Meta-analysis of the safety of outpatient Sotalol initiation in clinical practice

Sotalol is a class III anti-arrhythmic medication commonly used in maintaining sinus rhythm in patients with arrhythmias, most notably atrial fibrillation. Sotalol is conventionally initiated in an inpatient setting (typically three days) to allow close monitoring of its effects, particularly corrected QT interval (QTc) prolongation, which may predispose patients to fatal arrhythmias such as torsades de pointes.

In this meta-analysis, we aimed to assess the safety of initiating sotalol in an outpatient setting.

We searched PubMed, Scopus, Embase, Cochrane Library, Web of Science, Virtual Health Library, and Google Scholar for observational studies and randomized controlled trials assessing the safety of outpatient initiation of sotalol until January 2026. Our endpoints were the change from baseline in QTc interval at the longest follow-up and the rate of sotalol discontinuation due to adverse events. Standardized mean differences from baseline in QTc interval with 95% confidence intervals were pooled with a random-effects model using CMA V3 software.

We included three observational studies with a total cohort of 1248 patients. At the longest follow-up post-sotalol initiation in an outpatient setting, there was no statistically significant change in QTc interval from baseline (SMD = +0.15, 95% CI: -0.357 to 0.658, p = 0.56). Across 1140 patients, the rate of drug discontinuation due to adverse events at one-month post-sotalol initiation ranged from 4.7% (41/880 patients; 95% CI 3.4%-6.3%) in one study to 8.1% (21/260 patients; 95% CI 5.3%-12.1%) in another.

In carefully selected patients, the initiation of sotalol in an outpatient setting appears to be safe and associated with no significant adverse events. However, the current evidence is limited to a small number of observational cohorts, and large randomized controlled trials are warranted to establish the safety and efficacy of outpatient sotalol initiation.