PURPOSE: To examine the effects of COPD exacerbations on lung function and health status and to examine the effects of one year treatment with Fluticasone Propionate/Salmeterol Combination 250/50 (FSC) and Salmeterol 50mcg (SAL) on COPD exacerbations.
METHODS: Data from two identical randomized, double-blind, studies were pooled. Subjects with COPD (N=1579), ≥ 40 yrs of age, FEV1 of ≤; 50% predicted (mean=33.4%) and a history of a COPD exacerbation in the preceeding 12 months were enrolled. Subjects were randomized to FSC or SAL for 1 year following a 4-week run-in on FSC. The annual rate of moderate/severe COPD exacerbations, defined as worsening symptoms requiring treatment with oral corticosteroids, antibiotics, or hospitalization were examined. Subjects were stratified into 4 groups; FSC treated subjects and SAL treated subjects and then divided into those who did (+exac) and did not (−exac) experience an exacerbation. Health status was measured by St. Georges Respiratory Questionnaire (SGRQ).
RESULTS: Pooled data showed a significantly lower annual rate of moderate/severe exacerbations with FSC vs. SAL (1.10 vs. 1.58, respectively, treatment ratio=0.701, p<0.001). Subjects who suffered an exacerbation had lower mean screening FEV1 (921ml vs. 1002ml, p<0.001) and FEV1 at 52 weeks (995ml vs. 1138ml). FSC was superior to SAL in both groups; FEV1 at Week 52 was 1184ml (FSC−exac), 1080ml (SAL−exac), 1027ml (FSC+exac) and 962ml (SAL +exac).Subjects who suffered an exacerbation had higher mean SGRQ scores (worse health status) at baseline (49.6 vs. 46.1 p<0.001) and a marked worsening of health status during the study. Mean changes in SGRQ scores at endpoint were +0.5 (FSC−exac), +1.18 (SAL−exac), +3.51 (FSC+exac) and +4.82 (SAL+exac).
CONCLUSION: Subjects who suffered COPD exacerbations had worse health status and lung function, demonstrating the profound impact exacerbations have on COPD. Treatment with FSC reduced exacerbations, improved lung function and resulted in better health status compared with SAL alone. (SCO40043, SCO100250).
CLINICAL IMPLICATIONS: Exacerbations have a profound effect on lung function and QOL in subjects with COPD.
DISCLOSURE: Glenn Crater, Employee Employee of GlaxoSmith-Kline; No Product/Research Disclosure Information