589
Views
6
CrossRef citations to date
0
Altmetric
Original Article

Systematic literature review and meta-analysis of dual therapy with fenofibrate or fenofibric acid and a statin versus a double or equivalent dose of statin monotherapy

, , &
Pages 2273-2285 | Accepted 17 Sep 2015, Published online: 05 Nov 2015

References

  • Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010;376:1670-81
  • Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005;366:1267-78
  • Anderson TJ, Gregoire J, Hegele RA, et al. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol 2013;29:151-67
  • Teramoto T, Sasaki J, Ishibashi S, et al. Executive summary of the Japan Atherosclerosis Society (JAS) guidelines for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan - 2012 version. J Atheroscler Thromb 2013;20:517-23
  • Mihaylova B, Emberson J, Blackwell L, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012;380:581-90
  • National Institute for Health and Care Excellence. Lipid Modification: Cardiovascular Risk Assessment and the Modification of Blood Lipids for the Primary and Secondary Prevention of Cardiovascular Disease. NICE guidelines (CG181). 2014. Available at: http://www.nice.org.uk/guidance/CG181(Accessed on 20 October 2015)
  • Grundy SM, Cleeman JI, Merz NB, et al.; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004;110:227-39
  • Lewington S, Whitlock G, Clarke R, et al. Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. Lancet 2007;370:1829-39
  • Barzi F, Patel A, Woodward M, et al.; Asia Pacific Cohort Studies Collaboration. A comparison of lipid variables as predictors of cardiovascular disease in the Asia Pacific region. Ann Epidemiol 2005;15:405-13
  • Roberts WC. The rule of 5 and the rule of 7 in lipid-lowering by statin drugs. Am J Cardiol 1997;80:106e7
  • Nicholls SJ, Brandrup-Wognsen G, Palmer M, Barter PJ. Meta-analysis of comparative efficacy of increasing dose of atorvastatin versus rosuvastatin versus simvastatin on lowering levels of atherogenic lipids (from VOYAGER). Am J Cardiol 2010;105:69e76
  • Naci H, Dias S, Ades AE. Industry sponsorship bias in research findings: a network meta-analysis of LDL cholesterol reduction in randomised trials of statins. BMJ 2014;349:g5741
  • Di Angelantonio E, Sarwar N, Perry P, et al. Major lipids, apolipoproteins, and risk of vascular disease. JAMA 2009;302:1993-2000
  • Castelli WP, Doyle JT, Gordon T, et al. HDL cholesterol and other lipids in coronary heart disease. The cooperative lipoprotein phenotyping study. Circulation 1977;55:767-72
  • Gordon T, Castelli, WP, Hjortland MC, et al. High density lipoprotein as a protective factor against coronary heart disease. The Framingham Study. Am J Med 1977;62:707-14
  • Gordon DJ, Probstfield JL, Garrison RJ, et al. High-density lipoprotein cholesterol and cardiovascular disease. Four prospective American studies. Circulation 1989;79:8-15
  • Ridker PM, Genest J, Boekholdt SM, et al. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial. Lancet 2010;376:333-9
  • Barter P, Gotto AM, LaRosa JC, et al. Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med 2007;357:1301-10
  • Boekholdt SM, Arsenault BJ, Hovingh GK, et al. Levels and changes of HDL cholesterol and apolipoprotein A-I in relation to risk of cardiovascular events among statin treated patients: a meta-analysis. Circulation 2013;128:1504-12
  • Mahdy Ali K, Wonnerth A, Huber K, Wojta J. Cardiovascular disease risk reduction by raising HDL cholesterol – current therapies and future opportunities. Br J Pharmacol 2012;167:1177-94
  • Miller M, Stone NJ, Ballantyne C, et al.; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation 2011;123:2292-333
  • Chapman MJ, Ginsberg HN, Amarenco P, et al.; European Atherosclerosis Society Consensus Panel. Triglyceride-rich lipoproteins and high-density lipoprotein cholesterol in patients at high risk of cardiovascular disease: evidence and guidance for management. Eur Heart J 2011;32:1345-61
  • Boullart AC, de Graaf J, Stalenhoef AF. Serum triglycerides and risk of cardiovascular disease. Biochim Biophys Acta 2012;1821:867-75
  • Hokanson JE, Austin MA. Plasma triglyceride level is a risk factor for cardiovascular disease independent of high-density lipoprotein cholesterol level: a meta-analysis of population-based prospective studies. J Cardiovasc Risk 1996;3:213-19
  • Liu J, Zeng FF, Liu ZM, et al. Effects of blood triglycerides on cardiovascular and all-cause mortality: a systematic review and meta-analysis of 61 prospective studies. Lipids Health Dis 2013;12:159
  • Patel A, Barzi F, Jamrozik K, et al.; Asia Pacific Cohort Studies Collaboration. Serum triglycerides as a risk factor for cardiovascular diseases in the Asia-Pacific region. Circulation 2004;110:2678-86
  • Sarwar N, Danesh J, Eiriksdottir G, et al. Triglycerides and the risk of coronary heart disease: 10,158 incident cases among 262,525 participants in 29 Western prospective studies. Circulation 2007;115:450-8
  • Choi HD, Shin WG. Safety and efficacy of statin treatment alone and in combination with fibrates in patients with dyslipidemia: a meta-analysis. Curr Med Res Opin 2014;30:1-10
  • Geng Q, Ren J, Chen H, et al. Adverse events following statin–fenofibrate therapy versus statin alone: a meta-analysis of randomized controlled trials. Clin Exp Pharmacol Physiol 2013;40:219-26
  • Geng Q, Ren J, Chen H, et al. Adverse events of statin–fenofibric acid versus statin monotherapy: a meta-analysis of randomized controlled trials. Curr Med Res Opin 2013;29:181-8
  • Abourbih S, Filion KB, Joseph L, et al. Effect of fibrates on lipid profiles and cardiovascular outcomes: a systematic review. Am J Med 2009;122:962.e1-8
  • Fiévet C, Staels B. Combination therapy of statins and fibrates in the management of cardiovascular risk. Curr Opin Lipidol 2009;20:505-11
  • ACCORD Study Group, Ginsberg HN, Elam MB, et al. Effects of combination lipid therapy in type 2 diabetes. N Engl J Med 2010;362:1563-74
  • Guo J, Meng F, Ma N, et al. Meta-analysis of safety of the coadministration of statin with fenofibrate in patients with combined hyperlipidemia. Am J Cardiol 2012;110:1296-301
  • Sutton AJ, Abrams KR, Jones DR, et al. Methods for Meta-analysis in Medical Research. Chichester (UK): John Wiley & Sons, 2000
  • Smith MEB, Lee NJ, Haney E, Carson S. Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin: Final Report Update 5. Available at: http://www.ncbi.nlm.nih.gov/pubmed/21089253 (Accessed on 20 October 2015)
  • Neyelhoff JL, Fuchs SC, Moreira LB. Meta-analyses and forest plots using a Microsoft Excel spreadsheet: step-by-step guide focusing on descriptive data analysis. BMC Research Notes 2012;5:52
  • Chan DC, Hamilton SJ, Rye KA, et al. Fenofibrate concomitantly decreases serum proprotein convertase subtilisin/kexin type 9 and very-low-density lipoprotein particle concentrations in statin-treated type 2 diabetic patients. Diabetes Obes Metab 2010;12:752-6
  • Hamilton SJ, Chew GT, Davis TM, Watts GF. Fenofibrate improves endothelial function in the brachial artery and forearm resistance arterioles of statin-treated type 2 diabetic patients. Clin Sci (Lond) 2010;118:607-15
  • Buldak L, Dulawa-Buldak A, Krysiak R, et al. Randomized double blind, placebo controlled trial on effects of 90 day hypolipidemic treatment (mono and combined therapy) on adipokines and inflammatory markers. Abstracts of the 4th International Congress on Prediabetes and Metabolic Syndrome; Journal of Diabetes 2011;3(Suppl.1):42
  • Farnier M. A multicenter, double-blind, randomized, active comparator, forced-titration study to compare the efficacy and safety of the combination of 145 mg fenofibrate and 20 or 40 mg simvastatin with 40 mg simvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 20 mg simvastatin alone. Abbott internal report C LF0242780-01 0501. October 2009
  • Sullivan DR. Scott R. A multicenter, double-blind, randomized study to compare the efficacy and safety of the combination of 145 mg fenofibrate and 40 mg simvastatin with 40 mg simvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 40 mg simvastatin alone. Abbott internal report C LF0242780-01 0502. April 2009
  • Stahl HD. Multicenter, double-blind, randomized, forced-titration study to compare the efficacy and safety of the combination of 145 mg fenofibrate and 20 or 40 mg simvastatin with atorvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 10 mg atorvastatin alone. Abbott internal report C LF0242780-01 0503. July 2009
  • Behar S. A multicenter, double-blind, randomized, forced titration study to compare the efficacy and safety of the combination of 145 mg fenofibrate and 20 or 40 mg simvastatin with 40 mg pravastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 40 mg pravastatin alone. Abbott internal report C LF0242780-01 0504. June 2009
  • Farnier M, Ducobu J, Bryniarski L. Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy. Am J Cardiol 2010;106:787-92
  • Farnier M, Steinmetz A, Retterstol K Császár A. Fixed-dose combination fenofibrate/pravastatin 160/40 mg versus simvastatin 20 mg monotherapy in adults with type 2 diabetes and mixed hyperlipidemia uncontrolled with simvastatin 20 mg: a double-blind, randomized comparative study. Clin Ther 2011;33:1-12
  • Goldberg AC, Bays HE, Ballantyne CM, et al. Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia. Am J Cardiol 2009;103:515-22
  • Jones PH, Davidson MH, Kashyap ML, et al. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis 2009;204:208-15
  • Mohiuddin SM, Pepine CJ, Kelly MT, et al. Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. Am Heart J 2009;157:195-203
  • Roth EM, Rosenson RS, Carlson DM, et al. Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia – a phase 3 study. Cardiovasc Drugs Ther 2010;24:421-8
  • Roth EM, McKenney JM, Kelly MT, et al. Efficacy and safety of rosuvastatin and fenofibric acid combination therapy versus simvastatin monotherapy in patients with hypercholesterolemia and hypertriglyceridemia: a randomized, double-blind study. Am J Cardiovasc Drugs 2010;10:175-86
  • Derosa G, Cicero AE, Bertone G, et al. Comparison of fluvastatin + fenofibrate combination therapy and fluvastatin monotherapy in the treatment of combined hyperlipidemia, type 2 diabetes mellitus, and coronary heart disease: a 12-month, randomized, double-blind, controlled trial. Clin Ther 2004;26:1599-607
  • Grundy SM, Vega GL, Yuan Z, et al. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am J Cardiol 2005;95:462-8
  • Koh KK, Quon MJ, Han SH, et al. Additive beneficial effects of fenofibrate combined with atorvastatin in the treatment of combined hyperlipidemia. J Am Coll Cardiol 2005;45:1649-53
  • Muhlestein JB, May HT, Jensen JR, et al. The reduction of inflammatory biomarkers by statin, fibrate, and combination therapy among diabetic patients with mixed dyslipidemia: the DIACOR (Diabetes and Combined Lipid Therapy Regimen) study. J Am Coll Cardiol 2006;48:396-401
  • Monteiro CMC, Oliveira L, Izar MCO, et al. Early effects of lipid lowering treatment in subjects with metabolic syndrome and acute coronary syndromes. Int J Atheroscler 2008;3:93-9
  • Derosa G, Maffioli P, Salvadeo SA, et al. Fenofibrate, simvastatin and their combination in the management of dyslipidaemia in type 2 diabetic patients. Curr Med Res Opin 2009;25:1973-83
  • Krysiak R, Anna GD, Okopien B. Effect of simvastatin and fenofibrate on cytokine release and systemic inflammation in type 2 diabetes mellitus with mixed dyslipidemia. Am J Cardiol 2011;107:1010-18
  • Ruokoniemi P, Sund R, Arffman M, et al. Are statin trials in diabetes representative of real-world diabetes care: a population-based study on statin initiators in Finland. BMJ Open 2014;4:e005402
  • Mikhailidis DP, Lawson RW, McCormick AL, et al. Comparative efficacy of the addition of ezetimibe to statin vs statin titration in patients with hypercholesterolaemia: systematic review and meta-analysis. Curr Med Res Opin 2011;27:1191-210
  • Farnier M, Retterstøl K, Steinmetz A, Császár A. Comparative efficacy and safety of fenofibrate/pravastatin plus ezetimibe triple therapy and simvastatin/ezetimibe dual therapy in type 2 diabetic patients with mixed hyperlipidaemia and cardiovascular disease. Diabetes Vascular Disease Research 2012;9:205-15
  • Luo L, Yuan X, Huang W, et al. Safety of coadministration of ezetimibe and statins in patients with hypercholesterolemia: a meta-analysis. Intern Med J 2015;45:546–57
  • DiNicolantonio JJ, Chatterjee S, Lavie CJ, et al. Ezetimibe plus moderate dose simvastatin after acute coronary syndrome: what are we IMPROVEing on? Am J Med 2015;128:914e1-.e4

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.