The science and side effects behind the semaglutide weight loss drugs

Ozempic can help people to quickly lose weight but may also have serious side effects

Ute Grabowsky/imageBROKER/Shutterstock

Ozempic and Wegovy are brand names for the drug semaglutide. Many countries have approved Wegovy for weight loss in people who are obese or overweight and Ozempic for people with type 2 diabetes.

How do these drugs work?

Drugs such as semaglutide mimic the actions of a hormone called glucagon-like peptide-1, or GLP-1. These so-called GLP-1 analogues have several effects, including slowing stomach emptying, acting on the brain to reduce appetite and boosting the release of insulin, which helps to regulate blood sugar levels.

For more than a decade, GLP-1 analogues have been used to help people with type 2 diabetes control their blood sugar and some users experienced modest weight loss. “These drugs augment a system that already exists within the human body, whose role it is to suppress appetite following meal ingestion,” says Simon Cork at Imperial College London.

Why are they making headlines now?

GLP-1 analogues have started to be prescribed for weight loss in people without type 2 diabetes. They have also become available in formulations that are more potent and easier to use.

Initially GLP-1 analogues were approved for use at a lower dose and needed to be given by twice-daily injections. In the latest formulations they are once-weekly injections, with Wegovy’s full dose being 2.4 milligrams for weight loss and Ozempic being used at a maximum dose of 2 milligrams for type 2 diabetes.

How widely available are they?

In 2021, Wegovy was approved for weight loss in several countries, including the US and Canada. Praise from some celebrity users brought it widespread publicity.

Manufacturing problems meant its manufacturer, Novo Nordisk, had trouble meeting global demand, so some doctors started prescribing Ozempic, which had been approved for people with type 2 diabetes in certain countries several years earlier. This led to shortages for people who required it for diabetes control.

In the UK, Wegovy was approved in 2021, but only got the nod from England’s medical guidelines body the National Institute for Health and Care Excellence in March 2023, when it said the drug should be given by weight loss clinics within the country’s national health service. Wegovy is expected to become available in the UK this year, while Ozempic has been available for type 2 diabetes since 2019.

In June 2023, the UK government announced the introduction of a two-year pilot that gives people with obesity access to new drugs, such as Wegovy, outside of a hospital setting.

How effective are they?

Very. It is a cliche but obesity doctors are talking about a paradigm shift in the field of obesity management. Previously, a loss of about 5 per cent of body weight would be considered a good result for any weight loss intervention outside of stomach surgery and is considered a benchmark in obesity drug trials.

Wegovy leads to about a 15 per cent reduction in body weight over a year, when combined with exercise and eating healthily.

In fact, some people seem to feel that the GLP-1 analogues have caused them to become too gaunt, as reflected in the rise of the search terms “Ozempic face” and “Ozempic butt”. “Ozempic doesn’t do anything specific to the skin,” says Alexander Miras at Ulster University, UK. It is the weight loss that causes these apparent side effects, with similar outcomes often also occurring after weight loss surgery, he says.

Do the drugs have any side effects?

Side effects can be mild, such as nausea, constipation and diarrhoea, which tend to occur as people get used to the drug. More worrying side effects include inflammation of the pancreas, although this is relatively rare.

How about hair loss?

Hair loss has been reported by some semaglutide users. This is also sometimes seen after significant weight loss from other causes, such as stomach surgery, says Miras.

Hair loss following weight loss surgery is thought to be due to physiological stress on the body causing an increased number of hair follicles to enter their “resting” phase, which leads to the hairs falling out a few months later. It stops when the weight loss stabilises, however, the hair doesn’t always grow back, says Miras.

Do these drugs cause suicidal thoughts?

GLP-1 analogues – such as Ozempic and Wegovy – are being investigated by the European Medicines Agency (EMA) after recent reports that they may cause thoughts of suicide or self-harm. This was after Iceland’s health regulator received three such reports regarding semaglutide and another drug called liraglutide, which is an earlier GLP-1 analogue.

The EMA says it is analysing about 150 reports of possible cases of self-injury and suicidal thoughts. This doesn’t mean the medicines caused these effects, however, only that people reported these experiences after starting to take them. “More work is needed to determine if a causal link exists,” says Michael Schwartz at the University of Washington in Seattle.

A spokesperson at Novo Nordisk, the manufacturer of liraglutide and the semaglutide drugs Ozempic and Wegovy, told New Scientist: “GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for eight years. The safety data collected from large clinical trial programmes and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.”

Need a listening ear? UK Samaritans: 116123; US 988 Suicide & Crisis Lifeline: 988; hotlines in other countries.

Do these drugs help with addictions?

Perhaps. There have been many anecdotal reports of people taking these medicines for diabetes or weight control who lose their urge to drink alcohol or see waning of other habits that could be described as “behavioural addictions”, such as compulsive shopping.

This is supported by research in animals that found the GLP-1 analogues lower consumption of alcohol and addictive drugs. A small trial in people has hinted at a similar effect from a GLP-1 analogue called exenatide, which reduced heavy drinking, but only in people who were obese.

The explanation could be connected with the way the drugs act on the brain to reduce food cravings, but the exact mechanism is unclear. We are only at the beginning of understanding how these treatments could support people with alcohol and drug additions, says Daniel Drucker at Sinai Health in Toronto, Canada. “The clinical trial data is not yet in to substantiate the anecdotes.”

What happens to a user’s weight long-term?

The longest trial of Wegovy lasted two years and found that people’s weight broadly plateaued in the second year.

In most countries, Wegovy has been approved for two years’ use, but if people stop taking the drug, they generally regain the lost weight – two-thirds of it after one year, according to one trial.

“The weight loss is only sustained for as long as the drug is taken because as soon as you stop the drug, all of those physiological processes that are trying to get your body weight back up kick in again,” says Cork.

This suggests that after two years of use, there will be demand from consumers for doctors to continue prescribing the drug “off label”. “I think there’ll be a big push to try to change those guidelines,” says Cork.

Ozempic can be prescribed long-term for type 2 diabetes because the condition is usually life-long.

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#science #side #effects #semaglutide #weight #loss #drugs

Why we need to improve heart health in Europe

Cardiovascular diseases (CVDs) are the number one killer in Europe. They cost the EU an estimated €282 billion in 2021, larger than the entire EU budget itself.[1] Sixty million people live with CVDs in the EU, while 13 million new cases are diagnosed annually.[2]

Behind this data are individual stories of suffering and loss, of lives limited and horizons lowered by, for example, heart attack and stroke. These diseases directly affect every community in every country. And they strain our health services which must respond to cardiac emergencies as well as the ongoing care needs of chronic CVD patients.

Sixty million people live with CVDs in the EU, while 13 million new cases are diagnosed annually.

Cardiovascular health is a priority not just because of the scale of its impact, but because of the scope we see for significant advances in outcomes for patients. We should take inspiration from the past: between 2000 and 2012, the death rate from CVDs fell by 37 percent in the five largest western European countries (France, Germany, the U.K., Spain and Italy).[2] This progress was achieved through a combination of medical innovations, and supported by a mix of health care policies and guidelines that propelled progress and improved patients’ lives.

New treatments can now help prevent strokes or treat pulmonary embolisms. Others can delay kidney disease progression, while at the same time preventing cardiovascular events.

Despite progress, this downward trend has reversed and we are seeing an increase in the CVD burden across all major European countries.

And the research continues. Precision medicines are in development for inherited CVD-risk factors like elevated lipoprotein(a), which affects up to 20 percent of the population.[3] A new class of anti-thrombotics promises to bring better treatments for the prevention of clotting, without increasing the risk of bleeding. New precision cardiology approaches, such as gene therapy in congestive heart failure, are being investigated as potential cures.

Despite progress, this downward trend has reversed and we are seeing an increase in the CVD burden across all major European countries.[4]

Getting the definitions right

This year’s World Heart Day, spearheaded by the World Heart Federation, comes amid the revision of the EU pharmaceutical legislation. The European Commission’s proposal of a narrow definition of unmet medical need, which could hamper innovation is causing deep concern across stakeholders.

Instead, a patient-centered definition of unmet medical need taking the full spectrum of patient needs into consideration, would incentivize more avenues of research addressing the needs of people living with chronic conditions. It would provide a basis for drafting the next chapter in the history of cardiovascular medicines — one that we hope will be written in Europe and benefit people in the EU and beyond. Not only would this inspire advances that help people to live longer, but it would also improve quality of life for those at risk of, and affected by, cardiovascular events.

Unmet medical need criteria currently included in the draft Pharmaceutical Legislation would do a disservice to patients by downplaying the chronic nature of many CVDs, and the importance of patient-reported outcomes and experience.[5] And many of the advances seen in recent decades would fall short of the narrow definition under consideration. This limited approach disregards incremental innovation, which might otherwise reduce pain, slow disease progression, or improve treatment adherence by taking account of patient preferences for how therapies are administered.

Much of the illness and death caused by CVD is preventable — in fact, 9 out of 10 heart attacks can be avoided.

At this moment it is unclear how the unmet medical need criteria in the legislation will apply to these and other situations. Policymakers should create a multistakeholder platform with the space to discuss patients’ needs, getting expert views from medical societies, patients and industry to better understand the innovation environment. The European Alliance for Cardiovascular Health (EACH), a multistakeholder network comprised of 17 organizations in the CVD space in Europe, stands ready to inform policymakers about the CVD burden and the pressing needs of patients. [6] EACH not only supports the EU´s endeavor to develop more policies on CVD, it also supports and promotes the idea of an EU Cardiovascular Health Plan to work towards better patients’ health care across the EU and more equal health standards. So far, structured discussions with such stakeholders do not sufficiently take place, and we risk missing those opportunities, and lose in both patient access as well as R&D attractiveness of the EU.

Primary and secondary prevention

As well as driving future innovation, Europe must also make the best possible use of the tools we have now. We must do what works — everywhere.

At the heart of this approach is prevention. Much of the illness and death caused by CVD is preventable — in fact, 9 out of 10 heart attacks can be avoided.[7] Primary prevention can dramatically reduce rates of heart attack, stroke and other CVDs. Secondary prevention, which includes screening and disease management, such as simple blood tests and urine tests, as well as blood pressure and BMI monitoring, has a key role to play in containing the burden of disease. [8]

Joint cardiovascular and diabetes health checks at primary care level, taking an evidence-based approach, would help diagnose and treat CVD before the onset of acute symptoms.[9] By following current treatment guidelines and protocols, health care professionals across Europe can help to prevent complications, improve health outcomes for patients and save health care costs. Also here, a multistakeholder approach is key. Policymakers should not miss out on listening to the CVD multistakeholder alliances that have already formed — at EU and at EU member countries level, as for example EACH. These partnerships are great ways for policymakers to better understand the needs of patients and to get the experts’ views.

Research-driven companies exist to meet the needs of patients in Europe and around the world. We need to create an environment that enables companies to embark on complex and unpredictable trials. That means having the rights incentives and clarity on the regulatory pathway for future treatments.


[1] https://www.escardio.org/The-ESC/Press-Office/Press-releases/Price-tag-on-cardiovascular-disease-in-Europe-higher-than-entire-EU-budget

[2] https://iris.unibocconi.it/retrieve/handle/11565/4023471/115818/Torbica%20EHJ%202019.pdf

[3] https://www.acc.org/Latest-in-Cardiology/Articles/2019/07/02/08/05/Lipoproteina-in-Clinical-Practice

[4] https://www.efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/transforming-the-lives-of-people-living-with-cardiovascular-diseases/cvd-dashboards

[5] https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en

[6] https://www.cardiovascular-alliance.eu/

[7] https://www.ahajournals.org/doi/10.1161/STROKEAHA.119.024154

[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331469/

[9] https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/because-we-can-t-afford-not-to-let-s-make-a-joint-health-check-for-cardiovascular-disease-cvd-and-diabetes-happen/



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#improve #heart #health #Europe

The science and side effects of the drugs Ozempic and Wegovy

Ozempic can help people to quickly lose weight but may also have serious side effects

AP Photo/David J. Phillip/Alamy

Ozempic and Wegovy are brand names for the drug semaglutide. Many countries have approved Wegovy for weight loss in people who are obese or overweight and Ozempic for people with type 2 diabetes.

How do these drugs work?

Drugs such as semaglutide mimic the actions of a hormone called glucagon-like peptide-1, or GLP-1. These so-called GLP-1 analogues have several effects, including slowing stomach emptying, acting on the brain to reduce appetite and boosting the release of insulin, which helps to regulate blood sugar levels.

For more than a decade, GLP-1 analogues have been used to help people with type 2 diabetes control their blood sugar and some users experienced modest weight loss. “These drugs augment a system that already exists within the human body, whose role it is to suppress appetite following meal ingestion,” says Simon Cork at Imperial College London.

Why are they making headlines now?

GLP-1 analogues have started to be prescribed for weight loss in people without type 2 diabetes. They have also become available in formulations that are more potent and easier to use.

Initially GLP-1 analogues were approved for use at a lower dose and needed to be given by twice-daily injections. In the latest formulations they are once-weekly injections, with Wegovy’s full dose being 2.4 milligrams for weight loss and Ozempic being used at a maximum dose of 2 milligrams for type 2 diabetes.

How widely available are they?

In 2021, Wegovy was approved for weight loss in several countries, including the US and Canada. Praise from some celebrity users brought it widespread publicity.

Manufacturing problems meant its manufacturer, Novo Nordisk, had trouble meeting global demand, so some doctors started prescribing Ozempic, which had been approved for people with type 2 diabetes in certain countries several years earlier. This led to shortages for people who required it for diabetes control.

In the UK, Wegovy was approved in 2021, but only got the nod from England’s medical guidelines body the National Institute for Health and Care Excellence in March 2023, when it said the drug should be given by weight loss clinics within the country’s national health service. Wegovy is expected to become available in the UK this year, while Ozempic has been available for type 2 diabetes since 2019.

In June 2023, the UK government announced the introduction of a two-year pilot that gives people with obesity access to new drugs, such as Wegovy, outside of a hospital setting.

How effective are they?

Very. It is a cliche but obesity doctors are talking about a paradigm shift in the field of obesity management. Previously, a loss of about 5 per cent of body weight would be considered a good result for any weight loss intervention outside of stomach surgery and is considered a benchmark in obesity drug trials.

Wegovy leads to about a 15 per cent reduction in body weight over a year, when combined with exercise and eating healthily.

In fact, some people seem to feel that the GLP-1 analogues have caused them to become too gaunt, as reflected in the rise of the search terms “Ozempic face” and “Ozempic butt”. “Ozempic doesn’t do anything specific to the skin,” says Alexander Miras at Ulster University, UK. It is the weight loss that causes these apparent side effects, with similar outcomes often also occurring after weight loss surgery, he says.

Do the drugs have any side effects?

Side effects can be mild, such as nausea, constipation and diarrhoea, which tend to occur as people get used to the drug. More worrying side effects include inflammation of the pancreas, although this is relatively rare.

How about hair loss?

Hair loss has been reported by some semaglutide users. This is also sometimes seen after significant weight loss from other causes, such as stomach surgery, says Miras.

Hair loss following weight loss surgery is thought to be due to physiological stress on the body causing an increased number of hair follicles to enter their “resting” phase, which leads to the hairs falling out a few months later. It stops when the weight loss stabilises, however, the hair doesn’t always grow back, says Miras.

Do these drugs cause suicidal thoughts?

GLP-1 analogues – such as Ozempic and Wegovy – are being investigated by the European Medicines Agency (EMA) after recent reports that they may cause thoughts of suicide or self-harm. This was after Iceland’s health regulator received three such reports regarding semaglutide and another drug called liraglutide, which is an earlier GLP-1 analogue.

The EMA says it is analysing about 150 reports of possible cases of self-injury and suicidal thoughts. This doesn’t mean the medicines caused these effects, however, only that people reported these experiences after starting to take them. “More work is needed to determine if a causal link exists,” says Michael Schwartz at the University of Washington in Seattle.

A spokesperson at Novo Nordisk, the manufacturer of liraglutide and the semaglutide drugs Ozempic and Wegovy, told New Scientist: “GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for eight years. The safety data collected from large clinical trial programmes and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.”

Need a listening ear? UK Samaritans: 116123; US 988 Suicide & Crisis Lifeline: 988; hotlines in other countries.

Do these drugs help with addictions?

Perhaps. There have been many anecdotal reports of people taking these medicines for diabetes or weight control who lose their urge to drink alcohol or see waning of other habits that could be described as “behavioural addictions”, such as compulsive shopping.

This is supported by research in animals that found the GLP-1 analogues lower consumption of alcohol and addictive drugs. A small trial in people has hinted at a similar effect from a GLP-1 analogue called exenatide, which reduced heavy drinking, but only in people who were obese.

The explanation could be connected with the way the drugs act on the brain to reduce food cravings, but the exact mechanism is unclear. We are only at the beginning of understanding how these treatments could support people with alcohol and drug additions, says Daniel Drucker at Sinai Health in Toronto, Canada. “The clinical trial data is not yet in to substantiate the anecdotes.”

What happens to a user’s weight long-term?

The longest trial of Wegovy lasted two years and found that people’s weight broadly plateaued in the second year.

In most countries, Wegovy has been approved for two years’ use, but if people stop taking the drug, they generally regain the lost weight – two-thirds of it after one year, according to one trial.

“The weight loss is only sustained for as long as the drug is taken because as soon as you stop the drug, all of those physiological processes that are trying to get your body weight back up kick in again,” says Cork.

This suggests that after two years of use, there will be demand from consumers for doctors to continue prescribing the drug “off label”. “I think there’ll be a big push to try to change those guidelines,” says Cork.

Ozempic can be prescribed long-term for type 2 diabetes because the condition is usually life-long.

Topics:

Source link

#science #side #effects #drugs #Ozempic #Wegovy

Everything you need to know about the drugs Ozempic and Wegovy

Ozempic can cause weight loss in people with type 2 diabetes

Canadian Press/Shutterstock

Ozempic and Wegovy are brand names for the drug semaglutide. Many countries have approved Wegovy for weight loss in people who are obese or overweight and Ozempic for people with type 2 diabetes.

How do these drugs work?

Drugs such as semaglutide mimic the actions of a hormone called glucagon-like peptide-1, or GLP-1. These so-called GLP-1 analogues have several effects, including slowing stomach emptying, acting on the brain to reduce appetite and boosting the release of insulin, which helps to regulate blood sugar levels.

For more than a decade, GLP-1 analogues have been used to help people with type 2 diabetes control their blood sugar and some users experienced modest weight loss. “These drugs augment a system that already exists within the human body, whose role it is to suppress appetite following meal ingestion,” says Simon Cork at Imperial College London.

Why are they making headlines now?

GLP-1 analogues have started to be prescribed for weight loss in people without type 2 diabetes. They have also become available in formulations that are more potent and easier to use.

Initially GLP-1 analogues were approved for use at a lower dose and needed to be given by twice-daily injections. In the latest formulations they are once-weekly injections, with Wegovy’s full dose being 2.4 milligrams for weight loss and Ozempic being used at a maximum dose of 2 milligrams for type 2 diabetes.

How widely available are they?

In 2021, Wegovy was approved for weight loss in several countries, including the US and Canada. Praise from some celebrity users brought it widespread publicity.

Manufacturing problems meant its manufacturer, Novo Nordisk, had trouble meeting global demand, so some doctors started prescribing Ozempic, which had been approved for people with type 2 diabetes in certain countries several years earlier. This led to shortages for people who required it for diabetes control.

In the UK, Wegovy was approved in 2021, but only got the nod from England’s medical guidelines body the National Institute for Health and Care Excellence in March 2023, when it said the drug should be given by weight loss clinics within the country’s national health service. Wegovy is expected to become available in the UK this year, while Ozempic has been available for type 2 diabetes since 2019.

In June 2023, the UK government announced the introduction of a two-year pilot that gives people with obesity access to new drugs, such as Wegovy, outside of a hospital setting.

How effective are they?

Very. It is a cliche but obesity doctors are talking about a paradigm shift in the field of obesity management. Previously, a loss of about 5 per cent of body weight would be considered a good result for any weight loss intervention outside of stomach surgery and is considered a benchmark in obesity drug trials.

Wegovy leads to about a 15 per cent reduction in body weight over a year, when combined with exercise and eating healthily.

In fact, some people seem to feel that the GLP-1 analogues have caused them to become too gaunt, as reflected in the rise of the search terms “Ozempic face” and “Ozempic butt”. “Ozempic doesn’t do anything specific to the skin,” says Alexander Miras at Ulster University, UK. It is the weight loss that causes these apparent side effects, with similar outcomes often also occurring after weight loss surgery, he says.

Do the drugs have any side effects?

Side effects can be mild, such as nausea, constipation and diarrhoea, which tend to occur as people get used to the drug. More worrying side effects include inflammation of the pancreas, although this is relatively rare.

How about hair loss?

Hair loss has been reported by some semaglutide users. This is also sometimes seen after significant weight loss from other causes, such as stomach surgery, says Miras.

Hair loss following weight loss surgery is thought to be due to physiological stress on the body causing an increased number of hair follicles to enter their “resting” phase, which leads to the hairs falling out a few months later. It stops when the weight loss stabilises, however, the hair doesn’t always grow back, says Miras.

Do these drugs also help with addictions?

Perhaps. There have been many anecdotal reports of people taking these medicines for diabetes or weight control who lose their urge to drink alcohol or see waning of other habits that could be described as “behavioural addictions”, such as compulsive shopping.

This is supported by research in animals that found the GLP-1 analogues lower consumption of alcohol and addictive drugs. A small trial in people has hinted at a similar effect from a GLP-1 analogue called exenatide, which reduced heavy drinking, but only in people who were obese.

The explanation could be connected with the way the drugs act on the brain to reduce food cravings, but the exact mechanism is unclear. We are only at the beginning of understanding how these treatments could support people with alcohol and drug additions, says Daniel Drucker at Sinai Health in Toronto, Canada. “The clinical trial data is not yet in to substantiate the anecdotes.”

What happens to a user’s weight long-term?

The longest trial of Wegovy lasted two years and found that people’s weight broadly plateaued in the second year.

In most countries, Wegovy has been approved for two years’ use, but if people stop taking the drug, they generally regain the lost weight – two-thirds of it after one year, according to one trial.

“The weight loss is only sustained for as long as the drug is taken because as soon as you stop the drug, all of those physiological processes that are trying to get your body weight back up kick in again,” says Cork.

This suggests that after two years of use, there will be demand from consumers for doctors to continue prescribing the drug “off label”. “I think there’ll be a big push to try to change those guidelines,” says Cork.

Ozempic can be prescribed long-term for type 2 diabetes because the condition is usually life-long.

Topics:

Source link

#drugs #Ozempic #Wegovy

Don’t use sugar substitutes for weight loss, World Health Organization advises | CNN



CNN
 — 

Don’t use sugar substitutes if you are trying to lose weight, according to new guidance from the World Health Organization.

The global health body said a systematic review of the available evidence suggests the use of non-sugar sweeteners, or NSS, “does not confer any long-term benefit in reducing body fat in adults or children.”

“Replacing free sugars with non-sugar sweeteners does not help people control their weight long-term,” said Francesco Branca, director of WHO’s department of nutrition and food safety. “We did see a mild reduction of body weight in the short term, but it’s not going to be sustained.”

The guidance applies to all people except those with preexisting diabetes, Branca said. Why? Simply because none of the studies in the review included people with diabetes, and an assessment could not be made, he said.

The review also indicated that there might be “potential undesirable effects” from the long-term use of sugar substitutes such as a mildly increased risk of type 2 diabetes and cardiovascular diseases.

However, “this recommendation is not meant to comment on safety of consumption,” Branca said. “What this guideline says is that if we’re looking for reduction of obesity, weight control or risk of noncommunicable diseases, that is unfortunately something science been unable to demonstrate,” he said. “It’s not going to produce the positive health effects that some people might be looking for.”

Non-sugar sweeteners are widely used as an ingredient in prepackaged foods and beverages and are also sometimes added to food and drinks directly by consumers. WHO issued guidelines on sugar intake in 2015, recommending that adults and children reduce their daily intake of free sugars to less than 10% of their total energy intake. Following that recommendation, interest in sugar alternatives intensified, the review said.

“This new guideline is based on a thorough assessment of the latest scientific literature, and it emphasises that the use of artificial sweeteners is not a good strategy for achieving weight loss by reducing dietary energy intake,” said nutrition researcher Ian Johnson, emeritus fellow at Quadram Institute Bioscience, formerly the Institute of Food Research, in Norwich, United Kingdom.

“However, this should not be interpreted as an indication that sugar intake has no relevance to weight-control,” Johnson said in a statement.

Instead, one should cut back on using sugar-sweetened drinks, and try to use “raw or lightly processed fruit as a source of sweetness,” Johnson added.

Dr. Keith Ayoob, scientific adviser for the Calorie Control Council, an international association representing the low-calorie food and beverage industry, told CNN via email the WHO’s “insistence on focusing only on prevention of unhealthy ‎weight gain and non-communicable diseases is at the very least, misguided.”

Robert Rankin, president of the Calorie Control Council, said “low- and no-calorie sweeteners are a critical tool that can help consumers manage body weight and reduce the risk of non-communicable diseases.”

The guidance is meant for government health organizations in countries who may wish to use the scientific analysis to implement policy changes for their citizens, Branca said.

“That will likely depend on the way that which sweeteners are consumed in a specific country,” he said. “For example, in a country where consumption patterns are high, those countries might decide to take action in a way or another.”

A total of 283 studies were included in the review. Both randomized controlled trials, considered the gold standard of research, and observational studies were included. Observational studies can only show an association, not direct cause and effect.

Results from randomized trials found the use of non-sugar sweeteners had a “low” impact on reducing body weight and calorie intake when compared with sugar, and no change in Intermediate markers of diabetes such as glucose and insulin, according to the report.

Observational studies also found a low impact on body weight and fat tissue, but no change in calorie intake. However, those studies found a low increase in risk for type 2 diabetes, high blood pressure, stroke, heart disease and death from heart disease, the report noted. A very low risk was also found for bladder cancer and an early death from any cause.

WHO said that the recommendation was “conditional” because the identified link between sweeteners and disease outcomes might be confounded by complicated patterns of sweetener use and the characteristics of the study participants.

In an emailed statement, the International Sweeteners Association, an industry assocation, said “it is a disservice to not recognise the public health benefits of low/no calorie sweeteners and is disappointed that the WHO’s conclusions are largely based on low certainty evidence from observational studies, which are at high risk of reverse causality.”

However, observational studies that follow people over time are important, Branca said. “To show that overweight people can reduce their body weight requires a long-term study. And we’re not seeing that impact from the research we have.”

The recommendation included low or no calorie synthetic sweeteners and natural extracts, which may or may not be chemically modified, such as acesulfame K, aspartame, advantame, cyclamates, neotame, saccharin, sucralose, stevia and stevia derivatives and monkfruit, the report said.

“Stevia and monkfruit are newer sweeteners so so there’s less published research in the scientific literature,” Branca said. “However they probably work in the body with a similar physiological mechanism as other sweeteners. We cannot say they are different from the others based on the data we have — they play the same role.”

Many people consider stevia products to be more “natural,” since they are derived from the stevia plant. Some natural and artificial sweeteners add bulking sugars to their products to cut their sweetness and add bulk to the product for baking.

A recent study by researchers at the US-based Cleveland Clinic found erythritol — used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products — was linked to blood clotting, stroke, heart attack and early death.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, the study found.

Just as many people have learned to eat and cook without salt, they can learn to reduce their dependence on free sugars and non-nutritive sweetners, Branca said.

“We need to target children in early life,” he said. “For example, why do parents typically use sweeteners as a reward for children and after almost every meal? We need to recommend to parents to avoid building that sweetness Interest in young children — that’s a very important action to take.”

Even if you are a true sugar “addict,” the good news is that you can tame your sweet tooth, registered dietitian Lisa Drayer said in an article for CNN. She provides the following steps:

Train your taste buds. If you gradually cut back on sugar — including artificial sweeteners — and include more protein and fiber-rich foods in your diet, that can help you crave less sugar, Drayer said.

“When we consume protein and fiber, it slows the rise in blood sugar if we consume it with a sugar-containing food. It can help satisfy us and help us reduce our sugar intake as well,” she said in a previous interview.

Choose no-sugar-added foods and avoid all sugar-sweetened drinks. For example, choose whole-grain cereal or Greek yogurt with no sweeteners. The sugar-sweetened drinks to take off your grocery list should include sodas, energy drinks, sports drinks and fruit punch. Choose water instead.

“If you like sweet carbonated beverages, add a splash of cranberry or orange juice to seltzer or try flavored seltzers. You can also flavor your own waters with fruit slices for natural sweetness or try herbal fruit teas,” Drayer said.

Drink coffee and tea with no or fewer sugars. Be careful at coffee shops, Drayer suggested. All those lattes and flavored coffees can have as much sugar as a can of soda, or more.

Enjoy fruit for dessert. Try cinnamon baked apples, berries or grilled peaches instead of cookies, cake, ice cream, pastries and other sweet treats, Drayer said.

Watch for stealth sugars. Added sugars are often present in foods that you might not think of as “sweet,” like sauces, breads, condiments and salad dressings, Drayer said.

“Pre-packaged sauces — like ketchup, BBQ sauce and tomato sauce — tend to be some of the biggest offenders of hidden added sugars in the diet,” Kristi King, senior pediatric dietitian at Texas Children’s Hospital and a national spokesperson for the Academy of Nutrition and Dietetics, told Drayer in a prior interview.

Check nutrition facts labels. All foods and beverages must list the amount and kind of sugar on the label.

Added sugars can go by other names such as “agave, brown sugar, corn sweetener, corn syrup, dextrose, evaporated cane juice, fructose, fruit juice concentrate, fruit nectar, glucose, high-fructose corn syrup, honey, invert sugar, lactose, malt syrup, maltose, molasses, maple syrups, raw sugar, sucrose, trehalose and turbinado sugar,” Drayer said.

The higher up these added sugars are on the ingredients list, the greater the amount of added sugar in the product, she said.

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Ozempic prescriptions can be easy to get online. Its popularity for weight loss is hurting those who need it most | CNN



CNN
 — 

Telehealth and social media are playing a significant role in driving demand for Ozempic, a prescription drug that treats Type 2 diabetes, experts told CNN. The current drug shortage has limited access for patients with diabetes who rely on it to control their blood sugar.

Digital health companies make medications like Ozempic easier to get by providing prescriptions online. Many advertise quick and easy — sometimes same-day — access.

“Anecdotally, it’s almost easier to get medication [via digital health companies],” said Dr. Disha Narang, endocrinologist and director of obesity medicine at Northwestern Medicine, Lake Forest Hospital. “But not always the safest.” People who put in average weights on the online intake forms were still offered the antidiabetic drug, Narang told CNN.

In part because of Ozempic’s popularity, the prescription weight loss drug market has grown significantly, according to MarketData Enterprises, an independent market research and consulting firm. The market surpassed forecasters’ expectations for 2022 and is expected to become a nearly $2 billion industry in 2023.

WeightWatchers is also tapping into the telehealth prescription drug space. Last week, the company bought telehealth subscription service Sequence, which helps connect patients to doctors who can prescribe weight loss and diabetes drugs.

“At the start of 2022, these companies weren’t marketing this stuff,” Narang said, noting advertising around Ozempic took off in 2022. “I think we really need to start questioning our ethics around this.”

There are few across-the-board requirements when it comes to digital health companies’ intake processes, Dr. Bree Holtz, an associate professor at Michigan State University studying telemedicine, told CNN. Once a patient fills out the required forms online, information gets transferred to an in-state provider who can write the prescription. Some companies require that the patient hop on a video or phone call with the provider — others don’t require either.

“It’s a little scary that you can just wake up and get these appointments in — or these pharmaceuticals — and you’re not being cared for,” said Holtz.

Telehealth has been a game changer in providing access to health care, particularly during the pandemic. And especially for people living in places where high-quality primary care is not available, direct to consumer telehealth services can help fill a gap, said Dr. Laurie Buis, associate professor in the Department of Family Medicine at the University of Michigan, whose research focuses on digital health.

When patients begin to seek selective treatment from selective providers, however, Buis says it opens the door to problems like fragmented care or abuse. Telehealth providers may not have access to a patient’s full medical history and may be less able to provide holistic care that a primary care physician otherwise could.

“I have no doubt that some of these services are doing a good job,” said Buis. “There are also services that don’t take it quite as seriously. And that’s of concern.”

The US Food and Drug Administration first announced that Ozempic was in shortage last August. Supply will likely be strained through mid-March, according to the FDA drug shortages database.

Ozempic prescriptions in the US reached an all-time high in the last week of February, with over 373,000 prescriptions filled, according to a J.P. Morgan analysis of IQVIA data shared with CNN. That’s an increase of 111%, compared with the same week in 2022.

Of these, more than half were new prescriptions, according to a CNN review of J.P. Morgan’s analysis.​​

With many patients relying on Ozempic for diabetes treatment, providers like Narang are scrambling to figure out what alternatives to put their patients on.

“We’re getting messages daily about patients not being able to get their own medication,” Narang said. “It’s been tough for patients and providers alike.”

Ozempic currently holds more than 40% of the US market share of glucagon-like peptide 1 (GLP-1) agonists — a class of drugs that mimic an appetite-regulating hormone — according to analysis from J.P. Morgan. These drugs work by stimulating the release of insulin, which helps lower blood sugar. They also slow the passage of food through the gut.

Ozempic has grown quickly in popularity since it was first put on the market in 2018. The drug has safely and successfully been used to help diabetics improve blood sugar levels and put diabetes into remission, Narang told CNN. Ozempic is the most potent of all the GLP-1 medications, she said.

Behind the brand name Ozempic is the medication semaglutide. While Ozempic is used primarily to treat Type 2 diabetes, another drug by the name Wegovy — also semaglutide — is approved specifically for chronic weight management.

Although approved by the FDA in 2021, Wegovy was not readily available through most of last year, according to Narang, so people turned to Ozempic. According to the FDA drug shortages database, Wegovy was undersupplied starting at the end of last March but came back in stock earlier this year.

Social media buzz around the two drugs took off at the start of 2023. Celebrities shared their testimonies about how semaglutide helped them shed unwanted pounds. Elon Musk, for example, publicly credited Ozempic and Wegovy in part for his weight loss.

#Ozempic and #Wegovy have been “extremely popular” over the last few months on TikTok, according to company analytics.

The use of Ozempic and Wegovy for short-term weight loss has resulted in real consequences for patients who need the drugs most for diabetes treatment and chronic weight management, said Narang. For example, some insurance companies in the past have reportedly refused to cover Wegovy, one calling it a “vanity drug.”

Both drugs are intended for long-term use, not for short-term weight loss. Their appetite-regulating effects wear off quickly after you stop taking them.

“This is not meant to be a medication to take off your last five or 10 pounds to get ready for an event or something like that. It’s not for use of three or four weeks,” Narang said. “When we think about weight management, we’re thinking about the next 25 years of someone’s life.”



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Top Risk Factor to Good Health Is Probably Not What You Think

March 7, 2023 — If you think the biggest risk factor to good health is smoking or genetics, think again. 

According to Stephen Kopecky, MD, a preventive cardiologist at the Mayo Clinic, “nutrition is now the number one cause of early death and early disease in our country and the world.” Moreover, he says that while having genes for disease will increase your risk by 30% to 40%, having a bad lifestyle for disease will increase your risk by 300% to 400%.

About 20 years ago, Kopecky says, the cause of death worldwide changed from infection to non-infection (like non-communicable diseases). “In those last 20 years, that’s grown in terms of what kills us and what gets us sick,” he says. “The three big non-communicable diseases are heart disease, cancer, and rapidly rising is Alzheimer’s. But there’s also diabetes, obesity, and high blood pressure — all those things are also related to diet.”

Forty-eight-year-old James, of Fredericksburg, VA, knows this all too well. James asked that his last name not be printed, to protect his privacy. For the last 30 years, he’s been managing type 1 diabetes and complications of insulin resistance, along with high blood pressure, high cholesterol, thyroid disease, and low testosterone. As a former Division 1 college athlete, James exercised regularly and ate what he believed to be a responsible diet.

“Those weirdos in the gym at 5 a.m. who eat chicken salads for every lunch? Yeah, that’s me,” says James. 

But he went from a playing weight of 202 pounds to 320 pounds, despite continuing to lift weights and do cardiovascular exercise at least 5 days a week. “Whenever I went to the doctor and stepped on the scale, I got skeptical looks when I made claims of ‘exercising and eating right.’ In all honesty, I thought I was,” says James, noting he followed a low-carb, high-protein diet. “But I didn’t count calories or consider the impact of fat on my already insulin-resistant body,” he says.

After visiting many health professionals, James finally found success with Nancy Farrell Allen, a registered dietitian nutritionist.

Previous doctors applauded his diet, but Allen explained that his insulin resistance was linked to the amount of fat James consumed. “The more fat in my system, the more insulin I needed to inject,” he says. “The more insulin I injected, the more weight I’d gain. The more weight I’d gain, the more insulin I’d inject, continuing this regrettable cycle.” 

Allen suggested he shift his diet to a more balanced approach, with a strict eye on fat. “She completely changed my way of thinking about food, broke my belief that all carbs are bad, helped me identify my daily caloric needs, and focused me on eating a balanced diet enriched with fiber,” says James, who then lost 45 pounds in 3 months. “I found myself having more energy, sleeping better, focusing better, and taking less insulin than I had in nearly 20 years,” he says. 

Another patient, Sheila Jalili of Miami, took a proactive approach to her health when she turned 40, getting some tests and lab work done for a baseline comparison. “My BMI was around 20, I exercise every day, and I don’t have any diseases in my family,” Jalili says, noting everything checked out fine. 

She continued her annual checkups and tests, noticing her triglycerides and cholesterol numbers increasing. When her cholesterol reached alarming levels and her triglycerides skyrocketed to 1,230, she met with Kopecky, the Mayo Clinic cardiologist, who prescribed fish oil and asked about her diet. Jalili started tracking what she ate and did an exhaustive review of her fridge contents, noting the sodium levels, cholesterol levels, and fat levels in the foods. 

To her surprise, she discovered she ate a lot of unhealthy carbs and fats. “I went into overload. I changed everything. I did so much research,” she says. After 42 days of eating extremely healthy, she dropped her total cholesterol by about 100, halved her HDL, and reduced her triglycerides from 1,238 to 176.

A bad lifestyle often starts with what you eat — and what you don’t. Even if you think you’re eating healthy, you might want to revisit your diet. In particular, reconsider ultra-processed foods (like doughnuts, hot dogs, and fast-food burgers). Though convenient and affordable, they’re inflammatory and, over time, can cause many health issues.

“It bothers our tissues, our heart, our arteries, our brains, our pancreas, our liver, and our lungs, and that leads to disease,” Kopecky says. “It could be in the brain with Alzheimer’s, the heart with coronary artery disease, or cancers elsewhere.”

Ideally, you’d immediately overhaul an unhealthy diet. But that’s not a reality for most people. Making sweeping changes all at once can feel overwhelming. Take small steps instead.

Baby-Step Your Way to a Healthier Diet

Before making any dietary changes, Selvi Rajagopal, MD, MPH, advises having a conversation with your health care provider to figure out your specific health status. Rajagopal, assistant professor of medicine at Johns Hopkins University, says that, generally speaking, everyone will benefit from eating a balanced, healthy diet filled with a variety of nutrient-rich foods. 

That includes fruits, vegetables, whole grains, lean protein, low-fat/fat-free dairy, and healthy fats. However, talking with your doctor can help you identify any specific nutrient deficiencies, health issues, and lifestyle factors that need to be addressed. Then you can devise a healthy eating plan that works specifically for your needs.

Revamp how you organize your refrigerator. Most refrigerators put two opaque drawers labeled “Fruits” and “Vegetables” at the bottom, where you’re least likely to see them. Kopecky advises moving your produce to eye level and put the less-healthy options in those bottom drawers. “When we open the fridge, that’s what we see, and that’s what we tend to eat,” he says.

Change your perspective. “There isn’t one healthy weight or one healthy size,” says Rajagopal. Don’t aim for a number on the scale or a certain BMI or certain clothing size. Every body is different, not only in shape and size, but in health risk factors. Also, many people feel really overwhelmed trying to “be healthy.” Rajagopal says, “Healthy is just trying to do something to improve your health, and that improvement can be really small.”

Understand how to read food labels. Allen takes every patient to the grocery store to read and understand food labeling and to highlight different foods. She shares the guidelines below with her patients. 

  • Fat: Low-fat foods contain 3 grams of fat or less per serving.
  • Sugar: Four grams equal 1 teaspoon. When a serving of sugar lists 12 grams of sugar in a 2/3-cup serving, that means it contains roughly 3teaspoonsof sugar.
  • Fiber: A naturally high-fiber food can contain about 5 grams of fiber per serving. 
  • Sodium: A low-sodium food contains less than or equal to 140 milligrams of sodium per serving. 
  • Protein: Seven grams of protein equal about 1 ounce of protein. 

This approach is particularly important as the FDA is exploring a change in which foods can be labeled as healthy. The agency in September unveiled a proposed rule to try and counter the fact that, as the agency claims, more than 80% of people in the U.S. aren’t eating enough vegetables, fruit, and dairy. And most people consume too much added sugars, saturated fat, and sodium.

Under the proposed rule, in order to be labeled “healthy” on food packaging, products must contain “a certain meaningful amount” of food from at least one of the food groups or subgroups (e.g., fruit, vegetable, dairy, etc.) recommended by the agency’s dietary guidelines.

They must also stick to specific limits for certain nutrients, such as saturated fat, sodium, and added sugars. 

Breakfast cereals, for example, would need to contain 0.75 ounces of whole grains and contain no more than 1 gram of saturated fat, 230 milligrams of sodium, and 2.5 grams of added sugars to qualify, the agency said.

Don’t fear carbs or fat! Your body needs both to survive, as carbs help fuel your body and fat helps your body absorb fat-soluble nutrients like vitamins A, D, and E. But not all carbs or fats are equal. Choose complex carbohydrates found naturally in plant-based foods (like fruits, vegetables, and whole grains) over simple carbohydrates often found in processed foods (like white bread, enriched pasta, and white rice). 

Similarly, strive to include healthy, unsaturated fats (including polyunsaturated and monounsaturated fats) found in foods such as fatty fish, vegetable oils, avocadoes, and some seeds and nuts. Avoid foods with unhealthy saturated and trans fats found primarily in animal products (such as meat, eggs, high-fat dairy) and highly processed foods (frozen pizza and microwave popcorn). “Having a baseline understanding of what this means makes you a much savvier consumer,” says Rajagopal, who suggests going to the U.S. Department of Agriculture’s website to learn about these food components. 

Adopt healthier cooking methods. Maybe you’re buying healthy foods but preparing them in unhealthy ways. That lean, skinless chicken breast just got a lot less healthy once you breaded it, deep-fried it, and smothered it with cheese. Allen suggests lighter, leaner techniques such as baking, roasting, grilling, and steaming. “Frying, sautéing, breading, au gratin, buttery, and Alfredo all add additional calories to burn off,” says Allen.

Start small. Eliminate the all-or-nothing thinking, such as, “I want to cut out all sugar” or “I want to cook all my meals at home.” 

If you’ve been eating sugar your whole life or eating dinner out 5 nights a week, eliminating this bad habit at once is a huge undertaking. Instead, start small. For instance, reduce one sugary food item you frequently eat. 

“Maybe it’s soda,” says Rajagopal. “Maybe you go from four cans of soda a day to two cans. Make one change and see how it goes for a week or two.” 

Ditto for cooking — aim to add one more home-cooked meal a week rather than trying to cook at home 7 days a week. She also advises bringing in an accountability buddy to help you stay on track. 

Take one bite. “If you take a bite of a ground meat or sausage and replace that with a bite of something that’s a little healthier — like black beans or a vegetable — then, after doing this for a couple of years, that actually reduces your risk of heart attack and reduces your risk in the long-term of cancers and Alzheimer’s,” advises Kopecky. “Literally one bite difference.”

By making small, consistent changes, they can have a big impact over time. Pick one tip that resonates most, implement it, and stick to it until it becomes second nature. Once mastered, move on to another tip, building on that foundation of success.

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Eli Lilly to cut insulin prices, cap costs at $35 for many people with diabetes | CNN



CNN
 — 

Eli Lilly announced Wednesday a series of price cuts that would lower the price of the most commonly used forms of its insulin 70% and said it will automatically cap out-of-pocket insulin costs at $35 for people who have private insurance and use participating pharmacies.

Lilly says it will also expand its Insulin Value Program, which caps out-of-pocket costs at $35 or less per month for people who are uninsured.

President Joe Biden heralded the announcement as “a big deal.”

“For far too long, American families have been crushed by drug costs many times higher than what people in other countries are charged for the same prescriptions. Insulin costs less than $10 to make, but Americans are sometimes forced to pay over $300 for it. It’s flat wrong,” Biden said in a statement on Wednesday.

The President also urged other pharmaceutical companies to cut insulin prices.

“Last year, I signed a law to cap insulin at $35 for seniors and I called on pharma companies to bring prices down for everyone on their own. Today, Eli Lilly did that. It’s a big deal, and it’s time for other manufacturers to follow,” Biden said.

Eli Lilly says it will cut the list price of its nonbranded insulin to $25 a vial as of May 1, making it the lowest list-priced mealtime insulin available. Its current list price is $82.41 for a vial.

Lilly will also lower the list price of Humulin and its most commonly prescribed insulin, Humalog, in the fourth quarter of 2023. The current list price of a Humalog vial is $274.70, and the new list price will be $66.40. For people with commercial insurance who use participating pharmacies, the out-of-pocket costs will now be capped at $35.

Although insulin is relatively inexpensive to manufacture, the cost has been a problem for many Americans for years. At least 16.5% of people in the US who use it report rationing it because of cost.

The average price of insulin nearly tripled between 2002 and 2013, the American Diabetes Association says. GoodRx research shows that the trend has continued, with the average retail price of insulin rising 54% between 2014 and 2019.

Demand for insulin has grown significantly as diabetes has become the fastest-growing chronic disease in the world, a 2022 study found.

In the US alone, the number of adults with diabetes has doubled over the past 20 years, and more than 37.3 million people now have it, according to the US Centers for Disease Control and Prevention. Another 96 million Americans – 38% of the population – have prediabetes, a condition in which blood sugar levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. This can often lead to diabetes.

People with diabetes rely on insulin because their bodies have stopped producing enough of this hormone or aren’t using it efficiently to convert food into energy.

When a person eats, their body breaks down food, mostly into sugar. This sugar enters the bloodstream, and that signals the pancreas to release insulin, which works like a key that allows the sugar to energize cells. But if diabetes keeps sugar in the bloodstream for too long, it can lead to serious problems like kidney disease, heart problems and blindness. In 2019, diabetes was the seventh leading cause of death in the US, according to the American Diabetes Association.

This year’s Inflation Reduction Act capped insulin costs for seniors who get their health coverage through Medicare Part D at $35 a month. Congressional Democrats pushed to extend that price cap to people covered by private insurance, but Republicans stripped that measure from the bill.

The US Food and Drug Administration’s approvals of generic insulin and biosimilars – drugs similar to original versions that can be made differently or with slightly different substances – have driven down the price at least somewhat, according to GoodRx.

Some states have taken matters into their own hands. Twenty-two states and the District of Columbia have price caps ranging from $25 to $100 for insulin as well as diabetes supplies and devices – but that’s only for people covered by insurance plans regulated by those states.

“While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change,” David A. Ricks, Lilly’s chair and CEO, said in a statement. “The aggressive price cuts we’re announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap.”

Lilly has been one of the biggest players in the US insulin market since it became the first company to commercialize the lifesaving drug 100 years ago. The company said that its price changes should make a difference, but more is needed to help all Americans with diabetes – 7 out of 10 don’t use the company’s insulin.

The Medicare Part D cap “should be the new standard in America,” Ricks said on CNN This Morning on Wednesday.

He called on the insurance industry, policymakers and other manufacturers to join them in making insulin more affordable.

“We call on everyone to meet us at this point and take this issue away from a disease that’s stressful and difficult to manage already – to take away the affordability challenges,” Ricks told CNN’s Don Lemon.

Other companies have cut insulin costs over the years.

In 2019, Sanofi created the Insulin Valyou Savings Program, which charged patients $99 a month for insulin, regardless of income. In 2021, Novo Nordisk created a similar program called My$99Insulin.

Also that year, Novo Nordisk collaborated with Walmart to sell private-label analog insulin at a deep discount. Walmart said its ReliOn NovoLog vials and FlexPens save customers 58% to 75% off the cash price for branded insulin.

For Eli Lilly insulin, the new price cap will automatically apply at most pharmacies with no additional action from the patient. Otherwise, a coupon will be available for patients to use at the remaining 15% of pharmacies where the electronic system does not allow for the automatic price drop, Ricks said.

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Zero-calorie sweetener linked to heart attack and stroke, study finds | CNN



CNN
 — 

A sugar replacement called erythritol – used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products – has been linked to blood clotting, stroke, heart attack and death, according to a new study.

“The degree of risk was not modest,” said lead study author Dr. Stanley Hazen, director of the Center for Cardiovascular Diagnostics and Prevention at the Cleveland Clinic Lerner Research Institute.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, according to the study, published Monday in the journal Nature Medicine.

“If your blood level of erythritol was in the top 25% compared to the bottom 25%, there was about a two-fold higher risk for heart attack and stroke. It’s on par with the strongest of cardiac risk factors, like diabetes,” Hazen said.

Additional lab and animal research presented in the paper revealed that erythritol appeared to be causing blood platelets to clot more readily. Clots can break off and travel to the heart, triggering a heart attack, or to the brain, triggering a stroke.

“This certainly sounds an alarm,” said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health, a hospital in Denver, who was not involved in the research.

“There appears to be a clotting risk from using erythritol,” Freeman said. “Obviously, more research is needed, but in an abundance of caution, it might make sense to limit erythritol in your diet for now.”

In response to the study, the Calorie Control Council, an industry association, told CNN that “the results of this study are contrary to decades of scientific research showing reduced-calorie sweeteners like erythritol are safe, as evidenced by global regulatory permissions for their use in foods and beverages,” said Robert Rankin, the council’s executive director, in an email.

The results “should not be extrapolated to the general population, as the participants in the intervention were already at increased risk for cardiovascular events,” Rankin said.

The European Association of Polyol Producers declined to comment, saying it had not reviewed the study.

Like sorbitol and xylitol, erythritol is a sugar alcohol, a carb found naturally in many fruits and vegetables. It has about 70% of the sweetness of sugar and is considered zero-calorie, according to experts.

Artificially manufactured in massive quantities, erythritol has no lingering aftertaste, doesn’t spike blood sugar and has less of a laxative effect than some other sugar alcohols.

“Erythritol looks like sugar, it tastes like sugar, and you can bake with it,” said Hazen, who also directs the Cleveland Clinic’s Center for Microbiome and Human Health.

“It’s become the sweetheart of the food industry, an extremely popular additive to keto and other low-carb products and foods marketed to people with diabetes,” he added. “Some of the diabetes-labeled foods we looked at had more erythritol than any other item by weight.”

Erythritol is also the largest ingredient by weight in many “natural” stevia and monkfruit products, Hazen said. Because stevia and monkfruit are about 200 to 400 times sweeter than sugar, just a small amount is needed in any product. The bulk of the product is erythritol, which adds the sugar-like crystalline appearance and texture consumers expect.

The discovery of the connection between erythritol and cardiovascular issues was purely accidental, Hazen said: “We never expected this. We weren’t even looking for it.”

Hazen’s research had a simple goal: find unknown chemicals or compounds in a person’s blood that might predict their risk for a heart attack, stroke or death in the next three years. To do so, the team began analyzing 1,157 blood samples in people at risk for heart disease collected between 2004 and 2011.

“We found this substance that seemed to play a big role, but we didn’t know what it was,” Hazen said. “Then we discovered it was erythritol, a sweetener.”

The human body naturally creates erythritol but in very low amounts that would not account for the levels they measured, he said.

To confirm the findings, Hazen’s team tested another batch of blood samples from over 2,100 people in the United States and an additional 833 samples gathered by colleagues in Europe through 2018. About three-quarters of the participants in all three populations had coronary disease or high blood pressure, and about a fifth had diabetes, Hazen said. Over half were male and in their 60s and 70s.

In all three populations, researchers found that higher levels of erythritol were connected to a greater risk of heart attack, stroke or death within three years.

But why? To find out, researchers did further animal and lab tests and discovered that erythritol was “provoking enhanced thrombosis,” or clotting in the blood, Hazen said.

Clotting is necessary in the human body, or we would bleed to death from cuts and injuries. The same process is constantly happening internally, as well.

“Our blood vessels are always under pressure, and we spring leaks, and blood platelets are constantly plugging these holes all the time,” Hazen said.

However, the size of the clot made by platelets depends on the size of the trigger that stimulates the cells, he explained. For example, if the trigger is only 10%, then you only get 10% of a clot.

“But what we’re seeing with erythritol is the platelets become super responsive: A mere 10% stimulant produces 90% to 100% of a clot formation,” Hazen said.

“For people who are at risk for clotting, heart attack and stroke – like people with existing cardiac disease or people with diabetes – I think that there’s sufficient data here to say stay away from erythritol until more studies are done,” Hazen said.

Oliver Jones, a professor of chemistry at RMIT University in Victoria, Australia, noted that the study had revealed only a correlation, not causation.

“As the authors themselves note, they found an association between erythritol and clotting risk, not definitive proof such a link exists,” Jones, who was not involved in the research, said in a statement.

“Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” Jones said.

In a final part of the study, eight healthy volunteers drank a beverage that contained 30 grams of erythritol, the amount many people in the US consume, Hazen said, according to the National Health and Nutrition Examination Survey, which examines American nutrition each year.

Blood tests over the next three days tracked erythritol levels and clotting risk.

“Thirty grams was enough to make blood levels of erythritol go up a thousandfold,” Hazen said. “It remained elevated above the threshold necessary to trigger and heighten clotting risk for the following two to three days.”

Just how much is 30 grams of erythritol? The equivalent of eating a pint of keto ice cream, Hazen said.

“If you look at nutrition labels on many keto ice creams, you’ll see ‘reducing sugar’ or ‘sugar alcohol,’ which are terms for erythritol. You’ll find a typical pint has somewhere between 26 and 45 grams in it,” he said.

“My co-author and I have been going to grocery stores and looking at labels,” Hazen said. “He found a ‘confectionery’ marketed to people with diabetes that had about 75 grams of erythritol.”

There is no firm “accepted daily intake,” or ADI, set by the European Food Safety Authority or the US Food and Drug Administration, which considers erythritol generally recognized as safe (GRAS).

“Science needs to take a deeper dive into erythritol and in a hurry, because this substance is widely available right now. If it’s harmful, we should know about it,” National Jewish Health’s Freeman said.

Hazen agreed: “I normally don’t get up on a pedestal and sound the alarm,” he said. “But this is something that I think we need to be looking at carefully.”

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Weight loss surgery extends lives, study finds | CNN



CNN
 — 

Weight loss surgery reduces the risk of premature death, especially from such obesity-related conditions as cancer, diabetes and heart disease, according to a new 40-year study of nearly 22,000 people who had bariatric surgery in Utah.

Compared with those of similar weight, people who underwent one of four types of weight loss surgery were 16% less likely to die from any cause, the study found. The drop in deaths from diseases triggered by obesity, such as heart disease, cancer and diabetes, was even more dramatic.

“Deaths from cardiovascular disease decreased by 29%, while deaths from various cancers decreased by 43%, which is pretty impressive,” said lead author Ted Adams, an adjunct associate professor in nutrition and integrative physiology at the University of Utah’s School of Medicine.

“There was also a huge percentage drop — a 72% decline — in deaths related to diabetes in people who had surgery compared to those who did not,” he said. One significant downside: The study also found younger people who had the surgery were at higher risk for suicide.

The study, published Wednesday in the journal Obesity, reinforces similar findings from earlier research, including a 10-year study in Sweden that found significant reductions in premature deaths, said Dr. Eduardo Grunvald, a professor of medicine and medical director of the weight management program at the University of California San Diego Health.

The Swedish study also found a significant number of people were in remission from diabetes at both two years and 10 years after surgery.

“This new research from Utah is more evidence that people who undergo these procedures have positive, beneficial long-term outcomes,” said Grunvald, who coauthored the American Gastroenterological Association’s new guidelines on obesity treatment.

The association strongly recommends patients with obesity use recently approved weight loss medications or surgery paired with lifestyle changes.

“And the key for patients is to know that changing your diet becomes more natural, more easy to do after you have bariatric surgery or take the new weight loss medications,” said Grunvald, who was not involved in the Utah study.

“While we don’t yet fully understand why, these interventions actually change the chemistry in your brain, making it much easier to change your diet afterwards.”

Despite the benefits though, only 2% of patients who are eligible for bariatric surgery ever get it, often due to the stigma about obesity, said Dr. Caroline Apovian, a professor of medicine at Harvard Medical School and codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston. Apovian was the lead author for the Endocrine Society’s clinical practice guidelines for the pharmacological management of obesity.

Insurance carriers typically cover the cost of surgery for people over 18 with a body mass index of 40 or higher, or a BMI of 35 if the patient also has a related condition such as diabetes or high blood pressure, she said.

“I see patients with a BMI of 50, and invariably I will say, ‘You’re a candidate for everything — medication, diet, exercise and surgery.’ And many tell me, ‘Don’t talk to me about surgery. I don’t want it.’ They don’t want a surgical solution to what society has told them is a failure of willpower,” she said.

“We don’t torture people who have heart disease: ‘Oh, it’s because you ate all that fast food.’ We don’t torture people with diabetes: ‘Oh, it’s because you ate all that cake.’ We tell them they have a disease, and we treat it. Obesity is a disease, too, yet we torture people with obesity by telling them it’s their fault.”

Most of the people who choose bariatric surgery — around 80% — are women, Adams said. One of the strengths of the new study, he said, was the inclusion of men who had undergone the procedure.

“For all-causes of death, the mortality was reduced by 14% for females and by 21% for males,” Adams said. In addition, deaths from related causes, such as heart attack, cancer and diabetes, was 24% lower for females and 22% lower for males who underwent surgery compared with those who did not, he said.

Four types of surgery performed between 1982 and 2018 were examined in the study: gastric bypass, gastric banding, gastric sleeve and duodenal switch.

Gastric bypass, developed in the late 1960s, creates a small pouch near the top of the stomach. A part of the small intestine is brought up and attached to that point, bypassing most of the stomach and the duodenum, the first part of the small intestine.

In gastric banding, an elastic band that can be tightened or loosened is placed around the top portion of the stomach, thus restricting the volume of food entering the stomach cavity. Because gastric banding is not as successful in creating long-term weight loss, the procedure “is not as popular today,” Adams said.

“The gastric sleeve is a procedure where essentially about two-thirds of the stomach is removed laparoscopically,” he said. “It takes less time to perform, and food still passes through the much-smaller stomach. It’s become a very popular option.”

The duodenal switch is typically reserved for patients who have a high BMI, Adams added. It’s a complicated procedure that combines a sleeve gastrectomy with an intestinal bypass, and is effective for type 2 diabetes, according to the Cleveland Clinic.

One alarming finding of the new study was a 2.4% increase in deaths by suicide, primarily among people who had bariatric surgery between the ages of 18 and 34.

“That’s because they are told that life is going to be great after surgery or medication,” said Joann Hendelman, clinical director of the National Alliance for Eating Disorders, a nonprofit advocacy group.

“All you have to do is lose weight, and people are going to want to hang out with you, people will want to be your friend, and your anxiety and depression are going to be gone,” she said. “But that’s not reality.”

In addition, there are postoperative risks and side effects associated with bariatric surgery, such as nausea, vomiting, alcoholism, a potential failure to lose weight or even weight gain, said Susan Vibbert, an advocate at Project HEAL, which provides help for people struggling with eating disorders.

“How are we defining health in these scenarios? And is there another intervention — a weight neutral intervention?” Vibbert asked.

Past research has also shown an association between suicide risk and bariatric surgery, Grunvald said, but studies on the topic are not always able to determine a patient’s mental history.

“Did the person opt for surgery because they had some unrealistic expectations or underlying psychological disorders that were not resolved after the surgery? Or is this a direct effect somehow of bariatric surgery? We can’t answer that for sure,” he said.

Intensive presurgery counseling is typically required for all who undergo the procedure, but it may not be enough, Apovian said. She lost her first bariatric surgery patient to suicide.

“She was older, in her 40s. She had surgery and lost 150 pounds. And then she put herself in front of a bus and died because she had underlying bipolar disorder she had been self-medicating with food,” Apovian said. “We as a society use a lot of food to hide trauma. What we need in this country is more psychological counseling for everybody, not just for people who undergo bariatric surgery.”

Managing weight is a unique process for each person, a mixture of genetics, culture, environment, social stigma and personal health, experts say. There is no one solution for all.

“First, we as a society must consider obesity as a disease, as a biological problem, not as a moral failing,” Grunvald said. “That’s my first piece of advice.

“And if you believe your life is going to benefit from treatment, then consider evidence-based treatment, which studies show are surgery or medications, if you haven’t been able to successfully do it with lifestyle changes alone.”

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