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Bayer happy with Rivaroxaban (Xarelto) trial results

3 September 2014, 5:01 pm EDT By Rebecca Kaplan Tech Times
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A new drug, rivaroxaban (Xarelto), has had promising results, the company announced in a new press release. The study found that 20 mg of rivaroxaban was as safe as warfarin for treating atrial fibrillation patients who were waiting for cardioversion.

Rivaroxaban is a new novel oral anticoagulant, a drug similar to warfarin. In a randomized study, researchers found that rivaroxaban cut stroke and heart attack risk in half compared to warfarin. Patients who were put on rivaroxaban had a 0.51 percent chance of having a stroke or heart attack. In comparison, patients who were put on warfarin had a 1.02 percent chance of having a stroke or heart attack. The study also found a slightly lower chance of developing severe bleeding in patients who used rivaroxaban. However, Riccardo Cappato, MD, who led the study, said that that finding didn't mean very much because there were not many cases where both arms were affected and there was not a "statistically significant difference" between the two drugs.

The study found that four of the patients who were placed in the rivaroxaban group died, whereas only two of the patients in the control group (warfarin) died, but this was not a statistically significant difference because the numbers were so low.

The study's lead author, Cappato, presented the results of the study at the European Society of Cardiology's annual meeting. The study was titled X-VeRT: "eXplore the efficacy and safety of once-daily oral riVaroxaban for the prevention of caRdiovascular events in patients with nonvalvular aTrial fibrillation scheduled for cardioversion."

At the same time, the study was published in the European Heart Journal, where it can be viewed online.

The study consisted of people who came from 141 centers in 16 different countries. All of the patients were going to go through cardioversion. 97.6 percent of those were going through electrical cardioversion; 2.4 percent were going through pharmacological cardioversion.

Twice as many patients were chosen to use rivaroxaban as warfarin. The rivaroxaban part of the study had 978 participants, and the warfarin part had 492.

Doctors chose whether to give each patient either early cardioversion or delayed cardioversion. About 58 percent of the patients received early cardioversion.

The study's author found that more patients who received rivaroxaban also had an earlier cardioversion than those who used warfarin. Patients on rivaroxaban had cardioversion in an average of 22 days. Those on warfarin had cardioversion in an average of 30 days.

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