TIOtropium Safety and Performance In Respimat® (TIOSPIRTM): Analysis of Asian cohort of COPD patients

Nanshan Zhong, Hwa S. Moon, Kwan H. Lee, Aziah A. Mahayiddin, Watchara Boonsawat, Marie G D Isidro, Chun Xue Bai, Achim Mueller, Norbert Metzdorf, Antonio R Anzueto

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1397-1403
Number of pages7
JournalRespirology
Volume21
Issue number8
DOIs
StatePublished - Nov 1 2016
Externally publishedYes

    Fingerprint

Keywords

  • chronic obstructive pulmonary disease
  • clinical respiratory medicine
  • clinical trials

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Zhong, N., Moon, H. S., Lee, K. H., Mahayiddin, A. A., Boonsawat, W., Isidro, M. G. D., Bai, C. X., Mueller, A., Metzdorf, N., & Anzueto, A. R. (2016). TIOtropium Safety and Performance In Respimat® (TIOSPIRTM): Analysis of Asian cohort of COPD patients. Respirology, 21(8), 1397-1403. https://doi.org/10.1111/resp.12856