| Here is your full article text: | Children achieve sustained ADHD symptom improvement with long-term, once-daily use of Adderall XR
Contributed by: Terry Matlen, ACSW (Posted on 2003-05-22)
Public release date: 21-May-2003
Results from two-year study presented at American Psychiatric Association
Meeting
Children achieve sustained ADHD symptom improvement with long-term,
once-daily
use of a mixed salts amphetamine product
San Francisco, CA, May 21, 2003 - Shire Pharmaceuticals Group plc (NASDAQ:
SHPGY, LSE: SHP.L, TSE: SHQ CN) announced results of a long-term clinical
trial
that showed significant improvements in symptom control and quality of life
in
children with attention-deficit/hyperactivity disorder (ADHD) with
continued,
long-term treatment (two-year) using a once-daily mixed salts amphetamine
product. Moreover, these children sustained improvement in ADHD symptoms of
at
least 35 percent throughout the study. This information was presented today
at
the American Psychiatric Association (APA) annual meeting.
ADHD is the most commonly diagnosed psychiatric disorder in children and
adolescents. Approximately two million U.S. children, three to seven percent
of
all school-aged children, have been diagnosed with ADHD. The disorder is
characterized by symptoms of inattention, impulsiveness and hyperactive
behavior.
"ADHD is an all-day disorder that requires treatment to manage symptoms at
home, in school, and in socials settings. Our study shows that long-term
treatment with a once-daily mixed salts amphetamine product remains
effective
in significantly controlling the symptoms of ADHD in children, which is very
reassuring to health care providers and parents," said James McGough, M.D.,
associate professor, UCLA Neuropsychiatric Institute.
Long-Term Safety and Efficacy of Once-Daily Mixed Salts Amphetamine Product
in
Children With ADHD (APA Presentation Session #21) Prior to this two-year
extension trial, 560 children had participated in one of two short-term
clinical trials (three to four weeks) of the same medication. Results from
the
two-year study showed that, on average, the children achieved and maintained
a
significant improvement of at least 35 percent (compared to at the beginning
of
the study) in their ADHD symptoms during the two-year extension trial of the
drug, based on an analysis using a standard and validated measure, the
Conners'
Global Index Scale-Parent Version (CGIS-P) scores.
The 10-item CGIS-P scale monitors treatment response and effectiveness.
CGIS-P
total scores range from zero to 30, which decline as ADHD symptoms are
better
controlled. The CGIS-P scores declined throughout the study from their
initial-visit score average of 11.6 to 7.6 at 24 months and study conclusion
(P< 0.001), indicating that these patients were able to control their
symptoms
over an extended period of time. This improvement in ADHD symptoms also was
documented when patients were grouped based on their pre-extension study
therapy.
Specifically, the 138 children who stopped taking the study medication
between
the short-term trials and enrollment in this long-term extension study
(i.e.,
they were not receiving medication at the baseline visit for the long-term
study) showed significant improvement (>35 percent) from their initial
average
CGIS-P score their final average score (P <0.001). The 182 patients who
received a placebo during the short-term trials and then received the active
drug in the extension study also experienced a decrease in average CGIS-P
scores (>35 percent, P <0.001.) The 228 children already receiving the drug
during the short-term clinical trials and during the extension trial
maintained
ADHD symptom control. This last subset had already experienced an average of
at
least 35 percent improvement in symptom control during the short-term
pivotal
clinical trial prior to enrolling in this two-year extension.
"Since ADHD is a condition that requires ongoing treatment, many parents are
concerned that the medication may become less effective overtime, requiring
higher doses or a change of medication to maintain optimal ADHD symptom
control," said McGough. "The sustained improvement using the once daily
mixed
salts amphetamine product in controlling ADHD symptoms in this study should
alleviate the fears of families and physicians that the once daily mixed
salts
amphetamine product may lose its effectiveness over time. This study
documents
a robust response which is maintained even when the drug is used in the long
term."
The medication was generally well tolerated during the extension trial. The
common side effects seen over the 24 months included headache, loss of
appetite, insomnia, and abdominal pain. The majority of treatment-emergent
side
effects were mild and transient, with the majority occurring within the
first
three months of the extension study. No clinically significant changes in
the
patients' average heart rates or blood pressure measures occurred. Side
effects
were similar to those reported in previous short-term trials of the
medication.
Of the 560 enrollees, 273 (48 percent) completed the study, with only 84
(14.8
percent) withdrawing due to a side effect. The effectiveness of the once
daily
mixed salts amphetamine product for long-term use, i.e., for more than three
weeks, has not been systematically evaluated in controlled trials. Data are
inadequate to determine whether chronic use of stimulants in children,
including amphetamine, may be causally associated with suppression of
growth.
At enrollment, the extension trial participants' average age was 8.7 years,
78
percent were boys, 73 percent were white, 12 percent were black, 9 percent
were
Hispanic and 6 percent had another ethnicity.
Long-Term Mixed Salts Amphetamine Product Treatment Improves Quality of Life
in
ADHD Children (APA Poster #650) Treatment with a once-daily a mixed salts
amphetamine product also significantly enhanced the quality of life of
children
with ADHD and the improvement persisted during long-term treatment (up to
two
years), based on Quality of Life Enjoyment and Satisfaction Questionnaire
(Q-LES-Q) scores. The scores were generated based on parents' perspectives
and
assessed patients' physical health, mood and family relationships as well as
overall life satisfaction and contentment.
Specifically, the 560 children, aged 6 to 12 years, who participated in the
two-year extension study averaged significantly greater Q-LES-Q scores at
12,
18 and 24 months (56, 57 and 56 points, respectively), compared to the
average
score at study start (49), P<0.00001 for each time point. A higher Q-LES-Q
score indicates improvement in a patient's physical health, mood, family
relationships and overall quality of life.
About ADHD
Approximately two million U.S. children, three to seven percent of all
school-aged children, have been diagnosed with ADHD and as many as 66
percent
may still exhibit symptoms into adulthood, according to the National
Institute
of Mental Health. ADHD is a significant mental health concern that impacts
the
patients, their families and their social circle. Children with ADHD often
are
inattentive, impulsive, and hyperactive - difficulties serious enough to
interfere with their ability to function normally in home, academic or
social
settings. These symptoms continue beyond the school day, affecting all
aspects
of the child's life.
ADHD is a neurological brain disorder that manifests as a persistent pattern
of
inattention and/or hyperactivity-impulsivity that is more frequent and
severe
than is typically observed in individuals at a comparable level of
development.
Hyperactivity is seen less frequently as the patient ages, although
inattention
and impulsivity often remain.
Although there is no "cure" for ADHD, physicians, parents, teachers, nurses
and
advocates are finding ways to help people with the condition learn to adapt
to
their academic, social and work settings. ADHD usually can be successfully
managed with a combination of treatments, including educational approaches,
psychological and behavioral therapies and medication. A recent clinical
trial
found that therapies that include carefully monitored medication are more
effective than those that do not, such as behavioral therapy alone.
Medication
should be considered part of an overall multi-modal treatment plan for ADHD.
Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international
emerging pharmaceutical company with a strategic focus on four therapeutic
areas - central nervous system disorders (CNS), gastrointestinal (GI),
oncology, and anti-infectives. Shire also has three platform technologies:
advanced drug delivery, lead optimization for small molecules and Biologics.
Shire's core strategy is based on research and development combined with
in-licensing and a focus on eight key pharmaceutical markets.
The once-daily mixed salts amphetamine product is distributed in the United
States by Shire US Inc., the sales and marketing subsidiary of Shire
Pharmaceuticals, plc.
For further information on Shire, please visit the Company's website:
www.shire.com; or www.adhdsupportcompany.com.
###
Statements included herein that are not historical facts, are
forward-looking
statements. Such forward-looking statements involve a number of risks and
uncertainties and are subject to change at any time. In the event such risks
or
uncertainties materialize, Shire's results could be materially affected. The
risks and uncertainties include, but are not limited to, risks associated
with
the inherent uncertainty of pharmaceutical research, product development,
manufacturing and commercialization, the impact of competitive products,
including, but not limited to, the impact on Shire's Attention Deficit
Hyperactivity Disorder (ADHD) franchise, patents, including but not limited
to,
legal challenges relating to Shire's ADHD franchise, government regulation
and
approval, including but not limited to the expected product approval date of
lanthanum carbonate (FOSRENOL) and METHYPATCH , and other risks and
uncertainties detailed from time to time in our filings, including the
Annual
Report filed on Form 10-K by Shire with the Securities and Exchange
Commission.
APA Presentations #21, Wednesday, May 21, 11:00 AM to 12:30 PM
"Long-Term Safety and Efficacy of Adderall XR in Children With ADHD."
McGough,
James, M.D.
APA Poster #650, Wednesday, May 21, 3:00 PM to 5:00 PM
"Long-Term Adderall Extended Release Treatment Improves Quality of Life in
ADHD
Children." Lopez, Frank A., M.D.
Michle Roy - Director, Corporate Communications North America
450-978-7938
Andrea L. Pellicciari - Porter Novelli
212-601-8397/201-981-2699 on-site
Marion E. Glick - Porter Novelli
212-601-8273/917-301-4206 on-site
Contact: Michle Roy, Shire Pharmaceuticals Group plc 450-978-7938
Porter Novelli http://www.porternovelli.com/
http://www.eurekalert.org/pub_releases/2003-05/pn-cas051903.php
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