Evidence mapPaperPMID 32980290Full record

ArticleJournal of clinical lipidology

Bempedoic acid safety analysis: Pooled data from four phase 3 clinical trials.

Harold E Bays, Maciej Banach, Alberico L Catapano, P Barton Duell, Antonio M Gotto, Ulrich Laufs, Lawrence A Leiter, G B John Mancini, Kausik K Ray, LeAnne T Bloedon and 3 more

Registry-linked trialOpen access · bronzeAbstract read
PubMed Publisher
In one paragraph

Article in Journal of clinical lipidology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT07255820. Cited by 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 pooled it
13.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07255820 phase4completed

Comparative Efficacy and Safety of Dual Versus Triple Lipid-Lowering Therapies (Rosuvastatin/Ezetimibe, Bempedoic Acid/Ezetimibe, and Rosuvastatin/Ezetimibe/Bempedoic Acid ) in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol

Ran2026Enrolled126Registered outcomes8Posted comparisons0ConditionsHypercholesterolemia / Elevated LDL Cholesterol, Type 2 Diabetes MellitusArmsBempedoic Acid + Ezetimibe, Rosuvastatin + Ezetimibe, Rosuvastatin + Ezetimibe + Bempedoic Acid
Open the trial in the graph
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 97 citations in OpenAlex.

  1. Pooled it
  2. Bempedoic Acid can Reduce Cardiovascular Events in Combination with Statins or As Monotherapy: A Systematic Review and Meta-analysis.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023 · on this map
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Three months of bempedoic acid treatment does not affect cystatin C-based estimation of glomerular filtration rate.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2025
    Observational
  10. Review
  11. Article
  12. Review
  13. Article
  14. Bempedoic Acid: A Review in Cardiovascular Risk Reduction in Statin-Intolerant Patients.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025
    Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 6 countries.

Harold E BaysLouisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA. Electronic address: hbaysmd@outlook.com.
Maciej BanachDepartment of Hypertension, Medical University of Łódź, Łódź, Poland.
Alberico L CatapanoDepartment of Pharmacological and Biomolecular Sciences, University of Milan and Multimedica IRCCS, Milan, Italy.
P Barton DuellCenter for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon, USA.
Antonio M GottoHouston Methodist Research Institute, Houston, Texas, USA; Weill Cornell Medicine, New York, New York, USA.
Ulrich LaufsKlinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany.
Lawrence A LeiterDivision of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
G B John ManciniDivision of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.
Kausik K RayDepartment of Primary Care and Public Health, Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, UK.
LeAnne T BloedonEsperion Therapeutics, Inc., Ann Arbor, Michigan, USA.
William J SasielaEsperion Therapeutics, Inc., Ann Arbor, Michigan, USA.
Zhan YeEsperion Therapeutics, Inc., Ann Arbor, Michigan, USA.
Christie M BallantyneDepartment of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Esperion Therapeutics (United States) · USBaylor College of Medicine · USHouston Methodist · USImperial College London · GBLouisville Metabolic and Atherosclerosis Research Center · USMedical University of Lodz · PLOregon Health & Science University · USSt. Michael's Hospital · CAUniversity Hospital Leipzig · DEUniversity of British Columbia · CAUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn ongoing need exists for safe and effective lipid-lowering therapies (LLTs) for patients unable to achieve desired lipid levels with current treatment options.

objectiveThe objective of this study was to describe the safety profile of bempedoic acid, an oral, first-in-class, adenosine triphosphate (ATP)-citrate lyase inhibitor that significantly reduces low-density lipoprotein cholesterol (LDL-C) levels by 17.4%-28.5% vs placebo.

methodsThis was a pooled analysis of four phase 3, randomized (2:1), double-blind, placebo-controlled studies in patients with hypercholesterolemia who required additional LDL-C lowering, despite stable maximally-tolerated LLT. Patients received 180 mg of bempedoic acid (n = 2424) or placebo (n = 1197) once daily for 12 to 52 weeks. Assessments included treatment-emergent adverse events (TEAEs) and clinical laboratory tests.

resultsOf 3621 patients (the median drug exposure: 363 days), exposure-adjusted TEAE rates were 87.1/100 and 82.9/100 person-years (PY) for bempedoic acid and placebo, respectively. No single TEAE influenced the difference in rates. TEAEs leading to discontinuation occurred at rates of 13.4/100 and 8.9/100 PY for bempedoic acid vs placebo, with the most common cause being myalgia, which occurred less frequently with bempedoic acid vs placebo (1.5/100 vs 2.0/100 PY). Rates of myalgia and muscle weakness were comparable vs placebo. Bempedoic acid was associated with mild increases in blood urea nitrogen, creatinine, and uric acid and decreases in hemoglobin. These laboratory abnormalities were apparent by week 4, stable over time, and reversible after treatment cessation. Gout incidence was 1.6/100 vs 0.5/100 PY in the bempedoic acid vs placebo groups. New-onset diabetes/hyperglycemia occurred less frequently with bempedoic acid vs placebo (4.7/100 vs 6.4/100 PY). The safety profile was consistent across subgroups.

conclusionsBempedoic acid is generally safe and well tolerated among patients with hypercholesterolemia who require additional LLT.

Indexed as

AgedClinical Trials, Phase III as TopicDicarboxylic AcidsDouble-Blind MethodFatty AcidsFemaleHumansHypercholesterolemiaHypolipidemic AgentsMalePatient SafetyPrognosisRandomized Controlled Trials as Topic8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidDicarboxylic AcidsFatty AcidsHypolipidemic AgentsATP-Citrate lyase inhibitorHypercholesterolemiaLow-density lipoprotein cholesterolStatins

Identifiers

PMID32980290
OpenAlexW3082704660

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.