Key result
Tiotropium Respimat 5 µg resulted in a similar time to death compared to HandiHaler 18 µg in Asian patients with COPD (HR 0.96; 95% CI 0.67-1.38).
Why the study?
Does once-daily tiotropium Respimat 5 µg and 2.5 µg improve time to death and time to first COPD exacerbation compared to HandiHaler 18 µg in Asian patients with COPD?
RCT (n=2,356)
Yes
Does once-daily tiotropium Respimat 5 µg and 2.5 µg improve time to death and time to first COPD exacerbation compared to HandiHaler 18 µg in Asian patients with COPD?
Hazard Ratio: 0.96 (95% CI 0.67–1.38)
Tiotropium Respimat 5 µg showed similar safety and exacerbation efficacy profiles to HandiHaler 18 µg in Asian patients with COPD, consistent with global results.
Supports Respimat 5 µg as a safe alternative to HandiHaler for Asian COPD patients; confirms consistency with global trial results.
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.
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Zhong et al. (2016) conducted an RCT in COPD (n=2,356). Tiotropium Respimat vs. HandiHaler 18 µg was evaluated on time to death (HR 0.96, 95% CI 0.67-1.38). Tiotropium Respimat 5 µg resulted in a similar time to death compared to HandiHaler 18 µg in Asian patients with COPD (HR 0.96; 95% CI 0.67-1.38).
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