title: Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: a subgroup analysis from the SHINE study.
abstract: BACKGROUND
  COPD-related deaths are increasing in Japan, with ~5.3 million people at risk.
  
  
  METHODS
  The SHINE was a 26-week, multicenter, randomized, double-blind, parallel-group study that evaluated safety and efficacy of indacaterol (IND)/glycopyrronium (GLY) 110/50 μg once daily (od) compared with GLY 50 μg od, IND 150 μg od, open-label tiotropium (TIO) 18 μg od, and placebo. The primary end point was trough forced expiratory volume in 1 second (FEV1) at Week 26. Other key end points included peak FEV1, area under the curve for FEV1from 5 minutes to 4 hours (FEV1AUC5 min-4 h), Transition Dyspnea Index focal score, St George's Respiratory Questionnaire total score, and safety. Here, we present efficacy and safety of IND/GLY in the Japanese subgroup.
  
  
  RESULTS
  Of 2,144 patients from the SHINE study, 182 (8.5%) were Japanese and randomized to IND/GLY (n=42), IND (n=41), GLY (n=40), TIO (n=40), or placebo (n=19). Improvement in trough FEV1from baseline was 190 mL with IND/GLY and treatment differences versus IND (90 mL), GLY (100 mL), TIO (90 mL), and placebo (280 mL) along with a rapid onset of action at Week 26. IND/GLY showed an improvement in FEV1AUC5 min-4 hversus all comparators (allP<0.05). All the treatments were well tolerated and showed comparable effect on Transition Dyspnea Index focal score and St George's Respiratory Questionnaire total score. The effect of IND/GLY in the Japanese subgroup was consistent to overall SHINE study population.
  
  
  CONCLUSIONS
  IND/GLY demonstrated superior efficacy and comparable safety compared with its monocomponents, open-label TIO, and placebo and may be used as a treatment option for the management of moderate-to-severe COPD in Japanese patients.
authors: Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.
authors: Shu
authors: S
authors: Hashimoto
authors: Novartis Pharma KK, Minato-ku, Tokyo, Japan.
authors: Hisataro
authors: H
authors: Ikeuchi
authors: Novartis Pharma KK, Minato-ku, Tokyo, Japan.
authors: Shujiro
authors: S
authors: Murata
authors: Novartis Pharma KK, Minato-ku, Tokyo, Japan.
authors: Tetsuji
authors: T
authors: Kitawaki
authors: Novartis Pharma KK, Minato-ku, Tokyo, Japan.
authors: Kimitoshi
authors: K
authors: Ikeda
authors: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors: Donald
authors: D
authors: Banerji
mesh_terms: D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D019540:Area Under Curve; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005541:Forced Expiratory Volume; D006024:Glycopyrrolate / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007189:Indans / Q000008:administration & dosage* / Q000009:adverse effects; D007564:Japan; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D011237:Predictive Value of Tests; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D012372:ROC Curve; D020127:Recovery of Function; D012720:Severity of Illness Index; D013147:Spirometry; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D004338:Drug Combinations; D007189:Indans; D018727:Muscarinic Antagonists; D015363:Quinolones; C510790:indacaterol; D006024:Glycopyrrolate
keywords: COPD; Japanese subgroup; SHINE study; indacaterol/glycopyrronium; open-label tiotropium