Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD.
OBJECTIVE
This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD.


METHODS
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%.


CONCLUSIONS
Once-daily d-MPH-ER 20 to 40 mg is safe and effective for long-term treatment of adult ADHD.
Adler
Lenard A
LA
New York University School of Medicine, New York, NY 10016, USA. lenard.adler@med.nyu.edu
Spencer
Thomas
T
McGough
James J
JJ
Jiang
Hai
H
Muniz
Rafael
R
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002214:Capsules; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D064699:Dexmethylphenidate Hydrochloride; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010552:Personality Assessment; D016896:Treatment Outcome; D055815:Young Adult
D002214:Capsules; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D064699:Dexmethylphenidate Hydrochloride; D008774:Methylphenidate