Xarelto lowers CV risk, ups major bleeds in Phase III for artery disease

The Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) reported full data from the Phase III COMPASS trial showing that twice-daily 2.5 mg oral Xarelto rivaroxaban (BAY 59-7939) plus once-daily 100 mg aspirin significantly reduced the proportion of coronary and/or peripheral artery disease (CAD/PAD) patients with cardiovascular (CV) death, myocardial infarction (MI) or stroke, the primary endpoint, by 24% vs. aspirin alone (4.1% vs. 5.4%, HR=0.76, p<0.001). Janssen and partner Bayer AG (Xetra:BAYN) stopped the trial early in February after the drug met that primary endpoint (see BioCentury, Feb. 10).

For the individual components of the composite primary endpoint, 2.5 mg Xarelto plus aspirin reduced the risk of any stroke by 42% (HR=0.58, p<0.001), CV death by 22% (HR=0.78, p=0.02) and MI by 14% (HR=0.86, p=0.14) vs. aspirin alone. The incidence of major bleeding was significantly greater in patients receiving Xarelto plus aspirin vs. aspirin alone (3.1% vs. 1.9%, HR=1.7, p<0.001)...