title: TIOtropium Safety and Performance In Respimat®(TIOSPIRTM): Analysis of Asian cohort of COPD patients.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.affiliation: State Key Laboratory of Respiratory Disease, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
authors.forename: Nanshan
authors.initials: N
authors.lastname: Zhong
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Hwa S
authors.initials: HS
authors.lastname: Moon
authors.affiliation: Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Kwan H
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Institute of Respiratory Medicine, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia.
authors.forename: Aziah A
authors.initials: AA
authors.lastname: Mahayiddin
authors.affiliation: Division of Respiratory Medicine, Department of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Watchara
authors.initials: W
authors.lastname: Boonsawat
authors.affiliation: West Visayas State University Medical Center, Jaro Iloilo City, Philippines.
authors.forename: Marie G D
authors.initials: MG
authors.lastname: Isidro
authors.affiliation: Department of Pulmonary Medicine, Shanghai ZhonShan Hospital, Shanghai, China.
authors.forename: ChunXue
authors.initials: C
authors.lastname: Bai
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany.
authors.forename: Achim
authors.initials: A
authors.lastname: Mueller
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Metzdorf
authors.affiliation: Pulmonary/Critical Care Divison, University of Texas Health Science Center and South Texas Veterans Health Care system, San Antonio, Texas, USA. anzueto@uthscsa.edu.
authors.forename: Antonio
authors.initials: A
authors.lastname: Anzueto
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D000068600:Albuterol, Ipratropium Drug Combination / Q000008:administration & dosage / Q000009:adverse effects; D001208:Asia / Q000453:epidemiology; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D016903:Drug Monitoring; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D060046:Maintenance Chemotherapy / Q000379:methods; D008297:Male; D008875:Middle Aged; D009026:Mortality; D016016:Proportional Hazards Models; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000523:psychology; D000069447:Tiotropium Bromide / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000068600:Albuterol, Ipratropium Drug Combination; D001993:Bronchodilator Agents; D000069447:Tiotropium Bromide
keywords: chronic obstructive pulmonary disease; clinical respiratory medicine; clinical trials