I find it interesting that the FDA would approve a medication that found anti-liraglutide antibodies among the common adverse reactions in the LEAD Study (Liraglutide Effect and Action in Diabetes  Study) of 3,900 patients.  This is especially concerning to me since it is a long acting medication. The pancreatitis and thyroid tumor and thyroid cancer findings are also red flags of concern as a patient advocate. It seems that the glucagon-like peptide-1 (GLP-1) analogue, Victoza, has still to be discovered actions.The FDA in approving this medication warns against use of the drug in patients with a family history of medullary thyroid cancer or a genetic condition known as Multiple Endocrine Neoplasia syndrome type 2.  The FDA also requires NovoNordisk to conduct an epidemiological study using a health claims database to evaluate thyroid and other cancer risks. The Medication Guide on the Victoza website cautions patients to “report to their providers if they have a lump or swelling in your neck, hoarseness, trouble swallowing or shortness of breath.”  It notes that that thyroid tumors or cancer of the thyroid may result in the thyroid having to be removed.  The guide also cautions the patients to “tell your provider if they have had pancreatitis, stones in the gallbladder (gallstones), a history of alcoholism and high triglyceride levels” as these conditions can make them more likely to get pancreatitis.

Hi Patricia, I agree with many of your statements. As I was reading through the literature provided to me it states that Victoza should be used with caution in patients with renal and/or hepatic impairment.  How many diabetics have one or both of those??  Too many for safe use I believe. The literature, put out by the manufacturer also states that a common adverse reatcion is anti-liraglutide antibody formation.  My fear, same as fears realized by Byetta is that people, possibly non diabetics, will seek it out and obtain it for it's weight loss potential and it will be used inappropriately which then also puts the user at risk for not only pancreatitis but also thyroid C-cell tumors.

I think the info re: both thyroid cancer and pancreatitis with the use of the GLP1 group is highly exaggerated, to be honest.  When looking closely at the risk, Pat, for pancreatitis, there is no greater risk with Byetta for example, than there  is for patients who are not taking Byetta.  Anyone with type 2 diabetes is at increased risk for pancreatitis already.

I do share some of your concerns regarding the longer duration of action, though.  But knowing Novo-Nordisk as a company, and their history on safety and drugs they've actually withdrawn from testing and from potential market introduction, prior to release secondary to safety concerns, makes me a bit less concerned.

Have you had a chance to meet with any of the company representatives, or better yet, one of their clinical scientific liaisons?  I have an appoitment with them on Thursday, February 12th.  If anyone out there has any questions, I'd be happy to pose them and craft a summary after my meeting with them tomorrow.

Thanks, Judy , for your comments. I think we need to be patient advocates and at the very least inform patients regarding the pros and cons of any medication so they can decide if they would like to try it. There are so many options today with oral agents as well as injectables. I like to tell patients what types of medications are available, how they work and precautions related to specific meds they show an interest in.  Diabetes is, after all, a self management condition. The regimen  for glycemic control that a patient is given has to be a good fit for his/her lifestyle for it to work. Naturally, the patient needs to be a partner in the decision making.

Hi Donna,
Thanks for your comments. I agree with you that NovoNordisk is a reliable company and their insulin products and Prandin are excellent.  I also know that there is a race on with pharmaceutical companies to come up with a blockbuster drug for diabetes. The trend seems to be to get drugs that are long lasting with the idea that patients will be more compliant. It will be interesting to see what happens in the future.  When you meet with the Novo Nordisk rep ask them why a patient shoul choose Victoza over insulin injections.  I am sure that one of the reasons proposed would be fear of injection on the part of the patient and lack of diabetes educator support to teach people starting on insulin.  As Diabetes Educators, we all know that it is not difficult for patients to adapt to injections if they get the appropriate start with one of us.  If insufficient insulin production is the problem, insulin is a simple way to solve the problem if the patient does not want to risk potential side effects of any other diabetes med.

Very well said, Pat, and I will ask them about the use of Victoza as compared with insulin.  You're so right about the 'race' between the pharmaceutical companies.  I'm happy that this class of drugs exists, and do share some of your concerns re risks related to it's duration, and the half life of the drug.
I al;so agreed with what you said to Judy re letting patients know the classes of orals and injectables and the inherent risks of each so that they can make an informed decision.  That's truly part of our role as certified diabetes educators, and patient advocates.

I've my appt with the clinical liason next week.  Thanks for the leads on questions to query them about.  I have to say that the issue of safety is moot in my case due to the fact that the locations I work at won't add this drug to their formulary and it's very unlikely that the drug is going to be used by PCP's v. the endo's.  I'm working mostly with PCP's and they are so reluctant to prescribe anything new. 

One reason that both physicians and patients might chose liraglutide over insulin is the liraglutide’s ability to aid weight loss, and the possibility of insulin to limit weight loss.

Just today, I read the FDA's justification for approving this drug. I thought you might find it interesting as well. It's called Weighing Risks and Benefits of Liraglutide - The FDA's Review of a New Antidiabetic Therapy and is the New England Journal of Medicine. Volume 362: 744 - 777, March 4, 2010. You can find it here: http://content.nejm.org/cgi/content/full/362/9/774

Dear Ms. Linekin:

 I agree with your comment. The innovation is needed

in the treatment of Type 1 patients (C-Peptide < 0.1 ng/mL

by my definition). For the past several  years I have been able

to control all of my Type 2 patients (C-Peptide wnl). For details

see my book ("The Illa Protocol 3rd Edition") available on

amazon.com and most online booksellers.

Roberto Victor Illa, M.D.

www.chicodiabetesdoctor.com

Thank you for your comments, Dr Illa.  I did go to your website, and I am fascinated by your approach. It seems to me to be a very common sense approach that requires patience, really listening to the patient, and being mindful that the patient is a partner in decisions regarding the best route for them to achieve glycemic control.  After many years of interaction with patients, it is clear to me how unique each individual is. 

I am very disappointed when I hear type 2 diabetes described as leading inevitably to increased beta cell dysfunction and greater dependence on medication. That is a real motivation destroyer.  The approach that you describe seems to me to be one that offers an incentive for the patient to self monitor glycemic control and monitor all aspects of their daily life that can impact glycemic control.  I am sure we will hear more about your approach as time goes by.

Dear Ms. Linekin:

 I encourage my patients to send me their glucose readings by e-mail.

That way I keep in touch with their progress on a daily basis if necessary.

It is not just more attention but the combination of TZD and DPPIV-inhibitor

in the type 2 patient actually causes a regrowth of the beta cells. (David Bell

M.D.  Nov 2003 Am. J. Med.   See my other website of references and

Power Point presentations at www.diabetescontroltower.com.    I haven't

updated these recently....too busy...but they are still very informative.)

 I know you will be shocked by this....but....diet in my method is virtually

uninportant.  Just about all my Type 2's recover within a year. Those

are insulin can be taken off.  The method and case reports for all types

of diabetes and nesidioblastosis are laid out in the book.  "The Illa Protocol

3rd Edition"  You can Google this title).

Roberto Illa, M.D.

All -

This is an interesting dialogue. I wanted to make a few points related to what we currently know about the progression of type 2 diabetes:

No doubt it would be so much better in terms of disease outcomes if people were alerted when they had initial signs of insulin resistance, metabolic syndrome and/or prediabetes (I realize these are somewhat, but not completely overlapping terms) - whether low HDL, high TG, slightly elevated BG, elevated BP, etc. But a very low percentage of people even know/are told by their provider that they have pre-diabetes, insulin resistance, etc., until their A1c or BG is high enough to diagnose diabetes.

At this point, studies have shown, that this situation has been ongoing/worsening for five to 10 years or more. In addition, most people have lost at least 50% of their beta cell mass at diagnosis and I've heard Ralph DeFronzo, MD, state in his 2008 Banting Lecture at ADA that this loss is closer to 80%. The point is, and this point is made in the current ADA/EASD paper on the pharmacologial treatment of diabetes (Diabetes Care, December 2008), that by the time of diagnosis people are way down the path of beta cell mass destruction and need (most of the time) to start on medication. The ADA/EASD guidelines suggests starting metformin. I realize there are many ways to approach this situation and it looks like we have and will be seeing more medications...from liraglutide to a once a week exenatide (exenatide LAR) and more.

These days when I'm writing to or counseling people at risk for type 2 or with type 2 (particularly early onset) I feel it is my responsibility to let them know that this is the current knowledge/understanding of type 2 diabetes. I try to discuss (when I'm counseling) what their likely status is with their beta cell function (and let's remember this is now involves both insulin and amylin production...or lack thereof) and their likely impaired incretin function. I discuss the progressive nature of this disease. People don't know this b/c they think of type 2 diabetes as the more stable, less serious type of diabetes...you just take a pill.

Rather than being a motivation destroyer I think providing people with a current understanding is a reality orienter and a message to take action now to do all they can to slow down the progression of disease. If there's one thing we've learned from the recent trials (ACCORD, etc)...early and agressive intervention can slow the progression of disease and improve outcomes. Don't our clients deserve to know this and be motivated to take action NOW and know how to work with their providers to progress their therapy if they're not meeting their A1C, BP, and lipid targets? I think so.

Thanks,

Hope Warshaw, MMSc, RD, CDE

Nutrition Section Editor, www.PRESENTdiabetes.com 

Dear Ms. Warshaw:

 With my method diabetes Type 2 does not progress.   The ACCORD study, for the record,

had to be stopped 17 months early because of EXCESSIVE DEATHS. See NEJM

June 6, 2008. At the 68th Annual Scientific Session of the ADA

in S.F.  following this utter fiasco the ADA refused to withdraw their

deadly recommendations ( Diabetes 2008 Vol 17  June 11 2998 Issue 5) .

In fact they supported their deadly advice of using the HgbA1c as the

test to be followed in treatment and for diagnosis. (Diabetes Care  8/2009).

This was one of the underlying problems with ACCORD.  The HgbA1c has been

proven to be virtually useless in the medical literature.  The more severe diabetes

the greater the fluctuations in sugar....and themore worthless the HgbA1c.

Hundreds of so-called "experts" at various medical centers were

involved in ACCORD.  There were over 10,000 patient subjects with Type 2 diabetes.

This was the death knell for American Diabetes Association plan for controlling

diabetes mellitus.  See JAMA 2008 Editorial on controlling diabetes with bariatric

surgery.  I just attended a UC SF conference and surgery for diabetes was the

big push. ($ 15-20,000 per operation for 15 million U.S diabetics? Really?)

Additional references indicating conventional treatment is a disaster:

1.  Addition of Biphasic, Prandial, or Basal insulin to Oral Therapy in Type 2 Diabetes.

    Holman RR, et al   New England J of Med  2007: 357: 1716-30

2. Hypoglycemic Episodes and Risk of Dementia in Older Patients with Type 2 Diabetes

     JAMA  April 15 2009 vol 301, N 15.

3. Hypoglycemia in Childhood Type 1 Diabetes Mellitus: Understanding  and Managing

    the Dark Side of Intensive Insulin Therapy.  

Roberto Victor Illa, M.D.

As a health care professional/diabetes educator, I find it very frustrating that so many people don't want to take medicine. When I teach group classes, there are so many that tell me the reason they come is so that they can come off their medicine, or never start medication. Many of these people have A1Cs higher than 8% already! I'm glad they came to the class, but I'm sad at the information most have before the classes. As Hope said, by the time one is diagnosed they have already lost a good percentage of their beta cell function. 

So, my job is to teach about beta cell function, what has happened, what is happening, and what can and most likely will happen unless some real changes are made. To teach the importance of people knowing what their numbers should be, as well as what they are. To teach the importance of reaching these targets using whatever it takes. If it takes medications to go along with a healthy lifestyle, then it does. Interesting, most usually come around and thank me.

Another piece I want to mention is bargaining. I've (for the most part) stopped bargaining. You know, the person who says, I'll go to the gym, I'll eat less, etc, etc, just give me time before giving me more medication. Now I say, "How about taking this now, along with the things you tell me you are going to do. Then if your blood sugar gets too low, we can always decrease the amount of medication you are taking." At least I feel I've helped them reach the targets which are so important to reach.

And with this whole discussion, I think of the benefits vs. the risks.I'm sure you do too.

Thanks all for your great comments.

EnJOY!

Joy Pape, RN, BSN, CDE WOCN, CFCN
PRESENT Diabetes Contributing Nursing Editor

Dear Ms. Pape:

 Why is it people don't want to take medication? Very simple. Their doctors

have never been taught to use these medications properly. The drug companies

are hawking their medication over another. Recall the Novo Nordisk campaign...

said Novo will control your diabetes.  Result: See references above.....Utter failure...

with injury to patients.

  Medications for diabetes are TOOLS.    The true situation is reminiscent of

a carpenter building a house. The carpenter must first take measurements...

then define the task before choosing the tool.  (You never start with Metformin

first in everyone....bad choice.)

1. Measure C-Peptide. This tells you if the patient can still make their own insulin.

     If low (< 0.1 ng/ml) this means the patient will need injected insulin.  If "normal"

     even though their blood sugar is say,  700 mg%, in  few weeks or months they

     can be weaned off of insulin.   Simple. References for this date back to the 1980's.

2. Which insulin?   Now you are about to choose the insulin with a half-life

     appropriate to their kidney function.  It is best to use eGFR as your measure.

     eGFR  >60  (Normal kidney function)  1st choice Lantus insulin.  One injection

         24 hr action.

     eGFR  approximately 25-55 Use Levemir.  Start with small doses.

     eGFR under 25 start with Prandin in Type 2 patients.  This may be used for patients

       on dialysis. Why? Because it is metabolized in the liver, has no active byproducts

       of catabolism ....so it does not need functioning kidneys.   Type 1's: very short acting

       insulins once or twice per day depending on eGFR.

3.  Which alpha agent?  Do a 1 hour Glucagon test.  (Fasting and one hour after eating....

      ....eating anything they like).    Depending on the extent of of rise choose

       a) TZD only    very small.  TZD also active over long period of time on alpha cells.

       b) TZD plus  Januvia or Onglyza.    Very effective.

       c) Byetta.     Effective but poorly tolerated by most patients because of nausea and vomiting.

       d) Symlin    Better tolerated than Byetta, but requires three injections per day.  You have

             to be patient with these agents as it takes weeks to months to see their benefit.

  The method is straightforward and effective. Much more so than anything anyone has

   used to date.

   All diabetics oversecrete Glucagon after a meal. This causes most of the post meal rise

    in blood sugar. So all diabetics need "alpha-cell treatment.".   Most doctors who refer

    to me omit this.   When I add it their patients improve.

   Diet and excercise never controlled or cured any moderate to severely ill Type 2 or Type 1

   diabetic.  Most studies on diet and exercise are looking at people who are "at risk"

   for diabetes, or have very mild diabetes.  Even with this pre-selected healthy group

   more than 75 % go on to more severe diabetes after 1-2 years.

   Patients are non-compliant because " you can fool some of the people some of the time....

    ... but you can't fool all of the people all of the time."

  Roberto Victor Illa, M.D.

 The Illa Protocol 3rd Edition.

Dear Ms. Linekin:

  You have asked many questions.  Your comments contain  excerpts .....which in some instances...

have been taken out of context.   The book (The Illa Protocol 3rd Edition) contains over 200

references from the medical literature which you can access on Google or PubMed

(National Library of Medicine). I understand your disbelief and sympathize.  We have

all been misled for many years. I did my medical school at Stanford University and was

instructed by the eminent diabetologist, Dr. Gerald Reaven.  Although I have great regard

for the vast majority of his work and for him personally....I disagree strongly with his

support for the notion of "insulin resistance".  This was first proposed by Sir Percival Himsworth

in 1930. He was a prominent British physician. However, he was wrong.  No research

has ever confirmed the existence of this theory. 

  The work of Michael Somogyi, Ph.D. (1938 (Proceedings of the St. Lois Medical Society and 1959 

American Journal of Medicine) explain the "rebound" (within seconds) of sugar level when you

overtreat diabetes with insulin or other hypoglycemic agents.  This gives the appearance

of "insulin resistance" because the blood sugar does not "appear" to come down.  But it does

....to levels below 70 mg% at which point the "Somogyi phenomenon" takes over  (CNS induced

release of Glucagon which elicits rapid release of glucose from the liver).

  The "clamp studies" done by Dr. Reaven and others did not account for the all-important

role of the brain in the homeostasis of human blood sugar. Therefore, all their results

cannot be valid.  The French physiologist, Claude Bernard, established the role

of the CNS in blood sugar control in a series of animal experiments (1848-1856). (See book).

  Now to the issue of hyperglycemia.

  Yes, hyperglycemia is not good for cells...especially for beta-cell function.  I agree.

  However, my point is the following:  a) Do not correct hyperglycemia rapidly....as is done

in all ER's when a patient shows up with a "high" blood sugar. (sometimes only 300 mg%)

My issue is with the SPEED of correction.         b) Hyperglycemia is not as dangerous as

hypoglycemia...which you will see in my book may go as far as neuroglycopenia (usually

about 55 mg%) which leads to hypoglycemic infarcts (visible on MRI T2 Axial flair view).

Many MRI images of this are printed in the book.

c) Diabetic ketoacidosis is NOT the result of high blood sugar.  It results from an excess of

"ketone bodies" (which are acidic)  which result from a shift in metabolic pathways in the liver.

The direct determinant of this is the Insulin/Glucagon ratio.  Too little insulin....too much glucagon.

So.....there are many examples in the medical literature of patients going into ketoacidosis

with blood sugars under 70 mg%.  (I give one in my book....in great detail).

  There are too many issues for me to discuss in this forum.  But...yes....this book turns

your world upside down....but it does save lives.  All that I have said is heavily documented

and accessible to you. (See book references.)

Roberto Victor Illa, M.D.

I can assure you that this is happening already. Victoza was actually introduced to me (by my medical practitioner), as someone who is overweight and insulin-resistant, as a way to bring my weight down and hopefully stave off full-blown diabetes. Let me be the first to tell you that non-diabetics SHOULD NOT BE TAKING THIS DRUG! Fortunately, I am a very cautious person, and I monitored my blood glucose closely after I took my first injection (.6mg). Without going into too much detail (I plan on writing the whole incident up on my blog as a cautionary tale, once its over with), it basically brought my blood glucose down to levels (in the 70s) where I began to feel lightheaded and panicky. And because of the drug's nausea side effects, as well as how it slows the emptying of the stomach, I had to fight to get enough calories in, and keep them down, to bring my blood sugar back up to pleasant levels.

Needless to say I did not take a second dose.

What is scaring me now is the long-acting nature of the drug. Even without a second dose, my blood glucose fell precipitously overnight the second night, and I once again woke up this morning having to immediately work on raising it. At least today, the second day out, I am able to eat, and it seems to be staying down better. I'm just hoping that once the majority of the drug leaves my system, I will no longer be fighting hypoglycemia.

I hope this also helps to answer a few people's questions about why we patients are reticent about taking new drugs.

Thank you so much, Michelle, for your "real life" experience with Victoza. It is so important for us as nurses and other health care providers to hear feedback from people taking any medications.  I think it is always a good idea to take a shorter duration medication than a very long acting version for exactly the reason you described so well.  If you experience an adverse effect from a long acting medication, you are at risk for the duration of action unless an antidote is known.

Patricia, thank you so much for helping to create such a welcoming community!

I know I may not have a whole lot else to contribute beyond this thread, but at the time I made my original post I was feeling so awful, I just had to start getting the word out that this is not a drug to be taken lightly. I have since made my more complete write-up of my experience on my blog, here: http://couponfans.com/2010/06/15/victoza-for-weight-loss-not/ if anyone is interested in the long-winded version of how it affected me (or if such links are not welcome here, please delete).

I consider myself lucky because I had the tools and at least some of the knowledge to keep myself out of the emergency room, (and friends who had the rest of the puzzle, as well as who cared enough to help me through). I shudder to think what might happen to someone without past experience or knowledge of how to deal with sudden hypoglycemic attacks.

The other side of the coin is that, if a true diabetic still has functioning beta cells, I suspect this may be something of a wonder drug for them (assuming they can tolerate the side effects). I worked out the elimination schedule, and it is pretty much gone from my system now, yet I am still having some effects. I am still having to modify my eating habits (almost a week later) to avoid my blood glucose dropping too much overnight. It seems it has, in essence, turbo-charged my pancreas. I just hope there are no long-term detrimental effects to having my pancreas work overtime like this (and honestly, I'd be more comfortable going back to my old pre-diabetic condition, terrible as that may sound).

Hi again,Michelle
I forgot to add a very very important point...do not overlook the benefits of exercise. 

You don't have to start with a gym if you don't want to (check with your doctor before joining a gym), but even walking briskly 20 to 30 minutes a day can be beneficial not only in helping weight loss, but also in increasing a feeling of well being. If you wear a pedometer (I prefer Omron pedometers as I know they are accurate) it helps to give you an idea of how much physical activity you have in a day.  Each day you can increase the amount of steps you take daily.............10,000 to 14,000 steps a day is not always realistic for many people, but it is a good idea to see how many steps you usually take in a day and try to increase according to your desire to do so.

also

a good guide to health eating and choosing low carbohydrate foods is the South Beach Diet books. 

Hello again Patricia,

Sorry it has taken me so long to  respond; the past couple of weeks have been amazingly rough.  You are correct in that I had taken what I previously knew about treating hypoglycemic attacks in a diabetic and applied it to my situation. When I began feeling lightheaded and dizzy, and checked my blood glucose and found it low, I reacted the only way I knew how at the time. This is because I was not properly educated, either by my physician or my own research, as to how liraglutide operated (in reaction to carbohydrate digestion).

I am also very well acquainted with the good that exercise can do a body, particularly one with diabetes or one who is flirting with it, as I am. In fact, I had been exercising regularly (aerobics every other day) for about three months when I tried Victoza. When my blood sugar dropped, however, I was afraid to continue my exercise regimen. I laid off for a week, then when things seemed to be returning to normal, I exercised again, my normal workout, just 15 minutes of aerobics with a few toning exercises at the end. That is when my body threw in the towel.

When I finished with that workout, my blood glucose had plummeted, my heart rate simply would not return to normal (I usually recover with less than 5 minutes of cooldown), and my blood pressure was spiking and also would not return to normal. I was scared out of my wits. I thought if I got my blood glucose back up, everything would be OK, so I treated that first. After ensuring that was brought back up to an acceptable level, though, my heart rate (HR) and blood pressure (BP) were still sky high. So I suspected a panic attack (not unknown to me), and took half a valium, which usually calms me down within half an hour.

I also called a friend who does home care work and asked if I could come over and sit with her until my vitals calmed down, as I was afraid to be alone. She graciously accepted, thinking, like me, that it was just panic, and that it would pass.

It did not.

I had worked out at 9:30 in the morning. At 2:30 in the afternoon, after my friend and I had done everything we could think of to calm me down, I finally asked her to drop me off at the emergency room. My HR was still running 120-130 when I was sitting down, and my BP about 150/110 (my highest ever previous reading was 130/90). Given that my mother passed away a few months ago due to a brain hemhorrage caused by a spike in BP, and my brother had had a stroke just a couple months before that which paralyzed his entire left side, also accompanied by high BP, you can probably see why I was anxious.

In the ER waiting room I took a whole valium, still hoping to calm myself down, even though in reality, I was pretty calm, nerve-wise. I had long since exhausted myself just by being upright and breathing, given my constantly racing heart.

When I was finally seen, they did an EKG, which came back fine (thank goodness!) and took my BP lying down, sitting up, and standing. They then pronounced me dehydrated, gave me some water, and sent me home. Mind you, I had both a one-liter bottle of water and a smaller bottle of chocolate milk which I had been nursing during my time in the waiting room. My normal fluid intake is about 3 liters per day, and when I get dehydrated, I feel it in my mouth, throat, eyes, and get headaches. I guarantee you I was NOT dehydrated. But at the time, it seemed like a reasonable explanation, given that I wasn't thinking entirely straight.

My boyfriend comes and picks me up, and even runs out to get me some sports drinks to help replace my electrolytes. I sleep like a dead person that night, and wake up feeling like I had run a marathon overnight. My BP & HR are still ridiculously high (HR was 100 bpm LAYING DOWN, when it normally runs 72 sitting up). This lasted for a week, during which I got a second and THIRD opinion regarding why my HR & BP wouldn't go down. All they could tell me was take it easy and see if it didn't get better. They offered to do a stress test, but given that I'm uninsured and I was already wiped out by a $1,100 ER bill, I declined.

So I put myself more or less on bed rest until I could get health insurance and figure out what was wrong with me. Indeed, I shudder to think what would have happened if I hadn't put my puzzle pieces together myself. In addition to my rapid HR & high BP, I had shortness of breath, anxiety, random muscle cramps, constant diarrhea and severe trouble concentrating or remembering things. Oh, and my fluid intake increased as well. Where I would previously drink a few swallows of water each time I got up to use the bathroom at night, I was suddenly going through a FULL LITER of water overnight, and still waking up feeling dry.

Can you guess what was wrong with me?

I won't keep you in suspense. It was hypomagnesemia - low magnesium. No one had even mentioned electrolyte imbalance as a possiblity; I had to deduce this on my own. Thank God I'm good at internet research. One doc said it was just my body trying to deal with glucose overload. One told me dehydration. The third offered me a stress test (I fear that might have killed me, or at least put me in the hospital, so I'm really glad I didn't go that route).

So Victoza may be cleared of my previous accusations, though I have read that high insulin levels have a magnesium depleting effect, which is something I highly recommend keeping in mind. I also learned that renally impaired individuals can't supplement with magnesium the way I have, so it might be an even more critical thing to keep in mind for your patients.

Long story short, I've probably been magnesium deficient for years. And the really scary thing is, even if my doctors had tested for it, Mg in the blood is not a reliable indicator of its intracellular levels. That is to say, you can have normal serum levels, and still be way low where it counts - in your cells. And unlike calcium, which can be robbed from bones as needed (and yes I realize that's not a good thing to have happen), the magnesium in bones is not readily accessed; it must pretty much all come from diet and supplements.

Also wanted to mention, for the uninitated: Calcium and magnesium are antagonists, meaning that the have opposite functions in the body. One such antagonist pair is muscle contraction (done by calcium) and muscle relaxation (done by magnesium). Since I was deficient in magnesium, but not calcium, my muscles, including my heart and blood vessels, could contract just fine, but not relax properly.

The lesson in this is what you seem to have been saying all along: it's up to the patient to be responsible for their own health. Doctors may help (or they may not), but we have to be our own best advocate. Remember, doctors have MANY patients, and thus less time to concentrate on each one. You have only one (or, if you have a family, a few).

OK, I've been upright about as long as I can handle; still working my way back to good Mg levels. :) Just wanted to let you know how the story ended (or at least, I hope this is the end of it; I don't EVER want to feel that awful, or that close to death, again.

Thank you for the information, it truly has helped me. I began Victoza with great weight loss 5 weeks ago. Simple symptoms of nausea, diarrhea, and no appetite. Went back for recheck with Endo, in office he found my BP 123/100 and pulse 120. I have never had HBP, I have always been low. I had felt what I thought was mild anxiety symptoms that were new. Tons of labs for thyroid and kidney and cbc, all negative. PCP decided it had to be victoza, endo disagreed. I had my second episode today, with confusion and ataxia w/tremors. CBG was 119. No one could tell me what it is. As a nurse and a daughter of a mother that died from radiation malabsorption I should of seen the same symptoms in myself. It is totally the Mg!. I took some over the counter and am already feeling so much better. I will have to tell my PCP who I work with as her nurse in am. Finding your article has given me hope. I like the Victoza and want to stay on it if I can. I just need to get adjusted. Thanks again.

I, too, am a patient advocate. But we have to be careful about not scaring off patients to try new agents that will always carry with them rare, serious adverse effects.

If aspirin were to be newly introduced to the market today, I don't think it would pass muster by your strict cautionary guidelines, or even the FDA's. Yet, with all its side effects (which took decades to be discovered, not months or years), aspirin has been saving many lives.

I am sure that you know that during clinical trials of any new drug, all side effects that do occur in studied patients have to be reported, whether those side effects were directly linked to the drug or not.

Unfortunately, this is the nature of the beast. Unless you try a relatively-safe agent on the population as a whole, we can never find out its risk/benefit ratio. That's an unavoidable fact.

As a clinician, I would wait till more information is collected on "the beast" before I tried it. But I would never condemn it till the stats are clear and the jury is in. On the drug Victoza, we need more time before we can judge.

Cheers,

Samir Hafza, PharmD

As a patient, I have learned to be cautious about my doctors prescribing patterns.   Doctors will often prescribe the "newest" drugs even though there is no evidence that they are more effective or safer than older drugs.  I am constantly surprised to hear that new prediabetic and diabetic patients are prescribed new drugs like Victoza or Onglyza rather than metformin.  Why is that?  I believe that it is at least partly the result of how the drug industry is allowed to interact with front line doctors (drug reps).  And the biggest problem, the FDA has changed its overall approval process so that drugs get approved earlier pending further studies.  And one of the big assumptions is that adverse effects from drugs will be reported.  Unfortunately, my experience is that doctors fail to report adverse events.  I have had several doctors decline to report adverse events, an action that makes me question their objectivity.

My anecdotal evidence from those that I know who have taken Victoza suggest that it is highly effective with minimal side effects (nausea).  However, Victoza cost me $200/month co-pay and in the end was not effective.  Whenever I hear of someone being newly diagnosed with diabetes and placed on such a "new" drug, I point out to them that metformin is an older, well understood, effective medication that costs $4/month at Walmart.   My advice is that if you are prescribed a newly released  "designer" medication as first medication, you should really question your doctor.  I am not some human experiment, I am a patient who wants their best chance to be healthy.

ps. As a patient or practitioner, you can and should directly report adverse drug events to the FDA. 

I am a type2 and have been researching Victoza studiously for the last week after my doctor suggested I go on it.
My apprehensions are these - I was advised to take Victoza for weight loss by my doctor who said chances are I would come off insulin after a few days / weeks. However the literature seems to indicate that one should not take Victoza with insulin (I am also on Janumet1000/50 and amaryl1mg - which seem to be ok with victoza. Although I think the amaryl and victoza could lead to hypos?). i am on 44mg Lantis at night.

Also from what I can gather in the US, Canada, UK, Australia it is advised as a second or third line of defence. If your BMI is over 35 and / or if you are at risk for heart attack or stroke. I am however a slightly overweight 34yr old female with a BMI of 28. I have been diagnosed with diabetes for 2 years now of which the first year I was pregnant or had just had my baby. I have got the baby weight off and am not convinced that I am a prime candidate for Victoza.

Also, should serum calcitonin levels be routinely checked and how is that done? Or is that only for people with a family history of MTC? What are the anti lariglitude antibodies and can the creation of these enatibodies be reversed? Does not sound like a scenario that one would really want?!

I do understand that this is a chat about patient advocates  and whether they would prescribe Victoza - but I imagine that you would deal with these sorts of questions from a patient perspective if you were indeed to prescribe the drug? So I thought I would ask the questions here. I am also at a bit of a loss as I am used to the cacoon and hand holding of the NHS diabetes programmes and support. Now that I moved to India about 6 months ago I am a little apprehensive about the potential of a slightly cowboy attitude in prescribing drugs, or the potential of my doctor wanting to forge a name for himself by being a leader with a potentially promising drug. 

Perhaps I am just being cautious - but I do like to be armed with all the information I need before I take any new medication! (as was the case when I was started on Januvia and amaryl). Thank you. 

Dear Maneesha
First of all, I must congratulate you for wanting to be involved in decisions relating to your health care regimens. I also very much understand how stressful it is to move to a new place and have to adjust to finding a new health professional that you feel comfortable with. My hope is that you will be able to ask all those questions to the new doctor whom you now are seeing. If not, you can always look for a new doctor who will take the time to talk to you or who at least has a Certified Diabetes Educator or its equivalent inthe office setting.

This blog site is not one that can give individual advice to patients regarding their care. I do have 2 suggestions for you that may be helpful:
1. e-mail or call a Certified Diabetes Educator at the site in the United States that you have previously relied on. I know that if I have a patient who moved to a new area, I and many of my colleagues would certainy answer your phone call or e-mail to help you in adjusting to a new site of care. The people who previously worked with you know you best and can give you the best personalized advice until you are comfortable with your new care provider.

2. the next advice is to contact the pharmaceutical company that makes the medication in question as all of the have people available to answer questions pertaining to their medications, Here is the website for Januvia

https://www.stepstobalance.com/steps_to_balance/stepstobalance/faq/index.jsp?WT.svl=3

I wish you good luck in finding the personalized information that you want and deserve to get