Bempedoic Acid Receives Highest ESC/EAS Guideline Recommendation for Cardiovascular Risk Reduction
核心洞察
Bempedoic acid has received a Class I, Level A recommendation in the 2025 ESC/EAS Guidelines for Management of Dyslipidaemias (搜索), marking the strongest endorsement for a non-statin therapy.
The guidelines recommend bempedoic acid for patients unable to take statin therapy to lower LDL-C (搜索) levels and reduce cardiovascular events, with additional consideration for high-risk patients on maximally tolerated statin therapy.
The updated European guidelines emphasize earlier, aggressive combination therapy approaches, supporting Esperion's development of oral triple combination lipid-lowering therapies in the U.S.
Esperion Therapeutics (搜索) announced that bempedoic acid has received the highest level of recommendation in the 2025 Focused Update of the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemias (搜索). The drug stands as the only non-statin newly recommended for LDL-C (搜索) lowering and cardiovascular risk reduction in these updated guidelines.
"Recognition from Europe's premier cardiovascular medical association further validates the clinical benefit of bempedoic acid in cardiovascular risk reduction," said Sheldon Koenig, President and CEO of Esperion. "This recommendation marks a significant milestone for our European partner, Daiichi Sankyo Europe (搜索), as they continue to expand access across Europe, and is equally meaningful for our efforts in the U.S., where we anticipate the European guidelines will inform upcoming U.S. cholesterol treatment guidelines."
Key ESC/EAS Recommendations
The updated guidelines provide three specific recommendations for bempedoic acid:
Class I, Level A Recommendation: Non-statin therapies with proven cardiovascular benefit, including bempedoic acid, taken alone or in combination, are recommended for patients who are unable to take statin therapy to lower LDL-C (搜索) levels and reduce the risk of cardiovascular events. The choice should be based on the magnitude of additional LDL-C lowering needed.
Class I, Level B Recommendation: Bempedoic acid is recommended in patients who are unable to take statin therapy to achieve the LDL-C (搜索) goal.
Class IIa, Level C Recommendation: The addition of bempedoic acid to the maximally tolerated dose of statin with or without ezetimibe should be considered in patients at high or very high risk in order to achieve the LDL-C (搜索) goal.
Strategic Implications for Combination Therapy
The European updated guidelines emphasize the importance of earlier, aggressive combination therapy, an industry shift which Esperion foresaw and strategically positioned itself to lead by developing the first oral lipid lowering triple combination pill in the U.S. These polypills are designed to potentially provide unprecedented LDL-C (搜索) lowering, improved adherence with a single pill, and an earlier introduction into the treatment cycle.
These advanced therapies will provide physicians and patients with a flexible suite of oral options to improve outcomes and long-term success, including monotherapy (NEXLETOL® (bempedoic acid) tablets), dual therapy (NEXLIZET® (bempedoic acid and ezetimibe) tablets), and the upcoming triple combination of bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin.
Clinical Evidence and Safety Profile
The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction (搜索) and coronary revascularization in adults who are unable to take recommended statin therapy with established cardiovascular disease (搜索) or at high risk for a cardiovascular event but without established CVD. The medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial.
The most common adverse reactions in the primary hyperlipidemia (搜索) trials of bempedoic acid in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia (搜索), back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. In the cardiovascular outcomes trial, the most common adverse reactions at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout (搜索), and cholelithiasis.
Company Development Pipeline
Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase (搜索) 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.