Drug products: Efient, Prasugrel Krka
ATC code: B01AC22
Substances: prasugrel, prasugrel hydrochloride
In the large randomized studies comparing prasugrel and clopidogrel in patients with acute coronary syndrome and PCI (TRITON) or not (TRIOLOGY), no difference between men and women in effect on primary outcomes or severe bleeding.
Pharmacokinetics of prasugrel’s active metabolite is similar in healthy men and women [1-3]. No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of prasugrel have been found.
A large sex-specific meta-analysis of randomized phase III and IV trials compared the efficacy of P2Y12 inhibitors (prasugrel, ticagrelor, cangrelor) with clopidogrel or placebo in patients with coronary artery disease (63 346 men, 24 494 women). The potent P2Y12 inhibitors reduced the risk of major adverse cardiovascular events similarly in men and women . This finding was confirmed in a recent sex-specific meta-analysis of P2Y12 inhibitors (ticagrelor, prasugrel, clopidogrel) in patients with acute coronary syndrome . The meta-analyses included two clinical trials on prasugrel, which was compared to clopidogrel in patients with acute coronary syndromes who have undergone PCI (TRITON-TIMI 38) or not (TRILOGY-ACS). Maintenance doses in both studies were either prasugrel 10 mg daily or clopidogrel 75 mg daily. No significant sex differences were observed for the effect on primary events (cardiovascular death, nonfatal MI, or nonfatal stroke) [6, 7].
A sex-specific meta-analysis (63 346 men, 24 494 women) examining the risk of major bleeding from treatment with P2Y12 inhibitors (prasugrel, ticagrelor, cangrelor) in coronary artery disease suggested no significant difference in major bleeding in men and women [4, 6, 7]. This finding has been confirmed in an observational study . In a post-hoc analysis of predictors of bleeding events from prasugrel treatment (2922 men, 1111 women), female sex was one independent factor predicting major bleeding .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2018-12-21
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson