Plana E, Rivero-Ferrer E, Aguado J, Saigi-Morgui N, Nuevo J, Daoud SZ, Lei A, Perez-Gutthann S, Rebordosa C. Hospitalization for heart failure among patients using aclidinium bromide and other COPD medications: a post-authorisation safety study in the CPRD. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):1153. doi: 10.1002/pds.4864

BACKGROUND: Aclidinium is an inhaled, long-acting anticholinergic (LAMA) approved in Europe in 2012 as a maintenance bronchodilator to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). There have been safety concerns related to a potential increase in heart failure (HF) events with the use of LAMA medications.

OBJECTIVES: To estimate the adjusted incidence rate ratio (IRR) for HF in patients with COPD initiators of aclidinium, tiotropium, other LAMA, long-acting beta-agonists/inhaled corticosteroids (LABA/ICS), and LAMA/LABA compared with initiators of LABA.

METHODS: This population-based cohort study included patients with COPD aged 40 years or older initiating COPD medications in the Clinical Practice Research Datalink (CPRD) in the United Kingdom from 2012 to 2017. First-ever hospitalizations for HF events were identified in the Hospital Episode Statistics, the Office for National Statistics, and general practitioner (GP) records from the CPRD and validated by a review of patient profiles and questionnaires sent to GPs. Poisson regression models were used to estimate the IRR of HF for current use of COPD medications versus current use of LABA adjusting for age, sex, COPD severity (GOLD 2016 definition), asthma, diuretics, inhaled corticosteroids, and prior outpatient diagnosis of chronic heart failure.

RESULTS: The study included 4,350 new users of aclidinium, 23,405 of tiotropium, 6,977 of other LAMA, 3,122 of LAMA/LABA, 26,093 of LABA/ICS, and 5,678 of LABA (patients could enter more than one cohort). The mean age ranged from 69 to 70 years, and 48% to 52% were females across study cohorts. Aclidinium users had the highest proportion of severe COPD (category D), and LABA users had the lowest (35% vs. 19%). The number of HF events/person-years during current use was 36/3,783 for aclidinium, 136/24,490 for tiotropium, 40/5,036 for other LAMA, 13/1,571 for LAMA/LABA, 213/29,036 for LABA/ICS, and 30/4,339 for LABA. Incidence rates ranged from 6.9 in LABA to 9.5 per 1,000 person-years in aclidinium. Using LABA as reference, for current use, the adjusted IRRs (95% confidence interval) of HF were 0.90 (0.53, 1.53) for aclidinium, 1.02 (0.69, 1.51) for tiotropium, 0.86 (0.50, 1.47) for other LAMA, 1.09 (0.41, 2.92) for LAMA/LABA, and 1.01 (0.69, 1.48) for LABA/ICS.

CONCLUSIONS: Compared with LABA users, the study did not find an increased risk of HF in new users of aclidinium, despite increased COPD severity, nor in users of other COPD medications.

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