Is This the ACCORD Study’s Silver Lining?

Several months ago researchers suspended work on the landmark ACCORD (Action to Control Cardiovascular Risk in Diabetes) study, which tracked 10,251 type 2s, some of them undergoing very tight control of their blood sugar levels.

The study subjected participants to a rigorous combination of drug therapy, exercise, and cholesterol and blood pressure control to drive their A1c’s down to 6% or below. The expectation was that tight blood sugar control would lower vascular inflammation and, therefore, the risk of heart attack.

But ACCORD’s sponsor, the National Heart, Lung, and Blood Institute, suspended the study when it found that the participants under strict control were dying at a statistically higher rate from cardiovascular problems than participants who were not under tight control.

Now, several months later, it appears that one of the bright spots in the study was the discovery that ACCORD participants who took Byetta during the study had a 75 percent lower chance of dying than patients who were taking other diabetic drugs.

That’s the statistic reported at the recent ADA annual conference in San Francisco by Dr. Michael Miller, the ACCORD trial’s lead statistician and a professor of biostatistics at Wake Forest University in Winston-Salem, North Carolina.

However, said Dr. Miller, the ACCORD participants who were taking Byetta tended to be healthier than other study participants, so their lower mortality rate may have been the result of their better health rather than a consequence of taking Byetta.

Still, Dr. Miller’s remarks surprised the powers that be at Byetta’s co-marketers, Eli Lilly and Amylin. While the drug, which controls the amount and release of glucose in the body, does have beneficial side effects that can boost cardiovascular health, such as weight loss and appetite control, no one has previously claimed any life-extending powers for it.

While Lilly and Amylin are intrigued by the findings, they realize that any study designed to confirm Byetta’s usefulness as a life extender would take years of study involving thousands of participants.

About 250,000 people nationwide take Byetta, which is injected twice daily. Introduced in 2005, the drug now earns about $700 million per year. A once-weekly version is now in Phase 3 trials under FDA oversight.

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