Eli Lilly/ New ADHD Medication Strattera Effective in Girls...

02 декабря, 2002
Business Editors, Health & Medical Writers INDIANAPOLIS----Dec. 2, 2002--Strattera is effective in treating Attention-Deficit/Hyperactivity Disorder in school-age girls, according to a study published in the December online issue of the journal Pediatrics . Business Wire via NewsEdge Corporation : Business Editors, Health & Medical Writers INDIANAPOLIS--(BUSINESS WIRE)--Dec. 2, 2002--Strattera(tm) (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.(1) Core ADHD symptoms seen in girls are similar to those seen in boys.(2) ADHD affects 3-7 percent of school age children(3) 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. 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 less than 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. (1) Biederman J, Newcorn J, Sprich S. Comorbidity of attention deficit hyperactivity disorder with conduct, depressive, anxiety, and other disorders. Am J Psychiatry. 1991:148:564-577 (2) Biederman J, Faraone SV, Mick E, et al. Clinical correlates of ADHD in females: findings from a large group of girls ascertained from pediatric and psychiatric referral sources. J Am Acad Child Adolesc Psychiatry. 1999;38:966-975 (3) American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision. Washington, DC, American Psychiatric Association, 2000 (4) American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Washington, DC, American Psychiatric Association, 1994. (5) American Psychiatric Association: DSM-IV-TR.2000.85-93 Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med Clin of North Am. 2001; 85(3):757-777 --30--slb/cl* CONTACT: Eli Lilly and Company David Shaffer, 317/651-3710 KEYWORD: INDIANA INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL SOURCE: Eli Lilly and Company Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. URL: http://www.businesswire.com BWviaNewsEdge <> << Copyright ©2002 Business Wire >>
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