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NDT Advance Access published online on July 26, 2005
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfi009
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© The Author [2005]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org
Received March 23, 2005
Accepted June 15, 2005

Original Articles

Questionnaire-based evaluation of gastrointestinal disorders in de novo renal-transplant patients receiving either mycophenolate mofetil or enteric-coated mycophenolate sodium

Nassim Kamar 1*, Loubna Oufroukhi 1, Patrick Faure 2, David Ribes 1, Olivier Cointault 1, Laurence Lavayssiere 1, Marie Béatrice Nogier 1, Laure Esposito 1, Dominique Durand 1, and Lionel Rostaing 1

1 Department of Nephrology, Dialysis and Multiorgan Transplantation, CHU Rangueil, Toulouse, France
2 Department of Gastroenterology, CHU Rangueil, Toulouse, France

* To whom correspondence should be addressed.
Nassim Kamar, E-mail: nassim.kamar{at}free.fr



  Abstract

Background. Gastrointestinal (GI) disorders are one of the main adverse events in patients treated by mycophenolic acid (MPA). The aim of our prospective questionnaire-based study was to assess GI side-effects in de novo renal-transplant patients receiving either mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS).

Methods. Between January 2002 and April 2003, all patients receiving MPA with a functioning allograft at 1 month post-transplantation were enrolled in this study (n = 130). Ninety-three of them received MMF (group I), and 37 patients received EC-MPS (group II). Each month, every patient completed a questionnaire regarding GI disorders.

Results. During the first year post-transplantation, GI disorders occurred in 31 patients from the MMF group (33.3%) and 12 patients from the EC-MPS group (32.4%) (not significant). The incidence of upper GI disorders was also similar in both groups. Diarrhoea was observed in 18 patients (19.3%) from group I, and in five patients from group II (13.5%) (not significant). Its frequency and severity were similar in both groups. Weight loss was observed in three patients receiving MMF. Diarrhoea resolved spontaneously in 10 patients from group I and in all patients from group II. For the other eight patients in group I, the diarrhoea required MMF discontinuation in three patients and dose reduction in five patients.

Conclusions. In conclusion, in this questionnaire-based evaluation, the incidence of GI disorders was similar in patients receiving either MMF or EC-MPS during the first year post-transplantation.

Keywords: diarrhoea; dose modification; enteric-coated mycophenolic sodium; gastrointestinal disorders; mycophenolate mofetil.
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