The role of fluticasone propionate/salmeterol combination therapy in preventing exacerbations of COPD

Figures & data

Table 1 Clinical trials of the effect of fluticasone propionate/salmeterol combination therapy on lung function, symptoms and health status

Study	No. of patients (duration)	Treatment comparisons	Major findings: lung function	Major findings: health status and symptoms
Calverley et al 2003^Citation50	1465 (52 weeks)	Twice daily FSC 500/50 μg vs FP 500 μg, SAL 50 μg, or placebo	FEV 1 increased with FSC compared to FP, SAL and placebo	Health status score (SGRQ) was improved with FSC at week 8 (−4.3, SD 10.8) and 52 (−4.5, SD 12.9) compared to placebo and FP Dyspnea and use of relief medication improved with FSC compared to placebo, FP and SAL. Night-time awakenings decreased with FSC compared to placebo and SAL
Mahler et al 2002^Citation52	691 (24 weeks)	Twice daily FSC 500/50 μg vs FP 500 μg, SAL 50 μg, or placebo	Pre-dose FEV1 increased with FSC compared to SAL and placebo; 2-hour post-dose FEV1 increased with FSC compared to FP and placebo; dyspnea score improved with FSC compared to FP and placebo	Health status improved with FSC (CDRQ, 10.0) compared to placebo (5.0) and FP (4.8), but not compared to SAL (8.0) Dyspnea and use of relief medication improved with FSC compared to SAL, FP and placebo. Night-time awakenings decreased with FSC compared to SAL and placebo
Hanania et al 2003^Citation36	723 (24 weeks)	Twice daily FSC 250/50 μg vs FP 250 μg, SAL 50 μg, or placebo	Morning pre-dose FEV1 increased with FSC compared to SAL and placebo; 2-hour post-dose FEV1increased with FSC compared to FP and placebo	Health status improved with FSC compared to placebo (CDRQ, +5.2) but not compared to FP or SAL Dyspnea improved with FSC and SAL compared to placebo. Use of rescue medication decreased with FSC compared to placebo and FP. Night-time awakenings decreased with FSC compared to placebo and SAL
Celli et al 2008^Citation56	5343 (3 years)	Twice daily FSC 500/50 μg vs FP 500 μg, SAL 50 μg, or placebo	The rate of decline in FEV1 was reduced with FSC, FP and SAL compared to placebo; greatest reduction was with FSC compared to placebo; differences between treatment arms were not significant	Not assessed

Abbreviations: CRDQ, chronic respiratory disease questionnaire; FP, fluticasone propionate; FSC, fluticasone propionate/salmeterol combination; SAL, salmeterol; SGTQ, St George’s respiratory questionnaire; TDI, transition dyspnea index.

Table 2 Clinical trials of efficacy of fluticasone propionate/salmeterol combination therapy in the prevention of COPD exacerbations

Study	No. of patients (duration)	Treatment comparisons	Primary outcome measure	Major findings
Calverley et al 2007^Citation54	6112 (3 years)	Twice daily FSC 500/50 μg vs FP 500 μg, SAL 50 μg, or placebo	All cause mortality; exacerbations	Rate of moderate/severe exacerbations was 12% lower with FSC compared to SAL; 9% lower with FSC compared to FP Rate of exacerbations requiring oral corticosteroids was 13% lower with FSC compared to FP; 29% lower with FSC compared to SAL Differences in all-cause mortality between groups were not significant
Kardos et al 2007^Citation42	994 (44 weeks)	Twice daily FSC 500/50 μg vs SAL 50 μg	Exacerbations	Rate of moderate/severe exacerbations was 35% lower with FSC compared to SAL
Anzueto et al 2009^Citation53	797 (52 weeks)	Twice daily FSC 250/50 μg vs SAL 50 μg	Exacerbations	Rate of moderate/severe exacerbations was 30.4% lower with FSC compared to SAL Rate of exacerbations requiring systemic corticosteroids was 40% lower with FSC compared to SAL
Ferguson et al 2008^Citation51	782 (52 weeks)	Twice daily FSC 250/50 μg vs SAL 50 μg	Exacerbations	Rate of moderate/severe exacerbations was 30.5% lower with FSC compared to SAL Rate of exacerbations requiring systemic corticosteroids was 40% lower with FSC compared to SAL

Abbreviations: FP, fluticasone propionate; FSC, fluticasone propionate/salmeterol combination; NS, not statistically significant; SAL, salmeterol

Figure 1 (A) Reprinted with permission from Anzueto A, Ferguson GT, Feldman G, Chinksy K, et al. Effect of fluticasone propionate/salmeterol (250/50) on COPD exacerbations and impact on patient outcomes. COPD. 2009;6(5):320–329.⁵³ Copyright © 2009 Taylor & Francis. (B) Reprinted with permission from Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 μg) or salmeterol (50 μg) on COPD exacerbations. Respir Med. 2008;102(8): 1099–1108.⁵¹ Copyright © 2008 Elsevier.

Figure 2 Estimated prevalence of hospital discharges with selected comorbidities in patients with and without COPD.

Notes: Bars represent the age-adjusted percentage with SE bars. Black bars show patients with COPD (either as primary or secondary discharge diagnosis). White bars show patients without any mention of a COPD discharge diagnosis. The prevalence of all listed comorbidities is different across COPD categories (P < 0.01).
Abbreviations: IHD, ischemic heart disease; CHF, congestive heart failure; RF, respiratory failure; PVD, pulmonary vascular disease; TM, thoracic malignancy. Reprinted with permission from Holguin F, Folch E, Redd SC, Mannino DM. Comorbidity and mortality in COPD-related hospitalizations in the United States, 1979 to 2001. Chest. 2005;128(4):2005–2011.⁸⁴ Copyright © 2005 American College of Chest Physicians.

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