Conversion from valproic acid onto topiramate in adolescents and adults with epilepsy

Objective –  To explore efficacy and tolerability outcomes of topiramate (TPM) in patients with epilepsy transitioning from valproic acid (VPA) because of insufficient efficacy and/or tolerability onto TPM. Methods –  Multicenter, open label, single arm, non‐interventional study examining patients (...

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Veröffentlicht in:Acta neurologica Scandinavica 2009-05, Vol.119 (5), p.304-312
Hauptverfasser: Schreiner, A., Stollhoff, K., Ossig, W., Unkelbach, S., Lüer, W., Bogdanow, M., Schauble, B.
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container_start_page 304
container_title Acta neurologica Scandinavica
container_volume 119
creator Schreiner, A.
Stollhoff, K.
Ossig, W.
Unkelbach, S.
Lüer, W.
Bogdanow, M.
Schauble, B.
description Objective –  To explore efficacy and tolerability outcomes of topiramate (TPM) in patients with epilepsy transitioning from valproic acid (VPA) because of insufficient efficacy and/or tolerability onto TPM. Methods –  Multicenter, open label, single arm, non‐interventional study examining patients (≥12 years) with epilepsy, transitioning onto TPM from baseline mono‐or combination therapy with VPA. TPM was added onto the existing antiepileptic drug (AED) treatment and started at a dose of 25 mg once daily. The dose was titrated up with 25 mg/day increments, once every 1–2 weeks, until a final dose between 50–200 mg/day was reached. Based on clinical judgment, the treating physician decided whether or not and when the existing AED treatment especially with VPA could be withdrawn. Documented were type and frequency of seizures, TPM dose, quality of life (QOLIE‐10 questionnaire), subjective perception of improvement, and adverse events (AE). Results –  One hundered and forty‐seven patients (59% women, mean age 41 years) switched from baseline VPA treatment onto TPM because of insufficient efficacy (61%) and/or poor tolerability (81%). Average duration of follow‐up was 20.3 weeks with an overall discontinuation rate of 16.3% of patients, mainly because of AE (in 8.2% of 147 patients). At study endpoint, the intended shift to TPM monotherapy was achieved in 70% of patients at a median dose of 150 mg/day. A seizure reduction of ≥50% was achieved in 75% of patients in the last scheduled period (week 8–20), and 51% of patients entering that period remained seizure‐free. Quality of life improved significantly as compared with baseline for all domains of QOLIE‐10 (P 
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Methods –  Multicenter, open label, single arm, non‐interventional study examining patients (≥12 years) with epilepsy, transitioning onto TPM from baseline mono‐or combination therapy with VPA. TPM was added onto the existing antiepileptic drug (AED) treatment and started at a dose of 25 mg once daily. The dose was titrated up with 25 mg/day increments, once every 1–2 weeks, until a final dose between 50–200 mg/day was reached. Based on clinical judgment, the treating physician decided whether or not and when the existing AED treatment especially with VPA could be withdrawn. Documented were type and frequency of seizures, TPM dose, quality of life (QOLIE‐10 questionnaire), subjective perception of improvement, and adverse events (AE). Results –  One hundered and forty‐seven patients (59% women, mean age 41 years) switched from baseline VPA treatment onto TPM because of insufficient efficacy (61%) and/or poor tolerability (81%). Average duration of follow‐up was 20.3 weeks with an overall discontinuation rate of 16.3% of patients, mainly because of AE (in 8.2% of 147 patients). At study endpoint, the intended shift to TPM monotherapy was achieved in 70% of patients at a median dose of 150 mg/day. A seizure reduction of ≥50% was achieved in 75% of patients in the last scheduled period (week 8–20), and 51% of patients entering that period remained seizure‐free. Quality of life improved significantly as compared with baseline for all domains of QOLIE‐10 (P &lt; 0.001). Most frequent AEs were weight decrease (4.8%), paraesthesia and fatigue (4.1% each), speech disorder and headaches (2.7% each). Conclusions –  In patients with epilepsy not satisfactorily treated with VPA, conversion to TPM was associated with improved seizure control as well as improvement in several aspects of quality of life.</description><identifier>ISSN: 0001-6314</identifier><identifier>EISSN: 1600-0404</identifier><identifier>DOI: 10.1111/j.1600-0404.2008.01130.x</identifier><identifier>PMID: 19133865</identifier><identifier>CODEN: ANRSAS</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anticonvulsants - administration &amp; dosage ; Anticonvulsants - adverse effects ; Biological and medical sciences ; Child ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Resistance - drug effects ; Drug Resistance - physiology ; epilepsy ; Epilepsy - drug therapy ; Epilepsy - physiopathology ; Female ; Fructose - administration &amp; dosage ; Fructose - adverse effects ; Fructose - analogs &amp; derivatives ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Humans ; Male ; Medical sciences ; Middle Aged ; Nervous system (semeiology, syndromes) ; Neurology ; Patient Satisfaction ; QOLIE-10 ; Quality of Life ; Surveys and Questionnaires ; topiramate ; Treatment Outcome ; valproic acid ; Valproic Acid - administration &amp; dosage ; Valproic Acid - adverse effects ; Young Adult</subject><ispartof>Acta neurologica Scandinavica, 2009-05, Vol.119 (5), p.304-312</ispartof><rights>Copyright © 2008 The Authors. 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Methods –  Multicenter, open label, single arm, non‐interventional study examining patients (≥12 years) with epilepsy, transitioning onto TPM from baseline mono‐or combination therapy with VPA. TPM was added onto the existing antiepileptic drug (AED) treatment and started at a dose of 25 mg once daily. The dose was titrated up with 25 mg/day increments, once every 1–2 weeks, until a final dose between 50–200 mg/day was reached. Based on clinical judgment, the treating physician decided whether or not and when the existing AED treatment especially with VPA could be withdrawn. Documented were type and frequency of seizures, TPM dose, quality of life (QOLIE‐10 questionnaire), subjective perception of improvement, and adverse events (AE). Results –  One hundered and forty‐seven patients (59% women, mean age 41 years) switched from baseline VPA treatment onto TPM because of insufficient efficacy (61%) and/or poor tolerability (81%). Average duration of follow‐up was 20.3 weeks with an overall discontinuation rate of 16.3% of patients, mainly because of AE (in 8.2% of 147 patients). At study endpoint, the intended shift to TPM monotherapy was achieved in 70% of patients at a median dose of 150 mg/day. A seizure reduction of ≥50% was achieved in 75% of patients in the last scheduled period (week 8–20), and 51% of patients entering that period remained seizure‐free. Quality of life improved significantly as compared with baseline for all domains of QOLIE‐10 (P &lt; 0.001). Most frequent AEs were weight decrease (4.8%), paraesthesia and fatigue (4.1% each), speech disorder and headaches (2.7% each). Conclusions –  In patients with epilepsy not satisfactorily treated with VPA, conversion to TPM was associated with improved seizure control as well as improvement in several aspects of quality of life.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticonvulsants - administration &amp; dosage</subject><subject>Anticonvulsants - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Drug Resistance - drug effects</subject><subject>Drug Resistance - physiology</subject><subject>epilepsy</subject><subject>Epilepsy - drug therapy</subject><subject>Epilepsy - physiopathology</subject><subject>Female</subject><subject>Fructose - administration &amp; dosage</subject><subject>Fructose - adverse effects</subject><subject>Fructose - analogs &amp; derivatives</subject><subject>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neurology</subject><subject>Patient Satisfaction</subject><subject>QOLIE-10</subject><subject>Quality of Life</subject><subject>Surveys and Questionnaires</subject><subject>topiramate</subject><subject>Treatment Outcome</subject><subject>valproic acid</subject><subject>Valproic Acid - administration &amp; dosage</subject><subject>Valproic Acid - adverse effects</subject><subject>Young Adult</subject><issn>0001-6314</issn><issn>1600-0404</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkEFv0zAUxy0E2srYV0C-wC3hvdhxnAOHUW0DaSocmLab5TqOcEniYKdb--1x1qpc8cXv2b-__fQjhCLkmNanTY4CIAMOPC8AZA6IDPLdK7I4XbwmCwDATDDk5-RtjJvUFRXnZ-Qca2RMinJB7pd-eLIhOj_QNviePuluDN4Zqo1rqB8mTyc_uqB7PVnqBqob39lo7DBFqocm9dsulc9u-kXt6Do7xv078qbVXbSXx_2C3N9c_1x-ze6-335bXt1lhgsBGXJhoLZ13TbCYFVybtYa2FqWHKWUWMsGS1O2LQcm06GsCigQgAnN1w1r2AX5eHg3jfxna-OkepdG6zo9WL-NqoBSVAgsgfIAmuBjDLZVY3C9DnuFoGalaqNmc2o2p2al6kWp2qXo--Mf23Vvm3_Bo8MEfDgCOhrdtUEPxsUTVyArSikhcZ8P3HOStP_vAdTV6nquUj475F2c7O6U1-G3EhWrSvWwulU_VgwevywfVM3-AkmIn6A</recordid><startdate>200905</startdate><enddate>200905</enddate><creator>Schreiner, A.</creator><creator>Stollhoff, K.</creator><creator>Ossig, W.</creator><creator>Unkelbach, S.</creator><creator>Lüer, W.</creator><creator>Bogdanow, M.</creator><creator>Schauble, B.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>BSCLL</scope><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>7TK</scope></search><sort><creationdate>200905</creationdate><title>Conversion from valproic acid onto topiramate in adolescents and adults with epilepsy</title><author>Schreiner, A. ; Stollhoff, K. ; Ossig, W. ; Unkelbach, S. ; Lüer, W. ; Bogdanow, M. ; Schauble, B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4660-146c09e99fd6c17544cba03b8541888198d15c5ff40388548720210036a4bd3d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticonvulsants - administration &amp; dosage</topic><topic>Anticonvulsants - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Drug Resistance - drug effects</topic><topic>Drug Resistance - physiology</topic><topic>epilepsy</topic><topic>Epilepsy - drug therapy</topic><topic>Epilepsy - physiopathology</topic><topic>Female</topic><topic>Fructose - administration &amp; dosage</topic><topic>Fructose - adverse effects</topic><topic>Fructose - analogs &amp; derivatives</topic><topic>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>Neurology</topic><topic>Patient Satisfaction</topic><topic>QOLIE-10</topic><topic>Quality of Life</topic><topic>Surveys and Questionnaires</topic><topic>topiramate</topic><topic>Treatment Outcome</topic><topic>valproic acid</topic><topic>Valproic Acid - administration &amp; dosage</topic><topic>Valproic Acid - adverse effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schreiner, A.</creatorcontrib><creatorcontrib>Stollhoff, K.</creatorcontrib><creatorcontrib>Ossig, W.</creatorcontrib><creatorcontrib>Unkelbach, S.</creatorcontrib><creatorcontrib>Lüer, W.</creatorcontrib><creatorcontrib>Bogdanow, M.</creatorcontrib><creatorcontrib>Schauble, B.</creatorcontrib><creatorcontrib>TOPMAT-EPY-403 investigators</creatorcontrib><creatorcontrib>on behalf of the TOPMAT-EPY-403 investigators</creatorcontrib><collection>Istex</collection><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>Neurosciences Abstracts</collection><jtitle>Acta neurologica Scandinavica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schreiner, A.</au><au>Stollhoff, K.</au><au>Ossig, W.</au><au>Unkelbach, S.</au><au>Lüer, W.</au><au>Bogdanow, M.</au><au>Schauble, B.</au><aucorp>TOPMAT-EPY-403 investigators</aucorp><aucorp>on behalf of the TOPMAT-EPY-403 investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Conversion from valproic acid onto topiramate in adolescents and adults with epilepsy</atitle><jtitle>Acta neurologica Scandinavica</jtitle><addtitle>Acta Neurol Scand</addtitle><date>2009-05</date><risdate>2009</risdate><volume>119</volume><issue>5</issue><spage>304</spage><epage>312</epage><pages>304-312</pages><issn>0001-6314</issn><eissn>1600-0404</eissn><coden>ANRSAS</coden><abstract>Objective –  To explore efficacy and tolerability outcomes of topiramate (TPM) in patients with epilepsy transitioning from valproic acid (VPA) because of insufficient efficacy and/or tolerability onto TPM. Methods –  Multicenter, open label, single arm, non‐interventional study examining patients (≥12 years) with epilepsy, transitioning onto TPM from baseline mono‐or combination therapy with VPA. TPM was added onto the existing antiepileptic drug (AED) treatment and started at a dose of 25 mg once daily. The dose was titrated up with 25 mg/day increments, once every 1–2 weeks, until a final dose between 50–200 mg/day was reached. Based on clinical judgment, the treating physician decided whether or not and when the existing AED treatment especially with VPA could be withdrawn. Documented were type and frequency of seizures, TPM dose, quality of life (QOLIE‐10 questionnaire), subjective perception of improvement, and adverse events (AE). Results –  One hundered and forty‐seven patients (59% women, mean age 41 years) switched from baseline VPA treatment onto TPM because of insufficient efficacy (61%) and/or poor tolerability (81%). Average duration of follow‐up was 20.3 weeks with an overall discontinuation rate of 16.3% of patients, mainly because of AE (in 8.2% of 147 patients). At study endpoint, the intended shift to TPM monotherapy was achieved in 70% of patients at a median dose of 150 mg/day. A seizure reduction of ≥50% was achieved in 75% of patients in the last scheduled period (week 8–20), and 51% of patients entering that period remained seizure‐free. Quality of life improved significantly as compared with baseline for all domains of QOLIE‐10 (P &lt; 0.001). Most frequent AEs were weight decrease (4.8%), paraesthesia and fatigue (4.1% each), speech disorder and headaches (2.7% each). Conclusions –  In patients with epilepsy not satisfactorily treated with VPA, conversion to TPM was associated with improved seizure control as well as improvement in several aspects of quality of life.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>19133865</pmid><doi>10.1111/j.1600-0404.2008.01130.x</doi><tpages>9</tpages></addata></record>
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subjects Adolescent
Adult
Aged
Aged, 80 and over
Anticonvulsants - administration & dosage
Anticonvulsants - adverse effects
Biological and medical sciences
Child
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Resistance - drug effects
Drug Resistance - physiology
epilepsy
Epilepsy - drug therapy
Epilepsy - physiopathology
Female
Fructose - administration & dosage
Fructose - adverse effects
Fructose - analogs & derivatives
Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy
Humans
Male
Medical sciences
Middle Aged
Nervous system (semeiology, syndromes)
Neurology
Patient Satisfaction
QOLIE-10
Quality of Life
Surveys and Questionnaires
topiramate
Treatment Outcome
valproic acid
Valproic Acid - administration & dosage
Valproic Acid - adverse effects
Young Adult
title Conversion from valproic acid onto topiramate in adolescents and adults with epilepsy
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