Mipomersen: a safe and effective antisense therapy adjunct to statins in patients with hypercholesterolemia

Cardiol Rev. 2012 Mar-Apr;20(2):90-5. doi: 10.1097/CRD.0b013e31823424be.

Abstract

Mipomersen is an antisense oligonucleotide inhibitor of apolipoprotein (apo) B-100 currently in phase 3 of development for the treatment of hyperlipidemia in patients with a high risk for cardiovascular disease. The drug acts by inhibiting the production of apoB-100, which is the structural core for all atherogenic lipids, including low-density lipoprotein cholesterol (LDL-C). The agent has been shown to produce significant reductions in LDL-C from baseline values compared with placebos. Clinical trials have demonstrated that mipomersen reduces LDL-C up to 44% in patients with familial hypercholesterolemia and patients with significantly elevated LDL despite taking maximum doses of statins. Unlike other medications that target apoB-100, such as microsomal triglyceride transfer proteins, mipomersen does not cause hepatic steatosis or intestinal steatosis and does not affect dietary fat absorption. Adverse side effects encountered with mipomersen include flu-like symptoms, injection site reactions, and elevated liver transaminases. If future studies continue to show such promising results, mipomersen would likely be a viable additional lipid-lowering therapy for patients who are at high cardiovascular risk, intolerant to statins, and/or not at target lipid levels despite maximum doses of statin therapy. Clinical outcome studies looking at cardiovascular disease end points still need to be done.

Publication types

  • Review

MeSH terms

  • Administration, Cutaneous
  • Anticholesteremic Agents / pharmacokinetics
  • Anticholesteremic Agents / pharmacology
  • Anticholesteremic Agents / therapeutic use*
  • Apolipoprotein B-100 / antagonists & inhibitors*
  • Cardiovascular Diseases / prevention & control*
  • Clinical Trials as Topic
  • Drug Administration Schedule
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hypercholesterolemia / drug therapy*
  • Oligonucleotides / pharmacokinetics
  • Oligonucleotides / pharmacology
  • Oligonucleotides / therapeutic use*
  • Oligonucleotides, Antisense / pharmacokinetics
  • Oligonucleotides, Antisense / pharmacology
  • Oligonucleotides, Antisense / therapeutic use

Substances

  • Anticholesteremic Agents
  • Apolipoprotein B-100
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Oligonucleotides
  • Oligonucleotides, Antisense
  • mipomersen