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Respir Investig. 2016 Nov;54(6):428-435. doi: 10.1016/j.resinv.2016.06.006. Epub 2016 Aug 24.

Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: Pooled analysis of SHINE and ARISE.

Author information

1
Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan. Electronic address: kazuasai@med.osaka-cu.ac.jp.
2
Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan. Electronic address: kazutoh@msic.med.osaka-cu.ac.jp.
3
Nihon University School of Medicine, Tokyo, Japan. Electronic address: shuh@med.nihon-u.ac.jp.
4
Department of Respiratory Medicine, Juntendo University School of Medicine, Tokyo, Japan. Electronic address: yfukuchi@tea.ocn.ne.jp.
5
Novartis Pharma K.K., Tokyo, Japan. Electronic address: tetsuji.kitawaki@novartis.com.
6
Novartis Pharma K.K., Tokyo, Japan. Electronic address: kimitoshi.ikeda@novartis.com.
7
Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: robert.fogel@novartis.com.
8
Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: donald.banerji@novartis.com.

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 FEV1 at 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 FEV1 was significantly improved with IND/GLY compared with tiotropium (treatment differences=70mL and 80mL, respectively; both P≤0.001). FEV1 at 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.

KEYWORDS:

ARISE; COPD; IND/GLY; Japanese; SHINE

PMID:
27886854
DOI:
10.1016/j.resinv.2016.06.006
[Indexed for MEDLINE]

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