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🎙 The Truth on Diabetes: Medication and Guidelines Ep 226

• Dr. Michael Koren, Arpeta Gupta • Episode 226

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In part two of our Truth on Diabetes series, you will understand diabetes treatments as we sit down with Dr. Arpeta Gupta to dissect the latest guidelines and the transformative impact of newer diabetes medications. We will discuss how SGLT2 inhibitors and GLP-1 agonists are not only enhancing glycemic control but also delivering critical cardiovascular and renal benefits. We revisit the troubled history of TZD drugs like Avandia and contrast it with the safety profiles of today's leading medications. Drs. Gupta and Koren dive into the complexities of managing diabetes care across multiple specialties and share actionable strategies to improve interdisciplinary communication for better patient outcomes.

Navigating the hurdles of diabetes treatment access is no small feat, and we tackle this issue head-on by examining how insurance policies and cost barriers affect patient care. From the implications of prior authorization and step therapy to the financial strain on patients, particularly those on federal plans, we leave no stone unturned. We also explore the exciting potential of federal drug price negotiations and recent strides in lowering insulin costs. The significance of selecting therapies that safeguard end organs and the advantages of participating in clinical trials for cutting-edge treatments are underscored, ensuring you leave with a comprehensive view of the future landscape of diabetes care.

Koren's Key Three Takeaways:

  • Guidelines and Effectiveness of Diabetes Drugs
  • Diabetes treatment access and insurance
  • Challenges and Future of Diabetes Treatment

Recording Date: June 19, 2024

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Have a question for Dr. Koren? Email him at askDrKoren@MedEvidence.com

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Music: Storyblocks - Corporate Inspired

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Announcer:

Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts. Hosted by cardiologist and top medical researcher, Dr. Michael Koren.

Dr. Michael Koren:

Hello, I'm Dr. Michael Koren, the executive editor and host of MedEvidence, and Dr. Arpeta Gupton and myself have been having this really interesting conversation about endocrinology, diabetes and the drugs that we use to treat diabetes, and we've been talking about changes in the guidelines that are looking at ways of telling physicians in a general sense, giving us some information about which classes of diabetes drugs are better than other classes and whether or not the patients that we treat should be preferentially treated with one type of medicine versus another, and we started having this great discussion in our last session about these things and we're going to jump right back into it. So just a quick reminder for people that might have missed the first portion of this just in a sentence or two, just tell us about these new guidelines and how they're affecting doctors, or two just tell us about these new guidelines and how they're affecting doctors?

Dr. Arpeta Gupta:

So the new guidelines are starting to recognize the comorbidities associated with diabetes. We are finding evidence about the benefit of using newer medicines like SGLT2 inhibitors and GLP-1 agonists for reducing cardiovascular disease and reducing nephropathy, preventing coronary artery disease progression. So the guidelines have included algorithms that can guide physicians on when to use these classes of medicines and for what reason.

Dr. Michael Koren:

So this gets into a really interesting discussion that looks at evidence-based medicine and, as a person that does clinical trials all the time, I've actually been involved in a lot of clinical trials of diabetes drugs to show whether or not they're safe from a cardiovascular standpoint, and it's kind of interesting. You go back about 15, 20 years ago and there was a concern that certain diabetes medications actually made patients with heart disease worse. In particular, there was a class called TZDs. If memory serves me, thiazolidinediones, I think, is what TZD stands for so I'll pat myself on the back for pronouncing that somewhat correctly and these are drugs like Rezulin, which came off the market because of liver problems. Avandia and Actos are still on the market, I believe. Am I correct about that?

Dr. Arpeta Gupta:

Avandia is out of the market because it has shown cardiovascular deaths. Rosiglitazone that was Rosiglitazone. Pioglitazone, which is Actos, is still widely prescribed.

Dr. Michael Koren:

So, again because of this class had some controversy and ultimately was shown to not be the best for people with heart disease, and these are drugs that may be associated with worsening of congestive heart failure the FDA started to require very major studies looking at the safety, and we started doing safety studies on GLP-1 drugs, for example, or SGLT-2 inhibitors, and, lo and behold, not only were they safe but they actually improved cardiovascular outcomes, and so this whole other idea developed that drugs that were used for glycemic control, for sugar control, actually could be used independently of diabetics and be used directly for patients that could benefit from them, just because there are other effects. So your comment on that, Dr. Gupta, would be really, really interesting.

Dr. Arpeta Gupta:

This was a very welcome result that we saw. It wasn't surprising, though, because these molecules do have. They work on all these different organs. Like the GLP-1 analogs have receptors in the gastric, the GI tract, in the liver, in the heart, in the kidney. The SGLT2 inhibitors work on the kidney and the heart. So these were welcome results. I am glad the FDA has recognized it and given independent indications where these medicines can be used, like you said, independent of diabetes, just for preventing cardiovascular death or preventing hospitalizations from heart failure. Also, another one is obesity, right. So they are also approved for obesity, independent of having diabetes or not. But it does put us in a pickle, because then we have cardiology ordering it and nephrology ordering it and endocrinology. So where does one draw the line is the big question. How do we coordinate work as a team, close the gap so that we are doing what's right for the patient and everybody is not doing their own thing?

Dr. Michael Koren:

Yeah, and it's a great point. We're going to talk a little bit more about that. So just as a cardiologist, I'll see somebody on Actos that has a history of congestive heart failure and I immediately get heartburn because I know that that can be associated with fluid retention and potential worsening. To your point, not as much as Avandia, which was obviously taken off the market at this point, but still in the same class and the same type of drug, and I much prefer that that person be on some of these classes that are proven to be more beneficial for heart disease.

Dr. Michael Koren:

And in the modern era, with all the electronics that we have, it's still really hard to talk to people. You know, in the modern era, with all the electronics that we have, it's still really hard to talk to people. So you know, back in the old days you just get on the phone and you kind of hash it out, and now there's more email exchanges and other things that may make it trickier and confusing for patients. So just what strategies have kind of worked with your other consultants in these different specialties? Have kind of worked with your other consultants in these different specialties? Or how do we? Or just give everybody advice on how we can get better at giving rationalizations for the drugs that we choose for diabetes.

Dr. Arpeta Gupta:

So you're absolutely right that piaglitazone or Actos would not be my first line drug of choice, but it is also present. It's there to be used in the right person and you have to identify the reasons why it would be prescribed. So when you're going down the algorithm and I'm not talking about type 1, I'm not talking about insulin you have a person with insulin resistance, type 2 diabetes, who has maybe other comorbidities like hypertension, hyperlipidemia, obesity. Where do you start? So the first line of treatment does still remain metformin, according to the new guidelines the American Diabetes Association. It's a generic. It has been out for a very long time. It has a role for fatty liver. It prevents fatty liver. It has proven cardiovascular benefit. It is anti-inflammatory. It helps with weight loss. It is still the only medicine other than insulin that is safe in pregnancy, so it is a very important medicine that one cannot skip over. So in my opinion, it still does remain as long.

Dr. Michael Koren:

So let's just it's a really interesting point. So metformin, we know there's no question it's safe. But some may argue that the cardiovascular benefits of metformin are not necessarily on par with the cardiovascular benefits of the other classes that we mentioned. So how do you react to that? And are there times where you just break with the guidelines and say you know you don't need that much diabetic control but you're a cardiovascular mess? Maybe I don't go with metformin?

Dr. Arpeta Gupta:

Absolutely, you are right, and head-on-head randomized trials have shown that the newer medicines, like the GLP-1 analogs and the SGLT2 inhibitors, are far superior than metformin for cardiac and renal protection. But you know, in today's day and age, with rising healthcare costs, with how much money we are spending in healthcare, one does have to run a cost-effective analysis, a cost-benefit analysis, and when you actually break it down into that, then these medicines are not cost-effective. These are published, these are by the American Diabetes Association, and cost-benefit analysis favors metformin over GLP-1 analogs and SGLT2 inhibitors at the cost that they are today. Now down the road, if these become cheaper then there will be no discussion about this.

Dr. Michael Koren:

And that's a key point. So metformin is an inexpensive generic drug and just using the SGLT2s as an example, farziga and jardia are quite expensive. Our patients often struggle getting approval for these drugs. But the flip side of that just to be very transparent is that because the guidelines state that metformin is first line, sometimes we have the problem that insurance companies will not approve the newer drugs because they're saying you're not on metformin. That creates a dilemma for physicians if we actually think in that particular case there's a justification for the more expensive drug. So I don't know if you agree with that or not, but that's something I've seen from my patients.

Dr. Arpeta Gupta:

I agree with that wholeheartedly. There is a process called prior authorization. For the benefit of our listeners, it is an authorization that the physician's department has to do to get some medicines approved for you from the insurance companies, and some insurance companies requires a step therapy with metformin before they will let you proceed on to the more expensive medicines. That is always seen and the reason for that is the American Diabetes Association guidelines. However, taking it ahead, if somebody does get on them and they get approved by the insurance, still the cost is not zero dollars. The cost depends on your coverage plan, where the commercial plans will provide much better coverage than the federal plans. The companies also have savings cards that bring the cost down to zero dollars, ten dollars, twenty five dollars. However, those can only be used if you have a commercial plan and cannot be used with a federal plan. So the problem unfortunately we face is with our older population and even in that with the population on Medicare Advantage, because over there you are responsible for 20 percent cost of the medicines.

Dr. Arpeta Gupta:

The SGLT2 inhibitors are around $700 a month. The GLP-1 analogs are $1,200 a month. So 20% of that cost, even if approved by the insurance, is not doable for a lot of patients who are relying on retirement benefits only. So one does have to take that into consideration. So it does not matter if they are line one or line two on the guidelines, At the end of the day a patient can still not afford them. Also, we still are struggling with the concept of the gap, the coverage gap, also called a donut hole. So even if the insurance picks up these medicines and they are cheap for the first three months or so, they are going towards that coverage allowance and these people do then end up in the gap in their fourth or fifth month.

Dr. Michael Koren:

And that's a great explanation and really important. The other future wildcard and I don't think any of us know exactly how this is going to play out is that in about a year and a half, the federal government will be able to negotiate directly for the price of some of these diabetes drugs, and I think I know that's high on the list of places where the federal government is going to negotiate the prices. Have you heard any word about what type of savings people might see after that occurs?

Dr. Arpeta Gupta:

I'm really glad you brought that up. So the last year has been very exciting in terms of this for diabetes. The government has successfully brought the price down for insulin. It was long overdue. This molecule that has been out for 100 years still was not affordable. Now there has been a price gap on insulin, whether you have commercial insurance or Medicare or government insurance. It is $35 a month and it does not go towards your coverage gap. So insulin has definitely become much more affordable. However, unfortunately discussions are not in place for GLP-1 analogs or SGLT-2 inhibitors at this time because they are still under patent and that takes many years for it to go away. So no word on that. We are hearing word that the government might do away with the donut hole itself in the next year or so. That will definitely be a welcome change for our nation.

Dr. Michael Koren:

Yeah, in the quote Inflation Reduction Act bill that was passed a couple of years ago, there's now legislation that will introduce the concept of price controls for certain expensive and very widely used drugs, like the diabetes drugs that you mentioned. So we don't know how that's going to play out yet, but we'll be hearing a lot more about that over the next year or so and it'll be interesting because the US will join most countries around the world where the government is the biggest buyer of these drugs and is given some input in terms of what they sell for. So that's really going to be interesting from a number of perspectives. So, getting back to the final point I want to make which is, I think, something we've really alluded to but is really just so important that I want to really focus on this is that diabetic patients in general are extremely high risk for multiple medical complications of different flavors.

Dr. Michael Koren:

So, as you mentioned, they're at risk for cardiovascular disease, which is probably number one, the renal disease, they have problems with their eyes, neurological problems, et cetera, et cetera, and more and more. The treatment of diabetics is focused on how to protect these end organs and the decision of the endocrinologist is about what is at highest risk for these patients and how can I come up with a therapy that's going to ultimately help these people? And then the other part of this is kind of what I do day to day as a clinical trialist is we recruit patients for trials and we want to make sure that we're finding patients that can benefit from what we're doing. So, for example, when we're doing a cardiovascular outcomes trial whether it's a cholesterol medication or something that thins the blood we want to find diabetic patients, because their risk is much higher and because their risk is higher, their potential benefits are higher. So I just want you to kind of give us a little comment on your thoughts with regard to that.

Dr. Arpeta Gupta:

So I just want you to kind of give us a little comment on your thoughts with regard to that, both in general, having diabetic patients participate in clinical trials that may not be specifically related to glycemic control for some people who can otherwise not get them, and it is under controlled settings. So they are being monitored and regulated, so I do think there is a benefit for patients to enroll. There are ongoing clinical trials for weight loss with GLP-1 analogs. Those can be very helpful for patients to get into the NASH.

Dr. Michael Koren:

They're very popular. By the way, Our center runs a lot of those trials and that's the one trial that has a long waiting list of people that want to get in, so that is very popular. Thank you for bringing that up.

Dr. Arpeta Gupta:

Another one is non-alcoholic steatohepatitis. N is an extremely under-recognized entity in somebody with type 2 diabetes. We are now recognizing patients who come to us with cirrhosis. This is where prevention plays an important role. We are very lucky that there is recently an FDA approved medication for this condition now. It was long overdue, so clinical trials for this indication would be helpful. Also, I know the research center runs has FibroS cans that can be offered to patients for free to understand how much NASH they have or what level of fibrosis they have Hit the ground. Running is what I say. Knowledge is power. You need to know what you're dealing with because it's going to motivate you more, you know, encourage you to be better about optimizing your diabetes and weight loss and other comorbidities, so I think that's very helpful. Sleep apnea is, I understand, another area where you are heavily involved in with research. Sleep apnea increases the chance of developing diabetes by 30%. It increases risk for heart failure, as you know in cardiology, so sleep apnea trials would also be helpful at this time.

Dr. Michael Koren:

Yeah, all those areas we're working on. The drug that was approved for NASH, now called MASH they just changed the wording actually is a thyroid analog and, interestingly enough, it's certainly an area for endocrinologists to work on and it's an area that we also study and research. So we're learning more and more that all these systems, these hormonal systems, are connected to one another and working one system can help another system and vice versa. So that's a neat part of what we do day to day and also the intellectual challenge of clinical research. So it's fun to identify a patient, know that patients get a lot out of their experience in clinical research and then find the right project for the patient.

Dr. Michael Koren:

And so often people are interested in doing research for a number of reasons and our job as clinical researchers is to say, okay, well, we have like three or four things you can actually do and this one is probably going to be best for you because I think you're going to get the most long-term benefit from cardiovascular risk factor reduction or protecting your kidneys or fixing your liver fat or whatever the case may be. So to me that's part of the neat intellectual challenge and, ultimately, what we do to serve our patients. So thank you for that insight, sharing your insights. Anyhow, Arpeta, this was an amazing conversation. Thank you so much. I learned a lot. I love doing what I do because I learn every day and you certainly have taught me quite a bit during our discussion. And thank you for being a guest on MedEvidence and we'll definitely bring you back and we'll talk about another topic. You just name it.

Dr. Arpeta Gupta:

Thank you very much. Thanks for having me. This was wonderful.

Dr. Michael Koren:

Take care.

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