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Demographic Characteristics and Clinical Outcomes in Patients from Latin America Versus the Rest of the World: A TIOSPIR® Post-Hoc Analysis.
Anzueto, Antonio; Calverley, Peter M A; Mueller, Achim; Metzdorf, Norbert; Haensel, Michaela; Jardim, José R; Pizzichini, Emilio; Giraldo, Horacio; Ramirez-Venegas, Alejandra; Giugno, Eduardo R.
Afiliación
  • Anzueto A; Pulmonary/Critical Care, University of Texas and South Texas Veterans Health Care System, San Antonio, TX, USA. Electronic address: anzueto@uthscsa.edu.
  • Calverley PMA; Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
  • Mueller A; Biostatistics and Data Sciences Europe, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
  • Metzdorf N; Respiratory Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
  • Haensel M; Respiratory Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
  • Jardim JR; Respiratory Division, Federal University of São Paulo, São Paulo, Brazil.
  • Pizzichini E; The Federal University of Santa Catarina, Florianópolis, Brazil.
  • Giraldo H; Almirante Colón Medical Center, Clínica del Country, Bogotá, Colombia.
  • Ramirez-Venegas A; Tobacco Smoking and COPD Research Department, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • Giugno ER; Hospital Zonal Especializado de Agudos y Crónicos "Dr. Antonio Cetrángolo", Buenos Aires, Argentina.
Arch Bronconeumol (Engl Ed) ; 54(3): 140-148, 2018 Mar.
Article en En, Es | MEDLINE | ID: mdl-29317111
INTRODUCTION: Geographical variations may impact outcomes in chronic obstructive pulmonary disease (COPD). We evaluated differences in baseline characteristics and outcomes between patients enrolled in Latin America compared with the rest of the world (RoW) in the TIOtropium Safety and Performance In Respimat® (TIOSPIR®) trial. METHODS: TIOSPIR®, a 2-3-year, randomized, double-blind trial (n=17116; treated set), compared safety and efficacy of once-daily tiotropium Respimat® 5 and 2.5µg with tiotropium HandiHaler® 18µg. This post-hoc analysis pooled data from all treatment arms to assess mortality, exacerbations, cardiac events, and serious adverse events (SAEs) between both regions. RESULTS: At baseline, patients enrolled in Latin America (n=1000) versus RoW (n=16116) were older, with higher pack-years of smoking history and more exacerbations, but less cardiac history. In this analysis, patients in Latin America versus RoW had an increased risk of death (hazard ratio [HR] [95% confidence interval (CI)]: 1.52 [1.24-1.86]; P<.0001) or moderate-to-severe exacerbation (HR [95% CI]: 1.29 [1.18-1.41]; P<.0001), but a lower risk of severe exacerbation (HR [95% CI]: 0.82 [0.68-0.98]; P=.0333). SAE rates in Latin America were lower versus RoW (incidence rate ratio [IRR] [95% CI]: 0.82 [0.72-0.92]), including cardiac disorders (IRR [95% CI]: 0.68 [0.48-0.97]). Risk of major adverse cardiovascular events were similar (HR [95% CI]: 0.99 [0.71-1.40]; P=.9677). CONCLUSIONS: TIOSPIR® patients in Latin America had a higher risk of death or moderate-to-severe exacerbation, but a lower risk of severe exacerbation than those in RoW. Geographical differences may impact outcomes in COPD trials.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Broncodilatadores / Enfermedad Pulmonar Obstructiva Crónica / Bromuro de Tiotropio Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En / Es Revista: Arch Bronconeumol (Engl Ed) Año: 2018 Tipo del documento: Article Pais de publicación: España
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Broncodilatadores / Enfermedad Pulmonar Obstructiva Crónica / Bromuro de Tiotropio Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En / Es Revista: Arch Bronconeumol (Engl Ed) Año: 2018 Tipo del documento: Article Pais de publicación: España