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Pyridoxamine May Slow Early Diabetic Nephropathy

Posted: Saturday, November 05, 2011

Pyridoxamine (vitamin B6) is known to be an effective scavenger of reactive oxygen species and a potent inhibitor of advanced glycation end products. A new study demonstrated the benefits for patients with Type 2 diabetes.

A new published study demonstrates that although the drug may be of benefit in patients with type 2 diabetes who have minimal renal impairment, it failed to slow progression in patients with more advanced kidney disease.

Diabetes is the underlying medical problem in approximately 40% of patients requiring renal replacement therapy. Therapeutic interventions to decrease the progression of the rate of loss of renal function has been an area of intense research but continues to be a problem as the population of patients with type 2 diabetes keeps growing.

Edmund J. Lewis, MD, from Rush University Medical Center, Chicago, Illinois, led the double-blind, randomized, placebo-controlled study. It was conducted to assess the efficacy of pyridoxamine dihydrochloride (Pyridorin, NephroGenex), a vitamin B6 derivative, in delaying the progression of diabetic nephropathy.

The researchers enrolled a total of 317 patients and randomly assigned them to receive placebo (106 patients), pyridoxamine dihydrochloride 150 mg twice daily (105 patients), or pyridoxamine dihydrochloride 300 mg twice daily (106 patients) over the course of 52 weeks. The mean age of the patients was 63.9 years (standard deviation [SD], 9.5 years), the mean duration of diabetes was 17.6 years (SD, 8.5 years), the mean serum creatinine level was 2.2 mg/dL (SD, 0.6 mg/dL), and the mean protein-to-creatinine ratio was 2973 mg/g (SD, 1932 mg/g).

The primary endpoint of the study was the change in the serum creatinine level from baseline. Systolic blood pressure was controlled in all groups and remained stable throughout the study. Hemoglobin A1c values were similar for all groups, and treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers was consistent throughout the study period.

The study authors collected data for 307 patients up to the 52-week termination endpoint and found no statistically significant difference in serum creatinine among the 3 groups. A significant treatment effect was noted, however, for patients in the lowest tertile for serum creatinine (1.3 - 1.85 mg/dL) for both pyridoxamine dihydrochloride groups vs. placebo (P = .046). The incidence of adverse events was similar across the 3 groups.

Despite promising findings in earlier, 24-week trials, the authors were unable to demonstrate a statistically significant alteration in the progression of renal disease in this patient population. The patients in this study had advanced renal disease. However, previous observations with similar drugs have shown that a positive effect may be noted in patients with more intact renal function.

"Our overall study results failed to support therapeutic clinical efficacy of Pyridorin," the researchers note. However, the study did reveal data that suggested that patients with less severe renal impairment may benefit.

Dr. Lewis added, "We must consider the possibility that patients who had the most intact renal function may have achieved the desired therapeutic result. In view of our findings, a properly powered study of this latter subpopulation of patients is required."

According to independent commentator Vivian Fonseca, MD, professor of medicine, Tulane University, New Orleans, Louisiana, "Preliminary data suggested [pyridoxamine dihydrochloride] would work, but this is not the first time that preliminary findings were negated."

Source:, J Am Soc Nephrol. Published online October 27, 2011.

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