BACKGROUND: Aclidinium bromide was approved for the treatment of chronic obstructive pulmonary disease (COPD) in 2012. As part of the pharmacovigilance plan, a drug utilization study in several European countries is ongoing.
OBJECTIVE: To evaluate the severity of COPD in new users of aclidinium and other COPD medications in the United Kingdom (UK) and Denmark.
METHODS: A cohort in the UK Clinical Practice Research Datalink and the Danish National Health Databases (2012-2015) included new users aged 40 years or older with a diagnosis of COPD treated with long-acting muscarinic antagonists (LAMA) (aclidinium, tiotropium, other LAMA), long-acting beta2-agonists (LABA), or LABA/inhaled corticosteroids (LABA/ICS). COPD severity was defined according to a validated algorithm as Mild, no regular bronchodilator treatment; Moderate, regular bronchodilator treatment; Severe, ≥1 COPD hospitalization, or ≥2 exacerbations without hospitalization in the prior 12 months; and Very severe, use of oxygen therapy, scheduled lung transplant, or respiratory failure.
RESULTS: Overall, there were 5,820 new users of aclidinium, 3,295 in CPRD and 2,525 in Denmark, and 141,514 users of other COPD medications, 60,605 in CPRD and 80,909 in Denmark. Severe or very severe COPD was more frequent in new users of LAMA (range, 32.5%-45.8% in CPRD; 57.9%-68.9% in Denmark) than in new users of LABA (31.1%, CPRD; 55.3%, Denmark) and LABA/ICS (37.7%, CPRD; 55.2%, Denmark). New users of aclidinium had the highest severity. The aclidinium severity distribution in CPRD was Mild, 3.5%; Moderate, 50.7%; Severe, 43.8%; and Very severe, 2.0%. Distribution in Denmark was 5.0%, 26.0%, 58.0%, and 10.9%, respectively. The proportion of users of the study medications with severe and very severe COPD was higher in Denmark (range, 55.2%-68.9%) than in CPRD (range, 31.1%-45.8%).
CONCLUSION: New users of aclidinium had more severe COPD than new users of other LAMA and COPD medications. The higher COPD severity in Denmark is consistent with the nature of the database, which is based on hospital and outpatient clinic diagnoses.
