Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder

Objectives A secondary objective of this head-to-head study of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) was to assess treatment response rates in children and adolescents with attention-deficit hyperactivity disorder (ADHD) and an inadequate response to methylphenidate (MPH). The prim...

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Autores: Dittmann, Ralf W., Cardo-Jalon, Esther, Nagy, Peter, Anderson, Colleen S., Adeyi, Ben, Caballero, Beatriz, Hodgkins, Paul, Civil, Richard, Coghill, David R.
Tipo de recurso: artículo
Fecha de publicación:2014
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/17192
Acceso en línea:https://hdl.handle.net/20.500.13003/17192
Access Level:acceso abierto
Palabra clave:Dextroamphetamine
Remission Induction
Child
Treatment Outcome
Lisdexamfetamine Dimesylate
Atomoxetine Hydrochloride
Propylamines
Severity of Illness Index
Double-Blind Method
Attention Deficit Disorder with Hyperactivity
Adolescent
Humans
Drug Administration Schedule
Propilaminas
Humanos
Inducción de Remisión
Resultado del Tratamiento
Clorhidrato de Atomoxetina
Dimesilato de Lisdexanfetamina
Adolescente
Método Doble Ciego
Esquema de Medicación
Trastorno por Déficit de Atención con Hiperactividad
Índice de Severidad de la Enfermedad
Dextroanfetamina
Niño
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oai_identifier_str oai:docusalut.com:20.500.13003/17192
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network_name_str España
repository_id_str
dc.title.none.fl_str_mv Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder
title Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder
spellingShingle Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder
Dittmann, Ralf W.
Dextroamphetamine
Remission Induction
Child
Treatment Outcome
Lisdexamfetamine Dimesylate
Atomoxetine Hydrochloride
Propylamines
Severity of Illness Index
Double-Blind Method
Attention Deficit Disorder with Hyperactivity
Adolescent
Humans
Drug Administration Schedule
Propilaminas
Humanos
Inducción de Remisión
Resultado del Tratamiento
Clorhidrato de Atomoxetina
Dimesilato de Lisdexanfetamina
Adolescente
Método Doble Ciego
Esquema de Medicación
Trastorno por Déficit de Atención con Hiperactividad
Índice de Severidad de la Enfermedad
Dextroanfetamina
Niño
title_short Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder
title_full Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder
title_fullStr Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder
title_full_unstemmed Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder
title_sort Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity Disorder
dc.creator.none.fl_str_mv Dittmann, Ralf W.
Cardo-Jalon, Esther
Nagy, Peter
Anderson, Colleen S.
Adeyi, Ben
Caballero, Beatriz
Hodgkins, Paul
Civil, Richard
Coghill, David R.
author Dittmann, Ralf W.
author_facet Dittmann, Ralf W.
Cardo-Jalon, Esther
Nagy, Peter
Anderson, Colleen S.
Adeyi, Ben
Caballero, Beatriz
Hodgkins, Paul
Civil, Richard
Coghill, David R.
author_role author
author2 Cardo-Jalon, Esther
Nagy, Peter
Anderson, Colleen S.
Adeyi, Ben
Caballero, Beatriz
Hodgkins, Paul
Civil, Richard
Coghill, David R.
author2_role author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Dextroamphetamine
Remission Induction
Child
Treatment Outcome
Lisdexamfetamine Dimesylate
Atomoxetine Hydrochloride
Propylamines
Severity of Illness Index
Double-Blind Method
Attention Deficit Disorder with Hyperactivity
Adolescent
Humans
Drug Administration Schedule
Propilaminas
Humanos
Inducción de Remisión
Resultado del Tratamiento
Clorhidrato de Atomoxetina
Dimesilato de Lisdexanfetamina
Adolescente
Método Doble Ciego
Esquema de Medicación
Trastorno por Déficit de Atención con Hiperactividad
Índice de Severidad de la Enfermedad
Dextroanfetamina
Niño
topic Dextroamphetamine
Remission Induction
Child
Treatment Outcome
Lisdexamfetamine Dimesylate
Atomoxetine Hydrochloride
Propylamines
Severity of Illness Index
Double-Blind Method
Attention Deficit Disorder with Hyperactivity
Adolescent
Humans
Drug Administration Schedule
Propilaminas
Humanos
Inducción de Remisión
Resultado del Tratamiento
Clorhidrato de Atomoxetina
Dimesilato de Lisdexanfetamina
Adolescente
Método Doble Ciego
Esquema de Medicación
Trastorno por Déficit de Atención con Hiperactividad
Índice de Severidad de la Enfermedad
Dextroanfetamina
Niño
description Objectives A secondary objective of this head-to-head study of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) was to assess treatment response rates in children and adolescents with attention-deficit hyperactivity disorder (ADHD) and an inadequate response to methylphenidate (MPH). The primary efficacy and safety outcomes of the study, SPD489-317 (ClinicalTrials.gov NCT01106430), have been published previously. Methods In this 9-week, double-blind, active-controlled study, patients aged 6-17 years with a previous inadequate response to MPH were randomized (1:1) to dose-optimized LDX (30, 50 or 70 mg/day) or ATX (patients < 70 kg: 0.5-1.2 mg/kg/day, not to exceed 1.4 mg/kg/day; patients <70 kg: 40, 80 or 100 mg/day). Treatment response was a secondary efficacy outcome and was predefined as a reduction from baseline in ADHD Rating Scale IV (ADHD-RS-IV) total score of at least 25, 30 or 50 %. Sustained response was predefined as a reduction from baseline in ADHD-RS-IV total score (>= 25, >= 30 or >= 50 %) or a Clinical Global Impressions (CGI)-Improvement (CGI-I) score of 1 or 2 throughout weeks 4-9. CGI-Severity (CGI-S) scores were also assessed, as an indicator of remission. Results A total of 267 patients were enrolled (LDX, n = 133; ATX, n = 134) and 200 completed the study (LDX, n = 99; ATX, n = 101). By week 9, significantly (p < 0.01) greater proportions of patients receiving LDX than ATX met the response criteria of a reduction from baseline in ADHD-RS-IV total score of at least 25 % (90.5 vs. 76.7 %), 30 % (88.1 vs. 73.7 %) or 50 % (73.0 vs. 50.4 %). Sustained response rates were also significantly (p < 0.05) higher among LDX-treated patients (ADHD-RS-IV >= 25, 66.1 %; ADHD-RS-IV >= 30, 61.4 %; ADHD-RS-IV >= 50, 41.7 %; CGI-I, 52.0 %) than among ATX-treated individuals (ADHD-RS-IV >= 25, 51.1 %; ADHD-RS-IV >= 30, 47.4 %; ADHD-RS-IV >= 50, 23.7 %; CGI-I, 39.3 %). Finally, by week 9, 60.7 % of patients receiving LDX and 46.3 % of those receiving ATX had a CGI-S score of 1 (normal, not at all ill) or 2 (borderline mentally ill), and greater proportions of patients in the LDX group than the ATX group experienced a reduction from baseline of at least one CGI-S category. Conclusions Both LDX and ATX treatment were associated with high levels of treatment response in children and adolescents with ADHD and a previous inadequate response to MPH. However, within the parameters of the study, LDX was associated with significantly higher treatment response rates than ATX across all response criteria examined. In addition, higher proportions of patients in the LDX group than the ATX group had a CGI-S score of 1 or 2 by week 9, indicating remission of symptoms. Both treatments were generally well tolerated, with safety profiles consistent with those observed in previous studies.
publishDate 2014
dc.date.none.fl_str_mv 2014
2014-11-01
2014
2014-11-01
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.13003/17192
url https://hdl.handle.net/20.500.13003/17192
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv ADIS Int Ltd
publisher.none.fl_str_mv ADIS Int Ltd
dc.source.none.fl_str_mv reponame:Docusalut
instname:Conselleria de Salut i Consum del Govern de les Illes Balears
instname_str Conselleria de Salut i Consum del Govern de les Illes Balears
reponame_str Docusalut
collection Docusalut
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling Treatment Response and Remission in a Double-Blind, Randomized, Head-to-Head Study of Lisdexamfetamine Dimesylate and Atomoxetine in Children and Adolescents with Attention-Deficit Hyperactivity DisorderDittmann, Ralf W.Cardo-Jalon, EstherNagy, PeterAnderson, Colleen S.Adeyi, BenCaballero, BeatrizHodgkins, PaulCivil, RichardCoghill, David R.DextroamphetamineRemission InductionChildTreatment OutcomeLisdexamfetamine DimesylateAtomoxetine HydrochloridePropylaminesSeverity of Illness IndexDouble-Blind MethodAttention Deficit Disorder with HyperactivityAdolescentHumansDrug Administration SchedulePropilaminasHumanosInducción de RemisiónResultado del TratamientoClorhidrato de AtomoxetinaDimesilato de LisdexanfetaminaAdolescenteMétodo Doble CiegoEsquema de MedicaciónTrastorno por Déficit de Atención con HiperactividadÍndice de Severidad de la EnfermedadDextroanfetaminaNiñoObjectives A secondary objective of this head-to-head study of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) was to assess treatment response rates in children and adolescents with attention-deficit hyperactivity disorder (ADHD) and an inadequate response to methylphenidate (MPH). The primary efficacy and safety outcomes of the study, SPD489-317 (ClinicalTrials.gov NCT01106430), have been published previously. Methods In this 9-week, double-blind, active-controlled study, patients aged 6-17 years with a previous inadequate response to MPH were randomized (1:1) to dose-optimized LDX (30, 50 or 70 mg/day) or ATX (patients < 70 kg: 0.5-1.2 mg/kg/day, not to exceed 1.4 mg/kg/day; patients <70 kg: 40, 80 or 100 mg/day). Treatment response was a secondary efficacy outcome and was predefined as a reduction from baseline in ADHD Rating Scale IV (ADHD-RS-IV) total score of at least 25, 30 or 50 %. Sustained response was predefined as a reduction from baseline in ADHD-RS-IV total score (>= 25, >= 30 or >= 50 %) or a Clinical Global Impressions (CGI)-Improvement (CGI-I) score of 1 or 2 throughout weeks 4-9. CGI-Severity (CGI-S) scores were also assessed, as an indicator of remission. Results A total of 267 patients were enrolled (LDX, n = 133; ATX, n = 134) and 200 completed the study (LDX, n = 99; ATX, n = 101). By week 9, significantly (p < 0.01) greater proportions of patients receiving LDX than ATX met the response criteria of a reduction from baseline in ADHD-RS-IV total score of at least 25 % (90.5 vs. 76.7 %), 30 % (88.1 vs. 73.7 %) or 50 % (73.0 vs. 50.4 %). Sustained response rates were also significantly (p < 0.05) higher among LDX-treated patients (ADHD-RS-IV >= 25, 66.1 %; ADHD-RS-IV >= 30, 61.4 %; ADHD-RS-IV >= 50, 41.7 %; CGI-I, 52.0 %) than among ATX-treated individuals (ADHD-RS-IV >= 25, 51.1 %; ADHD-RS-IV >= 30, 47.4 %; ADHD-RS-IV >= 50, 23.7 %; CGI-I, 39.3 %). Finally, by week 9, 60.7 % of patients receiving LDX and 46.3 % of those receiving ATX had a CGI-S score of 1 (normal, not at all ill) or 2 (borderline mentally ill), and greater proportions of patients in the LDX group than the ATX group experienced a reduction from baseline of at least one CGI-S category. Conclusions Both LDX and ATX treatment were associated with high levels of treatment response in children and adolescents with ADHD and a previous inadequate response to MPH. However, within the parameters of the study, LDX was associated with significantly higher treatment response rates than ATX across all response criteria examined. In addition, higher proportions of patients in the LDX group than the ATX group had a CGI-S score of 1 or 2 by week 9, indicating remission of symptoms. Both treatments were generally well tolerated, with safety profiles consistent with those observed in previous studies.ADIS Int Ltd20142014-11-0120142014-11-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.13003/17192reponame:Docusalutinstname:Conselleria de Salut i Consum del Govern de les Illes BalearsInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:docusalut.com:20.500.13003/171922026-06-22T12:44:07Z
score 15,808905

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