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12:00 AM
 | 
Feb 11, 2008
 |  BioCentury  |  Product Development

Too low, too fast?

Contradictory data were reported last week from two similar studies seeking to reduce blood sugar in Type II diabetes patients to levels more like those seen in non-diabetics. In one study, the intensive glycemic arm was stopped because of a higher rate of deaths than that seen in patients receiving standard treatment. In the other study, intensive glycemic reduction resulted in significantly fewer deaths than standard therapy.

Because of the discordant results, it isn't possible to conclude that lowering HbA1c in Type II diabetics to levels approaching those of normal individuals is to blame for the higher death rate in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study. Indeed, in both trials, mortality rates in both the intensive and conventional treatment arms were well below the expected rate of 5% in a Type II diabetes population with a high risk for heart disease.

One possible explanation, according to Oluf Pedersen, professor of medicine at the Steno Diabetes Center and principal investigator of the Steno-2 study, is the way in which the glycemic target was pursued. Another possibility is that patients in ACCORD were older and sicker.

The intensive treatment arm in the larger study, ACCORD, was halted on Wednesday after a DSMB observed a 20% increase in mortality compared with the conventional therapy group over an average of almost four years of treatment. There were more total all-cause deaths in the intensive treatment group (257) than in the conventional treatment group (203): the number of observed deaths per 1,000 individuals per year was 1.4%...

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