In a non-inferiority study, Buhl et al randomized 1,600 adults with moderate or severe COPD to use the new extra-long-acting beta agonist indacaterol 150 mcg or tiotropium 18 mcg inhaled once daily for 12 weeks.
At the end of the study period, pre-dose FEV1 improvements were similar in both groups (~125 mL). Indacaterol induced higher post-dose FEV1 improvements at 5 minutes and 1 hour. Both drugs had roughly equal rates of adverse events (~9%). Indacaterol had a slight edge in subjective endpoints including the transitional dyspnea index and St. George’s Respiratory Questionnaire. Exacerbation rates were not reported during this short study.
Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Resp J 2011;38(4):797-803.
The FDA approved indacaterol in July 2011 at the 75 mcg dose, which was 1/2 the dose used in this trial, citing safety concerns at the higher doses. The main safety concern seemed to surround expected off-label use of the drug for asthma. (FDA.gov)
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