To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Anti-Epileptic Medication, Topamax, Can Improve Manic Symptoms Of Bipolar Disorder URL: http://www.pslgroup.com/dg/20F0A6.htm Doctor's Guide November 30, 2001
MONTE CARLO -- November 30, 2001 -- The severity of manic symptoms in patients with bipolar disorder was significantly reduced by Topamax® (topiramate) in a multi-centre study in patients who had a history of poor response or intolerance to mood stabilizers. The study of this potentially new use for Topamax, which is currently approved for the treatment of various types of epileptic seizures, was presented today at the International Forum on Mood and Anxiety Disorders, in Monte Carlo.
Seventy percent of the 61 adults who participated in the 12-week, open-label study experienced an improvement of 50 percent or greater in their scores on the Young Mania Rating Scale -- a widely accepted tool that measures the severity of manic symptoms. In addition, 41 percent met the criteria for remission.
"The data indicate that Topamax may be a promising therapy for the treatment of bipolar disorder, particularly in managing the manic symptoms that can be so destructive," says Eduard Vieta, MD, who conducted the study and is affiliated with the Bipolar Disorders Programme at the University of Barcelona in Spain. "What makes these positive results so compelling is that the study participants were resistant to or couldn't tolerate conventional mood stabilizers."
Thirty-nine percent of the study participants took only Topamax to treat their bipolar disorder during the trial. The remainder added Topamax to one or more other mood-stabilizing medications, including lithium (28 percent), valproate (16 percent) and carbamazapine (11 percent).
Many medications used to treat bipolar disorder cause weight gain, often leading to noncompliance. However, none of the patients who took Topamax in this study gained weight, and more than a third (39 percent) lost an average of 2-3 kg over the three-month period. Weight loss was most pronounced in individuals with the highest body mass index.
"The weight gain that is so often associated with many conventional bipolar treatments can be significant health problem, and a barrier to treatment compliance," Dr. Vieta comments. "Not only can it contribute or exacerbate other conditions such as cardiovascular disease, it can significantly undermine these individuals' already-low self-esteem."
In the study, participants were given a starting Topamax dose of 79 mg per day and were evaluated after two, four and 12 weeks. The dose was titrated up by 20 to 60 mg every three to seven days until maximum clinical response or optimal tolerability was achieved. The average dose at the end of the study was 214 mg per day.
Most common side effects (reported by 5-10 percent of patients) included paraesthesia, somnolence, nausea, abdominal pain, headache, tremor and cognitive disturbance. Only one patient, however, dropped out of the study due to side effects.
Bipolar disorder is difficult to diagnose, since the symptoms may be confused with depression or other mood disorders. Without treatment, the disease can be life threatening. Between 25 and 50 percent of those with the condition attempt suicide, and 10-15 percent of those individuals succeed.
This study, led by Dr. Vieta, supplements the findings of 10 other open-label trials involving more than 275 patients, all of which suggested that Topamax has mood-stabilizing properties.
Janssen-Cilag, which partially supported Dr. Vieta's study, and its research affiliate-the R.W. Johnson Pharmaceutical Research Institute-is currently conducting large-scale Phase III research into the use of Topamax for the treatment of bipolar disorder.
Topamax is marketed under various brand names in more than 75 countries and to date, has been prescribed to approximately 935,000 patients worldwide. Topamax is available in tablets and in capsules that can be opened and sprinkled onto food. It is marketed internationally by Janssen-Cilag, with the exception of Canada (where it is marketed by Janssen-Ortho) and the United States (Ortho-McNeil Pharmaceutical).
Bipolar disorder is diagnosed in approximately 1-2 percent of the world population
SOURCE: Janssen Pharmaceutica --------------------------------------------------------------------------------------------- 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. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.