Thymoglobulin induction and steroid avoidance in cardiac transplantation: results of a prospective, randomized, controlled study.
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.


OBJECTIVE
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.
Yamani
Mohamad H
MH
Department of Cardiovascular Medicine, Kaufman Center for Heart Failure, Cleveland Clinic Foundation, Cleveland, OH 44195, USA. yamanim@ccf.org
Taylor
David O
DO
Czerr
Jennifer
J
Haire
Christinna
C
Kring
Richard
R
Zhou
Lingmei
L
Hobbs
Robert
R
Smedira
Nicholas
N
Starling
Randall C
RC
D000328:Adult; D019072:Antibiotic Prophylaxis; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000961:Antilymphocyte Serum; D015519:Bone Density / Q000187:drug effects; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006084:Graft Rejection / Q000188:drug therapy; D016027:Heart Transplantation / Q000276:immunology / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D020551:Pulse Therapy, Drug; D016559:Tacrolimus / Q000008:administration & dosage; D014184:Transplantation, Homologous
D000911:Antibodies, Monoclonal; D000961:Antilymphocyte Serum; D005938:Glucocorticoids; C512542:thymoglobulin; D011241:Prednisone; D016559:Tacrolimus