Real-world analysis shows Xarelto reduces ischemic stroke and intracranial hemorrhage versus warfarin

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A retrospective database claims analysis found that adults with nonvalvular atrial fibrillation who received rivaroxaban (Xarelto) had a statistically significant 47 percent reduction in intracranial hemorrhage and non-statistically significant 29 percent reduction in ischemic stroke compared with adults who received warfarin.

Janssen Pharmaceuticals, the manufacturer of rivaroxaban,  announced the results in a news release on April 18.

The FDA has approved rivaroxaban to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and to treat deep vein thrombosis and pulmonary embolism.

In the REVISIT-US study, which was sponsored by Janssen and Bayer, researchers used U.S. MarketScan claims data to compare rivaroxaban and warfarin in a real-world setting among 30,988 patients with nonvalvular atrial fibrillation.

The rate of ischemic stroke was 0.54 percent per year in the rivaroxaban group and 0.83 percent per year in the warfarin group. The rate of intracranial hemorrhage was 0.49 percent per year and 0.96 percent per year, respectively.

Patients were included if they had a CHA 2DS2-VASC score of two or higher and had continuous medical coverage for at least 180 days. They were excluded if they had a prior stroke, systemic embolism or intracranial hemorrhage.