Monday, May 20, 2013

Living Longer with Byetta

By David Mendosa, Health Guide Sunday, August 10, 2008

The diabetes drug Byetta can help us control our blood glucose and lose weight. That's huge -- and just the beginning of the story.

Full disclosure: I own 100 shares of stock in Amylin, the company that developed Byetta.

About a year ago, after the Scientific Sessions of the American Diabetes Association in Chicago, I reported here how Byetta can reduce our risk of heart attacks and strokes. These are the most common and deadly complications of diabetes.

Now a study presented at the ADA's recent Scientific Sessions in San Francisco indicates that the reduced risk to our hearts may lead to previously unheard of benefits. Taking Byetta can lower our chance of dying compared with other diabetes drugs. The Times says that the chance of dying while taking Byetta is about 75 percent lower than on the other drugs.

While I attended these Scientific Sessions, I admit that I missed the big news then. But so did almost everyone else. It wasn't until The New York Times broke the story last Tuesday that it attracted public notice.

Other than The Times, the story doesn't seem to be in print. Times reporter Alex Berenson picked it up in an oral presentation at the ADA on the ACCORD study.

The presentation was a big and pleasant surprise to Amylin and to Eli Lilly, which markets Byetta for Amylin. "I was sitting in the audience, and my jaw just dropped," Dr. James Malone of Lily told The Times.

ACCORD stands for Action to Control Cardiovascular Risk in Diabetes. The New England Journal of Medicine online. But nowhere does it include the report on reduced death risk teased out by the drug that the study participants took.

This study included people with diabetes taking all the major classes of diabetes drugs. Some used insulin, others used the sulfonylureas, metformin, the thiazolidinediones, and a few were on Byetta. Only 826 of the 10,251 people in the trial were on Byetta.

That's a small subset, and the people taking Byetta could be different in some important ways from the others in the trial. For example, they could have been healthier from the start.

"We don't know whether it's the drug or the healthy participants," Dr. Michael Miller told The Times. He is a professor of biostatistics at Wake Forest University and the study's lead statistician.

The big question now is how and when Amylin and Lilly will try to confirm the exciting finding of Byetta's reduced risk of death. But the companies may never do the studies on Byetta itself, because they are looking forward to the once-weekly version, called exenatide LAR. They hope to have that version of the drug on the market next year. Since it promises to be an even greater success than Byetta with those of us who have diabetes, my guess is that Amylin and Lilly will do the life-extension testing on the once-weekly version.

Byetta would have been an even greater success if there were not some concern about pancreatitis and the fears of nausea. The Times article mentioned these issues, and people with diabetes are concerned about them. So I raised them with Dr. Joe Prendergast, an endocrinologist in Palo Alto, California, who has prescribed Byetta to hundreds of his patients ever since it first became available in Byetta's clinical trials.

By David Mendosa, Health Guide— Last Modified: 06/14/12, First Published: 08/10/08