Background D,l-sotalol (sotalol) is a major class III antiarrhythmic agent with associated significant β-blocker activity. β-Blockers have been shown to decrease mortality in patients with ischemic heart disease. The purpose of this analysis was to assess the effect of sotalol on all-cause mortality in patients treated with the drug for cardiac arrhythmias for over 1 year.
Methods The study design was a meta-analysis of five randomized placebo-controlled trials involving sotalol. A comprehensive literature scrutiny via search engines OVID and PubMed revealed 30 studies involving sotalol; 5 met preset inclusion criteria. The risk differences across the five studies were combined using the methods of DerSimonian and Laird. The differences in mortality rates in the sotalol group versus those in the placebo group were analyzed as the primary end point. The difference in the proarrhythmic event rates between the two groups was evaluated as the secondary end point.
Results Of the total of 2,426 patients combined from these studies, 1,468 patients had been randomized to sotalol and 940 to placebo. Patient characteristics included a mean age ranging from 53 to 67 years and a mean left ventricular ejection fraction ranging from 49 to 56%. Other patient characteristics between treatment groups also did not differ. Sixty-eight percent of the patients had ischemic heart disease or had a history of myocardial infarction and 78% of the patients were men. The crude mortality rate was 5.3% (n = 79) in the sotalol arm and 5.8% (n = 55) in the placebo arm. The relative risk reduction in mortality was 0.86. The overall naïve risk difference was 0.5%, and the weighed risk difference was 0.3% (DerSimonian and Laird, 95% CI −2.1 to +2.7, p = .623). Test for homogeneity yielded a Q stat of 3.6 (p = .26). There was no difference in proarrhythmic events between the two groups; both groups had a 1.4% rate of proarrhythmic events (95% CI −1.4 to +1.6; Q stat 1.84, p value .64). An increased risk in proarrhythmic events was not observed in this meta-analysis. The risk differences in mortality and in proarrhythmia were combinable and homogeneity was not rejected.
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