This is going to be a different type of blog post. Today we will discuss and summarize a recent paper published on June 21, 2024, in The New England Journal of Medicine exploring

Tirzepatide for treating sleep apnea and obesity.

Here we go!

Approximately 39 million US adults have obstructive sleep apnea, and 936 million adults worldwide are estimated to have mild to severe obstructive sleep apnea.

What is sleep apnea?

Obstructive sleep apnea is a common condition where the airway gets blocked during sleep, causing breathing to stop and start repeatedly. One of the main risk factors for this condition is obesity. People who are overweight are more likely to have obstructive sleep apnea because the extra weight can put pressure on the airway and make it more likely to collapse during sleep. Hence it was no surprise, that there is a press release about a study that looked at how Tirzepatide affects sleep apnea.

Sleep apnea in-depth

Before we get to the findings, let’s learn more about sleep apnea.

There are two types of sleep apnea. The first type is obstructive sleep apnea, which happens when the upper airway gets blocked during sleep. This blockage interferes with breathing and can cause a person to stop breathing for short periods while asleep.

The second type is central sleep apnea. This occurs when the brain doesn’t send the right signals to the muscles that control breathing. As a result, the muscles and nerves aren’t activated enough for breathing, leading to pauses in airflow during sleep.

The reason we care about sleep apnea is because, if left untreated, it can lead to many serious health problems. These include insulin resistance, type 2 diabetes, high blood pressure, abnormal cholesterol levels, high blood sugar, stroke, kidney disease, sexual dysfunction, and coronary artery diseases like heart failure.

Essentially, untreated sleep apnea can cause a wide range of medical issues. Additionally, several health conditions can increase the risk of developing sleep apnea, such as hypothyroidism, cleft lip or cleft palate, heart disease, kidney disease, large tonsils, obesity or higher body weight, and even menopause. These conditions can either cause sleep apnea or make it worse.

Now, how do you know if you have sleep apnea?

Some of the most common symptoms include excessive daytime sleepiness, where you go to sleep, wake up, and still feel unrested. You might also experience loud snoring. Another symptom is observed episodes where you stop breathing while sleeping. You might suddenly start breathing again with a gasp, or someone may need to nudge you awake to resume breathing. People with sleep apnea might also wake up gasping or coughing.

Additionally, some wake up with a dry mouth or sore throat in the morning. Morning headaches are also a common symptom. Sometimes, difficulty controlling blood pressure can be an indicator of sleep apnea. If you have any of these symptoms, it might be worth consulting a healthcare professional to get evaluated for sleep apnea.

Sleep study

If you think you might have sleep apnea and want to get diagnosed, the first step is to undergo a

sleep study. There are several types of sleep studies available. The most common one is done at a sleep clinic, where you stay overnight. During this study, called polysomnography, they place leads on your head to monitor brain activity, and sensors on your chest to check your heart and breathing. They also measure your oxygen levels while you sleep.

Another option is a home sleep test, which you can do in your bed. This test doesn’t use as many sensors. Typically, you’ll wear a device like a watch, have a band around your chest, a sensor in your nose to monitor airflow, and a pulse oximeter on your finger to check oxygen levels. This home test is more convenient and often less expensive than the in-clinic study, depending on your insurance. Both types of tests provide valuable information to help diagnose sleep apnea.

As we know, Tirzepatide is a once-weekly GIP and GLP-1 receptor agonist known to lead to a 20% reduction in body weight. If you are familiar with Semaglutide, you can think of Tirzepatide as its younger stronger brother.

Methods in the study

It is an industry-funded study, it was conducted in two phase 3, double-blind, randomized, controlled trials involving adults with moderate-to-severe obstructive sleep apnea and obesity. The participants were assigned to receive either the maximum tolerated dose of Tirzepatide (10 mg or 15 mg) or a placebo for 52 weeks.

In terms of the most salient exclusion criteria, type 1 diabetes, type 2 diabetes, a prior or planned surgery, or if they had a self-reported weight loss of more than 5kg in the past 3 months. The intervention was Tirzepatide, which started at a dose of approximately 2 and a half mg once a week and up to 15 mg once a week and to a comparison of placebo.

The outcome was change from the baseline in the Apnea-Hypopnea Index (AHI). In brief, the AHI index is essentially how many times a person stops breathing every hour, it’s assessed with a sleep study. So, all the participants in this study had a sleep study done at the beginning and a follow-up sleep study at the end of the trial.

The Results

Now, let’s dive into the actual results!

They recruited 470 adults, and as noted they were randomized to Tirzepatide or placebo. The average age was 50.

30% were women and 73% were white, the average BMI was 39 and the base AHI index was 50 as a point of reference “AHI above 30 is severe” In other words, this was the real deal in terms of sleep apnea.

So, what happened?

Well, in the group of Tirzepatide, those patients experienced a 25%-point reduction in their AHI index which is remarkable compared to the placebo which was only a 5% drop. Basically, the overall difference was a 20-point improvement with Tirzepatide.

In terms of other outcomes, adults who received Tirzepatide saw a reduction in body weight of approximately 20% of their body weight, whereas the placebo group lost closer to 2%.

Adults who received Tirzepatide also had improvements in systolic blood pressure and diastolic blood pressure, so on average with Tirzepatide the systolic blood pressure fell by 7mm mercury whereas in the placebo group, blood pressure fell by 2mm of mercury.

Adverse events

The adverse events were just as common in the 2 groups, with approximately 80 people of people. However, certain adverse events were much more common in the Tirzepatide group, for example, diarrhea, nausea, and burping.

Limitation

As we think about this trial, it’s of course important to think about what the limitations were. Overall, it was a relatively small study, it was of course industry-funded, but that’s not a fatal flaw. Cardiovascular events are still being studied hence conclusion is not complete.

This medication is not meant for all patients with sleep apnea. It is only for those with sleep apnea along obesity. It would not be useful for patients with sleep apnea with other factors.

Finally, is this trial practice changing? The are no definite conclusions until trials are at the absolute end.

Conclusion

The recent study published in The New England Journal of Medicine offers a beacon of hope for millions suffering from obstructive sleep apnea and obesity. The findings underscore Tirzepatide’s potential as a game-changer in managing these interconnected health issues. The significant 25% reduction in the Apnea-Hypopnea Index (AHI) and the 20% reduction in body weight among participants treated with Tirzepatide are not just numbers; they represent a profound improvement in quality of life for individuals struggling with these conditions and a comprehensive positive impact of Tirzepatide on overall health.