Safety and tolerability of a new oral formulation of cyclosporin A, Sandimmun Neoral, in renal transplant patients.

The current therapy with Sandimmun has been improved by the development of a new oral formulation of its active ingredient, Cyclosporine A and which is called Sandimmun Neoral. This new galenical formulation is based on the microemulsion technology and offers consistent oral absorption and pharmacokinetic predictability. In two studies of a 12 weeks duration each and including 466 stable renal transplant patients and 86 new renal transplant patients it was shown that Sandimmun Neoral is as well tolerated and as safe as Sandimmun. Stable renal transplant patients currently receiving Sandimmun can safely be switched to Sandimmun Neoral on a 1:1 dose level basis. However, as a result of the more consistent absorption of Sandimmun Neoral, poor absorbers with Sandimmun will become normal absorbers and than will need a considerable dose reduction to reach the same Cyclosporine A exposure. In new renal transplant patients kidney function seems to improve better and faster when Sandimmun Neoral is given as shown by creatinine and creatinine clearance values. In the Sandimmun Neoral group less patients experienced a rejection episode and time free of rejection was longer, this may reflect a better maintenance of immunosuppression. In addition, considerably lower doses (16% on average) are required for Sandimmun Neoral to achieve comparable cyclosporine A blood trough levels and these patients are also sooner stabilized in terms of Cyclosporine a therapy.

RCT Entities:   Population Interventions Outcomes