| アブストラクト | INTRODUCTION: In older adults with type 2 diabetes (T2D), overtreatment with hypoglycaemic drugs (HDs: sulfonylureas, glinides and/or insulins) is frequent and associated with increased 1-year mortality. Deintensification of HD is thus a key issue, for which evidence is though limited. The primary objective of this study will be to estimate the effect of deintensifying HD on clinical outcomes (hospital admission or death) within 3 months in older adults (>/=75 years) with T2D. METHODS: We will emulate with real-world data a target trial, within The Health Improvement Network cohort, a large-scale database of data collected from electronic medical records of 2000 general practitioners in France. From 1 January 2010 to 28 February 2019, we will include eligible patients >/=75 years who will have T2D, a stable dose of HDs, glycated haemoglobin A1c (HbA1c) value <75 mmol/mol (9.0%) and no deintensification in the past year. The target trial will be sequentially emulated (ie, eligibility assessed) every month in the database. Patients will be classified at baseline of each sequential trial in the intervention arm (deintensification of HDs: decrease of >/=50% in the total dose of HDs, including complete cessation) or control arm (no deintensification of HDs). The pooled dataset for all sequential emulated trials will be analysed. The primary outcome will be time to first occurrence of hospital admission or death, within 3 months. Secondary outcomes will be hospitalisation, death, appropriateness of glycaemic control and occurrence of HbA1c >75 mmol/mol within 1 year. Participants will be followed from baseline to 12 months after randomisation, administrative censoring, or death, whichever occurs first. A pooled logistic regression will be used to estimate the treatment effect on the incidence of the outcomes. DISSEMINATION AND ETHICS: No ethical approval is needed for using retrospectively this fully anonymised database. The results will be disseminated during conferences and through publications in scientific journals. |
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| 投稿者 | Christiaens, Antoine; Simon-Tillaux, Noemie; Thompson, Wade; Sinclair, Alan J; Henrard, Severine; Boland, Benoit B; Slaouti-Jegou, Yannis; Lekens, Beranger; Bonnet-Zamponi, Dominique; Tubach, Florence; Zerah, Lorene |
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| 組織名 | FNRS, Fund for Scientific Research, Bruxelles, Belgium;antoine.christiaens@uclouvain.be.;Clinical Pharmacy research group, Louvain Drug Research Institute, Universite;catholique de Louvain, Brussels, Belgium.;Institut Pierre Louis d'Epidemiologie et de Sante Publique, INSERM, Sorbonne;Universite, Paris, Ile-de-France, France.;Hopital Pitie Salpetriere, Departement de Sante Publique, Centre de;Pharmacoepidemiologie (Cephepi), UnitéEde Recherche Clinique PSL-CFX, CIC-1901,;Assistance Publique - Hopitaux de Paris, Paris, Ile-de-France, France.;Department of Anesthesiology, Pharmacology, and Therapeutics, Faculty of;Medicine, The University of British Columbia, Vancouver, British Columbia,;Canada.;Research Unit of General Practice, University of Southern Denmark, Odense,;Denmark.;Care for long term conditions - Diabetes research group, King's College London,;London, UK.;Foundation for Diabetes Research in Older People, Taplow, UK.;Institute of Health and Society, Universite catholique de Louvain, Brussels,;Belgium.;Geriatric Department, Cliniques universitaires Saint-Luc, Bruxelles, Belgium.;Claude Bernard, Resip, Boulogne-sur-mer, France.;Observatoire des medicaments, dispositifs medicaux, innovations therapeutiques;d'Ile-de-France, Paris, France.;Hopital Pitie Salpetriere, Departement de geriatrie, Assistance Publique -;Hopitaux de Paris, Paris, Ile-de-France, France. |
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