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TIOtropium Safety and Performance In Respimat ® (TIOSPIR TM ): Analysis of Asian cohort of COPD patients
Author(s) -
Zhong Nanshan,
Moon Hwa S.,
Lee Kwan H.,
Mahayiddin Aziah A.,
Boonsawat Watchara,
Isidro Marie G.D.,
Bai ChunXue,
Mueller Achim,
Metzdorf Norbert,
Anzueto Antonio
Publication year - 2016
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/resp.12856
Subject(s) - medicine , copd , cohort , tiotropium bromide , lung , lung function
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 .