Department of Internal Medicine, Jikei University School of Medicine, Minato-ku, Tokyo, Japan.
Milliman Inc, Chiyoda-ku, Tokyo, Japan.
BMJ Open. 2022 Mar 11;12(3):e045966. doi: 10.1136/bmjopen-2020-045966.
To compare the risk of cardiovascular events from the initiation of therapy between metformin and dipeptidyl peptidase-4 inhibitors (DPP-4i) as first-line therapy.
Retrospective cohort study using two claims databases.
The MDV database (provided by Medical Data Vision) comprised data from acute care hospitals, and the JMDC database (provided by JMDC) comprised data from individuals covered by health insurance societies.
Those who were diagnosed with type 2 diabetes at ≥18 years, prescribed metformin or DPP-4i as the first-line hypoglycaemic agent, had medical records of ≥6 months before the index prescription and had available glycated haemoglobin (HbA1c) data for the period, including the index date and 30 days before it (defined as the baseline) were included. Those diagnosed with type 1 diabetes and/or a history of myocardial infarction (MI) or cerebrovascular diseases were excluded.
The outcomes were cumulative risks from Kaplan-Meier curves or HRs of patients prescribed metformin compared with DPP-4i. The primary endpoint was the diagnosis of MI or stroke associated with hospitalisation. Patient demographics, prescribed drugs and laboratory test values of HbA1c and estimated glomerular filtration rate at baseline were adjusted. The study period starting from the index included treatment after initial monotherapy.
Overall, 2089 and 6686 patients in the MDV database and 1506 and 3635 in the JMDC database were prescribed metformin and DPP-4i, respectively. The HR of the primary endpoint was 0.879 with no statistical significance (95% CI 0.534 to 1.448, p=0.613) in the MDV database, while it was significantly lower, 0.398 (95% CI 0.213 to 0.742, 0.004) in the JMDC database.
Patients who received metformin as first-line therapy may have reduced cardiovascular events than those receiving DPP-4i. This study conforms to previous Japanese database studies, despite the consideration of its limitation being an observational design.
比较二甲双胍和二肽基肽酶-4 抑制剂（DPP-4i）作为一线治疗药物起始治疗时心血管事件的风险。
使用两个索赔数据库进行回顾性队列研究。
MDV 数据库（由 Medical Data Vision 提供）包含来自急症医院的数据，JMDC 数据库（由 JMDC 提供）包含来自健康保险协会覆盖个人的数据。
年龄≥18 岁被诊断为 2 型糖尿病、一线处方二甲双胍或 DPP-4i 作为降血糖药物、索引处方前有≥6 个月的病历记录且在该期间有可获得的糖化血红蛋白（HbA1c）数据（包括索引日期和之前的 30 天）的患者被纳入研究。排除被诊断为 1 型糖尿病和/或有心肌梗死（MI）或脑血管疾病病史的患者。
结局为 Kaplan-Meier 曲线的累积风险或与 DPP-4i 相比接受二甲双胍治疗的患者的 HR。主要终点是与住院相关的 MI 或中风诊断。调整了患者人口统计学、处方药物和基线时 HbA1c 和估算肾小球滤过率的实验室检查值。研究期间从索引开始包括初始单药治疗后的治疗。
在 MDV 数据库中，共有 2089 例和 6686 例患者被处方二甲双胍和 DPP-4i，在 JMDC 数据库中，分别有 1506 例和 3635 例患者被处方二甲双胍和 DPP-4i。MDV 数据库中主要终点的 HR 为 0.879，无统计学意义（95%CI 0.534 至 1.448，p=0.613），而在 JMDC 数据库中，HR 显著较低，为 0.398（95%CI 0.213 至 0.742，0.004）。
接受二甲双胍作为一线治疗的患者发生心血管事件的风险可能低于接受 DPP-4i 的患者。尽管考虑到这是一项观察性设计，但本研究与之前的日本数据库研究一致。
