ADA: TZD Debate Rages, but What Does It Mean?

(Caption: Diabetes - sometimes all the warning signs are right in front of you)

Type 2 diabetes is fat person diabetes. TZDs are used to treat it.

Safety issues -- especially cardiovascular risks -- continue to dog rosiglitazone (Avandia) and echo in faint whispers that touch its classmate, pioglitazone (Actos). As a result, the question that emerged here at the American Diabetes Association meeting was all-encompassing -- should the thiazolidinedione class continue to be used at all?

The controversy, which has been simmering for three years, heated up in anticipation of next month's FDA advisory committee meeting to consider whether to pull troubled rosiglitazone from the market.

For example, on a single day during the ADA meeting, three unrelated studies released results spanning the range from cardiovascular harm to cardiovascular benefit with rosiglitazone and an unfavorable comparison with pioglitazone.

In an update to his 2007 meta-analysis that first raised concerns, Steven E. Nissen, MD, of the Cleveland Clinic, reported a 28% to 39% relative risk for myocardial infarction (MI) with rosiglitazone (P=0.04) in a 56-trial mega- meta-analysis published online in the Archives of Internal Medicine.

This update supports the "totality of information" against rosiglitazone, Nissen said. But few saw it as a very compelling addition to the debate.

So Much Data, So Little Quality

More meta-analyses aren't going to change any minds or really answer the question, commented John Buse, MD, PhD, of the University of North Carolina in Chapel Hill.

He likened it to a further salvo in an unwinnable war.

At a debate here at the ADA meeting, Nissen said that in this case meta-analyses provided necessary evidence because of the lack of any quality, prospective, randomized clinical trial evidence on hard cardiovascular endpoints with rosiglitazone.

Better not to be a casualty in the "unwinnable war" of medicating for diseases of choice.

Better not to get the disease at all or reverse it without the drugs. (see here - scroll to bottom of page)