The mean age of the patients in the SHARP trial was 61 years; they did not have a history of MI or coronary revascularization.
The six panelists who voted in favor of approval for patient not yet on dialysis and those on dialysis included Dr. William Hiatt, professor of medicine, division of cardiology, at the University of Colorado, Denver, voted in favor of approval for both populations, based on the overall trial results. The differences between the two populations could be explained in the Vytorin label, and "the consistency between the vascular and atherosclerotic events led me to believe that the overall trial had integrity and the various components of the primary outcome were relatively consistent," he said. "To deny an indication to extend to patients who are on chronic hemodialysis ... would not respect the totality of the data," he added.
Dr. Lawrence Hunsicker, professor of medicine in the nephrology division, and emeritus medical director of organ transplantation, University of Iowa, Iowa City, also voted in favor of approval for both groups, but added that the FDA should ensure that advertising and detailing of the product should reflect that "the data are far more clear for patients not on dialysis."
The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of disclosures, although in some cases, they are given a waiver-but not at this meeting.