INDIANAPOLIS, May 23, 2007 /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.
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 stu dy 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.
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)
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 pati ents 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 irr itable 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 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 www.lilly.com.
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, ther e 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).
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