Efficacy and Safety of Bempedoic Acid in Japanese Patients With Hypercholesterolemia ― A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (the CLEAR-J Trial) ― DOI Open Access
Shizuya Yamashita,

Arihiro Kiyosue,

Hitomi Fujita

et al.

Circulation Journal, Journal Year: 2025, Volume and Issue: unknown

Published: March 27, 2025

Statins can effectively reduce low-density lipoprotein cholesterol (LDL-C), but additional options are needed for inadequate responses to statins or statin intolerance. Bempedoic acid is a small-molecule oral LDL-C-lowering drug that inhibits ATP citrate lyase, an enzyme 2 steps upstream of 3-hydroxy-3-methylglutaryl coenzyme A reductase in the metabolic pathway synthesis. The CLEAR-J trial evaluated bempedoic 180 mg/day 12 weeks Japanese patients with inadequately controlled LDL-C. Percentage changes LDL-C between baseline and Week (primary endpoint) were -25.25% -3.46% placebo groups, respectively, significant between-group difference (-21.78%; 95% confidence interval [CI] -26.71%, -16.85%; P<0.001). Changes secondary endpoints groups as follows: non-high-density cholesterol, -20.33% -2.76%, respectively (between-group -17.57%; CI -22.03%, -13.12%); total -16.36% -2.23%, -14.13%; -17.79%, -10.47%); apolipoprotein B -18.10% -0.67%, -17.43%; -21.97%, -12.89%). At weeks, 62.5% group had achieved target values. Treatment-emergent adverse events appeared 3 taking placebo. This study confirmed safety efficacy after treatment high who response

Language: Английский

Efficacy and Safety of Bempedoic Acid in Japanese Patients With Hypercholesterolemia ― A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (the CLEAR-J Trial) ― DOI Open Access
Shizuya Yamashita,

Arihiro Kiyosue,

Hitomi Fujita

et al.

Circulation Journal, Journal Year: 2025, Volume and Issue: unknown

Published: March 27, 2025

Statins can effectively reduce low-density lipoprotein cholesterol (LDL-C), but additional options are needed for inadequate responses to statins or statin intolerance. Bempedoic acid is a small-molecule oral LDL-C-lowering drug that inhibits ATP citrate lyase, an enzyme 2 steps upstream of 3-hydroxy-3-methylglutaryl coenzyme A reductase in the metabolic pathway synthesis. The CLEAR-J trial evaluated bempedoic 180 mg/day 12 weeks Japanese patients with inadequately controlled LDL-C. Percentage changes LDL-C between baseline and Week (primary endpoint) were -25.25% -3.46% placebo groups, respectively, significant between-group difference (-21.78%; 95% confidence interval [CI] -26.71%, -16.85%; P<0.001). Changes secondary endpoints groups as follows: non-high-density cholesterol, -20.33% -2.76%, respectively (between-group -17.57%; CI -22.03%, -13.12%); total -16.36% -2.23%, -14.13%; -17.79%, -10.47%); apolipoprotein B -18.10% -0.67%, -17.43%; -21.97%, -12.89%). At weeks, 62.5% group had achieved target values. Treatment-emergent adverse events appeared 3 taking placebo. This study confirmed safety efficacy after treatment high who response

Language: Английский

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