Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: a subgroup analysis from the SHINE study
Authors Hashimoto S, Ikeuchi H, Murata S, Kitawaki T, Ikeda K, Banerji D
Received 26 April 2016
Accepted for publication 22 July 2016
Published 11 October 2016 Volume 2016:11(1) Pages 2543—2551
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Charles Downs
Peer reviewer comments 3
Editor who approved publication: Dr Richard Russell
Shu Hashimoto,1 Hisataro Ikeuchi,2 Shujiro Murata,2 Tetsuji Kitawaki,2 Kimitoshi Ikeda,2 Donald Banerji3
1Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan; 2Novartis Pharma KK, Minato-ku, Tokyo, Japan; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
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 FEV1 from 5 minutes to 4 hours (FEV1 AUC5 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 FEV1 from 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 FEV1 AUC5 min–4 h versus all comparators (all P<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.
Conclusion: 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.
Keywords: SHINE study, Japanese subgroup, COPD, indacaterol/glycopyrronium, open-label tiotropium
A corrigendum has been received and published for this article.
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