The pharmaceutical company which produces the new obesity medication Zepbound (Tirzepatide) has just released the results of two studies that showed that Tirzepatide, when studied in obese patients who had a diagnosis of sleep apnea, resulted in great improvement in that condition. Obstructive sleep apnea (OSA) is commonly a complication of obesity. Associated with the weight loss accomplished with the help of Tirzepatide, the severity of the study subjects’ sleep apnea condition improved by approximately two thirds. Tirzepatide which is the ingredient in Zepbound is the same ingredient as the even more well known medication called Mounjaro, which is approved for use in diabetes but has become widely used for obesity as well.
To measure the severity of OSA (Obstructive Sleep Apnea), the study used a metric called the apnea-hypopnea index (AHI). The primary problem which identifies that a person suffers from sleep apnea, is that they severely slow down or even stop breathing for brief periods when they are sleeping. These temporary but repeated episodes of low oxygen flow to the brain and body have been documented to have great health risks for those who suffer from this condition.
https://www.ncbi.nlm.nih.gov/books/NBK459252/These well documented health risks include : Coronary artery disease and myocardial infarction, heart failure, high blood pressure, cardiac arrhythmia, stroke, diabetes, sleeplessness related accidents, and depression.
In their summary of the information relevant to Eli Lilly’s announcement, they refer to sleep apnea studies to highlight the importance of their scientific breakthrough that Zepbound is the first medication to effectively treat the obesity related condition OSA, so much so, that they consider their medication a scientific breakthrough deserving of recognition of it by the FDA. They are seeking an FDA approval of this medication specifically for treatment of OSA (Obstructive Sleep Apnea).
Because obesity is so common in the general population, sleep apnea is also a very common condition, although it most often goes undiagnosed.
Their scientific review overview states, “Sleep apnea is highly prevalent
in patients with cardiovascular disease. These
disordered breathing events are associated with a profile of perturbations that include
intermittent hypoxia,
oxidative stress, sympathetic activation, and
endothelial dysfunction, all of which are critical mediators of cardiovascular disease. Evidence supports a causal association of sleep apnea with the incidence and morbidity of hypertension, coronary heart disease, arrhythmia, heart failure, and stroke.”
This study claims that worldwide almost 1 billion people are affected by Sleep Apnea and the prevalence may be over 50% of adults in some countries. As a result they ask that effective diagnostic and treatment strategies are needed to minimise the negative health impacts of this condition.
The AHI- apnea (which means breathing stops)-Hypoxia (low oxygen) Index is a measure of the number of times a person’s breathing shows a blocked or restriction of their airflow, per hour of sleep. The AHI index has become a standard measure to define the severity of sleep apnea.
The two studies were called SURMOUNT-OSA 1 and SURMOUNT-OSA-2 and evaluated two populations of people with OSA (obstructive Sleep Apnea).
SURMOUNT-OSA Study 2 evaluated tirzepatide in study subjects with moderate-to-severe OSA and obesity who were using a CPAP (continuous airway pressure) machine, and planned to continue to use their CPAP device for 52 weeks. In this population, after 52 weeks using tirzepatide the AHI was measured and shown to be reduced by nearly 63%. During the time of the study, the users of tirzepatide, treating their obesity, lost a very significant amount of weight over the year. Their mean body weight reduction was approximately 20 % .
SURMOUNT-OSA Study 1 evaluated tirzepatide in study subjects with moderate-to-severe OSA and obesity who were not using a CPAP machine. Tirzepatide led to a mean reduction in the AHI score of 55%, Tirzepatide users in this study also had a significant weight loss with a mean body weight reduction of 18% .
In the statement announcing the release of these study results Eli Lilly spokesman Jeff Emmick, MD. pointed out that “OSA impacts 80 million adults in the U.S., with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated. ” He further explained, “addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease (Obstructive sleep apnea)”.
On November 8,2023 Eli Lilliy announced that the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol. Approximately 70% of American adults have obesity or are overweight, and many of those who are overweight have a weight-related condition. Losing body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease for those who are obese or overweight.
John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research said, “Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes. In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
Zepbound activates receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake. These two actions underlie its great success in treating overweight and obesity. Zepbound is administered by injection under the skin once weekly.
