DISCUSSION AND QUESTIONS
TO THE COMMITTEE
inhibitor use, angiotensin receptor blocker use, beta-blockers, and calcium channel
blocker is presented on this slide. We, at the present time, don’t have information on
nonsteroidals but we can address the questions about ACE inhibitors and beta-blockers.
meeting. Although this portion is open to public observers, public attendees may not
participate except at the specific request of the panel. In terms of overall agenda it’s
approximately 1:30, that will give us 30-35 minutes or so for each of the four questions
and I know that there is some overlap between each of the questions. Then we will end
that and then go to specific discussion of the voting issues and then vote. Let me read the
first questions and open it up for discussion.
which had been discussed. I am particularly interested in things like potentially
chronic Non-steroidal anti-inflammatory use, which may obviously increase, or such
things as, what was the percent of patients in groups that took Aspirin, Beta blockers,
ACE inhibitors, etc. that might alter cardiovascular events rates.
on that slide? Let me open further any comments by the committee to the FDA or the
Sponsor before we move on to discussion of the specific questions.
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DR. BURMAN: We will now begin the panel discussion portion of the
DR. WOLF: Could you please project slide 3-99. The frequency of ACE
DR. BURMAN: Thank you. Does anybody have any specific questions
Seeing none, then we shall move on.