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Betrixaban had dose-dependent effect on major, non-major bleeding
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American College of Cardiology 59th Annual Scientific Sessions
ATLANTA – Betrixaban therapy was associated with a similar or lower risk for major bleeding when compared with warfarin therapy in patients at high risk for stroke, according to new data from the phase-2 EXPLORE Xa trial.
Betrixaban (Merck), an investigational drug, directly inhibits the factor Xa enzyme.
For the phase-2 clinical trial, researchers assessed the safety and efficacy of oral betrixaban therapy in 508 patients (mean age, 74 years) who had non-valvular atrial fibrillation and at least one additional risk factor for stroke (diabetes or hypertension).
Patients were randomly assigned to one of three treatment arms: once-daily betrixaban 40 mg (n=116) 60 mg (n=115) or 80 mg (n=116) or dose-adjusted warfarin (Coumadin, Bristol-Myers Squibb; n=119). Patients were mainly white (97.8%) and men (66.5%). About 8% had a creatinine level <40; most had a level >70.
The primary outcome measure was time to major and clinically relevant non-major bleeding. Secondary measures were time to any bleeding, mortality, stroke, MI or systemic embolism. Follow-up was three to 12 months.
Only one patient assigned to betrixaban 40 mg had major or clinically relevant non-major bleeding compared with four patients assigned warfarin. However, bleeding rates were similar for those assigned to 60-mg and 80-mg betrixaban and warfarin (five patients vs. four patients). Stroke rates in the study population were anticipated by the researchers, who reported a CHAD score of 2.2 across all groups.
“The 40-mg dose demonstrated a slight increase in D-dimer levels, but the level was smaller than what would have been anticipated if there were a control group at baseline,” Michael D. Ezekowitz, MD, PhD, vice president of the Lankenau Institute for Medical Research and professor of medicine at Jefferson Medical College in Philadelphia, said during a presentation today.
“Betrixaban is in an early stage of development, but these results provide helpful indicators regarding the path forward for further development. The next step is to test this drug in a much larger population.”
The study was funded by Portola Pharmaceuticals and Merck. – by Jennifer Southall
It must be challenging not to know how to move forward. As far as the current data, the low-dose seems extremely safe, although it may seem doubting in regards to the D-dimer data. Therefore, compliance may be a problem.
– Lars Wallentin, MD, PhD
Professor of Cardiology, Head Uppsala Clinical Research Center, Uppsala University Hospital, Sweden
For more information:
- Ezekowitz MD. LBCT II. Presented at: American College of Cardiology 59th Annual Scientific Sessions; March 13-16, 2010; Atlanta.
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