Abstract
BackgroundThis study investigated the relationship between changes in lung function (as measured by forced expiratory volume in one second [FEV1]) and the St. George’s Respiratory Questionnaire (SGRQ) and economically significant outcomes of exacerbations and health resource utilization, with an aim to provide insight into whether the effects of COPD treatment on lung function and health status relate to a reduced risk for exacerbations.MethodsA systematic literature review was conducted in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials of adult COPD patients published in English since 2002 in order to relate mean change in FEV1 and SGRQ total score to exacerbations and hospitalizations. These predictor/outcome pairs were analyzed using sample-size weighted regression analyses, which estimated a regression slope relating the two treatment effects, as well as a confidence interval and a test of statistical significance.ResultsSixty-seven trials were included in the analysis. Significant relationships were seen between: FEV1 and any exacerbation (time to first exacerbation or patients with at least one exacerbation, p = 0.001); between FEV1 and moderate-to-severe exacerbations (time to first exacerbation, patients with at least one exacerbation, or annualized rate, p = 0.045); between SGRQ score and any exacerbation (time to first exacerbation or patients with at least one exacerbation, p = 0.0002) and between SGRQ score and moderate-to-severe exacerbations (time to first exacerbation or patients with at least one exacerbation, p = 0.0279; annualized rate, p = 0.0024). Relationships between FEV1 or SGRQ score and annualized exacerbation rate for any exacerbation or hospitalized exacerbations were not significant.ConclusionsThe regression analysis demonstrated a significant association between improvements in FEV1 and SGRQ score and lower risk for COPD exacerbations. Even in cases of non-significant relationships, results were in the expected direction with few exceptions. The results of this analysis offer health care providers and payers a broader picture of the relationship between exacerbations and mean change in FEV1 as well as SGRQ score, and will help inform clinical and formulary-making decisions while stimulating new research questions for future prospective studies.
Highlights
This study investigated the relationship between changes in lung function and the St
The current study aimed to investigate the relationship between changes in forced expiratory volume in one second (FEV1) and St. George’s Respiratory Questionnaire (SGRQ) score and economically significant outcomes of exacerbations and health resource use (HRU), by conducting a systematic literature review (SLR) and regression analysis of relevant studies of pharmacological interventions for Chronic obstructive pulmonary disease (COPD)
The search algorithms used keywords for COPD paired with terms for the endpoints of interest–SGRQ, FEV1, exacerbations, and HRU
Summary
This study investigated the relationship between changes in lung function (as measured by forced expiratory volume in one second [FEV1]) and the St. COPD presents a major clinical and humanistic burden, [4] despite the availability and use of standard treatments, which aim to relieve symptoms and slow disease progression [5] This heavy disease toll inevitably focuses interest on how patients are treated and the extent to which medications produce meaningful benefits. Assessment of such value in clinical trials has traditionally relied on measures of lung function (such as forced expiratory volume in one second [FEV1]), symptom control, health status, and rates of exacerbation over a period of up to one year. Payers tend to focus on this outcome in their formulary considerations, with the expectation that decreased exacerbation rates will likely result in lower costs for their plan
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