Abstract
BackgroundChronic obstructive pulmonary disease (COPD) is characterized by varying trajectories of decline. Information regarding the prognostic value of preventing short-term clinically important deterioration (CID) in lung function, health status, or first moderate/severe exacerbation as a composite endpoint of worsening is needed. We evaluated post hoc the link between early CID and long-term adverse outcomes.MethodsCID was defined as ≥100 mL decrease in forced expiratory volume in 1 s (FEV1), ≥4-unit increase in St George’s Respiratory Questionnaire (SGRQ) score from baseline, and/or a moderate/severe exacerbation during enrollment in two 3-year studies. Presence of CID was assessed at 6 months for the principal analysis (TORCH) and 12 months for the confirmatory analysis (ECLIPSE). Association between presence (+) or absence (-) of CID and long-term deterioration in FEV1, SGRQ, future risk of exacerbations, and all-cause mortality was assessed.ResultsIn total, 2870 (54%; TORCH) and 1442 (73%; ECLIPSE) patients were CID+. At 36 months, in TORCH, CID+ patients (vs CID-) had sustained clinically significant worsening of FEV1 (- 117 mL; 95% confidence interval [CI]: - 134, - 100 mL; P < 0.001) and SGRQ score (+ 6.42 units; 95% CI: 5.40, 7.45; P < 0.001), and had higher risk of exacerbations (hazard ratio [HR]: 1.61 [95% CI: 1.50, 1.72]; P < 0.001) and all-cause mortality (HR: 1.41 [95% CI: 1.15, 1.72]; P < 0.001). Similar risks post-CID were observed in ECLIPSE.ConclusionsA CID within 6–12 months of follow-up was consistently associated with increased long-term risk of exacerbations and all-cause mortality, and predicted sustained meaningful loss in FEV1 and health status amongst survivors.Trial registrationNCT00268216; NCT00292552.
Highlights
The heterogeneous and progressive nature of chronic obstructive pulmonary disease (COPD) has prompted interest in developing reliable measurements of its progression beyond mean decline rates in forced expiratory volume in 1 s (FEV1) [1,2,3]
Demographics and baseline characteristics were generally similar in the clinically important deterioration (CID)+ and CID- groups, the proportion of female patients, patients with ≥2 previous exacerbations, and patients receiving inhaled corticosteroids (ICS) in the 12 months prior to the run-in period was greater in the CID+ compared with the CID- group (Table 1)
Patients with Chronic obstructive pulmonary disease (COPD) included in analysis population patients withdrawn within the first 6 months patients analyzed at 6 months patients CID+ (54%)
Summary
The heterogeneous and progressive nature of chronic obstructive pulmonary disease (COPD) has prompted interest in developing reliable measurements of its progression beyond mean decline rates in forced expiratory volume in 1 s (FEV1) [1,2,3]. A composite measure of deterioration has been developed, comprising: lung function (≥100 mL decline in FEV1), health status (≥4-unit increase in St George’s Respiratory Questionnaire [SGRQ]), and the incidence of a moderate/severe exacerbation [10]. Several short-term COPD studies have employed this endpoint as an a priori and post hoc measure of instability [10, 13,14,15,16,17,18]. Information regarding the prognostic value of preventing short-term clinically important deterioration (CID) in lung function, health status, or first moderate/severe exacerbation as a composite endpoint of worsening is needed. We evaluated post hoc the link between early CID and long-term adverse outcomes
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