Drug products: Amias, Atacand, Atacand Plus, Atacand®, Atacand® Plus, Blopresid Comp, Blopress Comp, Candemox Comp, Candesarstad, Candesarstad Comp, Candesartan Actavis, Candesartan Krka, Candesartan Navamedic, Candesartan Orion, Candesartan Ranbaxy, Candesartan Sandoz, Candesartan/Hydrochlorothiazide 2care4, Candesartan/Hydrochlorothiazide Actavis, Candesartan/Hydrochlorothiazide Krka, Candesartan/Hydrochlorothiazide Navamedic, Candesartan/Hydrochlorothiazide Orion, Candesartan/Hydrochlorothiazide STADA, Candesartan/Hydrochlorothiazide Teva, Candexetil, Candexetil comp, Kairasec, Kandrozid, Racanda, Ratacand, Ratacand Plus
ATC code: C09CA06, C09DA06
Substances: candesartan, candesartan cilexetil
The antihypertensive effect of candesartan is similarin men and women. A study has shown Caucasian women and men to achieve a larger blood pressure reduction compared to African-American women and men. Candesartan reduces the risk of cardiovascular death and hospitalization for heart failure equally in men and women with heart failure.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
Pharmacokinetic studies have found no sex differences in the pharmacokinetic parameters in hypertensive patients receiving candesartan [1-5]. One study reported that AUC/dose corrected for body mass did not differ between men and women . A small pharmacokinetic study in hypertensive children (in total 10), receiving a single dose of candesartan (0.2 mg/kg), reported that the pharmacokinetic profile was independent of sex and weight . Based on the pharmacokinetics of candesartan, no initial dosage adjustment based on sex is considered necessary .
A meta-analysis (657 men, 771 women) of six European randomized, double-blind, placebo-controlled studies using candesartan (doses ranged from 2-16 mg once daily) has shown a clinically significant dose-dependent antihypertensive effect of candesartan, irrespective of sex .
In a multicenter study (203 men, 236 women), African-American and non-Hispanic white subjects with essential hypertension were treated with candesartan, 32 mg/day for 6 weeks. Blood pressure (BP) response to candesartan in non-Hispanic white women and men were greater than in their African-American counterparts. Non-Hispanic white women had the largest fall in systolic BP compared with all other groups (African American men and women and non-Hispanic white men). Diastolic BP also decreased more in non-Hispanic white women than in African Americans of either sex, but not more than in non-Hispanic white men .
An analysis of all three CHARM heart failure studies (5199 men, 2400 women) showed that the risk reduction in cardiovascular death or heart failure hospitalization was lower in women regardless of treatment. More women than men had preserved left ventricular ejection fraction, which might explain this results. However, the effect of candesartan (4-32 mg once daily) was similar in men and women .
Tolerability profile of candesartan during long-term studies is similar to that of short-term clinical trials and did not appear to be related to sex [9, 10].
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2014-01-21
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson