Bempedoic acid is an oral, non-statin LDL-cholesterol (LDL-C) lowering agent that inhibits ATP citrate lyase (ACL), upstream of HMG-CoA reductase (the enzyme inhibited by statins).
MDPI
+1
In patients with hypercholesterolemia who are unable to tolerate statins, or have sub-optimal statin adherence/tolerance, bempedoic acid has been shown to reduce LDL-C by \~20-30% (monotherapy) and more when added to other therapies (e.g., ezetimibe) (≈30-40%).
PubMed
* 2 medicinejournal.in * 2
In the large primary-prevention subgroup of the trial CLEAR Outcomes (statin-intolerant patients without prior cardiovascular event), bempedoic acid (180 mg daily) lowered LDL-C by \~21.3% and hs-CRP by \~21.5%. It also was associated with a significant reduction in major adverse cardiovascular events (MACE): hazard ratio 0.70 (95% CI 0.55-0.89) versus placebo over \~40 months.
PubMed +1
Regarding tolerability: muscle-related adverse events appear lower compared to statins (because bempedoic acid is activated only in the liver, not in skeletal muscle) and it appears generally well tolerated, but there are signals of increased uric acid/gout, elevated hepatic enzymes, and creatinine/renal effects.
MDPI
+1
Comparative cardiovascular benefit (when normalized per unit LDL-C reduction) suggests that bempedoic acid may yield similar relative risk reductions as statins, though absolute LDL-C lowering is less.
Adults aged ≥40 years with no established ASCVD (no prior myocardial infarction, stroke, or acute coronary syndrome).
Indicated for lipid-lowering therapy (LDL-C ≥130 mg/dL or 10-year ASCVD risk
Self-reported adherence <80% in the past 3 months, or
Prior statin discontinuation for adverse effects documented in the medical record.
Established ASCVD (secondary prevention).
Severe hepatic impairment (ALT or AST >3× upper limit of normal).
Severe renal impairment (eGFR <30 mL/min/1.73 m²).
Pregnancy, breastfeeding, or women of childbearing potential not using contraception.
Parallel
Bempedoic Acid 180 MG Oral Tablet
DrugBA 180mg OD
Rosuvastatin 5 mg
Drugrosuvastatin 5mg HS
Placebo
DrugPlacebo given OD
Percentage change in LDL-C
Percentage change in LDL-C from baseline LDL-C
Composite adherence/tolerability endpoint:
treatment discontinuation, muscle-related symptoms, or laboratory abnormalities (ALT/AST \>3× ULN, uric acid \>9 mg/dL).
Absolute change in LDL-C
Absolute change in LDL-C from baseline to 6 months.
Proportion achieving LDL-C <100 mg/dL (or <70 mg/dL for diabetics).
Proportion achieving LDL-C \<100 mg/dL (or \<70 mg/dL for diabetics).
Change in hs-CRP
Change in hs-CRP from baseline.
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Sohaib Ashraf
Lead sponsor
Sheikh Zayed Federal Postgraduate Medical Institute
Sponsor institution
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