Bayer and Janssen Research & Development revealed new data for their promising anticoagulant treatment rivaroxaban (Xarelto).
Researchers presented results from a late stage study, named COMPASS, showing that rivaroxaban in combination with aspirin is superior to aspirin alone in preventing further heart complications in people with either stable coronary artery disease (CAD) or peripheral artery disease (PAD).
Investigators tested three different dosage combinations in the randomized clinical trial: a 2.5 mg dose of rivaroxaban twice daily combined with 100 mg of aspirin once daily, a twice-daily 5 mg of rivaroxaban, or a once-daily 100 mg dose of aspirin. Patients were seen at one and six months followed by every six months upon dosage.
Patients receiving the first combination saw a significant reduction in the risk of major cardiovascular (CV) events — defined as CV death, heart attack, or stroke — drop by 24 percent compared to aspirin alone.
Also, this finding was driven by a 42 percent reduction in any stroke and 22 percent reduction in CV death, according to the announcement.
“Efforts to improve aspirin have focused primarily on combining aspirin with another antiplatelet drug or replacing aspirin with another antiplatelet drug, but this has had only limited success,” said co-principal investigator Dr. John Eikelboom, in a statement. He works as a principal investigator of the Population Health Research Institute of McMaster University.
The scientists also noted there was an increase in the chance of experiencing major bleeding, but these occurrences were mainly gastroenterological and not in critical organs.
“Using a different approach, COMPASS showed that combining aspirin with a low dose of an anticoagulant was substantially more effective than aspirin alone. Even small improvements in the effectiveness of treatments that prevent stroke and heart attack are important because cardiovascular disease is very common. In COMPASS the treatment effect was unexpectedly large,” continued Eikelboom.
COMPASS served as the largest clinical study of rivaroxaban with 27,395 patients with CAD and/or PAD enrolled in the study.
These findings were presented at the annual European Society of Cardiology Meeting taking place in Barcelona, Spain.
Filed Under: Drug Discovery