PT  - JOURNAL ARTICLE
AU  - Malcolm R. Sears
AU  - Finn Radner
TI  - Safety of formoterol in asthma clinical trials: an update
AID  - 10.1183/09031936.00004713
DP  - 2013 Jan 01
TA  - European Respiratory Journal
PG  - erj00047-2013
4099  - http://erj.ersjournals.com/content/early/2013/05/30/09031936.00004713.short
4100  - http://erj.ersjournals.com/content/early/2013/05/30/09031936.00004713.full
AB  - Use of long-acting beta-agonists (LABAs) in asthma remains controversial, and large safety trials are in progress. We previously reported safety outcomes with formoterol in 117 AstraZeneca asthma trials (78,339 patients, 92% using inhaled corticosteroids (ICS)) completed by December 2006, and have now added 32 trials with formoterol (26,124 patients, 100% using ICS) completed by December 2011. The primary dataset of 79 randomized controlled trials includes 94,684 patients, 67,380 exposed to formoterol, while the complete dataset comprises 149 trials and 104,463 patients. There were no new asthma-related deaths in the expanded primary dataset, with 8 asthma-related deaths among formoterol-randomized and 2 among non-LABA randomized patients (Relative Risk [RR] 1.13, 95% CI 0.23–10.9), and 15 vs 9 cardiac-related deaths (RR 0.47, 95% CI 0.19–1.22). Non-fatal asthma-related serious adverse events (SAEs) were significantly reduced with formoterol (RR 0.63, 95% CI 0.53–0.75) as were discontinuations due to adverse events. Examining 40 trials with direct formoterol vs non-LABA comparisons, Mantel Haenszel RR for asthma death was 2.75 (95% CI 0.52–14.4) and for SAEs 0.83 (95% CI 0.68–1.02). We conclude that this enlarged dataset indicates no increased risk for asthma-related deaths among patients exposed to formoterol compared with non-LABA treatments, although the wide CI precludes certainty.