Reply
Established Advisor
efpat
Total Posts: 341
Registered on: ‎11-01-2009

Byudereon Approved in US - New once a week version of Byetta

Byudereon has been approved in the US.  See HERE.  It was approved in the UK late last year.

 

This is a once a week version of Byetta.


Some of its advantages -  once a week and you don't have to time the shot to when you eat.  The data used to approve this vesion showed a better lowering of a1c and slightly better wieght loss (althought not much for each drug) than Byetta. 

 

Here is an except from Amylin's press release -

 

In the DURATION-5 head-to-head clinical study, after 24 weeks of treatment, patients taking once-weekly BYDUREON experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking BYETTA. A1C is a measure of average blood sugar over three months.  Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking BYDUREON and 3.0 pounds for patients taking BYETTA (weight loss was a secondary endpoint).The most frequently reported adverse event in both groups was nausea, reported less frequently by BYDUREON users (14 percent) than by BYETTA users (35 percent). Other common treatment-emergent adverse events in the BYDUREON group included diarrhea, upper respiratory tract infection and injection site nodules. There were no major hypoglycemic events.

 

Some disadvantages -  It took Amylin three times to get FDA to approve it.  There were serious concerns over rat studies that showed a risk for thyroid cancer. And there were other risks for pancreatitis and heart disease.

 

See this expert from the press release -


BYDUREON has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of BYDUREON outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of BYDUREON on medullary thyroid cancer and cardiovascular disease.

 

Other disadvantages -  While it is once a week dosage, it is a chemistry kit.  The drug is sold as a premeasured powder that must be mixed in a premeasured vial filled with solution that is then injected.  Many docs may requrie more than the initial visit to make sure the patient can mix and inject correctly.  The needle is also bigger than those used with Byetta, Victoza and insulin pens.

 

A fun trivia fact -  The amount of the actual drug is 2 mg.  Very small.  The powder contains other ingredients as carriers.  What did the geniuses at Amylin decide to use to inject into diabetics???  SUGAR.   I realize the amount is very smaill and it probably does not impact BS levels at alll. But really, did they have to use sugar????

 

And finally - we can't have a thread with mentioning Paula Deen can we?  Some of the articles I read about the approval seculate that the manufacture of Victoza hired Paula Deen now in an attempt to keep their market share in face of the new competition from Byudereon.

 

Complete disclosure - I have tried Byetta and Victoza.  I did it to help lose weight.  It was not succesful.    I don't know yet if I will try Byudereon.  Everyone need to make their own decision. I posted all of this info because the more info everyone has the better. 


Evan
Diagnosed November 2007. A1C - 11.4, A1C since 5.2-6.0. Metformin 1000 2x a day.
Best comment I ever heard from someone with diabetes. - "I take my meds and I cheat every now and then." This was from a 95 year old woman living with type 2 for over 50 years!
Trusted Contributor
morrisolder
Total Posts: 10,278
Registered on: ‎11-28-2009

Re: Byudereon Approved in US - New once a week version of Byetta

Thanks for the summ

ary!

Morris

Diagnosed Type 2, with an A1c of 11.4 in 2003; averaging a 5.0 A1c since then with diet, exercise and Glipizide XL + meds for blood pressure and cholesterol. 
A bit dated, but scroll down on this page if you want to know more ...


Super Advisor
carlking2
Total Posts: 2,578
Registered on: ‎04-08-2011

Re: Byudereon Approved in US - New once a week version of Byetta

While the allure of a once a week shot is appealing... I think I will wait to see how this limited release turns out...Maybe 5 years:smileyhappy:

Thanks Rick

Diagnosed T2 4/4/2011
04/04/2011, A1c 11.2
06/27/2011, A1c 5.6
10/07/2011, A1c 5.7
1/14/2012, A1c 5.4
4/17/2012, A1c 5.4
7/27/2012, A1c 5.3
01/30/2013, A1c 5.2
08/26/2013, A1c 5.3

Lipids TC 201, LDL 108, VLDL 16, Triglycerides 81, HDL 77
Managed by diet and exercise along....former insulin and Metformin user
Visitor
Mnc06002
Total Posts: 4
Registered on: ‎02-06-2012

Re: Byudereon Approved in US - New once a week version of Byetta

Keep in mind the mechanism of weight loss is increasing satiety.  As with any medication claiming to aid in weight loss, you can out eat the med with poor diet and lack of exercise.  This weight loss is usually negated when on another oral antidiabetic or insulin that increases weight gain.  Usual weight loss from medication alone is also very mild, 5-8 lbs.

 

This once weekly version will most likely come with the same risks as victoza including thyroid cancer and pancreatitis.  Risk is probably quite low but it may be a good idea to monitor post approval reports. 

 

Also keep in mind that in general these incretin mimetics only mildly reduce A1C and that they will only work if you actually have an incretin dysfunction (there are 8+ mechanisms to hyperglycemia in type 2 patients). 

 

Although many providers are not in agreement, it is my personal belief that incretin mimetics and DPP-4 inhibitors such as januvia and onglyza should be used earlier in therapy rather than added on later (as is the current philosophy). 

 

Take care everyone

 

mike C.

Pharm D

Trusted Contributor
morrisolder
Total Posts: 10,278
Registered on: ‎11-28-2009

Re: Byudereon Approved in US - New once a week version of Byetta

Hi Mike,

 

I think the reason that many doctors are hesitant to start with the newer drugs is simply that they are new, and they would rather the after-release, real world testing be done on other doctor's patients than their own.  And in many cases, the newer drugs have not proven to be more effective than the older ones. So it comes down to risks/rewards--with the older meds they pretty much know what to expect.

 

You do seem to know quite a bit about it, and that knowledge is unusual for a first-time poster here.  Does your signature mean that you are a licensed pharmacist? Maybe one who has diabetes?  Or just an interest in it?

 

Just curious because it is rare that we have someone here who has more than patient knowledge, gained through their own experience with diabetes, and perhaps from helping others.  Nothing wrong with that, but  medical training can often inform the conversation from a different perspective. In any case, welcome aboard... I hope you will find relevant conversation here...

 

 

 

 

Morris

Diagnosed Type 2, with an A1c of 11.4 in 2003; averaging a 5.0 A1c since then with diet, exercise and Glipizide XL + meds for blood pressure and cholesterol. 
A bit dated, but scroll down on this page if you want to know more ...


Visitor
Mnc06002
Total Posts: 4
Registered on: ‎02-06-2012

Re: Byudereon Approved in US - New once a week version of Byetta

Hi Morris,

 

im a pharmacist specializing in diabetes care.  Yes this was my first post on this site.  I decided that i wasnt getting enough patient feedback in my current practice settings (both retail and clinical) and figured that discussion boards would be the best place to see patient comments and concerns.  i realize that a lot of these drugs are new and i dont believe doctors should jump right in as soon as they come out.  BUT new diabetes research gets posted almost weekly and there is some solid theory claiming incretin dysfunction (incretins are what drugs like byetta, januvia, onglyza and trudjenta work to increase) occurs before insulin resistance (which is what drugs like actos and metformin work on).  This would indicate usage before Overt Diabetes rather than waiting for someone to have an A1C of 9 or 10.  It is difficult because like i mentioned in the prior post there are over 8 identified factors contributing to hyperglycemia and overt diabetes.  Testing each person for specific mechanisms is impossible because 1. some of the tests dont really exist outside of a closed laboratory setting AND 2. it would be impossible cost wise.  therefore doctors are left with A1C and finger sticks to direct therapy.  Like i said its just my personal belief that some of these therapies should be tried earlier in certain cases.  If somebody goes to the doctors office and blood work comes back with an A1C of 10 or 11 should they be started on Januvia?No, this person is clearly past the overt diabetes mark.  But if someone goes to the doctor and blood work comes back with an A1C of 6 or 7 should they be started on Januvia or byetta? Maybe.  As with any condition more and more is learned every day and hopefully there will be a definitive treatment plan that works for everybody sometime soon.  

 

Hope this helps clarify what i meant.  Take care and if you have any questions dont hesitate to ask.  Like i said i want to get more patient feedback. 

 

mike

Trusted Contributor
morrisolder
Total Posts: 10,278
Registered on: ‎11-28-2009

Re: Byudereon Approved in US - New once a week version of Byetta

Hi Mike,

 

Your reasoning does seem to based on some logic... rather than, say, the wiles of the ex-cheerleaders and beauty queens hired by pharmaceutical companies to convince doctors to use their drugs. Thanks for explaining why you think earlier use of these kinds of drugs might make sense--I had never thought of it that way before...

 

When you say that you are a pharmacist specializing in diabetes care, what does that mean?  You mention retail and clinical settings, but somehow I think of pharmacists as dispensing drugs, with little choice of the patients who might show up?  So how does a pharmacist specialize?

 

I know this isn't quite the feedback you had in mind, but I'm interested nonetheless...

Morris

Diagnosed Type 2, with an A1c of 11.4 in 2003; averaging a 5.0 A1c since then with diet, exercise and Glipizide XL + meds for blood pressure and cholesterol. 
A bit dated, but scroll down on this page if you want to know more ...


Visitor
Mnc06002
Total Posts: 4
Registered on: ‎02-06-2012

Re: Byudereon Approved in US - New once a week version of Byetta

its a good question.  More and more pharmacists are kind of moving away from the retail setting and actually working along with doctors much as a PA or nurse practitioner would.  Some states even give pharmacists prescribing power now under the guidance of an MD.  I kind of fall in the middle of the two extremes.  I believe i am a drug expert and i dont think i should be diagnosing or prescribing on my own.  However, i do believe i am in the position to give a doctor a suggestion based on a patients current battery of medications.  This service is helpful in a few situations with the most obvious being a patient who has bunch of doctors and is on a lot of different medications.  Again every state is different with how they define clinical pharmacy services but many states agree on the fact that adding a clinical pharmacist to the health team (in varying degrees) increases clinical outcomes and decreases patient/hospital cost.  Wtih that being said some of the services i provide are cost-effective drug analysis (is the added benefit worth the added price), chart reviews, monitoring patients who are on certain medications that are known to cause serious adverse side effects, medication therapy management, and drug adjustments via evidence based medicine.  Most pharmacists who veer out of the retail/dispensing setting usually specialize in an area much in the same way a doctor would.  when i say im specialized in diabetes i mean that I have extra schooling, certifications and experience in Diabetes/endocrinology care.  Like you mentioned before sometimes all a doctor has to go on is what the drug reps say and not all doctors have the time to sit at home and read all the new literature every night.  New literature comes out weekly and there are several medical journals dedicated to diabetes alone.  Having a pharmacist in the practice who knows how to correctly evaluate and scrutinize the literature takes the drug reps out of the picture and helps to provide better outcomes with health and cost. 

Trusted Contributor
morrisolder
Total Posts: 10,278
Registered on: ‎11-28-2009

Re: Byudereon Approved in US - New once a week version of Byetta

[ Edited ]

Reading between the lines, then Mike, would I be correct in guessing that you work partly or wholly for an endocrinology practice or group specializing in diabets?

Morris

Diagnosed Type 2, with an A1c of 11.4 in 2003; averaging a 5.0 A1c since then with diet, exercise and Glipizide XL + meds for blood pressure and cholesterol. 
A bit dated, but scroll down on this page if you want to know more ...


Visitor
Mnc06002
Total Posts: 4
Registered on: ‎02-06-2012

Re: Byudereon Approved in US - New once a week version of Byetta

yes sir.