Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study

Study Objectives: To evaluate adherence to sodium oxybate prescribing information for indication and dosage, patients' compliance with instructions for use, safety/tolerability in routine clinical practice, and abuse potential. Methods: A postauthorization, noninterventional surveillance study...

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Autores: Mayer, Geert, Plazzi, Giuseppe, Iranzo, Alex, Ortega-Albas, Juan, Quinnell, Timothy, Pesch, Hanna, Serralheiro, Pedro, Schlit, Anne-Francoise, Wuiame, Didier, Bentz, Jurgen W. G.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p2982
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/2982
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85054282860&doi=10.1093%2fsleep%2fzsy128&partnerID=40&md5=0c8911fdbb4d529c178296b77916b362
Access Level:acceso abierto
Palabra clave:sodium oxybate
narcolepsy
narcolepsy-pharmacotherapy
pediatrics-narcolepsy
postauthorization study
compliance
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spelling Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance studyMayer, GeertPlazzi, GiuseppeIranzo, AlexOrtega-Albas, JuanQuinnell, TimothyPesch, HannaSerralheiro, PedroSchlit, Anne-FrancoiseWuiame, DidierBentz, Jurgen W. G.sodium oxybatenarcolepsynarcolepsy-pharmacotherapypediatrics-narcolepsypostauthorization studycomplianceStudy Objectives: To evaluate adherence to sodium oxybate prescribing information for indication and dosage, patients' compliance with instructions for use, safety/tolerability in routine clinical practice, and abuse potential. Methods: A postauthorization, noninterventional surveillance study (NCT00244465) in patients who were prescribed sodium oxybate according to current practice by sleep disorders specialists. Patients were monitored for <= 18 months. Results: Overall, 749 patients were enrolled; 730 included in the intent-to-treat population (narcolepsy type 1 n = 670, other indications n = 60). We report on patients with narcolepsy type 1 (female 47.9%, mean age 39.4 years); 495/670 (73.9%) completed the study. Median dose: at start of study 4.5 g per night, 6 g per night throughout study, in two equal doses. According to the treatment compliance checklist, 35.5 per cent of patients consumed alcohol, 19.3 per cent took the medication <2 hr after food, and 27.1 per cent did not adhere to recommended time schedule, with few associated treatment-emergent adverse events (TEAEs). Incidences of higher-than-recommended doses, difficulty in preparing doses, and abuse were low. TEAEs were reported by 67.3 per cent, most frequently headache (11.6%) and nasopharyngitis (6.4%). Discontinuation due to TEAEs: 8.8 per cent. Serious TEAEs: 6.4 per cent. There were no reports of respiratory depression. No particular safety concerns were identified in pediatric or elderly patients, or those with underlying sleep apnea. Conclusions: In this large postauthorization safety study of sodium oxybate use, indication and dosage prescribing recommendations were generally followed, and most patients complied with instructions, with deviations around alcohol consumption, eating before dosing and timing. The overall safety profile was consistent with previous observations; incidence of abuse was low. Section: Neurological disorders. Clinical Trial: Postauthorization, noninterventional, surveillance, pharmacoepidemiology study to evaluate long-term safety, tolerability, and compliance in administration of Xyrem (sodium oxybate) oral solution in patients who receive treatment with this medication in regular clinical practice. https://clinicaltrials.gov/ct2/show/NCT00244465, ClinicalTrials.gov: NCT00244465.OXFORD UNIV PRESS INC2018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/2982https://www.scopus.com/inward/record.uri?eid=2-s2.0-85054282860&doi=10.1093%2fsleep%2fzsy128&partnerID=40&md5=0c8911fdbb4d529c178296b77916b362SLEEPISSN: 01618105ISSNe: 15509109reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p29822026-06-11T12:45:17Z
dc.title.none.fl_str_mv Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study
title Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study
spellingShingle Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study
Mayer, Geert
sodium oxybate
narcolepsy
narcolepsy-pharmacotherapy
pediatrics-narcolepsy
postauthorization study
compliance
title_short Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study
title_full Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study
title_fullStr Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study
title_full_unstemmed Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study
title_sort Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study
dc.creator.none.fl_str_mv Mayer, Geert
Plazzi, Giuseppe
Iranzo, Alex
Ortega-Albas, Juan
Quinnell, Timothy
Pesch, Hanna
Serralheiro, Pedro
Schlit, Anne-Francoise
Wuiame, Didier
Bentz, Jurgen W. G.
author Mayer, Geert
author_facet Mayer, Geert
Plazzi, Giuseppe
Iranzo, Alex
Ortega-Albas, Juan
Quinnell, Timothy
Pesch, Hanna
Serralheiro, Pedro
Schlit, Anne-Francoise
Wuiame, Didier
Bentz, Jurgen W. G.
author_role author
author2 Plazzi, Giuseppe
Iranzo, Alex
Ortega-Albas, Juan
Quinnell, Timothy
Pesch, Hanna
Serralheiro, Pedro
Schlit, Anne-Francoise
Wuiame, Didier
Bentz, Jurgen W. G.
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv sodium oxybate
narcolepsy
narcolepsy-pharmacotherapy
pediatrics-narcolepsy
postauthorization study
compliance
topic sodium oxybate
narcolepsy
narcolepsy-pharmacotherapy
pediatrics-narcolepsy
postauthorization study
compliance
description Study Objectives: To evaluate adherence to sodium oxybate prescribing information for indication and dosage, patients' compliance with instructions for use, safety/tolerability in routine clinical practice, and abuse potential. Methods: A postauthorization, noninterventional surveillance study (NCT00244465) in patients who were prescribed sodium oxybate according to current practice by sleep disorders specialists. Patients were monitored for <= 18 months. Results: Overall, 749 patients were enrolled; 730 included in the intent-to-treat population (narcolepsy type 1 n = 670, other indications n = 60). We report on patients with narcolepsy type 1 (female 47.9%, mean age 39.4 years); 495/670 (73.9%) completed the study. Median dose: at start of study 4.5 g per night, 6 g per night throughout study, in two equal doses. According to the treatment compliance checklist, 35.5 per cent of patients consumed alcohol, 19.3 per cent took the medication <2 hr after food, and 27.1 per cent did not adhere to recommended time schedule, with few associated treatment-emergent adverse events (TEAEs). Incidences of higher-than-recommended doses, difficulty in preparing doses, and abuse were low. TEAEs were reported by 67.3 per cent, most frequently headache (11.6%) and nasopharyngitis (6.4%). Discontinuation due to TEAEs: 8.8 per cent. Serious TEAEs: 6.4 per cent. There were no reports of respiratory depression. No particular safety concerns were identified in pediatric or elderly patients, or those with underlying sleep apnea. Conclusions: In this large postauthorization safety study of sodium oxybate use, indication and dosage prescribing recommendations were generally followed, and most patients complied with instructions, with deviations around alcohol consumption, eating before dosing and timing. The overall safety profile was consistent with previous observations; incidence of abuse was low. Section: Neurological disorders. Clinical Trial: Postauthorization, noninterventional, surveillance, pharmacoepidemiology study to evaluate long-term safety, tolerability, and compliance in administration of Xyrem (sodium oxybate) oral solution in patients who receive treatment with this medication in regular clinical practice. https://clinicaltrials.gov/ct2/show/NCT00244465, ClinicalTrials.gov: NCT00244465.
publishDate 2018
dc.date.none.fl_str_mv 2018
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/2982
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85054282860&doi=10.1093%2fsleep%2fzsy128&partnerID=40&md5=0c8911fdbb4d529c178296b77916b362
url https://fisabio.portalinvestigacion.com/publicaciones/2982
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85054282860&doi=10.1093%2fsleep%2fzsy128&partnerID=40&md5=0c8911fdbb4d529c178296b77916b362
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv OXFORD UNIV PRESS INC
publisher.none.fl_str_mv OXFORD UNIV PRESS INC
dc.source.none.fl_str_mv SLEEP
ISSN: 01618105
ISSNe: 15509109
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
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