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International Journal of Chronic Obstructive Pulmonary Disease Volume 11, 2016 - Issue
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Original Research

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

Shu Hashimoto1 Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, JapanCorrespondence[email protected]
,
Hisataro Ikeuchi2 Novartis Pharma KK, Minato-ku, Tokyo, Japan
,
Shujiro Murata2 Novartis Pharma KK, Minato-ku, Tokyo, Japan
,
Tetsuji Kitawaki2 Novartis Pharma KK, Minato-ku, Tokyo, Japan
,
Kimitoshi Ikeda2 Novartis Pharma KK, Minato-ku, Tokyo, Japan
&
Donald Banerji3 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
Pages 2543-2551 | Published online: 11 Oct 2016

Figures & data

Table 1 Demographic and baseline clinical characteristics of the Japanese subgroup

Figure 1 Patient disposition.

Note: n, number of patients.
Abbreviations: IND, indacaterol; GLY, glycopyrronium; od, once daily; TIO, tiotropium; ol, open label.
Figure 1 Patient disposition.

Figure 2 Trough FEV1 (L) after 26 weeks in the Japanese subgroup.

Notes: Data are presented as LSM (standard error). Trough FEV1 is defined as the average of the post dose 23 hours 15 minutes and 23 hours 45 minutes FEV1 values (excluding values taken outside 22 hours 45 minutes and 24 hours 15 minutes post dose) at Day 2.

Abbreviations: FEV1, forced expiratory volume in 1 second; LSM, least-squares mean; IND, indacaterol; GLY, glycopyrronium; od, once daily; TIO, tiotropium; ∆, treatment difference.

Figure 2 Trough FEV1 (L) after 26 weeks in the Japanese subgroup.Notes: Data are presented as LSM (standard error). Trough FEV1 is defined as the average of the post dose 23 hours 15 minutes and 23 hours 45 minutes FEV1 values (excluding values taken outside 22 hours 45 minutes and 24 hours 15 minutes post dose) at Day 2.Abbreviations: FEV1, forced expiratory volume in 1 second; LSM, least-squares mean; IND, indacaterol; GLY, glycopyrronium; od, once daily; TIO, tiotropium; ∆, treatment difference.

Figure 3 Trough FEV1 (L) over 26 weeks in the Japanese subgroup.

Note: Data are presented as LSM (standard error).

Abbreviations: FEV1, forced expiratory volume in 1 second; LSM, least-squares mean; IND, indacaterol; GLY, glycopyrronium; od, once daily; TIO, tiotropium.

Figure 3 Trough FEV1 (L) over 26 weeks in the Japanese subgroup.Note: Data are presented as LSM (standard error).Abbreviations: FEV1, forced expiratory volume in 1 second; LSM, least-squares mean; IND, indacaterol; GLY, glycopyrronium; od, once daily; TIO, tiotropium.

Figure 4 Peak FEV1 (L) from 5 minutes to 4 hours at Week 26 in the Japanese subgroup.

Notes: Data are presented as LSM (standard error). Peak FEV1 is defined as the maximum FEV1 during the first 4 hours after dosing.

Abbreviations: FEV1, forced expiratory volume in 1 second; LSM, least-squares mean; IND, indacaterol; GLY, glycopyrronium; od, once daily; TIO, tiotropium; ∆, treatment difference.

Figure 4 Peak FEV1 (L) from 5 minutes to 4 hours at Week 26 in the Japanese subgroup.Notes: Data are presented as LSM (standard error). Peak FEV1 is defined as the maximum FEV1 during the first 4 hours after dosing.Abbreviations: FEV1, forced expiratory volume in 1 second; LSM, least-squares mean; IND, indacaterol; GLY, glycopyrronium; od, once daily; TIO, tiotropium; ∆, treatment difference.

Figure 5 FEV1 AUC5 min–4 h (L) at Week 26 in the Japanese subgroup.

Note: Data are presented as LSM (standard error).
Abbreviations: FEV1 AUC5 min-4 h, area under the curve for FEV1 from 5 minutes to 4 hours; FEV1, forced expiratory volume in 1 second; LSM, least-squares mean; IND, indacaterol; GLY, glycopyrronium; od, once daily; TIO, tiotropium; ∆, treatment difference.
Figure 5 FEV1 AUC5 min–4 h (L) at Week 26 in the Japanese subgroup.

Table 2 Summary of AEs and SAEs by preferred terms in the Japanese subgroup

Table S1 List of relevant national and local ethics review boards

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