Pexelizumab and the APEX AMI Trial—Reply
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In Reply: The completion of the PRIMO-CABG II trial1-2 at a time when enrollment into the APEX AMI trial was still in progress enabled the steering committee and the trial sponsors to refine their estimates of the probability of detecting a clinically important benefit of pexelizumab on mortality. However, the reduction in sample size that occurred following their reassessment meant that the APEX AMI trial had only a 52% power to detect a 24% reduction in mortality at 30 days.
The APEX AMI investigators indicate that publication bias did not account for the apparent disagreement between the meta-analysis of phase 2 pexelizumab trials3 and the PRIMO-CABG II1-2 and APEX AMI trial results.4 Potential alternative explanations are that the pooled results of the phase 2 studies3 were inflated by the play of chance or that there is still a true benefit of pexelizumab to treat reperfusion injury. The latter explanation could . . . [Full Text of this Article]
John W. Eikelboom, MBBS
eikelbj@mcmaster.ca
Martin O’Donnell, MB
McMaster University
Hamilton, Ontario
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