Thursday, December 08, 2022
Esperion announced that the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg/day NEXLETOL compared to placebo.
“With the announcement of these positive topline results, bempedoic acid becomes the first ATP-citrate lyase inhibitor to demonstrate significant and clinically meaningful outcomes results for patients in whom existing lipid lowering therapies fall short,” said Sheldon Koenig, President and CEO of Esperion. “We thank the thousands of patients and investigators worldwide for bringing this study to a successful close. We look forward to sharing this data with the medical community and submitting to appropriate regulatory authorities as quickly as possible in 2023. CLEAR Outcomes further strengthens the clinical evidence supporting the role of bempedoic acid for patients.”
Cardiovascular disease remains the number one killer globallyi. A large proportion of patients at risk for cardiovascular events based on elevated LDL-cholesterol and apolipoprotein b are not adequately treated with existing therapies. Despite recent therapeutic advances, there remains a significant need for new treatment options to help improve long-term cardiovascular outcomesii.
CLEAR Cardiovascular Outcomes Trial
CLEAR Outcomes is a Phase 3, event-driven, randomized, multicenter, double-blind, placebo-controlled trial designed to evaluate whether treatment with bempedoic acid reduces the risk of cardiovascular events in patients with or who are at high risk for cardiovascular disease with documented statin intolerance (inability to tolerate two or more statins, one at a low dose) and elevated LDL-cholesterol levels (fasting blood LDL-C ≥ 100 (2.6 mmol/L)). The study included over 14,000 patients at over 1,200 sites in 32 countries.
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.
