Enteric-Coated Mycophenolate Sodium and Gastrointestinal Prophylaxis in Renal Transplant Patients

摘要

Background : The purpose of this study was to evaluate the discontinuation or reduction of gastrointestinal (GI) co-medication use and subjects' subsequent GI symptoms and psychological well-being after conversion from mycophenolate sodium (MMF) to enteric-coated mycophenolate sodium (EC-MPS). Study Design : Prospective, single-center, open label, longitudinal study. Settings and Participants : 54 renal transplant subjects who were successfully converted from MMF to EC-MPS previously due to GI symptoms. Intervention : Subjects were asked to reduce or discontinue their GI co-medication in a programmed fashion over a three month period. Subjects were subsequently followed for one year. Outcomes : Patient reported use of GI medications, symptoms, complaints, and overall quality of life. Measurements : Assessments were performed using validated patient-reported outcome instruments. Cost savings was also measured. Results : Successful discontinuation or reduction of GI co-medication was achieved in 78% patients after 30 days and maintained through day 90. No significant changes in GI symptom assessments were observed from baseline to day 30 or 90 despite discontinuation or reduction in GI co-medication. Twelve month follow up demonstrated sustained improvement in 91% of these patients. Annual cost savings per patient after reduction or discontinuation of GI medication were estimated to be $925-$1850 for H-2 blockers and $1861-$3722 for proton-pump inhibitors. Limitations : Results were based on a single center, open label experience and relied on patient reported data. Conclusions : This study supports successful long-term minimization of GI co-medications in maintenance renal transplant patients after conversion to EC-MPS. Data suggest that after conversion to EC-MPS renal transplant patients can successfully reduce or discontinue GI co-medication while maintaining their health-related quality of life and overall well-being.