February 8, 2017
Bayer and its partners at J&J, back in the fall of 2012, started a massive study to see if the drug Xarelto (rivaroxaban) could help prevent major cardiovascular events like myocardial infarction, stroke, and death in high risk patients with coronary artery disease or peripheral artery disease.
Very recently, a little more than 4 years and 27,000-plus patients later, investigators say that they hit the primary endpoint well ahead of schedule. Now they’re ending the trial early and launching an extension study where they will continue to dose patients.
Patients randomly received either rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone.
There’s no data yet, but the company says that the huge study delivered “overwhelming” evidence of the efficacy of the drug.
“Despite established and effective treatments, an unmet medical need in this patient population still exists with rates of CAD and PAD rising globally. Bayer is committed to an ongoing clinical development programme that addresses such unmet medical needs. We are excited about these results and look forward to making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events,” said Dr. Joerg Moeller, a member of the executive committee of Bayer AG’s Pharmaceutical Division and Head of Development.