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Glimepiride

Classification: B

Drug products: Amaryl®, Glimepirid 2care4, Glimepirid Actavis, Glimepirid Bluefish, Glimepirid Mylan, Glimepirid Orion, Glimepirid Sandoz, Glimepirid STADA

ATC code: A10BB12

Substances: glimepiride

Summary

Controlled studies on differences between men and women in glimepiride efficacy are lacking. Pharmacokinetic studies have not shown any large differences between men and women. In other studies, women treated with antidiabetics had a higher risk of hypoglycemia than men.

Additional information

Pharmacokinetics and dosing

Population pharmacokinetic analyses have found no sex differences in the pharmacokinetics of glimepiride after adjustment for body weight [3, 4]. No studies with a clinically relevant sex analysis regarding the dosing of glimepiride have been found.

Effects

No studies with a clinically relevant sex analysis regarding the effects of glimepiride have been found.

Adverse effects

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 [1].

Reproductive health issues

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

Other information

An observational retrospective study compared the effects of glimepiride or glibenclamide treatment on body weight over 12 months of treatment in patients with type 2 diabetes. Patient's sex had no significant influence on change in body weight or BMI [2].

Updated: 2020-10-06

Date of litterature search: 2020-07-09

References

  1. Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010;340:b5444. PubMed
  2. Martin S, Kolb H, Beuth J, van Leendert R, Schneider B, Scherbaum WA. Change in patients' body weight after 12 months of treatment with glimepiride or glibenclamide in Type 2 diabetes: a multicentre retrospective cohort study. Diabetologia. 2003;46:1611-7. PubMed
  3. Karim A, Zhao Z, Slater M, Bradford D, Schuster J, Laurent A. Replicate study design in bioequivalency assessment, pros and cons: bioavailabilities of the antidiabetic drugs pioglitazone and glimepiride present in a fixed-dose combination formulation. J Clin Pharmacol. 2007;47:806-16. PubMed
  4. AMARYL (glimepirid). Summary of Product Characteristics. Swedish Medical Products Agency (MPA) [updated 2018-12-01, cited 2020-07-09].
  5. 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: Diana Rydberg

Reviewed by: Carl-Olav Stiller

Approved by: Karin Schenck-Gustafsson