or visceral adiposity index between men and women with type 2 diabetes mellitus treated with empagliflozin were observed in analysis of data from five randomized placebo-controlled studies (1846 men, 1454 women). .
Empagliflozin treatment have been associated with increased incidence of genital infections in both men and women, as compared to placebo [1, 3].
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2017-05-10
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson