Lacosamide monotherapy in clinical practice: A retrospective chart review

Objective To assess effectiveness and tolerability of first‐line and conversion to lacosamide monotherapy for focal seizures. Materials and Methods Retrospective, non‐interventional chart review of lacosamide monotherapy patients aged ≥16 years in Europe. Outcomes included retention rate at observat...

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Veröffentlicht in:Acta neurologica Scandinavica 2018-09, Vol.138 (3), p.186-194
Hauptverfasser: Villanueva, V., Giráldez, B. G., Toledo, M., De Haan, G. J., Cumbo, E., Gambardella, A., De Backer, M., Joeres, L., Brunnert, M., Dedeken, P., Serratosa, J.
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container_end_page 194
container_issue 3
container_start_page 186
container_title Acta neurologica Scandinavica
container_volume 138
creator Villanueva, V.
Giráldez, B. G.
Toledo, M.
De Haan, G. J.
Cumbo, E.
Gambardella, A.
De Backer, M.
Joeres, L.
Brunnert, M.
Dedeken, P.
Serratosa, J.
description Objective To assess effectiveness and tolerability of first‐line and conversion to lacosamide monotherapy for focal seizures. Materials and Methods Retrospective, non‐interventional chart review of lacosamide monotherapy patients aged ≥16 years in Europe. Outcomes included retention rate at observational point (OP) 3 (12 ± 3 months), seizure freedom rates at OP2 (6 ± 3 months) and OP3 and adverse drug reactions (ADRs). Results A total of 439 patients were included (98 first‐line and 341 conversion to monotherapy; 128 aged ≥65 years [25 first‐line and 103 conversion to monotherapy]). First‐line and conversion to monotherapy retention rates were 60.2% (59/98; 95% confidence interval [CI] 49.8%‐70.0%) and 62.5% (213/341; 57.1%‐67.6%), respectively. Kaplan‐Meier estimates of 12‐month retention rates were 81.2% and 91.4% for first‐line and conversion to monotherapy, respectively. First‐line and conversion to monotherapy retention rates in patients aged ≥65 years were 60.0% (38.7%‐78.9%) and 68.9% (59.1%‐77.7%), respectively. At OP2, 66.3% of first‐line and 63.0% of conversion to monotherapy patients were seizure free. At OP3, 60.2% of first‐line and 52.5% of conversion to monotherapy patients were seizure free. In the ≥65 years subgroup, seizure freedom rates at OP2 were 72.0% and 68.0% for first‐line and converted to monotherapy, respectively, and at OP3, 68.0% and 56.3%, respectively. Overall, 52 of 439 (11.8%) patients reported ADRs (16.4% in ≥65 years subgroup), most commonly dizziness (5.0%), headache (2.1%) and somnolence (1.6%). Conclusions Lacosamide was effective and well tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal seizures.
doi_str_mv 10.1111/ane.12920
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G. ; Toledo, M. ; De Haan, G. J. ; Cumbo, E. ; Gambardella, A. ; De Backer, M. ; Joeres, L. ; Brunnert, M. ; Dedeken, P. ; Serratosa, J.</creator><creatorcontrib>Villanueva, V. ; Giráldez, B. G. ; Toledo, M. ; De Haan, G. J. ; Cumbo, E. ; Gambardella, A. ; De Backer, M. ; Joeres, L. ; Brunnert, M. ; Dedeken, P. ; Serratosa, J.</creatorcontrib><description>Objective To assess effectiveness and tolerability of first‐line and conversion to lacosamide monotherapy for focal seizures. Materials and Methods Retrospective, non‐interventional chart review of lacosamide monotherapy patients aged ≥16 years in Europe. Outcomes included retention rate at observational point (OP) 3 (12 ± 3 months), seizure freedom rates at OP2 (6 ± 3 months) and OP3 and adverse drug reactions (ADRs). Results A total of 439 patients were included (98 first‐line and 341 conversion to monotherapy; 128 aged ≥65 years [25 first‐line and 103 conversion to monotherapy]). First‐line and conversion to monotherapy retention rates were 60.2% (59/98; 95% confidence interval [CI] 49.8%‐70.0%) and 62.5% (213/341; 57.1%‐67.6%), respectively. Kaplan‐Meier estimates of 12‐month retention rates were 81.2% and 91.4% for first‐line and conversion to monotherapy, respectively. First‐line and conversion to monotherapy retention rates in patients aged ≥65 years were 60.0% (38.7%‐78.9%) and 68.9% (59.1%‐77.7%), respectively. At OP2, 66.3% of first‐line and 63.0% of conversion to monotherapy patients were seizure free. At OP3, 60.2% of first‐line and 52.5% of conversion to monotherapy patients were seizure free. In the ≥65 years subgroup, seizure freedom rates at OP2 were 72.0% and 68.0% for first‐line and converted to monotherapy, respectively, and at OP3, 68.0% and 56.3%, respectively. Overall, 52 of 439 (11.8%) patients reported ADRs (16.4% in ≥65 years subgroup), most commonly dizziness (5.0%), headache (2.1%) and somnolence (1.6%). Conclusions Lacosamide was effective and well tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal seizures.</description><identifier>ISSN: 0001-6314</identifier><identifier>EISSN: 1600-0404</identifier><identifier>DOI: 10.1111/ane.12920</identifier><identifier>PMID: 29542107</identifier><language>eng</language><publisher>Denmark: Hindawi Limited</publisher><subject>Acetamides - therapeutic use ; Adolescent ; Adult ; Aged ; Anticonvulsants - therapeutic use ; antiepileptic drug ; clinical practice ; epilepsy ; Europe ; Female ; focal seizures ; Geriatrics ; Headache ; Humans ; Lacosamide ; Male ; Middle Aged ; monotherapy ; Original ; partial ; partial‐onset ; Retention ; Retrospective Studies ; Seizures ; Seizures - drug therapy</subject><ispartof>Acta neurologica Scandinavica, 2018-09, Vol.138 (3), p.186-194</ispartof><rights>2018 The Authors. Published by John Wiley &amp; Sons Ltd</rights><rights>2018 The Authors. Acta Neurologica Scandinavica Published by John Wiley &amp; Sons Ltd.</rights><rights>Copyright © 2018 John Wiley &amp; Sons A/S. Published by John Wiley &amp; Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4430-b582559fcb4487cdc439420b051961108329c0a929db6504cf770b931b7fc7973</citedby><cites>FETCH-LOGICAL-c4430-b582559fcb4487cdc439420b051961108329c0a929db6504cf770b931b7fc7973</cites><orcidid>0000-0003-3208-2496</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fane.12920$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fane.12920$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29542107$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Villanueva, V.</creatorcontrib><creatorcontrib>Giráldez, B. G.</creatorcontrib><creatorcontrib>Toledo, M.</creatorcontrib><creatorcontrib>De Haan, G. J.</creatorcontrib><creatorcontrib>Cumbo, E.</creatorcontrib><creatorcontrib>Gambardella, A.</creatorcontrib><creatorcontrib>De Backer, M.</creatorcontrib><creatorcontrib>Joeres, L.</creatorcontrib><creatorcontrib>Brunnert, M.</creatorcontrib><creatorcontrib>Dedeken, P.</creatorcontrib><creatorcontrib>Serratosa, J.</creatorcontrib><title>Lacosamide monotherapy in clinical practice: A retrospective chart review</title><title>Acta neurologica Scandinavica</title><addtitle>Acta Neurol Scand</addtitle><description>Objective To assess effectiveness and tolerability of first‐line and conversion to lacosamide monotherapy for focal seizures. Materials and Methods Retrospective, non‐interventional chart review of lacosamide monotherapy patients aged ≥16 years in Europe. Outcomes included retention rate at observational point (OP) 3 (12 ± 3 months), seizure freedom rates at OP2 (6 ± 3 months) and OP3 and adverse drug reactions (ADRs). Results A total of 439 patients were included (98 first‐line and 341 conversion to monotherapy; 128 aged ≥65 years [25 first‐line and 103 conversion to monotherapy]). First‐line and conversion to monotherapy retention rates were 60.2% (59/98; 95% confidence interval [CI] 49.8%‐70.0%) and 62.5% (213/341; 57.1%‐67.6%), respectively. Kaplan‐Meier estimates of 12‐month retention rates were 81.2% and 91.4% for first‐line and conversion to monotherapy, respectively. First‐line and conversion to monotherapy retention rates in patients aged ≥65 years were 60.0% (38.7%‐78.9%) and 68.9% (59.1%‐77.7%), respectively. At OP2, 66.3% of first‐line and 63.0% of conversion to monotherapy patients were seizure free. At OP3, 60.2% of first‐line and 52.5% of conversion to monotherapy patients were seizure free. In the ≥65 years subgroup, seizure freedom rates at OP2 were 72.0% and 68.0% for first‐line and converted to monotherapy, respectively, and at OP3, 68.0% and 56.3%, respectively. Overall, 52 of 439 (11.8%) patients reported ADRs (16.4% in ≥65 years subgroup), most commonly dizziness (5.0%), headache (2.1%) and somnolence (1.6%). Conclusions Lacosamide was effective and well tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal seizures.</description><subject>Acetamides - therapeutic use</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Anticonvulsants - therapeutic use</subject><subject>antiepileptic drug</subject><subject>clinical practice</subject><subject>epilepsy</subject><subject>Europe</subject><subject>Female</subject><subject>focal seizures</subject><subject>Geriatrics</subject><subject>Headache</subject><subject>Humans</subject><subject>Lacosamide</subject><subject>Male</subject><subject>Middle Aged</subject><subject>monotherapy</subject><subject>Original</subject><subject>partial</subject><subject>partial‐onset</subject><subject>Retention</subject><subject>Retrospective Studies</subject><subject>Seizures</subject><subject>Seizures - drug therapy</subject><issn>0001-6314</issn><issn>1600-0404</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kctOxCAUhonR6HhZ-AKmiRtdVA8U2uLCZGK8TDLRja4JpdRh0pYK7Zh5e9GqURPZEA5fPg7nR-gQwxkO61y2-gwTTmADTXAKEAMFuokmAIDjNMF0B-16vwwnklG6jXYIZ5RgyCZoNpfKetmYUkeNbW2_0E5268i0kapNa5Sso85J1RulL6Jp5HTvrO90KKx0pBbS9aG2Mvp1H21Vsvb64HPfQ083149Xd_H84XZ2NZ3HitIE4oLlhDFeqYLSPFOlogmnBApgmKcYQ54QrkBywssiZUBVlWVQ8AQXWaUyniV76HL0dkPR6FLptneyFp0zjXRrYaURv29asxDPdiVS4DyhJAhOPgXOvgza96IxXum6DmO0gxcEMMWUjG8d_0GXdnBt-F6gcsZYwgkL1OlIqTAa73T13QwG8R6QCGbxEVBgj352_01-JRKA8xF4NbVe_28S0_vrUfkG9YqZEQ</recordid><startdate>201809</startdate><enddate>201809</enddate><creator>Villanueva, V.</creator><creator>Giráldez, B. G.</creator><creator>Toledo, M.</creator><creator>De Haan, G. J.</creator><creator>Cumbo, E.</creator><creator>Gambardella, A.</creator><creator>De Backer, M.</creator><creator>Joeres, L.</creator><creator>Brunnert, M.</creator><creator>Dedeken, P.</creator><creator>Serratosa, J.</creator><general>Hindawi Limited</general><general>John Wiley and Sons Inc</general><scope>24P</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>7TK</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-3208-2496</orcidid></search><sort><creationdate>201809</creationdate><title>Lacosamide monotherapy in clinical practice: A retrospective chart review</title><author>Villanueva, V. ; Giráldez, B. G. ; Toledo, M. ; De Haan, G. J. ; Cumbo, E. ; Gambardella, A. ; De Backer, M. ; Joeres, L. ; Brunnert, M. ; Dedeken, P. ; Serratosa, J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4430-b582559fcb4487cdc439420b051961108329c0a929db6504cf770b931b7fc7973</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Acetamides - therapeutic use</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Anticonvulsants - therapeutic use</topic><topic>antiepileptic drug</topic><topic>clinical practice</topic><topic>epilepsy</topic><topic>Europe</topic><topic>Female</topic><topic>focal seizures</topic><topic>Geriatrics</topic><topic>Headache</topic><topic>Humans</topic><topic>Lacosamide</topic><topic>Male</topic><topic>Middle Aged</topic><topic>monotherapy</topic><topic>Original</topic><topic>partial</topic><topic>partial‐onset</topic><topic>Retention</topic><topic>Retrospective Studies</topic><topic>Seizures</topic><topic>Seizures - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Villanueva, V.</creatorcontrib><creatorcontrib>Giráldez, B. G.</creatorcontrib><creatorcontrib>Toledo, M.</creatorcontrib><creatorcontrib>De Haan, G. J.</creatorcontrib><creatorcontrib>Cumbo, E.</creatorcontrib><creatorcontrib>Gambardella, A.</creatorcontrib><creatorcontrib>De Backer, M.</creatorcontrib><creatorcontrib>Joeres, L.</creatorcontrib><creatorcontrib>Brunnert, M.</creatorcontrib><creatorcontrib>Dedeken, P.</creatorcontrib><creatorcontrib>Serratosa, J.</creatorcontrib><collection>Wiley Online Library 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>Neurosciences Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Acta neurologica Scandinavica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Villanueva, V.</au><au>Giráldez, B. G.</au><au>Toledo, M.</au><au>De Haan, G. J.</au><au>Cumbo, E.</au><au>Gambardella, A.</au><au>De Backer, M.</au><au>Joeres, L.</au><au>Brunnert, M.</au><au>Dedeken, P.</au><au>Serratosa, J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lacosamide monotherapy in clinical practice: A retrospective chart review</atitle><jtitle>Acta neurologica Scandinavica</jtitle><addtitle>Acta Neurol Scand</addtitle><date>2018-09</date><risdate>2018</risdate><volume>138</volume><issue>3</issue><spage>186</spage><epage>194</epage><pages>186-194</pages><issn>0001-6314</issn><eissn>1600-0404</eissn><abstract>Objective To assess effectiveness and tolerability of first‐line and conversion to lacosamide monotherapy for focal seizures. Materials and Methods Retrospective, non‐interventional chart review of lacosamide monotherapy patients aged ≥16 years in Europe. Outcomes included retention rate at observational point (OP) 3 (12 ± 3 months), seizure freedom rates at OP2 (6 ± 3 months) and OP3 and adverse drug reactions (ADRs). Results A total of 439 patients were included (98 first‐line and 341 conversion to monotherapy; 128 aged ≥65 years [25 first‐line and 103 conversion to monotherapy]). First‐line and conversion to monotherapy retention rates were 60.2% (59/98; 95% confidence interval [CI] 49.8%‐70.0%) and 62.5% (213/341; 57.1%‐67.6%), respectively. Kaplan‐Meier estimates of 12‐month retention rates were 81.2% and 91.4% for first‐line and conversion to monotherapy, respectively. First‐line and conversion to monotherapy retention rates in patients aged ≥65 years were 60.0% (38.7%‐78.9%) and 68.9% (59.1%‐77.7%), respectively. At OP2, 66.3% of first‐line and 63.0% of conversion to monotherapy patients were seizure free. At OP3, 60.2% of first‐line and 52.5% of conversion to monotherapy patients were seizure free. In the ≥65 years subgroup, seizure freedom rates at OP2 were 72.0% and 68.0% for first‐line and converted to monotherapy, respectively, and at OP3, 68.0% and 56.3%, respectively. Overall, 52 of 439 (11.8%) patients reported ADRs (16.4% in ≥65 years subgroup), most commonly dizziness (5.0%), headache (2.1%) and somnolence (1.6%). Conclusions Lacosamide was effective and well tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal seizures.</abstract><cop>Denmark</cop><pub>Hindawi Limited</pub><pmid>29542107</pmid><doi>10.1111/ane.12920</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-3208-2496</orcidid><oa>free_for_read</oa></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects Acetamides - therapeutic use
Adolescent
Adult
Aged
Anticonvulsants - therapeutic use
antiepileptic drug
clinical practice
epilepsy
Europe
Female
focal seizures
Geriatrics
Headache
Humans
Lacosamide
Male
Middle Aged
monotherapy
Original
partial
partial‐onset
Retention
Retrospective Studies
Seizures
Seizures - drug therapy
title Lacosamide monotherapy in clinical practice: A retrospective chart review
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