Evidence map›Paper›PMID 24788672›Full record

SynthesisCNS drugs2014

A systematic review of the safety of lisdexamfetamine dimesylate.

David R Coghill, Beatriz Caballero, Shaw Sorooshian, Richard Civil

Registry-linked trialOpen access · hybridAbstract readSystematic Review
In one paragraph

Synthesis in CNS drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03337646 (A Multi-Center, Open Label, Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
5.2field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03337646 phase4completednot on this mapstarted 2018, after this paper: background citation

A Multi-Center, Open Label, Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder

TypeinterventionalSponsorJPM van Stralen Medicine ProfessionalRan2018 to 2023Enrolled48ConditionsAttention Deficit Hyperactivity Disorder, Autism Spectrum DisorderArmsLisdexamfetamine Dimesylate
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 87 citations in OpenAlex.

  1. Pooled it
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  17. A Case of Constipation and Gastrointestinal Retention of Lisdexamfetamine Dimesylate Capsules in an 11-Year-Old.Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent · 2021
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

David R CoghillDivision of Neuroscience, University of Dundee, Dundee, UK, d.r.coghill@dundee.ac.uk.
Beatriz Caballero
Shaw Sorooshian
Richard Civil
Takeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Attention Deficit Disorder with HyperactivityCentral Nervous System StimulantsClinical Trials, Phase III as TopicDextroamphetamineDose-Response Relationship, DrugHumansLisdexamfetamine DimesylateProdrugsRandomized Controlled Trials as TopicTime FactorsCentral Nervous System StimulantsDextroamphetamineLisdexamfetamine DimesylateProdrugs

Identifiers

PMID24788672
PMCPMC4057639
OpenAlexW2146886967

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.