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Effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES)

OBJECTIVE: To evaluate the effectiveness and tolerability of lacosamide added to one or two antiepileptic drugs (AEDs) in the treatment of patients with brain tumor–related epilepsy (BTRE), and to evaluate patients’ global impression of change and quality of life (QoL). METHODS: This was a prospecti...

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Autores principales: Rudà, Roberta, Houillier, Caroline, Maschio, Marta, Reijneveld, Jaap C., Hellot, Scarlett, De Backer, Marc, Chan, Jane, Joeres, Lars, Leunikava, Iryna, Glas, Martin, Grant, Robin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7384112/
https://www.ncbi.nlm.nih.gov/pubmed/32329527
http://dx.doi.org/10.1111/epi.16486
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author Rudà, Roberta
Houillier, Caroline
Maschio, Marta
Reijneveld, Jaap C.
Hellot, Scarlett
De Backer, Marc
Chan, Jane
Joeres, Lars
Leunikava, Iryna
Glas, Martin
Grant, Robin
author_facet Rudà, Roberta
Houillier, Caroline
Maschio, Marta
Reijneveld, Jaap C.
Hellot, Scarlett
De Backer, Marc
Chan, Jane
Joeres, Lars
Leunikava, Iryna
Glas, Martin
Grant, Robin
author_sort Rudà, Roberta
collection PubMed
description OBJECTIVE: To evaluate the effectiveness and tolerability of lacosamide added to one or two antiepileptic drugs (AEDs) in the treatment of patients with brain tumor–related epilepsy (BTRE), and to evaluate patients’ global impression of change and quality of life (QoL). METHODS: This was a prospective, multicenter, single‐arm, noninterventional study with a 6‐month observation period (EP0045; NCT02276053). Eligible patients (≥16 years old) had active BTRE secondary to low‐grade glioma (World Health Organization grade 1 and 2) and were receiving treatment with one or two AEDs at baseline. Lacosamide was initiated by the treating physician in the course of routine clinical practice. Primary outcomes were 50% responders (≥50% reduction in focal seizure frequency from baseline) and Patient's Global Impression of Change (PGIC) at month 6. Secondary outcomes included seizure‐free status and Clinical Global Impression of Change (CGIC) at month 6, change in QoL (5‐Level EuroQol‐5 Dimension Quality of Life Assessment) and symptom outcomes (MD Anderson Symptom Inventory–Brain Tumor) from baseline to month 6, and Kaplan‐Meier estimated 6‐month retention on lacosamide. Safety variables included adverse drug reactions (ADRs). RESULTS: Patients were recruited from 24 sites in Europe. Ninety‐three patients received lacosamide (mean [standard deviation] age = 44.5 [14.7] years; 50 [53.8%] male; median baseline focal seizure frequency = five seizures/28 days [range = 1‐280]), of whom 79 (84.9%) completed the study. At 6 months, 66 of 86 (76.7%) patients were 50% responders and 30 of 86 (34.9%) were seizure‐free. Improvements on PGIC were reported by 49 of 76 (64.5%) patients. Based on CGIC, 52 of 81 (64.2%) patients improved. QoL and symptoms outcome measures remained stable. Kaplan‐Meier estimated 6‐month retention rate was 86.0% (N = 93). Fifteen (16.1%) patients reported ADRs; four (4.3%) had ADRs leading to discontinuation (N = 93). SIGNIFICANCE: Results of this prospective, noninterventional study suggest that add‐on lacosamide is effective and generally well tolerated in patients with BTRE.
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spelling pubmed-73841122020-07-28 Effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES) Rudà, Roberta Houillier, Caroline Maschio, Marta Reijneveld, Jaap C. Hellot, Scarlett De Backer, Marc Chan, Jane Joeres, Lars Leunikava, Iryna Glas, Martin Grant, Robin Epilepsia Full‐length Original Research OBJECTIVE: To evaluate the effectiveness and tolerability of lacosamide added to one or two antiepileptic drugs (AEDs) in the treatment of patients with brain tumor–related epilepsy (BTRE), and to evaluate patients’ global impression of change and quality of life (QoL). METHODS: This was a prospective, multicenter, single‐arm, noninterventional study with a 6‐month observation period (EP0045; NCT02276053). Eligible patients (≥16 years old) had active BTRE secondary to low‐grade glioma (World Health Organization grade 1 and 2) and were receiving treatment with one or two AEDs at baseline. Lacosamide was initiated by the treating physician in the course of routine clinical practice. Primary outcomes were 50% responders (≥50% reduction in focal seizure frequency from baseline) and Patient's Global Impression of Change (PGIC) at month 6. Secondary outcomes included seizure‐free status and Clinical Global Impression of Change (CGIC) at month 6, change in QoL (5‐Level EuroQol‐5 Dimension Quality of Life Assessment) and symptom outcomes (MD Anderson Symptom Inventory–Brain Tumor) from baseline to month 6, and Kaplan‐Meier estimated 6‐month retention on lacosamide. Safety variables included adverse drug reactions (ADRs). RESULTS: Patients were recruited from 24 sites in Europe. Ninety‐three patients received lacosamide (mean [standard deviation] age = 44.5 [14.7] years; 50 [53.8%] male; median baseline focal seizure frequency = five seizures/28 days [range = 1‐280]), of whom 79 (84.9%) completed the study. At 6 months, 66 of 86 (76.7%) patients were 50% responders and 30 of 86 (34.9%) were seizure‐free. Improvements on PGIC were reported by 49 of 76 (64.5%) patients. Based on CGIC, 52 of 81 (64.2%) patients improved. QoL and symptoms outcome measures remained stable. Kaplan‐Meier estimated 6‐month retention rate was 86.0% (N = 93). Fifteen (16.1%) patients reported ADRs; four (4.3%) had ADRs leading to discontinuation (N = 93). SIGNIFICANCE: Results of this prospective, noninterventional study suggest that add‐on lacosamide is effective and generally well tolerated in patients with BTRE. John Wiley and Sons Inc. 2020-04-24 2020-04 /pmc/articles/PMC7384112/ /pubmed/32329527 http://dx.doi.org/10.1111/epi.16486 Text en © 2020 UCB Biopharma Srl. Epilepsia published by Wiley Periodicals, Inc. on behalf of International League Against Epilepsy This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Full‐length Original Research
Rudà, Roberta
Houillier, Caroline
Maschio, Marta
Reijneveld, Jaap C.
Hellot, Scarlett
De Backer, Marc
Chan, Jane
Joeres, Lars
Leunikava, Iryna
Glas, Martin
Grant, Robin
Effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES)
title Effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES)
title_full Effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES)
title_fullStr Effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES)
title_full_unstemmed Effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES)
title_short Effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES)
title_sort effectiveness and tolerability of lacosamide as add‐on therapy in patients with brain tumor–related epilepsy: results from a prospective, noninterventional study in european clinical practice (vibes)
topic Full‐length Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7384112/
https://www.ncbi.nlm.nih.gov/pubmed/32329527
http://dx.doi.org/10.1111/epi.16486
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