Merck's investigational anti-thrombotic medicine Vorapaxar has demonstrated greater reduction in the risk of cardiovascular (CV) death, heart attack, stroke or urgent coronary revascularisation when added to standard of care (e.g. aspirin, or thienopyridine or both).
The three-year Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA-2P) TIMI 50 study included 26,449 stable patients who had previously experienced an ischemic stroke or heart attack no less than two weeks and no more than 12 months before randomisation, or who had Peripheral Artery Disease (PAD).
In the TRA-2P trial, Vorapaxar was administered at a 2.5mg daily maintenance oral dose for more than one year, to evaluate the efficacy and safety of the drug compared with placebo in addition to standard of care in the secondary prevention setting.
The trial reported that Vorapaxar showed reduced risk of the protocol-specified primary composite endpoint and key secondary composite endpoints of CV death, heart attack and stroke and increased moderate or severe bleeding, as measured by the GUSTO scale.
Additionally, the study also reported considerable difference in the rate of fatal bleeding between the group receiving Vorapaxar and the group receiving standard of care alone.
Brigham and Women's Hospital Levine Cardiac Intensive Care Unit director and TIMI Study Group senior investigator David Morrow said results from the trial demonstrated for the first time that inhibition of another platelet pathway in addition to standard antiplatelet therapy reduced the risk of recurrent cardiovascular events in long-term secondary prevention.
Merck Research Laboratories atherosclerosis and cardiovascular disease therapeutic area head and clinical research vice president Francis Plat said the study data showed that the addition of Vorapaxar to standard of care, including aspirin, provided an additional reduction in risk.
Vorapaxar has now been evaluated in two major clinical outcomes studies: TRA-2P TIMI 50 and Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER).
Image: Merck KGaA's Headquarters in Darmstadt, Germany. Photo: Armin Kübelbeck.