Impact of frequency of COPD exacerbations on pulmonary function, health status and clinical outcomes.

Antonio R Anzueto, I. Leimer, S. Kesten

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Abstract

BACKGROUND: COPD exacerbations are responsible for the morbidity and mortality of this disease. The relationship between exacerbations and patient-related clinical outcomes is not clearly understood. METHODS: A retrospective analysis of two 1-year, placebo-controlled clinical trials with tiotropium 18 microg daily was conducted to examine relationships between exacerbations and other clinical outcomes. The relationship between FEV(1), St. George's Respiratory Questionnaire (SGRQ), and the transition dyspnea index (TDI) were examined based on the frequency of exacerbations (0, 1, 2, >2). RESULTS: 921 patients participated in the trials (mean age 65 years, mean FEV(1) = 1.02 L (39% predicted). The percent change from baseline in FEV(1) in the tiotropium group was +12.6%, +12.0%, +2.1% and +8.9%; and in the placebo group was -3.4%, -3.4%, -5.7% and -6.7% for exacerbation frequencies of 0, 1, 2, >2, respectively. Compared with baseline, the largest improvement in SGRQ occurred in patients with no exacerbations. In the placebo group, there was a significant association between an increased frequency of exacerbations and worsening SGRQ scores. A reduction in exacerbation rates of 4.4% to 42.0% such as that shown in this study cohort was associated with meaningful changes in questionnaire based instruments. CONCLUSIONS: In the placebo-treated patients increased frequency of exacerbations was associated with larger decrements in FEV(1), TDI, and SGRQ. A reduction in the frequency of exacerbations is associated with changes that are considered meaningful in these clinical outcomes.

Original languageEnglish (US)
Pages (from-to)245-251
Number of pages7
JournalInternational journal of chronic obstructive pulmonary disease
Volume4
StatePublished - 2009

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Chronic Obstructive Pulmonary Disease
Health Status
Lung
Placebos
Dyspnea
Controlled Clinical Trials
Cohort Studies
Surveys and Questionnaires
Morbidity
Mortality
Tiotropium Bromide

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{28be3fb686694e40babcd08ba9a13677,
title = "Impact of frequency of COPD exacerbations on pulmonary function, health status and clinical outcomes.",
abstract = "BACKGROUND: COPD exacerbations are responsible for the morbidity and mortality of this disease. The relationship between exacerbations and patient-related clinical outcomes is not clearly understood. METHODS: A retrospective analysis of two 1-year, placebo-controlled clinical trials with tiotropium 18 microg daily was conducted to examine relationships between exacerbations and other clinical outcomes. The relationship between FEV(1), St. George's Respiratory Questionnaire (SGRQ), and the transition dyspnea index (TDI) were examined based on the frequency of exacerbations (0, 1, 2, >2). RESULTS: 921 patients participated in the trials (mean age 65 years, mean FEV(1) = 1.02 L (39{\%} predicted). The percent change from baseline in FEV(1) in the tiotropium group was +12.6{\%}, +12.0{\%}, +2.1{\%} and +8.9{\%}; and in the placebo group was -3.4{\%}, -3.4{\%}, -5.7{\%} and -6.7{\%} for exacerbation frequencies of 0, 1, 2, >2, respectively. Compared with baseline, the largest improvement in SGRQ occurred in patients with no exacerbations. In the placebo group, there was a significant association between an increased frequency of exacerbations and worsening SGRQ scores. A reduction in exacerbation rates of 4.4{\%} to 42.0{\%} such as that shown in this study cohort was associated with meaningful changes in questionnaire based instruments. CONCLUSIONS: In the placebo-treated patients increased frequency of exacerbations was associated with larger decrements in FEV(1), TDI, and SGRQ. A reduction in the frequency of exacerbations is associated with changes that are considered meaningful in these clinical outcomes.",
author = "Anzueto, {Antonio R} and I. Leimer and S. Kesten",
year = "2009",
language = "English (US)",
volume = "4",
pages = "245--251",
journal = "International Journal of COPD",
issn = "1176-9106",
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T1 - Impact of frequency of COPD exacerbations on pulmonary function, health status and clinical outcomes.

AU - Anzueto, Antonio R

AU - Leimer, I.

AU - Kesten, S.

PY - 2009

Y1 - 2009

N2 - BACKGROUND: COPD exacerbations are responsible for the morbidity and mortality of this disease. The relationship between exacerbations and patient-related clinical outcomes is not clearly understood. METHODS: A retrospective analysis of two 1-year, placebo-controlled clinical trials with tiotropium 18 microg daily was conducted to examine relationships between exacerbations and other clinical outcomes. The relationship between FEV(1), St. George's Respiratory Questionnaire (SGRQ), and the transition dyspnea index (TDI) were examined based on the frequency of exacerbations (0, 1, 2, >2). RESULTS: 921 patients participated in the trials (mean age 65 years, mean FEV(1) = 1.02 L (39% predicted). The percent change from baseline in FEV(1) in the tiotropium group was +12.6%, +12.0%, +2.1% and +8.9%; and in the placebo group was -3.4%, -3.4%, -5.7% and -6.7% for exacerbation frequencies of 0, 1, 2, >2, respectively. Compared with baseline, the largest improvement in SGRQ occurred in patients with no exacerbations. In the placebo group, there was a significant association between an increased frequency of exacerbations and worsening SGRQ scores. A reduction in exacerbation rates of 4.4% to 42.0% such as that shown in this study cohort was associated with meaningful changes in questionnaire based instruments. CONCLUSIONS: In the placebo-treated patients increased frequency of exacerbations was associated with larger decrements in FEV(1), TDI, and SGRQ. A reduction in the frequency of exacerbations is associated with changes that are considered meaningful in these clinical outcomes.

AB - BACKGROUND: COPD exacerbations are responsible for the morbidity and mortality of this disease. The relationship between exacerbations and patient-related clinical outcomes is not clearly understood. METHODS: A retrospective analysis of two 1-year, placebo-controlled clinical trials with tiotropium 18 microg daily was conducted to examine relationships between exacerbations and other clinical outcomes. The relationship between FEV(1), St. George's Respiratory Questionnaire (SGRQ), and the transition dyspnea index (TDI) were examined based on the frequency of exacerbations (0, 1, 2, >2). RESULTS: 921 patients participated in the trials (mean age 65 years, mean FEV(1) = 1.02 L (39% predicted). The percent change from baseline in FEV(1) in the tiotropium group was +12.6%, +12.0%, +2.1% and +8.9%; and in the placebo group was -3.4%, -3.4%, -5.7% and -6.7% for exacerbation frequencies of 0, 1, 2, >2, respectively. Compared with baseline, the largest improvement in SGRQ occurred in patients with no exacerbations. In the placebo group, there was a significant association between an increased frequency of exacerbations and worsening SGRQ scores. A reduction in exacerbation rates of 4.4% to 42.0% such as that shown in this study cohort was associated with meaningful changes in questionnaire based instruments. CONCLUSIONS: In the placebo-treated patients increased frequency of exacerbations was associated with larger decrements in FEV(1), TDI, and SGRQ. A reduction in the frequency of exacerbations is associated with changes that are considered meaningful in these clinical outcomes.

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