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Sustained Efficacy and Long-term Safety of Oxcarbazepine: One-year Open-label Extension of a Study in Refractory Partial Epilepsy

dc.contributor.authorBeydoun, Ahmad A.en_US
dc.contributor.authorSachdeo, Rajesh C.en_US
dc.contributor.authorKutluay, Ekremen_US
dc.contributor.authorMcCague, Kevinen_US
dc.contributor.authorD'Souza, Josephen_US
dc.date.accessioned2010-04-01T15:11:22Z
dc.date.available2010-04-01T15:11:22Z
dc.date.issued2003-09en_US
dc.identifier.citationBeydoun, Ahmad; Sachdeo, Rajesh C.; Kutluay, Ekrem; McCague, Kevin; D'Souza, Joseph (2003). "Sustained Efficacy and Long-term Safety of Oxcarbazepine: One-year Open-label Extension of a Study in Refractory Partial Epilepsy." Epilepsia 44(9): 1160-1165. <http://hdl.handle.net/2027.42/65657>en_US
dc.identifier.issn0013-9580en_US
dc.identifier.issn1528-1167en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/65657
dc.identifier.urihttp://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=12919387&dopt=citationen_US
dc.description.abstractPurpose: To evaluate the long-term efficacy, tolerability, and safety of oxcarbazepine (OXC) in medically refractory partial epilepsy. Methods: This study is the open-label extension phase that followed a multicenter, randomized, double-blind, dose-response clinical study of OXC monotherapy in patients with medically refractory partial epilepsy. We analyzed the efficacy, tolerability, and safety of OXC during the first 48 weeks of open-label therapy. To evaluate efficacy, we compared the change in seizure frequency throughout the 48 weeks of treatment with OXC with the baseline seizure frequency that preceded the double-blind phase of the core study by an intent-to-treat and completer analysis. Safety and tolerability were evaluated by using an intent-to-treat analysis. Results: Of the 87 patients enrolled in the double-blind study, 76 patients participated in the open-label extension phase. Fifty-five (72%) patients completed 48 weeks of open-label treatment on a median OXC dose of 2,400 mg/day. Based on an intent-to-treat analysis, the median reduction in seizure frequency was 47% (p = 0.0054) ; the 50 and 75% responder rates were 46.1 and 25.0%, respectively, with 6.6% of patients remaining seizure free. The completer analysis yielded comparable efficacy results. OXC was well tolerated, with 13% of patients exiting because of adverse events. The six most common adverse events, irrespective of their causal relation to OXC, were dizziness, headache, fatigue, diplopia, nausea, and rash. For the most part, these adverse events tended to be transient. Conclusions: The efficacy of OXC is sustained with good safety and tolerability profiles during long-term treatment of patients with medically refractory partial epilepsy.en_US
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dc.format.extent3110 bytes
dc.format.mimetypeapplication/pdf
dc.format.mimetypetext/plain
dc.publisherBlackwell Science Incen_US
dc.rights2003 International League Against Epilepsyen_US
dc.subject.otherOxcarbazepineen_US
dc.subject.otherClinical Studyen_US
dc.subject.otherEfficacyen_US
dc.subject.otherAdverse Eventsen_US
dc.subject.otherEpilepsyen_US
dc.titleSustained Efficacy and Long-term Safety of Oxcarbazepine: One-year Open-label Extension of a Study in Refractory Partial Epilepsyen_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbsecondlevelMedicine (General)en_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.contributor.affiliationum* Department of Neurology, University of Michigan Health System, Ann Arbor, Michiganen_US
dc.contributor.affiliationother† University of Medicine and Dentistry of New Jersey, New Brunswick, New Jerseyen_US
dc.contributor.affiliationother† Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, U.S.A.en_US
dc.identifier.pmid12919387en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/65657/1/j.1528-1157.2003.54102.x.pdf
dc.identifier.doi10.1046/j.1528-1157.2003.54102.xen_US
dc.identifier.sourceEpilepsiaen_US
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dc.owningcollnameInterdisciplinary and Peer-Reviewed


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