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Apixaban Noninferior to Warfarin in AF Patients: ARISTOTLE

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Pyankov Vasily
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Apixaban Noninferior to Warfarin in AF Patients: ARISTOTLE

Сообщение Pyankov Vasily » Вт июл 05, 2011 12:39 pm

June 22, 2011 (Princeton, New Jersey and New York, New York) — Topline results from the ARISTOTLE trial, comparing apixaban (Eliquis, Pfizer/Bristol-Myers Squibb) with warfarin in subjects with atrial fibrillation (AF) and risk factors for stroke, suggest that the oral direct factor Xa inhibitor is noninferior to the older standard for the prevention of stroke and systemic embolism [1].

According to preliminary results of the study, released late Wednesday, apixaban also "met the key secondary end points of superiority on efficacy and on ISTH [International Society on Thrombosis and Haemostasis] major bleeding compared with warfarin."

Full results of the trial will be presented August 28 at the European Society of Cardiology 2011 meeting in Paris, France.

ARISTOTLE enrolled over 18 000 AF patients in more than 1000 centers in roughly 40 countries, the press release notes. The trial randomized patients to either a twice-daily dose of apixaban 5 mg or dose-adjusted warfarin.

If ultimately approved, apixaban would compete in this indication against dabigatran (Pradaxa, Boehringer Ingelheim), which is already on the US and other markets, as well as rivaroxaban (Xarelto, Bayer/Johnson & Johnson), still waiting for US approval. Rivaroxaban demonstrated noninferiority to warfarin in the ROCKET AF trial.

Earlier this year, apixaban proved itself superior to aspirin in the 5599-patient AVERROES study, conducted in patients with AF at risk for stroke who were not suitable candidates for warfarin therapy, as reported by heartwire. Preliminary AVERROES results were also released early, after a predefined interim analysis by the independent data monitoring committee saw a clear and "clinically important reduction in stroke and systemic embolism."

The first approval for apixaban was last month, in Europe, where regulators granted it approval for use in the 27 countries of the EU for the prevention of venous-thromboembolic (VTE) events in adult patients who have undergone elective hip- or knee-replacement surgery.

http://www.medscape.com/viewarticle/745 ... ews&spon=2

P.S. Пресс-релиз ARISTOTLE Study

http://www.bms.com/news/press_releases/ ... 6192849398


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