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Risk of mortality associated with formoterol: a systematic review and meta-analysis

¹ Medical Research Institute of New Zealand, Wellington, ² University of Otago Wellington, Wellington, New Zealand. ³ University of Southampton, Southampton, UK.

CORRESPONDENCE: R. Beasley, Medical Research Institute of New Zealand, PO Box 10055, Wellington 6143, New Zealand. E-mail: Richard.Beasley{at}mrinz.ac.nz

Keywords: Asthma, formoterol, meta-analysis, mortality, systematic review

Received: October 22, 2008
Accepted March 10, 2009

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.