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Biotech / Medical : AMLN (DIABETES DRUGS)

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To: Bhag Karamchandani who wrote (526)	8/19/1997 5:05:00 PM
From: David Bogdanoff	of 2173

Bhag; Good questions. So far as patients using more insulin, this is what amylin is supposed to prevent, I thought. If they continued to use more insulin, which I understand would affect glycated hemoglobin and possibly the other endpoints, the only thing that comes to my mind is to perform a statistical analysis adjusted for amylin usage, to separate out the effects of amylin from those of insulin. This can be difficult to do in practice, in part because detailed daily data are often incomplete in such studies. And such analysis typically assume rather simple biological models which are probably unrealistic and unconvincing. The other problem is also difficult and is found in studies of other chronic diseases, such as emphysema. Typically what is done is to find a number of surrogate endpoints which are thought to respond faster to an efficacious therapy. eg, cd4 counts(MONTHS) in AIDS patients instead of survival time(years). However, for this study it appears that a simple reduction (relative to control) of insulin usage would do the trick. What's puzzling is that insulin usage is reportedly increasing in enough patients to affect the results. David

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