title: Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: Pooled analysis of SHINE and ARISE.
abstract: BACKGROUND
  To better evaluate the efficacy and safety of the indacaterol/glycopyrronium (IND/GLY) fixed-dose combination versus tiotropium in Japanese patients, a pooled data analysis was conducted from the SHINE and ARISE studies, which were part of the IND/GLY clinical trial program.
  
  
  METHODS
  Japanese patients with moderate-to-severe COPD were included in the analysis. Efficacy in terms of pre-dose forced expiratory volume in one second (FEV1) at Week 12 and Week 24/26 (ARISE/SHINE) and FEV1at 30min and 60min post-dose at Day 1, Week 12, and Week 24/26 was evaluated. Health status using the St. George׳s Respiratory Questionnaire (SGRQ) score, rescue medication use (number of puffs/day), safety, and tolerability were also assessed.
  
  
  RESULTS
  In total, 340 patients (IND/GLY, n=161; IND, n=41; GLY, n=40; tiotropium, n=79; and placebo, n=19) were included in the analysis that focused on comparing IND/GLY versus tiotropium since they were included in both studies. At Week 12 and Week 24/26, pre-dose FEV1was significantly improved with IND/GLY compared with tiotropium (treatment differences=70mL and 80mL, respectively; both P≤0.001). FEV1at 30min and 60min post-dose, the SGRQ total score, and rescue medication use were more statistically significant with IND/GLY than with tiotropium for all assessed time-points. The overall incidence of adverse events (AEs) and serious AEs was similar between the IND/GLY- and tiotropium-treated groups.
  
  
  CONCLUSIONS
  Compared to tiotropium, IND/GLY provided significant improvements in lung function, health status, and rescue medication use, while having a good safety profile in Japanese patients with moderate-to-severe COPD.
authors.affiliation: Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan. Electronic address: kazuasai@med.osaka-cu.ac.jp.
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Asai
authors.affiliation: Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan. Electronic address: kazutoh@msic.med.osaka-cu.ac.jp.
authors.forename: Kazuto
authors.initials: K
authors.lastname: Hirata
authors.affiliation: Nihon University School of Medicine, Tokyo, Japan. Electronic address: shuh@med.nihon-u.ac.jp.
authors.forename: Shu
authors.initials: S
authors.lastname: Hashimoto
authors.affiliation: Department of Respiratory Medicine, Juntendo University School of Medicine, Tokyo, Japan. Electronic address: yfukuchi@tea.ocn.ne.jp.
authors.forename: Yoshinosuke
authors.initials: Y
authors.lastname: Fukuchi
authors.affiliation: Novartis Pharma K.K., Tokyo, Japan. Electronic address: tetsuji.kitawaki@novartis.com.
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Kitawaki
authors.affiliation: Novartis Pharma K.K., Tokyo, Japan. Electronic address: kimitoshi.ikeda@novartis.com.
authors.forename: Kimitoshi
authors.initials: K
authors.lastname: Ikeda
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: robert.fogel@novartis.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Fogel
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: donald.banerji@novartis.com.
authors.forename: Donald
authors.initials: D
authors.lastname: Banerji
mesh_terms: D000368:Aged; D044466:Asian People; D004359:Drug Therapy, Combination; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005541:Forced Expiratory Volume; D006024:Glycopyrrolate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013223:Statistics as Topic / Q000379:methods*; D000069447:Tiotropium Bromide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D007189:Indans; D015363:Quinolones; C510790:indacaterol; D006024:Glycopyrrolate; D000069447:Tiotropium Bromide
keywords: ARISE; COPD; IND/GLY; Japanese; SHINE