To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Risk of Stroke, MI, and Death Persists One Year After Discontinuation of Rofecoxib Treatment URL: http://www.pslgroup.com/dg/22EDF2.htm Doctor's Guide October 15, 2008
NEW YORK -- October 15, 2008 -- Long term follow-up data from the Adenomatous Polyp Prevention on Vioxx (APPROVe) trial confirms that use of the Cox-2 inhibitor rofecoxib (Vioxx) substantially increases the risk of stroke, myocardial infarction (MI), and death compared with placebo. John A Baron, Dartmouth Medical School, Lebanon, New Hampshire, and colleagues reported the conclusions of their study in an article published early online and in an upcoming edition of The Lancet. The randomised, placebo-controlled trial aimed to assess the effects of 3-year treatment with rofecoxib on recurrence of cancerous polyps in the bowel in 2587 patients from 108 centres worldwide. The researchers attempted to follow-up for 1 year all patients that had had to stop treatment because of cardiovascular toxicity. The end-point studied was the combined incidence of non-fatal myocardial infarction (MI), non-fatal stroke, and death from cardiovascular, haemorrhagic, or unknown causes (the Antiplatelet Trialists' Collaboration [APTC] combined endpoint). Follow-up data were obtained for 84% of participants, and the researchers found that the relative risk of reaching APTC was increased by 79% in the rofecoxib group compared with placebo. This was consistent with earlier findings of increased risk while on treatment or 14 days afterwards, in which the relative risk of reaching APTC was more than doubled (a 112% increased risk). In terms of the individual outcomes after 1-year follow up, the risk of MI or stroke was roughly doubled for rofecoxib patients compared with placebo, while the relative risk of death increased by 31%. There was no substantial change in the increased relative risk of cardiovascular events over time. "Our data are compatible with an early increase in risk that seems to persist for about 1 year after 3 years of treatment. The cardiovascular toxicity seems to be a class effect; indeed, studies of other selective COX-2 inhibitors have reported similar findings. Conventional non-aspirin NSAIDs may share the same toxicity to the extent that they are COX-2 selective. All these drugs are effective analgesic and anti-inflammatory agents, and seem to reduce risks of colorectal neoplasia. However, these benefits will have to be weighed against their proven or possible cardiovascular risks in assessing their suitability in various clinical settings," the authors wrote. In an accompanying comment, Colin Baigent, MD, Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, United Kingdom, and Carlo Patrono, MD, Catholic University of Rome, Rome, Italy, said: "The results of randomised trials are consistent with all coxibs having some vascular risk, but also that some traditional NSAIDs carry similar risks. Switching from a coxib to a traditional NSAID will not necessarily avoid these vascular hazards, but will result in a two-to-3-fold increase in the risk of a serious upper gastrointestinal complication." "A physician choosing between alternative anti-inflammatory regimens for a patient needs to be able to weigh each regimen's hazards, especially cardiovascular and gastrointestinal risks," they said. They add that further research is needed to create a validated method for estimating the risk of a serious gastrointestinal complication. SOURCE: The Lancet --------------------------------------------------------------------------------------------- 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.