Zepbound for Sleep Apnea: FDA Approves First Drug Treatment Option

This week, we're discussing a significant development in the treatment of obstructive sleep apnea (OSA). The FDA has recently approved Zepbound, a medication used in combination with diet and exercise, as the first drug option for moderate to severe OSA in adults with obesity. We'll break down how Zepbound works by targeting hormones that reduce appetite, which leads to weight loss, and how this can improve OSA symptoms. We'll also explore the details of the clinical trials that led to this approval, including how they measured the medication's effectiveness and what potential side effects patients should be aware of.

Takeaways

• ZepBound is a groundbreaking medication for sleep apnea.
• The FDA approved ZepBound for treating obesity and sleep apnea.
• Clinical trials showed significant weight loss with ZepBound.
• Participants in trials experienced fewer breathing disruptions.
• ZepBound activates GLP-1 and GIP hormone receptors.
• The approval of ZepBound offers new hope for patients.
• Health goals should be specific and attainable.
• Listeners are encouraged to share their health goals.
• The hosts emphasize the importance of consulting healthcare providers.

Keywords

ZepBound, sleep apnea, obesity, FDA approval, GLP-1 medications, health goals, clinical trials, patient education, health podcast

Transcript

Ed Delesky, MD (00:09)
Hi, welcome back to your checkup. We are the patient education podcast where we bring conversations from the doctor's office to your ears. On this podcast, we try to bring medicine closer to its patients. I'm Ed Delesky a family medicine resident in the Philadelphia area. And we are so excited you were able to join us here again today. So you're thinking about a, well, just to get started, had cookie day that we did, which was a glorious escapade.

Nicole Aruffo, RN (00:23)
and I'm Nicole Aruffo I'm a nurse.

glorious

weekend in the suburbs.

Ed Delesky, MD (00:40)
making some 600 cookies.

Nicole Aruffo, RN (00:45)
Were there actually, did you guys actually count that?

Ed Delesky, MD (00:47)
We

did, we counted that many. Guestimation, I think we got upwards of 590 and then there were some extra in the oven. I went to the dentist, I'm fine, but I went to the dentist and she asked what I was excited about and I said cookie day and she's like, oh, what do you do? And I guessed to me that we would make 100. That was laughably small. And she's like, oh, what are you going to do with the cookies? And I said, what do you mean? She's like, well, are going to donate them? I was like, no, this isn't an altruistic event. This is an event of gluttony.

So now we have, I mean, we probably have a hundred cookies here now.

Nicole Aruffo, RN (01:19)
Yeah, I don't know who's gonna eat all of them.

Ed Delesky, MD (01:21)
Well, mean, normally I'm like really thoughtful about trying not to snack too much and not have like too many T words. our intern is real close and I think he'll be.

Nicole Aruffo, RN (01:31)
T-word is a trigger for him.

Ed Delesky, MD (01:34)
I'll send them into a psychotic binge. But I can't I can't help myself with the the chocolate chip. No, no, the peanut butter ones, but that with the Hershey Kiss. they're amazing. We're going to share it my family later in the week and show them to. like we are. Well, yeah, your mom's going to give us some to bring over. Which one is your favorite? Which of the cookie?

Nicole Aruffo, RN (01:46)
Those are good.

I really liked those jelly ones that my mom made that like bar cookie. Yeah, me too.

Ed Delesky, MD (02:02)
Uhhhh

Do we have any of those here?

It's like the yellowish tint one. Yeah.

Nicole Aruffo, RN (02:13)
Yeah,

those are really good. And then next, actually, I think they're tied with the peanut butter blossoms.

Ed Delesky, MD (02:22)
Is that what that peanut butter cookie is called? Well, this was a whole big operation. mean, like you were the you were the production manager. I would say you were one A to the HBIC. And I I put the biochem degree to use. I made the white chocolate macadamia nut cookie struggling. Why? OK, here we go. Why on online recipes do people like

The instructions are one part and then 14 advertisements and five screen scrolls are the ingredients with the actual proportion that you need.

Do you notice that?

Nicole Aruffo, RN (03:05)
Yeah, it's because of like SEO and like making their blog posts of the recipe more searchable. Okay. Or more findable, I guess.

Ed Delesky, MD (03:17)
because

I find it the most frustrating thing.

Nicole Aruffo, RN (03:19)
really

annoying. But honestly on most of them there's a button that says like jump to recipe and you can do that.

Ed Delesky, MD (03:27)
Is it a floating button that lives there? Because this one certainly didn't have it.

Nicole Aruffo, RN (03:30)
Well,

it depends. Okay, I guess that one didn't have it.

Ed Delesky, MD (03:35)
Yeah. Well, that was that was a hard thing for me to know.

Nicole Aruffo, RN (03:40)
Or

if you just hit print, then it just like opens it up.

Ed Delesky, MD (03:44)
as it like opens a PDF or something. OK. All right. Well, there's that. Before we dive into our episode here, I wanted to propose something to our audience and. No, no, what I wanted to say was I wanted I wanted to offer that.

Nicole Aruffo, RN (03:58)
We don't need their permission.

thought you were going say something else.

Ed Delesky, MD (04:06)
theme

of the new year and we're anticipating the new year. You can never take tomorrow for granted, but we are thinking about if you will send us a health goal, send us your health goal on our fan mail and we will help develop a smart goal out of that. We're going to talk about smart goals coming up in our future episodes about how to make goals for your health that are attainable and that you can actually accomplish, but send us your health goal.

And then we're going to talk about it over the course of a couple episodes. And maybe depending on how many we'll get, we'll put a number to it. If it's overwhelming, that's great. But if it's just a couple, then we'll really focus on them. But I mean, we have listeners from all over and we would love to connect to you in that way. So send us a health goal from our fan mail and maybe you'll hear on the next episode of your checkup. Sound good? OK, so what are we going to talk about today, Nick?

Nicole Aruffo, RN (05:02)
talking about Zep-bound and sleep apnea. I thought we were talking about hypoglycemia.

Ed Delesky, MD (05:07)
No, we're doing we're going to talk about this one tonight because it is brand new news. And I figured it was topical and exciting. And so I wanted to include it as a little you know, we may at some point try to get break into the health news sphere. But we are going to be talking about Zep Bound and how this medication was approved as the first medication to treat sleep apnea and obesity, which is

a huge development. actually like I jumped up out of my seat when I saw it on the news and thought we immediately need to talk about this on the podcast. And here we are. So we did a whole episode on sleep apnea. If you haven't listened to that one, you'd probably get the most out of this episode if you go back and listen to that episode. But to save you the time and clicking out of this really engaging, exciting episode.

Nicole Aruffo, RN (05:45)
So here we are.

Ed Delesky, MD (06:02)
Sleep apnea is a really common condition where the upper airway becomes blocked during sleep. And this causes pauses and breathing. It's more common in people with overweight or obesity. And it's really something that is chronically left untreated. And if left untreated can lead to major cardiovascular complications. And so cue introduction of Zepbound Usually the only way to treat sleep apnea was with CPAP.

continuous positive airway pressure. This is the mask that goes over the face or the nose or working with your sleep doctor on other creative options. But like within the last couple of days, the FDA came out and said that ZepBound is the first medication approved to treat obstructive sleep apnea. And I mean, just a big reaction was like, wow. mean, so these GLP medications, ZepBound or otherwise called

the active ingredient tirzepatide which has the same active ingredient as Mungiro, and it's a cousin of Ozempic and Wegovy really were used for weight loss and treatment of diabetes. But now this is a whole different realm. And what we're going to talk about today is how they came to this and what the studies looked like that led them to make this decision. We also did an episode on the GLP medications over the summer.

And so you can feel free to refer back to that episode to learn more about them. But in short, ZepBound works by activating receptors of hormones, GLP-1 and GIP, that are secreted from the intestine, basically to reduce overall appetite and food intake. And so ZepBound was a weight loss medicine, and now that's used to treat obstructive sleep apnea.

Nicole Aruffo, RN (07:53)
Tell us about this clinical trial.

Ed Delesky, MD (07:56)
Well, I think before we dive into this specific clinical trial, it's important to understand a couple of keywords. So the FDA approval was based on two randomized double blind placebo controlled studies. We're going to take maybe a minute here, maybe less and explain what each of those words means. So randomized means that exactly what you might imagine it to is that participants were randomly assigned to either receive ZepPound or a placebo.

And the next part of this would be what's a placebo. So a placebo is an inactive substance that's used to compare the effect of a drug and to see the effects. You compare the inactive substance to the active substance. Double blind means that neither the participants nor the researchers know who is receiving the active or inactive medication. And so in this case, the researchers and the participants didn't know if they were receiving ZepBound.

or placebo.

Nicole Aruffo, RN (08:58)
So what about this specific randomized double-blind placebo-controlled study?

Ed Delesky, MD (09:05)
Absolutely. So it was based on the Sermount OSA phase three clinical trial. We're not going to go into what phase three means, but essentially one study included participants using positive airway pressure to the CPAP therapy, which is the standard treatment for moderate to severe obstructive sleep apnea. And the other study included participants who were unwilling or unable to try the PAP therapy. So in total there were 469 participants and all of them

did not have type 2 diabetes. so participants were either given 10 or 15 milligrams of ZetBound once a week or placebo once a week for 52 weeks. And so when they actually took all of this and what they measured was the change in baseline or change from baseline in the apnea hypopnea index. What does that mean? So.

The AHI or apnea hypopnea index is a measurement of how many times a person stops breathing, otherwise called apnea, or breathes shallowly, hypopnea. So per hour during sleep. And so at the beginning of this study, there is an average of about 50 events per hour for these people included. And so after 52 weeks of treatment, the people who received ZepPound experienced a statistically and clinically significant reduction

in the AHI compared to the placebo, which I mean, this is astounding that there's actually a medication that can be used and not just the appliance. And so let's talk about the two groups. There was the group that didn't use the PAP therapy. ZepBound led to 25 fewer breathing disruptions per hour compared to the placebo group who had five fewer breathing disruptions. And then the people who use the PAP therapy.

If they were using the PAP therapy and they had ZEPP-bound, they found 29 fewer breathing disruptions per hour. And then that compares to the placebo who had six fewer breathing disruptions. And so what they also found, which is astounding, is that a large proportion of these people who were treated with ZEPP-bound and were using the CPAP machine actually had remission or dramatic improvement of their obstructive sleep apnea. And some of them even not using the PAP therapy at all.

All that to say, people of course had a decrease in their body weight when they were treated with the ZepBound. So adults who were taking the ZepBound on average lost about 45 pounds or 18 % of their body weight. And the people who were on ZepBound who were using the PAP therapy on average actually lost about 50 pounds and a 20 % of their body weight compared to the placebo group that lost 2%, basically coming out to about four pounds. But they also looked at other

Other things like they looked at how much their low low blood oxygen was there and systolic blood pressure that was also found to have benefits there as well. My takeaway is that like this is huge to give people access to another option to treat sleep apnea. I mean, like you and I were talking earlier today, we know plenty of people in our lives who have this and could use all of this. That is to say that.

The nature of obstructive sleep apnea comes from the narrowing of the airway. So if there's adipose tissue or fat tissue around more areas in the throat, around the tongue that make the airway narrower, that's why people who have obesity are more susceptible. And so to say it out loud, it is the weight loss that is the main factor in how ZepPound improves people's obstructive sleep apnea.

This is to say that of course the medicine isn't perfect. There are side effects. I don't think we really need to dive into them all today. We do cover them in that other episode that we have. So we'll keep it streamlined and focused. Zepbound is now approved for adults with moderate to severe obstructive sleep apnea and who have obesity. Honestly, it should of course be used in combination with a reduced calorie diet and increased physical activity. But I mean, it might be time to ask your clinician if Zepbound is right for you.

This is not an endorsement. This is not medical advice. But as things go and we're learning more about these GLP medications, more exciting things are coming out. Do you have any thoughts? So please reach out to us in the comments. Reach out to us on our fan mail. We were really excited to do this episode today, given that this was new news. Next week, we actually might be taking a little holiday ourselves, preparing for the new year.

and just taking a vacation, frankly. And so we're really excited and we respect that we give you stuff weekly to listen to, but you might expect that you might not see something come across your phone Monday morning next week. And we appreciate your leniency. But we look forward to you coming back after that to wrap up the rest of our diabetes series. We'll probably talk about low blood sugar or hypoglycemia going into an episode about how to manage your diabetes with lifestyle.

Any last thoughts as we head into the holiday? Nope. Okay. We want to wish everyone a happy holiday and Merry Christmas and thank you for coming back to another week of your checkup. Hopefully you were able to learn something for yourself, a loved one or

Nicole Aruffo, RN (14:38)
a neighbor who has obesity and sleep apnea.

Ed Delesky, MD (14:43)
Check out our Instagram, send us an email, send us a fan mail, and we will look forward to seeing you next time. Until next time, stay healthy, my friends. I'm Ed Delesky Thank you and goodbye. Bye.

Nicole Aruffo, RN (14:53)
I'm Nicole Aruffo

Ed Delesky, MD (14:58)
This information may provide a brief overview of diagnosis, treatment, and medications. It's not exhaustive and is a tool to help you understand potential options about your health. It doesn't cover all details about conditions, treatments, or medications for a specific person. This is not medical advice or an attempt to substitute medical advice. You should contact a healthcare provider for personalized guidance based on your unique circumstances. We explicitly disclaim any liability relating to the information given or its use.

This content doesn't endorse any treatments or medications for a specific patient. Always talk to your healthcare provider for a complete information tailored to you. In short, I'm not your doctor, and make sure you go get your own checkup with your own personal doctor.

Nicole Aruffo, RN (15:35)
I am not your nurse.