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The impact of olodaterol on the risk of mortality and serious adverse events: a systematic review and meta‐analysis

AIMS
Olodaterol is a novel inhaled long-acting β2 -agonist (LABA) that showed efficacy as a bronchodilator for patients with chronic obstructive pulmonary disease (COPD) and asthma. However, it is unclear whether olodaterol reduces mortality; the safety issues of olodaterol have not been fully evaluated.


METHODS
Randomized controlled trials comparing olodaterol with placebo for patients with COPD or asthma, which evaluated mortality or serious adverse events, were included. Eighteen trials reporting mortality and 26 trials reporting nonfatal serious adverse events were included.


RESULTS
Inhaled olodaterol did not reduce the risk of mortality (Peto fixed OR 1.31; 95% CI 0.90-1.89) and had no significant impacts on nonfatal serious adverse events (Peto fixed OR 1.03; 95% CI 0.91-1.15).


CONCLUSIONS
Inhaled olodaterol has no impact on mortality risk in clinical trials conducted on patients with COPD and asthma. However, the interpretation is limited by a high OR (1.31) and a wide CI that includes the hazardous effect. We could not find any relationship between inhaled olodaterol use and nonfatal serious adverse events.