Byetta and Its Cousins

Byetta was the star of the show at the just concluded 66th Scientific Sessions of the American Diabetes Association in Washington. HealthCentral.com made it possible for me to attend this huge convention and report on it here.

Introduced to the U.S. market just a bit over a year ago, Byetta has taken off faster than any drug in the history of diabetes. That’s Byetta’s biggest problem.

So many people are clamoring for the doctors to put them on Byetta to reduce both their blood glucose and their weight that they can’t keep up with demand. Strangely, neither the manufacturer, Amylin Pharmaceuticals nor its partner in distribution, Eli Lilly and Company, said anything about it at the convention. They haven’t even yet issued a press release about the problem.

But these companies are asking doctors to hold off on prescribing Byetta to new patients so that people like me who already rely on it will continue to be able to get it. The problem is the pen cartridges, not the drug itself. The British company that makes them can’t keep up, according to Jeff Swiatek, who covers Lilly for The Indianapolis Star.

The shortage has driven down Amylin’s stock price, which tells me that some investors are in it strictly for the short term. This speculator mentality doesn’t make me happy, because I own some of Amylin’s stock. But it’s not anything that bothers me because I’m delighted with what it does for me, as I have already written here.

Byetta generated huge excitement among many of the 17,000 to 18,000 people who attended the ADA convention. The biggest presentations there drew crowds of about 1,000 people each on June 10 and June 11 to listen to experts on Byetta and its cousins.

Byetta is the first in its class of a new drug called GLP-1 (glucagon-like peptide-1) analogs. Our bodies release GLP-1, a peptide hormone, to promote insulin release when we eat. It also lowers our levels of glucagon in our blood and makes us feel full, partly because it slows gastric emptying. And at least in animal studies, including poster 446-P presented at the convention, it stimulates the birth of new beta cells, makes more beta cells develop, prevents or slows the death of beta cells, and increases beta cell mass.

The trouble with GLP-1 itself is that it lasts just a couple of minutes. The only way that we could use it is by continuous infusion with a device something like an insulin pump.

On the other hand, Byetta has a half-life of 2 to 4 hours. Besides the Byetta shortage, the biggest problem with it is that it doesn’t cover lunch too well, since you take it only before breakfast and dinner. Its main effect on blood glucose levels is to reduce them after eating, according to presentations I saw, 116-OR and 118-OR.

Byetta’s closest cousin, the long-acting release (LAR) formulation, will overcome these problems and more. It’s not available yet, and we probably won’t be able to get it for a couple of years. But then we will have something that keeps working on one injection for a week while providing around-the-clock coverage.

LAR also reduces fasting blood glucose – the dawn phenomenon — much more than Byetta does, according to the best presentation I saw at the convention. Dr. Michael Nauck from Bad Lauterberg, Germany, like about half of the people at the convention, came from another country. His presentation was so up-to-date that he synthesized his PowerPoint slides on the airplane coming to Washington. Unfortunately, neither Dr. Nauck nor the ADA has yet published his great presentation.

Because LAR works so well, it results in unheard of reductions in blood glucose, according to the most impressive poster I ever saw, 487-P. It reported on a 15-week study showing an average reduction in A1C of about 2 percent among those taking the higher of two trial doses compared with those taking a placebo. That means, for example, that someone who had an unsatisfactory A1C of 9.0 at the beginning of the study would have a good A1C of about 7.0 after less than four months.

People in the LAR study also lost even more weight than in the original Byetta studies. They averaged a weight loss of 8.4 pounds after 15 weeks and seemed not to be plateauing. They also had much less nausea than people on Byetta often experience. No one dropped out of the study because of side effects. The poster presenting this wonderful news is 487-P.

The news about Byetta’s cousin, LAR, was stunning. Of the 63 symposia, 49 oral sessions, and 1,600 posters in the five days of the ADA convention, this got me most excited.

But two other GLP-1 analogs also grabbed the attention of the thousands of people who went to the ADA convention. Within the next week I’ll write here about these more distant cousins.

This article is based on an earlier version of my article published by HealthCentral.