A systematic review of the safety of lisdexamfetamine dimesylate

David R. Coghill (Lead / Corresponding author), Beatriz Caballero, Shaw Sorooshian, Richard Civil

    Research output: Contribution to journalArticle

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    Abstract

    Background
    Here we review the safety and tolerability profile of lisdexamfetamine dimesylate (LDX), the first long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD).

    Methods
    A PubMed search was conducted for English-language articles published up to 16 September 2013 using the following search terms: (lisdexamfetamine OR lisdexamphetamine OR SPD489 OR Vyvanse OR Venvanse OR NRP104 NOT review [publication type]).

    Results
    In short-term, parallel-group, placebo-controlled, phase III trials, treatment-emergent adverse events (TEAEs) in children, adolescents, and adults receiving LDX were typical for those reported for stimulants in general. Decreased appetite was reported by 25–39 % of patients and insomnia by 11–19 %. The most frequently reported TEAEs in long-term studies were similar to those reported in the short-term trials. Most TEAEs were mild or moderate in severity. Literature relating to four specific safety concerns associated with stimulant medications was evaluated in detail in patients receiving LDX. Gains in weight, height, and body mass index were smaller in children and adolescents receiving LDX than in placebo controls or untreated norms. Insomnia was a frequently reported TEAE in patients with ADHD of all ages receiving LDX, although the available data indicated no overall worsening of sleep quality in adults. Post-marketing survey data suggest that the rate of non-medical use of LDX was lower than that for short-acting stimulants and lower than or equivalent to long-acting stimulant formulations. Small mean increases were seen in blood pressure and pulse rate in patients receiving LDX.

    Conclusions
    The safety and tolerability profile of LDX in individuals with ADHD is similar to that of other stimulants
    Original languageEnglish
    Pages (from-to)497-511
    Number of pages15
    JournalCNS Drugs
    Volume28
    Issue number6
    DOIs
    Publication statusPublished - Jun 2014

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    Safety
    Attention Deficit Disorder with Hyperactivity
    Sleep Initiation and Maintenance Disorders
    Lisdexamfetamine Dimesylate
    Placebos
    Therapeutics
    Prodrugs
    Appetite
    Marketing
    PubMed
    Weight Gain
    Publications
    Sleep
    Body Mass Index
    Language
    Heart Rate
    Blood Pressure

    Cite this

    Coghill, D. R., Caballero, B., Sorooshian, S., & Civil, R. (2014). A systematic review of the safety of lisdexamfetamine dimesylate. CNS Drugs, 28(6), 497-511. https://doi.org/10.1007/s40263-014-0166-2
    Coghill, David R. ; Caballero, Beatriz ; Sorooshian, Shaw ; Civil, Richard. / A systematic review of the safety of lisdexamfetamine dimesylate. In: CNS Drugs. 2014 ; Vol. 28, No. 6. pp. 497-511.
    @article{745a53a2a6a741af9c315c5085361c62,
    title = "A systematic review of the safety of lisdexamfetamine dimesylate",
    abstract = "BackgroundHere we review the safety and tolerability profile of lisdexamfetamine dimesylate (LDX), the first long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD).MethodsA PubMed search was conducted for English-language articles published up to 16 September 2013 using the following search terms: (lisdexamfetamine OR lisdexamphetamine OR SPD489 OR Vyvanse OR Venvanse OR NRP104 NOT review [publication type]).ResultsIn short-term, parallel-group, placebo-controlled, phase III trials, treatment-emergent adverse events (TEAEs) in children, adolescents, and adults receiving LDX were typical for those reported for stimulants in general. Decreased appetite was reported by 25–39 {\%} of patients and insomnia by 11–19 {\%}. The most frequently reported TEAEs in long-term studies were similar to those reported in the short-term trials. Most TEAEs were mild or moderate in severity. Literature relating to four specific safety concerns associated with stimulant medications was evaluated in detail in patients receiving LDX. Gains in weight, height, and body mass index were smaller in children and adolescents receiving LDX than in placebo controls or untreated norms. Insomnia was a frequently reported TEAE in patients with ADHD of all ages receiving LDX, although the available data indicated no overall worsening of sleep quality in adults. Post-marketing survey data suggest that the rate of non-medical use of LDX was lower than that for short-acting stimulants and lower than or equivalent to long-acting stimulant formulations. Small mean increases were seen in blood pressure and pulse rate in patients receiving LDX.ConclusionsThe safety and tolerability profile of LDX in individuals with ADHD is similar to that of other stimulants",
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    Coghill, DR, Caballero, B, Sorooshian, S & Civil, R 2014, 'A systematic review of the safety of lisdexamfetamine dimesylate', CNS Drugs, vol. 28, no. 6, pp. 497-511. https://doi.org/10.1007/s40263-014-0166-2

    A systematic review of the safety of lisdexamfetamine dimesylate. / Coghill, David R. (Lead / Corresponding author); Caballero, Beatriz; Sorooshian, Shaw; Civil, Richard.

    In: CNS Drugs, Vol. 28, No. 6, 06.2014, p. 497-511.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - A systematic review of the safety of lisdexamfetamine dimesylate

    AU - Coghill, David R.

    AU - Caballero, Beatriz

    AU - Sorooshian, Shaw

    AU - Civil, Richard

    PY - 2014/6

    Y1 - 2014/6

    N2 - BackgroundHere we review the safety and tolerability profile of lisdexamfetamine dimesylate (LDX), the first long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD).MethodsA PubMed search was conducted for English-language articles published up to 16 September 2013 using the following search terms: (lisdexamfetamine OR lisdexamphetamine OR SPD489 OR Vyvanse OR Venvanse OR NRP104 NOT review [publication type]).ResultsIn short-term, parallel-group, placebo-controlled, phase III trials, treatment-emergent adverse events (TEAEs) in children, adolescents, and adults receiving LDX were typical for those reported for stimulants in general. Decreased appetite was reported by 25–39 % of patients and insomnia by 11–19 %. The most frequently reported TEAEs in long-term studies were similar to those reported in the short-term trials. Most TEAEs were mild or moderate in severity. Literature relating to four specific safety concerns associated with stimulant medications was evaluated in detail in patients receiving LDX. Gains in weight, height, and body mass index were smaller in children and adolescents receiving LDX than in placebo controls or untreated norms. Insomnia was a frequently reported TEAE in patients with ADHD of all ages receiving LDX, although the available data indicated no overall worsening of sleep quality in adults. Post-marketing survey data suggest that the rate of non-medical use of LDX was lower than that for short-acting stimulants and lower than or equivalent to long-acting stimulant formulations. Small mean increases were seen in blood pressure and pulse rate in patients receiving LDX.ConclusionsThe safety and tolerability profile of LDX in individuals with ADHD is similar to that of other stimulants

    AB - BackgroundHere we review the safety and tolerability profile of lisdexamfetamine dimesylate (LDX), the first long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD).MethodsA PubMed search was conducted for English-language articles published up to 16 September 2013 using the following search terms: (lisdexamfetamine OR lisdexamphetamine OR SPD489 OR Vyvanse OR Venvanse OR NRP104 NOT review [publication type]).ResultsIn short-term, parallel-group, placebo-controlled, phase III trials, treatment-emergent adverse events (TEAEs) in children, adolescents, and adults receiving LDX were typical for those reported for stimulants in general. Decreased appetite was reported by 25–39 % of patients and insomnia by 11–19 %. The most frequently reported TEAEs in long-term studies were similar to those reported in the short-term trials. Most TEAEs were mild or moderate in severity. Literature relating to four specific safety concerns associated with stimulant medications was evaluated in detail in patients receiving LDX. Gains in weight, height, and body mass index were smaller in children and adolescents receiving LDX than in placebo controls or untreated norms. Insomnia was a frequently reported TEAE in patients with ADHD of all ages receiving LDX, although the available data indicated no overall worsening of sleep quality in adults. Post-marketing survey data suggest that the rate of non-medical use of LDX was lower than that for short-acting stimulants and lower than or equivalent to long-acting stimulant formulations. Small mean increases were seen in blood pressure and pulse rate in patients receiving LDX.ConclusionsThe safety and tolerability profile of LDX in individuals with ADHD is similar to that of other stimulants

    U2 - 10.1007/s40263-014-0166-2

    DO - 10.1007/s40263-014-0166-2

    M3 - Article

    VL - 28

    SP - 497

    EP - 511

    JO - CNS Drugs

    JF - CNS Drugs

    SN - 1172-7047

    IS - 6

    ER -

    Coghill DR, Caballero B, Sorooshian S, Civil R. A systematic review of the safety of lisdexamfetamine dimesylate. CNS Drugs. 2014 Jun;28(6):497-511. https://doi.org/10.1007/s40263-014-0166-2