New Type 2 Drugs Januvia and Byetta Offer Big Benefits

Charlie Fletcher is a freelance medical writer who lives and works with his wife and children in Spokane, Wash.

BYETTA is an injectable medicine and comes in a prefilled pen with simple, fixed dosing for all patients.

| May 3, 2007

The 21st century may be remembered as the time when diabetes became a worldwide epidemic. However, it may also be known as the time when the disease was cured.

Currently, new type 2 diabetes treatments are coming to market every six to nine months. With so many new treatment options on the market, things are quickly getting quite confused. How should a diabetes patient evaluate which therapy is best? Endocrinologists suggest a cautious approach. “We’ve got some good agents already on the market. So whatever you’re starting needs to have more benefit than anything that’s currently available,” says Athena Philis-Tsimikas, MD, executive director of the Whittier Institute for Diabetes, of San Diego, Calif. The institute is a subsidiary of Scripps Health.

“I’ll be the first to admit that I’m relatively conservative about using new drugs,” says Jonathan R. Anolik, MD, chief of the endocrinology section at Virtua Memorial Hospital, in Mt. Holly, N.J. “When you have an old drug that has good tolerability, works well, and has good outcomes data associated with it, then it makes sense to use an old drug before a new drug.”

The biggest disadvantage to the new treatments is their cost. All of the new drugs coming to market are entering at a premium price point. “Insurance companies can be charging anywhere from $20 to $40 per prescription in co-payments,” says Tsimikas. “But the costs of the actual agents to the insurance plan are large as well, and those costs will eventually get transferred to the patients. There’s no getting around that. It might not be a direct cost, but it will eventually contribute to what the health plan charges.”

Nevertheless, a great many endocrinologists are finding that the benefits of diabetes treatments that have come to market in the past few years are worth evaluating.

Byetta: The New Gold Standard?

For the type 2 diabetic, the most important new drug to come to market is very likely Byetta (exenatide), which is manufactured and marketed by Eli Lilly & Co. and Amylin Pharmaceuticals Inc. Byetta is the first entrant into the market of a new type of drug called an incretin mimetic. Approved for market by the U.S. Food and Drug Administration in April, 2005, Byetta is a synthetic hormone that lowers blood sugar and, in many cases, also causes patients to lose weight.

It is this combination of blood sugar control and weight loss that has made quite a few endocrinologists consider Byetta to be the new gold standard of type 2 treatment. “Byetta improves blood glucose and does not have hypoglycemia associated with it,” says Tsimikas. “It causes weight loss instead of weight gain. It’s not even weight neutral.”

However, the new drug is not without its limitations. Not only is it necessary to inject Byetta twice daily, but it can also cause nausea when patients first begin using it. “I think Byetta is the most significant of the new drugs,” says Leann Olansky, MD, a clinical endocrinologist at the Cleveland Clinic, in Cleveland, Ohio. “But it’s not very convenient, because it has to be injected twice a day.”

A long-acting version of the drug that would only require injections once a week is currently being evaluated and may be available in 2008. In fact, some specialists think the long-acting version may work better than the twice-daily formulation because it will sustain a more consistent level of the drug in the blood throughout the day.

Januvia Provides Oral Blood Sugar Control But No Weight Loss

On the other hand, another drug recently debuted that is neither injected nor prone to cause nausea. Januvia (sitagliptin) is a new oral, anti-diabetic drug that is manufactured and marketed by Merck & Co. Inc. It received FDA market clearance in October 2006 and is also widely available internationally. Januvia is the first of a new class of drugs called dipeptidyl peptidase-4 inhibitors, or DPP-4s. “Januvia seems to have very little if any side effects,” said Olansky. “It’s a pill that you take once a day. You don’t have to think about it.”

In some ways, Januvia’s mode of action is a little bit like Byetta, but instead of adding a hormone to the bloodstream, it blocks the breakdown of that hormone. The result is that, like Byetta, Januvia helps to control the blood sugar. However, it does not cause a patient to lose weight. In some cases, Januvia may be an attractive alternative for recently diagnosed diabetics who would otherwise receive a sulfonylurea. “Theoretically, Januvia would be a much better choice than the sulfonylurea agents that we currently use because it doesn’t cause hypoglycemia, whereas sulfonylureas can,” says Tsimikas.

Byetta is typically prescribed for patients who have already failed to obtain effective blood sugar control on at least one or two other oral diabetes drugs. However, some specialists prescribe the drug earlier, especially when weight loss is important. It is usually given in combination with other oral diabetes medications, or even with insulin, in some cases.

Januvia is indicated for use earlier. However, some specialists say that newly diagnosed patients have had difficulty getting the drug covered by their insurance. “Even though the FDA approved Januvia to be used as initial therapy in a brand new diabetic, the insurers are not anxious to pay for that,” says Olansky. “They want people to be on at least one other oral agent and to add Januvia if the one agent is not controlling them sufficiently.”

In March, the FDA approved another Merck drug, called Janumet, which is a combination of Januvia and metformin in one pill. Specialists say the new formulation could be more convenient for patients needing to add Januvia to their existing metformin prescription because only one co-payment would be necessary to fill the prescriptions. However, unlike Januvia, which is taken once a day, Janumet is taken twice daily.

The future of diabetes treatment has many in the endocrinology community optimistic about the future. However, the best treatment option continues to be avoiding diabetes onset through diet and exercise. “It’s exciting that we have all these new medications that allow us to control the blood sugars in effective ways without the weight gain or hypoglycemia,” says Tsimikas. “But what would be more exciting would be to get the message across that lifestyle changes and other methods of weight control and dietary habits are what we need for the long term.”

Sources:
Athena Philis-Tsimikas, MD, Whittier Institute for Diabetes
Jonathan R. Anolik, MD, Endocrine Associates of South Jersey
Leann Olansky, MD, Cleveland Clinic

 

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Categories: Blood Glucose, Blood Sugar, Byetta, Diabetes, Diabetes, Food, Insulin, Januvia, Losing weight, Low Blood Sugar, Type 2 Issues, Type 2 Medications, Weight Loss


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Comments

Posted by Anonymous on 14 November 2007

Does anyone know where you can obtain a carry case for the Byetta pen?

Posted by Anonymous on 19 November 2007

I've been on Novalog 70/30 for over a year now. I feel like I have too much insulin running around. My doctor said if I had too much insulin I would have hypoglycemia. I know what he is saying is true to a point, but with insulin resistance being my problem, wouldn't switching to Januvia with less insulin be better for me?

Posted by Anonymous on 12 December 2007

Byetta gave me diarrhea and terrible stomach cramps and had to stop it.

Posted by Anonymous on 11 January 2008

I've been on Byetta for over a year and I just can't take the nausea and vomiting any more. I lost about 40 pounds but at what price? My employer is getting on my case because I had to miss work or go home early because I was so sick all the time.

Posted by Anonymous on 3 March 2008

I had a allergic reaction to using Byetta!

Posted by Anonymous on 15 September 2008

I've been on Byetta for about 9 months - lost 15 lbs and have better control. Recently though i have had three "episodes" of severe stomach pain, nausea, vomiting a,d dry heaving. I'm seeing my doctor in 2 days and I have taken MYSELF off of Byetta.

Posted by David D. Galbraith on 10 June 2009

June 10th, 2009 I tried Byetta. It gave me severe acid reflux, which caused an infection in my esophagus that took two regiments of powerful antibiotics to get rid of. I already did not like the fact that It was injectable, but I decided to try it because I needed to lose weight. Byetta makes you lose weigh , by making you sick to your stomach. Another diabetic told me that it gives him diarrhea. Either way, it is a real crappy way to lose weight. I would have been better off with an amphetamine, which doctors don't seem to mind giving to 6 year old children, in large dosages, for years until they are in college, but are reluctant to give to over weight Diabetics that may die or go blind or have heart attacks or loose parts. I am damned mad about this. In order to get an amphetamine that I need to save my life, I would need to break the law, and risk imprisonment. I want to know why, and don't tell me they don't work or that they are dangerous because I know better. What I fear are the medications I am taking now that have all kinds of side effects. Why is it that most Diabetic medicines cause drowsiness and weight gain?!!! Isn't this diametrically opposed to the goals for treating diabetes. Or is this just a way to sell more pharmaceuticals and healthcare later on down the road after a heart attack or an amputation or what ever. My treatment for diabetes is an outrage. My doctors are treating symptoms rather than the cause of my diabetes, and are making me worse, rather than making me better. I have gained over 40 lbs. in the last year and a half and my ankles and now my legs are swelling with water weight, all symptoms of the diabetic drugs I take. Especially the Actos, which the FDA warns us about. I take 5 diabetic drugs and Lipitor and Zestril, plus synthroid because I have Graves disease. No test have been done to tell what any two of these drugs will do in combination, let alone the combination of the eight. I feel sure that if I could take amphetamine that I could lose weight, be more active and ween myself off of most of these drugs that will only kill me in the long run. I have read that over 70% of people that have diabetes and had stomach operations that restrict their eating are free of diabetes symptoms within a week. I see no need for this kind of invasive procedure, in my case, because I can do the same thing with a pill. The benifets far out weigh the risk and the decision should be mine to make. With so many treatment option on the marked and so many more on the way every six to nine months, you just have to wonder. If there wasn't so much money in treating Diabetes, would there be more incentive to cure Diabetes?!!!!! I question the motives of the people making these drugs, the people prescribing these drugs and even the people that write about these drugs, like Diabetes Health. You are not asking the right questions when you investigate and I don't feel informed or inspired. I will find a doctor that will help me, and I will keep you informed on my progress. I hope your interested. I would love to hear from anyone that has any comment, even if you disagree. David

Posted by David D. Galbraith on 11 June 2009

I don't understand why you removed the paragraph structure from my comment. I want it put back. How dare you?!!!!!!!!!!!!!!!!!! This is just an attempt on your part to keep people from reading it. I also see no need for you to remove my full name and my email address when I stated in my letter that I am looking for response from my letter. I take full responsibility for my own actions. If you have a problem contact me. Offended, David D. Galbraith


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