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The EULEV cohort study: rates of and factors associated with continuation of levetiracetam after 1 year
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Levetiracetam has shown good safety/tolerability and efficacy in regulatory trials. This was confirmed in observational investigations performed soon after marketing by using continuation or retention rates as a composite measure. • When an anti‐epileptic d...
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Published in: | British journal of clinical pharmacology 2011-01, Vol.71 (1), p.121-127 |
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creator | Droz‐Perroteau, Cécile Dureau‐Pournin, Caroline Vespignani, Hervé Marchal, Cécile Blin, Patrick Blazejewski, Sylvie Pollet, Clothilde Jové, Jérémy Robinson, Philip Moore, Nicholas Fourrier‐Réglat, Annie |
description | WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Levetiracetam has shown good safety/tolerability and efficacy in regulatory trials. This was confirmed in observational investigations performed soon after marketing by using continuation or retention rates as a composite measure.
• When an anti‐epileptic drug first becomes available; however, there is evidence of channelling to more severe patients than thereafter.
WHAT THIS STUDY ADDS
• This study was performed several years after marketing of levetiracetam and found high rates of continuation.
• It also further explores this measure by determining the continuation in the absence of initiation of additional anti‐epileptic drugs.
AIMS To investigate real‐life effectiveness of levetiracetam in patients initiating treatment in a stable market situation.
METHODS Epileptic adults who had initiated levetiracetam between 1 January and 31 August in 2005 or 2006 were included and followed for 1 year by hospital or nonhospital neurologists practising in France. One‐year continuation rates were estimated using Kaplan–Meier analysis. Among those still treated at end of study, treatment goals were investigated. Factors associated with discontinuation were investigated using Cox proportional hazards regression.
RESULTS A total of 794 subjects were included in the cohort, and 753 subjects were followed up and included in the analysis. Among these, mean (SD) age was 42.6 (±17.0) years, 51.1% were female, 76.6% had partial epilepsy, 93.5% had seizures in the 6 months preceding levetiracetam initiation and 82.9% had at least one concomitant anti‐epileptic drug when starting levetiracetam. One‐year levetiracetam continuation rate was 83.5% (95% confidence interval, 80.5–86.0%). Of the 579 patients still using levetiracetam at end of study, 46.8% were seizure free during the last 6 months, and 24% were on levetiracetam monotherapy. Reasons for discontinuation (n= 122) were adverse events (45%), lack of efficacy (38%) or both (9%). Levetiracetam discontinuation was most strongly associated with previous exposure to more than four anti‐epileptic drugs, whereas continuation was most strongly associated with presence of seizure‐related falls in the 6 months preceding levetiracetam initiation.
CONCLUSIONS This population‐based cohort study in a stable market situation found a high 1 year levetiracetam continuation rate compared with previous studies done sooner after market introduction. |
doi_str_mv | 10.1111/j.1365-2125.2010.03805.x |
format | article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3018033</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>821481835</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5035-2558fbf1c408c7f1e954651f8ab9d383eb80bf56a7bc3dae5324cfef596bed723</originalsourceid><addsrcrecordid>eNqNkUFvGyEQhVHUqHHS_oWIS9WTHViWNa7USqnlpJEspYekVzTLDjHWekmBTeJ_XzZ23fZWLiDeN2-e9AihnE14PhfrCReVHBe8kJOC5V8mFJOTlyMyOghvyIgJVo1lIfkJOY1xzRgXvJJvyUnBeSkkUyPycLdCurhfLn5Q41c-JBpT32w_0QAJI_WWQtdQCyb5ECnE6I3LSkOfXVrlkS65rofkfDewLT5hcgEMJthQsAkD5XSLEN6RYwttxPf7-4zcXy3u5t_Gy9vrm_nlcmwkEzm4lMrWlpuSKTO1HGeyrCS3CupZI5TAWrHaygqmtRENoBRFaSxaOatqbKaFOCNfdr6Pfb3BxmCXArT6MbgNhK324PS_SudW-sE_acG4YkJkg497g-B_9hiT3rhosG2hQ99HrQpeKq6EzKTakSb4GAPawxbO9FCTXuuhDT20oYea9GtN-iWPnv-d8jD4u5cMfNgDEA20NkBnXPzDZVsupyxzn3fcs2tx-98B9Nf59-ElfgE3s6-8</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>821481835</pqid></control><display><type>article</type><title>The EULEV cohort study: rates of and factors associated with continuation of levetiracetam after 1 year</title><source>Wiley:Jisc Collections:Wiley Read and Publish Open Access 2024-2025 (reading list)</source><creator>Droz‐Perroteau, Cécile ; Dureau‐Pournin, Caroline ; Vespignani, Hervé ; Marchal, Cécile ; Blin, Patrick ; Blazejewski, Sylvie ; Pollet, Clothilde ; Jové, Jérémy ; Robinson, Philip ; Moore, Nicholas ; Fourrier‐Réglat, Annie</creator><creatorcontrib>Droz‐Perroteau, Cécile ; Dureau‐Pournin, Caroline ; Vespignani, Hervé ; Marchal, Cécile ; Blin, Patrick ; Blazejewski, Sylvie ; Pollet, Clothilde ; Jové, Jérémy ; Robinson, Philip ; Moore, Nicholas ; Fourrier‐Réglat, Annie ; EULEV Study Group ; on behalf of the EULEV Study Group</creatorcontrib><description>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Levetiracetam has shown good safety/tolerability and efficacy in regulatory trials. This was confirmed in observational investigations performed soon after marketing by using continuation or retention rates as a composite measure.
• When an anti‐epileptic drug first becomes available; however, there is evidence of channelling to more severe patients than thereafter.
WHAT THIS STUDY ADDS
• This study was performed several years after marketing of levetiracetam and found high rates of continuation.
• It also further explores this measure by determining the continuation in the absence of initiation of additional anti‐epileptic drugs.
AIMS To investigate real‐life effectiveness of levetiracetam in patients initiating treatment in a stable market situation.
METHODS Epileptic adults who had initiated levetiracetam between 1 January and 31 August in 2005 or 2006 were included and followed for 1 year by hospital or nonhospital neurologists practising in France. One‐year continuation rates were estimated using Kaplan–Meier analysis. Among those still treated at end of study, treatment goals were investigated. Factors associated with discontinuation were investigated using Cox proportional hazards regression.
RESULTS A total of 794 subjects were included in the cohort, and 753 subjects were followed up and included in the analysis. Among these, mean (SD) age was 42.6 (±17.0) years, 51.1% were female, 76.6% had partial epilepsy, 93.5% had seizures in the 6 months preceding levetiracetam initiation and 82.9% had at least one concomitant anti‐epileptic drug when starting levetiracetam. One‐year levetiracetam continuation rate was 83.5% (95% confidence interval, 80.5–86.0%). Of the 579 patients still using levetiracetam at end of study, 46.8% were seizure free during the last 6 months, and 24% were on levetiracetam monotherapy. Reasons for discontinuation (n= 122) were adverse events (45%), lack of efficacy (38%) or both (9%). Levetiracetam discontinuation was most strongly associated with previous exposure to more than four anti‐epileptic drugs, whereas continuation was most strongly associated with presence of seizure‐related falls in the 6 months preceding levetiracetam initiation.
CONCLUSIONS This population‐based cohort study in a stable market situation found a high 1 year levetiracetam continuation rate compared with previous studies done sooner after market introduction.</description><identifier>ISSN: 0306-5251</identifier><identifier>EISSN: 1365-2125</identifier><identifier>DOI: 10.1111/j.1365-2125.2010.03805.x</identifier><identifier>PMID: 21143508</identifier><identifier>CODEN: BCPHBM</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anticonvulsants - therapeutic use ; antiepileptic drug ; Biological and medical sciences ; cohort ; Cohort Studies ; effectiveness ; epilepsy ; Epilepsy - drug therapy ; Epilepsy - epidemiology ; Female ; France - epidemiology ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Humans ; levetiracetam ; Male ; Medical sciences ; Middle Aged ; Nervous system (semeiology, syndromes) ; Neurology ; Pharmacoepidemiology ; Pharmacology. Drug treatments ; Piracetam - analogs & derivatives ; Piracetam - therapeutic use ; Time Factors ; Treatment Outcome ; Young Adult</subject><ispartof>British journal of clinical pharmacology, 2011-01, Vol.71 (1), p.121-127</ispartof><rights>2010 The Authors. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society</rights><rights>2015 INIST-CNRS</rights><rights>2010 The Authors. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society.</rights><rights>Copyright © 2011 The British Pharmacological Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5035-2558fbf1c408c7f1e954651f8ab9d383eb80bf56a7bc3dae5324cfef596bed723</citedby><cites>FETCH-LOGICAL-c5035-2558fbf1c408c7f1e954651f8ab9d383eb80bf56a7bc3dae5324cfef596bed723</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,4024,27923,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23651570$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21143508$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Droz‐Perroteau, Cécile</creatorcontrib><creatorcontrib>Dureau‐Pournin, Caroline</creatorcontrib><creatorcontrib>Vespignani, Hervé</creatorcontrib><creatorcontrib>Marchal, Cécile</creatorcontrib><creatorcontrib>Blin, Patrick</creatorcontrib><creatorcontrib>Blazejewski, Sylvie</creatorcontrib><creatorcontrib>Pollet, Clothilde</creatorcontrib><creatorcontrib>Jové, Jérémy</creatorcontrib><creatorcontrib>Robinson, Philip</creatorcontrib><creatorcontrib>Moore, Nicholas</creatorcontrib><creatorcontrib>Fourrier‐Réglat, Annie</creatorcontrib><creatorcontrib>EULEV Study Group</creatorcontrib><creatorcontrib>on behalf of the EULEV Study Group</creatorcontrib><title>The EULEV cohort study: rates of and factors associated with continuation of levetiracetam after 1 year</title><title>British journal of clinical pharmacology</title><addtitle>Br J Clin Pharmacol</addtitle><description>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Levetiracetam has shown good safety/tolerability and efficacy in regulatory trials. This was confirmed in observational investigations performed soon after marketing by using continuation or retention rates as a composite measure.
• When an anti‐epileptic drug first becomes available; however, there is evidence of channelling to more severe patients than thereafter.
WHAT THIS STUDY ADDS
• This study was performed several years after marketing of levetiracetam and found high rates of continuation.
• It also further explores this measure by determining the continuation in the absence of initiation of additional anti‐epileptic drugs.
AIMS To investigate real‐life effectiveness of levetiracetam in patients initiating treatment in a stable market situation.
METHODS Epileptic adults who had initiated levetiracetam between 1 January and 31 August in 2005 or 2006 were included and followed for 1 year by hospital or nonhospital neurologists practising in France. One‐year continuation rates were estimated using Kaplan–Meier analysis. Among those still treated at end of study, treatment goals were investigated. Factors associated with discontinuation were investigated using Cox proportional hazards regression.
RESULTS A total of 794 subjects were included in the cohort, and 753 subjects were followed up and included in the analysis. Among these, mean (SD) age was 42.6 (±17.0) years, 51.1% were female, 76.6% had partial epilepsy, 93.5% had seizures in the 6 months preceding levetiracetam initiation and 82.9% had at least one concomitant anti‐epileptic drug when starting levetiracetam. One‐year levetiracetam continuation rate was 83.5% (95% confidence interval, 80.5–86.0%). Of the 579 patients still using levetiracetam at end of study, 46.8% were seizure free during the last 6 months, and 24% were on levetiracetam monotherapy. Reasons for discontinuation (n= 122) were adverse events (45%), lack of efficacy (38%) or both (9%). Levetiracetam discontinuation was most strongly associated with previous exposure to more than four anti‐epileptic drugs, whereas continuation was most strongly associated with presence of seizure‐related falls in the 6 months preceding levetiracetam initiation.
CONCLUSIONS This population‐based cohort study in a stable market situation found a high 1 year levetiracetam continuation rate compared with previous studies done sooner after market introduction.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticonvulsants - therapeutic use</subject><subject>antiepileptic drug</subject><subject>Biological and medical sciences</subject><subject>cohort</subject><subject>Cohort Studies</subject><subject>effectiveness</subject><subject>epilepsy</subject><subject>Epilepsy - drug therapy</subject><subject>Epilepsy - epidemiology</subject><subject>Female</subject><subject>France - epidemiology</subject><subject>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</subject><subject>Humans</subject><subject>levetiracetam</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neurology</subject><subject>Pharmacoepidemiology</subject><subject>Pharmacology. Drug treatments</subject><subject>Piracetam - analogs & derivatives</subject><subject>Piracetam - therapeutic use</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0306-5251</issn><issn>1365-2125</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><recordid>eNqNkUFvGyEQhVHUqHHS_oWIS9WTHViWNa7USqnlpJEspYekVzTLDjHWekmBTeJ_XzZ23fZWLiDeN2-e9AihnE14PhfrCReVHBe8kJOC5V8mFJOTlyMyOghvyIgJVo1lIfkJOY1xzRgXvJJvyUnBeSkkUyPycLdCurhfLn5Q41c-JBpT32w_0QAJI_WWQtdQCyb5ECnE6I3LSkOfXVrlkS65rofkfDewLT5hcgEMJthQsAkD5XSLEN6RYwttxPf7-4zcXy3u5t_Gy9vrm_nlcmwkEzm4lMrWlpuSKTO1HGeyrCS3CupZI5TAWrHaygqmtRENoBRFaSxaOatqbKaFOCNfdr6Pfb3BxmCXArT6MbgNhK324PS_SudW-sE_acG4YkJkg497g-B_9hiT3rhosG2hQ99HrQpeKq6EzKTakSb4GAPawxbO9FCTXuuhDT20oYea9GtN-iWPnv-d8jD4u5cMfNgDEA20NkBnXPzDZVsupyxzn3fcs2tx-98B9Nf59-ElfgE3s6-8</recordid><startdate>201101</startdate><enddate>201101</enddate><creator>Droz‐Perroteau, Cécile</creator><creator>Dureau‐Pournin, Caroline</creator><creator>Vespignani, Hervé</creator><creator>Marchal, Cécile</creator><creator>Blin, Patrick</creator><creator>Blazejewski, Sylvie</creator><creator>Pollet, Clothilde</creator><creator>Jové, Jérémy</creator><creator>Robinson, Philip</creator><creator>Moore, Nicholas</creator><creator>Fourrier‐Réglat, Annie</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><general>Blackwell Science Inc</general><scope>IQODW</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><scope>5PM</scope></search><sort><creationdate>201101</creationdate><title>The EULEV cohort study: rates of and factors associated with continuation of levetiracetam after 1 year</title><author>Droz‐Perroteau, Cécile ; Dureau‐Pournin, Caroline ; Vespignani, Hervé ; Marchal, Cécile ; Blin, Patrick ; Blazejewski, Sylvie ; Pollet, Clothilde ; Jové, Jérémy ; Robinson, Philip ; Moore, Nicholas ; Fourrier‐Réglat, Annie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5035-2558fbf1c408c7f1e954651f8ab9d383eb80bf56a7bc3dae5324cfef596bed723</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticonvulsants - therapeutic use</topic><topic>antiepileptic drug</topic><topic>Biological and medical sciences</topic><topic>cohort</topic><topic>Cohort Studies</topic><topic>effectiveness</topic><topic>epilepsy</topic><topic>Epilepsy - drug therapy</topic><topic>Epilepsy - epidemiology</topic><topic>Female</topic><topic>France - epidemiology</topic><topic>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</topic><topic>Humans</topic><topic>levetiracetam</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>Neurology</topic><topic>Pharmacoepidemiology</topic><topic>Pharmacology. Drug treatments</topic><topic>Piracetam - analogs & derivatives</topic><topic>Piracetam - therapeutic use</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Droz‐Perroteau, Cécile</creatorcontrib><creatorcontrib>Dureau‐Pournin, Caroline</creatorcontrib><creatorcontrib>Vespignani, Hervé</creatorcontrib><creatorcontrib>Marchal, Cécile</creatorcontrib><creatorcontrib>Blin, Patrick</creatorcontrib><creatorcontrib>Blazejewski, Sylvie</creatorcontrib><creatorcontrib>Pollet, Clothilde</creatorcontrib><creatorcontrib>Jové, Jérémy</creatorcontrib><creatorcontrib>Robinson, Philip</creatorcontrib><creatorcontrib>Moore, Nicholas</creatorcontrib><creatorcontrib>Fourrier‐Réglat, Annie</creatorcontrib><creatorcontrib>EULEV Study Group</creatorcontrib><creatorcontrib>on behalf of the EULEV Study Group</creatorcontrib><collection>Pascal-Francis</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><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Droz‐Perroteau, Cécile</au><au>Dureau‐Pournin, Caroline</au><au>Vespignani, Hervé</au><au>Marchal, Cécile</au><au>Blin, Patrick</au><au>Blazejewski, Sylvie</au><au>Pollet, Clothilde</au><au>Jové, Jérémy</au><au>Robinson, Philip</au><au>Moore, Nicholas</au><au>Fourrier‐Réglat, Annie</au><aucorp>EULEV Study Group</aucorp><aucorp>on behalf of the EULEV Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The EULEV cohort study: rates of and factors associated with continuation of levetiracetam after 1 year</atitle><jtitle>British journal of clinical pharmacology</jtitle><addtitle>Br J Clin Pharmacol</addtitle><date>2011-01</date><risdate>2011</risdate><volume>71</volume><issue>1</issue><spage>121</spage><epage>127</epage><pages>121-127</pages><issn>0306-5251</issn><eissn>1365-2125</eissn><coden>BCPHBM</coden><abstract>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Levetiracetam has shown good safety/tolerability and efficacy in regulatory trials. This was confirmed in observational investigations performed soon after marketing by using continuation or retention rates as a composite measure.
• When an anti‐epileptic drug first becomes available; however, there is evidence of channelling to more severe patients than thereafter.
WHAT THIS STUDY ADDS
• This study was performed several years after marketing of levetiracetam and found high rates of continuation.
• It also further explores this measure by determining the continuation in the absence of initiation of additional anti‐epileptic drugs.
AIMS To investigate real‐life effectiveness of levetiracetam in patients initiating treatment in a stable market situation.
METHODS Epileptic adults who had initiated levetiracetam between 1 January and 31 August in 2005 or 2006 were included and followed for 1 year by hospital or nonhospital neurologists practising in France. One‐year continuation rates were estimated using Kaplan–Meier analysis. Among those still treated at end of study, treatment goals were investigated. Factors associated with discontinuation were investigated using Cox proportional hazards regression.
RESULTS A total of 794 subjects were included in the cohort, and 753 subjects were followed up and included in the analysis. Among these, mean (SD) age was 42.6 (±17.0) years, 51.1% were female, 76.6% had partial epilepsy, 93.5% had seizures in the 6 months preceding levetiracetam initiation and 82.9% had at least one concomitant anti‐epileptic drug when starting levetiracetam. One‐year levetiracetam continuation rate was 83.5% (95% confidence interval, 80.5–86.0%). Of the 579 patients still using levetiracetam at end of study, 46.8% were seizure free during the last 6 months, and 24% were on levetiracetam monotherapy. Reasons for discontinuation (n= 122) were adverse events (45%), lack of efficacy (38%) or both (9%). Levetiracetam discontinuation was most strongly associated with previous exposure to more than four anti‐epileptic drugs, whereas continuation was most strongly associated with presence of seizure‐related falls in the 6 months preceding levetiracetam initiation.
CONCLUSIONS This population‐based cohort study in a stable market situation found a high 1 year levetiracetam continuation rate compared with previous studies done sooner after market introduction.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21143508</pmid><doi>10.1111/j.1365-2125.2010.03805.x</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Aged Aged, 80 and over Anticonvulsants - therapeutic use antiepileptic drug Biological and medical sciences cohort Cohort Studies effectiveness epilepsy Epilepsy - drug therapy Epilepsy - epidemiology Female France - epidemiology Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Humans levetiracetam Male Medical sciences Middle Aged Nervous system (semeiology, syndromes) Neurology Pharmacoepidemiology Pharmacology. Drug treatments Piracetam - analogs & derivatives Piracetam - therapeutic use Time Factors Treatment Outcome Young Adult |
title | The EULEV cohort study: rates of and factors associated with continuation of levetiracetam after 1 year |
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