So, with about 17,000 of the anticipated 18,000 patients enrolled in IMPROVE-IT, Merck just announced that -- at approximately the half-way point -- the independent safety panel reviewing the study has green-lighted a continuation of the study. [It is still not entirely clear that IMPROVE-IT will ever reach the ultimate end-point -- a pre-specified number of cardiac events, though.]
Stripped of all else, all this tells us is that the panel did not see a statistically-significant increase in heart-attack risk, or certain cancers, in the treatment arm of the study -- those patients being given Vytorin®.
It also means that the panel did not see such a compelling benefit from Vytorin, that it would be ethically bound to stop the study and recommend that the other arms of the study be given Vytorin. So, other than confirming that the study will not likely be reported out before the end of 2013, there is scant news here. But here is Merck's release -- just the same:
. . . .Merck today said that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT study has performed a pre-specified interim analysis of efficacy data and also reviewed safety data from the IMPROVE-IT trial and has approved continuing the study. The interim efficacy analysis was conducted by the DSMB after the trial had reached approximately fifty percent of the 5,250 pre-specified clinical endpoints called for in the study design. Merck remains blinded to the actual results of the interim analysis and other IMPROVE-IT data.
In addition, Merck also said that nearly 17,000 patients worldwide have been successfully enrolled in the ongoing IMPROVE-IT clinical trial. . . .
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