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Published on: February 28, 2013
Preventing microalbuminuria in type 2 diabetes.
Piero Ruggenenti1, Anna Fassi, Anelja Parvanova Ilieva
1Mario Negri Institute for Pharmacological Research, Clinical Research Center for Rare Diseases, Aldo e Cele Daccò, Villa Camozzi, Ranica, Bergamo, Italy. manuelap@marionegri.it
Trandolapril, alone or with verapamil, significantly reduced microalbuminuria in patients with type 2 diabetes and hypertension. Verapamil alone showed no benefit over placebo in preventing this complication.
Area of Science:
- Nephrology
- Cardiology
- Endocrinology
Background:
- The Bergamo Nephrologic Diabetes Complications Trial (BENEDICT) investigated preventative strategies for kidney complications in diabetic patients.
- Hypertension and type 2 diabetes mellitus are key risk factors for microvascular damage, including microalbuminuria.
Purpose of the Study:
- To evaluate the efficacy of angiotensin-converting-enzyme inhibitors (trandolapril) and non-dihydropyridine calcium-channel blockers (verapamil), alone or in combination, in preventing microalbuminuria.
- To assess the impact of these antihypertensive agents on the progression of kidney disease in diabetic patients with normal urinary albumin excretion.
Main Methods:
- A multicenter, double-blind, randomized trial involving 1204 subjects with hypertension, type 2 diabetes, and normoalbuminuria.
- Participants received trandolapril, verapamil, a combination of both, or placebo for at least three years, targeting a blood pressure of 120/80 mm Hg.
- The primary endpoint was the development of persistent microalbuminuria, defined as overnight albumin excretion ≥20 µg/min at two consecutive visits.
Main Results:
- Trandolapril plus verapamil (5.7%) and trandolapril alone (6.0%) significantly reduced the incidence of microalbuminuria compared to placebo (10.0%).
- Verapamil alone (11.9%) did not show a significant benefit over placebo (P=0.54).
- Trandolapril-containing regimens delayed the onset of microalbuminuria by factors of 2.6 (combination) and 2.1 (trandolapril alone). Serious adverse events were comparable across all groups.
Conclusions:
- Trandolapril, with or without verapamil, effectively decreases the incidence of microalbuminuria in patients with type 2 diabetes and hypertension who have normoalbuminuria.
- Verapamil monotherapy demonstrated no significant protective effect against microalbuminuria in this population.
- These findings highlight the renoprotective role of ACE inhibitors in diabetic hypertensive patients at early stages of kidney disease.
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