Efficacy and safety of enteric-coated mycophenolate sodium in de novo renal transplant recipients: pooled data from three 12-month multicenter, open-label, prospective studies.

BACKGROUND: The myfortic Prospective Multicenter Study (myPROMS) utilizes a core protocol in which renal transplant patients receive enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion. Substudies investigate specific aspects of the immunosuppressive regimen.

METHODS: A pooled analysis of three 12-month myPROMS substudies in de novo renal transplant patients was undertaken. Patients in the US01 and DE01 substudies were randomized to higher or lower cyclosporine C(2) target ranges; patients in FR01 were randomized to early or delayed introduction of cyclosporine. All patients received steroids and interleukin-2 receptor antagonist induction.

RESULTS: In total, 456 patients were included in the pooled analysis. Treatment failure (biopsy-proven acute rejection, graft loss, or death) occurred in 118 patients (25.9%) by month 12, with biopsy-proven acute rejection reported in 101 patients (22.1%). Fourteen patients (3.1%) lost their graft, and six patients died (1.3%). Median calculated creatinine clearance was 62.9 mL/min at month 12 (median serum creatinine, 138 +/- 51 mumol/L). Gastrointestinal (GI) adverse events were reported in 354 patients (77.6%); these were mild or moderate in 323 patients. Within 12 months, 16.2% of patients required EC-MPS dose changes for GI adverse events. GI disorders led to EC-MPS discontinuation in only 10 patients (2.2%). Over the 12-month study, mean EC-MPS dose was 1352 +/- 230 mg/d (94% of recommended dose).

CONCLUSION: Cyclosporine, EC-MPS, and steroids with interleukin-2 antagonist induction offers effective and well-tolerated immunosuppression following renal transplantation. Graft survival was excellent and renal function was stable. High EC-MPS dosing was sustained throughout (>90% recommended dose) and dose modifications due to EC-MPS-related adverse events or infections were infrequent.