BARCELONA, SPAIN — The BRONCHIOLE randomized trial evaluated metoprolol plus standard care versus standard care alone in patients with chronic obstructive pulmonary disease (COPD) without cardiovascular disease. Patients randomized to metoprolol plus standard care had no fewer primary endpoint events during 1 year of follow-up compared to standard care alone (27.4% vs 29.9%, HR 0.87, 95% CI 0.73-1.05).

Josefin Sundh, MD, PhD, of Örebro University in Sweden, reported the trial results at the European Respiratory Society Congress in Barcelona, Spain. The study was published simultaneously in NEJM Evidence.

The trial was conducted at 30 sites in Sweden as an open-label, pragmatic trial. Enrolled patients were aged 40 years or older with COPD, sinus rhythm, and no cardiovascular disease.

Subgroup analyses revealed divergent outcomes based on sex. Metoprolol was not associated with benefit in men regarding the primary composite endpoint (HR 1.28, 95% CI 0.94-1.74).

The hazard ratio for death was 0.92 (95% CI 0.48-1.77) in the metoprolol group compared to standard care. The hazard ratio for exacerbations requiring hospitalization was 0.87 (95% CI 0.58-1.28) in the metoprolol group compared to standard care.

Adverse event rates differed between the treatment and control arms. Nonserious adverse events occurred in 34.6% of the metoprolol group and 29.2% of the control group.

The most commonly reported symptoms with metoprolol were fatigue (21.7%), symptoms attributed to low blood pressure (15.9%), and gastrointestinal symptoms (7.9%). Adherence to the medication regimen varied among participants. Of those assigned metoprolol, 49.4% reached the target dose of 100 mg once daily.

Of those assigned metoprolol, 30.8% continued with 50 mg once daily. Of those assigned metoprolol, 19.8% discontinued metoprolol during follow-up.

The BRONCHIOLE trial was limited by its lack of blinding of investigators or patients and a lower-than-expected event rate. Cardioselective beta-blockers have been shown to improve survival in patients with COPD who have ischemic heart disease or heart failure.

Why It Matters

Chronic obstructive pulmonary disease is a lung disease involving long-term poor airflow. While cardioselective beta-blockers have established benefits for COPD patients with concurrent ischemic heart disease or heart failure, this trial addressed their utility in patients without cardiovascular disease. The findings indicate that adding metoprolol to standard care does not reduce primary endpoint events in this specific population over one year, though the observed benefit in women suggests potential avenues for further investigation.

What's New

A study titled "Optimal assessment and management of chronic obstructive pulmonary disease (COPD). The European Respiratory Society Task Force" was published in 1995 in European Respiratory Journal. Chronic obstructive pulmonary disease is a lung disease involving long-term poor airflow.