UK multicentre study to assess the safety and tolerability of Neoral in stable renal transplant patients

  • R. H. Moore
  • The UK Neoral Study Group
Conference paper

Abstract

The safety and tolerability of transferring maintained renal transplant patients from Sandimmun to Neoral is being assessed in a multicentre, open-label, single-arm study. A total of 250 patients has been enrolled and results are available from 75 patients up to 12 months post-transfer. A slight trend to higher mean cyclosporin trough levels was seen in this cohort, but trough levels were unchanged in the sub-group receiving ≥1 dose changes. The mean dose fell by 13%. Creatinine levels showed a slight overall upward trend. Blood pressure and uric acid were un-changed and adverse events were typical of those seen with Sandimmun. Neoral was well-tolerated. Data from the full cohort of 250 patients up to 3 months post-transfer support these findings. These results indicate that transfer from Sandimmun to Neoral is safe and well-tolerated and provides appropriate immunosuppression at a lower average dose than Sandimmun. The Neoral dose should be adjusted promptly, as required, to maintain the target trough level.

Key words

Cyclosporin Neoral Immunosuppression 

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References

  1. 1.
    Kovarik JM, Mueller EA, Bree JB van, et al (1994) Reduced inter-and intraindividual variability in cyclosporin pharmacokinetics from a microemulsion formulation. J Pharm Sci 83: 444–446PubMedCrossRefGoogle Scholar
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    Kovarik JM, Mueller EA, Bree JB van, et al (1994) Cyclosporine pharmacokinetics and variability from a microemulsion formulation—a multicenter investigation in kidney transplant patients. Transplantation 58: 658–663PubMedGoogle Scholar
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    Opelz G, for the Collaborative Transplant Study (1992) Collaborative transplant Study–10-year report. Transplant Proc 24: 2342–2355Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1996

Authors and Affiliations

  • R. H. Moore
    • 1
  • The UK Neoral Study Group
  1. 1.Cardiff Royal InfirmaryCardiffUK

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