Bempedoic acid with statins safely reduces LDL in hypercholesterolemia
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Bempedoic acid with maximally tolerated statins safely decreased LDL compared with placebo among patients with hypercholesterolemia, researchers found.
In a pooled analysis published in JAMA Cardiology, Maciej Banach, MD, PhD, president of Polish Mother’s Memorial Hospital Research Institute in Lodz, Poland, and professor of cardiology and head of the department of hypertension at Medical University of Lodz, and colleagues analyzed data from 3,623 patients (mean age, 66 years) with hypercholesterolemia who were taking stable lipid-lowering therapy and required additional LDL reductions.
These patients were enrolled in one of four trials conducted from 2016 to 2018: CLEAR Harmony, CLEAR Wisdom, CLEAR Tranquility and CLEAR Serenity. Patients in all of the studies were assigned 180 mg bempedoic acid (Nexletol, Esperion Therapeutics; n = 2,425) or placebo (n = 1,198) once daily for 12 to 52 weeks.
Patients were then categorized as those having atherosclerotic CVD, heterozygous familial hypercholesterolemia or both who were receiving statin therapy (mean baseline LDL, 107.6 mg/dL) or patients with statin tolerance who were receiving maximally tolerated statins (mean baseline LDL, 144.4 mg/dL).
All four trials had a primary efficacy endpoint of the percentage change in LDL from baseline to 12 weeks.
At 12 weeks, patients with ASCVD, heterozygous familial hypercholesterolemia or both who were assigned bempedoic acid had a percentage change in LDL from baseline of 16% compared with 1.8% who were assigned placebo (difference, 17.8 percentage points; 95% CI, 19.5 to 16; P < .001). The percentage changes in LDL for patients with statin intolerance who were assigned bempedoic acid was 23% vs. 1.5% for those assigned placebo (difference, 24.5 percentage points; 95% CI, 27.8 to 21.1; P < .001).
LDL decreases with bempedoic acid were sustained at 24 weeks in patients with statin intolerance (difference, 22.2%) and at 52 weeks in those with ASCVD, heterozygous familial hypercholesterolemia or both (difference, 12.7%).
Compared with placebo, patients assigned bempedoic acid had greater decreases in total cholesterol, non-HDL, high-sensitivity C-reactive protein and apolipoprotein B.
Several treatment-emergent adverse events occurred more often in the bempedoic acid group compared with the placebo group including gout (1.4% vs. 0.4%), increased blood uric acid level (2.1% vs. 0.5%), increased levels of hepatic enzymes (2.8% vs. 1.3%) and decreased glomerular filtration rate (0.7% vs. < 0.1%).
“An alternative such as bempedoic acid has the potential to fulfill an unmet clinical need for high-risk patients in whom the administration of a statin or a statin plus ezetimibe does not adequately decrease LDL-C levels and for patients with statin intolerance,” Banach and colleagues wrote.
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