Is intravenous glucocorticoid therapy better than an oral regimen for asymptomatic cardiac rejection? A randomized trial.
OBJECTIVE
This study assessed whether treatment with oral prednisone (bolus plus tapered doses) is comparable to intravenous methylprednisolone sodium succinate (Solu-Medrol) therapy in patients with asymptomatic moderate cardiac allograft rejection episodes without hemodynamic compromise.


BACKGROUND
Intravenous Solu-Medrol therapy is frequently administered for moderate rejection episodes after heart transplantation but has not previously been compared with an oral prednisone therapy for asymptomatic cardiac rejection in a randomized trial. Compared with oral prednisone therapy, the administration of intravenous Solu-Medrol is more costly and resource intensive, and it can require loss of work time for patients and the family members who accompany them to treatment.


METHODS
Forty-one heart transplant patients with 43 episodes of asymptomatic moderate cardiac rejection were randomized to receive 3 days of 1,000 mg of intravenous Solu-Medrol (20 episodes) or prednisone as a bolus dose of 100 mg orally for 3 days, tapering to the previous maintenance dosage over 14 days (23 episodes). Follow-up endomyocardial biopsies were performed at 2 and 4 weeks. Infectious complications were monitored and the cost of the two forms of therapy was assessed.


RESULTS
Resolution of moderate rejection occurred within  4 weeks in 19 (95%) of 20 patients treated with intravenous steroids and in 21 (91%) of 23 patients treated with oral prednisone. No significant difference in infectious complications occurred between the two groups in the ensuing 3 months after therapy. The cost of the oral prednisone therapy was $6.30 compared with the cost of $180 to $966 for administration of intravenous Solu-Medrol.


CONCLUSIONS
Oral prednisone (bolus plus tapered doses) appears to be as effective and to have similar infectious complication rates as intravenous Solu-Medrol for the treatment of asymptomatic cardiac rejection. The convenience and lower cost of oral prednisone therapy may warrant its routine use for this type of cardiac rejection.
Kobashigawa
J A
JA
Division of Cardiology, UCLA Schoof of Medicine, University of California.
Stevenson
L W
LW
Moriguchi
J D
JD
Kawata
N
N
Brownfield
E
E
Drinkwater
D C
DC
Laks
H
H
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000465:Algorithms; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy*; D017048:Health Care Costs; D016027:Heart Transplantation; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008776:Methylprednisolone Hemisuccinate / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome
D008776:Methylprednisolone Hemisuccinate; D011241:Prednisone