Slide Lecture with Audio
This activity is based on a 45-minute slide lecture presented by Dr. Carlos A. Camargo. This program is available as read only and with accompanying audio.
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Slide 1: Welcome to "Asthma Guideline Update: Developments in Diagnosis and Management.” This activity is sponsored by Princeton CME and is supported by an educational grant from Genentech, Inc. and Novartis Pharmaceutical Corporation. My name is Carlos Camargo and I'm an Associate Professor of Medicine in Epidemiology at Harvard Medical School in Boston, Massachusetts. I'll be your presenter today. Please note that all faculty disclosures for this activity are included in the front of your activity booklet. To receive continuing education credit following the conclusion of this activity, each participant must complete the post-test and evaluation form. These forms can be easily completed online for immediate receipt of credit at www.princetoncme.com. Thank you for joining us.
This presentation is important to managed care health professionals because as you know, asthma affects literally millions and millions of Americans. Both the 22 million with current asthma; also all the people who live and work with someone with asthma. The recent release of the 2007 National Asthma Guidelines provides a great opportunity to improve asthma control and I look forward to reviewing these new guidelines with you.
So, why don't we turn to the first slide, which has the title of this presentation and moving now to slide two, "The Learning Objectives."
Slide 2: As you can see, our goal over this next hour is to describe the significant changes in the guidelines, to recognize the burden of moderate-to-severe persistent asthma, to also look at severity versus control. The new guidelines have a big emphasis on this distinction. Our goal overall, is to have you apply these updated guidelines in the management of modern to severe persistent asthma and we hope that after hearing this talk you'll be able to do so.
Slide 3: Let us move to the next slide. An outline of the presentation and we'll start with an overview of asthma. We'll then talk about the guidelines; a little bit about the older guidelines which were in place up until only 2 months ago, which is from 1997, the second expert panel or sometimes called the EPR-2; the new guidelines which were released in late August are the third expert panel, and you'll hear me sometimes refer to that as EPR-3. I mentioned that we're going to make this distinction between severity and control and we'll also talk about some of the preferred asthma medications for the moderate-to-severe persistent asthmatic.
Slide 4: So, for this overview of asthma, we are going to explore the definitions and touch very briefly of course, on pathophysiology and some of the epidemiology, diagnosis and of the different types of asthma. The bulk of our talk though, will be on the guidelines themselves. Let us move to the next slide, number 5.
Slide 5: The definition of asthma traditionally and now for 20 years has been as summarized here on the first bullet, which is a chronic lung disease characterized by airway narrowing that's reversible, maybe or maybe not completely, either spontaneously or with treatment. The second component is airway inflammation and the third is airway hyper-responsiveness to a variety of stimuli. Now, this is a very useful research tool and also one that can be applied in specialized settings, but it's quite challenging to measure inflammation clinically and it's not always possible to test for hyper-responsiveness, for instance in an urgent care setting. And so a popular and formal, not as tight, definition has become quite commonly used, which is episodic dyspnea, or cough generally associated with wheezing that improves with an inhaled beta agonist.
Now the ATS definition, the first one, is the official definition, but I think it's always helpful to keep in mind that for many people their asthma diagnosis, and this includes patients and clinicians, is from that second definition and not the one that's emphasized in the literature or in the guidelines.
Slide 6: "Terms of Pathophysiology", I promised you it would be brief and it is. One picture, and the key issue in asthma as you all know is it's a chronic inflammatory condition, and this inflammation can lead to airway hyper-responsiveness and increased twitchiness and ability to contract. It also can lead to airway obstruction and these things interact as you see here on the slide. And all of these together add up to the clinical symptoms that we see, such as the shortness of breath, the wheezing, cough and a sense of chest tightness being the most classic asthma symptoms.
Slide 7: Here we see the prevalence of childhood asthma which is when asthma usually begins. And, it shows what's happening over the years 1980-2005 with the asthma prevalence increasing really linearly, just every year a little bit more and more. Now, these people with asthma rarely die of their asthma. It does happen. We will talk a little bit more about that shortly. But for most people with asthma, it is a disease of day to day living and quality of life impairment and limitations in activities and as you can see, more and more Americans are being affected by this and not just themselves, but also their families and the people they work with, who also are affected by asthma. As you look at this slide, on the far right, you will see some new measures that were introduced in the late 1990s. It says "Asthma attack prevalence" and that line actually is fairly flat. So, what's happening is that more and more people are getting asthma, but I think we're doing a better and better job of controlling it, and this speaks to the medications that are now available, such as the inhaled corticosteroids, which are again, controlling the people with asthma, their symptoms, and better. But we have not managed to interrupt the inflow of more and more people, and that primary prevention is something that a lot of researchers are working on now. What is it that causes asthma? But for now, we are mostly just trying to treat the people who have it to make sure their lives are as normal as possible.
Slide 8: The numbers are summarized here, 32 million with an asthma diagnosis sometime in their lifetime, but 22 million with a current diagnosis. And every year, about 12 million people with asthma attacks, 2 million emergency department visits, 500,000 hospitalizations and as I noted earlier, relatively small number of deaths, but still 4,000, which means that basically 11 people die from asthma in this country every day and as a preventable condition, it remains, of course, a tragedy and something that we need to focus on. But the big story here again, is the 22 million with current asthma and how their lives are affected day in and day out.
Slide 9: Now, this slide with the title of "Moderate-Severe Persistent Asthma" actually went to a large group of people. It was in part of a survey, a household telephone survey done called "Asthma in America". Thousands of people were contacted around the country and they were asked about their short-term symptoms, they were asked about their long-term symptoms, and you can see these on the bottom of the figure. The short-term meaning four week recall, the long-term meaning the past year, and the functional impact meaning their activity limitations. As people answered this, they were assigned into one of the EPR-2, the 1997 guidelines, according to their severity, and that could be listed as mild-intermittent, mild-persistent or moderate-severe persistent. If you just listen to those responses and put them into the severity level, for instance with the short-term, you see that it looks like 40-something percent are mild-intermittent, and less are mild-persistent and then again, somewhere in the 30s is moderate. Well, investigators did that again for long-term symptoms, and then with functional impact, you see a very different shape. Now, when you pull these all together and you take the most severe problem as the marker of that asthma severity, you see in that final graph that actually only 11 percent had a symptom burden consistent with intermittent asthma, 77 percent had moderate-to-severe asthma. I think a very important message from this survey and others like it, is that we tend to think that a lot of people have intermittent asthma, but when you ask across multiple dimensions, you end up concluding, as is shown in this study and recommended by the guidelines, that people actually have more severe asthma than we think.
Slide 10: So, the diagnosis of asthma has not changed in the last couple of years and it is not in the new guidelines. Key features are the medical history, a physical exam and also spirometry and this is, of course, very challenging in the youngest children where the asthma is first appearing, but above an age of 5 or 6, really it should be a primary activity for understanding this reversible airway disease. Other studies might be necessary to exclude alternate diagnoses, but again, these are the key features as outlined in the current guidelines.
Slide 11: I also said that I would talk a little bit about the different types of asthma, and in this slide I have summarized some of those different groupings. I think one very obvious distinction would be the asthma that begins in a 3 or 4-year-old, childhood asthma versus the asthma that begins for really mysterious reasons at age 50 or 60. Now, some of those adult onset asthma are actually childhood asthma that was never called that. It may have been called just wheezy bronchitis or had 10 other names. It happened every year and then during the teenage years it got quiet and then now here in the late in adult life, it comes back and it is adult onset asthma. Well, it really was not. But then again, there are definitely people who truly began later in their life. Are these the same diseases, and I think they are not. There are things that are common about them, but this is an area of research where we probably one day will understand that the childhood onset is different from the adult onset, which is different from some of the other ones that I see listed here -- nocturnal asthma, which is predominately happening at night, exercise-induced asthma.
There is a group of people who have poor perception of dyspnea. These individuals, their airways start to close and they can not really feel it closing. It closes and closes and closes until it is so tight that they're just about to fall over and that's when they finally realize it. As you might predict, this is a group that's at much higher risk of having a near-fatal or fatal event, because they do not catch it until it is almost too late. So, these distinctions have important implications for management. Somebody who had for instance, poor perception, is a person that you would want to encourage to check peak flow for instance, when they have caught a cold or when somebody in their family had a cold. Again, reminding them that they do not know when their airway gets so tight, until it is very late. So, it is nice to have an objective measure.
Other things that influence asthma or puts people in different groups were allergy status. Is this somebody who has lots of allergies and maybe that is going to be part of their treatment. Also, the guidelines emphasize comorbidities and one that gets a lot of attention in the last year or two is obesity. And this is becoming increasingly clear that obesity increases the risk of developing asthma, but also for people who have asthma and are obese or overweight, it is harder to control their asthma. And so this is a very exciting area of research, which again, in the future may lead to more tailored therapy for this group. Gastroesophageal reflux disease or GERD is another area of research that could be important for clinicians as they try to manage somebody who has difficult to control asthma and the magic intervention that finally works is to control their GERD. There is also a group of people with asthma that have what appears to be steroid refractory asthma. This is a very unusual group, but again, they may require some special therapies.
Slide 12: I think it is important to include this slide because we are about to review the guidelines and they are after all, guidelines. They are going to apply to most people and they are going to help most people, but there is always a need for individual clinician judgment and when people fall into these different types of asthma, they may need a little more or less of different interventions, whether they are educational or environmental or pharmacotherapeutic.
So, the guidelines, they come from the National Institutes of Health or the NIH and there is a program within it called the National Asthma Education and Prevention Program (NAEPP). Now, this program exists within one of the institutes, the National Heart, Lung, and Blood (NHLBI). So, with all of this alphabet soup, you can easily see why this guideline has many different names. It's sometimes called the NIH Guidelines, the NAEPP Guidelines, the NHLBI Guidelines and I mentioned to you earlier that it was written by the third expert panel, EPR-3. So, all of these things are synonymous and it sometimes leads to confusion because of all the different names.
On this slide, slide number 12, you see the first guidelines were released in 1991, they were updated in 1997 by the second expert panel, EPR-2 and then in 2002, there was a feeling that there were some very large trials that had been conducted and published that were very important for asthma care, specifically showing the benefits and safety of inhaled steroids in children. And so, a few questions were asked and in 2002, those were investigated thoroughly and there was an update of the 1997 guidelines.
Slide 13: The third expert panel was initiated in 2004 and it took many years. And the reason why was because just like that 2002 update, the idea here was this would be evidence-based, systematic review with comprehensive searches of literature for abstracts, table productions, two reviewers, etc., etc. But not just for 5 or 6 questions, but for everything in the guidelines. Now, some elements had not changed at all since EPR-2 and so, to make this a little more doable, the decision was made that the review would focus on information since 1997 and again, it took many years, but finally in February a draft was posted, put out for public comment, the first time that has been done. Hundreds and hundreds of comments came in and then during the spring and early summer, the expert panel deliberated over these changes to newer evidence and finally the large new 2007 Guidelines were posted on August 29th.
I was actually part of this committee, so I am quite familiar with all the different sections and I can tell you it was a lot of work and the time to finish that work was quite arbitrary. I mean, it got to the point where we just had to finish because every time you turned around, there were more abstracts and more papers and so we put a close to it, but the literature keeps advancing. So, these are now the most recent guidelines available anywhere and you see here at the bottom of your slide, a link that will get you right to the PDF file that you can download for this large document. And I say large because it is over 400 pages long. Now, we on the committee, recognize that very few people are going to read a 400-and-something page document and so, don't worry, there is an executive summary that's being developed and will be released this fall and also -- and this is probably going to make the most people happy -- the absolute core material will be condensed onto a pocket card. And I am going to show you some of the pictures from that pocket card in the slides ahead.
Slide 14: Here is the website that you will go to if you want to download it and again, what you are downloading is the resource document released in August. It has all of the background information that drives the guidelines recommendations.
Slide 15: So, looking at EPR-2 versus EPR-3 or the 2007 version, what were the changes? The big changes involved assessment and monitoring and a conceptual shift from looking at only severity to severity, control and responsiveness to treatment and we will get into these terms shortly. Another shift from the EPR-2 to EPR-3 was that it was expanded to 3 age groups. But the children were now represented across actually all 3 groups was 0 - 4,
5 - 11, and 12-plus and the adults of course, falling into the 12-plus group. We do not have the time today to go over all of the guidelines, so I am going to focus on that 12-plus group and again, the goal being to show you the key tables and how to navigate them. And then you can use this information, to look over the other ones for the different age groups.
Another change was the number of steps of "what to do now", expanded to six. Because in the more severe group, there actually are more options available today and so these are clarified. And now, we'll go through this one by one, of the different severity control and the steps of treatment.
Slide 16: Here are the definitions of the words that I was just using and let us go through them carefully. Severity. Severity is the intrinsic intensity of the asthma process and it is measured clinically in untreated patients or by the least amount of medication required to achieve control. So, this is what you would assign when somebody for instance, came to you and was on no treatment and you just were making their asthma diagnosis.
Control is the degree to which the manifestations of asthma are minimized and the goals of therapy are met. So, after you have made that diagnosis, you have assigned their severity, you now start to do things -- environmental control, education, start them on medicines -- and at that point, all you care about is control. All you care about is, are they responding to what you are doing. The responsiveness is the ease with which control is achieved. So, control becomes the bulk of your management. And that is very different from the earlier guidelines because the earlier guidelines assigned a severity level and then you lived with that severity level forever and patients and clinicians found that confusing, because here is somebody with severe persistent asthma, they almost died, now they are you know, doing things differently, they changed their environment, they are on the right medicines, they now have no symptoms, now they are doing great and they still have severe persistent asthma. And people found that odd and did not like that and I think this new approach which is to assign the severity so that you can start the treatment, but then after that, all that matters is whether or not they are in control. I think that is more intuitive and I think will work better in the care of asthma patients.
Slide 17: Looking at these key definitions of severity and control, there are some other terms that I think are important. One is "impairment" and one is "risk" and these apply to both severity and control, impairment meaning the frequency and intensity of symptoms and functional limitations, things that we are very used to asking about for asthma. The risk being the new one that is really highlighted in the guidelines, which is the likelihood of exacerbation, the likelihood of progressive decline in lung function and adverse effects from medications. And in thinking about severity, it's important to consider both impairment, how bad their breathing is and their FEV-1, but also their risk. Because if you saw a patient that had very mild shortness of breath, seemed to be doing OK generally, but had been intubated a month ago, I think you would treat that patient very differently from one that did not have that history. And the difference is that the intubation conveys an increased risk for that individual, that it will happen again. And so, good clinicians took that into account and our goal with the guidelines is to make sure that both impairment and risk go into the assessment of severity and control as you will see shortly.
Slide 18: So, the goals of therapy -- control and that is to reduce impairment, to prevent symptoms, infrequent short acting beta agonist use, normal activities, normal lung function -- or as near as possible and satisfied patients. Reducing risk means preventing recurrent exacerbations, decreasing healthcare utilization, preventing lung function decline, optimal treatment with little if any adverse effects.
Slide 19: So, again, the highlights. Severity is what you use to initiate therapy, control is what you monitor and then adjust therapy to achieve, and we will now go through these key figures. They are called figures in the guidelines, they look sometimes more like tables, but we are going to go through them one by one. Severity, the step one is approach and then control. So, let us go to the next slide, which is slide 20.
Slide 20: This busy slide (for a larger version, click on Printer Friendly Slide Booklet at the top of this page; see appendix) I want to just walk you through, to help you navigate it, and the goal is not to review every box. If you look across the top, you see the severity levels and they should be familiar to you -- intermittent, mild, moderate and severe-persistent. Notice the mild intermittent -- that the mild has been dropped and I think that was a very easy and right thing to do because it never made sense to me and I am sure to many others why we would call someone a mild-intermittent, when they had just had a severe exacerbation and were perhaps intubated in the ICU. That does not sound very mild and the concept here is this is chronic asthma severity. So, you could be intermittent, but die of your asthma. You could be moderate-persistent and have a mild exacerbation. They are actually separate and so dropping the mild I think, was a very good move. If you look at the left side, you are going to see those terms again. The components of severity, you have impairment and you have risk. And again, the risk portion of it, which is in a darker color, you are going to appreciate is much more emphasized than it was in the previous guidelines.
If you have more than two exacerbations requiring steroids per year, it is as if you had the impairment shown above. In other words, you have had more than two days a week of symptoms, more than two nights per month, etc. Now, if you look at the severity levels, at the bottom, the final row, you will see that for intermittent, they go to step 1, for mild they go to step 2 and then for moderate step 3 and then severe has step 4 or 5. Those steps are shown on the next slide, number 21.
Slide 21: So, intermittent asthma leads to step 1, and that's just short-acting beta agonist as needed. No change from the old guidelines. Step 2, for the mild persistent is again, low-dose inhaled steroid, no change. Step 3 actually does involve a change, which is where in the old guidelines, it recommended use of combination therapy -- inhaled steroid and long-acting beta agonist – that is still on here, but also the option of medium dose inhaled steroids are given. And we are going to return to why that addition was made, if you keep going up the steps, though all of them above step 3 are based on the combination therapy of inhaled steroid and a long-acting beta agonist. So, in step 4 it becomes medium-dose inhaled steroid with long-acting beta agonist or LABA. Step 5 is high-dose inhaled steroid and LABA and for some people who qualify the use of an injectable drug called Omalizumab and we'll return to that shortly, but this is a medicine which was not available at the time the old guidelines were written. Step 6, high dose combination therapy and an oral corticosteroid and again, consider Omalizumab. Let us move to the next slide, 22.
Slide 22: This slide refers to the evidence that we use to reach these conclusions and speaks to the systematic review of this effort and all of these different recommendations are graded as A, B, C or D when there was new evidence, from 1997, this grading system gives you a sense of the quality of the data behind it. So, A would be lots of randomized trials, very rich body of data. B, less randomized trials, smaller maybe we are relying primarily on a med analysis of several not-so-good trials, but maybe together are solid. And I think that's generally the case. C, non-randomized trials and observational studies, and then D, panel consensus judgment. Now it is tempting to say D, oh that does not sound too solid, but D may be something that is just intuitive, and everybody would agree this is pretty reasonable and nobody is going to do a randomized trial to look at them, but keep that in mind before you say, oh that is a D. That is not going to be right, because, many of the things in the guidelines, back in 1991, were D. Now they did not use the system at that time, but if you look back, there, it was a lot of expert opinion and judgment about what was right and now, many years in the future, the ones that have been tested, have generally been shown to be quite effective. So, these guys, back in 1991, the experts, they did more often than not, get it right.
Slide 23: Here are the steps again and the level of evidence for each of them. The first one, the short-acting beta agonist, that is no different from EPR-2, without any substantive evidence since 1997 to really change that recommendation. The use of low-dose inhaled steroids, is a level A. Low inhaled steroid with LABA, level A. Medium, level A. The next up, medium inhaled steroids, LABA B. The next one, B. Omalizumab B. And then finally, adding systemic steroids, no substantive new data since 1997. So, these recommendations for age 12-plus are pretty solid, based on a lot of data and if you want to see all that evidence, you just need to go to the online and you can look at page after page after page of tables summarizing the individual trials.
Slide 24: I said I would comment a little more on step three and this was the idea that the old guidelines said combination therapy, the new ones actually give an option of medium dose inhaled steroid, and this follows a big study called the "Smart Study". This was published by Nelson and Chest, 2006, but the results if it were known a few years earlier and led to what is often called the "Black Box Warning". And this is used by the FDA for medications that have some potential risks associated with them and what you see on the slide is the actual words from the Black Box Warning for one of the products used for asthma. And the key comments here are that the FDA has decided and as written right here in this text, that one can use combination therapy for patients not adequately controlled on other asthma controller medications or whose disease's severity clearly warrants initiation of treatment with two maintenance therapies. That is a green light to a clinician to make that decision at the moderate-persistent at really at any level, but the trials show that moderate-persistent is where the combination therapy does work well. Now, the reason why all of this is out there is because the Smart Study and 1 or 2 other studies like it, suggested that there was a higher risk of asthma death in people who use one of the agents in it, the long-acting beta agonist. And there is a lot of controversy around that point.
Slide 25: If you go to the next slide you will see that in the United States at least, for the last 13, 14 years, there has been this progressive rise in the use of a long-acting beta agonist, specifically salmeterol and you can see that after the year 2000, with the introduction of a combination product that had both the inhalant steroid and salmeterol, that the use continues upward, upward, upward. I am an epidemiologist and one of the things that you would expect if this drug really did hurt people would be that you would see that rises in deaths.
Slide 26: If you go to the next slide, these are actual data of the CDC, looking at the number of asthma deaths in the United States and you can see from 1979 onward, it just goes up, up, up, up, up and then in the mid-1990s it seems to flatten and it actually has gone down during the time when more and more Americans are using a long-acting beta agonist with an inhaled corticosteroid. And so, my own view on this is there is some uncertainty there and in my opinion, it is really not a major issue. There is a Black Box Warning. And so at the end of the day, the committee weighing this evidence thought that it was probably best to let people know about this issue and then have the doctor and patient make a decision. If you are worried about it, go with the medium dose. If you're not worried about it, go with the combination therapy. And if you look at head-to-head comparisons of combination therapy versus medium dose, the combination therapy basically wins on every outcome that has been measured in these many, many trials. But still there is this Black Box Warning and a little concerned, so we wanted to include that in the recommendation.
Slide 27: Let us go to the next slide. So, back to the same table and you see that the figure at the end -- the step 5 and step 6 -- there was that Omalizumab that was added. So, let us talk a little bit more about that.
Slide 28: Omalizumab is an anti-IGE antibody. It is given by injection and it's given in steps 5 and 6 only, and there actually is very good data that has come out over the last years that it decreases exacerbations in severe-persistent asthma. If you go to the guidelines, the resource document on the web, you will see there are numerous trials. Of note, earlier this year, the FDA did have a warning about Omalizumab saying that in very rare cases -- kind of like that asthma death with the LABAs -- very rarely there is a risk of a bad thing, specifically anaphylaxis. So, that is important to know and when you think about this medication, but again, note how very small it is and that these are very sick people who are actually proven to get benefit from this medication. Now, it's not for everyone. The eligibility is listed here. You need to be on inhaled steroids, you need to have a body weight within a certain range, you need to have serum total IGE within a range and remember, it is an anti-IGE, if you don't have IGE one could imagine that it won't work very well. This is how it has been tested and this is what is actually recommended for eligibility. Finally, you need to have evidence of aero-allergen positivity. So, this would be again, these are the factors that would predict that this person would benefit from this anti-IGE antibody.
Slide 29: All right, so we are moving into the stretch here. Because after you've assessed the severity and you've started them on the treatment, the next thing to do is look at the control. And one of things that has been added to the new guidelines is that there are now patient tools that can be used to assess control and one of them is shown here, the asthma control test (for a larger version, click on Printer Friendly Slide Booklet at the top of this page; see appendix).
Slide 30: This test, if you go to the next slide, slide 30 -- fits into an assessment of control. So, going across the top we have well-controlled, not well-controlled and very poorly controlled and again, if you go down the left side of the slide, you see impairment and you see risk and you see many of the same ideas that were in the previous slide for severity. At the bottom of the impairment, there are the validated questionnaires including the one that we just discussed very briefly -- something that a patient can fill out, that challenges them about their symptoms and whether or not they are controlled. Now, if the individual is not well-controlled, they should go up a step. If they are very poorly controlled, they should go up at least one, maybe two steps. But all that matters at this point is whether or not they're in control, using this key figure from the guidelines.
A figure that will again, be highlighted in the pocket card. And again, my goal is not to go through the specifics, but just to familiarize you with the shape of it and how to use it.
Slide 31: So, why don't people respond consistently to therapy? Now, one reason of course, is wrong diagnosis and this gets back to one of our earlier slides, the importance of the history of the physicals, spirometry and thinking about alternative diagnoses. Another probably very important one and I think widely appreciated these days is poor adherence to the treatment. And so, this is obviously a subject from an entire lecture, how do you get people to take the medicines that you prescribed to them or change their homes in the way you hope they will, but this is probably you know, the thing that you should most often jump to if you are not finding control is to make sure the medicine is actually getting into the patient.
Another reason people would not be controlled is an under-estimation of asthma severity. Think back about that survey I showed you, where if you only measured on one domain, the short-term for instance, you would assign them a lower severity level than they really were. And also, we talked briefly about the comorbidity such as obesity and gastroesophageal reflux. These are comorbidities that could be treated and if treated, there's reasonable evidence that most patients will do better with their asthma when these other conditions are under control.
Slide 32: So, you have assessed their severity, you put them on the treatment, you now are looking to see if they are under control and those follow up visits will happen every 2-6 weeks until control is achieved and at those visits you are asking things like are the goals being met, are adjustments necessary and as we talked about, stepping up or stepping down as needed. And remembering that it is more than medicine, there is also environment, adherence, comorbidities, education. When you finally do achieve control, then the contact can be reduced to every 3-6 months.
Slide 33: When control has been achieved for at least 3 months, you might want to think about decreasing some of these medicines and specifically the inhaled corticosteroids. And as shown in this slide, the guidelines recommend a drop by 25% - 50% every 3 months until you get the lowest effective dose. Now remember that if you totally take them off, that some patients -- in fact, many patients, if they are in that more severe group -- will fall again out of control.
Slide 34: An issue that always comes up is when do you refer to a specialist and in this slide, number 34, we have some of the issues that we talk about in the guidelines. If difficulty achieving or maintaining control is the issue, then that is probably a time that you might think about sending them to an asthma specialist, if step 4, higher care, is required. if immunotherapy or Omalizumab are considered, which again would be a more complex patient. If the patient has had an asthma hospitalization, you might consider a referral to a specialist and for some, referral for step 3 care is something that would be doable, perhaps beneficial, but I think in general step four up specialist and step three is considered.
Slide 35: All right, just one slide on another issue in the guidelines which is asthma exacerbations, and I just want to highlight some of the key changes there. Probably the most important is that the cut points for what constitutes a mild, moderate or severe exacerbation have been changed. They have actually been returned to the level used in 1991. In 1997, there was, I think, a desire to harmonize everything and the 50/80% rule was good, so that was used in the emergency department or acute management as well. But actually the 40/70% are more helpful because when somebody presents with less than 40% of predicted, that is a patient that is actually going to benefit from adjunct therapies. Things like anticholinergics, perhaps magnesium, perhaps heliox, perhaps continuous beta agonist nebulization, whereas in the high 40s, these approaches don't really help. So, the old system of less than 50% was severe, was not terribly helpful because that actually represents the majority of people in the emergency department. It is not a very good way of separating, so we changed it back to less than 40% is severe and that again, is the group that might benefit from adjunct treatments. On the other end, we use 70%, which is a nice target to shoot for in terms of discharge. You do not have to get to 70%, in fact most people are discharged from urgent care or an emergency department, probably in the 60s, but if you could get somebody to 70%, you would be, I think pretty confident all things being equal at home, etc., that they would do fine. There is no way people are going to sit around until they hit 80% in an emergency department, so again, I think these new cut points of 40 and 70 are actually not that new, they go back to '91, but will work more effectively for clinicians.
A change that I think is going to take a little work is that it has become quite popular to double the dose of inhaled steroid at the sign of an asthma exacerbation and as noted in the guidelines, there now are trials that have looked at this and it does not work. So, this is something that we should stop doing. If a patient cannot take systemic steroids and the preference of the clinician is to increase the inhaled steroids, you have to increase it by at least four-fold before it starts to work. And the general feeling of the guideline committee was that you may as well just give them systemic steroids. Now, there are patients with diabetes or who have a steroid related psychiatric issues again and those in that subset, you need to increase the amount of steroid four-fold to improve their exacerbation. The guidelines also look at pre-hospital, trying to improve care there and in the emergency department, as I mentioned, focus on the adjunct therapies for the severe group and also emphasize initiating inhaled corticosteroids at discharge -- to consider that important step for patients who frequent the emergency department, most of whom have persistent asthma, most of whom should be on inhaled steroids but are not.
And finally, in the hospital, it has become popular to use albuterol with anticholinergics -- ipratropium for instance. And in the hospital setting, there is not good evidence that that works. It works well for severe exacerbations in the acute setting in the emergency department, but after they have gone upstairs, there is not much value to doing this combined albuterol/ipratropium treatment in the inpatient setting.
Slide 36: So, in summary, we talked about the key elements of the guidelines. We talked about severity versus control, the different steps. We also reviewed the impairment and risk domains which are part of severity and control and again, the emphasis throughout all of this in the new guidelines is that the goal of asthma therapy is control. And that is the control of the impairment and risk domain and this is assessed through clinical means, through talking with patients, examining them, testing them and also through giving them these self-completed questionnaires which are now validated and available.
I mentioned earlier that this resource document is enormous and I am happy to tell you that a summary of it will be released this fall and also a pocket card. And that pocket card will have the severity, steps and control figures that we've reviewed for the different age groups. So, hopefully with this talk, I have given you the tools to navigate them and improve control of your asthma patients.
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