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

Jagmeet P Singh, Carina Blomström-Lundqvist, Mintu P Turakhia, A John Camm, Mir Sohail Fazeli, Bahij Kreidieh, Christopher Crotty, Peter R Kowey, Jagmeet P Singh, Carina Blomström-Lundqvist, Mintu P Turakhia, A John Camm, Mir Sohail Fazeli, Bahij Kreidieh, Christopher Crotty, Peter R Kowey

Abstract

Background: There are limited comparative data on safety and efficacy within commonly used Vaughan-Williams (VW) class III antiarrhythmic drugs (AADs) for maintenance of sinus rhythm in adults with atrial fibrillation (AF).

Hypothesis: We hypothesized that dronedarone and sotalol, two commonly prescribed VW class III AADs with class II properties, have different safety and efficacy effects in patients with nonpermanent AF.

Methods: A systematic literature review was conducted searching MEDLINE®, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to June 15, 2021 (NCT05279833). Clinical trials and observational studies that evaluated safety and efficacy of dronedarone or sotalol in adults with AF were included. Bayesian random-effects network meta-analysis (NMA) was used to quantify comparative safety and efficacy. Where feasible, we performed sensitivity analyses by including only randomized controlled trials (RCTs).

Results: Of 3581 records identified through database searches, 37 unique studies (23 RCTs, 13 observational studies, and 1 nonrandomized trial) were included in the NMA. Dronedarone was associated with a statistically significantly lower risk of all-cause death versus sotalol (hazard ratio [HR] = 0.38 [95% credible interval, CrI: 0.19, 0.74]). The association was numerically similar in the sensitivity analysis (HR = 0.46 [95% CrI: 0.21, 1.02]). AF recurrence and cardiovascular death results were not significantly different between dronedarone and sotalol in all-studies and sensitivity analyses.

Conclusion: The NMA findings indicate that, across all clinical trials and observational studies included, dronedarone compared with sotalol was associated with a lower risk of all-cause death, but with no difference in AF recurrence.

Keywords: antiarrhythmia agents; atrial fibrillation; dronedarone; network meta-analysis; sotalol; systematic review.

Conflict of interest statement

Jagmeet P. Singh receives consultation fees from Abbott Inc, Biotronik Inc, Boston Scientific, Cardiologs Inc, CVRx Inc, Cardiac Rhythm Group, EBR Inc, Impulse Dynamics, Implicity Inc, Medtronic Inc, Medscape Inc, Microport Inc, New Century Health, Nopras Inc, Orchestra BioMed Inc, Octagos Health Inc, and Sanofi.

Carina Blomström‐Lundqvist has received grants or personal fees from Medtronic Inc, Boston Scientific, Sanofi, Bayer, MSD, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, Philips, CathPrint, Milestone, and Abbott.

Mintu P. Turakhia has received grants or personal fees from Medtronic Inc, Abbott, Bristol Myers Squibb, American Heart Association, Biotronik Inc, Pfizer, Apple, Bayer, Myokardia, Johnson & Johnson, Milestone Pharmaceuticals, InCarda Pharmaceuticals, 100Plus, AliveCor, Sanofi, Gilead Sciences, and the Food and Drug Administration, and he is an employee of iRhythm Technologies, Inc. outside of the submitted work.

A. John Camm has received grants or personal fees from Abbott, Medtronic Inc, Boston Scientific, Biotronik Inc, Sanofi, Johnson & Johnson, Incarda Pharmaceuticals, Acesion, Arca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Menarini, Pfizer, and Bristol Myers Squibb. Dr. Camm is the editor‐in‐chief of Clinical Cardiology; however, he has recused himself from the peer‐review, editorial, and selection process conducted by the journal.

Mir Sohail Fazeli and Christopher Crotty are, or were, employed by Evidinno Outcomes Research Inc. (Vancouver, BC, Canada) at the time of this study, which was contracted by Sanofi to conduct this study.

Bahij Kreidieh reports no conflict of interest.

Peter R. Kowey receives consultation fees from Sanofi.

© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.

Figures

Figure 1
Figure 1
PRISMA flow diagram.
Figure 2
Figure 2
Network meta‐analysis of safety outcomes with dronedarone versus sotalol as (A) hazard ratios and (B) risk ratios. CV, cardiovascular; RCT, randomized controlled trial.
Figure 3
Figure 3
Network meta‐analysis of efficacy outcomes with dronedarone versus sotalol as risk ratios. AF, atrial fibrillation; CV, cardiovascular; MI, myocardial infarction; RCT, randomized controlled trial.

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