Enisoprost in renal transplantation

Mark B. Adams, Wesley J. Alexander, Mohammed R. Alijani, Roland Anthone, William M. Bennett, Peter N. Bretan, Lewis Burrows, Richard W. Carson, Alan Cheung, Jame Perkins, J. Louis Choen, Raymond Dandavino, Roland F. Dyck, Ahmed Osama Gaber, Stuart M. Greenstein, Carl E. Haisch, Mark A. Hardy, G. Baird Helfrich, Gregory J. Jaffers, S. L. JindalPaul A. Keown, David N. Landsberg, Jimmy A. Light, Peter N. Madras, Roman Mangel, John F. Neylan, Carl W. Nohr, Leehdert C. Paul, Thomas J. Peters, Leslie Rocher, J. Thomas Rosenthal, David Roth, David Russell, Anthony Y. Smith, Donald Steinmuller, Stephen Tomlanovich, Carlos Stempel, J. A. Velosa, Charles F. Zukowski, Suzanne Boots, Michael Cole, Richard Dean, Valerie Hyndman, Linda Metcalf, Mark Moran, Gillies O’bryan-Tear, Marilyn West, Don Wood

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20 Scopus citations

Abstract

Prostaglandins of the E-series (PGE) mediate a wide variety of physiologic processes and have been shown to have regulatory roles in cell immunity. Previous animal and human trials have shown lower incidence of acute rejection when prostaglandins are administered in conjunction with standard immunosuppressives. This study evaluated the effects of the PGE analogue, enisoprost (EP), in a multicenter (39 centers) prospective, randomized, double-blind trial in 374 patients undergoing renal transplantation. Groups were placebo, enisoprost 50 ng p.o. q.i.d. (EP-50 fig), and enisoprost 100 ng p.o. q.i.d. (EP-100 11%). Patients received cyclosporine, azathi-oprine, corticosteroids, and Minnesota antilymphocyte globulin or OKT3 according to each center's protocol. Prophylactic antibody therapy (MALG or OKT3) was not randomized. Two hundred fifty-five patients completed the 8-week study period. Of the 119 patients who were withdrawn, 73 did so because of an adverse event. Rejection episodes occurred in 98 of 374 patients (26%). There was no statistically significant difference in the incidence of rejection between placebo- and EP-treated patients (P=0.782). There was no significant difference in episodes of cyclosporine nephrotoxicity between placebo- and EP-treatment groups (P=0.883). There was also no difference between incidence of acute tubular necrosis, duration of initial hospitalization, or need for rehospitalization between placebo- and EP-treated groups. Administration of EP was associated with frequent adverse events including elevation of body temperature, dyspepsia, and diarrhea. Antibody-treated patients had a higher percentage of black recipients, higher mean body weight, greater cold ischemic times, fewer living-related donors, and higher panel reactivity. Patients not receiving antibody prophylaxis were better matched immunologically than those receiving either MALG or OKT3. Despite these immunologic differences, there was no significant difference in the incidence of rejection in patients who did or did not receive antibody prophylaxis. Cyclosporine toxicity was more common in MALG-treated patients (P=0.02). Renal function was worse in antibody-treated patients. There was no detectable effect of enisoprost on the incidence of acute rejection, renal function, or hospitalization in a multicenter prospective, randomized, double-blind trial in 374 patients undergoing renal transplantation.

Original languageEnglish (US)
Pages (from-to)338-345
Number of pages8
JournalTransplantation
Volume53
Issue number2
StatePublished - Feb 1992

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ASJC Scopus subject areas

  • Transplantation

Cite this

Adams, M. B., Alexander, W. J., Alijani, M. R., Anthone, R., Bennett, W. M., Bretan, P. N., Burrows, L., Carson, R. W., Cheung, A., Perkins, J., Choen, J. L., Dandavino, R., Dyck, R. F., Gaber, A. O., Greenstein, S. M., Haisch, C. E., Hardy, M. A., Helfrich, G. B., Jaffers, G. J., ... Wood, D. (1992). Enisoprost in renal transplantation. Transplantation, 53(2), 338-345.