Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder

In the citing paper

“Discontinuations due to TEAEs with LDX in these studies (6.3% and 3.9%) are comparable to a published phase 2 study of LDX in BED (McElroy et al, 2015), to other clinical studies of LDX for which LDX is indicated (Adler et al, 2008; Wigal et al, 2010), and to other BED pharmacotherapy trials with other agents (Claudino et al, 2007; McElroy et al, 2003, 2007a, b).”

In the citing paper

“The safety and tolerability profile of LDX observed regarding overall TEAEs, TEAEs leading to discontinuation, vital signs, and ECGs were consistent with published reports in adults with BED (McElroy et al, 2015) or attention-deficit/hyperactivity disorder (Adler et al, 2008; Wigal et al, 2010).”

In the citing paper

“Lisdexamfetamine dimesylate is not metabolized by cytochrome P450 enzymes and unlikely to be involved in drug interactions involving CYP enzymes or P-glycoprotein; however, it is contraindicated during or within 2 weeks following the administration of monoamine oxidase inhibitors.”

In the citing paper

“in placebo-controlled LDX trials in ADHD, participants were considered treatment “responders” if they had a ≥ 30% reduction in ADHD symptoms using a standardized scale [27–29].”

In the citing paper

“Improvements observed from LDX versus placebo in this trial were comparable to those observed in LDX interventions for adults with ADHD [16,27–29].”

In the citing paper

“Previously reported abuse liability studies support the reduced abuse potential of LDX administered orally at doses ≤150 mg or intravenously at doses ≤50 mg, compared with d-amphetamine immediate-release 40 mg oral or 20 mg intravenous doses, respectively.21”

In the citing paper

“An intention-to-treat analysis was applied in two studies.16,18”

In the citing paper

“Unfortunately, only one study reported remission rates,16 and its pooled remission rate could not be calculated.”

In the citing paper

“Although some randomized controlled trials (RCTs) of LDX demonstrated its efficacy and tolerability, compared with placebo, in the treatment of adult ADHD,16,18–21 they had a limited sample size.”

In the citing paper

“The evidence suggests that LDX is an effective, safe, well-tolerated medication for children aged 6 to 12 years through to adulthood, with ADHD.16,17”

In the citing paper

“Additionally, allocation concealment was reported in two trials18,21 and blinding of outcome assessment was reported in three trials.16,20,21”

In the citing paper

“Six percent of subjects in the lisdexamfetamine group discontinued the drug owing to side effects, the most common being insomnia. Palpitations, hypertension, and dyspnea were also more common in the treatment group than in the placebo group.”

In the citing paper

“In a randomized, placebo-controlled trial of 420 adult subjects with ADHD, Adler et al27 found statistically significant improvements in ADHD-RS-IV and CGI scores for all doses of lisdexamfetamine (30–50 mg) compared with placebo. These improvements were evident from the first week.”

In the citing paper

“The common AEs in the current study, including decreased appetite, dry mouth, headache, and insomnia, are consistently seen in studies of long-acting stimulant medications administered to adults [12,18,35,36].”

In the citing paper

“LDX has demonstrated efficacy in reducing core ADHD symptoms in a randomized, controlled trial in adults [26], using the ADHD Rating Scale IV (ADHD-RS-IV) [27,28]”

In the citing paper

“The overall safety and tolerability findings observed in these studies are consistent with previously published studies of LDX augmentation for MDD with other clinical studies of LDX for which LDX is approved for use (Adler et al., 2008;Madhoo et al., 2014;McElroy et al., 2016;Trivedi et al., 2013Wigal et al., 2010).”

In the citing paper

“Multiple randomized, double-blind, placebo-controlled trials have shown LDX to be an effective treatment for children, adolescents and adults with ADHD, with a tolerability and safety profile consistent with the known effects of psychostimulant therapy [9–15].”

In the citing paper

“These results support previous placebo-controlled trials of LDX, which have demonstrated a robust treatment response in a range of patient groups [9, 11–13].”

In the citing paper

“Both therapies displayed safety profiles consistent with findings from previous studies [9, 11–13, 28–30].”

In the citing paper

“The most frequently reported TEAEs in the LDX treatment group (decreased appetite, decreased weight, headache, nausea and insomnia) and in patients receiving ATX (headache, nausea, somnolence, decreased appetite and fatigue) are consistent with findings from previous studies [9, 11–13, 28–30].”