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Therapeutics
Irbesartan reduced progression of nephropathy caused by type 2 diabetes independent of the effect on blood pressure

https://doi.org/10.1136/ebm.7.3.81

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    (2001) N Engl J Med 345, 851. Lewis EJ, Hunsicker LG, Clarke WR, et al, for the Collaborative Study Group.. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.. Sep 20;. :. –60.
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 QUESTION: In patients with type 2 diabetes mellitus, diabetic nephropathy, and hypertension, what effect does the angiotensin II receptor antagonist (ARA) irbesartan and the calcium channel blocker amlodipine have on renal disease?

    Design

    Randomised (allocation concealed*), blinded (clinicians, patients, outcome assessors, and statisticians),* placebo controlled trial with mean follow up of 2.6 years (the Irbesartan Diabetic Nephropathy Trial [IDNT]).

    Setting

    210 clinical centres worldwide.

    Patients

    1715 patients between 30 and 70 years of age (mean age 59 y, 66% men) who had type 2 diabetes, hypertension, proteinuria defined as a urinary protein excretion rate ≥ 900 mg/24 hours, and serum creatinine concentrations between 88 and 265 μmol/l in women and between 106 and 265 μmol/l in men. Follow up was 99%.

    Intervention

    Patients were allocated to irbesartan, titrated to 300 mg/day (n=579); amlodipine, titrated to 10 mg/day (n=567); or placebo (n=569). Treatment targeted a systolic blood pressure ≤ 135 mm Hg and a diastolic blood pressure ≤ 85 mm Hg by using drugs other than angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and calcium channel blockers, if necessary.

    Main outcome measures

    The primary outcome was the composite of a doubling of the baseline serum creatinine concentration, onset of end stage renal disease, or all cause mortality. The secondary outcome was the composite of cardiovascular mortality, non-fatal myocardial infarction, heart failure resulting in admission to hospital, neurological deficit caused by a cerebrovascular event, or above ankle lower limb amputation.

    Main results

    Analysis was by intention …

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    Footnotes

    • ↵* See glossary.

    • Sources of funding: Bristol-Myers Squibb Institute for Medical Research and Sanofi-Synthelabo.

    • For correspondence: Dr E J Lewis, Rush–Presbyterian–St. Luke's Medical Center, Chicago, Illinois, USA.