title: Indacaterol vs tiotropium in COPD patients classified as GOLD A and B.
abstract: BACKGROUND
  According to current GOLD strategy, patients with COPD classified as groups A and B may be treated with inhaled bronchodilators, either long-acting β2-agonist (LABA) or long-acting muscarinic antagonist (LAMA). However, there is little guidance on which class of agent is preferred and a lack of prospective data to differentiate the two.
  
  
  METHODS
  In this study, we performed post-hoc analyses of pooled data from two prospective, controlled clinical trials comparing the LABA indacaterol and LAMA tiotropium in 1422 patients with moderate airflow limitation and no history of exacerbations in the previous year. This population fits the definitions of GOLD A and B groups and could be further stratified by symptom severity using Baseline Dyspnea Index (i.e. modeling GOLD A or B) and inhaled corticosteroid (ICS) use at baseline. Outcomes measured after 12 weeks of treatment were lung function (forced expiratory volume in 1 s; FEV1), health status (St George's Respiratory Questionnaire; SGRQ), symptoms (Transition Dyspnea Index; TDI) and rescue medication use.
  
  
  RESULTS
  In 'GOLD A' patients not receiving ICS, differences favored indacaterol versus tiotropium (trough FEV1 0.05 L; rescue medication use -0.41 puffs/day; TDI total score 0.94 points; SGRQ total score -3.13 units, all p < 0.01). In 'GOLD B, no ICS' patients, compared with tiotropium, indacaterol treatment increased trough FEV1 (0.055 L, p < 0.05) and permitted a larger reduction in rescue medication use (-0.81 puffs/day, p = 0.004). In all patients, and in patients not using ICS, differences favored indacaterol for all variables.
  
  
  CONCLUSIONS
  Our findings suggest that patients in GOLD groups A and B may experience greater benefits with indacaterol than with tiotropium.
authors.affiliation: Section of Pulmonary & Critical Care Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH 03755, USA. Electronic address: mahlerdonald@gmail.com.
authors.forename: Donald A
authors.initials: DA
authors.lastname: Mahler
authors.affiliation: University of Groningen, Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, Groningen, The Netherlands; University of Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, Groningen, The Netherlands. Electronic address: h.a.m.kerstjens@umcg.nl.
authors.forename: Huib A M
authors.initials: HA
authors.lastname: Kerstjens
authors.affiliation: Pulmonary Diseases and Critical Care Medicine, Department of Medicine, University of North Carolina School of Medicine, CB# 7020, 130 Mason Farm Rd, 4th Floor Bioinformatics Building, Chapel Hill, NC 27599, USA. Electronic address: james_donohue@med.unc.edu.
authors.forename: James F
authors.initials: JF
authors.lastname: Donohue
authors.affiliation: Pulmonary Department, Mainz University Hospital, Langenbeckstrasse 1, Mainz D-55131, Germany. Electronic address: r.buhl@3-med.klinik.uni-mainz.de.
authors.forename: Roland
authors.initials: R
authors.lastname: Buhl
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: davejlawrence@hotmail.com.
authors.forename: David
authors.initials: D
authors.lastname: Lawrence
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: pablo.altman@novartis.com.
authors.forename: Pablo
authors.initials: P
authors.lastname: Altman
mesh_terms: D001993:Bronchodilator Agents / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005540:Forced Expiratory Flow Rates / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D007189:Indans / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage*; D000069447:Tiotropium Bromide / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D007189:Indans; D015363:Quinolones; C510790:indacaterol; D000069447:Tiotropium Bromide
keywords: COPD; Efficacy; GOLD; Indacaterol; Tiotropium