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非诺贝特的使用与糖尿病患者的死亡率降低和心血管事件减少相关:来自韩国国家健康保险服务队列的 10114 名患者的结果。

Fenofibrate Use Is Associated With Lower Mortality and Fewer Cardiovascular Events in Patients With Diabetes: Results of 10,114 Patients From the Korean National Health Insurance Service Cohort.

机构信息

Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang-si, South Korea

Data Science Team, Hanmi Pharmaceutical Co., Ltd., Seoul, South Korea.

出版信息

Diabetes Care. 2021 Aug;44(8):1868-1876. doi: 10.2337/dc20-1533. Epub 2021 Jun 22.

Abstract

OBJECTIVE

We investigated the long-term clinical efficacy of fenofibrate use with regard to mortality and cardiovascular outcomes in patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS

We performed a population-based cohort study using data of the South Korean National Health Insurance Service from 2003 to 2014. Of 63,727 participants with diabetes aged 40-79 years, 5,057 users of fenofibrate only were compared with 5,057 nonusers of fenofibrate and/or omega-3 fatty acid with 1:1 propensity matching. The primary end point was a composite of myocardial infarction, stroke, percutaneous coronary revascularization, and cardiac death for a median of 3 years.

RESULTS

The primary end point was significantly lower in fenofibrate users compared with those using neither fenofibrate nor omega-3 fatty acid (13.4 vs. 15.5 per 1,000 person-years; hazard ratio [HR] 0.76; 95% CI 0.62-0.94; = 0.010). Cardiac death (1.8 vs. 3.1 per 1,000 person-years; HR 0.59; 95% CI 0.352-0.987; = 0.0446), all-cause death (7.6 vs. 15.3 per 1,000 person-years; HR 0.437; 95% CI 0.340-0.562; < 0.0001), and stroke (6.5 vs. 8.6 per 1,000 person-years; HR 0.621; 95% CI 0.463-0.833; = 0.0015) were significantly lower in the fenofibrate group. When the duration of fenofibrate use was stratified by quartile, the risk decreased in quartile 4, with an HR of 0.347 (95% CI 0.226-0.532; < 0.0001). In subgroup analysis, the favorable effect of fenofibrate was sustained consistently across all subsets of patients, including those classified by LDL cholesterol, HDL cholesterol, and triglyceride levels.

CONCLUSIONS

Use of fenofibrate was associated with a lower rate of total and cardiac mortality and cardiovascular events in patients with type 2 diabetes during a 3-year follow-up in real-world large populations.

摘要

目的

我们研究了使用非诺贝特治疗 2 型糖尿病患者的长期临床疗效,包括死亡率和心血管结局。

研究设计和方法

我们使用韩国国家健康保险服务 2003 年至 2014 年的数据进行了一项基于人群的队列研究。在年龄为 40-79 岁的 63727 名糖尿病患者中,比较了仅使用非诺贝特的 5057 名患者与未使用非诺贝特和/或欧米伽-3 脂肪酸的 5057 名患者,采用 1:1 倾向评分匹配。主要终点是心肌梗死、中风、经皮冠状动脉血运重建和心脏死亡的复合终点,中位随访时间为 3 年。

结果

与既未使用非诺贝特也未使用欧米伽-3 脂肪酸的患者相比,非诺贝特使用者的主要终点显著降低(每 1000 人年 13.4 例 vs. 15.5 例;风险比 [HR] 0.76;95%CI 0.62-0.94; = 0.010)。心脏死亡(每 1000 人年 1.8 例 vs. 3.1 例;HR 0.59;95%CI 0.352-0.987; = 0.0446)、全因死亡(每 1000 人年 7.6 例 vs. 15.3 例;HR 0.437;95%CI 0.340-0.562; < 0.0001)和中风(每 1000 人年 6.5 例 vs. 8.6 例;HR 0.621;95%CI 0.463-0.833; = 0.0015)的发生率显著降低。当按四分位数分层时,非诺贝特使用时间在四分位数 4 时风险降低,HR 为 0.347(95%CI 0.226-0.532; < 0.0001)。在亚组分析中,非诺贝特的有利作用在所有患者亚组中持续存在,包括根据 LDL 胆固醇、HDL 胆固醇和甘油三酯水平分类的患者。

结论

在现实世界的大人群中,使用非诺贝特治疗 2 型糖尿病患者,在 3 年的随访期间,总死亡率、心脏死亡率和心血管事件发生率较低。

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