This news out of ACC 2009 [was it really only a year ago, today, that the ACC panel laid waste to Vytorin? Wow!], and in the NEJM, was widely-expected -- there must have been seven separate threads over at CafePharma predicting this -- but now it is official: Schering's Early ACS trial has missed both the primary and secondary endpoints.
If/when the Merck merger transaction goes through, this bad ACS outcome might actually be transformed into a mild positive -- if Merck uses it as an contra-example -- and has the discipline to allocate resources away from these sorts of studies. But then again, there is this -- so Early ACS may well remain a[nother] Hassan-inflicted black-eye -- from the study press release, today:
. . . .Significantly higher rates of bleeding were observed in the study group, with 118 patients experiencing a TIMI major bleeding event, compared to 83 in the delayed provisional group (p=0.015). Investigators reported a 7.6 percent vs. 5.1 percent rate of moderate or severe bleeding (p<0.001) in the study group as compared to the delayed provisional group, as measured by the GUSTO scale. Red blood cell transfusions occurred in 8.6 percent of patients in the study group vs. 6.7 percent of patients in the delayed provisional group (p=0.001). There were no significant differences in mortality or any serious adverse events between the two groups. . . .
It increases bleeding -- not. a. good. thing. There really is no way to paint a happy face on that data.
No comments:
Post a Comment