Indacaterol inhalation
powder (Onbrez® Breezhaler®) is a long-acting, selective β(2)-adrenoceptor agonist that is indicated for the maintenance
bronchodilator treatment of airflow obstruction in adults with
chronic obstructive pulmonary disease (
COPD). This article reviews the clinical efficacy and tolerability of
indacaterol 150 and 300 μg once daily in adults with moderate to severe
COPD, as well as reviewing
indacaterol's pharmacological properties and results of a cost-utility analysis.
Indacaterol has a fast onset of action after the first dose and is effective over 24 hours, allowing for once-daily administration. In short-term trials (≤21 days) in patients with
COPD, once-daily
indacaterol 150 or 300 μg significantly improved lung function, exercise endurance and lung hyperinflation relative to placebo. In large, longer-term clinical studies (12 weeks to 1 year) in patients with moderate to severe
COPD, once-daily
indacaterol 150 or 300 μg improved lung function (primary endpoint) significantly more than placebo, and improvements were significantly greater than twice-daily
formoterol 12 μg or
salmeterol 50 μg, and noninferior to once-daily
tiotropium bromide 18 μg (all agents were administered via inhalation). Overall,
indacaterol improved dyspnoea, use of rescue medication and general health status significantly more than placebo,
salmeterol or
tiotropium bromide, and the degree of improvement in these endpoints was similar to or greater than that achieved with
formoterol. Improvements were sustained over the long term (1 year), with no evidence of tolerance. Combination
therapy with
indacaterol plus
tiotropium bromide improved lung function, dyspnoea, rescue medication use and general health status significantly more than
tiotropium bromide alone in patients with moderate to severe
COPD.
Indacaterol is generally well tolerated when used alone or in combination with
tiotropium bromide in patients with
COPD and has not been associated with any safety issues. The most common adverse event in clinical trials was
COPD worsening, which occurred more commonly with placebo than
indacaterol.
Indacaterol was not associated with an increased risk of cardiovascular adverse events. In a cost-utility analysis from a German healthcare payer perspective, once-daily
indacaterol 150 μg was dominant (i.e. more effective with lower total costs) to once-daily
tiotropium bromide 18 μg and twice-daily
salmeterol 50 μg in the treatment of patients with
COPD. In conclusion,
indacaterol provides a valuable option for the maintenance treatment of adults with
COPD.