What is the clinical evidence from this study?

Study design: RCT. Population: chronic premature ventricular complexes (n=56). Intervention: Sotalol vs. Placebo. Primary outcome: prospectively defined criterion of efficacy (≥75% arrhythmia reduction) (p=<0.001).

What question did this study set out to answer?

This study aims to assess the effectiveness of sotalol in suppressing frequent ventricular arrhythmias compared to placebo.

June 4, 2026

Multicenter trial of sotalol for suppression of frequent, complex ventricular arrhythmias: A double-blind, randomized, placebo-controlled evaluation of two doses

Q: What are the key findings of this study?

Sotalol therapy significantly increased the proportion of patients achieving ≥75% arrhythmia reduction compared to placebo (59% vs 11%; p<0.001).

Q: What question did this study set out to answer?

This study aims to assess the effectiveness of sotalol in suppressing frequent ventricular arrhythmias compared to placebo.

Key Result

Sotalol therapy significantly increased the proportion of patients achieving ≥75% arrhythmia reduction compared to placebo (59% vs 11%; p<0.001).

Key Points

This study aims to assess the effectiveness of sotalol in suppressing frequent ventricular arrhythmias compared to placebo.
Double-blind randomized placebo-controlled trial across four hospitals
56 patients with chronic premature ventricular complexes received either 320 mg or 640 mg/day of sotalol for 6 weeks
Assessment of arrhythmia frequency via ambulatory electrocardiographic recording over 48 hours.
Sotalol therapy reduced median arrhythmia frequency by 77% (320 mg) and 83% (640 mg) compared to 6% in placebo (p<0.001)
59% of sotalol-treated patients achieved at least 75% arrhythmia reduction compared to 11% in placebo (p<0.001)
Sotalol reduced couplets by 94% and runs by 89%, showing significant antiarrhythmic effect with an increase in the QTc interval.

Study Design

Type

RCT (n=56)

Blinding

Double-blind

Randomization

randomized

Multicenter

Yes

Structured PICO

Does sotalol reduce the frequency of ventricular arrhythmias in patients with chronic premature ventricular complexes?

Population

56 patients with chronic premature ventricular complexes at a frequency of 30/h or more, evaluated over a 6-week period.

Intervention

Sotalol 320 mg/day or 640 mg/day (in two divided doses) for 6 weeks

Comparator

Placebo

Outcome

Prospectively defined criterion of efficacy (greater than or equal to 75% arrhythmia reduction)surrogate

Sotalol at doses of 320 and 640 mg/day is highly effective and well-tolerated for suppressing frequent, complex ventricular arrhythmias.

Main Result

Absolute Event Rate: 59% vs 11%

p-value: p=<0.001

Abstract

Sotalol is a unique beta-adrenergic blocking agent with additional actions characteristic of Vaughn-Williams class III antiarrhythmic agents in experimental models. To test the efficacy of sotalol to suppress ventricular arrhythmias, a 6 week parallel, placebo-controlled out-patient study of two doses (320 and 640 mg/day, in two divided doses) was performed in four hospitals in 56 patients with chronic premature ventricular complexes at a frequency of 30/h or more (mean +/- SE, 528 +/- 60/h) on 48 hour ambulatory electrocardiographic recording. During a placebo week, no change occurred in arrhythmia frequency (532 +/- 76/h). Subsequent sotalol therapy significantly reduced median arrhythmia frequency in patients receiving both low (n = 19) and high (n = 18) doses compared with that in patients receiving placebo (by 77 and 83%, respectively, versus 6%; p less than 0.001). Twenty-two (59%) of 37 sotalol-treated patients, 11 in each group, reached the prospectively defined criterion of efficacy (greater than or equal to 75% arrhythmia reduction) versus 2 (11%) of 19 placebo control patients (p less than 0.001). Sotalol reduced the median frequency of couplets by 94% (p less than 0.0001) and that of runs by 89% (p less than 0.0007). The electrocardiographic effects of sotalol included reductions in heart rate (by 17 to 27%) and increases in the QTc (by 6 to 9%) and PR (by 6%) intervals. Ejection fraction was unchanged. The most common adverse side effect was fatigue, but drug discontinuation was required in only three patients taking 640 mg/day. No proarrhythmic events or biochemical abnormalities were observed. In summary, sotalol displays significant antiarrhythmic activity of moderately high degree with good tolerance in doses of both 320 and 640 mg/day. Its antiarrhythmic actions are distinguished from those reported for other beta-blockers by its effects on the QTc interval and its moderately high degree of antiarrhythmic activity.

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