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Ces essais ont comparé Eliquis à la warfarine et à l’acide acétylsalicylique (AAS), respectivement, en ce qui a trait à l’efficacité contre les AVC et les embolies systémiques et à l’innocuité relativement aux saignements majeurs, à titre de principaux critères d’évaluation, et à en ce qui a trait à l’innocuité relativement aux décès de toutes causes, à titre de critère d’évaluation secondaire8,9.
Health Canada’s approval of Eliquis is based on data from global studies (ARISTOTLE and AVERROES), which evaluated almost 24,000 patients in what is the largest clinical trial program conducted to date in patients with AF, in which Canada was a significant participant.[6],[7]The studies compared Eliquis with warfarin and acetylsalicylic acid (ASA), respectively, and looked at efficacy relating to stroke and systemic embolism and safety relating to major bleeding as the primary endpoints, and all-cause death as a secondary endpoint.8,9
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Il a été démontré que, pour la prévention secondaire à court ou à long terme, l'utilisation de PLAVIX en association avec de l'AAS permet de réduire le risque d'accidents athérothrombotiques (décès d'origine cardiovasculaire, infarctus du myocarde, AVC ischémique ou ischémie réfractaire) chez les patients atteints d'un syndrome coronarien aigu (angine instable ou infarctus du myocarde sans onde Q), y compris ceux faisant l'objet d'un traitement médical et ceux qui subiront une angioplastie coronarienne percutanée (avec ou sans mise en place d'une endoprothèse) ou un pontage coronarien5.
“This new indication is an important advance in the treatment of ACS for patients with STEMI as myocardial infarction is a life-threatening condition. Previously, clopidogrel taken with aspirin was shown to reduce the risk of death, recurrent heart attacks or stroke in patients with unstable angina or less severe heart attacks1,” said Dr. Shamir R. Mehta, Associate Professor of Medicine and Director of Interventional Cardiology and the Acute Coronary Syndrome Research Program, Population Health Research Institute, McMaster University and Hamilton Health Sciences. “Now, based on the positive results of two clinical trials, COMMIT2 and CLARITY-TIMI 283, clopidogrel has been approved for use with aspirin in patients with the most severe types of heart attacks, thereby extending the benefit of clopidogrel to patients across the spectrum of acute coronary syndromes.”
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De nombreux patients atteints de FA présentant un risque modéré ou élevé d’AVC ne sont pas traités par un AVK21. Actuellement, la seule solution de rechange à un AVK indiquée en présence de FA est un traitement antiplaquettaire par l’AAS13.
The AVERROES (Apixaban, Versus Acetylsalicylic Acid [ASA] to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment) study, led out of McMaster University in Hamilton, Ontariowas designed to determine the efficacy and safety of apixaban, at a dose of 5 mg twice-daily, as compared with ASA, at a dose of 81 to 324 mg daily, for the treatment of patients with AF for whom vitamin K antagonist (VKA, such as warfarin) was considered unsuitable.The primary objective of the study was to determine whether apixaban 5 mg twice-daily (2.5 mg twice-daily in selected patients) was superior to ASA (81 to 324 mg QD) in the prevention of stroke or systemic embolism. Assessments of superiority of apixaban versus ASA were also pre-specified for major vascular events (composite outcome of stroke, systemic embolism, myocardial infarction or vascular death) and all-cause death.3