PMID- 25015027 OWN - NLM STAT- MEDLINE DCOM- 20150511 LR - 20211021 IS - 1179-1918 (Electronic) IS - 1173-2563 (Print) IS - 1173-2563 (Linking) VI - 34 IP - 9 DP - 2014 Sep TI - Open-label dose optimization of methylphenidate modified release long acting (MPH-LA): a post hoc analysis of real-life titration from a 40-week randomized trial. PG - 639-49 AB - BACKGROUND AND OBJECTIVES: In the management of attention-deficit hyperactivity disorder (ADHD) in adults it is important to recognize that individual patients respond to a wide range of methylphenidate doses. Studies with methylphenidate modified release long acting (MPH-LA) in children have reported the need for treatment optimization for improved outcomes. We report the results from a post hoc analysis of a 5-week dose optimization phase from a large randomized, placebo-controlled, multicenter 40-week study (9-week double-blind dose confirmation phase, 5-week open-label dose optimization phase, and 26-week double-blind maintenance of effect phase). METHODS: Patients entering the open-label dose optimization phase initiated treatment with MPH-LA 20 mg/day; up/down titrated to their optimal dose (at which there was balance between control of symptoms and side effects) of 40, 60, or 80 mg/day in increments of 20 mg/week by week 12 or 13. Safety was assessed by monitoring the adverse events (AEs) and serious AEs. Efficacy was assessed by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, Attention-Deficit Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores. RESULTS: At the end of the dose confirmation phase, similar numbers of patients were treated optimally with each of the 40, 60, and 80 mg/day doses (152, 177, and 160, respectively) for MPH-LA. Mean improvement from baseline in the dose confirmation phase in total scores of DSM-IV ADHD RS and SDS were 23.5 +/- 9.90 and 9.7 +/- 7.36, respectively. CONCLUSIONS: Dose optimization with MPH-LA (40, 60, or 80 mg/day) improved treatment outcomes and was well-tolerated in adult ADHD patients. FAU - Huss, Michael AU - Huss M FAU - Ginsberg, Ylva AU - Ginsberg Y FAU - Arngrim, Torben AU - Arngrim T FAU - Philipsen, Alexandra AU - Philipsen A FAU - Carter, Katherine AU - Carter K FAU - Chen, Chien-Wei AU - Chen CW FAU - Gandhi, Preetam AU - Gandhi P FAU - Kumar, Vinod AU - Kumar V LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Clin Drug Investig JT - Clinical drug investigation JID - 9504817 RN - 0 (Central Nervous System Stimulants) RN - 0 (Delayed-Action Preparations) RN - 207ZZ9QZ49 (Methylphenidate) SB - IM MH - Adult MH - Attention Deficit Disorder with Hyperactivity/*drug therapy/physiopathology MH - Central Nervous System Stimulants/*administration & dosage/adverse effects/therapeutic use MH - Delayed-Action Preparations MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Methylphenidate/*administration & dosage/adverse effects/therapeutic use MH - Middle Aged MH - Psychiatric Status Rating Scales MH - Treatment Outcome MH - Young Adult PMC - PMC4143596 EDAT- 2014/07/13 06:00 MHDA- 2015/05/12 06:00 PMCR- 2014/07/12 CRDT- 2014/07/13 06:00 PHST- 2014/07/13 06:00 [entrez] PHST- 2014/07/13 06:00 [pubmed] PHST- 2015/05/12 06:00 [medline] PHST- 2014/07/12 00:00 [pmc-release] AID - 213 [pii] AID - 10.1007/s40261-014-0213-2 [doi] PST - ppublish SO - Clin Drug Investig. 2014 Sep;34(9):639-49. doi: 10.1007/s40261-014-0213-2.