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| |  ASN: Pimagedine Has Potential For Prevention Of Diabetic Complications RAMSEY, N.J. -- November 8, 1999 -- Alteon Inc. announced today that the first data on the Phase III ACTION I trial of pimagedine in Type 1 diabetic patients with overt nephropathy has been published and presented at the American Society of Nephrology (ASN) 32nd Annual Meeting and Scientific Exposition in Miami Beach, Florida. The randomized, double-blind multicenter ACTION I trial examined the ability of pimagedine to preserve renal function in patients with Type 1 diabetes and overt diabetic nephropathy. The Phase III trial involved 690 patients at 56 clinical sites in North America. Patients received the best available medical therapy, including ACE inhibitors, plus placebo or pimagedine at a low dose or high dose level (300 mg or 600 mg BID, titrated for kidney function). Alteon reported in November 1998 preliminary data from the ACTION I trial showing that pimagedine therapy resulted in a statistically significant and clinically meaningful reduction of urinary protein excretion. However, the results also showed that while pimagedine reduced the risk of doubling of serum creatinine, the study’s primary endpoint, the results did not reach statistical significance for this parameter. Pimagedine also reduced, to a statistically significant extent, LDL cholesterol and triglycerides as well as the progression of retinopathy. The three abstracts presented at the ASN meeting were as follows: 1. "Pimagedine Lowers Total Urinary Protein and Slows Progression of Overt Diabetic Nephropathy in Patients with Type 1 Diabetes Mellitus" was presented as an oral presentation on Sunday, November 7, 1999 at 4:00 p.m. Representing the ACTION I Investigator Group are authors Gerald Appel, M.D., Columbia Presbyterian Medical Center, New York, NY; Kline Bolton, M.D., University of Virginia Medical Center, Charlottesville, VA; Barry Freedman, M.D., North Carolina Baptist Hospital, Winston-Salem, NC; Jean-Paul Wuerth, M.D., Ph.D. and Kenneth Cartwright, MB ChB, MFCM, MRCPsych., Alteon, Inc., Ramsey, NJ. Pimagedine reduced the level of total urinary protein in a highly statistically significant manner (low dose p<0.001, high dose p=0.001, combined p<0.001) in patients exposed to optimal medical therapy. Statistical significance was reached at the low dose at each visit from month 6 to month 36. Pimagedine also slowed the progression of diabetic renal disease, particularly in patients with less advanced nephropathy and in those demonstrating a reduction in total urinary protein. 2. "Pimagedine Reduces Progression of Retinopathy and Lowers Lipid Levels in Patients with Type 1 Diabetes Mellitus" was presented as a poster session on Sunday, November 7, 1999. Representing the ACTION I Investigator Group are Philip Raskin, M.D., University of Texas Southwestern Medical Center, Dallas, TX; Daniel Cattran, M.D., Toronto General Hospital, Toronto, Canada; Mark Williams, M.D., Ph.D., Joslin Diabetes Center, Boston, MA; Jean-Paul Wuerth, M.D., Ph.D. and Kenneth Cartwright MB ChB, MFCM, MRCPsych., Alteon Inc., Ramsey, NJ. Progression of retinopathy, measured as an increase by 3 or more steps in the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, was observed in 16 percent of placebo patients, compared to 11 percent in low dose patients (odds ratio 0.58, p=0.112), 8 percent in high dose patients (odds ratio 0.46, p=0.044), and 10 percent in the combined treatment group (odds ratio 0.53, p=0.030). The overall reduction for placebo, low dose, high dose and combined treatment groups for total cholesterol was 5.2, 21.3 (p<0.001), 18.3 (p=0.008), and 19.8 (p<0.001) mg/dL, and for LDL cholesterol was 11.7, 22.3 (p=0.012), 23.5 (p=0.009), and 22.9 (p=0.002) respectively. Thus, pimagedine slowed the progression of retinopathy and lowered lipid levels in optimally treated patients with Type 1 diabetes mellitus. 3. "Pimagedine Safety Profile in Patients with Type 1 Diabetes Mellitus" was published as an abstract. Representing the ACTION I Investigator Group are authors Frederick Whittier, M.D., Mercy Medical Center, Canton, OH; Bruce Spinowitz, M.D., New York Hospital Medical Center of Queens, New York, NY; Jean-Paul Wuerth, M.D., Ph.D. and Kenneth Cartwright MB ChB, MFCM, MRCPsych., Alteon Inc., Ramsey, NJ. Relevant pimagedine-related adverse events included a transient flu-like syndrome, anemia, and induction of autoantibodies. Overall the authors conclude that pimagedine was well tolerated in the low-dose treatment arm with a safety profile comparable to the placebo arm.
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