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Previous Volume 345:861-869 September 20, 2001 Number 12 Next

	Full Text PDF Editorial by Hostetter, T. H. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Diabetic nephropathy is the leading cause of end-stage renal disease. Interruption of the renin–angiotensin system slows the progression of renal disease in patients with type 1 diabetes, but similar data are not available for patients with type 2, the most common form of diabetes. We assessed the role of the angiotensin-II–receptor antagonist losartan in patients with type 2 diabetes and nephropathy.

Methods A total of 1513 patients were enrolled in this randomized, double-blind study comparing losartan (50 to 100 mg once daily) with placebo, both taken in addition to conventional antihypertensive treatment (calcium-channel antagonists, diuretics, alpha-blockers, beta-blockers, and centrally acting agents), for a mean of 3.4 years. The primary outcome was the composite of a doubling of the base-line serum creatinine concentration, end-stage renal disease, or death. Secondary end points included a composite of morbidity and mortality from cardiovascular causes, proteinuria, and the rate of progression of renal disease.

Results A total of 327 patients in the losartan group reached the primary end point, as compared with 359 in the placebo group (risk reduction, 16 percent; P=0.02). Losartan reduced the incidence of a doubling of the serum creatinine concentration (risk reduction, 25 percent; P=0.006) and end-stage renal disease (risk reduction, 28 percent; P=0.002) but had no effect on the rate of death. The benefit exceeded that attributable to changes in blood pressure. The composite of morbidity and mortality from cardiovascular causes was similar in the two groups, although the rate of first hospitalization for heart failure was significantly lower with losartan (risk reduction, 32 percent; P=0.005). The level of proteinuria declined by 35 percent with losartan (P<0.001 for the comparison with placebo).

Conclusions Losartan conferred significant renal benefits in patients with type 2 diabetes and nephropathy, and it was generally well tolerated.

Source Information

From the Renal Division, Brigham and Women's Hospital, Boston (B.M.B.); the Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia (M.E.C.); the Department of Clinical Pharmacology, University of Groningen, Groningen, the Netherlands (D.Z.); the Department of Medicine, Hennepin County Medical Center, Minneapolis (W.F.K.); the Renal Division, Emory University, Atlanta (W.E.M.); Steno Diabetes Center, Gentofte, Denmark (H.-H.P.); Laboratori Negri Bergamo, Istituto di Ricerche Farmacologiche Mario Negri, Bergamo, Italy (G.R.); and Merck Research Laboratories, Blue Bell, Pa. (S.M.S., Z.Z., S.S.).

Address reprint requests to Dr. Brenner at the Renal Division, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at bbrenner{at}partners.org.

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