Key result
Aliskiren added to losartan reduces proteinuria ~21% versus placebo in diabetic nephropathy.
Why the study?
Does aliskiren added to losartan reduce albuminuria independent of baseline blood pressure in hypertensive type 2 diabetic patients with nephropathy?
RCT (n=599)
Does aliskiren added to losartan reduce albuminuria independent of baseline blood pressure in hypertensive type 2 diabetic patients with nephropathy?
Effect estimate: 19 to 22% reduction
Aliskiren added to losartan provides antiproteinuric effects independent of baseline blood pressure in patients with type 2 diabetes and nephropathy.
May support aliskiren add-on for proteinuria reduction irrespective of BP in diabetic nephropathy; hypothesis-generating pending randomized outcome trials.
BACKGROUND AND OBJECTIVES: Elevated BP contributes to development and progression of proteinuria and decline in renal function in patients with type 2 diabetes. Our post hoc analysis assessed the baseline BP influence on the antiproteinuric effect in the Aliskiren in the Evaluation of Proteinuria in Diabetes (AVOID) study. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In the AVOID study, 599 hypertensive type 2 diabetic patients with nephropathy received 6 months of aliskiren (150 mg force titrated to 300 mg daily after 3 months) or placebo added to losartan (100 mg) daily and optimal antihypertensive therapy. Changes in early morning urinary albumin:creatinine ratio and eGFR at week 24 were assessed by subgroups of baseline BP: Group A (prespecified target), <130/80 mmHg (n=159); Group B, <140/90 mmHg but ≥130/80 mmHg (n=189); and Group C (insufficient BP control), ≥140/90 mmHg (n=251). RESULTS: Mean baseline BP (mmHg) levels for Groups A, B, and C were 120/71, 133/78, and 145/81, respectively. BP during the trial was nearly identical to baseline levels in all groups. The antiproteinuric effects of aliskiren were consistent across subgroups of baseline BP (19 to 22% reduction versus placebo). In Group C, the decline in eGFR was significantly lower with aliskiren than with placebo (P=0.013). CONCLUSIONS: Aliskiren (300 mg) added to losartan (100 mg) plus optimal antihypertensive therapy provides antiproteinuric effects independent of BP in patients with type 2 diabetes and nephropathy. Renal function was better preserved with aliskiren in patients with insufficient BP control.
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Persson et al. (2011) conducted an RCT in Type 2 diabetes and nephropathy (n=599). Aliskiren vs. Placebo was evaluated on Changes in early morning urinary albumin:creatinine ratio and eGFR at week 24 (19 to 22% reduction). Aliskiren added to losartan reduced proteinuria by 19 to 22% versus placebo across all baseline blood pressure subgroups in patients with type 2 diabetes and nephropathy.
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