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Glibenclamide

Classification: A

Drug products: Daonil®, Glibenklamid RPH Pharma

ATC code: A10BB01

Substances: glibenclamide

Summary

Controlled studies on differences between men and women in glibenclamide (also called glyburide) efficacy are lacking.

In some studies, women treated with antidiabetics had a higher risk of hypoglycemia than men. Other studies in patients treated with glibenclamide found that the risk of hypoglycemia did not differ between men and women.

Additional information

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of glibenclamide have been found.

Effects

No studies with a clinically relevant sex analysis regarding the blood glucose lowering effects of glibenclamide have been found. A study investigated whether the use of glibenclamide both at the time of stroke and during hospitalization result in better neurological and functional outcomes in patients with diabetes mellitus (23 men, 10 women). Improvements occurred in patients with nonlacunar strokes and were independent of patient’s sex [3].

 

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].In a study of 57 reported cases of glibenclamide-associated hypoglycemia to the Swedish Adverse Drug Reactions Advisory Committee in 1983, there was a female preponderance (61%). However, no adjustments for proportion women and men prescribed glibenclamide were made, which makes the results difficult to interpret. Patient's sex did not predict the clinical course of the hypoglycemic events [4].

The frequency of hypoglycemia events was investigated in patients 66 years or older using sulfonylureas, i.e. glipizide or glibenclamide (also called glyburide). The participants also filled a prescription for one of the 16 most commonly prescribed antimicrobials for this population (n=44,991 male prescriptions, n=88,544 female prescriptions). There was no significant interaction between patient’s sex on the odds of subsequent hypoglycemia [5].

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].In a retrospective cohort population-based study in Colombia, the time to and factors associated with insulin initiation were analyzed in patients (496 men, 546 women) with type 2 diabetes mellitus treated with oral antidiabetics (glibenclamide, metformin, glibenclamide+metformin). Women had a shorter time to insulin therapy start (31.6 for men and 29.2 for women; range: 1–60 months). Furthermore, women at least 55 years of age were more likely to initiate insulin therapy than were other members of the cohort (p = 0.04). Men ≥45 years (OR: 0.59; 95% CI: 0.37–0.96; p = 0.034) were associated with a significantly decreased risk of insulin therapy initiation [6].

Updated: 2020-10-06

Date of litterature search: 2020-07-08

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. Kunte H, Schmidt S, Eliasziw M, del Zoppo GJ, Simard JM, Masuhr F et al. Sulfonylureas improve outcome in patients with type 2 diabetes and acute ischemic stroke. Stroke. 2007;38:2526-30. PubMed
  4. Asplund K, Wiholm BE, Lithner F. Glibenclamide-associated hypoglycaemia: a report on 57 cases. Diabetologia. 1983;24:412-7. PubMed
  5. Parekh TM, Raji M, Lin YL, Tan A, Kuo YF, Goodwin JS. Hypoglycemia after antimicrobial drug prescription for older patients using sulfonylureas. JAMA Intern Med. 2014;174(10):1605-12. PubMed
  6. Machado-Alba, JE, Machado-Duque, ME, and Moreno-Gutierrez, PA. Time to and factors associated with insulin initiation in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2015;107(3):332-7. PubMed
  7. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk
  8. 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