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Byetta May Extend Lives

Posted: Friday, August 15, 2008

According to the results of a major clinical trial, patients who took Byetta had a much lower chance of dying, about 75 percent lower, than those who took any other drug.

The results come from the ACCORD trial. The finding, presented in June, has generated a stir among diabetes researchers, although so far it has attracted little public notice. Neither Eli Lilly or Amylin, the companies that jointly market Byetta, are publicizing the findings, in part because no one is sure whether the reduction in the death rate is real or a chance finding. Only about 825 patients in the 10,000-patient Accord trial took Byetta, and those who did were likelier to be healthier than other patients.

"We don�t know whether it's the drug or the healthy participant," said Dr. Michael Miller, professor of biostatistics at Wake Forest University and the lead statistician on the Accord trial.

The trial's finding came as a surprise even to Lilly and Amylin, said Dr. James Malone, the global medical director of Byetta for Lilly.

"We were not aware of the results before they were presented at A.D.A., and I was sitting in the audience and my jaw just dropped," Dr. Malone said. The trials that Lilly and Amylin have conducted on Byetta, have not shown a reduction in mortality in patients taking the medicine, but they were not designed to do so.

For the Accord finding to be proven, it must be tested in a large trial that would compare the cardiac health and overall death rates of thousands of patients, half receiving Byetta and half receiving a placebo. So far, Lilly and Amylin have not committed to undertaking such a trial, which would take years and cost tens of millions of dollars.

Further complicating the issue is the fact that the two companies are working a reformulated version of Byetta, which could be injected once-weekly instead of twice-daily, and they might prefer to run the trial on the new medicine, which has not yet been approved by the Food and Drug Administration.

Dr. Malone said the two companies hoped to make a decision on conducting a large mortality trial by the end of the year.

Even so, the finding adds to an emerging body of evidence that Byetta the first in a new class of diabetes medicines called incretin mimetics may work better than other diabetes medicines, at least for people who can tolerate its side effects, which can include severe nausea.

"My suspicion is that when you look at the determinants of mortality, which were weight gain and hypoglycemia in that study, Byetta would be the anti-mortality drug, because it's associated with weight loss and less hypoglycemia," said Dr. Alan Garber, an endocrinologist and professor of medicine at Baylor University. In addition, animal trials offer some evidence that Byetta may directly benefit the heart, Dr. Malone said.

Source: Diabetes In Control