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ADHD
Public release date: 21-May-2003
Contact: Michele Roy, Shire Pharmaceuticals Group plc
450-978-7938
Porter Novelli
http://www.porternovelli.com/
Children achieve sustained ADHD symptom improvement with
long-term, once-daily use of Adderall XR.
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) 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.
"Long-Term
Adderall Extended Release Treatment Improves Quality of Life
in ADHD Children." Lopez, Frank A., M.D.
Michele
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
http://www.eurekalert.org/pub_releases/2003-05/pn-cas051903.php
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