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Comparative acute efficacy and tolerability of OROS and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder

BACKGROUND: The main aim of this study was to compare the safety and efficacy of IR MPH administered three times daily to those of once daily OROS-MPH. METHODS: Subjects were outpatient adults satisfying full diagnostic criteria for DSM-IV ADHD between 19 and 60 years of age. Data from two independe...

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Autores principales: Biederman, Joseph, Mick, Eric O, Surman, Craig, Doyle, Robert, Hammerness, Paul, Michel, Evan, Martin, Jessica, Spencer, Thomas J
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2075491/
https://www.ncbi.nlm.nih.gov/pubmed/17868455
http://dx.doi.org/10.1186/1471-244X-7-49
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author Biederman, Joseph
Mick, Eric O
Surman, Craig
Doyle, Robert
Hammerness, Paul
Michel, Evan
Martin, Jessica
Spencer, Thomas J
author_facet Biederman, Joseph
Mick, Eric O
Surman, Craig
Doyle, Robert
Hammerness, Paul
Michel, Evan
Martin, Jessica
Spencer, Thomas J
author_sort Biederman, Joseph
collection PubMed
description BACKGROUND: The main aim of this study was to compare the safety and efficacy of IR MPH administered three times daily to those of once daily OROS-MPH. METHODS: Subjects were outpatient adults satisfying full diagnostic criteria for DSM-IV ADHD between 19 and 60 years of age. Data from two independently conducted 6-week placebo controlled, randomized clinical trials of IR-MPH (tid) and of OROS-MPH were pooled to create three study groups: Placebo (N = 116), IR-MPH (tid) (N = 102) and OROS-MPH (N = 67). RESULTS: Eight-five percent (N = 99) of placebo treated subjects, 77% (N = 79) of the IR-MPH (tid) treated subjects, and 82% (N = 55) of the OROS-MPH treated subjects completed the 6-week trial. Total daily doses at endpoint were 80.9 ± 31.9 mg, 74.8 ± 26.2 mg, and 95.4 ± 26.3 mg in the OROS-MPH, IR-MPH (tid), and placebo groups, respectively. At endpoint, 66% (N = 44) of subjects receiving OROS-MPH and 70% (N = 71) of subjects receiving IR-MPH (tid) were considered responders compared with 31% (N = 36) on placebo. CONCLUSION: Comparison of data from two similarly designed, large, randomized, placebo-controlled, trials, showed that equipotent daily doses of once daily OROS-MPH had similar efficacy to that of TID administered IR MPH. TRIAL REGISTRATION: The trial of OROS-MPH was registered at clinicaltrials.gov, number NCT00181571.
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spelling pubmed-20754912007-11-13 Comparative acute efficacy and tolerability of OROS and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder Biederman, Joseph Mick, Eric O Surman, Craig Doyle, Robert Hammerness, Paul Michel, Evan Martin, Jessica Spencer, Thomas J BMC Psychiatry Research Article BACKGROUND: The main aim of this study was to compare the safety and efficacy of IR MPH administered three times daily to those of once daily OROS-MPH. METHODS: Subjects were outpatient adults satisfying full diagnostic criteria for DSM-IV ADHD between 19 and 60 years of age. Data from two independently conducted 6-week placebo controlled, randomized clinical trials of IR-MPH (tid) and of OROS-MPH were pooled to create three study groups: Placebo (N = 116), IR-MPH (tid) (N = 102) and OROS-MPH (N = 67). RESULTS: Eight-five percent (N = 99) of placebo treated subjects, 77% (N = 79) of the IR-MPH (tid) treated subjects, and 82% (N = 55) of the OROS-MPH treated subjects completed the 6-week trial. Total daily doses at endpoint were 80.9 ± 31.9 mg, 74.8 ± 26.2 mg, and 95.4 ± 26.3 mg in the OROS-MPH, IR-MPH (tid), and placebo groups, respectively. At endpoint, 66% (N = 44) of subjects receiving OROS-MPH and 70% (N = 71) of subjects receiving IR-MPH (tid) were considered responders compared with 31% (N = 36) on placebo. CONCLUSION: Comparison of data from two similarly designed, large, randomized, placebo-controlled, trials, showed that equipotent daily doses of once daily OROS-MPH had similar efficacy to that of TID administered IR MPH. TRIAL REGISTRATION: The trial of OROS-MPH was registered at clinicaltrials.gov, number NCT00181571. BioMed Central 2007-09-14 /pmc/articles/PMC2075491/ /pubmed/17868455 http://dx.doi.org/10.1186/1471-244X-7-49 Text en Copyright © 2007 Biederman et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Biederman, Joseph
Mick, Eric O
Surman, Craig
Doyle, Robert
Hammerness, Paul
Michel, Evan
Martin, Jessica
Spencer, Thomas J
Comparative acute efficacy and tolerability of OROS and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder
title Comparative acute efficacy and tolerability of OROS and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder
title_full Comparative acute efficacy and tolerability of OROS and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder
title_fullStr Comparative acute efficacy and tolerability of OROS and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder
title_full_unstemmed Comparative acute efficacy and tolerability of OROS and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder
title_short Comparative acute efficacy and tolerability of OROS and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder
title_sort comparative acute efficacy and tolerability of oros and immediate release formulations of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2075491/
https://www.ncbi.nlm.nih.gov/pubmed/17868455
http://dx.doi.org/10.1186/1471-244X-7-49
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