my personal edition > psychiatry other > news


  E-Mail this DGNews to a colleague

DGNews

Largest-Ever ADHD Trial Shows Adderall XR Safely and Effectively Improves ADHD Symptoms and Improves Quality of Life in Children With the Disorder

- Parents and Physicians Note Satisfaction With and Preference For Adderall XR -

MIAMI, FL -- October 17, 2002 -- Results from the largest-ever ADHD (attention deficit-hyperactivity disorder) clinical trial show that Adderall XRŽ (mixed salts of a single-entity amphetamine product), a once-daily extended-release ADHD medication, significantly improves the hallmark symptoms of ADHD and the quality of life of children living with the condition. Quality-of-life assessments show significant improvements in social relationships with friends and family, as well as scholastic, emotional, and physical functioning of the child. The study, known as LADD.CAT, involves nearly 3,000 children with ADHD, and was presented today at the 14th Annual CHADD (Children and Adults with Attention-Deficit Hyperactivity Disorder) International Conference on ADHD in Miami.

The study showed that both the children's parents as well as their physicians were satisfied with Adderall XR and preferred the medication by a significant margin to their previous ADHD medication regimens. Children in LADD.CAT (which stands for Long-Acting Adderall Community Assessment Trial) previously were taking either immediate-release AdderallŽ or a methylphenidate formulation, such as RitalinŽ or ConcertaŽ, and were switched to Adderall XR.(1)

"ADHD is an all-day disorder that requires treatment to manage symptoms at home, in school, and in social settings. This large-scale study is important because it demonstrates Adderall XR can be administered safely and is effective in the real-world setting," said the study's lead investigator, Paul J. Ambrosini, M.D., Professor of Psychiatry at MCP Hahnemann University. "Adderall XR helps children improve their functioning, such as getting along with other children, paying attention in class, and completing tasks. This translates into a positive impact not only on the child but also on his or her family."

LADD.CAT also demonstrated the safety of Adderall XR. Most adverse events were mild or moderate. The medication had no significant impact on weight in children during the course of the study. The most frequently reported adverse events were headache, insomnia, decreased appetite, and abdominal pain.

About LADD.CAT
LADD.CAT is a phase IIIb, open-label, community assessment, 7-week study (with an 8-week extension) involving 2,968 children with ADHD (ages 6-12) in 378 sites in the United States, conducted between June and December 2001. Depending on the dose, type, and frequency of ADHD medication they previously were taking, children received a starting dose of 10 mg, 20 mg, 30 mg, or 40 mg of Adderall XR, administered once a day. They were titrated up (to a maximum of 40 mg) or down, if necessary, to achieve symptom control and minimize side effects. Children were evaluated 8 and 12 hours post-dose at weeks 1, 3, and 7.

Study results include:

* Parent Evaluation -- The Conners' 10-item Global Index Scale -- Parent version (CGIS-P) was used to measure improvement in ADHD symptoms. The lower the CGIS-P score, the more improvement seen in symptoms of ADHD.

After switching to Adderall XR, ADHD symptoms in patients improved significantly. Compared to symptom levels on previous treatment regimens, there was a statistically significant improvement in the mean CGIS-P scores at week 7. On previous treatments, the mean CGIS-P score was 10.2 at 8 hours post dose and 11.7 at 12 hours post dose; at week seven, Adderall XR treatment produced a score of 5.4 at 8 hours (P<0.0001) and 7.4 at 12 hours (P<0.0001). These findings were consistent with the highly significant results of the key Adderall XR registration studies.

* Physician Evaluation -- The Clinical Global Impression (CGI) Scale, a global evaluation of improvement over time rated by a clinician, demonstrated that 60 percent of children were much improved or very much improved at week 7 on Adderall XR compared to their previous treatment regimen.

* Quality of life measurements -- The PedsQL™ Scales, completed by the same parent or caregiver for each child, are designed to measure the core dimensions of physical as well as emotional, social, and school functioning. On previous treatment regimens the PedsQL total score (physical health and psychosocial health) was 74.5, and improved to a score of 81.0 at week 7 on Adderall XR (P<0.0001).

* In a parent satisfaction survey, 50 percent of parents strongly agreed they were satisfied with Adderall XR at the end of the study. This compares to 18 percent of parents who strongly agreed they were satisfied with their child's previous treatment at the beginning of the study.

* In parent and physician preference surveys, Adderall XR was shown to be the preferred treatment, compared with previous treatment regimens taken. For parents surveyed, 83 percent preferred Adderall XR treatment for their children vs. 9 percent who preferred the previous treatment regimens. For physicians, 88 percent preferred Adderall XR treatment for their patients vs. 6 percent who preferred the previous treatment regimens.

The study was supported by Shire Pharmaceutical Development Inc.

About Adderall XR
Adderall XR is designed to provide symptom control throughout the day with just one morning dose. Studies show that its rapid onset of action lasts throughout the afternoon -- a time when many children participate in after-school activities or do homework, and need a long-acting treatment. The Food and Drug Administration (FDA) approved Adderall XR in October 2001. It is the long-acting version of Adderall, which was approved by the FDA in 1996.

Adderall XR was generally well tolerated in clinical studies. The most common side effects are decreased appetite, stomachache, difficulty falling asleep, and emotional lability.

Talk to your doctor if you have a history of high blood pressure or any heart conditions, glaucoma, thyroid problems, emotional instability, mental illness or a known allergy to this type of medication. Adderall XR may not be right for you. If you are currently or have recently taken a type of antidepressant called a MAO inhibitor you should not take Adderall XR. There is a potential for worsening of motion or verbal tics and Tourette's syndrome.
Abuse of amphetamines may lead to dependence. Report any new psychological symptoms to your physician.

About ADHD
ADHD is considered the most commonly diagnosed psychiatric disorder among school-aged children. Children with ADHD often are inattentive, impulsive, and hyperactive -- difficulties serious enough to interfere with their ability to function normally in academic or social settings. These symptoms continue beyond the school day, making an impact on all areas of the patient's life. In addition, up to 66 percent of children with ADHD will continue to show symptoms into adulthood.(2)

Although there is no "cure" for ADHD, physicians, parents, teachers, nurses, and advocates are finding ways to help people with the condition learn to adapt to their academic, social, and work settings. ADHD usually can be successfully managed with a combination of treatments, including educational approaches, psychological and behavioral therapies, and medication. A recent government-sponsored clinical trial found that therapies that include carefully monitored medication are more effective than those that do not, such as behavioral therapy alone. Medication should be considered part of an overall multimodal treatment plan for ADHD. Shire supports the use of its medication only after a thorough assessment and diagnosis of ADHD by a physician.

For more information about ADHD, call 1-888-774-3000 or go to http://www.adhdsupportcompany.com.

About Shire Pharmaceuticals Group plc
Shire is a fast-growing international specialty pharmaceutical company with a strategic focus on three therapeutic areas: central nervous system disorders, oncology, and anti-infectives.

(1) Medications previously taken include Adderall QD, Adderall BID+, methylphenidate BID+QD, methylphenidate TID+, and Concerta(R).
(2) Weiss G, Hechtman L, Milroy T, Perlman T. Psychiatric Status of Hyperactives as Adults: A Controlled Prospective 15-Year Follow-up of 63 Hyperactive Children. J Am Acad Child Adolesc Psychiatry. 1985;24:211-220.


SOURCE: Shire Pharmaceuticals Group plc

E-Mail this DGNews to a colleague

To print, use this version