The safety and tolerability of cyclosporine emulsion versus cyclosporine in a randomized, double-blind comparison in primary renal allograft recipients

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

Research output: Contribution to journalArticlepeer-review

41 Scopus citations

Abstract

A 12-week, randomized, double-blind, multicenter pharmacokinetic 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 emulsion group than 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.

Original languageEnglish (US)
Pages (from-to)968-970
Number of pages3
JournalTransplantation
Volume61
Issue number6
DOIs
StatePublished - Mar 27 1996

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