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Cardiovascular risk associated with glucagon-like peptide-1 receptor agonists versus other conventional glucose-lowering drugs in patients with type-2 diabetes: protocol for a nationwide observational comparative study in routine care.

dc.rights.licenseopenen_US
dc.contributor.authorDANCHIN, Nicolas
dc.contributor.authorLEMESLE, Gilles
dc.contributor.authorMAZIGHI, Mikael
hal.structure.identifierBiologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
dc.contributor.authorMOHAMMEDI, Kamel
dc.contributor.authorSCHIELE, Francois
dc.contributor.authorSIBON, Igor
dc.contributor.authorCARON, Alexandre
dc.contributor.authorEMERY, Corinne
dc.contributor.authorNEVORET, Camille
dc.contributor.authorVIGIÉ, Lucile
dc.contributor.authorMASSIEN, Christine
dc.contributor.authorDETOURNAY, Bruno
dc.contributor.authorFAUCHIER, Laurent
dc.date.accessioned2025-03-04T13:14:00Z
dc.date.available2025-03-04T13:14:00Z
dc.date.issued2025-01-09
dc.identifier.issn2044-6055en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/205342
dc.description.abstractEnSeveral cardiovascular outcome trials have been conducted to assess the cardiovascular safety and efficacy of glucagon-like peptide-1 receptor agonists (GLP1-RAs) on cardiorenal outcomes in patients with type-2 diabetes (T2D). However, the strict requirements of randomised controlled trials to avoid most confounding factors are at the expense of external validity. Using national real-world data, we aimed to evaluate the effectiveness of GLP-1RAs in association with metformin especially on cardiovascular events, hospitalisation for heart failure and all-cause death in comparison with other diabetes treatment schemes using dipeptidyl peptidase IV inhibitors, sulfonylureas/glinides or insulin also associated with metformin. Sodium-glucose transport protein 2 inhibitors (SGLT-2i) will be excluded as comparators, as this class of oral hypoglycaemic agents just started in 2020 to be marketed in France. The Système National des Données de Santé is a comprehensive nationwide administrative healthcare database in France that covers approximately 67 million people.Several cohorts of adult patients with T2D initiating any GLP1-RA in dual or triple therapies, as recommended by the French Health authorities, will be identified in this database over the period 2016-2021. These cohorts will be defined by the combination of glucose-lowering drugs prescribed simultaneously with GLP1-RA and diabetes treatment received over a 6-month period before GLP1-RA initiation. They will be first matched with T2D controls (1:3 ratio) based on the year of drug initiation and treatment regimens before and simultaneously with GLP1-RA in the different selected cohorts. Comparative analyses will be conducted versus these control groups, adjusting for cardiovascular event history and a propensity score considering age, sex, area of residence, deprivation index, comorbidities, duration of diabetes, use of lipid-lowering drugs, anticoagulants, antiplatelet therapies and blood pressure-lowering therapies. Comparative analyses will be conducted versus these control groups, using a high-dimensional propensity scores method and fixed baseline characteristics. Treatment effects on the different outcomes measured will be estimated for each GLP1-RA group, through HR and their corresponding CIs (95% CI) using Cox regressions and/or competitive risk regressions when necessary. The study has been approved by an independent ethics committee (Comité éthique et scientifique pour les recherches, les études et les évaluations dans le domaine de la santé, Paris, France; reference: 8699786, dated 2 June 2022) and has been registered with the French National Data Protection Commission (Commission Nationale de l'Informatique et des Libertés, Paris, France; reference: 922161, dated 26 June 2022). The findings of this study will be published in peer-reviewed scientific journals and presented at international conferences. F20220803152803.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enHumans
dc.subject.enDiabetes Mellitus
dc.subject.enType 2
dc.subject.enHypoglycemic Agents
dc.subject.enGlucagon-Like Peptide-1 Receptor
dc.subject.enCardiovascular Diseases
dc.subject.enFrance
dc.subject.enObservational Studies as Topic
dc.subject.enMetformin
dc.subject.enHeart Disease Risk Factors
dc.subject.enSulfonylurea Compounds
dc.subject.enFemale
dc.subject.enMale
dc.subject.enDrug Therapy
dc.subject.enCombination
dc.subject.enDipeptidyl-Peptidase IV Inhibitors
dc.subject.enResearch Design
dc.subject.enGlucagon-Like Peptide-1 Receptor Agonists
dc.title.enCardiovascular risk associated with glucagon-like peptide-1 receptor agonists versus other conventional glucose-lowering drugs in patients with type-2 diabetes: protocol for a nationwide observational comparative study in routine care.
dc.title.alternativeBMJ Openen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1136/bmjopen-2024-087790en_US
dc.subject.halSciences du Vivant [q-bio]/Médecine humaine et pathologieen_US
dc.identifier.pubmed39788759en_US
bordeaux.journalBMJ Openen_US
bordeaux.pagee087790en_US
bordeaux.volume15en_US
bordeaux.hal.laboratoriesBiologie des maladies cardiovasculaires (BMC) - UMR 1034en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.import.sourcepubmed
hal.identifierhal-04976052
hal.version1
hal.date.transferred2025-03-04T13:14:03Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
workflow.import.sourcepubmed
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=BMJ%20Open&rft.date=2025-01-09&rft.volume=15&rft.issue=1&rft.spage=e087790&rft.epage=e087790&rft.eissn=2044-6055&rft.issn=2044-6055&rft.au=DANCHIN,%20Nicolas&LEMESLE,%20Gilles&MAZIGHI,%20Mikael&MOHAMMEDI,%20Kamel&SCHIELE,%20Francois&rft.genre=article


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