Lomitapide

(Juxtapid®)

Lomitapide

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Drug updated on 4/15/2024

Dosage FormCapsule (oral; 5 mg, 10 mg, 20 mg, 30 mg)
Drug ClassMicrosomal triglyceride transfer protein inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Summary
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  • Lomitapide (Juxtapid) is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high density lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia.
  • Two studies were analyzed. These studies provided information regarding the safety and effectiveness of Lomitapide compared to other nonstatin lipid-lowering therapies.
  • In a study from Japan focusing on patients with homozygous familial hypercholesterolemia over 42 months, Lomitapide effectively reduced mean LDL-C levels from 225.9 mg/dl predose to 159.4 mg/dl at 12 months, despite adverse events such as gastrointestinal disorders and liver-related issues being reported by a significant portion of patients.
  • Compared with other nonstatin therapies added to maximally tolerated statins in populations at high cardiovascular risk, not limited only to genetic conditions like HoFH but also elevated LDL-C levels, evolocumab and alirocumab were the most efficacious regimens in reducing LDL-C at both week 12 and week 24. Bempedoic acid/ezetimibe and ezetimibe monotherapy demonstrated effectiveness but weren't as potent when compared against PCSK9 inhibitors.
  • The evaluation of Lomitapide's safety focused on individuals with HoFH, a severe genetic disorder leading to significantly elevated cholesterol levels, providing valuable insight into its performance outside controlled trials within this high-risk population group.
  • Lomitapide appears effective for lowering LDL-C in patients suffering from homozygous familial hypercholesterolemia, considering the severity of the condition. However, it requires careful monitoring due to its safety profile marked by gastrointestinal and liver-related adverse events.