Guidelines Include Strattera as a First-Line ADHD Therapy Option

Main Category: ADHD
Article Date: 28 Apr 2004 - 0:00 PDT


The American Academy of Child and Adolescent Psychiatry (AACAP), the leading professional organization for child and adolescent psychiatry, today issued guidelines that highlight the importance of accurate diagnosis and appropriate treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

The guidelines include new recommendations for treatment in which Strattera® (atomoxetine HCl) is a first-line therapy option for ADHD. This marks the first time AACAP has listed a nonstimulant as a first-line therapy option for ADHD.

Strattera works differently than stimulants as it is a norephinephrine reuptake inhibitor. It is the only medication indicated specifically for the treatment of ADHD in children, adolescents and adults. Strattera provides full-day symptom control without insomnia in most children and adolescents.

"Strattera is an excellent means by which to treat this chronic and impairing disorder effectively and safely," says David Duesenberg, M.D., a member of AACAP, staff psychiatrist at St. John's Mercy Medical Center, and affiliated with St. Louis University. "AACAP's decision to place Strattera as a first-line therapy option will have a positive impact on the lives of many patients and their families who struggle with the disorder."

"Strattera offers a different treatment option and this option has a lot of potential benefits," explained Albert J. Allen, M.D., Ph.D., Lilly Research Laboratories. "The fact that AACAP approved a nonstimulant as a first-line therapy option has shifted the paradigm, helping us to refocus ADHD treatment from a 'one-medication-fits-all' strategy to matching the medications to each patients' needs."

To date, health care providers have written more than four million prescriptions and more than one million patients have taken Strattera.

About ADHD

ADHD affects 3 to 7 percent of school-age children and manifests itself in levels of attention, concentration, activity, distractibility, and impulsivity that are inappropriate to the child's age.1 In addition, 60 percent of children with the disorder carry their symptoms into adulthood.2 Experts estimate 4 percent of adults in the United States, more than 8 million people, have ADHD.3,4

About Strattera

The U.S. Food and Drug Administration approved Strattera on Nov. 26, 2002, for the treatment of ADHD in children, adolescents and adults.

Strattera, a selective norepinephrine reuptake inhibitor, works differently than other FDA-approved treatments for the disorder, all of which are stimulants.

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 (Pliska, 1996).

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 or in geriatric patients. 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 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. Quick Links for the News Media

For an online media kit for Strattera, please visit
http://www.lillymedia.com/rep_guides/Strattera.html

About Lilly

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. More information about Lilly is available at www.lilly.com.

For full prescribing information visit www.strattera.com.

This press release contains forward-looking statements about the potential of 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 commercialization. There is also 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. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, Washington, D.C., American Psychiatric Association, 2000.

2. Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med Clin of North Am. 2001; 85(3):757-777

3. Murphy K, Barkley, RA. J Atten disord. 1996; 1:147-161.

4. United States Census Summary File; 2000

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