The salmeterol/fluticasone combination is more effective than fluticasone plus oral montelukast in asthma

Abstract

The aim of this study was to compare the efficacy and safety of salmeterol/fluticasone propionate combination product (SFC) with fluticasone propionate (FP) plus oral montelukast (M) over 12 weeks in symptomatic asthma patients. The study was a multinational, randomised, double-blind, double-dummy, parallel-group design in patients aged > or = 15 years. After a 4-week run-in during which all patients received FP 100 microg twice daily, patients were randomised to inhaled SFC (50/100 microg) twice daily or inhaled FP 100 microg twice daily and oral M 10 mg once daily. Patients kept daily records of their peak expiratory flow (PEF) symptom scores and use of rescue medication. Over the 12-week treatment period, the adjusted increase in mean morning PEF was significantly greater in the SFC group (36 l/min) than the FP/M group (19 l/min; P < 0.001). The improvement in FEV1 was also significantly greater in the SFC group (mean treatment difference 0.11 l; P < 0.001). SFC provided significantly better control of daytime and night-time symptoms and there were fewer exacerbations. Patients in the SFC group were also significantly more likely to have a rescue-free day. Both treatments were equally well tolerated. Combination therapy with FP plus salmeterol (SFC) produced significantly greater improvements in lung function and asthma control than the addition of montelukastto FP.

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

“…20 Clinical studies have established the superior efficacy of FSC compared with either FP or SAL alone, 12-13 montelukast, 21,22 or the combination of montelukast and FP. 23,24 Users of FSC had reduced postindex albuterol use in each of these studies. This study of claims data is consistent with results published in clinical trials.…”

Long-Acting Beta-Agonists in Adult Asthma: Evidence that these Drugs are Safe

“…A meta-analysis of nine randomized, controlled studies of salmeterol vs. theophylline, in which the majority were using inhaled corticosteroids, similarly showed salmeterol to be superior in terms C o p y r ig h t G e n e r a l P r a c t ic e A ir w a y s G r o u p R e p r o d u c t io n p r o h ib it e d of both symptoms and pulmonary function [15]. At least three studies have compared, in patients whose asthma was not adequately controlled by low dose inhaled corticosteroids, the addition of salmeterol or a leukotriene receptor antagonist [16][17][18]. For each study, all measures of symptom control, rescue albuterol use and pulmonary function improvement, favored the addition of the LABA over the addition of the leukotriene receptor antagonist.…”

“…A meta-analysis examining the addition of salmeterol to low dose inhaled corticosteroids as compared to at least doubling the dose of ICS confirmed the findings of FACET [14] -namely, that the addition of the LABA produced a greater reduction in exacerbations than the higher dose of ICS. Furthermore, two studies comparing the addition of salmeterol or the leukotriene antagonist montelukast to an inhaled corticosteroid found that there were significantly fewer exacerbations of asthma with the LABA plus ICS compared to the LTRA plus ICS [16,18].…”

Administrative Claims Analysis of Asthma-Related Health Care Utilization for Patients Who Received Inhaled Corticosteroids With Either Montelukast or Salmeterol as Combination Therapy

“…Among patients randomized to SAL/fluticasone combination product compared with those randomized to fluticasone plus MON, Ringdal et al report significantly greater improvements in forced expiratory volume in 1 second (FEV 1 ) from baseline (mean treatment difference = 0.11 L; 95% CI, 0.06-0.16; P < 0.001) and more asthma rescue-free days (odds ratio [OR] = 1.29; 95% CI, 1.02-1.63; P = 0.03). 6 Nelson et al also note greater improvement in asthma control among patients treated with combination fluticasone plus SAL than those treated with fluticasone plus MON (FEV 1 : + 0.34 L vs. + 0.20 L, P < 0.001; days without albuterol use: + 26.3% vs. + 19.1%, P = 0.03). 5 Lastly, in a study of symptomatic patients adding SAL or MON to ICS therapy, Fish et al also report greater improvement in lung function and asthma symptoms among patients adding SAL (morning peak expiratory flow: 35.0 L/min vs. 21.7 L/min; P <0.001; symptom-free days: 24% vs. 16%; P < 0.001).…”

“…Results of clinical trials examining ICSs plus LRAs versus ICSs plus LABAs reveal both combination therapies to be effective, 3 but the results from the clinical trials are inconsistent and do not provide a clear advantage for either therapeutic regimen. [4][5][6][7][8][9] In a 52-week trial, Bjermer et al found that 20.1% of the patients receiving montelukast (MON) and fluticasone had an asthma exacerbation compared with 19.1% in the group receiving salmeterol (SAL) and fluticasone (relative risk [RR] = 1.05 for MON/fluticasone vs. SAL/fluticasone; 95% confidence interval [CI], 0.86-1.29). 8 Ilowite et al conducted a 48-week study of patients with moderate-to-severe persistent asthma symptomatic on inhaled fluticasone (220 mg daily) randomized to the addition of SAL (84 mg/day) or MON (10 mg/day).…”