{"id":29,"date":"2009-01-17T15:41:02","date_gmt":"2009-01-17T14:41:02","guid":{"rendered":"https:\/\/blogs.bmj.com\/heart-journalscan\/?p=29"},"modified":"2015-11-12T13:12:03","modified_gmt":"2015-11-12T12:12:03","slug":"new-approve-data-confirm-vioxx-cardiovascular-risk","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/heart\/2009\/01\/17\/new-approve-data-confirm-vioxx-cardiovascular-risk\/","title":{"rendered":"New APPROVE data confirm vioxx cardiovascular risk"},"content":{"rendered":"<p>In September 2004 the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial was stopped early due to concerns about increased cardiovascular mortality in patients taking the drug.\u00a0 An analysis of the long-term outcomes of the patients in the trial has now been published in the Lancet.<!--more--><\/p>\n<p>After the early termination of the trial, all 2587 participants were followed up for at least one year after stopping treatment.\u00a0 The investigators examined the incidence of non-fatal myocardial infarction and stroke, and also deaths from cardiovascular, haemorrhagic, or unknown causes.<\/p>\n<p>Post-treatment cardiovascular follow-up data was available from 84% of patients and extended mortality follow-up from 95%.\u00a0 Overall 59 patients had one of the prespecified events in the rofecoxib group, and 34 in the placebo group (p=0.06).\u00a0 In the first year after treatmentwith rofecoxib, there was a non-significant increase in the risk of these endpoints, although the hazard ratio did not change over time.<\/p>\n<p>Although the number of outcomes available for analysis in this trial was small, the two &#8220;take-home&#8221; messages from this trial are:<\/p>\n<ul>\n<li>the risk associated with rofecoxib use could be seen early<\/li>\n<li>the risk persisted over the course of a year<\/li>\n<\/ul>\n<p>Nonetheless, it should be recalled that NSAID therapy is also associated with increased cardiovascular risk, and the p value in the above paper is marginal. \u00a0Therefore physicians choosing an anti-inflammatory for their patient must try to balance the risks and benefits of a chosen therapy for their patient.<\/p>\n<ul>\n<li>Baron JA, Sandler RS, Bresalier RS, et al. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. <em>Lancet<\/em> 2008; DOI:10.1016\/SO140-6736(08)61490-7.<\/li>\n<li><a name=\"bib_2\"><\/a>Baigent C and Patrono C. Selective COX-2 inhibitors: where do we go from here? <em>Lancet<\/em> 2008; DOI:10.1016\/SO140-6736(08)61491-9.<\/li>\n<\/ul>\n<p><!--TrendMD v2.4.8--><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In September 2004 the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial was stopped early due to concerns about increased cardiovascular mortality in patients taking the drug.\u00a0 An analysis of the long-term outcomes of the patients in the trial has now been published in the Lancet. [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/heart\/2009\/01\/17\/new-approve-data-confirm-vioxx-cardiovascular-risk\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":47,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[279],"tags":[661,651,647],"class_list":["post-29","post","type-post","status-publish","format-standard","hentry","category-general-cardiology","tag-anti-inflammatory","tag-cardiovascular-risk","tag-rofecoxib"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New APPROVE data confirm vioxx cardiovascular risk - Heart<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/heart\/2009\/01\/17\/new-approve-data-confirm-vioxx-cardiovascular-risk\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New APPROVE data confirm vioxx cardiovascular risk - Heart\" \/>\n<meta property=\"og:description\" content=\"In September 2004 the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial was stopped early due to concerns about increased cardiovascular mortality in patients taking the drug.\u00a0 An analysis of the long-term outcomes of the patients in the trial has now been published in the Lancet. 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