FNRS, Fund for Scientific Research, Bruxelles, Belgium
Clinical Pharmacy research group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.
BMJ Open. 2023 Nov 19;13(11):e073081. doi: 10.1136/bmjopen-2023-073081.
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.
介绍:在患有 2 型糖尿病(T2D)的老年患者中,过度使用降糖药物(HD:磺酰脲类、格列奈类和/或胰岛素)很常见,并且与 1 年死亡率增加相关。因此,减少 HD 的剂量是一个关键问题,尽管目前这方面的证据有限。这项研究的主要目的是估计在 T2D 老年患者(≥75 岁)中,减少 HD 剂量对 3 个月内临床结局(住院或死亡)的影响。
方法:我们将在真实世界的数据中模拟一个目标试验,该试验将在 The Health Improvement Network 队列中进行,这是一个来自法国 2000 名全科医生电子病历的数据大型数据库。从 2010 年 1 月 1 日至 2019 年 2 月 28 日,我们将纳入符合条件的≥75 岁患者,这些患者患有 T2D、HD 稳定剂量、糖化血红蛋白 A1c(HbA1c)值<75mmol/mol(9.0%)且过去一年未进行过剂量减少。该目标试验将在数据库中每月依次进行模拟(即评估合格性)。患者将在每个连续试验的基线时被分为干预组(HD 剂量减少≥50%,包括完全停药)或对照组(HD 剂量未减少)。所有连续模拟试验的汇总数据集将进行分析。主要结局是 3 个月内首次发生住院或死亡的时间。次要结局包括住院、死亡、血糖控制的适当性和 1 年内 HbA1c 值>75mmol/mol 的发生情况。参与者将从基线随访至随机分组后 12 个月、行政截止或死亡,以先发生者为准。将使用汇总逻辑回归估计治疗对结局发生率的影响。
传播和伦理:使用这个完全匿名的数据库进行回顾性研究不需要伦理批准。研究结果将在会议上和通过在科学期刊上发表文章进行传播。
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