Comparative efficacy of indacaterol in chronic obstructive pulmonary disease

Abstract

Long-acting bronchodilators have been shown to improve multiple clinical outcomes in chronic obstructive pulmonary disease (COPD) including lung function, symptoms, dyspnea, quality of life, and exacerbations. Indacaterol is a novel, inhaled, long-acting β2-agonist providing 24-hour bronchodilation with once-daily dosing. It is currently approved for the maintenance treatment of COPD to be administered as 150 or 300 μg once-daily doses as licensed in many countries and 75 μg as licensed in the US by means of a single-dose dry powder inhaler. The data from clinical development support a favorable safety and tolerability profile within the β2-agonist drug class, with no relevant issues identified. Current evidence indicates that indacaterol is suitable for use as first-line monotherapy in COPD patients with moderate disease (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II) and beyond that do not require an inhaled corticosteroid (ICS) as per GOLD guidelines, or in combination with an ICS in severe or very severe patients with repeated exacerbations. Data from trials with the novel once-daily β2-agonist, indacaterol, indicate superior bronchodilation and clinical efficacy over twice-daily long-acting β2-agonists and at least equipotent bronchodilation as once-daily tiotropium. Bronchodilators are central in the symptomatic management of COPD. It is likely that once-daily dosing of a bronchodilator would be a significant convenience and probably a compliance-enhancing advantage, leading to improved overall clinical outcomes in patients with COPD.

Keywords: bronchodilators; chronic obstructive pulmonary disease; indacaterol; long-acting β2-agonists; once-daily; onset of action.

Figure 1

Serial measurements of FEV₁ from 15 minutes to 24 hours postdose measured in a subset with serial spirometry measurements (12-hour serial spirometry subset) at week 12. Notes: Data are least squares means 6 SE. Treatment differences: P < 0.001 for indacaterol (both doses) versus placebo at each time point; P < 0.05 for formoterol versus placebo at time points from 5 minutes to 11 hours and 45 minutes postdose; P < 0.05 for indacaterol 300 mg versus formoterol at 15 minutes, 2 hours, and from 6 hours to 23 hours 45 minutes; P < 0.05 for indacaterol 600 mg versus formoterol at all time points apart from 5 minutes postdose. Abbreviations: FEV₁, forced expiratory volume in 1 second; bd, twice daily; od, once daily.

Figure 2

Serial measurements of (A) FEV₁ and (B) FVC from 250 minutes to 23 hours 45 minutes postdose measured in subsets with 12-hour serial spirometry at week 26. Notes: Data are least squares means 6 SE. Treatment differences for FEV₁: P = 0.05 for indacaterol (both doses) and tiotropium versus placebo at all time points; P = 0.05 for indacaterol 300 mg versus tiotropium at 250, 215, and 5 minutes, 2 hours, 4 hours, and 23 hours 10 minutes. Treatment differences for FVC: P = 0.05 for indacaterol (both doses) and tiotropium versus placebo at all time points; P = 0.05 for indacaterol 300 mg versus 150 mg at 2 hours, 4 hours, 23 hours 10 minutes, and 24 hours 45 minutes. Abbreviations: FVC, forced vital capacity; FEV₁, forced expiratory volume in 1 second; qd, once daily.