Rebordosa C, Varas-Lorenzo C, Castellsague J, Plana E, Bui C, Aguado J, Garcia Gil E, Perez-Gutthann S. Characteristics of new users of aclidinium bromide in the United Kingdom. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):677.


BACKGROUND: Aclidinium bromide, a long-acting antagonist of lung M3 receptors (LAMA), was approved in Europe in 2012 as maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). As part of the pharmacovigilance plan, a drug utilization study in several European countries is ongoing.

OBJECTIVES: To describe the characteristics of new users of aclidinium, tiotropium, and other LAMAs (glycopyrronium and umeclidinium) in the United Kingdom (UK).

METHODS: Observational cohort study of new users of LAMAs in the Clinical Practice Research Datalink in the UK, between 2012 and 2015. New users were identified through recorded general practitioner prescriptions. Patients with COPD were identified through Read codes and ICD-10 hospital discharge codes in Hospital Episode Statistics. Annual age- and sex-standardized prevalence of use of each LAMA was estimated using the 2013 adult European Union population. Descriptive statistics were performed to characterize new users of LAMAs.

RESULTS: We identified 3,604 new users of aclidinium, 30,705 new users of tiotropium, and 3,288 new uses of other LAMAs. The standardized annual prevalence of use per 100,000 adults ranged from 0.6 in 2012 to 80.2 in 2015 for aclidinium, from 1,442.8 in 2012 to 1,254.8 in 2015 for tiotropium, and from 33.6 in 2013 to 76.9 for other LAMAs. Approximately 53% of users of aclidinium and 51% of users of tiotropium or other LAMAs were men. The percentage of users aged greater than or equal to 60 years was higher in users of aclidinium and other LAMAs (80%) than in users of tiotropium (77%). The percentage of former smokers was higher in users of aclidinium and other LAMA (57%) than in users of tiotropium (53%). A higher proportion of users of aclidinium (92%) than users of tiotropium (82%) or other LAMAs (88%) had a recorded diagnosis of COPD. A higher proportion of users of aclidinium (43%) than users of tiotropium (37%) or other LAMAs (39%) had severe or very severe COPD.

CONCLUSIONS: In this study, new users of aclidinium in the UK were older, more frequently former smokers, and had more severe COPD than new users of tiotropium and new users of other LAMAs.

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