Effectiveness and Safety of Bempedoic Acid in Taiwanese Patients With Hypercholesterolemia: A Pragmatic Phase 4 Study (CLEAR Taiwan Study)

Background: Elevated low-density lipoprotein cholesterol (LDL-C) is a risk factor for cardiovascular disease. Despite available lipid-lowering therapies, lipid control remains suboptimal. Bempedoic acid offers a nonstatin 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 prospective, pragmatic phase 4 study enrolled 180 patients with inadequately controlled hypercholesterolemia to receive bempedoic acid for 12 weeks in addition to background lipid-lowering therapy. The primary end point was the percentage change in LDL-C. Secondary end points included changes in other lipid parameters, hs-CRP (high-sensitivity C-reactive protein), 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, -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, -10.8% for total cholesterol, -11.5% for apolipoprotein B, and -34.0% for hs-CRP (all P<0.01). Minimal effects were noted on triglycerides (0.2%), high-density lipoprotein cholesterol (-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; and <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 lipid-lowering therapy, including statins. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT06925100.