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

Research output: Contribution to journalArticle

20 Citations (Scopus)

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 Of the 119 patients who were withdrawn, 73 did so because of an adverse event.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 - 1992

Fingerprint

Kidney Transplantation
Muromonab-CD3
Placebos
Antibodies
Incidence
Cyclosporine
enisoprost
Synthetic Prostaglandins E
Hospitalization
Ficus
Kidney
Cold Ischemia
Antilymphocyte Serum
Living Donors
Dyspepsia
Immunosuppressive Agents
Prostaglandins E
Body Temperature
Prostaglandins
Diarrhea

ASJC Scopus subject areas

  • Transplantation

Cite this

Adams, M. B., Alexander, W. J., Alijani, M. R., Anthone, R., Bennett, W. M., Bretan, P. N., ... Wood, D. (1992). Enisoprost in renal transplantation. Transplantation, 53(2), 338-345.

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

In: Transplantation, Vol. 53, No. 2, 1992, p. 338-345.

Research output: Contribution to journalArticle

Adams, MB, Alexander, WJ, Alijani, MR, Anthone, R, Bennett, WM, Bretan, PN, Burrows, L, Carson, RW, Cheung, A, Perkins, J, Choen, JL, Dandavino, R, Dyck, RF, Gaber, AO, Greenstein, SM, Haisch, CE, Hardy, MA, Helfrich, GB, Jaffers, GJ, Jindal, SL, Keown, PA, Landsberg, DN, Light, JA, Madras, PN, Mangel, R, Neylan, JF, Nohr, CW, Paul, LC, Peters, TJ, Rocher, L, Rosenthal, JT, Roth, D, Russell, D, Smith, AY, Steinmuller, D, Tomlanovich, S, Stempel, C, Velosa, JA, Zukowski, CF, Boots, S, Cole, M, Dean, R, Hyndman, V, Metcalf, L, Moran, M, O’bryan-Tear, G, West, M & Wood, D 1992, 'Enisoprost in renal transplantation', Transplantation, vol. 53, no. 2, pp. 338-345.
Adams MB, Alexander WJ, Alijani MR, Anthone R, Bennett WM, Bretan PN et al. Enisoprost in renal transplantation. Transplantation. 1992;53(2):338-345.
Adams, Mark B. ; Alexander, Wesley J. ; Alijani, Mohammed R. ; Anthone, Roland ; Bennett, William M. ; Bretan, Peter N. ; Burrows, Lewis ; Carson, Richard W. ; Cheung, Alan ; Perkins, Jame ; Choen, J. Louis ; Dandavino, Raymond ; Dyck, Roland F. ; Gaber, Ahmed Osama ; Greenstein, Stuart M. ; Haisch, Carl E. ; Hardy, Mark A. ; Helfrich, G. Baird ; Jaffers, Gregory J. ; Jindal, S. L. ; Keown, Paul A. ; Landsberg, David N. ; Light, Jimmy A. ; Madras, Peter N. ; Mangel, Roman ; Neylan, John F. ; Nohr, Carl W. ; Paul, Leehdert C. ; Peters, Thomas J. ; Rocher, Leslie ; Rosenthal, J. Thomas ; Roth, David ; Russell, David ; Smith, Anthony Y. ; Steinmuller, Donald ; Tomlanovich, Stephen ; Stempel, Carlos ; Velosa, J. A. ; Zukowski, Charles F. ; Boots, Suzanne ; Cole, Michael ; Dean, Richard ; Hyndman, Valerie ; Metcalf, Linda ; Moran, Mark ; O’bryan-Tear, Gillies ; West, Marilyn ; Wood, Don. / Enisoprost in renal transplantation. In: Transplantation. 1992 ; Vol. 53, No. 2. pp. 338-345.
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title = "Enisoprost in renal transplantation",
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.",
author = "Adams, {Mark B.} and Alexander, {Wesley J.} and Alijani, {Mohammed R.} and Roland Anthone and Bennett, {William M.} and Bretan, {Peter N.} and Lewis Burrows and Carson, {Richard W.} and Alan Cheung and Jame Perkins and Choen, {J. Louis} and Raymond Dandavino and Dyck, {Roland F.} and Gaber, {Ahmed Osama} and Greenstein, {Stuart M.} and Haisch, {Carl E.} and Hardy, {Mark A.} and Helfrich, {G. Baird} and Jaffers, {Gregory J.} and Jindal, {S. L.} and Keown, {Paul A.} and Landsberg, {David N.} and Light, {Jimmy A.} and Madras, {Peter N.} and Roman Mangel and Neylan, {John F.} and Nohr, {Carl W.} and Paul, {Leehdert C.} and Peters, {Thomas J.} and Leslie Rocher and Rosenthal, {J. Thomas} and David Roth and David Russell and Smith, {Anthony Y.} and Donald Steinmuller and Stephen Tomlanovich and Carlos Stempel and Velosa, {J. A.} and Zukowski, {Charles F.} and Suzanne Boots and Michael Cole and Richard Dean and Valerie Hyndman and Linda Metcalf and Mark Moran and Gillies O’bryan-Tear and Marilyn West and Don Wood",
year = "1992",
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TY - JOUR

T1 - Enisoprost in renal transplantation

AU - Adams, Mark B.

AU - Alexander, Wesley J.

AU - Alijani, Mohammed R.

AU - Anthone, Roland

AU - Bennett, William M.

AU - Bretan, Peter N.

AU - Burrows, Lewis

AU - Carson, Richard W.

AU - Cheung, Alan

AU - Perkins, Jame

AU - Choen, J. Louis

AU - Dandavino, Raymond

AU - Dyck, Roland F.

AU - Gaber, Ahmed Osama

AU - Greenstein, Stuart M.

AU - Haisch, Carl E.

AU - Hardy, Mark A.

AU - Helfrich, G. Baird

AU - Jaffers, Gregory J.

AU - Jindal, S. L.

AU - Keown, Paul A.

AU - Landsberg, David N.

AU - Light, Jimmy A.

AU - Madras, Peter N.

AU - Mangel, Roman

AU - Neylan, John F.

AU - Nohr, Carl W.

AU - Paul, Leehdert C.

AU - Peters, Thomas J.

AU - Rocher, Leslie

AU - Rosenthal, J. Thomas

AU - Roth, David

AU - Russell, David

AU - Smith, Anthony Y.

AU - Steinmuller, Donald

AU - Tomlanovich, Stephen

AU - Stempel, Carlos

AU - Velosa, J. A.

AU - Zukowski, Charles F.

AU - Boots, Suzanne

AU - Cole, Michael

AU - Dean, Richard

AU - Hyndman, Valerie

AU - Metcalf, Linda

AU - Moran, Mark

AU - O’bryan-Tear, Gillies

AU - West, Marilyn

AU - Wood, Don

PY - 1992

Y1 - 1992

N2 - 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.

AB - 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.

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