| アブストラクト | BACKGROUND AND OBJECTIVES: Aclidinium bromide was approved in the European Union for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients in 2012 and in a fixed-dose combination with formoterol in 2014. We characterised new users of aclidinium, aclidinium/formoterol and other COPD medications and evaluated off-label prescribing of these medications in three European populations. METHODS: We described demographic characteristics, comorbidities, comedications, COPD severity and off-label prescribing of new users of aclidinium, aclidinium/formoterol and other COPD medications in patients with COPD aged >/= 40 years in the Clinical Practice Research Datalink (CPRD, UK), Danish National Health Databases, and German Pharmacoepidemiological Research Database (GePaRD) between 2015 and 2017. RESULTS: We included 17,668 new users of aclidinium (CPRD, 4871; Denmark, 2836; GePaRD, 9961) and 14,808 new users of aclidinium/formoterol (CPRD, 2153; Denmark, 2586; GePaRD, 10,069). Study patients were of similar age, except in GePaRD, where users of long-acting beta2-agonists (LABA)/inhaled corticosteroids were younger. Patients had multiple comorbidities and used multiple comedications-most frequently hypertension (50-79%) and short-acting beta2-agonists (26-84%). Aclidinium users in CPRD and long-acting anticholinergics/LABA users in Denmark and GePaRD had the highest frequency of severe/very severe COPD. Off-label prescribing of aclidinium (5.0% [CPRD]-8.9% [Denmark]) and aclidinium/formoterol (2.6% [GePaRD]-3.2% [CPRD]) was low, and the main reason was asthma without a COPD diagnosis. CONCLUSIONS: Aclidinium and aclidinium/formoterol were mostly prescribed according to label, with preference given to older patients with more severe COPD and to patients with a high prevalence of comorbidities and comedication use. |
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| ジャーナル名 | Clinical drug investigation |
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| 投稿日 | 2022/3/16 |
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| 投稿者 | Rivero-Ferrer, Elena; Olesen, Morten; Plana, Estel; Aguado, Jaume; Saigi-Morgui, Nuria; Rubino, Annalisa; Daoud, Sami Z; Lei, Alejhandra; Perez-Gutthann, Susana; Schink, Tania; Kristiansen, Nina Sahlertz; Hallas, Jesper; Pottegard, Anton; Rebordosa, Cristina |
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| 組織名 | RTI Health Solutions, Pharmacoepidemiology and Risk Management, Av. Diagonal 605,;9-1, 08028, Barcelona, Spain. erivero@rti.org.;Department of Public Health, University of Southern Denmark, Clinical;Pharmacology, Pharmacy, and Environmental Medicine, Odense, Denmark.;RTI Health Solutions, Biostatistics, Barcelona, Spain.;9-1, 08028, Barcelona, Spain.;Epidemiology, Respiratory and Immunology, AstraZeneca, Cambridge, UK.;BioPharmaceuticals Research and Development, Late-Stage Development Research and;Innovation, AstraZeneca, Gaithersburg, MD, USA.;Patient Safety Biopharma, Chief Medical Office, AstraZeneca, Barcelona, Spain.;Department of Clinical Epidemiology, Leibniz Institute for Prevention Research;and Epidemiology-BIPS, Bremen, Germany. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35290649/ |
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