Early experience with enteric-coated mycophenolate sodium in de novo kidney transplant recipients

Introduction We sought to evaluate the efficacy of enteric-coated mycophenolate sodium (EC-MPS) and the gastrointestinal (GI) adverse events in de novo kidney transplant recipients. Methods This noncontrolled, retrospective review includes 22 de novo kidney transplant recipients. All patients received a standard course of basiliximab and were maintained on triple-drug therapy with EC-MPS, cyclosporine microemulsion (CsA), and prednisolone. The follow-up lasted 7.9 ± 1.2 months. The incidence of GI adverse effects were compared with those of historical mycophenolate mofetil (MMF) studies. Results The serum creatinine was maintained within 1.4 ± 0.7 mg/dL. The 2-hour CsA postdose level was 1080 ± 327 ng/mL initially and gradually tapered to 851 ± 435 ng/mL. The daily EC-MPS dose was 1404 ± 180 mg initially and gradually tapered to 1098 ± 288 mg. The GI adverse effects at the daily dose of EC-MPS 1422 ± 126 mg included dyspepsia 27%, acid regurgitation 18.2%, epigastralgia 9%, nausea 9%, vomiting 4.5%, and poor appetite 4.5%. In comparison those from historical MMF 2 g/d studies included dyspepsia 3.1% to 40%, epigastralgia 10%, nausea 3.7% to 34%, and vomiting 0.6% to 10.7%. Conclusion Immunosuppression with CsA, EC-MPS, and steroids maintains stable graft functions. Minimal dose reduction of EC-MPS decreases GI adverse events but without significance. EC-MPC and MMF have respective GI side effects; they can be used alternatively in patients with individual GI intolerance.