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Lisdexamfetamine beneficial for adults with ADHD, new data indicate

Monday, October 29 2007 | Comments

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What's This? Adult patients with attention-deficit/hyperactivity disorder demonstrate significant improvements in symptom control within a week of taking lisdexamfetamine, Phase III trial data show.

The double-blind, dose-escalation study included 420 adults aged 18 to 55 years who met DSM-IV-TR criteria for ADHD and whose diagnosis was confirmed by the Adult ADHD Clinician Diagnostic Scale v1.2. Clinicians rated the participants as having moderate to severe ADHD based on scores of >=28 on the ADHD Rating Scale (ADHD-RS).

After a washout period, the patients were randomized to receive placebo or 30 mg, 50 mg, or 70 mg of lisdexamfetamine each day for 4 weeks. The intent-to-treat analysis included 414 patients. The ADHD-RS at endpoint, which was administered by using DSM-IV-TR adult prompts, served as the primary efficacy measure.

The patients allocated to the placebo, 30 mg, 50 mg, and 70 mg groups had average ADHD-RS total scores of 39.4, 40.7, 40.8, and 41.1, respectively, at baseline.

All 4 of the treatment arms demonstrated improvements in ADHD-RS scores at the end of the study, with corresponding mean changes of -8.2, -16.2, -17.4, and -18.6 from baseline. There were statistically significant differences that showed the superiority of all lisdexamfetamine doses as compared with placebo. This result was evident as early as week 1 and during each subsequent treatment week.

Additionally, at each time point, a significantly greater proportion of the adults who received lisdexamfetamine relative to those who received placebo improved on the investigator-rated Clinical Global Impression-Improvement scale, as defined by a score of 1 (very much improved) or 2 (much improved; P<.01). The percentage of patients who improved with lisdexamfetamine ranged from 57% to 61%.

All groups exhibited improvements in sleep quality at study end on the Pittsburgh Sleep Quality Index.

A majority of adverse events were mild to moderate in severity, with the most common being decreased appetite (27%), dry mouth (26%), and insomnia (19%). Mean heart rate increased more from baseline with lisdexamfetamine (range, 4.4 bpm-5.5 bpm) than with placebo (0.9 bpm).

These data are the first to be released about the use of lisdexamfetamine among adults with ADHD, Dr. Lenard Adler, the lead study investigator, told VerusMed. He explained that there were no dose-dependent effects, as the effect of the lowest dose was so robust. (Poster B34.)

This information concerns a use that has not been approved by the Food and Drug Administration.

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