Trandolapril Prevents Microalbuminura in Type 2 Diabetic Patients

Internal Medicine World ReportFebruary 2005

Trandolapril Prevents Microalbuminura in Type 2 Diabetic Patients

By Jill Stein

ST. LOUIS, Missouri/BERGAMO, Italy—The use of the angiotensin-converting enzyme (ACE) inhibitor trandolapril (Mavik) alone or in combination with the nonhydropyridine calcium channel blocker verapamil (Calan) thwarts the onset of microalbuminuria to a similar degree in patients with hypertension, type 2 diabetes, and normal urinary albumin excretion, according to new findings presented at the American Society of Nephrology annual meeting and later published in the New England Journal of Medicine (2004;351:1941-1951).

Microalbuminuria is generally the first clinical sign of renal dysfunction in patients with diabetes.

The data, from the Bergamo Nephrologic Diabetes Complications Trial (BENEDICT), also show that the effect of verapamil alone is similar to that of placebo.

The investigators compared results in 1204 patients who had been randomized to 4 treatment groups: trandolapril (2 mg/d) plus sustained-release verapamil (180 mg/d); trandolapril alone (2 mg/d); sustained-release verapamil alone (240 mg/d); or placebo.

“Type 2 diabetes is a public health concern, and its anticipated effects are dire,” Giuseppe Remuzzi, MD, study coauthor and director, Mario Negri Institute for Pharmacological Research, Bergamo, Italy, and colleagues elsewhere, pointed out. “Presently, there are more than 170 million cases worldwide, and this number is expected to surge to 370 million over the next 2 decades.”

About one third of type 2 diabetic patients develop progressive renal decline that is initially evidenced by the presence of microalbuminuria, he added. In addition, microalbuminuria is associated with an increased risk of cardiovascular sequelae. In fact, cardiovascular disease is responsible for about half of all deaths in type 2 diabetics with microalbuminuria.

Because of the adverse effects of microalbuminuria on both the kidneys and the heart, preventing, or at least postponing, its development is important for both renoprotection and cardioprotection, Dr Remuzzi said.

The study’s primary end point was the incidence of persistent microalbuminuria, defined as urinary albumin excretion of ³20 mg/min in at least 3 of 3 consecutive overnight collections confirmed 2 months apart.

Results showed that 5.7% of patients in the trandolapril plus verapamil group, 6.0% of patients who received trandolapril alone, 11.9% of patients treated with verapamil alone, and 10.0% of placebo-treated patients developed persistent microalbuminuria at a median follow-up of 3.6 years,.

No patients dropped out of the study prematurely because of acute deterioration of renal function or hyperkalemia, and serious adverse side effects were similar in the 4 groups.

In their article, Dr Remuzzi and colleagues noted that the data indicated that the addition of a nonhidropyridine calcium channel blocker does not improve upon the renoprotection achieved by ACE inhibition alone. “These findings suggest that in hypertensive patients with type 2 diabetes and normal renal function, an ACE inhibitor may be the medication of choice for controlling blood pressure,” they wrote. “The apparent advantage of ACE inhibitors over other agents include a protective effect on the kidney against the development of microalbuminuria, which is a major risk factor for cardiovascular events and death in this population.”

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