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Review: formoterol increases serious adverse events in children and adults with chronic asthma

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In patients with chronic asthma, what are the risks of mortality and non-fatal serious adverse events associated with formoterol?


Included studies compared inhaled formoterol once or twice daily for ⩾12 weeks with placebo or short-acting β2 agonists in children and adults with chronic asthma. Leukotriene receptor antagonists, inhaled or oral corticosteroids, or theophylline were allowed if they were not part of the randomised intervention. Outcomes were all-cause mortality and all-cause non-fatal serious adverse events.


Cochrane Airways Group Specialised Register of trials (to Jul 2008), reference lists, clinical trial register websites, and Federal Drug Administration submissions were searched for randomised controlled trials (RCTs). 22 RCTs (n = 8032; weighted mean duration of 16 wks for 19 placebo-controlled RCTs) were included.


All-cause mortality: formoterol v placebo (14 RCTs, n = 5463). All-cause mortality did …

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  • Source of funding: National Institute of Health Research Programme Grant (UK).