Hi. I am Dr. Anne Peters, and today I am going to talk about long-acting exenatide (Bydureon™; Amylin Pharmaceuticals; San Diego, California). Bydureon is basically short-acting exenatide (also known as Byetta®) that is incorporated into microspheres that make it very long-acting. Therefore, you only have to give it once a week. Bydureon is "once-a-week Byetta." Many things about this drug are very similar to Byetta. Byetta is a GLP-1 agonist. These drugs work like GLP-1 in the body: They improve insulin secretion, they lower blood glucose levels, they lower glucagon levels, and they help patients lose weight.
Bydureon is perhaps even a little more effective than Byetta. You get a somewhat greater reduction in A1c and maybe a slightly greater weight loss. Results, as you well know, vary based on the individual patient, but overall the drug seems to be well tolerated and effective in clinical trials. In terms of side effects, as with all of the GLP-1 agonists, the most common side effects are gastrointestinal, and the most common is nausea. Bydureon causes less nausea than with the shorter-acting Byetta, perhaps because it is much more slowly absorbed and patients get used to it and are able to tolerate the dose. You don't dose-adjust Bydureon; you start out with 2 mg per week, and that is what a patient continues on. They are not changing the dose over time.
In terms of other side effects, there is a black box warning for medullary thyroid carcinoma, because in rodents there is an increase in C-cell tumors, both malignant and benign, with this agent. It is not known if this occurs in humans, but because of the rodent data, there is a black box warning. This drug should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia (MEN) syndrome. There is also a warning about pancreatitis, and as we know from other GLP-1 agonists on the market, pancreatitis has been reported with these agents. We don't know for sure whether these agents cause pancreatitis, but because of these reports, it is in the label and we need to warn patients to look for signs and symptoms of pancreatitis. If they develop them, they need to come to medical attention to be diagnosed and treated appropriately.
Otherwise, most of the warnings and indications are similar to what you are used to, although this drug has an interesting indication: It can be used as monotherapy (but not as first-line monotherapy), which basically means that after diet and exercise are not effective, patients are started on metformin. If metformin isn't tolerated, then they can take Bydureon as a second-line monotherapy. It is also approved for use with other oral agents with sulfonylurea agents, thiazolidinediones, and metformin, but it is not currently approved for use with insulin or in children.
To get to the practical nitty-gritty, I am going to show you a picture of what a vial looks like. This is a 2-mg vial, and patients will use one of these weekly. As you can see, patients have to reconstitute this drug and they need to reconstitute it just before they use it. They cannot reconstitute in advance and then give later.
Bydureon will come in a box. This is the box, and in this box is everything the patient needs for reconstituting the agent. There are careful step-by-step instructions that patients are to follow to give this. It is a subcutaneous injection, but in the immediate term, they are going to need to do this preparation to give the drug. The manufacturer is working on a pen that will be much simpler.
From my own perspective, this is a lot like giving glucagon. My patients, at least those on insulin, know how to give glucagon. I am just going to show you how you mix up a glucagon injection, which is a lot like mixing up a Bydureon injection except that there are going to be more careful instructions. There is also an orange connector that connects the two. Inside the Bydureon box will be a syringe that has diluent in it. In essence, the patient will have to inject the diluent into the vial, mix it up, then pull out the solution and pull it back and give the injection. After the first time a patient does this they will find it pretty simple, but it is important to go through this with your patients and then refer them to appropriate resources in case they need to know anything more about giving the drug.
In terms of other practical features, this should be available in pharmacies in February, so pretty quickly patients will be able to use this. In terms of cost, if you just buy it over the counter it is going to cost a little bit more than Byetta and a little bit less than the maximal dose of liraglutide. In terms of formularies, we will see how that plays out. For some formularies, this is just going to be a line extension of Byetta, just a once-a-week form. They may accept it early. Others may take a while, but I am really excited that we now have another drug and perhaps a drug that for some patients will make adherence easier, because this is now just a once-a-week injection as opposed to giving injections more often. This is Dr. Anne Peters for Medscape.
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