CONCERTA shows significant improvement in ADHD patients: StudyNovember 14th, 2007 - 2:55 am ICT by admin
In the study, led by Sally Berry, M.D., PhD., of Johnson and Johnson Pharmaceutical Research and Development, LLC, 229 patients with ADHD were examined.
The patients were in the age group 18-65 years who were randomised to receive CONCERTA 36-108 mg/day or placebo, for seven weeks, while the final analysis set contained data from 226 patients.
fficacy was measured as a change in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score, in the study.
The analysis of the study showed that CONCERTA achieved a significantly superior reduction in AISRS total score compared to placebo.
Additionally, CONCERTA was significantly superior compared to placebo for the key secondary efficacy variables, including- change in Clinical Global Impression-Improvement (CGI-I) rating, change in Conners’ Adult ADHD Rating Scale-Self Report, total score, and change in percent of subjects meeting pre-defined Responder criteria.
Adverse events were reported by 93 (84.5 percent) of patients in the CONCERTA group compared with 74 (63.8 percent) in the placebo group.
The most commonly reported adverse events with CONCERTA included decreased appetite (25.5 percent), headache (25.5 percent), dry mouth (20 percent), anxiety (16.4 percent), nausea (12.7 percent), increased blood pressure (10 percent), insomnia (9.1 percent), initial insomnia (7.3 percent), increased heart rate (7.3 percent), bruxism (6.4 percent), irritability (6.4 percent), and muscle tightness (6.4 percent).
There were no serious treatment emergent adverse events reported and 16 (14.5 percent), and 6 (5.2 percent), subjects in the CONCERTA and placebo groups, respectively, discontinued due to adverse events.
“Pharmacological treatment of children and adolescents with ADHD is clearly established but relatively less is known about the treatment of adults with ADHD,” Berry said. (ANI)
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