bempedoic acid: clinical use

Prescribing considerations

• Confirm the indication, background lipid-lowering treatment, statin tolerance and cardiovascular-risk context.
• Review history of gout or hyperuricaemia and counsel about symptoms.
• Experience is limited in severe renal impairment and dialysis; additional adverse-effect monitoring may be appropriate.
• Severe hepatic impairment has not been studied.
• Safety and efficacy are not established in people younger than 18 years.
• The product contains lactose.

Contraindications and cautions

• Hypersensitivity to bempedoic acid or an excipient
• Pregnancy
• Concurrent simvastatin above the product's permitted limit

Monitoring

• Liver function at initiation; discontinue if clinically significant persistent transaminase elevation develops.
• LDL cholesterol response and adherence.
• Uric acid when clinically indicated, particularly with gout history or symptoms.
• Unexplained muscle symptoms when used with a statin; check creatine kinase when myopathy is suspected.
• Triglycerides and HDL cholesterol during concomitant fibrate treatment.
• Adverse effects more closely in severe renal impairment.

Clinical pharmacology

An oral prodrug activated mainly in the liver to inhibit ATP citrate lyase upstream of HMG-CoA reductase. It is highly protein-bound, undergoes glucuronidation and has little unchanged renal clearance.

Formulation and product differences

• The selected product is a white to off-white oval film-coated tablet intended to be swallowed whole.
• It contains lactose and is essentially sodium-free.
• It contains bempedoic acid alone rather than the fixed combination with ezetimibe.

Tablet

Route: Oral

Strengths: 180 mg