News | Cardiovascular Clinical Studies | February 20, 2023

Esperion Announces Positive CLEAR Outcomes Results To Be Presented as Late-Breaking Clinical Trial at ACC.23/WCC

NEXLETOL (bempedoic acid) is the first ATP citrate lyase inhibitor and first oral non-statin to meet the major adverse cardiovascular events (MACE-4) primary endpoint

NEXLETOL (bempedoic acid) is the first ATP citrate lyase inhibitor and first oral non-statin to meet the major adverse cardiovascular events (MACE-4) primary endpoint –

February 20, 2023 — Esperion announced 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.” 

Late Breaking Clinical Trial Presentation 

Title: 

  

  

CLEAR Outcomes Trial: Bempedoic Acid and Cardiovascular Outcomes in Statin Intolerant Patients at High Cardiovascular Risk 

Location: 

  

  

Main Tent (Great Hall) 

Date & Time: 

  

  

3/4/2022, 9:30 – 9:42 AM CST 

Speaker: 

  

  

Steven Nissen, MD, Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic 

  

  

  

  

Industry Expert Theatre 

Title: 

  

  

A Next Step in LDL-C–Lowering Therapy: Oral Nonstatin Therapies 

Location: 

  

  

Industry Expert Theatre #2, Location 2455 

Date & Time: 

  

  

3/5/2022, 11:15 AM – 12:15 PM CST 

Speaker: 

  

  

Kausik Ray, BSc (hons), MBChB, FRCP (Lon), FRCP (Ed), MD, MPhil (Cantab), FACC, FESC, FAHA 

  

  

  

  

CLEAR Outcomes Late Breaking Clinical Trial Deep Dive – Session 408 

Title: 

  

  

Bempedoic Acid And Cardiovascular Outcomes In Statin Intolerant Patients At High Cardiovascular Risk 

Location:  

  

  

Main Tent (Great Hall) 

Date & Time: 

  

  

3/5/2022, 2:00 – 2:05 PM CST 

Speaker: 

  

  

Steven Nissen, MD, Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic 


INDICATION

NEXLETOL 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

For more information: www.esperion.com 

Find more ACC23 coverage here 


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