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Previous Volume 345:870-878 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 Microalbuminuria and hypertension are risk factors for diabetic nephropathy. Blockade of the renin–angiotensin system slows the progression to diabetic nephropathy in patients with type 1 diabetes, but similar data are lacking for hypertensive patients with type 2 diabetes. We evaluated the renoprotective effect of the angiotensin-II–receptor antagonist irbesartan in hypertensive patients with type 2 diabetes and microalbuminuria.

Methods A total of 590 hypertensive patients with type 2 diabetes and microalbuminuria were enrolled in this multinational, randomized, double-blind, placebo-controlled study of irbesartan, at a dose of either 150 mg daily or 300 mg daily, and were followed for two years. The primary outcome was the time to the onset of diabetic nephropathy, defined by persistent albuminuria in overnight specimens, with a urinary albumin excretion rate that was greater than 200 µg per minute and at least 30 percent higher than the base-line level.

Results The base-line characteristics in the three groups were similar. 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 201 patients 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 blood pressure during the course of the study was 144/83 mm Hg in the placebo group, 143/83 mm Hg in the 150-mg group, and 141/83 mm Hg in the 300-mg group (P=0.004 for the comparison of systolic blood pressure between the placebo group and the combined irbesartan groups). Serious adverse events were less frequent among the patients treated with irbesartan (P=0.02).

Conclusions Irbesartan is renoprotective independently of its blood-pressure–lowering effect in patients with type 2 diabetes 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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