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Irbesartan reduced progression of nephropathy caused by type 2 diabetes independent of the effect on blood pressure

Christian G. Rabbat, MD
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*See Glossary.

†A correction was made at this point in the text. See Notices and Corrections for details.

Sources of funding: Bristol-Myers Squibb Institute for Medical Research and Sanofi-Synthelabo.

For correspondence: Dr. E.J. Lewis, Rush–Presbyterian–St. Luke’s Medical Center, Chicago, IL, USA.

Ann Intern Med. 2002;136(3):83. doi:10.7326/ACPJC-2002-136-3-083
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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: Randomized (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 centers 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 levels 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/d (n = 579); amlodipine, titrated to 10 mg/d (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 level, onset of end-stage renal disease, or all-cause mortality. The secondary outcome was the composite of cardiovascular mortality, nonfatal myocardial infarction, heart failure resulting in hospitalization, neurologic deficit caused by a cerebrovascular event, or above-ankle lower-limb amputation.

Main results: Analysis was by intention to treat. After adjusting for mean blood pressure, irbesartan lowered the risk for the primary composite outcome more than did amlodipine (P = 0.005) or placebo (P = 0.03); this outcome did not differ for amlodipine and placebo (P = 0.47) (Table). The 3 groups did not differ for the secondary composite outcome.

Conclusion: In patients with type 2 diabetes, nephropathy, and hypertension, irbesartan was more effective in reducing progression of nephropathy independent of the effect on blood pressure than was amlodipine or placebo.

Irbesartan, amlodipine, or placebo for risk for a composite outcome in diabetic nephropathy and hypertension at mean 2.6 y‡

ComparisonsEvent ratesAdjusted RRR (95% CI)NNT (CI)
Irbesartan vs amlodipine33% vs 41%24% (8 to 37)12 (7 to 35)
Irbesartan vs placebo33% vs 39%19% (1 to 33)16 (8 to 121)
Adjusted RRI (CI)NNH
Amlodipine vs placebo41% vs 39%7% (−11 to 29)Not significant

‡Composite outcome = doubling of baseline serum creatinine level, end-stage renal disease, or all-cause mortality. Abbreviations defined in Glossary; RRR, RRI, and CI adjusted for mean arterial blood pressure; NNT, NNH, and CI calculated from data in article.





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