---
title: "Bempedoic Acid Lowers Major Adverse Limb Events and Cardiovascular Events in Statin‑Intolerant Pat"
id: "pubmed-42610264"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42610264"
content_type: "clinical_feed_article"
specialty: "Cardiology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42610264/"
doi: "10.1161/CIRCULATIONAHA.125.078469"
published_at: "2026-09-15T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Bempedoic Acid Lowers Major Adverse Limb Events and Cardiovascular Events in Statin‑Intolerant Pat
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42610264
- **Specialty:** [Cardiology](https://medichelpline.com/clinical-feed/cardiology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42610264/)
- **DOI:** [10.1161/CIRCULATIONAHA.125.078469](https://doi.org/10.1161%2FCIRCULATIONAHA.125.078469)
- **Published At:** 2026-09-15T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This analysis from the randomized CLEAR Outcomes trial evaluated effects of **bempedoic acid** 180 mg versus placebo on limb and cardiovascular outcomes in statin‑intolerant patients, focusing on those with investigator‑reported **peripheral artery disease (PAD)** at baseline. - Of 13,970 randomized participants, 1,624 had PAD (mean age 63.9 years; 56.3% female). Outcomes included time to first and total events for major adverse limb events (MALE) adjudicated by two blinded vascular specialists. - In the placebo PAD subgroup, 8.3% experienced a first MALE over median 40.6 months; recurrent MALE rate was 4.0% per year. - Bempedoic acid reduced risk of first MALE by 36% (HR 0.64; 95% CI 0.44–0.93; P = 0.018) and reduced total MALE events by 45% (RR 0.55; 95% CI 0.35–0.85; P = 0.007). - The composite first event of MACE‑4 or MALE was reduced overall by 13% (HR 0.87; 95% CI 0.80–0.95); the reduction within the PAD subgroup was directionally consistent but not statistically significant for first events (HR 0.82; 95% CI 0.64–1.04). - Total MACE‑4 or MALE events were reduced overall (RR 0.81; 95% CI 0.73–0.90) with consistent effects in patients with PAD (RR 0.71; 95% CI 0.54–0.95). - Authors conclude that lowering **LDL‑cholesterol** with **bempedoic acid** reduces both cardiovascular and limb events in patients with atherosclerotic vascular disease, with notable absolute benefit in those with PAD. - Conflict of interest disclosures note involvement of several authors with academic institutions, industry funding, employment or consultancy links to Esperion Therapeutics and other companies; specific financial relationships are reported in the source.
## Clinical Analysis & Structured Key Points
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Epub 2026 Aug 18. # Bempedoic Acid and First and Recurrent Limb Outcomes in Statin-Intolerant Patients With Peripheral Artery Disease: Insights From the CLEAR Outcomes Trial [Marc P Bonaca](https://pubmed.ncbi.nlm.nih.gov/?term=Bonaca+MP&cauthor_id=42610264)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-1 "CPC Clinical Research, University of Colorado School of Medicine, Aurora \(M.P.B., M.E.C.\).")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-2 "Department of Medicine, University of Colorado, Aurora \(M.P.B., M.E.C.\)."), [Mario Enrico Canonico](https://pubmed.ncbi.nlm.nih.gov/?term=Canonico+ME&cauthor_id=42610264)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-1 "CPC Clinical Research, University of Colorado School of Medicine, Aurora \(M.P.B., M.E.C.\).")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-2 "Department of Medicine, University of Colorado, Aurora \(M.P.B., M.E.C.\)."), [Na Li](https://pubmed.ncbi.nlm.nih.gov/?term=Li+N&cauthor_id=42610264)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-3 "Esperion Therapeutics, Inc, Ann Arbor, MI \(N.L., W.J.S.\)."), [William J Sasiela](https://pubmed.ncbi.nlm.nih.gov/?term=Sasiela+WJ&cauthor_id=42610264)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-3 "Esperion Therapeutics, Inc, Ann Arbor, MI \(N.L., W.J.S.\)."), [Steven E Nissen](https://pubmed.ncbi.nlm.nih.gov/?term=Nissen+SE&cauthor_id=42610264)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-4 "Department of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research \(C5Research\), Cleveland Clinic, OH \(S.E.N., A.M.L.\)."), [A Michael Lincoff](https://pubmed.ncbi.nlm.nih.gov/?term=Lincoff+AM&cauthor_id=42610264)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-4 "Department of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research \(C5Research\), Cleveland Clinic, OH \(S.E.N., A.M.L.\)."), [Stephen J Nicholls](https://pubmed.ncbi.nlm.nih.gov/?term=Nicholls+SJ&cauthor_id=42610264)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#full-view-affiliation-5 "Victorian Heart Institute, Monash University, Melbourne, Victoria, Australia \(S.J.N.\).") Affiliations Expand ### Affiliations * 1 CPC Clinical Research, University of Colorado School of Medicine, Aurora (M.P.B., M.E.C.). * 2 Department of Medicine, University of Colorado, Aurora (M.P.B., M.E.C.). * 3 Esperion Therapeutics, Inc, Ann Arbor, MI (N.L., W.J.S.). * 4 Department of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland Clinic, OH (S.E.N., A.M.L.). * 5 Victorian Heart Institute, Monash University, Melbourne, Victoria, Australia (S.J.N.). * PMID: **42610264** * DOI: [ 10.1161/CIRCULATIONAHA.125.078469 ](https://doi.org/10.1161/circulationaha.125.078469) Item in Clipboard Randomized Controlled Trial # Bempedoic Acid and First and Recurrent Limb Outcomes in Statin-Intolerant Patients With Peripheral Artery Disease: Insights From the CLEAR Outcomes Trial Marc P Bonaca et al. Circulation. 2026. Show details Display options Display options Format Abstract PubMed PMID Circulation Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Circulation%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Circulation%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42610264/) . 2026 Sep 15;154(11):966-975. doi: 10.1161/CIRCULATIONAHA.125.078469. Epub 2026 Aug 18. ### Authors [Marc P Bonaca](https://pubmed.ncbi.nlm.nih.gov/?term=Bonaca+MP&cauthor_id=42610264)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-1 "CPC Clinical Research, University of Colorado School of Medicine, Aurora \(M.P.B., M.E.C.\).")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-2 "Department of Medicine, University of Colorado, Aurora \(M.P.B., M.E.C.\)."), [Mario Enrico Canonico](https://pubmed.ncbi.nlm.nih.gov/?term=Canonico+ME&cauthor_id=42610264)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-1 "CPC Clinical Research, University of Colorado School of Medicine, Aurora \(M.P.B., M.E.C.\).")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-2 "Department of Medicine, University of Colorado, Aurora \(M.P.B., M.E.C.\)."), [Na Li](https://pubmed.ncbi.nlm.nih.gov/?term=Li+N&cauthor_id=42610264)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-3 "Esperion Therapeutics, Inc, Ann Arbor, MI \(N.L., W.J.S.\)."), [William J Sasiela](https://pubmed.ncbi.nlm.nih.gov/?term=Sasiela+WJ&cauthor_id=42610264)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-3 "Esperion Therapeutics, Inc, Ann Arbor, MI \(N.L., W.J.S.\)."), [Steven E Nissen](https://pubmed.ncbi.nlm.nih.gov/?term=Nissen+SE&cauthor_id=42610264)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-4 "Department of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research \(C5Research\), Cleveland Clinic, OH \(S.E.N., A.M.L.\)."), [A Michael Lincoff](https://pubmed.ncbi.nlm.nih.gov/?term=Lincoff+AM&cauthor_id=42610264)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-4 "Department of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research \(C5Research\), Cleveland Clinic, OH \(S.E.N., A.M.L.\)."), [Stephen J Nicholls](https://pubmed.ncbi.nlm.nih.gov/?term=Nicholls+SJ&cauthor_id=42610264)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42610264/#short-view-affiliation-5 "Victorian Heart Institute, Monash University, Melbourne, Victoria, Australia \(S.J.N.\).") ### Affiliations * 1 CPC Clinical Research, University of Colorado School of Medicine, Aurora (M.P.B., M.E.C.). * 2 Department of Medicine, University of Colorado, Aurora (M.P.B., M.E.C.). * 3 Esperion Therapeutics, Inc, Ann Arbor, MI (N.L., W.J.S.). * 4 Department of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland Clinic, OH (S.E.N., A.M.L.). * 5 Victorian Heart Institute, Monash University, Melbourne, Victoria, Australia (S.J.N.). * PMID: **42610264** * DOI: [ 10.1161/CIRCULATIONAHA.125.078469 ](https://doi.org/10.1161/circulationaha.125.078469) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Patients with peripheral artery disease (PAD) are at high risk of major adverse limb events (MALE) and major adverse cardiovascular events (MACE). Recently, bempedoic acid was shown to reduce MACE in primary and secondary prevention patients. Whether bempedoic acid reduces the risk of MALE in patients with PAD is unknown. **Methods:** CLEAR Outcomes (Cholesterol Lowering via Bempedoic Acid [ETC1002], an ACL-Inhibiting Regimen) randomized 13 970 patients to bempedoic acid 180 mg or placebo from December 22, 2016, to August 14, 2019. The trial primary end point was MACE-4, defined as death resulting from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. A clinical history of PAD was reported by investigators at baseline. Two blinded vascular medicine specialists independently adjudicated MALE, including adverse events indicating worsening PAD symptoms leading to revascularization, chronic limb-threatening ischemia, and acute limb ischemia. Outcomes were assessed as time to first event and total (including recurrent) events with a negative binomial approach. **Results:** A total of 1624 of the enrolled patients (mean±SD age, 63.9±9.9 years; 915 [56.3%] female) had PAD at baseline. In patients with PAD in the placebo group, 69 (8.3%) had MALE over a median of 40.6 months, with rate of recurrent events of 4.0%/y. Bempedoic acid reduced the risk of MALE by 36% (hazard ratio, 0.64 [95% CI, 0.44-0.93]; _P_ =0.018). Bempedoic acid reduced total MALE by 45% (relative risk, 0.55 [95% CI, 0.35-0.85]; _P_ =0.007). First MACE-4 or MALE was reduced overall by 13% (hazard ratio, 0.87 [95% CI, 0.80-0.95]) with consistent effects with PAD (hazard ratio, 0.82 [95% CI, 0.64-1.04]) and without PAD (hazard ratio, 0.87 [95% CI, 0.79-0.86]; _P_ interaction=NS) but not statistically significant within the PAD subgroup alone. Total MACE-4 or MALE was reduced (relative risk, 0.81 [95% CI, 0.73-0.90]) overall with consistent effects in PAD (relative risk, 0.71 [95% CI, 0.54-0.95]) and without PAD (relative risk, 0.82 [95% CI, 0.73-0.92]; _P_ interaction=NS). **Conclusions:** Patients with PAD are at high risk of MALE and MACE. Bempedoic acid reduces both MACE and MALE in patients with atherosclerotic vascular disease, with notable absolute benefits in patients with PAD. These findings support (1) the importance of lowering low-density lipoprotein cholesterol in patients with PAD to reduce overall vascular risk and (2) the benefits of bempedoic acid in this population. **Keywords:** 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; cardiovascular diseases; cholesterol, LDL; hypolipidemic agents; lipoproteins; peripheral artery disease. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Drs Canonico and Bonaca receive salary support from CPC, a nonprofit academic research organization affiliated with the University of Colorado that receives or has received research grant/consulting funding from the following organizations: 35Pharma, Inc; Abbott Laboratories; Agios Pharmaceuticals, Inc; Alexion Pharma Godo Kaisha; Amgen Inc; Anthos Therapeutics, Inc; Arrowhead Pharmaceuticals; AstraZeneca Pharma India; AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd; Autonomy Bio, Inc; Bayer; Bristol-Myers Squibb; Cleerly, Inc; Eidos Therapeutics, Inc; EluraBio; Ely Lilly, Inc; Esperion Therapeutics, Inc; Faraday Pharmaceuticals, Inc; Gasherbrum Bio, Inc; Insmed; IsomAb Ltd; JanOne Biotech Holdings, Inc; Janssen Global Services, Janssen Pharmaceuticals, Inc; Lexicon Pharmaceuticals, Inc; Lilly USA, LLC; Medison Pharma; Merck Sharp & Dohme Corp; Nectero Medical, Inc; NewAmsterdam Pharma; Novartis Pharmaceuticals Corp; Novo Nordisk, Inc; Pfizer; Prothena Biosciences Ltd; Regeneron; Sanofi; Silence Therapeutics PLC; Stealth BioTherapeutics In.; Tourmaline Bio, Inc; VarmX; and Verve Therapeutics. Dr Li is a compensated employee of Esperion Therapeutics, Inc and may own shares of Esperion stock. Dr Sasiela is a former employee and currently a paid consultant to Esperion Therapeutics, Inc and owns stock in Esperion Therapeutics. Dr Nicholls received grant/research support from AstraZeneca, NewAmsterdam Pharma, Amgen, Anthera, Cyclarity, Eli Lilly, Esperion, Novartis, Cerenis, The Medicines Company, Resverlogix, InfraReDx, Roche, Sanofi-Regeneron, and LipoScience. Dr Nicholls was a consultant for Abcentra, AstraZeneca, Amarin, Akcea, Eli Lilly, Anthera, Omthera, Merck, Takeda, Resverlogix, Sanofi-Regeneron, CSL Behring, Esperion, Boehringer Ingelheim, Daiichi Sankyo, Scribe, Silence Therapeutics, CSL Seqirus, and Vaxxinity. Dr Nissen reports that the Cleveland Clinic Coordinating Center for Clinical Research (C5Research) has received funding to perform clinical trials from Abbvie, AstraZeneca, Amgen, Arrowhead, Bristol Myers Squibb, Kardigan, CRISPR Therapeutics, Eli Lilly, Esperion, Medtronic, MyoKardia, New Amsterdam Pharmaceuticals, Novartis, Pfizer, and Silence Therapeutics. Dr Nissen is involved in conducting these clinical trials but receives no personal remuneration for his participation. Dr Nissen consults for these pharmaceutical companies but does not accept compensation. Dr Lincoff reports receipt of honoraria/consultancy fees from Novo Nordisk, Eli Lilly, Alnylam, Amgen, Ardelyx, Brainstorm Cell, Cadrenal, Canary Cure, GlaxoSmithKline, Johnson & Johnson, Medtronic, Neovasc, ReCor, and TD Cowen. Dr Lincoff has received research funding to Cleveland Clinic from AbbVie, AstraZeneca, CSL Behring, Eli Lilly, Esperion, and Novartis. ## Similar articles * [ Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. ](https://pubmed.ncbi.nlm.nih.gov/36876740/) Nissen SE, Lincoff AM, Brennan D, Ray KK, Mason D, Kastelein JJP, Thompson PD, Libby P, Cho L, Plutzky J, Bays HE, Moriarty PM, Menon V, Grobbee DE, Louie MJ, Chen CF, Li N, Bloedon L, Robinson P, Horner M, Sasiela WJ, McCluskey J, Davey D, Fajardo-Campos P, Petrovic P, Fedacko J, Zmuda W, Lukyanov Y, Nicholls SJ; CLEAR Outcomes Investigators.Nissen SE, et al.N Engl J Med. 2023 Apr 13;388(15):1353-1364. doi: 10.1056/NEJMoa2215024. Epub 2023 Mar 4.N Engl J Med. 2023.PMID: 36876740Clinical Trial. * [ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients. ](https://pubmed.ncbi.nlm.nih.gov/37354546/) Nissen SE, Menon V, Nicholls SJ, Brennan D, Laffin L, Ridker P, Ray KK, Mason D, Kastelein JJP, Cho L, Libby P, Li N, Foody J, Louie MJ, Lincoff AM.Nissen SE, et al.JAMA. 2023 Jul
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