fenofibrate (Antara, TriCor, Triglide, Lofibra, Proctofene, Trilipix)
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Introduction
Tradename: Antara, TriCor, Triglide, Lofibra, Trilipix.
Indications
- treatment of hypertriglyceridemia*
- hyperlipoproteinemia type 4 & hyperlipoproteinemia type 5
- serum triglycerides 1000-2000 mg/dL
- 2nd line agent for treatment of hypercholesterolemia, & hypertriglyceridemia associated with hypoalphalipoproteinemia
- may reduce serum urate & incidence of gout in patients with diabetes mellitus type-2[13]
- may slow progression of diabetic retinopathy (not FDA-approved)[15]
- number needed to treat for 4 years = 15
* did not improve cardiovascular mortality in diabetics with or without cardiovascular disease (see Field study)
* improved serum triglycerides, but no clinical benefit (see ACCORD trial)
* has not been shown to reduce cardiovascular events[12] (avoid)
* gemfibrozil in agent of choice in this class
Dosage
- mixed hyperlipidemia:
- hypertriglyceridemia:
- impaired renal function or elderly:
- maximum: 130 mg PO QD
- optimize bioavailability
- Antara, Lofibra : with meals
- TriCor, Triglide: give without regards to meals[4]
Capsules: Antara micronized capsules: 43, 87, 130 mg
Tabs: TriCor nanocrystal tablets: 48, 145 mg
Capsules: Lofibra micronized capsules: 67, 134, 200 mg
Triglide: 50, 160 mg
Trilipix formulation for use with statin
Monitor
liver function tests periodically[8]
Adverse effects
- increased serum transaminases (< 3X) 6%
- may increase homocysteine levels
- pancreatitis[5]
- pulmonary embolism[5]
- nephrotoxicity (> 6 months after initiation)[14]
Mechanism of action
- maximal effect
- total cholesterol: decrease of 15%
- LDL cholesterol: decrease of 20%
- HDL cholesterol: increase of 10%
- triglycerides: decrease of 50%
- lowers serum urate 20%[13]
More general terms
Additional terms
References
- ↑ Abbott Laboratories
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, Update 9/99
- ↑ Prescriber's Letter 7(2):8, Feb. 2000
- ↑ 4.0 4.1 Prescriber's Letter 12(9): 2005 Fenofibrate Formulations Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210909&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 5.0 5.1 5.2 Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, Forder P, Pillai A, Davis T, Glasziou P, Drury P, Kesaniemi YA, Sullivan D, Hunt D, Colman P, d'Emden M, Whiting M, Ehnholm C, Laakso M; FIELD study investigators. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005 Nov 26;366(9500):1849-61. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16310551
Colhoun H. After FIELD: should fibrates be used to prevent cardiovascular disease in diabetes? Lancet. 2005 Nov 26;366(9500):1829-31. No abstract available. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16310536 - ↑ Prescriber's Letter 16(2): 2008 Comparison of Fenofibric Acid and Fenofibrate Products Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=250211&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 7.0 7.1 Prescriber's Letter 16(8): 2009 Clinically Significant Statin Drug Interactions Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=250812&pb=PRL
- ↑ 8.0 8.1 Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260704&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 9.0 9.1 FDA MedWatch: Nov 9, 2011 Trilipix (fenofibric acid): Drug Safety Communication - Label Change http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm279185.htm
- ↑ Deprecated Reference
- ↑ 11.0 11.1 Elam MB, Ginsberg HN, Lovato LC et al. Association of fenofibrate therapy with long-term cardiovascular risk in statin-treated patients with type 2 diabetes. JAMA Cardiol 2016 Dec 28 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28030716
- ↑ 12.0 12.1 Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
- ↑ 13.0 13.1 13.2 Waldman B, Ansquer JC, Sullivan DR et al Effect of fenofibrate on uric acid and gout in type 2 diabetes: a post-hoc analysis of the randomised, controlled FIELD study. Lancet Diabetes & Endocrinology. Feb 26, 2018 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29496472 <Internet> http://www.thelancet.com/pdfs/journals/landia/PIIS2213-8587(18)30029-9.pdf
- ↑ 14.0 14.1 Medical Knowledge Self Assessment Program (MKSAP) 18, American College of Physicians, Philadelphia 2018
- ↑ 15.0 15.1 Preiss D, Sammons E, Zayed M et al. Effect of fenofibrate on progression of diabetic retinopathy. NEJM Evid 2024 Jun 21:EVIDoa2400179 PMID: https://www.ncbi.nlm.nih.gov/pubmed/38905569 https://evidence.nejm.org/doi/10.1056/EVIDoa2400179