Neoral is as effective as tacrolimus in preventing acute rejection in liver transplant patients whilst also being better tolerated according to the 6 month analysis of the LIS2T study presented at the annual International Liver Transplant Society (ILTS) meeting in Barcelona. The study is the first ever multi-centre head-to-head comparison of the efficacy and tolerability of Neoral versus tacrolimus, where Neoral was monitored by C2 blood levels. Previous studies have compared Neoral and tacrolimus based on trough monitoring (C0), however the benefits of Neoral C2 monitoring have since been recognised.

The analysis of the randomised, multi-centre study assessed 499 patients up until six months following their transplant and compared the efficacy and tolerability of Neoral using C2 monitoring versus tacrolimus, in combination with steroids or steroids and azathioprine.

The results showed that the rates of acute liver rejection for Neoral and tacrolimus were similar, as were the incidences of graft loss and death. However, the study found that significantly more patients treated with tacrolimus suffered from diabetes and diarrhoea following their transplant. Specifically, the results showed that:
· Significantly more patients treated with tacrolimus suffered from new-onset diabetes following transplantation compared to patients treated with Neoral (14 per cent versus 7 per cent respectively, p<0.05)
· Significantly more patients treated with tacrolimus suffered from diarrhoea compared to patients treated with Neoral (28 per cent versus 14 per cent respectively, p<0.001)
· There were no significant differences in rates of acute graft rejection (29 per cent in the Neoral group versus 25 per cent in the tacrolimus group).
· There were no significant differences in the incidence of graft loss or death (11 per cent in patients receiving Neoral versus 12 per cent in patients receiving tacrolimus).

Professor Federico Villamil, Medical Director of the Liver Unit at Favaloro Foundation and Professor of Medicine at Favaloro University (Buenos Aires, Argentina) who presented the results commented: "The important result to note is that Neoral and tacrolimus have comparable efficacy and that there is a difference in tolerability - patients receiving Neoral experienced significantly less diabetes and diarrhoea compared to those receiving tacrolimus. Diabetes increases the patient's risk of organ failure, the long term risk of cardiovascular disease and finally the risk of death. Minimising the risk of diabetes in transplant patients is a key challenge facing physicians today."

A total of 499 patients were recruited into the study from 17 countries. Patients will be followed up until one year after transplantation. These results follow an independent analysis presented earlier this month at the American Transplant Congress in Washington which showed that the long-term chances of survival of a transplant kidney from a living donor are significantly greater with immunosuppressive therapy based on Neoral than with therapy based on tacrolimus.

Neoral is a cornerstone of immunosuppressive therapy for the majority of transplant patients, with one of the longest records of proven clinical experience. Neoral C2 monitoring involves making Neoral dose adjustments based on the measurement of the concentration of cyclosporine in a patient's blood two hours (C2) after the dose. This allows for more precise dosing of Neoral in individual patients. Patient management by Neoral C2 has been demonstrated to improve the outcome of transplantation with Neoral when compared to the traditional C0 monitoring, including reducing significantly the incidence of moderate and severe rejection episodes in liver transplantation.