Randomized trial of tacrolimus monotherapy: tacrolimus in combination, tacrolimus alone compared (the TICTAC trial)
| Autor: | Daniel J. Goldstein, Marc Cohen, M.M. Alwarshetty, Mark J. Zucker, David A. Baran, L.H. Arroyo, Alan Gass, Candace Carr, Margarita Camacho, Maria R. Ramirez, Thomas Prendergast |
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| Rok vydání: | 2007 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male medicine.medical_specialty Combination therapy medicine.medical_treatment Urology Drug Administration Schedule Tacrolimus law.invention Postoperative Complications Randomized controlled trial law Adrenal Cortex Hormones medicine Clinical endpoint Lung transplantation Humans Aged Heart transplantation Transplantation business.industry Graft Survival Middle Aged Mycophenolic Acid Surgery Clinical trial Calcineurin surgical procedures operative Treatment Outcome Cytomegalovirus Infections Heart Transplantation Drug Therapy Combination Female Cardiology and Cardiovascular Medicine business Immunosuppressive Agents |
| Zdroj: | The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation. 26(10) |
| ISSN: | 1557-3117 |
| Popis: | Background Prior retrospective studies have suggested that tacrolimus monotherapy is an option associated with excellent outcomes and reduced toxicities. Method We conducted a prospective, randomized, 2-center study of tacrolimus combination therapy vs monotherapy. From April 16, 2004, to September 15, 2005, 58 adult heart transplant patients were studied. All received oral tacrolimus, mycophenolate mofetil, and corticosteroids. Patients were then randomized to a group where mycophenolate was maintained (COMBO) or to a group where it was discontinued (MONO) 14 days post-transplant. Corticosteroids were rapidly withdrawn in both groups between 8 and 12 weeks. Result The primary end point (mean 6-month International Society of Heart and Lung Transplantation biopsy score) was 0.44 ± 0.04 in the MONO group and 0.60 ± 0.05 in the COMBO group ( p = 0.013, unpaired Student's t -test). The freedom from rejection grade of 2R or higher at 6 and 12 months was 93.3% with MONO and 92.9% with COMBO ( p = NS). Conclusion Tacrolimus monotherapy appears to be safe and efficacious in heart transplant recipients and is not associated with excess rejection in the first year post-transplant. Further studies of this approach are warranted. |
| Databáze: | OpenAIRE |
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