Beta-Blockers Do Not Improve Cardiorespiratory Outcomes in COPD: The Lancet
Australia: A new study has found that among people with chronic obstructive pulmonary disease (COPD), beta-blocker therapy does not provide benefit for cardiorespiratory outcomes, indicating the limited clinical value of this treatment approach in COPD management.
The findings are from a multicentre, double-blind, randomized, controlled phase 3 trial published in The Lancet Respiratory Medicine by Prof Christine R Jenkins from The George Institute for Global Health and the University of New South Wales, Sydney, Australia, along with colleagues. The study evaluated whether adding the cardioselective beta-blocker bisoprolol to standard care for patients with COPD could reduce adverse cardiac and respiratory events in those with moderate to severe disease.
Cardiovascular disease is common in people with COPD and significantly increases morbidity and mortality. Although beta-blockers are central to cardiovascular care, their benefit in COPD remains uncertain due to respiratory safety concerns and mixed evidence. This trial evaluated whether bisoprolol could improve overall cardiorespiratory outcomes without worsening lung function.
The study was conducted at 22 centers across Australia, India, New Zealand, and Sri Lanka. It enrolled adults aged 40–85 years with COPD, a post-bronchodilator FEV1 of 30%–70% predicted, and at least one COPD exacerbation in the previous two years. A total of 280 participants were randomly assigned to receive bisoprolol or a placebo once daily for two years in addition to standard COPD care.
Bisoprolol was administered at doses ranging from 1.25 mg to 5 mg. Randomization was stratified by site, smoking status, and prior cardiovascular disease. Participants, investigators, and study staff remained blinded throughout the trial. The primary outcome was a hierarchical composite including death, cardiorespiratory hospitalizations, COPD exacerbations, quality of life, and lung function.
Of the 280 randomized participants, 249 completed the full two-year follow-up. The majority were men, and the mean age was 68 years. Baseline lung function reflected moderately severe airflow limitation, with a mean post-bronchodilator FEV1 of 45% predicted.
The following were the key findings:
- No significant difference was observed between the bisoprolol and placebo groups for the composite primary outcome.
- The win ratio did not favor either group, indicating no overall cardiorespiratory benefit with bisoprolol.
- All-cause mortality rates were similar between the bisoprolol and placebo groups.
- Rates of major adverse cardiac events did not differ significantly between the two groups.
- Cardiorespiratory hospitalizations occurred at comparable frequencies in both groups.
- The incidence of moderate to severe COPD exacerbations was similar with bisoprolol and placebo.
- Lung function measures showed no meaningful differences between treatment groups.
- Respiratory symptoms and quality-of-life scores were unaffected by bisoprolol therapy.
- Adverse events occurred at similar rates in both groups, with COPD exacerbations being the most common.
- Deaths were comparable between groups, and none were attributed to the study medication.
Overall, the trial demonstrates that in patients with moderately severe COPD, adding bisoprolol to usual care does not improve cardiorespiratory outcomes or survival. These findings suggest that routine use of beta-blocker therapy solely to prevent adverse cardiac events may not be justified in this population, highlighting the need for individualized treatment decisions in COPD management.
Reference:
Jenkins CR, Martin A, Chang CL, Beasley R, Wrobel JP, McDonald VM, Dobler CC, Yang IA, Farah CS, Cochrane B, Hillis GS, Polak Scowcroft C, Ranasinha CD, De Silva HA, Aggarwal AN, Billot L, Devaux A, Gianacas C, Galgey S, Hancox RJ; PACE investigators. Bisoprolol to prevent adverse cardiac events (PACE) in COPD: a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Respir Med. 2026 Jan 21:S2213-2600(25)00390-X. doi: 10.1016/S2213-2600(25)00390-X. Epub ahead of print. PMID: 41579873.
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