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Cardiovascular safety of salmeterol in COPD
Gary T Ferguson1, Christian Funck-Brentano, Tracy Fischer
1Pulmonary Research Institute of SouthEast Michigan, Livonia, MI 48152, USA.
Insights
Long-acting beta-agonists like salmeterol are used for COPD. A pooled analysis found that salmeterol, 50 micro g twice daily, does not increase cardiovascular risks in COPD patients compared to placebo.
Area of Science:
- Pulmonary Medicine
- Cardiology
- Clinical Pharmacology
Background:
- Patients with Chronic Obstructive Pulmonary Disease (COPD) face elevated cardiovascular disease (CVD) risks.
- Long-acting beta-agonists (LABAs) offer clinical benefits for COPD but may pose cardiovascular risks, including tachyarrhythmia.
Purpose of the Study:
- To assess the cardiovascular safety of salmeterol in COPD patients.
- To conduct a pooled analysis of cardiovascular safety data from relevant clinical trials.
Main Methods:
- Pooled analysis of seven randomized, double-blind, parallel-group, multiple-dose studies.
- Included 1,410 patients receiving salmeterol (50 micro g twice daily) and 1,443 patients receiving placebo.
- Median treatment duration was 24 weeks.
Main Results:
- Salmeterol (50 micro g twice daily) showed no increased risk of cardiovascular adverse events (AEs) versus placebo (RR 1.03, 95% CI 0.8-1.3).
- Similar incidences of cardiovascular events (8%), including deaths, were observed in both groups.
- Cardiovascular AE risk increased with age, comorbidities, and certain medications, but comparably across treatment groups.
Conclusions:
- Salmeterol, 50 micro g twice daily, is not associated with an increased risk of cardiovascular AEs in COPD patients compared to placebo.
- No significant differences in cardiac events, arrhythmias, or vital signs were noted between salmeterol and placebo groups.
Background:
Patients with COPD have an increased risk of cardiovascular disease. Despite the clinical benefits of long-acting beta-agonist agents in the treatment of COPD, patients may be at an increased risk of cardiovascular toxicity, including tachyarrhythmia due to beta-adrenergic stimulation.
Objective:
To evaluate the cardiovascular safety of salmeterol in COPD patients by conducting a pooled analysis of cardiovascular safety data.
Design:
Randomized, double-blind, parallel group, multiple-dose studies, which included salmeterol, 50 micro g bid, and placebo arms.
Study Selection:
Seven of a total of 17 studies met the predefined inclusion requirements and were pooled. A total of 1,443 patients received placebo, while 1,410 patients received salmeterol, 50 micro g bid. The median duration of treatment was 24 weeks (range, 12 to 52 weeks).
Results:
Treatment with salmeterol, 50 micro g bid, showed no increased risk of cardiovascular adverse events (AEs) compared with placebo (relative risk, 1.03; 95% confidence interval, 0.8 to 1.3; p = 0.838). Both groups had a similar incidence of cardiovascular events (8%), including cardiovascular deaths. The incidence of cardiovascular AEs increased with age, concurrent cardiovascular conditions, and treatment with antiarrhythmic/bradycardic agents, although increases were comparable in both treatment groups. There were no episodes of sustained ventricular tachycardia, and no clinically significant differences were observed in 24-h heart rate, ventricular and supraventricular ectopic events, qualitative ECGs, QT intervals, or vital signs between the salmeterol, 50 micro g bid, group and the placebo group. Similar findings were observed when patients were stratified for age of > 65 years or the known presence of cardiovascular disease.
Conclusions:
Treatment with salmeterol, 50 micro g bid, does not increase the risk of cardiovascular AEs in this population of COPD patients compared with placebo.