Apixaban 5 mg vs 2.5 mg and Increased Bleeding Threat in Atrial Fibrillation With CKD
Amongst sufferers with atrial fibrillation (AF) and extreme persistent kidney illness (CKD), 5-mg apixaban twice day by day, in contrast with 2.5-mg apixaban twice day by day, is related to an elevated danger for bleeding, researchers reported in Circulation.
The retrospective cohort examine used knowledge from the Optum Labs Knowledge Warehouse to evaluate the chance for bleeding and stroke/systemic embolism related to 2 apixaban dosages in grownup sufferers with AF and nondialysis-dependent CKD stage 4/5. Sufferers initiated apixaban use from January 1, 2013, to December 31, 2021.
Stabilized inverse likelihood of therapy weighting (IPTW) with propensity rating was used to account for variations in baseline traits between the teams.
The cohort included 4313 sufferers, of whom 40% (n=1705) began with a dose of 5 mg twice day by day and 60% (n=2608) with a dose of two.5 mg twice day by day. Within the unweighted analyses, individuals who acquired the 5-mg dose had been youthful (imply age, 72 vs 80 years), had an elevated physique weight (95 vs 80 kg), and had a better serum creatinine degree (2.7 vs 2.5 mg/dL) in contrast with those that acquired the two.5-mg dose.
Proceed Studying
A bleeding-related hospitalization occurred in 61 (4%) sufferers on the 5-mg dose vs 81 (3%) on the two.5-mg dose throughout a median follow-up of 8 (IQR, 4-15) months. Remedy with the 5-mg dose was considerably related to an elevated danger for any bleeding vs the two.5-mg dose, with an absolute danger distinction of three.1% throughout a 2-year follow-up, in accordance with the IPTW analyses. The elevated bleeding danger related to 5-mg apixaban was constant for all subgroups (all Pinterplay ≥.10).
Stroke or systemic embolism occurred in 39 (2%) sufferers within the 5-mg dose group vs 86 (3%) within the 2.5-mg dose group. Within the IPTW analyses, the chance for stroke/systemic embolism was not completely different primarily based on apixaban dose (incidence fee distinction, 0.2 [95% CI, -1.0 to 1.4] occasions per 100 person-years; subdistribution hazard ratio, 1.01 [95% CI, 0.59-1.73]). The findings had been constant in subgroup analyses (all Pinterplay ≥.10).
Mortality was reported in 116 sufferers (7%) within the 5-mg dose group vs 288 (11%) within the 2.5-mg dose group. Within the IPTW analyses, no statistical variations had been discovered between the two teams in mortality danger (5 mg vs 2.5 mg dose: incidence fee distinction, 0.5 [95% CI, -1.6 to 2.6] occasions per 100 person-years; hazard ratio, 1.03 [95% CI, 0.77-1.38]).
Limitations of the examine embrace treatment use primarily based on prescriptions, in addition to potential residual confounding. Additionally, the follow-up was comparatively quick, and few main bleeding occasions occurred in each dose teams, which may restrict the statistical energy.
“These findings suggest that 2.5-mg apixaban may be a better choice than 5 mg for patients with AF and severe CKD, supporting the KDIGO [Kidney Disease: Improving Global Outcomes] guidelines’ dosing suggestion for this population and apixaban dosing recommendations based on kidney function by [the] European Medicines Agency, which differ from those issued by the US Food and Drug Administration,” wrote the researchers.
Disclosure: A number of the examine authors declared affiliations with biotech, pharmaceutical, and/or machine corporations. Please see the unique reference for a full checklist of authors’ disclosures.
Reference
Xu Y, Chang AR, Inker LA, McAdams-DeMarco M, Grams ME, Shin J-I. Associations of apixaban dose with security and effectiveness outcomes in sufferers with atrial fibrillation and extreme persistent kidney illness. Circulation. Revealed on-line September 8, 2023. doi: 10.1161/CIRCULATIONAHA.123.065614
This text initially appeared on The Cardiology Advisor
