SAFETY AND TOLERABILITY OF CYCLOSPORINE MICROEMULSION VERSUS CYCLOSPORINE - 2-YEAR DATA IN PRIMARY RENAL-ALLOGRAFT RECIPIENTS - A REPORT OFTHE NEORAL STUDY-GROUP

Background. The new microemulsion formulation of cyclosporine (CsA-ME) is more bioavailable than cyclosporine (CsA) in de novo renal transpl ant patients. Therefore, it was of interest to compare the safety prof ile of each formulation in such patients. Methods. In a multicenter, d ouble-blind, parallel-group study, 101 renal transplant recipients wer e randomized after transplantation to receive either CsA (n=50) or CsA -ME (n=51) capsules twice daily for 2 years. Of these patients, 54 (Cs A, n=26; CsA-ME, n=28) completed 1 year of the study and entered the s econd-year, double-blind extension. Initial dose at the time of transp lantation was 5 mg/kg b.i.d.; doses were titrated to target trough lev els. Results. The mean (+/-SD) doses at the end of 2 years were 4.6+/- 1.8 and 3.8+/-1.1 mg/kg per day for CsA- and CsA-ME-treated patients, respectively. The mean (+/-SD) CsA trough levels at end point were 187 +/-63 and 210+/-95 ng/ml for CsA- and CsA-ME-treated patients, respect ively. At least one adverse event was reported by 25/26 (96%) of CsA- and 27/28 (96%) of CsA-ME-treated patients. No patient discontinued th e study because of adverse events. No deaths occurred during the study . Renal function, as measured by serum creatinine levels, and blood pr essure were comparable over time in both treatment groups. Conclusions . There was no significant difference in safety and tolerability betwe en CsA- and CsA-ME-treated kidney recipients for 2 years after transpl antation.