Study Affirms Safety of Anti-Clotting Drug

January 17, 2015

Ryan Marotta, Assistant Editor

Article

Preliminary results of an ongoing post-marketing study examining Janssen Pharmaceuticals' rivaroxaban (Xarelto) in patients with non-valvular atrial fibrillation (NVAF) indicate that the anti-clotting drug's safety in real-world settings is consistent with the findings of previous phase 3 clinical trials.

Preliminary results of an ongoing post-marketing study examining Janssen Pharmaceuticals’ rivaroxaban (Xarelto) in patients with non-valvular atrial fibrillation (NVAF) indicate that the anti-clotting drug’s safety in real-world settings is consistent with the findings of previous phase 3 clinical trials.

The study, which was designed by Janssen in collaboration with the US Department of Defense and Health ResearchTx, analyzed the potential side effects of once-daily Xarelto use in NVAF patients, particularly major bleeding events, associated risk factors, and bleeding-related clinical outcomes.

The research team evaluated the data on 27,467 NVAF patients who were treated with Xarelto in real-world clinical settings from January 1, 2013, to March 31, 2014. In doing so, the investigators found that incidents of major bleeding were observed at a rate of 2.86 per 100 person-years, which was comparable to the rates reported in phase 3 clinical trials.

The researchers also found that the average age of patients who experienced major bleeding was 78, and noted that fatal outcomes were rare.

“These findings reaffirm the safety profile of Xarelto,” said study co-author W. Frank Peacock, MD, FACEP, in a press release. “We anticipate future findings from this 5-year observational study will continue to provide real-world information about the use of Xarelto in routine clinical practice.”

Janssen Vice President Paul Burton, MD, PhD, added that “after more than 3 years on the market and more than 10 million patients prescribed, we continue to monitor the safety performance of our medicine.”

“We are pleased with these findings, which demonstrate Xarelto is performing as expected in the real-world setting,” Dr. Burton said. “With studies completed in over 85,000 patients and ongoing post-marketing studies that will include more than 74,000 patients, we continue to advance our real world data to ensure doctors and patients are equipped with the latest information about Xarelto to optimize patient care.”