ImpactU Versión 3.11.2 Última actualización: Interfaz de Usuario: 16/10/2025 Base de Datos: 29/08/2025 Hecho en Colombia
SAFETY ASSESSMENT OF THE CONVERSION FROM MYCOPHENOLATE MOFETIL TO MYCOPHENOLATE SODIUM IN STABLE RENAL TRANSPLANT RECIPIENTS. FULL DOSE TOLERABILITY WITH ENTERIC COATED MYCOPHENOLATE SODIUM
P207 Aims: The inclusion of mycophenolates in immunosuppressive regimes has provided several advantages to the therapeutic armamentarium: mainly reduction in early and late acute rejection episodes, and also better long term graft function. These excellent results are related to MPA exposure and are jeopardized when dose reductions have to be performed due to adverse events. A new product, which has been designed to improve gastrointestinal tolerability, has been recently introduced into the market: enteric-coated mycophenolate sodium (EC-MPS). Methods: A prospective, multicentre, open-label, 6 month trial to assess the safety and tolerability of the conversion from MMF to EC-MPS, in stable renal transplant recipients was performed. A total of 237 stable renal transplant recipients (at least 3 months post transplant) receiving different doses of MMF (total daily dose ≤ 2000 mg) were enrolled, 47/237 adult patients were converted from MMF 1400 ± 150 mg/day to EC-MPS 1440 mg/day (equimolar to MMF 2000 mg/day). These patients were on a reduced dose due to: site standard of practice (36.2%), previous AEs: haematological (6.4%), infectious: (17.0%), and gastrointestinal (total 40.4%; 21.3% of them being diarrhoea). Tolerability to full dose EC-MPS was evaluated in these 47 cases. Patients were 40.4 ± 13.0 years-old (22 Caucasians, 1 African American, 1 Oriental, and 23 Other). There were 28 (59.6%) males and 19 (40.4%) females with a mean post- transplant time of 3.3 ± 3.0 years. Results: After the conversion, the incidence of adverse events (AEs) was 57.4%, with a 29.7 % incidence of gastrointestinal (GI) AEs, including 17 % upper-GI, and 10.6 % diarrhoea. The incidence of haematological AEs was 6.4 % and of infections 29.8%. Safety laboratory variables remained stable throughout the six month trial duration.FigureOnly 7 patients (15 %) required dose reductions due to AEs: diarrhoea (2), abdominal pain (1), leukopenia (2), hyperbilirrubinemia (1), cholecystolithiasis (1). All AEs were rated as mild/moderate. Conclusions: Patients can be safely converted from MMF to EC-MPS. In this subgroup, EC-MPS was administered within a six month trial at higher than equimolar doses of MMF with satisfactory tolerability, as 85% of patients required no dose adjustments.