Adverse Events in Medication Treatment-Naïve Children with Attention-Deficit/Hyperactivity Disorder: Results from a Small, Controlled Trial of Lisdexamfetamine Dimesylate

2012 ◽  
Vol 22 (2) ◽  
pp. 149-156 ◽  
Author(s):  
Sharon B. Wigal ◽  
Amanda A. Wong ◽  
Angela Jun ◽  
Annamarie Stehli ◽  
Robin Steinberg-Epstein ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Adverse Events ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Lisdexamfetamine Dimesylate ◽  
Medication Treatment ◽  
Hyperactivity Disorder ◽  
Treatment Naïve

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.

Treatment of attention deficit/hyperactivity disorder in children with CHD

2021 ◽  
pp. 1-4
Author(s):  
Alyson R. Pierick ◽  
Melodie Lynn ◽  
Courtney M. McCracken ◽  
Matthew E. Oster ◽  
Glen J. Iannucci
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
General Population ◽  
Adverse Events ◽  
Supraventricular Tachycardia ◽  
Medical Therapy ◽  
Attention Deficit ◽  
Case Reports ◽  
Single Centre ◽  
Hyperactivity Disorder ◽  
Increased Risk

Abstract Introduction: The prevalence of attention deficit/hyperactivity disorder in the general population is common and is now diagnosed in 4%–12% of children. Children with CHD have been shown to be at increased risk for attention deficit/hyperactivity disorder. Case reports have led to concern regarding the use of attention deficit/hyperactivity disorder medications in children with underlying CHD. We hypothesised that medical therapy for patients with CHD and attention deficit/hyperactivity disorder is safe. Methods: A single-centre, retrospective chart review was performed evaluating for adverse events in patients aged 4–21 years with CHD who received attention deficit/hyperactivity disorder therapy over a 5-year span. Inclusion criteria were a diagnosis of CHD and concomitant medical therapy with amphetamines, methylphenidate, or atomoxetine. Patients with trivial or spontaneously resolved CHD were excluded from analysis. Results: In 831 patients with CHD who received stimulants with a mean age of 12.9 years, there was only one adverse cardiovascular event identified. Using sensitivity analysis, our median follow-up time was 686 days and a prevalence rate of 0.21% of adverse events. This episode consisted of increased frequency of supraventricular tachycardia in a patient who had this condition prior to initiation of medical therapy; the condition improved with discontinuation of attention deficit/hyperactivity disorder therapy. Conclusion: The incidence of significant adverse cardiovascular events in our population was similar to the prevalence of supraventricular tachycardia in the general population. Our single-centre experience demonstrated no increased risk in adverse events related to medical therapy for children with attention deficit/hyperactivity disorder and underlying CHD. Further population-based studies are indicated to validate these findings.

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