Key result
Salmeterol, with or without fluticasone, does not increase cardiovascular adverse events in COPD.
RCT (n=6,184)
Double-blind
Randomized
Yes
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BACKGROUND: Previous studies have suggested that long-term use of beta agonists to treat chronic obstructive pulmonary disease (COPD) may increase the risk of cardiovascular adverse events. In this post hoc analysis, data from the TOwards a Revolution in COPD Health (TORCH) study were used to investigate whether use of the long-acting beta(2) agonist salmeterol over 3 years increased the risk of cardiovascular adverse events in patients with moderate to severe COPD. METHODS: TORCH was a randomised, double-blind, placebo controlled study conducted at 444 centres in 42 countries. Patients (n=6184; safety population) received twice daily combined salmeterol 50 microg plus fluticasone propionate 500 microg (SFC), either component alone, or placebo. Adverse events were recorded every 12 weeks for 3 years. RESULTS: The probability of having a cardiovascular adverse event by 3 years was 24.2% for placebo, 22.7% for salmeterol, 24.3% for fluticasone propionate and 20.8% for SFC. Although a history of myocardial infarction doubled the probability of cardiovascular adverse events, the event rates remained similar across treatment groups. CONCLUSION: Post hoc analysis of the 3-year TORCH dataset showed that salmeterol alone or in combination (SFC) did not increase the risk of cardiovascular events in patients with moderate to severe COPD.
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Calverley et al. (2010) conducted an RCT in Moderate to severe chronic obstructive pulmonary disease (COPD) (n=6,184). Salmeterol alone or combined with fluticasone propionate (SFC) vs. Placebo was evaluated on Cardiovascular adverse event by 3 years. Salmeterol alone or combined with fluticasone propionate did not increase 3-year cardiovascular adverse events vs placebo in COPD.
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