Drug products: Ozempic, Rybelsus
ATC code: A10BJ06
Women seem to have a somewhat larger weight drop compared to men. Otherwise, no clinically relevant sex differences have been described. A post-hoc analysis of a randomized trial indicates higher risk of gastrointestinal adverse events in women.
Both men and women have been included in published pharmacokinetic studies, but results have not been presented separately. The pharmaceutical company does not recommend different doses according to patient’s sex to be necessary .
A post-hoc analysis of data from four trials in the SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes) programme (n=1552, around 50% women) found the effect on HbA1C to be similar in men and women. However, women had a greater weight loss than men (-7.0% vs. -4.5% compared to baseline) .
The ACCORD study (Action to Control Cardiovascular Risk in Diabetes) was a randomized, controlled trial designed to test the effect of intensive glucose control compared with standard control on cardiovascular outcomes in patients with type 2 diabetes. The study showed that women had a higher risk of hypoglycemia than men regardless of treatment in general .Analyses of other insulins have shown a higher risk for women to have hypoglycemic events [8-12].
In a post-hoc analysis of the SUSTAIN 6 trial including patients with type 2 diabetes and high cardiovascular risk who received semaglutide or placebo once a week (2002 men, 1295 women), gastrointestinal adverse events in all treatment groups were more common among women than men (55.6 vs 48.5% for semaglutide and 37.7 vs 32.0% for placebo), but rates of premature treatment discontinuation were similar for men and women (12.5 and 13.9%, respectively) .
Semaglutide can increase the exposure for levonorgestrel at steady state but this is not observed for ethinylestradiol . Semaglutide is contraindicated for use during pregnancy. Semaglutide should be discontinued at least two months before a planned pregnancy due to the long half-life .
Regarding teratogenic aspects, please consult the Janusmed Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Two observational studies from the 1990’s (43 men, 374 women) reported intentional insulin omission among 1/3 of women to control their weight [2,3].
In a retrospective study in 124 women, peri-menstrual changes in self-reported glucose concentrations were found in 61%. Use of oral contraceptives did not diminish variability in blood glucose . In another study based on questionnaires (406 women) 67% of the participants reported changes in blood glucose levels or glycosuria pre-menstrually and 70% during the menstrual phase. Those with more cravings had larger elevations in blood glucose levels suggesting that giving in to cravings might cause the changes .
Date of litterature search: 2020-02-01
Reviewed by: Mia von Euler, Carl-Olav Stiller
Approved by: Karin Schenck-Gustafsson