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Intensive and effective but more deaths!

June 14, 2008

ADA: Intensive Diabetes Treatment to Blame for Excess Mortality Risk

And here is the rest of it.The elevated mortality seen among patients with type 2 diabetes in a major trial of intensive glucose management cannot be pegged to either rosiglitazone (Avandia) or hypoglycemia, researchers said here.

Rather, they suggested, it was the multiple-agent treatment and rapid decrease in glycosylated hemoglobin levels to a target 6.5% that increased mortality 22% (1.41% versus 1.14% per year, P=0.04) compared with a standard approach targeting 7% in the ACCORD trial.

The results of ACCORD and two other large, randomized trials of tight glucose control made waves at the American Diabetes Association meeting. (See: ADA: ACCORD Diabetes Trial a Complete Bust)

I believe it is logical that using more drugs for a problem will likely cause problems. The point of intensive control is to decrease deaths. Thus, physicians must balance errors of commission against errors of omission. In fact we always have to consider the consequences of our treatments on the patient (rather on the disease.)

Now Dr. Mintz reads these data in a different way - AACCORD and ADVANCE: Good News for Type 2 diabetes…really.. He says:

All of the reports (linked to above) point out that these studies failed to prove that aggressive treatment makes any difference in heart attacks or strokes, and in the case of ACCORD seemed to (surprisingly) cause more heart attacks. However, they are missing a majorly important finding of both studies. Treating diabetes aggressively is quite effective!

I must disagree with Dr. Mintz. Death is the ultimate poor outcome, and death rates caused investigators to stop the ACCORD study,.

The real question is summed up with the expression - how hard must we squeeze to get the juice? And the hard squeeze does more than produce the juice.

We must focus on patient outcomes, not disease outcomes. The importance of these studies is that they reinforce that message.

Perhaps we should examine each drug to see if it helps patients. Then we should look at specific 2 drug combinations to see what happens. We should work at treating patients, observing patient and disease related outcomes. We should eschew intermediate outcomes, until and unless they are shown to really matter.

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