Tag Archives: Management of obesity

An Effective Obesity Drug Has Now Been Approved for Teens

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The Food and Drug Administration has recently expanded the eligibility of an effective obesity drug known as Wegovy to children as young as 12. In a clinical trial, children who took Wegovy lost far more weight than those who took a placebo. The label expansion is the latest success for this new generation of obesity treatments, though the drugs themselves continue to be in short supply and expensive without insurance coverage.

The FDA approved Wegovy in June 2021 for adults with a BMI over 30 (the definition of obesity) or with a BMI over 27 and at least one possibly weight-related condition, such as high blood pressure. It was the first new obesity treatment approved in seven years. However, the active ingredient of Wegovy, called semaglutide, had previously been approved in a lower dose formulation by the FDA for type 2 diabetes in 2017, sold under the brand name Ozempic. Both Wegovy and Ozempic are made by the Danish pharmaceutical Novo Nordisk.

In the major randomized and controlled clinical trials that led to Wegovy’s original approval, the once-weekly injectable drug was shown to help people lose an average of 12.4% of their initial body weight over a 68-week period compared to people who received placebo, or about a total 15% weight loss. And Wegovy appears to be just as effective in teens.

According to the results of the company’s STEP TEENS trial, published last month in the New England Journal of Medicine, teens who took the drug lost an average 14.7% of their initial body weight over a year’s time, while those on placebo gained 2.7% on average. The treatment group also saw an average 16.1% loss in BMI, compared to a 0.6% increase in the placebo group. The safety profile of Wegovy seems to be similar in teens. The most common adverse events reported in these trials include nausea, vomiting, and diarrhea, which often appeared early on in treatment as people gradually increased their dosage and waned over time. The rate of discontinuation, or people who decide to stop taking treatment, was low and similar across both groups (around 5%).

Obesity rates have continued to increase in the U.S. and many parts of the world over time, including among teens and young children. These trends only seem to have accelerated during the covid-19 pandemic. And though there remains much debate over the exact health effects of obesity, childhood obesity is thought to raise the risk of serious health problems later in life, such as type 2 diabetes.

“The prevalence of teen obesity in the U.S. continues to rise, affecting teens and their families. Now, more than ever, we need new options to support teens,” said Aaron S. Kelly, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota and one of the STEP-TEENS study authors, in a statement released last week by Novo Nordisk following the FDA’s decision. “This FDA approval offers an additional tool to address this serious, chronic, progressive disease.”

Up until now, medications have been modestly effective at best in helping people lose weight, or have come with dangerous side-effects, such as stimulants that can cause an unhealthy dependence. And while a balanced diet and exercise is healthy for many reasons, people generally do not achieve and maintain significant weight loss through lifestyle changes alone. Many, but not necessarily all, experts agree that semaglutide represents the first in a class of drugs, known as incretins, that can lead to sustained and safe weight loss, along with many other possible health benefits.

At the same time, Wegovy has been in short supply since its debut, due to unexpected demand and production issues last year that caused the temporary shutdown of one of Novo Nordisk’s key manufacturing facilities. These shortages have likely led to an increase in off-label prescriptions of Ozempic, which is now also in limited supply. At least some patients have complained that they’ve been denied Ozempic for their previously existing diabetes as a result.

Novo Nordisk has claimed that these supply issues will be cleared up by early next year. But even if that happens, Wegovy and similar drugs expected to be approved soon will remain out of reach for many people, due to their hefty price tag. Obesity drugs in general aren’t eligible to be covered by Medicare currently, and many private insurers have been reluctant to cover Wegovy so far. Without insurance, Wegovy can cost upwards of $1,500 a month, and it’s likely that many patients will need to keep taking it in order to maintain their weight loss.

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WHO Warns of Surge in Chronic Disease by 2030 If People Don’t Start Exercising

Image: Timothy A. Clary (Getty Images)

A new report from the World Health Organization finds that our collective lack of exercise will exact a heavy toll in the years to come if nothing changes. The report estimates that there will be nearly a half-billion new cases of noncommunicable disorders like heart disease and diabetes due to physical inactivity by 2030. It also found that many countries are doing little to help people stay active, such as building safer walkable roads.

The findings come from the WHO’s first ever global status report on physical activity. It analyzes data from 194 countries on how often people are physically active and the policies put in place by countries to promote physical activity. As part of the report, the authors also calculated the potential effects on healthcare systems if people’s level of exercise stayed the same up through 2030. These latter estimates will be published in an upcoming paper but can be viewed in a preprint from the Lancet that was released last week.

Often, more than one factor contributes to a person’s heart disease or other noncommunicable disorder (NCD), and only some of these risk factors are preventable or can change for the better. But many studies have shown that any amount of exercise, no matter a person’s age, can help people stay healthier. Based on other research, the authors tried to calculate the fraction of preventable NCDs strongly tied to a lack of physical activity that would emerge over the next decade, focusing specifically on seven major conditions: heart disease, stroke, type 2 diabetes, hypertension, certain cancers, dementia, and depression.

Overall, the authors estimated that almost 500 million new cases of these conditions would occur between 2020 and 2030 worldwide. These cases would also rack up around $300 billion (USD) in direct medical costs during that time period and about $27 billion annually by 2030. Most of these cases (about 74%) would occur in low-to-middle income countries, but the economic costs would be greater in higher-income countries (about 64%).

“This study calls for urgent actions by countries to prioritize investments in interventions that reduce this modifiable risk factor,” the authors wrote.

So far, though, it appears that most countries are falling far short of these investments. The WHO report found less than half of countries even have a national physical activity policy. Only 30% of countries have stated national physical activity guidelines for all age groups. And while most countries do have some way of tracking how active adults are, less than 30% do the same for children younger than 5. The implementation of many of these policies, such as nationally organized running or walking events, have been further disturbed by the covid-19 pandemic, the report authors note.

There are a multitude of reasons why people aren’t as physically active as they could be, and many of those are out of people’s control, such as the kind of job and working hours they have. But the report also highlights the actions that governments are failing to take to encourage a more active lifestyle for residents. Only 40% of countries, for instance, have standards for designing roads that would make walking and biking safer.

“We need more countries to scale up implementation of policies to support people to be more active through walking, cycling, sport, and other physical activity. The benefits are huge, not only for the physical and mental health of individuals, but also for societies, environments, and economies,” said Tedros Adhanom Ghebreyesus, WHO Director-General, in a statement announcing the report. “We hope countries and partners will use this report to build more active, healthier, and fairer societies for all.”

Some of the recommendations provided by the WHO to encourage physical activity include more public open spaces, walkable roads and other infrastructure, and more sports or gym activities in school. There’s also a need for better data collection, since there’s little known about people’s access to parks and other ways to help people become more active.

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