Esperion (ESPR) announced that it had presented pooled analysis from four Phase 3 clinical studies of NEXLETOL at the American Diabetes Association 80th Scientific Sessions. The company says American Diabetes Association (ADA) guidelines as per Elevated LDL cholesterol has been remained a common problem for people with diabetes so because of hyperlipidemia this condition greatly raised the risk of developing cardiovascular disease.
The presentation that the company presented has title as; “Efficacy and Safety of Bempedoic acid in Patients with Diabetes, Prediabetes, and Normoglycemia: Analysis of Pooled Patient-Level Data From 4 Phase 3 Clinical Trials.” Lawrence A. Leiter delivered the presentation who is the MD, FRCPC, FACP, FACE, Director FAHA of the Lipid Clinic at St. Michael’s Hospital and Professor of Medicine and Nutritional Sciences, University of Toronto.
NEXLETOL is a ATP Citrate Lyase (ACL) inhibitor that works in lowering the LDL-C by diluting cholesterol biosynthesis and regularize the LDL receptors.
According to the analysis, the patients treated with NEXLETOL saw a significant decrease in LDL-Cholesterol as compared to placebo in all glycemic status subgroups. The results also showed that use of NEXLETOL significantly lowered total cholesterol, non-HDL-C, Apo B and hsCRP throughout all subgroups. While NEXLETOL did not decline the measurements of glycemic control or also didn’t increase the occurrence of new-onset diabetes as compared to placebo. The safety profile of NEXLETOL has remained similar in patients throughout the glycemic status subgroups.
Esperion’s President and chief executive officer Tim Mayleben commented, “We are pleased with the pooled analysis showing NEXLETOL significantly lowered LDL-C and that this was consistent across all glycemic status subgroups as well as reduced HbA1c by 0.19% in patients with diabetes which is something we will continue to evaluate in ongoing clinical trials.” He further added, “Importantly, this analysis adds to the growing body of information regarding the efficacy and safety of NEXLETOL for the millions of appropriate patients needing to lower their bad cholesterol.”
Completed Phase 3 studies conducted in more than 3,000 patients, with over 2,000 patients treated with NEXLETOL, demonstrated an average 18 percent placebo corrected LDL-C lowering when used in patients on moderate or high-intensity statins. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was approved by the FDA in February 2020.