Rivero-Ferrer E, Witzleb AJ, Olesen M, Plana E, Aguado J, Saigi-Morgui N, Rubino A, Daoud SZ, Lei A, Perez-Gutthann S, Schink T, Kristiansen NS, Pottegard A, Rebordosa C. Are aclidinium and aclidinium/formoterol used according to their approved indication in Europe? Results of a multicountry drug utilization postauthorization safety study. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.

BACKGROUND: Aclidinium bromide was approved in the European Union for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients in 2012 and aclidinium/formoterol in 2014. A drug utilisation study in three European countries is part of the pharmacovigilance plan.

OBJECTIVES: To evaluate the potential indication of aclidinium, and aclidinium/formoterol, and characteristics of new users of study medications in Denmark, Germany, and the United Kingdom (UK).

METHODS: Cohorts in the Danish National Health Databases (2015-2017), the German Pharmacoepidemiological Research Database (2015), and the UK Clinical Practice Research Datalink (CPRD GOLD, 2015-2017) included new users treated with long-acting muscarinic antagonists (LAMA) (aclidinium, aclidinium/formoterol, tiotropium, other LAMA), long-acting beta2-agonists (LABA), or LABA/inhaled corticosteroids (LABA/ICS). On-label was defined as use in adults with a diagnosis of COPD with or without asthma. Off-label use was defined as use in patients aged < 18 years or use in patients with a recorded diagnosis of asthma without a COPD diagnosis. Absence of a recorded diagnosis of COPD and asthma was classified as unknown indication.

RESULTS: There were 4,871 users of aclidinium and 2,153 users of aclidinium/formoterol in the UK, 2,836 users of aclidinium and 2,586 of aclidinium/formoterol in Denmark, and 9,961 users of aclidinium and 10,069 users of aclidinium/formoterol in Germany. Among users of aclidinium, a COPD diagnosis was present in 89% of users in the UK, 87.4% in Germany, and 56.0% in Denmark. For aclidinium/formoterol, this percentage was 90.5% in the UK, 92.8% in Germany, and 57.7% in Denmark. There was no or minimal paediatric use. Among users of aclidinium, diagnosis of asthma with no COPD diagnosis occurred in 5.0% in the UK, 5.4% in Germany, and 8.8% in Denmark. For aclidinium/formoterol, it occurred in 3.2% in the UK, 2.6% in Germany, and 3.0% in Denmark. The indication was unknown in 6% of users of aclidinium in the UK, 7.2% in Germany, and 35.0% in Denmark. For aclidinium/formoterol, this percentage was 6.3% in the UK, 4.6% in Germany, and 39.2% in Denmark.

CONCLUSIONS: Aclidinium and aclidinium/formoterol are prescribed mainly according to the approved indication. Based on recorded diagnoses, it cannot be ruled out that a patient may have had childhood asthma that later resolved or evolved to asthma-COPD syndrome in adulthood. Paediatric use was anecdotal. The high proportion of ’unknown indication’ in Denmark is driven by the lack of primary care diagnoses.

Share on: