Study Suggests Strattera(R) was Effective in Treating ADHD in Children and Adolescents with ADHD and Reading Disorders
October 27 2006 - 9:00AM
PR Newswire (US)
INDIANAPOLIS, Oct. 27 /PRNewswire-FirstCall/ -- New data suggest
that Strattera(R) (atomoxetine HCl) improved ADHD symptoms in
children and adolescents who had both ADHD and a reading disorder,
like dyslexia. Results were announced today at a meeting of child
and adolescent psychiatrists. The primary objective of the study
was to measure Strattera's efficacy in treating the symptoms of
ADHD in children and adolescents with ADHD and a comorbid reading
disorder (ADHD+RD). Patients with ADHD alone were compared to
patients with ADHD+RD. After taking Strattera for 16 weeks, both
groups of patients aged 10 to 16 reported an improvement of nearly
50 percent in ADHD symptoms like inattentiveness, hyperactivity and
impulsivity. Additionally, patients with ADHD+RD displayed an
average reading composite improvement of approximately two years
compared to 17 months for participants with ADHD alone. Reading
composite is defined as the combined score for reading decoding and
reading comprehension. Strattera is not approved to treat reading
disorders. "We are encouraged by the results of this study which
highlight the importance of considering appropriate treatment
options when treating ADHD in patients with ADHD and comorbid
conditions," said Richard Rubin, M.D., clinical associate professor
of psychiatry, University of Vermont College of Medicine. "Since
ADHD is often combined with reading disabilities, considering
treatment options that are effective in treating ADHD without
having an adverse effect on reading performance may provide the
best outcome." The two most common developmental disabilities of
school-age children are ADHD and learning disabilities, including a
reading disorder, like dyslexia.(1,2) It is estimated that 15 - 30
percent of children with ADHD will also have a reading
disorder.(2,3,4,5) While research suggests that students with both
ADHD and a reading disorder are no more anxious, hyperactive or
aggressive than students with ADHD only, the reading disorder does
impact school performance, which may subsequently impact family and
peer relationships.(6) Study Highlights * At the study endpoint,
mean change from baseline to endpoint analyses revealed
statistically significant improvement for both the patients with
ADHD and the patients with ADHD and a comorbid reading disorder
(ADHD+RD) on the ADHD RS Total Score (improved 52 percent and 49.2
percent, respectively) * Age equivalence improvements (in months)
were statistically significant for both groups on the following
items: -- Total reading composite: improved 17.2 months for the
ADHD group and 23.5 months for the ADHD+RD group -- Reading
decoding (+17.8 months and +16.9 months, respectively) -- Reading
comprehension (+17.0 months and +26.0 months, respectively) --
Spelling (+9.7 months and +8.7 months, respectively) * In this
study, Strattera was well tolerated with no differences between
groups and commonly reported adverse events similar to those
reported in previous studies. The most common adverse events
(occurring in greater than 5 percent of patients taking Strattera)
were somnolence, nausea, decreased appetite, headache, abdominal
pain, vomiting, nasopharyngitis and cough. Methods In this
open-label, parallel-design pilot study conducted in the United
States, patients received 1.0 to 1.4 mg/kg of Strattera once daily
for approximately 16 weeks. Patients with ADHD (n = 20) were
compared to patients with ADHD+RD (n = 36). All patients were
required to have an ADHD symptom severity score at least 1.5
standard deviations above age and gender norms for at least one of
the diagnostic subtypes: inattentive, hyperactive/impulsive, or the
total score for the combined subtype as assessed by the
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD RS).
Patients diagnosed as ADHD+RD were also required to have at least a
22-point discrepancy between ability and achievement, based on
intelligence quotient (K-BIT) and reading composite (K- TEA)
scores. An IQ Composite score of >80 was required on the Kaufman
Brief Intelligence Test (K-BIT) for the patient to participate in
the study. The ADHD RS was the primary efficacy measure. The second
analysis measured patients' reading performance using the Kaufman
Test of Educational Achievement (K-TEA) Reading Decoding,
Comprehension and Spelling Subtests and Reading Composite Scale.
The Working Memory Test Battery for Children (WMTB- C) and Life
Participation Scale Investigator and Parent-Rated versions (LPS-C)
were additional secondary measures. The patients were allowed to
continue to receive educational services/assistance throughout the
study. About ADHD ADHD is a complex disorder that often occurs in
tandem with other conditions like reading disorders(7). Therefore,
proper diagnosis of all a patient's symptoms is vital for choosing
appropriate treatment and monitoring for both safety and
efficacy.(8) Untreated ADHD can have lifelong consequences,
including poor peer relations, poor academic and work performance
and increased risk-taking behaviors, such as substance abuse.(9)
About Strattera Strattera is indicated for the treatment of
Attention- Deficit/Hyperactivity Disorder (ADHD) in children,
adolescents and adults. Strattera, a selective norepinephrine
reuptake inhibitor, is the first FDA-approved non-stimulant to
treat ADHD. It is not known precisely how Strattera 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.(10)
Since its first approval in the United States in 2002, more than
4.2 million patients have taken Strattera 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, Strattera increases the risk of suicidal thoughts. A
combined analysis of 12 studies of Strattera showed that, in
children and teens, this risk was 0.4 percent for those taking
Strattera compared to none for those taking a sugar pill. A similar
analysis in adults treated with Strattera 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. Strattera 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.
Tell your doctor if you or a family member has a history of high or
low blood pressure, increased heart rate, heart or blood vessel
disease or structural heart defects. If you experience any cardiac
symptoms, such as chest pain or fainting while taking Strattera,
you should report them to your doctor right away. In rare cases,
Strattera can cause liver problems. Call your doctor right away if
you have itching, dark urine, yellow skin/eyes, upper right-side
abdominal tenderness, or unexplained "flu-like" symptoms. If your
child develops new psychological symptoms, such as abnormal
thoughts/behaviors and/or extreme elevated or irritable moods while
taking Strattera, you should report them to your child's doctor
right away. For male patients, if you are taking Strattera and
experience priapism, a painful or prolonged erection lasting more
than four hours, call your doctor right away. As with all ADHD
medications, growth should be monitored during treatment, although
height and weight data measured for up to three years indicates
minimal, if any, long-term effects. 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
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.strattera.com/. For full Prescribing
Information, including Boxed Warning information, visit
http://www.strattera.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 Strattera 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) Goldman LS, Genel M, Bezman
RJ, Slanetz PJ. 1998. Diagnosis and treatment of
attention-deficit/hyperactivity disorder in children and
adolescents. Journal of the American Medical Association; 279(14):
1100-1107. (2) Shaywitz BA and Shaywitz SE. 1994. Learning
disabilities and attention disorders. In: KF Swaiman (Ed.),
Pediatric Neurology: Principles and practice, Vol II: 1119-1151;
St. Louis, MO: CV Mosby. (3) Barkley RA. 2002. Major Life Activity
and Health Outcomes Associated with Attention-Deficit/Hyperactivity
Disorder. J Clin Psychiatry; 63 (suppl 12): 10-15. (4) Brown TE.
2000. Attention-Deficit Disorders and Comorbidities in Children,
Adolescents, and Adults. Washington DC American Psychiatric Press.
(5) Semrud-Clikeman M, Biederman J, Sprich-Buckminster S, Lehman
BK, Faraone SV, Norman D. 1992. Comorbidity between ADHD and
learning disability: A review and report in a clinically referred
sample. J Am Acad Child Adolesc Psychiatry 31(3):439-48. (6) ADHD
and Coexisting Disorders,
http://www.help4adhd.org/treatment/coexisting/WWK5 (7) Greenhill
LL. Diagnosing attention-deficit/hyperactivity disorder in
children. J Clin Psychiatry 1998; 59 (Suppl 7): 31-41. (8) Barkley.
ADHD: A Handbook for Diagnosis and Treatment. New York: Guilford
Press; 1998. (9) Faraone S, Beiderman J, et al. ADHD in adults: an
overview. Biol Psychiatry 2000; 48:9-20. (10) 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 )
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Eli Lilly and Company CONTACT: Tarra Ryker, Eli Lilly and Company,
+1-317-276-3787, cell: +1-317-332-7502; Bob Josefsberg, Chamberlain
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