{"id":31357,"date":"2012-08-27T05:52:44","date_gmt":"2012-08-27T09:52:44","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=31357"},"modified":"2012-08-28T08:32:42","modified_gmt":"2012-08-28T12:32:42","slug":"the-return-of-vorapaxar-this-time-for-post-mi-patients","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/08\/27\/the-return-of-vorapaxar-this-time-for-post-mi-patients\/","title":{"rendered":"The Return of Vorapaxar, This Time for Post-MI Patients"},"content":{"rendered":"

The once highly promising\u00a0novel antiplatelet agent vorapaxar, widely thought to be dead on arrival after unacceptably high serious bleeding rates were found in\u00a0two large clinical trials<\/a>, has now returned to active duty. On Sunday the drug’s sponsor, Merck,\u00a0announced<\/a>\u00a0that it would seek approval of the drug, with a narrower indication than originally planned, based on new data from a prespecified analysis of the\u00a0TRA 2P-TIMI 50 trial presented at the ESC and\u00a0published simultaneously in the\u00a0Lancet<\/em>.<\/a><\/p>\n

Merck said it planned to file applications next year in the United States and Europe for an indication for the prevention of CV events in patients with a history of MI and no history or stroke or TIA.<\/p>\n

The new hope for the drug is based on an analysis of the\u00a0Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events trial, which was originally presented in March at the ACC and\u00a0published simultaneously in the New England Journal of Medicine<\/em><\/a>. In the overall trial, which\u00a0randomized 26,449 patients with a history of MI, ischemic stroke, or peripheral arterial disease to either vorapaxar or placebo in addition to standard therapy,\u00a0the rate of CV death, MI, or stroke was significantly reduced by vorapaxar, but a doubling of the rate of intracranial bleeding left many convinced the drug was not commercially viable.<\/p>\n

The new analysis, presented at the ESC by Ben Scirica, \u00a0focused on the subgroup of 17,779 TRA 2P patients — a group larger than usually found in the entire population of most clinical trials, it should be noted — with a history of myocardial infarction. After a median 2.5 years of follow-up, the rate of CV death, MI, or stroke was significantly lower in the vorapaxar group than in the placebo group, although vorapaxar was also associated with an increased risk for bleeding, but not intracranial bleeding:<\/p>\n