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临床试验/NCT07239414
NCT07239414尚未招募3 期

Bempedoic Acid Versus Statins in Primary-Prevention Patients With Suboptimal Statin Adherence: Effects on LDL-C Reduction and Tolerability

Sohaib Ashraf0 个研究点目标入组 690 人开始时间: 2025年11月10日最近更新:
干预措施

试验速览

阶段
3 期
状态
尚未招募
发起方
Sohaib Ashraf
入组人数
690
主要终点
Percentage change in LDL-C

研究概览

简要总结

Bempedoic acid is an oral, non-statin LDL-cholesterol (LDL-C) lowering agent that inhibits ATP citrate lyase (ACL), upstream of HMG-CoA reductase (the enzyme inhibited by statins).

MDPI

+1

In patients with hypercholesterolemia who are unable to tolerate statins, or have sub-optimal statin adherence/tolerance, bempedoic acid has been shown to reduce LDL-C by ~20-30% (monotherapy) and more when added to other therapies (e.g., ezetimibe) (≈30-40%).

PubMed

  • 2 medicinejournal.in
  • 2

In the large primary-prevention subgroup of the trial CLEAR Outcomes (statin-intolerant patients without prior cardiovascular event), bempedoic acid (180 mg daily) lowered LDL-C by ~21.3% and hs-CRP by ~21.5%. It also was associated with a significant reduction in major adverse cardiovascular events (MACE): hazard ratio 0.70 (95% CI 0.55-0.89) versus placebo over ~40 months.

PubMed +1

Regarding tolerability: muscle-related adverse events appear lower compared to statins (because bempedoic acid is activated only in the liver, not in skeletal muscle) and it appears generally well tolerated, but there are signals of increased uric acid/gout, elevated hepatic enzymes, and creatinine/renal effects.

MDPI

+1

Comparative cardiovascular benefit (when normalized per unit LDL-C reduction) suggests that bempedoic acid may yield similar relative risk reductions as statins, though absolute LDL-C lowering is less.

详细描述

Mechanism: Bempedoic acid works by inhibiting ACL in the cholesterol-synthesis pathway; since the activating enzyme is present only in the liver (not muscle), the risk of muscle-related side-effects is diminished.

Frontiers

Indication/Use Case: Particularly useful in patients who (a) are at elevated cardiovascular risk (primary prevention or secondary), (b) cannot tolerate statins or have suboptimal adherence, and (c) need further LDL-C reduction beyond statin (or in place of statin) therapy.

Efficacy:

~20-30% LDL-C lowering as monotherapy in statin-intolerant patients. PubMed

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm A (Bempedoic acid)

Active Comparator

BA 180 mg once daily + placebo statin.

干预措施: Bempedoic Acid 180 MG Oral Tablet (Drug)

Arm A (Bempedoic acid)

Active Comparator

BA 180 mg once daily + placebo statin.

干预措施: Placebo (Drug)

Arm B (Statin)

Placebo Comparator

Rosuvastatin 5 mg once daily + placebo BA.

干预措施: Rosuvastatin 5 mg (Drug)

Arm B (Statin)

Placebo Comparator

Rosuvastatin 5 mg once daily + placebo BA.

干预措施: Placebo (Drug)

结局指标

主要结局

Percentage change in LDL-C

时间窗: 6 months

Percentage change in LDL-C from baseline LDL-C

Composite adherence/tolerability endpoint:

时间窗: 6 months

treatment discontinuation, muscle-related symptoms, or laboratory abnormalities (ALT/AST \>3× ULN, uric acid \>9 mg/dL).

次要结局

  • Absolute change in LDL-C(6 months)
  • Proportion achieving LDL-C <100 mg/dL (or <70 mg/dL for diabetics).(6 months)
  • Change in hs-CRP(6 months)

研究者

发起方
Sohaib Ashraf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sohaib Ashraf

Consultant Cardiologist

Sheikh Zayed Federal Postgraduate Medical Institute

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