Fenofibrate-associated changes in renal function and relationship to clinical outcomes among individuals with type 2 diabetes: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) experience

Diabetologia

Volumn 55, Issue 6, 2012, Pages 1641-1650

  Bonds, D E ^a   Craven, T E ^b   Buse, J ^c   Crouse, J R ^b   Cuddihy, R ^d,k   Elam, M ^e   Ginsberg, H N ^f   Kirchner, K ^g   Marcovina, S ^h   Mychaleckyj, J C ⁱ   O'connor, P J ^j   Sperl Hillen, J A ^j  

^a NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^b WAKE FOREST SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^d INTERNATIONAL DIABETES CENTER   (United States)

^e VETERANS AFFAIRS MEDICAL CENTER   (United States)

^f College of Physicians and Surgeons ^*  (United States)

^g Montgomery Veterans Administration Medical Center   (United States)

^h UNIVERSITY OF WASHINGTON   (United States)

ⁱ UNIVERSITY OF VIRGINIA   (United States)

^j HEALTHPARTNERS RESEARCH FOUNDATION   (United States)

^k SANOFI   (France)

more..

Author keywords

Cardiovascular; Creatinine; Fenofibrate; Outcomes; Renal

Indexed keywords

CREATININE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; FENOFIBRATE; GLITAZONE DERIVATIVE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METFORMIN; PLACEBO; ROSIGLITAZONE; SIMVASTATIN; TRIACYLGLYCEROL; ANTILIPEMIC AGENT;

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CHOLESTEROL BLOOD LEVEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIASTOLIC BLOOD PRESSURE; DISEASE DURATION; DRUG DOSE TITRATION; DRUG WITHDRAWAL; FEMALE; GLOMERULUS FILTRATION RATE; GLYCEMIC CONTROL; HEART INFARCTION; HEART PROTECTION; HEMOGLOBIN BLOOD LEVEL; HUMAN; KIDNEY DISEASE; KIDNEY FUNCTION; MACROALBUMINURIA; MAJOR CLINICAL STUDY; MALE; MASS SPECTROMETRY; MICROALBUMINURIA; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; RACE DIFFERENCE; SEX DIFFERENCE; STROKE; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; TREATMENT RESPONSE; TRIACYLGLYCEROL BLOOD LEVEL; AGED; BLOOD; CLINICAL TRIAL; DRUG EFFECT; KIDNEY; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL;

AGED; CARDIOVASCULAR DISEASES; CREATININE; DIABETES MELLITUS, TYPE 2; FEMALE; FENOFIBRATE; HUMANS; HYPOLIPIDEMIC AGENTS; KIDNEY; MALE; MIDDLE AGED;

EID: 84865413263     PISSN: 0012186X     EISSN: 14320428     Source Type: Journal    
DOI: 10.1007/s00125-012-2524-2     Document Type: Article

References (28)

1. Food and Drug Administration (2011) Prescibing information Trilipix. Available from www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm? fuseaction0Search. DrugDetails, accessed 13 December 2011
2. Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, Krumholz HM (2011) Use of fibrates in the United States and Canada. JAMA 305:1217-1224
3. Hottelart C, el Esper N, Achard JM, Pruna A, Fournier A (1999) Fenofibrate increases blood creatinine, but does not change the glomerular filtration rate in patients with mild renal insufficiency. Nephrologie 20:41-44 (Pubitemid 29091030)
4. Broeders N, Knoop C, Antoine M, Tielemans C, Abramowicz D (2000) Fibrate-induced increase in blood urea and creatinine: is gemfibrozil the only innocuous agent? Nephrol Dial Transplant 15:1993-1999
5. Ansquer JC, Foucher C, Rattier S, Taskinen MR, Steiner G (2005) Fenofibrate reduces progression to microalbuminuria over 3 years in a placebo-controlled study in type 2 diabetes: results from the Diabetes Atherosclerosis Intervention Study (DAIS). Am J Kidney Dis 45:485-493 (Pubitemid 40341327)
6. Keech A, Simes RJ, Barter P et al (2005) Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet 366:1849-1861
7. Meade TW (2001) Design and intermediate results of the Lower Extremity Arterial Disease Event Reduction (LEADER) * trial of bezafibrate inmenwith lower extremity arterial disease [ISRCTN4119421]. Curr Contr Trials Cardiovasc Med 2:195-204 (Pubitemid 32780807)
8. Rizos E, Bairaktari E, Ganotakis E, Tsimihodimos V, Mikhailidis DP, Elisaf M (2002) Effect of ciprofibrate on lipoproteins, fibrinogen, renal function, and hepatic enzymes. J Cardiovasc Pharmacol Therapeut 7:219-226 (Pubitemid 35471357)
9. Lipscombe J, Bargman JM (2001) Fibrate-induced increase in blood urea and creatinine. Nephrol Dial Transplant 16:1515 (Pubitemid 32640622)
10. Deighan CJ, Caslake MJ, McConnell M, Boulton-Jones JM, Packard CJ (2001) Comparative effects of cerivastatin and fenofibrate on the atherogenic lipoprotein phenotype in proteinuric renal disease. J Am Soc Nephrol 12:341-348 (Pubitemid 32116376)
11. Ansquer JC, Dalton RN, Causse E, Crimet D, LeMalicot K, Foucher C (2008) Effect of fenofibrate on kidney function: a 6-week randomized crossover trial in healthy people. Am J Kidney Dis 51:904-913 (Pubitemid 351697561)
12. Ellen RL, McPherson R (1998) Long-term efficacy and safety of fenofibrate and a statin in the treatment of combined hyperlipidemia. Am J Cardiol 81:60B-65B (Pubitemid 28113948)
13. Buse JB, Bigger JT, Byington RP et al (2007) Action to control cardiovascular risk in diabetes (ACCORD) trial: design and methods. Am J Cardiol 99:21i-33i
14. Ginsberg HN, Elam MB, Lovato LC et al (2010) Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 362:1563-1574
15. Ginsberg HN, Bonds DE, Lovato LC et al (2007) Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 99:56i-67i
16. Levey AS, Coresh J, Greene T et al (2006) Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med 145:247-254 (Pubitemid 46768608)
17. Levey AS, Stevens LA, Schmid CH et al (2009) A new equation to estimate glomerular filtration rate. Ann Intern Med 150:604-612
18. Foucher C, Rattier S, Flavell DM et al (2004) Response to micronized fenofibrate treatment is associated with the peroxisomeproliferatoractivated receptors alpha G/C intron7 polymorphism in subjects with type 2 diabetes. Pharmacogenetics 14:823-829 (Pubitemid 40054337)
19. Stulc T, Kasalova Z, Krejci H, Dolezalova R, Ceska R (2005) Effect of rosiglitazone on homocysteine and creatinine levels in patients with type 2 diabetes. Atherosclerosis 183:367-368 (Pubitemid 41579291)
20. Arora MK, Reddy K, Balakumar P (2010) The low dose combination of fenofibrate and rosiglitazone halts the progression of diabetes-induced experimental nephropathy. Eur J Pharmacol 636:137-144
21. Gerstein HC, Miller ME, Byington RP et al (2008) Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 358:2545-2559 (Pubitemid 351831356)
22. Forsblom C, Hiukka A, Leinonen ES, Sundvall J, Groop PH, Taskinen MR (2010) Effects of long-term fenofibrate treatment on markers of renal function in type 2 diabetes: the FIELD Helsinki substudy. Diabetes Care 33:215-220
23. Davis TM, Ting R, Best JD et al (2011) Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia 54:280-290
24. Hottelart C, El Esper N, Rose F, Achard JM, Fournier A (2002) Fenofibrate increases creatininemia by increasing metabolic production of creatinine. Nephron 92:536-541
25. Mandard S, Muller M, Kersten S (2004) Peroxisome proliferatoractivated receptor alpha target genes. Cell Mol Life Sci 61:393-416 (Pubitemid 38316578)
26. Schiffrin EL (2005) Peroxisome proliferator-activated receptors and cardiovascular remodeling. Am J Physiol Heart Circ Physiol 288:H1037-H1043 (Pubitemid 40270004)
27. Huang H, Morisseau C, Wang J et al (2007) Increasing or stabilizing renal epoxyeicosatrienoic acid production attenuates abnormal renal function and hypertension in obese rats. Am J Physiol Renal Physiol 293:F342-F349 (Pubitemid 47345035)
28. Nagelkerke NJD (1991) A note on a general definition of the coefficient of determination. Biometrika 78:691-692