Vorapaxar use linked to reduced heart risks, but increased bleeding risks.

The Wall Street Journal (3/24, Loftus, Winslow, Subscription Publication) reported that while the experimental anticlotting medication vorapaxar may reduce heart risks, it may also increase bleeding risks, according to research presented at the American College of Cardiology meeting and published online in the New England Journal of Medicine.

        The AP (3/24) reported that the study, which included "more than 26,000 patients" in more than 30 countries, "was aimed at preventing repeat heart attacks and strokes in people who had already suffered one."

        Bloomberg News (3/24, Langreth) reported that researchers found that participants who received "vorapaxar along with standard therapy were 13 percent less likely to have another heart attack or die from cardiovascular causes than those on standard treatment." However, "171 more patients on vorapaxar experienced moderate to severe bleeding." Additionally, "the rate of brain bleeding doubled in the vorapaxar group."

        MedPage Today (3/24, Neale) reported, "The advantage for vorapaxar on the primary endpoint was greatest among the patients with a history of MI." Meanwhile, "the increased risk of intracranial hemorrhage that accompanied vorapaxar treatment was magnified in the patients with a history of stroke."

        HeartWire (3/24, Hughes) reported that, when "asked whether he thought this would be sufficient for approval of the drug," lead investigator Dr. David Morrow "said: 'While I can't speak for the FDA, I can say that the overall trial did meet its primary end point; the MI subgroup was a very large one -- close to 18,000 patients, like a trial unto itself; and this was a prespecified group. So we think this result is valid.'"

        The Forbes (3/24, Husten) "CardioBrief" blog reported that the findings from this trial, called "TRA 2P-TIMI 50, were broadly consistent with the TRACER trial (published last November in the New England Journal of Medicine), which tested the same drug in patients with acute coronary syndromes." TRACER data also indicated that "vorapaxar effectively reduced negative outcomes but at the cost of an increase in serious bleeding complications." Reuters (3/24, Pierson, Sherman) also covered the story.