Original investigationsPathogenesis and treatment of kidney disease and hypertensionFenofibrate reduces progression to microalbuminuria over 3 years in a placebo-controlled study in type 2 diabetes: Results from the Diabetes Atherosclerosis Intervention Study (DAIS)
Section snippets
Study design and population
This study was performed in a representative sample of DAIS participants. DAIS is a randomized, double-blind, placebo-controlled, angiographic study. Participants were selected to be men or women of middle age, to have undergone coronary intervention or not, and to have mild to moderate lipid level abnormalities typical of patients with type 2 diabetes. Selection criteria and baseline characteristics have been published.9 Among selection criteria, participants were not to have significant renal
Baseline characteristics of participants
There were no differences in clinical and biochemical characteristics between the placebo and fenofibrate groups (Table 1, Table 2). There was no significant difference in age between participants with normal and abnormal albumin excretion or in the distribution of men, participants with previous coronary intervention, and smoking status (Table 1). However, body mass index (BMI) and blood pressure were significantly greater in the group with abnormal albumin excretion than in the group with
Discussion
The present study shows that treatment of people with type 2 diabetes with micronized fenofibrate reduces the progression of urinary albumin excretion. This was evidenced by a reduction in number of participants with microalbuminuria at the end of the treatment period and less progression from normoalbuminuria to microalbuminuria (Table 3) in a representative subset of participants with clinical and biochemical characteristics close to those of the DAIS population.8 In the placebo group, the
References (21)
- et al.
Laboratory standardisation of a large international clinical trial: The DAIS experience: DAIS Project Group. Diabetes Atherosclerosis Intervention Study
Clin Biochem
(2000) - et al.
Effect of lipid reduction on the progression of renal diseaseA meta-analysis
Kidney Int
(2001) - et al.
Atherogenic lipoprotein changes in diabetic nephropathy
Atherosclerosis
(2001) Microalbuminuria predicts clinical proteinuria and early mortality in maturity-onset diabetes
N Engl J Med
(1984)- et al.
Microalbuminuria in type 2 diabetesAn independent predictor of cardiovascular mortality
Aust N Z J Med
(1996) - et al.
The importance of microalbuminuria as a cardiovascular risk indicatorA review
Can J Cardiol
(2002) Treatment of the participant with diabetes mellitus and risk of nephropathyWhat do we know, and what do we need to learn?
Arch Intern Med
(2004)- et al.
Lipid nephrotoxicity in chronic progressive glomerular and tubulo-interstitial disease
Lancet
(1982) - et al.
Multifactorial intervention and cardiovascular disease in participants with type 2 diabetes
N Engl J Med
(2003) - et al.
Risk factors for development of incipent and overt diabetic nephropathy in participants with non-insulin dependent diabetes mellitusProspective, observational study
BMJ
(1997)
Cited by (0)
Originally published online as doi:10.1053/j.ajkd.2004.11.004 on January 14, 2005.
A full list of DAIS investigators is provided in Lancet 357:905-910, 2001.
J-C.A., C.F., and S.R. are employees of Laboratoires Fournier SA, which manufactures fenofibrate. M-R.T. and G.S. are part of the DAIS study group that received unrestricted grants from Laboratoires Fournier SA to conduct the trial.