Summarizing the FIELD study: lessons from a ‘negative' trial

Bibliography

• Tsimihodimos V, Florentin M, Elisaf MS. How should we treat hypertension and dyslipidemia in patients with prediabetes? Curr Pharm Des 2013;19:3773-87
   PubMed Web of Science ®Google Scholar
• Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care 1993;16:434-44
   PubMed Web of Science ®Google Scholar
• Turner RC, Millns H, Neil HA, et al. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: united Kingdom Prospective Diabetes Study (UKPDS: 23). BMJ 1998;316:823-8
   PubMed Web of Science ®Google Scholar
• Collins R, Armitage J, Parish S, et al. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet 2003;361:2005-16
   PubMed Web of Science ®Google Scholar
• Pyorala K, Pedersen TR, Kjekshus J, et al. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease. A subgroup analysis of the Scandinavian Simvastatin Survival Study (4S). Diabetes Care 1997;20:614-20
   PubMed Web of Science ®Google Scholar
• Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004;364:685-96
   PubMed Web of Science ®Google Scholar
• Lamarche B, St-Pierre AC, Ruel IL, et al. A prospective, population-based study of low density lipoprotein particle size as a risk factor for ischemic heart disease in men. Can J Cardiol 2001;17:859-65
   PubMed Web of Science ®Google Scholar
• Sampson UK, Fazio S, Linton MF. Residual cardiovascular risk despite optimal LDL cholesterol reduction with statins: the evidence, etiology, and therapeutic challenges. Curr Atheroscler Rep 2012;14:1-10
   PubMed Web of Science ®Google Scholar
• Tsimihodimos V, Miltiadous G, Daskalopoulou SS, et al. Fenofibrate: metabolic and pleiotropic effects. Curr Vasc Pharmacol 2005;3:87-98
   PubMedGoogle Scholar
• Robins SJ, Rubins HB, Faas FH, et al. Insulin resistance and cardiovascular events with low HDL cholesterol: the Veterans Affairs HDL Intervention Trial (VA-HIT). Diabetes Care 2003;26:1513-17
   PubMed Web of Science ®Google Scholar
• Tenenbaum A, Motro M, Fisman EZ, et al. Bezafibrate for the secondary prevention of myocardial infarction in patients with metabolic syndrome. Arch Intern Med 2005;165:1154-60
   PubMed Web of Science ®Google Scholar
• Effect of fenofibrate on progression of coronary-artery disease in type 2 diabetes: the Diabetes Atherosclerosis Intervention Study, a randomised study. Lancet 2001;357:905-10
   PubMed Web of Science ®Google Scholar
• FIELD Study Investigators. The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Cardiovasc Diabetol 2004;3:9
   PubMed Web of Science ®Google Scholar
• Willey KA, Kidd JF, Harris JP, et al. Albuminuria is an independent predictor of carotid intima-media thickness and atherosclerosis in NIDDM patients. Diabetes Care 1995;18:1502-3
   PubMed Web of Science ®Google Scholar
• Mykkanen L, Zaccaro DJ, O'Leary DH, et al. Microalbuminuria and carotid artery intima-media thickness in nondiabetic and NIDDM subjects. The Insulin Resistance Atherosclerosis Study (IRAS). Stroke 1997;28:1710-16
   PubMed Web of Science ®Google Scholar
• Keech AC, Grieve SM, Patel A, et al. Urinary albumin levels in the normal range determine arterial wall thickness in adults with Type 2 diabetes: a FIELD substudy. Diabetes Med 2005;22:1558-65
   PubMed Web of Science ®Google Scholar
• Drury PL, Ting R, Zannino D, et al. Estimated glomerular filtration rate and albuminuria are independent predictors of cardiovascular events and death in type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Diabetologia 2011;54:32-43
   PubMed Web of Science ®Google Scholar
• Mooradian AD. Dyslipidemia in type 2 diabetes mellitus. Nat Clin Pract Endocrinol Metab 2009;5:150-9
   PubMedGoogle Scholar
• Keech A, Simes RJ, Barter P, et al. 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;366:1849-61
   PubMed Web of Science ®Google Scholar
• McQueen MJ, Hawken S, Wang X, et al. Lipids, lipoproteins, and apolipoproteins as risk markers of myocardial infarction in 52 countries (the INTERHEART study): a case-control study. Lancet 2008;372:224-33
   PubMed Web of Science ®Google Scholar
• Kastelein JJ, van der Steeg WA, Holme I, et al. Lipids, apolipoproteins, and their ratios in relation to cardiovascular events with statin treatment. Circulation 2008;117:3002-9
   PubMed Web of Science ®Google Scholar
• Taskinen MR, Barter PJ, Ehnholm C, et al. Ability of traditional lipid ratios and apolipoprotein ratios to predict cardiovascular risk in people with type 2 diabetes. Diabetologia 2010;53:1846-55
   PubMed Web of Science ®Google Scholar
• Scott R, Donoghoe M, Watts GF, et al. Impact of metabolic syndrome and its components on cardiovascular disease event rates in 4900 patients with type 2 diabetes assigned to placebo in the FIELD randomised trial. Cardiovasc Diabetol 2011;10:102
   PubMed Web of Science ®Google Scholar
• Selvin E, Bolen S, Yeh HC, et al. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med 2008;168:2070-80
   PubMed Web of Science ®Google Scholar
• Simpson SH, Majumdar SR, Tsuyuki RT, et al. Dose-response relation between sulfonylurea drugs and mortality in type 2 diabetes mellitus: a population-based cohort study. CMAJ 2006;174:169-74
   PubMed Web of Science ®Google Scholar
• Sullivan D, Forder P, Simes J, et al. Associations between the use of metformin, sulphonylureas, or diet alone and cardiovascular outcomes in 6005 people with type 2 diabetes in the FIELD study. Diabetes Res Clin Pract 2011;94:284-90
   PubMed Web of Science ®Google Scholar
• Burgess DC, Hunt D, Li L, et al. Incidence and predictors of silent myocardial infarction in type 2 diabetes and the effect of fenofibrate: an analysis from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Eur Heart J 2010;31:92-9
   PubMed Web of Science ®Google Scholar
• Keating GM, Croom KF. Fenofibrate: a review of its use in primary dyslipidaemia, the metabolic syndrome and type 2 diabetes mellitus. Drugs 2007;67:121-53
   PubMed Web of Science ®Google Scholar
• Hiukka A, Leinonen E, Jauhiainen M, et al. Long-term effects of fenofibrate on VLDL and HDL subspecies in participants with type 2 diabetes mellitus. Diabetologia 2007;50:2067-75
   PubMed Web of Science ®Google Scholar
• Taskinen MR, Sullivan DR, Ehnholm C, et al. Relationships of HDL cholesterol, ApoA-I, and ApoA-II with homocysteine and creatinine in patients with type 2 diabetes treated with fenofibrate. Arterioscler Thromb Vasc Biol 2009;29:950-5
   PubMed Web of Science ®Google Scholar
• Maranghi M, Hiukka A, Badeau R, et al. Macrophage cholesterol efflux to plasma and HDL in subjects with low and high homocysteine levels: a FIELD substudy. Atherosclerosis 2011;219:259-65
   PubMed Web of Science ®Google Scholar
• Lambert G. Unravelling the functional significance of PCSK9. Curr Opin Lipidol 2007;18:304-9
   PubMed Web of Science ®Google Scholar
• Lambert G, Ancellin N, Charlton F, et al. Plasma PCSK9 concentrations correlate with LDL and total cholesterol in diabetic patients and are decreased by fenofibrate treatment. Clin Chem 2008;54:1038-45
   PubMed Web of Science ®Google Scholar
• Hiukka A, Westerbacka J, Leinonen ES, et al. Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus. J Am Coll Cardiol 2008;52:2190-7
   PubMed Web of Science ®Google Scholar
• Tonkin A, Hunt D, Voysey M, et al. Effects of fenofibrate on cardiovascular events in patients with diabetes, with and without prior cardiovascular disease: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Am Heart J 2012;163:508-14
   PubMed Web of Science ®Google Scholar
• Tenkanen L, Manttari M, Manninen V. Some coronary risk factors related to the insulin resistance syndrome and treatment with gemfibrozil. Experience from the Helsinki Heart Study. Circulation 1995;92:1779-85
   PubMed Web of Science ®Google Scholar
• Scott R, O'Brien R, Fulcher G, et al. Effects of fenofibrate treatment on cardiovascular disease risk in 9,795 individuals with type 2 diabetes and various components of the metabolic syndrome: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Diabetes Care 2009;32:493-8
   PubMed Web of Science ®Google Scholar
• Ginsberg HN, Elam MB, Lovato LC, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74
   PubMed Web of Science ®Google Scholar
• Ginsberg HN. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) Lipid trial: what we learn from subgroup analyses. Diabetes Care 2011;34(Suppl 2):S107-8
   Google Scholar
• American Diabetes Association. Standards of medical care in diabetes–2013. Diabetes Care 2013;36(Suppl 1):S11-66
   PubMed Web of Science ®Google Scholar
• Ting RD, Keech AC, Drury PL, et al. Benefits and safety of long-term fenofibrate therapy in people with type 2 diabetes and renal impairment: the FIELD Study. Diabetes Care 2012;35:218-25
   PubMed Web of Science ®Google Scholar
• Keech AC, Mitchell P, Summanen PA, et al. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Lancet 2007;370:1687-97
   PubMed Web of Science ®Google Scholar
• Sasso FC, Chiodini P, Carbonara O, et al. High cardiovascular risk in patients with Type 2 diabetic nephropathy: the predictive role of albuminuria and glomerular filtration rate. The NID-2 Prospective Cohort Study. Nephrol Dial Transplant 2012;27:2269-74
   PubMed Web of Science ®Google Scholar
• Tsimihodimos V, Kakafika A, Elisaf M. Fibrate treatment can increase serum creatinine levels. Nephrol Dial Transplant 2001;16:1301
   PubMed Web of Science ®Google Scholar
• Onat A, Can G, Ornek E, et al. Abdominal obesity with hypertriglyceridaemia, lipoprotein(a) and apolipoprotein A-I determine marked cardiometabolic risk. Eur J Clin Invest 2013; published online; doi:10.1111/eci.12150
   PubMed Web of Science ®Google Scholar
• Onat A, Can G. Enhanced Proinflammatory State and Autoimmune Activation: a Breakthrough to Understanding Chronic Diseases. Curr Pharm Des 2013; published online; doi:CPD-EPUB-20130402-2 [pii]
   Web of Science ®Google Scholar
• Forsblom C, Hiukka A, Leinonen ES, et al. Effects of long-term fenofibrate treatment on markers of renal function in type 2 diabetes: the FIELD Helsinki substudy. Diabetes Care 2010;33:215-20
   PubMed Web of Science ®Google Scholar
• Davis TM, Ting R, Best JD, et al. Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia 2011;54:280-90
   PubMed Web of Science ®Google Scholar
• Rajamani K, Colman PG, Li LP, et al. Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): a prespecified analysis of a randomised controlled trial. Lancet 2009;373:1780-8
   PubMed Web of Science ®Google Scholar
• Chan KH, O'Connell RL, Sullivan DR, et al. Plasma total bilirubin levels predict amputation events in type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Diabetologia 2013;56:724-36
   PubMed Web of Science ®Google Scholar
• Onat A, Can G, Ornek E, et al. Serum gamma-glutamyltransferase: independent predictor of risk of diabetes, hypertension, metabolic syndrome, and coronary disease. Obesity (Silver Spring) 2012;20:842-8
   PubMed Web of Science ®Google Scholar
• Giral P, Ratziu V, Couvert P, et al. Plasma bilirubin and gamma-glutamyltransferase activity are inversely related in dyslipidemic patients with metabolic syndrome: relevance to oxidative stress. Atherosclerosis 2010;210:607-13
   PubMed Web of Science ®Google Scholar
• Dierkes J, Westphal S, Luley C. Serum homocysteine increases after therapy with fenofibrate or bezafibrate. Lancet 1999;354:219-20
   PubMed Web of Science ®Google Scholar
• Herrmann M, Whiting MJ, Veillard AS, et al. Plasma homocysteine and the risk of venous thromboembolism: insights from the FIELD study. Clin Chem Lab Med 2012;50:2213-19
   PubMed Web of Science ®Google Scholar