Evidence map›Paper›PMID 26073387›Full record

Trial reportJournal of clinical lipidology

Use of ETC-1002 to treat hypercholesterolemia in patients with statin intolerance.

Paul D Thompson, John Rubino, Matthew J Janik, Diane E MacDougall, Scott J McBride, Janice R Margulies, Roger S Newton

5 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report 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 NCT02659397. Cited by 44 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 5 pooled it
13.0field-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.

NCT02659397 phase2completed

A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients

Ran2015Enrolled68Registered outcomes8Posted comparisons0ConditionsHyperlipidemiaArmsAtorvastatin, ETC-1002, Placebo
PMID 24385236PMID 25463109PMID 24978142PMID 23770179other papers from this trial
Open the trial in the graph
NCT03001076 phase3completed

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC 1002) 180 mg/Day as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C

Ran2016Enrolled269Registered outcomes14Posted comparisons17ConditionsAtherosclerosis, Hypercholesterolemia, Statin Adverse ReactionArmsBempedoic acid, Ezetimibe, Placebo
PMID 27892461PMID 29910030PMID 27138185PMID 27206943PMID 27663902other papers from this trial
Open the trial in the graph
NCT01751984 phase2completednot on this map

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and a History of Statin Intolerance

TypeinterventionalSponsorEsperion Therapeutics, Inc.Ran2012 to 2013Enrolled56ConditionsHypercholesterolemiaArmsETC-1002, Placebo
NCT02993406 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant

TypeinterventionalSponsorEsperion Therapeutics, Inc.Ran2016 to 2022Enrolled13,970ConditionsCardiovascular Diseases, Statin Adverse ReactionArmsBempedoic acid 180 mg tablet, Matching placebo tablet
NCT03051100 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Triplet Therapy With Bempedoic Acid (ETC 1002) 180 mg, Ezetimibe 10 mg, and Atorvastatin 20 mg in Patients With Elevated LDL C

TypeinterventionalSponsorEsperion Therapeutics, Inc.Ran2017 to 2017Enrolled63ConditionsHypercholesterolemiaArmsBempedoic acid 180mg, Ezetimibe 10mg, Atorvastatin 20mg, Placebo
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 5 syntheses or guidelines pooled it, 156 citations in OpenAlex.

  1. Pooled it
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  6. Trial
  7. Bempedoic Acid: From Guidelines to the Real World.Journal of lipid and atherosclerosis · 2026
    Review
  8. Review
  9. Cardiovascular risk management beyond statins: review of new therapies available in Italy.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2025
    Review
  10. Review
  11. Review
  12. Bempedoic Acid: A Review in Cardiovascular Risk Reduction in Statin-Intolerant Patients.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025
    Review
  13. Article
  14. Review
  15. Review
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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

7 authors at 4 institutions in 1 country.

Paul D ThompsonDepartment of Cardiology, Hartford Hospital, Hartford, CT, USA. Electronic address: paul.thompson@hhchealth.org.
John RubinoPMG Research of Raleigh, Raleigh, NC, USA.
Matthew J JanikDepartment of Cardiology, Wilmington Health, Wilmington, NC, USA; PMG Research of Wilmington, Wilmington, NC, USA.
Diane E MacDougallEsperion Therapeutics, Inc., Ann Arbor, MI, USA.
Scott J McBrideUnited BioSource Corporation, Ann Arbor, MI, USA.
Janice R MarguliesEsperion Therapeutics, Inc., Ann Arbor, MI, USA.
Roger S NewtonEsperion Therapeutics, Inc., Ann Arbor, MI, USA.
Esperion Therapeutics (United States) · USHartford Hospital · USPMG Research · USUniversity of North Carolina Wilmington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOnce-daily, oral ETC-1002 reduces low-density lipoprotein cholesterol (LDL-C) and has beneficial effects on other cardiometabolic risk factors but has not been examined in statin intolerant patients.

objectivesTo study the efficacy and safety of ETC-1002 (a novel LDL-C-lowering agent) in patients with hypercholesterolemia and a history of statin intolerance.

methodsPatients intolerant to at least 1 statin were entered into this multicenter, double-blind, 8-week trial. Participants were required to have a history of muscle complaints that developed during statin treatment and resolved within 4 weeks of statin discontinuation. Patients (n = 56) were randomized in a 2:1 ratio to ETC-1002 60 mg daily or placebo. The ETC-1002 dose was increased at 2-week intervals to 120 mg, 180 mg, and 240 mg. The primary end point was the percentage change from baseline to week 8 in calculated LDL-C.

resultsETC-1002 reduced LDL-C 28.7% more than placebo (95% confidence interval, -35.4 to -22.1; P < .0001). ETC-1002 significantly reduced non-high-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein. Triglycerides and high-density lipoprotein cholesterol did not change with ETC-1002 treatment. Sixty-two percent of patients receiving ETC-1002 and none in the placebo group achieved the 2004 National Cholesterol Education Program Adult Treatment Panel III LDL-C goal (P < .0001). Muscle-related adverse events occurred with similar frequency in the placebo and ETC-1002 treatment groups, causing no discontinuations in ETC-1002-treated patients.

conclusionsETC-1002 appears to be effective at reducing LDL-C and was well tolerated in patients with statin-associated muscle complaints. Longer and larger studies are required to confirm the absence of muscle side effects.

Indexed as

AdolescentAdultAgedAged, 80 and overCholesterol, LDLDicarboxylic AcidsDouble-Blind MethodFatty AcidsFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaMaleMiddle AgedTime FactorsTriglycerides8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidCholesterol, LDLDicarboxylic AcidsFatty AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsTriglyceridesETC-1002HypercholesterolemiaLDL-cholesterolMuscle complaintsStatin intolerance

Identifiers

PMID26073387
OpenAlexW2093391254

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.