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Aldosterone-inhibiting Hormone Can Be Added Safely to ACE Inhibitor Therapy for Type 2 Diabetes: Presented at AACE

By John Otrompke

CHICAGO, I.L. -- April 27, 2006 -- Adding an aldosterone antagonist to a standard therapy for type 2 diabetes can decrease albuminuria without contributing to hyperkalemia, according to preliminary results from a prospective study presented here at the annual meeting of the American Association of Clinical Endocrinologists (AACE).

To address the problem of persistent proteinuria associated with use of angiotensin-converting enzyme (ACE) inhibitor use, Michael B. Davidson, DO, endocrinology fellow, Cleveland Clinic, Cleveland, Ohio, United States, and colleagues designed a study that would evaluate the efficacy of spironolactone, which inhibits aldosterone, to diabetic therapy.

The study will enroll a total of 40 diabetic patients with albuminuria who will receive spironolactone for 12 weeks. In their poster presented on April 26^th the researchers presented data on 18 patients enrolled so far.

"Interestingly, there was no significant hyperkalemia among our patients, none of whom had to be withdrawn from the study for that reason," said Dr. Davidson, noting that hyperkalemia, or high potassium, can be associated with some standard therapies for type 2 diabetes. "When you introduce another drug that can cause hyperkalemia, that can be of concern to clinicians."

All patients in the study are on ACE inhibitor therapy. "We excluded patients on angiotensin receptor blockers (ARBs), because it's a small trial, and we wanted the patient population to be as homogenous as possible," Davidson explained.

To further protect patients from hyperkalemia, the study population was limited to those with normal renal function, and a very low dose of the hormone spironolactone was given.

"Long before renal function begins to deteriorate in these patients, the first thing you see if protein leakage from the kidneys into the urine, which can then progress to a decline in kidney function and a need for transplantation or dialysis," Dr. Davidson said, and added that spironolactone has long been in use for heart failure patients.

Albuminuria in the study was defined as protein greater than 100 mg/g of creatinine, Dr. Davidson said. By the end of the study, patients will be evenly divided between those with microalbuminuria and those with macroalbuminuria, he said.


[Presentation title: Addition of Spironolactone Reduces Albuminuria in Patients With Type 2 Diabetes Who Are on ACE Inhibitors. Abstract 166]

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