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Therapeutics
Irbesartan was renoprotective in patients with type 2 diabetes, hypertension, and microalbuminuria

http://dx.doi.org/10.1136/ebm.7.3.80

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    (2001) N Engl J Med 345, 870. Parving H-H, Lehnert H, Bröchner-Mortensen J, et al, for the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group.. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes.. Sep 20;. :. –8.
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 QUESTION: In patients with type 2 diabetes mellitus, hypertension, and persistent microalbuminuria, what is the effectiveness of the angiotensin II receptor antagonist (ARA) irbesartan for delaying or preventing the development of nephropathy?

    Design

    Randomised {allocation concealed*}†, blinded {clinicians, patients, and outcome assessors}†,* placebo controlled trial with 2 years of follow up.

    Setting

    96 centres worldwide.

    Patients

    611 patients between 30 and 70 years of age who had type 2 diabetes; hypertension defined as systolic blood pressure > 135 mm Hg or diastolic blood pressure > 85 mg, or both; persistent microalbuminuria defined as an albumin excretion rate of 20 to 200 μg/minute; and a serum creatinine concentration ≤ 133 μmol/l for men or ≤ 97 μmol/l for women. Exclusion criteria were non-diabetic kidney disease, cancer, fatal disease, or indication for angiotensin converting enzyme (ACE) inhibitors or ARAs. 590 of 611 (97%) patients (mean age 58 y, 68% men) completed follow up.

    Intervention

    Patients were allocated to receive irbesartan, 150 mg/day (n=195) or 300 mg/day (n=194), or placebo (n=201). Patients were treated with antihypertensive drugs as needed, but ACE inhibitors were not allowed. Patients continued their usual diabetes care. Dietary salt and protein were not restricted.

    Main outcome measure

    Development of nephropathy, defined by a urinary albumin excretion rate > 200 μg/minute that is at least 30% higher than the baseline rate.

    Main results

    Analysis was by intention to treat. At 2 years, unadjusted analyses showed that placebo was associated with a …

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    Footnotes

    • ↵* See glossary.

    • ↵† Information provided by author.

    • Sources of funding: Sanofi-Synthelabo and Bristol-Myers Squibb.

    • For correspondence: Dr H Parving, Steno Diabetes Center, Gentofte, Denmark. hhp{at}novo.dk.