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Twice-daily doses of apixaban reduced risk of VTE
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ATLANTA — Both 2.5 mg and 5 mg twice-daily doses of apixaban reduced the risk of symptomatic recurrent fatal or non-fatal venous thromboembolism by approximately 80% without increasing the rate of major bleeding, according to results of a double-blind study presented at the 2012 American Society of Hematology Meeting and Exposition.
Although both apixaban doses reduced arterial thrombotic events, the lower apixaban dose may be preferable for extended treatment due to the tendency for less clinically relevant, nonmajor bleeding.
Prior studies have shown that, although warfarin is effective for preventing blood clots from forming or growing larger, it requires regular blood testing and dose adjustment. It also is associated with the risk of uncontrolled bleeding. Unlike warfarin, apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) can be given in fixed doses and does not require routine laboratory monitoring.
Giancarlo Agnelli
To determine whether apixaban could be an effective alternative for the prevention of recurrent VTE, Giancarlo Agnelli, MD, director of the department of internal and cardiovascular medicine and the stroke unit at Perugia University Hospital in Italy, and colleagues randomly assigned 2,486 patients with VTE to receive one of three regimens — apixaban 2.5 mg twice daily, apixaban 5 mg twice daily or placebo — for 12 months.
Symptomatic recurrent VTE or all-cause mortality served as the primary efficacy outcome. Secondary efficacy outcomes included the composite of symptomatic VTE or VTE-related death, and the composite of symptomatic VTE, VTE-related death, myocardial infarction, stroke or cardiovascular-related death.
Major bleeding served as the primary safety outcome. Secondary safety outcomes were major and clinically relevant non-major bleeding.
According to study results, both doses of apixaban reduced the risk of recurrent VTE and VTE-related death by approximately 80% compared with placebo.
Recurrent VTE or VTE-related death occurred in 1.7% of patients in either the low-dose or high-dose apixaban groups compared with 8.8% of patients in the placebo group.
Major bleeding rates associated with both the 2.5 mg (0.2%) and 5 mg (0.1%) doses of apixaban were similar to those observed in patients assigned to placebo (0.5%). Those results demonstrate the safety of both doses of apixaban as a long-term VTE therapy, the researchers said.
Rates of symptomatic recurrent VTE or all-cause mortality were 11.6% in the placebo group vs. 3.8% in the 2.5 mg apixaban group (95% CI, 5.3% to 10.3%; P<0.001) and 4.2% in the 5 mg group (95% CI, 4.8% to 10%; P<0.001).
“These results indicate that apixaban — at both low and high doses — provides an attractive risk-benefit profile for use as an ongoing treatment option in patients at risk of recurrent VTE,” Agnelli said. “This regimen has the potential to eliminate many of the challenges we face when we treat patients with warfarin, including drug and food interactions and the need for ongoing monitoring, which can greatly simplify ongoing management of this condition.”
For more information:
Agnelli G. Abstract #LBA-1. Presented at: the 2012 American Society of Hematology Annual Meeting; Dec. 8-11, 2012; Atlanta.