A Post Hoc Analysis of d-threo-Methylphenidate Hydrochloride (Focalin) Versus d,l-threo-Methylphenidate Hydrochloride (Ritalin) - 24/08/11
, MICHAEL WASDELL, M.A., JOHN PATIN, M.S.ABSTRACT |
Objective: |
To evaluate clinical measures of the benefit/risk ratio in a post hoc analysis of a clinical trial of d-threo-methylphenidate hydrochloride (d-MPH) and d,l-threo-methylphenidate hydrochloride (d,l-MPH).
Method: |
Data from a phase III clinical trial was used to compare equimolar doses of d-MPH and d,l-MPH treatment for attention-deficit/hyperactivity disorder (ADHD) on clinician ratings of improvement/deterioration, teacher ratings of remission, and duration of action.
Results: |
d-MPH was clinically and statistically significantly superior to d,l-MPH on clinician’s dimensional ratings of global improvement, teacher ratings of remission of ADHD symptoms and parent 6:00 p.m. ADHD symptom ratings. No treatment differences were observed for symptom ratings at 3:00 p.m. and for 6:00 p.m. math test performance.
Conclusion: |
The results suggest that the two drugs may have distinct profiles on the measures analyzed. Because d-MPH may have be more than twice the potency of d,l-MPH, the differences reported here are only applicable to the doses of the study drugs involved in the clinical trial. The results are limited by the exploratory nature of our analysis, small samples, and multiple analyses. The findings are suggestive that further study is warranted to look at these differences prospectively but cannot be used to draw clinical conclusions at this time.
Le texte complet de cet article est disponible en PDF.Key Words : attention-deficit/hyperactivity disorder, stimulant, d-threo-methylphenidate hydrochloride
Plan
| 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. |
Vol 43 - N° 11
P. 1415-1421 - novembre 2004 Retour au numéro
Article précédent
- A Double-Blind, Placebo-Controlled Trial of Dexmethylphenidate Hydrochloride and d,l-threo-Methylphenidate Hydrochloride in Children With Attention-Deficit/Hyperactivity Disorder
- SHARON WIGAL, JAMES M. SWANSON, DAVID FEIFEL, R BART SANGAL, JOSEPHINE ELIA, CHARLES D. CASAT, JEROME B. ZELDIS, C KEITH CONNERS
- Comparative Pharmacodynamics and Plasma Concentrations of d-threo-Methylphenidate Hydrochloride After Single Doses of d-threo-Methylphenidate Hydrochloride and d,l-threo-Methylphenidate Hydrochloride in a Double-Blind, Placebo-Controlled, Crossover Laboratory School Study in Children With Attention-Deficit/Hyperactivity Disorder
- DECLAN QUINN, SHARON WIGAL, JAMES SWANSON, SHARON HIRSCH, YVONNE OTTOLINI, MAGHSOUD DARIANI, MARK ROFFMAN, JEROME ZELDIS, THOMAS COOPER
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