(RxWiki News) Prior to its approval last year, there was much debate about Xarelto (rivaroxaban), an anti-clotting drug designed to prevent stroke among patients with atrial fibrillation, a common heart arrhythmia.
A U.S. Food and Drug Administration panel had warned against approval of the medication in September after voicing concerns about safety and effectiveness as compared to Coumadin (warfarin), the current standard of treatment at the time.
"Ask your cardiologist how best to treat your atrial fibrillation."
However, a new review of the original large-scale ROCKET AF trial suggests rivaroxaban may do a better job of preventing strokes, while minimizing the risk of brain bleeding.
Dr. Graeme J. Hankey, lead author and neurologist at the Royal Perth Hospital and University of Western Australia, noted that patients at risk of bleeding into the brain need to be identified since doctors must use care when giving them anti-coagulants. Among these patients, a lower risk of brain bleeding is key.
During a sub-analysis of the randomized ROCKET AF trial, which enrolled more than 14,000 high-risk atrial fibrillation patients to compare rivaroxaban against warfarin, investigators found that patients receiving rivaroxaban were 34 percent less likely to experience intracranial hemorrhage as compared to warfarin.
The new study also identified risk factors that could heighten an atrial fibrillation patient's risk of bleeding in the brain. They found older individuals were at an increased risk one higher for every 10 years of age, while a prior stroke or mini-stroke increased the risk by 51 percent.
A low platelet count and decreased levels of serum albumin, a protein that helps keep fluid from leaking out of blood vessels, also increased the risk of intracranial bleeding. Blacks also were at a risk 4.2 times higher than whites, while Asians were at a two-fold higher risk.
About 10 percent of strokes are from intracranial hemorrhage. Patients with atrial fibrillation are at a stroke risk that is five times higher than individuals without the abnormal heart rhythm.
In approving rivaroxaban last year, FDA officials found that rivaroxaban was not inferior to warfarin in preventing strokes and blood clots in atrial fibrillation patients.
Drugmakers Johnson & Johnson and Bayer HealthCare funded the study.
The research was presented Thursday at the American Stroke Association’s International Stroke Conference 2012 in New Orleans.
