Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder

results from a randomized, controlled trial

David R. Coghill (Lead / Corresponding author), Tobias Banaschewski, Michel Lecendreux, Alessandro Zuddas, Ralf W. Dittmann, Isabel Hernández Otero, Richard Civil, Ralph Bloomfield, Liza A. Squires

    Research output: Contribution to journalArticle

    19 Citations (Scopus)
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    Abstract

    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).
    Original languageEnglish
    Pages (from-to)61-68
    Number of pages8
    JournalEuropean Child & Adolescent Psychiatry
    Volume23
    Issue number2
    DOIs
    Publication statusPublished - Feb 2014

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    Attention Deficit Disorder with Hyperactivity
    Methylphenidate
    Randomized Controlled Trials
    Placebos
    Least-Squares Analysis
    Therapeutics
    Adolescent Behavior
    Prodrugs
    Child Behavior
    Lisdexamfetamine Dimesylate

    Cite this

    Coghill, David R. ; Banaschewski, Tobias ; Lecendreux, Michel ; Zuddas, Alessandro ; Dittmann, Ralf W. ; Otero, Isabel Hernández ; Civil, Richard ; Bloomfield, Ralph ; Squires, Liza A. / Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder : results from a randomized, controlled trial. In: European Child & Adolescent Psychiatry. 2014 ; Vol. 23, No. 2. pp. 61-68.
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    abstract = "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).",
    author = "Coghill, {David R.} and Tobias Banaschewski and Michel Lecendreux and Alessandro Zuddas and Dittmann, {Ralf W.} and Otero, {Isabel Hern{\'a}ndez} and Richard Civil and Ralph Bloomfield and Squires, {Liza A.}",
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    Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder : results from a randomized, controlled trial. / Coghill, David R. (Lead / Corresponding author); Banaschewski, Tobias; Lecendreux, Michel; Zuddas, Alessandro; Dittmann, Ralf W.; Otero, Isabel Hernández; Civil, Richard; Bloomfield, Ralph; Squires, Liza A.

    In: European Child & Adolescent Psychiatry, Vol. 23, No. 2, 02.2014, p. 61-68.

    Research output: Contribution to journalArticle

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    T1 - Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder

    T2 - results from a randomized, controlled trial

    AU - Coghill, David R.

    AU - Banaschewski, Tobias

    AU - Lecendreux, Michel

    AU - Zuddas, Alessandro

    AU - Dittmann, Ralf W.

    AU - Otero, Isabel Hernández

    AU - Civil, Richard

    AU - Bloomfield, Ralph

    AU - Squires, Liza A.

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    AB - 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).

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