February 10, 2009
Amy Tenderich of DiabetesMine.com
Amylin Pharmaceuticals is working on something they’re hailing as a potential miracle drug: the first-ever once-weekly diabetes treatment that’s guaranteed to bring down your blood sugar levels and help you lose weight and keep it off. It certainly sounds amazing, no?
The drug is a new “extended” version of exenatide (commercial name: Byetta, an injectable used to treat Type 2 diabetes) that will be submitted for FDA approval by the end of 2009. It belongs to a class of drugs called GLP-1s, gut hormones that lower glucose levels by increasing insulin secretion from the pancreas and suppressing the release of glucagon (glucose in the bloodstream). It also curbs your appetite by slowing gastric emptying.
In studies, patients testing the new long-acting drug achieved an AVERAGE of a two percentage-point drop in their A1C (measure of glucose levels over the last three months), and also lost an average of 9.5 pounds and kept the weight off for at least six months, Amylin reports. That kind of impact is extraordinary, to be sure
The company is positioning this new once-weekly as the “missing link” in diabetes care due to the killer combination of these unprecedented results, and the fact that it will be so easy to use that patients can and will more consistently stick to their treatment regimen.
They say it can also be safely combined with metformin and other oral drugs, and they’ll be studying its efficacy against these drugs and also against insulin itself in the next few years.
At a recent healthcare investor’s conference in San Francisco, where I learned about the drug, Amylin was even quoting prominent physicians as saying this drug – when it’s ready for market – will create an entirely “new class of treatment for Type 2 diabetes.”
Wow! I hope they are right. We hear about potential miracle meds all the time, so it’s wise to take this news with a grain of salt as well. As always, there are some good reasons for optimism and pessimism alike:
A bit about Byetta:
The current version of Byetta is administered in an injection pen with a tiny needle twice daily, usually before the first and last meal of the day. Because of its effectiveness with glucose control and weight loss, Byetta has quickly become one of the most widely prescribed diabetes treatments in the US.
However, its main side effect is nausea and other gastrointestinal discomfort, so it’s not meant for people who already have problems in that area. Also, there was a recent safety scare when several patients using the drug showed up with acute pancreatitis, including several deaths. But the FDA has continued to sanction the drug since no definite causal relationship has been established.
FDA hurdles:
One potential roadblock is tightening FDA regulations for approval of all new diabetes drugs. After the evidence that a controversial drug called Avandia may significantly increase patients’ risk of heart attack, the FDA is cracking down with stringent new research requirements. Some folks are worried that this may slow down approvals of new diabetes drugs “to the pace of molasses.”
Let’s hope they can strike a balance between safety and progress towards innovative new treatments. Because according to experts like diabetes researcher Andre J. Scheen, MD, PhD, of Belgium's University of Liege, the once-weekly version of exenatide will provide better blood sugar control and reduced nausea. “This new strategy might substantially change the management of Type 2 diabetes," he writes.
| From | Comment |
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Jocelyn |
March 12, 2009 8:21 PM I read the article about this drug in the current Diabetic Living magazine. I took notes and will speak with my primary care provider next appointment. The Metformin initially helped me begin to lose weight, but not working so much now...I am cautious about taking drugs... so reading others experience is helpful... |
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Birdy |
February 28, 2009 11:38 PM I have been taking Byetta (10) for approximately nine months now and have lost about 40 lbs, although the weight loss has slowed down considerably in the last couple of months. I take it along with Metformin and it really does lower my blood sugar so I find it a wonderful diabetic aid for me. It will help even more if it is only a once week injection rather than the twice a day! |
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MMoore42 |
February 27, 2009 7:07 AM I wonder how well this drug is really going to work??? Also what are the side effects going to be?? |
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2catty |
February 24, 2009 5:47 AM I get sick off of it all the time but I still don't lose weight. If I throw up then I just wind up having to deal with low blood sugar then I eat everything not nailed down and then wind up with high blood sugar all over again. |
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Beany |
February 24, 2009 4:51 AM I was excited also when I first started byetta. All went well for a couple of months. Then I became extremly constapated to the point I was passing blood. Could'nt figure out why. Finally ended up at a specialist and had to do a colonoscipy only to find out I spent many miserable days and a lot of money over a shot of byetta that was causeing all my problems and keeping me sick everytime I used it. It deffinately wasn't worth looseing a few pounds. I've also had a friend who has tried it and it eventually cause so much stomach upset that she too has had to go off it. I dont believe this is a good drug to use at all when you hear how many people that is sick from it. Obviously if your sick all the time your going to loose weight but is it worth it? From what I have heard it happens slowly so you think at first you've found the perfect thing. Becareful and dont get to excited about it and not realize how sick you get before you give it up. |