Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD
Lenard A Adler1, Thomas Spencer, James J McGough
1New York University School of Medicine, New York, NY 10016, USA. lenard.adler@med.nyu.edu
Objective:
This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD.
Method:
Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness outcomes included change from Week 5 on ADHD Rating Scale (ADHD-RS) and proportion of responders on Clinical Global Impressions-Improvement (CGI-I) scale.
Results:
103 patients completed OLE, and effectiveness was evaluable in 102 patients. d-MPH-ER was well tolerated; the most common adverse events (>15%) were headache, insomnia, and decreased appetite. Mean improvements in ADHD-RS score were -10.2 for patients switched from placebo to d-MPH-ER (n = 20) and -8.4 for those maintained on d-MPH-ER (n = 82). Respective CGI-I responder rates were 95.0% and 95.1%.
Conclusion:
Once-daily d-MPH-ER 20 to 40 mg is safe and effective for long-term treatment of adult ADHD.
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