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Journal of Attention Disorders
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Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

Lenard A. Adler

New York University School of Medicine, New York VA Harbor Healthcare System, lenard.adler{at}med.nyu.edu

Thomas Spencer

Massachusetts General Hospital, Boston

James J. McGough

UCLA Semel Institute for Neuroscience and Human Behavior

Hai Jiang

The Adult ADHD Research Group, Novartis Pharmaceuticals Corporation, East Hanover

Rafael Muniz

The Adult ADHD Research Group, Novartis Pharmaceuticals Corporation, East Hanover

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. (J. of Att. Dis. 2009; 12(5) 449-459)

Key Words: adult ADHD • d-MPH-ER • long-term effectiveness • long-term safety

Journal of Attention Disorders, Vol. 12, No. 5, 449-459 (2009)
DOI: 10.1177/1087054708320397
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