Lege Artis Medicinae

[Effect of mycophenolate sodium therapy on quality of life of renal transplant patients]


JULY 20, 2015

Lege Artis Medicinae - 2015;25(06-07)

[Enteric-coated mycophenolate sodium (EC-MPS; Myfortic®, Novartis Pharma AG, Basel, Switzerland) is an enteric-coated formulation delivering MPA. Enteric-coated MPS has been developed with the aim of improving the upper GI tolerability of MPA while providing a therapeutical equivalence. The primary objective of the study was to measure the quality of life of kidney transplant patients, with special attention to gastrointestinal symptoms during mycophenolate sodium therapy. The secondary objective was to measure the mean daily mycophenolate sodium dose during routine therapy. These two parameters can significantly influence long-term graft survival of the patients. The study was a multicentric, non-interventional, 12 weeks, single arm, cohort, observational study, in which 251 adult, kidney transplant patients were enrolled in 4 study centers. As part of the study, the patient completed a questionnaire to assess the gastrointestinal status: the Gastrointestinal Symp­tom Rating Scale (GSRS). The patient’s average age was 51.03 years by the time of the inclusion. 61% of the patients were male and 39% female. Kidney transplant was performed averagely 6.3 years (SD: 4.3 years) prior to the screening visit. At the first visit the average intensity of gastrointestinal side effects was 0.87, at the final visit was 0.28. The change of the average number of gastrointestinal side effects between the first and last visit was examined by Wilcoxon test, and it was significant (p<0.0001). Patients had to complete the GSRS questionnaire aiming at five gastrointestinal symptom groups. In all five symp­tom-groups significant (p<0.0001) improvement was observed between the visits. Our results support that, in renal transplant patients with gastrointestinal undesirable effects due to MMF, using enteric-coated mycophenolate sodium may increase the maximum tolerated dose of MPA and reduce GI disorders.]



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