苯甲多酸和主要心血管不良事件在整个肾功能谱：明确结果试验的二次分析

IF 5.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American journal of preventive cardiology Pub Date : 2025-09-01 DOI:10.1016/j.ajpc.2025.101126

Carolina P. Zingano MD , Danielle Brennan MS , Steven E. Nissen MD , Luke J. Laffin MD

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引用次数: 0

摘要

治疗领域acvd预防——主要和次要背景肾功能下降是心血管发病率和死亡率增加的独立危险标志。他汀类药物是预防心血管疾病的基石，然而他汀类药物经常不能耐受。苯培多酸可预防他汀类药物不耐受患者的主要不良心血管事件（MACE）。然而，在不同肾功能水平下，苯戊酸对MACE的预防作用尚不清楚。CLEAR Outcomes试验将他汀类药物不耐受的高风险或已确诊心血管疾病的成年人随机分配至180mg苯甲多酸组或安慰剂组。我们通过估算肾小球滤过率(eGFR)≥90来分析亚组中MACE-4和MACE-3的结局；≥60 ~ 90；≥45 ~ 60；和& lt; 45 ml / min / 1.73平方米。我们还以连续的方式分析了治疗效果与eGFR之间的相互作用。结果13970名成人随机分为苯戊多酸组和安慰剂组，其中eGFR≥90ml /min/1.73m2的有2449人，60 ~ 90ml /min/1.73m2的有8604人，45 ~ 60ml /min/1.73m2的有2342人，低于45ml /min/1.73m2的有574人。对于MACE-4 （pinteraction = 0.93）和MACE-3 (pinteraction = 0.51)，不同eGFR组间苯戊酸对MACE的预防作用均无差异。通过检测eGFR作为连续测量，未检测到相互作用。两组中出现不良事件的患者比例随着基线eGFR的降低而增加，但在苯甲多酸组和安慰剂组之间相似。结论：与安慰剂相比，苯甲多酸降低了他汀类药物不耐受患者的MACE，与基线eGFR无关。

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BEMPEDOIC ACID AND MAJOR ADVERSE CARDIOVASCULAR EVENTS ACROSS THE SPECTRUM OF KIDNEY FUNCTION: A SECONDARY ANALYSIS OF THE CLEAR OUTCOMES TRIAL

Therapeutic Area

CVD Prevention – Primary and Secondary

Background

Decreased kidney function is an independent risk marker for increased cardiovascular morbidity and mortality. Statins are a cornerstone of cardiovascular disease prevention, however statins are frequently not tolerated. Bempedoic acid prevents major adverse cardiovascular events (MACE) among statin-intolerant patients. However, the effect of bempedoic acid in preventing MACE at different levels of kidney function is unknown.

Methods

The CLEAR Outcomes trial randomized statin-intolerant adults at high risk of, or with established cardiovascular disease, to bempedoic acid 180 mg or placebo. We analyzed MACE-4 and MACE-3 outcomes in subgroups by estimated glomerular filtration rate (eGFR), ≥90; ≥60 to <90; ≥45 to <60; and <45mL/min/1.73m2. We also analyzed the interaction between treatment effects and eGFR in a continuous manner.

Results

13970 adults were randomized to bempedoic acid or placebo, 2449 of them had eGFR ≥90 ml/min/1.73m2, 8604 had eGFR of 60-90 ml/min/1.73m2, 2342 had eGFR of 45-60 ml/min/1.73m2 and 574 had eGFR below 45 ml/min/1.73m2. The effect of bempedoic acid on prevention of MACE did not differ by eGFR groups for both MACE-4 (pinteraction = 0.93) and MACE-3 (pinteraction = 0.51). No interaction was detected by examining eGFR as a continuous measurement. The proportion of patients experiencing any adverse event in both groups increased with decreasing baseline eGFR but was similar between the bempedoic acid and placebo groups.