Journal of the American Academy of Child & Adolescent Psychiatry
ARTICLESA Post Hoc Analysis of d-threo-Methylphenidate Hydrochloride (Focalin) Versus d,l-threo-Methylphenidate Hydrochloride (Ritalin)
Section snippets
METHOD
Full details of the clinical trial design can be found in the original study report (Wigal et al., 2004). We discuss those aspects of the methodology that are relevant to the analysis reported here. Because this study involves a post hoc analysis of data presented by other investigators, the primary methodology lies in our selection of measures and choice of statistical analysis.
Clinician Ratings
Summary data are presented in Table 1. Direct comparison of end point mean CGI-I scores between d-MPH and d,l-MPH showed a significant difference between the two active treatments with d-MPH superiority, t(1,87) = 2.39, p = .019. Analysis of the proportion of treatment responders based on CGI-I ratings of “much improved” and “very much improved” favored d-MPH, but the difference was not significant (χ21 = 3.346, p = .067).
Of patients who received d,l-MPH, 11.1% deteriorated in treatment (rated
DISCUSSION
For the doses used within the study design and for this post hoc analysis, d-MPH was statistically significantly superior to d,l-MPH on clinician ratings of overall improvement, teacher ratings of the percentage of children achieving full remission, and parent ratings of ADHD symptoms at 6:00 p.m. Child performance on the math test done 6 hours post-dose did not differ between the two treatments. Of the patients on d,l-MPH, 11.1% deteriorated and none on d-MPH did, a difference that was not
REFERENCES (14)
- et al.
Clinical relevance of the primary findings of the MTA: success rate based on severity of ADHD and ODD symptoms at the end of treatment
J Am Acad Child Adolesc Psychiatry
(2001) Rating scales for use in drug studies with children
Psychopharmacol Bull
(1973)- et al.
Stereoselective effects of methylphenidate on motor hyperactivity in juvenile rats induced by neonatal 6-hydroxydopamine lesioning
Psychopharmacology (Berl)
(2002) - et al.
Chiral drugs: comparison of the pharmacokinetics of [11C]d-threo and L-threo-methylphenidate in the human and baboon brain
Psychopharmacology (Berl)
(1997) - et al.
Summary of the practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults
J Am Acad Child Adolesc Psychiatry
(2001) - et al.
Drug chirality and its clinical significance
Drugs
(1996)
Cited by (16)
Efficacy of Dexmethylphenidate for the Treatment of Fatigue After Cancer Chemotherapy: A Randomized Clinical Trial
2009, Journal of Pain and Symptom ManagementCitation Excerpt :Dexmethylphenidate HCl (d-MPH, Focalin®, Celgene Corp., Summit, NJ, the d-isomer of d,l-threo-methylphenidate [d,l-MPH]), the product used in this study, has been approved in the United States for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents, and a once-a-day formulation of d-MPH (Focalin XR®) has been approved in the United States for the treatment of ADHD in children, adolescents, and adults. Both the pharmacological properties12–15 and the clinical efficacy16 of d,l-MPH reside in both the d and l enantiomers and, therefore, d-MPH is efficacious at roughly half the dose of d,l-MPH.17 No adverse events (AEs) unique to chirally pure d-MPH have been reported.18
The Utility of Methylphenidate for Fatigue in Long-Term Neurological Conditions: A Meta-analytical Review
2023, Clinical NeuropharmacologyEthanol Interactions with Dexmethylphenidate and dl-Methylphenidate Spheroidal Oral Drug Absorption Systems in Healthy Volunteers
2017, Journal of Clinical PsychopharmacologyAbsorption Differences between Immediate-Release Dexmethylphenidate and dl-Methylphenidate
2016, Drug Metabolism and DispositionOld Drugs Yield New Discoveries: Examples from the Prodrug, Chiral Switch, and Site-Selective Deuteration Strategies
2012, Drug Repositioning: Bringing New Life to Shelved Assets and Existing Drugs
This study was supported by Celgene Corporation.
Disclosure: Current industry financial relationships for Dr. Weiss are as follows: consultant, advisory board, speakers’ bureau and research contracts with Eli Lilly and Janssen Ortho; consultant, advisory board, and speakers’ bureau with Shire; consultant with Johnson & Johnson and Purdue Pharma; research contract with Circa Dia BV. Dr. Weiss has received payment for consultation and work as a clinical investigator from Celgene Corporation and Novartis Corporation. Mr. Patin is a full-time employee of Celgene Corporation and owner of stock through employment options.