Journal Article

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

Banerji, Donald, Ikeuchi, Hisataro, Kitawaki, Tetsuji, Murata, Shujiro, Hashimoto, Shu, Ikeda, Kimitoshi

2016

Overview

COPD-related deaths are increasing in Japan, with ~5.3 million people at risk. 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 (FEV ) at Week 26. Other key end points included peak FEV , area under the curve for FEV from 5 minutes to 4 hours (FEV AUC ), 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. 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 FEV 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 FEV AUC versus all comparators (all <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. 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.

• Publisher: Dove Medical Press Limited,Dove Medical Press Ltd,Dove Press,Dove Medical Press
• Subject: Administration, Inhalation / Adrenergic beta-2 Receptor Agonists - administration & dosage / Adrenergic beta-2 Receptor Agonists - adverse effects / Aged / Analysis / Area Under Curve / Bronchodilator Agents - administration & dosage / Bronchodilator Agents - adverse effects / Chronic obstructive lung disease / Chronic Obstructive Pulmonary Disease / COPD / Double-Blind Method / Drug Combinations / Dyspnea / Female / Forced Expiratory Volume / Glycine / Glycopyrrolate - administration & dosage / Glycopyrrolate - adverse effects / Humans / Indacaterol/Glycopyrronium / Indans - administration & dosage / Indans - adverse effects / Japan / Japanese subgroup / Lung - drug effects / Lung - physiopathology / Lung diseases / Male / Middle Aged / Muscarinic Antagonists - administration & dosage / Muscarinic Antagonists - adverse effects / open-label tiotropium / open-label tiotropiumA corrigendum has been received and published for this article / Original Research / Patients / Predictive Value of Tests / Pulmonary Disease, Chronic Obstructive - diagnosis / Pulmonary Disease, Chronic Obstructive - drug therapy / Pulmonary Disease, Chronic Obstructive - physiopathology / Quality of life / Quinolones - administration & dosage / Quinolones - adverse effects / Recovery of Function / ROC Curve / Severity of Illness Index / SHINE study / Spirometry / Steroids / Surveys and Questionnaires / Time Factors / Treatment Outcome / Values / Vital Capacity