Even if, as the IMPROVE-IT PI now rather rosily posits, the study will reach 5,000 events by June 2013, it will -- he admits -- likely show only a small incremental effect, if one is seen at all. We also know it very well may take more than six months to publish, once the study has ended. So, we are still at a 2014 date -- before we know anything, really. "No news here; move along, people" (except that the study's PI is now accepting the probability of this longer timeline).
Remember -- all of this assumes that all goes perfectly from here forward. If the past has shown us anything, it is that nothing has been perfect, on any study involving Vytorin's non-statin ingredient. Any hiccup could push this into 2015, or beyond.
I still think Drs. Kastelein, Bots and Nissen have the better part of this argument. I think it likely this study is never completed (or completed very near the date of patent expiry on the combo-pill), thus (from TheHeart.org):
. . . .In a recent editorial accompanying the Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6: HDL and LDL Treatment Strategies in Atherosclerosis (ARBITER 6-HALTS) study, Drs John Kastelein (Academic Medical Center, Amsterdam, the Netherlands) and Michel Bots (University Medical Center, Utrecht, the Netherlands) raised concerns about whether IMPROVE-IT would ever reach completion. Similarly, Dr Steven Nissen (Cleveland Clinic, OH) questioned whether the trial would be completed because more than 5,000 hard clinical end points are needed for the study to reach statistical significance, an unusually high number given that past studies required a few hundred events.
According to the IMPROVE-IT investigators, 18,000 patients will be enrolled in the clinical-outcomes study by June 2010. . . .
Um, here's to hopin', anyway. On March 10, 2010, they were still 1,000 short.
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