![]() ![]() We look forward to sharing the detailed results with health authorities.”ĭr. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Results of the Phase III THALES trial showed BRILINTA, in combination with aspirin, improved outcomes in patients who had experienced a minor acute ischemic stroke or high-risk transient ischemic attack. ![]() The preliminary safety findings in the THALES trial were consistent with the known profile of BRILINTA, with an increased bleeding rate in the treatment arm. THALES was conducted in over 11,000 patients who had a minor acute ischemic stroke or high-risk transient ischemic attack (TIA) in the 24 hours prior to treatment initiation. Stockholm: Socialstyrelsen.WILMINGTON, Del.-( BUSINESS WIRE)-High-level results from the Phase III THALES trial showed AstraZeneca’s BRILINTA (ticagrelor) 90 mg used twice daily and taken with aspirin for 30 days, reached a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone. Long-term use of ticagrelor in patients with prior myocardial infarction. Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC et al.The efficacy of ticagrelor is maintained in women with acute coronary syndromes participating in the prospective, randomized, PLATelet inhibition and patient Outcomes (PLATO) trial. Husted S, James SK, Bach RG, Becker RC, Budaj A, Heras M et al.Differences in relative and absolute effectiveness of oral P2Y12 inhibition in men and women: a meta-analysis and modelling study. Lee KK, Welton N, Shah AS, Adamson PD, Dias S, Anand A et al.Potent P2Y12 Inhibitors in Men Versus Women: A Collaborative Meta-Analysis of Randomized Trials. Lau ES, Braunwald E, Murphy SA, Wiviott SD, Bonaca MP, Husted S et al.Pharmacokinetic, pharmacodynamic and pharmacogenetic profile of the oral antiplatelet agent ticagrelor. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). Adverse effectsĪ 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 Reproductive health issues No significant sex differences were observed for the primary efficacy endpoint (cardiovascular death, myocardial infarctions, or stroke). 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). This finding was confirmed in a recent sex-specific meta-analysis of P2Y12 inhibitors (ticagrelor, prasugrel, clopidogrel) in patients with acute coronary syndrome. The potent P2Y12 inhibitors reduced the risk of major adverse cardiovascular events similarly in men and women. EffectsĪ 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). ![]() No dose adjustment based on sex is necessary. However, these differences are not considered to be clinically important. The mean half-life was 22% longer in women than in men. Additional information Pharmacokinetics and dosingįollowing a single 200 mg dose of ticagrelor in healthy patients, women had 37% higher AUC and 52% higher Cmax than men. ![]()
0 Comments
Leave a Reply. |