Study Suggests Atomoxetine Significantly Improved Functioning in Children with Both ADHD and Anxiety Disorders
25 May 2006 - 3:00AM
PR Newswire (US)
TORONTO, May 24 /PRNewswire-FirstCall/ -- Data from a recent
clinical study suggest that atomoxetine HCl significantly improved
measures of psychosocial functioning (the impact of ADHD on various
aspects of your life such as quality of relationships with family
and peers) in children and adolescents who also had anxiety
disorders. The results of the 12-week study were presented today at
the 159th annual meeting of the American Psychiatric Association.
The functioning assessment was part of a larger trial, of which the
primary endpoint was to examine atomoxetine's ability to treat ADHD
in children and adolescents with ADHD and anxiety disorders. At the
end of the study, atomoxetine significantly reduced ADHD symptoms
such as inattention, hyperactivity and impulsivity by 39 percent,
compared to a four percent improvement in patients taking sugar
pill. Atomoxetine also significantly reduced anxiety symptoms like
excessive worry, sweating and trembling by 32 percent, compared
with 19 percent of patients taking sugar pill. The secondary
analysis examined atomoxetine's affect on patient functioning. At
the end of the study, patients taking atomoxetine saw a significant
improvement in functioning compared to sugar pill as measured on
the following scales, Multidimensional Anxiety Scale for Children
(MASC), 9 percent improvement for atomoxetine vs. 4 percent
worsening for sugar pill; Life Participation Scale for ADHD-Revised
(LPS-ADHD-R), 31 percent improvement for atomoxetine vs. 10 percent
improvement for sugar pill and the Child Health
Questionnaire-Parent Completed Full Length (CHQ-PF50) 23 percent
improvement for atomoxetine vs. 11 percent improvement for sugar
pill. "Treating ADHD in children is challenging, because of the
complexity of the disease and the presentation of underlying issues
such as anxiety," said Daniel Geller, MD, director of the Pediatric
Obsessive Compulsive Disorder program at Massachusetts General
Hospital in the Division of Pediatric Psychopharmacology. "This
study suggests that atomoxetine improved ADHD and anxiety symptoms
in children with both ADHD and anxiety disorders." Up to 35 percent
of children with ADHD also suffer from anxiety disorders(1) like
separation anxiety, generalized anxiety or social phobia. Children
with ADHD and anxiety report more school, family and social/peer
problems than children who only have ADHD. Children with ADHD
accompanied by anxiety are less likely to appear hyperactive and
disruptive, but instead appear more slowed down or inefficient.(2)
Study Highlights * At the study endpoint, 12 weeks, the response
rate for improvement in ADHD symptoms for eligible patients was
significantly higher for atomoxetine relative to sugar pill
(hyperactivity /impulsivity: -4.5 vs. -0.8; inattention: -4.6 vs.
0.1 on the ADHD Rating Scale-IV - Parent Version (ADHDRS-IV-PI) --
Mean change from baseline also showed greater improvement for
atomoxetine-treated patients than those taking sugar pill
(decreases of 10.5 points vs. 1.4 respectively, or 39 percent vs. 4
percent) * Atomoxetine patients also experienced significantly
greater improvement in anxiety symptoms on the Pediatric Anxiety
Rating Scale (PARS) compared with sugar pill (decreases of 5.5
points vs. 3.2 respectively, or 32 percent vs. 19 percent) --
Secondary analyses also showed significant improvement in anxiety
(a decrease of -4.6 vs. an increase of 2.1 on the MASC) * In this
study, the most common adverse events (occurred at a rate of
greater than or equal to 5 percent and at least twice the rate of
placebo) were decreased appetite, upper abdominal pain, vomiting,
nausea and influenza * There were no clinically significant
baseline-to-endpoint treatment differences in electrocardiogram
(ECG) or laboratory measures, nor were there significant
differences in the incidence of clinically important or treatment-
emergent abnormal ECG or laboratory measures Methods In this
randomized, double-blind, placebo-controlled study of patients who
met the DSM-IV criteria for ADHD and either separation anxiety,
generalized anxiety or social phobia, 87 atomoxetine-treated
(dosage increased from 0.8 mg/kg/day to a target dose of
approximately 1.2 mg/kg/day and not exceeding 120 mg/day), and 89
treated with a sugar pill, participated in a 12-week comparison. A
total of 66 patients in each group completed the study. In the
study, which comprised six visits over approximately 12 weeks,
patients were assessed according to the 18-item ADHDRS-IV-PI scale
and total patient- and parent-reported PARS score. The secondary
analysis examined patient functioning on the MASC, LPS-ADHD-R and
CHQ-PF50 scales. This study was designed to examine atomoxetine's
ability to improve symptoms of ADHD and comorbid anxiety in
children with both ADHD and anxiety. It was not designed to study
the effects of atomoxetine on ADHD or anxiety alone. Sample sizes
in this study were not sufficient to detect uncommon safety
differences between treatments. Because of the 12-week duration,
long term efficacy and safety conclusions cannot be drawn from this
data. Additionally, generalizabilty is limited since the patients
in this study were clinically referred, and results do not indicate
whether atomoxetine is independently beneficial for treatment of
any single anxiety disorder. About ADHD(3,4,5) ADHD is a complex
disorder that can be difficult to diagnose and often occurs in
tandem with other psychiatric diagnoses like anxiety or depression.
Therefore, proper diagnosis of all a patient's symptoms is vital
for choosing appropriate treatment and monitoring for both safety
and efficacy. ADHD is a serious disorder that can have lifelong
consequences, including poor peer relations, poor academic and work
performance, and increased risk- taking behaviors such as substance
abuse. About Atomoxetine Atomoxetine, a selective norepinephrine
reuptake inhibitor, is the first FDA-approved non-stimulant to
treat ADHD. It is not known precisely how atomoxetine reduces ADHD
symptoms, but scientists believe it works by blocking or slowing
reabsorption of norepinephrine, a chemical in the brain considered
important in regulating attention, impulsivity and activity levels.
This keeps more norepinephrine at work in the spaces between
neurons in the brain. Improved efficiency in the norepinephrine
system is associated with improvement in symptoms of ADHD.(6) Since
its first approval in the United States in 2002, more than 3.7
million patients have taken atomoxetine worldwide. It has been
studied in more than 6,000 patients in clinical trials, some for as
long as three years. Important Safety Information In some children
and teens, atomoxetine increases the risk of suicidal thoughts. A
combined analysis of 12 studies of atomoxetine showed that in
children and teens this risk was 0.4 percent for those taking
atomoxetine compared to none for those taking a sugar pill. A
similar analysis in adults treated with atomoxetine did not reveal
an increased risk of suicidal thoughts. Parents should call their
doctor right away if their child has thoughts of suicide or sudden
changes in mood or behavior, especially at the beginning of
treatment or after a change in dose. Atomoxetine should not be
taken at the same time as, or within two weeks of taking, a
monoamine oxidase inhibitor (MAOI) 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 atomoxetine. Atomoxetine has not
been tested in children less than 6 years of age or in geriatric
patients. As with all ADHD medications, growth should be monitored
during treatment although height and weight data measured for up to
3 years indicates minimal, if any, long-term effects. Atomoxetine
can cause liver damage in rare cases. Patients should tell their
doctor right away if they have itching, dark urine, yellow
skin/eyes, upper right-sided abdominal tenderness or unexplained
"flu-like" symptoms. Most people in clinical studies who
experienced side effects were not bothered enough to stop using
atomoxetine. The most common side effects in children and
adolescents in medical studies were upset stomach, decreased
appetite, nausea and vomiting, dizziness, tiredness and mood
swings. In adults, the most common side effects were constipation,
dry mouth, nausea, decreased appetite, dizziness, problems
sleeping, sexual side effects, problems urinating and menstrual
cramps. For Medication Guide, visit http://www.atomoxetine.com/.
For full Prescribing Information, including Boxed Warning, visit
http://www.atomoxetine.com/. About Eli Lilly and Company Lilly, a
leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and 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. Additional information about
Lilly is available at http://www.lilly.com/. P-LLY This press
release contains forward-looking statements about atomoxetine for
the treatment of ADHD and reflects Lilly's current beliefs.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of development and
commercialization, including the risk of side effects and other
safety concerns. There is no guarantee that the product will
continue to be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's filings with
the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements. (1)
Biederman J: Comorbidity of attention-deficit/hyperactivity
disorder with conduct, depressive, anxiety and other disorders. Am
J Psych 1991; 148:564-577 (2) ADHD and Coexisting Disorders,
http://www.help4adhd.org/en/treatment/coexisting/WWK5 (3) Greenhill
LL. Diagnosing attention-deficit/hyperactivity disorder in
children. J Clin Psychiatry 1998; 59 (Suppl 7): 31-41. (4) Faraone
S, Beiderman J, et al. ADHD in adults: an overview. Biol Psychiatry
2000; 48:9-20. (5) Barkley. ADHD: A Handbook for Diagnosis and
Treatment. New York: Guilford Press; 1998. (6) Pliszka SR, et al.
Journal of the American Academy of Child and Adolescent Psychiatry.
1996, 35(264-272). (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Tarra Ryker of Eli Lilly and
Company, +1-317-276-3787, cell: +1-317-332-7502; or Bob Josefsberg
of Chamberlain Communications Group, +1-212-884-0677
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