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Cardiovascular Safety of Salmeterol in COPD^*

^* From the Pulmonary Research Institute (Dr. Ferguson) of SouthEast Michigan, Livonia, MI; Hopital Saint Antoine (Dr. Funck-Brentano), Paris, France; and GlaxoSmithKline (Drs. Fischer, Darken, and Reisner), Research Triangle Park, NC.

Correspondence to: Gary T. Ferguson, MD, FCCP, Pulmonary Research Institute of SouthEast Michigan, 28807 Eight Mile Rd, Suite 103, Livonia, MI 48152

Background: Patients with COPD have an increased risk of cardiovascular disease. Despite the clinical benefits of long-acting ß-agonist agents in the treatment of COPD, patients may be at an increased risk of cardiovascular toxicity, including tachyarrhythmia due to ß-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 µg 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 µg bid. The median duration of treatment was 24 weeks (range, 12 to 52 weeks).

Results: Treatment with salmeterol, 50 µg 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 µg 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 µg bid, does not increase the risk of cardiovascular AEs in this population of COPD patients compared with placebo.

Key Words: cardiovascular safety • COPD • salmeterol

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