Long-Term Effectiveness and Safety of Lisdexamfetamine Dimesylate in School-Aged Children with Attention-Deficit/Hyperactivity Disorder

CNS Spectrums ◽  
2008 ◽  
Vol 13 (7) ◽  
pp. 614-620 ◽  
Author(s):  
Robert L. Findling ◽  
Ann C. Childress ◽  
Suma Krishnan ◽  
James J. McGough
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Clinical Global Impression ◽  
Attention Deficit ◽  
Rating Scale ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Hyperactivity Disorder ◽  
Scale Scores ◽  
Clinical Global Impression Improvement

ABSTRACTIntroduction:Lisdexamfetamine dimesylate (LDX), a prodrug stimulant, is indicated for attention-deficit/hyperactivity disorder (ADHD) in children 6–12 years of age and in adults. In shortterm studies, once-daily LDX provided efficacy throughout the day. This study presented here was conducted to assess the long-term safety, tolerability, and effectiveness of LDX in 6- to 12-year-olds with ADHD.Methods:This open-label, multicenter, singlearm study enrolled children with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for ADHD. Following 1-week screening and washout periods, subjects were titrated to LDX 30, 50, or 70 mg/day over 4 weeks and placed on maintenance treatment for 11 months. The ADHD Rating Scale and Clinical Global Impression-Improvement scale measured effectiveness.Results:Of 272 subjects receiving LDX, 147 completed the study. Most adverse events were mild to moderate and occurred during the first 4 weeks. There were no clinically meaningful changes in blood pressure or electrocardiographic parameters. From baseline to endpoint, mean ADHD Rating Scale scores improved by 27.2 points (P<.0001). Improvements occurred during each of the first 4 weeks, and were maintained throughout. Based on Clinical Global Impression-Improvement scale scores, >80% of subjects at endpoint and >95% of completers at 12 months were rated “improved.”Conclusion:Long-term 30, 50, and 70 mg/day LDX was generally well tolerated and effective in children with ADHD.

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.

scholarly journals High Attention-Deficit/Hyperactivity Disorder Scale Scores Among Patients with Persistent Chronic Nonspecific Low Back Pain

2021 ◽  
pp. E299-E307
Author(s):  
Satoshi Kasahara
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Low Back Pain ◽  
Back Pain ◽  
Attention Deficit ◽  
Rating Scales ◽  
Rating Scale ◽  
Pain Clinic ◽  
Low Back ◽  
Hyperactivity Disorder ◽  
Scale Scores

Background: Associations between attention-deficit/hyperactivity disorder (ADHD) and chronic pain disorders, such as fibromyalgia, have been reported. However, associations between persistent chronic nonspecific low back pain (CNLBP) and ADHD have not yet been investigated. Objectives: This study aimed to investigate the positive rates of possible ADHD, as assessed by selfreported ADHD scales, in patients with persistent CNLBP, using data from self-reported questionnaires completed by patients and their families. This study also aimed to compare the self-reported scores obtained from existing standardized data for healthy individuals, and to examine whether the ADHD scale scores of patients with persistent CNLBP are associated with pain variables. Study Design: Cross-sectional study. Setting: The specialized pain clinic at our university hospital. Methods: This cross-sectional study included 60 consecutive patients with persistent CNLBP who were diagnosed with a possible somatic symptom disorder and were referred to a psychiatrist in our pain clinic. The Conners’ Adult ADHD Rating Scales (CAARS) self-report (CAARS-S) and observer-rated (CAARS-O) questionnaires were utilized. We investigated the CAARS scores, and the association between the CAARS subscale scores and pain variables (pain duration and pain Numeric Rating Scale) in patients with persistent CNLBP. Results: Of the 60 patients, 19 (31.7%) were positive on both CAARS-S and CAARS-O questionnaires (T-score > 65). The ADHD indices, which comprised subscales of the CAARS estimating the necessity of treatment for ADHD, were significantly higher in both male and female patients with persistent CNLBP than in the Japanese standardized sample (P < 0.005). CAARS-S hyperactivity/restlessness, CAARS-O hyperactivity/restlessness, and the Diagnostic and Statistical Manual of Mental Disorders, fourth edition hyperactive-impulsive symptom subscale scores also correlated with the pain intensity (P < 0.05). Limitations: In this study, ADHD tendency was evaluated using only a self-reported questionnaire. Hence in the future, accurate and precise assessments of ADHD symptoms using structured clinical interviews conducted by ADHD experts are warranted. Additionally, the study only included patients with persistent CNLBP. Therefore in the future, it will be valuable to investigate ADHD scale scores (e.g., CAARS) among patients with CNLBP and nonspecific low back pain with larger sample sizes. Conclusions: Our findings revealed that the subscale scores on an ADHD scale were considerably high in patients with persistent CNLBP. As a previous study of our clinical experience indicates that persistent CNLBP can be substantially relieved by administering ADHD medications, ADHD screening is warranted in the treatment of persistent CNLBP. Key words: Attention-deficit/hyperactivity disorder, neurodevelopmental disorders, chronic nonspecific low back pain, chronic pain, Conners’ Adult ADHD Rating Scales (CAARS), Numeric Rating Scale, pain duration, pain clinic, somatic symptom disorder

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