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Diabetes Core Update
Special Edition - OSA Part 4 – Bringing it All Together
00:28:43
In this special episode on Obstructive Sleep Apnea our host, Dr. Neil Skolnik will discuss treatment of OSA. In Part 1 we discussed an overview of OSA, in Part 2 we discussed making the diagnosis, Part 3 was treatment, and in Part 4 we bring it all...
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- [00:04]
A
Welcome to this special edition of Diabetes Core Update. This is the last in a special four part series where we've been discussing obstructive sleep apnea OSA. This is important because the prevalence of OSA has increased over the last 30 years. It is closely linked to obesity and it is common in people with diabetes. It has many consequences including reduced quality of life, difficult to control hypertension, impaired blood glucose control, and increased rates of heart failure, MI and stroke. It's also important for us to understand that by any estimate, it's quite underdiagnosed. I'm your host, Dr. Neal Skolnick, professor of Family and Community Medicine at the Sidney Kimmel Medical College of Thomas Jefferson University. This special series of Diabetes Core UP Update is sponsored by Lilly. In the first episode we focused on the basics of osa. We discussed what it is and some of the underlying pathophysiology. We discussed epidemiology, how severity is described, as well as the consequences of osa. In the second episode, we focused on making the diagnosis and interpreting the results of sleep studies. In the third episode, we did a deep dive on treatment and the different forms of treatment that are available. And now we're going to bring it all together and focus on some of the challenging decisions and changes in approaches by discussing a case in detail. Joining us for Today's episode are two master clinicians. Dr. Sanjay Patel is a professor of medicine, epidemiology, and clinical and translational science, as well as the Director of the center for Sleep and Cardiovascular Outcomes Research, as well as medical Director of the Comprehensive Sleep Disorders Program at the University of Pittsburgh Medical Center. Dr. Patel also wrote the New England Journal of Medicine editorial for the Surmount OSA trial, which we'll be talking a bit about later. Welcome, Sanjay.
- [02:19]
B
Thanks so much, Neil. It's great to be back.
- [02:21]
A
Also joining us today is Dr. Susan Cuchera. Dr. Kucera is the Program Director of the Jefferson Health Abbotton Family Medicine Residency Program and is a Clinical Associate professor of Family and Community Medicine in the Sidney Kimmel Medical College of Thomas Jefferson University. Welcome, Sue.
- [02:42]
C
Thanks, Neil. You know how much I love a good clinical case discussion. I can't wait to get into it.
- [02:47]
A
Great. Today we're going to focus on specific aspects of care, using a case based format to bring out learning points. What I'd like to do during this podcast is is try to tease out some of the difficult decision notes and as is so often the case, this occurs in areas where the information is changing and I'd like to try to make explicit areas of uncertainty, either because there's simply uncertainty in the evidence or because the uncertainty is due to evolving changes in practice habits. So let's start with the case of the third 58 year old male who presents to his primary care physician's office with a more than one year history of excessive daytime sleepiness. Not an unusual case. He tells us that his wife reports that he has loud snoring at night to the point that they've begun sleeping in separate rooms. He often wakes unrefreshed. He struggles with concentration at work on physical exam. He has a BMI of 36, he has a thick neck and otherwise his physical exam is unremarkable. Sue, your thoughts at this point?
- [03:59]
C
This is such a common story, right? We see this in our office every single day. And when we think about pretest probability of a problem, right, right here, this is like super high. We know this guy has osa, right? We know the answer and we know that his BMI of 36 is probably contributing to that diagnosis. So first steps, how do we diagnose him with the sleep apnea that we're 99% sure he has? We need that diagnosis. And I think this is interesting because in different parts of the country, I think the way that people go about this is very different. Interestingly, I practice in suburban Philadelphia, which you would think is this really well resourced area, but it's really hard to get people in for a sleep study. We have an insurer mix that doesn't really love home sleep studies and we have a three to four month wait to get into any sleep center locally. Right? So for me, I'm like, gosh, I know this guy has osa, I'm going to have a hard time getting him a formal diagnosis. Where do I go from here? The more I think about this, right, and the more that practice is changing. I sure wish I could order that home sleep study because I think that would be a really great place to start. Sanjay, what do you think about this case? Is this someone who you think a home sleep study would be the best first step for him?
- [05:11]
B
Yeah, definitely. I think a home sleep test would be the easiest way to proceed. As you said, this patient clearly has a high pretest probability. And so you're really just using the test for confirmatory purposes. There are lots of data that show that in patients with high probability, such as this patient, home sleep tests have equivalent performance to in lab sleep study. Home testing is quicker, easier, more convenient for patients because they can sleep in the comfort of their own home Studies have suggested that something like 75 to 80% of patients would rather do a home test. And so I think that would be the best option in this case.
- [05:51]
A
So, Sanjay, it seems like home sleep tests are clearly more convenient. They're very accurate, yet they're not the same as in lab sleep tests. In this case, the home sleep study did come back showing an OSA with an Apnea Hypopnea Index, an AHI of 46. For our listeners, that means he's having on the average 4046 occurrences of either apnea or hypopnea per hour during the duration of the sleep study. And that equates to severe osa. But before talking about how we might approach treatment, Sanjay, can you address how you would approach this case if a couple of things were different here? One, if his wife sometimes noted that she had periods where he'd stop breathing, although already we talked about his pretest probability is very high. If in this setting of a high pretest probability, what would you do if Instead of an AHI of 46, the home sleep study showed that he only had an AHI of about 3, meaning it came back showing he didn't have sleep apnea, how do you approach that?
- [07:03]
B
So I think it's really important to recognize that both in lab and home sleep studies can give false negative results. The rates of false negative tests are higher with home sleep studies for two reasons. One is that we aren't actually measuring sleep. So for some reason on the night of testing, the patient spent a large amount of the recorded time awake, then his breathing will look normal during that period of time and so that apnea hypopnea index will be underestimated. The second reason is the signal quality from a home sleep test is typically worse than in lab studies since the patients are self applying the monitors themselves. And so it's really important to place the results of the home sleep test in the appropriate clinical context. If your clinical suspicion is high, as in this case, I wouldn't believe a negative home sleep test and instead I would follow up with further testing, either troubleshooting and seeing if they didn't do the home sleep test correctly, then maybe repeating it, or if the home sleep test seemed to go well and you still don't, the results still don't make sense, then following up with an in lab study.
- [08:04]
A
I think it's so important. Basics are always important in any area of medicine. And when you get a test that is dissonant from what you expect, be careful, don't just accept the results of the test. And think about how you might approach things differently if a confirmatory test is needed. This happens all the time for us when we order a stress test. For instance, if the stress test doesn't make sense, we don't stop with a simple stress test. Moving forward. In this case that we're talking about, the home sleep study did show a severe OSA with an AHI of 46. And again, as a reminder to our listeners, mild sleep apnea is defined as an AHI of 1 to 14.9 events per hour of sleep, moderate is 15 to 29.9 events per hour of sleep, and severe OSA is an AHI greater than or equal to 30. So with an AHI of 46, our patient clearly had severe sleep apnea. Sue, what are you thinking about at this point?
- [09:12]
C
We have a diagnosis, so that's a great start. But we have to think about treatment options. And in years past, we would pass this patient along to the sleep specialist and pat ourselves on the back for a job well done, and that would be the end of it. But things are different now, and the landscape of how we help this patient looks very different. We know that obesity is related to sleep apnea, and we know that the treatment landscape for obesity has changed so much in the past number of years. But now we also have this new data in the surmount OSA trial and the subsequent approval of tirzepatide for OSA in December of 2024, that we really do need to pause in primary care and think about our role in OSA management too. So just to talk about that trial Briefly, the surmount OSA trial, they looked at about 500 patients. They had a mix of moderate to severe OSA, they had obesity, and of note, they did not have diabetes. They randomized them into tirzepatide at a maximally tolerated dose, about 10 to 15, or placebo. And they evaluated AHI for their primary endpoint, but also looked at blood pressure, weight and high sensitivity CRPs for inflammation. Interestingly, they had two trial groups. So one of them had OSA and had very consistent Pap use. The other one had OSA but did not use their papa. I think it was interesting that they looked at those two groups. We had about 70% male. The average AHI was about 50, so well into that severe range. And the average BMI here was 39, so well into the obesity range. What they found was a reduction in AHI of somewhere between 20 to 24 depending on the group, with a significant difference that started as early as 20 weeks. Into therapy with tirzepatide. All of the secondary outcomes also showed improvement. Folks here lost an average, average about 18% of their total body weight. This really forces us to consider the use of tirzepatide in our patients with obesity and moderate to severe osa. We know that OSA confers cardiovascular risk. Interestingly though, randomized controlled trials of Pap therapy haven't been able to show benefit for cardiovascular risk reduction, although that they have seen in some observational studies. We really don't have that data. And we also know in primary care that Pap adherence isn't rate and a lot of folks are intolerant and they fall out of contact with their sleep medicine provider and land in our office with this diagnosis. So the question is clinically how does this trial fit into our practice? For me first I plan to still be sending folks to sleep medicine for evaluations. Right. They have expertise well beyond what I am trained to do. But I think this has really changed to a broader co management situation. There's nuance to Pap therapy and testing and different other treatments that are available that is well beyond my expertise. But if they have an indication for tirzepatide 1 that's an easy add on. So they've got diabetes, they've got significant cardiovascular risk. I'm like this makes sense. We always love to have a twofer. But then the next part is asking that patient, can we have a conversation about how your weight is impacting your OSA diagnosis? And this is a conversation we have every day in our office about obesity management. And with this new data, GLP1s are always part of that discussion. But I think it really makes the case for considering it in this circumstance even more convincing. Then finally, I really see this being a great tool in my toolbox for folks who are not using their Pap therapy. These folks have often fallen out of follow up with their sleep medicine team and again they're seeing me for whatever other health problems they have and I think it gives me a really good evidence based option for treatment of their OSA and maybe a way to re engage them in treatment for their osa. Maybe I get them back to their sleep specialist eventually, but I think it engages them with treatment and gives them an option that might be more tolerable for them. So I think these are situations where I'm planning to add this to my practice. Sanjay, I'd be interested to see what your thoughts are and how you think this trial changes the landscape for osa.
- [13:25]
B
Yeah, I think I agree with What a lot of what you had said. My approach with this patient would be to start with by just understanding better what the patient's goals are with treatment. And to some extent it may be also including the wife, as some of the symptoms seem to be or complaints seem to be coming from her. But it sounds if the goal for this patient is to address symptoms like the snoring or the unrefreshing sleep or the daytime sleepiness, then I'd probably start by talking about some of the more traditional treatments like CPAP or a dental appliance, both because the onset of feeling better will be quicker with those treatments than with tirzepatide. That may take 20, 24 weeks to see improvements, but also because the symptom benefit from tirzepatide, at least in the Shermont OSA trial, was relatively small and didn't really meet the minimum. Clinically important difference for things like sleepiness or quality of life. Sleep related quality of life. But if the patient's goals are to try to address their cardiometabolic risk, then clearly the Sermon OSA trial showed much larger improvements in blood pressure than what we see with CPAP or a dental appliance. And clearly from non sleep apnea trials we know that tirzepatide, as you pointed out, provides much greater benefit in terms of preventing diabetes. And then with other GLP1 agonists, we know the cardiovascular benefit is much larger than what has been seen with cpap. And again, I think we find that for many patients, both of those sets of benefits are goals for the patient and so they may want to address both of them and get treated with both CPAP and tirzepatide. I do think, as you said, that when a patient is first diagnosed with sleep apnea and has comorbid obesity, that is really an opening for whether it's a sleep specialist or the primary care doctor to start talking about obesity and how it's contributing to sleep apnea. We see a lot in the sleep medicine field that sleep apnea is often the first downstream consequence of obesity that patients are diagnosed with before they get diagnosed with diabetes or other things. And so it's the first time patients are facing head on, hey, my excess weight is really causing me health problems and maybe I do want to take care of that underlying risk factor. And obviously tirzepatide gives one a potent tool to deal with that.
- [16:02]
A
It's interesting. I suspect that we're going to be seeing a lot more. Sue, as you mentioned, co management, we've begun to see this with coronary disease, where GLP1 semaglutide was shown in a study to decrease vascular outcomes in people with previous ascvd. And we're doing a lot more co management along with our cardiology colleagues where they'll be referred back to us for management of the GLP1 where we have a lot of that experience and are used to shepherding because they're not the easiest medicines to use. Sanjay, do you see that occurring here as well with sleep apnea and tirzepatide?
- [16:46]
B
I think so. I think there's a. Right now there's a lot of reluctance amongst older sleep medicine specialists that prescribe GLP1 agonists just because they're worried about how to do it and not being familiar with prescribing injectables and things like that. I think the younger generation of people who've done a medicine residency and have seen it in their residency, they're much more familiar with it and able to take care of it. But I think the frequency with which you may need to follow up with these people is something that we probably don't have capacity to do. And so given that primary care is generally comfortable with it, it seems like the obvious thing to hand off and co manage with.
- [17:27]
A
Yeah, that makes sense. Sue, are there any other questions that you might have that you see coming up?
- [17:34]
C
Yeah, and I think one of the things that I'm reflecting on about this is often again, I have lots of patients who are like, I'm not wearing a cpap, it doesn't matter who. Again, I think this is a great option, try and help treat their osa, but who are those patients, Sanjay, that really it's critical for them to see sleep medicine. And I'm also wondering people on the lower end of a BMI scale. Right. Who don't fit into the study characteristics. Right. Should we really be making sure they get into sleep medicine? What are those patients? What are that patient characteristic that you're like, we really need to prioritize primary care, getting these folks in to see sleep medicine.
- [18:10]
B
Sure. So I think clearly people who have severe symptoms, so people who are having trouble keeping their eyes open, where it's impacting their work performance, where it's affecting their driving and safety issues, clearly we should see because there are other treatment options. I think that's the other thing to recognize is that often the amount of support that patients have gotten in their prior attempts to use CPAP has been minimal. And there are things we can do to help make the CPAP more comfortable, whether it's a different mask or adjusting the pressures. But it's also discussing other options like dental appliances or surgical options that can often be game changers for patients in terms of the quality of their life.
- [18:57]
C
That's helpful for me to hear because I think we often need those reasons to convince people to go to see you. So I think that's just so helpful to put that in some context of who we need to how we get people into your office too.
- [19:10]
A
Now I have a question. The patient, like the one we discussed here, who we have a high clinical suspicion and say in an area like sue and I practice and where it can be a few months, they get into the sleep lab. Is there any reason not to start prescribing Tirzepatide because he's got other indications as well. Will that interfere with your evaluation or can we begin that and send him on?
- [19:36]
B
I think the main issue that I've seen, quite honestly, is that patients are begun on Tirzepatide without insurance coverage and so they're paying out of pocket for it. And then they come see me three months later when they can get an appointment. And by that time they've lost £25 and we do the sleep study and they no longer have moderate to severe sleep apnea. Their sleep apnea is now mild. And so I present with them the option of do you want to gain the weight back and we can redo the sleep study, or do you want to continue paying out of pocket? That's the complicated issue with our health insurance system that we're dealing with.
- [20:17]
A
Yeah, that's a really important practical thing. I want to go back now to talk about fundamentals again. On the third podcast of this series, you talked about behavioral aspects of treatment clearly will be important whether someone is on turzicular, Zepatides, cpap, both. Can you just touch on those behavioral aspects briefly?
- [20:39]
B
Sure. So I think in terms of addressing sleep apnea related symptoms, a lot of those symptoms can also be due to other things. So sleepiness obviously can be due to insufficient sleep. And so it's really important to make sure that patients are giving themselves enough time, setting aside eight hours for sleep, keeping a regular schedule, things like that. In terms of things that can help improve their sleep apnea, avoiding alcohol close to bedtime and avoiding sleeping on their back, trying to sleep on their side will reduce sleep apnea severity. So those are things that can help improve their sleep apnea even without any direct treatment. But I think another important part of this is doing the lifestyle changes to help try to lose weight. So diet and exercise, and particularly exercise, has been shown to have important effects on improving sleep quality and reducing daytime fatigue. And I think if you look at the surmount OSA trial results, it's important to remember that both arms in that trial got behavioral lifestyle intervention. And you can see that the symptom improvement in the control arm was quite substantial. There ended up being a small difference between the group that got tirzepatide and the group that didn't. And some of that may be a placebo effect, but I think a large effect of that was getting all of these patients on a regular exercise regimen really helped improve their symptoms.
- [22:11]
A
That's such a good point. And it's something I talk about all the time when I discuss obesity, that all of the obesity trials had really tight behavioral inputs with people seeing dietitians frequently at the beginning of the trials. And we need to make sure we at least do that when we're seeing people outpatients in our practices. Last episode we talked about the full range of treatments. For the sake of covering this case, let's just focus on Pap therapy. And briefly, as we think about this patient, remind our listeners, how effective is Pap therapy?
- [22:50]
B
Sure. So I think from the standpoint of, of eliminating the obstructive respiratory events, it can be thought of as being 100% efficacious at normalizing breathing. In terms of the biggest limitation for how effective it is, it really is tied to adherence. And as Susan mentioned, a lot of patients just can't tolerate CPAP just having the mask on their face. But even people who are adherent, we generally have about 75% of people nationally can meet Medicare adherence thresholds at three months. But there's a slow reduction in adherence over time. And just as with any chronic treatment, adherence slowly wanes. You really need to have a regular bedtime routine. You need to sleep in the same place every night. Right. You can't really take your CPAP around other places if you like going camping. It's, it's complicated to take it with you if you don't have regular electricity and all of those things. So there are a lot of challenges for long term adherence.
- [24:00]
A
Okay, that's helpful. And then with this patient thinking about moving on to Pap therapy, many primary care physicians do order Pap therapy. That's self titrating. Many don't. For those that don't, can you discuss how self titled titrating Pap therapy works? And does that make it easier to prescribe yeah.
- [24:23]
B
So I do think that's really revolutionized the care of patients with Pap therapy is this ability of the machine to titrate the pressure. So currently, all CPAP machines on the market are able to sense an obstructed breathing episode from the flow pattern that comes out of the patient. And so based on that, the manufacturers have developed algorithms where the pressure will go up if the machine senses there's obstructed breathing. And then if there's a period of time where the breathing looks completely normal, it will start to drop the pressure again. To try to get you to the lowest pressure you need to be at, what this allows is you can start at really low pressures at the beginning of the night and not have the pressure go up until you're asleep and starting to have obstructions. And so it's a little bit easier on the patient to start low and then only go up when you need it. The other nice thing about it is you can just prescribe a wide range, like 4-20 cm of water, which is a full range of commercial CPAP machines, to every patient. So you don't need to worry about how do I prescribe it for this patient or that patient. It's the same prescription for every patient.
- [25:35]
A
And I imagine then that allows that change over time that we anticipate would occur. Someone started on tirzepatide, they lose 15 to 20% of their body weight. They have less obstruction. Would this automatically accommodate to that?
- [25:52]
B
That's another advantage, is that if the patient loses weight, the machine will automatically lower the pressure over time. And similarly, if they slowly gain weight, it will increase pressures. And so if the person doesn't follow up with the sleep specialist for two, three, four years, it's not a big deal. As long as their machine is working well.
- [26:12]
A
That's great. So we're about out of time. We've covered a lot of ground, talked about a lot of very practical aspects of treatment and decision making. Sue, do you have any final thoughts for our listeners?
- [26:24]
C
Yeah. Again, I think this is just one more tool in our toolbox and realizing that all of our patients are complex and multiple medical comorbidities that we might be able to unite with one medication. And I will say it was really great to hear Sanjay go through those behavioral strategies again. I think we are really good in primary care at talking through these with patients. And so it was such a good reminder of that other piece that we should be really reinforcing when we see our patients in the office.
- [26:52]
A
So important. Sanjay, do you have any final thoughts for our listeners?
- [26:56]
B
I think it's really great that the Sermon OSA trial has gotten so much press and gotten so much interest about sleep apnea amongst the primary care community because this is really something that we could use the help of the primary care doctors in taking care of and appetite really gives us another tool that we can really use to improve the care of these patients.
- [27:17]
A
So important. Dr. Sue Kucera, thank you so much for joining us.
- [27:21]
C
My pleasure.
- [27:23]
A
Dr. Sanjay Patel, thank you so much for joining us.
- [27:26]
B
Thank you so much.
- [27:27]
A
And most of all, of course, thanks to our listeners. Thank you for joining us on this fourth and final installment of this multi part series on obstructive sleep apnea. In the first part of the series, we focused on basics, epidemiology, pathophys, staging of severity and consequences of osa. In the second episode we focused on making the diagnosis and interpreting the results of sleep studies. And in the third episode we did a deep dive on all sorts of different aspects of treatment. And today we put it all together using a case emphasizing the practical decisions that we all deal with every day and need to make decisions about. This special series of Diabetes Core Update is sponsored by Lilly. We thank you for listening. For the American diabetes association, I'm Dr. Neal Skolnick. Till next time, stay safe and keep learning.
- [28:32]
B
Sam.