ANN ARBOR, Mich., Feb.  20, 2023  (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announces that the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial will be presented as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology.

“Since releasing the positive topline results, we have fielded enthusiastic inquiries from health care providers and scientific leaders, so we are eager to share CLEAR Outcomes data in greater detail,” said Sheldon Koenig, Esperion’s president and chief executive officer. “We are honored to kick off the Late Breaking Clinical Trial sessions at ACC.23/WCC and look forward to showcasing the broad cardiovascular risk reduction results that NEXLETOL has demonstrated.”

INDICATIONNEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.Limitations of Use: The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions: Hyperuricemia: NEXLETOL may increase blood uric acid levels. Hyperuricemia may occur early in treatment and persist throughout treatment, and may lead to the development of gout, especially in patients with a history of gout. 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. In clinical trials, tendon rupture occurred in 0.5% of patients treated with NEXLETOL versus 0% of patients treated with placebo, and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting NEXLETOL. Tendon rupture may occur more frequently in patients over 60 years of age, patients taking corticosteroid or fluoroquinolone drugs, patients with renal failure, and patients with previous tendon disorders. Discontinue NEXLETOL at the first sign of tendon rupture. Avoid NEXLETOL in patients who have a history of tendon disorders or tendon rupture.

Adverse Reactions: In clinical trials, the most commonly reported adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. Reactions reported less frequently, but still more often than with placebo, included benign prostatic hyperplasia and atrial fibrillation.

Drug Interactions: Simvastatin and Pravastatin: Concomitant use results in increased concentrations and increased risk of simvastatin or pravastatin-related myopathy. Use with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided.

Lactation and Pregnancy: It is not recommended that NEXLETOL be taken during breastfeeding. Discontinue NEXLETOL when pregnancy is recognized, unless the benefits of therapy outweigh the potential risks to the fetus. Based on the mechanism of action, NEXLETOL may cause fetal harm.

Please see full Prescribing Information here.

Esperion TherapeuticsAt Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on Twitter at twitter.com/EsperionInc.

Contact:Corporate Communicationscorporateteam@esperion.com

Esperion Announces Positive CLEAR Outcomes Results To Be

Esperion announced that the results of the CLEAR Outcomes trial, focusing on cholesterol lowering via Bempedoic acid, will be presented at the American College of Cardiology’s Annual Scientific Session. Sheldon Koenig, CEO of Esperion, expressed enthusiasm for sharing detailed data from the trial, which aims to demonstrate significant cardiovascular risk reduction through NEXLETOL.