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The effect of ruboxistaurin on nephropathy in type 2 diabetes

Katherine R Tuttle1, George L Bakris, Robert D Toto

  • 1Research Department, The Heart Institute and Sacred Heart Medical Center, Spokane, WA 99204-2340, USA. ktuttle@this.org

Diabetes Care
|October 27, 2005
PubMed
Abstract

Insights

Ruboxistaurin significantly reduced albuminuria in patients with type 2 diabetes and kidney disease. This protein kinase C-beta inhibitor also helped maintain estimated glomerular filtration rate over one year.

Area of Science:

  • Nephrology
  • Endocrinology
  • Pharmacology

Background:

  • Diabetic nephropathy is a major complication of type 2 diabetes.
  • Protein kinase C-beta (PKC-\\u03b2) plays a role in the pathogenesis of diabetic kidney disease.
  • Ruboxistaurin is a selective PKC-\\u03b2 inhibitor that has shown efficacy in animal models.

Purpose of the Study:

  • To evaluate the efficacy and safety of ruboxistaurin in patients with type 2 diabetes and diabetic nephropathy.
  • To assess the effect of ruboxistaurin on albuminuria and renal function.

Main Methods:

  • A randomized, double-blind, placebo-controlled, multicenter pilot study.
  • 123 participants with type 2 diabetes and persistent albuminuria received either 32 mg/day ruboxistaurin or placebo for 1 year.
  • Primary endpoint was the change in albumin-to-creatinine ratio (ACR); estimated glomerular filtration rate (eGFR) was also monitored.

Main Results:

  • Ruboxistaurin treatment led to a significant reduction in ACR (-24%) compared to placebo (-9%) (P=0.020).
  • The drug appeared to stabilize eGFR, whereas the placebo group showed a significant decline (-4.8 ml/min/1.73 m2) (P=0.009).
  • Although not statistically significant due to study power, trends favored ruboxistaurin for both ACR and eGFR changes.

Conclusions:

  • Ruboxistaurin effectively reduced albuminuria in patients with type 2 diabetes and nephropathy.
  • The drug demonstrated a potential to preserve renal function over a 1-year period.
  • Ruboxistaurin may offer additional benefits when used alongside existing therapies for diabetic nephropathy.

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