Nanshan Zhong1, Hwa S Moon2, Kwan H Lee3, Aziah A Mahayiddin4, Watchara Boonsawat5, Marie G D Isidro6, ChunXue Bai7, Achim Mueller8, Norbert Metzdorf9, Antonio Anzueto10. 1. State Key Laboratory of Respiratory Disease, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China. 2. Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea. 3. Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea. 4. Institute of Respiratory Medicine, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia. 5. Division of Respiratory Medicine, Department of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand. 6. West Visayas State University Medical Center, Jaro Iloilo City, Philippines. 7. Department of Pulmonary Medicine, Shanghai ZhonShan Hospital, Shanghai, China. 8. Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany. 9. Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany. 10. Pulmonary/Critical Care Divison, University of Texas Health Science Center and South Texas Veterans Health Care system, San Antonio, Texas, USA. anzueto@uthscsa.edu.
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.
RCT Entities:
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.
Authors: Kyu Yean Kim; Marc Miravitlles; Pawel Sliwinski; Richard Costello; Victoria Carter; Jessica Tan; Therese Sophie Lapperre; Bernardino Alcazar; Caroline Gouder; Cristina Esquinas; Juan Luis García-Rivero; Anu Kemppinen; Augustine Tee; Miguel Roman-Rodríguez; Juan José Soler-Cataluña; David Price; Chin Kook Rhee Journal: Int J Chron Obstruct Pulmon Dis Date: 2019-07-25