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Effectiveness and Safety of Bempedoic Acid in Taiwanese Patients With Hypercholesterolemia: A Pragmatic Phase 4 Study
I-Chang Hsieh1, Dong-Yi Chen1, Chih-Sheng Chu2,3
1Department of Cardiology Chang Gung Memorial Hospital, Linkou Branch Taoyuan Taiwan.
Insights
Bempedoic acid effectively lowered low-density lipoprotein cholesterol (LDL-C) by 19% in Taiwanese patients with hypercholesterolemia. This nonstatin therapy demonstrated a favorable safety profile, offering a new oral option for lipid management.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Elevated low-density lipoprotein cholesterol (LDL-C) is a significant risk factor for cardiovascular disease.
- Current lipid-lowering therapies often result in suboptimal lipid control.
- Bempedoic acid presents a nonstatin oral treatment option for hypercholesterolemia, with limited real-world data in Asian populations.
Purpose of the Study:
- To investigate the effectiveness of bempedoic acid in managing hypercholesterolemia in Taiwan.
- To assess the safety profile of bempedoic acid in a real-world Taiwanese setting.
- To evaluate the impact of bempedoic acid on LDL-C and other lipid parameters.
Main Methods:
- A prospective, pragmatic phase 4 study involving 180 patients with inadequately controlled hypercholesterolemia.
- Patients received bempedoic acid for 12 weeks as an add-on to existing lipid-lowering therapy.
- Primary endpoint: percentage change in LDL-C; Secondary endpoints: changes in lipid parameters, hs-CRP, and safety.
Main Results:
- A median 19% reduction in LDL-C was observed from baseline to week 12 (P<0.01).
- Significant reductions were also noted in non-high-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and hs-CRP (all P<0.01).
- The safety outcomes were consistent with the approved label, with no new safety signals.
Conclusions:
- Bempedoic acid is an effective oral therapy for Taiwanese patients with inadequately controlled LDL-C.
- The drug demonstrates a favorable safety profile in this population.
- Bempedoic acid provides a valuable therapeutic option, particularly for patients on existing lipid-lowering treatments, including statins.
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.
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