154. Tirzepatide | New Ground Breaking FDA Approved Weight Loss Medication That You Have to Know

Exciting news!

Check out the latest episode of Health Bite podcast where they discuss the biggest headlines in weight loss news!

Hosted by Dr. Adrienne Youdim, a triple board-certified internist, obesity medicine, and physician nutrition specialist. With almost 20 years of experience, she's here to redefine nutrition and help you nourish yourself physically, mentally, and emotionally. 

In this episode, we'll cover the approval and release of a groundbreaking weight loss drug, Tirzepatide, which is said to be the most effective drug ever for obesity treatment. 

Plus, we’ll dive into the latest research on GLP-1 analogs and their impact on cardiovascular health, debunking concerns about thyroid cancer risks, and warning about copycat drugs.

If you're looking for reliable information and resources on health, wellness, and weight loss, this podcast is for you!

Tune in now to Health Bite and stay up-to-date with the latest in weight loss news and more! Don't miss out on this valuable information! 

What You’ll Learn from this Episode

• Learn about the approval and effectiveness of the new weight loss drug tirzepatide. 
• Find out how tirzepatide works to enhance satiety and induce weight loss. 
• Discover the potential side effects and long-term benefits of tirzepatide for weight loss and cardiovascular health.

“Tirzepatide is by far the most effective drug we have ever had for the treatment of obesity.” - Adrienne Youdim

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Transcript

 Welcome back, friends. Welcome back to Health Bite, where we'll be talking today about the biggest headlines in weight loss news. And by far, the greatest headline that came out this past month is the approval and release of a brand new weight loss drug, terzapotide. It is by far the most effective drug we have ever had for the treatment of obesity. We'll be talking about terzapotide and more in the news  this week on Health Bite.

 Welcome back. I'm your host, Dr. AdrienneYoudim. I am a triple board certified internist, obesity medicine, and physician nutrition specialist. I have worked with patients for almost 20 years, helping them redefine nutrition to not only eat well,  but to nourish themselves physically, mentally, and emotionally. And right alongside all of the work that I do with my patients in terms of mindset and emotional eating, I offer them the latest tools and therapies for the treatment of obesity. And we have something incredible in our toolkit as of now. Just this past week,  we received approval on Tirzepatide, the latest drug in the armamentarium against obesity. Now, you may know Tirzepatide by the name of mounjaro. mounjaro has been available for almost two years for the treatment of diabetes. It is the latest in a stream of injectable weight loss drugs that are hormonal agents used for the treatment of obesity. Now,  In the past, semaglutide, which is sold under the brand name of Ozempic when it's sold for diabetes and Wagovi when it is sold for the indication of obesity, is an analog of a single hormone. So that means it mimics one gut hormone  GLP-1 that does a host of things in the body. Number one, it helps the body release more insulin, and that is why it is approved for the treatment of diabetes, helping the body process sugar. But it also, as we've discussed in the past,  does two other things that help with weight loss. Number one, it slows down gut transit. That means food hangs out in the gut longer, increasing or enhancing the feeling of satiety. But its number one role is to signal fullness  in the brain. So when we consume food regularly, our bodies will naturally release a hormone called GLP-1, which then travels to the hypothalamus of the brain and shuts off that hunger valve.  Well, this new drug terzapotide does the same, but does it in two ways. So terzapotide is not only a GLP-1 agonist, but it also mimics another hormone called GIP.  and it's a big anacronym, glucose-dependent insulinotropic polypeptide, which is, again, abbreviated as GIP. What you need to know is that this hormone also not only helps with the processing of sugar in the blood,  which is why it is used to treat diabetes, but it is yet another signal that tells the brain that we are full. So Tirzepatide, now approved under the name of CepBound, acts to enhance satiety and induce weight loss in two ways, by mimicking two hormones that help with satiety. And the results represent that.  So ZepBound has been shown to result in significant weight loss in individuals who are on this drug. Patients who are on ZepBound for 38 weeks were shown to lose approximately 20% of their body weight. 20%, that is really significant as compared to semaglutide, which resulted in about 15 to 17% of weight loss.  In individuals on this drug who continue to use it for 88 weeks, so that's roughly 20 months, they were able to lose 25.3% of their body weight. So again, tremendous, losing a quarter of their body weight at less than two years. These are really significant results and comparable to what we see with bariatric or weight loss surgery.  So let's talk about how this medication is delivered. Like the other injectables, Tirzepatide or Cepound is offered as a pen. So usually, or always, these come in packs of four, one pen administered weekly for four weeks.  and is continued thereafter. There are several doses of Tirzepatide. Patients will start at an initial dose of 2.5 milligrams. They can from there go to 5 milligrams, 7.5 milligrams, 10 milligrams,  12.5 milligrams and the max dose of Tirzepatide is 15 milligrams for the treatment of diabetes and weight loss. Now how should this be dosed? Your physician should always start you at the lowest dose.  and never escalate you faster than the four-week interval. Why? Because these medications are dosed as such to help you not only get the maximal amount of weight loss, but also adjust to the potential side effects, which we will discuss.  At the end of four weeks, when patients are done with the individual pack of four, you can have a conversation with your physician and decide whether you should escalate to the higher dose or continue at the current dose that you're on. Now for me,  I will have a conversation with my patients every single month, and we decide together whether or not to escalate the dose. The way in which I decide this is based on two things. Number one, efficacy. Are you actually getting the benefit of the drug? Are you feeling satiety? Are you seeing weight loss? And number two is side effect profile. Do the side effects allow us  to escalate the dose. If a patient is already experiencing significant side effects, nausea, vomiting, uncomfortable changes in bowel movements, then I will not escalate the dose until the patient has adjusted  And typically patients do adjust to the side effects at a particular dose, after which time we can decide to escalate the dose. Now, the other thing I look at is how the person is eating. Remember that these weight loss or anti-obesity medications can result in really significant reductions  in hunger. And in fact, some patients will say that they absolutely can't even eat. They will skip meals or be satisfied with very small portions. Now, this may seem appealing to some, but consider this, what you eat directly impacts  the kind of weight that you lose. So if individuals are barely eating and consuming very little amounts of protein, then they are not only losing fat mass, but they are losing muscle. And when we lose muscle, we actually  increase the percent body fat in the body. This is not something that you're going to see on the scale, but would see if you get bioelectric impedance. There's other more invasive studies like  CT scans or DEXA scans, and I say invasive because it exposes you to radiation, but these are studies that can give us definitively quantification of an individual's fat mass or lean body mass. But you don't have to do these tests to know. If you are consuming limited amounts of protein, I can guarantee you that you're losing muscle. And why is this important?  Number one, body composition is important in terms of metabolic health and overall health and well-being. We don't want an individual who's  skinny on the outside, but fat on the inside, but also it impacts your metabolism, the ability to be able to maintain that weight loss. The more muscle you lose, the greater the reductions in your metabolic rate or the calories that you burn to survive, and therefore the amount of calories that you need to live. The less or the lower your metabolic rate, the harder it is to maintain that weight loss.  So talking about all of this, let's get right into the side effects. What can we expect? Well, this drug is a gut hormone. So it makes sense that the side effects are going to be related to the gut. By far the most common side effects are nausea and vomiting. And usually patients will experience this day one and typically day two of administration  And for most, the side effects will peter out over the course of the week. For some people, the side effects are so severe that they experience nausea and vomiting all week long. And of course, if that's the case, then you need to have a conversation with your physician if this drug is actually right for you. In some cases, we administer an anti-nausea medication like Zofran,  to help get people over the hump. Keep in mind that Zofran and other anti-nausea medications have their own potential downsides, including constipation, which can be problematic with this drug. But if the nausea is mild and can be mitigated with small doses of anti-nausea medication, then that may be a route to go. Another side effect is change in bowel movements.  Now, some people will experience diarrhea, some people experience constipation. We can't really predict which way people will go, but if you already have constipation or if you already have IBS, this is something to keep in mind because it may exacerbate your underlying habits, your bowel patterns.  We know from experience that the diet can impact these side effects. So remember that these drugs also slow down the gut. So consider how you might feel if you eat a really heavy meal or if you eat a really fatty meal. Some people experience significant diarrhea when they eat fried foods or fatty foods anyway.  On this drug, those symptoms are only going to be exacerbated. So for my patients who are experiencing significant nausea,  or significant diarrhea, I always ask, what is it that you're eating? And many times we find that they experience more of these side effects after they went out to eat or after they consumed fatty or heavy meals. So know that if you are experiencing side effects with these drugs, with terzapatide or the other drugs like semaglutide, they can often be managed by or through dietary change.  Other side effects, you can experience injection site reactions. So that basically means a rash or irritation at the site of where you injected. Individuals can inject this drug in the abdomen or in the thighs. You should be changing the location. So don't inject in the same place, in the same site every single week. And keep in mind that if it,  If the injection site is more than just mildly irritated, if there's a significant rash, if the rash extends to the rest of the body, if there's any blistering or bubbling, these are all signs of important and very serious injection site reactions that must be brought to the attention of your physician.  Other side effects, fatigue. Now, some people will report fatigue with this injection by itself, but oftentimes I find that it's a function of severe caloric restriction. So again, these drugs are in a lot of cases really blunting people's appetite, but the goal isn't to stop eating completely. You may not feel hunger, but you may experience side effects of  too limited of an intake by experiencing fatigue. By experiencing other side effects like hair loss, remember that the body is not really set up to lose weight. It sees weight loss as a threat. And so some of the potential side effects include hair loss, for example.  If you're not on a multivitamin while you're on terzapotite or these injectable drugs, you should be. Keep in mind that protein deficiency can also cause hair loss as well as severe caloric restriction. So the goal here, again, is to limit your calorie intake, to reduce your intake so that you are losing weight, but not so much so that you are losing weight too quickly  or developing malnutrition from  inadequate nutrients, and in particular, protein deficiency. Now there are potential for more severe side effects, which include pancreatitis. Now this is an inflammation of the pancreas. It also presents with nausea, vomiting, but very different than what you would experience from just a side effect of the drug. Pancreatitis presents with a really abrupt  and significant nausea and vomiting. Basically, people with pancreatitis cannot consume anything without vomiting afterwards. And also pancreatitis is associated with severe pain in the gut. No one should experience abdominal pain with these drugs unless it is a serious side effect.  Nausea, yes. Vomiting, yes. Change in bowel movements, yes. But severe abdominal pain should be a sign that something more serious is going on and that patients should present to their doctor. And then finally, there's the potential  for thyroid tumors. We'll talk about this a little bit more in the next news headline, but in animal studies, animals who receive this drug developed thyroid tumors. So it is contraindicated in people who have a family history of a certain type of thyroid cancer called medullary carcinoma. It is a  severe and often fatal type of thyroid cancer, you would know if you have a family history of this, or of a syndrome called MEN, which also includes in it a history of thyroid cancer. So should you have personal or family history of thyroid cancer,  bring this up with your physician and it probably means that this drug is not for you. So let's move on to, we talked about dosing, we talked about weight loss, we talked about side effects. Now let's talk about cost because these drugs, if not approved by insurance, are very costly. First, let's talk about when they will be approved by insurance. So  We talk about weight loss drugs, but really that's a misnomer. These are not weight loss drugs. They are anti-obesity medication. Why do we say that? We say that because these medications are indicated in individuals who have obesity, not people who are intending to lose 5, 10, 15 pounds.  Who has a diagnosis of obesity? Number one, individuals who have a BMI or body mass index of 30 or greater. This translates into roughly 30 pounds of excess weight. So if you have about 30 pounds of excess weight for your height,  then you are a candidate for these drugs. The second category of individuals who are considered candidates for anti-obesity medication are individuals who have a BMI of 27 or greater with a comorbidity, which means a medical condition that is related to their excess weight, something like  high blood pressure, high cholesterol, diabetes. So people who are considered to be overweight and have a comorbidity of excess weight are also candidates. And typically these are the people who are going to be approved for terzapatide by insurance. Now, what happens if you are not approved?  and you still want to be on the drug. And unfortunately, just because we have guidelines for the treatment of these, for the use of these drugs, doesn't mean that our insurance companies are falling suit. And we're seeing that in many cases,  insurance companies are not actually approving these drugs when they are deemed clinically necessary. So what if you fall into that camp? Well, unfortunately, these drugs are costly. They cost, in the case of traceptide, it will be over $1,000 per month, so about $260 or $70 per pen  per week, but the manufacturer is at least for now offering a coupon for individuals who have commercial insurance but are not approved. They can get this drug under the coupon for 12 months  at around 550, $560. So it's still pretty costly, but it's kind of like the cost of therapy per week. It comes out to about 150 some odd dollars per week if you have commercial insurance that is not approving this drug. How long should you be on this drug?  Patients will often say that they want to use this drug short-term or they want to use it as a jumpstart. And I want to tell you that that is really the wrong way to think about these medications. These drugs are indicated for long-term use. Why? The reason is that they will only work  while you are on this drug, just like any other medication. We don't expect, for example, a  blood pressure medication to continue to control blood pressure after we have opted to discontinue it. Similarly, we cannot expect for weight loss drugs to continue to help suppress appetite and result in weight loss and or maintenance once we are off of it. When individuals come off of these drugs, they typically will experience a surge in their hunger.  because these drugs are created to help suppress hunger. And because of that, they typically will regain their weight. All of our clinical studies are showing that for the most part, patients who discontinue these drugs will start to regain their weight. Another point to keep in mind is that  Hormones that regulate appetite will go up anyway when people lose weight. So whether or not you use a drug to help with your weight loss, your appetite will increase after you lose weight. And that is a function of our normal physiology. Again, the body does not think it's normal for us to lose weight.  we have evolved in times of food scarcity and calorie restriction and weight loss was viewed by the body as a sign of distress. So when the body experiences calorie restriction or weight loss, it will go gangbusters and all  all signals to promote hunger and to drive an individual to seek food will go up. So this is to say that if you lose weight with this drug that is helping manage your hunger,  and you discontinue that drug and you've already lost weight, all the signaling is going to physiologically shift towards inducing greater hunger in your body and inducing weight regain. This is not a character flaw. This is not a matter of willpower. This is a matter of physiology.  So these drugs are approved for long term use and that's something to keep in mind now.  Patients, of course, are concerned about long-term side effects. And that takes me to another study that came out this month from the EMA that I wanna share with you. And I'm pulling up my notes here to talk to you about it. But basically,  one of the severe or potentially most concerning side effects of this drug is the link to thyroid cancer. And in all of these drugs, liraglutide, which was one of the earlier daily injectables, semaglutide, which we've discussed is the weekly injectable, and now Tirzepatide, all of these injectable drugs  have been shown in animal studies to result in thyroid cancer. Well, late October, the EMA, the European Medicines Agency, an agency that is in Europe that looks at medications and their potential side effects and safety,  released a report that actually debunked this link between GLP-1 drugs and thyroid cancer. The panel reviewed post-marketing data as well as clinical studies of all GLP-1 analogs, again, including Ozempic and Weigovi,  including succenda and victosa. Those are the daily injectables which contain loraglitide and showed that actually this risk that was seen in animal studies does not translate into humans. Studies of course are ongoing, but I think this should be a big sigh of relief to us as physicians and to patients who are on these medications showing that  the link to thyroid cancer that was seen in animal studies is actually not being seen in human studies. I think this is a big win.  Another win for these drugs, and again, another reason to contemplate and view these medications for long-term use, is a study that came out just this weekend in the New England Journal of Medicine.  This was a study that came out, the largest study, the longest study that looked at cardiovascular outcomes in individuals with or on semaglutide. So in this study,  They looked at over 17,600 patients were enrolled, and they compared individuals who were on semaglutide, again, Wagovy and Ozempic, as compared to placebo, followed them for  over five years to see what happened to their cardiovascular status. And what they found and showed was that individuals who were on semaglutide at the maximum dose of 2.4 milligrams had a significant reduction in cardiovascular outcomes, including myocardial infarction or heart attack,  in stroke, as well as death from cardiovascular causes. So these drugs are not only resulting in successful weight loss, but they are resulting in successful long-term cardiovascular risk reduction, which includes a reduction in heart attack, stroke, and death.  The reduction was significant and was on the order of 20%. So just to reiterate or recap,  Obesity, of course, is not a cosmetic disease. It is a disease that is associated with a whole host of medical conditions, most prominently cardiovascular conditions. And as cardiovascular disease is the number one cause of death in men and women in the United States, the use of these drugs, I think, is going to be a significant tool in our toolbox to reduce the risk of  cardiovascular disease and death in the United States. Super important and super exciting news that came out this month. Now I want to end with this because with all of this hullabaloo around terzapatide and semaglutide in terms of  the successful weight loss outcomes and successful cardiovascular risk reduction, we are faced with ongoing shortages. These drugs are highly popular.  Drug companies have been unable to meet the demand. That has resulted in shortages of semaglutide. And we expect, even though Eli Lilly, which is the drug company that makes terzapatide, has increased and ramped up their manufacturing capacity,  we suspect that terzapatide is also going to be faced with a shortage sometime during this year. What does that result in? It results in copycats. And I've reported on Health Bite in the past that compounding pharmacies have popped up  across the United States and on the internet. This is a loophole of the FDA because the FDA actually allows for compounding pharmacies to create drugs when they are in a shortage situation, but they actually don't regulate these compounding pharmacies. So it basically becomes our word against theirs  in terms of safety of compounded drugs, efficacy of compounded drugs, and we have seen that many of these compounding drugs that have been made available have in fact used materials or ingredients that were not tested for safety or efficacy and have resulted in harm.  This has been taken to the next level because now copycats are actually creating pens. So remember that these drugs never come in vials. You are never expected to draw out the medication. They come in packs of four and they come as pens. They are self-administered by the patient. In the case of  ozempic. These pens can be titrated, that means you can actually escalate the dose by clicking increase in doses on the pen. In the case of Wagovy and terceptide, they come as fixed dose pens. Now this is important to note because  It is a way that you can determine copycats. Copycats will come in doses that are not or packaged in ways that are not as intended by the drug company. So how can you tell a copycat? Number one,  These medications come as pens and they come in packs of four. You know you've received a copycat if it comes in a pack of five or in a pack of six. This is not the way that the drug company is providing these pens. Another tip-off that you've received a copycat is if the label is frayed or is not sticking on the pen properly,  This should be kind of obvious, but if the label is not affixed properly, that is a tip-off that you've received a copycat, or if the label is faded. These drugs have just recently been found in the US in these counterfeit ways. The FDA is cracking down on them, and they've already shown that these copycat drugs have resulted in side effects or in  significant harm and adverse effects, including sadly miscarriage. And just as an aside, these drugs and no weight loss drugs should ever be taken while an individual is pregnant. They are teratogens, which means they can cause harm to the fetus.  These drugs have also resulted in fainting, in hypoglycemia resulting in coma, as well as other severe side effects that have resulted in hospitalizations.  Please bear with potential shortages. Do not receive these drugs from compounding pharmacies, from internet sources, and be wary. If it looks funny, then it probably is a copycat that can cause you harm. That was a mouthful.  And that is our recap for the month. So again, super exciting news on the release of terzepidide under the name ZepBound for the treatment of overweight and obesity. Number two, great, great data showing cardiovascular outcomes with  these GLP-1 analogs showing that they result in significant reduction in heart attack, stroke, and death from all cardiovascular causes. Number three, data coming out of Europe showing that we can be less concerned about the potential link between these drugs, the GLP-1 analogs, and the risk of thyroid cancer. What we've seen in animal studies does not seem to be bearing out in humans.  And finally, be wary of copycats. We are going to see these come out more as shortages ensue due to the popularity of these drugs.  I want to reiterate that this podcast is for informational purposes only. I am a physician, but I am not your physician. So none of what I have said or what I ever say should be taken as personal medical advice. You can take these informations or this information to your own physician and have a conversation about how it might  apply to you. And last but not least, I have a ton of resources available for you at my website. You can go down into the show notes right now. Click the link to sign up for my newsletter where you will receive weekly information and updates as well as information on my resources, blogs, podcasts,  book, and all things health, wellness, and weight loss. I'm so excited to have had you here today. If you have any questions for me, DM me on Instagram. And if not, I'll see you back here on Health Bite next week. Until then.