ATLANTA, GA — March 20, 2002 — Treating hypertensive patients with type 2 diabetes and albuminuria using eplerenone, the first selective aldosterone receptor antagonist, may yield a significantly greater decrease in proteinuria than treatment with the angiotensin-converting enzyme (ACE)-inhibitor enalapril.
The data, from two phase III trials presented at the 51st Annual Scientific Session of the American College of Cardiology (ACC), also show that the two drugs produce similar reductions in left ventricular (LV) mass.
Dr. Murray Epstein and associates at the University of Miami Medical Center in Miami, Florida, United States, compared the effects of three antihypertensive strategies on urinary albumin excretion levels, blood pressure lowering, and tolerability in 257 type 2 diabetics with hypertension and albuminuria. Subjects were randomized to doses that were titrated up to 200 mg of eplerenone, 40 mg of enalapril, or 200 mg of eplerenone in combination with 10 mg of enalapril.
The primary efficacy endpoint was the mean percentage change in urinary albumin to creatinine ratio (UACR) at 24 weeks.
Eplerenone monotherapy was associated with a significant 62 percent decrease in UACR. Enalapril monotherapy produced a 45 percent reduction, and combination therapy yielded a 74 percent reduction.
Both drugs were well tolerated. Overall, 8.6 percent of patients in the eplerenone group, 1.2 percent in the enalapril group, and 6.9 percent in the eplerenone/enalapril combination group had potassium levels greater than or equal to 6.0 mEq/L. More patients in the combination group dropped out of the study prematurely because of sustained hyperkalemia than in the other two groups.
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