Healthcare company Janssen Pharmaceutical Companies onTuesday updated and published the positive findings from the US Food and Drug Administration (FDA) Mini-Sentinel pilot project assessment of XARELTO (rivaroxaban) under the phase III ROCKET AF clinical trials in Pharmacoepidemiology & Drug Safety.

The company said the findings from the US Food and Drug Administration (FDA) Mini-Sentinel assessment confirms the safety and efficacy profile of XARELTO (rivaroxaban) established in the phase III ROCKET AF clinical trials for the treatment of atrial fibrillation (AF), an irregular heartbeat.

In conjunction, the US FDA Mini-Sentinel report noted a lower risk of ischemic stroke was associated with the use of XARELTO compared to warfarin and lasted throughout the more than three-year analysis. XARELTO is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem.

Under the US FDA analysis, the company evaluated the safety of XARELTO in people with nonvalvular atrial fibrillation (AF) who initiated XARELTO or warfarin from November 2011 to April 2015. To examine the safety of both products, methodologies included assessing ICD-9-CM codes from inpatient claims and evaluating rates of gastrointestinal (GI) bleeding, ischemic stroke and intracranial hemorrhage in patients with AF.

In the US FDA report, the agency concludes this study, "demonstrates the capability of Sentinel to conduct prospective safety monitoring with sophisticated re-usable tools and does not raise any new safety concerns regarding use of rivaroxaban", concluded the company.