RT Journal Article
SR Electronic
T1 Risk of mortality associated with formoterol: a systematic review and meta-analysis
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 803
OP 811
DO 10.1183/09031936.00159708
VO 34
IS 4
A1 M. Wijesinghe
A1 M. Weatherall
A1 K. Perrin
A1 M. Harwood
A1 R. Beasley
YR 2009
UL http://erj.ersjournals.com/content/34/4/803.abstract
AB There is concern long-acting β-agonist (LABA) drugs may increase the risk of asthma mortality. We undertook a systematic review which included the AstraZeneca Formoterol Clinical Trial Safety Database and Novartis Food and Drug Aministration Formoterol Briefing Document. Randomised controlled clinical trials of duration ≥4 weeks that compared formoterol with a non-LABA comparator treatment in asthma were included in a meta-analysis of the risk of all-cause mortality and asthma death. Simple contingency tables, Peto's one-step method and a Bayesian analysis were used. There were 42 deaths (nine from asthma) recorded in 62 studies with 49,327 subjects. The simple contingency table odds ratio for risk of all-cause mortality with formoterol was 1.1 (95% CI 0.6–2.2) and for asthma death was 2.7 (95% CI 0.5–26.7). Analyses by the other methods using both “as randomised” and “as exposed” classifications of treatment gave similar risk estimates with wide confidence and credible intervals. We conclude that there was insufficient power to determine whether formoterol increases the risk of mortality. However, the point estimates of a 2.0- to 3.2-fold increased risk of asthma death are not reassuring and add weight to evidence that LABA use in certain circumstances may increase the risk of asthma mortality.