Bayer and Janssen’s Xarelto shows promising results in reducing blood clot recurrence

Bayer AG and Janssen Pharmaceuticals, two giants in the pharmaceutical industry, have announced significant findings from their EINSTEIN CHOICE clinical trial, showcasing the effectiveness of Xarelto (rivaroxaban), an oral blood thinner, in substantially reducing the risk of recurrent life-threatening blood clots in vein, known as venous thromboembolism (VTE).

Breakthrough in VTE Management

The late-breaking study involved more than 3,000 patients who were administered either 10 mg or 20 mg of rivaroxaban daily, compared to a 100 mg daily dosage of aspirin. These patients had previously undergone anticoagulant therapy for six to twelve months due to VTE, which includes conditions such as pulmonary embolism (PE) and symptomatic deep vein thrombosis (DVT).

Clinical Trial Outcomes

The trial results were impressive, with the 20 mg dose of rivaroxaban reducing the risk of recurrent VTE by 66%, and the 10 mg dose showing an even greater reduction at 74%, compared to those taking aspirin. These findings highlight rivaroxaban’s potential in providing extended protection against the recurrence of VTE.

Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development, reflected on the significance of these results: “EINSTEIN CHOICE is another example of Bayer’s commitment to help answer important medical questions that arise in daily clinical practice. These new data add important additional insights on how best to provide extended protection for patients with a VTE.”

Expert Insights

Professor Jeffrey Weitz, co-chair of the EINSTEIN CHOICE clinical trial and Professor of Medicine at McMaster University, emphasized the importance of having flexible treatment options: “In patients with unprovoked VTE or with ongoing risk factors, the risk of recurrence is up to 10% in the first year if anticoagulation therapy is stopped after 3, 6 or 12 months. The findings from EINSTEIN CHOICE demonstrated exactly what the study name promised: once approved, rivaroxaban 10 mg once daily will be available to physicians as an additional choice in their armamentarium against recurrent VTE alongside the already approved 20 mg once-daily dose.”

This flexibility will enable physicians to adopt a precision approach to selecting the most appropriate extended treatment based on the assessment of individual patient characteristics.

Safety Profile

The trial also met its principal safety outcome, showing that both the 20 mg and 10 mg dosages of rivaroxaban had comparable and low major bleeding rates, on par with those observed in aspirin therapy. This aspect is crucial as it addresses one of the primary concerns of long-term anticoagulation therapy—the risk of significant bleeding.

The results from the EINSTEIN CHOICE trial represent a pivotal advancement in the treatment of VTE, providing patients and healthcare providers with more effective and flexible management options. The trial not only reaffirms the efficacy of rivaroxaban in preventing the recurrence of VTE but also reinforces its safety profile, making it a valuable addition to the therapeutic options available for managing this challenging condition.