– Obese patients taking NEXLETOL were 23% less likely to experience a major cardiovascular event (MACE-4) compared to placebo –
– NEXLETOL demonstrated clinical benefit in historically underrepresented groups: women and Hispanic/Latino patients with and without cardiovascular disease (CVD) –
– CLEAR Results Set New Standard for Diversity and Inclusion with 48% Women and 17% Hispanic/Latino Patients Enrolled –
ANN ARBOR, Mich., April 7, 2024 (GLOBE NEWSWIRE) — Esperion (Nasdaq: ESPR) today announced the 2024 American College of Cardiology Annual Scientific Sessions (ACC. 24): Women, Hispanics/Latinos; Obese patients. These results encourage a culture change across the profession to ensure that cardiovascular care teams are as diverse as the patients they care for and that all patients are included in cardiovascular research, the American College of Cardiology said. Consistent with our strong diversity, equity and inclusion program. The data also strengthens ACC's mission to transform cardiovascular care for everyone.
“These analyzes demonstrate the benefits of the bempedoic acid components of NEXLETOL and NEXLIZET.® (Bempedoic acid and ezetimibe) Tablets are being administered to some important populations, but they are understudied,” said Joan Foudy, MD, FACC, FAHA, Esperion's chief medical officer. “Bempedoic acid is the only FDA-approved non-statin LDL-lowering therapy that demonstrates reductions in MACE in both primary and secondary prevention patient populations. Women with or at risk for CVD and Hispanics / In Latino patients, bempedoic acid reduced LDL cholesterol (LDL-C) and inflammatory markers without worsening blood sugar or weight, which in turn lowered the risk of major major cardiovascular events (MACE). The results continue to emphasize the importance of early and aggressive lowering of LDL-C to reduce cardiovascular events, and the 'lower, earlier is better' paradigm. We are emphasizing.”
Harold Bays, MD, FOMA, FTOS, FACC, FNLA, FASPC, Louisville Center for Metabolic and Atherosclerosis Research, University of Louisville School of Medicine;Bempedoic acid for prevention of cardiovascular events in obese patients: a subset analysis of distinct results” Almost 45% of patients in CLEAR Outcomes were obese (BMI ≥30 kg/m3).2) at the beginning of the study. In this analysis, obese patients treated with bempedoic acid were significantly less likely to suffer from MACE-4 (cardiovascular death (CV), non-fatal myocardial infarction (MI), non-fatal stroke, or coronary revascularization) compared to placebo. patients were 23% less likely to experience “Given that obesity is an epidemic and a risk factor for cardiovascular disease, clinicians and their patients will benefit from knowledge of cardiovascular disease outcomes in obese patients treated with specific cardiometabolic therapies. You can make more informed treatment decisions,” Dr. Bayes said.
Fatima Rodriguez, M.D., Stanford University M.D., said, “Characteristics and outcomes of statin-intolerant Hispanic/Latino participants receiving bempedoic acid: Results of a prespecified subgroup analysis of CLEAR outcomes.Hispanic/Latino patients made up nearly 17% of patients enrolled in the CLEAR Outcomes trial. Although the Hispanic population is the largest ethnic minority in the United States, they are a historically underrepresented population in clinical trials. This subgroup analysis showed a 21% reduction in LDL-C with bempedoic acid compared to placebo in Hispanics/Latinos and non-Hispanics/Latinos alike, with LDL-C lowering contributing to CV risk reduction. and bempedoic acid was confirmed to be well tolerated. regardless of ethnicity. This analysis Journal of the American College of Cardiology (JACC).
Dr. Leslie Cho of the Cleveland Clinic said,Characteristics and results of statin-intolerant women treated with bempedoic acid in the CLEAR outcomes trial” CLEAR Outcomes is notable for having the highest female enrollment rate (48%) of any recent lipid-lowering cardiovascular outcomes trial. The CLEAR Outcomes trial confirmed the LDL-C-lowering effect of bempedoic acid on CV risk reduction regardless of gender, as the risk of MACE-4 was similarly reduced in women treated with bempedoic acid compared to placebo. Ta.This analysis was published simultaneously Circulation.
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NEXLIZET and NEXLETOL are shown:
Important safety information
NEXLIZET and NEXLETOL are contraindicated in patients with a history of hypersensitivity to bempedoic acid, ezetimibe, or any excipient. Serious hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, have been reported.
Hyperuricemia: Bempedoic acid, an ingredient in Nexlisette and Nexletol, can increase blood uric acid levels and cause gout. Hyperuricemia occurs early in treatment, persists throughout treatment, and may return to baseline after treatment is discontinued. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia and initiate treatment with uric acid-lowering drugs if necessary.
tendon rupture: Bempedoic acid, an ingredient in NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon ruptures may occur more frequently in patients over 60 years of age, those taking corticosteroids or fluoroquinolone drugs, those with renal failure, and those with previous tendon disease. Discontinue use of NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapies for patients with a history of tendinopathy or tendon rupture.
In primary hyperlipidemia studies of bempedoic acid, a component of Nexlisette and Nexletol, the most common side effects in 2% or more of patients and more common than placebo were upper respiratory tract infections, muscle spasms, and hyperuricemia. symptoms, back pain, abdominal pain, or discomfort. Bronchitis, pain in the extremities, anemia, elevated liver enzymes.
Side effects that were reported in more than 2% of patients treated with ezetimibe (a component of NEXLIZET), and whose incidence was higher than with placebo in clinical trials, include upper respiratory tract infections, diarrhea, joint pain, sinusitis, extremity I was in pain, tired, and had the flu.
In the primary hyperlipidemia trial of NEXLIZET, the most commonly reported side effects observed with NEXLIZET (incidence ≥3%, greater than placebo) were not observed in clinical trials with bempedoic acid or ezetimibe, but He had a urinary tract infection, nasopharyngitis, and constipation.
The most common side effects in cardiovascular outcome studies of bempedoic acid, a component of Nexriset and Nexletol, were hyperuricemia, kidney damage, anemia, elevated liver enzymes, muscle spasms, and gout, with an incidence of 2% or more. , 0.5% higher than placebo. , cholelithiasis.
Discontinue use of Nexlisette or Nexletol if you become pregnant, unless the benefits of treatment outweigh the potential risks to the fetus. Breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL due to the potential for serious side effects in breastfed infants.
Pregnancy may be reported to Esperion Therapeutics, Inc.'s Adverse Event Reporting Line at 1-833-377-7633.
Esperion Therapeutics
Esperion discovers, develops and commercializes innovative medicines that help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. Currently, the health needs of millions of people with high cholesterol are not being met. That's why our team of passionate industry leaders breaks through the barriers that prevent patients from achieving their goals. Healthcare providers work to lower LDL cholesterol levels as low as possible as quickly as possible. We provide the next steps to get patients there. Because if you have high cholesterol levels, achieving your goals is not optional. It is our life's work. For more information, please visit: Esperion.com and esperionscience.com Follow me on X twitter.com/Esperion Co., Ltd.
CLEAR Cardiovascular Outcomes Study
CLEAR Outcomes is part of NEXLETOL's CLEAR clinical research program® (Bempedoic acid) tablets and Nexlysit® (bempedoic acid and ezetimibe) tablets. The CLEAR program provides important information regarding the safety and efficacy of bempedoic acid, a first-in-class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET, and its potential role in addressing additional important unmet medical needs. We aim to generate clinical evidence. More than 60,000 people will participate by the time the program is complete. The CLEAR program includes five label-validated Phase III studies and other important studies that have the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C. Phase IV studies are included.
Forward-looking statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the federal securities laws, including, but not limited to, our marketing strategies and commercialization plans, current and planned operating expenses, future expectations and expectations. Includes descriptions of operations, products, and clinical development. , the design and planning of the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and prospects, including anticipated funding runway; Other statements that include the word “expect”. , “intend”, “may”, “plan”, “anticipate”, “project”, “propose”, “target”, “could”, “will” , “would'', “could'', “should'', “continue'', etc. Statements contained in this press release, express or implied, that are not statements of historical fact are deemed forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual performance to differ materially from expectations. This includes Esperion's commercial product net sales, profitability, growth, clinical activity and results, supply chain, commercial development, and implementation plans, the results of litigation proceedings and settlements, and anticipated benefits to the Securities and Exchange Commission. including the risks detailed in Esperion's filings. The forward-looking statements contained in this press release speak only as of the date of this press release, and Esperion does not warrant the forward-looking statements contained in this press release, except to the extent required by law. We disclaim any obligation or undertaking to update or amend.
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