Listen as Kristina Kratovil, M.D., Sentara Comprehensive Weight Loss Solutions, describes treatment plans for obesity, reviews FDA approved AOMs, and defines use and misuse of these medications.
I'm Christy Ville. Um, I'm with Center Comprehensive Weight loss. I'm one of the Bariatrician. I'm, uh, out of, uh, Norfolk and I, uh, also work out of O BC on Tuesdays. Uh, so with my, um, amazing team of bar other Barat A PPS and as I call them my surgeons. So, um, so we're gonna talk about, uh, misuse use of weight loss medications or weight loss drugs and, uh, like any, like any talk that I like to do, I like to go over a treatment plan for obesity and also define what obesity is. We're gonna just briefly review FDA approved anti obesity medications and medications we commonly use as anti obesity medications. Um, I'm going to define quote unquote use and misuse, uh, which is a little bit of my opinion on what that means. Um, or maybe a lot, my opinion on what that means, but I'll try not to be too snarky. And then, um, we're gonna discuss a couple of cases, uh, that I just think would, will bring it to light into practice a little more applicable for what we're doing day to day. And then we can, uh, you know, open the floor to questions and comments. Um So describing a treatment plan for obesity. Um so the obesity Medical Association or O ma defines obesity as a chronic progressive relapsing, treatable multifactorial neurobehavioral disease wherein an increase in body fat promotes one adipose tissue dysfunction and two abnormal fat mass physical forces. This results in an adverse metabolic biome and I'm sorry, an adverse metabolic biomechanical and psychosocial health consequences. I like to break it out a little bit like that to really put into play that, you know, this is about adipose tissue dysfunction as well as abnormal fat mass, physical forces. So there's the sick fat disease and what we call the fat mass disease that work together uh to cause the problems that our patients struggling with obesity deal with every day. So this is, you know, an out an algorithm that the O MA has put out and this is from 2022. There is uh an update but there's not much of an update to, to this actual um picture. So identifying obesity as a disease, which we just did. Um and then data collection. So the AM E in July had their annual meeting and you may or may not have heard that BM I is out and they're, they, they are endorsing that we are looking at things like body fat, uh percentage and uh waist circumference, other ways to define uh and measure obesity. But I point that out because under data collection. I do think the BM I still serves an excellent purpose for, for screening and so patients um when we're collecting our data on who we're going to uh treat that needs to be a part of that, the evaluation and assessment. Um H MP, you know, we're all familiar with this, looking at um looking objectively at lab reports, et cetera and management decisions. This is that shared decision making with the patient of what needs to happen next. Um What, what are they ready to do? And and what are you, what are you ready to help with and what resources are available? The the bottom line here of nutritional intervention, physical activity, behavior therapy. This is a very important part of the treatment plan. This overall management of obesity, pharmacotherapy and bariatric procedures. Um some would say should be the adjunctive treatment and this is the foundation here. Um I think that all of these things I like how the O MA puts them equally because I do think that they need to be equally considered and part of the treatment plan for patients. So the American College of Lifestyle Medicine uh has an obesity position statement um stating that adequately dosed lifestyle interventions may unilaterally achieve success. But obesity again is a complex multi factorial disease. So patients require approaches beyond just lifestyle lifestyle interventions are too often, however, not adequately dosed. And I like the way this is put because it's thought makes, makes us think about um lifestyle interventions as, as a prescription for care rather than just, um rather than just a, you know, an adjunct. So FDA approved anti obesity medications and medications commonly used as anti obesity medications. So FDA approval of a drug means that data on the drug's effects have been reviewed by the center for drug evaluation and research and the drug is determined to provide benefits that outweigh the known and potential risk for the intended population. So, when I have this discussion with patients about pharmacotherapy, a lot of that's uh to allay fears of the risks, uh, that have been uh associated with a lot of these medications in the past and to also put it into a, a more objective perspective. Not I have a friend who tried it and this happened. Um, so FDA approved anti obesity medications are on label. So we have our sympathy, metics, soph and die appropriate. Our schedule for, um, metics of stimulants that help with appetite suppression and what I like to call productive energy. Uh, Thometz and ben amphetamine or schedule three, these are not common patients don't really tolerate them very well. In my experience, pharmacists don't know them and they're hard to get in or don't know them very well and they're hard to get. So I don't prescribe these very often. I may be prescribed a dozen times. Um, but phetamine death appropriate are I use fairly routinely. Um, as a a as appetite suppressant to help get us started on the uh weight loss journey and treatment of obesity CIA is uh is the on label or FDA approved uh weight loss medication for um uh uh phetamine into a pyramid. So it's approved for chronic use for maintenance use. So once a patient gets to their goal, um and once you have uh gotten them to a healthy state, you can continue them on QIA uh long term, same with Contrave. Contrave is also approved for long term use. Now, Rexon bro Xeno or, or um also ally over the over the counter uh is works at the level of the gut to block fat and is usually not very well tolerated. Um Plan is actually a device that is uh in that you take in, in a capsule form that takes up space in the stomach. Basically, it's uh I kind of joke that it's the, the fiber and uh and apple Cider vinegar solution that we've been using for many, many years that somebody was smart enough to put into a capsule. So not me but somebody and then uh G LP one R A is the the hot topic. Uh So they've kind of stolen the show Saxena and Wigo on um the, the uh magic bullet for weight loss. Um I mentioned these two MMK which I can never say, right. Um which is for inherited metabolic disorders and Vivian, which I do prescribe for patients who have been diagnosed with the DS M five binge eating disorder. Um Vivian does help patients who have binge eating disorder. I have not, I have not uh prescribed uh set mela before. Um this is only for inherited metabolic disorders such as patients who have Bardi beetle or um uh palm c uh leptin receptor deficiencies. So not something you're gonna see yet, but I know that there is uh some stuff coming out about this for patients beyond just the hypothalamic disorders. So that's our, those are our FDA approved A O MS. OK. On label, commonly used off label, which is where most of us lived for many, many years and uh treating our patients with obesity. So sympathy medics, anything beyond three months for these medications is considered off label. I'll leave. I will tell you that I had an insurance company today, not approve one of my patients because she has been been prescribed phentermine more than three months and they will not, they will not give it to her anymore since it's off label FDA usage at this point. Even though she is still losing weight on the medication to pram off label uh for obesity, not only on label for migraines and seizures. Now, Trex on label for uh substance use disorders, uh part of Contrave on label for obesity but not on its own as is Broin off label uh for weight loss on its own. But on label as a part of Contrave. Also on label for our patients who are uh using it as Zyban for tobacco cessation uh or well butter for weight uh or excuse me for depression. So this can be a nice choice when you're, these two can be a nice choice when you're trying to kind of dual treat people for um substance use disorder, depression. Uh as with the pyramid, if you're trying to help a patient who has migraines, you can always titrate up for weight loss. Um GOP one ras, so these are our uh type two diabetes approved GOP one ras. Victoza Zic rebels etta Trulicity. Um that off label can be used for weight loss. I will tell you you're not going to have very much success getting them approved for obesity and weight loss. Um But if you can get them approved for pre uh excuse me for prediabetes, um Glycemic control metabolic syndrome, uh uh even PC OS with insulin resistance, um some insurers will approve now that is uh changing the tide is changing on that. Um And I expect that we're going to start to see a lot of uh our patients who were previously approved for these medications for those indications no longer getting approval, which is going to be a problem. Uh TPI or Manjar right now is only FD approved as Manjar for type two diabetes. Uh Lily should have the TPI weight loss version out uh at the end of this year, um, more to follow. So we should use these medications for an FDA approved indication when we can so that we're able to keep patients on it and patients don't get abruptly taken off them and experience things like weight cycling or, uh, or recurrence of weight or weight regain. Um, and off label for obesity and weight loss as an adjunctive treatment. When we can, I will say these are um these medications, you know, we all we had for a long time to use. And so the off label use is, is widely accepted of these uh medications for weight loss and obesity. So to define use and misuse, um I really wanna put use as more appropriate use. And to me this doesn't mean just on label, this means appropriate use is any anti obesity medication or common or medication commonly used as one on or off label, as long as we're not using it just on its own. And see you back in a couple of months as long as we're doing this responsibly and, and trying to get the patient to the resources for intensive lifestyle interventions at the same time. Um and also as a part of that comprehensive treatment plan that I mentioned in the beginning, um we need to be looking at this as a dynamic, uh It's a dynamic treatment, things are going to change, it's going to branch off. Uh just because a patient didn't want bariatric surgery at A BM I of 50 got down to 42 with weight loss medications. Doesn't mean that they wouldn't still benefit from bariatric surgery. I would argue that patient would benefit more from bariatric surgery and putting their disease in remission. Um, misuse only off label. I again disagree. I think that, um, any anti obesity medication on or off label can be misused if it's used in a vacuum. So I don't think giving a patient will go and sending them on their way. That's not going to work. These, these medications, um, were, uh studied with intensive behavioral and lifestyle interventions and that's where we are seeing excellent weight loss. I see really great weight loss because this is what we do here every day with these patients that we're using in combination with uh dietary support, um, medication bariatric surgery following up with us every few months. You know, we're, they're not being used in a vacuum and also individualized goals. I say it this way because one of the questions I ask people when I first meet them is, you know, what, what has been your challenge? What is your greatest challenge? And I feel that's a very, uh, very, uh powerful question, uh because you get a lot of different answers. And, um, and it helps guide me on where, what the, what the patient's goals are in terms of, you know, numbers in terms of I, you know, need to get back surgery. I wanna have a, I wanna have a baby. Um, I, you know, wanna wear jeans I wore in high school, which I usually try and stray people away from. But, you know, there's a lot of different goals out there and if we can meet somewhere in the middle, then I think that appropriate use of these, uh, medications, uh, with a comprehensive treatment plan is, is what we're looking for. I put this in here just as another ob obesity position statement um that I liked that the comprehensive Lifestyle medicine approach prevents and treats other comorbidities associated with obesity and overweight and including not limited to our very common comorbidities as well as reducing the risk of many types of cancer. And that uh lifestyle medicine should become a foundation of comprehensive treatment with or without surgery and or medications as adjunctive therapies. The reason I put it in here is that that bottom line of the algorithm that I talked about. I, I think that is very powerful in the uh foundation is not just medication, not just surgery, not just lifestyle or not just behavior, not just exercise. I mean, there's, this is all equal and if we're able to provide patients with the resources necessary, uh then I think we're going to see it's going to be game changing with medications. So the first case is a patient that uh she's 44 surgical assistant was Centra um came to me with, uh, obesity at a BM I of 37 had, uh, osteoarthritis of the knees, which was becoming a problem as a surgical assistant. Um, and was one of her big reasons for wanting to, to lose weight. Um, also, uh, so started seeing me, um, in January of 2022 she was very consistent with her appointments, uh, was very compliant. Um, we talked dietary interventions in the beginning. I always provide a meal plan. Um uh dietary resources, she was skipping a lot of meals. So we worked on that. Uh Also, you know, strategic dehydration in the or so we uh also came up with ways to make sure she was getting the, the right fluids in the right amount of fluid in. And I always tell people if you can get nothing else out of today on that first visit, you know, lean low fat proteins, uh high fiber and water is what I want you to start thinking about. Um So that helps uh limit animal proteins increase our plant based proteins in fiber and then get that water and she was already using her pelot. So we, I just told her to keep doing that and uh medications, she uh though she was doing meal skips, she would find that she was ravenous. So I thought at the end of the day and also with her kids, uh she would tend to want a snack with them at night. Um and she and she and her wife would like to have some drinks at night. So to help kind of curb that, I thought the toy would be a, a nice choice. It can help, uh, with, uh, people with, uh, decreasing the amount of alcohol they're taking in as well as the phentermine was going to help. I hoped with some uh productive energy as well as um helping with the, uh, helping with the metabolism and appetite suppression at the end of the day. So in three months, she was able to lose uh £24.5 or 9.2% of her body weight more than I would expect at three months on phentermine. Um and she was at the 37.5 mg at that point to pyramid, 100 mg twice a day, which is kind of the goal off label dosing you're looking for um for to pyramid much higher than that. You don't usually see much benefit. And that's usually reserved for patients who are uh who have a seizure disorder. Um And that's really the highest dose of ph I I don't always uh go that high, but this was what was working for her. Um So if I were to continue with an on label use, I would have stopped the phetamine at this point because we're at three months and I would never have started the, the top pyramid because it's not on label for obesity So, at, in July, when I just saw her, she's lost 25.4% of her body weight, £67.5 in a year and a half. And we're continuing phetamine to pyramid. She's continuing to lose weight. Um, she's, uh, able to, uh, not use Motrin, uh, vitamin M constantly, uh, for her knee pain, which is almost resolved. Um, and she also has an, you know, an improved quality of life with her family at home, um keeping up with her kids, uh much better. Um So for this patient, if I wouldn't have, if we wouldn't have done these things, uh that were all off label, then, you know, if she wouldn't have had, I don't think just with dietary intervention and Peloton, uh the success that she did so appropriate misuse, um you know, we did talk intensive lifestyle interventions. She had already, you know, done a lot of this herself, but I provide a little bit more guidance for her focusing in on a couple of areas where she could uh have made, made some improvements. Um femine again off label beyond three months to pate is off label entirely for obesity. But why didn't I use Kimia? She's a, a centaur employee. We have coverage um at that time of her initial appointment in January of 2022 we did not have the insurance coverage yet um for, for our, for our uh employees. But when we did get coverage the following year. Um, or I think we just had gotten it in 2022. Um, but anyway, I, I, it wasn't broke so I didn't fix it and, and kept her on the phetamine and the pram so some take home points for her. Um, we already kind of covered. I, I am sure weight gain would have occurred if I had stopped, uh, the phentermine at three months. Um, and whereas long term use of phetamine is off label and use of to pyramid is off label maintenance. Use of CIA both of these medications together is on label. So, uh, phetamine was, you know, came out in 1959 FDA approved in the seventies for three months, for three months or short term use will not be studied on its own again because, um, this is where my snark will come in and I will keep it short because you got to follow the money and that's, that's not gonna bring it in. So case number two, 46 year old male longshoreman, um, his, uh, his, uh, BM I was 47.6 when he started with me. He was prediabetic skirting the diabetic line at 6.4% for many years. Uh, OS A on CPAP hypertension, uh, had ad D not being treated. Um, and bed seven is the binge eating disorder screener and he tested positive for a, uh, uh, aspects of binge eating disorder. Um, started seeing me in July of 2021. Um I saw him very irregularly. He was inconsistent with his appointments a lot due to the nature of his work. Um, we saw each other lessons, uh, 10 times over the course of that year and a half. Um, I did try to work with him on dietary interventions, cutting fried food and liquid calories, which was a big part of his, uh, his diet due to, again the nature of his work, um, where he worked, uh, convenience and just what he'd been doing for, you know, a very long time. Um, a little education went a long way with that eventually, uh, he was active on his job but no other dedicated exercise. So due to the limitations on, uh, on medications that I could prescribe just with his coverage, we decided to try phetamine into pyramid to pyramid. I was hoping would help with, uh, one of the side effects with, to pyramid. People get a funny taste in the mouth when they drink something carbonated. So I was hoping that would help deter some of those liquid calories. Um, and, and it did, um, and then, uh, the phentermine, um, definitely helped with his, uh, snacking throughout the day, not, uh, when there was things in the, the kitchen or where he was at, um, where at, with his workplace, he, he felt didn't feel the need to, to have the, the doughnuts that were brought in that sort of thing. So that did help him out. Um, and then met Foreman to help improve his insulin resistance, uh, and known, uh, uh, uh, diabetes prediabetes, excuse me. And then we did discuss bariatric surgery. Uh, at the time. I, he wasn't sure if he had coverage. Um, and he also said he wasn't interested. He wanted to try this first, uh, bariatric surgery is an ongoing conversation I have with patients. I don't talk to them necessarily every single time I see them, but I do talk to them uh, periodically throughout their treatment, especially if I think that there, it's, it's, it's still an integral part of their treatment plan. Um, depending on how they're doing. So in December of 2022 he had only had a £3 weight loss. He'd been off and on phetamine and consistently taking all these medications and coming into appointments. So I, I, uh talked to him about bariatric surgery again, but compliance was an issue. So I did have some concerns regarding that as well as uh continuing or starting a G LP one if we could get it approved for prediabetes. Um, since he didn't have any obesity medication coverage, I was able to get Victoza approved. I did not do Ozempic first because there was a shortage in December of 2022 and we were unable to get Ozempic. Um, so I started Victoza and I started it off label for Glycaemic Control and prediabetes, uh, as well as off label for obesity and, uh, and weight loss. Uh, continued him on the Fraine into pramine as well as the Metformin, which I will, uh, as an aside, all of those medications are being used off label in this patient, Metformin is not FDA approved for prediabetes. That is the AD A that has approved it, uh, as their only treatment for prediabetes. So we need to keep in mind that is not an FDA approved indication for prediabetes either. So at that time, in those few months, he lost about £12 or 3%. I saw him three times. Um, he was, uh in the process of changing jobs and at April, uh, time frame, we no longer had a supply issue with the Ozempic. So knowing what I knew about the weight loss, uh, potential with some male, I switched him to Ozempic. Um, and I saw him the other day and he's now down £36.10 percent of his body weight. So between, uh, December and July really is when he had the majority of his weight loss. So he was more compliant with the lifestyle modifications, uh, changed jobs. So he was able to have more control over, um, his activity levels as well as what he, uh, was able to have available to him for consumption and with, uh, taking medications, uh, he had more control over that as well, but, and felt that he was able to focus more on uh his health. So the behavior stage of change was definitely different starting in December of 2022. That being said we do know that the, uh the profile, the uh result profile for Ozempic is excellent. And so I think this, you know, plays into that with lifestyle interventions. He, he saw the weight loss that greater weight loss than I would expect on ZIC in three months. So, um I still uh am discussing bariatric surgery with him again. He's had he's now able to be more compliant. He uh is definitely far more engaged in the repair versus program at this point. Um So I decided uh the next appointment, he and I will, you know, go over this again, so appropriate misuse um intensive lifestyle interventions again. We, I think I covered that phetamine Plus toy. I didn't mention this. I did take him off phetamine in April, but I did continue the to pyramid because that was helping him stay away from the sodas. Uh Victoza again off label, um changed him to Ozempic uh due to the known effectiveness for weight loss. Um and I delayed the G LP one R A use due to compliance um as well as coverage and I wasn't sure of either and I didn't see him frequently enough to uh to, to really engage in pursuing that. I did not try for cuss sender will go uh because he did not have insurance coverage. So I continued phetamine into a pyramid despite weight gain and treatment breaks. Um, because I couldn't, uh, I couldn't convince, uh, myself that, uh, he wouldn't have had weight loss on them or that when he was taking the phetamine into a pyramid that this wasn't preventing him from having further weight gain, I didn't mention, but he had consistently gained weight over the last several years and this was the first time when he didn't, when he had the £3 weight loss over that year and a half, he was very pleased with that because he didn't have weight gain. As was I, so, but it wasn't the loss we would expect being in a program like he was GOP one R A should only be started when program compliance really had improved. Um, so that's why I didn't, uh, do that and I mentioned this earlier there. I do have a lot of concerns regarding ongoing coverage issues, uh, for the off label use of the G LP one R A. Si think this is we're going to be coming into a, a rough time right now where, um, uh, insurers are not going to want to cover these. Um, the excuse being, um, patients who need the medications aren't getting them. Whereas there, yes, obviously there is, there is truth in that. Um, I would argue that patients like this gentleman here that I just presented who's been skirting diabetes at 6.4% would is benefiting more um than a patient who is well controlled A one C at the age of 27. No other core morbidities on Ozempic with a BM I of 27. So, um so simply stated, there's no flashy right or wrong answer to use or misuse in this weight loss drug debate, which I prefer to call them anti obesity medications. We do have an, an, an opportunity to do things right here. Meaning a comprehensive approach, uh, dynamic treatment plans so frequently reviewing, uh, whether patients need to be on medications or don't, uh, if the treatment plan needs to change, um, and goals of treatment go far beyond just weight loss. Uh, you know, remission, like we talked about with the surgical assistant able to stand longer, do your job better, um, stay employed, not go on unemployment. Um, you know, the people have their depression go into remission. You know, you all know the list goes on. So it's not just about a number or BM I, it's, it's far beyond that.
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