Transporter Genetics in Clinical Endpoint Analysis

The ultimate research goal of transporter pharmacogenetics is to further our understanding of the ways in which transporter genetics influence clinical endpoints so that current drug treatment can be made safer and more efficacious and investigational therapies can be better developed. The literature consists of a multitude of studies that have evaluated drug efficacy and toxicity and have made associations between these parameters and polymorphisms in drug transporters (4,20,23). The FDA recommends several endpoints to evaluate specific diseases, and those endpoints should be evaluated when making associations between a genetic variation and the treatment of diseases with drugs (see www.fda.gov/cder/guidance; accessed November 22, 2006). In pharmacogenetic studies, these endpoints should be evaluated in a standard fashion in similar populations to establish the predictive value of a polymorphism. Unfortunately, the literature has not typically been consistent, mainly because of the low availability of samples for analysis, and perhaps this is the reason that transporter polymorphisms have not been consistently validated. Thus far, all studies linking pharmacogenomics of membrane transporters with clinical outcome have been retrospective, taking place in eclectic populations with relatively low statistical power. It is essential that prospective studies are undertaken, prior to any treatment modification, to assess the true effects of these polymorphisms and determine whether the effect is drug specific or disease related.

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