AUSTIN, TEX. (FRONTLINE MEDICAL NEWS) – Extended treatment with any of the novel oral anticoagulants, but with apixaban in particular, provides a net clinical benefit in patients at risk of recurrent venous thromboembolism, according to a review of three randomized trials.
Apixaban appears to provide the optimal net clinical benefit, with the lowest number needed to treat to avoid one venous thromboembolic or major bleeding event, Dr. Alpesh Amin reported at the annual meeting of the American College of Chest Physicians.
In 5,035 patients in three trials of extended treatment with novel oral anticoagulants (NOACs) for venous thromboembolism (VTE) – including the RE-SONATE trial, the EINSTEIN-EXT trial, and the AMPLIFY-EXT trial – the differences in event rates, compared with placebo, were –5.15% for dabigatran, –5.74% for rivaroxaban, –7.14% for 2.5 mg apixaban, and –7.0% for 5 mg apixaban, reported Dr. Amin of the University of California, Irvine.
The number needed to treat to avoid one VTE or major bleeding event was 21 for dabigatran, 20 for rivaroxaban, 14 for 2.5 mg apixaban, and 13 for 5 mg apixaban, Dr. Amin said.
“The good news is that the number needed to treat for all of [the oral anticoagulants] is actually less than 25,” he said.
As for costs, the savings from avoiding a recurrent VTE were $2,995 with dabigatran, $3,300 for rivaroxaban, and $4,100 for both 2.5 and 5 mg apixaban.
For major bleeding events, the corresponding rates, compared with placebo, were 0.29%, 0.67%, –0.20%, and –0.36%.
There was a net clinical benefit for all patients treated with the NOACs, but in those treated with 5 mg apixaban, the rates of improvement were highest at –7.44%, followed by –7.38% for 2.5 mg apixaban. The rates were –5.0% with rivaroxaban and –4.85% with dabigatran.
“So we see a low number needed to treat, and a significant amount of cost avoidance by using the NOACs across the board,” he said, adding that apixaban may provide the best net clinical benefit for the lowest number needed to treat to avoid one VTE or major bleeding event, and is associated with the greatest medical cost avoidance.
“In terms of safety endpoints, dabigatran and rivaroxaban cost the system a little bit of money, whereas apixaban actually decreased the cost,” he said.
“How these results translate into real-world outcomes will require further evaluation, and as we get more numbers out there, we will actually be looking at the impact in the real world,” he said.
Dr. Amin reported serving as a paid consultant and/or member of a speakers bureau or advisory committee for Bristol-Myers Squibb and Pfizer.