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Oral rivaroxaban superior to standard therapy for VTE
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ATLANTA — The risk–benefit profile of oral rivaroxaban appeared more favorable than standard therapy for treatment of symptomatic venous thromboembolism, according to a pooled analysis of the EINSTEIN-PE and EINSTEIN-DVT trials presented at the 54th American Society of Hematology Annual Meeting and Exposition.
The study results, presented by Harry Roger Büller, MD, PhD, of the department of vascular medicine at Academic Medical Center in Amsterdam, showed rivaroxaban (Xarelto, Janssen Pharmaceuticals) was associated with comparable efficacy and less bleeding, study results showed.
Harry Roger Büller
The intention-to-treat population included 4,150 patients assigned to rivaroxaban and 4,131 patients assigned to standard therapy with subcutaneous body weight-adjusted enoxaparin (Lovenox, Sanofi-Aventis) followed by a vitamin K antagonist.
Results indicated that rivaroxaban was noninferior to standard therapy, with events occurring in 2.1% of patients assigned to the study drug and 2.3% of patients assigned to standard therapy (HR=0.89; 95% CI, 0.66-1.19).
In terms of safety, major and clinically relevant non-major bleeding occurred in 9.4% of patients in the rivaroxaban group vs. 10% of patients in the standard therapy group (HR=0.93; 95% CI, 0.81-1.06). Similarly, major bleeding occurred in 1% of patients assigned to rivaroxaban vs. 1.7% of patients assigned to standard therapy (HR=0.54; 95% CI, 0.37-0.79).
The researchers also found that efficacy remained consistent for rivaroxaban vs. standard therapy across all subgroups, including body weight, age and renal function.
The reduction in major bleeding associated with rivaroxaban was most pronounced among elderly patients, as well as those with moderate renal impairment, the researchers wrote. Major bleeding also remained consistently lower in the rivaroxaban group across all body weight categories.
“This analysis demonstrates that the simple, single-drug approach with oral rivaroxaban has an improved benefit–risk profile compared with standard therapy for the treatment of symptomatic venous thromboembolism,” Buller and colleagues wrote.
EINSTEIN-DVT and EINSTEIN-PE were open-label, randomized, noninferiority trials designed to compare oral, fixed-dose rivaroxaban alone with enoxaparin followed by warfarin or aceocoumarol for 3, 6 or 12 months. Symptomatic recurrent VTE served as the primary efficacy outcome, while safety outcomes included the composite of major and clinically relevant non-major bleeding and major bleeding alone.
In November, the FDA approved rivaroxaban for treatment of deep vein thrombosis and pulmonary embolism. The drug also is approved to reduce the risk for recurrent events.
For more information:
Büller HR. Abstract #20. Presented at: the 2012 ASH Annual Meeting and Exposition; Dec. 8-11, 2012; Atlanta.
Disclosure: Büller has served as a consultant for or received research funding from Bayer, Bristol-Myers Squibb, Daiichi, Isis, GlaxoSmithKline, Pfizer, Sanofi-Aventis, Roche and Thrombogenics.