Effect of losartan on microalbuminuria in normotensive patients with type 2 diabetes mellitus - A randomized clinical trial
2003
textabstractBACKGROUND: Angiotensin-converting enzyme inhibitors have shown
antiproteinuric effects in normotensive and hypertensive diabetic
patients. Angiotensin-receptor antagonists reduce urinary albumin
excretion and the risk for renal and cardiovascular complications in
hypertensive patients with type 2 diabetes mellitus. The effect of
angiotensin-receptor antagonists in normotensive diabetic patients with
microalbuminuria has not yet been reported. OBJECTIVE: To assess the
antiproteinuric effects of losartan in normotensive patients with type 2
diabetes and microalbuminuria. DESIGN: Multicenter randomized,
double-blind, placebo-controlled clinical trial. SETTING: 19 outpatient
clinics in the Netherlands. PATIENTS: 147 normotensive patients with type
2 diabetes mellitus and microalbuminuria. INTERVENTION: 74 patients were
randomly assigned to receive losartan and 73 patients were assigned to
receive placebo for 10 weeks; 71 patients in each group completed the
study. The losartan dose was 50 mg during the first 5 weeks and 100 mg
during the subsequent 5 weeks. MEASUREMENTS: Change in urinary albumin
excretion rate after 5 and 10 weeks, change in creatinine clearance and
blood pressure, and safety and tolerability of losartan. RESULTS: A
significant 25% relative reduction in the albumin excretion rate occurred
after 5 weeks of the 50-mg losartan dose, with further improvement over
the subsequent 5 weeks with the 100-mg dose (relative reduction, 34%). In
the losartan group, creatinine clearance did not improve and blood
pressure decreased slightly. Side effects did not differ between treatment
groups. CONCLUSIONS: The angiotensin-receptor antagonist losartan reduces
urinary albumin excretion in normotensive patients with type 2 diabetes
and microalbuminuria. In multivariate analysis, the antiproteinuric effect
of losartan was independent of the associated reduction in blood pressure.
Losartan was safe and well tolerated in these normotensive patients.
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