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CNS Drugs
Published in: CNS Drugs 6/2014

Open Access 01-06-2014 | Systematic Review

A Systematic Review of the Safety of Lisdexamfetamine Dimesylate

Authors: David R. Coghill, Beatriz Caballero, Shaw Sorooshian, Richard Civil

Published in: CNS Drugs | Issue 6/2014

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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.
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Metadata
Title
A Systematic Review of the Safety of Lisdexamfetamine Dimesylate
Authors
David R. Coghill
Beatriz Caballero
Shaw Sorooshian
Richard Civil
Publication date
01-06-2014
Publisher
Springer International Publishing
Published in
CNS Drugs / Issue 6/2014
Print ISSN: 1172-7047
Electronic ISSN: 1179-1934
DOI
https://doi.org/10.1007/s40263-014-0166-2

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