To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Generic Tacrolimus Leads to Poorer Clinical Outcomes in Adult, Paediatric Renal Transplant Patients Compared With Nongeneric Formulation: Presented at TTS URL: http://www.pslgroup.com/dg/228966.htm Doctor's Guide August 14, 2008
By Rachel Parratt SYDNEY, Australia -- August 14, 2008 -- Patients receiving the generic formulation of tacrolimus (Tenacrine) after first renal transplant had a greater tendency to develop acute rejection compared with the nongeneric form (Prograf), according to a post hoc analysis presented at the 22nd International Congress of the Transplantation Society (TTS 2008). Alberto Holm Corzo, MD, Department of Transplantation, La Raza General Hospital, National Medical Centre, Mexico City, Mexico, presented the findings here on August 13. The 3-year randomised, open-label, controlled study compared the efficacy and safety of generic tacrolimus with the nongeneric formulation in patients undergoing a first renal transplant. A total of 222 patients were randomised to treatment with nongeneric tacrolimus (n = 101) or generic tacrolimus (n = 121). Mean tacrolimus blood levels were lower in patients treated with the generic form at 3, 6, and 9 months post-transplant when compared with baseline (P < .05). This was the most important variable leading to acute rejection. Approximately twice as many patients receiving the generic formulation (20.8%) developed acute rejection compared with patients receiving the nongeneric form (11.8%) (P = .080). Patients receiving generic tacrolimus had a median time to rejection of 2 months, compared with a median time to rejection of 5 months for patients receiving the nongeneric formulation. For generic tacrolimus, there was a significant difference in mean creatinine levels at 3 and 6 months post-transplant compared with baseline and a significant difference at month 6 for creatinine clearance (P < .05). Age (<10 years) and the presence of coronary artery disease and cytomegalovirus were statistically significant variables for developing acute rejection for both formulations of tacrolimus (P < .05). "These study data suggest that the use of generic tacrolimus, now available in Mexico, results in poorer clinical outcomes in renal transplant patients when compared with [nongeneric tacrolimus]," said Dr. Holm Corzo. [Presentation title: A Post-Hoc Analysis of the Safety and Efficacy of Tacrolimus (Prograf) Versus a Generic Formulation of Tacrolimus (Tenacrine) as Primary Immunosuppressive Therapy in LRD and CAD Adults and Pediatric Renal Transplant Recipients. Mini-Oral Session 18 WMO18] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.