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Master Thesis

Exploration de la corrélation entre le risque d’effet indésirable médicamenteux issu de méta-analyses et les mesures de disproportionnalité issues de la base de pharmacovigilance de l’OMS

Abstract : Pharmacovigilance databases allow, through disproportionality analyses, to detect safety signals related to adverse drug reactions (ADRs). These analyses do not provide risk quantification of the ADR occurrence, but only offer an approximate of the strength of the signal. However, recently some studies used disproportionality analyses as a proxy of the relative risk of an ADR among a drug class but very few studies demonstrated this hypothesis. In this study, we evaluated the correlation between relative risks of certain ADRs from meta-analyses and disproportionality measures from the WHO pharmacovigilance database (Vigibase®). We extracted all meta-analyses evaluating ADRs within a drug class published in the last 5 years in 7 high impact journals. Reporting Odds Ratios (ROR) were calculated for each ADRs and drug class. Several disproportionality analyses were performed taking into account different bias. This study provides further evidence that a correlation exists between effect sizes from meta-analyses and those obtained from disproportionality analyses. In the absence of better estimates, disproportionality analyses could be used to hierarchize an ADR risk among a drug or therapeutic class. This study also emphasized that disproportionality methods widely affect this correlation and have to be, a priori, well justified and designed. Further work is needed to understand the ADR and disproportionality analysis factors that affect this relationship.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02349278
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Submitted on : Tuesday, November 5, 2019 - 3:52:21 PM
Last modification on : Wednesday, July 15, 2020 - 8:56:03 AM
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  • HAL Id : dumas-02349278, version 1

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Camille Petit. Exploration de la corrélation entre le risque d’effet indésirable médicamenteux issu de méta-analyses et les mesures de disproportionnalité issues de la base de pharmacovigilance de l’OMS. Sciences pharmaceutiques. 2018. ⟨dumas-02349278⟩

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