ezetimibe/simvastatin (Vytorin)
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Introduction
Combination therapy for hypercholesterolemia.
- ezetimibe (Zetia) 10 mg
- simvastatin (Zocor) 10, 20, 40, or 80 mg
Indications
Contraindications
- despite lowering LDL, does not favorably influence coronary artery disease with or without aortic stenosis[3]
Dosage
Monitor
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
More general terms
Components
References
- ↑ Prescriber's Letter 11(8): 2004 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200606&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 2.0 2.1 2.2 2.3 Prescriber's Letter 11(9): 2004 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200902&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 3.0 3.1 3.2 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2
- ↑ Mitka M. Cholesterol drug controversy continues. JAMA. 2008 May 21;299(19):2266. PMID: https://www.ncbi.nlm.nih.gov/pubmed/18492963
- ↑ Mitka M. Controversies surround heart drug study: questions about Vytorin and trial sponsors' conduct. JAMA. 2008 Feb 27;299(8):885-7. PMID: https://www.ncbi.nlm.nih.gov/pubmed/18314425
- ↑ In brief: Zetia and Vytorin: the ENHANCE study. Med Lett Drugs Ther. 2008 Jan 28;50(1278):5. PMID: https://www.ncbi.nlm.nih.gov/pubmed/18219263
- ↑ 7.0 7.1 Prescriber's Letter 15(10): 2008 Does Vytorin (Ezetimibe/Simvastatin) Cause Cancer? Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=241004&pb=PRL (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 - ↑ 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
- ↑ 9.0 9.1 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) - ↑ 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
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/21663949 Free PMC Article
- ↑ 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