The United States Food and Drug Administration (FDA) gave its approval to Zepbounda drug initially developed for weight loss, as the first drug treatment for obstructive sleep apnea (OSA). This advance represents a crucial step in the management of this condition commonly associated with obesity.
According to the information of ABC Newsthe authorization of the use of Zepbound It is aimed at obese people who suffer from moderate or severe obstructive sleep apnea. The approval opens the door for insurers, including Medicarecan cover this medication for eligible patients, something that does not happen when it comes exclusively to weight loss, the media explained.
The FDA based its decision on the results of two clinical trials sponsored by the pharmaceutical company Eli Lillycarried out with a sample of 470 participants.
According to CNNthese trials showed that “in patients not using continuous positive airway pressure (CPAP) devices, Zepbound was able to reduce, on average, 25 episodes of respiratory interruption per hour after one year, compared to five events of those who took a placebo.”
Obstructive sleep apnea is a disorder that affects nearly thirty million people in USAaccording to the American Academy of Sleep Medicine. This syndrome not only interferes with the quality of rest, but also carries serious cardiovascular and neurological risks.
As indicated Patrik Jonssonpresident of Eli Lilly’s Cardiometabolic Health area, in statements reported by CNN“many cases of OSA go undiagnosed and untreated, leaving millions of people exposed to serious medical consequences.”
Among the most promising findings of the trials, it was observed that patients treated with Zepbound They presented, in addition to a substantial improvement in obstructive apnea, a notable reduction in body weight.
“On average, participants lost up to 20% of their initial weight, which is equivalent to between 20 and 23 kilograms, while those who used a placebo only lost between 0.7 and 1 kg,” he reported. ABC News.
The results were published in the journal New England Journal of Medicinewhere researchers described additional benefits, such as a decrease in blood pressure and inflammatory markers, key elements in managing cardiovascular risk related to obstructive apnea.
The relationship between both diseases is widely recognized in the medical community. People with obesity often show significant improvements in their sleep apnea symptoms when they manage to reduce their weight significantly, the study indicated. This link underscores the importance of therapeutic options that combine weight control with improvements in respiratory function.
Until now, standard treatments for obstructive sleep apnea were limited to the use of devices CPAPwhich keep the airways open through positive pressure. However, this method has limitations, as it is not always comfortable or effective for all patients.
“The development of Zepbound as a pharmacological option represents a significant advance in this field,” highlighted the director of the FDA’s Division of Pulmonology, Allergy and Critical Care, Dr. Sally Seymour.
Although the cost of the medication reaches $1,060 a month without insurance, the pharmacist Eli Lilly offers discounts and cheaper versions using manual injectable vials, instead of automatic pens. In this context, the Joe Biden administration’s proposal to change the coverage policy of Medicare around obesity medications could be key to facilitating their access.
The potential impact of Zepbound goes beyond treating obstructive sleep apnea. As pointed out ABC Newsthis medication could benefit an estimated 15 to 20 million adults in the United States living with both conditions: obesity and severe apnea.
Among the most commonly observed side effects are mild or moderate gastrointestinal discomfort, especially during the initiation of treatment or when increasing the dose. However, researchers conclude that the benefits far outweigh the potential initial discomfort.
