Two randomised controlled trials (RCT; 3,288 patients) and a published meta-analysis of these two RCTs (see Other Publications of Related Interest) were included.
Bisoprolol reduced all-cause mortality by 29% (P=0.00003) in the published meta-analysis of two trials; no confidence intervals (CIs) were given. The results from the individual trials both showed a beneficial effect, which reached statistical significance in one trial (hazard ratio, HR=0.66, 95% CI: 0.54, 0.81, n=2,647) but not in the other (HR 0.80, 95% CI: 0.56, 1.15, n=641).
One trial reported fewer CV deaths (9% versus 12%) and hospitalisations (33% versus 39%), and a significant reduction in the combined outcome of CV death or CV hospitalisation in patients on bisoprolol compared with placebo. In the meta-analysis of the two trials, no excess of strokes was seen in patients treated with bisoprolol, but the results from the individual studies were inconsistent.
In terms of adverse events, based on one trial, patients on bisoprolol had a higher incidence of bradycardia (15.2% versus 4.5%), dizziness (13.3% versus 9.5%), hypotension (11.4% versus 7.3%) and fatigue (9.3% versus 7.1%). On both trials, treatment withdrawal between the bisoprolol and placebo groups was similar.