In people with type 2 diabetes, microalbuminuria is a strong, independent risk factor for
diabetic nephropathy and cardiovascular morbidity and mortality. ACE inhibitor therapy
decreased the risk of microalbuminuria in hypertensive subjects with type 2 diabetes and
normoalbuminuria by about 40%. Available data suggest that angiotensin II receptor blockers
(ARBs) might have a similar renoprotective effect and that this effect might be increased by
combined ACE inhibitor therapy.
The study will evaluate the effects, at similar blood pressure control (systolic/diastolic
<130/80 mmHg), for a period of three years, of dual renin-angiotensin-system (RAS) blockade
by benazepril and valsartan combination therapy as compared to single RAS blockade by
benazepril or valsartan alone on microalbuminuria and cardiovascular events in high-risk
patients with type 2 diabetes, creatinine <1.5 mg/dl, no evidence of microalbuminuria but at
high risk of renal disease, with hypertension and a urinary albumin excretion between 7 and
19 microgram/min. The relationship between albuminuria and cardiovascular outcomes will also
be evaluated.
The study is expected to show a more effective prevention of microalbuminuria and
cardiovascular events with combined than with single drug ACE inhibitor or ARB therapy. As
compared to ACE inhibitor, ARB therapy is expected to have a similar effect on
microalbuminuria, but an inferior cardioprotective effect. Applied to clinical practice, the
findings should help preventing renal and cardiovascular complications, and related treatment
costs, of type 2 diabetes.
Phase:
Phase 3
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research