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Title: Three Of 12 Patients Taking Pyridorin (Pyridoxamine Dihydrochloride) Convert From Macro- To Microalbuminuria: Presented at ASN

"Three Of 12 Patients Taking Pyridorin (Pyridoxamine Dihydrochloride) Convert From Macro- To Microalbuminuria: Presented at ASN"

By Maggie Schwarz Special to DG News PHILADELPHIA, PA -- November 3, 2002 -- The advanced glycation end product (AGE) inhibitor Pyridorin (pyridoxamine dihydrochloride) has potential in treating diabetic nephropathy, researchers reported here November 1 at the 35th Annual Meeting of the American Society of Nephrology (ASN). Dr. Thorsten P. Degenhardt and colleagues from BioStratum Incorporated, in Durham, North Carolina, United States, conducted a randomised, placebo-controlled trial including 12 patients with type 2 diabetes and macroalbuminuria greater than 300 mg/day. They randomised patients to receive Pyridorin or placebo at a 3 to 1 ratio and escalated the dose of Pyridorin based on tolerability, from 50 mg b.i.d. on days 1 through 7 to 250 mg b.i.d. on days 9 through 15, to 500 mg b.i.d. on days 17 through 44. Pharmacokinetic assessments were performed after the first (0 to 12 hours) and last (0 to 48 hours) dose of each dosing level. After the first dose of each dosing level, the time of maximum concentration was approximately 2.5 hours. The maximum drug concentration was 1 and 1.5 ľg/hr/mL at 250 and 500 mg doses, respectively. Pharmacokinetic parameters observed after multiple dosings were not significantly different than after a single dose, indicating lack of drug accumulation, Dr. Degenhardt said. Pyridorin metabolism followed the known metabolic pathways for the B6 vitamer family, with pyridoxal and 4-pyridoxic acid being the primary detectable metabolites. No conversion to pyridoxine was detected. The researchers found all dose levels of Pyridorin were well tolerated, with no serious adverse events reported and no discontinuations due to an adverse event. Patients taking Pyridorin experienced an average decrease from baseline 24-hour urinary albumin excretion of 32 percent at day 45. Three patients receiving Pyridorin converted to microalbuminuria by the end of the trial. Pyridorin is in phase 2 clinical development for diabetic nephropathy and has inhibited both development and progression of diabetic nephropathy in animal models of type 1 and 2 diabetes. Dr. Thorsten concluded that Pyridorin holds promise in the treatment of diabetic nephropathy.

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