To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Pregabalin Safely Treats Fibromyalgia Pain for Up to 1 Year: Presented at WCP URL: http://www.pslgroup.com/dg/229DE6.htm Doctor's Guide August 25, 2008
By Sara Freeman GLASGOW, United Kingdom -- August 25, 2008 -- Pregabalin safely and effectively treats the chronic, widespread pain associated with fibromyalgia for up to 1 year, according to data from an open-label, extension study. The study findings, which were presented here on August 20 at the 12th World Congress on Pain (WCP), add to the growing body of evidence showing that pregabalin is an effective option for treating fibromyalgia-related pain. Pregabalin has been approved for use in the United States as a treatment for fibromyalgia pain since June 2007. Teresa Leon, Pfizer Global Pharmaceuticals, New York, New York, and associates conducted the latest trial to look at the effects of 12 months of continued treatment with pregabalin following a 13-week treatment trial. For the open-label extension trial, a total of 429 patients were treated with a pregabalin starting dose of 300 mg daily. Of these patients, 117 were treated with placebo and the remainder had been given doses of pregabalin of 300 to 600 mg/day in the previous trial. During the 12-month, open-label study, patients were seen once monthly for the first 3 months and every 3 months thereafter. At each visit patients were asked to provide details of any pain they were experiencing using the Present Pain Intensity (PPI) Index and Pain Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire. The PPI Index measured pain on a 6-point scale (0 = no pain, 6 = the worst pain) while the VAS rate pain on a 100-mm scale (0 = no pain, 100 = the worst pain). Following treatment with pregabalin for a median of 357 days (range 1-402 days), noticeable improvements in pain scores were seen, including a mean decrease of 0.9 points in the PPI Index, with a 21-point reduction in the VAS score from baseline to 12 months of treatment. "Withdrawal rates owing to adverse effects were relatively low," the researchers said. Permanent discontinuation of pregabalin occurred in 12.4% of patients. Serious adverse events related to pregabalin use were reported by 6.8% of patients, most commonly dizziness, abdominal pain, and somnolence. Weight gain and peripheral oedema occurred in more patients than previously seen in short-term trials with the drug, although central nervous system effects were less of a problem, "as would be expected with prior pregabalin exposure," Dr. Leon and associates said. They concluded that not only does the drug remain effective for up to 1 year in patients with chronic pain due to fibromyalgia, but also "the adverse event profile emerging from this study is consistent with previously reported safety and tolerability of pregabalin." Funding for this study was provided by Pfizer Inc. [Presentation title: Safety and Tolerability of Pregabalin Treatment in a Long-Term Study in Patients With Fibromyalgia. Abstract PW016] --------------------------------------------------------------------------------------------- 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.