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| |  Long-Term Once-Daily Tacrolimus Monotherapy Safe, Effective for Liver Transplant Recipients: Presented at ATC By Cheryl Lathrop BOSTON -- June 4, 2009 -- The majority of de novo liver transplant recipients can be maintained on a simplified once-daily prolonged-release tacrolimus (TAC QD) monotherapy regimen, according to a study presented here at the 2009 American Transplant Congress (ATC). According to the researchers, TAC QD dose can be tailored to patients’ needs in the same way as TAC twice-daily (TAC BID), but with the convenience of once-daily treatment. The objective of the study reported here was to assess the efficacy and safety of TAC QD as a long-term treatment in liver transplant recipients. Findings were presented in an oral presentation on June 2. Pavel Trunecka, MD, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic, and colleagues conducted an open, multicentre, prospective, single-arm follow-up of adult transplant recipients who had participated in a 1-year European phase 3 de novo liver study (randomised, double-blind, double-dummy). The primary endpoint was patient and graft survival at 1-year follow-up. Secondary endpoints were incidence of biopsy-proven acute rejection (BPAR), renal function (creatinine clearance and serum creatinine), and adverse events (AE). A total of 130 patients were enrolled (70% male; mean age, 54 years). Patients remained on their original immunosuppressive regimen unless medical needs necessitated otherwise. Study visits were scheduled every 3 months. Of the patients, 119 (91.5%) completed the 2-year follow-up (completers). One patient died from a cardiac disorder and 10 were withdrawn due to various reasons. The efficacy and safety results were similar to that expected with TAC BID. The mean daily dose of TAC QD decreased from 0.066 mg/kg at months 13 to 15 to 0.059 mg/kg at months 22 to 24. The mean whole-blood trough level was 6.9 ng/mL between months 22 to 24. Renal function remained stable throughout the single-arm follow-up period. There was stable creatinine clearance with a mean in mL/min at months 3, 6, 9, and 12 of 83.5, 77.3, 78.7, and 77.9, respectively. Serum creatinine was also stable with a mean in mumol/L at months 3, 6, 9, and 12 of 103.7, 107.5, 111.0, and 108.4, respectively. AEs were infrequent and consistent with the known safety profile of tacrolimus. Rejection episodes were infrequent and 96% (125/130) were free from BPAR during the 12-month study period. Of the 5 cases of BPAR reported, 2 were mild, 2 were moderate, and 1 was severe. By month 12 of the follow-up, 69.7% of the 119 completers were on TAC QD monotherapy for their immunosuppressive regimen. [Presentation title: Excellent Efficacy and Renal Function in Liver Recipients with Tacrolimus Once-Daily Prolonged Release: 2-Year Follow-Up. Abstract 474]
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