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The introduction of Sandimmune (SAND) in the early eighties proved to be a powerful tool in the management of organ transplant recipients. However, due to the pharmacokinetic variability and dependence on bile for absorption, the need arose to find a more predictable formulation of cyclosporine. The microemulsion formulation, Neoral (NEO) has been shown to have less variability and greater bioavailability. NEO has been advocated as the cyclosporine formulation of choice, but administration of NEO to all transplant recipients remains in question. The focus of this study was to compare the safety and tolerability of the two formulations of cyclosporine. Forty-nine articles and abstracts were included in the meta-analysis. The total number of patients in the NEO (n=4024) and SAND (n=3133) groups were recorded, along with the adverse events (AE), rejections (rej), graft losses (gl), and serum creatinine levels associated with each group.
The serum creatinine levels comparing the NEO and SAND groups showed no significant differences at the beginning or end of each study. `NEO clearly demonstrates better results when administered de novo as Indicated by the significantly lower incidence of rejection, which can be attributed to an increased bioavailability, plus a trend towards lower numbers of AE. However, when switching from SAND to NEO in stable patients, results from the NEO group demonstrate a similar incidence of rejection and AE as the SAND group. In conclusion, de novo patients should receive NEO, where the benefits clearly outweigh disadvantages. In addition, consideration must be given to switching stable patients from SAND to NEO as a cost effective measure.