Safety of indacaterol in the treatment of patients with copd

Purpose: Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting B-agonist for chronic obstructive pulmonary disease (COPD). Patients and methods: Data were pooled from clinical studies of 3-12 months' duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 |Xg (n = 449), 150 |Xg (n = 2611), 300 |Xg (n = 1157), or 600 |Xg once daily (n = 547); formoterol 12 |Xg twice daily (n = 556); salmeterol 50 |Xg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 (Xg once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs. Results: The commonest adverse events with indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were