Preparat: Daonil®, Glibenklamid RPH Pharma
ATC kod: A10BB01
Det saknas kontrollerade studier om skillnader mellan könen avseende effekt.
Vissa studier indikerar att kvinnor har högre risk att få hypoglykemi vid antidiabetikabehandling än män. Mindre studier har inte hittat några könsskillnader i risk för hypoglykemi vid glibenklamidbehandling.
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 .
Fler män än kvinnor hämtade ut tabletter innehållande glibenklamid (ATC-kod A10BB01) på recept i Sverige år 2019, totalt 3 636 män och 2 141 kvinnor. Det motsvarar 7 respektive 4 personer per tiotusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 75 år och äldre hos båda könen. I genomsnitt var tabletter innehållande glibenklamid 1,7 gånger vanligare hos män . Detta speglar könsskillnaden i prevalens av typ 2-diabetes .
Faktagranskat av: Carl-Olav Stiller
Godkänt av: Karin Schenck-Gustafsson