An Open-Label, Single-Dose, Parallel-Group Study of the Effects of Chronic Hepatic Impairment on the Safety and Pharmacokinetics of Desvenlafaxine

Baird-Bellaire, Susan; Behrle, J. A.; Parker, Vernon D.; Patat, Alain; Paul, Jeffrey; Nichols, Alice I.

doi:10.1016/j.clinthera.2013.03.013

Cited by 17 publications

(14 citation statements)

References 16 publications

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“…These findings are consistent with a study for assessment of Desvenlafaxine succinate pharmacokinetic changes when administered with or without food and that did not report significant changes in the molecule Bioavailability when interacting with food in the intestine [4]. The obtained values for C max and AUC 0-t either for the Test and Reference products are similar to those obtained in other studies [17].…”

Section: Discussionsupporting

confidence: 91%

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Jba¹

2014

J Bioequiv Availab

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Section: Discussionsupporting

confidence: 91%

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Jba¹

2014

J Bioequiv Availab

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“…Consistent with this route of elimination, desvenlafaxine exposure tends to increase with increasing severity of renal impairment compared with normal control subjects . A modest increase in exposure has been observed in subjects with moderate to severe hepatic impairment . Concomitant administration of desvenlafaxine has a minimal effect on exposure to drugs metabolized via the CYP2D6 and/or CYP3A4 pathway .…”

mentioning

confidence: 74%

“…20,21 A modest increase in exposure has been observed in subjects with moderate to severe hepatic impairment. 22 Concomitant administration of desvenlafaxine has a minimal effect on exposure to drugs metabolized via the CYP2D6 23,24 and/or CYP3A4 pathway. 25 Desvenlafaxine exposure also is not significantly affected by CYP2D6 phenotype (ie, poor vs extensive metabolizer status), 26,27 suggesting that desvenlafaxine PK would not be expected to vary between groups that differ in the prevalence of CYP2D6 genotypes, including races or ethnic populations.…”

mentioning

confidence: 99%

Population Pharmacokinetics of Desvenlafaxine: Pharmacokinetics in Korean Versus US Populations

Nichols

Liao²,

Abbas

2017

Clinical Pharm in Drug Dev

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Desvenlafaxine exposure in Korean and US populations was compared using population pharmacokinetic (PK) analysis. Data from a single- and multiple-dose study of desvenlafaxine (50, 100, and 200 mg) in 30 healthy Korean subjects were added to a population PK model previously developed using sparse PK samples from patients with major depressive disorder, including 140 Korean patients, combined with rich PK data from healthy volunteers. The structural PK model was an open 1-compartment linear disposition model with parallel first-order and 0-order inputs. The effects of Korean status on apparent oral clearance (CL/F) and apparent volume of distribution (V/F) were tested against the base model separately. External validation results indicated good agreement between the model predictions and observed desvenlafaxine concentrations for Korean subjects. The geometric mean CL/F and V/F of Korean subjects were 9.1% and 16.7% lower, respectively, than those of US subjects, who had a 20% higher mean body weight. Results for patients with major depressive disorder were similar. There were no meaningful differences for weight-normalized CL/F and V/F values between Korean and US subjects or patients. The minor differences in CL/F and V/F observed between Korean and US populations appear to be solely due to lower body weights in the Korean population.

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“…Despite this, the half-life of both venlafaxine and O-desmethylvenlafaxine has shown to be significantly prolonged in those with renal impairment and in those receiving dialysis [38]. Desvenlafaxine, the commercially available O-desmethyldesvenlafaxine metabolite, is about 45% excreted unchanged in the urine and about 55% metabolized through phase II glucuronidation via UDP-glucuronosyltransferase enzymes [40,41]. This has also shown to have a prolonged half-life in those with renal impairment [37,40].…”

Section: Select Antidepressantsmentioning

confidence: 99%

Pharmacotherapeutic Management of Neuropathic Pain in End-Stage Renal Disease

et al. 2020

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Background: Chronic noncancer pain is pervasive throughout the general patient population, transcending all chronic disease states. Patients with end-stage renal disease (ESRD) present a complicated population for which medication management requires careful consideration of the pathogenesis of ESRD and intimate knowledge of pharmacology. The origin of pain must also guide treatment options. As such, the presentation of neuropathic pain in ESRD can present a challenging case. The authors aim to provide a review of available classes of medications and considerations for the treatment of neuropathic pain in ESRD. Summary: In this narrative review, the authors discuss important strategies and considerations for the treatment of neuropathic pain in ESRD, including the pathogenesis of neuropathic pain, physiological changes for consideration in ESRD patients, and disease-specific consideration for medication selection. Pharmacotherapeutic classes discussed include: anticonvulsants, antiarrhythmics, antidepressants, topicals, and opioids. Key Message: Pain management in ESRD patients re-quires careful assessment of drug-specific properties, accumulation, metabolism (presence of active/toxic metabolites), extraction by dialysis, and presence of drug -drug interactions. In the absence of pharmacokinetic data in ESRD patients, therapeutic window and potential risks should be factored in the decision making along with continued monitoring throughout therapy.

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An Open-Label, Single-Dose, Parallel-Group Study of the Effects of Chronic Hepatic Impairment on the Safety and Pharmacokinetics of Desvenlafaxine

Cited by 17 publications

References 16 publications

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Population Pharmacokinetics of Desvenlafaxine: Pharmacokinetics in Korean Versus US Populations

Pharmacotherapeutic Management of Neuropathic Pain in End-Stage Renal Disease

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