Abstract 9626: Tolerability of Apixaban-Insights From A Meta-Analysis of Discontinuation Rates in Randomized Trials

Abstract

Background: Apixaban is one of the most promising newer oral anti-coagulant agents being considered as a viable alternative for warfarin. However tolerability of the new drug, as reflected by rates of discontinuation in randomized trials for various indications, is conflicting. Objective: To evaluate the tolerability of apixaban by assessing discontinuation rates in trials of apixaban.

Methods: A search was made of the PubMed, CENTRAL and EMBASE databases for randomized controlled trials that reported discontinuation rates of apixaban and comparator (could be pharmacologically active or not). The random effects (DerSimonian-Laird) Mantel-Haenszel (M-H) test was used to compare discontinuation rates of apixaban against comparators by evaluating relative risk (RR; 95% confidence interval [CI]). Statistical analysis was done with Review Manager V5.1 .

Results: Analysis of eight RCTs (N=43277) revealed no significant increase in risk of discontinuation with apixaban compared to a variety of comparators (RR 1.09, 95% CI 0.91-1.30). On restricting the analysis to pharmacologically active agents, there was a definite trend towards improved discontinuation rates with apixaban, compared with warfarin, enoxaparin and aspirin (RR 0.95, 95% CI 0.90-1.00), without evidence of significant heterogeneity.

Conclusion: Apixaban is well tolerated, when compared against a variety of comparators, as evidenced by comparable discontinuation rates in randomized trials.

Figure: Forest Plot of Relative Risk of Discontinuation of Apixaban Compared with All and Pharmacologically Active Comparators in Randomized Trials