Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy
•We assessed myoclonic and absence seizure outcomes with perampanel from Study 332.•Add-on perampanel and placebo reduced myoclonic and absence seizure frequency.•Treatment-emergent adverse events were consistent with perampanel’s safety profile.•Outcomes were maintained during long-term (>104 we...
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| Veröffentlicht in: | Seizure (London, England) England), 2020-08, Vol.80, p.115-123 |
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| creator | Brandt, Christian Wechsler, Robert T. O’Brien, Terence J. Patten, Anna Malhotra, Manoj Ngo, Leock Y. Steinhoff, Bernhard J. |
| description | •We assessed myoclonic and absence seizure outcomes with perampanel from Study 332.•Add-on perampanel and placebo reduced myoclonic and absence seizure frequency.•Treatment-emergent adverse events were consistent with perampanel’s safety profile.•Outcomes were maintained during long-term (>104 weeks) perampanel treatment.•Overall, there was no worsening of absence seizures with perampanel.
This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures. |
| doi_str_mv | 10.1016/j.seizure.2020.06.011 |
| format | Article |
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This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.</description><identifier>ISSN: 1059-1311</identifier><identifier>EISSN: 1532-2688</identifier><identifier>DOI: 10.1016/j.seizure.2020.06.011</identifier><identifier>PMID: 32563171</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Absence seizures ; Anticonvulsants - therapeutic use ; Double-Blind Method ; Drug Therapy, Combination ; Epilepsy, Generalized - drug therapy ; Humans ; Idiopathic generalized epilepsy ; Myoclonic seizures ; Nitriles ; Open-label extension ; Perampanel ; Pyridones - adverse effects ; Seizure-free days ; Seizures - drug therapy ; Treatment Outcome</subject><ispartof>Seizure (London, England), 2020-08, Vol.80, p.115-123</ispartof><rights>2020 The Authors</rights><rights>Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c482t-20adf7d5b8f5bb64ed2072ff61223bef4ec4f7f7d6364a2ffa5324b09833ef543</citedby><cites>FETCH-LOGICAL-c482t-20adf7d5b8f5bb64ed2072ff61223bef4ec4f7f7d6364a2ffa5324b09833ef543</cites><orcidid>0000-0002-4315-8284 ; 0000-0002-8184-1367</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.seizure.2020.06.011$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32563171$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brandt, Christian</creatorcontrib><creatorcontrib>Wechsler, Robert T.</creatorcontrib><creatorcontrib>O’Brien, Terence J.</creatorcontrib><creatorcontrib>Patten, Anna</creatorcontrib><creatorcontrib>Malhotra, Manoj</creatorcontrib><creatorcontrib>Ngo, Leock Y.</creatorcontrib><creatorcontrib>Steinhoff, Bernhard J.</creatorcontrib><title>Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy</title><title>Seizure (London, England)</title><addtitle>Seizure</addtitle><description>•We assessed myoclonic and absence seizure outcomes with perampanel from Study 332.•Add-on perampanel and placebo reduced myoclonic and absence seizure frequency.•Treatment-emergent adverse events were consistent with perampanel’s safety profile.•Outcomes were maintained during long-term (>104 weeks) perampanel treatment.•Overall, there was no worsening of absence seizures with perampanel.
This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.</description><subject>Absence seizures</subject><subject>Anticonvulsants - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Epilepsy, Generalized - drug therapy</subject><subject>Humans</subject><subject>Idiopathic generalized epilepsy</subject><subject>Myoclonic seizures</subject><subject>Nitriles</subject><subject>Open-label extension</subject><subject>Perampanel</subject><subject>Pyridones - adverse effects</subject><subject>Seizure-free days</subject><subject>Seizures - drug therapy</subject><subject>Treatment Outcome</subject><issn>1059-1311</issn><issn>1532-2688</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc1u1TAQhS1ERUvhEUBesknwX5yEDaoq_qRKZQFry7HHXF8lcbCdVulr9IXx5V7YdmV75ps58jkIvaGkpoTK9_s6gX9YI9SMMFITWRNKn6EL2nBWMdl1z8udNH1FOaXn6GVKe0JILyh_gc45aySnLb1Aj1d2v84m-zvAC0Q9LXqGEevZ4mkLZgyzN39fekgwG8An1fQBfw8p4104tPW4JZ9wcNjqrLGLYcIpr3bDnDPsZ7zo7GHOCd_7vMPe-lAqu7L6F8xFdfQPYDEsfoQlba_QmdNjgten8xL9_Pzpx_XX6ub2y7frq5vKiI7lihFtXWuboXPNMEgBlpGWOScpY3wAJ8AI1xZCcil0aehijRhI33EOrhH8Er077l1i-L1CymryycA4FgvCmhQTtGFd39O2oM0RNTGkFMGpJfpJx01Rog55qL06OaMOeSgiVcmjzL09SazDBPb_1L8ACvDxCED56J2HqJLxB6Otj2CyssE_IfEHotiiNQ</recordid><startdate>20200801</startdate><enddate>20200801</enddate><creator>Brandt, Christian</creator><creator>Wechsler, Robert T.</creator><creator>O’Brien, Terence J.</creator><creator>Patten, Anna</creator><creator>Malhotra, Manoj</creator><creator>Ngo, Leock Y.</creator><creator>Steinhoff, Bernhard J.</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-4315-8284</orcidid><orcidid>https://orcid.org/0000-0002-8184-1367</orcidid></search><sort><creationdate>20200801</creationdate><title>Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy</title><author>Brandt, Christian ; Wechsler, Robert T. ; O’Brien, Terence J. ; Patten, Anna ; Malhotra, Manoj ; Ngo, Leock Y. ; Steinhoff, Bernhard J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c482t-20adf7d5b8f5bb64ed2072ff61223bef4ec4f7f7d6364a2ffa5324b09833ef543</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Absence seizures</topic><topic>Anticonvulsants - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Epilepsy, Generalized - drug therapy</topic><topic>Humans</topic><topic>Idiopathic generalized epilepsy</topic><topic>Myoclonic seizures</topic><topic>Nitriles</topic><topic>Open-label extension</topic><topic>Perampanel</topic><topic>Pyridones - adverse effects</topic><topic>Seizure-free days</topic><topic>Seizures - drug therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brandt, Christian</creatorcontrib><creatorcontrib>Wechsler, Robert T.</creatorcontrib><creatorcontrib>O’Brien, Terence J.</creatorcontrib><creatorcontrib>Patten, Anna</creatorcontrib><creatorcontrib>Malhotra, Manoj</creatorcontrib><creatorcontrib>Ngo, Leock Y.</creatorcontrib><creatorcontrib>Steinhoff, Bernhard J.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Seizure (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brandt, Christian</au><au>Wechsler, Robert T.</au><au>O’Brien, Terence J.</au><au>Patten, Anna</au><au>Malhotra, Manoj</au><au>Ngo, Leock Y.</au><au>Steinhoff, Bernhard J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy</atitle><jtitle>Seizure (London, England)</jtitle><addtitle>Seizure</addtitle><date>2020-08-01</date><risdate>2020</risdate><volume>80</volume><spage>115</spage><epage>123</epage><pages>115-123</pages><issn>1059-1311</issn><eissn>1532-2688</eissn><abstract>•We assessed myoclonic and absence seizure outcomes with perampanel from Study 332.•Add-on perampanel and placebo reduced myoclonic and absence seizure frequency.•Treatment-emergent adverse events were consistent with perampanel’s safety profile.•Outcomes were maintained during long-term (>104 weeks) perampanel treatment.•Overall, there was no worsening of absence seizures with perampanel.
This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>32563171</pmid><doi>10.1016/j.seizure.2020.06.011</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-4315-8284</orcidid><orcidid>https://orcid.org/0000-0002-8184-1367</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present); EZB-FREE-00999 freely available EZB journals |
| subjects | Absence seizures Anticonvulsants - therapeutic use Double-Blind Method Drug Therapy, Combination Epilepsy, Generalized - drug therapy Humans Idiopathic generalized epilepsy Myoclonic seizures Nitriles Open-label extension Perampanel Pyridones - adverse effects Seizure-free days Seizures - drug therapy Treatment Outcome |
| title | Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy |
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