Two Studies Show Efficacy of Rivaroxaban, Other NOACs in Preventing Stroke

Paul Burton, MD

Two studies, one of which is an expansive real-world meta-analysis, demonstrate the effectiveness of rivaroxaban (Xarelto) and other novel oral anticoagulants (NOACs) in treating stroke.

In the meta-analysis of 95 real-world studies, published in the Journal of Market Access & Health Policy, rivaroxaban significantly lowered the risk of ischemic stroke (IS) and intracranial hemorrhage (ICH) compared to warfarin (Coumadin). The meta-analysis was funded by Bayer AG.

Dabigatran (Pradaxa) was also associated with a significantly lower risk of IS and ICH, but not for nonpersistence with treatment, compared with vitamin K antagonists (VKAs). Apixaban (Eliquis) was associated with a lower risk of ICH than VKAs but performed the same as VKAs in terms of IS and nonpersistence with treatment.

“Xarelto was also the only NOAC to show significantly reduced nonpersistence rates compared to warfarin, meaning that patients were significantly less likely to have a gap in therapy of 60 days,” Paul Burton, MD, vice president of medical affairs, Internal Medicine, at Janssen Scientific Affairs, tells Drug Topics. Janssen Pharmaceuticals is the maker of Xarelto.

However, rivaroxaban was associated with a higher risk of gastrointestinal bleeding compared to warfarin in the meta-analysis. In addition, the risks of heart attack, hemorrhagic stroke, and venous thromboembolism were similar between rivaroxaban and warfarin.

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Still, the findings show that certain NOACs, such as rivaroxaban, “are performing exceptionally well, and that physicians should feel confident prescribing them to prevent strokes that can often result in irreversible harm and even death,” says Craig Coleman, PharmD, professor of pharmacy practice, University of Connecticut, in a statement from Janssen.

In a separate real-world study, which will be presented at the American College of Cardiology Scientific Sessions (ACC.19), newly-diagnosed patients with nonvalvular atrial fibrillation (NVAF) taking rivaroxaban had significantly fewer strokes (37% overall), less severe strokes, and significantly fewer stroke-related deaths compared to those taking warfarin.

The risk for poststroke mortality within 30 days for patients with NVAF taking rivaroxaban was reduced by 73%, and at any time by 22% compared to warfarin.

“While randomized clinical trials help to establish the efficacy and safety profile of Xarelto, real-world research complements and confirms how Xarelto is performing in everyday clinical practice,” Burton says. “With stroke prevention remaining a top priority for NVAF, we’re confident that physicians will consider these findings, along with Xarelto’s proven once-daily dosing regimen, when treating their patients.”