Effectiveness and Safety of Bempedoic Acid in Taiwanese Patients with Hypercholesterolemia ― A Pragmatic Phase IV Study (CLEAR Taiwan Study)

ABSTRACT Background Elevated low-density lipoprotein cholesterol (LDL-C) is a risk factor for cardiovascular disease. Despite available lipid-lowering therapies (LLT), lipid control remains suboptimal. Bempedoic acid offers a non-statin oral treatment for hypercholesterolemia. However, real-world data in Asia are limited. The study aimed to investigate the effectiveness and safety of bempedoic acid in Taiwan. Methods This pragmatic phase IV study enrolled 180 patients with inadequately controlled hypercholesterolemia to receive bempedoic acid for 12 weeks in addition to background LLT. The primary endpoint was the percentage change in LDL-C. Secondary endpoints included changes in other lipid parameters, high-sensitivity C-reactive protein (hsCRP), and safety outcomes. Results Among 180 patients, 160 (88.9%) completed the study. The median percentage change in LDL-C from baseline to week 12 was -19% (interquartile range [IQR]: -36.4% to -3.6%), decreasing from 117.5 to 92 mg/dL ( p < 0.01). The median percentage changes from baseline to week 12 were -13.3% for non-high-density lipoprotein cholesterol (non-HDL-C), -10.8% for total cholesterol, -11.5% for apolipoprotein B, and -34.0% for hsCRP (all p < 0.01). Minimal effects were noted on triglycerides (+0.2%), HDL-C (-5.5%), and lipoprotein(a) (+2.6%) (all p > 0.05). At week 12, 31.3% of patients achieved LDL-C targets (< 100 mg/dL for primary prevention; < 55 or < 70 mg/dL for secondary prevention). The safety outcomes were consistent with the locally approved label, with no new safety signals identified. Conclusions Bempedoic acid offers an effective and safe oral therapeutic option for Taiwanese patients whose LDL-C levels remain inadequately controlled with existing LLT, including statins. Registration URL: https://clinicaltrials.gov/study/NCT06925100 ; Unique identifier: NCT06925100 Clinical Perspective What Is New? ◆ This pragmatic phase IV study provides the first real-world evidence from Taiwan demonstrating that bempedoic acid leads to clinically meaningful reductions in LDL-C (median percentage change: -19%) at week 12 when added to background lipid-lowering therapy in patients with inadequately controlled hypercholesterolemia. ◆ Approximately one-third of patients achieved guideline-recommended LDL-C targets within 12 weeks, with a safety profile consistent with the locally approved label and no new safety signals identified. What Are the Clinical Implications? ◆ Bempedoic acid represents an effective and well-tolerated oral add-on lipid-lowering option for Taiwanese patients who fail to achieve LDL-C goals with existing therapies, including those unable to tolerate or intensify statin treatment.