Population Pharmacokinetics of Orally Administered Duloxetine in Patients

Lobo, Evelyn D.; Quinlan, Tonya; O’Brien, Lisa M.; Knadler, Mary Pat; Heathman, Michael

doi:10.2165/00003088-200948030-00005

Cited by 46 publications

(45 citation statements)

References 25 publications

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“…However, in a combined dataset of five studies and 2000 participants, the apparent oral clearance was clearly lower in females than in males and this finding is in line with the lower CYP1A2 activity in women [75]. Mildly lower fluoxetine exposure and higher metabolite exposure in women ++ Fluvoxamine…”

Section: Sertralinementioning

confidence: 70%

Sex differences in pharmacokinetics of antidepressants

Kokras

Dalla

Papadopoulou-Daifoti

2010

Expert Opinion on Drug Metabolism & Toxicology

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Although the available pharmacokinetic evidence indicates that women should receive lower doses of antidepressants and men should receive higher doses, current guidelines do not recommend dose adjustment, because these sex differences are considered to be clinically insignificant. Unless we understand the link between pharmacokinetics and pharmacodynamics of antidepressants, it will be difficult to determine whether sex differences are of clinical importance or not. Thus, further systematic and particularly focused research is needed on sex differences in pharmacokinetics.

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Section: Sertralinementioning

confidence: 70%

Sex differences in pharmacokinetics of antidepressants

Kokras

Dalla

Papadopoulou-Daifoti

2010

Expert Opinion on Drug Metabolism & Toxicology

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“…Twenty-one articles were included in this review: seven are about fluvoxamine (FLV) [18–24], two about fluoxetine (FLX) [12, 13], sertraline [14, 15], venlafaxine (VEN) [25, 26], duloxetine [27, 28] and mirtazapine [30, 31], one about escitalopram [16], citalopram [17], trazodone [29] and bupropion [32]. No studies were found about paroxetine, milnacipran or agomelatine.…”

Section: Resultsmentioning

confidence: 99%

Smoking and antidepressants pharmacokinetics: a systematic review

et al. 2017

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BackgroundDespite an increasingly recognized relationship between depression and smoking, little is known about how smoking influences antidepressant response and treatment outcomes. The aim of this study was to systematically review the evidence of the impact of smoking on new-generation antidepressants with an emphasis on the pharmacokinetic perspective.MethodsWe present a systematic review of clinical trials comparing the serum levels of new-generation antidepressants in smokers and nonsmokers. Data were obtained from MEDLINE/PubMed, Embase, and other sources. Risk of bias was assessed for selection, performance, detection, attrition, and reporting of individual studies.ResultsTwenty-one studies met inclusion criteria; seven involved fluvoxamine, two evaluated fluoxetine, sertraline, venlafaxine, duloxetine or mirtazapine, and escitalopram, citalopram, trazodone and bupropion were the subject of a single study. No trials were found involving other common antidepressants such as paroxetine or agomelatine. Serum levels of fluvoxamine, duloxetine, mirtazapine and trazodone were significantly higher in nonsmokers compared with smokers.ConclusionsThere is evidence showing a reduction in the concentration of serum levels of fluvoxamine, duloxetine, mirtazapine and trazodone in smoking patients as compared to nonsmokers. The evidence regarding other commonly used antidepressants is scarce. Nonetheless, smoking status should be considered when choosing an antidepressant treatment, given the risk of pharmacokinetic interactions.

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“…82 Nonpregnant women have a 64% higher average steady-state concentration than men, in part because of lower CYP1A2 activity in women. 83 No pharmacokinetic studies during pregnancy were located for duloxetine; however, 1 study reported duloxetine plasma levels in healthy lactating postpartum women comparable with those observed in healthy adults. 84 …”

Section: Resultsmentioning

confidence: 99%

Pharmacotherapy for Mood Disorders in Pregnancy

Deligiannidis¹,

Byatt

Freeman³

2014

Journal of Clinical Psychopharmacology

161

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Objective Pharmacotherapy for mood disorders during pregnancy is often complicated by pregnancy-related pharmacokinetic changes and the need for dose adjustments. The objectives of this review are to summarize the evidence for change in perinatal pharmacokinetics of commonly used pharmacotherapies for mood disorders, discuss the implications for clinical and therapeutic drug monitoring (TDM), and make clinical recommendations. Methods The English-language literature indexed on MEDLINE/PubMed was searched for original observational studies (controlled and uncontrolled, prospective and retrospective), case reports, and case series that evaluated or described pharmacokinetic changes or TDM during pregnancy or the postpartum period. Results Pregnancy-associated changes in absorption, distribution, metabolism, and elimination may result in lowered psychotropic drug levels and possible treatment effects, particularly in late pregnancy. Mechanisms include changes in both phase 1 hepatic cytochrome P450 and phase 2 uridine diphosphate glucuronosyltransferase enzyme activities, changes in hepatic and renal blood flow, and glomerular filtration rate. Therapeutic drug monitoring, in combination with clinical monitoring, is indicated for tricyclic antidepressants and mood stabilizers during the perinatal period. Conclusions Substantial pharmacokinetic changes can occur during pregnancy in a number of commonly used antidepressants and mood stabilizers. Dose increases may be indicated for antidepressants including citalopram, clomipramine, imipramine, fluoxetine, fluvoxamine, nortriptyline, paroxetine, and sertraline, especially late in pregnancy. Antenatal dose increases may also be needed for lithium, lamotrigine, and valproic acid because of perinatal changes in metabolism. Close clinical monitoring of perinatal mood disorders and TDM of tricyclic antidepressants and mood stabilizers are recommended.

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Population Pharmacokinetics of Orally Administered Duloxetine in Patients

Abstract: Given the clinically insignificant change in the magnitude of duloxetine steady-state exposure and the considerable overlap in duloxetine exposure between the patient subgroups, specific dose recommendations based on sex, smoking status, age, dose and ethnicity are not warranted.

Cited by 46 publications

References 25 publications

Sex differences in pharmacokinetics of antidepressants

Sex differences in pharmacokinetics of antidepressants

Smoking and antidepressants pharmacokinetics: a systematic review

Pharmacotherapy for Mood Disorders in Pregnancy

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