The FDA has approved Xarelto (rivaroxaban, Janssen Pharmaceutical Companies of Johnson & Johnson, Titusville, New Jersey) to reduce the risk of major cardiovascular (CV) events in people with chronic coronary or peripheral artery disease (CAD/PAD). The drug is now the first and only factor Xa inhibitor approved for patients with these conditions.
Significant results from the milestone COMPASS trial––a 24% reduction in the risk of major CV events in patients with chronic CAD and/or PAD––led to the new indication. The trial also revealed a 42% reduction in stroke, 22% reduction in CV death, and 14% reduction in heart attack.
COMPASS, a phase 3 clinical study of more than 27,000 patients with chronic CAD or PAD from 33 countries, examined the use of Xarelto, alone or combined with aspirin, for the long-term prevention of major adverse CV events, including heart attack, stroke, and CV death. The successful outcome in patients using Xarelto 2.5 mg plus aspirin caused the study to be halted early, in February 2017, based on the recommendation of the Independent Data and Safety Monitoring Board.
Although it is seldom fatal, atherosclerosis is the most common underlying cause of chronic CAD and PAD, which affect 16.5 million and 10 million Americans, respectively. The use of aspirin alone has proved insufficient at preventing the thrombotic risk associated with chronic CAD and PAD.
Source: Drugs.com, October 15, 2018