Drug products: Daonil®, Glibenklamid RPH Pharma
ATC code: A10BB01
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.
No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of glibenclamide have been found.
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 .
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 .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 .
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 .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
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 .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 .
Date of litterature search: 2020-07-08
Reviewed by: Carl-Olav Stiller
Approved by: Karin Schenck-Gustafsson