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Glimepiride

Classification: B

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

ATC code: A10BB12

Substances: glimepiride

Summary

Glimepiride is used for treatment of type-2 diabetes when lifestyle-modifying treatment has been insufficient.
Controlled studies on differences between men and women in glimepiride efficacy and safety are lacking. Sex differences in glimepiride pharmacokinetics have not been observed.
Some studies indicate that women have a higher risk of hypoglycemia during antidiabetic treatment than men.
 
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.

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 [1].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (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. Sex had no significant influence on change in body weight or BMI [2].

Updated: 2019-02-26

Date of litterature search: 2014-04-28

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). Produktresumé. Läkemedelsverket (MPA); 2013.
  5. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson