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Vol. 54. Num. 3.March 2018
Pages 115-174
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Vol. 54. Num. 3.March 2018
Pages 115-174
Original Article
DOI: 10.1016/j.arbr.2017.11.015
Demographic Characteristics and Clinical Outcomes in Patients from Latin America Versus the Rest of the World: A TIOSPIR® Post-Hoc Analysis
Características demográficas y resultados clínicos en pacientes de Latinoamérica respecto al resto del mundo: un análisis post-hoc de TIOSPIR®
Antonio Anzuetoa,
Corresponding author

Corresponding author.
, Peter M.A. Calverleyb, Achim Muellerc, Norbert Metzdorfd, Michaela Haenseld, José R. Jardime, Emilio Pizzichinif, Horacio Giraldog, Alejandra Ramirez-Venegash, Eduardo R. Giugnoi
a Pulmonary/Critical Care, University of Texas and South Texas Veterans Health Care System, San Antonio, TX, USA
b Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK
c Biostatistics and Data Sciences Europe, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
d Respiratory Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany
e Respiratory Division, Federal University of São Paulo, São Paulo, Brazil
f The Federal University of Santa Catarina, Florianópolis, Brazil
g Almirante Colón Medical Center, Clínica del Country, Bogotá, Colombia
h Tobacco Smoking and COPD Research Department, National Institute of Respiratory Diseases, Mexico City, Mexico
i Hospital Zonal Especializado de Agudos y Crónicos “Dr. Antonio Cetrángolo”, Buenos Aires, Argentina
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Tables (3)
Table 1. Patient baseline characteristics by region.
Table 2. Number of, and time to: (A) deaths,a (B) moderate-to-severe exacerbations,b (C) severe (hospitalized) exacerbations,b and (D) MACEc and fatal MACEa by region.
Table 3. Adjudicated causes of death by region (vital status analysis).
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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.


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.


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).


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.

Latin America

Las variaciones geográficas pueden afectar a los resultados en la enfermedad pulmonar obstructiva crónica (EPOC). Evaluamos las diferencias en las características basales y los resultados de los pacientes incluidos en Latinoamérica en comparación con el resto del mundo (RdM) en el ensayo TIOtropium Safety and Performance In Respimat® (TIOSPIR®).


TIOSPIR®, es un estudio aleatorizado, doble ciego de 2-3 años de duración (n=17.116; conjunto tratado), comparó la seguridad y la eficacia del tiotropio Respimat® una vez al día en dosis de 5 y 2,5μg con respecto al tiotropio HandiHaler® 18μg. Este análisis post-hoc reunió datos de todos los brazos de tratamiento para evaluar la mortalidad, las exacerbaciones, los acontecimientos cardíacos y los acontecimientos adversos graves (AAG) entre ambas regiones.


Al inicio del estudio, los pacientes reclutados en América Latina (n=1.000) versus RdM (n=16.116) eran de mayor edad, con más paquetes/año de consumo de tabaco en sus antecedentes y más exacerbaciones, pero menos antecedentes cardíacos. En este análisis, los pacientes de Latinoamérica versus RdM tenían un mayor riesgo de muerte (razón de riesgo [HR] intervalo de confianza del 95% [IC 95%]: 1,52 [1,24-1,86]; p<0,0001) y de exacerbación moderada a grave (HR [IC 95%]: 1,29 [1,18-1,41]; p<0,0001), pero menor riesgo de exacerbación grave (HR [IC 95%]: 0,82 [0,68-0,98]; p=0,0333). Las tasas de AAG en Latinoamérica fueron más bajas frente al RdM (tasa de incidencia [IRR] [IC 95%]: 0,82 [0,72-0,92]), incluidos los trastornos cardíacos (IRR [IC 95%]: 0,68 [0,48-0,97]). El riesgo de acontecimientos cardiovasculares adversos mayores fue similar (HR [IC 95%]: 0,99 [0,71-1,40]; p=0,9677).


Los pacientes de TIOSPIR® en Latinoamérica tuvieron un mayor riesgo de muerte y de exacerbación moderada a grave, pero un menor riesgo de exacerbación grave que aquellos en el RdM. Las diferencias geográficas pueden afectar los resultados en los ensayos de la EPOC.

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