Vorapaxar reduces adverse outcomes, increases bleeding
MedWire News: Top-line results of the TRA-2P study show that vorapaxar significantly reduces adverse cardiovascular (CV) outcomes, but increases bleeding risk.
The results are in contrast to those of the TRA•CER study, which, as reported previously by MedWire News, revealed that the oral protease-activated-receptor 1 (PAR-1) antagonist vorapaxar given in addition to standard therapy did not significantly reduce the risk for CV disease or mortality when compared with standard therapy alone in patients with acute coronary syndromes.
TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) was led by the Thrombolysis in Myocardial Infarction study group from Brigham and Women's Hospital. It involved 26,449 patients who experienced myocardial infarction, ischemic stroke, or documented peripheral vascular disease.
The findings suggest that when added to standard care, vorapaxar significantly reduced the risk for the primary endpoint of the trial, which was the composite of CV death, myocardial infarction, stroke, or urgent coronary revascularization, in comparison to standard therapy alone.
However, there was a significant increase in the risk for bleeding, including intracranial hemorrhage (ICH), among patients taking vorapaxar compared with standard care alone.
"We are pleased that TRA-2P met its primary endpoint, and we look forward to discussing the results with the scientific community," commented Peter Kim, President of Merck Research Laboratories, which manufactured and trialed the drug, in a press statement.
The data from the TRA-2P and TRA•CER studies will be reviewed by the company in collaboration with the investigators and other experts, in order to examine vorapaxar's drug profile and investigate potential regulatory filings.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012
By Piriya Mahendra