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Abstract
Objective:
To examine duration of efficacy in long-acting stimulant treatment of attention-deficit/hyperactivity disorder (ADHD) in clinical trials using analog classroom protocols.
Research design and methods:
Published reports of clinical trials examining duration of medication efficacy using analog classroom protocols were identified in a systematic literature search of PubMed, BIOSYS, and EMBASE, through June 2009 using combinations of terms: attention-deficit/hyperactivity disorder, ADHD, attention-deficit disorder with hyperactivity, stimulant, methylphenidate (MPH), amphetamine, laboratory school or classroom, analog classroom, math test, and Permanent Product Measure of Performance (PERMP). Reports of short-acting, nonoral or nonstimulant formulations, or inadequate data on duration of efficacy were excluded.
Main outcome measures:
Main outcomes examined were PERMP scores for number of math problems attempted (PERMP-A) and correctly answered (PERMP-C) based on a standard 10-minute math test given at regular intervals during the postdose period.
Results:
Fifteen trials were included in the analysis. All except one trial in adults (18–55 years) were conducted in children with ADHD (6–15 years) and employed randomized, double- or single-blind, placebo-controlled designs. Duration of efficacy, based on PERMP-A/-C scores (vs. placebo), ranged from 8 hours with long-acting MPH to 14 hours with lisdexamfetamine dimesylate; most formulations exerted therapeutic effects for 12 hours after a single morning dose. Duration of efficacy assessment may be limited by duration of observation (12 hours postdose for most studies). Outcomes may have been influenced by differences in study designs, population characteristics, lack of comparable, equivalent dosages of different extended-release stimulants, and limited ability to extrapolate safety and tolerability from short-term studies to long-term clinical use. Results from cross-study comparisons must be interpreted with caution.
Conclusions:
Most long-acting stimulants exerted beneficial effects on ADHD symptoms for up to 12 hours as measured by the PERMP; the longest duration of efficacy versus placebo was seen with lisdexamfetamine dimesylate (14 hours postdose).
Transparency
Declaration of funding
Shire Development Inc. funded this study and resultant paper.
Declaration of financial/other relationships
M.B. has disclosed that he is a speaker for Cephalon, Eli Lilly, McNeil, Novartis, Pfizer, Shire, and Wyeth. E.M. has disclosed that he serves or has served on the speakers’ bureaus of AstraZeneca, Eli Lilly, McNeil, Novartis, and Sanofi-Aventis; and has received research support from Abbott Laboratories, CNS Response, Eli Lilly, Johnson & Johnson, Pfizer, Sanofi-Aventis, Shire, Synosia Therapeutics, Takeda, and UCB, Inc. M.P. has disclosed that he is an employee of Health Learning Systems, part of CommonHealth. Health Learning Systems was funded by Shire Development for authorship support and editing this manuscript. F.A.L. has disclosed that he is a consultant for Bristol-Myers Squibb, Celltech, Cephalon, Eli Lilly, New River Pharmaceuticals, Novartis, Pfizer, and Shire; has received grant/research support from Bristol-Myers Squibb, Celltech, Cephalon, Eli Lilly, New River Pharmaceuticals, Novartis, Pfizer, and Shire; is on the speakers bureau for Cephalon, Novartis, and Shire; and is an advisory board member for Celltech, Cephalon, Eli Lilly, Novartis, and Shire.
Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.
Acknowledgment
Editorial assistance in the form of proofreading, copy editing, and fact checking was provided by Health Learning Systems, funded by Shire Development. Although the sponsor was involved in the design, collection, analysis, interpretation, and fact checking of information, the ultimate interpretation was made by the independent authors, as was the content of this manuscript and the decision to submit it for publication in Current Medical Research and Opinion.