Randomized Trial of Tacrolimus Monotherapy: Tacrolimus In Combination, Tacrolimus Alone Compared (The TICTAC Trial)

David A. Baran, Mark J. Zucker, Luis H. Arroyo, Mamata M. Alwarshetty, Maria R. Ramirez, Thomas W. Prendergast, Daniel J. Goldstein, Margarita Camacho, Alan L. Gass, Candace Carr, Marc Cohen

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

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 Corticosteroids were rapidly withdrawn in both groups between 8 and 12 weeks.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.

Original languageEnglish (US)
Pages (from-to)992-997
Number of pages6
JournalJournal of Heart and Lung Transplantation
Volume26
Issue number10
DOIs
StatePublished - Oct 2007
Externally publishedYes

Fingerprint

Tacrolimus
Transplants
Adrenal Cortex Hormones
Heart-Lung Transplantation
Mycophenolic Acid
Retrospective Studies
Students
Biopsy
Therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Transplantation

Cite this

Baran, D. A., Zucker, M. J., Arroyo, L. H., Alwarshetty, M. M., Ramirez, M. R., Prendergast, T. W., ... Cohen, M. (2007). Randomized Trial of Tacrolimus Monotherapy: Tacrolimus In Combination, Tacrolimus Alone Compared (The TICTAC Trial). Journal of Heart and Lung Transplantation, 26(10), 992-997. https://doi.org/10.1016/j.healun.2007.07.022

Randomized Trial of Tacrolimus Monotherapy : Tacrolimus In Combination, Tacrolimus Alone Compared (The TICTAC Trial). / Baran, David A.; Zucker, Mark J.; Arroyo, Luis H.; Alwarshetty, Mamata M.; Ramirez, Maria R.; Prendergast, Thomas W.; Goldstein, Daniel J.; Camacho, Margarita; Gass, Alan L.; Carr, Candace; Cohen, Marc.

In: Journal of Heart and Lung Transplantation, Vol. 26, No. 10, 10.2007, p. 992-997.

Research output: Contribution to journalArticle

Baran, DA, Zucker, MJ, Arroyo, LH, Alwarshetty, MM, Ramirez, MR, Prendergast, TW, Goldstein, DJ, Camacho, M, Gass, AL, Carr, C & Cohen, M 2007, 'Randomized Trial of Tacrolimus Monotherapy: Tacrolimus In Combination, Tacrolimus Alone Compared (The TICTAC Trial)', Journal of Heart and Lung Transplantation, vol. 26, no. 10, pp. 992-997. https://doi.org/10.1016/j.healun.2007.07.022
Baran, David A. ; Zucker, Mark J. ; Arroyo, Luis H. ; Alwarshetty, Mamata M. ; Ramirez, Maria R. ; Prendergast, Thomas W. ; Goldstein, Daniel J. ; Camacho, Margarita ; Gass, Alan L. ; Carr, Candace ; Cohen, Marc. / Randomized Trial of Tacrolimus Monotherapy : Tacrolimus In Combination, Tacrolimus Alone Compared (The TICTAC Trial). In: Journal of Heart and Lung Transplantation. 2007 ; Vol. 26, No. 10. pp. 992-997.
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