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Oral factor Xa inhibitors: Apixaban was noninferior to conventional therapy for the treatment of acute venous thromboembolism


Apixaban ( Eliquis ), an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism.

In the randomized, double-blind study ( AMPLIFY ), researchers have compared Apixaban ( at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months ) with conventional therapy ( subcutaneous Enoxaparin [ Clexane, Lovenox ], followed by Warfarin [ Coumadin ] ) in 5395 patients with acute venous thromboembolism.

The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism.
The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding.

The primary efficacy outcome occurred in 59 of 2609 patients ( 2.3% ) in the Apixaban group, as compared with 71 of 2635 ( 2.7% ) in the conventional-therapy group ( relative risk, RR=0.84; difference in risk [ Apixaban minus conventional therapy ], -0.4 percentage points ).

Apixaban was noninferior to conventional therapy ( P less than 0.001 ) for predefined upper limits of the 95% confidence intervals for both relative risk ( less than 1.80 ) and difference in risk ( less than 3.5 percentage points ).

Major bleeding occurred in 0.6% of patients who received Apixaban and in 1.8% of those who received conventional therapy ( RR=0.31; P less than 0.001 for superiority ).
The composite outcome of major bleeding and clinically relevant nonmajor bleeding occurred in 4.3% of the patients in the Apixaban group, as compared with 9.7% of those in the conventional-therapy group ( RR=0.44; P less than 0.001 ).
Rates of other adverse events were similar in the two groups.

A fixed-dose regimen of Apixaban alone was noninferior to conventional therapy for the treatment of acute venous thromboembolism and was associated with significantly less bleeding ( Xagena )

Agnelli G et al, N Engl J Med 2013; 369:799-808

XagenaMedicine_2013



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