Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies recently announced analysis data on the benefits of Xarelto.
The Phase 3 Voyager PAD clinical trial evaluated the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER).
Data from two analyses reinforced the benefit of Xarelto by demonstrating positive effects delivered by the vascular dose in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy. Xarelto significantly reduced hospitalizations due to thrombotic events in patients who underwent LER compared to patients who took aspirin alone, Janssen said in a news release.
Voyager PAD, a study of 6,564 patients across 542 sites in 34 countries, randomized patients at a 1:1 ratio for receiving the Xarelto vascular dose or aspirin alone. Patients were stratified by revascularization procedure type (endovascular vs. surgical) and the use of clopidogrel and they were followed for a median of 28 months.
The study met its primary efficacy and principal safety endpoints, demonstrating Xarelto’s superiority to aspirin alone as it reduced the risk of major adverse limb and cardiovascular events by 15% in patients with symptomatic PAD after LER. There was no significant increase in major bleeding observed in Xarelto patients as well.
“At Janssen, we are continuing to invest in clinical research to help evolve the standard of care for people living with serious cardiovascular diseases, like PAD, an area of critical unmet need,” Janssen Research & Development Global Therapeutic Area Head for Cardiovascular, Metabolism and Retina Dr. James F. List said. “Our research continues to support the use of the Xarelto vascular dose and is a treatment option physicians should consider for patients with PAD or coronary artery disease.”
Filed Under: Cardiovascular, clinical trials, Drug Discovery, Drug Discovery and Development, Pulmonology