Health
FDA approves first medication for obstructive sleep apnea, which also promotes weight loss
The first medication for obstructive sleep apnea has been approved by the U.S. Food and Drug Administration (FDA).
On Dec. 20, the FDA announced that the agency has approved Eli Lilly’s Zepbound (tirzepatide) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
The drug is to be paired with a reduced-calorie diet and increased physical activity, the FDA noted.
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Sally Seymour, M.D., director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research in Washington, D.C., applauded the approval in an announcement.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Seymour wrote. “This is a major step forward for patients with obstructive sleep apnea.”
OSA occurs when the upper airway becomes blocked and causes pauses in breathing during sleep, according to the FDA. The condition is more common in people who are overweight or obese.
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Similar to semaglutide treatments like Ozempic and Wegovy, Zepbound activates receptors of hormones secreted from the intestine (GLP-1 and GIP) to reduce appetite and food intake.
About 30 million people suffer from sleep apnea in the U.S.
Studies show that by reducing body weight, Zepbound “also improves OSA,” the FDA noted.
In a 52-week study, participants treated with Zepbound experienced “statistically significant and clinically meaningful reduction in events of apnea or hypopnea,” and a large share of participants achieved remission or “resolution of symptoms.”
Zepbound-treated patients also reported a significant decrease in body weight, the FDA mentioned.
The drug can reportedly cause side effects like nausea, diarrhea, vomiting, constipation, stomach discomfort and pain, injection site reactions, fatigue, allergic reactions (typically fever and rash), burping, hair loss and gastroesophageal reflux disease.
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While Zepbound causes thyroid C-cell tumors in rats, it’s unknown whether it causes these tumors in humans, so it should not be used by patients with a personal or family history of medullary thyroid cancer or with multiple endocrine neoplasia syndrome type 2, per the FDA.
The agency encourages all OSA patients to consult with a doctor before taking Zepbound and to monitor for any complications.
Sleep expert Dr. Wendy Troxel, who is a RAND Corporation senior behavioral specialist and licensed clinical psychologist in Utah, called the FDA’s approval a “promising advancement for the millions of people who suffer from this condition.”
“Zepbound promotes weight loss and has been shown to reduce apnea events.”
About 30 million people suffer from sleep apnea in the U.S., Troxel told Fox News Digital.
While the most common treatment for sleep apnea — positive airway pressure (PAP) — is “highly effective” at treating the condition, up to 50% of patients are “non-adherent,” she said.
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“Zepbound promotes weight loss and has been shown to reduce apnea events,” Troxel noted.
“For obese individuals with moderate to severe sleep apnea, this new treatment option may offer an important alternative or adjunctive treatment, particularly for those who struggle with sleep apnea therapies, such as positive airway pressure.”
Troxel added that treating sleep apnea is “critical not only for the patient’s health and well-being, but also for their bed partners, who are often the ‘hidden casualties’ of untreated sleep apnea, given that loud snoring and gasping for air are primary symptoms,” she said.
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Dr. William Lu, medical director of Dreem Health in San Francisco, told Fox News Digital that obesity and sleep apnea are “two of the most prevalent health conditions that affect Americans today.”
“We still need to emphasize shifting the diet and health habits of many, but this is a fantastic start.”
“And they go hand in hand,” he said. “For the patients who qualify and have no contraindications, tirzepatide has the opportunity to be a generational medication that can help people lose weight, reduce the severity of sleep apnea and improve overall health.”
“We still need to emphasize shifting the diet and health habits of many, but this is a fantastic start.”
Getting tested for sleep apnea is “critical for your health,” Lu said, and could also be a requirement for getting coverage for the medication.
Fox News Digital reached out to Eli Lilly requesting comment.
Health
5 sleep tips to get better rest during the busy holiday season
Getting a good night’s sleep can be a little more challenging amid the hype of the holidays.
With changes in routine, diet and potentially time zones, quality sleep could be difficult to come by.
Around 42% of U.S. adults struggle with sleep issues during the holiday season, according to a CNET survey.
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More than half of millennials and Gen Zers said their sleep quality was impacted significantly over the holidays, the survey found.
Dr. Brian Licuanan, a board-certified clinical psychologist in California, told Fox News Digital that there are a variety of reasons sleep can be disrupted, including medical and mental health conditions, diet, alcohol intake and other lifestyle behaviors, like screen exposure.
Spending the holidays in someone else’s home or experiencing a change in a normal wake/sleep routine can also impact sleep quality, he said.
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Licuanan, author of “How to Get Your Resisting Loved One Into Treatment,” offered the following five tips on how to improve sleep during the holiday season.
1. Prepare to sleep away from home
Especially for those who are traveling across time zones, sleep schedules will most likely take a hit.
“Try to adjust accordingly,” the expert suggested. “If you’re in a time zone ahead of your usual one, consider going to bed earlier, since you may feel sleepy sooner.”
“If you’re in a time zone behind your usual one, try delaying your bedtime to allow your body to build up enough sleepiness.”
If you’re staying as a guest in someone’s home or at a hotel, it might be helpful to bring some tools to help ensure a good night’s sleep.
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This could include earplugs or eye masks, Licuanan said, which are “good ways to replicate the quiet and darkness that you may have in your home.”
2. Be mindful of changes in diet, alcohol and exercise
As many people may eat and drink more than usual during the holidays, Licuanan advised being mindful of the amount of consumption.
Exercise routines are likely to shift during this time as well.
“[Alcohol] could impair certain stages of sleep, causing you to feel groggy and tired the following day,” he said.
“Carve out time for exercise and healthy eating habits, as that will help you relax and promote better sleep.”
3. Stay organized
Keeping organized during the busy holiday season can help prevent the mind from racing before bed, according to Licuanan.
He recommended making a list of items or tasks that need to be done the next day to organize your thoughts.
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“Writing things down can help you feel more relaxed and take out the extra and unnecessary thoughts that can disrupt your sleep,” Licuanan said.
4. Communicate with your partner
Balancing relationships over the holidays can also cause unwanted stress and sleep disruption.
To prevent unnecessary hiccups, Licuanan encouraged having an open dialogue with your partner about holiday expectations.
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“Divvy up responsibilities, so one person is not overwhelmed with things to do,” he advised.
“Such activities can include buying groceries, wrapping gifts, picking up family members at the airport or providing entertainment for guests.”
5. Practice mindfulness and relaxation techniques
While the holidays can be filled with potential stressors, Licuanan suggested practicing mindfulness and relaxation techniques to fuel good sleep later.
“Continual social gatherings, travel and spontaneous activities can all heighten stress levels,” he said.
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“Managing the levels of stress with mindfulness and relaxation techniques can help ensure that you are relaxed physically and mentally in order to better accomplish good, relaxed sleep.”
Licuanan encouraged all holiday celebrants to stay positive, have fun and try to enjoy the season.
“Though the holidays may present a level of stress, it’s important to remember things such as gratitude and the positive things in life, as a positive mindset can lower stress, which will likely improve sleep quality,” he added.
Health
Stem cell therapy to correct heart failure in children could 'transform lives'
Renowned visionary English physician William Harvey wrote in 1651 about how our blood contains all the secrets of life.
“And so I conclude that blood lives and is nourished of itself and in no way depends on any other part of the body as being prior to it or more excellent,” he wrote. “So that from this we may perceive the causes not only of life in general … but also of longer or shorter life, of sleeping and waking, of skill, of strength and so forth.”
Dr. Kevin Watt, team leader of the Heart Regeneration and Disease Laboratory at the Murdoch Children’s Research Institute (MCRI) in Melbourne, Australia, understands this concept deeply.
STEM CELL RESEARCH SHOWING NEW POSSIBILITIES FOR TREATING INFANT HEART DISEASE
He lives it every day, as he and his fellow researchers study and reprogram the potential of the blood to treat disease, specifically heart failure in children.
Building on the work of Dr. Shinya Yamanaka of Japan, who discovered that specialized cells could be reprogrammed back to immature stem cells, Watt and his collaborators have taken this work several steps further.
They have used small molecules to turn these new stem cells from the blood into heart cells.
Small heart organoids are developed in the lab — which can then be injected into the failing hearts of children.
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Relying on the philanthropic support of the Murdoch Institute, the work is progressing rapidly and has been shown to be effective already in mice, pigs and sheep.
“The vision of our research is to develop new therapies that can transform the lives of children with heart failure.”
Clinical trials in humans will be starting soon, and as Dr. Watt told me in an interview from Australia, “Large sheets of heart tissue will be stitched into the failing heart.”
Congenital heart failure as well as side effects of chemotherapy in children will be targets for this miracle therapy. Millions of children around the world suffer daily from these conditions.
Watt said that certain chemotherapy (anthracyclines) have a higher risk of heart failure – up to 15% of the time – and this treatment may be useful to protect the heart.
Watt said, “Heart failure remains an urgent, unmet clinical challenge across the world. While we have made significant advances over several decades in managing the disease, we lack targeted therapies to treat these devastating conditions.”
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He added, “More than 500,000 children around the world live with advanced heart failure that requires transplantation. The vision of our research is to develop new therapies that can transform the lives of children with heart failure.”
To achieve this, he said, “we use a technology called induced pluripotent stem cells, where we can convert blood or skin cells of patients with heart failure into stem cells that we then turn into heart cells … or even make engineered heart tissues that can be stitched onto the patient’s heart to help it pump.”
The cells that are targeted in the blood are known as peripheral blood mononuclear cells (PBMCs).
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They are “pushed back in time to an earlier time before they became differentiated into heart or kidney cells,” he said.
Then they can be pushed forward to become healthy heart cells or mutations — or other abnormalities can be corrected.
While the team at the Murdoch Children’s Research Institute is making heart cells from stem cells in the blood for clinical use, it’s also using these stem cells to figure out new drugs to treat heart failure directly.
Said Watt, “Using stem cells from patients with heart failure caused by chemo, we are actively developing new drugs and cell-based treatments that we believe will transform the lives of patients with these conditions … Our research group has pioneered methods to turn these stem cells into miniature heart tissues that can be used to model disease-in-a-dish, to identify new drug targets for the development of new therapies.”
These treatments are personalized and highly expensive, but they’re also highly effective.
Correcting heart failure in young children is only a few years away from becoming a reality.
It’s a Christmas miracle that relies on the kind of philanthropic support that MCRI is famous for arranging.
“Philanthropic support plays a critical role in accelerating the development of these new, transformative treatments,” said Watt, “and this support will be essential as we work toward bringing stem cell-based precision therapies for heart failure to every child who needs it.”
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Visit go.fox/MCRI to donate or to learn more about MCRI’s important research.
Health
First rare human case of bird flu reported in Los Angeles County
The first human case of H5N1, more commonly known as avian influenza or bird flu, has been confirmed in Los Angeles County in California, in connection with an adult who was exposed to livestock.
The Los Angeles County Department of Public Health said the person who contracted bird flu had mild symptoms, was treated with antivirals and is now recovering at home.
While this is the first human case in the county, the public health department said the overall risk of H5 bird flu to the public remains low, adding that there is currently no evidence of person-to-person spread of the virus.
Still, those who are in close contact with the infected person, as well as other workers at the worksite, are being monitored for symptoms and have been offered testing, antiviral prophylaxis and personal protective equipment.
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The case is part of an ongoing investigation which involves the county public health department, the California Department of Public Health and the Centers for Disease Control and Prevention.
“People rarely get bird flu, but those who interact with infected livestock or wildlife have a greater risk of infection. This case reminds us to take basic precautions to prevent being exposed,” LA County health officer Muntu Davis said. “People should avoid unprotected contact with sick or dead animals including cows, poultry, and wild birds; avoid consuming raw or undercooked animal products, such as raw milk; and protect pets and backyard poultry from exposure to wild animals.”
Davis also encouraged the public to get the seasonal flu vaccine, which he said can help prevent severe seasonal flu illness and lower the risk of getting seasonal and bird flu infections at the same time if exposed.
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Bird flu symptoms in humans include eye redness or discharge, fever, cough or difficulty breathing, sore throat, muscle aches, diarrhea and vomiting.
The news comes just days after California Gov. Gavin Newsom declared a state of emergency due to bird flu.
Newsom issued the state of emergency after an outbreak of the virus occurred among dairy cows in Southern California farms.
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After initially being reported in Texas and Kansas in March, bird flu has been confirmed in cattle across 16 U.S. states, as the Centers for Disease Control and Prevention (CDC) has reported.
“This proclamation is a targeted action to ensure government agencies have the resources and flexibility they need to respond quickly to this outbreak,” Newsom said in a statement.
Also, last week, the first case of severe bird flu was confirmed in a human patient in Louisiana, according to the CDC.
The health agency maintains that “the current public health risk is low,” but said it is “watching the situation carefully.”
Fox News Digital’s Melissa Rudy contributed to this report.
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