Treatment intensification with bempedoic acid to achieve LDL-C goal in patients with ASCVD: A simulation model using a real-world patient cohort in the US

IF 1.4 Q3 PERIPHERAL VASCULAR DISEASE Atherosclerosis plus Pub Date : 2024-03-01 DOI:10.1016/j.athplu.2024.01.006
Kristen Migliaccio-Walle , David Elsea , Anand Gupta , Evelyn Sarnes , Kristel Griffith , Rajshree Pandey , Kristin Gillard
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Abstract

Background and aims

Guidelines recommend that high-risk patients with atherosclerotic cardiovascular disease (ASCVD) be treated with maximally tolerated statins to lower low-density lipoprotein cholesterol (LDL-C) levels and reduce the risk of major adverse cardiovascular events. In patients whose LDL-C remains elevated, non-statin adjunct therapies, including ezetimibe (EZE), bempedoic acid (BA), and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are recommended.

Methods

The impact of BA and EZE in a fixed-dose combination (FDC) on LDL-C goal attainment was evaluated using a simulation model developed for a United States cohort of high-risk adults with ASCVD. Treatment was simulated for 73,056 patients not at goal (LDL-C >70 mg/dL), comparing BA + EZE (FDC), EZE only, and no oral adjunct therapy (NOAT). The addition of PCSK9 inibitors was assumed after 1 year in patients not at LDL-C goal. Treatment efficacy was estimated from clinical trials. Patient-level outcomes were predicted over a 10-year horizon accounting for treatment discontinuation and general mortality.

Results

Baseline mean age of the cohort was 67 years, most were White (79%) and male (56%). A majority had established coronary artery disease (75%), 48% had diabetes, and mean LDL-C was 103.0 mg/dL. After 1 year, 79% of patients achieved LDL-C goal (mean, 61.1 mg/dL) with BA + EZE (FDC) compared to 58% and 42% with EZE (71.7 mg/dL) and NOAT (78.4 mg/dL), respectively.

Conclusions

This simulation shows that adding BA + EZE (FDC) to maximally tolerated statins would result in more patients achieving LDL-C goal than adding EZE alone or NOAT.

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使用贝母倍多酸加强治疗以实现 ASCVD 患者的低密度脂蛋白胆固醇目标:使用美国真实世界患者队列的模拟模型
背景和目的指南建议动脉粥样硬化性心血管疾病(ASCVD)高危患者接受最大耐受量他汀类药物治疗,以降低低密度脂蛋白胆固醇(LDL-C)水平,减少主要不良心血管事件的风险。对于低密度脂蛋白胆固醇(LDL-C)仍然升高的患者,建议使用非他汀类辅助疗法,包括依折麦布(EZE)、贝美多酸(BA)和9型丙蛋白转换酶亚基酶/kexin(PCSK9)抑制剂。方法使用针对美国高风险成人 ASCVD 患者队列开发的模拟模型,评估了固定剂量复方制剂(FDC)中的 BA 和 EZE 对实现 LDL-C 目标的影响。对 73,056 名未达目标(LDL-C 70 mg/dL)的患者进行了模拟治疗,比较了 BA + EZE(FDC)、仅 EZE 和无口服辅助疗法(NOAT)。假定未达到 LDL-C 目标的患者在 1 年后添加 PCSK9 抑制剂。疗效根据临床试验估算。在考虑治疗中断和一般死亡率的情况下,对 10 年内的患者水平结果进行了预测。大多数患者已患有冠状动脉疾病(75%),48%患有糖尿病,平均低密度脂蛋白胆固醇为 103.0 mg/dL。1 年后,79% 的患者使用 BA + EZE (FDC) 达到了 LDL-C 目标(平均值为 61.1 mg/dL),而使用 EZE(71.7 mg/dL)和 NOAT(78.4 mg/dL)的患者分别为 58% 和 42%。
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来源期刊
Atherosclerosis plus
Atherosclerosis plus Cardiology and Cardiovascular Medicine
CiteScore
2.60
自引率
0.00%
发文量
0
审稿时长
66 days
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