PURPOSE: Most clinical studies evaluating asthma are conducted in young adults and there is limited clinical data in an older population. Therefore, the purpose of this analysis is to examine the safety and efficacy of fluticasone propionate plus salmeterol (FSC) or fluticasone propionate (FP) alone in asthmatics ≥ 50 years of age.
METHODS: A retrospective analysis from 6 twelve-week, multi-center, randomized, double-blind studies (SFCA3002, SFCA3003, SAS30001, SAS30003, SAS30004, SAS30017) examined subjects ≥ 50 years of age (range 50–82). Subjects were experiencing asthma symptoms at study enrollment. Subjects with a diagnosis of COPD, current smokers or significant co-morbid conditions were excluded from these studies. Treatments included FSC via a single device at doses of 100/50mcg or 250/50mcg twice daily (n=98) or FP at doses of 100mcg or 250mcg twice daily (n=118) via Diskus® or MDI. For analysis, FSC and FP treatment groups were pooled by dose within treatment. Mean baseline percent predicted FEV1 was 62.5% and 65.0% for the FSC and FP treatment groups, respectively. Efficacy was evaluated using AM PEF, FEV1, symptoms, and albuterol use. Safety was evaluated from adverse event reporting.
RESULTS: There were significant differences between treatments in all outcomes measured (p<0.001). Mean change from baseline AM PEF was 52.3 L/min for FSC vs 12.6 L/min for FP. Mean change in FEV1 was 0.31 L for FSC and 0.18 L for FP. Symptoms were reduced by 51% in the FSC group vs. 12% in the FP group. Supplemental albuterol use was reduced by over 65% with FSC and 23% for FP alone. There were no differences between treatment groups with regard to adverse events including cardiac events or pneumonia.
CONCLUSION: FSC provides significant clinical benefit compared with FP in patients ≥ 50 years old with asthma. The safety profiles were similar.
CLINICAL IMPLICATIONS: These results suggest that FP alone may not adequately control asthma in older patients and that salmeterol and FP (FSC) administered in a single device is more effective in this population.
DISCLOSURE: Hector Ortega, No Product/Research Disclosure Information; Employee Employee of GlaxoSmithKline