恩帕格利弗洛辛的有效性和安全性:EMPRISE研究的最终结果
Phyo T Htoo1, Helen Tesfaye1, Sebastian Schneeweiss1
1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Diabetologia
|March 21, 2024
概括
与DPP-4抑制剂相比,empagliflozin在2型糖尿病患者中显著降低了心脏病发作和中风等心血管风险. 虽然增加了糖尿病酸症的风险,但它降低了急性损伤和低血糖的风险.
科学领域:
- 心脏病学 心脏病学
- 内分泌学 在内分泌学.
- 药物监督 药物监督 药物监督
背景情况:
- 有限的比较数据存在于empagliflozin与其他降血糖药物对2型糖尿病患者有不同的心血管风险.
- 为了弥补这一差距,使用现实数据启动了EMPagliflozin比较有效性和安全性研究 (EMPRISE).
研究的目的:
- 为了比较empagliflozin的安全性和有效性与二乙酶-4抑制剂 (DPP-4i) 在2型糖尿病管理中.
- 通过使用电子医疗数据库,在大型队列中评估心血管和安全结果.
主要方法:
- 一个1: 1的倾向评分与115116名2型糖尿病患者的队列研究相匹配,在2014-2019年期间启动了empagliflozin或DPP-4i.
- 有效性结局包括心肌梗塞 (MI),中风,心力衰竭 (HHF) 的住院治疗,主要不良心血管事件 (MACE) 和心血管死亡率.
- 安全性结果包括糖尿病酸性酸症 (DKA),急性损伤 (AKI),低血糖症,视网膜病变进展和其他不良事件.
主要成果:
- 与DPP-4i相比,empagliflozin显示了心脏病/中风 (HR 0.88),高血压 (HR 0.50),MACE (HR 0.73) 和心血管死亡率/高血压 (HR 0.57) 的风险降低.
- 绝对风险降低在老年患者和具有先前存在动脉样硬化心血管疾病 (ASCVD) 或心力衰竭的患者中更为明显.
- 恩帕格利弗洛辛与增加的DKA风险 (HR 1.78) 相关,但降低了AKI (HR 0.62),低血糖 (HR 0.75) 和视网膜病变进展 (HR 0.78) 的风险.
结论:
- 与DPP-4i相比,empagliflozin对心血管有显著的益处,特别是在高风险患者中.
- 安全性概况包括增加DKA风险,但也有利于AKI,低血糖和视网膜病变.
- 这些发现支持empagliflozin在2型糖尿病管理中的作用,特别是在患有心血管风险因素的患者中.
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