Nov. 18, 2024 — In November, Esperion presented an analysis from the CLEAR Outcomes study focused on patients with Peripheral Artery Disease (PAD) who were unable or unwilling to take statin medications. These data were presented at the 2024 American Heart Association Scientific Sessions, in Chicago, IL. Additionally, two exploratory analyses from the CLEAR Outcomes trial and a real-world analysis of bempedoic acid usage were presented at the conference.
“Major adverse limb events are an important cause of morbidity and disability in patients with PAD. Recent analyses support LDL-C as a target for reducing the risk of limb outcomes and that achieving very low LDL-C should be a priority in our patients with PAD. Many patients will need combination therapy in order to achieve LDL-C goals and the current analyses from CLEAR Outcomes supports bempedoic acid as an oral, safe, and well tolerated option for lowering LDL-C and the risk of major adverse limb events in patients with PAD,” said Marc P. Bonaca, MD, MPH, FAHA, FACC, the lead author for the PAD analyses for the CLEAR Outcomes trial and Executive Director at CPC Clinical Research and Director of Vascular Research at University of Colorado School of Medicine.
“The ongoing presentation of exploratory analyses from our CLEAR Outcomes trial at important medical meetings, such as AHA, offers us an exceptional opportunity to showcase the clinical benefits and value of NEXLETOL and NEXLIZET (bempedoic acid and ezetimibe) before an audience of the key physicians who treat patients in need of managing their cardiovascular risk,” said Sheldon Koenig, President and Chief Executive Officer of Esperion.
The featured science presentation was titled, “Bempedoic Acid and Limb Outcomes in Statin-Intolerant Patients with Peripheral Artery Disease.” It was presented on behalf of all authors by Marc P. Bonaca, MD, MPH, FAHA, FACC, CPC Clinical Research.
This analysis focused on the incidence of major adverse limb events (MALE) in patients with pre-existing PAD enrolled in the CLEAR Outcomes trial. Bempedoic acid reduced MALE (e.g. worsening PAD symptoms leading to revascularization, chronic limb threatening ischemia, and acute limb ischemia events) by 36% compared to placebo.
Three additional exploratory analyses from the CLEAR Outcomes trial also were presented at the conference:
“Liver Steatosis and Liver Fibrosis Predict Major Adverse Cardiovascular Events: Analysis of the CLEAR Outcomes Trial Population.” – presented on behalf of all authors by Diederick (Rick) Grobbee, MD, PhD, FESC, University Medical Center Utrecht and Julius Clinical in The Netherlands. Results suggest bempedoic acid treatment resulted in a lower incidence of major adverse cardiovascular events (MACE) versus placebo in patients with higher liver steatosis scores at study enrollment.
“Statin Intolerance due to Muscle Symptoms Affects Management of Patients: Insights from the CLEAR Outcomes Trial” – presented on behalf of all authors by Ulrich Laufs, MD, PhD, Universitätsklinikum Leipzig, Leipzig Germany, describes the variable characteristics of statin intolerance in patients enrolled in CLEAR Outcomes and their clinical course in the study.
“Effectiveness of Lipid-lowering Therapy with Bempedoic Acid plus Ezetimibe in a Real-world Cohort” – presented on behalf of all authors by Evelyn Sarnes, PharmD, Esperion, used US claims data to evaluate the effectiveness of the combination of bempedoic acid plus ezetimibe in reducing or maintaining LDL-C <100 mg/dL. After 3 months 67% of patients on bempedoic acid and ezetimibe had LDL-C <100 mg/dL, a significant increase over the 30% at baseline, and by 12 months 55% had maintained LDL-C levels <100 mg/dL.
Please see full Safety and Prescribing Information at NEXLIZET and NEXLETOL.
November 08, 2024 
