Friday, October 19, 2007

Unreasonable expectations for new type 2 diabetes drugs

Physiology and clinical epidemiology give us no reason to expect that glycemic control with any drug should prevent heart attacks or strokes (macrovascular benefit). In fact, the most time tested and trusted class of oral agents for type 2 diabetes is associated with macrovascular harm. Had macrovascular benefit been the standard for approval of drugs for type 2 diabetes all along we would now have only two drugs available: metformin and pioglitazone.

Of course all this got started as a result of the Avandia bru-ha-ha. I‘ve ranted about this macrovascular issue here and elsewhere. Here’s an expert who seems to agree, commenting in a recent issue of DOC News:

But as a medical community, do we want to prove that our agents to treat type 2 diabetes improve heart attack and stroke risk before approval?

I think not.


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