Irbesartan and Amlodipine in Patients with Nephropathy due to Type 2 Diabetes

Overall Study Question

These investigators examined the benefit of treating hypertensive patients with nephropathy due to type 2 diabetes with irbesartan, amlodipine, or placebo.


1715 hypertensive patients with nephropathy due to type 2 diabetes.


Irbesartan 300 mg po daily, amlodipine 10 mg po daily or placebo.


2.6 years


Doubling of SCr, ESRD (dialysis, renal transplant or Cr of at least 530 umoles/L) (%) ESRD (%) CV death, MI, CHF, stroke, limb amputation (%) Serious adverse effects (%)
Irbesartan 32.6 14.2 23.8 61
Amlodipine 41.1 18.3 22.6
Placebo 39 17.8 25.3
Relative Risk Reduction
(Irbesartan versus Placebo)
16 NSS
Absolute Risk Reduction 6.4
NNT/NNH over 2.6 years 16

NNT = numbers needed to treat, NNH = numbers needed to harm, NSS = not statistically significant

Mean arterial pressure was 3.3 mmHg lower in the drug groups – approximately 3/3 mmHg lower in the drug groups.

How does this study contribute to the drug therapy of hypertensive type 2 diabetics with nephropathy?

This study showed that an angiotensin-II-receptor blocker reduced the chance of the doubling of SCr, ESRD -dialysis, renal transplant or Cr of at least 530 by 6.4% compared to placebo in hypertensive type 2 diabetic patients with nephropathy over 2.6 years.

Original Citation

Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz I. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851-60.

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