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An Eye-Opening Interview with Steven Edelman, MD, PART 2

Jul 19, 2011

This week, we present the second half of our publisher Steve Freed’s interview with Dr. Steven Edelman at the recent ADA Scientific Sessions in San Diego.

Steve Freed: One of the more exciting things I have read about is the extra eyelet effect on the GLP-1 compounds on the heart and cardiovascular disease and its direct relationship?

Dr. Steven Edelman: I think that probably has more promise….


I mean to be honest, I’m not really privy to that data but I do know that there’s some pretty nice effects on cardiovascular function. We know that there are improvements in surrogate markers like blood pressure, lipids, but in terms of congestive heart failure, cardiac output and stuff like that I think there’s some impressive data, I just don’t know enough about it to speak on it.

SF: As far as how the GLP-1 works, do we know if there’s a particular nutrient like the fat or the carbs that promotes the release of the GLP-1 peptide because I’ve seen information that it’s really the fat.

Dr. Edelman: I really don’t know, but that’s a great question.

SF: What kind of results have you seen with the GLP-1 as far as reducing A1c in lipids?

Dr. Edelman: I think in reality it sort of comes down to how much weight they lose, because the more weight people lose it seems like their A1c drops more.

So I’m seeing very typically 1 to 1.5 percent drop in addition to the 20 to 25 pounds weight loss, and I think that’s pretty darn impressive.

SF: Is it the GLP-1 compound that is responsible for the lowering of blood pressure or is it the weight loss?  Not that it really makes any difference because the end result is what counts.

Dr. Edelman: Well, I’ve heard people at Amylin, say that when they do all their little sub-analysis and subtract the effect that you would expect with weight that there’s some additional benefits. So I think I agree with you, it doesn’t really matter, you’re getting the benefit and that’s what you want.

SF: Have you seen any positive results as far as neuropathy goes or in nephropathy when it comes to using the GLP-1s?

Dr. Edelman: No, not at all. Once again, I don’t want to sugar-coat anything, but I think these medications are under FDA scrutiny and anything that occurs to anybody on these drugs, they get listed and then they have to revise the package insert. You know, how many times patients have gone into renal insufficiency on insulin, you just don’t know if it is the insulin or not?

I just think we have to be cautious on looking at the side effects; we have to always look for them but I’m not convinced that GLP-1s including Byetta can cause renal insufficiency. I think they just caught someone in that stage in their kidney function and since they were on the drug it got listed and it got reported.

But once again I don’t know for sure. There’s just no physiologic sense either for that.

SF: And from your knowledge and from what you’ve seen, what is the GLP-1s effect on beta cells as far as apoptosis and regeneration. We have seen improvements in animals, but we have no way to measure the effect in humans. What is your take on that?

Dr. Edelman: Well, I might have misinterpreted your other question earlier but I was referring to that when I was talking about David Harlan who did human studies in type 1’s with beta cell function, and they were put on Byetta with or without immunosuppressants and they showed no difference.

And in that one-year study when I looked at beta cell function and type 2’s they only saw effects on insulin secretion and stimulation, with or without arginine only while they were taking the drug, and then when they stopped Byetta their insulin secretory abilities returned to baseline.

So, once again, it’s only been animal studies; it has not been shown in humans.

SF: How do you overcome the fear of injection with your patients?

Dr. Edelman: I think that the way I do it is: I inject them right there in the office with a 31 gauge or a 32 gauge, 4 millimeter ultrafine needle. I don’t inject the drug I just get out the syringe and/or pen and I ask them if they can feel it — and I do it in the back of their arm, and I say, “I’m going to put this needle in you with or without that cap.”

And I always do it without the cap first and I do like the little dart motion, and I say, “Did you feel that?” And they say, “No.” And I say, “Take a look.” And I have them look over their shoulder and there’s the syringe just dangling in the arm. So I think that is my own personal attempt to overcome the phobia and most of the time they say, “That’s all?”

So, as you know Steve, it comes down to the first injection.

SF: What are your thoughts, with pre-diabetes becoming an epidemic and the numbers growing and growing, what do you think of possibly — and obviously it’s an off-label use — using the GLP-1s as the number one choice after metformin as far as treating these people because of the weight and the possible weight loss, and that’s where most of the problem comes from.

Dr. Edelman: Yes, I think that’s where it’s really going to make a huge impact. Think about, when someone has pre-diabetes, you know the vast, vast, vast majority are overweight, it does not cause hypoglycemia, leads to weight loss, you’re mimicking a natural hormone. I think it would be tremendous.

And this is the one drug that if you put someone on a caloric-restrictive diet they might be able to follow it because of the effects on satiety.

SF: And is there a time when you would prefer a DPP-4 over a GLP-1 if self-injecting was not an issue?

Dr. Edelman: Well to be honest, no. If self-injecting is not an issue, you know, the only thing is — do you want weight loss or do you want weight neutral? Do you want more A1c reduction or do you want less A1c reduction?

The only issue is the side effects; you have to get past the nausea stage.
SF: Do you think there’s any relationship to beta cell function to GLP-1’s, or are they really independent of each other?

Dr. Edelman: I don’t think any of these hormones are independent of each other to be honest with you.

SF: Do you think the cost of the GLP-1 compounds has been a factor in your prescribing it to your patients? If they have insurance the co-pay can be ridiculously high: if they don’t have insurance that’s a huge expense.

Dr. Edelman: Yes, it’s a big factor – developing all these new drugs and devices is one thing, getting access to them is another and that’s a huge pushback, I mean these things are expensive.

You know, for my debate, I went on to Drugstore.com and got $450.00 for Victoza at the higher dose and $350.00 for Byetta; that’s one month. So I think that’s an issue, I really do.

SF: What do you think is the key to physicians’ acceptance of the GLP-1 therapy? Because I know many physicians want to wait ten years to make sure that there are no side effects and yet the drug has proven itself over the last five to seven years — it’s been very effective.

Dr. Edelman: I think we’re getting there. I’ve heard it takes ten years for a physician in practice to change his or her practice habits after a drug is being marketed, for a drug to really take hold, and I think that’s going to be true with GLP-1. If you look at the usage now it’s very low and growing very slowly.

So I think Victoza was a nice addition because it’s once a day and you don’t have to take it in relation to any meals. And soon we’ll have once weekly and then maybe once monthly and maybe they’ll develop formulations with less nausea. So I think all of that is going to help improve the situation. But it’s going to take time and, it’s hard to change caregiver’s practice habits once he or she has left their training program.

SF: Are you looking forward to the release of Bydureon?

Dr. Edelman: Oh sure, absolutely. I don’t think it’s going to be a slam dunk, it’s going to be difficult because you still have to teach people how to mix it and the gauge is much smaller like a 25-gauge needle and you have to mix it.

It’s not real hard but it’s just a couple added steps that would be nice if we just gave it in the pen.

SF: My last question is what other new therapies in the pipeline are you really most excited about that you’re familiar with?

Dr. Edelman: I would say this; I’m looking forward to — even though I’m pretty happy with my DexCom — I’m looking forward to more accurate and more accessible continuous glucose monitoring devices. I’m looking forward to eventual closed loop, I think that’s going to come before any artificial pancreas, any cure for type 1’s, but that’s going to be a while.

Wait, I take that back! My single biggest hope in the future is the ultra-rapid-acting insulin’s, because that’s a big frustration now in that the sub Q insulins act too slowly; so that’s my number one wish for type 1s.

For type 2s I would say this — two things — I think the SGTL2 inhibitors — I don’t think they’re going to be blockbusters, but I do think they’re going to be another drug that’s going to help with weight loss, no hypoglycemia and oral administration. And of course that class can be used in type 1 as well. So I would say those two things.

SF: Dr. Edelman, thanks again for your time today
Edelman: Steve, thank you for your friendship and your support and it was a pleasure.
SF: Okay, you take care and keep doing what you’re doing with your program as far as educating patients because I think you have a huge impact and you probably don’t even realize how huge of an impact that you have.

Dr. Edelman: Well, I appreciate that. We all do our part and you do yours too.

SF: Thanks a lot.
Copyright © 2011 Diabetes In Control, Inc.

edelmanDr. Steven Edelman is a native of Southern California and has been living with type 1 diabetes since the age of 15. After completing his diabetes specialty training at the Joslin Diabetes Center in Boston, he came to the University of California at San Diego, where he has been on staff since 1990. Dr. Edelman is an international leader in diabetes treatment, research, and especially education. Dr. Edelman champions the cause of patient advocacy and has dedicated his life to helping people with diabetes live healthier and happier lives. He is founder and director of Taking Control Of Your Diabetes (TCOYD). Dr. Edelman is a professor of medicine in the Division of Endocrinology, Diabetes & Metabolism at the University of California at San Diego (UCSD) and the Veterans Affairs (VA) Healthcare System of San Diego and the director of the Diabetes Care Clinic, VA Medical Center. He achieved high honors during his undergraduate studies at the University of California at Los Angeles and was the valedictorian of his medical school class at the University of California Davis Medical School. Dr. Edelman received his internal medicine training at the University of California Los Angeles, and completed his endocrinology fellowship training at the Joslin and Lahey Clinics in Boston, Mass., as well as a research fellowship at UCSD. Dr. Edelman has strong interests in education and patient advocacy.

He is the founder and director of Taking Control of Your Diabetes (TCOYD), a not-for-profit organization with the goal of teaching and motivating patients in diabetes self-care. Since 1995, TCOYD has reached hundreds of thousands of people living with diabetes through a variety of education portals including national conferences, publications, television, and community programs.

Dr. Edelman has written more than 200 articles and five books. He has won numerous awards for teaching and humanitarianism and was recognized by San Diego Magazine as a Top Doctor seven of the last eight years, an honor only achieved by a handful of physicians. He was chosen as the teacher of the year amongst the over 400 faculty members at UCSD numerous times. He is an active member of the American Association of Clinical Endocrinologists, The Endocrine Society, the Juvenile Diabetes Research Foundation, the American Diabetes Association, the American Association of Diabetes Educators, and the International Diabetes Federation.