Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: A randomized, double-blind, placebo-controlled, multicenter, pilot study was performed to evaluate the effects of 32 mg/day ruboxistaurin for 1 year in persons (n = 123) with type 2 diabetes and persistent albuminuria ( albumin-to- creatinine ratio [ACR] 200-2,000 mg/g), despite therapy with renin-angiotensin system inhibitors. The primary end point was a change in the ACR. Estimated glomerular filtration rate (eGFR) (four-component equation from the Modification of Diet in Renal Disease study) was also calculated. RESULTS: At baseline, urinary ACR was 764 +/- 427 mg/g (means +/- SD), and eGFR was 70 +/- 24 ml/min per 1.73 m2. Systolic and diastolic blood pressures were 135 +/- 14 and 75 +/- 9 mmHg, respectively. HbA(1c) was 8.0 +/- 1.2%. After 1 year, urinary ACR decreased significantly (-24 +/- 9%) in participants treated with ruboxistaurin (P = 0.020) and nonsignificantly (-9 +/- 11%) in the placebo group (P = 0.430). The ACR-lowering effect of ruboxistaurin appeared by 1 month. eGFR did not decline significantly in the ruboxistaurin group (-2.5 +/- 1.9 ml/min per 1.73 m2) (P = 0.185), whereas the placebo group lost significant eGFR over 1 year (-4.8 +/- 1.8 ml/min per 1.73 m2) (P = 0.009). Between-group differences for changes in ACR and eGFR were not statistically significant, but this pilot study was underpowered to determine such differences. CONCLUSIONS:
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Authors | Katherine R Tuttle, George L Bakris, Robert D Toto, Janet B McGill, Kuolung Hu, Pamela W Anderson |
Journal | Diabetes care
(Diabetes Care)
Vol. 28
Issue 11
Pg. 2686-90
(Nov 2005)
ISSN: 0149-5992 [Print] United States |
PMID | 16249540
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Enzyme Inhibitors
- Indoles
- Maleimides
- ruboxistaurin
- Creatinine
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Topics |
- Black or African American
(statistics & numerical data)
- Aged
- Albuminuria
(physiopathology, prevention & control)
- Creatinine
(analysis)
- Diabetes Mellitus, Type 2
(complications, drug therapy, physiopathology)
- Diabetic Nephropathies
(complications, drug therapy, physiopathology)
- Double-Blind Method
- Enzyme Inhibitors
(adverse effects, therapeutic use)
- Female
- Glomerular Filtration Rate
(drug effects)
- Humans
- Indoles
(adverse effects, therapeutic use)
- Male
- Maleimides
(adverse effects, therapeutic use)
- Middle Aged
- Pilot Projects
- Time Factors
- United States
(epidemiology, ethnology)
- White People
(statistics & numerical data)
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