Generic
Bempedoic acid + Ezetimibe
1 brands available in the market
At a glance
Bempedoic acid + Ezetimibe is a combination lipid-lowering medication used as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Description
Bempedoic acid + Ezetimibe is a combination of two lipid-lowering agents: Bempedoic acid (an ATP-citrate lyase inhibitor) and Ezetimibe (a cholesterol absorption inhibitor). Bempedoic acid reduces hepatic cholesterol synthesis by inhibiting ACL, while Ezetimibe reduces intestinal cholesterol absorption. Together, they provide complementary LDL-C lowering through dual mechanisms.
Common side effects include upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain, bronchitis, and anemia.
Indications
- Heterozygous familial hypercholesterolemia
- Atherosclerotic cardiovascular disease
- Patients requiring additional LDL-C lowering despite maximally tolerated statin therapy
Therapeutic class
Other Anti-anginal & Anti-ischaemic drugs
Pharmacological class
ACL Inhibitor + Cholesterol Absorption Inhibitor
Pharmacology
Bempedoic acid is an ATP-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. ACL is an enzyme upstream of HMG-CoA reductase in the cholesterol biosynthesis pathway. Bempedoic acid is activated in the liver by very-long-chain acyl-CoA synthetase 1 (ACSVL1).
Ezetimibe is a potent and selective inhibitor of cholesterol absorption that reduces the overall delivery of cholesterol to the liver, promoting LDL receptor synthesis and subsequent reduction of serum LDL-C.
Mechanism of action
Bempedoic acid reduces hepatic cholesterol synthesis by inhibiting ACL and increases LDL receptor numbers to enhance LDL-C clearance. Ezetimibe reduces intestinal cholesterol absorption, decreasing cholesterol delivery to the liver. Together, they provide complementary LDL-C lowering through dual mechanisms.
Dosage
Recommended Dose: 180 mg Bempedoic acid + 10 mg Ezetimibe, once daily, orally.
May be taken with or without food. Should be used in combination with maximally tolerated statin therapy.
With Simvastatin: Avoid concomitant use with simvastatin greater than 20 mg.
With Pravastatin: Avoid concomitant use with pravastatin greater than 40 mg.
Administration
Take 180 mg/10 mg tablet once daily with or without food. Swallow the tablet whole; do not chew or crush.
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Side effects
- Upper respiratory tract infection
- Muscle spasms
- Hyperuricemia
- Back pain
- Abdominal pain or discomfort
- Bronchitis
- Pain in extremity
- Anemia
- Elevated liver enzymes
Precautions & warnings
- Hyperuricemia: Bempedoic acid may increase serum uric acid levels. Monitor uric acid levels periodically. Inform your doctor if you have a history of gout.
- Tendon Rupture: Tendon rupture has been reported. Discontinue at the first sign of tendon pain, swelling, or inflammation. Avoid use in patients with a history of tendon disorders or tendon rupture.
- Discontinue when pregnancy is recognized unless benefits outweigh risks.
- Not recommended during breastfeeding.
Contraindications
- Known hypersensitivity to ezetimibe (anaphylaxis, angioedema, rash, urticaria)
- Concomitant use with simvastatin >20 mg
- Concomitant use with pravastatin >40 mg
Drug interactions
- Simvastatin: Bempedoic acid increases simvastatin plasma concentrations; avoid co-administration with doses >20 mg.
- Pravastatin: Bempedoic acid increases pravastatin plasma concentrations; avoid co-administration with doses >40 mg.
Food interactions
Can be taken with or without food.
Use in pregnancy
[CONSULT YOUR DOCTOR] There are no adequate data on use in pregnant women. Discontinue when pregnancy is recognized unless the benefits outweigh the potential risks to the fetus.
Use in lactation
[CONSULT YOUR DOCTOR] There is no information regarding the presence in human milk. Breastfeeding is not recommended during treatment.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric use
No dose adjustment needed for elderly patients. However, the risk of tendon rupture is higher in patients over 60 years of age.
Renal / hepatic impairment
Caution in severe renal impairment. Monitor uric acid levels.
Caution in hepatic impairment. Monitor liver enzymes.
Overdose effects
No specific antidote for overdose. Provide symptomatic and supportive treatment.
Storage conditions
Store below 30°C, away from light and moisture. Keep out of reach of children.
Chemical structure
Bempedoic acid (C₁₉H₃₆O₅) + Ezetimibe (C₂₄H₂₁F₂NO₃)