Bayer says rivaroxaban meets primary endpoint in ROCKET AF

Rivaroxaban (Xarelto) was as effective as warfarin in patients with AF in the ROCKET AF study, according to an announcement released by Bayer on Sunday ahead of the scheduled presentation of the trial at the AHA on November 15.

ROCKET AF randomized more than 14,000 patients with non-valvular AF to either rivaroxaban or warfarin. The goal of the study was to establish the noninferiority of rivaroxaban to warfarin. The primary efficacy endpoint  was a composite of all-cause stroke and non-CNS systemic embolism. The primary safety endpoint was the composite of major and non-major clinically relevant bleeding events.

According to Bayer:

Rivaroxaban has met its primary efficacy endpoint versus dose-adjusted warfarin. The rates of the composite of major and non-major clinically relevant bleeding were comparable.

Harlan Krumholz, on CardioExchange, noted the following important remaining questions about the trial:

  • Were the event rates comparable to what might be expected in practice — or is there evidence that the study population was highly selected?
  • Was the warfarin treatment optimized? How well was the INR maintained?
  • Are there any safety concerns with rivaroxaban? How do bleeding rates compare?
  • Is there any suggestion that the drug is particularly good or bad for a particular subgroup? This would be an exploratory analysis and would not likely be considered definitive.
  • Is there any evidence that rivaroxaban is more effective than warfarin?
  • And then, if at the end of the day, rivaroxaban really looks to be no better than warfarin — will it find a niche in clinical care?

Rivaroxaban is a factor Xa inhibitor under development by Bayer and Johnson & Johnson. Another eagerly anticipated factor Xa inhibitor is apixaban, under joint development by Pfizer and Bristol-Myers. In recent weeks dabigatran (Pradaxa) became the first new anticoagulant approved for stroke prevention in AF.

Click here for previous coverage of rivaroxaban on CardioBrief.

Here is the text of the Bayer announcement:

Ad-hoc-Announcement according to § 15 WpHG Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com

Bayer AG: Phase III ROCKET AF Study of Rivaroxaban meets its primary efficacy endpoint with Comparable Safety vs. Warfarin

Leverkusen, Germany, October 31, 2010

Bayer today announced the preliminary results of the pivotal Phase III ROCKET AF study of rivaroxaban, the full details of which will be presented at the Late Breaker Session on November 15, 2010, [10:45 am – 10:55 am CST], at the Scientific Sessions of the American Heart Association (AHA) in Chicago, USA.

The primary objective of the study was to establish the non-inferiority of 20 mg rivaroxaban once-daily (or 15 mg in patients with moderate renal impairment at screening) compared to dose-adjusted warfarin in patients with non-valvular atrial fibrillation (AF) at risk of stroke and non-CNS systemic embolism. The primary efficacy endpoint was a composite of all-cause stroke and non-CNS systemic embolism. The primary safety endpoint was the composite of major and non-major clinically relevant bleeding events.

Rivaroxaban has met its primary efficacy endpoint versus dose-adjusted warfarin. The rates of the composite of major and non-major clinically relevant bleeding were comparable.

ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) was an event-driven, prospective, randomized, double-blind Phase III study in which more than 14,000 patients have been enrolled from more than 1,100 centers across 45 countries worldwide.

The study was led by the Duke Clinical Research Institute, Durham, North Carolina, USA, and an international academic executive committee.

Forward-Looking Statements

This Ad-hoc Statement contains forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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