Pharmacogenomics
REVIEW
Neuropsychopharmacology REVIEWS (2009) 34, 159–172
& 2009 Nature Publishing Group All rights reserved 0893-133X/09 $30.00 ............................................................................................................................................................... www.neuropsychopharmacology.org 159
Pharmacogenomics: The Promise of Personalized Medicine for CNS Disorders
Jose de Leon*,1,2,3,4
1 Mental Health Research Center, Eastern State Hospital, University of Kentucky, Lexington, KY, USA; 2College of Medicine, University of Kentucky, Lexington, KY, USA; 3College of Pharmacy, University of Kentucky, Lexington, KY, USA; 4Psychiatry and Neurosciences Research Group (CTS-549), Institute of Neurosciences, Medical School, University of Granada, Granada, Spain
This review focuses first on the concept of pharmacogenomics and its related concepts (biomarkers and personalized prescription). Next, the first generation of five DNA pharmacogenomic tests used in the clinical practice of psychiatry is briefly reviewed. Then the possible involvement of these pharmacogenomic tests in the exploration of early clinical proof of mechanism is described by using two of the tests and one example from the pharmaceutical industry (iloperidone clinical trials). The initial attempts to use other microarray tests (measuring RNA expression) as peripheral biomarkers for CNS disorders are briefly described. Then the challenge of taking pharmacogenomic tests (compared to drugs) into clinical practice is explained by focusing on regulatory oversight, the methodological/scientific issues concerning diagnostic tests, and cost-effectiveness issues. Current information on medicine-based evidence and cost-effectiveness usually focuses on average patients and not the outliers who are most likely to benefit from personalized prescription. Finally, future
Neuropsychopharmacology REVIEWS (2009) 34, 159–172
& 2009 Nature Publishing Group All rights reserved 0893-133X/09 $30.00 ............................................................................................................................................................... www.neuropsychopharmacology.org 159
Pharmacogenomics: The Promise of Personalized Medicine for CNS Disorders
Jose de Leon*,1,2,3,4
1 Mental Health Research Center, Eastern State Hospital, University of Kentucky, Lexington, KY, USA; 2College of Medicine, University of Kentucky, Lexington, KY, USA; 3College of Pharmacy, University of Kentucky, Lexington, KY, USA; 4Psychiatry and Neurosciences Research Group (CTS-549), Institute of Neurosciences, Medical School, University of Granada, Granada, Spain
This review focuses first on the concept of pharmacogenomics and its related concepts (biomarkers and personalized prescription). Next, the first generation of five DNA pharmacogenomic tests used in the clinical practice of psychiatry is briefly reviewed. Then the possible involvement of these pharmacogenomic tests in the exploration of early clinical proof of mechanism is described by using two of the tests and one example from the pharmaceutical industry (iloperidone clinical trials). The initial attempts to use other microarray tests (measuring RNA expression) as peripheral biomarkers for CNS disorders are briefly described. Then the challenge of taking pharmacogenomic tests (compared to drugs) into clinical practice is explained by focusing on regulatory oversight, the methodological/scientific issues concerning diagnostic tests, and cost-effectiveness issues. Current information on medicine-based evidence and cost-effectiveness usually focuses on average patients and not the outliers who are most likely to benefit from personalized prescription. Finally, future
References: 170 Arranz MJ, Munro J, Sham P, Kirov G, Murray RM, Collier DA et al (1998) 171 Newcomer JW, Haupt DW (2006)