Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial.


Autoria(s): Coghill, David R; Banaschewski, Tobias; Lecendreux, Michel; Zuddas, Alessandro; Dittmann, Ralf W; Hernández Otero, Isabel; Civil, Richard; Bloomfield, Ralph; Squires, Liza A
Data(s)

26/03/2014

26/03/2014

01/02/2014

Resumo

Lisdexamfetamine dimesylate (LDX) is a long-acting, prodrug stimulant therapy for patients with attention-deficit/hyperactivity disorder (ADHD). This randomized placebo-controlled trial of an optimized daily dose of LDX (30, 50 or 70 mg) was conducted in children and adolescents (aged 6-17 years) with ADHD. To evaluate the efficacy of LDX throughout the day, symptoms and behaviors of ADHD were evaluated using an abbreviated version of the Conners' Parent Rating Scale-Revised (CPRS-R) at 1000, 1400 and 1800 hours following early morning dosing (0700 hours). Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference treatment, but the study was not designed to support a statistical comparison between LDX and OROS-MPH. The full analysis set comprised 317 patients (LDX, n = 104; placebo, n = 106; OROS-MPH, n = 107). At baseline, CPRS-R total scores were similar across treatment groups. At endpoint, differences (active treatment - placebo) in least squares (LS) mean change from baseline CPRS-R total scores were statistically significant (P < 0.001) throughout the day for LDX (effect sizes: 1000 hours, 1.42; 1400 hours, 1.41; 1800 hours, 1.30) and OROS-MPH (effect sizes: 1000 hours, 1.04; 1400 hours, 0.98; 1800 hours, 0.92). Differences in LS mean change from baseline to endpoint were statistically significant (P < 0.001) for both active treatments in all four subscales of the CPRS-R (ADHD index, oppositional, hyperactivity and cognitive). In conclusion, improvements relative to placebo in ADHD-related symptoms and behaviors in children and adolescents receiving a single morning dose of LDX or OROS-MPH were maintained throughout the day and were ongoing at the last measurement in the evening (1800 hours).

Journal Article;

This study was supported by funding from Shire Development LLC.

Identificador

Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, et al. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 ; 23(2):61-8

1435-165X (Online)

1018-8827 (Print)

PMC3918120

http://hdl.handle.net/10668/1552

23708466

10.1007/s00787-013-0421-y

Idioma(s)

en

Publicador

Springer Verlag

Relação

European child & adolescent psychiatry

http://link.springer.com/article/10.1007%2Fs00787-013-0421-y

Direitos

Acceso abierto

Palavras-Chave #ADHD #Lisdexamfetamine dimesylate #Randomized controlled trial #Central nervous system stimulants #Maintenance of efficacy #Conners’ parent rating scale #Estimulantes del sistema nervioso central #Conducta del adolescente #Trastorno por déficit de atención con hiperactividad #Anfetaminas #Resultado del tratamiento #Ensayo clínico controlado aleatorio #Dextroanfetamina #Niño #Adolescente #Medical Subject Headings::Psychiatry and Psychology::Mental Disorders::Mental Disorders Diagnosed in Childhood::Attention Deficit and Disruptive Behavior Disorders::Attention Deficit Disorder with Hyperactivity #Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amines::Ethylamines::Phenethylamines::Amphetamines #Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Stimulants #Medical Subject Headings::Named Groups::Persons::Age Groups::Child #Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans #Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amines::Ethylamines::Phenethylamines::Amphetamines::Amphetamine::Dextroamphetamine #Medical Subject Headings::Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Adolescent Behavior #Medical Subject Headings::Health Care::Health Services Administration::Quality of Health Care::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)::Treatment Outcome #Medical Subject Headings::Publication Characteristics::Study Characteristics::Clinical Trial::Randomized Controlled Trial #Medical Subject Headings::Named Groups::Persons::Age Groups::Adolescent
Tipo

info:eu-repo/semantics/article

info:eu-repo/semantics/published

Artículo