Combined Salmeterol 50 μ g and Fluticasone Propionate 250 μ g in the Diskus Device for the Treatment of Asthma

Abstract

Three hundred forty-nine patients with asthma previously treated with medium doses of inhaled corticosteroids during a 2-wk, single-blind, run-in period were randomized to treatment with salmeterol 50 microg combined with fluticasone propionate (FP) 250 microg, salmeterol 50 microg, FP 250 microg, or placebo, each given twice daily through a Diskus device for 12 wk. Mean change in FEV(1) at endpoint was significantly (p </= 0.001) greater with the salmeterol/FP combination product (0.48 L) than with placebo (-0.11 L), salmeterol (0.05 L), or FP (0.25 L). The combination product significantly increased the area under the 12-h serial FEV(1) curve relative to baseline over that with placebo, salmeterol, or FP at Day 1, Week 1, and Week 12 (p </= 0.025). Patients in the combination-product group had a significantly greater probability of remaining in the study without being withdrawn because of worsening asthma than did patients in the placebo, salmeterol, or FP groups (p </= 0.002). The combination product significantly increased (p < 0. 001) morning PEF at endpoint (53.5 L/min) as compared with placebo (-14 L/min), salmeterol (-11.6 L/min), or FP (15.2 L/min). The combination product significantly (p </= 0.011) reduced asthma symptom scores and supplemental albuterol use, and significantly increased the percentage of nights with no awakenings as compared with placebo, salmeterol, and FP (p </= 0.016). Combination treatment with salmeterol 50 microg and FP 250 microg given twice daily from the Diskus device provided better asthma control and greater improvement in pulmonary function than did the individual agents, and may simplify the management of asthma in patients who need both classes of drugs for optimal control of their disease.

Asthma-related exacerbations, therapy switching, and therapy discontinuation: a comparison of 3 commonly used controller regimens

“…The observed lower risk of this asthma-related morbidity in the FSC cohort may be due to the greater efficacy noted in the clinical trials [12][13][14] and increased compliance noted in observational studies. 18,19 The less frequent observation of switching controller medication seen with FSC may reflect patient preference associated with both the better outcomes and ease of administration.…”

“…9 These results support previous clinical trial findings that demonstrate the superiority of FSC compared with therapy with FP, SAL, or FP ϩ SAL. [12][13][14] Asthma exacerbations that result in asthma-related ED visits or hospitalization episodes are one of the major cost drivers for asthma. 4,6 Most clinical trials are not powered to detect changes in the rates of exacerbations.…”

“…8 -11 The present study was designed to evaluate whether the better clinical outcomes noted in randomized trials that favored fluticasone propionate and salmeterol as a single inhaler (FSC) compared with fluticasone propionate alone (FP) and fluticasone propionate plus salmeterol dispensed as separate inhalers (FP ϩ SAL) would be noted in observational studies. [12][13][14] Outcome parameters used to evaluate effectiveness of therapy included postindex exacerbations indicated by administrative claims for ED or hospital utilization, loss of symptom control evaluated by the filling of prescriptions for albuterol or other short-acting ␤-agonists (SABAs), and switch or discontinuation of controller medication.…”

Inhaled fluticasone propionate and adrenal effects in adult asthma: systematic review and meta-analysis

“…Two further studies could not be included in the meta-analysis as the findings were published in abstract form only and data were not available in standardised form [23,24]. Five studies were excluded in which subjects took either inhaled or intranasal corticosteroids at the time of recruitment or took concomitant intranasal corticosteroids during the period of the study [25][26][27][28][29]. There was one published study in which data were not in the required format [30], three studies in which adrenal function was assessed by urine cortisol assessment [28,31,32] and one study with a duration of 3 weeks [33].…”

“…It was necessary to exclude studies in which subjects used regular ICS therapy during the period prior to enrolment in the study, or concomitant use of intranasal corticosteroids during the study [15,[26][27][28][29]. The current authors also excluded studies in healthy nonasthmatic subjects due to the differential response in terms of adrenal suppression observed between asthmatic and nonasthmatic subjects [37,38].…”