|
New ADHD Medication Strattera™
Effective in Girls
Press Release – December 2, 2002 Eli Lilly
Pharmaceuticals
Strattera™ (atomoxetine HCl) is effective in
treating Attention-Deficit/Hyperactivity Disorder (ADHD) in school-age
girls, according to a study published in the December online issue
of the journal Pediatrics (Volume 110, Number 6).
This study seeks to augment the limited amount of data available
on the efficacy of pharmacologic treatments in girls specifically.
"This is one of the largest studies of treatment
effects of medication in this (school-age girls) population,"
said John Heiligenstein, M.D., Medical Advisor, Eli Lilly and Company,
a study co-author. "The study confirms the efficacy of Strattera
in treating ADHD in boys and girls."
The lack of information regarding ADHD treatment in
girls is likely because many more boys than girls are referred for
treatment. Boys have greater rates of more noticeable disruptive
behaviors that affect others, often as a result of comorbid oppositional
defiant disorder and conduct disorder, which are less common in
girls.i Core ADHD symptoms seen in girls are similar to those seen
in boys.ii
ADHD affects 3-7 percent of school age children3 and
manifests itself in levels of attention, concentration, activity,
distractibility, and impulsivity that are inappropriate to the child's
age.4 Experts estimate 60 percent of children with the disorder carry
their symptoms into adulthood.5
The Pediatrics study was a subset analysis
of 51 girls (Strattera n=30, placebo n=21) that found Strattera
efficacy superior to placebo on all parent and investigator rating
scales. The data come from two identical, double-blind, placebo-controlled
9-week clinical trials of 291 children conducted in the United States.
"It is encouraging to see focused attention given
to addressing ADHD in girls and finding effective treatments," said
Patricia Quinn, M.D., co-founder of the National Center for Gender
Issues and AD/HD and author of Understanding Girls with ADHD.
Results
Patients treated with Strattera experienced a decrease
in their ADHD RS Total Score that was statistically significant
compared to placebo (15.8 vs 5.8, respectively). Strattera- and
placebo- treated patients’ ratings on the Inattentive subscale
(-8.8 and –3.4, respectively) and Hyperactive/Inattentive subscale
(-7.0 and –2.3, respectively) showed a significant drug effect
as well. CPRS-R and CGI-ADHD-S scores also showed significant improvement
for Strattera patients. According to the authors, Strattera significantly
decreased ADHD signs and symptoms in girls with ADHD. The data reported
from this subset analysis addresses an important void in what is
known about treatment of school-age girls with ADHD.
The study found that Strattera was generally safe
and well-tolerated in school-age girls. The most commonly-reported
side effects of patients taking Strattera were abdominal pain, rhinitis
and headache. Only one patient each from the Strattera and placebo
groups discontinued due to an adverse event (chest pain and somnolence,
respectively).
Study Design
The study included 291 children and adolescents, ages
7-13, who met criteria for ADHD as spelled out in the Diagnostic
and Statistical Manual for Mental Disorders, 4th edition (DSM-IV).
The DSM-IV includes 18 core symptoms of ADHD – nine related
to inattention and nine related to hyperactivity and impulsivity.
All diagnoses were confirmed through clinical interviews.
Exclusion criteria included poor metabolism of the
cytochrome P450 2D6 isoenzyme; weight <25 kg at the initial visit;
a documented history of bipolar I or II disorder or history of psychosis;
history of an organic brain disease or a seizure disorder; currently
taking psychotropic medication; history of alcohol or drug abuse
within the past 3 months; positive screening for drugs of abuse;
or significant previous or current medical conditions (e.g., human
immunodeficiency virus positive, surgically corrected congenital
heart defects, leukemia in remission).
After a two-week medication washout period, patients
were divided into two groups based on their previous exposure to
psychostimulants. Patients never treated with psychostimulants were
randomized to double-blind treatment with Strattera, placebo or
methylphenidate, while patients with a history of psychostimulant
use were randomized to double-blind treatment with Strattera or
placebo. The methylphenidate arm of the study was included to validate
the study design. The Strattera dose was titrated based on clinical
response to a maximum daily dose of 2.0 mg/kg/day.
The ADHD Rating Scale-IV-Parent Version: Investigator
Administered (ADHD RS), an 18-item scale based on an interview with
the patient's primary caretaker was the primary measure of symptom
response. Each item on the ADHD RS corresponds to one of the 18
DSM-IV criteria. The ADHD Index subscale of the Conners’ Parent
Rating Scale-Revised: Short Form (CPRS-R) and the Clinical Global
Impressions of Severity of ADHD (CGI-ADHD-S) scales were also used.
A limitation of this data is the lack of teacher-rated efficacy
measurements.
Strattera
Strattera is a selective norepinephrine reuptake inhibitor
marketed by Eli Lilly and Company (NYSE:LLY) for treatment of ADHD
in children, adolescents and adults. Strattera is the only noncontrolled
medication approved for the treatment of ADHD. The precise mechanism
of action of Strattera is unknown, however, scientists believe it
works by selectively blocking the reabsorption of norepinephrine
into certain nerve cells in the brain. Norepinephrine is a neurotransmitter,
a chemical that moves messages from brain cell to brain cell, and
is thought to be important in regulating attention and controlling
impulses.
Strattera should not be taken at the same time as,
or within two weeks of taking, a monoamine oxidase inhibitor, or
by patients with narrow angle glaucoma. Patients with a history
of high or low blood pressure, increased heart rate, or any heart
or blood vessel disease should tell their doctor before taking Strattera.
Strattera has not been tested in children less than 6 years of age.
Some children may lose weight when starting treatment with Strattera.
As with all ADHD medications, growth should be monitored during
treatment.
Most people in clinical studies who experienced side
effects were not bothered enough to stop using Strattera. The most
common side effects in children and adolescents were decreased appetite,
nausea, vomiting, tiredness and upset stomach. In adults, the most
common side effects were problems sleeping, dry mouth, decreased
appetite, upset stomach, nausea or vomiting, dizziness, problems
urinating, and sexual side effects.
Lilly, a leading innovation-driven corporation, is
developing a growing portfolio of best-in-class pharmaceutical products
by applying the latest research from its own worldwide laboratories
and from collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly provides answers – through medicines
and information – for some of the world's most urgent medical
needs.
Next: Success Stories >>
|
