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

被引:42
作者
Adler, Lenard A. [1 ]
Spencer, Thomas [2 ,3 ]
McGough, James J. [4 ,5 ]
Jiang, Hai
Muniz, Rafael [6 ]
机构
[1] New York VA Harbor Healthcare System, New York, NY USA
[2] Harvard Univ, Sch Med, Cambridge, MA 02138 USA
[3] Massachusetts Gen Hosp, Clin & Res Program Pediat Psychopharmacol, Boston, MA 02114 USA
[4] Univ Calif Los Angeles, Div Child & Adolescent Psychiat, Los Angeles, CA 90024 USA
[5] Univ Calif Los Angeles, Program Attent Deficit Hyperact Disorders, Los Angeles, CA 90024 USA
[6] Novartis Pharmaceut, USCD & MA, E Hanover, NJ USA
关键词
adult ADHD; d-MPH-ER; long-term effectiveness; long-term safety; ATTENTION-DEFICIT/HYPERACTIVITY DISORDER; DEFICIT HYPERACTIVITY DISORDER; DL-THREO-METHYLPHENIDATE; DOUBLE-BLIND; D; L-THREO-METHYLPHENIDATE HYDROCHLORIDE; ENANTIOSELECTIVE PHARMACOKINETICS; LABORATORY SCHOOL; BABOON BRAIN; CHILDREN; PHARMACODYNAMICS;
D O I
10.1177/1087054708320397
中图分类号
B844 [发展心理学(人类心理学)];
学科分类号
040202 ;
摘要
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)
引用
收藏
页码:449 / 459
页数:11
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