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Bempedoic Acid

Bempedoic acid is an innovative drug being studied in clinical trials for its potential to lower cholesterol levels and reduce cardiovascular risk. This article explores the use of bempedoic acid in various clinical trials, examining its efficacy, safety, and potential benefits for patients with hyperlipidemia and other cardiovascular risk factors.

Table of Contents

What is Bempedoic Acid?

Bempedoic acid is a medication used to lower cholesterol levels in the blood. It’s also known by the brand names Nexletol (when used alone) and Nexlizet (when combined with another cholesterol-lowering drug called ezetimibe)[1]. Bempedoic acid is a new type of cholesterol-lowering drug that works differently from other medications like statins.

How Does It Work?

Bempedoic acid works by blocking an enzyme in the body called ATP-citrate lyase (ACL). This enzyme is involved in the production of cholesterol in the liver. By inhibiting ACL, bempedoic acid reduces the amount of cholesterol your body makes[2]. This leads to lower levels of LDL-C (often called “bad” cholesterol) in your blood. It also helps your liver remove more LDL-C from your bloodstream.

What Conditions Does Bempedoic Acid Treat?

Bempedoic acid is primarily used to treat the following conditions:

  • Hypercholesterolemia: This is a condition where you have high levels of cholesterol in your blood[3].
  • Atherosclerotic Cardiovascular Disease (ASCVD): This refers to the buildup of plaque in your arteries, which can lead to heart attacks and strokes[3].
  • Heterozygous Familial Hypercholesterolemia (HeFH): This is an inherited condition that causes very high cholesterol levels from birth[4].

Bempedoic acid is usually prescribed for people who can’t take statins (another type of cholesterol-lowering drug) due to side effects, or for those who need additional cholesterol lowering even when taking the highest tolerated dose of statins[5].

How Effective is Bempedoic Acid?

Clinical trials have shown that bempedoic acid can significantly lower LDL-C levels. When added to other cholesterol-lowering treatments, it can provide additional benefits:

  • When added to maximally tolerated statin therapy, bempedoic acid lowered LDL-C by about 18% more than placebo after 12 weeks of treatment[3].
  • In patients who can’t take statins, bempedoic acid lowered LDL-C by about 28% compared to placebo after 12 weeks[5].
  • When combined with ezetimibe (another cholesterol-lowering drug), the combination lowered LDL-C by about 38% more than placebo[1].

In addition to lowering LDL-C, bempedoic acid also reduces other markers of cardiovascular risk, such as non-HDL cholesterol, total cholesterol, and apolipoprotein B[3].

Potential Side Effects

Like all medications, bempedoic acid can cause side effects. Common side effects reported in clinical trials include:

  • Upper respiratory tract infections
  • Muscle spasms
  • Back pain
  • Abdominal pain or discomfort
  • Increased levels of uric acid in the blood

In some cases, bempedoic acid may cause increases in liver enzymes or creatinine (a marker of kidney function). Your doctor will monitor these with blood tests[6].

Use in Special Populations

Bempedoic acid is being studied in various populations:

  • Children and Adolescents: A study is underway to evaluate the use of bempedoic acid in children and adolescents (ages 6-17) with heterozygous familial hypercholesterolemia[4].
  • Pregnant Women: A pregnancy surveillance program is in place to assess the safety of bempedoic acid in pregnant women and their babies[7].
  • People with HIV: A study is investigating the effects of bempedoic acid on cardiovascular risk in people living with HIV[2].

Ongoing Research

Research on bempedoic acid is ongoing. Some areas of current investigation include:

  • Long-term safety and effectiveness[8]
  • Use in combination with other cholesterol-lowering drugs[6]
  • Effects on liver fat in people with non-alcoholic fatty liver disease and type 2 diabetes[9]

These ongoing studies will help researchers and doctors better understand how to use bempedoic acid to improve heart health in different groups of patients.

Aspect Details
Primary Use Lowering LDL cholesterol in patients with hyperlipidemia
Mechanism of Action Inhibition of ATP-citrate lyase enzyme in the liver
Efficacy Significant reduction in LDL-C levels (17-18% vs placebo in some trials)
Safety Profile Generally well-tolerated; long-term safety data still being collected
Combination Therapy Studied with statins, ezetimibe, and as monotherapy
Target Populations Patients with hyperlipidemia, ASCVD, statin intolerance, HeFH
Additional Benefits Potential improvements in inflammation markers and glycemic parameters
Ongoing Research Long-term cardiovascular outcomes, use in specific populations (e.g., pediatric HeFH)

FAQ

  • What is bempedoic acid? Bempedoic acid is an oral medication that works by inhibiting an enzyme called ATP-citrate lyase, which is involved in cholesterol synthesis in the liver. It is being studied as a treatment for lowering LDL cholesterol levels in patients with hyperlipidemia.
  • How effective is bempedoic acid in lowering cholesterol? Clinical trials have shown that bempedoic acid can significantly lower LDL cholesterol levels. For example, one study found that it reduced LDL-C by 17-18% compared to placebo after 12 weeks of treatment.
  • Is bempedoic acid safe to use? The safety profile of bempedoic acid is being closely monitored in clinical trials. So far, it appears to be generally well-tolerated, with the most common side effects being mild to moderate. However, long-term safety data is still being collected.
  • Can bempedoic acid be used with other cholesterol-lowering medications? Yes, clinical trials are studying bempedoic acid both as a standalone treatment and in combination with other lipid-lowering therapies, such as statins and ezetimibe. Some studies are specifically looking at its use in patients who are statin-intolerant.
  • What types of patients might benefit from bempedoic acid? Bempedoic acid is being studied in various patient populations, including those with hyperlipidemia, atherosclerotic cardiovascular disease, and those who are statin-intolerant. It may be particularly beneficial for patients who need additional LDL-C lowering beyond what can be achieved with current therapies.

Ongoing Clinical Trials on Bempedoic Acid

  • Comparison of Obicetrapib and Bempedoic Acid in Patients with Dyslipidemia at High to Very High Cardiovascular Risk

    Recruiting

    1 1 1
    Investigated drugs:
    Czechia Germany Italy The Netherlands Poland Slovakia +1

  • Study on MK-0616, Ezetimibe, and Bempedoic Acid for Adults with High Cholesterol

    Not recruiting

    1 1 1
    Investigated drugs:
    France Spain

  • Study of Bempedoic Acid for Children Aged 6-17 with Familial Hypercholesterolemia

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Germany The Netherlands Spain

  • Study on Bempedoic Acid with Atorvastatin and Ezetimibe for Patients with Coronary Artery Disease After Heart Attack

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany

  • Study Comparing Inclisiran and Bempedoic Acid for Lowering LDL Cholesterol in Patients with Atherosclerotic Cardiovascular Disease

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany

Glossary

  • Hyperlipidemia: A condition characterized by abnormally high levels of lipids (fats) in the blood, including cholesterol and triglycerides.
  • LDL-C: Low-density lipoprotein cholesterol, often referred to as 'bad' cholesterol. High levels of LDL-C are associated with an increased risk of cardiovascular disease.
  • ATP-citrate lyase: An enzyme involved in the production of cholesterol in the liver. Bempedoic acid works by inhibiting this enzyme.
  • Statin: A class of drugs commonly used to lower cholesterol levels by inhibiting an enzyme involved in cholesterol production in the liver.
  • Atherosclerotic Cardiovascular Disease (ASCVD): A condition where plaque builds up inside the arteries, leading to a narrowing of the blood vessels and increased risk of heart attack and stroke.
  • Ezetimibe: A medication that lowers cholesterol by reducing its absorption in the intestines.
  • Heterozygous Familial Hypercholesterolemia (HeFH): A genetic disorder characterized by very high levels of LDL cholesterol from birth, leading to an increased risk of early cardiovascular disease.
  • High-sensitivity C-reactive Protein (hsCRP): A marker of inflammation in the body, often used to assess cardiovascular risk.
  • Non-HDL-C: All cholesterol that is not high-density lipoprotein (HDL) cholesterol. It includes LDL-C and other atherogenic lipoproteins.
  • Apolipoprotein B (Apo B): A protein component of many lipoproteins, including LDL. Levels of Apo B are used as an indicator of cardiovascular risk.

References

  1. https://clinicaltrials.gov/study/NCT03337308
  2. https://clinicaltrials.gov/study/NCT05488431
  3. https://clinicaltrials.gov/study/NCT02991118
  4. https://clinicaltrials.eu/trial/study-of-bempedoic-acid-for-children-aged-6-17-with-familial-hypercholesterolemia/
  5. https://clinicaltrials.gov/study/NCT02988115
  6. https://clinicaltrials.gov/study/NCT03193047
  7. https://clinicaltrials.gov/study/NCT05103254
  8. https://clinicaltrials.gov/study/NCT03067441
  9. https://clinicaltrials.gov/study/NCT06035874