Characteristics of New Users of Aclidinium Bromide, Aclidinium/Formoterol, and Other COPD Medications in the United Kingdom, Denmark, and Germany

In: Rivero-Ferrer , E , Olesen , M , Plana , E , Aguado , J , Saigí-Morgui , N , Rubino , A , Daoud , S Z , Lei , A , Perez-Gutthann , S , Schink , T , Kristiansen , N S , Hallas , J , Pottegård , A & Rebordosa , C 2022 , ' Characteristics of New Users of Aclidinium Bromide, Aclidinium/Formoterol, and Other COPD Medications in the United Kingdom, Denmark, and Germany ' , Clinical Drug Investigation , vol. 42 , no. 4 , pp. 319-331 . https://doi.org/10.1007/s40261-022-01120-2

Abstract

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.