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• W2053871442 abstract "The Article by Mark Dransfield and colleagues1Dransfield MT Bourbeau J Jones PW et al.Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials.Lancet Respir Med. 2013; 1: 210-223Summary Full Text Full Text PDF PubMed Scopus (279) Google Scholar reports replicate studies of the efficacy of fluticasone furoate and vilanterol on exacerbations in chronic obstructive pulmonary disease (COPD). The primary objective was to test the effect of a once-daily combination inhaler, so it is surprising that there was no comparator group of conventional twice-daily dosing. The distinctly modest improvement in comparison to the once-daily long-acting β agonist is certainly not greater, and perhaps even less than, that seen in several other studies using the twice-daily regimen. One cannot conclude that superior efficacy has been demonstrated for the once-daily dosing. Compliance may be improved with once-daily therapy but remains unproven for this class of drug. Furthermore, as in many other studies of inhaled corticosteroid and long-acting β agonists, the significance of pre-study therapy is ignored. Over two thirds of patients in the studies of Dransfield and colleagues were taking an inhaled corticosteroid at study entry. Thus, those randomised to vilanterol alone underwent steroid withdrawal. Figure 4 in the Article shows that any difference in exacerbation rate occurs within 90 days of treatment initiation. The hypothesis that withdrawal of steroids increases exacerbations in COPD is well established.2Suissa S Barnes PJ Inhaled corticosteroids in COPD: the case against.Eur Respir J. 2009; 34: 13-16Crossref PubMed Scopus (113) Google Scholar Re-analysis of the OPTIMAL study by Suissa and colleagues3Suissa S Ernst P Vandemheen KL Aaron SD Methodological issues in therapeutic trials of COPD.Eur Respir J. 2008; 31: 927-933Crossref PubMed Scopus (139) Google Scholar demonstrated no advantage for inhaled corticosteroids in addition to long-acting β agonists in steroid-naive patients, whereas those previously taking inhaled corticosteroids who were assigned to long-acting β agonist alone had a worse prognosis. We ask the authors to present the effects of fluticasone furoate and vilanterol on exacerbation rates stratified by inhaled corticosteroid pre-trial therapy. Until such evidence is forthcoming, we cannot rule out that any positive effects reported may be due to a simple artefact of trial design. Even if anticipated, the confirmation of a significant excess of pneumonia with fluticasone furoate in a 1 year study is disappointing. This excess of pneumonia has been difficult to demonstrate with other inhaled corticosteroids4Sin DD Tashkin D Zhang X et al.Budesonide and the risk of pneumonia: a meta-analysis of individual patient data.Lancet. 2009; 374: 712-719Summary Full Text Full Text PDF PubMed Scopus (166) Google Scholar and may be due to the greater lipophilicity and slower clearance of fluticasone, which with repeated dosing results in accumulation in the lung. Given this confirmation of fluticasone toxicity, should the position of high-dose fluticasone drugs be re-examined? In England, the market leader is fluticasone propionate (250 μg), salmeterol (25 μg) metred-dose inhaler, with sales of £170 million in 2011.5Health and Social Care Information CentrePrescribing and Primary CarePrescription cost analysis—England.http://www.ic.nhs.uk/article/2021/WebsiteSearch?productid=5461&q=+prescriptions+cost+analysis+2011&sort=Relevance&size=10&page=1&area=both#topDate: 2011Google Scholar Although unlicensed for COPD, its market position indicates confusion among doctors as to the diagnostic subtleties between severe asthma and COPD. We believe that the withdrawal of high-dose fluticasone preparations on safety grounds is now justified, and would also save patients and health-care providers a great deal of money. JBM has received speaker fees and sponsorship to attend the ERS, ATS, BPS, and BTS conferences, and educational grants from pharmaceutical companies including Novartis, Boehringer Ingelheim, GlaxoSmithKline, Chiesi, Merck Sharp & Dohme, Pfizer, Amgen, Napp, Almirall, and Teva. AHM has received speaker fees and sponsorship to attend the ERS, ATS, and BPS conferences from pharmaceutical companies including Novartis, Boehringer Ingelheim, GlaxoSmithKline, Chiesi, Proctor & Gamble, Almirall, AstraZeneca, Glenmark, and Philips Home Healthcare Solutions. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trialsAddition of fluticasone furoate to vilanterol was associated with a decreased rate of moderate and severe exacerbations of COPD in patients with a history of exacerbation, but was also associated with an increased pneumonia risk. Full-Text PDF Fluticasone furoate and vilanterol for COPD – Authors' replyWe thank Jaymin Morjaria and Alyn Morice for their interest in our report about fluticasone furoate and vilanterol for treatment of chronic obstructive pulmonary disorder (COPD).1 A direct comparison of exacerbation rates between twice daily fluticasone propionate and salmeterol and once daily fluticasone furoate and vilanterol was not included in the initial drug development programme that led to the recent US FDA approval of fluticasone furoate and vilanterol, although we agree that larger studies to directly compare the effectiveness of these treatment strategies would be very valuable. Full-Text PDF" @default.
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• W2053871442 title "Fluticasone furoate and vilanterol for COPD" @default.
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