AVAPRO is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, AVAPRO reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-state renal disease (need for dialysis or
renal transplantation).
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AVAPRO significantly decreased the rate of progression of nephropathy in patients with hypertension and type 2 diabetes
†11
AVAPRO demonstrated early (3 months) and sustained (2.6 years) renal protection
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Multicenter, randomized, double-blind, placebo-controlled study.
Primary composite end point: time to occurrence of doubling of baseline serum creatinine, end-stage renal disease [ESRD] (serum creatinine >6 mg/dL, dialysis, or
renal transplantation), or all-cause death. Patients reaching primary end point: 32.6% (189/579) in the AVAPRO group; 41.1% (233/567) in the amlodipine group; and 39.0% (222/569) in the control group.
Adjunctive antihypertensive therapy (excluding ACE inhibitors, ARBs, and CCBs) used as necessary to achieve target BP in all 3 groups: systolic <135 mm Hg; diastolic <85 mm Hg.
†Nephropathy is defined as elevated serum creatinine and proteinuria (>300 mg/day).
‡Control defined as placebo plus permitted adjunctive antihypertensive therapy.
In patients with proteinuria, monitor serum potassium.
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AVAPRO significantly lowered proteinuria
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Adverse drug experiences included dizziness, orthostatic dizziness, and orthostatic hypotension.
§Last observation carried forward; mean duration of follow up was 2.6 years.
‡Control defined as placebo plus permitted adjunctive antihypertensive therapy.
In IDNT, nephropathy was defined as proteinuria >900 mg/day and elevated serum creatinine.
