Abstract
This is a retrospective cohort study of 20 children and adolescents to evaluate the clinical utility of a pharmacogenetic decision support tool. Twenty children and adolescents underwent pharmacogenetic testing between June 2014 and May 2017. All children and adolescents were evaluated at Puerta de Hierro University Hospital-Majadahonda (Madrid, Spain). We report the proportion of patients achieving clinical improvement, amelioration of side effects, and changes in number of drugs. Data normality was assessed with the Shapiro–Wilk test, and changes of pre- and post-pharmacogenetic testing were analyzed with the Wilcoxon test for paired samples. A two-sided p value threshold of 0.05 was considered for significance. Pharmacogenetic testing helped to improve the clinical outcome as measured by the Clinical Global Impressions (CGI) Scale in virtually all children (95%; 19 out of 20 children). The CGI improvement (CGI-I) was 2 (0.79) (range 1–4), 2.1 (0.56) (range 1–3), and 1.9 (0.99) (range 1–4) in foster and non-foster care children, respectively. Pharmacogenetic testing also helped to reduce the number of children using polypharmacy (from 65 to 45%), the mean number of drugs per children (from 3.3 to 2.4 drugs, p = 0.017), and self-reported relevant side effects (p = 0.006). Pharmacogenetic testing helped to improve the clinical outcome, and to reduce polypharmacy and the number of drugs used in children and adolescents with severe mental disorders. More evidence using robust (i.e., clinical trials) independent studies is required to properly determine the clinical utility and cost-effectiveness of pharmacogenetic testing tools in children and adolescents with mental disorders.
Highlights
An increasingly large proportion of the worldwide population lives with a mental disorder
The present naturalistic retrospective descriptive cohort study of 20 children suggests that pharmacogenetic testing may have clinical utility in improving clinical outcomes, reducing polypharmacy, reducing the number of drugs used per child, and reducing side effects in children with severe mental disorders
In a recent systematic review of clinical trials and costeffectiveness studies of PGx testing on the clinical outcome of major depressive disorder (MDD), the authors concluded that clear-cut demonstration of improved health outcomes and cost-effectiveness of pharmacogenomics were not yet supported with replicated evidence; they recognized that some studies have reported promising results for the clinical utility of PGx testing (Rosenblat et al 2017)
Summary
An increasingly large proportion of the worldwide population lives with a mental disorder. The worldwide prevalence of mental disorders is 20% in adult populations (Kessler et al 2009; Steel et al 2014), and 13.4% (95% CI 11.3–15.9) in children and adolescents (Polanczyk et al 2015). Medications are frequently used to treat mental disorders, but “choosing the right medication for each patient is challenging” (Health Quality Ontario 2017). A great proportion of patients discontinue medication because of lack of response or adverse effects (Health Quality Ontario 2017). The treatment for major depressive disorder (MDD) does not achieve remission in approximately 50% of patients following two drug trials (Rush 2007).
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