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ezetimibe/simvastatin (Vytorin)

Combination therapy for hypercholesterolemia. - ezetimibe (Zetia) 10 mg - simvastatin (Zocor) 10, 20, 40, or 80 mg Indications: - hypercholesterolemia Contraindications: - despite lowering LDL, does not favorably influence coronary artery disease with or without aortic stenosis [3] Dosage: -> evening or QHS dosing [2] Monitor: liver function tests [2] Adverse effects: - see simvastatin & ezetimibe - may increase risk of cancer (all-types) [3,7] Mechanism of action: - Vytorin 10/20 lowers LDL cholesterol by 50% [2] - simvastatin inhibits HMG CoA reductase - ezetimibe inhibits intestinal absorbtion of cholesterol - see simvastatin & ezetimibe Clinical trials - manufacturer-designed & sponsored study found Vytorin to lower cardiovascular risk in patients with chronic kidney disease; no comparison with statin only [9] Notes: - generic FDA-approved April 2017

Interactions

drug interactions

General

pharmacologic combination

References

  1. Prescriber's Letter 11(8): 2004 Detail-Document#: 200606 (subscription needed) http://www.prescribersletter.com
  2. Prescriber's Letter 11(9): 2004 Detail-Document#: 200902 (subscription needed) http://www.prescribersletter.com
  3. FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2
  4. Mitka M. Cholesterol drug controversy continues. JAMA. 2008 May 21;299(19):2266. PMID: 18492963
  5. Mitka M. Controversies surround heart drug study: questions about Vytorin and trial sponsors' conduct. JAMA. 2008 Feb 27;299(8):885-7. PMID: 18314425
  6. In brief: Zetia and Vytorin: the ENHANCE study. Med Lett Drugs Ther. 2008 Jan 28;50(1278):5. PMID: 18219263
  7. Prescriber's Letter 15(10): 2008 Does Vytorin (Ezetimibe/Simvastatin) Cause Cancer? Detail-Document#: 241004 (subscription needed) http://www.prescribersletter.com - FDA Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) FDA Investigates a Report from the SEAS Trial http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm
  8. FDA MedWatch Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communication about an Ongoing Data Review http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ezetimibe
  9. Baigent C et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): A randomised placebo-controlled trial. Lancet 2011 Jun 9; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960739-3/abstract - Stevens KK and Jardine AG. SHARP: A stab in the right direction in chronic kidney disease. Lancet 2011 Jun 9 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960822-2/fulltext)
  10. Health advisers on Wednesday unanimously recommended use of Merck & Co's cholesterol-lowering drug Vytorin for preventing stroke and other heart problems in patients with chronic kidney disease, but only in those patients not yet on dialysis. Reuters, Nov 2, 2011 http://www.reuters.com/article/2011/11/02/us-fda-merck-vytorin-idUSTRE7A178620111102
  11. Baigent C, Landray MJ, Reith C et al The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. PMID: 21663949 Free PMC Article
  12. NEJM Journal Watch Editors Generic Vytorin to Hit U.S. Market. Physician's First Watch, April 28, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org

Components

ezetimibe (Zetia) simvastatin (Zocor)