1. Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: a subgroup analysis from the SHINE study
- Author
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Shujiro Murata, Tetsuji Kitawaki, Shu Hashimoto, Hisataro Ikeuchi, Donald Banerji, and Kimitoshi Ikeda
- Subjects
Male ,Time Factors ,Vital Capacity ,Quinolones ,indacaterol/glycopyrronium ,Severity of Illness Index ,Gastroenterology ,Pulmonary Disease, Chronic Obstructive ,0302 clinical medicine ,Japan ,Forced Expiratory Volume ,Surveys and Questionnaires ,Medicine ,030212 general & internal medicine ,Lung ,Original Research ,COPD ,integumentary system ,Area under the curve ,Treatment options ,General Medicine ,Middle Aged ,Bronchodilator Agents ,Drug Combinations ,Treatment Outcome ,Area Under Curve ,Indans ,Population study ,Female ,Corrigendum ,medicine.drug ,medicine.medical_specialty ,Subgroup analysis ,Muscarinic Antagonists ,International Journal of Chronic Obstructive Pulmonary Disease ,Placebo ,03 medical and health sciences ,Double-Blind Method ,Predictive Value of Tests ,Internal medicine ,Administration, Inhalation ,Humans ,SHINE study ,Adrenergic beta-2 Receptor Agonists ,Aged ,business.industry ,Recovery of Function ,biochemical phenomena, metabolism, and nutrition ,medicine.disease ,Glycopyrrolate ,open-label tiotropium ,ROC Curve ,030228 respiratory system ,Spirometry ,Indacaterol ,Once daily ,business ,Japanese subgroup - Abstract
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, EastHanover, 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) 110/50µg once daily (od) compared with GLY 50µg od, IND 150µg od, open-label tiotropium (TIO) 18µg od, and placebo. The primary end point was trough forced expiratory volume in 1second (FEV1) at Week 26. Other key end points included peak FEV1, area under the curve for FEV1 from 5minutes to 4hours (FEV1 AUC5min–4h), 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 190mL with IND/GLY and treatment differences versus IND (90mL), GLY (100mL), TIO (90mL), and placebo (280mL) along with a rapid onset of action at Week 26. IND/GLY showed an improvement in FEV1 AUC5min–4h versus all comparators (all P
- Published
- 2016