четверг, 28 февраля 2008 г.

Salmeterol/fluticasone propionate via diskus(tm) once daily versus fluticasone propionate twice daily in patients with mild asthma not previously receiving maintenance corticosteroids.

ARTICLE LINKS: SALMETEROL/FLUTICASONE PROPIONATE VIA DISKUS(TM) ONCE DAILY VERSUS FLUTICASONE PROPIONATE TWICE DAILY IN PATIENTS WITH MILD ASTHMA NOT PREVIOUSLY RECEIVING MAINTENANCE CORTICOSTEROIDS.ORIGINAL RESEARCH ARTICLE Clinical Drug Investigation._ Chuchalin, Alexander 1; Jacques, Loretta 2; Frith, Lucy 2 _ ABSTRACT: Background: and objective: The efficacy and safety of twice-daily inhaled salmeterol/fluticasone propionatebination (SFC) therapy have been well established in the treatment of adults and adolescents with asthma.Administration of SFC could also be appropriate in patients with mild persistent asthma.Study aimed to investigate whether once-daily SFC 50 g twice daily, and more effective than twice-daily placebo, over 52 weeks as initial maintenance therapy in patients with mild persistent asthma.Was a randomized, double-blind, double-dummy, placebo-controlled, multicentre, parallel-group study carried out in primary and secondary care.Aged between 12 and 79 years with a documented clinical history of asthma for >=6 months who were currently receiving inhaled short-acting g (i.Twice the dose of FPpared with SFC) or placebo for 52 weeks.Primary efficacy endpoints were mean morning peak expiratory flow (PEF), as recorded by patients prior to the use of bronchodilator or study medication, and the rate of investigator-recorded asthma exacerbations.Receiving twice-daily FP and once-daily SFC showed greater improvements in mean morning PEFpared with those receiving placebo (FP, difference in means 20.95% CI 14.P < 0.Difference in means 14.95% CI 9.P < 0.The difference in adjusted mean PEF between once-daily SFC and twice-daily FP was -5.(95% CI -9. PEF results showed that once-daily SFC was non-inferior to twice-daily FP.52 weeks, there was a 35% reduction in exacerbation rates with once-daily SFC, which in this respect demonstrated superiority over placebo (p < 0.Between once-daily SFC and twice-daily FP with respect to exacerbation rates was not shown.SFC significantly improved clinic forced expiratory flow between 25% and 75% of forced vital capacity (difference in means 0.P < 0.Clinic PEF (difference in means 10.P < 0.FP.Treatments were well tolerated and the safety profile of each was similar to that seen with placebo.Patients with mild persistent asthma not previously receiving maintenance therapy, once-daily SFC 50 g with respect to mean morning PEF.In this study, once-daily SFC was not as efficacious as twice-daily FP in reducing asthma exacerbation rates.
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