Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study.

Abstract

This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group. In both groups, Tac was given orally at the initial daily dose of 0.075 mg/kg twice daily, and MMF was given at the initial daily dose of 2 g/day. Steroid withdrawal was planned at 3 months after liver transplantation. The results were evaluated with respect to acute rejection incidence, patient and graft survival, graft function, and medical complications until 5 years or death for all patients. No significant differences were found between groups for the incidence of acute rejection at 5 years (11.4% versus 14.3%), 5-year patient survival (77.3% versus 87.8%), graft function, or postoperative renal function. One patient in the TMG- group underwent retransplantation. There was no difference between groups with respect to the incidence of medical complications, excepted for a higher rate of leukopenia in the TMG+ group, during the 5-year follow-up. In conclusion, the results of this prospective randomized study suggest that the addition of TMG to a triple immunosuppressive regimen (Tac, MMF, and steroids) did not modify the incidence of acute rejection episodes or long-term survival and was responsible for increased leukopenia rates.

• Authors: Olivier Boillot, Belhassen Seket, Jérôme Dumortier, Gabriella Pittau, Catherine Boucaud, Yves Bouffard, Jean-Yves Scoazec
• Journal: Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society (Liver Transpl) Vol. 15 Issue 11 Pg. 1426-34 (Nov 2009) ISSN: 1527-6473 [Electronic] United States
• PMID: 19877264 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal
• Antilymphocyte Serum
• Immunosuppressive Agents
• Steroids
• thymoglobulin
• Mycophenolic Acid
• Tacrolimus

Topics

• Acute Disease
• Adult
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antilymphocyte Serum
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Graft Rejection (drug therapy, mortality)
• Graft Survival
• Humans
• Immunosuppressive Agents (administration & dosage, adverse effects)
• Incidence
• Kidney (physiology)
• Liver (physiology)
• Liver Transplantation (mortality)
• Male
• Middle Aged
• Mycophenolic Acid (administration & dosage, adverse effects, analogs & derivatives)
• Prospective Studies
• Steroids (administration & dosage, adverse effects)
• Survival Rate
• Tacrolimus (administration & dosage, adverse effects)