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eicosapentaenoic acid ethyl ester; ethyl icosapentate (Vascepa)

Indications: - adjunct therapy for severe hypertriglyceridemia - serum triglyceride > 500 mg/dL, FDA approved July 26, 2012 - patients with both diabetes & atherosclerotic cardiovascular disease or other cardiac risk factors + elevated triglycerides & controlled LDL cholesterol while taking statins [7] - FDA allows off-label use to lower serum triglycerides < 500 mg/dL - may reduce major cardiovascular events [5] - FDA-approved for cardiovascular risk reduction [8] - provides additional cardiovascular risk reduction beyond statins in patients with serum triglycerides 135-500 mg/dL [6]* - 25% relative cardiovascular risk reduction in patients > 50 years with diabetes mellitus, hypertriglyceridemia & at least one additional cardiovascular risk factor (REDUCE-IT) [10] (compare with ref [9]) - it seems that the mineral oil placebo used in the REDUCE-IT trial increased cardiovascular risk & icosapent ethyl (Vascepa) had little effect [11] - NEJM knowledge+ does not recognize ref [11] * achieving higher EPA plasma levels through pharmacological means does not reduce adverse cardiovascular outcomes in patients taking statins with elevated serum triglycerides [9] Dosage: - 2 grams/day BID with food - capsules 1 gram * swallow VASCEPA capsules whole * Do not break open, crush, dissolve, or chew VASCEPA Pharmacokinetics: - hydrolyzed to 5,8,11,14,17-eicosapentaenoic acid (EPA) - 1/2life of EPA is 89 hours [3] Adverse effects: - arthralgias - may cause atrial fibrillation [12] Mechanism of action: - converted to eicosapentaenoic acid - reduces serum triglycerides (up to 27%) - does not increase in LDL cholesterol - does not decrease HDL cholesterol - increases cholesterol & triglyceride in skeletal muscle

Related

omega-3-fatty acid ethyl esters (Omacor, Lovaza)

General

omega-3-fatty ester

Database Correlations

PUBCHEM correlations

References

  1. Amarin Announces FDA Approval of Vascepa(TM) (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=696027
  2. Prescriber's Letter 20(1): 2013 CHART: Non-Statin Lipid-Lowering Agents Detail-Document#: 290122 (subscription needed) http://www.prescribersletter.com
  3. PubChem: 9831415
  4. Orciari Herman A, Sadoughi S, Saitz R FDA Allows Omega-3 Company to Market Product for Unapproved Use. Physician's First Watch, March 10, 2016 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
  5. Gever J Vascepa Prevents Major Cardiovascular Events, Says Manufacturer. Big win for proprietary fish-oil product. MedPage Today. September 24, 2018 https://www.medpagetoday.com/cardiology/prevention/75271 - ClinicalTrials.gov. April 2, 2018 A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT) https://clinicaltrials.gov/ct2/show/NCT01492361
  6. Bhatt DL, Steg PG, Miller M et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med 2018 Nov 10; PMID: 30415628 https://www.nejm.org/doi/10.1056/NEJMoa1812792
  7. American Diabetes Association Issues Critical Updates to the 2019 Standards of Medical Care in Diabetes. News Release. March 27, 2019 http://www.diabetes.org/newsroom/press-releases/2019/ada-issues-critical-updates-to-2019-standards-of-care.html
  8. Styles S FDA Approves Amarin's Vascepa for Cardiovascular Risk Reduction. Medscape. Dec 13, 2019. https://www.medscape.com/viewarticle/922673 - FDA News Release. Dec 13, 2019 FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups. https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups
  9. Nissen SE, Lincoff M, Wolski K et al Association Between Achieved omega-3 Fatty Acid Levels and Major Adverse Cardiovascular Outcomes in Patients With High Cardiovascular Risk. A Secondary Analysis of the STRENGTH Trial. JAMA Cardiol. Published online May 16, 2021 PMID: 33993205 https://jamanetwork.com/journals/jamacardiology/fullarticle/2779978
  10. Medical Knowledge Self Assessment Program (MKSAP) 19. American College of Physicians, Philadelphia 2021 - Bhatt DL et al Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22 PMID: 30415628 Clinical Trial. https://www.nejm.org/doi/10.1056/NEJMoa1812792
  11. Ridker PM et al. Effects of randomized treatment with icosapent ethyl and a mineral oil comparator on interleukin-1beta, interleukin-6, C-reactive protein, oxidized low-density lipoprotein cholesterol, homocysteine, lipoprotein(a), and lipoprotein-associated phospholipase A2: A REDUCE-IT biomarker substudy. Circulation 2022 Jun 28; [e-pub]. PMID: 35762321 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059410 - Harrington RA. Trials and tribulations of randomized clinical trials. Circulation 2022 Jul 1; [e-pub]. PMID: 35775415 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.060649
  12. van den Heuvel M EMA Warns That Omega-3-Acid Ethyl Esters May Cause AF. Medscape. Oct 13, 2023 https://www.medscape.com/viewarticle/997348
  13. Precribing Information. icosapent ethyl (Vascepa) http://www.vascepa.com/vascepa-pi-ppi-%28clean%29-P00120G-6-15.pdf