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Losartan was renoprotective in diabetic nephropathy independent of its effect on blood pressure

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 QUESTION: In patients with type 2 diabetes mellitus and nephropathy, what is the renoprotective effect of the angiotensin II receptor antagonist (ARA) losartan?

Design

Randomised (allocation concealed*), blinded (clinicians, patients, outcome assessors, and statisticians),* placebo controlled trial with mean follow up of 3.4 years (the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan [RENAAL] Study).

Setting

250 centres worldwide.

Patients

1513 patients between 31 and 70 years of age (mean age 60 y, 63% men) who had type 2 diabetes and nephropathy defined as a urinary albumin : creatinine ratio ≥ 300 mg/g and a serum creatinine concentration between 115 and 265 μmol/l (≥ 133 μmol/l for men weighing > 60 kg). Exclusion criteria included type 1 diabetes and non-diabetic renal disease. Follow up was 99.8%.

Intervention

After stratification by baseline level of proteinuria, patients were allocated to receive losartan, 50 to 100 mg/day (n=751), or placebo (n=762). Conventional antihypertensive treatment (excluding angiotensin I converting enzyme inhibitors and ARAs) was adjusted to target a systolic and diastolic blood pressure < 140 and < 90 mm Hg, respectively.

Main outcome measures

The primary outcome was the composite of a doubling of the baseline serum creatinine concentration, end stage renal disease (ESRD), or death. The secondary outcome was the composite of cardiovascular morbidity or mortality.

Main results

Analysis was by intention to treat. Losartan reduced the risk for the primary composite outcome (unadjusted p=0.02; p=0.03 after adjustment …

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