Abstract
In addition to an analysis of the final results of phase I/II and phase III clinical trials of sirolimus (SRL), this review focuses on the recent results of several studies in renal transplantation, which include diverse combinations of SRL with other immunosuppressive agents. While SRL was initially introduced as an adjunctive agent to calcineurin inhibitors, it is now serving as the base for therapies that spare or avoid these nephrotoxic drugs. However, to optimize the use of SRL as base therapy, further work is necessary to determine target concentrations, requirement for concomitant steroids and/or nucleoside synthesis blockers, and countermeasure therapy to overcome the drug's adverse effects.
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