Weight-loss drug treats sleep apnea, possibly eliminates need for CPAP machines

[00:00:00] Host Amber Smith: Upstate Medical University in Syracuse, New York invites you to be "The Informed Patient" with the podcast that features experts from Central New York's only academic medical center. I'm your host, Amber Smith. A drug that's been used for diabetes and for obesity has been shown to scientifically improve obstructive sleep apnea. Here to tell us about it is Dr. Antonio Culebras. He's a professor of neurology who specializes in sleep medicine and started the first sleep center in Syracuse in 1978 at the Veteran Affairs Medical Center. Welcome back to "The Informed Patient," Dr. Culebras.

[00:00:39] Antonio Culebras, MD: Thank you. My pleasure.

[00:00:42] Host Amber Smith: Now, this medication was studied by an international team of researchers who published in the New England Journal of Medicine recently about its use to treat sleep apnea when people stop breathing while they're sleeping. What is this drug and what can you tell us about it?

[00:00:58] Antonio Culebras, MD: Yes, indeed. It was an article, a scientific article, that appeared in the New England Journal of Medicine just a couple of weeks ago. And it is a major successful event, the fact that there is a medication that reduces not only obesity, but reduces sleep apnea significantly.

Just a reminder that there are 900 million people worldwide who suffer sleep apnea. Of course here in the United States is also a significant number of people who suffer sleep apnea. Most of them, if it isa large or a significantsleep apnea problem, are treated with CPAP, (continuous positive airway pressure.) But CPAP is uncomfortable and, after one or two years, 50% of people drop their CPAP therapy.

There are some Interventions and surgical interventions that are successful, but they are costly, and of course there are complications and so forth. So we are really left with a large number of sleep apnea patients who remain untreated, without control. And sleep apnea is a significant risk factor. Cardiovascular and cerebrovascular events, for worsening of diabetes, for a variety of neurological problems, and so on and so on. So the fact that now we may have a pharmaceutical agent, to improve sleep apnea by the way of weight loss in patients who are obese is a significant advancement.

[00:02:50] Host Amber Smith: Now you mentioned CPAP, that continuous positive airway pressure. That's that mask that people wear at night, and they're hooked up to a machine. Are you saying that a medication like this might replace the need for CPAP?

[00:03:04] Antonio Culebras, MD: It might. It might because this particularscientific research has shown that half of the persons who were obese and had sleep apnea reduced their weight such that their sleep apnea came down to a level that did not require CPAP any longer. One half of them. That is very, very significant.

[00:03:35] Host Amber Smith: So how does this drug do that? Can you explain to us how it works?

[00:03:40] Antonio Culebras, MD: This drug by the name of tirzepatide has been available for patients who are obese and have diabetes, but it had not been shown that by reducing weight would also improve sleep apnea, although the suspicion was high.

Over a period of two years, there were two trials. Trial No. 1, patients who were not using PAP (positive airway pressure) devices. And trial No. 2, patients who were using PAP devices. And, the structure of the trial was that half of the patients received the medication, tirzepatide, and the other half did not receive the medication.

[00:04:36] Host Amber Smith: From what I understand, the research included two double-blind randomized controlled trials -- that's the gold standard -- involving men and women with moderate to severe sleep apnea and obesity. Half got the medication during the trial and the other half received a placebo or a fake medication. Is that right?

[00:04:57] Antonio Culebras, MD: That is correct.There were 235 participants in trial No. 1. And there were a similar number of participants in trial No. 2.

[00:05:12] Host Amber Smith: And they looked at some people that used CPAP and some people who don't use CPAP. Why did they look at both groups?

[00:05:21] Antonio Culebras, MD: Because in the real world, half of the patients who have significant sleep apnea do not use their CPAP, are not compliant with the CPAP. And, the trial looked at that and also whether there was any additional effect of the CPAP on the activity or the effect of this medication.

[00:05:43] Host Amber Smith: This is Upstate's "The Informed Patient" podcast. I'm your host, Amber Smith. I'm talking with sleep expert, Dr. Antonio Culebras, a professor of neurology at Upstate, about a medication that may help for obstructive sleep apnea.

So in general, what were the findings?

[00:06:01] Antonio Culebras, MD: Well, the inclusion criteria were to have moderate to severe sleep apnea. That is more than 15 events per hour of sleep. And also to be obese with a body mass index of 30 or higher. Now patients with diabetes were excluded, because in the past this medication had already been tested for patients who were obese with diabetes. And actually it is an indication right now for prescription of this medication.

Now in trial No. 1, theaverageapnea hypopnea index -- that is the number of respiratory events per hour of sleep -- was 51 per hour, which is high. And the average BMI (body mass index) was 39, which is high. In trial No. 1 after 52 weeks of receiving medication subcutaneously once per week, there was a reduction in respiratory events from the 51 that I mentioned before to 25 per hour with tirzepatide. Whereas with placebo, there was only five events per hour reduction.

Now, placebo patients also had minimal improvement because they ate a diet prescribed by the study. And they had also some physical activity. So that resulted in a minor loss of body weight.

In trial No. 2, where patients had access to the PAP device, they started with 49 events per hour of sleep, and the reduction with tirzepatide was down to 29 events per hour. BMI also was reduced significantly. So compared with placebo, these are very, very interesting results.

So let me mention that one half of the patients who were taking tirzepatide lost a lot of weight, and their apnea hypopnea index dropped to levels where the CPAP is no longer needed. One half of patients, 50% of patients, came down to the point of no more need for a CPAP. That's fantastic because as I said before, many patients with sleep apnea do not like their CPAP, are not compliant with their CPAP, and they drop the use of the CPAP after at least one year of using it. So now we have a pharmaceutical intervention that is effective.

[00:09:21] Host Amber Smith: Now, the study was paid for by the drug maker, Eli Lilly. Can we trust the results?

[00:09:27] Antonio Culebras, MD: Yes. The resultswere obtained in the trial that covered nine countries in all continents. And, Eli is a very well known pharmaceutical company. And, these results are to be trusted. Of course, confirmation is needed later. Now they are trusted to the point that the pharmaceutical company has requested a fast track pathway to approve this drug to be sold in pharmacies with a indication of sleep apnea, and that may occur before the end of this year.

[00:10:15] Host Amber Smith: Interesting.

[00:10:16] Antonio Culebras, MD: It is quite possible that starting in January, I should be able to prescribe this medication with the indication of sleep apnea.

[00:10:29] Host Amber Smith: So let me ask you, were there any side effects from the medication in the trials?

[00:10:35] Antonio Culebras, MD: Yes, there were some side effects, but they were modest. Mostly gastrointestinal issues. But they tended to disappear over time. There were two cases of acute pancreatitis, but every single research project has an occasional serious event. So overall I think that the side effects were quite acceptable.

[00:11:05] Host Amber Smith: So do you think, there's other drugs that are being used like for weight loss and diabetes -- semaglutide, Wegovy and Ozempic -- do you think that drug would have the same effect as tirzepatide?

[00:11:19] Antonio Culebras, MD: It is very likely that any other drug that causes significant weight loss will have an effect on sleep apnea. What is important here is that if the pharmaceutical company gets from the FDA (Food and Drug Administration),, an indication for obstructive sleep apnea and obesity, then I would be able to prescribe the medication. Right now, I cannot prescribe the medication. And, if a medication is prescribed without FDA approval, the insurance company will not accept it. And, as I said before, this is a very expensive drug, $12,000 or more per year. So it is very important to get that FDA approval, which I hope will occur sometime in January.

[00:12:09] Host Amber Smith: Now, since this is a medication that maybe people are already using for diabetes or weight loss, do you think there may be people out there taking it who've already seen an improvement in their sleep apnea and maybe they don't even know to credit the medication?

[00:12:23] Antonio Culebras, MD: Most likely. Most likely. There are anecdotal reports of people using the weight losing medications for other conditions like obesity and diabetes, who have found an improvement, who have noticed an improvement in their sleep apnea. But those are anecdotal reports. By that I mean that they were not measured properly, scientifically, but now we have scientific proof.

[00:12:57] Host Amber Smith: Well, and it's really nice of you to make time to share this information with us. Thank you.

[00:13:01] Antonio Culebras, MD: My pleasure.

[00:13:02] Host Amber Smith: My guest has been Dr. Antonio Culebras. He's a professor of neurology who specializes in sleep medicine at Upstate. "The Informed Patient" is a podcast covering health, science, and medicine brought to you by Upstate Medical University in Syracuse, New York, and produced by Jim Howe, with sound engineering by Bill Broeckel and graphic design by Dan Cameron. Find our archive of previous episodes at upstate.edu/informed. If you enjoyed this episode, please tell a friend to listen too. And you can rate and review "The Informed Patient" podcast on Spotify, Apple podcasts, YouTube, or wherever you tune in. This is your host, Amber Smith, thanking you for listening.