Effectiveness and Duration of Effect of Open-Label Lisdexamfetamine Dimesylate in Adults With ADHD

LDX has demonstrated efficacy at 14 hours post dose in adults.

“Lisdexamfetamine dimesylate has demonstrated efficacy at 14 hours post dose in adults”

In the Wigal et al trial, PERMP total scores were greater at all post dose time points from 2 to 14 hours for adults on LDX compared with placebo.

“The PERMP total scores were greater at all post dose time points from 2 to 14 hours for adults on LDX compared with placebo (P < .001).”

In the Wigal et al trial, ADHD-RS-IV total scores improved from baseline and CGI-I scores suggested that 76.5% of participants improved while taking LDX and 23.1% improved on placebo.

“The ADHD-RS-IV total scores improved from baseline (P < .0001) and the CGI-I scores suggested that 76.5% of participants improved while taking LDX and 23.1% of participants improved on placebo (P < .0001).”

A 2-week placebo-controlled crossover trial by Wigal et al using a simulated Adult Workplace Environment demonstrated maintenance of therapeutic effects of LDX from 2 to 14 hours post dose in adults with ADHD, as noted by improvements in PERMP scores compared with placebo.

“A 2-week placebo-controlled crossover trial by Wigal et al24 used a simulated Adult Workplace Environment (AWE) design and demonstrated the maintenance of therapeutic effects of LDX from 2 to 14 hours post dose in adults with ADHD, as noted by improvements in the Permanent Product Measure of Performance (PERMP) scores, a 10-minute skill adjusted math test, compared with placebo.”

In the Wigal et al trial, PERMP-Attempted and PERMP-Correct scores at post dose time points were significantly improved for adults who received LDX compared with placebo at each time point.

“the PERMP-Attempted (PERMP-A) and PERMP-Correct (PERMP-C) scores at post dose time points were significantly improved for adults who received LDX compared with placebo at each time point (P ≤ .0031).”

In the Wigal et al trial, patients treated with LDX had greater improvement in average PERMP total scores, with a least squares mean difference of 23.4.

“Patients treated with LDX had greater improvement in average PERMP total scores, as measured by difference in LS mean at 23.4 (P < .0001).”

The efficacy and safety of once-daily LDX in adults aged 18-55 diagnosed with ADHD according to DSM-IV-TR criteria was demonstrated in short-term, randomized, double-blind, placebo-controlled multicenter studies incorporating a parallel-group or crossover design.

“The efficacy and safety of once-daily LDX in adults (aged 18-55 years) diagnosed with ADHD according to Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria was demonstrated in short-term, randomized, double-blind, placebo-controlled multicenter studies incorporating a parallel-group22,23 or crossover design.24”

In that study, insomnia was a common adverse effect, one patient could not tolerate a dose increase for this reason, and six patients withdrew from the study due to side effects.

“However, insomnia was a common adverse effect and one patient could not tolerate a dose increase for this reason. It was also reported that six patients withdrew from the study due to side effects.”

In an open-label study of 40 adults treated with lisdexamfetamine for 12 weeks, Adler et al found a significant reduction in ADHD-RS-IV scores and a significant improvement on the Time-Sensitive ADHD Symptom Scale.

“In an open-label study of 40 adults treated with lisdexamfetamine for 12 weeks, Adler et al31 found a significant reduction in ADHD-RS-IV scores. Based on assessments using the Time-Sensitive ADHD Symptom Scale, they asked patients to rate their ADHD symptoms a few hours earlier, and a significant improvement was reported.”

In that study, lisdexamfetamine had a smooth medication effect throughout the day, with fewer rebound symptoms.

“They also found that lisdexamfetamine had a smooth medication effect throughout the day, with fewer rebound symptoms.”