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Bem4.3

Bempedoic Acid Research

Mostly mechanism / observationalModerate safety

7 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

Most Bempedoic Acid studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.

Most evidence is from medium-quality meta-analyses and randomised trials published 2016–2023 with a typical study size of 2,230 participants.

Based on 7 studies · 1 meta-analysis · 5 RCTs · 21,413 total participants

Confidence

High

By outcome

LDL cholesterol & lipids
Mostly mechanism / observational6 studies
Safety profile
Mostly mechanism / observational5 studies
Cardiovascular events
Mostly mechanism / observational3 studies
Glucose & metabolic
Mostly mechanism / observational3 studies
Liver health
Too few graded studies1 study

Steady research

1 study in the last 5 years · Latest meta-analysis: 2020

20162023

1RCTn=13,970 · very large study2023

Among statin-intolerant patients, treatment with bempedoic acid was associated with a lower risk of major adverse cardiovascular events.

Nissen, Lincoff, Brennan, Ray, Mason, Kastelein · The New England journal of medicine (2023)

CLEAR Outcomes: ~13,970 statin-intolerant patients randomized to bempedoic acid 180 mg vs placebo
Significant reduction in the primary composite of major adverse cardiovascular events
Landmark cardiovascular-outcomes evidence — the strongest support for the drug

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2RCTn=2,230 · very large study2019

Bempedoic acid added to maximally tolerated statin therapy significantly lowered LDL cholesterol levels.

Ray, Bays, Catapano, Lalwani, Bloedon, Sterling · The New England journal of medicine (2019)

CLEAR Harmony: 2,230 patients with ASCVD and/or familial hypercholesterolemia on maximally tolerated statins
Bempedoic acid lowered LDL-C significantly more than placebo at week 12
Adverse-event rates were broadly similar; higher rates of gout and elevated uric acid

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3RCTn=779 · large study2019

Bempedoic acid added to maximally tolerated statins significantly lowered LDL cholesterol over 52 weeks.

Goldberg AC, Leiter LA, Stroes ESG, Baum SJ, Hanselman JC, Bloedon LT, Lalwani ND, Patel PM, Zhao X, Duell PB. · JAMA (2019)

CLEAR Wisdom: 779 high-cardiovascular-risk patients on maximally tolerated statins
Bempedoic acid reduced LDL-C by ~15-17 percentage points more than placebo
Confirmed durable LDL lowering as add-on therapy

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4Meta-Analysisn=3,788 · very large study2020

Bempedoic acid significantly reduced LDL cholesterol and was associated with increased risk of gout and elevated uric acid.

Cicero, Fogacci, Hernandez, Banach · PLoS medicine (2020)

Systematic review and meta-analysis of 10 randomized trials (~3,788 patients)
Pooled LDL-C reduction of roughly 22-24% versus placebo
Quantified higher risk of gout, hyperuricemia, and elevated liver enzymes

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5RCTn=345 · medium study2019

In statin-intolerant patients, bempedoic acid significantly reduced LDL cholesterol versus placebo.

Laufs, Banach, Mancini, Gaudet, Bloedon, Sterling · Journal of the American Heart Association (2019)

CLEAR Serenity: 345 statin-intolerant patients
Bempedoic acid lowered LDL-C by ~21 percentage points more than placebo
Demonstrated efficacy specifically in the statin-intolerant population

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6RCTn=301 · medium study2020

Bempedoic acid plus ezetimibe added to statins produced greater LDL-cholesterol lowering than either component alone.

Ballantyne, Laufs, Ray, Leiter, Bays, Goldberg · European journal of preventive cardiology (2020)

Phase-3 trial of the bempedoic acid + ezetimibe fixed-dose combination
Combination lowered LDL-C by ~36% versus placebo at week 12
Supports the Nexlizet combination for larger LDL reductions

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7Preclinical2016

Bempedoic acid is a liver-specific ATP-citrate lyase inhibitor that lowers LDL-cholesterol and attenuates atherosclerosis.

Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. · Nature communications (2016)

Established the ATP-citrate lyase mechanism upstream of HMG-CoA reductase
Showed liver-selective activation explaining the lack of muscle effects
Lowered LDL-C and reduced atherosclerosis in preclinical models

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View in Research Library

Bempedoic Acid Research

Mostly mechanism / observational

Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients.

Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol.

Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial.

Efficacy and safety of bempedoic acid for the treatment of hypercholesterolemia: A systematic review and meta-analysis.

Efficacy and safety of bempedoic acid in patients with hypercholesterolemia and statin intolerance.

Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy.

Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis.