To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Extended Release Hydrocodone/Acetaminophen Reduces Pain After Bunionectomy Better Than Placebo: Presented at AAPM URL: http://www.pslgroup.com/dg/21D7EE.htm Doctor's Guide February 20, 2008
By Ed Susman KISSIMMEE, FL -- February 20, 2008 -- Postsurgical pain after bunionectomy can be treated effectively with the experimental combination of extended-release hydrocodone and acetaminophen. "Two tablets provided consistently superior pain relief as compared with 1 tablet," said Andrea Best, MD, Global Project Head, Abbott Pain Care, Abbott Laboratories, Abbott Park, Illinois, United States. However, she said that either 1 or 2 tablets were potent enough to be superior to placebo in relieving pain associated with this procedure. Dr. Best presented the results in a poster session on February 14 here at the American Academy of Pain Management (AAPM) 24th Annual Meeting. The researchers recruited 163 patients undergoing unilateral first metatarsal bunionectomy and divided them into 3 treatment arms: 56 patients received 2 tablets of extended-release hydrocodone/acetaminophen every 12 hours; 54 received 1 active tablet and 1 placebo tablet every 12 hours; 53 patients received 2 placebo tablets every 12 hours. The primary endpoint of the study was the time-interval weighted sum of pain intensity difference over the first 12 hours after administration of the study medication, measured through a visual analogue scale. Higher scores on the scale represent improvement in pain relief. In the first 12 hours, placebo patients improved less than 50 points on the 450-point scale; patients taking 1 tablet of active treatment and 1 placebo tablet improved by 200 points (P < .001 vs placebo); those receiving 2 tablets of hydrocodone/acetaminophen extended release achieved a 350-point improvement in pain relief (P < .001 vs placebo and 1 tablet). "The safety profile of hydrocodone/acetaminophen extended release in this study was consistent with that of a mu-opioid receptor agonist-containing agent," Dr. Best said. There were no serious adverse events that were possibly or probably related to the study drugs, Dr. Best reported. Two serious adverse events involved thromboembolic events, but were believed to have been caused by the patients' immobility after the surgery. Funding for the study was provided by Abbott Laboratories. [Presentation title: Safety and Efficacy of 12-Hour Extended Release Hydrocodone/ Acetaminophen for Acute Pain Following Bunionectomy: A Phase 3, Randomized, Double-Blind Study. Abstract 164] --------------------------------------------------------------------------------------------- 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.