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
Background It is unknown whether either the angiotensin-II–receptorblocker irbesartan or the calcium-channel blocker amlodipineslows the progression of nephropathy in patients with type 2diabetes independently of its capacity to lower the systemicblood pressure.
Methods We randomly assigned 1715 hypertensive patients withnephropathy due to type 2 diabetes to treatment with irbesartan(300 mg daily), amlodipine (10 mg daily), or placebo. The targetblood pressure was 135/85 mm Hg or less in all groups. We comparedthe groups with regard to the time to the primary compositeend point of a doubling of the base-line serum creatinine concentration,the development of end-stage renal disease, or death from anycause. 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. Treatmentwith irbesartan was associated with a risk of the primary compositeend point that was 20 percent lower than that in the placebogroup (P=0.02) and 23 percent lower than that in the amlodipinegroup (P=0.006). The risk of a doubling of the serum creatinineconcentration was 33 percent lower in the irbesartan group thanin the placebo group (P=0.003) and 37 percent lower in the irbesartangroup than in the amlodipine group (P<0.001). Treatment withirbesartan was associated with a relative risk of end-stagerenal disease that was 23 percent lower than that in both othergroups (P=0.07 for both comparisons). These differences werenot explained by differences in the blood pressures that wereachieved. The serum creatinine concentration increased 24 percentmore slowly in the irbesartan group than in the placebo group(P=0.008) and 21 percent more slowly than in the amlodipinegroup (P=0.02). There were no significant differences in therates of death from any cause or in the cardiovascular compositeend point.
Conclusions The angiotensin-II–receptor blocker irbesartanis effective in protecting against the progression of nephropathydue to type 2 diabetes. This protection is independent of thereduction 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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