Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs.

Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs. Research Abstract Details 

Research Abstract Table of Contents

Jump to the:

Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs. Abstract Text:

Kenneth W Sommerville,Sandeep Dutta,Victor Biton,Yiming Zhang,James C Cloyd,Basim Uthman,

OBJECTIVES: To compare the bioavailability of divalproex extended release (divalproex-ER) given once daily relative to the conventional divalproex formulation given once every 8 hours, using various divalproex-ER doses that are 8-20% greater than the corresponding divalproex total daily doses. DESIGN AND SUBJECTS: This multiple-dose, fasting, randomised, two-period, crossover design study in 76 subjects with epilepsy taking a concomitant enzyme-inducing antiepileptic drug compared the bioavailability of divalproex once-every-8-hours regimens with 8-20% higher daily dose divalproex-ER once-daily regimens. RESULTS: The 8-20% higher divalproex-ER once-daily-dose regimens were equivalent, with respect to exposure (area under the concentration-time curve; 1551 vs 1539 mg . h/L), to the corresponding total daily divalproex dose regimens. The divalproex-ER maximum concentration central value was significantly lower (83.3 vs 92.6 mg/L), and the minimum concentration mean was not significantly different (45.8 vs 44.8 mg/L) from the corresponding values for the divalproex regimen. The peak-to-trough fluctuation in plasma concentrations was significantly lower for once-daily divalproex-ER (64%) compared with once-every-8-hours divalproex (79%). The size of the divalproex dose and the presence of a concomitant enzyme-inducing antiepileptic drug did not have a statistically significant effect on divalproex-ER/divalproex relative bioavailability. No adverse event occurred in more than 5% of subjects on either treatment; all were mild or moderate in severity with none resulting in discontinuation. Both tested formulations were well tolerated by the subjects. CONCLUSION: This study demonstrated that patients with epilepsy taking divalproex may switch to 8-20% higher doses of divalproex-ER and have equivalent valproic acid exposure, lower fluctuation in valproic acid concentrations, and similar tolerability.

Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs. Publishing Authors By Initials

KW Sommerville,S Dutta,V Biton,Y Zhang,JC Cloyd,B Uthman,

For similar abstracts research abstracts see: abstracts research

PUBMED ID PMID:

MEDLINE DATE:

Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Clinical drug investigation

VOLUME: 23

Page Numbers: 661-70

Journal Abbreviation:

ISSN: 1173-2563

DAY: 30

MONTH: 05

YEAR: 2003

Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 9504817

Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs. Keywords Mesh Terms:

KEYWORDS:

MESH TERMS:

Chemical & Substance for Abstract: Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs. Information

Substance Name:

Registry Number:

Grant and Affiliation Information for Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs.

AFFILIATION: Abbott Laboratories, Abbott Park, Illinois, USA.

Country: New Zealand

AGENCY:

GRANT:

ACRONYM:

MEDLINETA: Clin Drug Investig

REFSOURCE:

DATABASENAME:

ACCESSION NUMBER:

Number Hits: 0

Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs Related Publications

• A calculous acute typhoid cholecystitis.
• Bioavailability of a Divalproex Extended-Release Formulation versus the Conventional Divalproex Formulation in Adult Patients Receiving Enzyme-Inducing Antiepileptic Drugs.
• Cancer of the pancreas experience at the American University of Beirut.
• Correlation of fiberoptic endoscopy and x-ray in gastro-esophageal lesions.
• Diagnosis of nonconvulsive status epilepticus (NCSE) in adults with altered mental status: clinico-electroencephalographic considerations.
• Familial hypercholesterolemia.
• Geographical variations and contextual effects on age of initiation of sexual intercourse among women in Nigeria: a multilevel and spatial analysis.
• Geography of Africa biomedical publications: An analysis of 1996-2005 PubMed papers.
• Giardiasis.
• HIV/AIDS in Nigeria: a bibliometric analysis.
• Intestinal amebiasis. Radiological and surgical aspects.
• Intestinal parasites in Lebanon.
• Letter: Tests for lactose malabsorption in adults.
• Management of massive upper gastrointestinal bleeding.
• Plasma lipids in diabetes mellitus.
• Prevalence and pattern of HIV-related malnutrition among women in sub-Saharan Africa: a meta-analysis of demographic health surveys.
• Some complications of diphenoxylate hydrochloride with atropine.
• Spectrum of diverticular disease of the colon in Lebanon AUBMC experience.
• Synovial fluid findings in a case of familial hypercholesterolemia.
• The significance of gastric juice analysis.
• Treatment of amebiasis.