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fenofibrate (Antara, TriCor, Triglide, Lofibra, Proctofene, Trilipix)

Tradename: Antara, TriCor, Triglide, Lofibra, Trilipix. Indications: 1) treatment of hypertriglyceridemia* a) probably fibrate of choice for use with statin [7] b) may not lower risk of cardiovascular event when used in combination with statin [9] c) no evidence of benefit in patients with diabetes also taking a statin [11] 2) hyperlipoproteinemia type 4 & hyperlipoproteinemia type 5 3) serum triglycerides 1000-2000 mg/dL 4) 2nd line agent for treatment of hypercholesterolemia, & hypertriglyceridemia associated with hypoalphalipoproteinemia 5) may reduce serum urate & incidence of gout in patients with diabetes mellitus type-2 [13] 6) 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: 1) mixed hyperlipidemia: a) Antara: start 130 mg PO QD b) TriCor: start 145 mg PO QD c) Triglide: start 160 mg PO QD d) Lofibra: start 200 mg PO QD 2) hypertriglyceridemia: a) Antara: start 43-130 mg PO QD b) TriCor: start 48-145 mg PO QD c) Triglide: start 50-160 mg PO QD d) Lofibra: start 67-200 mg PO QD 3) impaired renal function or elderly: a) Antara: start 43 mg QD b) TriCor: start 48 mg QD c) Triglide: start 50 mg QD d) Lofibra: start 67 mg QD 4) maximum: 130 mg PO QD a) Antara: 130 mg QD b) TriCor: 145 mg QD c) Triglide: 160 mg QD d) Lofibra: 200 mg QD 5) optimize bioavailability a) Antara, Lofibra : with meals b) 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: 1) increased serum transaminases (< 3X) 6% 2) may increase homocysteine levels 3) pancreatitis [5] 4) pulmonary embolism [5] 5) nephrotoxicity (> 6 months after initiation) [14] Mechanism of action: - maximal effect a) total cholesterol: decrease of 15% b) LDL cholesterol: decrease of 20% c) HDL cholesterol: increase of 10% d) triglycerides: decrease of 50% - lowers serum urate 20% [13]

Interactions

drug interactions drug adverse effects (more general classes) monitor with fibrates

Related

Field study

General

carboxylate fibrate

Database Correlations

PUBCHEM cid=3339

References

  1. Abbott Laboratories
  2. Kaiser Permanente Northern California Regional Drug Formulary, Update 9/99
  3. Prescriber's Letter 7(2):8, Feb. 2000
  4. Prescriber's Letter 12(9): 2005 Fenofibrate Formulations Detail-Document#: 210909 (subscription needed) http://www.prescribersletter.com
  5. 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: 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: 16310536
  6. Prescriber's Letter 16(2): 2008 Comparison of Fenofibric Acid and Fenofibrate Products Detail-Document#: 250211 (subscription needed) http://www.prescribersletter.com
  7. Prescriber's Letter 16(8): 2009 Clinically Significant Statin Drug Interactions Detail-Document#: 250812
  8. Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: 260704 (subscription needed) http://www.prescribersletter.com
  9. FDA MedWatch: Nov 9, 2011 Trilipix (fenofibric acid): Drug Safety Communication - Label Change http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm279185.htm
  10. Deprecated Reference
  11. 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: 28030716
  12. Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
  13. 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 PMID: 29496472 http://www.thelancet.com/pdfs/journals/landia/PIIS2213-8587(18)30029-9.pdf
  14. Medical Knowledge Self Assessment Program (MKSAP) 18, American College of Physicians, Philadelphia 2018
  15. Preiss D, Sammons E, Zayed M et al. Effect of fenofibrate on progression of diabetic retinopathy. NEJM Evid 2024 Jun 21:EVIDoa2400179 PMID: 38905569 https://evidence.nejm.org/doi/10.1056/EVIDoa2400179