Business
Esperion Announces Publication of CLEAR Harmony Open-Label Extension Study Data for Bempedoic Acid in the American Journal of Cardiology
Analysis of open-label extension data demonstrated that bempedoic acid was generally well tolerated and demonstrated sustained efficacy with up to 2.5 years
About this update from Esperion Therapeutics, Inc.
[{"type":"text","content":"Analysis of open-label extension data demonstrated that bempedoic acid was generally well tolerated and demonstrated sustained efficacy with up to 2.5 years of continuous treatment\nANN ARBOR, Mich., May 02, 2022 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the publication of data from the CLEAR Harmony Open-Label Extension (OLE) Study of bempedoic acid, also known as NEXLETOL®, in the American Journal of Cardiology. The paper, “Long-term Safety and Efficacy of Bempedoic Acid in Patients with Atherosclerotic Cardiovascular Disease and/or Heterozygous Familial Hypercholesterolemia (From the CLEAR Harmony Open-Label Extension Study),” described the results from the 78-week, Phase 3, OLE study that followed the 52-week CLEAR Harmony Phase 3 study. In the CLEAR Harmony study, patients were randomized 2:1 to bempedoic acid or placebo for 52 weeks. During the OLE, patients who received bempedoic acid continued treatment (≤130 weeks) and patients who received placebo initiated bempedoic acid (≤78 weeks).The purpose of the CLEAR Harmony OLE study was to build on the findings from the CLEAR Harmony parent study and evaluate the long-term safety and efficacy of bempedoic acid for up to 130 weeks. “The results from the CLEAR Harmony OLE study support the long-term safety and efficacy of bempedoic acid in lowering and maintaining LDL-C levels in patients,” said JoAnne Foody, M.D., FACC, FAHA, chief medical officer of Esperion. “Importantly, the safety profile of bempedoic acid in the OLE study was comparable to findings from the parent study and no new safety concerns were observed. Additionally, bempedoic acid produced stable reductions in LDL-C which remained durable for up to 130 weeks.” Bempedoic acid was generally well tolerated, with a safety profile that was comparable to that observed in the parent study, and no new safety signals were identified. The results of the OLE study demonstrated that the decrease in LDL-C levels for patients who had received bempedoic acid in the 52-week parent study (n=970) remained relatively stable during the 78-week OLE study, with a mean (SE) percent change in LDL-C from parent study baseline to week 78 of the OLE study of -14.2 ± 0.9% [mean (SE) change from baseline of -16.0 ± 1.0 mg/dL]. Patients who received placebo in the parent study (n=492) experienced a similar degree of LDL-C lo...