BACKGROUND: Chronic use of corticosteroids (CS) following transplantation is associated with significant long-term morbidities. Minimizing exposure to CS to improve long-term outcomes, without compromising allograft function, remains an important goal in transplantation. OBJECTIVES: This single-center, prospective, randomized, open-label study was designed to evaluate the efficacy of Thymoglobulin as part of a CS-sparing regimen in cardiac transplantation. METHODS:Thirty-two low-risk cardiac transplant patients were randomized in a 1:1 ratio to receive either a Thymoglobulin-based CS-avoidance regimen (CS-avoidance group; n = 16) or a long-term CS-based regimen with no antibody induction (control group; n = 16). Pulse CS therapy was used for the treatment of acute cellular rejection in both groups. RESULTS: Baseline characteristics were similar between groups. At one yr, there was no significant difference in the mean incidence of acute cellular rejection (>or=3A) episodes between the CS-avoidance and control groups, 0.81+/-1.05 and 1.07+/-1.03, respectively. Importantly, the CS-avoidance patients had significant improvement in muscle strength and less bone loss compared with the control patients during the first six months post-transplant. CONCLUSIONS: CS-avoidance regimen with Thymoglobulin induction appeared to be safe and effective in cardiac transplantation. Further studies are required to demonstrate the long-term safety and benefits of such a regimen.
RCT Entities:
BACKGROUND: Chronic use of corticosteroids (CS) following transplantation is associated with significant long-term morbidities. Minimizing exposure to CS to improve long-term outcomes, without compromising allograft function, remains an important goal in transplantation. OBJECTIVES: This single-center, prospective, randomized, open-label study was designed to evaluate the efficacy of Thymoglobulin as part of a CS-sparing regimen in cardiac transplantation. METHODS: Thirty-two low-risk cardiac transplant patients were randomized in a 1:1 ratio to receive either a Thymoglobulin-based CS-avoidance regimen (CS-avoidance group; n = 16) or a long-term CS-based regimen with no antibody induction (control group; n = 16). Pulse CS therapy was used for the treatment of acute cellular rejection in both groups. RESULTS: Baseline characteristics were similar between groups. At one yr, there was no significant difference in the mean incidence of acute cellular rejection (>or=3A) episodes between the CS-avoidance and control groups, 0.81+/-1.05 and 1.07+/-1.03, respectively. Importantly, the CS-avoidance patients had significant improvement in muscle strength and less bone loss compared with the control patients during the first six months post-transplant. CONCLUSIONS: CS-avoidance regimen with Thymoglobulin induction appeared to be safe and effective in cardiac transplantation. Further studies are required to demonstrate the long-term safety and benefits of such a regimen.
Authors: Tajinder P Singh; Carey Faber; Elizabeth D Blume; Sarah Worley; Christopher S Almond; Leslie B Smoot; Shay Dillis; Colleen Nasman; Gerard J Boyle Journal: J Heart Lung Transplant Date: 2010-01-12 Impact factor: 10.247
Authors: Andreas Zuckermann; Uwe Schulz; Tobias Deuse; Arjang Ruhpawar; Jan D Schmitto; Andres Beiras-Fernandez; Stephan Hirt; Martin Schweiger; Laurenz Kopp-Fernandes; Markus J Barten Journal: Transpl Int Date: 2014-11-11 Impact factor: 3.782
Authors: Markus J Barten; Uwe Schulz; Andres Beiras-Fernandez; Michael Berchtold-Herz; Udo Boeken; Jens Garbade; Stephan Hirt; Manfred Richter; Arjang Ruhpawar; Jan Dieter Schmitto; Felix Schönrath; Rene Schramm; Martin Schweiger; Markus Wilhelm; Andreas Zuckermann Journal: Transplant Direct Date: 2016-05-20