You are here

Xarelto Approved for Chronic Coronary Artery Disease, Peripheral Artery Disease

COMPASS Trial Shows 24% Reduction in Major CV Events

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

Recent Headlines

First New Medication for Seizure Clusters in More Than Two Decades
Novel, Low-cost Device Highly Accurate at Screening Newborn Jaundice
Mode Delivers Antivirals Safely, Cheaply to Remote Regions
First Devices Cleared for Diagnostic Testing Via Throat, Rectum Specimens
Averts Disease Worsening, Reduces Potential for Blindness
Risk May Remain for 6 Months After Treatment
FDA Removes Boxed Warning With Drug’s Fifth Approval
Overeager Use of Recommendations Creates Problems
Artificial Intelligence Enables Platform to Detect Amyloid PET Status