Department of Information Engineering, University of Padova, 35100, Padova, Italy.
Arsenàl.IT, Veneto's Research Centre for eHealth Innovation, 31100, Treviso, Italy.
Cardiovasc Diabetol. 2021 Nov 13;20(1):222. doi: 10.1186/s12933-021-01414-3.
We aimed to compare cardiovascular outcomes of patients with type 2 diabetes (T2D) who initiated GLP-1 receptor agonists (GLP-1RA) or basal insulin (BI) under routine care.
We accessed the administrative claims database of the Veneto Region (Italy) to identify new users of GLP-1RA or BI in 2014-2018. Propensity score matching (PSM) was implemented to obtain two cohorts of patients with superimposable characteristics. The primary endpoint was the 3-point major adverse cardiovascular events (3P-MACE). Secondary endpoints included 3P-MACE components, hospitalization for heart failure, revascularizations, and adverse events.
From a background population of 5,242,201 citizens, 330,193 were identified as having diabetes. PSM produced two very well matched cohorts of 4063 patients each, who initiated GLP-1RA or BI after an average of 2.5 other diabetes drug classes. Patients were 63-year-old and only 15% had a baseline history of cardiovascular disease. During a median follow-up of 24 months in the intention-to-treat analysis, 3P-MACE occurred less frequently in the GLP-1RA cohort (HR versus BI 0.59; 95% CI 0.50-0.71; p < 0.001). All secondary cardiovascular endpoints were also significantly in favor of GLP-1RA. Results were confirmed in the as-treated approach and in several stratified analyses. According to the E-value, confounding by unmeasured variables were unlikely to entirely explain between-group differences in cardiovascular outcomes.
Patients with T2D who initiated a GLP-1RA experienced far better cardiovascular outcomes than did matched patients who initiated a BI in the same healthcare system. These finding supports prioritization of GLP-1RA as the first injectable regimen for the management of T2D.
本研究旨在比较常规治疗下起始使用胰高血糖素样肽-1 受体激动剂(GLP-1RA)或基础胰岛素(BI)的 2 型糖尿病(T2D)患者的心血管结局。
我们访问了意大利威尼托地区的行政索赔数据库,以确定 2014 年至 2018 年期间新使用 GLP-1RA 或 BI 的患者。实施倾向评分匹配(PSM)以获得具有相似特征的两组患者。主要终点为 3 点主要不良心血管事件(3P-MACE)。次要终点包括 3P-MACE 组成部分、心力衰竭住院、血运重建和不良事件。
在 5242201 名背景人群中,有 330193 人被确定患有糖尿病。PSM 产生了两组非常匹配的患者,每组 4063 人,他们在平均使用 2.5 种其他糖尿病药物后开始使用 GLP-1RA 或 BI。患者年龄为 63 岁,仅有 15%的患者有心血管疾病的基线史。在意向治疗分析的中位随访 24 个月期间,GLP-1RA 组发生 3P-MACE 的频率较低(HR 与 BI 为 0.59;95%CI 0.50-0.71;p<0.001)。所有次要心血管终点也明显有利于 GLP-1RA。在实际治疗方法和几种分层分析中都得到了证实。根据 E 值,未测量变量引起的混杂不太可能完全解释两组间心血管结局的差异。
在同一医疗体系中,起始使用 GLP-1RA 的 T2D 患者的心血管结局明显优于起始使用 BI 的匹配患者。这些发现支持将 GLP-1RA 作为 T2D 管理的首选注射方案。