Evidence map›Paper›PMID 29910030›Full record

Trial reportAtherosclerosis2018

Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study.

Christie M Ballantyne, Maciej Banach, G B John Mancini, Norman E Lepor, Jeffrey C Hanselman, Xin Zhao, Lawrence A Leiter

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Atherosclerosis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03001076. Cited by 164 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
164citing papers in PubMed, 13 pooled it
39.1field-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.

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 26073387PMID 27138185PMID 27206943PMID 27663902other papers from this trial
Open the trial in the graph
NCT06381947 phase4unknown statusstarted 2024, after this paper: background citation

Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients: a Randomized Crossover Trial

Ran2024Enrolled130Registered outcomes19Posted comparisons0ConditionsCardiovascular Diseases, Dyslipidemias, Lipid Metabolism Disorders, Statin Adverse ReactionArmsLipid-lowering therapy combination with PCSK9 inhibitors and ezetimibe, Lipid-lowering therapy combination with PCSK9 inhibitors, bempedoic acid and ezetimibe
PMID 26030325PMID 25825402PMID 30662020PMID 26638010PMID 25687353PMID 26027630PMID 27892461PMID 16424354PMID 26687696PMID 26330422PMID 25606700PMID 20525997other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

164 citing papers in PubMed, 13 syntheses or guidelines pooled it, 411 citations in OpenAlex.

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  5. 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
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  7. Is a PCSK9 Inhibitor Right for Your Patient? A Review of Treatment Data for Individualized Therapy.International journal of environmental research and public health · 2022
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104 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Commented on by
    2021
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    2021
5 · Who and what money

Authors and funding

7 authors at 6 institutions in 3 countries.

Christie M BallantyneDepartment of Medicine, Baylor College of Medicine, One Baylor Plaza, BCM 285, Houston, TX, 77030, USA. Electronic address: cmb@bcm.edu.
Maciej BanachDepartment of Hypertension, Medical University of Lodz, Zeromskiego 113, 90-549, Lodz, Poland.
G B John ManciniDivision of Cardiology, University of British Columbia, 2775 Laurel Street 10th Floor, Vancouver, V5Z 1M9, British Columbia, Canada.
Norman E LeporDavid Geffen School of Medicine at UCLA and Cedars-Sinai Medical Center, Los Angeles, CA, USA; Westside Medical Associates of Los Angeles, 99 La Cienega Blvd. #203, Beverly Hills, CA, 90211, USA.
Jeffrey C HanselmanClinical Development, Esperion Therapeutics, Inc., 3891 Ranchero Dr., Ann Arbor, MI, 48108, USA.
Xin ZhaoClinical Development, Esperion Therapeutics, Inc., 3891 Ranchero Dr., Ann Arbor, MI, 48108, USA.
Lawrence A LeiterDivision of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, 61 Queen St East #6121, Toronto, M5C 2T2, Ontario, Canada.
Esperion Therapeutics (United States) · USBaylor College of Medicine · USCedars-Sinai Medical Center · USMedical University of Lodz · PLSt. Michael's Hospital · CAUniversity of British Columbia · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsPatients with hyperlipidemia who are unable to tolerate optimal statin therapy are at increased cardiovascular risk due to ongoing elevations in low-density lipoprotein cholesterol (LDL-C). The objective of CLEAR Tranquility (NCT03001076) was to evaluate the efficacy and safety of bempedoic acid when added to background lipid-modifying therapy in patients with a history of statin intolerance who require additional LDL-C lowering.

methodsThis phase 3, multicenter, randomized, double-blind, placebo-controlled study enrolled patients with a history of statin intolerance and an LDL-C ≥100 mg/dL while on stable lipid-modifying therapy. After a 4-week ezetimibe 10 mg/day run-in period, patients were randomized 2:1 to treatment with bempedoic acid 180 mg or placebo once daily added to ezetimibe 10 mg/day for 12 weeks. The primary endpoint was the percent change from baseline to week 12 in LDL-C.

resultsThe study population comprised 269 patients (181 bempedoic acid, 88 placebo). Bempedoic acid added to background lipid-modifying therapy that included ezetimibe reduced LDL-C by 28.5% more than placebo (p < 0.001; -23.5% bempedoic acid, +5.0% placebo). Significant reductions in secondary endpoints, including non-high-density lipoprotein cholesterol (-23.6%), total cholesterol (-18.0%), apolipoprotein B (-19.3%), and high-sensitivity C-reactive protein (-31.0%), were observed with bempedoic acid vs. placebo (p < 0.001). Bempedoic acid was well tolerated; rates of treatment-emergent adverse events, muscle-related adverse events, and discontinuations were similar in the bempedoic acid and placebo treatment groups.

conclusionsBempedoic acid may provide an oral therapeutic option complementary to ezetimibe in statin intolerant patients who require additional LDL-C lowering.

Indexed as

AgedBiomarkersCanadaCholesterol, LDLDicarboxylic AcidsDouble-Blind MethodDown-RegulationDrug Therapy, CombinationEuropeEzetimibeFatty AcidsFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaHypolipidemic Agents8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidBiomarkersCholesterol, LDLDicarboxylic AcidsEzetimibeFatty AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsCardiovascular diseaseETC-1002HyperlipidemiaLow-density lipoprotein cholesterolPreventionStatin-associated muscle symptomsStatin intolerance

Identifiers

PMID29910030
OpenAlexW2808641584

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.