The safety and tolerability of cyclosporine emulsion versus cyclosporine in a randomized, double-blind comparison in primary renal allograft recipients. The Neoral Study Group.
A 12-week, randomized, double-blind, multicenter pharmacokinetics study was conducted to compare the clinical safety and tolerability of cyclosporine capsules and oral solution for microemulsion and cyclosporine in 101 primary renal transplant recipients Cyclosporine emulsion has more complete absorption and improved bioavailability compared with cyclosporine, and dosing of both cyclosporine formulations was adjusted to achieve comparable whole-blood trough levels. Mean serum creatinine values were higher in the cyclosporine emulsion group at baseline, 8, and 12 weeks (P<0.05). The incidence of acute rejection was similar in both treatment groups although fewer patients required monoclonal antibody therapy in the cyclosporine group (31% vs. 82%, respectively). Despite the increased bioavailability of cyclosporine emulsion, no significant differences in the incidence of adverse events were observed; the safety, tolerability, and efficacy of cyclosporine emulsion and cyclosporine were comparable.
Barone
G
G
The Department of Vascular and Tranplant Surgery, University of Arkansas, Little Rock, USA.
Bunke
C M
CM
Choc
M G
MG
Hricik
D E
DE
Jin
J H
JH
Klein
J B
JB
Marsh
C L
CL
Min
D I
DI
Pescovitz
M D
MD
Pollak
R
R
Pruett
T L
TL
Stinson
J B
JB
Thompson
J S
JS
Vasquez
E
E
Waid
T
T
Wombolt
D G
DG
Wong
R L
RL
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001682:Biological Availability; D002214:Capsules; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D004311:Double-Blind Method; D004655:Emulsions; D005260:Female; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged
D002214:Capsules; D004655:Emulsions; D016572:Cyclosporine