BICS
Trial question
What is the role of bisoprolol in patients with COPD at high risk of exacerbation?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 514
514 patients (241 female, 274 male).
Inclusion criteria: patients with COPD who had at least moderate airflow obstruction on spirometry and at least two exacerbations treated with oral corticosteroids and/or antibiotics in the prior 12 months.
Key exclusion criteria: diagnosis of asthma before age 40 years; resting HR < 60/min; SBP < 100 mmHg; interacting drugs, such as CCBs or class I antiarrhythmic drugs; conditions for which β-blockers are recommended by guidelines.
Interventions
N=259 bisoprolol (at an oral dose of 1.25 mg daily titrated to maximum of 5 mg daily).
N=255 placebo (matching placebo).
Primary outcome
Incidence of number of patient-reported chronic obstructive pulmonary disease exacerbations at 1 year
2.03
2.01
2.0 events...
1.5 events...
1.0 events...
0.5 events...
0.0 events...
Bisoprolol
Placebo
No significant
difference ↔
No significant difference in the incidence of number of patient-reported COPD exacerbations at 1 year (2.03 events / y vs. 2.01 events / y; IRR 0.97, 95% CI 0.84 to 1.13).
Secondary outcomes
No significant difference in median time to first COPD exacerbation (96 days vs. 70 days; HR 0.94, 95% CI 0.78 to 1.16).
No significant difference in all-cause mortality (4.2% vs. 5.1%; HR 0.77, 95% CI 0.34 to 1.73).
No significant difference in COPD-related pulmonary admissions (27.4% vs. 26.7%; IRR 1, 95% CI 0.67 to 1.5).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with COPD who had at least moderate airflow obstruction on spirometry and at least two exacerbations treated with oral corticosteroids and/or antibiotics in the prior 12 months, bisoprolol was not superior to placebo with respect to the incidence of number of patient-reported COPD exacerbations at 1 year.
Reference
Graham Devereux, Seonaidh Cotton, Mintu Nath et al. Bisoprolol in Patients With Chronic Obstructive Pulmonary Disease at High Risk of Exacerbation: The BICS Randomized Clinical Trial. JAMA. 2024 Aug 13;332(6):462-470.
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