To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: PSYCHIATRY CONGRESS: Paxil Effective Treatment For Social Anxiety Disorder URL: http://www.pslgroup.com/dg/11DDEA.htm Doctor's Guide August 6, 1999
HAMBURG, GERMANY -- Aug. 6, 1999 -- Results of a clinical trial published in this week's issue of the British Journal of Psychiatry demonstrated that the percentage of responders treated with SmithKline Beecham Pharma Canada's Paxil® (paroxetine HCl) for Social Anxiety Disorder/Social Phobia was double that of patients treated with placebo. Patients were assessed using Clinical Global Impression-global improvement scores, a measure of improvement of symptoms. These findings were presented today by Dr. David Baldwin of the University of Southampton, at the 11th World Congress of Psychiatry in Hamburg. This important newly published data confirms that Paxil is an effective drug treatment for social anxiety disorder. This 12-week, multi-centre, double-blind, placebo-controlled clinical trial compared the efficacy of Paxil (20-50 mg daily, flexible dose) with placebo, in 290 patients with social anxiety disorder. Treatment efficacy was assessed by the CGI scale and the Liebowitz Social Anxiety Scale (LSAS), which provides an assessment of a patient's level of fear and avoidance of performance and/or social situations. The results revealed a statistically significant symptom improvement in patients treated with Paxil within as little as four weeks of treatment, as measured by LSAS scores. "This trial further demonstrates that paroxetine is a very effective treatment for Social Anxiety Disorder," Dr. Baldwin said. "This is welcome news to people whose lives have been affected by this disabling condition." In a separate study, presented by Dr. Hans-Ulrich Wittchen of the Max Planck Institute of Psychiatry, Munich, Germany direct and indirect costs of the disorder were examined in a large American Health Maintenance Organization (HMO) with 180,000 members. Results demonstrated that the disorder was present in 8.2 per cent of patients, and was associated with higher medical utilisation, lower quality of life and reduced occupational functioning. The implications of these findings demonstrate the severity of the disorder on not only physical well being, but on life fulfilment. For example, with each 10 point increase observed in LSAS scores: -- Wages decreased between 1.5 and 2.9 per cent (a higher level of severity of social anxiety disorder was a statistically significant predictor of lower hourly wages). -- The probability of college graduation decreased by 1.8 per cent (sufferers were less likely to graduate from college than others without the disorder). Social anxiety disorder was identified as one of the most prevalent psychiatric disorders in this HMO population. Many of those found to be suffering from social anxiety disorder had not been previously diagnosed. However, the severity of their clinical symptoms were found to be as high as those patients observed in the clinical trial program, thus highlighting the need for greater awareness, recognition and diagnosis of this disorder. "This study is an indication of the long-term burden of social anxiety disorder," said Dr. Wittchen, who presented the findings of the study. "Despite these data being US-specific, the results can easily be extrapolated and applied anywhere in the world." The efficacy of Paxil in the treatment of social anxiety disorder has now been established in three recent and important clinical trials that demonstrate consistent results in more than 800 patients. In all three studies treatment with Paxil was associated with a definitive reduction in symptoms of social anxiety disorder, increased participation in social activity, as well as a significant improvement in the overall condition. "Social Anxiety Disorder is a serious clinical condition that is often misunderstood and under diagnosed," Dr. Wittchen said. "The findings of these important studies are a significant step forward in helping patients with this disabling condition." Social anxiety disorder, often under diagnosed, is a serious condition that requires treatment. In its most severe form, it affects between two to five per cent of people at some point in their lives. The typical age of onset is during the teenage years, which is a critical time when social and personal relationships are being formed. The earlier the onset, the more severe and disabling the consequences are on personal life, educational achievement and career progression. Paxil is approved for use in patients over the age of 18. It is not approved for use in adolescent or pediatric patients. Characterised by the fear of being observed or evaluated by others, sufferers report an overwhelming fear of embarrassment in social and performance situations and often will avoid or endure a situation while suffering intense emotional distress. They frequently avoid situations which most people take for granted. Sufferers may have few friends, may have poor academic performance or drop out of school, experience reduced work performance, have lower income and may abuse alcohol and/or drugs. The disorder can lead to demoralisation, depression and other psychiatric disorders. "In recent years we have learned much about this disorder. The key, now that we have identified a safe and effective treatment, is encouraging people to come forward to seek help," said Dr. James Ballenger of the Medical University of South Carolina, who presented findings on the disorder at the congress. "Far too many people with social anxiety disorder struggle in silence. Today we know we're closer to being able to help patients return to a mentally healthier, more socially active life," he added. Efficacy-both clinician and patient-rated measures consistently established that Paxil is an effective and well-tolerated treatment for social anxiety disorder. The Paxil groups, throughout the entire clinical development program for social anxiety disorder, were consistently significantly better than placebo. This difference was apparent from as early as week two on some scales and was sustained throughout the end of the study. Significant condition and symptom improvement-during treatment with Paxil, patients experienced a marked reduction in social anxiety and avoidance with increased participation in social activity. A simple and effective dose of 20 mg once daily was established as the starting and effective dose for Paxil in social anxiety disorder. Paxil is approved in 82 countries for the treatment of depression, obsessive-compulsive disorder and panic disorder in patients over the age of 18. It is currently indicated for the treatment of generalised social anxiety disorder in 35 countries including Canada, the United Kingdom, the United States and Germany. --------------------------------------------------------------------------------------------- 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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