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

dc.rights.licenseopenen_US
dc.contributor.authorJAMBON-BARBARA, Clement
dc.contributor.authorBERNARDEAU, Claire
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBEZIN, Julien
dc.contributor.authorROUSTIT, Matthieu
dc.contributor.authorBLAISE, Sophie
dc.contributor.authorCRACOWSKI, Jean-Luc
dc.contributor.authorKHOURI, Charles
dc.date.accessioned2023-11-16T14:54:40Z
dc.date.available2023-11-16T14:54:40Z
dc.date.issued2023-09
dc.identifier.issn1179-1942en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/184819
dc.description.abstractEnINTRODUCTION: 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 Generaliste des Beneficiaires (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.
dc.language.isoENen_US
dc.title.enUse of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database
dc.title.alternativeDrug Safen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1007/s40264-023-01336-xen_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
bordeaux.journalDrug Safetyen_US
bordeaux.page905-916en_US
bordeaux.volume46en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue9en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamAHEAD_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04289809
hal.version1
hal.date.transferred2023-11-16T14:54:41Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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