title: Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan and Mowel after liver transplantation.
abstract: 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).
  
  
  CONCLUSIONS
  In summary, the use of the generics TAP/MOW is effective and seems to be safe and cost-efficient in stable liver-transplantation patients.
authors.affiliation: First Department of Internal Medicine, Gastroenterology and Hepatology, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Johanna
authors.initials: J
authors.lastname: Vollmar
authors.affiliation: First Department of Internal Medicine, Gastroenterology and Hepatology, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Maren Christina
authors.initials: MC
authors.lastname: Bellmann
authors.affiliation: First Department of Internal Medicine, Gastroenterology and Hepatology, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Darstein
authors.affiliation: Department of Hepatobiliary and Transplantation Surgery, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Maria
authors.initials: M
authors.lastname: Hoppe-Lotichius
authors.affiliation: Department of Hepatobiliary and Transplantation Surgery, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Mittler
authors.affiliation: Department of Hepatobiliary and Transplantation Surgery, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Heise
authors.affiliation: Panacea Biotec Germany GmbH, Munich, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Rüttger
authors.affiliation: Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Veronika
authors.initials: V
authors.lastname: Weyer
authors.affiliation: First Department of Internal Medicine, Endocrinology and Metabolic Diseases, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Anca
authors.initials: A
authors.lastname: Zimmermann
authors.affiliation: Department of Hepatobiliary and Transplantation Surgery, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Hauke
authors.initials: H
authors.lastname: Lang
authors.affiliation: First Department of Internal Medicine, Gastroenterology and Hepatology, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Galle
authors.affiliation: First Department of Internal Medicine, Gastroenterology and Hepatology, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Zimmermann
mesh_terms: D000368:Aged; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry / Q000627:therapeutic use; D011446:Prospective Studies; D012449:Safety; D016559:Tacrolimus / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus
keywords: generics; immunosuppression; liver transplantation; mycophenolate mofetil; tacrolimus