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Original Article
Volume 345:851-860 September 20, 2001 Number 12
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Renoprotective Effect of the Angiotensin-Receptor Antagonist Irbesartan in Patients with Nephropathy Due to Type 2 Diabetes
Edmund J. Lewis, M.D., Lawrence G. Hunsicker, M.D., William R. Clarke, Ph.D., Tomas Berl, M.D., Marc A. Pohl, M.D., Julia B. Lewis, M.D., Eberhard Ritz, M.D., Robert C. Atkins, M.D., Richard Rohde, B.S., Itamar Raz, M.D., for the Collaborative Study Group

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 by Hostetter, T. H.

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ABSTRACT

Background It is unknown whether either the angiotensin-II–receptor blocker irbesartan or the calcium-channel blocker amlodipine slows the progression of nephropathy in patients with type 2 diabetes independently of its capacity to lower the systemic blood pressure.

Methods We randomly assigned 1715 hypertensive patients with nephropathy due to type 2 diabetes to treatment with irbesartan (300 mg daily), amlodipine (10 mg daily), or placebo. The target blood pressure was 135/85 mm Hg or less in all groups. We compared the groups with regard to the time to the primary composite end point of a doubling of the base-line serum creatinine concentration, the development of end-stage renal disease, or death from any cause. We also compared them with regard to the time to a secondary, cardiovascular composite end point.

Results The mean duration of follow-up was 2.6 years. Treatment with irbesartan was associated with a risk of the primary composite end point that was 20 percent lower than that in the placebo group (P=0.02) and 23 percent lower than that in the amlodipine group (P=0.006). The risk of a doubling of the serum creatinine concentration was 33 percent lower in the irbesartan group than in the placebo group (P=0.003) and 37 percent lower in the irbesartan group than in the amlodipine group (P<0.001). Treatment with irbesartan was associated with a relative risk of end-stage renal disease that was 23 percent lower than that in both other groups (P=0.07 for both comparisons). These differences were not explained by differences in the blood pressures that were achieved. The serum creatinine concentration increased 24 percent more slowly in the irbesartan group than in the placebo group (P=0.008) and 21 percent more slowly than in the amlodipine group (P=0.02). There were no significant differences in the rates of death from any cause or in the cardiovascular composite end point.

Conclusions The angiotensin-II–receptor blocker irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes. This protection is independent of the reduction in blood pressure it causes.


Source Information

From the Department of Medicine, Rush–Presbyterian–St. Luke's Medical Center, Chicago (E.J.L., R.R.); the Department of Internal Medicine, University of Iowa College of Medicine (L.G.H.), and the Department of Biostatistics, University of Iowa College of Public Health (W.R.C.), Iowa City; the Department of Internal Medicine, University of Colorado School of Medicine, Denver (T.B.); the Department of Medicine, Cleveland Clinic Foundation, Cleveland (M.A.P.); the Department of Medicine, Vanderbilt University School of Medicine, Nashville (J.B.L.); the Department of Medicine, Ruperto Carola University, Heidelberg, Germany (E.R.); the Department of Nephrology, Monash Medical Center, Melbourne, Australia (R.C.A.); and the Department of Medicine, Hadassah University, Jerusalem, Israel (I.R.).

Address reprint requests to Dr. Edmund J. Lewis at Rush–Presbyterian–St. Luke's Medical Center, 1650 W. Harrison, Suite 515 RA, Chicago, IL 60612.

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