Abstract
Background and objective
To determine the impact of non-adherence to 5-Aminosalicylates (5-ASA) on the risk of flares and to identify risk factors of non-adherence.
Methods
Observational, cohort study of ulcerative colitis (UC) patients in clinical remission at least 6 months on 5-ASA monotherapy maintenance prescribed by an electronic management program. Adherence was considered when 80% of the prescribed 5-ASA had been dispensed at the pharmacy. The study analyzed the existence and degree of 5-ASA adherence, disease course, UC phenotypic expression, and 5-ASA dose and regimen, and consumption of non-UC chronic drugs during 2-year follow-up.
Results
The study included 274 patients, 49% males with a median age of 38 (27–49) years old. Overall, 41% of patients were non-adherent to 5-ASA. Risk of flares was reduced in the adherent group (36% vs 54%; OR = 0,484; p = 0,004), mainly the mild ones (26% vs 38%; OR = 0,559; p = 0,031). Non-adherence was associated with younger age at diagnosis (32 (26–45) vs 41.5 (21–50), p = 0.000) and no-consumption of other chronic treatments (1.1 vs 2.1; OR = 1709; p = 0,048).
Conclusion
Non-adherence to 5-ASA evaluated by the pharmaceutical management system was at 41% with a higher risk of relapse. Younger patients and patients who do not receive non-UC chronic treatments showed lower adherence rate.
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Conception and design of the study: Ballester MP, Martí-Aguado D, Fullana M, Bosca-Watts MM, and Minguez M
Acquisition of data: Ballester MP, Martí-Aguado D, Fullana M, Romero E, Sanchez A, Navarro P, and Anton R
Analysis and interpretation of data: Ballester MP, Martí-Aguado D, Bosca-Watts MM, Tosca J, and Minguez M
Manuscript writing: Ballester MP, Martí-Aguado D, Bosca-Watts MM, Tosca J, Mora F, and Minguez M
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M. Minguez has served as a speaker, a consultant, and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Janssen, Shire Pharmaceuticals, Allergan.
M.M. Bosca-Watts declares educational activities, research projects, scientific meetings, and advisory boards sponsored by MSD, Ferring, Abbvie, Janssen, and Takeda.
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All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
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The study was reviewed and approved by the University Clinic Hospital of Valencia, Institutional Review Board.
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Ballester, M.P., Marti-Aguado, D., Fullana, M. et al. Impact and risk factors of non-adherence to 5-aminosalicylates in quiescent ulcerative colitis evaluated by an electronic management system. Int J Colorectal Dis 34, 1053–1059 (2019). https://doi.org/10.1007/s00384-019-03271-9
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DOI: https://doi.org/10.1007/s00384-019-03271-9