Article Text
Abstract
Background Previous studies have suggested that long-term use of β 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 β2 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 μg plus fluticasone propionate 500 μg (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.
- COPD Pharmacology
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Footnotes
Funding This work was supported by GlaxoSmithKline.
Competing interests PMAC has received consulting fees from AstraZeneca, GlaxoSmithKline, Nycomed and Pfizer; speaking fees from GlaxoSmithKline and Nycomed; and grant support from Boehringer-Ingelheim and GlaxoSmithKline. JAA, CC, LRW and JCY are employed by and hold stock in GlaxoSmithKline. BC has received consulting fees from Altana, AstraZeneca, Boehringer-Ingelheim and GlaxoSmithKline; speaking fees from Altana, AstraZeneca, Boehringer-Ingelheim and GlaxoSmithKline; and grant support from Boehringer-Ingelheim and GlaxoSmithKline. GTF has received consulting fees from Boehringer-Ingelheim, GlaxoSmithKline, Novartis and Schering Plough; speaking fees from Boehringer-Ingelheim, GlaxoSmithKline and Pfizer; and grant support from Altana, Boehringer-Ingelheim, Emphasys Medical Inc, Forrest, GlaxoSmithKline, Mannkind Corporation and Novartis. CJ has received consulting fees from Altana, AstraZeneca, Boehringer-Ingelheim and GlaxoSmithKline; speaking fees from Altana, AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline and Novartis; and grant support from GlaxoSmithKline. PWJ has received consulting fees from AstraZeneca, GlaxoSmithKline, Novartis and Roche; speaking fees from AstraZeneca and GlaxoSmithKline; and grant support from Boehringer-Ingelheim and GlaxoSmithKline. JV has received consulting fees from AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Hoffman-LaRoche and Nycomed; speaking fees from AstraZeneca, Boehringer-Ingelheim and GlaxoSmithKline; and grant support from GlaxoSmithKline.
Ethics approval The study was approved by local ethics review committees and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All patients gave written informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.