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November 27, 2023 — Esperion announced the presentation of results from a pre-specified, exploratory analysis of CLEAR Outcomes at the 2023 American Heart Association (AHA) Scientific Sessions. Results were also simultaneously published in Circulation which can be accessed here.
“The analysis presented at AHA and published in Circulation highlights yet another important benefit of bempedoic acid (contained in NEXLETOL and NEXLIZET): its potential to reduce vascular inflammation in patients, including in those who are intolerant of statins,” said JoAnne Foody, MD, FACC, FAHA, Chief Medical Officer of Esperion. “Inflammation is an important contributing factor to cardiovascular risk. CLEAR Outcomes demonstrates that bempedoic acid not only reduces LDL-C levels but also reduces an established marker of inflammation, which is a key differentiator compared to other LDL-lowering therapies such as ezetimibe monotherapy and PCSK9 inhibitors.”
“We know in 2023 that ‘lower is better’ is true both for cholesterol and for inflammation,” said Paul Ridker, MD, MPH, of the Brigham and Women’s Hospital and the Harvard Medical School and a pioneer in the role of inflammation inhibition as a method going beyond cholesterol to improve patient outcomes. “In the future, it can be anticipated that virtually all atherosclerosis patients will receive aggressive inflammation inhibition along with aggressive cholesterol reduction,” Ridker added.
Dr. Ridker presented a pre-specified analysis in an oral presentation titled, “Inflammation and Cholesterol as Predictors of Cardiovascular Events and Risk Reduction with Bempedoic Acid Among Statin Intolerant Patients: An Analysis of the CLEAR Outcomes Trial.” The analysis focused on vascular inflammation, as measured by the inflammatory marker hsCRP as a major determinant of atherosclerotic risk regardless of background statin use. In the exploratory analysis, participants with baseline hsCRP in the top 25% of all participants were 43% more likely to experience MACE, twice as likely to experience cardiovascular death, and 121% more likely to experience all-cause mortality compared to those in the lowest 25%. In CLEAR Outcomes, patients who were randomized to bempedoic acid experienced a 21.6% reduction in hsCRP compared to placebo at 6 months.
INDICATION
NEXLIZET or NEXLETOL are 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 NEXLIZET or NEXLETOL on cardiovascular morbidity and mortality has not been determined.
IMPORTANT SAFETY INFORMATION
NEXLIZET is contraindicated in patients with a known hypersensitivity to ezetimibe tablets. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported with ezetimibe, a component of NEXLIZET.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout. 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: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture occurred within weeks to months of starting NEXLIZET or 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 NEXLIZET or NEXLETOL at the first sign of tendon rupture. Avoid NEXLIZET or NEXLETOL in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions In clinical trials of bempedoic acid (a component of NEXLIZET and NEXLETOL) 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.
In clinical trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥3% and greater than placebo) observed that not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL. Report pregnancies to the Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
For more information: www.esperion.com
Find more AHA23 conference coverage here
February 09, 2024 
