Chapters Transcript Video Asthma Update 2023 Thanks so much Scott. It's a pleasure to be here. Um We're gonna change gears. I wish I could give a lecture on just one drug, right? That would be the whole hour. But asthma, as you know, has 80 zillion drugs. And uh every uh every year is a new update of new drugs and new combinations of these inhalers. So it's a challenge. And I think uh our, our goals today are really to try and walk you through the current understanding of what should be out there at a primary care level for uh for asthma practice. I do a lot of research. Uh Most of my uh world is in clinical trials and so I work with a lot of different companies, particularly those that have a drug, one of the 18 in the pipeline for Alpha One Antri and Deficiency. Um And uh our learning objectives today is really to learn how to uh really assess asthma severity. Well, because those severity indicators figure out when those patients need to go to specialty care and when they can stay in your practice, uh we'll talk about the newest asthma guidelines and then talk about our new treatment algorithms and step care. Well, everybody uh our favorite uh diagnostic test in pulmonary medicine, as everybody knows is a test that's done uh begrudgingly in the primary care world. Uh It, it's a test that's hard to do. Um But it is the way that we determine the two different diseases we're gonna talk about today. Asthma and COPD. And part of this is the COPD has fixed air flow obstruction and asthma is reversible. So every week I get somebody that's been called asthma forever and really has COPD. And as you'll see over time, what's happening is our treatment algorithms are increasingly divergent between the two disease states. And we recognize this group of patients that have an overlap uh obstruct where they've had asthma forever, but now have fixed air flow obstruction and we can talk about those if you want to. But the spirometry itself uh is um now has mobile options. We have spirometers that people have at home. We have uh ways to do this in an office practice as well, but it just disrupts that flow of patients every 15 minutes through your office practice. And uh and you need a champion in the office that knows how to do it well, because there are some quality indicators here. Um We have the biggest uh breath we can, we blast it out for six seconds and we hold that forced uh maneuver. We have to have uh at least two tests that are maximum and within 100 and 50 mL, uh, to make sure you're getting a good test. Uh, we end up, uh, defining obstruction as having an fev one. What air comes out in that first? Second, less than 70% of what eventually comes out as your force power capacity. Can't tell you how many times we have patients that are short of breath come in and don't have obstruction and yet end up on all these expensive medicines. Uh and are called asthma because they're episodically short of breath. Most common cause of that is obesity. Uh obesity gives you restriction. That means the extra weight on the chest lowers your lung volumes. Uh You don't have as much capacity when you exercise. And what happens then is that if you lower your forced vital capacity because of extra thoracic obesity, then there's no way you're gonna get a normal uh force vial capacity. And therefore your fev one mandatorily has to be lower. You can never have an FEV one greater than an FEC and so your FEV one falls. So if you just are looking at your FEV ones, you'll end up uh not making the right diagnosis and over prescribing and over diagnosing particularly asthma, but also COPD. So our current definition of asthma, reversible air flow obstruction. If, if spirometry is your box, you've got lots of other diseases in here. Next hour, we'll talk about chronic bronchitis and emphysema. But asthma is a reversible air flow obstruction. So, the great majority of people if you treat them well, will not have obstruction anymore. They'll come back and have normal spirometry again. And so the hallmark of episodic dysphonia with normal sperry uh is asthma. So that's your definition. Ok. So let's move on into our therapies. This is a pharmacy for pharmaceuticals, are, are really the hallmark of how to treat asthma well. And we're really addressing all the different components of the airway from the inflamed airways. Uh when you have inflamed airways, you get extra mucus. Um And then what happens there is that with this, if you don't treat the inflammation, then you get a thing called bronchial hyper responsiveness. It means your airways are twitchy. And we have, we know that many of our medications like Albuterol actually increase the twitchiness while still opening up the airway. And so our real challenge here is to take out the inflammation. Um There's been lots of work uh done and South Carolina is not unique in being uh asthma being cared for at the specialty level by really two specialties, one of which is the allergy and asthma population and one of which is the pulmonary uh uh asthma specialist. And at the heart of all this is trying to figure out can we if you're allergic to something, can we get rid of it? Uh, avoidance is sometimes difficult, although if you have the cat sleeping in the bed with you and you're cat allergic, then there's an opportunity there for everybody. Um And yet, uh the whole process around allergy desensitization shots has not proven to be very effective. And asthma actually adds risk and we'll show that in the guidelines in just a second. So why do we have so many allergic people in the world? Uh Is the question we've asked for about 30 years and it's a, it's a wonderful uh a group of articles and literature and science can this uh sorting out how our lymphocytes in our body respond to the world around us. I think they last count, there are only 600,000 antigens to which we're all exposed every day. So your limp sites have to recognize what's normal and what's not normal and a lot of your lymphocyte um memory happens in the first two years of life. So if we start looking at the first two years of life about your, your lymphocytes and, and how they respond, recognize that when you're 60 years old, you might not be able to reprogram them quite as easily. You can around some infectious diseases, COVID and other things with immunizations. Um But the things that are associated with uh this uh protective immunity versus the allergic disease are really the things uh associated with this Orban lifestyle. So, what we really want in the first two years of life is for the kids to go play in the dirt with their older siblings. Pick up every antigen, they wanna expose all 600,000 antigens to your kids in the first two years of life. That's a hard message for moms to get in, in their brain about how trying to keep their kids clean when really you want to go throw them out and let them roll around with the farm animals, right? So, uh so that whole process of uh washing your hands too much uh uh cleanliness in the home contributes downstream to this increasing burden of allergic disease that we all see in all western societies. And so we're not gonna really touch on this, but it does have implications for uh allergy, desensitization and, and all the other pieces as opposed to just controlling uh the inflammation. The other part about asthma control is that the airway really starts in our nose. And so it's the same epithelium that goes through our nasal ciliated epithelium down through our trachea, down through our airways. So poor control of allergic rhinitis contributes to worse asthma. Uh Most patients with asthma actually do have some allergic rhinitis. So remember to treat both sides of the airway. This is a adult predominant disease. Um More than two thirds of patients are adults. Uh even though we often focus on the kids with asthma, um it's a lot of patients and women have a little bit higher predilection and a percent predicted of the population basis. Our communities of color, have a little bit more asthma, but it is really divided between uh our four categories of asthma, mild, intermittent, mild, persistent, moderate, persistent and severe, persistent, pretty equally. And so you're gonna have patients if you're in primary care that have each of these and couldn't put it into the right category, helps you fit them into the guidelines. Well, I love this slide. Y'all are gonna hate it, but this is uh what's happened over this came out this past year is called a rivers diagram. And, and what it does is it kind of takes our on the left, all of our different age groups and figures out where by the width of the river, all of our money is spent and where, which, which disease you end up with on the right. And so if you look at asthma up here on the top, notice that there are a smattering of people that uh are younger, but most people are middle aged and older that end up there. And where do we spend all of our diseases? Well, it's on pharmaceuticals and what's happened over time has been that the pharmaceutical dollars flowing into asthma and to some degree COPD uh have been a bigger chunk of how much money we spend there. But it's for good reason. It's our, our on good therapies. Asthma does uh very, very well. Um And uh if you look at other diseases um down this list, then you notice that for instance, COPD, most of our uh care is really spent in hospitalizations. And so those are some of our difficulties, but this is uh our pharmaceutical dollars uh from 1996 to 2016 increasing over time. Uh And so I think we recognize that uh we don't have very many inpatient asthmatics as our medicines get better. And that's a, a reasonable trade off and this number has started to plateau. Although of recent vintage, all of our new injectables that you see on the TV, every weekend are uh for asthma, high end care with um with uh preventive therapies uh that really work are likely to kind of send this uh that trajectory on upwards a little bit further. OK. So for those of you that handle asthma in your clinic, there's a test out there that you can put on the clipboard in the waiting room and let them fill out. It's called our asthma control test. And this is a test that's been out there for 25 years. It's used in every single pharmaceutical trial to be able to figure out. Uh we're only gonna enroll people with their asthma control between X and X to try and get people of the same vintage of asthma enrolled in this trial to figure out what does better. It's, it's pretty easy. You just add up all the individual boxes, the things that impact asthma in the community though are really important to look at the number. The questions really, it's really centered on the past four weeks. How often have you had shortness of breath? Um How much of the time did asthma keep you from doing your work or your um school? And uh the other ones, uh how often do you use your rescue inhaler including albuterol, which is one of the very seminal indicators of how good your asthma control is because we really think that albuterol need a correlates with mortality and asthma and also is one of those measures that really lets us figure out how well we're doing on controlling the inflammation of the airway. And I will talk to get to the as the Albuteral paradox here in just a second and then a global question on asthma control there. But it's a real easy uh uh um tool to use in the office practice is real important. OK. So let's get to our drugs. We only have a few of them. Um They uh have different doses, they're divided into meter dose inhalers, dry powders and mist nebulizers. And they, we start using abbreviations here. So nobody loves abbreviations. But I think in respiratory medicine these days, you have to understand short acting beta agonists and long acting beta agonist or two different classes of medicines. Um and we have only one right now short acting muscarinic antagonist uh which is aprium. And the point is that that one is likely to expand because we have a few more coming, we have long acting muscarinic antagonist and some new ones down here over the past few years. Um And so we're gonna be talking about Llamas and LAMAs. And when we add one class of bronchodilator to another class of bronchodilators, we get uh not synergistic effect but a little bit additional effect. Whereas if you go up the lava and you add more lava, all you get is more side effects. So we have a uh a process by which when we start adding in combination, we think about uh 20% of patients end up having inhalers that have two different lava in them. And now all they're having is cramps and tremulousness and trying to sort out all the mix of different inhalers is a really, really big topic. Um I think this also worthy to recognize we're gonna come back to this in a minute that uh the insurance companies know that if you give a kid in the emergency department with asthma, a home nebulizer, they don't show up at the emergency room as much. Therefore, they can drop their coughs. Well, what's that all about? Well, if you look at a puff of a meter dose inhaler for albuterol, it's 90 micrograms or 0.09 mg. So two puffs is 0.18 mg and the dose you put in a nebulizer of 2.5 mg is only equal to 28 puffs of your albuterol puffer. So, if you come in the emergency room, you're short of breath. You got a kid with asthma. All you gotta do is give him 28 puffs of Albuterol and they'll be ok. Right. And the answer is, yeah, it works. And randomized trials show there's no difference. So, do you tell your kids that? Oh, you ain't hang out at home until you're uh, failing 28 puffs of Albuterol? No, we don't do that because we want to turn on other therapy or inhaled steroids and an oral or, or injectable steroids. If we need them for that group of patients that have airways inflammation, the sun control and we know that Albuterol use is associated with mortality. And so this whole process around whether we put albuterol over the counter or not, um, it becomes part of this uh whole uh combination story. And so as we kind of look at our, our just Bronchodilator medicines here, recognize there's a lot of complexity to this. It really what happens in primary care is you find one you love and you start prescribing it until the insurance company says, oh no, we want you to switch to the different one and, and then you gotta go and do some reading and uh and or prior authorization process. So, Albuterol generally safe there is this whole discussion. Now, if you put Prima mist on the over the counter, why isn't Albuterol there? Right? Uh a medicine that's actually safer. Um, there is a tolerance that develops with albuterol. If you use more, you'll still get the same peak effect of airway opening, but it won't last as long. Your, your tolerance develops on dura duration. And so if you have persistent symptoms that leads you into using more and more and more over time, um, all of them increase the twitchiness of your airway. So just because you open up the airway does not make it less twitchy. It means that you still, you walk into the cat room or your aunt's house and where their cats and your cat allergic, you can lock down much more easily if you have albuterol uh overuse on board and the improvements in albuterol. And the reason that patients think that this is the medicine that cures my asthma is that the rapidity of improvement in symptoms is usually about five minutes. Facts about inhaled steroids. Our alternative is that it takes about one week to improve lung function. So people tend to use them intermittently. Um And that's just the natural history, but I think they fail to recognize that your dosing and the decrease in inflammation has its benefits really a week into the future. So it's the way I co counsel my patients, there's a very flat dose response curve. So some of our um uh inhaled steroids have uh have doses of 100 2 5500. Everybody starts at 500. And as a general medical community, we fail to deescalate and bring people on back down, uh as aggressively as we could. They do decrease that twitchiness of your airways, the airways hyper responsiveness. And uh the camp study studied two year olds with inhaled steroids versus not every aspect of asthma control improved uh in the two year olds out to age five in this big NH study. And that was a study about 15 years ago that let all the pediatricians kind of buy into inhaled steroids, uh being a drug of choice down to really low ages. And, and so we really have very few concerns about using these. Even in our youngest uh kids, the high doses of inhaled steroids, particularly in the kids is associated with some growth suppression. Um but as you taper your steroids, then there is a rebound and almost everybody at age 18 is just as tall as they otherwise would have been high doses associated with osteoporosis. So we screen in people on persistent inhaled steroids and then the long term use of oral canis, we can talk about in the question answers. I think most of us have that under our um our treatment algorithms, the dysphonia of inhaled steroids helped by spacer devices and the skin thinning, which we can't do too much about uh with long term inhaled steroid use. Um Well, as many of you know, there was this whole deal whenever you prescribed a combination agent with an inhaled steroid uh and a long acting beta agonist. This big warning popped up and you're just giving this, you're trying to convince the patient to use something other than Albuterol. And the first prescription you give them, it came back to the office with uh this medicine increases your risk for death. And asthma, it was this long, long conversation and it was all associated with this very old study that just gave Beta Agnes alone uh without the inhaled steroids. So about five years ago, the FDA challenged all the pharma companies to go in deep into their databases. Every single trial they ever been done was reviewed and actually showed that inhaled steroids plus the beta Agnes decreased the risk of death and asthma. Um So they finally took this down for combination products, but they left it on for our beta agonist alone products. You'll still see this warning around and recognize that in COPD, Beta Agnes alone without the inhaled steroid A. Ok. It's fine to take them in that disease. Uh But you'll end up with this warning to not use them in asthma. So how do I know if I have my patient can take a Beta Agnes by itself or not? Well, it depends upon your disease state at the increasingly important designation between who has asthma and who has COPD. Um One of the reasons we think that we can improve mortality when we add an inhaled steroid to the regimen is that there is this synergism between the beta agony that actually brings more glucocorticoid receptors to the surface of our airways. And therefore you have more active uh inhaled steroids when they're applied and vice versa. The inhale steroids actually help the beta Agnes responsiveness and cyclic A MP production within the cell and, and to the subjacent muscles in the airway. So we think that the two hitting the same cell actually improve uh at a very basic and molecular level our use in asthma. Ok. Let's enter the world of combination inhalers. Um As y'all know, the combination inhaler uh piece adds benefit from having less individual inhalers devices that you could screw up, but also adds complexity. And uh so in our inhaled Cor Asteroid Lava world, we've had many of these medicines on the list available for lots and lots of years. And thankfully, uh we are getting our first generics out to the population. And so you'll notice that once we get more than one generic, the prices start to drop as are happening with the fluticasone propionate, salmeterol preparations that are out there. Um The uh for or Simba Court now has a generic, there's only one generic out there and therefore the price has stayed the same. We need two or three more generics to enter the space uh and we will hopefully get those prices falling soon. Uh The others uh up here, uh Y'all should be familiar with because insurance companies will make you flip from one to another every other week. So just recognize that these are those inhalers and we don't really have differences between them uh in their inhaled steroid um activity. We do have some differences in time to bronchodilation effect. Um With some of these that we go through in just a second on the new group called the Llama Lava. These are dual bronchodilators. Both of these open up your uh airways and allow more air to come out, which is important for COPD. And these will talk in the next hour of transition to being drug of choice, uh for uh symptomatic COPD uh and dropping the inhaled steroids for reasons we'll talk about next hour, but just recognize we have a lot of uh agents up here, but you don't have the inhaled steroid. That's so important for asthma in any of these inhalers. So, uh you don't want people to get a laba llama added to an I CS Lava because now you've got to do a lava therapies. And so learning these names and which ones they're associated with uh is a challenge. All right. So our guidelines also are a little bit complicated. I think many of us grew up living by the National Institute of Health writing guidelines as they did in 2007. They did their next update in 2015, but they didn't publish them for another five years in 2020. And uh they didn't really make very many changes here in short acting beta agonist being step one on everything. And yet the literatures moved uh much farther ahead. And so I think most of us have transitioned to learning the Gina guidelines. Uh The Global Initiative uh guidelines put out by the quad A I, the American Academy of allergy uh and asthma. And in 2018, they had this deal where everybody gets albuterol. And then they tried to convince people to use inhaled steroids without any beta agonist in the mix at all. And only once disease became uh more recalcitrant to kind of add in uh the uh long acting beta agony and head on up through the ladders. Um There were some in 2018, our very first use of immunotherapy ended up being in our uh footnotes there and that fine prints uh goes through, you know, consider adding da da da da. But one of these was consider adding uh sublingual immunotherapy in adult house dust mites, sensitive patients with allergic rhinitis who have exacerbations despite inhaled corticosteroid treatment provided your f one is greater than 70% predicted. That statement still stands today. This is the only mention of allergy desensitization in any way in any of the American Academy of Allergies guidelines. So this recognized that they have no data that allergy shots improve asthma, very good for allergic rhinitis. But uh the point here is that these allergists are using the same guidelines that we are to advance inhaled steroids in appropriate dose and universal uh use to treat asthma. And they are our best drugs and they do the best in our outcomes. So just be careful about the whole allergy shot piece in, in your practice. Um has its role uh in allergic rhinitis. Uh I'm uh this is uh a single study that was 2018, 2019 was the biggest change in our asthma guidelines that has happened in the past 50 years. Uh It came with the uh recommendation to stop using albuterol. And uh they recognize that when we have severe asthma enough to make it to the emergency room or the hospital, uh, that a third of adults get there from mild asthma to severe asthma and a drop of a hat. And that's usually about a 20 minute sudden onset of attack that happens with exposure to an antigen to which you're allergic. Uh So if you're cat allergic, you walk into somebody's house, you can be in status asthmatica need intubation within 20 minutes. If your airways are more twitchy, what contributes to twitchiness of your airways? Well, it's over use of beta agonists including albuterol. So this is 16% of patients with near fatal asthma. Uh, and 15 to 20% of as of adults dying of asthma even though death and asthma is relatively rare. Um, everybody has different triggers to their asthma. We can talk about those later. And just think about albuterol is our first line treatment for 50 years has really been based upon this old theory that asthma is a disease of twitchy airways. Let's open up our airways and, and it's reinforced by the patients who feel so much better when they take Albuterol, their airways open up. This is the drug that cures my disease. Um And so the patient's satisfaction with Albuterol is high. Uh patients commonly believe my reliever gives me control over my asthma and yet here come the deaths and the adverse events afterwards. So, um the the beta receptor down regulation we've talked about um there's increased the NFL airways uh uh in asthma and we have uh more you use the more uh deaths. Uh and that's more than 12 canisters per year. So what does the canister a month to more death? And so intermittent use of albuterol will still always and forever be in the guidelines. But the next question is, isn't there a better way to do this? And um uh and so this whole concept that when we start talking about mild asthma, but only uh the 30% of all asthma does happen in mild disease. I I tend not to use the word mild so much anymore. I say you've got asthma, you have a disease that we can control with appropriate therapy. Let's get inhaled steroids into your regimen. And so 2018, the main treatment figure transitioned in 2019 to say as needed low dose, inhaled Cor asteroid for moderate as step one therapy. At the time, we only had two medicines they were. And um and Symbicort that are for mode containing I CS lava preparations and guidelines go out of their way to make sure that we're not uh being um um associated with any single drug here. And so I think that was one of the things that let them say I CS for mode. The reason is that for mode has an onset of effect, that's about five minutes identical to albuterol and our other I CS lava have a 10 to 15 minute onset to effect for those acute asphyxia, asthma patients that otherwise might head to an emergency room or to the, or to the intensive care unit. And then what happens after you get uh as needed I CS for mode, you need, you continue as needed low dose I CS for mode all the way across the whole bottom part of this algorithm. And uh what happens is that if you get short of breath, playing basketball and you need some relief and you take an I CS for mode bronchodilator that just happens to last for 12 hours, then what does that mean? Well, we're able to decompress the airways inflammation appropriately for the amount of uh of symptoms that you're having. So you're up escalating your inhaled steroids as with an as needed, inhaled steroid containing medication, this controlling disease while at the same time providing the patient, the bronchodilation that they uh need. So the alternative, if you can't afford one of these combinations is you take your albuterol and then you reach for your generic inhaled steroid and you, and you take it to the same time. So every puff of albuterol reaches for a puff of uh inhaled steroid and I'll show you those studies in just a second. So this is called single maintenance and reliever therapy. It's a single formoterol containing I CS lava for all severity of asthma taken as needed. So, and it's based upon this uh for improvement within five minutes when the need is higher, our inhaled steroid dose gets higher, less I CS exposure than regular prescriptions of a, twice a day I CS containing medication. So, if you watch people over the course of a year, they'll only use this when they need it. And so globally, you'll end up having less uh I CS exposure. Uh It's, we'll talk about the expense. Uh and we've been waiting for these generics because I think that's one of the biggest barriers to having the guidelines written in 2019 come into effect in 2023. Um Europe is 100% on board with this America's really lagging behind an acceptance of these guidelines. And importantly, many of the insurance companies really are, aren't on board with the guidelines. They'll try and make you switch from one to another based on price rather than on uh guideline directed therapy. And so, uh in our professional organizations, we're taking that part on, but this is what it looks like. Um, if you are uh having worsen asthma control and your short acting beta agos use, uh starts getting more and more and more frequent and your patient thinks that's the way to go. You eventually hit it the crisis. If you, the same event happens in someone for which you're using an I CS for mode containing inhaler, then what happens is you blunt that acute effect, you no longer go to the emergency room, you no longer get admitted to the hospital, you no longer die. And so this whole concept is that we're blunting those acute crises that happen in asthma by this sort of regimen and look at the amount of inhaled steroids that we use. It is a lot right here. But then what happens is you might be in control for the next three weeks because of all that inhaled steroid you took and all the airways inflammation takes a long time to build back up. And so globally, your amount of inhaled steroid uh is globally less. Um And so this is uh a wonderful article that came out this year in one of our premier respiratory journals that kind of goes through all the evidence and and all backs up the whole new concept of smart therapy for asthma and why it's, uh, uh, if anybody wants to read a whole lot more about this, uh, then go. Um, so our first question, the advantages of smart therapy over traditional drug treatment strategies for asthma include all the following except and up have to go back. Previous active poll. I gotta wait a minute and let y'all, uh, answer this on your slider. So I hit it before anybody had recorded their answers. You know, I don't know why the answers didn't show up here. We've got a less mortality. All right. The advantages uh include all the following except all right, we've had a minute out there. Let's uh oh, still didn't go in previous. So the answer here is cost. We um we recognize there is less mortality, there's better control. There's globally use less use of inhaled corticosteroids and yet it is more expensive to be on an I CS lava containing preparation, at least at current prices. One of the reasons that Europe who ends up having uh global care uh paid for at the um at the level of the country. Um It has so embraced this uh treatment recommendation. All right. The, the next concept here is what if you can't afford it. And so, uh we know that Nebuli albuterol is cheap, um Generic albuterol MD is, are out there now and these are cheap and smart therapies remain expensive and this expenses a burden to those who have the worst outcomes. And therefore for every um every puff of albuterol we should take in as needed, inhaled steroid. And because the nebuli albuterol dose is so big. If you're gonna go the nebulizer, you should use five puffs of your inhaled steroid. And this is patient activated reliever, triggered, inhaled steroids. And this was a large trial that came out uh last year, 1200 patients uh that were uh in our populations of color, all who were prescribed daily I CS with or without a and they had to have a bad asthma control test score and they were randomized to doing uh a Qvar uh dose, uh one puff for every puff of albuterol or five puffs for every nebulizer or best uh alternative care, single uh study visit pragmatic trial. And then they went through the medical records and what happened looking at the number of exacerbations per patient. Uh Huge difference is an outcome. So it is the alternative to all those kids on nebulizers. Mom, moms lose uh love them every time you have to now give them five puffs of a beclomethasone every time you use a nebulizer, uh that might make them use the nebulizer less. And so, uh but that's the alternative to going ahead and making the transition. Um But these uh improvements were also in the asthma control test got better um as well as having uh lower doses of inhaled steroids in the group that were given as needed um, of those sorts of outcomes. Ok. Our newest medicine, uh, Doctor Wert loves to highlight and he might have this in his talk is the uh albuterol Budesonide combination that's just been through two trials in the past year and just got FDA approved. And so, um this is the 20 January 2023 approval. It means that we have now hooked up albuterol with an inhaled steroid. Does that make sense? Yes. The same concept as the for it's the only one out there. It's proprietary. I haven't seen the price yet, but it's probably not gonna be cheap or as cheap as albuterol. And so if you're now gonna put albuterol over the counter, should you also put this medicine over the counter? Yeah. So this is might be the long term. If we can get it out to being nonproprietary and generic, we'll go over the counter in 20 years. So everybody's gonna be practicing in 20 years. This is what we want to see out there as the medicine uh control your asthma here and it really will work. And so it's that whole same concept is every time you hit a Beta Agnes, you're gonna get the inhaled steroid at the same time. Um And so um it's two puffs, uh you uh suggested no more than 12 inhalations, but because the FDA says you really shouldn't take one puff of inter meter dose inhaler because the priming effect uh is not 100% in the first puff, you should always take two puffs by D A guidance. Although patients don't do that, the second dose is fully primed and always comes out in the whole 90 microgram dose. Uh Patients do this all the time where they'll take one puff. But if you're skiing in Colorado with your inhaler upside down in your pocket and you try and take a puff, nothing comes out in the first one, you prime it uh and the second puff comes out. And so it's all conditional upon how you treat your inhalers. They're on the window sill in your breakfast and it's nice and warm. You can probably get away with taking one puff most of the time. But the whole priming effect of all of our meter dose inhalers has the two puffs up to 12 inhalations a day though, means that you're playing back basketball and you're still short of breath after 20 minutes. Sure, go ahead and take another and sure take another in another hour if you're having an attack in somebody's house and you can go ahead and really add up your inhaled steroid dosing here and we know the inhaled steroids are so safe. Uh that uh it's really the um piece of this that uh got FDA approval, ok, using short acting beta agonist, albuterol or epinephrine alone for mild asthma is associated with which of the following. And I don't know why my questions aren't showing up again. It's an active pole. So pop go look at the answers in there. If it's not working, we'll just move on. Sorry. It's a free text field. OK? Um Associated with death. So, um so the point here is that it's uh inadequate control obviously. And so uh we want to move on ahead. So we've been through most of that. Yeah, everybody is getting it here. There we go. Um So let's talk for a minute or two before we take uh transition into questions here about um the next steps in asthma care when inhaled steroids and compliance is not meeting our goals of care. And I think there's a lot here because a lot of patients uh say that they're doing their inhalers just right. And yet they still have bad asthma symptoms and trying to un package that in some meaningful way as part of all of our jobs as, as good doctors and, and pharmacists. One of the things that happens uh is that we do have the option of adding additional inhalers. So, uh studies looking at lava I CS care and then adding uh lama to the combination uh have shown that there is benefit in bronchodilation. Uh So that's part of uh there is an asthma indication for tiotropium. Um And what that did, it generated the whole triple inhaler um uh set of studies. And so the captain study was uh in asthma 2000 patients. And what they did looking at asthma control at 12 weeks, they did our uh typical I CS lava combination and then added the llama and then increase the dose of inhaled steroid inside the uh llama laba I CS inhalers. And so what happened as we, we went up this ladder was that asthma control improved uh and exacerbation numbers decreased. And so we now have a triple inhaler for asthma as well as for COPD. Uh It's just that the 200 mg increased, steroid is only licensed for asthma. The 100 mg is for COPD uh of the two inhalers. And there isn't another triple inhaler that's had a license for asthma yet, one more differentiating feature of asthma versus COPD uh in our drug regimens that we end up using. Um So kind of who needs a triple therapy inhaler? It only cost $800 a month. Um So should we uh push this out to this first drug for everybody? No, because the great majority of asthma is mild and moderate. Uh and so that we can cover the ground with about 80 to 90% of patients without going to triple therapy. But if things are really going poorly and you think it's asthma and you try this and it fails, that's probably not asthma. And therefore, that's the patient that you come and send on to specialty care and we'll sort out how, what else is going on uh with those individuals um, but just recognize this is one of our, um, uh, our most difficult topics in all of medicine is to sort out the short of breath patient. Uh, if you think it's asthma but doesn't respond to good therapies for asthma, then it's often something else. Uh, number one on this list is patient noncompliance. So, of all the inhalers that we write and send to the pharmacy world, what percent of them for respiratory inhalers are actually filled by patients? Anybody got, guess how many people think that's uh 75% 50% 40% 30%. It's about 30 to 40% in all the series that are done. So just recognize that noncompliance is common and why would that be? Well, it's because they don't really know that this inhaler helps them and uh and use and, and expense obviously. But um the point is that to build compliance, you need to have good rationale and therapies that work and particularly for COPD, that's sometimes more difficult than it is for asthma in which these inhalers tend to sometimes be life changing, uh inadequate inhaler technique. Every one of our devices that goes through the FDA has to be matched drug with inhaler that has led to inhaler device proliferation. All the pharmacists in the room know that what that looks like. It's like every different uh medicine has a different package insert of how you're supposed to take this dry powder inhalers. You personally inhale the, the meter dose inhalers. You want a slow inhalation technique to decrease the inertial infection as it makes that hard right hand turn in the back of your throat. Um But uh which ones uh need spacers? Well, all these drugs go through the FDA without a spacer in place. And so the spacers are an optional add on. And so there's a lot of stuff to un package around inhaler um technique training. One of our diagnostic codes uh that our Pulmonary Function laboratory Rey therapist put in often because they'll ask, they'll do an albuterol and the PFT and they'll see, you know, as the inhalation of albuterol rather than uh putting it up to your mouth and other things like this. So just uh don't be afraid to have your patients take their inhalers in the uh office setting, uh or even in the pharmacy setting to kind of show that they've got a reasonable technique week of actuation of inhaler, inspiratory effort. 12th breath hold after each puff, not after the series of puffs and uh one puff at a time and exhale the comfort and go ahead and do the next one right away. We do have some occupational asthma uh that is out there. Uh This is the story where I feel pretty good on the weekends when I go into work first thing in the morning. And uh I am getting more short of breath and wheezy through the day And so you ask them, what do you work on? And all the piece, there's one of these that's really quite common is the icy where two parts per million in the back corner of the warehouse floats across. And this TD I sensitive patient, uh, is having symptoms that only worsen through the work week. And so we'll give these people peak flow meters to take into work and, or three weeks of vacation, uh with the uh peak flow meter and show that it cures their disease, get all the uh the sheets of all the chemicals being used in their workplace and go at it that way. Food allergies are actually pretty rare. Uh but they're on the list, probably number one on this list behind noncompliance is wrong diagnosis. We have a lot of patients with congestive heart failure that we use intermittently. We have a lot of um vocal cord dysfunction where people paradoxically bring their voice box together and wheeze in their upper airway. A lot of this happens in uh obesity. And so we get wrong diagnosis. Therefore, medicines don't help. We have some rare diseases. Uh This is the previous church straus vasculitis now called granulomatosis with poly. Um So this everybody a little tidbit for everybody in the room. Um and allergic bronchopulmonary aspergillosis where you had some asper aspergillus living in your airways that you just happen to be allergic to. And so that's a hard one to treat because it's hard to get Aspergillus out of your lungs, uncontrolled sinus disease, uncontrolled reflux, it increases the airways, hyper responsiveness. We have a few rare patients that are allergic to steroids and they're very difficult to treat and we'll do different steroid skin tests to sort those out. And then we have the very sensitive patients with twitchy airways due to their eye drops that every time they put their eye drops in, they wheeze. And so, uh beta blocker and aspirin sensitivity are not uncommon in this disease. And, and yet we know that in most patients with coronary disease and they have beta blockers on for a good reason. We really don't want to take the beta blockers away unless we really have to. Um, over time, we've kind of figured out that we do have options uh for severe asthma. And for about 20 years, we've had an anti IgE antibody uh injectable that's out there. Omalizumab. And this one is a injection that patients can do at home. Uh It does take that you have elevated IgE to have your most beneficial patient population on this therapy. The rest of these are anti opic therapies, uh the next three down the list. And so it's always nice if you have a CBC sitting in your um in your medical record to kind of look at the percentage of eys that are on there and 3% and higher says this patient is likely to respond very well to these, uh, $35,000 a year medications. And so it's really the, uh, when you get on these therapies, you can often wean people off of Prednizone if they're, uh, on Prednizone as a kind of a maintenance therapy. Um, and then the first non IgE developed is an anti thymic Stroop lympho protein, um, anti TS LP therapy that, uh, made it through the FDA. And we're using some of that in the non e ail asthmas. And so the point is that we really need, we're trying to sort out the molecular biology of our airway inflammation and apply, apply appropriate therapy at the end of the list, we have more predi zone. And so if you have somebody really failing and uh we have to park them on, uh you're not sure it's asthma or not. And why don't we give you 5 mg of prenazone a day for two weeks and see if your disease gets better. And that's uh absolutely ok. Thing to do not for life, but to try and help with the diagnosis and if it is prenazone responsive, let's make sure they have the inhaled steroid uh compliance as you wean the steroids off. And people, sometimes you recover that patient uh really nicely enough to build trust and, and work with you on continuing their inhaled steroid care at high levels. But there are a lot of people on these drugs these days that really think they've changed their lives, got them off of prenazone and so don't shy away from these medications. Uh, uh It's a lot of getting them through the insurance company and proving that your previous regimen has not worked for a patient with asthma. They work through preventing esnle flux from the bone marrow transitioning into the airways and, and how the ESN releases all of its inflammatory Granules. Uh, this slides in there just for your reference, but it's the target here are really uh aisle five, aisle four, aisle 13, the pathways that bring ES nils to the lungs. Um And uh just to mention that we do have a bronchoscopy uh therapy for severe asthma, which uh what happens over years is that we end up building up the muscles of the airways because you've been very active with your airway twitchiness and your muscle. Um uh enlarges. What happens is we go in with a bronchoscopy device that actually gives radio frequency ablation to the muscles. We go sequentially through your airways and decrease the muscle uh by uh by killing muscle cells and airways open up and you can breathe again. It's a about a three hour procedure. We sometimes do it in two sessions. Um It's not cheap but it decreases the twitchiness of your airway as well. I think we're using this procedure much less now that we have all of our biologics out there that really tend to help most people uh equally as well and doesn't have a big procedure associated with it. Uh, last comment before we go to questions is really to, uh, just talk about acute asthma care and those of you that work in emergency departments. And, uh, and, um, we do have other options there where we really just ply on the albuterol uh to get people out of, uh, trouble. But we now allow, uh, Charleston Ems to carry, um, prednizone uh in their uh little bag of tricks. And what we know is that you, if you give uh oral corticosteroids that are 95% bioavailable through absorption of the stomach within 20 minutes that uh by the time you in the home take some prenazone hop in the ambulance, get to the emergency room that many people are significantly better 20 minutes later. Uh if they take uh a dose of steroid at home. So I'll let some of my very brittle asthmatics actually have some prenazone at home for just this reason, bad attack. Uh Let you uh take some prenazone call the office, let's talk about how to improve your care longitudinally from that. And so in the emergency department, it doesn't really matter. We often give it IV in the emergency department, but uh oral works just as well. Um and kind of letting that happen. Um We do not have uh a guidance that viral PC RS make a different in acute asthma care here. And this was a big uh literature review that happened this past year and showed no difference in outcomes uh or what we do because we end up giving everybody antibiotics anyway, even though they probably have no activity uh in the acute asthmatic patient at all. Um we only reserve oxygen only if they're hypoxemic. Uh What happens with progressive dysphonia is that we do need that blood gas, not for the oxygen but to watch the carbon dioxide level that might be rising and who needs a assistive ventilation. Uh magnesium IV uh If you have severe disease is still on our guidelines, this efficacy is small but it's not zero. And the one thing that embraced by some emergency departments, it really takes an an active champion is actually pulling out that uh $10 peak expiratory flow meter and using it through your asthma care and knowing when people can go home versus get admitted to the hospital. It's been shown nicely that you can decrease hospital admissions when your peak flow returns to uh two thirds of their normal um baseline best and obviously with ongoing care uh to try and get them in a better home asthma regimen that uses more inhaled steroids. Um So in summary, uh evaluate your asthma patients based on their disease impairment, symptom burden and uh reinforce compliance inhaler technique. This whole smart therapy of I CS for, for pr and use of albuterol is embraced. Uh give this lecture a lot around the United States and uh every time how many people are using smart therapy and it's about used to be uh one person in an audience of 200. Now it's about half the audience has really turned on over the course of the four years. This guideline has been out in the big changes. So uh I wanna ask the question here today because there's some non practitioners in the room. But the point is that this uh this wheel is turning and, and just recognize that uh when the insurance company gives you the letter that says, we notice that your patient doesn't have albuterol that the insurance companies and all of our uh infrastructure around health care needs to change with this guideline and hasn't done so yet. Um But using regular inhaled steroids, having triple therapy options just means we've got a smorgasbord of good care uh for these patients that we didn't have 10 years ago. And asthma patients are the beneficiaries, they're doing better even though we're paying more for our medicines uh over the course of time. So let's take our questions. We have uh about five minutes here to answer some of these and we'll pull up is singular, used anywhere today in the treatment of asthma. And so singular uh is a Leuco trine inhibitor, actually has most of this activity in the upper airway rather than in asthma. Moms love it for their kids because it's a pill and you don't have to do as much. And so, uh, it's just that the inhaled steroid raids are about twice as effective as singular if you have really mild asthma. Sure. Um, there is, there is an fde indication in asthma. Um, most of the use in adults is really to uh further treat the allergic rhinitis when they don't wanna take a nasal steroid as well. Uh, osteoporosis screening practices for adult patients with asthma. Um and those getting frequent oral steroid burst are not really controversial. Uh What we do for osteoporosis screening in America is abysmal. Anyway, we got a whole talk on osteoporosis. Uh They were gonna talk, I think my favorite uh statistic is of all the people that show up in the hospital with a broken and bone, only 10% of them get osteoporosis screening. Um So more is better here. We think that the oral steroid burst even once a year is enough to screen for osteoporosis. And that's much uh more risky than escalating doses of inhaled steroids. I usually pull out the inhaled steroids screening about at age uh 50 for people that have been on inhaled steroids for more than 10 years is a reasonable and there's no real public health service guidance on when to do this for inhaled steroids. Uh Can you be on a duo, NAB and Spiriva? So when Tetro Spiriva was first FD approved, they never did their co use um uh studies with uh IUM that was then in use, they could have, they chose not to and it's always left this uh conundrum around whether to use a llama plus a uh uh short acting masic antagonist is just kind of been out there over 30 years of use. We really don't have much toxicity with Muscarinic antagonist even though the packages or doesn't say that they can go together, I use them all the time together and don't really worry about a, a the short acting agents. Really. Um I think the real, the highest use in our Medicare population who gets the, the do and E for free through their part B Medicare and they don't want to use their part D because there's the copay assistance, they didn't uh buy that on. So, um so that's the reason I let uh that just happen. And if somebody has open angle glaucoma urinary retention, then you can, you can peel back your um Muscarinic Agnes overuse for patients getting pneumonia, higher rate on inhaled steroids. Are there any ways to reduce this risk? Uh go down on the I CS dose if possible. Yes. Use an I CS Lava. No, the increased risk of pneumonia associated with inhaled steroids is a class effect. Uh It doesn't really um matter whether it's mixed with another inhaler or not. And so uh use the lowest dose possible and I think we generally fail to uh drop our inhaled steroid doses. Um enough So steroids take consistent use to work wise. It's thought that the PR N is more effective. Well, it's because patients use them. And if, if only 30 to 40% of your prescriptions actually end up being filled and, and you're building this mindset that when I have an asthma flare, I'm gonna take my inhaler and your inhaler contains the inhaled steroids, then you're gonna be compliant with your inhaled steroids at the time that they're needed. And we've shown that as needed. Inhaled steroids during times of flair actually works well and decreases your global I CS burden over the course of a year is the rationale. And now the actualization of the good studies that have shown that um our particular geographic regions, more allergy asthma prone, more specifically Southeastern. What happens around America is that we're, we have a lot of geography here and so we have a lot of different kinds of allergens, but you'll have allergens everywhere. And so when you lock yourself up in the Northeast, it's just your dust mite allergies and your pet allergies that take prominence. Whereas here in the Southeast is grasses and trees and we're not gonna cut down all of our grasses and trees here in the Southeast. Um Generic Symbicort is available, it's been available. Um It's just exactly the same price as Simor. Um And that's because we only have one generic out there. How should we think about te compared to other ey asthma options. Any advantages you can see without having um high E OS or IgEs this test fires, the anti TLSP biologic that does not require you to have high eys to let the insurance company approve it. Therefore, if you don't have high ESN fills, then the drug company, uh your insurance really uh been looking at are the patients uh bad enough and on predniSONE and other oral steroids to kind of let you through the conundrum because you've tried everything else. Well, uh so thanks for having me. We'll see you again in another hour after our break. So, Scott, you wanna say anything? Ok. Published Created by
