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Achieving Optimal Immunosuppresion

When cyclosporin A was introduced as Sandimmun 15 years ago, it provided a novel basis for immunosuppression. However, experience in the clinic showed that there were marked pharwacokinetic variations, which led to development of the new tormulation, Neoral . Interesting data on Neoral were presented at the meeting.


Evidence continues to emerge showing that the wore predictable pharmacokinetics and improved absorption of Neoral make it a clinically and economically superior immunosuppressive agent to Sandimmun in all terms ut adult and paediatric organ transpiantatiuri (Figure 1). Data trom the Neoral Global Database - a pooled analysis of 76 randumised adult maintenance kidney transplantation studies evaluating the etficacy and/or satety ot Neural - contirm that transterring trum Sandimmun to Neural is sate with no increase in side-eftects. Analysis ot the database shows that Neoral increases exposure to cyclospurin A, otten allowing dosage reduction, and is particularly ettective in individuals previously observed to be poor absorbers ut Sandimmun such as diabetics, blacks and the elderly.

" Neoral is a clinically and superior immunosuppressive agent to Sandimmun "

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Liver transplantation

Positive tindings emerging trum the 1 2-month results ut the MILTON study, comparing Sandimmun to Neoral in de nuvo liver transplant patients, were presented by Dr Max-Gerd Otto from Germany. In this double-blind, multicentre study, SOD orthutopic liver transplant recipients were randumised to receive Neoral or Sandimmun. Despite all patients receiving post-operative intravenous cyclospurin A, which is now known to be a sub-optimal procedure, Neoral was found to signiticantly reduce fewer infections and recurrence of hepatitis was halved. Pharmacoeconomic analysis of the preliminary four-month results from the same study, presented by Dr Pascall Peeters, showed that immunusuppression of liver transplant patients using Neural dramatically reduces the need fur additional anti-rejection and ariti-infection therapy compared with Sandimmun. Total duration of hospital stay post-transplant was reduced with Neural from 42 to 37 days and there was an   overall reduction in direct medical charges of around 10 to 15 per cent.

Heart transplantation

The findings of a double-blind study of Neural versus Sandimmun in de cove cardiac transplant recipients presented by Howard Fisen (Philadelphia), also showed promising results with Neural. The preliminary six-month findings of this two-year randumised, multicentre study show a reduction in the incidence and severity of acute rejection episodes. A significantly reduced incidence of acute rejection episodes requiring antibody therapy was also seen in the Neural-treated arm (5.9 per cent vs 14,1 per cent; p=O.O1 0). No increase in side-effects was seen with Neural. Ongoing studies are elucidating optimal use of Neural, and other immunosuppressive agents, in different organs. The challenge for the future will be to develop algorithms tailored to the needs of the individual patient.