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Previous Volume 351:1952-1961 November 4, 2004 Number 19 Next

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ABSTRACT

Background Few studies have directly compared the renoprotective effects of angiotensin II–receptor blockers and angiotensin-converting–enzyme (ACE) inhibitors in persons with type 2 diabetes.

Methods In this prospective, multicenter, double-blind, five-year study, we randomly assigned 250 subjects with type 2 diabetes and early nephropathy to receive either the angiotensin II–receptor blocker telmisartan (80 mg daily, in 120 subjects) or the ACE inhibitor enalapril (20 mg daily, in 130 subjects). The primary end point was the change in the glomerular filtration rate (determined by measuring the plasma clearance of iohexol) between the baseline value and the last available value during the five-year treatment period. Secondary end points included the annual changes in the glomerular filtration rate, serum creatinine level, urinary albumin excretion, and blood pressure; the rates of end-stage renal disease and cardiovascular events; and the rate of death from all causes.

Results After five years, the change in the glomerular filtration rate was –17.9 ml per minute per 1.73 m² of body-surface area, where the minus sign denotes a decrement, with telmisartan (in 103 subjects), as compared with –14.9 ml per minute per 1.73 m² with enalapril (in 113 subjects), for a treatment difference of –3.0 ml per minute per 1.73 m² (95 percent confidence interval, –7.6 to 1.6 ml per minute per 1.73 m²). The lower boundary of the confidence interval, in favor of enalapril, was greater than the predefined margin of –10.0 ml per minute per 1.73 m², indicating that telmisartan was not inferior to enalapril. The effects of the two agents on the secondary end points were not significantly different after five years.

Conclusions Telmisartan is not inferior to enalapril in providing long-term renoprotection in persons with type 2 diabetes. These findings do not necessarily apply to persons with more advanced nephropathy, but they support the clinical equivalence of angiotensin II–receptor blockers and ACE inhibitors in persons with conditions that place them at high risk for cardiovascular events.

Source Information

From the Division of Medical Sciences, University of Birmingham and Birmingham Heartlands and Solihull National Health Service Trust (Teaching), Birmingham, United Kingdom (A.H.B., S.C.B.); the Department of Internal Medicine, Bosch Medicentre, Den Bosch, the Netherlands (P.B.); University Hospital, Linköping, Linköping, Sweden (B.K.); the Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark (S.M.); University Hospital of Oslo, Oslo (J.J.); and the Department of Internal Medicine, Tampere University Hospital, Tampere, Finland (J.M.).

Address reprint requests to Dr. Barnett at the Undergraduate Center, Birmingham Heartlands Hospital, Bordesley Green E., Birmingham B9 5SS, United Kingdom, or at anthony.barnett{at}heartsol.wmids.nhs.uk.

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Telmisartan vs. Enalapril in Type 2 Diabetes
Asgari A. A., Sarvghadi F., Zahed N., Parving H.-H., Hovind P., Rossing P., Loewenstein J. E., Bain S. C., Barnett A.
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N Engl J Med 2005; 352:835-836, Feb 24, 2005. Correspondence

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