information we had regarding the increased CPKs and the most information we could
find in connection was those subjects who were discontinued because of increased CPKs.
Those were subjects that had narratives. From those narratives that we reviewed, these
did not appear to be cardiac events. I don't have a full listing of them, but in general,
again they were random CPK elevations associated with exercise, associated with
possible Statin use, but again, there was no suggestion that these were cardiac events.
events of increased CPK, the information was fairly limited. Another thing to point
out was these CPK elevations in general were not serious adverse events; again, giving us
limited information. In general, these were elevated CPKs found on study visits in which
blood was drawn and the increased CPKs were found and reported to be an adverse event
by these individual investigators.
question that was asked before regarding how many of the subjects in general in this
development program were on Statins, I'm not sure if the Sponsor yet has that
information, but for instance, in the monotherapy studies, I can say at least study 11, I
believe about a third of patients were on cholesterol medications with the use of Statins
was about 8%, anywhere from 7% to 10%. So again overall, fairly low, but I don’t have
that exact information about how many of those increased CPKs were associated with
Statin use. They were certainly not all of them.
Given all those constraints, we did recently take a look at whatever
DR. BURMAN: Thank you. The Sponsor had a comment?
DR. LOWRY: I don’t have the exact information. In regards to the
DR. BURMAN: One more question on that if I might, do you have any
idea what percentage of these people who had elevated CPKs were on Statins?
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