According to a press release issued by Esperion on December 7, 2022, 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.”
Heart Disease Overview
Heart disease is the leading cause of death globally; in 2019, an estimated 17.9 million people died from cardiovascular diseases (CVDs), representing 32% of all global deaths. In the U.S., coronary heart disease is the most common type of CVD – killing 382,820 people in 2020. High blood pressure and cholesterol are key risk factors for heart disease, causing premature death, disability, and health care expenditure. From 2017 to 2018, heart disease cost the U.S. approximately $229 billion per year.
CLEAR Outcomes Trial
The CLEAR Outcomes trial sought to determine if treatment with bempedoic acid (Nexletol) versus placebo decreased the risk of major cardiovascular events in patients with – or at high risk for – CVD who are also statin intolerant. The Phase 3, randomized, double-blind, placebo-controlled study included over 14,000 patients at over 1,200 sites in 32 countries. The trial’s primary endpoint was a measure of four major adverse cardiac events (MACE-4): CVD-related death, nonfatal myocardial infraction, nonfatal stroke, or hospitalization for unstable angina.
CLEAR Trial Results
Nexletol, an ATP-citrate lyase inhibitor, first won U.S. Food and Drug Administration (FDA) approval in 2020 as an adjunct to diet and maximally tolerated statin therapy to treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic CVD who require additional lowering of LDL-C. Esperion has now announced that the CLEAR Outcomes study met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg per day of Nexletol compared to placebo.
Sheldon Koenig, President and CEO of Esperion, said: “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.” Koenig also mentioned a forthcoming comprehensive presentation of the data to the medical community in the first quarter of 2023.