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EPA-0513 – Methylphenidate Hydrochloride Modified release (mph-la) Maintained Efficacy Over Long-term in the Treatment of Adult Attention Deficit Hyperactivity Disorder (adhd)

Published online by Cambridge University Press:  15 April 2020

Y. Ginsberg ,
T. Tvedten ,
T. Arngrim ,
A. Philipsen ,
P. Gandhi ,
CW. Chen ,
V. Kumar  and
M. Huss
Y. Ginsberg
Affiliation:
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
T. Tvedten
Affiliation:
Centre for Therapy and Supervision, Centre for Therapy and Supervision, Skien, Norway
T. Arngrim
Affiliation:
Private Clinic, Private Clinic, Aarhus, Denmark
A. Philipsen
Affiliation:
University Medical Centre, University Medical Centre, Freiburg, Germany
P. Gandhi
Affiliation:
Novartis Health Care Pvt. Ltd., Novartis Health Care Pvt. Ltd., Madhapur Hyderabad, India
CW. Chen
Affiliation:
Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation, East Hanover, USA
V. Kumar
Affiliation:
Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation, East Hanover, USA
M. Huss
Affiliation:
Department of Child and Adolescent Psychiatry, University of Medicine, Mainz, Germany

Abstract

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Introduction:

Previously, we reported the clinical efficacy of MPH-LA in adult ADHD evaluated in a 40-week, randomised, double-blind, placebo-controlled, multicentre core study [comprising of dose confirmation (9-week), real-life dose optimisation (5-week) and maintenance of effect phases (6- month)] (Atten Defic Hyperact Disord. 2013;(5):219–220). Here, we report the long-term efficacy from the 26-week extension phase of the same study.

Methods:

During the extension phase, patients initiated treatment with MPH-LA 20 mg/day (oral, once daily capsules); uptitrated to optimal dose of 40, 60 or 80 mg/day in increments of 20 mg/week. Change in DSM-IV ADHD rating scale (RS) and SDS total scores at the end of study, were evaluated from the baseline of maintenance of effect phase of the core study and the baseline of extension phase.

Results:

At the end of the extension phase, the mean change in DSM-IV ADHD RS and SDS total scores from baseline of the maintenance of effect phase was −0.9 and −1.4 points respectively; and from baseline of extension phase was −7.2 and −4.8 respectively (Table). No new or unexpected safety concerns were observed during the extension phase.

Conclusions:

MPH-LA continued to maintain clinical efficacy in adult ADHD patients over long-term.

Table DSM-IV ADHD RS, SDS total scores and change from baseline at the end of extension phase

 DSM-IV ADHD RS N= 298 (Mean ± SD)SDS N= 298 (Mean ± SD)
Week 26 Extension phase* (LOCF)12.0 ± 7.788.0 ± 5.46
Maintenance of effect phase (baseline)12.9 ± 6.7149.3 ± 5.78
Mean Change from maintenance of effect phase baseline−0.9 ± 7.78−1.4 ± 5.50
Extension phase (baseline)19.2 ± 12.0012.8 ± 7.28
Mean Change from extension phase baseline−7.2 ± 11.00−4.8 ± 6.88
*

LOCF: Last observation carried forward applied for each patient with data in extension period. If no post-baseline was available, it was considered as missing.

Type
EPW09 - Psychopharmacology and Pharmacoeconomics 1
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014
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