A study investigating the effectiveness of the blood thinner Xarelto in patients with coronary artery disease (CAD) or peripheral arty disease (PAD) was halted prematurely after an interim analysis showed the medication helped prevent heart attacks, strokes and cardiovascular death. But the study has yet to reveal the rate of bleeding events, a known side effect of Xarelto.
CAD and PAD are conditions in which there is a narrowing and blocking of the arteries in various critical regions of the body. CAD affects the heart’s arteries whereas PAD usually affects the arteries in the legs, but can also be used to describe plaque buildup that occurs in the arteries of the neck and kidneys.
Patients with CAD and PAD are at a significant risk of fatal or debilitating heart attacks and strokes from blood clots. Aspirin is the current medication used to reduce the risk of blood clots in these patients but its effectiveness is only mild at best.
The Cardiovascular Outcomes for People using Anticoagulation Strategies, or COMPASS, study began in 2013 with the primary efficacy endpoint being whether Xarelto could help prevent heart attacks, strokes and cardiovascular death in patients. The primary safety endpoint was determining major bleeding risk.
Xarelto was approved in 2011 and is used to prevent stokes in patients with atrial fibrillation, to prevent or treat deep vein thrombosis or pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. The drug increases the risk of major and sometimes fatal bleeding events in people, including gastrointestinal bleeds, rectal bleeds, and brain bleeds. There is currently no antidote available to reverse the bleeding effect of Xarelto in the event of a bleeding emergency.
The COMPASS study, conducted by Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, involved more than 27,000 patients who were treated with Xaerlto alone, Xarelto and aspirin, or aspirin alone. The estimated completion date for the study was March 2018, but was halted early due to the overwhelming effectiveness of the drug.
Johnson & Johnson says it will present a complete analysis of the trial’s data at a medical meeting later this year. That information should also provide insight into adverse events, including the rate of major bleeds.
Later this year, J&J, Janssen and Bayer will face the first trial among thousands of lawsuits waged by users of Xarelto who claim the drug companies did not adequately warn of bleeding risks associated with the drug.