2 results
49 Combinatorial Pharmacogenomics to Guide Treatment Selection for Major Depressive Disorder: A Large, Blinded, Randomized Controlled Trial
- John F. Greden, Anthony J. Rosthschild, Michael Thase, Boadie W. Dunlop, DMH Charles DeBattista, Charles R. Conway, Brent P. Forester, Francis M. Mondimore, Richard C. Shelton, James Li, Alexa Gilbert, Lindsey Burns, Michael Jablonski, Bryan Dechairo, Sagar Parikh
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- Journal:
- CNS Spectrums / Volume 24 / Issue 1 / February 2019
- Published online by Cambridge University Press:
- 12 March 2019, pp. 202-203
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Background
Major depressive disorder (MDD) is a leading cause of disease burden worldwide, with lifetime prevalence in the United States of 17%. Here we present the results of the first prospective, large-scale, patient- and rater-blind, randomized controlled trial evaluating the clinical importance of achieving congruence between combinatorial pharmacogenomic (PGx) testing and medication selection for MDD.
Methods1,167 outpatients diagnosed with MDD and an inadequate response to ≥1 psychotropic medications were enrolled and randomized 1:1 to a Treatment as Usual (TAU) arm or PGx-guided care arm. Combinatorial PGx testing categorized medications in three groups based on the level of gene-drug interactions: use as directed, use with caution, or use with increased caution and more frequent monitoring. Patient assessments were performed at weeks 0 (baseline), 4, 8, 12 and 24. Patients, site raters, and central raters were blinded in both arms until after week 8. In the guided-care arm, physicians had access to the combinatorial PGx test result to guide medication selection. Primary outcomes utilized the Hamilton Depression Rating Scale (HAM-D17) and included symptom improvement (percent change in HAM-D17 from baseline), response (50% decrease in HAM-D17 from baseline), and remission (HAM-D17<7) at the fully blinded week 8 time point. The durability of patient outcomes was assessed at week 24. Medications were considered congruent with PGx test results if they were in the ‘use as directed’ or ‘use with caution’ report categories while medications in the ‘use with increased caution and more frequent monitoring’ were considered incongruent. Patients who started on incongruent medications were analyzed separately according to whether they changed to congruent medications by week8.
ResultsAt week 8, symptom improvement for individuals in the guided-care arm was not significantly different than TAU (27.2% versus 24.4%, p=0.11). However, individuals in the guided-care arm were more likely than those in TAU to achieve remission (15% versus 10%; p<0.01) and response (26% versus 20%; p=0.01). Remission rates, response rates, and symptom reductions continued to improve in the guided-treatment arm until the 24week time point. Congruent prescribing increased to 91% in the guided-care arm by week 8. Among patients who were taking one or more incongruent medication at baseline, those who changed to congruent medications by week 8 demonstrated significantly greater symptom improvement (p<0.01), response (p=0.04), and remission rates (p<0.01) compared to those who persisted on incongruent medications.
ConclusionsCombinatorial PGx testing improves short- and long-term response and remission rates for MDD compared to standard of care. In addition, prescribing congruency with PGx-guided medication recommendations is important for achieving symptom improvement, response, and remission for MDD patients.
Funding Acknowledgements: This study was supported by Assurex Health, Inc.
170 Prospective Evaluation of the Economic Utility of Combinatorial Pharmacogenomics in Generalized Anxiety Disorder and Major Depressive Disorder
- Nathan Roe, Catherine Passariello, Lisa Brown, James Li, Michael Jablonski, Bryan M Dechairo
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- Journal:
- CNS Spectrums / Volume 23 / Issue 1 / February 2018
- Published online by Cambridge University Press:
- 15 June 2018, pp. 99-100
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Abstract
Mental illness is one of the leading causes of disability, with direct and indirect costs posing a significant financial burden. Previously, a large prospective economic utility study (n>13,000) showed that the GeneSight® test, a psychiatric pharmacogenomic decision support tool powered by CPGx® technology, reduced medication costs, increased adherence, andreduced polypharmacy for patients who had failed monotherapy for psychiatric disorders. The current study, which is a sub-analysis of this larger study, assessed cost savings associated with combinatorial pharmacogenomic testing in patients with generalized anxiety disorder (GAD) and major depressive disorder (MDD). Medication costs were extracted using pharmacy claims data provided by Medco, a large pharmacy benefits manager, for patients with GAD (n=318) and MDD (n=459). Medication cost savings per member per year (PMPY) for 1 year following the test were compared between patients whose medication regimens were congruent with the test recommendations and those whose medication regimens were incongruent with these recommendations. When healthcare providers’ decisions were congruent with combinatorial pharmacogenomic testing, PMPY savings was $6,747 (p<0.004) for GAD patients and $3,738 (p<0.004) for MDD patients versus incongruent decisions within these disease states. Among the congruent group, GAD patients experienced greater savings in central nervous system (CNS) medications (2-fold) compared to MDD patients. Additionally, analysis of a subset of patients prescribed at least one benzodiazepine six months prior to testing (n=660) demonstrated a significant decrease in benzodiazepine drug counts (p<0.001) and refills (p<0.001) after testing. Using the GeneSight test as a treatment decision support tool for patients with GAD or MDD resulted in significant medication cost savings when HCPs made congruent decisions with the combinatorialpharmacogenomic results. Furthermore, use of the GeneSight test decreased the use of benzodiazepines.
Funding AcknowledgementsResearch was funded by Assurex Health, Inc.