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initially discussed and considered for approval, but it is important to make sure we have

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in place a follow-up system that if something starts to show up in one of these groups that

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has not been adequately studied, we will find the signal early rather than 10 years from

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now when someone writes a paper like was written about one of the other drug classes a

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few years ago that caused a big furor as to what’s being going on for the last 10 years, the

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answer to which we are still are not entirely sure.

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disease. The progression of diabetes itself with its complication, say the development of

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autonomic neuropathy, probably increases the risk. The use of complex medical

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regimens with multiple drugs that have not been fully studied in the circumstances in

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which they are used, there may very well be some drug interactions that we don’t

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understand.

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mentioned earlier that if they don’t have already established cardiovascular disease, I am

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probably paraphrasing this wrong, their risk of having a coronary event is low. Can you

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comment on why then several major scientific organizations actually view diabetes as

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already a CHD risk? My memory is failing here, if anybody on the panel remembers the

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Statin trial of CARDS, which was in type 2 diabetics, was that a primary prevention

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population? I think it was. I could be wrong. If it was a primary prevention population,

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that is actually a patient population of diabetes where they don’t already have established

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So it isn’t reasonable to try and cover all of these things before a drug gets

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studies in the past year is that cardiovascular complications of diabetes are probably

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more complex than we had previously thought.

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DR. BURMAN: Yes, Dr. Parks.

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DR. PARKS: I actually wanted to ask Dr. Teerlink a question. When you

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There are a variety of things that can increase risk at various stages of the

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