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The IDNT Trial

The IDNT Trial. Reference Lewis EJ, et al . Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med . 2001;345(12). Background

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The IDNT Trial

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  1. The IDNT Trial Reference Lewis EJ, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345(12).

  2. Background It is not known if Irbesartan, the angiotensin II receptor blocker or amlodipine, the calcium channel blocker, slows down the progression of nephropathy in patients with type II diabetes independently of its capacity to lower the systemic blood pressure.

  3. Aim To investigate the renoprotective effect of the angiotensin-receptor antagonist Irbesartan in patients with nephropathy due to type 2 diabetes.

  4. Method Study design: A multicenter, randomized, study was performed in IDNT trial. Study population: The 1715 patients were enrolled in the study were between 30 and 70 years of age, had type 2 diabetes. Inclusion criteria were: a sedentary BP of 135/85 mmHg, serum creatinine level of 1.0–3.0 and 1.2–3.0 mg/dl in women and men, respectively, no recent cardiovascular events, serum potassium inside normal range, BMI<45 km/m2. The patients were divided in three groups and were given Irbesartan (n=579), placebo (n=569) and amlodipine (n=567). End point: The primary end point was the time taken for doubling the baseline serum creatinine and end-stage renal disease (ESRD/renal transplantation), need for dialysis or serum creatinine ≥6.0 mg/dL, death (due to all causes). The secondary end point was time taken to cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, permanent neurological deficit due to stroke and above the ankle amputation.

  5. Result • Irbesartan reduced the risk for progression of advanced diabetic nephropathy by reducing the primary end point by 20% as compared to the placebo. A 23% reduction was seen in the primary end point in the Irbesartan group as compared to the amlodipine group.

  6. a. Primary end point: Doubling of serum creatinine, ESRD or death.

  7. b. Secondary end point: Time to composite of CV diseases Irbesartan was safe and generally well tolerated.

  8. Conclusion The angiotensin-II-receptor blocker Irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes. Irbesartan, angiotensin-II-receptor blocker, is effective in protecting against the progression of nephropathy in patient with type 2 diabetes.

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