Bisoprolol makes no difference in moderately severe COPD

In the treatment of patients with moderately severe chronic obstructive pulmonary disease (COPD), the use of bisoprolol has no significant effect on overall cardiorespiratory health, all-cause mortality, or serious cardiorespiratory events when compared with placebo, as shown in a phase III study.

The study included 280 COPD patients aged 40–85 years (mean age 68 years, 83 percent male) who had post-bronchodilator FEV₁ 30–70 percent predicted and at least one COPD exacerbation event in the previous 2 years.

The patients were randomly assigned to receive bisoprolol at 1.25–5 mg doses (n=143) or matching placebo (n=137). Treatment was administered orally, once daily for 2 years, with patients in both treatment groups continuing to receive usual COPD care.

The primary outcome was a composite of cardiac and respiratory effects, starting with the most important outcome of death, then cardiac or respiratory hospital admissions, exacerbations, quality-of-life measures, and FEV₁.

A total of 249 patients completed the study. Mean post-bronchodilator FEV₁ at baseline was 45 percent predicted. According to the hierarchy of outcomes, cardiorespiratory health was better with bisoprolol for 3,041 of 6,763 comparisons (45 percent) and with placebo for 3,240 (48 percent), with 482 (7 percent) showing no difference. This corresponding win ratio and net benefit were 0.95 (95 percent confidence interval [CI], 0.72 to 1.25; p=0.72) and –2 percent (95 percent CI, –15 to 10), respectively, with bisoprolol.

All-cause mortality, cardiorespiratory hospitalizations, major adverse cardiac events, or moderate or severe COPD exacerbations did not significantly differ between bisoprolol and placebo. Moreover, no significant between-group differences were observed in FEV₁, COPD symptoms, or quality of life, or adverse events.

The most common adverse events were COPD exacerbations, occurring in 58 percent of bisoprolol-treated patients and 64 percent of those who received placebo. A total of 15 (10 percent) and 11 (8 percent) patients in the bisoprolol and placebo groups, respectively, died. None of these deaths were deemed related to the treatment.