Abstract
The authors wish to express their concern regarding the recently published recommendations for Neoral C2 monitoring (supplement to Transplantation, May 15, 2002), which have been made in the absence of any supportive evidence from controlled clinical trials (1–3). The editorial accompanying the three articles concluded that “there is clear evidence for the benefits of C2 monitoring compared to C0 monitoring,” citing observed associations between C2 cyclosporine levels and short- to medium-term transplant outcomes in cohort studies. However, although such studies are hypothesis-generating, they do not prove causality. Controlled clinical trials comparing C2 versus C0 monitoring are ultimately required to determine whether these statistical associations lead to improved patient outcomes.
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