Esperion Announces New Data from CLEAR Outcomes Highlighting Value of NEXLETOL® (bempedoic acid) in Oral and Poster Presentations at the AHA Scientific Sessions 2025
– Analysis of Patients from CLEAR Outcomes Receiving No Other Background Lipid Lowering Therapies, Bempedoic Acid Alone Reduced MACE-4 by 14% Compared to Placebo –
– An Exploratory Analysis of CLEAR Outcomes Reports Patients Who Took Bempedoic Acid Were 42% Less Likely to Experience Venous Thromboembolism Events Compared to Placebo –
ANN ARBOR, Mich., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the presentation of two post hoc analyses from CLEAR Outcomes focused on: 1) risk of major adverse cardiovascular event in ~8200 patients receiving no background lipid lowering therapies (LLT) and 2) risk of venous thromboembolism (VTE) with bempedoic acid compared to placebo. These data were presented in oral and poster presentations, respectively, at the 2025 American Heart Association (AHA) Scientific Sessions, taking place November 7-10, 2025, in New Orleans, LA.
"Bempedoic acid is a proven drug to reduce risk for adverse cardiovascular (CV) outcomes such as heart attack and stroke in patients who cannot take recommended statin therapy. The new data demonstrates the efficacy of bempedoic acid alone on reducing CV risk and suggests bempedoic acid may have benefits beyond preventing atherosclerosis by preventing deep venous thrombosis and pulmonary embolism," said Luke Laffin, MD, senior author for these CLEAR Outcomes sub analyses, and Associate Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
"These new analyses from CLEAR Outcomes continue to reinforce the clinical value of NEXLETOL as a foundational therapy for cardiovascular risk reduction, particularly in patients who are unable to tolerate statins," said Sheldon Koenig, President and Chief Executive Officer of Esperion. "The consistency of benefit seen with bempedoic acid monotherapy - both in lowering LDL-C and reducing major adverse cardiovascular events - underscores its potential to address a critical unmet need in preventive cardiology. We are proud to see this data presented at AHA, one of the most influential forums in cardiovascular medicine, and remain committed to advancing therapies that improve outcomes for patients worldwide."
Key data presented at the 2025 AHA Scientific Sessions
- Bempedoic acid monotherapy, LDL cholesterol and cardiovascular events: a secondary analysis of the CLEAR Outcomes trial presented by Carolina Pires Zingano, MD (Cleveland Clinic)
Highlights
- Over half (59%) of the 13,970 participants in CLEAR Outcomes were not receiving any background LLT during the study.
- Compared with placebo, bempedoic acid monotherapy lowered LDL-C by -20.6% at 6 months and reduced MACE-4 (CV death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization) by 14%.
- Safety that included total adverse events, serious adverse events and adverse events that led to study drug discontinuation were similar amongst patients on bempedoic acid or placebo.
- Effects of Bempedoic Acid on Venous Thromboembolism: a Post-Hoc Analysis of the CLEAR Outcomes trial presented by Bernardo Frison Spiazzi, MD (Cleveland Clinic)
Highlights
- Treatment with bempedoic acid in patients with statin intolerance and at high risk for, or with established cardiovascular disease, was associated with a reduction in venous thromboembolic (VTE; deep vein or lung blood clots) events.
- In total, 106 VTE events occurred over 40.6 months of follow up.
- Compared with placebo, bempedoic acid reduced the risk of any VTE by 42% [risk of deep venous thrombosis (DVT) was reduced by 44% and pulmonary embolism (PE) by 39%].
INDICATION
NEXLETOL is indicated:
- To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLETOL is contraindicated in patients with a prior serious hypersensitivity reaction to bempedoic acid or any of the excipients. Serious hypersensitivity reactions, such as angioedema, have occurred.
Hyperuricemia: NEXLETOL may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: NEXLETOL is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of NEXLETOL in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.
The most common adverse reactions in the cardiovascular outcomes trial for NEXLETOL at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.
Concomitant use of NEXLETOL with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided due to the potential for increased risk of simvastatin- or pravastatin-related myopathy.
Discontinue NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion's commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:
Investors:
Alina Venezia
[email protected]
(734) 887-3903
Media:
Tiffany Aldrich
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(616) 443-8438
