Diskus Inhaler Safe, Effective in COPD

Laurie Barclay, MD

September 15, 2003

Sept. 15, 2003 -- The combination of fluticasone propionate (FP) with salmeterol (SM) in the Diskus inhaler substantially improved lung function in patients with chronic obstructive pulmonary disease (COPD) compared with either drug alone, according to the results of a randomized trial published in the September issue of Chest. This combination of corticosteroid (FP) and long-acting beta-2 agonist (SM) administered together in a single inhaler posed no additional safety risks compared with its individual components.

"Recent in vitro and in vivo evidence suggesting a mechanistic interaction at the molecular level between inhaled corticosteroids and beta-2 agonists may explain the improved efficacy of therapy with a combination of FP and SM compared with therapy using either medication alone," write Nicola A. Hanania, MD, FCCP, from Baylor College of Medicine in Houston, Texas, and colleagues.

In this multicenter, double-blind study, 723 patients at least 40 years of age with COPD and a mean baseline FEV 1 of 42% predicted received FP (250 µg), SM (50 µg), FP plus SM combined in a single inhaler (FSC), or placebo administered twice daily through the Diskus device for 24 weeks.

After the last treatment, morning predose (trough) FEV 1 was 165 mL for FSC, 91 mL for SM, and 1 mL for placebo ( P = .012 for both comparisons.) Two-hour postdose (peak) FEV 1 was 281 mL for FSC, 147 mL for FP, and 58 mL for placebo ( P = .001).

Improvements in the average daily morning peak expiratory flow rate with FSC compared with FP and SM, and with FP and SM compared with placebo ( P = .034), were noted within 24 hours after treatment began, indicating an early onset of effect. Dyspnea, quality of life, and symptoms of chronic bronchitis were significantly better in the FSC group than in the placebo group. Except for an increase in oral candidiasis with FSC and FP, the incidence of adverse effects was similar among the treatment groups.

"Treatment with FSC (FP, 250 µg, and SM, 50 µg) twice daily substantially improved morning lung function and sustained these improvements for over a period of 24 weeks compared with FP or SM treatment alone in patients with COPD, with no additional safety concerns for the combination treatment vs. that with the individual components," the authors write. "For many patients, the treatment of both the inflammation and bronchoconstriction associated with COPD may be needed to achieve clinically important effects.... A combination product containing two common classes of medications used in the treatment of COPD in a single inhaler may simplify therapy for many patients, may improve adherence, and may represent a valuable treatment option for many patients."

GlaxoSmithKline, the maker of fluticasone, provided research support to Dr. Hanania and employs several study authors.

Chest. 2003;124:834-843

Reviewed by Gary D. Vogin, MD



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