bempedoic acid + ezetimibe: clinical use

Prescribing considerations

• Confirm the indication, previous lipid-lowering therapy and treatment goals.
• Review statin tolerance, statin selection and potential myopathy risk.
• Use cautiously with previous gout, hyperuricaemia or severe renal impairment.
• Not recommended in moderate or severe hepatic impairment.
• Account for lactose content in patients with relevant rare hereditary disorders.

Contraindications and cautions

• Hypersensitivity to either active substance or an excipient.
• Pregnancy.
• Concomitant simvastatin use where prohibited by the product information.
• Use with a statin in active liver disease or unexplained persistent serum-transaminase elevation.

Monitoring

• Assess lipid response and adherence after initiation and periodically thereafter.
• Check liver function at initiation and investigate significant or persistent transaminase elevations.
• Assess uric acid and gout symptoms where clinically indicated.
• Check creatine kinase if significant muscle symptoms occur, particularly with a statin.
• Monitor triglycerides and HDL cholesterol with a fibrate.
• Monitor INR with coumarin anticoagulants or fluindione, and ciclosporin concentrations during concomitant use.
• Consider additional adverse-effect monitoring in severe renal impairment.

Clinical pharmacology

Bempedoic acid is a liver-activated prodrug that inhibits ATP-citrate lyase. Ezetimibe inhibits intestinal NPC1L1-mediated sterol uptake. These complementary mechanisms reduce hepatic cholesterol availability and increase LDL clearance.

Formulation and product differences

• Fixed-combination film-coated tablet that may replace the two active ingredients taken separately.
• Swallowed whole and suitable for use with or without food.
• Contains lactose and is essentially sodium-free.

Tablet

Route: Oral

Strengths: 180 mg + 10 mg