Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan® and Mowel® after liver transplantation
Authors Vollmar J, bellmann M, Darstein F, Hoppe-Lotichius M, Mittler J, Heise M, Rüttger B, Weyer V, Zimmermann A, Lang H, Galle P, Zimmermann T
Received 16 July 2015
Accepted for publication 17 September 2015
Published 17 November 2015 Volume 2015:9 Pages 6139—6149
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Prof. Dr. Wei Duan
Johanna Vollmar,1 Maren Christina Bellmann,1 Felix Darstein,1 Maria Hoppe-Lotichius,2 Jens Mittler,2 Michael Heise,2 Bernd Rüttger,3 Veronika Weyer,4 Anca Zimmermann,5 Hauke Lang,2 Peter R Galle,1 Tim Zimmermann1
1First Department of Internal Medicine, Gastroenterology and Hepatology, Johannes Gutenberg University, Mainz, Germany; 2Department of Hepatobiliary and Transplantation Surgery, Johannes Gutenberg University, Mainz, Germany; 3Panacea Biotec Germany GmbH, Munich, Germany; 4Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center, Johannes Gutenberg University, Mainz, Germany; 5First Department of Internal Medicine, Endocrinology and Metabolic Diseases, Johannes Gutenberg University, Mainz, Germany
Background: Expensive pharmaceuticals are a major reason for cost intensive health care systems. Long-term immunosuppressive therapy plays a relevant role after organ transplantation. Patents of original drugs have expired and cheaper products are available. Little data are available regarding efficacy and safety of generic immunosuppressive agents.
Methods: In this prospective study, 25 patients, who were clinically stable for a minimum of 2 years after liver transplantation, were converted from the original formulations of tacrolimus (TAC) and mycophenolate mofetil to the generics Tacpan® (TAP) and Mowel® (MOW). Patients were followed-up for 6 months. Results were compared retrospectively to 25 age- and sex-matched controls treated with the original brands.
Results: In the matched-pair analysis of TAC trough level/dose ratio, no significant difference was found between TAP/MOW and TAC/mycophenolate mofetil groups. No acute rejection occurred in either group. In total, 17 patients reported mild side effects in the TAP/MOW group. The most common side effects were gastrointestinal symptoms. Intra-individual analysis of costs revealed a considerable cost reduction in the TAP/MOW group (in median 25.03%; P<0.001).
Conclusion: In summary, the use of the generics TAP/MOW is effective and seems to be safe and cost-efficient in stable liver-transplantation patients.
Keywords: immunosuppression, liver transplantation, generics, tacrolimus, mycophenolate mofetil
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