Dronedarone versus sotalol in patients with atrial fibrillation: a systematic literature review and network meta-analysis

Abstract

Abstract Background There are limited comparative data on safety and efficacy within Vaughn Williams class III anti-arrhythmic drugs (AADs) for maintenance of sinus rhythm in adults with atrial fibrillation (AF). Purpose We sought to compare the safety and efficacy of dronedarone and sotalol, two commonly prescribed Vaughn Williams class III AADs with class II rate-controlling properties in patients with non-permanent AF. Methods A systematic literature review was conducted by searching MEDLINE®, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to June 15, 2021. Clinical trials and observational studies that evaluated safety and efficacy of dronedarone or sotalol in adults with AF were included. Where feasible, Bayesian random-effects network meta-analysis (NMA) was conducted to estimate comparative safety and efficacy. Where possible, sensitivity analyses were conducted by including only randomized controlled trials (RCTs). Results Of 3,581 records identified through database searches, 37 unique studies (23 RCTs, 13 observational studies, and 1 non-randomized trial) were included in the NMA. Dronedarone was associated with a statistically significantly lower risk of all-cause death versus sotalol in the all-studies NMA (hazard ratio [HR]: 0.38; 95% credible interval [CrI]: 0.19, 0.74; 22 studies); sensitivity analysis followed the same trend numerically (HR: 0.46; 95% CrI: 0.21, 1.02; 16 RCTs). Risk ratios of AF recurrence were not significantly different between dronedarone and sotalol in both all-studies and sensitivity analyses. Conclusion Dronedarone, compared with sotalol, was associated with significantly lowered risk of all-cause death in the analysis combining RCTs and observational studies, with no differences in AF recurrence observed between the two therapies. This meta-analysis provides a comprehensive assessment of safety and efficacy evidence useful in evaluating treatment options in AF. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Sanofi