Mycophenolate mofetil versus enteric-coated mycophenolate sodium after simultaneous pancreas-kidney transplantation.
BACKGROUND
Adverse gastrointestinal events are frequent after mycophenolate use. The objectives of the present study were to report the incidence of acute noninfectious diarrhea, to determine the risk factors, and to compare the severity of reactions between mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) after simultaneous pancreas kidney transplantation (SPKT).


METHODS
We included 165 SPKT patients from December 2000 to May 2007. Uni- and multivariate analyses were performed, using acute noninfectious diarrhea as the dependent variable. P < .05 was considered significant.


RESULTS
Mean age and duration of dialysis and of diabetes were 34.9 +/- 8.2 years, 27.3 +/- 18.3 months, and 21.9 +/- 16.2 years, respectively. Sixty-three percent used MMF, 36.4% used EC-MPS, and 0.6% used azathioprine. Multivariate analysis showed that the duration of diabetes (P = .049, confidence interval [CI] 1.0- 1.13) and MMF use (P = .013, 95% CI 0.2-0.82) were the main determinants of acute diarrhea after SPKT. MMF dose reduction (79.2% vs 62.3%, P = .024) and severity of diarrhea associated with orthostatic hypotension were more pronounced among MMF than EC-MPS patients (42.4% vs 15.1%, P = .001). There was no difference between MMF and EC-MPS after dose reduction in relation to the occurrence of acute kidney rejection (30.8% vs 26.7%, P = .53).


CONCLUSIONS
Acute noninfectious diarrhea after SPKT was related to the duration of diabetes and to prescription of MMF. Preferential use of EC-MPS was associated with a lower necessity of dose reduction and less severe episodes of acute diarrhea compared with MMF, although dose reduction was equally associated with acute episodes of kidney rejection.
Rangel
E B
EB
Nephrology Division, Universidade Federal de São Paulo, Rua Botucatu, 740 VilaClementino, 04023-900 São Paulo, Brazil. erikabr@uol.com.br
Melaragno
C S
CS
Sá
J R
JR
Gonzalez
A M
AM
Linhares
M M
MM
Salzedas
A
A
Medina-Pestana
J O
JO
D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000627:therapeutic use; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery; D003928:Diabetic Nephropathies / Q000601:surgery; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016035:Pancreas Transplantation / Q000276:immunology*; D010530:Peritoneal Dialysis / Q000706:statistics & numerical data; D011182:Postoperative Care; D006435:Renal Dialysis / Q000706:statistics & numerical data; D012189:Retrospective Studies; D013608:Tablets, Enteric-Coated
D000925:Anticoagulants; D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D006493:Heparin; D009173:Mycophenolic Acid