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恩格列净对慢性心力衰竭患者的长期替代心血管结局:系统评价和荟萃分析。

Long-term surrogate cardiovascular outcomes of SGLT2 inhibitor empagliflozin in chronic heart failure: a systematic review and meta-analysis.

机构信息

Department of Cardiology, Bishan Hospital of Chongqing Medical University, Bishan Hospital of Chongqing, Chongqing, P.R. China.

Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, P.R. China.

出版信息

BMC Cardiovasc Disord. 2024 Nov 22;24(1):663. doi: 10.1186/s12872-024-04316-w.

DOI:10.1186/s12872-024-04316-w
PMID:39578752
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11583546/
Abstract

The sodium‒glucose cotransporter-2 (SGLT2) inhibitor empagliflozin (EMPA) has been demonstrated to reduce the risk of cardiovascular mortality or hospitalization for heart failure (HF) in patients. Nevertheless, data concerning the long-term cardiovascular effects in clinically important subgroups are scarce. A prespecified meta-analysis of randomized controlled trials (RCTs) was conducted to assess the long-term effects of EMPA on cardiovascular outcomes in HF patients, regardless of HF type and glycemic status. The assessment included parameters related to left ventricular (LV) remodeling, including the LV volume, the LV mass index (LVMI), the ejection fraction, the systolic blood pressure, and biomarkers. Moreover, the effects of the treatment on exercise capacity and quality of life (QoL) were analyzed. Furthermore, these cardiovascular parameters were evaluated in prespecified subgroups of HF patients, including type of HF, type 2 diabetes status, and duration of therapy. The quantitative meta-analysis was synthesized and analyzed via the statistical software Stata 17.0. The meta-analysis revealed that EMPA administration significantly contributed to a reduction in systolic blood pressure (SBP) (MD = 4.93 mmHg, 95% CI=[-9.67, -0.19]; P < 0.0001) and left ventricular end-diastolic volume (LVEDV) (MD=-18.03 mL, 95% CI=[-25.4, -10.67], P < 0.0001). Furthermore, left ventricular end-systolic volume (LVESV) (MD=-16.09 mL, 95% CI=[-26.94, -5.25]; P < 0.0001) and N-terminal pro-B-type NP (NT-proBNP) (SMD=-0.54, 95% CI=[-0.94, -0.13]; P = 0.01) significantly decreased. These decreases were accompanied by improvements in the 6-minute walk distance (6MWD, SMD = 0.78, 95% CI=[-0.22, -1.79], P = 0.13) and KCCQ score (MD = 1.98, 0.97-2.99; P < 0.0001). The results of the subgroup analysis indicated that EMPA administration was associated with more pronounced benefits in terms of cardiac remodeling, function and exercise capacity for specific populations, including (1) HF with a reduced ejection fraction (HFrEF); (2) the absence of diabetes; and (3) treatment for no less than 6 months. Additionally, EMPA may lead to an increased risk of cardiovascular adverse events (AEs) but is less effective for improving the QoL in HF patients with preserved EF (HFpEF) populations.

摘要

钠-葡萄糖共转运蛋白 2 (SGLT2) 抑制剂恩格列净 (EMPA) 已被证明可降低心血管死亡率或心力衰竭 (HF) 住院风险。然而,有关临床重要亚组的长期心血管影响的数据仍然很少。进行了一项预先指定的随机对照试验 (RCT) 的荟萃分析,以评估 EMPA 对 HF 患者心血管结局的长期影响,无论 HF 类型和血糖状态如何。评估包括与左心室 (LV) 重塑相关的参数,包括 LV 容积、LV 质量指数 (LVMI)、射血分数、收缩压和生物标志物。此外,还分析了治疗对运动能力和生活质量 (QoL) 的影响。此外,还在 HF 患者的预设亚组中评估了这些心血管参数,包括 HF 类型、2 型糖尿病状态和治疗持续时间。通过统计软件 Stata 17.0 对定量荟萃分析进行了综合和分析。荟萃分析显示,EMPA 给药显著有助于降低收缩压 (SBP) (MD = 4.93 mmHg,95% CI [−9.67,−0.19];P < 0.0001) 和左心室舒张末期容积 (LVEDV) (MD = -18.03 mL,95% CI [−25.4,−10.67],P < 0.0001)。此外,左心室收缩末期容积 (LVESV) (MD = -16.09 mL,95% CI [−26.94,−5.25];P < 0.0001) 和 N 末端 pro-B 型 NP (NT-proBNP) (SMD = -0.54,95% CI [−0.94,−0.13];P = 0.01) 也显著降低。这些减少伴随着 6 分钟步行距离 (6MWD,SMD = 0.78,95% CI [−0.22,−1.79],P = 0.13) 和 KCCQ 评分 (MD = 1.98,0.97-2.99;P < 0.0001) 的改善。亚组分析结果表明,EMPA 给药与特定人群的心脏重塑、功能和运动能力的更显著获益相关,包括 (1) 射血分数降低的心力衰竭 (HFrEF);(2) 无糖尿病;和 (3) 治疗时间不少于 6 个月。此外,EMPA 可能会增加心血管不良事件 (AE) 的风险,但对改善射血分数保留的心力衰竭 (HFpEF) 患者的生活质量效果较差。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cbb/11583546/f5ecc3b3caf5/12872_2024_4316_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cbb/11583546/c9c0e16e3a72/12872_2024_4316_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cbb/11583546/f66226b62b02/12872_2024_4316_Fig2_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cbb/11583546/c9c0e16e3a72/12872_2024_4316_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cbb/11583546/f66226b62b02/12872_2024_4316_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cbb/11583546/f5ecc3b3caf5/12872_2024_4316_Fig3_HTML.jpg

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本文引用的文献

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Empagliflozin: A Review in Symptomatic Chronic Heart Failure.恩格列净:在有症状的慢性心力衰竭中的评价。
Drugs. 2022 Nov;82(16):1591-1602. doi: 10.1007/s40265-022-01778-0. Epub 2022 Nov 14.
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Comparison of Cardiovascular Outcomes Between Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes: A Meta-Analysis.达格列净与恩格列净治疗2型糖尿病患者心血管结局的比较:一项荟萃分析
Cureus. 2022 Jul 26;14(7):e27277. doi: 10.7759/cureus.27277. eCollection 2022 Jul.
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Empagliflozin for Heart Failure With Preserved Left Ventricular Ejection Fraction With and Without Diabetes.
恩格列净治疗伴有或不伴有糖尿病的射血分数保留的心力衰竭。
Circulation. 2022 Aug 30;146(9):676-686. doi: 10.1161/CIRCULATIONAHA.122.059785. Epub 2022 Jun 28.
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Empagliflozin Improves Cognitive Impairment in Frail Older Adults With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction.恩格列净可改善伴有射血分数保留的心力衰竭的 2 型糖尿病虚弱老年患者的认知障碍。
Diabetes Care. 2022 May 1;45(5):1247-1251. doi: 10.2337/dc21-2434.
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The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial.钠-葡萄糖协同转运蛋白 2 抑制剂恩格列净治疗急性心力衰竭住院患者的多中心随机试验。
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