Diabetes

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 marketsByetta 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.

Last October I covered the pancreatitis issue here -- as a non-issue. Dr. Prendergast confirms my report.

"With pancreatitis the numbers were seemingly less than seen the general population," Dr. Prendergast told me. "I couldn't see how they could ascribe it to that. It's small enough that it's unlikely to be associated in any way."

Nausea is more real. But I know from my experience on Byetta that nausea isn't inevitable and reported here the many strategies different people use to deal with it.

"If nausea occurs, we do use medications now," Dr. Prendergast says. "We use Phenergan (promethazine), which is an easy drug. It is just an antihistamine with some anti-nausea capabilities. It's maybe 50 years old.

"If there is any nausea at all, we just say to take it just once a day, just before bedtime, because you probably won't be nauseous all night long. Don't do the second shot. I tell them that I don't care if it takes three months or six, we will just hang in there, because we know that everybody gets over the nausea eventually and we want you to as well. We are not going to hurry it."

He says that his patients get the results they want -- lower blood glucose levels and weight loss. "But the most exciting thing is that we see all the complications diminish."

He says that several opthamologists told him about the surprising good results that Byetta had on the retinopathy of their patients. "With that I was emboldened to try it on a gentleman who already had a lot of retinal hemorrhage and was losing his sight. I said, 'Let us try small amounts of Byetta and see what it does.' And the reports started coming back saying that he was stable. All of a sudden after six or nine months his vision was improving."

It reversed his retinopathy? "He's not seeing like when he was 16, but it reversed a little. And we weren't doing anything else except Byetta."

So far we have only preliminary reports on Byetta's benefits for controlling complications. But the evidence of how it might help our hearts, our eyes, and even living longer lives keeps on coming.

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