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Patients Taking Pyridorin (Pyridoxamine Dihydrochloride) Conver

May 6, 2002

The advanced glycation end product (AGE) inhibitor Pyridorin (pyridoxamine dihydrochloride) has potential in treating diabetic nephropathy. That, according to researchers 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,, conducted a randomized, placebo-controlled trial including 12 patients with type 2 diabetes and macroalbuminuria greater than 300 mg/day.

They randomized 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 µg/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.

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.