Julian 1982.
| Study characteristics | ||
| Methods | Randomised trial at 21 sites in Scotland between January 1978 and August 1980 | |
| Participants | 1456 participants, surviving for 5 to 14 days after onset of acute myocardial infarction and between 30 and 69 years of age, were included Male:female = 1156:300 Mean age = 55.3 years Exclusion criteria: heart block greater than first degree; heart rate < 54 per minute; women of child‐bearing potential; history of asthma or obstructive airways disease; insulin‐dependent diabetes; clinical evidence of heart failure at the 12th post‐infarction day; systolic blood pressure persistently < 100 mmHg; positive antinuclear factor; other cardiac or non‐cardiac conditions thought to be serious enough to worsen the short‐term prognosis; lack of cooperation by the patient or inability to follow up with the patient for psychological or geographical reasons. Patients previously on a beta‐adrenoceptor blocking agent were entered only if they had been off this therapy for at least 5 days |
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| Interventions | Experimental group: sotalol (320 mg orally daily) (n = 873) Control group: placebo (n = 583) Co‐intervention: in patients for whom anginal symptoms could not be controlled by regulation of physical activity and treatment with trinitrin and/or long‐acting nitrates, additional open administration of sotalol was permissible, irrespective of the randomised study medication Excluded medication: quinidine, procainamide, diphenylhydantoin, mexiletine, disopyramide, monoamine oxidase inhibitors, tricyclic antidepressant drugs, adrenoceptor blocking agents, calcium antagonists |
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| Outcomes | Primary: death; confirmed or suspected fatal + non‐fatal myocardial reinfarction Time point reported: 12 months |
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| Notes | No email was found Mean time from acute myocardial infarction to time of randomisation was 8.2 days MACE was calculated and was reported as "confirmed or suspected reinfarction plus cardiovascular death" Study was funded by Bristol‐Myers International Division, which also supplied the study medication (sotalol and placebo) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described sufficiently, other than "Randomisation was undertaken separately for each centre in blocks of ten, each block containing six allocations to sotalol and four to placebo" |
| Allocation concealment (selection bias) | Unclear risk | Not described sufficiently; however it is said that "the time of randomisation was determined as that when the next available numbered package was opened and the first dose given to the patient" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts were described. 340 (222 on sotalol and 121 on placebo) were withdrawn from the trial; however they were included in the analysis following the intention‐to‐treat method |
| Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained; however mortality and serious adverse events were reported |
| Other bias | Low risk | No other biases were found |