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Article ; Online: Fluoxetine pharmacokinetics and tissue distribution quantitatively supports a therapeutic role in COVID-19 at a minimum dose of 20 mg per day.

Eugene, Andy R

2021 Volume 10, Page(s) 477

Abstract: Background. ...

Abstract	Background.
MeSH term(s)	Humans ; COVID-19/drug therapy ; SARS-CoV-2 ; Fluoxetine/pharmacology ; Fluoxetine/therapeutic use ; Tissue Distribution ; Antidepressive Agents
Chemical Substances	Fluoxetine (01K63SUP8D) ; Antidepressive Agents
Language	English
Publishing date	2021-06-16
Publishing country	England
Document type	Journal Article
ZDB-ID	2699932-8
ISSN	2046-1402 ; 2046-1402
ISSN (online)	2046-1402
ISSN	2046-1402
DOI	10.12688/f1000research.53275.2
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Association of sleep among 30 antidepressants: a population-wide adverse drug reaction study, 2004-2019.

Eugene, Andy R

PeerJ

2020 Volume 8, Page(s) e8748

Abstract: ... 95% confidence interval (95% CI) were computed and all computations and graphing conducted in R ...

Abstract	Background: Sleep is one of the most essential processes required to maintain a healthy human life, and patients experiencing psychiatric illness often experience an inability to sleep. The aim of this study is to test the hypothesis that antidepressant compounds with strong binding affinities for the serotonin 5-HT2C receptor, histamine H1 receptors, or norepinephrine transporter (NET) will be associated with the highest odds of somnolence. Methods: Post-marketing cases of patient adverse drug reactions were obtained from the United States Food and Drug Administration Adverse Events Reporting System (FAERS) during the reporting window of January 2004 to September 2019. Disproportionality analyses of antidepressants reporting somnolence were calculated using the case/non-case method. The reporting odds-ratios (ROR) and corresponding 95% confidence interval (95% CI) were computed and all computations and graphing conducted in R. Results: There were a total of 69,196 reported cases of somnolence out of a total of 7,366,864 cases reported from January 2004 to September 2019. Among the 30 antidepressants assessed, amoxapine ( Conclusion: Among the thirty tested antidepressants, consistent with the original hypothesis, amoxepine has strongest 5-HT2C receptor binding affinity and has the highest reporting odds of somnolence. Atomoxetine, ranked second in reporting odds of somnolence overall, binds to the NET with with the strongest binding affinity among the thirty compounds. Mirtazapine, a tetracyclic antidepressant, was ranked 11th in reporting odds of somnolence and had the strongest H1 receptor binding affinity. This study provides an informative ranking of somnolence among thirty antidepressant compounds with an already wide array of clinical indications as well as provides insight into potential drug repurposing in psychopharmacology.
Language	English
Publishing date	2020-03-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	2703241-3
ISSN	2167-8359
ISSN	2167-8359
DOI	10.7717/peerj.8748
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Article: Optimizing drug selection in psychopharmacology based on 40 significant CYP2C19- and CYP2D6-biased adverse drug reactions of selective serotonin reuptake inhibitors.

Eugene, Andy R

PeerJ

2019 Volume 7, Page(s) e7860

Abstract: ... with one of two aforementioned DMEs. All data homogenization and computations were performed in R ...

Abstract	Background: Selective serotonin reuptake inhibitors (SSRIs) are among the most widely prescribed class of drugs in the practice of psychiatry. Cytochrome P450 (CYP) 2C19 and CYP2D6 are established as clinically relevant drug metabolizing enzymes (DMEs) that influence the pharmacokinetics of SSRIs and may either be grouped as being primarily metabolized by CYP2C19 or CYP2D6. The aim of this study is to test the hypothesis that the primary drug metabolizing pathway for SSRI antidepressants are associated with adverse drug reactions (ADRs) related to physiological modulation of organs with the highest gene tissue expression. Methods: Post-marketing ADR cases were obtained from the United States Food and Drug Administration's Adverse Events Reporting System from each of the four quarters for the years 2016 and 2017. Cases were grouped based on one of two primary pharmacokinetic pharmacogenomic pathway biomarkers CYP2C19 and CYP2D6. Citalopram, escitalopram, and sertraline were grouped as CYP2C19 substrates and fluvoxamine, fluoxetine, and paroxetine as CYP2D6 substrates. Logistic regression was computed for the reported SSRI ADRs associated with one of two aforementioned DMEs. All data homogenization and computations were performed in R for statistical programming. Results: The most commonly reported ADR among the SSRIs was anxiety (
Language	English
Publishing date	2019-10-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	2703241-3
ISSN	2167-8359
ISSN	2167-8359
DOI	10.7717/peerj.7860
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Article ; Online: Association of sleep among 30 antidepressants

Andy R. Eugene

PeerJ, Vol 8, p e

a population-wide adverse drug reaction study, 2004–2019

2020 Volume 8748

Abstract: ... were computed and all computations and graphing conducted in R. Results There were a total of 69,196 ...

Abstract	Background Sleep is one of the most essential processes required to maintain a healthy human life, and patients experiencing psychiatric illness often experience an inability to sleep. The aim of this study is to test the hypothesis that antidepressant compounds with strong binding affinities for the serotonin 5-HT2C receptor, histamine H1 receptors, or norepinephrine transporter (NET) will be associated with the highest odds of somnolence. Methods Post-marketing cases of patient adverse drug reactions were obtained from the United States Food and Drug Administration Adverse Events Reporting System (FAERS) during the reporting window of January 2004 to September 2019. Disproportionality analyses of antidepressants reporting somnolence were calculated using the case/non-case method. The reporting odds-ratios (ROR) and corresponding 95% confidence interval (95% CI) were computed and all computations and graphing conducted in R. Results There were a total of 69,196 reported cases of somnolence out of a total of 7,366,864 cases reported from January 2004 to September 2019. Among the 30 antidepressants assessed, amoxapine (n = 16) reporting odds-ratio (ROR) = 7.1 (95% confidence interval [CI] [4.3–11.7]), atomoxetine (n = 1,079) ROR = 6.6 (95% CI [6.2–7.1]), a compound generally approved for attention deficit hyperactivity disorder (ADHD), and maprotiline (n = 18) ROR = 6.3 (95% CI, 3.9–10.1) were the top three compounds ranked with the highest reporting odds of somnolence. In contrast, vortioxetine (n = 52) ROR = 1.3 (95% CI [1.0–1.8]), milnacipran (n = 58) ROR = 2.1 (95% CI [1.7–2.8]), and bupropion (n = 1,048) ROR = 2.2 (95% CI [2.1–2.4]) are least significantly associated with somnolence. Moreover, levomilnacipran (n = 1) ROR = 0.4 (95% CI [0.1–2.9]) was not associated with somnolence. Conclusion Among the thirty tested antidepressants, consistent with the original hypothesis, amoxepine has strongest 5-HT2C receptor binding affinity and has the highest reporting odds of somnolence. Atomoxetine, ranked second in ...
Keywords	Sleep ; Somnolence ; CYP2C19 poor metabolizers ; CYP2D6 poor metabolizers ; Glymphatic system ; Insomnia ; Medicine ; R ; Biology (General) ; QH301-705.5
Subject code	540 ; 333
Language	English
Publishing date	2020-03-01T00:00:00Z
Publisher	PeerJ Inc.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Optimizing drug selection in psychopharmacology based on 40 significant CYP2C19- and CYP2D6-biased adverse drug reactions of selective serotonin reuptake inhibitors

Andy R. Eugene

PeerJ, Vol 7, p e

2019 Volume 7860

Abstract: ... with one of two aforementioned DMEs. All data homogenization and computations were performed in R ...

Abstract	Background Selective serotonin reuptake inhibitors (SSRIs) are among the most widely prescribed class of drugs in the practice of psychiatry. Cytochrome P450 (CYP) 2C19 and CYP2D6 are established as clinically relevant drug metabolizing enzymes (DMEs) that influence the pharmacokinetics of SSRIs and may either be grouped as being primarily metabolized by CYP2C19 or CYP2D6. The aim of this study is to test the hypothesis that the primary drug metabolizing pathway for SSRI antidepressants are associated with adverse drug reactions (ADRs) related to physiological modulation of organs with the highest gene tissue expression. Methods Post-marketing ADR cases were obtained from the United States Food and Drug Administration’s Adverse Events Reporting System from each of the four quarters for the years 2016 and 2017. Cases were grouped based on one of two primary pharmacokinetic pharmacogenomic pathway biomarkers CYP2C19 and CYP2D6. Citalopram, escitalopram, and sertraline were grouped as CYP2C19 substrates and fluvoxamine, fluoxetine, and paroxetine as CYP2D6 substrates. Logistic regression was computed for the reported SSRI ADRs associated with one of two aforementioned DMEs. All data homogenization and computations were performed in R for statistical programming. Results The most commonly reported ADR among the SSRIs was anxiety (n = 3,332). The top two ADRs associated with SSRIs metabolized by CYP2D6 are: nightmare (n = 983) reporting odds-ratio (OR) = 4.37 (95% confidence interval (CI) [3.67–5.20]) and panic attack (n = 1,243) OR = 2.43 (95% CI [2.11–2.79]). Contrastingly, the top two ADRs for CYP2C19 metabolized SSRIs are: electrocardiogram QT prolonged (n = 351) OR = 0.18 (95% CI [0.13–0.24]) and small for dates baby (n = 306) OR = 0.19 (95% CI [0.14–0.26]). The study tested and produced 40 statistically significant CYP2C19- and CYP2D6-biased ADRs. In overall context, the results suggest that CYPC19 SSRI substrates are associated with ADRs related to modulation of the autonomic nervous system, seizure, pain, ...
Keywords	Pharmacogenomics in psychiatry ; Psychopharmacology ; Antidepressants side effects ; Pharmacovigilance ; Precision medicine ; Clinical pharmacology ; Medicine ; R ; Biology (General) ; QH301-705.5
Language	English
Publishing date	2019-10-01T00:00:00Z
Publisher	PeerJ Inc.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Head-to-Head Comparison of Sedation and Somnolence Among 37 Antipsychotics in Schizophrenia, Bipolar Disorder, Major Depression, Autism Spectrum Disorders, Delirium, and Repurposed in COVID-19, Infectious Diseases, and Oncology From the FAERS, 2004-2020.

Eugene, Andy R / Eugene, Beata / Masiak, Marek / Masiak, Jolanta Sylwia

Frontiers in pharmacology

2021 Volume 12, Page(s) 621691

Abstract: Objective: ...

Abstract	Objective:
Language	English
Publishing date	2021-03-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2021.621691
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Article: CYP2B6 Genotype Guided Dosing of Propofol Anesthesia in the Elderly based on Nonparametric Population Pharmacokinetic Modeling and Simulations.

Eugene, Andy R

International journal of clinical pharmacology & toxicology

2017 Volume 6, Issue 1, Page(s) 242–249

Abstract: ... Modeling (NLME) was conducted using the PMETRICS R package while population pharmacokinetic model ... The precision of the goodness-of-fit plots resulted in an R: Conclusion: Based on the pharmacometric modeling ...

Abstract	Objective: The primary aim of this article is to test the hypothesis that nonparametric pharmacometric modeling will accurately identify CYP2B6 genotype subgroups based on data from a study that reported results based on parametric pharmacokinetics (PK). Methods: Propofol concentration-time data were originally reported in the Kansaku et al. 2011 publication. Nonparametric Nonlinear Mixed Effects Modeling (NLME) was conducted using the PMETRICS R package while population pharmacokinetic model parameters were estimated using a FORTRAN compiler. Finally, model-based dosing simulations were conducted in the MATLAB Simbiology. Results: A total of 51 patients were included in the final PK analysis. A two-compartment gamma multiplicative error model adequately described the propofol concentration-time data. The precision of the goodness-of-fit plots resulted in an R Conclusion: Based on the pharmacometric modeling and simulation, if no dosage adjustments are made for the elderly CYP2B6 AA and AG genotypes, a 250% higher propofol blood exposure will be evident within 1-hour from the start of the infusion. Thus, based on the pharmacokinetic model, genotyping elderly patients for the CYP2B6 AA and AG gene variants will decrease the total propofol blood exposure during anesthesia and sedation when an infusion dose adjustment is made to 25mg/kg/min.
Language	English
Publishing date	2017-01-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	2781465-8
ISSN	2167-910X
ISSN	2167-910X
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Article: A Model-Based Meta-Analysis Evaluating Gender Differences on Blood Flow Responses to Brachial Artery Infusions of Acetylcholine, Albuterol, ATP, Bradykinin, Estradiol, Glyceryl Trinitrate, L-NMMA, Nevibolol, Norepinephrine, Sodium Nitroprusside, Substance P, and Verapamil.

Eugene, Andy R

MEDtube science

2017 Volume 4, Issue 2, Page(s) 16–28

Abstract: Introduction: Numerous studies have emerged over the course of several decades describing the properties of drugs eliciting vasodilatory or vasoconstrictor responses in the human vasculature. During drug development, decisions to move forward with ... ...

Abstract	Introduction: Numerous studies have emerged over the course of several decades describing the properties of drugs eliciting vasodilatory or vasoconstrictor responses in the human vasculature. During drug development, decisions to move forward with testing with a new chemical entity are very costly. To fund or not to fund development, go or no-go, decisions are often limited by efficacy comparisons with the current products on the market. The primary aim of this paper is to use dose-response modeling and simulations to quantify differences in blood flow to Acetylcholine, Albuterol, ATP, Bradykinin, 17β-Estradiol, Glyceryl Trinitrate, L-NMMA, Nevibolol, Norepinephrine, Sodium Nitroprusside, Substance P, and Verapamil. Methods: Five studies were identified in the literature that included a total of 12 compounds. Infusion doses were normalized to nmol/min and forearm blood flow values were normalized and scaled to the percent increase or decrease in forearm blood flow from baseline resting values. The original published studies were mathematically modeled using the Emax model or Sigmoid Emax model equation parameters. Lastly, dose-response simulations of higher doses using a virtual population were produced to account for population variability. Results: The gender difference between the Emax estimates, interpreted as the %Change from Baseline resting forearm blood flow, were found to be: Albuterol 253%, Acetylcholine 231%, Substance P 159%, Verapamil 145%, Bradykinin 42%, Sodium Nitroprusside 41%, and Glyceryl Trinitrate 26%. Contrastingly, Norepinephrine and L-NMMA Emax gender difference resulted in a 6% and 7% difference, respectively. Conclusion: These results provide insight into the differences in men and women seen in anti-hypertensive patient management. Further, the modeling estimates provide pharmacometricians evaluating new compounds with mathematical parameters for comparative efficacy studies through the various phases of drug development.
Language	English
Publishing date	2017-02-14
Publishing country	Poland
Document type	Journal Article
ISSN	2353-5687
ISSN	2353-5687
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Article ; Online: An opportunity for clinical pharmacology trained physicians to improve patient drug safety: A retrospective analysis of adverse drug reactions in teenagers.

Eugene, Andy R / Eugene, Beata

F1000Research

2018 Volume 7, Page(s) 677

Abstract: Background: ...

Abstract	Background:
MeSH term(s)	Adolescent ; Adverse Drug Reaction Reporting Systems ; Biomarkers ; Child ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions/complications ; Female ; Gynecomastia/etiology ; Humans ; Male ; Pharmacology, Clinical/methods ; Pneumothorax/etiology ; Retrospective Studies ; Risperidone/adverse effects ; Treatment Outcome ; United States ; United States Food and Drug Administration
Chemical Substances	Biomarkers ; Risperidone (L6UH7ZF8HC)
Language	English
Publishing date	2018-05-30
Publishing country	England
Document type	Journal Article
ZDB-ID	2699932-8
ISSN	2046-1402 ; 2046-1402
ISSN (online)	2046-1402
ISSN	2046-1402
DOI	10.12688/f1000research.14970.2
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Metoprolol Dose Equivalence in Adult Men and Women Based on Gender Differences: Pharmacokinetic Modeling and Simulations.

Eugene, Andy R

Medical sciences (Basel, Switzerland)

2016 Volume 4, Issue 4

Abstract: Recent meta-analyses and publications over the past 15 years have provided evidence showing there are considerable gender differences in the pharmacokinetics of metoprolol. Throughout this time, there have not been any research articles proposing a ... ...

Abstract	Recent meta-analyses and publications over the past 15 years have provided evidence showing there are considerable gender differences in the pharmacokinetics of metoprolol. Throughout this time, there have not been any research articles proposing a gender stratified dose-adjustment resulting in an equivalent total drug exposure. Metoprolol pharmacokinetic data was obtained from a previous publication. Data was modeled using nonlinear mixed effect modeling using the MONOLIX software package to quantify metoprolol concentration-time data. Gender-stratified dosing simulations were conducted to identify equivalent total drug exposure based on a 100 mg dose in adults. Based on the pharmacokinetic modeling and simulations, a 50 mg dose in adult women provides an approximately similar metoprolol drug exposure to a 100 mg dose in adult men.
Language	English
Publishing date	2016-11-15
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2754473-4
ISSN	2076-3271
ISSN	2076-3271
DOI	10.3390/medsci4040018
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