Principal Findings:

The average age was 59 years, 67% male, 58% insulin dependent, 28% had cardiovascular disease and mean values for clinical variables were: BMI 30.5kg/m2, BP 160/87 mm Hg, creatinine 1.67 mg/dL, urine protein 2.9 g/hrs and glycosylated Hgb 8.2%. Average follow-up was 2.6 years. Irbestartan therapy was associated with a 20% reduction in the primary end point compared to placebo (p=0.02) and 23% less than amlodipine (p = 0.006). The mean rate of change in serum creatinine was 0.45 mg/dL/year on irbesarten, 0.57mg/dL/year on amlodipine and 0.59mg/dL/year on placebo. Proteinuria was reduced by an average of 33% with irbesartan compared to 6% with amlodipine and 10% with placebo. The results were independent of the blood pressure lowering which was similar with irbesartan and amlodipine and each slightly greater than placebo. There were no between group differences in deaths or composite CV events, but compared to placebo, there were 23% less hospitalizations for CHF with irbesartan and 41% less non-fatal MIs with amlodipine.

The angiotensin-II receptor blocker irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes. The protection is independent of the reduction in blood pressure.