NEW YORK, June 28 /PRNewswire/ -- The results of a new analysis of data by Columbia University Medical Center and New York State Psychiatric Institute researchers demonstrate that patients between the ages of 6 - 17 who were treated for Attention-Deficit/Hyperactivity Disorder (ADHD) with CONCERTA(R) (methylphenidate HCl) were more likely to remain on long-term therapy (12 months) than patients who were prescribed other forms of extended-release or immediate-release methylphenidate formulations. The study, which is titled "Continuity of Methylphenidate Treatment for Attention-Deficit/Hyperactivity Disorder," is published in the June 2005 issue of Archives of Pediatrics & Adolescent Medicine.
"More than 80% of the children and adolescents in the United States who have been diagnosed with ADHD are treated with stimulant medications," said Mark Olfson, MD, MPH, Professor of Clinical Psychiatry, Columbia University Medical Center, a psychiatric researcher at the New York State Psychiatric Institute and a co-author of the new report. "In addition, a majority of these patients are likely to experience ADHD symptoms until they reach early adulthood. Therefore, it is important to determine whether specific methylphenidate products are more likely to be associated with greater continuity of ADHD treatment. The results of this study, which demonstrate that patients who were treated with CONCERTA were more likely to remain on therapy for longer periods of time, provide important information for physicians to consider when prescribing ADHD treatment for their patients." The study is an analysis of data from the statewide California Medicaid claims for more than 11,000 patients aged 6 - 17 who initiated therapy with either an immediate-release or an extended-release formulation of methylphenidate during a three-year period. The investigators divided the sample into two study cohorts: patients who received an extended-release MPH (n=3,444) or immediate- release MPH (n=8,093) formulation. The duration of the MPH treatment for each patient was calculated by counting the continuous prescriptions using the date of the prescription and the number of days of medications supplied. Treatment was considered to have terminated if a gap of 30 or more days occurred from the end of the last prescription supply and the start of the subsequent prescription.
Study investigators analyzed the data to determine whether patients on specific forms of methylphenidate were more likely to continue with long-term therapy than patients on other formulations of the methylphenidate. The results of the analysis demonstrated that patients who were treated with extended-release methylphenidate recorded a 37% increase in duration of treatment than patients who were treated with an immediate-release formulation. Importantly, patients who were treated with a specific extended- release formulation, CONCERTA HCl were associated with the longest treatment continuity. Patients on CONCERTA recorded a mean treatment period of 147 days as compared with patients who were treated with other extended-release products including Ritalin(R) LA (methylphenidate) (101 days) and Metadate(R) CD (methylphenidate) (113 days).
About Concerta
Concerta is an extended release formulation of methylphenidate for ADHD treatment that is designed to last through 12 hours, with just one morning dose. CONCERTA uses an advanced OROS(R) extended-release delivery system. The OROS(R) trilayer tablet is designed to release the medication in CONCERTA in a controlled pattern providing symptom management throughout the day.
CONCERTA should not be taken by patients who: have significant anxiety, tension, or agitation, since CONCERTA may make these conditions worse; are allergic to methylphenidate or any of the other ingredients in CONCERTA; have glaucoma, an eye disease; have tics or Tourette's syndrome, or a family history of Tourette's syndrome; are taking a prescription for monoamine oxidase inhibitor (MAOI). CONCERTA should not be administered to patients with preexisting severe gastrointestinal narrowing. CONCERTA should not be used in children under six years, since safety and efficacy in this age group have not been established. In the clinical studies with patients using CONCERTA, the most common form of side effects were headache, stomach pain, sleeplessness, and decreased appetite.
CONCERTA should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence. (See Boxed Warning in the full U.S. Prescribing Information for CONCERTA).
CONCERTA was approved by the U.S. Food and Drug Administration in 2000. It is marketed in the United States by McNeil Consumer & Specialty Pharmaceuticals. For more information about CONCERTA, call 1-888-440-7903 or visit http://www.concerta.net.
About ADHD
Attention Deficit Hyperactivity Disorder is a real, common and treatable medical condition characterized by a variable attention span and/or hyperactivity-impulsivity. According to a report by the Centers for Disease Control and Prevention, approximately 7.5% of school-age children in the U.S. have ADHD.
About Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, medical education, and health care. The medical center trains future leaders in health care and includes the dedicated work of many physicians, scientists, nurses, dentists, and other health professionals at the College of Physicians & Surgeons, the School of Dental & Oral Surgery, the School of Nursing, the Mailman School of Public Health, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. With a strong history of some of the most important advances and discoveries in health care, its researchers are leading the development of novel therapies and advances to address a wide range of health conditions. http://www.cumc.columbia.edu
About New York State Psychiatric Institute
Founded in 1896, the New York State Psychiatric Institute (PI) continues to contribute importantly to knowledge about understanding and treating psychiatric disorder and is ranked among the best psychiatric research facilities in the world today. Noted for its research on depression and suicide, schizophrenia, anxiety and child psychiatric disorders, PI is also at the forefront of research dedicated to unraveling the brain's mysteries. Its scientists constitute the core of the Department of Psychiatry at Columbia University. In 2000, Dr. Eric Kandel was awarded the Nobel Prize in Physiology or Medicine for research in his labs at PI on the cellular basis of memory. http://www.nyspi.org
About McNeil Consumer & Specialty Pharmaceuticals
McNeil Consumer & Specialty Pharmaceuticals markets prescription and over- the-counter (OTC) pharmaceutical products. Prescription products include CONCERTA(R) (methylphenidate HCl) and FLEXERIL(R) (cyclobenzaprine HCl) 5 mg. The company's OTC products include complete lines of TYLENOL(R) Acetaminophen and MOTRIN(R) IB Ibuprofen products for adults and children. Other McNeil brands include IMODIUM(R) (loperamide HCI) A-D Anti-Diarrheal, ST. JOSEPH(R) Adult Regimen Aspirin and NIZORAL(R) A-D (ketoconazole) Shampoo.
Columbia University Medical Center