恩格列净与胰高血糖素样肽-1 受体激动剂对心肾的疗效：来自 EMPRISE 研究的最终年度结果。
Cardiorenal effectiveness of empagliflozin vs. glucagon-like peptide-1 receptor agonists: final-year results from the EMPRISE study.
机构信息
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, USA.
出版信息
Cardiovasc Diabetol. 2024 Feb 8;23(1):57. doi: 10.1186/s12933-024-02150-0.
BACKGROUND
No randomized clinical trials have directly compared the cardiorenal effectiveness of empagliflozin and GLP-1RA agents with demonstrated cardioprotective effects in patients with a broad spectrum of cardiovascular risk. We reported the final-year results of the EMPRISE study, a monitoring program designed to evaluate the cardiorenal effectiveness of empagliflozin across broad patient subgroups.
METHODS
We identified patients ≥ 18 years old with type 2 diabetes who initiated empagliflozin or GLP-1RA from 2014 to 2019 using US Medicare and commercial claims databases. After 1:1 propensity score matching using 143 baseline characteristics, we evaluated risks of outcomes including myocardial infarction (MI) or stroke, hospitalization for heart failure (HHF), major adverse cardiovascular events (MACE - MI, stroke, or cardiovascular mortality), a composite of HHF or cardiovascular mortality, and progression to end-stage kidney disease (ESKD) (in patients with chronic kidney disease stages 3-4). We estimated hazard ratios (HR) and rate differences (RD) per 1,000 person-years, overall and within subgroups of age, sex, baseline atherosclerotic cardiovascular disease (ASCVD), and heart failure (HF).
RESULTS
We identified 141,541 matched pairs. Compared with GLP-1RA, empagliflozin was associated with similar risks of MI or stroke [HR: 0.99 (0.92, 1.07); RD: -0.23 (-1.25, 0.79)], and lower risks of HHF [HR: 0.50 (0.44, 0.56); RD: -2.28 (-2.98, -1.59)], MACE [HR: 0.90 (0.82, 0.99); RD: -2.54 (-4.76, -0.32)], cardiovascular mortality or HHF [HR: 0.77 (0.69, 0.86); RD: -4.11 (-5.95, -2.29)], and ESKD [0.75 (0.60, 0.94); RD: -6.77 (-11.97, -1.61)]. Absolute risk reductions were larger in older patients and in those with baseline ASCVD/HF. They did not differ by sex.
CONCLUSIONS
The cardiovascular benefits of empagliflozin vs. cardioprotective GLP-1RA agents were larger in older patients and in patients with history of ASCVD or HF, while they did not differ by sex. In patients with advanced CKD, empagliflozin was associated with risk reductions of progression to ESKD.
背景
没有随机临床试验直接比较过恩格列净和 GLP-1RA 类药物在具有广泛心血管风险的患者中的心脏肾脏效果，这些药物已被证实具有心脏保护作用。我们报告了 EMPRISE 研究的最终年度结果，该监测计划旨在评估恩格列净在广泛的患者亚组中的心脏肾脏效果。
方法
我们使用美国医疗保险和商业索赔数据库，确定了 2014 年至 2019 年期间开始使用恩格列净或 GLP-1RA 类药物的年龄≥18 岁的 2 型糖尿病患者。使用 143 项基线特征进行 1:1 倾向评分匹配后，我们评估了包括心肌梗死（MI）或中风、心力衰竭（HF）住院、主要不良心血管事件（MACE - MI、中风或心血管死亡率）、HF 或心血管死亡率复合终点以及进展为终末期肾病（ESKD）（慢性肾脏病 3-4 期患者）在内的结局风险。我们总体评估和在年龄、性别、基线动脉粥样硬化性心血管疾病（ASCVD）和心力衰竭（HF）亚组内，估计了每 1000 人年的危险比（HR）和率差（RD）。
结果
我们确定了 141541 对匹配的患者。与 GLP-1RA 相比，恩格列净与 MI 或中风的风险相似[HR：0.99（0.92，1.07）；RD：-0.23（-1.25，0.79）]，HF 住院的风险更低[HR：0.50（0.44，0.56）；RD：-2.28（-2.98，-1.59）]，MACE 的风险更低[HR：0.90（0.82，0.99）；RD：-2.54（-4.76，-0.32）]，心血管死亡率或 HF 的风险更低[HR：0.77（0.69，0.86）；RD：-4.11（-5.95，-2.29）]，ESKD 的风险更低[0.75（0.60，0.94）；RD：-6.77（-11.97，-1.61）]。在年龄较大的患者和基线有 ASCVD/HF 的患者中，绝对风险降低幅度更大。它们在性别上没有差异。
结论
与具有心脏保护作用的 GLP-1RA 类药物相比，恩格列净的心血管益处更大，在年龄较大的患者和有 ASCVD 或 HF 病史的患者中更大，而在性别上没有差异。在晚期 CKD 患者中，恩格列净与进展为 ESKD 的风险降低相关。
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