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A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder.
Can J Clin Pharmacol. 2006 Winter; 13(1):e50-62.CJ

Abstract

BACKGROUND

The thrice daily dosing regimen of immediate release methylphenidate (IR-MPH) for Attention Deficit/Hyperactivity Disorder (ADHD) requires in-school dosing, leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children?s privacy and the embarrassment associated with taking medication in public at school. OROS-methylphenidate (OROS-MPH) is a once-daily controlled-release formulation of methylphenidate (MPH) developed to overcome some of the limitations associated with IR-MPH and first-generation sustained-release formulations. Randomized, controlled trials (RCTs) that focus on treatment efficacy provide the best evidence for demonstrating whether an intervention works, but under ideal conditions one cannot discount the importance of efficacy study results. However, the most useful information to clinicians comes from an effectiveness study design.

OBJECTIVES

To evaluate the effectiveness and tolerability of OROS-MPH versus usual care with IR-MPH in children aged 6 to 12 years with ADHD.

METHODS

This 8 week, multicentre, open-label study randomized 147 subjects to either once-daily OROS-MPH or usual care with IR-MPH. Subjects were titrated to a clinically effective dose of either study medication over 4 weeks and maintained on that dose for an additional 4 weeks. The SNAP-IV parent-rating scale was used to assess effectiveness.

RESULTS

OROS-MPH showed statistically significant superiority to IR-MPH in remission rate based on the 18 ADHD symptoms (p=0.0002, X2=13.8, df=1) and severity of ADHD and ODD symptoms (p=0.004, F=8.4, df=1,127), as well as on the following secondary assessments: IOWA Conners, Conners Parent Rating Scale (short version), Parent Stress Index, (short version); Visual Analogue Scale for social play; Clinical Global Impression-Severity, Clinical Global Impression-Improvement and Parent Satisfaction with treatment. OROS-MPH and IR-MPH were both well tolerated with a similar side effect profile.

CONCLUSIONS

Once-daily OROS-MPH is significantly more effective than usual care with IR-MPH based on multiple outcome measures including remission rate.

Authors+Show Affiliations

Department of Psychiatry, Pediatrics and Family Medicine, University of Western Ontario, London, ON. margaret.steele@lhsc.on.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16456216

Citation

Steele, Margaret, et al. "A Randomized, Controlled Effectiveness Trial of OROS-methylphenidate Compared to Usual Care With Immediate-release Methylphenidate in Attention Deficit-hyperactivity Disorder." The Canadian Journal of Clinical Pharmacology = Journal Canadien De Pharmacologie Clinique, vol. 13, no. 1, 2006, pp. e50-62.
Steele M, Weiss M, Swanson J, et al. A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder. Can J Clin Pharmacol. 2006;13(1):e50-62.
Steele, M., Weiss, M., Swanson, J., Wang, J., Prinzo, R. S., & Binder, C. E. (2006). A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder. The Canadian Journal of Clinical Pharmacology = Journal Canadien De Pharmacologie Clinique, 13(1), e50-62.
Steele M, et al. A Randomized, Controlled Effectiveness Trial of OROS-methylphenidate Compared to Usual Care With Immediate-release Methylphenidate in Attention Deficit-hyperactivity Disorder. Can J Clin Pharmacol. 2006;13(1):e50-62. PubMed PMID: 16456216.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder. AU - Steele,Margaret, AU - Weiss,Margaret, AU - Swanson,James, AU - Wang,Jenny, AU - Prinzo,Rosanna S, AU - Binder,Carin E, Y1 - 2006/01/23/ PY - 2006/2/4/pubmed PY - 2006/8/19/medline PY - 2006/2/4/entrez SP - e50 EP - 62 JF - The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique JO - Can J Clin Pharmacol VL - 13 IS - 1 N2 - BACKGROUND: The thrice daily dosing regimen of immediate release methylphenidate (IR-MPH) for Attention Deficit/Hyperactivity Disorder (ADHD) requires in-school dosing, leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children?s privacy and the embarrassment associated with taking medication in public at school. OROS-methylphenidate (OROS-MPH) is a once-daily controlled-release formulation of methylphenidate (MPH) developed to overcome some of the limitations associated with IR-MPH and first-generation sustained-release formulations. Randomized, controlled trials (RCTs) that focus on treatment efficacy provide the best evidence for demonstrating whether an intervention works, but under ideal conditions one cannot discount the importance of efficacy study results. However, the most useful information to clinicians comes from an effectiveness study design. OBJECTIVES: To evaluate the effectiveness and tolerability of OROS-MPH versus usual care with IR-MPH in children aged 6 to 12 years with ADHD. METHODS: This 8 week, multicentre, open-label study randomized 147 subjects to either once-daily OROS-MPH or usual care with IR-MPH. Subjects were titrated to a clinically effective dose of either study medication over 4 weeks and maintained on that dose for an additional 4 weeks. The SNAP-IV parent-rating scale was used to assess effectiveness. RESULTS: OROS-MPH showed statistically significant superiority to IR-MPH in remission rate based on the 18 ADHD symptoms (p=0.0002, X2=13.8, df=1) and severity of ADHD and ODD symptoms (p=0.004, F=8.4, df=1,127), as well as on the following secondary assessments: IOWA Conners, Conners Parent Rating Scale (short version), Parent Stress Index, (short version); Visual Analogue Scale for social play; Clinical Global Impression-Severity, Clinical Global Impression-Improvement and Parent Satisfaction with treatment. OROS-MPH and IR-MPH were both well tolerated with a similar side effect profile. CONCLUSIONS: Once-daily OROS-MPH is significantly more effective than usual care with IR-MPH based on multiple outcome measures including remission rate. SN - 1710-6222 UR - https://www.unboundmedicine.com/medline/citation/16456216/A_randomized_controlled_effectiveness_trial_of_OROS_methylphenidate_compared_to_usual_care_with_immediate_release_methylphenidate_in_attention_deficit_hyperactivity_disorder_ L2 - https://ClinicalTrials.gov/search/term=16456216 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -