Cargando…

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 observ...

Descripción completa

Detalles Bibliográficos
Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099342/
https://www.ncbi.nlm.nih.gov/pubmed/29542107
http://dx.doi.org/10.1111/ane.12920
_version_ 1783348643510616064
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_facet 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 Villanueva, V.
collection PubMed
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.
format Online
Article
Text
id pubmed-6099342
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-60993422018-08-23 Lacosamide monotherapy in clinical practice: A retrospective chart review 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. Acta Neurol Scand Original Articles 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. John Wiley and Sons Inc. 2018-03-14 2018-09 /pmc/articles/PMC6099342/ /pubmed/29542107 http://dx.doi.org/10.1111/ane.12920 Text en © 2018 The Authors. Acta Neurologica Scandinavica Published by John Wiley & Sons Ltd 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 Original Articles
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.
Lacosamide monotherapy in clinical practice: A retrospective chart review
title Lacosamide monotherapy in clinical practice: A retrospective chart review
title_full Lacosamide monotherapy in clinical practice: A retrospective chart review
title_fullStr Lacosamide monotherapy in clinical practice: A retrospective chart review
title_full_unstemmed Lacosamide monotherapy in clinical practice: A retrospective chart review
title_short Lacosamide monotherapy in clinical practice: A retrospective chart review
title_sort lacosamide monotherapy in clinical practice: a retrospective chart review
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099342/
https://www.ncbi.nlm.nih.gov/pubmed/29542107
http://dx.doi.org/10.1111/ane.12920
work_keys_str_mv AT villanuevav lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT giraldezbg lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT toledom lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT dehaangj lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT cumboe lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT gambardellaa lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT debackerm lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT joeresl lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT brunnertm lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT dedekenp lacosamidemonotherapyinclinicalpracticearetrospectivechartreview
AT serratosaj lacosamidemonotherapyinclinicalpracticearetrospectivechartreview