The Effect of Ruboxistaurin on Nephropathy in Type 2 Diabetes
Why the study?
Does ruboxistaurin reduce albuminuria in persons with type 2 diabetes and persistent albuminuria despite renin-angiotensin system inhibitors?
Population
123 persons with type 2 diabetes and persistent albuminuria despite therapy with renin-angiotensin system…
Comparison
Ruboxistaurin 32 mg/day for 1 year vs Matching placebo
Design
RCT, randomized, double-blind
Follow-up
1 year
Authors
Discussion
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Member takes
Implication
Does not support ruboxistaurin use for albuminuria in type 2 diabetes; leaves open efficacy in larger powered trials.
Structured PICO
Does ruboxistaurin reduce albuminuria in persons with type 2 diabetes and persistent albuminuria despite renin-angiotensin system inhibitors?
P
Population
123 persons with type 2 diabetes and persistent albuminuria (albumin-to-creatinine ratio [ACR] 200-2,000 mg/g) despite therapy with renin-angiotensin system inhibitors
I
Intervention
Ruboxistaurin 32 mg/day for 1 year
C
Comparator
Matching placebo
O
Outcome
Change in the albumin-to-creatinine ratio (ACR) at 1 yearsurrogate
In a pilot study of patients with type 2 diabetes and nephropathy, ruboxistaurin reduced albuminuria from baseline, but the study was underpowered to show a statistically significant difference compared to placebo.
Limitations
- underpowered to determine between-group differences
Cite This Study
Tuttle et al. (2005) studied this question.