2018
DOI: 10.1002/cpdd.577
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Effects of Intrinsic Factors on the Clinical Pharmacokinetics of Vortioxetine

Abstract: Vortioxetine is an antidepressant agent with multimodal activity that is approved for the treatment of major depressive disorder at doses of 5 to 20 mg once daily. Vortioxetine is a medium-clearance drug that undergoes extensive metabolism via several cytochrome P450 isozymes. A series of single- and multiple-dose pharmacokinetic studies were performed to evaluate the impact of intrinsic (ie, subject-related) factors, such as age, sex, race, and renal and hepatic function, on the pharmacokinetics of vortioxeti… Show more

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Cited by 7 publications
(3 citation statements)
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References 19 publications
(48 reference statements)
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“…In a phase 4 double-blind randomized, controlled trial, the novel antidepressant vortioxetine was shown to be associated with less TESD than paroxetine [177]. It appears that its pharmacokinetics are not altered by renal or hepatic impairment [178], and dose-adjustment is not necessary in the setting of CKD and ESRD [179].…”
Section: Iatrogenic Sdmentioning
confidence: 99%
“…In a phase 4 double-blind randomized, controlled trial, the novel antidepressant vortioxetine was shown to be associated with less TESD than paroxetine [177]. It appears that its pharmacokinetics are not altered by renal or hepatic impairment [178], and dose-adjustment is not necessary in the setting of CKD and ESRD [179].…”
Section: Iatrogenic Sdmentioning
confidence: 99%
“…23 Vortioxetine is primarily metabolized by the CYP2D6 enzyme, and less so by CYP2C19, but, given that the ratios of maximum plasma concentration for the inhibitor (vortioxetine or its metabolites) and the dissociation constant of the inhibitor (Ki) were far below 0.1, the inhibition is considered clinically irrelevant. [23][24][25] Nonetheless, it cannot be ruled out that concomitant use of vortioxetine and paroxetine may have resulted in increased plasma concentrations of the former as a result of significant CYP2D6 inhibition by the latter.…”
Section: Discussionmentioning
confidence: 99%
“…Moreover, among studies of vortioxetine in generalized anxiety disorder (GAD) (n = 5), three 8-week trials exhibited negative results [78][79][80], while 8-week and 20-week trials showed a significant benefit over placebo [81,82]. Key information derived from experimental pharmacokinetics studies (n = 7) is summarized in Table 5 [83][84][85][86][87][88][89]. Vortioxetine metabolism does not differ between sexes.…”
Section: Experimental Studiesmentioning
confidence: 99%