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Mar 13

Weight-loss drug Wegovy approved by FDA to cut heart attack, stroke risk – New York Post

The popular weight-loss drug Wegovy, which has helped millions of Americans shed pounds, can now be used to reduce the risk of stroke, heart attacks and other serious cardiovascular problems in patients who are overweight or who have obesity,federal regulators said Friday.

The Food and Drug Administration approved a label change requested by drugmaker Novo Nordisk that expands the use of semaglutide.

The decision was based on theresults of a studythat found that Wegovy cut the risk of serious heart problems including heart attack, stroke and heart-related deaths. Higher-weight patients with heart disease but not diabetes were 20% less likely to experience those problems compared with patients who took placebo, or dummy shots, the study found.

Wegovy is the first medication approved to help prevent the potentially life-threatening events in this population, the agency said.

Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health, said Dr. John Sharretts, who directs FDAs division of diabetes, lipid disorders and obesity.

The move will change the way many heart patients are treated, said Dr. Martha Gulati, a cardiologist at Cedars-Sinai Medical Center in Los Angeles. It confirms that the new class of obesity medications are useful for improving health, not just losing weight.

The hope is that insurers will start understanding that this is not a vanity drug, said Gulati, who estimated that nearly 70% of her heart patients could be eligible for treatment.

Wegovy is a higher-dose version of Ozempic, the diabetes treatment that was previously approved to cut the risk of serious heart problems in people with that disease. The weight-loss drug typically costs about $1,300 a month.

Novo Nordisk has also asked European Union regulators to expand the use of the drug for heart problems. EU regulators have not weighed in on the request.

The FDA cautioned that Wegovy carries the risk of serious side effects, including thyroid tumors and certain cancers. Other possible side effects can include low blood sugar; pancreas, gallbladder, kidney or eye problems; and suicidal behavior or thinking.

About a third of the more than 17,600 participants in the clinical trial reported serious side effects. About 17% in the group that took Wegovy and about 8% of those who received placebo left the study because of those effects.

The new indication could increase coverage of the drug by Medicare, experts said. The federal health insurance program for older Americans is currently barred by law from covering drugs for weight loss alone. The agency spent nearly $3 billion in 2021 covering Ozempic to treat diabetes, according to latest available figures.

Im not sure it opens the floodgates, but it would open the door to allow more people on Medicare to gain access to Wegovy, said Tricia Neuman, a Medicare policy specialist at KFF, a nonprofit that researches health policy.

Private insurers will evaluate the new indication for Wegovy before making coverage decisions, said a spokesperson for AHIP, Americas Health Insurance Plans, an industry trade group.

Drugmakers and obesity advocates have been pushing for expanded coverage,including legislationthat would require Medicare to pay for the obesity drugs.

At issue has been whether the cost of the expensive medications will be offset by the savings of reduced spending on medical care related to obesity and, now, heart disease.

One lingering obstacle to broader use is limited supply of the drug, which has beenin shortagefor more than a year, according to the FDA. Novo Nordisk officials say theyre working to increase production.

Wider access cant come soon enough, said Gulati.

Everybodys waiting to get this medication, she said. Lower the cost, dont be greedy and make sure the drug is available for use.

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Weight-loss drug Wegovy approved by FDA to cut heart attack, stroke risk - New York Post

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Mar 13

Oprah Winfrey To Address Ozempic And Other Weight Loss Aids In New TV Special – BET

Media mogul, bread-lover, and weight-loss warrior Oprah Winfrey is releasing a new TV special on March 18 on ABC (and streaming on Hulu March 19) called An Oprah Special: Shame, Blame and the Weight Loss Revolution. This special will be exploring the controversial, growing trend of people using alternative methods to lose weight. It will feature a signature sit-down conversation with Oprah with medical experts and everyday people who have used Ozempic, Mounjaro, Wegovy, and other prescription diabetes and weight loss medications.

In a press statement, Winfrey said, It is a very personal topic for me and for the hundreds of millions of people impacted around the globe who have for years struggled with weight and obesity.

The billionaire will talk to her guests about health equity and obesity, intending to ultimately release the shame, judgment, and stigma surrounding weight.

Oprah doesnt do anything without intention. And its obvious that from the start of her stance in the spotlight, Winfrey has dealt with weight loss issues and has been transparent about her struggle. Shes been scrutinized, judged, and ultimately shamed through the years for her weight loss journey.

Winfrey decided to rid herself of any shame attached to getting assistance with her weight loss. She told PEOPLE, The fact that theres a medically approved prescription for managing weight and staying healthier, in my lifetime, feels like relief, like redemption, like a gift, and not something to hide behind and once again be ridiculed for. Im absolutely done with the shaming from other people and particularly myself. And now, she also wants the public to rid themselves of the shame with her special.

I had an awareness of [weight-loss] medications, but felt I had to prove I had the willpower to do it. I now no longer feel that way, Winfrey said as she moderated a The State of Weight panel alongside obesity specialists Dr. Fatima Cody Stanford and Dr. Melanie Jay, psychologist Dr. Rachel Goldman and Sima Sistani, the CEO of WeightWatchers in 2023. A very svelte Winfrey shared how she overcame her own shame related to taking medication to slim down, though avoiding details on what medication she took.

Winfrey said, Even when I first started hearing about the weight loss drugs, at the same time I was going through knee surgery, and I felt, Ive got to do this on my own. Because if I take the drug, thats the easy way out. She continued, It should be yours to own and not to be shamed about it. As a person whos been shamed for so many years, Im just sick of it. Im just sick of it. Im just sick of it.

Winfrey was also a spokesperson and board member for Weight Watchers, a weight loss lifestyle brand. She has since stepped down and proposed donating her 10% share in the company to the National Museum of African American History and Culture (NMAAHC).

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Oprah Winfrey To Address Ozempic And Other Weight Loss Aids In New TV Special - BET

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Mar 13

Daily shot of kitchen cupboard staple could help you shed 18lb in just 3 months, scientists say… – The Sun

A SHOT of apple cider vinegar daily could help you lose weight in weeks, a study shows.

People who endured a sour start to the day shed up to 8kg (18lb) in just three months, Lebanese researchers found.

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They also had better blood sugar and cholesterol measures after starting the routine.

Researchers said new guidelines could suggest obese people start taking a daily dose of the vinegar although perhaps not on chips.

Dr Rony Abou-Khalil, of Holy Spirit University of Kaslik, said: Apple cider might have potential benefits in improving metabolic parameters related to obesity.

The results might contribute to evidence-based recommendations for the use of apple cider vinegar as a dietary intervention in the management of obesity.

Around a quarter of English adults are obese, with a further 38 per cent overweight but not obese.

More than one billion people around the world are now obese, according to the World Health Organization.

Research has shown overweight people cost the NHS an extra 13.7billion a year.

Obesity is linked with a range of deadly conditions, including heart disease, stroke, diabetes and various forms of cancer.

Previous studies have shown drinking a few tablespoons of apple cider vinegar can help people lose up to 4lb of weight in three months.

The latest research, published in BMJ Nutrition, Prevention & Health, found the kitchen staple may have a larger effect.

Researchers gave doses of 5, 10 or 15ml of apple cider vinegar or a placebo mixed with 250ml of water to 120 young people.

This included 46 men and 74 women with an average age of 17 who were overweight or obese with a BMI between 27 and 34.

They recorded what they ate in a diet diary, and provided information on their physical activity.

Those drinking the vinegar lost between 6kg and 9kg on average and reduced their BMI by 2.7 to three points, depending on the dose.

People drinking the highest dose saw the largest weight loss and BMI drop, falling from an average of 77 kg to just over 70 kg.

Apple cider vinegar may offer benefits for weight loss and for lowering blood sugar

At 10ml, the average weight went from 79 kg to 72 kg, and at 5ml they dropped from 79 to 74kg.

Those on the placebo were left with a sour taste in their mouth, seeing their weight stay around 79kg on average

Independent experts said the amount of weight lost by people on apple cider vinegar was remarkable but warned it is not a silver bullet for health.

Dr Daisy Coyle, of the George Institute for Global Health, said: Apple cider vinegar may offer benefits for weight loss and for lowering blood sugar.

While apple cider vinegar may offer some short-term health benefits, particularly for young and overweight individuals, it should not be viewed as a solution to the obesity epidemic.

Losing weight should be a long-term commitment to healthier living, rather than any drastic measures.

The NHS tips - which can be adopted slowly - include:

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Daily shot of kitchen cupboard staple could help you shed 18lb in just 3 months, scientists say... - The Sun

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Mar 13

Running may not help lose weight but it’s very good for you long-term – ZME Science

After the January rush of motivation, most people simply give up on their new-year-new-me fitness goals. But those that persist and stick with it are likely to see some noticeable results.

Take running, for instance. When someone whos unfit or overweight starts running and keeps up with it for a little time, they may see some quick results. But after a few months, most people start to hit a plateau both in performance, and in physical improvement. In fact, a new study suggests that running doesnt help you lose a lot of weight long term. However, it does keep you healthy and prevents you from gaining fat long-term.

Our data clearly shows that lifelong running exercise, be it long-distance or repeated short-distance sprinting, maintains lower fat mass levels than a typical physically active lifestyle and also more than participating in competitive strength sports. says Dr. Simon Walker, a Docent in Exercise Physiology from the Faculty of Sport and Health Sciences.

The researcher added that this is excellent motivation for himself as a runner.

Absolutely this result motivates me to continue running. Id certainly be happy with a fat percentage of 1618% when Im in my 70s and 80s, continues Dr. Walker.

The study involved 109 participants aged 20-39, 147 participants competitive male athletes aged 70-89, as well as 147 healthy age-matched controls. The athletes were separated by their focus (on strength, sprint, and long-distance running). Researchers assessed the body composition of all participants (fat mass, muscle mass, etc).

The study made several important findings. For starters, individuals participating in lifelong resistance training maintained their muscle mass much better than those participating sprinting. In addition, the older strength trainers had a similar amount of muscle mass as their young counterparts. Also, people who engaged in lifelong running had less fat than other participants.

So, if you want to get the best of both worlds, you need to get involved in both worlds. Essentially, in order to maintain a higher muscle mass and a lower fat mass, the best approach is doing both strength and resistance training.

In terms of enhancing body composition through both heightened muscle mass and maintenance of a non-health affecting fat mass, it seems that a combined approach is recommendable.

We know that both tissues, fat and muscle, influence overall health and function opposingly. Therefore, the best strategy would be to optimize both.

However, there are limits to what exercise alone can achieve. All older athlete groups showed higher average fat mass than the young groups, suggesting that you need more than just exercise to keep fat under control.

Nevertheless, this research shows just how much physical activity matters in remaining healthy as one ages.

The key is perhaps to prevent a rise in fat mass or loss in muscle mass in the first place and maintain exercise throughout the lifespan. Thus, lifelong engagement in regular exercise does help to maintain a healthy body composition. That is no myth.

There are some limitations to the study. For starters, its a pretty small sample size. All the study participants were also all males, although Walker says he expects the findings to carry over to everyone just as well.

While we studied males only, I see no reason why our results would not be applicable for females too, especially considering the effects of menopause and other age-related effects.

Plenty of different studies have highlighted the beneficial effect of endurance and strength training. Different types of exercise help in different ways, but the overarching theme is clear: a balanced approach to physical activity is crucial for long-term health and fitness. Incorporating a mix of endurance and strength training can help individuals achieve a healthier body composition, improve cardiovascular health, and maintain mobility as they age.

The study was published in Frontiers in Sports and Active Living.

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Mar 13

Experimental weight loss pill seems to be more potent than Ozempic – New Scientist

An oral weight loss drug could help people with obesity who dislike needles

Kseniya Ovchinnikova/Getty Images

An experimental pill looks set to cause more weight loss than existing injectable treatments such as Ozempic, Wegovy and Mounjaro, based on early trial results reported on 7 March.

The medicine, called amycretin, caused people to lose 13 per cent of their weight over three months, more than twice the amount seen with Ozempic and Wegovy specifically. This approach seems to be a little bit more exciting, from the limited data that we have, says Daniel Drucker at the University of Toronto in Canada.

The results are from a placebo-controlled trial lasting three months, so it is too soon to know how amycretin stacks up against the other medicines for long-term effectiveness and safety, says Drucker, who wasnt involved in the trial but has consulted for the manufacturer Novo Nordisk, as well as other pharmaceutical firms.

The diabetes drug Ozempic and the weight loss drug Wegovy are two brand names for the compound semaglutide. They work by mimicking a gut hormone called GLP-1 that is normally released after eating. This makes people feel full, reduces their appetite and boosts the release of the blood-sugar-regulating hormone insulin.

Semaglutide leads to the loss of about 15 per cent of body weight after it has been taken for one year, although weight then plateaus and people need to continue the injections long term or it tends to creep back up.

Another weight loss injection was launched last year, called Mounjaro, also known as tirzepatide or Zepbound. This mimics GLP-1 and an additional gut hormone called GIP. Mounjaro seems to lead to people losing about 21 per cent of their weight over the first year and five months of use, before their weight loss plateaus.

Amycretin, however, mimics GLP-1 and a different hormone called amylin, which seems to make it more potent still at least over the first three months of treatment. People taking amycretin lost 13 per cent of their weight in this period, Novo Nordisk announced today, according to a report by Reuters. Those taking placebo pills lost 1 per cent.This is more than the equivalent figures for Wegovy and Ozempic, of 6 per cent, and for Mounjaro, of about 7.5 per cent.

However, we can only know for sure how the drugs measure up long term when they are compared under exactly the same circumstances in a single study, says Drucker. These are not head-to-head trials.

Another caveat is that medicines that work by mimicking GLP-1 have been used for more than a decade to treat type 2 diabetes and so their safety profile is well understood, which isnt the case for an amylin mimic.

Novo Nordisk has also said that amycretins side effects were similar to those of Wegovy, which tend to be nausea, vomiting and diarrhoea, especially for people who increase the dose too quickly.

Being available in tablet form would be a great advantage for people who dont like injections, says Daniel Chancellor at global pharmaceutical business analysts Citeline. An oral pill is very attractive.

As well as these three medicines, other weight loss drugs that mimic other gut hormones are also in development.

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Mar 13

Weight-loss drugs like Wegovy are meant for long-term use. Some patients want to stop – Herald Palladium

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Mar 13

Male hormonal birth control? It may be closer than you think – University of California

Matthew Trevio and Emily Fletcher are self-described DINKWADs double income, no kids, with a dog. The Sacramento couple, who met and work at UC Davis, are as committed to each other as they are to not having children, which makes reliable birth control especially important. But except for condoms or a vasectomy, all birth control options currently available are for women. Trevio, 35, and Fletcher, 28, believe contraception should be more of a shared responsibility.

Maybe the burden is on the wrong side, said Trevio. I kind of think its unfair, that it only lands on the women.

They have been participating in a clinical trial at UC Davis Health to test a reversible hormonal birth control gel for men. If successful, male hormonal birth control has the potential to make the responsibility of contraception more equitable. The clinical trial, funded by the National Institutes of Health and taking place at sites around the world, is currently in its fourth year at UC Davis Health.

The hormonal gel, developed by the Population Council and the NIH, is applied to the shoulders and works by suppressing sperm production while maintaining testosterone levels. The gel works with the same principles as female hormonal birth control, which uses two hormones progestin and estrogen to prevent pregnancy.

The gel has a progestin called Nesterone, which prevents the testes from making sperm, explained Mitchell Creinin, professor of obstetrics and gynecology and a family planning specialist at UC Davis Health. During that process, natural testosterone production also stops.

For a man to feel normal and even be able to have sex, he needs testosterone. So, we give Nesterone plus testosterone.

Participating in the trial wasnt an easy decision for the couple. Fletcher had been on some form of birth control since age 12. The trial meant going off birth control at a pivotal time just when Roe v. Wade was overturned.

I was worried, said Fletcher. There was still a thought in the back of my mind that maybe this will be an issue if the drug doesnt work and I get pregnant.

Fletcher and Trevio did their homework on the trial and examined the data. They both work as researchers. Ultimately, they both decided it was the right thing for themselves and for their relationship.

The hormonal gel comes in a canister about the size of a can of shaving cream, and it holds two weeks worth of doses. Trevio, a former Marine, has made applying the hormonal gel part of his morning routine, squirting just a small amount on his tattooed shoulders.

The list of possible side effects from the gel is long and includes dry or oily skin, increased or decreased libido, hair growth or loss, and mood swings. Besides what may be a little weight gain from the drug, Trevio has had only one other side effect.

Ive only experienced increased libido, he said. Maybe Im just lucking out but I hope this is the case for the majority of participants. If it is, its definitely going to change contraception as a whole.

Fletcher said shes had to adjust to Trevios increased libido. But she says their sex life comes with a lot less worry.

Knowing that his sperm count is essentially zero is definitely peace of mind, Fletcher said.

Researchers hoped the gel would work about as well as the female birth control pill, but its working even better than expected, said Creinin.

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Mar 13

Kenyan Winnie Jemutai Boinett banned three years for testosterone – Athletics Illustrated

Winnie Jemutai Boinetthas been suspended by the Athletics Integrity Unit (AIU) for three years as she tested positive for testosterone.

Boinetts sample that she provided in competition at the XLI Cross Internacional de Italica in Seville, Spain, on November 12, 2023, had the presence of testosterone. Testosterone is banned under the World Anti-Doping Agencys (WADA) prohibited list.

The 20-year-old 5000-metre runner admitted to the violation and accepted the consequences, including the forfeiture of any medals, titles, points, prize money, and other prizes won since the date of the provisional suspension. Therefore she had a reduced sentence from four years to three years.

The World Anti-Doping Agency (WADA) and the Anti-Doping Agency of Kenya (ADAK) may appeal the decision to the Court of Arbitration for Sport in Lausanne, Switzerland.

The World U20 bronze medallist in the 1500m may have also age-doped as Wikipedia lists her birthday as 4 October 4, 2003, June 4, 2003, or February 9, 2002. She has run the 5000m as fast as 14:39.05.

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Mar 13

Hype of New Weight Drugs Ignores Complex Full Story – Lockton

The growing obesity crisis in the United States has fostered a host of debilitating and costly chronic conditions, and even premature death. With working-age Americans having the highest obesity rates in the country, employers are now feeling pressure to fund pricey new weight loss drugs that promise a fast track to a healthier population.

Obesity in the workplace increases health plan and workers compensation costs as well as absenteeism due to chronic conditions such as high blood pressure and Type 2 diabetes. Since data estimate upwards of 45 percent of an employers adult health plan population meet criteria for a weight loss drug prescription, these expensive new medications have created a conundrum.

Some companies are now facing employee questions/demands to cover the new weight loss medications, fueled by media, and heightened by direct marketing to consumers, providers, and employers. Employers that opted to cover them, quickly found these drugs soared to their top five most expensive health plan costs within 90 days of initiating coverage, according to Locktons data.

Escaping the buzz around GLP-1s (glucagon-like peptides), better known under their brand names of Wegovy, Saxenda, and Zepbound, is impossible given the bombardment of ads and celebrities touting their transformative effect.

The reality is the benefit of these new weight loss drugs in the health journey of Americans struggling with obesity remains an open question as sustained use is required to measure their long-term effects.And, with limited longer-term data available, there is still much we dont know about their potential side effects.

But the quest for fast fixes to lose weight isnt new, nor is repurposing of drugs used for treating other issues that offer weight reduction as a side effect. Unlike diet pills that acted to suppress the appetite, these new drugs slow the passage of food through the digestive system and reduce food cravings.

While they are a welcomed option to the toolkit to reduce obesity and related chronic illnesses, theyre not a panacea. Any effective treatment plan needs to address biology and behavior simultaneously.

Here are some considerations for assessing coverage of new weight loss drugs:

Commercially insured Americans are the focus. Approximately 75 percent of the total addressable market (TAM) for the weight loss drug pipeline exists within the commercially insured space, according to a recent Goldman Sachs analysis 1. Drug manufacturers are directly appealing to employers to cover these drugs (https://www.novonordiskworks.com/ (opens a new window))

Read behind the hype: News stories touting weight loss drugs reducing major adverse cardiovascular events, like heart attacks and strokes, dont tell employers the full story related to their insured population. Real-world users of new weight loss drugs tend to be females in their 30s to mid-40s with no previous history of heart or vascular disease. Conversely, participants in the study behind the headlines were in their 60s, had previous history of heart attack, stroke, or peripheral vascular disease, and just under 30 percent were female. So, more research is needed before concluding the efficacy of these new drugs in preventing heart and vascular disease in the broader population with obesity.

To spend or not: Drug manufacturers own research shows that when someone discontinues these medications, their weight quickly returns to the unhealthy range. Real-world data, including our own, indicates 60 to 80 percent of users abandon them in the first year. Any health benefit and positive return on investment are likely lost.

Why the fast abandonment? Our data indicates potentially unmanageable side effects in those using weight loss drugs, causing an increased use in anti-nausea drugs and emergency room visits. This, coupled with reports of severe stomach and intestinal problems, raises questions about the sustained risk-benefit of these new weight loss drugs. Answers require more data.

Employers should keep in mind that these new weight loss drugs are intended to be an adjunct to lifestyle modification, not a primary therapy without supporting intervention. Recently, programs have launched coupling the new drugs with lifestyle changes and support. This change may provide a road map to the healthier population these new weight loss drugs portend.

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Mar 13

Does the GOLO Diet work? Experts explain the pros, cons, and risks – Fortune

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