Article

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.

0 Bookmarks
 · 
114 Views
  • Source
    Journal of Drug Assessment. 03/2013; 2.
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract How to generalize from randomized placebo controlled trials of ADHD drug treatment in adults to ‘real-world’ clinical practice is intriguing. This open-labeled prospective observational study examined the effectiveness of long-term stimulant and non-stimulant medication in adult ADHD including dose, side-effects and comorbidity in a clinical setting. A specialized ADHD outpatient clinic gave previously non-medicated adults (n=250) with ADHD methylphenidate as first-line drug according to current guidelines. Patients who were non-tolerant or experiencing low efficacy were switched to amphetamine or atomoxetine. Primary outcomes were changes of ADHD-symptoms evaluated with the Adult ADHD Self-Report Scale (ASRS) and overall severity by the Global Assessment of Functioning (GAF). Secondary outcomes were measures of mental distress, and response on the Clinical-Global-Impressions-Improvement Scale. Data at baseline and follow-ups were compared in longitudinal mixed model analyses for time on-medication, dosage, comorbidity, and side-effects. As results, 232 patients (93%) completed examination at the 12 month endpoint, and 163 (70%) remained on medication. Compared with the patients who discontinued medication, those still on medication had greater percentage reduction in ASRS-scores (median 39%, versus 13%, P<0.001) and greater improvement of GAF (median 20% versus 4%, P<0.001) and secondary outcomes. Continued medication and higher cumulated doses showed significant associations to sustained improvement. Conversely, psychiatric comorbidity and side-effects were related to lower effectiveness and more frequent termination of medication. Taken together, one-year treatment with stimulants or atomoxetine was associated with a clinically significant reduction in ADHD symptoms and mental distress, and improvement of measured function. No serious adverse events were observed.
    European Neuropsychopharmacology 10/2014; · 5.40 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Lisdexamfetamine dimesylate (LDX) is a long-acting oral prodrug stimulant. It is inactive until enzymatically hydrolyzed in the blood to active d-amphetamine. The pharmacological action of this compound involves blocking norepinephrine (NE) and dopamine reuptake into presynaptic neurons and promoting the release of NE and dopamine into the extraneuronal space. LDX has been approved for treating ADHD, which is the most common psychiatric disorder in children and adolescents. Also, LDX has been proposed for other psychiatric conditions related with dopaminergic and NE CNS. LDX is the first long-acting oral prodrug indicated for the treatment of ADHD in children (6-12 years), adolescents (13-17 years) and in adults in the USA and Canada, whereas, in Europe, LDX is licensed in several countries for the treatment of children and adolescents with ADHD who have had a clinically inadequate response to methylphenidate. This article covers the most important pharmacological aspects of LDX as well as data on the efficacy, tolerability and safety of this long-acting amphetamine prodrug collected from clinical studies recently published in the literature.
    Expert Review of Neurotherapeutics 06/2014; · 2.96 Impact Factor

Full-text (2 Sources)

Download
41 Downloads
Available from
Jun 1, 2014