Long-term safety and effectiveness of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder

Department of Psychiatry, University of North Carolina, Chapel Hill, USA.
CNS spectrums (Impact Factor: 1.3). 10/2009; 14(10):573-85.
Source: PubMed

ABSTRACT To evaluate the long-term safety and effectiveness of lisdexamfetamine dimesylate (LDX) in the treatment of adults with attention-deficit/hyperactivity disorder (ADHD).
Following a 4-week, placebo-controlled, double-blind trial, 349 adults with ADHD were enrolled into an open-label, single-arm study for up to 12 months. Treatment was initiated at 30 mg/day and titrated up to 70 mg/day at subsequent visits to achieve optimal effectiveness and tolerability. Safety assessments included adverse events inquiries, vital signs, and electrocardiograms while the primary effectiveness assessment was the ADHD Rating Scale (ADHD-RS) total score.
A total of 191 (54.7%) subjects completed the study. The most common treatment-emergent adverse events (TEAEs) were upper respiratory tract infection (21.8%), insomnia (19.5%), headache (17.2%), dry mouth (16.6%), decreased appetite (14.3%), and irritability (11.2%). Most TEAEs were mild to moderate in severity. At endpoint, small but statistically significant increases in pulse and blood pressure were noted. Significant improvements in mean ADHD-RS total scores were observed at week 1 and sustained throughout the study (P < .0001 at all postbaseline visits). At endpoint, the mean improvement from baseline ADHD-RS total score was 24.8 (P < .0001).
LDX demonstrated a safety profile consistent with long-acting stimulant use and provided continued effectiveness in adults with ADHD for up to 12 months.

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    • "Lisdexamfetamine, which can be administered once-daily, is a prodrug that is metabolised by red blood cells to yield its active metabolite, d-amphetamine, and L-lysine (Pennick, 2010). Lisdexamfetamine has been shown to be effective in the treatment of ADHD (evidence level Ia) in a number of randomised, double-blind, placebo-controlled trials that have been performed in children (Biederman et al., 2007a, 2007b) and adults (Adler et al., 2008), and also in open-label, long-term investigations (Findling et al., 2008; Weisler et al., 2009). The side-effect profile of this prodrug (Vyvanse® US Prescription Drug Label, 2012) is similar to that of d-ampheta-mine or methylphenidate (Heal et al., 2013), but there is evidence from studies performed in drug-experienced human volunteers that indicates its liability for recreational abuse may be substantially lower than that of immediate-release d-amphetamine (Jasinski and Krishnan, 2009a, 2009b). "
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