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.