TY - JOUR
T1 - TIOtropium Safety and Performance In Respimat® (TIOSPIRTM)
T2 - Analysis of Asian cohort of COPD patients
AU - Zhong, Nanshan
AU - Moon, Hwa S.
AU - Lee, Kwan H.
AU - Mahayiddin, Aziah A.
AU - Boonsawat, Watchara
AU - Isidro, Marie G.D.
AU - Bai, Chun Xue
AU - Mueller, Achim
AU - Metzdorf, Norbert
AU - Anzueto, Antonio
N1 - Funding Information:
The authors wish to thank the other TIOSPIR Publication Steering Committee members (Professors Peter M.A. Calverley, Ronald Dahl, Daniel Dusser and Robert Wise) for their input to the analyses. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors, were fully responsible for all content and editorial decisions and were involved at all stages of the manuscript's development. This study was previously presented at the Annual APSR Congress 2014. This clinical trial was supported by Boehringer Ingelheim. Editorial and writing assistance was provided by Sarah J. Petit from PAREXEL, funded by Boehringer Ingelheim. A.M. reports receiving lecture fees from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, MSD and MundiPharma. W.B. received consulting fees, lecture fees and travel support from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Novartis and grant support from GlaxoSmithKline and AstraZeneca. A.M. and N.M. are employees of Boehringer Ingelheim. A.A. received consulting fees, lecture fees and travel support from AstraZeneca, Boehringer Ingelheim, Forest Laboratories, GlaxoSmithKline and Novartis and grant support from GlaxoSmithKline.
Publisher Copyright:
© 2016 The Authors. Respirology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Respirology
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Background and objective: The TIOtropium Safety and Performance In Respimat (TIOSPIR) trial showed similar safety and exacerbation efficacy profiles for tiotropium Respimat and HandiHaler in patients with COPD. The TIOSPIR results for patients in Asia are presented here. Methods: TIOSPIR evaluated once-daily tiotropium Respimat 5 and 2.5 µg with HandiHaler 18 µg in patients with COPD. Primary endpoints included time to death and time to first COPD exacerbation. Safety and exacerbation efficacy profiles were determined for the Asian region, and for Asia (all treatment arms pooled) versus the rest of the world (RoW). Results: In Asia (n = 2356), time to death was similar for Respimat 5 and 2.5 µg versus HandiHaler 18 µg (hazard ratio (HR) (95% CI): 0.96 (0.67, 1.38) and 1.23 (0.87, 1.73)). Risk of COPD exacerbation was similar for Respimat 5 µg, but increased for 2.5 µg versus HandiHaler 18 µg (HR (95% CI): 0.99 (0.85, 1.15) and 1.17 (1.00, 1.35)). Time to death in Asia and RoW was similar (HR (95% CI): 1.15 (0.99, 1.35)). Time to first COPD exacerbation was longer (HR (95% CI): 0.84 (0.78, 0.89)) and exacerbation rates were lower in Asia, but severe exacerbations were more frequent than in the RoW. Risk of major adverse cardiovascular events was similar for both regions. Conclusion: Similar safety and exacerbation efficacy profiles were observed for tiotropium Respimat 5 µg and HandiHaler 18 µg in patients with COPD from Asia, analogous to the global analysis. Asian patients had lower risk of, and fewer exacerbations overall, but a higher proportion of severe exacerbations than in the RoW.
AB - Background and objective: The TIOtropium Safety and Performance In Respimat (TIOSPIR) trial showed similar safety and exacerbation efficacy profiles for tiotropium Respimat and HandiHaler in patients with COPD. The TIOSPIR results for patients in Asia are presented here. Methods: TIOSPIR evaluated once-daily tiotropium Respimat 5 and 2.5 µg with HandiHaler 18 µg in patients with COPD. Primary endpoints included time to death and time to first COPD exacerbation. Safety and exacerbation efficacy profiles were determined for the Asian region, and for Asia (all treatment arms pooled) versus the rest of the world (RoW). Results: In Asia (n = 2356), time to death was similar for Respimat 5 and 2.5 µg versus HandiHaler 18 µg (hazard ratio (HR) (95% CI): 0.96 (0.67, 1.38) and 1.23 (0.87, 1.73)). Risk of COPD exacerbation was similar for Respimat 5 µg, but increased for 2.5 µg versus HandiHaler 18 µg (HR (95% CI): 0.99 (0.85, 1.15) and 1.17 (1.00, 1.35)). Time to death in Asia and RoW was similar (HR (95% CI): 1.15 (0.99, 1.35)). Time to first COPD exacerbation was longer (HR (95% CI): 0.84 (0.78, 0.89)) and exacerbation rates were lower in Asia, but severe exacerbations were more frequent than in the RoW. Risk of major adverse cardiovascular events was similar for both regions. Conclusion: Similar safety and exacerbation efficacy profiles were observed for tiotropium Respimat 5 µg and HandiHaler 18 µg in patients with COPD from Asia, analogous to the global analysis. Asian patients had lower risk of, and fewer exacerbations overall, but a higher proportion of severe exacerbations than in the RoW.
KW - chronic obstructive pulmonary disease
KW - clinical respiratory medicine
KW - clinical trials
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U2 - 10.1111/resp.12856
DO - 10.1111/resp.12856
M3 - Article
C2 - 27490162
AN - SCOPUS:84991508543
SN - 1323-7799
VL - 21
SP - 1397
EP - 1403
JO - Respirology
JF - Respirology
IS - 8
ER -