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Risk Scores for Predicting Outcomes in Patients with Type 2 Diabetes and Nephropathy: The RENAAL Study

William F. Keane^*, Zhongxin Zhang^*, Paulette A. Lyle^*, Mark E. Cooper, Dick de Zeeuw, Jean-Pierre Grunfeld, James P. Lash^||, Janet B. McGill^¶, William E. Mitch^**, Giuseppe Remuzzi, Shahnaz Shahinfar^*, Steven M. Snapinn^*, Robert Toto, Barry M. Brenner; for the RENAAL Study Investigators

^* Merck & Co., Inc., Whitehouse Station, New Jersey; Baker Heart Research Institute, Melbourne, Victoria, Australia; Department of Clinical Pharmacology, University Medical Center Groningen, Groningen, The Netherlands; Service de Nephrologie, Hopital Necker, Paris, France; ^|| University of Illinois at Chicago, Chicago, Illinois; ^¶ Department of Medicine, Division of Endocrinology, Washington University, St. Louis, Missouri; ^** Department of Medicine, Renal Division, Emory University, Atlanta, Georgia; Instituto Di Ricerche Farmacologiche Mario Negri, Laboratories Negri Bergamo, Bergamo, Italy; Division of Nephrology, Baylor College of Medicine, Houston, Texas; and Department of Medicine, Renal Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

Address correspondence to: Dr. William F. Keane, Merck & Co., Inc., PO Box 4, UG4A-025, West Point, PA 19486-0004. Phone: 267-305-2018; Fax: 267-305-2845; williamf_keane{at}merck.com

Diabetic nephropathy is the most important cause of ESRD. The aim of this study was to develop a risk score from risk predictors for ESRD, with and without death, in the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study and to compare ability of the ESRD risk score and its components to predict ESRD. The risk score was developed from coefficients of independent risk factors from multivariate analysis of baseline variables and equals (1.96 x log [urinary albumin:creatinine ratio]) – (0.78 serum albumin [g/dl]) + (1.28 x serum creatinine [mg/dl]) – (0.11 x hemoglobin [g/dl]). It was robust with respect to severity of nephropathy, gender, race, and treatment group. The risk score for ESRD or death was comparable. The four risk predictors for progression of kidney disease were independent of therapy. For combined treatment groups, the hazard ratio between the fourth and first quartiles of the ESRD risk score was 49.0, as compared with the corresponding hazard ratios for each component: 14.7 for urinary albumin:creatinine ratio, 9.2 for serum creatinine, 5.5 for hemoglobin, and 10.2 for serum albumin. The RENAAL risk scores for ESRD with or without death emphasize the importance of identification of level of albuminuria, serum albumin, serum creatinine, and hemoglobin to predict development of ESRD in patients with type 2 diabetes and nephropathy. Although albuminuria is a strong risk factor for ESRD, the contribution of serum albumin, serum creatinine, and hemoglobin level further enhances prediction of ESRD. Future trials with a similar patient population and outcomes measures should consider adjusting analyses for baseline risk factors.

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