To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Breakfast Choice May Affect Day-To-Day Reliability of ADHD Medication, New Study Suggests URL: http://www.pslgroup.com/dg/216DD2.htm Doctor's Guide June 26, 2002
Unique OROS Delivery System of Concerta Unaffected by Diet; Adderall XR Susceptible to Fluctuations in Early Blood Levels Following Breakfast FORT WASHINGTON, PA -- June 26, 2002 -- For individuals taking medication to treat attention deficit/hyperactivity disorder (ADHD), what they eat for breakfast may affect the day-to-day reliability of the medication itself, a new study suggests. Research from the CAFE (Concerta, Adderall XR, Food Evaluation) study demonstrates that blood levels of individuals taking a single daily dose of Concerta® (methylphenidate HCl) Cll are not affected by what they eat for breakfast, enabling a consistent therapeutic effect. In contrast, early levels of Adderall XR™ (extended-release mixed amphetamine salts) would be significantly decreased during school or work depending on what the person eats each morning. The study, published in the July issue of Current Medical Research and Opinion, also suggests that the effect or lack of effect of food may be linked to the delivery system of the particular medication. The study compared the effect of a high-fat breakfast on blood levels following a morning dose of the two once-daily extended-release ADHD stimulant medications. Concerta is an extended-release OROS® formulation of methylphenidate HCl that controls ADHD symptoms effectively through 12 hours. Adderall XR is an extended-release bead formulation of dextroamphetamine and amphetamine salts that provides long-acting control of ADHD symptoms. Once-daily extended release stimulants provide an initial dose of medication shortly after being taken in the morning. The rest of the medication is then released gradually throughout the day. Consistency in the first four to eight hours of delivery and absorption is essential to reduce variability in blood levels and ensure that patients have the best opportunity to receive the full benefits of the medication. Significant effects of food may alter therapeutic efficacy (i.e., improvements in attention, behavior), and therefore, the reliability of the medication. "Because breakfast diets may change every day, an extended-release stimulant medication with a delivery system susceptible to alteration by food may result in clinically-relevant, day-to-day fluctuations in blood levels, which may affect the medication's desired improvement on symptoms of ADHD," explained Cathy Gelotte, Ph.D., Executive Director, Medical & Regulatory Product Development, McNeil Consumer & Specialty Pharmaceuticals. "This study demonstrates the unique OROS delivery system of Concerta is largely unaffected by food, and thereby provides a reliable and consistent daily therapeutic effect," said Dr. Gelotte. "Whereas the beaded delivery system of Adderall XR may result in more to day-to-day variability of blood levels within eight hours after taking the medication depending on what a patient eats." About the Study Thirty-six healthy adults between the ages of 18 and 50 participated in this single dose, open-label, randomized, crossover study which was designed to measure changes in blood levels over the first four to eight hours after subjects fasted or ate a high-fat breakfast. All subjects participated in each of four scenarios. They received either one 36 mg dose of Concerta or one 20 mg dose of Adderall XR following an overnight fast, or 15 minutes after eating a high-fat breakfast (two fried eggs, two slices of buttered bread, two strips of bacon, four-ounces of hash brown potatoes, and eight-ounces of whole milk). Blood samples were collected and measured 18 times in a 28-hour period. For subjects taking Concerta, methylphenidate exposure over the first eight hours was similar in the fed and fasted states. Ingestion of food significantly reduced Adderall XR subjects' exposure to the amount of amphetamine in the bloodstream available for therapeutic use. Changes in blood levels within plus or minus 20 percent after consuming a high-fat breakfast indicated no food effect. On average, during the first four hours after taking the medication with a full breakfast, the amount of Concerta in the bloodstream varied no more than three percent, and only 10 of 36 study participants (28 percent) experienced between 20-40 percent loss of early methylphenidate. In contrast, during the first four hours Adderall XR in the bloodstream decreased by 55 percent on average. Thirty-two out of 36 (89 percent) who took Adderall XR after breakfast experienced significant loss of early amphetamine exposure between 20 to 80 percent. "For a parent, this is the equivalent of sending your child to school every day not knowing if they are getting the full dose of medication you thought they were taking," said Dr. Gelotte. The type and frequency of adverse events in this study were consistent with the known safety profiles of methylphenidate and amphetamine salts. There were no unusual or unexpected adverse events. Researchers at McNeil Consumer & Specialty Pharmaceuticals, marketers of Concerta, conducted the study. About Concerta Concerta, taken once a day, is an integral part of a total ADHD treatment program. Concerta uses an advanced OROS extended-release delivery system to deliver a controlled rate of medication throughout the day. The OROS trilayer tablet is designed to release the medication in Concerta in a smoothly delivered pattern maintaining improved attention and behavior through 12 hours, including during activities outside of school or work. Because of its unique OROS system, Concerta minimizes the ups and downs patients often experience with stimulant medications taken several times a day. Research confirms that a single dose of Concerta is as effective as the standard three-times-a-day dosing regimen of methylphenidate, the most commonly prescribed medication for ADHD. Concerta also eliminates the need for dosing in and out of school or work, since it is taken once in the morning (with or without food). This is especially important for patients who participate in academic, job-related, or social activities outside of school or work. 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 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. 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). McNeil Consumer & Specialty Pharmaceuticals markets Concerta in the United States. For more information about Concerta, call 1-888-440-7903 or visit http://www.concerta.net. SOURCE: McNeil Consumer & Specialty Pharmaceuticals --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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