ATRIAL FIBRILLATION

Standard Apixaban Dose Beneficial for Patients with Atrial Fibrillation

August 4, 2016

Patients with atrial fibrillation with either advanced age, low body weight, or renal dysfunction who received the standard dose of the anticoagulant apixaban (5 mg twice daily), despite having a dose-reduction criterion, had higher risk of stroke or systemic embolism and major bleeding than patients with no dose-reduction criteria. However, both groups of patients showed consistent benefits with the standard dose of apixaban over warfarin.

The new findings stem from a secondary analysis of the ARISTOTLE (Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation) trial, which found apixaban superior to warfarin in preventing stroke or systemic embolism with less bleeding.

“The 5 mg twice daily dose of apixaban is safe, efficacious, and appropriate for patients with only 1 dose-reduction criterion,” researchers reported July 27 in the online JAMA Cardiology.

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The new analysis included 17,322 patients from the ARISTOTLE trial, 3966 of whom had 1 of the following dose-reduction criteria: 80 years or older, weight 60 kg or less, and creatinine level 1.5 mg/dL or higher. Researchers looked at how the 5-mg dose twice daily affected the population.

Compared with patients with no dose-reduction criteria, patients with 1 dose-reduction criteria who received the standard dose of apixaban or warfarin had higher rates of stroke or systemic embolism and major bleeding, researchers reported.

When they looked at how apixaban compared with warfarin in each patient group, researchers found the 5-mg twice daily dose of apixaban was similarly beneficial on stroke or systemic embolism as well as on major bleeding among patients with 1 dose-reduction criteria and no dose-reduction criteria.

Researchers recommended the 2.5-mg twice-daily dose be reserved for patients with at least 2 dose-reducing criteria, MedPage Today reported.—Jolynn Tumolo

 

References:

Alexander JH, Andersson U, Lopes RD, et al. Apixaban 5 mg twice daily and clinical outcomes in patients with atrial fibrillation and advanced age, low body weight, or high creatinine: a secondary analysis of a randomized clinical trial [published online ahead of print July 27, 2016]. JAMA Cardiol. doi:10.1001/jamacardio.2016.1829.

Jenkins K. Full-dose NOAC safe with single dose-reduction factor. MedPage Today. July 29, 2016.