The Effect of Irbesartan on the Development of Diabetic Nephropathy in Patients with Type 2 Diabetes
Hans-Henrik Parving, M.D., D.M.Sc., Hendrik Lehnert, M.D., Jens Brochner-Mortensen, M.D., D.M.Sc., Ramon Gomis, M.D., Steen Andersen, M.D., Peter Arner, M.D., D.M.Sc., for the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group
Background Microalbuminuria and hypertension are risk factorsfor diabetic nephropathy. Blockade of the reninangiotensinsystem slows the progression to diabetic nephropathy in patientswith type 1 diabetes, but similar data are lacking for hypertensivepatients with type 2 diabetes. We evaluated the renoprotectiveeffect of the angiotensin-IIreceptor antagonist irbesartanin hypertensive patients with type 2 diabetes and microalbuminuria.
Methods A total of 590 hypertensive patients with type 2 diabetesand microalbuminuria were enrolled in this multinational, randomized,double-blind, placebo-controlled study of irbesartan, at a doseof either 150 mg daily or 300 mg daily, and were followed fortwo years. The primary outcome was the time to the onset ofdiabetic nephropathy, defined by persistent albuminuria in overnightspecimens, with a urinary albumin excretion rate that was greaterthan 200 µg per minute and at least 30 percent higherthan the base-line level.
Results The base-line characteristics in the three groups weresimilar. Ten of the 194 patients in the 300-mg group (5.2 percent)and 19 of the 195 patients in the 150-mg group (9.7 percent)reached the primary end point, as compared with 30 of the 201patients in the placebo group (14.9 percent) (hazard ratios,0.30 [95 percent confidence interval, 0.14 to 0.61; P<0.001]and 0.61 [95 percent confidence interval, 0.34 to 1.08; P=0.08]for the two irbesartan groups, respectively). The average bloodpressure during the course of the study was 144/83 mm Hg inthe placebo group, 143/83 mm Hg in the 150-mg group, and 141/83mm Hg in the 300-mg group (P=0.004 for the comparison of systolicblood pressure between the placebo group and the combined irbesartangroups). Serious adverse events were less frequent among thepatients treated with irbesartan (P=0.02).
Conclusions Irbesartan is renoprotective independently of itsblood-pressurelowering effect in patients with type 2diabetes and microalbuminuria.
Source Information
From the Steno Diabetes Center, Copenhagen, Denmark (H.-H.P., S.A.); the Department of Endocrinology and Metabolism, Magdeburg University Medical School, Magdeburg, Germany (H.L.); the Department of Clinical Physiology, Aalborg Hospital, Aalborg, Denmark (J.B.-M.); the Department of Endocrinology, University of Barcelona, Barcelona, Spain (R.G.); and the Department of Medicine, Huddinge Hospital, Huddinge, Sweden (P.A.).
Address reprint requests to Dr. Parving at the Steno Diabetes Center, Niels Steensens Vej 2, DK-2820 Gentofte, Denmark.
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