Usual Apixaban Dose May Be OK for Renally Impaired Patients
5 mg apixaban twice daily deemed safe, appropriate for those with 1 criterion in ARISTOTLE trial.
(HealthDay News) -- For patients in the Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation (ARISTOTLE) trial, the 5 mg twice daily dose of apixaban is beneficial and appropriate for those with 1 dose-reduction criterion, according to a study published online in JAMA Cardiology.
John H. Alexander, MD, from the Duke Clinical Research Institute in Durham, NC, and colleagues analyzed data on 17,322 participants from the ARISTOTLE trial. Of patients with one or no dose-reduction criteria assigned to receive the 5 mg twice daily dose of apixaban or warfarin, 3,966 had 1 dose-reduction criterion.
The researchers found that patients with 1 dose-reduction criterion had higher rates of stroke or systemic embolism and major bleeding compared to those with no dose-reduction criteria. Similar benefits were seen for 5 mg twice daily apixaban vs warfarin on stroke or systemic embolism among patients with one (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.66 to 1.32) or no dose-reduction (HR, 0.77; 95% CI, 0.62 to 0.97) criterion (P for interaction = 0.36). Benefits were also similar for major bleeding (HRs, 0.68 [95% CI, 0.53 to 0.87] and 0.72 [95% CI, 0.60 to 0.86], respectively) (P for interaction = 0.71). Patterns were similar for each dose-reduction criterion and across the spectrum of age, body weight, and creatinine level and clearance.
"Patients with atrial fibrillation and isolated advanced age, low body weight, or renal dysfunction have a higher risk of stroke or systemic embolism and major bleeding but show consistent benefits with the 5 mg twice daily dose of apixaban versus warfarin compared with patients without these characteristics," the authors write. "The 5 mg twice daily dose of apixaban is safe, efficacious, and appropriate for patients with only one dose-reduction criterion."
Several authors disclosed financial ties to pharmaceutical companies, including Bristol-Myers Squibb and Pfizer, which manufacture apixaban and funded the study.
1. 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. JAMA Cardiol. 2016 Jul 27. doi:10.1001/jamacardio.2016.1829.[Epub ahead of print]
2. Weitz JI and Eikelboom JW. Appropriate Apixaban Dosing JAMA Cardiol. 2016 Jul 27. doi:10.1001/jamacardio.2016.1841. [Epub ahead of print]