Evidence map›Paper›PMID 40833562›Full record

Trial reportAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2026

Cost-Effectiveness of Bempedoic Acid in High Cardiovascular Risk Patients with Statin Intolerance: An Analysis of the CLEAR Outcomes Trial.

Stephen J Nicholls, Kausik K Ray, A Michael Lincoff, Evelyn Sarnes, Kristin K Gillard, LeAnne Bloedon, Kristen Migliaccio-Walle, David Elsea, Steven E Nissen

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02993406 (A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

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
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Bempedoic Acid: From Guidelines to the Real World.Journal of lipid and atherosclerosis · 2026
    Review
  3. Review
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

9 authors.

Stephen J NichollsVictorian Heart Institute, Monash University, 631 Blackburn Road, Clayton, VIC, 3168, Australia. stephen.nicholls@monash.edu.
Kausik K RayImperial College London, London, UK.
A Michael LincoffCleveland Clinic, Cleveland, OH, USA.
Evelyn SarnesEsperion Therapeutics, Ann Arbor, MI, USA.
Kristin K GillardEsperion Therapeutics, Ann Arbor, MI, USA.
LeAnne BloedonEsperion Therapeutics, Ann Arbor, MI, USA.
Kristen Migliaccio-WalleCurta Inc., Seattle, WA, USA.
David ElseaCurta Inc., Seattle, WA, USA.
Steven E NissenCleveland Clinic, Cleveland, OH, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the CLEAR Outcomes study, 13,970 high cardiovascular risk patients with hypercholesterolemia and statin intolerance were randomized to treatment with bempedoic acid or standard of care (placebo). Bempedoic acid reduced the risk of major adverse cardiovascular events by 13%. However, the cost-effectiveness of bempedoic acid in this patient population is unknown.

methodsMarkov modeling estimated cost-effectiveness of bempedoic acid versus standard of care alone to reduce cardiovascular risk from a US third-party payer perspective. Baseline risk was estimated by applying individual patient characteristics from the trial to established risk equations. Treatment benefit was extrapolated over a lifetime horizon using hazard ratios for individual major adverse cardiovascular event (MACE) components from CLEAR Outcomes. Scenario analyses included on-treatment analysis, alternate bempedoic acid costs, and modeling effects of the fixed-dose combination with ezetimibe on low-density lipoprotein cholesterol (LDL-C) reduction and predicted MACE.

resultsBempedoic acid was estimated to reduce lifetime MACE (1.58 versus 1.95 per patient) versus standard of care. At list price, bempedoic acid was associated with increased costs (+ $22,600) and improved quality-adjusted life-years (QALYs, + 0.14), resulting in an incremental cost-effectiveness ratio (ICER) of $166,830 per QALY. The on-treatment analysis resulted in an ICER of $70,279 per QALY. Reduction in bempedoic acid price by 25% resulted in lower incremental total costs and an ICER of $99,993 per QALY. Modeling the effects of the fixed-dose combination resulted in an ICER of $40,317 per QALY.

conclusionsUse of bempedoic acid offers improved lifetime cardiovascular (CV) risk reduction over standard of care in patients with or at high risk for CV disease (CVD) at common cost-effectiveness thresholds ($150,000 per QALY).

trial registrationClinicalTrials.gov identifier: NCT02993406 (CLEAR Outcomes study).

Indexed as

Cardiovascular DiseasesDicarboxylic AcidsFatty AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaAgedAnticholesteremic AgentsCholesterol, LDLCost-Benefit AnalysisEzetimibeFemaleHeart Disease Risk FactorsHumansMaleMarkov ChainsMiddle Aged8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidAnticholesteremic AgentsCholesterol, LDLDicarboxylic AcidsEzetimibeFatty AcidsHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID40833562
PMCPMC12779746

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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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 OpenQuestion graph.