Psychiatry - October 2008 - (Page 16)

Psych Rx STUDY SHOWED ONCE-DAILY LISDEXAMFETAMINE IMPROVED ADHD SYPMPTOMS IN ADULTS WITH ADHD In a clinical study of adults, lisdexamfetamine (Vyvanse®) taken once-daily significantly improved the symptoms of ADHD within one week. The study was published in the September issue of the Journal of Clinical Psychiatry. This study is the phase 3 pivotal trial submitted to the FDA and supported the approval in April 2008 of lisdexamfetamine for adults with ADHD. Lisdexamfetamine was introduced in July 2007 for the treatment of ADHD in children aged 6 to 12 years “This study adds to the growing body of research of ADHD in adults, and showed that lisdexamfetamine provided effective symptom control for adults with this disorder,” said Lenard A. Adler, MD, lead researcher in this study and director of the Adult ADHD program at the NYU Langone Medical Center, Associate Professor of Psychiatry, Neurology, and Child and Adolescent Psychiatry at the New York University School of Medicine. “It is important for people to realize that in adults, the core symptoms of ADHD—inattention, hyperactivity, and impulsivity—may present as inner restlessness, a lack of focus and organization, poor time management, or an inability to finish tasks, which can impact adults’ daily lives. In this study, lisdexamfetamine was shown, within the first week, to significantly improve ADHD symptoms of inattention, such as the ability to focus and organize, and hyperactivity and impulsivity, 16 Psychiatry 2008 [OCTOBER] such as restlessness, and interrupting.” In this randomized, double-blind, placebo-controlled, parallel-group, four-week study with dose escalations in 414 adults aged 18 to 55 years, adults with ADHD experienced significant improvements in ADHD symptoms within one week of treatment with once-daily lisdexamfetamine. Treatment with lisdexamfetamine at all doses studied (30mg, 50mg, 70mg) was significantly more effective than placebo, with a mean reduction in ADHD Rating Scale (ADHD-RS-IV) scores (16.2–18.6 points; P<0.0001); demonstrating a 40-to 45-percent decrease at endpoint. Investigators also measured the efficacy of lisdexamfetamine using the Clinical Global Impressions-Improvement (CGI-I) scale. On this scale, the percentage of adults taking lisdexamfetamine rated by investigators as “much improved” or “very much improved” ranged from 57 to 61 percent at endpoint and was significantly greater than placebo (P<0.01). The most common adverse events in the study were decreased appetite, difficulty falling asleep, and dry mouth. Lisdexamfetamine is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active damphetamine. The conversion of lisdexamfetamine to damphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in normal GI transit times. Lisdexamfetamine is available in six dosage strengths of 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg. Additional information about lisdexamfetamine and full prescribing information are available at www.vyvanse.com . Dr. Adler has received grant/research support from Shire and is a member of the advisory board and consultant for Shire. STUDY FINDS ANTIDEPRESSANT DISCONTINUATION MOST LIKELY AT THE START OF THERAPY AMONG NEWLY TREATED AND PREVIOUSLY LAPSED PATIENTS BURLINGTON, Mass.—Business Wire—Adheris, Inc., a leader in patient adherence and education programs, announced recently the results of a new study that examined adherence rates among patients on SSRI/SNRI antidepressant therapy. Study results showed that patients new to antidepressant treatment and those who had restarted therapy after a lapse of six or more months were twice as likely to discontinue therapy in the first 30 days of treatment versus patients previously dispensed an antidepressant. According to lead author Mark Vanelli, MD, MHS, a practicing psychiatrist at Harvard Medical School and Chief Medical Officer at Adheris, Inc., “The practical implications of this study are that while all patients lapsed at an alarming rate over time, increased patient follow-up and education within the first 30 days of therapy in newly treated and lapsed patients restarting therapy are critical to help improve adherence and patient outcomes.” The study also found that the greatest differences in the duration of antidepressant use were observed not among patients taking different antidepressants, but among patients taking the same antidepressant but who had 16 http://www.vyvanse.com

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Psychiatry - October 2008 Editor’s Message Editorial Advisory Board Contents Psych Rx Treatment of Migraine and the Role of Psychiatric Medications Play Therapy: A Case-based Example of a Nondirective Approach Delirium and Antipsychotics: A Systematic Review of Epidemiologyand Somatic Treatment Options Severely Mood-disordered Youth Respond Less Well to Treatment in a Community Clinic than Youth with Bipolar Disorder Beyond Informed Consent: The Ethics of Informing, Anticipating, and Warning Asthma: Wheezing, Woes, and Worries Classified Advertising Journal Watch Information for Authors

Psychiatry - October 2008

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