评估依洛尤单抗对高胆固醇血症和心血管疾病一级预防的效果：NHANES 1999-2018 研究。

Estimating the effect of inclisiran on hypercholesterolemia and primary prevention of cardiovascular disease: the NHANES 1999-2018 study.

机构信息

Department of Cardiology, Shanghai Tenth People's Hospital, School of Medicine, Tongji University, 301 Middle Yanchang Road, Shanghai, 200072, China.

Department of Cardiology, Guizhou Provincial People's Hospital, 83 Zhongshan East Road, Guiyang, Guizhou, 550002, China.

出版信息

Lipids Health Dis. 2024 Sep 27;23(1):313. doi: 10.1186/s12944-024-02294-8.

DOI:10.1186/s12944-024-02294-8

PMID:39334296

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11430533/

Abstract

BACKGROUND

Hypercholesterolemia has been identified as an independent predictor of cardiovascular disease (CVD). Inclisiran, an innovative small interfering RNA agent, is anticipated to result in a notable reduction of approximately 50% in low-density lipoprotein cholesterol (LDL-C) levels. Given its transformative impact, this study scrutinized the eligibility of the US population for inclisiran treatment and evaluated its potential effects on hypercholesterolemia and the primary prevention of CVD.

METHODS

This study applied the eligibility criteria from the ORION 10 and 11 trials to the 1999-2018 National Health and Nutrition Examination Survey (NHANES) dataset to estimate the size of the eligible population for atherosclerotic cardiovascular disease (ASCVD) and ASCVD-risk equivalents. Utilizing the reduction in LDL-C levels from ORION 10, this study predicted the impact of inclisiran on LDL-C levels among ASCVD patients. Similarly, leveraging the changes in lipid levels from ORION 11, this study predicted inclisiran's effect on the 10-year change in CVD risk and preventable CVD events in the ASCVD-risk equivalents population, employing the Framingham CVD Risk Score.

RESULTS

The study identified 579 ASCVD patients (5 million) and 382 ASCVD-risk equivalents (2.66 million) who met the eligibility criteria from ORION 10 and 11. Among the ASCVD population, 3.5 million (70.2%) would achieve a ≥ 50% reduction in LDL-C levels after treatment. Furthermore, 4.6 million (91.3%) would achieve LDL-C levels < 70 mg/dL, and 3.8 million (75%) would achieve LDL-C levels < 55 mg/dL after treatment. For the ASCVD-risk equivalents population, the estimated 10-year CVD risk would decrease from 25.3 to 17.7%, an absolute reduction of 7.6% and a relative reduction of 30% following inclisiran treatment, potentially preventing 202,353 CVD events over a decade, including 138,084 coronary heart disease cases, 37,351 strokes, and 23,894 congestive heart failure cases.

CONCLUSIONS

Inclisiran has the potential to substantially reduce the prevalence of hypercholesterolemia and prevent nearly 200,000 CVD events in eligible US adults.

摘要

背景

高胆固醇血症已被确定为心血管疾病（CVD）的独立预测因子。Inclisiran 是一种创新的小干扰 RNA 药物，预计可将低密度脂蛋白胆固醇（LDL-C）水平降低约 50%。鉴于其变革性的影响，本研究对美国人群接受 inclisiran 治疗的资格进行了审查，并评估了其对高胆固醇血症和 CVD 一级预防的潜在影响。

方法

本研究应用 ORION 10 和 11 试验的入选标准，对 1999-2018 年全国健康和营养调查（NHANES）数据集进行分析，以估算适合治疗动脉粥样硬化性心血管疾病（ASCVD）和 ASCVD 风险等效物的人群规模。利用 ORION 10 中的 LDL-C 降低水平，本研究预测了 inclisiran 在 ASCVD 患者中的 LDL-C 水平的影响。同样，利用 ORION 11 中的血脂变化，本研究预测了 inclisiran 在 ASCVD 风险等效物人群中对 10 年 CVD 风险变化和可预防 CVD 事件的影响，采用弗雷明汉 CVD 风险评分。

结果

本研究确定了 579 名 ASCVD 患者（500 万人）和 382 名 ASCVD 风险等效物（266 万人）符合 ORION 10 和 11 的入选标准。在 ASCVD 人群中，350 万人（70.2%）在治疗后 LDL-C 水平降低≥50%。此外，460 万人（91.3%）的 LDL-C 水平将<70mg/dL，380 万人（75%）的 LDL-C 水平将<55mg/dL。对于 ASCVD 风险等效物人群，估计的 10 年 CVD 风险将从 25.3%降至 17.7%，绝对降低 7.6%，相对降低 30%，经 inclisiran 治疗后，可能预防未来 10 年发生 202353 例 CVD 事件，包括 138084 例冠心病、37351 例中风和 23894 例充血性心力衰竭。