Safety and tolerability of cyclosporine microemulsion versus cyclosporine: Two-year data in primary renal allograft recipients: A report of the Neoral Study Group

Mark D. Pescovitz, Gary Barone, M. Gerry Choc, Donald E. Hricik, Dar Shong Hwang, Judy Hyun Ju Jin, Jon B. Klein, Christopher L. Marsh, David I. Min, Raymond Pollak, Timothy L. Pruett, James B. Stinson, John S. Thompson, Eva Vasquez, Thomas Waid, Duane G. Wombolt, Robert L. Wong

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24 Scopus citations

Abstract

Background. The new microemulsion formulation of cyclosporine (CsA-ME) is more bioavailable than cyclosporine (CsA) in de novo renal transplant patients. Therefore, it was of interest to compare the safety profile of each formulation in such patients. Methods. In a multicenter, double-blind, parallel-group study, 101 renal transplant recipients were randomized after transplantation to receive either CsA (n=50) or CsA-ME (n=51) capsules twice daily for 2 years. Of these patients, 54 (CsA, n=26; CsA-ME, n=28) completed 1 year of the study and entered the second-year, double-blind extension. Initial dose at the time of transplantation was 5 mg/kg b.i.d.; doses were titrated to target trough levels. 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, respectively. 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 the study because of adverse events. No deaths occurred during the study. Renal function, as measured by serum creatinine levels, and blood pressure were comparable over time in both treatment groups. Conclusions. There was no significant difference in safety and tolerability between CsA- and CsA-ME- treated kidney recipients for 2 years after transplantation.

Original languageEnglish (US)
Pages (from-to)778-780
Number of pages3
JournalTransplantation
Volume63
Issue number5
DOIs
StatePublished - Mar 15 1997

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