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Preliminary data for rivaroxaban vs warfarin in AF

By News team

Rivaroxaban is non-inferior to warfarin for the prevention of stroke in patients with atrial fibrillation (AF), according to preliminary results of the ROCKET-AF study, presented at the American Heart Association Scientific Sessions in Chicago (13–17 November 2010).

In the study, 14,269 patients with AF who would routinely be prescribed warfarin (CHADS2 score =2) were randomised to receive either rivaroxaban 20mg daily or dose-adjusted warfarin (target international normalised ratio 2–3).

Helen Williams, consultant pharmacist for cardiovascular disease in south London, explained that, although rivaroxaban was shown to be non-inferior to warfarin for the prevention of stroke or systemic embolism in high-risk patients with AF, it failed to show superiority in the intention-to-treat analysis.

“Naturally, these results will be compared with those of the RE-LY study [New England Journal of Medicine 2009;361:1139] in which dabigatran demonstrated superiority over warfarin; although the trial designs (double blind, double dummy in ROCKET-AF versus open-label, blinded endpoint in RE-LY) and the study populations (high-risk population in ROCKET-AF versus lower-risk patients in RE-LY) were very different,” she told Clinical Pharmacist.

“The debate over the relative strengths of these two agents will begin in earnest once ROCKET-AF has been published in full. For now, it is clear that they will change clinical practice dramatically over the next few months and years.”

Ms Williams said that healthcare professionals have long sought agents that deliver the effectiveness of warfarin without the need for ongoing monitoring and with less risk of bleeding.

However, she noted: “It is expected that these drugs will come at a premium price and the challenge for pharmacists will be to manage their introduction in a controlled way, ensuring that patients with the most to gain are prioritised for treatment and at the same time managing the patient lobby which is likely to seek access for all patients once this additional indication is approved.”

RE-LY sub-analysis

A sub-analysis of the RE-LY study (Lancet Neurology 2010;9:1157), suggests that dabigatran is as good as warfarin for the secondary prevention of stroke or transient ischaemic attack in patientswith AF.

Citation: Clinical Pharmacist URI: 11048908

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