Effectiveness and Safety of Bempedoic Acid Across Clinically Relevant Subgroups: Insights from the CLEAR Taiwan Study
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Background
Despite available lipid-lowering therapies (LLT), many patients fail to achieve low-density lipoprotein cholesterol (LDL-C) targets. This gap persists across clinically relevant subgroups. Bempedoic acid has demonstrated effective LDL-C lowering with a favorable safety profile in the CLEAR Taiwan study; however, its effects across subgroups in Asian populations remains limited.
Methods
The phase IV CLEAR Taiwan study ( NCT06925100 ) enrolled patients with inadequately controlled hypercholesterolemia who received bempedoic acid for 12 weeks in addition to background LLT. This analysis evaluated changes in lipid parameters, high-sensitivity C-reactive protein (hsCRP), and safety outcomes in clinically relevant subgroups, including cardiovascular risk, diabetes, age, statin tolerance, and sex.
Results
A total of 180 patients were included. Bempedoic acid achieved significant LDL-C reductions in all subgroups. Numerically greater LDL-C reductions were observed in primary prevention, statin-intolerant, younger (< 65 years), and female patients, while comparable reductions were observed across diabetes status. Reductions in non-high-density lipoprotein cholesterol, total cholesterol, and apolipoprotein B were consistent with LDL-C findings. Significant decreases in hsCRP were observed in all subgroups, with numerically greater reductions in patients aged < 65 years and those without diabetes. Bempedoic acid was well tolerated, with a low incidence of adverse events and no new safety signals identified. Changes in liver enzymes, renal function, and uric acid were minimal within subgroups.
Conclusion
Subgroup analyses from the CLEAR Taiwan study demonstrate consistent efficacy and safety of bempedoic acid across clinically relevant subgroups and support its use as a flexible option to address residual gaps in lipid management.
Registration
URL: https://clinicaltrials.gov/study/NCT06925100 ; Unique identifier: NCT06925100
Clinical Perspective
What Is New?
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This subgroup analyses of CLEAR Taiwan study provides the real-world evidence demonstrating that bempedoic acid leads to clinically meaningful reductions in LDL-C, lipid parameters, and hsCRP across clinically relevant subgroups, including cardiovascular risk, diabetes, age, statin tolerance, and sex. Bempedoic acid was well tolerated, with a low incidence of adverse events and no new safety signals identified in subgroups.
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LDL-C reductions appeared to be numerically greater in primary prevention, statin-intolerant, younger (< 65 years), and female patients, which may be partly explained by differences in baseline LDL-C level and lipid-lowering therapy intensity.
What Are the Clinical Implications?
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Bempedoic acid is effective and safe across a range of clinically relevant patient populations, including those commonly encountered in routine practice who present therapeutic challenges. These results support the role of bempedoic acid as a flexible treatment option to address residual gaps in lipid management and may help inform more individualized lipid-lowering strategies in clinical practice.
