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Extended release stimulant effective
for long-term ADHD treatment
Study finds no significant side effects
in children treated up to two years
BOSTON - October 3, 2005 - A new study has found that an
all-day, extended-release stimulant for treating attention-deficit
hyperactivity disorder (ADHD) remains effective for up to two years
without significant side effects. In the October issue of the Journal
of the American Association of Child & Adolescent Psychiatry,
a multi-institutional research team reports finding that treatment
with Concerta, a once-daily form of the drug methylphenidate, successfully
controlled ADHD symptoms in more than 200 children with ADHD. The
study was supported by McNeil Pharmaceuticals, which manufactures
Concerta.
"Although ADHD is recognized as a chronic disease, we've known
very little about the effects of chronic treatment," says Timothy
Wilens, MD, of the Massachusetts General Hospital (MGH) Pediatric
Psychopharmacology Unit, lead author of the JAACAP report.
"There have been concerns about whether the stimulant medications
that are a mainstay of treatment continue to be effective, whether
patients build up tolerance, or whether the drugs might have adverse
effects on cardiovascular health or growth. This investigation sheds
some important light on those questions."
The study initially enrolled more than 400 children, ages 6 to 13,
who previously had participated in short-term, placebo-controlled
trials of Concerta. In the new trial, all participants received
the active medication at one of three dose levels. Dosage could
be adjusted to improve effectiveness or reduce side effects. Participants'
height and weight, blood pressure, heart rate and other clinical
measures were taken at regular intervals during the study period.
The children's parents and teachers were surveyed periodically regarding
whether they believed treatment was effective in controlling ADHD
symptoms.
The entire, two-year study was completed by 229 participants, with
others dropping out for a variety of reasons. Throughout the study
period, measures of treatment effectiveness were consistent, with
around 85 percent of parents and teachers reporting treatment results
to be good or excellent. However, it was necessary to increase the
children's dose by about 25 percent during the study, with most
increases happening during the first year. All the children grew
at rates considered normal for their age, and they gained only slightly
less weight than would have been expected. In general, there were
no clinically significant effects on blood pressure, heart rate,
or other cardiac measures.
"We found these medications do continue to be effective in
the long-term. While some particicipants did need to increase dosage
beyond what could be attributed to their growth, any tolerance that
developed seemed to be slight and limited to the first year,"
says Wilens. "We haven't seen any clinically meaningful problems
with height and weight or any cardiovascular difficulties in this
study, which also is the first to evaluate this kind of daylong
treatment in a large group of children."
Wilens is an associate professor of Psychiatry at Harvard Medical
School. The study's co-authors are Keith McBurnett, PhD, University
of California at San Francisco; Mark Stein, PhD, University of Chicago;
Marc Lerner, MD, University of California at Irvine; Thomas Spencer,
MD, MGH; and Mark Wolraich, MD, University of Oklahoma
Massachusetts General Hospital, established in 1811, is the original
and largest teaching hospital of Harvard Medical School. The MGH
conducts the largest hospital-based research program in the United
States, with an annual research budget of more than $450 million
and major research centers in AIDS, cardiovascular research, cancer,
cutaneous biology, medical imaging, neurodegenerative disorders,
transplantation biology and photomedicine. In 1994, MGH and Brigham
and Women's Hospital joined to form Partners HealthCare System,
an integrated health care delivery system comprising the two academic
medical centers, specialty and community hospitals, a network of
physician groups, and nonacute and home health services.
Media Contact: Sue
McGreevey, MGH Public Affairs
Physician Referral Service: 1-800-388-4644
Information about Clinical Trials
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