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Baseline predictors of end-stage renal disease risk in patients with type 2 diabetes and nephropathy: new lessons from the RENAAL Study.

Treatment of diabetic nephropathy represents a significant economic burden, one that currently cannot be met in many regions in the world. The incidence of diabetes in the United States and Europe continues to rise, while regions such as Asia, the Pacific, and Latin America are facing a pandemic [1]. These regions do not have the medical or financial resources necessary to face this burden. In addition, present knowledge of the risk factor(s) that contribute to progressive diabetic nephropathy is limited. Therefore, the ability to identify those patients at high risk of end-stage renal disease (ESRD), and the power to focus therapeutic modalities to delay the progression to ESRD, are severely lacking. The RENAAL study represents a large repository of clinical information that allows a greater understanding of nephropathy in patients with type 2 diabetes. The RENAAL study was initiated to investigate the longterm renal protective role of losartan in patients (N = 1513) with type 2 diabetes and nephropathy [defined as urinary albumin to creatinine ratio of 300 mg/g and serum creatinine values greater than 1.3 mg/dL (female) and 1.5 mg/dL (male)]. Patients were randomized to either losartan or placebo, with additional antihypertensive medications added until the goal blood pressure of <140/90 mm Hg was reached. Patients were followed for a mean of 3.4 years. The population of RENAAL was ethnically diverse, with Asians accounting for 17%, blacks 15%, Hispanics 18%, and whites 48% of the patients. The study demonstrated that losartan, compared with placebo, significantly reduced the incidence, and delayed the time to the composite outcome of a doubling of serum creatinine concentration (DSCr), ESRD (defined as the need for dialysis or transplantation), or death (risk