address, basically. The upper limit of the confidence interval, you know, tells you how
bad it could be and so I think, you know, these results do rule out significant harm at
least, you know, if you look at the, the more specific the cardiovascular event, I think
these confidence intervals do rule out, you know, much harm at all. If there is any harm
it would have to be very small in this population.
impossible question to answer, but from a statistical standpoint what’s the likelihood,
given the data that we have, that we are missing a significant event of higher cardiac
events at a larger population, even if it’s the same population?
CAS study, which was brought up before with the 1C antiarrhythmic agents, there is
actually molecular basis for the harm that we have seen there and it’s not Torsade, which
is class 1A sodium blockage. It’s 1C, where in an ischemic population where you
provide potent sodium blockade and conduction block, when the ischemia occurs you
shorten refractory periods, therefore you engage re-entrance cycle in the circuit.
even in that case will be very difficult to figure out whether the treatment effect is
different in that group than in the group without cardiac disease.
DR. BURMAN: From a statistical standpoint, correct.
DR. PROSCHAN: Well, I mean that’s what the confidence intervals
DR. BURMAN: Thank you. Dr. Veltri.
DR. VELTRI: I just want to make a short comment and that is, with the
So in CAS, I think in the ischemic population as opposed to non-ischemic
population, there is a molecular basis for that. I think in this particular arena, I don’t see
DR. BURMAN: Thank you. Let me ask you, I know this is probably an
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DR. PROSCHAN: So you are saying, what, how likely is it that what we
are seeing is misleading?