Statins and fibrates: Should they be recommended?

Combination Therapy In Dyslipidemia

Volumn , Issue , 2015, Pages 11-23

  Toth, Peter ^c   Rysz, Jacek ^a   Banach, Maciej ^a  

^a MEDICAL UNIVERSITY OF LODZ   (Poland)

^b ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

^c UNIVERSITY OF ILLINOIS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84950111879     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/9783319204338_2     Document Type: Chapter

References (61)

1. Dreyer C, Krey G, Keller H, Givel F, Helftenbein G, Wahli W. Control of the peroxisomal beta-oxidation pathway by a novel family of nuclear hormone receptors. Cell. 1992;68: 879-887.
2. Issemann I, Green S. Activation of a member of the steroid hormone receptor superfamily by peroxisome proliferators. Nature. 1990;347:645-650.
3. Willson TM, Brown PJ, Sternbach DD, Henke BR. The PPARs: from orphan receptors to drug discovery. J Med Chem. 2000;43:527-550.
4. Robinson-Rechavi M, Carpentier AS, Duffraisse M, Laudet V. How many nuclear hormone receptors are there in the human genome? Trends Genet. 2001;17:554-556.
5. Nuclear Receptors Nomenclature Comittee. A unifid nomenclature system for the nuclear receptor superfamily. Cell. 1999;97:161-163.
6. Kliewer S, Sundseth S, Jones S, Brown P, Wisely G, Koble C, Devchand P, Wahli W, Willson T, Lenhard J, Lehmann J. Fatty acids and eicosanoids regulate gene expression through direct interactions with peroxisome proliferator-activated receptors alpha and gamma. Proc Natl Acad Sci U S A. 1997;94:4318-4323.
7. Forman B, Chen J, Evans R. Hypolipidemic drugs, polyunsaturated fatty acids, and eico- sanoids are ligands for peroxisome proliferator-activated receptors alpha and delta. Proc Natl Acad Sci U S A. 1997;94:4312-4317.
8. Devchand P, Keller H, Peters J, Vazquez M, Gonzalez F, Wahli W. The PPARa-leukotriene B4 pathway to inflammation control. Nature. 1996;384:39-43.
9. Schoonjans K, Staels B, Auwerx J. Role of the peroxisome proliferator activated receptor (PPAR) in mediating effects of fibrates and fatty acids on gene expression. J Lipid Res. 1996;37:907-25. 26.
10. Schoonjans K, Staels B, Auwerx J. The peroxisome proliferator activated receptors (PPARs) and their effects on lipid metabolism and adipocyte differentiation. Biochim Biophys Acta. 1996;1302:93-109.
11. Gulick T, Cresci S, Caira T, Moore D, Kelly D. The peroxisome proliferator-activated receptor regulates mitochondrial fatty acid oxidative enzyme gene expression. Proc Natl Acad Sci U S A. 1994;91:11012-6.
12. Heller F, Harvengt C. Effects of clofibrate, bezafibrate, fenofibrate, and probucol on plasma lipolytic enzymes in normolipidaemic subjects. Eur J Clin Pharmacol. 1983;23:57-63.
13. Malmendier C, Lontie J-F, Delcroix C, Dubois D, Magot T, De Roy L. Apolipoproteins C-II and C-III metabolism in hypertriglyceridemic patients: effect of a drastic triglyceride reduction by combined diet restriction and fenofibrate administration. Atherosclerosis. 1989;77: 139-149.
14. Martin G, Schoonjans K, Lefebvre A, Staels B, Auwerx J. Coordinate regulation of the expression of the fatty acid transporter protein (FATP) and acyl CoA synthetase (ACS) genes by PPARa and PPARg activators. J Biol Chem. 1997;272:28210-28217.
15. Schoonjans K, Watanabe M, Suzuki H, Mahfoudi A, Krey G, Wahli W, Grimaldi P, Staels B, Yamamoto T, Auwerx J. Induction of the acylcoenzyme A synthetase gene by fibrates and fatty acids is mediated by a peroxisome proliferator response element in the C promoter. J Biol Chem. 1995;270:19269-19276.
16. Caslake M, Packard C, Gaw E, Murray E, Griffin B, Vallance B, Shepherd J. Fenofibrate and LDL metabolic heterogeneity in hypercholesterolemia. Arterioscler Thromb. 1993;13:702-711.
17. Bruckert E, Dejager S, Chapman M. Ciprofibrate therapy normalises the atherogenic low- density lipoprotein subspecies profile in combined hyperlipidemia (published erratum appears in Atherosclerosis. 1993 102:129). Atherosclerosis. 1993;100:91-102.
18. De Graaf J, Hendriks J, Demacker P, Stalenhoef A. Identification of multiple dense LDL subfractions with enhanced susceptibility to in vitro oxidation among hypertriglyceridemic subjects: normalization after clofibrate treatment. Arterioscler Thromb. 1993;13:712-719.
19. Mann C, Yen F, Grant A, Bihain B. Mechanism of plasma cholesteryl ester transfer in hypertriglyceridemia. J Clin Invest. 1991;88:2059-2066.
20. Vu-Dac N, Schoonjans K, Kosykh V, Dallongeville J, Fruchart J, Staels B, Auwerx J. Fibrates increase human apolipoprotein A-II expression through activation of the peroxisome proliferator-activated receptor. J Clin Invest. 1995;96:741-750.
21. Berthou L, Duverger N, Emmanuel F, Langouet S, Auwerx J, Guillouzo A, Fruchart J-C, Rubin E, Denefle P, Staels B, Branellec D. Opposite regulation of human versus mouse apolipoprotein A-I by fibrates in human apo A-I transgenic mice. J Clin Invest. 1996;97:2408-2416.
22. Bard J-M, Parra HJ, Camare R, Luc G, Ziegler O, Dachet C, Bruckert E, Douste-Blazy P, Drouin P, Jacotot B, De Gennes JL, Keller U, Fruchart J-C. A multicenter comparison of the effects of simvastatin and fenofibrate therapy in severe primary hypercholesterolemia, with particular emphasis on lipoproteins defined by their apolipoprotein composition. Metabolism. 1992;41:498-503.
23. Lussier-Cacan S, Bard J-M, Boulet L, Nestruck A, Grothe A-M, Fruchart J-C, Davignon J. Lipoprotein composition changes induced by fenofibrate in dysbetalipoproteinemia type III. Atherosclerosis. 1989;78:167-182.
24. Franceschini G, Favari E, Calabresi L, Simonelli S, Bondioli A, Adorni MP, Zimetti F, Gomaraschi M, Coutant K, Rossomanno S, Niesor EJ, Bernini F, Benghozi R. Differential effects of fenofi- brate and extended-release niacin on high-density lipoprotein particle size distribution and cholesterol efflux capacity in dyslipidemic patients. J Clin Lipidol. 2013;7(5):414-422.
25. Kei A, Liberopoulos E, Tellis C, Elisaf M, Tselepis A. Lipid-modulating treatments for mixed dyslipidemia increase HDL-associated phospholipase A2 activity with differential effects on HDL subfractions. Lipids. 2013;48(10):957-965.
26. Han SH, Quon MJ, Koh KKZ. Beneficial vascular and metabolic effects of peroxisome proliferator-activated receptor-alfa activators. Hypertension. 2005;46:1086-1092.
27. Israelin-Konaraki Z, Reaven PD. Peroxisome proliferator-activated receptor-alfa and atherosclerosis: from basic mechanisms to clinical implications. Cardiol Rev. 2005;13:240-26. 4.
28. Frick MH, Elo O, Haapa K, Heinonen OP, Heinsalmi P, Helo P, Huttunen JK, Kaitaniemi P, Koskinen P, Manninen V, et al. Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med. 1987;317(20):1237-1245.
29. Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med. 1999;341(6):410-418.
30. Israeli Society for Prevention of Heart Attacks, Tel-Hashomer, Israel. Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease. Bezafibrate Infarction Prevention (BIP) study. Circulation. 2000;102(1):21-27.
31. Meade T, Zuhrie R, Cook C, Cooper J. Bezafibrate in men with lower extremity arterial disease: randomised controlled trial. BMJ. 2002;325(7373):1139.
32. 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, The 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;366:1849-1861.
33. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010;362:1563-74.
34. Katsiki N, Nikolic D, Montalto G, Banach M, Mikhailidis DP, Rizzo M. The role of fibrate treatment in dyslipidemia: an overview. Curr Pharm Des. 2013;19(17):3124-3131.
35. Fruchart JC, Sacks F, Hermans MP, et al. The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Am J Cardiol. 2008;102(supl. 10):1K-34.
36. Otocka-Kmiecik A, Mikhailidis DP, Nicholls SJ, Davidson M, Rysz J, Banach M. Dysfunctional HDL: a novel important diagnostic and therapeutic target in cardiovascular disease? Prog Lipid Res. 2012;51(4):314-324.
37. Keech AC, Mitchell P, FIELD Study Investigators. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Lancet. 2007;370(9600):1687-1697.
38. ACCORD Eye Study Group, Chew EY, Ambrosius WT, Davis MD, et al. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med. 2010;363:233-44.
39. Chew EY, Davis MD, Danis RP, Lovato JF, Perdue LH, Greven C, Genuth S, Goff DC, Leiter LA, Ismail-Beigi F, Ambrosius WT, Action to Control Cardiovascular Risk in Diabetes Eye Study Research Group. The effects of medical management on the progression of diabetic retinopathy in persons with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. Ophthalmology. 2014;121(12):2443-2451.
40. Adkins JC, Faulds D. Micronised fenofibrate: a review of its pharmacodynamic properties and clinical efficacy in the management of dyslipidaemia. Drugs. 1997;54:615-633.
41. Kirchgassler KU, Schmitz H, Bach G. Effectiveness and tolerability of 12-week treatment with micronised fenofibrate 200mg in a drug-monitoring programme involving 9884 patients with dyslipidaemia. Clin Drug Investig. 1998;15:197-204.
42. Blane GF. Comparative toxicity and safety profile of fenofibrate and other fibric acid derivatives. Am J Med. 1987;83:26-36.
43. Roberts WC. Safety of fenofibrate-US and worldwide experience. Cardiology. 1989;76: 169-179.
44. Guay DR. Micronized fenofibrate: a new fibric acid hypolipidemic agent. Ann Pharmacother. 1999;33:1083-1103.
45. Farnier M, Bonnefous F, Debbas N, Irvine A. Comparative efficacy and safety of micronized fenofibrate and simvastatin in patients with primary type IIa or IIb hyperlipidemia. Arch Intern Med. 1994;154:441-449.
46. Leroy D, Dompmartin A, Lorier E, Leport Y, Audebert C. Photosensitivity induced by fenofi- brate. Photodermatol Photoimmunol Photomed. 1990;7:136-137.
47. Jones PH, Davidson MH. Reporting rate of rhabdomyolysis with fenofibrate + statin versus gemfibrozil + any statin. Am J Cardiol. 2005;95:120-122.
48. Franssen R, Vergeer M, Stroes ES, Kastelein JJ. Combination statin-fibrate therapy: safety aspects. Diabetes Obes Metab. 2009;11:89-94.
49. Harivenkatesh N, David DC, Haribalaji N, Sudhakar MK. Efficacy and safety of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia: a randomized controlled trial. J Cardiovasc Pharmacol Ther. 2014;19(3):296-303.
50. Geng Q, Ren J, Chen H, Lee C, Liang W. Adverse events following statin-fenofibrate therapy versus statin alone: a meta-analysis of randomized controlled trials. Clin Exp Pharmacol Physiol. 2013;40(3):219-226.
51. Rysz J, Aronow WS, Stolarek RS, Hannam S, Mikhailidis DP, Banach M. Nephroprotective and clinical potential of statins in dialyzed patients. Expert Opin Ther Targets. 2009;13(5):541-550.
52. Reiner Z, Catapano AL, DeBacker G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011;32:1769-1818.
53. Stone NJ, Robinson JG, American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S1-45.
54. Hegele RA, Ginsberg HN, Chapman MJ, et al. The polygenic nature of hypertriglyceridaemia: implications for definition, diagnosis, and management. Lancet Diabetes Endocrinol. 2014; 2(8):655-666.
55. Bekolo CE, Nguena MB, Ewane L, Bekoule PS, Kollo B. The lipid profile of HIV-infected patients receiving antiretroviral therapy in a rural Cameroonian population. BMC Public Health. 2014;14:236.
56. Koopal C, Retterst0l K, Sjouke B, Hovingh GK, Ros E, de Graaf J, Dullaart RP, Bertolini S, Visseren FL. Vascular risk factors, vascular disease, lipids and lipid targets in patients with familial dysbetalipoproteinemia: a European cross-sectional study. Atherosclerosis. 2015; 240(1):90-97.
57. Lipid Modification: Cardiovascular Risk Assessment and the Modification of Blood Lipids for the Primary and Secondary Prevention of Cardiovascular Disease. National Clinical Guideline Centre (UK). 2014. http://www.ncbi.nlm.nih.gov/pubmed/25340243.
58. 19 May 2011, Advisory Committee meeting for choline fenofibrate/fenofibric acid (Trilipix) and the ACCORD-Lipid trial. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM255550.pdf.
59. Otvos JD, Jeyarajah EJ, Cromwell WC. Measurement issues related to lipoprotein heterogeneity. Am J Cardiol. 2002;90(8A):221-229.
60. Miller M, Cannon CP, Murphy SA, Qin J, Ray KK, Braunwald E, PROVE IT-TIMI 22 Investigators. Impact of triglyceride levels beyond low-density lipoprotein cholesterol after acute coronary syndrome in the PROVE IT-TIMI 22 trial. J Am Coll Cardiol. 2008; 51(7):724-730.
61. Sarwar N, Danesh J, Eiriksdottir G, Sigurdsson G, Wareham N, Bingham S, Boekholdt SM, Khaw KT, Gudnason V. Triglycerides and the risk of coronary heart disease: 10,158 incident cases among 262,525 participants in 29 Western prospective studies. Circulation. 2007;115(4):450-458. Epub 2006 Dec 26.