Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database.

Autor: Jambon-Barbara C; Pharmacovigilance Department, Grenoble Alpes University Hospital, 38043, Grenoble, France., Bernardeau C; Pharmacovigilance Department, Grenoble Alpes University Hospital, 38043, Grenoble, France., Bezin J; University Bordeaux, INSERM, BPH, Team AHeaD, U1219, 33000, Bordeaux, France.; Clinical Pharmacology Unit, CHU de Bordeaux, 33000, Bordeaux, France., Roustit M; University Grenoble Alpes, Inserm U1300, HP2, 38000, Grenoble, France.; University Grenoble Alpes, Inserm CIC1406, Grenoble Alpes University Hospital, 38000, Grenoble, France., Blaise S; University Grenoble Alpes, Inserm U1300, HP2, 38000, Grenoble, France.; Department of Vascular Medicine, Grenoble Alpes University Hospital, University Grenoble Alpes, 38000, Grenoble, France., Cracowski JL; Pharmacovigilance Department, Grenoble Alpes University Hospital, 38043, Grenoble, France.; University Grenoble Alpes, Inserm U1300, HP2, 38000, Grenoble, France., Khouri C; Pharmacovigilance Department, Grenoble Alpes University Hospital, 38043, Grenoble, France. ckhouri@chu-grenoble.fr.; University Grenoble Alpes, Inserm U1300, HP2, 38000, Grenoble, France. ckhouri@chu-grenoble.fr.; University Grenoble Alpes, Inserm CIC1406, Grenoble Alpes University Hospital, 38000, Grenoble, France. ckhouri@chu-grenoble.fr.; Centre Regional de Pharmacovigilance, CHU Grenoble Alpes, CS 10217, 38043, Grenoble Cedex 9, France. ckhouri@chu-grenoble.fr.
Jazyk: angličtina
Zdroj: Drug safety [Drug Saf] 2023 Sep; Vol. 46 (9), pp. 905-916. Date of Electronic Publication: 2023 Aug 02.
DOI: 10.1007/s40264-023-01336-x
Abstrakt: Introduction: Previous pre-clinical and pharmacovigilance disproportionality analyses highlighted a safety signal of cutaneous ulcer with bisphosphonate use. Therefore, our objective is to evaluate this risk and assess whether unmeasured confounding factors could explain this association.
Methods: This study is a population-based cohort study from a representative sample (1/97th) of the French health insurance claims database: Echantillon Généraliste des Bénéficiaires (EGB) from 2006 to 2019. To limit the impact of our study design and methodological choices on any association between skin ulceration and exposure to bisphosphonates, we used several methods: a Cox proportional hazards analysis and a prior event rate ratio (PERR) analysis, using two propensity matched control groups, and either the first episode of incident ulceration or multiple event-time outcomes.
Results: There were 7402 individuals newly exposed to bisphosphonates matched to 29,605 unexposed individuals on propensity score. The primary outcome was skin ulcer occurrence assessed by at least 2 deliveries of wound dressing during the period of one month. Among 6911 individuals newly exposed to bisphosphonates and 28,072 unexposed individuals with no previous skin ulcer, the Cox regression yielded a hazard ratio (HR) of 1.40 (95% CI 1.26-1.56) for newly exposed individuals. Among 7402 exposed and 29,605 unexposed individuals, the PERR analysis found a non-significant HR of 1.03 (95% CI 0.87-1.24). Results were similar on the different sensitivity analyses.
Conclusion: No association between bisphosphonate and skin ulcers was found in the French population. The association observed in previous pharmacovigilance studies and in the Cox regression analysis is likely due to unmeasured confounding factors.
(© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
Databáze: MEDLINE
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