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Low-Dose Eplerenone (EPL) Reduces Proteinuria in Type 2 Diabetes Patients Without Increasing Serum Potassium: Presented at ASH(HYP)

By Jill Stein

NEW YORK, NY -- May 15, 2003 -- Eplerenone (EPL) (50 - 100 mg) coadministered with the ACE inhibitor enalapril (ENAL) produces a similar antiproteinuric effect as EPL at a dose of 200 mg, while obviating the elevated potassium levels seen with the higher dose, researchers report.

The finding was presented here on May 15^th at the 18^th Annual Scientific Meeting of the American Society of Hypertension.

EPL, a selective aldosterone blocker recently approved for the treatment of hypertension, was previously shown to decrease proteinuria, but also to increase potassium levels at a dose of 200 mg per day. Murray Epstein, MD of the University of Miami, Miami, Florida, led a team of researchers in determining whether lower doses of EPL would be as effective while reducing this dangerous side effect.

The multicenter study included 268 patients with type 2 diabetes and albuminuria (with or without a history of hypertension) being treated with ENAL 20 mg.

Patients were randomized to receive EPL 50 mg or 100 mg daily, or placebo in addition to ENAL therapy. If blood pressure was not controlled at week 4, amlodipine 2.5 mg was added, with the dose doubled every 2 weeks, up to 10 mg, if necessary.

Uncontrolled hypertension was defined as levels greater than 130/180 mm Hg. Patients were assessed at weeks 4, 8, and 12.

Patients who received EPL and ENAL in combination had a significantly reduced urinary albumin:creatinine ratio compared with the ENAL monotherapy group.

Incidence of both sustained and severe potassium increases were similar in the 3 treatment groups, and were not clinically relevant. The incidence rates were generally lower in patients receiving 50 mg or 100 mg EPL coadministered with ENAL when compared with results from an earlier trial that used EPL 200 mg with or without ENAL 10 mg in hypertensive patients with diabetes and albuminuria (Epstein M, et al. Am J Hypertens 2002;15(Suppl 1):A24).

Other adverse events (including gynecomastia, mastodynia, and impotence) were rare or absent and did not differ among treatment groups.

This study was sponsored by Pharmacia Corporation of Peapack, New Jersey.


[Study title: Characterization of the Antiproteinuric Effect of Eplerenone in Patients With Type 2 Diabetes Mellitus. Abstract P-181a]

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