A Cochrane review on antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation [Abstract] 1 included 59 studies with a total of 20 981 subjects. Sotalol was included in 22 of the studies (n=6 281), and 12 of them compared sotalol with placebo or no treatment.
Sotalol reduced recurrence of atrial fibrillation (RR 0.83, 95% CI 0.80 to 0.87; 14 studies, n=3 179, statistical heterogeneity I2 =54%) compared to placebo or no treatment corresponding to a recurrence rate of 78.8% in people not treated or receiving placebo and 65.4% (95% CI 63.1% to 68.6%) in people receiving sotalol; NNTB was 7 (95% CI 6 to 10).
There was increased proarrhythmia rates on sotalol compared to placebo or no treatment (RR 3.55, 95% CI 2.16 to 5.83; 12 studies, n=2 989) corresponding to 12 cases per 1000 people in the control group and 41 (95% CI 25 to 68) cases per 1000 people in the sotalol group; NNTH was 33 (95% CI 17 to 72). Sotalol increased withdrawals due to adverse effects compared to placebo or no treatment (RR 1.95, 95% CI 1.23 to 3.11; 12 studies, n=2 688; I2 =56%); NNTH was 11 (95% CI 5 to 46).
People receiving sotalol had a higher all-cause mortality rate than those with placebo or no treatment (RR 2.23, 95% CI 1.03 to 4.81; 5 studies, n=1 882) corresponding to 8 deaths per 1000 people in the control group and 19 (95% CI 9 to 40) deaths per 1000 people in the sotalol group; NNTH for sotalol was 102 (95% CI 33 to 4167).
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