Long-term oral budesonide treatment and risk of osteoporotic fractures in patients with microscopic colitis.

Autor: Reilev M; Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense University Hospital, Odense, Denmark., Hallas J; Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense University Hospital, Odense, Denmark., Thomsen Ernst M; Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense University Hospital, Odense, Denmark.; OPEN - Open Patient data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Nielsen GL; Department of Internal Medicine, Aalborg University Hospital, Aalborg, Denmark.; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark., Bonderup OK; Diagnostic Centre, Regional Hospital Silkeborg, and University Research Clinic for Innovative Patient Pathways, Aarhus University, Aarhus, Denmark.
Jazyk: angličtina
Zdroj: Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2020 Mar; Vol. 51 (6), pp. 644-651. Date of Electronic Publication: 2020 Jan 30.
DOI: 10.1111/apt.15648
Abstrakt: Background: Due to a substantial first-pass metabolism of oral budesonide, systemic bioavailability is low compared to other oral corticosteroids, thereby possibly avoiding adverse effects of systemic corticosteroid use.
Aim: To determine whether use of oral budesonide is associated with osteoporotic fractures in patients with microscopic colitis (MC).
Methods: Applying data from the Danish nationwide health registries, we conducted a case-control study nested within a cohort of patients with MC from 2004 to 2012. We estimated odds ratios (ORs) for the association between budesonide use and osteoporotic fractures (hip, wrist and spinal fractures).
Results: We identified 417 cases with a first occurrence of an osteoporotic fracture. Eighty-six per cent were women and the median age was 78 years. The OR for the overall association between ever-use of budesonide and any osteoporotic fractures did not reach statistical significance (OR 1.13, CI: 0.88-1.47). The highest risk was observed for spinal fractures (OR 1.98, CI: 0.94-4.17), where a dose-response association seemed to exist, followed by hip and wrist fractures (OR 1.17 [CI: 0.79-1.73] and OR 0.99 [CI: 0.66-1.47] respectively). We generally found modestly increased ORs across subgroups at suspected high or low risk of fractures (1.00-2.49). No overall dose-response association was evident (OR for doubling of cumulative dose 0.93 (CI: 0.84-1.03).
Conclusion: No overall association between use of oral budesonide and osteoporotic fractures was demonstrated among individuals with MC. There seemed to be an isolated adverse effect of budesonide on the risk of spinal fractures, which appears to be dose related.
(© 2020 John Wiley & Sons Ltd.)
Databáze: MEDLINE
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