Open-label steady-state pharmacokinetic drug interaction study on co-administered quetiapine fumarate and divalproex sodium in patients with schizophrenia, schizoaffective disorder, or bipolar disorder
| Autor: | Jennifer E. Hamer-Maansson, Helen Winter, Carlos Figueroa, Mark A. Smith, Patty Davis, Debra J. Ennis, C. Lindsay DeVane |
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| Rok vydání: | 2007 |
| Předmět: |
Divalproex
Adult Male medicine.medical_specialty Dibenzothiazepines Bipolar Disorder Cmax Schizoaffective disorder Pharmacology Gastroenterology Cohort Studies Cmin Quetiapine Fumarate Antimanic Agents Internal medicine medicine Humans Pharmacology (medical) Drug Interactions Prospective Studies Valproic Acid business.industry Middle Aged medicine.disease United States Psychiatry and Mental health Neurology Tolerability Area Under Curve Schizophrenia Quetiapine Female Schizophrenic Psychology Neurology (clinical) business medicine.drug Antipsychotic Agents |
| Zdroj: | Human psychopharmacology. 22(7) |
| ISSN: | 0885-6222 |
| Popis: | Objective To determine whether there is a pharmacokinetic drug interaction between quetiapine fumarate and divalproex sodium. Methods The pharmacokinetics and short-term tolerability and safety of coadministered quetiapine and divalproex were examined in adults with schizophrenia/schizoaffective disorder (Cohort A) or bipolar disorder (Cohort B) in an open-label, parallel, 2-cohort drug-interaction study conducted at three centers in the United States. Cohort A was administered quetiapine (150 mg bid) prospectively for 13 days, with divalproex (500 mg bid) added on days 6–13. Cohort B was administered divalproex (500 mg bid) for 16 days, with quetiapine (150 mg bid) added on days 9–16. Quetiapine and valproic acid plasma concentration–time data over a 12-h steady-state dosing interval were used to determine Cmax, Tmax, Cmin, area under the plasma concentration–time curve (AUCτ), and oral clearance (CL/F). Results In Cohort A (n = 18), addition of divalproex did increase the Cmax of quetiapine by 17% but did not change AUCτ. In Cohort B (n = 15), addition of quetiapine decreased both total valproic acid Cmax and AUCτ by 11%. No differences were observed in adverse events (AEs) with either quetiapine or divalproex monotherapy or their combination. Conclusion Combination therapy with quetiapine (150 mg bid) and divalproex (500 mg bid) resulted in small and statistically non-significant pharmacokinetic changes. Copyright © 2007 John Wiley & Sons, Ltd. |
| Databáze: | OpenAIRE |
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