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. 2019 Sep 4;2019(9):CD005049. doi: 10.1002/14651858.CD005049.pub5

Comparison 9. Sotalol versus placebo or no treatment.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 All‐cause mortality – main analysis 5 1882 Risk Ratio (M‐H, Fixed, 95% CI) 2.23 [1.03, 4.81]
2 All‐cause mortality – intention to treat (ITT) worse case: missing participants counted as events 10 2757 Risk Ratio (M‐H, Fixed, 95% CI) 2.02 [1.28, 3.20]
3 All‐cause mortality – sensitivity analysis: persistent atrial fibrillation 3 1311 Risk Ratio (M‐H, Fixed, 95% CI) 2.51 [1.06, 5.98]
4 All‐cause mortality – sensitivity analysis: low risk of bias studies 3 1311 Risk Ratio (M‐H, Fixed, 95% CI) 2.51 [1.06, 5.98]
5 All‐cause mortality – sensitivity analysis: studies > 200 participants 4 1826 Risk Ratio (M‐H, Fixed, 95% CI) 2.65 [1.16, 6.09]
6 Withdrawals due to adverse effects – main analysis 12 2688 Risk Ratio (M‐H, Random, 95% CI) 1.95 [1.23, 3.11]
7 Withdrawals due to adverse effects – sotalol: heterogeneity study 12 2688 Risk Ratio (M‐H, Random, 95% CI) 1.95 [1.23, 3.11]
7.1 PAFAC and SOPAT trials 2 987 Risk Ratio (M‐H, Random, 95% CI) 0.96 [0.74, 1.25]
7.2 Rest of studies 10 1701 Risk Ratio (M‐H, Random, 95% CI) 2.77 [1.81, 4.22]
8 Withdrawals due to adverse effects – sensitivity analysis: persistent atrial fibrillation 6 1350 Risk Ratio (M‐H, Fixed, 95% CI) 1.75 [1.28, 2.41]
9 Withdrawals due to adverse effects – sensitivity analysis: low risk of bias studies 4 1686 Risk Ratio (M‐H, Random, 95% CI) 1.52 [0.82, 2.81]
10 Withdrawals due to adverse effects – sensitivity analysis: studies > 200 participants 5 1900 Risk Ratio (M‐H, Random, 95% CI) 1.81 [0.97, 3.35]
11 Proarrhythmia – main analysis 12 2989 Risk Ratio (M‐H, Fixed, 95% CI) 3.55 [2.16, 5.83]
12 Proarrhythmia – sotalol: heterogeneity study 11 2826 Risk Ratio (M‐H, Fixed, 95% CI) 3.43 [2.07, 5.67]
12.1 PAFAC and SOPAT trials 2 986 Risk Ratio (M‐H, Fixed, 95% CI) 1.49 [0.51, 4.37]
12.2 Rest of studies 9 1840 Risk Ratio (M‐H, Fixed, 95% CI) 4.32 [2.40, 7.76]
13 Proarrhythmia – sensitivity analysis: persistent atrial fibrillation 6 1687 Risk Ratio (M‐H, Fixed, 95% CI) 4.37 [2.25, 8.52]
14 Proarrhythmia – sensitivity analysis: low risk of bias studies 4 1686 Risk Ratio (M‐H, Fixed, 95% CI) 3.05 [1.73, 5.40]
15 Proarrhythmia – sensitivity analysis: studies > 200 participants 6 2293 Risk Ratio (M‐H, Fixed, 95% CI) 3.00 [1.77, 5.06]
16 Stroke – main analysis 3 1161 Risk Ratio (M‐H, Fixed, 95% CI) 1.47 [0.48, 4.51]
17 Stroke – sensitivity analysis: persistent atrial fibrillation 1 393 Risk Ratio (M‐H, Fixed, 95% CI) 1.35 [0.36, 5.00]
18 Stroke – sensitivity analysis: low risk of bias studies 2 768 Risk Ratio (M‐H, Fixed, 95% CI) 1.85 [0.20, 16.71]
19 Stroke – sensitivity analysis: studies > 200 participants 3 1161 Risk Ratio (M‐H, Fixed, 95% CI) 1.47 [0.48, 4.51]
20 Atrial fibrillation recurrence – main analysis 14 3179 Risk Ratio (M‐H, Fixed, 95% CI) 0.83 [0.80, 0.87]
21 Atrial fibrillation recurrence – sensitivity analysis: persistent atrial fibrillation 7 1743 Risk Ratio (M‐H, Fixed, 95% CI) 0.81 [0.77, 0.86]
22 Atrial fibrillation recurrence – sensitivity analysis: low risk of bias studies 4 1686 Risk Ratio (M‐H, Fixed, 95% CI) 0.86 [0.82, 0.91]
23 Atrial fibrillation recurrence – sensitivity analysis: studies > 200 participants 6 2293 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.81, 0.89]