The impact of treatment with indacaterol in patients with COPD: A post-hoc analysis according to GOLD 2011 categories A to D.
BACKGROUND
Indacaterol is an inhaled, once-daily, ultra-long-acting β2-agonist for the treatment of chronic obstructive pulmonary disease (COPD). We report on the effectiveness of indacaterol and other bronchodilators compared with placebo in patients across the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 categories A to D.


METHODS
A post-hoc, subgroup pooled analysis of 6-month efficacy data from three randomized, placebo-controlled, parallel-group studies involving 3862 patients was performed across GOLD 2011 categories A to D, according to baseline forced expiratory volume in 1 s (FEV1) % predicted, modified Medical Research Council (mMRC) dyspnea scale, and exacerbation history in the 12 months prior to entry. Efficacy of once-daily indacaterol 150 and 300 μg, open-label tiotropium 18 μg, twice-daily salmeterol 50 μg, and formoterol 12 μg was compared with placebo. End points analysed were trough FEV1, transition dyspnea index (TDI), and St George's Respiratory Questionnaire (SGRQ) total score, all at Week 26, and mean rescue medication use over 26 weeks.


RESULTS
Indacaterol 150 and 300 μg significantly improved FEV1, compared with placebo across all GOLD groups. Indacaterol 150 and 300 μg also significantly improved TDI, SGRQ total score, and mean rescue medication use compared with placebo across most GOLD subgroups.


CONCLUSIONS
Treatment selection according to patient's symptoms as well as lung function is an important consideration in maintenance treatment of COPD. Indacaterol 150 and 300 μg effectively improved lung function and symptoms in patients across all GOLD 2011 categories.
University of Groningen, University Medical Center, and Groningen Research Institute for Asthma and COPD GRIAC, Groningen, the Netherlands. Electronic address: h.a.m.kerstjens@umcg.nl.
Huib A M
HA
Kerstjens
Service de Pneumologie, Hôpital Maison Blanche, INSERM U903, CHU de Reims, France. Electronic address: gdeslee@chu-reims.fr.
Gaëtan
G
Deslée
Allergy Centre, Odense University Hospital, Odense, Denmark. Electronic address: Ronald.Dahl2@rsyd.dk.
Ronald
R
Dahl
Department of Medicine, University of North Carolina, NC, USA. Electronic address: james_donohue@med.unc.edu.
James F
JF
Donohue
Novartis Horsham Research Centre, Horsham, West Sussex, UK. Electronic address: david.young@young-communications.com.
David
D
Young
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: david-1.lawrence@novartis.com.
David
D
Lawrence
IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany. Electronic address: kornmann@ikf-pneumologie.de.
Oliver
O
Kornmann
D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D007189:Indans; D015363:Quinolones; C510790:indacaterol
Chronic obstructive pulmonary disease; GOLD categories; Indacaterol; Lung function; Symptoms