CLINICAL AND TRANSLATIONAL RESEARCH Gastrointestinal Quality of Life Improvement of Renal Transplant Recipients Converted From Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium Drugs or Agents: Mycophenolate Mofetil and Enteric-Coated Mycophenolate Sodium Francisco Ortega, 1,10 Ana Sa ´nchez-Fructuoso, 2 Jose ´ María Cruzado, 3 Juan Carlos Go ´mez-Alamillo, 4 Antonio Alarco ´n, 5 LluísPallard´o, 6 Jose ´ María Morales, 7 Juan Oliver, 8 and Guillermo Guinea; 9 on Behalf of MYVIDA Study Group Background. In renal transplant (RT) recipients, treatment with enteric-coated mycophenolate sodium (EC-MPS) improves gastrointestinal (GI) tolerability compared with mycophenolate mofetil (MMF). The impact of conversion from MMF to EC-MPS on patient’s health-related quality of life (HRQoL) using GI-specific instruments has been scarcely evaluated in randomized trials. Methods. The present randomized, multicenter, open-labeled, 12-week study included RT recipients experiencing GI adverse events due to MMF treatment. Patients were randomized to continue with MMF (n=54) or change to EC-MPS (n=59). Patients were converted at equimolar doses, and dose was optimized between weeks 2 and 6 to achieve maximum tolerated dose. Results. Incidence of GI complications (particularly diarrhea) was significantly lower in the EC-MPS group (67.8% vs. 87.0%, P=0.015). The baseline-adjusted mean global scores at 12 weeks in GI quality of life index were significantly higher in the EC-MPS group versus MMF (P=0.014). Results at 12 weeks for all secondary scales indicated better HRQoL in the EC-MPS group compared with the MMF group (Gastrointestinal Symptom Rating Scale, Psychological General Well-Being Index, and overall treatment effect). In the EC-MPS group, a higher percentage of patients were receiving intermediate doses of mycophenolic acid (720 mg/day) at 12 weeks compared with MMF (55.4% vs. 27.4%, P=0.003), whereas no differences were observed for high doses (720 mg/day). Conclusions. In RT patients with GI undesirable effects due to MMF, switching from MMF to EC-MPS may enable an increase in the maximum tolerated dose of mycophenolic acid and reduce GI complications, thus enhancing patients’ GI HRQoL. Keywords: Immunosuppression, Mycophenolate mofetil, Mycophenolate sodium, Kidney transplantation, Gastrointestinal disorders. (Transplantation 2011;92: 426–432) K idney transplantation is the best replacement therapy for patients with end-stage renal disease (1). In the last decade, important advances in the surgical procedures and immunosup- pressive treatments have improved short-term patient survival up to 95% at 1 to 2 years (2). Two mycophenolic acid (MPA) formulations are currently used as part of the maintenance im- munosuppressive regimen. Mycophenolate mofetil (MMF) was the first MPA agent to be approved for the prevention of acute rejection after renal transplantation, in combination with cy- closporine and steroids (3, 4). Enteric-coated mycophenolate sodium (EC-MPS) was subsequently developed to help cir- cumvent the gastrointestinal (GI) side effects associated with This work was supported by Novartis Farmace ´utica, S.A. Guillermo Guinea is an employee of Novartis Farmace ´utica S.A. The other authors declare no conflicts of interest. 1 H U Central de Asturias, Nephrology Department, Oviedo, Spain. 2 H. Clinico San Carlos, Nephrology Department, Madrid, Spain. 3 H Bellvitge, Nephrology Department, Barcelona, Spain. 4 H U Marque ´s de Valdecilla, Kidney Transplant Unit, Santander, Spain. 5 H Son Dureta, Nephrology Department, Mallorca, Spain. 6 H Dr Peset, Nephrology Department, Valencia, Spain. 7 H 12 Octubre, Kidney Transplant Unit, Madrid, Spain. 8 H Universitario A Corun ˜a, Nephrology Department A, Corun ˜a, Spain. 9 Medical Department, Novartis Farmace ´utica S.A., Spain. 10 Address correspondence to: Francisco Ortega MD, PhD., A ´ rea de Gestio ´n Clínica de Nefrología, Urología y Metabolismo O ´ seo, Hospital Universi- tario Central de Asturias, c/Celestino Villamil s/n, Oviedo 33006, Spain. E-mail: fortega@hca.es F.O. contributed substantially to the design, performance, analysis, and re- porting of the work. The other authors contributed substantially to the performance and reporting of this work. Received 10 February 2011. Revision requested 7 March 2011. Accepted 28 April 2011. Copyright © 2011 by Lippincott Williams & Wilkins ISSN 0041-1337/11/9204-426 DOI: 10.1097/TP.0b013e31822527ca 426 | www.transplantjournal.com Transplantation • Volume 92, Number 4, August 27, 2011