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Pyridorin in type 2 diabetic nephropathy
Edmund J Lewis1, Tom Greene, Samuel Spitalewiz
1Rush University Medical Center, Chicago, Illinois, USA.
Journal of the American Society of Nephrology : JASN
|October 29, 2011
Summary
Pyridoxamine dihydrochloride (Pyridorin) did not significantly slow kidney function decline in patients with diabetic nephropathy over one year. However, early results suggest potential benefits for individuals with less severe kidney impairment.
Area of Science:
- Nephrology
- Endocrinology
- Pharmacology
Background:
- Diabetic nephropathy is a leading cause of kidney failure.
- Advanced glycation end products (AGEs) and oxidative stress contribute to diabetic kidney disease.
- Pyridoxamine dihydrochloride (Pyridorin) inhibits AGE formation and scavenges reactive oxygen species.
Purpose of the Study:
- To evaluate the renoprotective effects of Pyridorin in patients with type 2 diabetic nephropathy.
- To determine if Pyridorin slows the progression of kidney disease as measured by serum creatinine levels.
Main Methods:
- Double-blind, randomized, placebo-controlled trial.
- 317 patients with proteinuric type 2 diabetic nephropathy were assigned to placebo, Pyridorin 150 mg twice daily, or Pyridorin 300 mg twice daily for 52 weeks.
- Primary endpoint was the change in serum creatinine from baseline to 52 weeks.
Main Results:
- No statistically significant difference in serum creatinine change was observed between Pyridorin groups and placebo over 52 weeks.
- A subgroup analysis indicated that patients with lower baseline serum creatinine (less renal impairment) showed a trend towards a beneficial effect with Pyridorin.
- No significant treatment effect was found in patients with moderate to severe renal impairment.
Conclusions:
- Pyridoxamine dihydrochloride (Pyridorin) did not demonstrate a significant renoprotective effect in slowing serum creatinine progression in proteinuric type 2 diabetic nephropathy over one year.
- The study suggests a potential benefit of Pyridorin in patients with early-stage diabetic kidney disease.
- Further research is warranted to explore Pyridorin's efficacy in specific patient subgroups with diabetic nephropathy.
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