– Analysis Demonstrated 22% Reduced Risk of Ischemic Stroke for Patients Taking Bempedoic Acid Compared to Placebo –
– Analysis of CLEAR Outcomes Reports Bempedoic Acid Reduced MACE in High-Risk Patients with Autoimmune or Inflammatory Diseases (AIID) Similarly to Those Without AIID –
ANN ARBOR, Mich., March 30, 2026 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today announced the presentation of two post-hoc analyses from CLEAR Outcomes focused on risk of ischemic stroke and risk of major adverse cardiovascular events (MACE) in patients with autoimmune or inflammatory diseases. These data were presented as moderated poster presentations at the American College of Cardiology’s Annual Scientific Session (ACC.26) which took place March 28-30, 2026, in New Orleans, LA.
“These analyses provide important insights into how bempedoic acid performs in high-risk patient populations,” said Luke Laffin, MD, senior author of the CLEAR Outcomes sub analyses and Associate Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. “Patients with autoimmune and inflammatory diseases face a significantly elevated cardiovascular burden, and these data reinforce that bempedoic acid delivers meaningful reductions in cardiovascular events in this vulnerable group. In addition, when we examine ischemic stroke patients specifically, this analysis shows a clear and clinically relevant reduction in risk for statin intolerant patients. Together, these findings underscore the value of bempedoic acid as an effective, well tolerated therapy for reducing cardiovascular risk across diverse patient populations.”
“These new analyses from CLEAR Outcomes further strengthen the evidence base supporting NEXLETOL as a proven therapy for cardiovascular risk reduction – especially for patients who cannot tolerate statin therapy,” said Sheldon Koenig, President and Chief Executive Officer of Esperion. “The consistency of benefit observed in high-risk populations, including those with autoimmune or inflammatory diseases, highlights the broad clinical relevance of bempedoic acid. We are proud to continue expanding the data that informs treatment decisions and supports the recent incorporation of bempedoic acid into U.S. dyslipidemia guidelines.”
Key data presented at ACC.26
- Bempedoic acid and incidence of stroke among statin-intolerant patients: an analysis of the CLEAR Outcomes trial presented by Carolina Pires Zingano, MD (Cleveland Clinic)
Highlights
-
- In CLEAR Outcomes, 293 patients had a fatal or non-fatal stroke, 268 (90%) of which were ischemic strokes.
- Bempedoic acid reduced the risk of ischemic stroke by 22% compared to placebo.
-
Bempedoic acid and cardiovascular outcomes in patients with autoimmune or inflammatory diseases: an analysis of the CLEAR Outcomes trial presented by Bernardo Frison Spiazzi, MD (Cleveland Clinic)
Highlights
- Approximately 10% of the 13,970 participants in CLEAR Outcomes had prior autoimmune and inflammatory diseases (AIID) which further increase risk of MACE compared to those without.
- Patients with AIID derived a similar clinical benefit with the use of bempedoic acid as those without AIID.
INDICATION
NEXLIZET and NEXLETOL are indicated:
- bempedoic acid, a component of NEXLIZET and NEXLETOL, is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin).
- as an adjunct to diet and exercise:
- NEXLIZET is indicated to reduce LDL-C in adults with hypercholesterolemia, including HeFH.
- NEXLETOL is indicated, 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 hypercholesterolemia, including HeFH.
IMPORTANT SAFETY INFORMATION
- NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
- Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Monitor as clinically indicated and initiate treatment with urate-lowering drugs as appropriate.
- Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. Tendon rupture occurred in 0.5% of patients treated with bempedoic acid in primary hypercholesterolemia trials, versus 0% on placebo. In the cardiovascular outcomes trial, the rates were 1.2% for bempedoic acid and 0.9% for placebo. Discontinue NEXLIZET or 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 hypercholesterolemia trials of bempedoic acid 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.
- Adverse reactions reported in ≥2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.
- The most common adverse reactions (incidence ≥3% and greater than placebo) observed with NEXLIZET but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.
- The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, 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 NEXLIZET or 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. Concomitant use with fibrates may increase triglycerides and decrease high-density lipoprotein cholesterol. Monitor and adjust therapies as recommended.
- Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. The benefits of breastfeeding should be considered along with the mother’s clinical need for NEXLIZET or NEXLETOL and any potential adverse effects on the breastfed infant from NEXLIZET or NEXLETOL or from the underlying maternal condition.
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 dedicated to developing and delivering innovative cardiometabolic and rare/orphan disease therapies. The Company leverages deep domain expertise in ACLY biology to develop and commercialize transformative medicines for patients worldwide. Esperion currently markets two oral, once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels and are at risk of cardiovascular disease.
With a broad U.S. commercial infrastructure and global approvals across more than 40 countries, Esperion is well positioned to serve as a partner-of-choice for global innovators seeking U.S. market access through acquisition, in-license, co-promotion and revenue share opportunities. In tandem, the Company is advancing its leadership in ACLY biology to build a diversified pipeline of novel product candidates, including treatments for Primary Sclerosing Cholangitis and renal diseases. 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 and business development 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, business development, 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
[email protected]
(616) 443-8438
