study reveals diabetes drug as potential treatment for obstructive sleep apnea
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new use of diabetes drug could reduce or eliminate the need for cpap machines for those living with osa.
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results from studies based on the surmount-osa clinical trials published in the new england journal of medicine (nejm) have found a potential new therapy that can reduce or resolve moderate-to-severe obstructive sleep apnea (osa).
the drug tirzepatide, an injection developed by eli lilly, is currently being used in the treatment of diabetes. new results from clinical trials, however, show an off-label use that could benefit people living with osa.
osa and its effects
osa is a chronic condition driven by interruptions in normal breathing patterns while someone is asleep. it is driven by the narrowing and collapse of airways that lead to the blockage of airflow.
to be diagnosed with osa, people must experience breathing interruption events for longer than 10 seconds at least five times per hour throughout the night. in some cases, osa can be mild, but it can range significantly into severe territory.
the severity is characterized by the apnea-hypopnea index (ahi), which measures the number of completely restricted and semi-restricted breathing episodes a person has throughout the night. people with severe osa have an ahi greater than 30, whereas those with moderate have an ahi between 15 and 30. mild occurs when a person has an ahi between five and 15.
osa is driven by the complete relaxation of the body, mainly the muscles that help with breathing. these muscles can relax to the point where it becomes harder to breathe, leading to episodes of restricted or completely blocked breathing. the symptoms of osa include:
- snoring that comes and goes because it is interrupted by periods of apnea (non-breathing)
- snoring that resumes loudly after an episode of apnea
- headaches upon waking
- falling asleep during the day
- waking in the night to urinate
- changes in mood, such as irritation or depression
- difficulty with memory
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the lack of oxygen intake during the night caused by sleep apnea can severely reduce a person’s quality of life when they are awake. it has also been shown to increase the risk of cardiovascular complications, including high blood pressure and heart disease.
current treatments include machines that foster continuous breathing, surgery, and lifestyle changes, such as reducing overall body weight.
“obstructive sleep apnea is a very common, under recognized disease. when untreated, it can lead to many serious adverse health impacts,” said dr. najib ayas, professor of medicine at the university of british columbia, in a press release.
the connection between obesity and osa
while anyone can develop osa, it is most commonly found in people who have obesity or overweight. people living with obesity have a much higher chance of developing osa. as many as 90 per cent of individuals who have obesity with a body mass index (bmi) over 40 develop osa.
there are a couple of reasons why people living with obesity are the most at risk for osa, all of which come down to excess weight. when fat deposits build up in the tissues surrounding the upper airways or the area between the neck and the abdomen, known as the thorax, there is an increased need for oxygen.
at the same time, the fat deposits can cause narrowing of the airway and compression of the chest, leading to further issues with getting full breaths. the combination of overly relaxed muscles, narrow airways, and chest compression drive osa in people living with obesity.
using tirzepatide for sleep apnea
tirzepatide is a combination drug made up of glucose-dependent insulinotropic polypeptide (gip) receptor and glucagon-like peptide-1 (glp-1) receptor antagonist. for diabetes, gip drugs work by inducing insulin secretion and sensitivity in the body, and glp-1 drugs enhance insulin release to lower blood sugar levels.
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the study investigating the use of tirzepatide for osa was conducted in two phase iii, double-blind, randomized controlled trials with 469 participants over the course of 52 weeks. some participants were told to keep using continuous positive airway pressure (cpap) machines; others were not.
to measure the drug’s efficacy against osa, the researchers examined various markers of osa, including:
- weight
- ahi
- hypoxic burden (measurement to determine levels of desaturation in respiratory events)
- hscrp concentration (measure of inflammation in the body)
- systolic blood pressure
- patient-reported sleep satisfaction
the results showed a clinically significant improvement in breathing interruptions throughout the night, reducing the severity of osa. in some participants, the reduction in breathing disruptions led to them no longer needing a cpap machine.
since tirzepatide can also reduce body weight, it helped on both levels: reducing weight in those living with obesity or overweight and reducing breathing disruptions with osa.
in both phase iii trials, participants saw a reduction in their disease to the point of resolution. the first study saw 43 per cent of people experience the complete resolution of disease, and 52.5 per cent experienced the same results in the second study. as it pertains to this study, disease resolution means the number of people who experience fewer than five sleep disruption events per hour.
“tirzepatide demonstrated that patients with moderate-to-severe osa with obesity were able to achieve osa disease resolution based on predetermined ahi and ess measures. the surmount-osa data is promising and provides a potential new treatment option for some patients with osa,” said dr. sandy henderson, vice president, medical director of lilly canada, in a press release.
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overall, the participants who saw the benefits were able to reduce their sleep events, get better sleep, lose weight, and reduce their risk for osa-related cardiovascular disease.
future directions for off-label use of tirzepatide
tirzepatide is currently approved for the use of weight management and diabetes under the commercial names zepbound in the u.s. and mounjaro in other places outside the u.s. the use of the drug for osa in adults living with obesity was submitted to the u.s. food and drug administration (fda) based on the study results, with the fda granting fast track designation to help bring the drug to those who need it faster.
it’s the hope of researchers and those at lilly that the drug will be approved later this year, and if all goes well, tirzepatide will be the first-ever drug-based therapy for osa.
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