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

Clément Jambon-Barbara, Claire Bernardeau, Julien Bezin, Matthieu Roustit, Sophie Blaise, Jean-Luc Cracowski and Charles Khouri ()
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Clément Jambon-Barbara: Grenoble Alpes University Hospital
Claire Bernardeau: Grenoble Alpes University Hospital
Julien Bezin: University Bordeaux, INSERM, BPH, Team AHeaD, U1219
Matthieu Roustit: University Grenoble Alpes, Inserm U1300, HP2
Sophie Blaise: University Grenoble Alpes, Inserm U1300, HP2
Jean-Luc Cracowski: Grenoble Alpes University Hospital
Charles Khouri: Grenoble Alpes University Hospital

Drug Safety, 2023, vol. 46, issue 9, No 8, 905-916

Abstract: Abstract 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.

Date: 2023
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DOI: 10.1007/s40264-023-01336-x

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