Kazuhisa Asai1, Kazuto Hirata2, Shu Hashimoto3, Yoshinosuke Fukuchi4, Tetsuji Kitawaki5, Kimitoshi Ikeda6, Robert Fogel7, Donald Banerji8. 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 versustiotropium 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. Copyright Â
RCT Entities:
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. Copyright Â