Introduction Indacaterol (IND) is an inhaled, once-daily, 24 hr long-acting β 2 -agonist for the treatment of COPD. We report on the effectiveness of IND and other long-acting bronchodilators compared to placebo in patients of GOLD 2011 groups A and B. Methods A post-hoc, subgroup pooled analysis of 6-month efficacy data from 3 randomized, placebo controlled studies (n=3862) was performed across GOLD groups A–D categorized according to FEV 1 % predicted, mMRC dyspnea scale and exacerbation history in the 12 months prior to entry (yes/no). Once-daily IND 150µg or 300µg, open-label tiotropium (TIO) 18µg; twice-daily salmeterol (SAL) 50µg or formoterol (FOR) 12µg were compared to placebo. Endpoints included trough FEV 1 , TDI, and SGRQ total score, all at Week 26, and mean rescue medication use over 26 weeks. Results In GOLD groups A and B, IND 150µg and 300µg significantly improved FEV 1 , TDI, SGRQ total score and mean rescue medication use compared with placebo. Adjusted mean treatment difference vs placebo FEV 1 (mL) SGRQ total score TDI Mean rescue use (puffs/day) GOLD group A/B A/B A/B A/B IND 150μg 209*/156* -3.4 ‡ /-5.6* 1.0 † /1.1 † -0.80*/-1.05* IND 300μg 216*/177* -3.6 ‡ /-3.2 ‡ 1.2*/1.1 † -0.86*/-1.23* FOR 80 ‡ /99 † -1.3/-3.8 § 0.5/0.8 § -0.87 † /-0.96* TIO 171*/120* -0.9/-3.4 § 1.1 ‡ /0.8 § -0.52 § /-0.53 § SAL 158*/111 ‡ -2.8/-5.6 ‡ 0.4/1.0 § -0.77 ‡ /-0.99 † Group A, n=1134; Group B, n=1008; *p<0.0001; † p<0.001; ‡ p<0.01; § p<0.05 vs placebo Conclusion Treatment selection according to patient’s symptoms as well as risk is an important consideration in the treatment of COPD as per GOLD. IND 150µg and 300µg effectively improved lung function, health status, and symptoms in GOLD 2011 group A and B patients.
Kerstjens et al. (Sun,) studied this question.