Profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline

Vanessa Delgado Nunes,1 Laura Sawyer,2 Julie Neilson,1 Grammati Sarri,1 J Helen Cross3,4 1National Clinical Guideline Centre, Royal College of Physicians, London, UK; 2Symmetron Limited, Elstree, UK; 3UCL Institute of Child Health, Great Ormond Street Hospital for Children, London, UK; 4Young Epilep...

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Autores principales:	Delgado Nunes V, Sawyer L, Neilson J, Sarri G, Cross JH
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/a6610bba8313454382c479e5b0b59516
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spelling	oai:doaj.org-article:a6610bba8313454382c479e5b0b595162021-12-02T03:42:14ZProfile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline1176-63281178-2021https://doaj.org/article/a6610bba8313454382c479e5b0b595162013-04-01T00:00:00Zhttp://www.dovepress.com/profile-of-lacosamide-and-its-role-in-the-long-term-treatment-of-epile-a12692https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Vanessa Delgado Nunes,1 Laura Sawyer,2 Julie Neilson,1 Grammati Sarri,1 J Helen Cross3,4 1National Clinical Guideline Centre, Royal College of Physicians, London, UK; 2Symmetron Limited, Elstree, UK; 3UCL Institute of Child Health, Great Ormond Street Hospital for Children, London, UK; 4Young Epilepsy, Lingfield, UK Aim: The goal of antiepileptic treatment is to achieve seizure freedom or seizure control. The aim of this paper is to review the evidence for the use of lacosamide for adjunctive treatment of refractory focal seizures with or without secondary generalization, within the scope of the 2012 update of the Clinical Guideline published by the National Institute for Health and Clinical Excellence (NICE). Methods: Clinical evidence for the use of lacosamide and other antiepileptic drugs (AEDs) was systematically reviewed, evaluated, and presented to the Guideline Development Group. Only randomized clinical trials were included. Outcomes of clinical efficacy (seizure freedom, 50% reduction in seizure frequency, time to first seizure, time to 12-month remission, treatment withdrawal, and time to treatment withdrawal), experience of adverse events, and cognitive and quality of life outcomes were reviewed. A decision model was built to weigh the clinical benefits of each adjunctive AED, measured by seizure control and seizure reduction, compared with the harm from adverse events, as measured by withdrawals from treatment due to adverse events. Results: Lacosamide was included as part of the recommended AEDS to be used in tertiary epilepsy centers. The evidence review showed that more participants who received lacosamide as an adjunctive treatment had at least a 50% reduction in seizure frequency compared with those taking placebo. However, more participants on lacosamide were found to experience adverse events and withdrawal from treatment compared with those on placebo. The cost-effectiveness analysis showed that compared with placebo, the benefits gained from adjunctive lacosamide were modest and uncertain, whereas the costs were significantly high. Compared with other AEDs licensed for adjunctive therapy in focal seizures, lacosamide was associated with fewer quality-adjusted life years and higher costs. Therefore, the Guideline Development Group noted that the balance of benefit and harm needs to be carefully monitored in all patients. Keywords: focal seizures, anti-epileptic drug, adjunctive therapy, clinical guidelineDelgado Nunes VSawyer LNeilson JSarri GCross JHDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2013, Iss default, Pp 467-476 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Delgado Nunes V Sawyer L Neilson J Sarri G Cross JH Profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline
description	Vanessa Delgado Nunes,1 Laura Sawyer,2 Julie Neilson,1 Grammati Sarri,1 J Helen Cross3,4 1National Clinical Guideline Centre, Royal College of Physicians, London, UK; 2Symmetron Limited, Elstree, UK; 3UCL Institute of Child Health, Great Ormond Street Hospital for Children, London, UK; 4Young Epilepsy, Lingfield, UK Aim: The goal of antiepileptic treatment is to achieve seizure freedom or seizure control. The aim of this paper is to review the evidence for the use of lacosamide for adjunctive treatment of refractory focal seizures with or without secondary generalization, within the scope of the 2012 update of the Clinical Guideline published by the National Institute for Health and Clinical Excellence (NICE). Methods: Clinical evidence for the use of lacosamide and other antiepileptic drugs (AEDs) was systematically reviewed, evaluated, and presented to the Guideline Development Group. Only randomized clinical trials were included. Outcomes of clinical efficacy (seizure freedom, 50% reduction in seizure frequency, time to first seizure, time to 12-month remission, treatment withdrawal, and time to treatment withdrawal), experience of adverse events, and cognitive and quality of life outcomes were reviewed. A decision model was built to weigh the clinical benefits of each adjunctive AED, measured by seizure control and seizure reduction, compared with the harm from adverse events, as measured by withdrawals from treatment due to adverse events. Results: Lacosamide was included as part of the recommended AEDS to be used in tertiary epilepsy centers. The evidence review showed that more participants who received lacosamide as an adjunctive treatment had at least a 50% reduction in seizure frequency compared with those taking placebo. However, more participants on lacosamide were found to experience adverse events and withdrawal from treatment compared with those on placebo. The cost-effectiveness analysis showed that compared with placebo, the benefits gained from adjunctive lacosamide were modest and uncertain, whereas the costs were significantly high. Compared with other AEDs licensed for adjunctive therapy in focal seizures, lacosamide was associated with fewer quality-adjusted life years and higher costs. Therefore, the Guideline Development Group noted that the balance of benefit and harm needs to be carefully monitored in all patients. Keywords: focal seizures, anti-epileptic drug, adjunctive therapy, clinical guideline
format	article
author	Delgado Nunes V Sawyer L Neilson J Sarri G Cross JH
author_facet	Delgado Nunes V Sawyer L Neilson J Sarri G Cross JH
author_sort	Delgado Nunes V
title	Profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline
title_short	Profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline
title_full	Profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline
title_fullStr	Profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline
title_full_unstemmed	Profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline
title_sort	profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated nice guideline
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/a6610bba8313454382c479e5b0b59516
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Profile of lacosamide and its role in the long-term treatment of epilepsy: a perspective from the updated NICE guideline

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