More Byetta News

A press release from Eli Lilly was released concerning Byetta LA.

This announcement was carried by Diabetes In Control.

We are increasingly pleased with our ability to control nausea with the twice a day Byetta and what we read about the new product seems to have better news.

Those individuals in our office who had testing to see if Byetta would work for them may have stopped Byetta use due to nausea. This positive report gives reason to consider Byetta LA or even retry the twice a day Byetta as we use new nausea prevention therapy.

Most patients who have nausea have underlying Autonomic Neuropathy but are unaware of it. I will discuss this soon but for now you could look it up on Wikipedia to get an understanding of what Autonomic Neuropathy is about and the symptoms that accompany the disorder.

http://www.google.com/search?q=Autonomic+Neuropathy&btnGNS=Search+wikipedia.org&oi=navquery_searchbox&sa=X&as_sitesearch=wikipedia.org&hl=en

Autonomic Neuropathy has been noted to occur in 50% of people with diabetes 1 or 2 but we have also seen it in a high percentage that have Metabolic Syndrome. Those individuals with Autonomic Neuropathy have a higher chance of having nausea.

The good news is we can reverse the autonomic neuropathy for most people in about 3 months and then diminish the treatment medications. So far there seems to be little chance of recurrent autonomic neuropathy.

Today my biggest concern is for those who have Metabolic Syndrome alone. This may be the precursor of diabetes, cardiovascular disease or Alzheimer’s Syndrome. Formerly these were thought to come from different sources and I believe this is still true. However there is a trigger for these disorders and the increased activity of the Metabolic Syndrome may just be that trigger. That “Brown fat” that is associated with the metabolic Syndrome is still growing around your waist and it is very resistant to diet alone.

Diabetes In Control, the same issue in the link above, reveals research on new drug that delays the progression of diabetes 1. For Diabetes 2 and Metabolic Syndrome, Byetta LA will surpass the very good control with twice a day injections. We are ever broadening all targets with these tools so now we can even use them for weight loss alone. Our patients have literally lost tons of weight.

It’s time to learn about where you fit in all these problems so that you can take charge of your health, own your health and discard all the thoughts that you have no control over these disorders that have you in their grip. It’s your time.

Dr Joe

All About Byetta

Endocrine Metabolic Medical Center will again be hosting a class on “all about Byetta”.

It will be on Thursday, December 17, 2009 10:00 AM to 11:30 AM. Please contact the office to RSVP.

Since it will involve a number of people who are thinking about Byetta as well as those who are long on Byetta, many are looking to have more perspective on Byetta after they have been using it for as long as two to four years.

We are going to try some new technology then as well. Hope to see you then.

Revisions to Byetta's Drug Label

Below is a piece or information just released about the use of Byetta. This does not mean it causes kidney disease but that some care should be taken when kidney disease is present. We have had several people in this category and have not had any problems.

“Dr. Joe” Prendergast



November 3, 2009

Dear Member:

Yesterday, the Food and Drug Administration (FDA) announced that it had approved drug label revisions for Eventide (Byetta), an approved addition to diet and exercise used to improve glycolic control in adults with type 2 diabetes. The drug label is revised to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

According to the FDA, from April 2005 through October 2008, the agency received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Eventide. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.

The FDA has made the following changes to the drug label:

• Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Eventide should not be used in patients with severe renal impairment (creatinine clearance <30>
• Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Exenatide from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
• Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Exenatide if kidney dysfunction is suspected while using the product.
• Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Exenatide.

Additional information on the revisions to Byetta's drug label, including specific information for physicians and patients, can be found on the FDA website.

New Byetta Class

For those who use, have used or are interested in Byetta, we will have two more educational meetings here in the office. Contact Us to reserve a place in the class.

First will be 10-29-2009, a Thursday 10:00-11:30 AM.

The second will be 12-3-2009, a Thursday 10:00-11:30 AM

There has been increased interest in Byetta due to the scheduled once a week injection Byetta LA in March of next year. This will allow easier start mechanisms, less expensive starting procedures and a dramatic decrease in the nausea. The weight loss is touted to be three times more effective in decreasing weight and twice as effective in growing the cells that produce insulin back into action.

We have been quite successful in all aspects of making Byetta the mainstay of regaining health if you have diabetes. The complications wither in the face of steady Byetta use. The relentless decrease in weight, especially, ultimately, the Brown Fat in the upper abdomen that is the hallmark of the Metabolic Syndrome, is so satisfying.

But so many individuals finished the testing that indicated they could be helped by Byetta then got nausea and perhaps vomiting with their first shot and said “it’s not for me”. We now know that many of these people have autonomic neuropathy that must be cared for first to avoid the nausea. I would invite anyone in this category to return for restart to gain success. We can succeed.

We have now been able to start Byetta on line. This is one of the reasons we have restarted the Internet Care of the metabolic syndrome, type one and type two diabetes.

All this can help you regain control of your body and your life.

It’s your time.

Byetta Class July 28, 2009

The class will be held at Endocrine Metabolic Medical Center at 10am on Tuesday, July 28, 2009. Contact Ashley at (650) 566-9810 or by email to save your place .

Byetta Does Not Cause Pancreatitis

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Byetta Does Not Cause Pancreatitis

Review of the records of deaths from patients who died of pancreatitis seems to have no reason to believe that Byetta plays a role in their deaths.

Remember that the “FDA Amendments Act requires dissemination of safety data, including in cases where causality has not been definitely determined.”

These deaths were all in type 2 patients, a diabetes group that has three times more common incidence of diabetes when compared to the general population. One million patients have taken Byetta which gives a rate of 0.34 events per 1,000 patient years.

The causes of death were as follows.
• Morbid obesity with extensive gallstone disease.
• Patient had stopped taking Byetta some months before the pancreatitis.
• Two patients died of complications of gall bladder surgery.
• One died of recurrent leukemia 2.5 months after recovering from pancreatitis.

David Nathan, Chief of the Diabetes Unit at Massachusetts General Hospital sees any cause is “not clear.”

“I’ve had 550-plus patients on Byetta and not a hint of pancreatitis,” Joseph Prendergast, founder and medical director of the Endocrine Metabolic Medical Center, told BioCentury. “I would think that we must get the information on those people who died, all their previous history, how it was used, and what kind of physician was using it.”

He added: “I don’t consider it to be a problem, and I surely don’t consider it to be related to the drug.”

Kenneth Burman, chief of the endocrine section at Washington Hospital Center, Washington, DC also did not find a reason to attribute pancreatitis to Byetta. The other endocrinologists at his center have not hesitated to use Byetta as before.

BioCentury Vol 16, #39, Pg. A15-16

Once a Week Byetta

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Text Summary
Once-weekly byetta.- Diabetes Care, 2007 June; 30(6): 1487-93

This is the first publication on the new Byetta product given weekly. It was approved by the FDA in early December but will not be released for use in the USA until the summer of 2009.

Beta cell mass is expected to double from the treatment and the weight loss will triple as compared to the present twice a day treatment

Oral communication on the product during the ADA meeting in early February 2008 also added more information that generally a 60 to 70% drop in nausea is expected as well.

How David Mendosa uses Byetta

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Click here to see David Mendosa's book on Amazon.com.

Byetta for Type 1 December 8, 2007

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Dr. Joe refers to an article in Science News

A Byetta Story

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Losing Weight with Diabetes Medication

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Byetta Pancreatitis

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Byetta's First Ad

For all of us who have had wondered when the first ads for Byetta would come and what they cover, look here.

Click here to watch.

I doesn’t say much really but it also suggests that it will out there like all the other diabetic agents. It also suggests that there will be a much expanded use by many physicians.

Interview with John Dodson

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Byetta and Diabetes Complications

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Free Byetta

We have free Byetta coupons for the 5 mcg pen. These are for any of our patients. Come in and pick it up with the Rx if you can use it.

They expire by the end of this month!!!!!!!!!!!!!!!!!!!

Byetta and Insulin Relase

Exenatide, with the trade name of Byetta, has been a useful addition to treatment options for type 2 diabetes. It is particularly useful in regulating after meal glucose. Diabet Med 2006 3;23(3):240-5

Since the timing of insulin dosing in relation to a meal is critical to such glucose regulation it is important to know the optimal time of Byetta administration. This research is an observation that the insulin values are markedly increased if the Byetta is given after meal as compared to Byetta given within an hour before a meal. Could the optimal time to give byetta be after a meal in certain circumstances?

This study provides very reassuring information suggesting that there is a large before meal window during which the drug can be administered.

Further research is warranted to understand the mechanisms underlying and the implications of the exaggerated insulin rise if the drug is administered after a meal.

Insulin Resistance in Children

This is a very informative paper relating to children early in life already manifesting early cardiovascular and diabetes 2 risk. This study evaluated age 13 year old patients’ risk factors. Their level of insulin resistance was then measured. They initially were evaluated at mean age of 13 then follow up at 15, and 19 years of age. Hypertension 2006 10;48(4):730-6

3 risk factors and the clustering of the factors associated with fasting insulin were followed. The results on follow-up found that the degree of change of insulin resistance from age 13 to 19 predicted levels of the classic risk factors, i.e. increased systolic blood pressure & serum triglycerides, with lower HDL cholesterol. All of these risk factors clustered with the fasting insulin.

This is the first time childhood insulin resistance were shown to significantly predict future levels of risk factors independent from the effects of weight. The authors felt that this suggested that higher degrees of insulin resistance predict a clustering of risk factors that represented what many call insulin resistance syndrome (dysmetabolic).

This allows early treatments of insulin resistance with traditional medications including Byetta.

Byetta and Autonomic Neuropathy

More Byetta information in response to problems.

Dr. Joe, Now that I am using the 10mcg 3 times a day I am having a constant problem with my hands and feet being extremely cold - there is almost no time of day, other than when I am in hot bath, that they are warm. I am concerned that this is a sign of a circulation problem - is there anything that can be done for this? Should I be concerned about long range impact here? Otherwise it is working great and helping me to my goal!

These symptoms are not from circulation but from the Byetta stimulating the autonomic nervous system. Since you are losing weight, your metabolism wants to "shut down" to prevent heat loss.

The first thing is to make your trunk warm. Sweater, jacket, long John's and the like. Secondly wear a hat. Lastly gloves.

This is normal.

Nausea and Byetta

I will be sending out a regular email concerning the use of Byetta for type 1 and 2 diabetes. I have observed many people dropping out for various reasons that could have been circumvented with a suggestion or two.

Nausea is one of the first things that people find incompatible with living with Byetta. Although it is frequently gone after a month, it will persist in 4% of patients. This is what we suggest.
1. Ginger in all forms, not sugar free, a short while before the shot.
2. Coca-cola

If the nausea persists, we use phenergan 25 mg pills for use in anticipation of problems.

It that does not work we retreat on the dosage of Byetta. That might be going back to the 5 mcg twice a day or switch to whatever dose given usually to only at bedtime.

Most of these things work and then we would just go slowly for a month or longer before we even think of raising the dose. It just takes longer to get to goal. Don’t even think it’s not possible to get there.

If you have dropped out, we are waiting to help you reach your goal. It’s your time.