PMID- 27886854 OWN - NLM STAT- MEDLINE DCOM- 20170508 LR - 20221207 IS - 2212-5353 (Electronic) IS - 2212-5345 (Linking) VI - 54 IP - 6 DP - 2016 Nov TI - Efficacy and safety of indacaterol/glycopyrronium in Japanese patients with COPD: Pooled analysis of SHINE and ARISE. PG - 428-435 LID - S2212-5345(16)30071-5 [pii] LID - 10.1016/j.resinv.2016.06.006 [doi] AB - 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 (FEV(1)) at Week 12 and Week 24/26 (ARISE/SHINE) and FEV(1) 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 FEV(1) was significantly improved with IND/GLY compared with tiotropium (treatment differences=70mL and 80mL, respectively; both P