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 FEV₁ from 5 minutes to 4 hours (FEV₁ AUC_{5 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 AUC_{5 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

View correction statement:

Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: a subgroup analysis from the SHINE study [Corrigendum]

Supplementary material

Table S1 List of relevant national and local ethics review boards

Acknowledgments

The authors would like to thank their colleagues who were involved in the planning, execution, and analysis of the SHINE study and all the study participants. This study was sponsored by Novartis Pharma AG, Basel, Switzerland. The authors were assisted in the preparation of this manuscript by Kevin Roche and Santanu Bhadra of Novartis Healthcare Pvt. Ltd., Hyderabad, India.

Author contributions

All authors contributed toward data analysis, drafting and critically revising the paper and agree to be accountable for all aspects of the work.

Disclosure

SH had received grants and/or lecture fees from Astellas Pharma Inc., AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., KYORIN Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co. Ltd., Torii Pharmaceutical Co. Ltd., and Novartis Pharma K.K. within the last 3 years. SM, TK, KI, and DB are employees of the study sponsor Novartis. The authors report no other conflicts of interest in this work.