Impact of preventing exacerbations on deterioration of health status in COPD

Abstract

Exacerbations of chronic obstuctive pulmonary disease (COPD) are associated with worse health status. The Inhaled Steroids in Obstructive Lung Disease in Europe (ISOLDE) study showed that treatment with fluticasone propionate (FP) reduced exacerbation frequency and the rate of deterioration in health status as compared with placebo. The present study analysed these data to test whether the effect of FP on health status was attributable to its effect on exacerbations.Rates of deterioration in St George9s Respiratory Questionnaire (SGRQ) total score were obtained for 613 patients with moderate to severe COPD followed for a maximum of 3 yrs. Exacerbation rates were skewed and could not be normalised, therefore, patients were stratified into three exacerbation groups: none, infrequent (v1.65 exacerbations?yr -1 ) and frequent (w1.65 exacerbations?yr -1 ). There were 91 patients with no exacerbations, 285 with infrequent exacerbations and 235 with frequent exacerbations. Frequent exacerbations were independently associated with a worse baseline SGRQ score (pv0.0001) and a more rapid rate of deterioration in health status (p=0.0003). Exacerbation frequency and rate of decline in forced expiratory volume in one second were independently related to the rate of deterioration in SGRQ score.Statistical modelling showed the beneficial effect of fluticasone propionate on deterioration in health status to be largely due to its effect on exacerbation frequency. The current analysis was supported by a grant from GlaxoSmithKline, UK.Chronic obstructive pulmonary disease (COPD) is a complex disease characterised by incompletely reversible airways obstruction, progressive loss of lung function, recurrent exacerbations and poor health. The relationship between health status and exacerbations is well established; poor health is associated with a higher frequency of exacerbations [1,2], an increased likelihood of hospitalisation [3] and increased mortality [4]. Recent meta-analyses have reported that inhaled corticosteroids (ICS) have a minimal or no effect on the rate of decline in forced expiratory volume in one second (FEV1) [5,6], but they do reduce the severity [7] and frequency of exacerbations [8], and reduce the rate of deterioration in health status [8,9]. A number of recent studies have also shown that inhaled therapy can reduce exacerbations and improve health status over 1 yr [10][11][12]. While there appears to be an association between exacerbations and health status, the mechanism has not yet been established. Furthermore, there is no direct evidence that reducing exacerbation frequency can improve health. The aim of the present study was to re-analyse data from the 3-yr Inhaled Steroids in Obstructive Pulmonary Lung Disease in Europe (ISOLDE) study of fluticasone propionate (FP) in COPD [8], using statistical models, to test whether there is evidence of a direct association between exacerbation frequency and deterioration in health status, and whether the effect of FP on health status is attributable to its ...

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