A prospectively planned meta-analysis based on two randomized trials has shown that de novo renal transplant recipients treated with an initially intensified regimen of enteric-coated mycophenolate sodium (EC-MPS) have a lower rate of acute rejection than patients treated with a standard regimen.

“Approximately half of patients treated with ciclosporin and standard mycophenolate doses have exposure below the recommended target dose,” says investigator Klemens Budde. “Patients with low exposure in the first month are known to have an increased risk of rejection.”

The two randomized trials were designed to evaluate the effect of two EC-MPS dosing regimens on drug exposure and adverse events. Participants (n = 441) were randomly assigned within 24 h before transplantation to intensified or standard treatment. The primary efficacy end point was the proportion of patients with treatment failure (biopsy-proven acute rejection [BPAR], graft loss or death) 6 months after transplantation.

Treatment failure rates were similar in the intensified and standard treatment groups (17.4% and 22.4%, respectively). Although the incidence of BPAR was significantly lower and an adequate mycophenolic acid exposure was achieved earlier in the intensified treatment group than in the standard group, these findings did not translate into improvement in graft function or survival. No difference in rates of adverse events was reported.

“An initially intensified mycophenolate treatment regimen may offer the opportunity for a low-cost induction therapy and, in combination with tacrolimus, could offer the opportunity for better treatment of patients at high immunological risk,” says Budde.