THE SAFETY AND TOLERABILITY OF CYCLOSPORINE EMULSION VERSUS CYCLOSPORINE IN A RANDOMIZED, DOUBLE-BLIND COMPARISON IN PRIMARY RENAL-ALLOGRAFT RECIPIENTS

A 12-week, randomized, double-blind, multicenter pharmacokinetic study was conducted to compare the clinical safety and tolerability of cycl osporine 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 c yclosporine, and dosing of both cyclosporine formulations was adjusted to achieve comparable whole-blood trough levels, Mean serum creatinin e 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 a ntibody therapy in the cyclosporine emulsion group than in the cyclosp orine group (31% vs, 82%, respectively). Despite the increased bioavai lability of cyclosporine emulsion, no significant differences in the i ncidence of adverse events were observed; the safety, tolerability, an d efficacy of cyclosporine emulsion and cyclosporine were comparable.