Comparison of Neoral and Sandimmune cyclosporine for induction of immunosuppression after heart transplantation.
OBJECTIVE
To compare the efficacies of Neoral cyclosporine (N-CSA [Sandoz]) and Sandimmune cyclosporine (S-CSA [Sandoz]) in induction of immunosuppression immediately after heart transplantation.


METHODS
A prospective and a retrospective cohort.


METHODS
Patients who underwent heart transplant operations at the Montreal Heart Institute, Montreal, Quebec.


METHODS
To evaluate the results of both formulations of cyclosporine (CSA), a cohort of 20 consecutive patients who underwent heart transplant operations between 1994 and 1995, and who were administered N-CSA, azathioprine, prednisone and intravenous CSA (10 patients) or rabbit antithymocyte globulin (RATG) (10 patients) were compared with 21 patients who underwent heart transplant operations between 1993 and 1994, and were treated with RATG, S-CSA, azathioprine and prednisone. Preoperative patient characteristics were similar in all groups.


RESULTS
There were no significant differences in daily CSA doses after the fourth day following transplantation. Higher trough levels of CSA were observed during the first four days, from days 12 to 14 and one month after transplantation in the two groups that were administered N-CSA. Serum levels of creatinine were significantly higher three to five days after transplantation in both groups who received N-CSA. Creatinine levels were also higher between days 13 and 14 in patients who received N-CSA and intravenous CSA. Oral administration of N-CSA was stopped temporarily in two patients (20%) who received intravenous CSA because of a sudden decrease in urine output and rise in serum creatinine. Three months after transplantation actuarial freedom rate from acute rejection averaged 33 +/- 10% in the S-CSA group, 10 +/- 9% in patients treated with N-CSA and intravenous CSA and 24 +/- 15% in patients treated with N-CSA and RATG (P = 0.25). The risk (hazard) of early rejection was higher in the group that received intravenous CSA and N-CSA.


CONCLUSIONS
While similar averaged doses of N- and S-CSA were administered early after transplantation, the use of N-CSA resulted in higher blood levels of CSA. N-CSA appears to be well absorbed early after cardiac transplantation, but renal toxicity remains a significant concern.
Carrier
M
M
Department of Surgery, Montreal Heart Institute, Quebec. carrier@icm.umontreal.ca
White
M
M
Pellerin
M
M
Pelletier
G B
GB
Pelletier
L C
LC
D000284:Administration, Oral; D015331:Cohort Studies; D016572:Cyclosporine / Q000008:administration & dosage*; D016027:Heart Transplantation; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008875:Middle Aged; D011184:Postoperative Period; D011446:Prospective Studies; D012189:Retrospective Studies
D007166:Immunosuppressive Agents; D016572:Cyclosporine