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

Original Research

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Authors: A Anzueto, I Leimer, S Kesten

Published Date June 2009 Volume 2009:4 Pages 245 - 251

DOI: http://dx.doi.org/10.2147/COPD.S4862

A Anzueto¹, I Leimer², S Kesten³

¹The University of Texas Health Science Center at San Antonio and the South Texas Veterans Health Care System, Audie L Murphy Division, San Antonio, Texas, USA; ²Boehringer Ingelheim, Ridgefield, Connecticut, USA; ³Boehringer Ingelheim GmbH, Ingelheim, Germany

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 µg daily was conducted to examine relationships between exacerbations and other clinical outcomes. The relationship between FEV₁, 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 FEV₁ = 1.02 L (39% predicted). The percent change from baseline in FEV₁ 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 FEV₁, TDI, and SGRQ. A reduction in the frequency of exacerbations is associated with changes that are considered meaningful in these clinical outcomes.

Keywords: exacerbations, chronic obstructive pulmonary disease, FEV₁, dyspnea, quality of life

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