Drug products: Brilique
ATC code: B01AC24
In the large randomized studies comparing ticagrelor with clopidogrel or placebo in patients with coronary artery disease (PLATO and PEGASUS-TIMI 54), no difference between men and women in effect on primary outcomes or severe bleeding.
Following a single 200 mg dose of ticagrelor in healthy patients, women had 37% higher AUC and 52% higher Cmax than men. The mean half-life was 22% longer in women than in men. However, these differences are not considered to be clinically important [1-3]. No dose adjustment based on sex is necessary [1-3].
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 large trials on ticagrelor, one compared ticagrelor and clopidogrel in patients with acute coronary syndrome (PLATO) and one compared ticagrelor and placebo in patients with myocardial infarction (PEGASUS-TIMI 54). No significant sex differences were observed for the primary efficacy endpoint (cardiovascular death, myocardial infarctions, or 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]
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2019-01-22
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson