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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 …
Footnotes
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Sources of funding: Bristol-Myers Squibb Institute for Medical Research and Sanofi-Synthelabo.
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For correspondence: Dr E J Lewis, Rush–Presbyterian–St. Luke's Medical Center, Chicago, Illinois, USA.