NEJM report confirms Xarelto as safe and effective as warfarin, says Bayer

Data newly-published in the New England Journal of Medicine (NEJM) demonstrate that German drug major Bayer (BAY: DE) and the USA’s Johnson & Johnson’s (NYSE: JNJ) one tablet once-daily, oral, direct Factor Xa inhibitor Xarelto (rivaroxaban) successfully met its primary efficacy endpoint versus dose-adjusted warfarin in the double blind, double dummy ROCKET AF Phase III clinical study. The principal safety outcome - the composite of major and non-major clinically relevant bleeding events - was similar in both treatment arms.

Rivaroxaban met the primary efficacy endpoint of non-inferiority to warfarin in the prevention of stroke and non-CNS systemic embolism. In the primary analysis, stroke or non-CNS systemic embolism occurred in 188 patients in the rivaroxaban group and in 241 patients in the warfarin group (1.7% versus 2.2% per year, hazard ratio in the rivaroxaban group, 0.79; CI 0.66 to 0.96, p<0.001 for non inferiority). Subsequent hierarchical testing confirmed superior efficacy of rivaroxaban versus warfarin whilst on active treatment, with a 21% relative risk reduction (RRR) per year and an absolute risk reduction (ARR) of 0.5% per year in stroke and non-CNS systemic embolism in the pre-specified on-treatment population (1.7% vs 2.2% per year, p=0.01 for superiority).

An additional sensitivity analysis in the ITT population which followed all patients in the trial until its completion demonstrated non-inferiority (2.1% vs 2.4% per year, (HR 0.88; 95% CI, 0.75 to 1.03; P<0.001 for non-inferiority).