Open-Label Administration of Lisdexamfetamine Dimesylate Improves Executive Function Impairments and Symptoms of Attention-Deficit/Hyperactivity Disorder in Adults

2010 ◽  
Vol 122 (5) ◽  
pp. 7-17 ◽  
Author(s):  
Thomas E. Brown ◽  
Matthew Brams ◽  
Joseph Gao ◽  
Maria Gasior ◽  
Ann Childress
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Executive Function ◽  
Attention Deficit ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Hyperactivity Disorder

scholarly journals Long-Term Safety and Effectiveness of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder

CNS Spectrums ◽  
2009 ◽  
Vol 14 (10) ◽  
pp. 573-586 ◽  
Author(s):  
Richard Weisler ◽  
Joel Young ◽  
Greg Mattingly ◽  
Joseph Gao ◽  
Liza Squires ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Adverse Events ◽  
Attention Deficit ◽  
Rating Scale ◽  
Upper Respiratory Tract ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Double Blind ◽  
Hyperactivity Disorder

ABSTRACTObjective: To evaluate the long-term safety and effectiveness of lisdexamfetamine dimesylate (LDX) in the treatment of adults with attention-deficit/hyperactivity disorder (ADHD).Methods: 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.Results: 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).Conclusions: LDX demonstrated a safety profile consistent with long-acting stimulant use and provided continued effectiveness in adults with ADHD for up to 12 months.

Clinical Response and Symptomatic Remission in Children Treated With Lisdexamfetamine Dimesylate for Attention-Deficit/Hyperactivity Disorder

CNS Spectrums ◽  
2010 ◽  
Vol 15 (9) ◽  
pp. 559-568 ◽  
Author(s):  
Robert L. Findling ◽  
Ben Adeyi ◽  
Gary Chen ◽  
Bryan Dirks ◽  
Thomas Babcock ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Clinical Response ◽  
Attention Deficit ◽  
Rating Scale ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Long Term Study ◽  
Symptomatic Remission

ABSTRACTObjective: To examine clinical response and symptomatic remission in two studies of lisdexamfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD).Methods: In a 4-week, placebo-controlled, double-blind trial, children 6–12 years of age with ADHD received LDX (30–70 mg/day) or placebo. In an open-label trial, children from previous studies were titrated to optimal dose over 4 weeks and maintained up to 1 year. Primary and secondary efficacy assessments were the ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions-Improvement (CGI-I) scale, respectively. Clinical response was defined as ≥30% reduction in ADHD-RS-IV total score with a CGI-I rating of 1 or 2; symptomatic remission was defined by ADHD-RS-IV total score ≤18.Results: In the 4-week study (N=285), at any postdose assessment, 79.3% achieved response (median 13 days) and 67.1% achieved remission (median 22 days) with LDX versus 29.2% and 23.6% with placebo. In the long-term study (N=251), at any postdose assessment, 96.0% responded and 62.7% maintained response; 88.8% achieved remission and 46.4% maintained remission.Conclusion: Most children treated with LDX achieved clinical response and symptomatic remission at one time point; once achieved, almost half maintained remission.

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