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Bempedoic acid safety analysis: Pooled data from four phase 3 clinical trials.
Harold E Bays1, Maciej Banach2, Alberico L Catapano3
1Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA.
Journal of Clinical Lipidology
|September 27, 2020
Summary
Bempedoic acid, a novel lipid-lowering therapy, demonstrates a favorable safety profile in patients with hypercholesterolemia. This study confirms its tolerability and effectiveness in managing cholesterol levels when added to existing treatments.
Area of Science:
- Cardiovascular Pharmacology
- Lipid Metabolism Disorders
- Clinical Trial Analysis
Background:
- Persistent need for effective lipid-lowering therapies (LLTs) for patients with suboptimal cholesterol control.
- Current treatments may not achieve desired low-density lipoprotein cholesterol (LDL-C) levels in all patients.
Purpose of the Study:
- To evaluate the safety and tolerability of bempedoic acid, an adenosine triphosphate (ATP)-citrate lyase inhibitor.
- To assess the efficacy of bempedoic acid in reducing LDL-C levels in hypercholesterolemia patients.
Main Methods:
- Pooled analysis of four Phase 3, randomized, double-blind, placebo-controlled studies.
- Inclusion of 3621 patients with hypercholesterolemia requiring additional LDL-C lowering.
- Assessment of treatment-emergent adverse events (TEAEs) and laboratory tests over 12-52 weeks.
Main Results:
- Bempedoic acid showed comparable rates of treatment-emergent adverse events (TEAEs) to placebo.
- Myalgia and muscle weakness rates were similar between bempedoic acid and placebo groups.
- Mild, reversible laboratory abnormalities (e.g., BUN, creatinine, uric acid) and decreased hemoglobin were observed with bempedoic acid.
Conclusions:
- Bempedoic acid is generally safe and well-tolerated in patients with hypercholesterolemia needing additional LLT.
- The safety profile was consistent across various patient subgroups.
- Bempedoic acid offers a valuable therapeutic option for managing lipid levels.
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