Bempedoic Acid Versus Statins in Primary-Prevention Patients With Suboptimal Statin Adherence: Effects on LDL-C Reduction and Tolerability

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorSohaib Ashraf

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bempedoic Acid 180 MG Oral Tablet
  • Rosuvastatin 5 mg
  • Placebo

Treatment groups

690 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Sohaib Ashraf

Lead sponsor

Sheikh Zayed Federal Postgraduate Medical Institute

Sponsor institution