Clinical Studies Demonstrate Once-Daily Modified Release Prograf(R) Formula to Be Promising Treatment Option - Health News - redOrbitSEATTLE, May 24 /PRNewswire/ -- Two studies presented today at the 6th American Transplant Congress (ATC) demonstrate the safety and efficacy of once-daily Modified Release (MR) Prograf (TAC or tacrolimus) as compared to standard Prograf. MR Prograf is an extended release version of the FDA- approved twice-daily formulation of Prograf, a leading immunosuppressive agent for patients with kidney or liver transplants. The two studies, conducted in stable liver recipients and stable kidney recipients, provide one year follow-up data of a milligram-to-milligram comparison of the dosing regimens of Prograf, demonstrating the equivalency of the two versions of the drug. Results from the study of stable kidney patients also showed a decrease in the need for agents used to treat hypertension and hyperlipidemia vs. twice-daily Prograf, while there was no change in the need for medications to treat diabetes. A third study, designed to evaluate Prograf exposure and trough levels in stable pediatric liver recipients converted to the modified release formula, found that the steady- state pharmacokinetics of tacrolimus on MR Prograf is equivalent to Prograf after a milligram-to-milligram conversion. The study was designed to assess safety and efficacy after one-year of stable kidney patients converted from the administration of Prograf BID (administered twice daily) to once-daily Modified Release (MR) Prograf. Sixty- seven patients who entered the long-term extension on MR Prograf after completing the pharmacokinetic portion of the study (0-35 days) were evaluated for MR Prograf dosing and trough levels, laboratory values, concomitant medications, graft survival and adverse events. The mean dose of MR Prograf at conversion was 5.7 mg/day (1-19 mg/day) and 5.9 mg/day (1-17 mg/day) at one year.
