Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled data.

Abstract

BACKGROUND:

Indacaterol is an inhaled, once-daily long-acting β(2)-agonist bronchodilator for regular use in patients with chronic obstructive pulmonary disease (COPD). As indacaterol is the first once-daily β(2)-agonist to be developed, it is relevant to evaluate its bronchodilator efficacy, safety, and tolerability.

METHODS:

Data were pooled from three randomized, double-blind, clinical studies in patients with moderate-to-severe COPD treated with indacaterol 150 μg qd (n = 627) or placebo (n = 1021). Bronchodilator efficacy was assessed as trough (24-hour post-dose) forced expiratory volume in 1 second (FEV(1)) after 12 weeks (primary endpoint in individual studies) and FEV(1) measured serially post-dose. Rescue use of albuterol was monitored.

RESULTS:

At week 12, indacaterol increased trough FEV(1) by 160 mL compared with placebo (P < 0.001), exceeding the 120 mL level prespecified as clinically important. FEV(1) during the first 12-hour post-dose at week 12 averaged 210 mL higher with indacaterol than with placebo (P < 0.001). Patients receiving indacaterol recorded 53% of days without use of rescue albuterol, compared with 38% of days in the placebo group (P < 0.001). Adverse events (mostly mild or moderate) were reported for 52% and 46% of patients receiving indacaterol and placebo, respectively, and serious adverse events for 4% and 5%. Worsening of COPD was the most frequent adverse event (10% indacaterol; 15% placebo). Indacaterol had little effect on pulse or blood pressure or measures of systemic β(2)-adrenoceptor activity (blood glucose, serum potassium, and corrected QT interval).

CONCLUSION:

Indacaterol was an effective bronchodilator and was well tolerated, with a good safety profile over 12 weeks of treatment. It should prove a useful treatment for patients with moderate-to-severe COPD.

• Authors: Eugene R Bleecker, Thomas Siler, Roger Owen, Benjamin Kramer
• Journal: International journal of chronic obstructive pulmonary disease (Int J Chron Obstruct Pulmon Dis) Vol. 6 Pg. 431-8 ( 2011) ISSN: 1178-2005 [Electronic] New Zealand
• PMID: 22003288 (Publication Type: Journal Article, Meta-Analysis, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Adrenergic beta-2 Receptor Agonists
• Bronchodilator Agents
• Indans
• Quinolones
• indacaterol
• Albuterol

Topics

• Administration, Inhalation
• Adrenergic beta-2 Receptor Agonists (administration & dosage, adverse effects)
• Aged
• Albuterol (administration & dosage)
• Bronchodilator Agents (administration & dosage, adverse effects)
• Drug Administration Schedule
• Female
• Forced Expiratory Volume
• Humans
• Indans (administration & dosage, adverse effects)
• Lung (drug effects, physiopathology)
• Male
• Middle Aged
• Pulmonary Disease, Chronic Obstructive (diagnosis, drug therapy, physiopathology)
• Quinolones (administration & dosage, adverse effects)
• Randomized Controlled Trials as Topic
• Severity of Illness Index
• Time Factors
• Treatment Outcome