| Pregabalin add-on therapy using a flexible, optimized dose schedule in refractory partial epilepsies: a double-blind, randomized, placebo-controlled, multicenter trial. | |
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MedLine Citation:
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PMID: 19222545 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To evaluate the efficacy and safety of pregabalin (PGB) as adjunctive therapy, using a flexible-dosing schedule in Korean patients with refractory partial-onset seizures. METHODS: This randomized, double-blind (DB), placebo-controlled trial consists of a 6-week baseline, a 12-week DB treatment, and a 1-week taper phase. Patients having recurrent partial seizures (>or=4 seizures during baseline phase) under adequate pharmacotherapy were recruited to be randomized to PGB or placebo (PLC) in a 2 to 1 ratio. Starting dose was 150 mg/day, increased every 2 weeks by 150-mg/day increments up to maximum dose of 600 mg/day. The primary efficacy parameter was response ratio (RRatio) for all partial seizures. RESULTS: A total of 178 patients (119 in PGB, 59 in PLC) were assigned to the study. Median daily doses of PGB and PLC were 367 and 420 mg/day, respectively. RRatio least squares (LS) mean was -35.8 in the PGB group and -23.2 in the PLC group, with estimated difference in RRatios being -12.6 [95% confidence interval (CI): -22.7 to -2.5, p = 0.015] in the intent-to-treat (ITT) population. Analysis of secondary efficacy measures showed a general trend favoring PGB over PLC. Seventy-seven patients (64.7%) in the PGB group and 18 patients (30.5%) in the PLC group developed adverse events (AEs) related to the study drug. Seven patients (5.9%) in the PGB group discontinued the study prematurely because of AEs. In the post hoc analysis, a significant weight gain (>or=7% of baseline body weight) was found in 24.8% of patients taking PGB, which was more frequent in patients with a lower body mass index (BMI <or=20). DISCUSSION: PGB was effective and easily tolerable as add-on treatment in an Asian population with refractory partial-onset seizures. |
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Authors:
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Byung In Lee; Sangdoe Yi; Seung Bong Hong; Myeong-Kyu Kim; Sang Ahm Lee; Sang Kun Lee; Dong-Jin Shin; Jae Moon Kim; Hong Ki Song; Kyoung Heo; Wing Lowe; Teresa Leon |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-02-13 |
Journal Detail:
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Title: Epilepsia Volume: 50 ISSN: 1528-1167 ISO Abbreviation: Epilepsia Publication Date: 2009 Mar |
Date Detail:
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Created Date: 2009-03-25 Completed Date: 2009-04-13 Revised Date: 2009-08-28 |
Medline Journal Info:
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Nlm Unique ID: 2983306R Medline TA: Epilepsia Country: United States |
Other Details:
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Languages: eng Pagination: 464-74 Citation Subset: IM |
Affiliation:
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Department of Neurology, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea. bilee@yuhs.ac |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anticonvulsants / adverse effects, therapeutic use* Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug Therapy, Combination Epilepsies, Partial / drug therapy* Female Humans Korea Male Middle Aged Patient Satisfaction Treatment Outcome Young Adult gamma-Aminobutyric Acid / adverse effects, analogs & derivatives*, therapeutic use |
| Chemical | |
Reg. No./Substance:
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0/Anticonvulsants; 0/pregabalin; 56-12-2/gamma-Aminobutyric Acid |
| Comments/Corrections | |
Erratum In:
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Epilepsia. 2009 Aug;50(8):2010 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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