title: Safety of indacaterol in the treatment of patients with COPD.
abstract: OBJECTIVE
  Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β(2)-agonist for chronic obstructive pulmonary disease (COPD).
  
  
  METHODS
  Data were pooled from clinical studies of 3-12 months' duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 μg (n = 449), 150 μg (n = 2611), 300 μg (n = 1157), or 600 μg once daily (n = 547); formoterol 12 μg twice daily (n = 556); salmeterol 50 μg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 μg 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 < 1 for all indacaterol doses. Notable values for vital signs and measures of systemic β(2)-adrenoceptor activity were rare with indacaterol. The number of deaths adjusted per patient-year was lower with indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07-0.660], P = 0.008).
  
  
  CONCLUSIONS
  Indacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.
authors: University of North Carolina, Chapel Hill, NC 27599, USA. james_donohue@med.unc.edu
authors: James F
authors: JF
authors: Donohue
authors: Dave
authors: D
authors: Singh
authors: Oliver
authors: O
authors: Kornmann
authors: David
authors: D
authors: Lawrence
authors: Cheryl
authors: C
authors: Lassen
authors: Benjamin
authors: B
authors: Kramer
mesh_terms: D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007189:Indans / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016016:Proportional Hazards Models; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy*; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D007189:Indans; D015363:Quinolones; C510790:indacaterol