Study Suggests Strattera(R) Improved ADHD Symptoms in Patients With Comorbid Alcohol Abuse
May 23 2007 - 3:00PM
PR Newswire (US)
Prevalence of Alcohol Abuse Among ADHD Patients Nearly Triple That
of General Population, Affecting Approximately 1 Million People
INDIANAPOLIS, May 23 /PRNewswire-FirstCall/ -- Data from a recent
clinical study showed Strattera(R) (atomoxetine HCl) improved
symptoms of Attention- Deficit/Hyperactivity Disorder (ADHD) in
patients with comorbid alcohol abuse disorder, suggesting ADHD can
be treated safely and effectively with Strattera in patients with
both disorders. Results from the 12-week study were presented today
at a major medical meeting of psychiatrists. The study was designed
to test the hypothesis that Strattera is superior to placebo in the
treatment of ADHD symptoms and prevention of relapse of alcohol
abuse in adult patients with both ADHD and comorbid alcohol abuse
disorder who were recently abstinent. "ADHD is present in at least
one-quarter of adults with alcohol abuse or dependence. Treating
ADHD in adults with co-occurring alcohol abuse can be challenging,
and up until now, no data have been available to help us know how
to treat these patients. Often the first course of action is to
treat the alcohol problem first, then later the ADHD," said study
author Timothy E. Wilens, M.D., director of substance abuse
services in the Pediatric Psychopharmacology Clinics at
Massachusetts General Hospital and associate professor of
psychiatry at Harvard Medical School in Boston. "While additional
studies are needed, this study is encouraging because it is the
first to show that ADHD can be treated safely and effectively with
Strattera in patients with ADHD and very recent alcohol abuse."
Results of the study of 147 adults who met full DSM-IV-TR
(Diagnostic and Statistical Manual of Mental Disorders) criteria
for ADHD and comorbid alcohol abuse, showed that Strattera was
superior to placebo in the reduction of ADHD symptoms as measured
by the ADHD Investigator Symptom Rating Scale (AISRS). At study
endpoint of 12 weeks the reduction of ADHD symptoms in subjects
with comorbid alcohol abuse disorder was significantly improved for
the Strattera group (-13.63) relative to the placebo group (-8.31).
The study showed no significant difference in time to alcohol abuse
relapse between the Strattera and placebo treatment groups.
However, an exploratory post hoc analysis undertaken to examine
drinking throughout the study suggested a positive trend in
reducing cumulative heavy drinking days by 26 percent in the
treated group compared to placebo, though more study is needed to
determine the validity of this specific finding. ADHD is a
potential risk factor for developing alcohol abuse problems.(1) In
addition, alcohol abuse problems may be more common among people
with ADHD than among those without ADHD. According to data from the
National Comorbidity Survey Replication, nearly three times the
number of individuals with ADHD (12 percent) have comorbid alcohol
abuse or dependence disorder compared to the general population
(4.4 percent).(2) Strattera was generally well-tolerated in this
study. Adverse events were similar to those noted in previous
trials and discontinuations due to adverse events were not
different between groups. The most common adverse events reported
were nausea, dry mouth, decreased appetite, dizziness, fatigue,
constipation and urinary hesitation. Discontinuation rates reported
in this study from adverse events were 9.7 percent for the
Strattera group compared to 2.7 percent for the placebo group.
Methods In this randomized, placebo-controlled study, 72 patients
received Strattera (25-100 mg daily) and 75 patients received
placebo for approximately 12 weeks, at which time, their ADHD
symptoms were measured using the AISRS. Study subjects were
recently abstinent from alcohol at least four days before study
randomization and included 125 men and 22 women, mean age
approximately 34 years-old. The study design allowed investigators
to evaluate whether Strattera is superior to placebo in the
treatment of ADHD symptoms and effective in preventing alcohol
abuse relapse in adults with ADHD and comorbid alcohol abuse
disorder. Time to relapse was defined as four standard alcoholic
drinks for females or five standard alcoholic drinks for males
within 24 hours, or at least three standard alcoholic drinks per
day for at least one week. A standard alcoholic drink was defined
in this study as 12 ounces of regular beer, 5 ounces of wine or 1.5
ounces of 80-proof distilled spirits. Cumulative heavy drinking
days were measured post hoc with a stratified Andersen-Gill
recurrent-event Cox model. About ADHD ADHD is the most common
psychiatric disorder to appear in children, and for many it is a
chronic condition that carries over into adulthood. If left
untreated, ADHD can have long-term effects on a child's emotional
well-being and social skills, like making friends or doing well at
school or at work.(3) It is estimated that ADHD affects 4.4 percent
of adults in the United States and incidence is higher among men,
the previously married, unemployed and non- Hispanic whites.(2)
Studies have shown that almost a third of patients with ADHD in
adulthood will have difficulty with emotional dysregulation,(2)
which can include emotional overactivity, temper, rapidly changing
emotions, decreased ability to handle routine stress and frequent
feelings of being overwhelmed.(2) Additionally, many people with
ADHD also suffer from anxiety disorders and depression. Therefore,
proper diagnosis of all a patient's symptoms is vital for choosing
appropriate treatment and monitoring for both safety and
efficacy.(3,4,5) About Strattera Strattera, a selective
norepinephrine reuptake inhibitor, is the first FDA-approved
non-stimulant to treat ADHD in children, adolescents and adults.
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. 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.(4) 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. References (1) Marshal, MP,
Molina, BSG, et al. "Attention-Deficit Hyperactivity Disorder
Moderates the Life Stress Pathway to Alcohol Problems in Children
of Alcoholics." Alcoholism: Clinical & Experimental Research.
2007; 31:564-574:643-652. (2) Kessler, RC, Adler L, Barkley R, et
al. "The Prevalence and Correlates of Adult ADHD in the United
States: Results from the National Comorbidity Survey Replication."
Am J Psychiatry. 163:4, April 2006. (3) National Institute of
Mental Health. "NIMH research on treatment for attention-deficit
hyperactivity disorder (ADHD): The multimodal treatment study -
questions and answers." Available at:
http://www.nimh.nih.gov/childhp/mtaqa.cfm. Accessed on March 13,
2007. (4) 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: Amy Sousa of Eli Lilly and Company,
+1-317-276-8478 or +1-317-997-1481
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