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Lisdexamfetamine improves parent-rated measures of ADHD

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
Treatment with lisdexamfetamine dimesylate appears to significantly improve parent-rated measures of attention-deficit/hyperactivity disorder in children relative to placebo, a post hoc analysis shows.

The secondary analysis was based on data from a double-blind, Phase III trial in which 290 children aged 6 to 12 years were randomized to receive placebo or lisdexamfetamine in once-daily doses of 30 mg, 50 mg, or 70 mg for 4 weeks. For this analysis, researchers assessed a cross-section of ADHD-related symptoms and problem behaviors using the Conners' Parent Rating Scale-Revised Short Version (CPRS) ADHD Index subscale, which is composed of the 12 items that best differentiate children with ADHD from children without the disease.

Parents rated their child's behavior for the 2 hours preceding 10 AM, 2 PM, and 6 PM.

At 4 weeks, CPRS total scores significantly improved for each of the lisdexamfetamine groups relative to placebo at all time points measured (P<.0001 for all).

In addition, improvements in CPRS ADHD Index scores among lisdexamfetamine-treated patients were significantly greater than those seen among placebo-treated patients (P<.0001 for all). For lisdexamfetamine-treated patients, the least squares mean percent changes from baseline to endpoint at 10 AM, 2 PM, and 6 PM were -51.7%, -51.7%, and -46.0%, respectively, versus -3.4%, -3.9%, and -1.9% for placebo-treated patients.

"No other drug under the sun shows that result [at 6 PM]," Dr. Lawrence Ginsberg, the lead study author, told VerusMed.

Patients were also classified according to the Clinical Global Impression-Severity (CGI-S) scale of 1 (no symptoms) to 7 (very severe symptoms). For those who were classified as CGI-S 3 to 4 (mildly to moderately ill) at baseline and those who were classified as CGI-S 5 to 7 (markedly to extremely ill) at baseline, CPRS ADHD Index scores significantly improved at all time points for those who received lisdexamfetamine as compared with those who received placebo. (Poster 113.)

The researchers also assessed the CPRS oppositional subscale items (angry and resentful, argues with adults, loses temper, irritable, actively defies or refuses to comply with adults' requests, and deliberately does things that annoy other people).

Improvements in the CPRS oppositional scores at 10 AM and 2 PM, but not at 6 PM, were significantly greater for those who received lisdexamfetamine as compared with those who received placebo. The least squares mean percent change from baseline to endpoint were -35.6%, -30.1%, and -22.3%, respectively, for lisdexamfetamine-treated patients versus -1.2%, 0.8%, and 0.2% for placebo-treated patients.

The least squares mean percent change in CPRS oppositional score was significantly greater than placebo at 10 AM for the lisdexamfetamine 50 mg/day and 70 mg/d groups (P<.01) and at 2 PM for the lisdexamfetamine 70 mg/d group (P<.001).

Patients who were classified as CGI-S 5 to 7 had significantly greater improvements in CPRS oppositional score relative to placebo at all time points (P<.0001). However, the improvements in CPRS oppositional scores seen in those classified as CGI-S 3 to 4 who received lisdexamfetamine versus placebo were not significant. The authors noted that this was possibly due to a large placebo effect. (Poster 114.)

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