Johnson & Johnson (NYSE:JNJ) subsidiary Janssen touted data today from a pivotal Phase III trial showing that Xarelto plus aspirin reduced the risk of major cardiovascular events in patients with stable coronary and peripheral artery disease compared to aspirin alone.
Treatment with Xarelto twice per day and aspirin once-daily cut the risk of major cardiovascular events by 24%, including a 42% reduction in strokes and a 22% reduction in cardiovascular death, the company reported.
Data from the Compass trial were presented at the European Society of Cardiology Congress.
The company added that the risk of major bleeding was significantly higher in patients taking the Xarelto-aspirin combo, but that there was no significant increase in fatal or intracranial bleeds.
“The results of Ccompass represent a true breakthrough in CAD and PAD, as they confirm the combination regimen of Xarelto and aspirin is highly effective and well-tolerated in preventing the devastating and irreversible CV events that often occur in these patients,” lead investigator Dr. John Eikelboom said in prepared remarks. “In addition to achieving a positive balance of efficacy and safety, we observed a considerable reduction in stroke and CV death, which could have a profound effect on how physicians manage patients with stable CAD and PAD.”
The trial enrolled 27,395 patients and randomized them into three groups, with one arm taking the Xarelto 2.5 milligram twice-daily vascular dose plus aspirin 100 milligram once-daily regimen, another group taking the Xarelto 5 milligram twice-daily regimen and the final group taking 100 milligrams of aspirin once-daily.
Janssen and Bayer said earlier this year that the Compass trial would stop nearly one year ahead of schedule, since the study met its primary efficacy endpoint.
The companies reported that 4.1% of patients receiving the Xarelto-aspirin combo experienced a cardiovascular event compared to 5.4% of those receiving just aspirin.
“Compass is the only clinical study to investigate the use of a Factor Xa inhibitor in people with stable CAD and PAD. The study embodies everything the Explorer program represents, which is to alleviate the burden felt by millions at high risk of having a major CV event,” Dr. James List, global therapeutic area head for Janssen’s cardiovascular & metabolism business, added. “The combination regimen of the Xarelto 2.5 mg vascular dose and aspirin holds much promise for these patients, and we look forward to discussing these meaningful and significant data with the U.S. Food & Drug Administration.”