| アブストラクト | INTRODUCTION: This retrospective database study explored treatment patterns and potential off-label prescribing among patients newly prescribed fluticasone furoate/vilanterol (FF/VI) in a UK primary care setting. METHODS: In Europe, FF/VI is approved in two strengths: 100/25 microg for adults with chronic obstructive pulmonary disease (COPD) and 100/25 microg or 200/25 microg for treatment of asthma in patients aged 12 or older. Using electronic health records from the Clinical Practice Research Datalink, new users of FF/VI or other inhaled corticosteroid/long-acting beta-agonist fixed-dose combination products were identified and classified into one of three groups: COPD diagnosis, asthma diagnosis, and other diagnosis (not COPD or asthma). RESULTS: During 2014-2015, 4373 patients initiated FF/VI: 3380 on FF/VI 100/25 (65% in the COPD diagnosis group) and 993 on FF/VI 200/25 (51% in the asthma diagnosis group). During up to 12 months of follow-up, the median number (interquartile range) of prescriptions of the index strength issued per patient was 7 (2-8) for FF/VI 100/25 and 5 (2-8) for FF/VI 200/25; most new users did not change from the index strength prescribed (93.0% COPD; 89.7% asthma, of all patients initiating treatment with FF/VI). Potential off-label FF/VI prescribing in children < 12 years old was rare (< 0.29% in the combined asthma and other diagnosis groups), and up to one in five new users of FF/VI with COPD were potentially prescribed FF/VI 200/25 off-label during the study period. Much of the potential off-label prescribing in COPD occurred in patients with a history of asthma, those presenting with greater disease severity, and/or prior treatment with high-dose steroids. CONCLUSIONS: The prescription of FF/VI is rare in children under 12 years of age in the UK, according to our findings, but up to one in five COPD patients in the UK may have been prescribed FF/VI 200/25, some of which may have been off-label. FUNDING: This study was funded by GlaxoSmithKline plc (study 205052). STUDY REGISTRATION: GlaxoSmithKline plc Clinical Trial Registry study number 205052. |
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| ジャーナル名 | Pulmonary therapy |
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| 投稿日 | 2020/2/7 |
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| 投稿者 | Dedman, Daniel; Coton, Sonia J; Ghosh, Rebecca E; Meeraus, Wilhelmine; Crim, Courtney; Harvey, Catherine; Amelio, Justyna; Landis, Sarah H |
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| 組織名 | Clinical Practice Research Datalink (CPRD), Medicines and Healthcare Products;Regulatory Agency (MHRA), London, UK. Daniel.Dedman@mhra.gov.uk.;Regulatory Agency (MHRA), London, UK.;GlaxoSmithKline plc, Epidemiology, Value Evidence and Outcomes, Stockley Park,;Uxbridge, UK.;GlaxoSmithKline plc, Research and Development, Research Triangle Park, NC, USA.;GlaxoSmithKline plc, Global Clinical Safety and Pharmacovigilance, Stockley Park,;GlaxoSmithKline plc, Epidemiology, Value Evidence and Outcomes, Stevenage, UK. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/32026429/ |
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