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Semaglutide

Classification: A

Drug products: Ozempic, Rybelsus

ATC code: A10BJ06

Substances: semaglutide

Summary

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.

Additional information

Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2].

Pharmacokinetics and dosing

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 [3].

Effects

A post-hoc analysis of data from four trials in the SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes) programme (776 men, 776 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) [4].

Adverse effects

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) [5].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Updated: 2022-11-09

Date of litterature search: 2020-02-01

References

  1. Ozempic (semaglutide). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2019-02-20, cited 2020-02-01].
  2. Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018;20(9):2238-2245. PubMed
  3. Leiter LA, Bain SC, Hramiak I, Jódar E, Madsbad S, Gondolf T et al. Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial. Cardiovasc Diabetol. 2019;18(1):73. PubMed
  4. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk
  5. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15. PubMed
  6. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28. PubMed

Authors: Emelie Elfving, Linnéa Karlsson Lind

Reviewed by: Carl-Olav Stiller, Diana Rydberg

Approved by: Karin Schenck-Gustafsson