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Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: What a clinician should know on disproportionality analysis of spontaneous reporting systems

dc.rights.licenseopenen_US
dc.contributor.authorRASCHI, E.
dc.contributor.authorPOLUZZI, E.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSALVO, Francesco
IDREF: 221043470
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorPARIENTE, Antoine
IDREF: 13395711X
dc.contributor.authorDE PONTI, F.
dc.contributor.authorMARCHESINI, G.
dc.contributor.authorMORETTI, U.
dc.date.accessioned2020-12-15T16:11:24Z
dc.date.available2020-12-15T16:11:24Z
dc.date.issued2018-06
dc.identifier.issn0939-4753en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/23558
dc.description.abstractEnSodium-glucose co-transporter-2 inhibitors (SGLT2-Is) have consistently demonstrated a clinically significant reduction of cardiovascular mortality. However, their safety in clinical practice is still incompletely characterized, and post-marketing monitoring is required considering the expected increase in clinical use. Different analyses of international spontaneous reporting systems, known as disproportionality analyses (DAs), have highlighted the occurrence of ketoacidosis, amputations, acute renal failure and skin toxicity. In this viewpoint, we critically appraise these pharmacovigilance data on SGLT2-Is, with the aim of supporting clinicians in proper interpretation of these studies, and discussing their risk-benefit profile. To this aim, we offer a broad perspective on basic technical aspects subtending DAs of spontaneous reporting databases (describing peculiarities of the Food and Drug Administration Adverse Event Reporting System), their common and evolving uses, key pitfalls in presenting study results (in terms of "risk" or "association") and relevant strategies to account for major confounders. This will also facilitate reviewers and editors in proper evaluation of DAs, and prompt pharmacovigilance experts in converging towards a set of minimum requirements in standardization of design, performance and reporting of DAs. A consensus on quality assessment of DAs will finally establish their transferability to clinical practice. It is anticipated that DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgment in the individual patient.
dc.language.isoENen_US
dc.subject.enPharmacoEpi-Drugs
dc.subject.enCIC1401
dc.title.enPharmacovigilance of sodium-glucose co-transporter-2 inhibitors: What a clinician should know on disproportionality analysis of spontaneous reporting systems
dc.title.alternativeNutr Metab Cardiovasc Disen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.numecd.2018.02.014en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed29625780en_US
bordeaux.journalNutrition, metabolism, and cardiovascular diseasesen_US
bordeaux.page533-542en_US
bordeaux.volume28en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue6en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.teamCIC1401en_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03070209
hal.version1
hal.date.transferred2020-12-15T16:11:31Z
hal.exporttrue
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