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FDA Removes Harmful Chemicals From Food Packaging
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.
FDA Warns Against Using Unauthorized Glucose Monitors
The US Food and Drug Administration (FDA) is warning against the use of smartwatches and rings that are claimed to measure a person’s glucose levels without piercing the skin.
The warning doesn’t apply to authorized smartwatch applications that display glucose values from an FDA-approved continuous glucose monitor with a sensor implanted under the skin.
Rather, the warning pertains to watches or rings sold through online marketplaces or directly from sellers who claim that the devices measure blood sugar noninvasively without requiring the wearer to prick their finger or pierce their skin. These products are manufactured by dozens of companies and sold under many different brand names. The FDA’s warning applies to all of them.
These devices have not been evaluated by the FDA for safety and effectiveness, and their use by people with diabetes could result in inaccurate blood glucose measurements, with potentially serious consequences if relied upon for medication dosing.
“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said in a statement issued on February 21, 2024.
They added, “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”
People who experience any problems with inaccurate blood glucose measurement or experience any adverse events from using an unauthorized smartwatch or smart ring are urged to report it to the FDA through its MedWatch program.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) is warning against the use of smartwatches and rings that are claimed to measure a person’s glucose levels without piercing the skin.
The warning doesn’t apply to authorized smartwatch applications that display glucose values from an FDA-approved continuous glucose monitor with a sensor implanted under the skin.
Rather, the warning pertains to watches or rings sold through online marketplaces or directly from sellers who claim that the devices measure blood sugar noninvasively without requiring the wearer to prick their finger or pierce their skin. These products are manufactured by dozens of companies and sold under many different brand names. The FDA’s warning applies to all of them.
These devices have not been evaluated by the FDA for safety and effectiveness, and their use by people with diabetes could result in inaccurate blood glucose measurements, with potentially serious consequences if relied upon for medication dosing.
“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said in a statement issued on February 21, 2024.
They added, “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”
People who experience any problems with inaccurate blood glucose measurement or experience any adverse events from using an unauthorized smartwatch or smart ring are urged to report it to the FDA through its MedWatch program.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) is warning against the use of smartwatches and rings that are claimed to measure a person’s glucose levels without piercing the skin.
The warning doesn’t apply to authorized smartwatch applications that display glucose values from an FDA-approved continuous glucose monitor with a sensor implanted under the skin.
Rather, the warning pertains to watches or rings sold through online marketplaces or directly from sellers who claim that the devices measure blood sugar noninvasively without requiring the wearer to prick their finger or pierce their skin. These products are manufactured by dozens of companies and sold under many different brand names. The FDA’s warning applies to all of them.
These devices have not been evaluated by the FDA for safety and effectiveness, and their use by people with diabetes could result in inaccurate blood glucose measurements, with potentially serious consequences if relied upon for medication dosing.
“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said in a statement issued on February 21, 2024.
They added, “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”
People who experience any problems with inaccurate blood glucose measurement or experience any adverse events from using an unauthorized smartwatch or smart ring are urged to report it to the FDA through its MedWatch program.
A version of this article appeared on Medscape.com.
‘Deep Phenotyping’ Identifies Abnormalities in ME/CFS
Postinfectious myalgic encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS) is a distinct, centrally mediated condition, with evidence of autonomic, immune, and metabolic dysfunction, new "deep phenotyping" data suggested.
The study was initiated in 2016 at the US National Institutes of Health. Its aim was to better elucidate the underlying pathophysiology of ME/CFS, a multisystem disorder characterized by persistent and disabling fatigue, post-exertional malaise, cognitive complaints, and other physical symptoms. A total of 17 carefully selected individuals with PI-ME/CFS onset within the prior 5 years were compared with 21 healthy volunteers on a more extensive set of biologic measurements than has been examined in any prior study of the condition.
Overall, the findings suggested that ME/CFS is “a distinct entity characterized by somatic and cognitive complaints that are centrally mediated,” with fatigue that is “defined by effort preferences and central autonomic dysfunction,” Brian T. Walitt, MD, of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, and colleagues wrote in the paper, published on February 21 in Nature Communications.
In addition, “there are distinct sex signatures of immune and metabolic dysregulation which suggest persistent antigenic stimulation.” Physical deconditioning over time, while not the source of the condition, “is an important consequence,” the authors added.
Asked to comment, Hector Bonilla, MD, director of the ME/CFS Clinic and codirector of the Stanford Post-Acute COVID-19 Syndrome Clinic, Atherton, California, pointed out that the sample was small and the study was cross-sectional and therefore likely missed dynamic changes in the patients.
Nonetheless, Dr. Bonilla told this news organization, “they have shown clear objective changes in patients with ME/CFS not seen in the controls. These are present in the microbiome, in the immune system, and in metabolites, especially in spinal fluid, that lead to a neuroinflammatory condition. And these are linked with autonomic dysfunction that can explain many of the symptoms that patients experience ... The symptoms are not manufactured by them.”
Thus far, the only treatments for ME/CFS are symptomatic. Understanding the pathophysiology is essential to identifying disease-modifying therapy, study lead author Avindra Nath, MD, Senior Investigator and Clinical Director of Intramural Research at NINDS, told this news organization.
“The disease is real. But our medical profession is limited in what they can do to diagnose or impact them ... The first thing we need to do is try to understand the pathophysiology. So that’s why the study was put together,” Dr. Nath said.
Postinfectious syndromes including ME/CFS have been given many names, including post-Lyme disease, Gulf War illness, and more recently, long COVID. With ME/CFS, the Epstein-Barr virus has historically been one of the most commonly associated triggers, although several other viral, bacterial, and environmental toxins have been implicated.
“There are a whole host of these things that have very similar symptoms or overlapping symptoms ... It’s quite possible that the underlying pathophysiology overlaps between all these syndromes,” Dr. Nath noted.
Another ME/CFS expert not involved in the study, researcher Michael VanElzakker, PhD, of the Neurotherapeutics Division at Harvard Medical School and Massachusetts General Hospital, Boston, said that the possibility of antigen persistence of the infectious pathogen arising from the immune system profiling conducted in the study is noteworthy and merits further study.
“To me, the obvious next step would be techniques like tissue-based assays and T-cell sequencing to try and understand what exactly those antigens are and what their source might be. Importantly, it is probably not the same antigen or pathogen source in all patients, but that’s a question that needs an answer,” Dr. VanElzakker said.
Of note, the 17 study participants had been adjudicated by an expert panel from an initial 484 inquiries and 217 who underwent detailed case reviews. They had to meet at least one of three published ME/CFS criteria and to have moderate to severe clinical symptom severity as determined by several fatigue scores. None met the criteria for psychiatric diagnoses.
Yet, even in the cases that met study criteria, underlying causes emerged in 20% of the participants over time, suggesting diagnostic misattribution. “This misclassification bias has important ramifications on the interpretation of the existing ME/CFS research literature,” the authors wrote.
Dr. VanElzakker noted, “The fact that this research study was probably the most detailed workup many of these patients had ever gotten is a serious indictment of our current profit-based healthcare system’s prioritization of 15-minute doctor’s appointments. It is almost certain that other patients would also benefit from an intensive detailed workup.”
Multiple Abnormalities Identified
There were no differences between the PI-ME/CFS and control groups in ventilatory function, muscle oxygenation, mechanical efficiency, resting energy expenditure, basal mitochondrial function of immune cells, muscle fiber composition, or body composition, suggesting the absence of a resting low-energy state, the authors said.
In 40-minute head-up tilt-table testing, there were no differences between the ME/CFS and control groups in frequency or orthostatic hypotension or extensive orthostatic tachycardia. However, a 24-hour ambulatory electrocardiogram showed that the patients with PI-ME/CFS had diminished heart rate variability. They also showed increased heart rate throughout the day, suggesting increased sympathetic activity, and a diminished drop in nighttime heart rate, suggesting decreased parasympathetic activity.
“Considered together, these data suggest that there is an alteration in autonomic tone, implying central nervous system regulatory change,” Dr. Walitt and colleagues wrote.
On the “Effort-Expenditure for Rewards Task,” the participants with PI-ME/CFS showed significant differences in “effort preference,” or a tendency to avoid the harder tasks, as well as a slowing of button-pushing over time, compared with the controls, even with easier tasks. This pattern suggests that those with PI-ME/CFS were “pacing to limit exertion and associated feelings of discomfort,” the authors wrote.
Dr. Nath describes this behavior as akin to “if you develop a flu, you feel that you just want to lay down in bed and not hurt yourself. It’s not that you’re not capable of doing [the task], but your body tells you don’t do it. Your body just wants to fight the infection ... these people just never bounce back.”
Compared with the controls, the participants with PI-ME/CFS failed to maintain a moderate grip force even though there was no difference in maximum grip strength or arm muscle mass. This performance difference correlated with decreased activity of the right temporal-parietal junction, a novel observation suggesting that the fatigue in the PI-ME/CFS group “is due to dysfunction of integrative brain regions that drive the motor cortex, the cause of which needs to be further explored,” Dr. Walitt and colleagues wrote.
On cardiopulmonary testing, peak power, peak respiratory rate, peak heart rate, and peak VO2 were all lower in the PI-ME/CFS group, correlating to a difference of approximately 3.3 metabolic equivalent of task units. The differential cardiorespiratory performance relates to “autonomic function, hypothalamic-pituitary-adrenal axis hyporesponsiveness, and muscular deconditioning from disuse that clinically impacts activities of daily life,” they said.
In the participants with PI-ME/CFS, catechol levels in cerebrospinal fluid correlated with grip strength and effort preference, and several metabolites of the dopamine pathway correlated with several cognitive symptoms.
“This suggests that central nervous system catechol pathways are dysregulated in PI-ME/CFS and may play a role in effort preference and cognitive complaints,” as well as decreased central catecholamine biosynthesis. Similar findings have been seen in patients with long COVID, the authors noted.
There were increased naive B cells and decreased switched memory B cells in blood of participants with PI-ME/CFS. Contrary to prior studies, there was no consistent pattern of autoimmunity across all participants with PI-ME/CFS, and no previously undescribed antibodies were identified.
However, programmed cell death protein 1, a marker of T-cell exhaustion and activation, was elevated in the cerebrospinal fluid of the patients with PI-ME/CFS.
Several sex-based differences were noted, including in immune cell expression in cerebrospinal fluid, peripheral blood mononuclear cell gene expression, and muscle gene expression. Males and females also differed in the cerebrospinal metabolomics that distinguished the participants with PI-ME/CFS from controls.
What Do These Findings Suggest About Treatment?
The data point to several treatment implications. For one, the finding of possible immune exhaustion suggests that immune checkpoint inhibitors may be therapeutic by promoting clearance of foreign antigens. Immune dysfunction leads to neurochemical alterations that affect neuronal circuits, which may be another point of intervention, the authors suggested.
On the other hand, “attempting to target downstream mechanisms with exercise, cognitive behavioral therapy, or autonomic directed therapies may have limited impact on symptom burden, as it would not address the root cause of PI-ME/CFS,” they noted.
Combination therapy targeting multiple pathways along with a personalized medicine approach should be considered, they said.
“I think the most important thing is not to discount these patients,” Dr. Nath told this news organization. “They have a real disease, and we need to be empathetic towards them. We also need to make sure that they don’t have something underlying that is treatable, and then treat them symptomatically the best that you can. If not, then refer them to ME/CFS studies or clinics where people specialize in these conditions and work with them.”
The study authors and Dr. VanElzakker reported no relevant financial relationships. Dr. Bonilla consults for United Health and Resverlogix.
A version of this article appeared on Medscape.com.
Postinfectious myalgic encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS) is a distinct, centrally mediated condition, with evidence of autonomic, immune, and metabolic dysfunction, new "deep phenotyping" data suggested.
The study was initiated in 2016 at the US National Institutes of Health. Its aim was to better elucidate the underlying pathophysiology of ME/CFS, a multisystem disorder characterized by persistent and disabling fatigue, post-exertional malaise, cognitive complaints, and other physical symptoms. A total of 17 carefully selected individuals with PI-ME/CFS onset within the prior 5 years were compared with 21 healthy volunteers on a more extensive set of biologic measurements than has been examined in any prior study of the condition.
Overall, the findings suggested that ME/CFS is “a distinct entity characterized by somatic and cognitive complaints that are centrally mediated,” with fatigue that is “defined by effort preferences and central autonomic dysfunction,” Brian T. Walitt, MD, of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, and colleagues wrote in the paper, published on February 21 in Nature Communications.
In addition, “there are distinct sex signatures of immune and metabolic dysregulation which suggest persistent antigenic stimulation.” Physical deconditioning over time, while not the source of the condition, “is an important consequence,” the authors added.
Asked to comment, Hector Bonilla, MD, director of the ME/CFS Clinic and codirector of the Stanford Post-Acute COVID-19 Syndrome Clinic, Atherton, California, pointed out that the sample was small and the study was cross-sectional and therefore likely missed dynamic changes in the patients.
Nonetheless, Dr. Bonilla told this news organization, “they have shown clear objective changes in patients with ME/CFS not seen in the controls. These are present in the microbiome, in the immune system, and in metabolites, especially in spinal fluid, that lead to a neuroinflammatory condition. And these are linked with autonomic dysfunction that can explain many of the symptoms that patients experience ... The symptoms are not manufactured by them.”
Thus far, the only treatments for ME/CFS are symptomatic. Understanding the pathophysiology is essential to identifying disease-modifying therapy, study lead author Avindra Nath, MD, Senior Investigator and Clinical Director of Intramural Research at NINDS, told this news organization.
“The disease is real. But our medical profession is limited in what they can do to diagnose or impact them ... The first thing we need to do is try to understand the pathophysiology. So that’s why the study was put together,” Dr. Nath said.
Postinfectious syndromes including ME/CFS have been given many names, including post-Lyme disease, Gulf War illness, and more recently, long COVID. With ME/CFS, the Epstein-Barr virus has historically been one of the most commonly associated triggers, although several other viral, bacterial, and environmental toxins have been implicated.
“There are a whole host of these things that have very similar symptoms or overlapping symptoms ... It’s quite possible that the underlying pathophysiology overlaps between all these syndromes,” Dr. Nath noted.
Another ME/CFS expert not involved in the study, researcher Michael VanElzakker, PhD, of the Neurotherapeutics Division at Harvard Medical School and Massachusetts General Hospital, Boston, said that the possibility of antigen persistence of the infectious pathogen arising from the immune system profiling conducted in the study is noteworthy and merits further study.
“To me, the obvious next step would be techniques like tissue-based assays and T-cell sequencing to try and understand what exactly those antigens are and what their source might be. Importantly, it is probably not the same antigen or pathogen source in all patients, but that’s a question that needs an answer,” Dr. VanElzakker said.
Of note, the 17 study participants had been adjudicated by an expert panel from an initial 484 inquiries and 217 who underwent detailed case reviews. They had to meet at least one of three published ME/CFS criteria and to have moderate to severe clinical symptom severity as determined by several fatigue scores. None met the criteria for psychiatric diagnoses.
Yet, even in the cases that met study criteria, underlying causes emerged in 20% of the participants over time, suggesting diagnostic misattribution. “This misclassification bias has important ramifications on the interpretation of the existing ME/CFS research literature,” the authors wrote.
Dr. VanElzakker noted, “The fact that this research study was probably the most detailed workup many of these patients had ever gotten is a serious indictment of our current profit-based healthcare system’s prioritization of 15-minute doctor’s appointments. It is almost certain that other patients would also benefit from an intensive detailed workup.”
Multiple Abnormalities Identified
There were no differences between the PI-ME/CFS and control groups in ventilatory function, muscle oxygenation, mechanical efficiency, resting energy expenditure, basal mitochondrial function of immune cells, muscle fiber composition, or body composition, suggesting the absence of a resting low-energy state, the authors said.
In 40-minute head-up tilt-table testing, there were no differences between the ME/CFS and control groups in frequency or orthostatic hypotension or extensive orthostatic tachycardia. However, a 24-hour ambulatory electrocardiogram showed that the patients with PI-ME/CFS had diminished heart rate variability. They also showed increased heart rate throughout the day, suggesting increased sympathetic activity, and a diminished drop in nighttime heart rate, suggesting decreased parasympathetic activity.
“Considered together, these data suggest that there is an alteration in autonomic tone, implying central nervous system regulatory change,” Dr. Walitt and colleagues wrote.
On the “Effort-Expenditure for Rewards Task,” the participants with PI-ME/CFS showed significant differences in “effort preference,” or a tendency to avoid the harder tasks, as well as a slowing of button-pushing over time, compared with the controls, even with easier tasks. This pattern suggests that those with PI-ME/CFS were “pacing to limit exertion and associated feelings of discomfort,” the authors wrote.
Dr. Nath describes this behavior as akin to “if you develop a flu, you feel that you just want to lay down in bed and not hurt yourself. It’s not that you’re not capable of doing [the task], but your body tells you don’t do it. Your body just wants to fight the infection ... these people just never bounce back.”
Compared with the controls, the participants with PI-ME/CFS failed to maintain a moderate grip force even though there was no difference in maximum grip strength or arm muscle mass. This performance difference correlated with decreased activity of the right temporal-parietal junction, a novel observation suggesting that the fatigue in the PI-ME/CFS group “is due to dysfunction of integrative brain regions that drive the motor cortex, the cause of which needs to be further explored,” Dr. Walitt and colleagues wrote.
On cardiopulmonary testing, peak power, peak respiratory rate, peak heart rate, and peak VO2 were all lower in the PI-ME/CFS group, correlating to a difference of approximately 3.3 metabolic equivalent of task units. The differential cardiorespiratory performance relates to “autonomic function, hypothalamic-pituitary-adrenal axis hyporesponsiveness, and muscular deconditioning from disuse that clinically impacts activities of daily life,” they said.
In the participants with PI-ME/CFS, catechol levels in cerebrospinal fluid correlated with grip strength and effort preference, and several metabolites of the dopamine pathway correlated with several cognitive symptoms.
“This suggests that central nervous system catechol pathways are dysregulated in PI-ME/CFS and may play a role in effort preference and cognitive complaints,” as well as decreased central catecholamine biosynthesis. Similar findings have been seen in patients with long COVID, the authors noted.
There were increased naive B cells and decreased switched memory B cells in blood of participants with PI-ME/CFS. Contrary to prior studies, there was no consistent pattern of autoimmunity across all participants with PI-ME/CFS, and no previously undescribed antibodies were identified.
However, programmed cell death protein 1, a marker of T-cell exhaustion and activation, was elevated in the cerebrospinal fluid of the patients with PI-ME/CFS.
Several sex-based differences were noted, including in immune cell expression in cerebrospinal fluid, peripheral blood mononuclear cell gene expression, and muscle gene expression. Males and females also differed in the cerebrospinal metabolomics that distinguished the participants with PI-ME/CFS from controls.
What Do These Findings Suggest About Treatment?
The data point to several treatment implications. For one, the finding of possible immune exhaustion suggests that immune checkpoint inhibitors may be therapeutic by promoting clearance of foreign antigens. Immune dysfunction leads to neurochemical alterations that affect neuronal circuits, which may be another point of intervention, the authors suggested.
On the other hand, “attempting to target downstream mechanisms with exercise, cognitive behavioral therapy, or autonomic directed therapies may have limited impact on symptom burden, as it would not address the root cause of PI-ME/CFS,” they noted.
Combination therapy targeting multiple pathways along with a personalized medicine approach should be considered, they said.
“I think the most important thing is not to discount these patients,” Dr. Nath told this news organization. “They have a real disease, and we need to be empathetic towards them. We also need to make sure that they don’t have something underlying that is treatable, and then treat them symptomatically the best that you can. If not, then refer them to ME/CFS studies or clinics where people specialize in these conditions and work with them.”
The study authors and Dr. VanElzakker reported no relevant financial relationships. Dr. Bonilla consults for United Health and Resverlogix.
A version of this article appeared on Medscape.com.
Postinfectious myalgic encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS) is a distinct, centrally mediated condition, with evidence of autonomic, immune, and metabolic dysfunction, new "deep phenotyping" data suggested.
The study was initiated in 2016 at the US National Institutes of Health. Its aim was to better elucidate the underlying pathophysiology of ME/CFS, a multisystem disorder characterized by persistent and disabling fatigue, post-exertional malaise, cognitive complaints, and other physical symptoms. A total of 17 carefully selected individuals with PI-ME/CFS onset within the prior 5 years were compared with 21 healthy volunteers on a more extensive set of biologic measurements than has been examined in any prior study of the condition.
Overall, the findings suggested that ME/CFS is “a distinct entity characterized by somatic and cognitive complaints that are centrally mediated,” with fatigue that is “defined by effort preferences and central autonomic dysfunction,” Brian T. Walitt, MD, of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, and colleagues wrote in the paper, published on February 21 in Nature Communications.
In addition, “there are distinct sex signatures of immune and metabolic dysregulation which suggest persistent antigenic stimulation.” Physical deconditioning over time, while not the source of the condition, “is an important consequence,” the authors added.
Asked to comment, Hector Bonilla, MD, director of the ME/CFS Clinic and codirector of the Stanford Post-Acute COVID-19 Syndrome Clinic, Atherton, California, pointed out that the sample was small and the study was cross-sectional and therefore likely missed dynamic changes in the patients.
Nonetheless, Dr. Bonilla told this news organization, “they have shown clear objective changes in patients with ME/CFS not seen in the controls. These are present in the microbiome, in the immune system, and in metabolites, especially in spinal fluid, that lead to a neuroinflammatory condition. And these are linked with autonomic dysfunction that can explain many of the symptoms that patients experience ... The symptoms are not manufactured by them.”
Thus far, the only treatments for ME/CFS are symptomatic. Understanding the pathophysiology is essential to identifying disease-modifying therapy, study lead author Avindra Nath, MD, Senior Investigator and Clinical Director of Intramural Research at NINDS, told this news organization.
“The disease is real. But our medical profession is limited in what they can do to diagnose or impact them ... The first thing we need to do is try to understand the pathophysiology. So that’s why the study was put together,” Dr. Nath said.
Postinfectious syndromes including ME/CFS have been given many names, including post-Lyme disease, Gulf War illness, and more recently, long COVID. With ME/CFS, the Epstein-Barr virus has historically been one of the most commonly associated triggers, although several other viral, bacterial, and environmental toxins have been implicated.
“There are a whole host of these things that have very similar symptoms or overlapping symptoms ... It’s quite possible that the underlying pathophysiology overlaps between all these syndromes,” Dr. Nath noted.
Another ME/CFS expert not involved in the study, researcher Michael VanElzakker, PhD, of the Neurotherapeutics Division at Harvard Medical School and Massachusetts General Hospital, Boston, said that the possibility of antigen persistence of the infectious pathogen arising from the immune system profiling conducted in the study is noteworthy and merits further study.
“To me, the obvious next step would be techniques like tissue-based assays and T-cell sequencing to try and understand what exactly those antigens are and what their source might be. Importantly, it is probably not the same antigen or pathogen source in all patients, but that’s a question that needs an answer,” Dr. VanElzakker said.
Of note, the 17 study participants had been adjudicated by an expert panel from an initial 484 inquiries and 217 who underwent detailed case reviews. They had to meet at least one of three published ME/CFS criteria and to have moderate to severe clinical symptom severity as determined by several fatigue scores. None met the criteria for psychiatric diagnoses.
Yet, even in the cases that met study criteria, underlying causes emerged in 20% of the participants over time, suggesting diagnostic misattribution. “This misclassification bias has important ramifications on the interpretation of the existing ME/CFS research literature,” the authors wrote.
Dr. VanElzakker noted, “The fact that this research study was probably the most detailed workup many of these patients had ever gotten is a serious indictment of our current profit-based healthcare system’s prioritization of 15-minute doctor’s appointments. It is almost certain that other patients would also benefit from an intensive detailed workup.”
Multiple Abnormalities Identified
There were no differences between the PI-ME/CFS and control groups in ventilatory function, muscle oxygenation, mechanical efficiency, resting energy expenditure, basal mitochondrial function of immune cells, muscle fiber composition, or body composition, suggesting the absence of a resting low-energy state, the authors said.
In 40-minute head-up tilt-table testing, there were no differences between the ME/CFS and control groups in frequency or orthostatic hypotension or extensive orthostatic tachycardia. However, a 24-hour ambulatory electrocardiogram showed that the patients with PI-ME/CFS had diminished heart rate variability. They also showed increased heart rate throughout the day, suggesting increased sympathetic activity, and a diminished drop in nighttime heart rate, suggesting decreased parasympathetic activity.
“Considered together, these data suggest that there is an alteration in autonomic tone, implying central nervous system regulatory change,” Dr. Walitt and colleagues wrote.
On the “Effort-Expenditure for Rewards Task,” the participants with PI-ME/CFS showed significant differences in “effort preference,” or a tendency to avoid the harder tasks, as well as a slowing of button-pushing over time, compared with the controls, even with easier tasks. This pattern suggests that those with PI-ME/CFS were “pacing to limit exertion and associated feelings of discomfort,” the authors wrote.
Dr. Nath describes this behavior as akin to “if you develop a flu, you feel that you just want to lay down in bed and not hurt yourself. It’s not that you’re not capable of doing [the task], but your body tells you don’t do it. Your body just wants to fight the infection ... these people just never bounce back.”
Compared with the controls, the participants with PI-ME/CFS failed to maintain a moderate grip force even though there was no difference in maximum grip strength or arm muscle mass. This performance difference correlated with decreased activity of the right temporal-parietal junction, a novel observation suggesting that the fatigue in the PI-ME/CFS group “is due to dysfunction of integrative brain regions that drive the motor cortex, the cause of which needs to be further explored,” Dr. Walitt and colleagues wrote.
On cardiopulmonary testing, peak power, peak respiratory rate, peak heart rate, and peak VO2 were all lower in the PI-ME/CFS group, correlating to a difference of approximately 3.3 metabolic equivalent of task units. The differential cardiorespiratory performance relates to “autonomic function, hypothalamic-pituitary-adrenal axis hyporesponsiveness, and muscular deconditioning from disuse that clinically impacts activities of daily life,” they said.
In the participants with PI-ME/CFS, catechol levels in cerebrospinal fluid correlated with grip strength and effort preference, and several metabolites of the dopamine pathway correlated with several cognitive symptoms.
“This suggests that central nervous system catechol pathways are dysregulated in PI-ME/CFS and may play a role in effort preference and cognitive complaints,” as well as decreased central catecholamine biosynthesis. Similar findings have been seen in patients with long COVID, the authors noted.
There were increased naive B cells and decreased switched memory B cells in blood of participants with PI-ME/CFS. Contrary to prior studies, there was no consistent pattern of autoimmunity across all participants with PI-ME/CFS, and no previously undescribed antibodies were identified.
However, programmed cell death protein 1, a marker of T-cell exhaustion and activation, was elevated in the cerebrospinal fluid of the patients with PI-ME/CFS.
Several sex-based differences were noted, including in immune cell expression in cerebrospinal fluid, peripheral blood mononuclear cell gene expression, and muscle gene expression. Males and females also differed in the cerebrospinal metabolomics that distinguished the participants with PI-ME/CFS from controls.
What Do These Findings Suggest About Treatment?
The data point to several treatment implications. For one, the finding of possible immune exhaustion suggests that immune checkpoint inhibitors may be therapeutic by promoting clearance of foreign antigens. Immune dysfunction leads to neurochemical alterations that affect neuronal circuits, which may be another point of intervention, the authors suggested.
On the other hand, “attempting to target downstream mechanisms with exercise, cognitive behavioral therapy, or autonomic directed therapies may have limited impact on symptom burden, as it would not address the root cause of PI-ME/CFS,” they noted.
Combination therapy targeting multiple pathways along with a personalized medicine approach should be considered, they said.
“I think the most important thing is not to discount these patients,” Dr. Nath told this news organization. “They have a real disease, and we need to be empathetic towards them. We also need to make sure that they don’t have something underlying that is treatable, and then treat them symptomatically the best that you can. If not, then refer them to ME/CFS studies or clinics where people specialize in these conditions and work with them.”
The study authors and Dr. VanElzakker reported no relevant financial relationships. Dr. Bonilla consults for United Health and Resverlogix.
A version of this article appeared on Medscape.com.
Can Gargling With Mouthwash Help Manage Type 2 Diabetes?
TOPLINE:
in people with type 2 diabetes (T2D), especially younger adults.
METHODOLOGY:
- A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
- Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.
TAKEAWAY:
- Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
- By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
- Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
- After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
- However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
- Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.
IN PRACTICE:
“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”
SOURCE:
This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.
LIMITATIONS:
Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.
DISCLOSURES:
This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.
A version of this article appeared on Medscape.com.
TOPLINE:
in people with type 2 diabetes (T2D), especially younger adults.
METHODOLOGY:
- A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
- Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.
TAKEAWAY:
- Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
- By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
- Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
- After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
- However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
- Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.
IN PRACTICE:
“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”
SOURCE:
This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.
LIMITATIONS:
Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.
DISCLOSURES:
This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.
A version of this article appeared on Medscape.com.
TOPLINE:
in people with type 2 diabetes (T2D), especially younger adults.
METHODOLOGY:
- A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
- Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.
TAKEAWAY:
- Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
- By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
- Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
- After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
- However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
- Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.
IN PRACTICE:
“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”
SOURCE:
This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.
LIMITATIONS:
Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.
DISCLOSURES:
This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.
A version of this article appeared on Medscape.com.
Statement: Prioritize Patient Experience in Diabetes Care
A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.
The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.
“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.
The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”
The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.
Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”
Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:
- The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
- Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
- Referring patients for diabetes self-management education and support
- Navigating available therapeutic options and explaining complex regimens to patients
- Minimizing therapeutic and clinical inertia
- Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
- Discussing strategies to minimize hypoglycemia when relevant
- Using telehealth when appropriate
- Integrating diabetes technologies into routine diabetes management
Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.
In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”
Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”
Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.
However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”
Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”
The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
A version of this article appeared on Medscape.com.
A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.
The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.
“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.
The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”
The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.
Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”
Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:
- The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
- Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
- Referring patients for diabetes self-management education and support
- Navigating available therapeutic options and explaining complex regimens to patients
- Minimizing therapeutic and clinical inertia
- Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
- Discussing strategies to minimize hypoglycemia when relevant
- Using telehealth when appropriate
- Integrating diabetes technologies into routine diabetes management
Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.
In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”
Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”
Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.
However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”
Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”
The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
A version of this article appeared on Medscape.com.
A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.
The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.
“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.
The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”
The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.
Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”
Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:
- The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
- Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
- Referring patients for diabetes self-management education and support
- Navigating available therapeutic options and explaining complex regimens to patients
- Minimizing therapeutic and clinical inertia
- Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
- Discussing strategies to minimize hypoglycemia when relevant
- Using telehealth when appropriate
- Integrating diabetes technologies into routine diabetes management
Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.
In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”
Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”
Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.
However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”
Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”
The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
A version of this article appeared on Medscape.com.
Can a Plant-Based Diet Lower Type 2 Diabetes Risk?
TOPLINE:
Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.
METHODOLOGY:
- The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
TAKEAWAY:
- Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
- During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
- After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
- As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
- Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
- Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
- Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
- Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.
IN PRACTICE:
“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”
SOURCE:
The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.
LIMITATIONS:
The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.
DISCLOSURES:
The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.
METHODOLOGY:
- The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
TAKEAWAY:
- Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
- During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
- After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
- As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
- Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
- Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
- Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
- Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.
IN PRACTICE:
“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”
SOURCE:
The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.
LIMITATIONS:
The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.
DISCLOSURES:
The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.
METHODOLOGY:
- The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
TAKEAWAY:
- Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
- During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
- After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
- As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
- Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
- Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
- Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
- Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.
IN PRACTICE:
“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”
SOURCE:
The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.
LIMITATIONS:
The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.
DISCLOSURES:
The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.
A version of this article appeared on Medscape.com.
Weight Management Therapies Work, But Utilization Low
TOPLINE:
A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.
Yet, low WMT utilization hindered population-level benefit.
METHODOLOGY:
This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.
TAKEAWAY:
- From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
- Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
- Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
- In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.
IN PRACTICE:
“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”
“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”
SOURCE:
This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .
LIMITATIONS:
Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.
DISCLOSURES:
The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.
A version of this article appeared on Medscape.com.
TOPLINE:
A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.
Yet, low WMT utilization hindered population-level benefit.
METHODOLOGY:
This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.
TAKEAWAY:
- From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
- Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
- Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
- In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.
IN PRACTICE:
“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”
“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”
SOURCE:
This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .
LIMITATIONS:
Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.
DISCLOSURES:
The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.
A version of this article appeared on Medscape.com.
TOPLINE:
A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.
Yet, low WMT utilization hindered population-level benefit.
METHODOLOGY:
This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.
TAKEAWAY:
- From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
- Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
- Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
- In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.
IN PRACTICE:
“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”
“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”
SOURCE:
This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .
LIMITATIONS:
Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.
DISCLOSURES:
The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.
A version of this article appeared on Medscape.com.
Disparities Seen in Weight Loss Drug Prescriptions, Fills
Socioeconomic factors and insurance type greatly influence the odds of a person with obesity receiving a prescription for a weight loss medication and subsequently filling it, new research finds.
The results come from a retrospective study of Florida and Ohio electronic health records of more than 50,000 adults with a body mass index (BMI) of ≥ 30 kg/m2 who sought care for obesity from 2015 through June 2023.
The fill rate increased to 26% in 2022-2023 after the newer glucagon-like peptide 1 (GLP-1) agonists became available, but the identified disparities persisted throughout, study author Hamlet Gasoyan, PhD, told this news organization. “Things are changing, but this study provides a very good picture of who’s getting prescriptions and the implications for policy decisions.”
Dr. Gasoyan, of the Center for Value-Based Care Research at the Cleveland Clinic, Cleveland, Ohio, noted that Medicare doesn’t currently cover antiobesity medications nor do most Medicaid programs (neither Florida’s nor Ohio’s do), but there is now at least one bill in Congress to change that. “Medicare and other government payers are currently facing important policy decisions about antiobesity medication coverage. I think they should consider how their policies could impact existing inequalities in obesity care.”
Another noteworthy finding, Dr. Gasoyan said, is that “despite all the recent hype, the real data shows these medications are underutilized and probably will remain so.”
Asked to comment, David B. Sarwer, PhD, Director of the Center for Obesity Research and Education at Temple University, Philadelphia, Pennsylvania, told this news organization, “there’s a tremendous amount of enthusiasm in the obesity treatment community that these newer medications have the potential to be game-changers. I think what this study shows us, as does other work from this group and others, is that we still have some significant issues around access to care and long-term engagement with these medications that we need to address for them to realize their full potential.”
Dr. Sarwer acknowledged, as did Dr. Gasoyan, that the study timing is a limitation and more data will need to be collected prospectively with the new incretin drugs. As of now, though, “These medications are very expensive. While there are some insurance plans that are offering payment for them, many are not. Until we wrestle that to the ground there are always going to be questions about whether these medications are getting to the people who need them the most. I think one of the highlights of this paper is it reminds us that obesity is a disease that differentially impacts persons from underserved groups.”
Moreover, Dr. Sarwer noted, “In this day and age, many physicians don’t have a lot of time to spend with individual patients. Conversations around weight can be challenging and often very emotional for patients. I’m not sure we’ve trained physicians how to have productive, targeted conversations that lead to effective use of a weight-loss intervention. Maybe in some ways that’s what we’re seeing here.”
Disparities Seen in Both Prescriptions and Fills
The 50,678 study subjects all not only met BMI criteria (≥ 30 kg/m2) but also attended at least one weight management program (n = 48,711) and/or received a weight-loss medication prescription (n = 4047). “We know BMI isn’t a perfect measure of obesity, so we specifically looked at where the patient or provider had identified excess weight as an issue and wanted to do something about it…You would expect that in this group the use of antiobesity medications would be high, but it wasn’t, unfortunately,” Dr. Gasoyan commented.
Participants had a mean BMI of 38 kg/m2 and mean age 50 years. Slightly more than half (54%) were women, 66% were White individuals, 24% Black individuals, and 5.3% Hispanic individuals. A majority (56%) had private insurance, and 41% had diabetes. Mean follow-up time was 4.7 years.
The main measures were prescriptions for naltrexone-bupropion, orlistat, phentermine-topiramate, 3.0 mg liraglutide, 2.4 mg semaglutide, and a fill for one of those during the study follow-up.
Overall, 8.0% had a new anti-obesity medication prescription, and of those, 55% had at least one documented fill of the prescription. Among the fills, 39% were for naltrexone-buproprion, 29% for phentermine-topiramate, 19% for semaglutide, 11% for liraglutide, and 1.2% for orlistat.
In the multivariable model, receipt of an antiobesity medication prescription was significantly less likely among Black patients (adjusted odds ratio, 0.68), Hispanic individuals (0.72), and those from other racial or ethnic backgrounds (0.70) than among White patients. Men had lower odds than women (0.38).
Compared with privately insured patients, significantly lower odds of receiving prescriptions were seen in those with Medicaid (0.44), traditional Medicare (0.35), Medicare Advantage (0.36), and self-paying (0.65) and other insurance types (0.53). Those in the highest quartile of economic disadvantage also had lower antiobesity medication prescription odds (0.81).
Also associated with lower prescription odds were younger age, higher age-adjusted Charlson comorbidity score, presence of diabetes diagnosis, and a history of myocardial infarction or heart failure.
Factors associated with lower odds of filling antiobesity medication prescriptions included Hispanic ethnicity vs White ethnicity (0.51) but not Black race. Compared with private insurance, lower odds of filling the prescriptions were seen among those with Medicaid (0.41), traditional Medicare (0.38), and Medicare Advantage (0.37).
Over the study period, compared with naltrexone-buproprion, phentermine-topiramate had higher odds of being filled (1.27), while liraglutide (0.61) and orlistat (0.11) had lower odds, and semaglutide didn’t differ significantly (0.90).
Older age, female sex, and the presence of diabetes diagnosis were associated with higher odds of prescription fills, while deprivation quartile, history of myocardial infarction, history of heart failure, and age-adjusted Charlson comorbidity score were not significantly associated with medication fill.
Dr. Gasoyan told this news organization, “This study is unique in that we were able to look at patterns of use and barriers at several stages…We just recently published another study where we found patients weren’t often taking these medications long-term. So, patients are facing challenges on receiving obesity pharmacotherapy at several stages. …Hopefully these data will highlight the issues and inform future decisions. We see clear areas where we could obviously do better.”
Dr. Gasoyan had no disclosures. Dr. Sarwer received grant funding from the National Institutes of Health and declared having consulting relationships with NovoNordisk and Twenty30 Health.
A version of this article appeared on Medscape.com.
Socioeconomic factors and insurance type greatly influence the odds of a person with obesity receiving a prescription for a weight loss medication and subsequently filling it, new research finds.
The results come from a retrospective study of Florida and Ohio electronic health records of more than 50,000 adults with a body mass index (BMI) of ≥ 30 kg/m2 who sought care for obesity from 2015 through June 2023.
The fill rate increased to 26% in 2022-2023 after the newer glucagon-like peptide 1 (GLP-1) agonists became available, but the identified disparities persisted throughout, study author Hamlet Gasoyan, PhD, told this news organization. “Things are changing, but this study provides a very good picture of who’s getting prescriptions and the implications for policy decisions.”
Dr. Gasoyan, of the Center for Value-Based Care Research at the Cleveland Clinic, Cleveland, Ohio, noted that Medicare doesn’t currently cover antiobesity medications nor do most Medicaid programs (neither Florida’s nor Ohio’s do), but there is now at least one bill in Congress to change that. “Medicare and other government payers are currently facing important policy decisions about antiobesity medication coverage. I think they should consider how their policies could impact existing inequalities in obesity care.”
Another noteworthy finding, Dr. Gasoyan said, is that “despite all the recent hype, the real data shows these medications are underutilized and probably will remain so.”
Asked to comment, David B. Sarwer, PhD, Director of the Center for Obesity Research and Education at Temple University, Philadelphia, Pennsylvania, told this news organization, “there’s a tremendous amount of enthusiasm in the obesity treatment community that these newer medications have the potential to be game-changers. I think what this study shows us, as does other work from this group and others, is that we still have some significant issues around access to care and long-term engagement with these medications that we need to address for them to realize their full potential.”
Dr. Sarwer acknowledged, as did Dr. Gasoyan, that the study timing is a limitation and more data will need to be collected prospectively with the new incretin drugs. As of now, though, “These medications are very expensive. While there are some insurance plans that are offering payment for them, many are not. Until we wrestle that to the ground there are always going to be questions about whether these medications are getting to the people who need them the most. I think one of the highlights of this paper is it reminds us that obesity is a disease that differentially impacts persons from underserved groups.”
Moreover, Dr. Sarwer noted, “In this day and age, many physicians don’t have a lot of time to spend with individual patients. Conversations around weight can be challenging and often very emotional for patients. I’m not sure we’ve trained physicians how to have productive, targeted conversations that lead to effective use of a weight-loss intervention. Maybe in some ways that’s what we’re seeing here.”
Disparities Seen in Both Prescriptions and Fills
The 50,678 study subjects all not only met BMI criteria (≥ 30 kg/m2) but also attended at least one weight management program (n = 48,711) and/or received a weight-loss medication prescription (n = 4047). “We know BMI isn’t a perfect measure of obesity, so we specifically looked at where the patient or provider had identified excess weight as an issue and wanted to do something about it…You would expect that in this group the use of antiobesity medications would be high, but it wasn’t, unfortunately,” Dr. Gasoyan commented.
Participants had a mean BMI of 38 kg/m2 and mean age 50 years. Slightly more than half (54%) were women, 66% were White individuals, 24% Black individuals, and 5.3% Hispanic individuals. A majority (56%) had private insurance, and 41% had diabetes. Mean follow-up time was 4.7 years.
The main measures were prescriptions for naltrexone-bupropion, orlistat, phentermine-topiramate, 3.0 mg liraglutide, 2.4 mg semaglutide, and a fill for one of those during the study follow-up.
Overall, 8.0% had a new anti-obesity medication prescription, and of those, 55% had at least one documented fill of the prescription. Among the fills, 39% were for naltrexone-buproprion, 29% for phentermine-topiramate, 19% for semaglutide, 11% for liraglutide, and 1.2% for orlistat.
In the multivariable model, receipt of an antiobesity medication prescription was significantly less likely among Black patients (adjusted odds ratio, 0.68), Hispanic individuals (0.72), and those from other racial or ethnic backgrounds (0.70) than among White patients. Men had lower odds than women (0.38).
Compared with privately insured patients, significantly lower odds of receiving prescriptions were seen in those with Medicaid (0.44), traditional Medicare (0.35), Medicare Advantage (0.36), and self-paying (0.65) and other insurance types (0.53). Those in the highest quartile of economic disadvantage also had lower antiobesity medication prescription odds (0.81).
Also associated with lower prescription odds were younger age, higher age-adjusted Charlson comorbidity score, presence of diabetes diagnosis, and a history of myocardial infarction or heart failure.
Factors associated with lower odds of filling antiobesity medication prescriptions included Hispanic ethnicity vs White ethnicity (0.51) but not Black race. Compared with private insurance, lower odds of filling the prescriptions were seen among those with Medicaid (0.41), traditional Medicare (0.38), and Medicare Advantage (0.37).
Over the study period, compared with naltrexone-buproprion, phentermine-topiramate had higher odds of being filled (1.27), while liraglutide (0.61) and orlistat (0.11) had lower odds, and semaglutide didn’t differ significantly (0.90).
Older age, female sex, and the presence of diabetes diagnosis were associated with higher odds of prescription fills, while deprivation quartile, history of myocardial infarction, history of heart failure, and age-adjusted Charlson comorbidity score were not significantly associated with medication fill.
Dr. Gasoyan told this news organization, “This study is unique in that we were able to look at patterns of use and barriers at several stages…We just recently published another study where we found patients weren’t often taking these medications long-term. So, patients are facing challenges on receiving obesity pharmacotherapy at several stages. …Hopefully these data will highlight the issues and inform future decisions. We see clear areas where we could obviously do better.”
Dr. Gasoyan had no disclosures. Dr. Sarwer received grant funding from the National Institutes of Health and declared having consulting relationships with NovoNordisk and Twenty30 Health.
A version of this article appeared on Medscape.com.
Socioeconomic factors and insurance type greatly influence the odds of a person with obesity receiving a prescription for a weight loss medication and subsequently filling it, new research finds.
The results come from a retrospective study of Florida and Ohio electronic health records of more than 50,000 adults with a body mass index (BMI) of ≥ 30 kg/m2 who sought care for obesity from 2015 through June 2023.
The fill rate increased to 26% in 2022-2023 after the newer glucagon-like peptide 1 (GLP-1) agonists became available, but the identified disparities persisted throughout, study author Hamlet Gasoyan, PhD, told this news organization. “Things are changing, but this study provides a very good picture of who’s getting prescriptions and the implications for policy decisions.”
Dr. Gasoyan, of the Center for Value-Based Care Research at the Cleveland Clinic, Cleveland, Ohio, noted that Medicare doesn’t currently cover antiobesity medications nor do most Medicaid programs (neither Florida’s nor Ohio’s do), but there is now at least one bill in Congress to change that. “Medicare and other government payers are currently facing important policy decisions about antiobesity medication coverage. I think they should consider how their policies could impact existing inequalities in obesity care.”
Another noteworthy finding, Dr. Gasoyan said, is that “despite all the recent hype, the real data shows these medications are underutilized and probably will remain so.”
Asked to comment, David B. Sarwer, PhD, Director of the Center for Obesity Research and Education at Temple University, Philadelphia, Pennsylvania, told this news organization, “there’s a tremendous amount of enthusiasm in the obesity treatment community that these newer medications have the potential to be game-changers. I think what this study shows us, as does other work from this group and others, is that we still have some significant issues around access to care and long-term engagement with these medications that we need to address for them to realize their full potential.”
Dr. Sarwer acknowledged, as did Dr. Gasoyan, that the study timing is a limitation and more data will need to be collected prospectively with the new incretin drugs. As of now, though, “These medications are very expensive. While there are some insurance plans that are offering payment for them, many are not. Until we wrestle that to the ground there are always going to be questions about whether these medications are getting to the people who need them the most. I think one of the highlights of this paper is it reminds us that obesity is a disease that differentially impacts persons from underserved groups.”
Moreover, Dr. Sarwer noted, “In this day and age, many physicians don’t have a lot of time to spend with individual patients. Conversations around weight can be challenging and often very emotional for patients. I’m not sure we’ve trained physicians how to have productive, targeted conversations that lead to effective use of a weight-loss intervention. Maybe in some ways that’s what we’re seeing here.”
Disparities Seen in Both Prescriptions and Fills
The 50,678 study subjects all not only met BMI criteria (≥ 30 kg/m2) but also attended at least one weight management program (n = 48,711) and/or received a weight-loss medication prescription (n = 4047). “We know BMI isn’t a perfect measure of obesity, so we specifically looked at where the patient or provider had identified excess weight as an issue and wanted to do something about it…You would expect that in this group the use of antiobesity medications would be high, but it wasn’t, unfortunately,” Dr. Gasoyan commented.
Participants had a mean BMI of 38 kg/m2 and mean age 50 years. Slightly more than half (54%) were women, 66% were White individuals, 24% Black individuals, and 5.3% Hispanic individuals. A majority (56%) had private insurance, and 41% had diabetes. Mean follow-up time was 4.7 years.
The main measures were prescriptions for naltrexone-bupropion, orlistat, phentermine-topiramate, 3.0 mg liraglutide, 2.4 mg semaglutide, and a fill for one of those during the study follow-up.
Overall, 8.0% had a new anti-obesity medication prescription, and of those, 55% had at least one documented fill of the prescription. Among the fills, 39% were for naltrexone-buproprion, 29% for phentermine-topiramate, 19% for semaglutide, 11% for liraglutide, and 1.2% for orlistat.
In the multivariable model, receipt of an antiobesity medication prescription was significantly less likely among Black patients (adjusted odds ratio, 0.68), Hispanic individuals (0.72), and those from other racial or ethnic backgrounds (0.70) than among White patients. Men had lower odds than women (0.38).
Compared with privately insured patients, significantly lower odds of receiving prescriptions were seen in those with Medicaid (0.44), traditional Medicare (0.35), Medicare Advantage (0.36), and self-paying (0.65) and other insurance types (0.53). Those in the highest quartile of economic disadvantage also had lower antiobesity medication prescription odds (0.81).
Also associated with lower prescription odds were younger age, higher age-adjusted Charlson comorbidity score, presence of diabetes diagnosis, and a history of myocardial infarction or heart failure.
Factors associated with lower odds of filling antiobesity medication prescriptions included Hispanic ethnicity vs White ethnicity (0.51) but not Black race. Compared with private insurance, lower odds of filling the prescriptions were seen among those with Medicaid (0.41), traditional Medicare (0.38), and Medicare Advantage (0.37).
Over the study period, compared with naltrexone-buproprion, phentermine-topiramate had higher odds of being filled (1.27), while liraglutide (0.61) and orlistat (0.11) had lower odds, and semaglutide didn’t differ significantly (0.90).
Older age, female sex, and the presence of diabetes diagnosis were associated with higher odds of prescription fills, while deprivation quartile, history of myocardial infarction, history of heart failure, and age-adjusted Charlson comorbidity score were not significantly associated with medication fill.
Dr. Gasoyan told this news organization, “This study is unique in that we were able to look at patterns of use and barriers at several stages…We just recently published another study where we found patients weren’t often taking these medications long-term. So, patients are facing challenges on receiving obesity pharmacotherapy at several stages. …Hopefully these data will highlight the issues and inform future decisions. We see clear areas where we could obviously do better.”
Dr. Gasoyan had no disclosures. Dr. Sarwer received grant funding from the National Institutes of Health and declared having consulting relationships with NovoNordisk and Twenty30 Health.
A version of this article appeared on Medscape.com.
Are You Giving Your Patients With T2D the Meds They Want?
Patients with type 2 diabetes and their clinicians may not share the same priorities when it comes to choosing a second-line drug after metformin, new research suggested.
Notably, most patients rated blindness and death as the most important health outcomes to avoid and efficacy in lowering blood glucose and A1c as the most important medication attributes. Avoidance of cardiovascular outcomes was ranked slightly lower. The data were published recently in Clinical Diabetes.
“We really need to ask our patients about what is important to them. That’s how you have a relationship and engage in shared decision-making,” lead author Rozalina G. McCoy, MD, Associate Division Chief for Clinical Research in the Division of Endocrinology, Diabetes, and Nutrition at the University of Maryland, Baltimore, told this news organization.
Patient education should be approached in that way, she added. “They might not think their diabetes is related to heart disease risk or that anything they do can impact it. That’s a conversation starter ... We first have to understand what motivates them and then tailor education to what is important to them,” she said.
Asked to comment, endocrinologist Cecilia C. Low Wang, MD, Professor of Medicine at the University of Colorado, Aurora, told this news organization, “the fact that death and blindness are key health outcomes in the patients surveyed indicates to me that patients place great importance on ‘irreversible’ bad outcomes. We as clinicians do not tend to discuss benefits for all-cause mortality with our diabetes medications. Maybe we should include this in our discussions.”
Dr. Low Wang also noted, as did Dr. McCoy, that the emphasis on lowering glucose reflects decades of public health messaging, and that while it’s certainly important, particularly for microvascular outcomes, it’s just one of several factors influencing cardiovascular and all-cause mortality risk.
“I think what this finding tells us is that we need to focus on a more nuanced message of improved glycemic control and reduction of risk of both micro- and macrovascular complications and weight management, healthy diet, and regular physical activity ... that it is not just glycemic control that is important but glycemic control in the context of a healthy lifestyle and good overall health,” Dr. Low Wang said.
Blindness and Death Bigger Concerns Than Heart Attack or Heart Failure
The study participants included 25 from the Mayo Health System in Rochester, Minnesota (where McCoy formerly worked), and 15 from Grady Memorial Hospital in Atlanta, Georgia. Half were White, and just over a third were Black. All had active prescriptions for a glucagon-like peptide 1 receptor agonist, sodium-glucose cotransporter 2 inhibitor, dipeptidyl peptidase 4 inhibitor, and/or a sulfonylurea.
They were first given a multistep ranking exercise regarding health outcomes and medication attributes selected from a list and then were asked to add any others that were important to them and re-ranked the entire list.
For health outcomes, the most common listed as “very important” were blindness (63%) and death (60%), followed by heart attack (48%) and heart failure (48%). Those endorsed less often were hospital admission (28%), severe hypoglycemia (25%), and pancreatitis (15%).
Dr. Low Wang noted, “Heart attack and heart failure and stroke were not far behind ... Maybe the messaging about risks of [atherosclerotic cardiovascular disease] in diabetes is working at least to some degree and in some populations.”
Combinations of outcomes selected as “very important” varied widely, with just one combination (end-stage kidney disease, heart attack, blindness, and any event causing death) endorsed by more than a single participant. This was unexpected, Dr. McCoy noted.
“Usually, a qualitative study is very small, so we thought 40 was huge and we’d see a lot of similar things, but I think the first surprising finding was just how much variability there is in what people with type 2 diabetes consider as motivating factors for choosing a diabetes medication ... So when we talk about patient-centered care and shared decision-making, that’s really important because patient priorities are very different,” she said.
For medication attributes, greater reductions in blood glucose and A1c were most often endorsed as “very important” (68%), followed by oral administration (45%) and absence of gastrointestinal side effects (38%).
Nearly half (47.5%) added one or more outcomes as important to them in deciding on a medication for type 2 diabetes. The most common had to do with affordability (n = 10), minimizing the total number of drugs (n = 3) and avoiding drowsiness (n = 2).
Dr. Low Wang said, “Some of the health outcomes we as clinicians feel are important, such as serious infection, hospitalization, kidney dysfunction or failure, and diabetic foot problems, were not felt to be as important to the patients surveyed. This could be due to other health outcomes outweighing these, or highlights the need for more focus, education, and discussion with patients.”
Five Themes Describe Patients’ Perceptions of Health Outcomes
Throughout the ranking process, a researcher asked participants (via phone or Zoom) about their reasons for ranking items as “very important” or “not very important” in choosing medications. For health outcomes, five broad themes emerged from their comments: The outcome’s severity (with permanence and potential lethality prominent), their perceived personal susceptibility to it, salience (ie, whether they knew someone who had experienced the outcome), their beliefs about causation, and about the consequences of the outcome.
With medication attributes, the medication’s ability to lower blood glucose was deemed a priority by nearly all. By contrast, there was much more variation in the responses regarding the influence of various side effects in their decision-making based on personal preferences, beliefs, and previous experiences.
This paper is one part of research funded by the Patient-Centered Outcomes Research Institute (PCORI) examining the effects of second-line glucose-lowering medications in patients with type 2 diabetes who are at moderate, rather than high, cardiovascular risk. The main paper, looking at prespecified cardiovascular outcomes, is scheduled to be published soon, Dr. McCoy said.
She’s now planning a follow-up study to look at actual outcomes for the second-line drugs based on the patients’ preferences. “We don’t have the evidence necessarily to tell our patients what is best given their specific preferences ... The question is, if our patients tell us what they want, how would that change what we recommend to them?”
The study was funded by PCORI. Dr. McCoy received support from the National Institutes of Health and AARP. She also served as a consultant to Emmi (Wolters Kluwer) for developing patient education materials related to prediabetes and diabetes. Dr. Low Wang received research support from Dexcom Inc, Virta Health, and CellResearch Corp within the past 24 months.
A version of this article appeared on Medscape.com.
Patients with type 2 diabetes and their clinicians may not share the same priorities when it comes to choosing a second-line drug after metformin, new research suggested.
Notably, most patients rated blindness and death as the most important health outcomes to avoid and efficacy in lowering blood glucose and A1c as the most important medication attributes. Avoidance of cardiovascular outcomes was ranked slightly lower. The data were published recently in Clinical Diabetes.
“We really need to ask our patients about what is important to them. That’s how you have a relationship and engage in shared decision-making,” lead author Rozalina G. McCoy, MD, Associate Division Chief for Clinical Research in the Division of Endocrinology, Diabetes, and Nutrition at the University of Maryland, Baltimore, told this news organization.
Patient education should be approached in that way, she added. “They might not think their diabetes is related to heart disease risk or that anything they do can impact it. That’s a conversation starter ... We first have to understand what motivates them and then tailor education to what is important to them,” she said.
Asked to comment, endocrinologist Cecilia C. Low Wang, MD, Professor of Medicine at the University of Colorado, Aurora, told this news organization, “the fact that death and blindness are key health outcomes in the patients surveyed indicates to me that patients place great importance on ‘irreversible’ bad outcomes. We as clinicians do not tend to discuss benefits for all-cause mortality with our diabetes medications. Maybe we should include this in our discussions.”
Dr. Low Wang also noted, as did Dr. McCoy, that the emphasis on lowering glucose reflects decades of public health messaging, and that while it’s certainly important, particularly for microvascular outcomes, it’s just one of several factors influencing cardiovascular and all-cause mortality risk.
“I think what this finding tells us is that we need to focus on a more nuanced message of improved glycemic control and reduction of risk of both micro- and macrovascular complications and weight management, healthy diet, and regular physical activity ... that it is not just glycemic control that is important but glycemic control in the context of a healthy lifestyle and good overall health,” Dr. Low Wang said.
Blindness and Death Bigger Concerns Than Heart Attack or Heart Failure
The study participants included 25 from the Mayo Health System in Rochester, Minnesota (where McCoy formerly worked), and 15 from Grady Memorial Hospital in Atlanta, Georgia. Half were White, and just over a third were Black. All had active prescriptions for a glucagon-like peptide 1 receptor agonist, sodium-glucose cotransporter 2 inhibitor, dipeptidyl peptidase 4 inhibitor, and/or a sulfonylurea.
They were first given a multistep ranking exercise regarding health outcomes and medication attributes selected from a list and then were asked to add any others that were important to them and re-ranked the entire list.
For health outcomes, the most common listed as “very important” were blindness (63%) and death (60%), followed by heart attack (48%) and heart failure (48%). Those endorsed less often were hospital admission (28%), severe hypoglycemia (25%), and pancreatitis (15%).
Dr. Low Wang noted, “Heart attack and heart failure and stroke were not far behind ... Maybe the messaging about risks of [atherosclerotic cardiovascular disease] in diabetes is working at least to some degree and in some populations.”
Combinations of outcomes selected as “very important” varied widely, with just one combination (end-stage kidney disease, heart attack, blindness, and any event causing death) endorsed by more than a single participant. This was unexpected, Dr. McCoy noted.
“Usually, a qualitative study is very small, so we thought 40 was huge and we’d see a lot of similar things, but I think the first surprising finding was just how much variability there is in what people with type 2 diabetes consider as motivating factors for choosing a diabetes medication ... So when we talk about patient-centered care and shared decision-making, that’s really important because patient priorities are very different,” she said.
For medication attributes, greater reductions in blood glucose and A1c were most often endorsed as “very important” (68%), followed by oral administration (45%) and absence of gastrointestinal side effects (38%).
Nearly half (47.5%) added one or more outcomes as important to them in deciding on a medication for type 2 diabetes. The most common had to do with affordability (n = 10), minimizing the total number of drugs (n = 3) and avoiding drowsiness (n = 2).
Dr. Low Wang said, “Some of the health outcomes we as clinicians feel are important, such as serious infection, hospitalization, kidney dysfunction or failure, and diabetic foot problems, were not felt to be as important to the patients surveyed. This could be due to other health outcomes outweighing these, or highlights the need for more focus, education, and discussion with patients.”
Five Themes Describe Patients’ Perceptions of Health Outcomes
Throughout the ranking process, a researcher asked participants (via phone or Zoom) about their reasons for ranking items as “very important” or “not very important” in choosing medications. For health outcomes, five broad themes emerged from their comments: The outcome’s severity (with permanence and potential lethality prominent), their perceived personal susceptibility to it, salience (ie, whether they knew someone who had experienced the outcome), their beliefs about causation, and about the consequences of the outcome.
With medication attributes, the medication’s ability to lower blood glucose was deemed a priority by nearly all. By contrast, there was much more variation in the responses regarding the influence of various side effects in their decision-making based on personal preferences, beliefs, and previous experiences.
This paper is one part of research funded by the Patient-Centered Outcomes Research Institute (PCORI) examining the effects of second-line glucose-lowering medications in patients with type 2 diabetes who are at moderate, rather than high, cardiovascular risk. The main paper, looking at prespecified cardiovascular outcomes, is scheduled to be published soon, Dr. McCoy said.
She’s now planning a follow-up study to look at actual outcomes for the second-line drugs based on the patients’ preferences. “We don’t have the evidence necessarily to tell our patients what is best given their specific preferences ... The question is, if our patients tell us what they want, how would that change what we recommend to them?”
The study was funded by PCORI. Dr. McCoy received support from the National Institutes of Health and AARP. She also served as a consultant to Emmi (Wolters Kluwer) for developing patient education materials related to prediabetes and diabetes. Dr. Low Wang received research support from Dexcom Inc, Virta Health, and CellResearch Corp within the past 24 months.
A version of this article appeared on Medscape.com.
Patients with type 2 diabetes and their clinicians may not share the same priorities when it comes to choosing a second-line drug after metformin, new research suggested.
Notably, most patients rated blindness and death as the most important health outcomes to avoid and efficacy in lowering blood glucose and A1c as the most important medication attributes. Avoidance of cardiovascular outcomes was ranked slightly lower. The data were published recently in Clinical Diabetes.
“We really need to ask our patients about what is important to them. That’s how you have a relationship and engage in shared decision-making,” lead author Rozalina G. McCoy, MD, Associate Division Chief for Clinical Research in the Division of Endocrinology, Diabetes, and Nutrition at the University of Maryland, Baltimore, told this news organization.
Patient education should be approached in that way, she added. “They might not think their diabetes is related to heart disease risk or that anything they do can impact it. That’s a conversation starter ... We first have to understand what motivates them and then tailor education to what is important to them,” she said.
Asked to comment, endocrinologist Cecilia C. Low Wang, MD, Professor of Medicine at the University of Colorado, Aurora, told this news organization, “the fact that death and blindness are key health outcomes in the patients surveyed indicates to me that patients place great importance on ‘irreversible’ bad outcomes. We as clinicians do not tend to discuss benefits for all-cause mortality with our diabetes medications. Maybe we should include this in our discussions.”
Dr. Low Wang also noted, as did Dr. McCoy, that the emphasis on lowering glucose reflects decades of public health messaging, and that while it’s certainly important, particularly for microvascular outcomes, it’s just one of several factors influencing cardiovascular and all-cause mortality risk.
“I think what this finding tells us is that we need to focus on a more nuanced message of improved glycemic control and reduction of risk of both micro- and macrovascular complications and weight management, healthy diet, and regular physical activity ... that it is not just glycemic control that is important but glycemic control in the context of a healthy lifestyle and good overall health,” Dr. Low Wang said.
Blindness and Death Bigger Concerns Than Heart Attack or Heart Failure
The study participants included 25 from the Mayo Health System in Rochester, Minnesota (where McCoy formerly worked), and 15 from Grady Memorial Hospital in Atlanta, Georgia. Half were White, and just over a third were Black. All had active prescriptions for a glucagon-like peptide 1 receptor agonist, sodium-glucose cotransporter 2 inhibitor, dipeptidyl peptidase 4 inhibitor, and/or a sulfonylurea.
They were first given a multistep ranking exercise regarding health outcomes and medication attributes selected from a list and then were asked to add any others that were important to them and re-ranked the entire list.
For health outcomes, the most common listed as “very important” were blindness (63%) and death (60%), followed by heart attack (48%) and heart failure (48%). Those endorsed less often were hospital admission (28%), severe hypoglycemia (25%), and pancreatitis (15%).
Dr. Low Wang noted, “Heart attack and heart failure and stroke were not far behind ... Maybe the messaging about risks of [atherosclerotic cardiovascular disease] in diabetes is working at least to some degree and in some populations.”
Combinations of outcomes selected as “very important” varied widely, with just one combination (end-stage kidney disease, heart attack, blindness, and any event causing death) endorsed by more than a single participant. This was unexpected, Dr. McCoy noted.
“Usually, a qualitative study is very small, so we thought 40 was huge and we’d see a lot of similar things, but I think the first surprising finding was just how much variability there is in what people with type 2 diabetes consider as motivating factors for choosing a diabetes medication ... So when we talk about patient-centered care and shared decision-making, that’s really important because patient priorities are very different,” she said.
For medication attributes, greater reductions in blood glucose and A1c were most often endorsed as “very important” (68%), followed by oral administration (45%) and absence of gastrointestinal side effects (38%).
Nearly half (47.5%) added one or more outcomes as important to them in deciding on a medication for type 2 diabetes. The most common had to do with affordability (n = 10), minimizing the total number of drugs (n = 3) and avoiding drowsiness (n = 2).
Dr. Low Wang said, “Some of the health outcomes we as clinicians feel are important, such as serious infection, hospitalization, kidney dysfunction or failure, and diabetic foot problems, were not felt to be as important to the patients surveyed. This could be due to other health outcomes outweighing these, or highlights the need for more focus, education, and discussion with patients.”
Five Themes Describe Patients’ Perceptions of Health Outcomes
Throughout the ranking process, a researcher asked participants (via phone or Zoom) about their reasons for ranking items as “very important” or “not very important” in choosing medications. For health outcomes, five broad themes emerged from their comments: The outcome’s severity (with permanence and potential lethality prominent), their perceived personal susceptibility to it, salience (ie, whether they knew someone who had experienced the outcome), their beliefs about causation, and about the consequences of the outcome.
With medication attributes, the medication’s ability to lower blood glucose was deemed a priority by nearly all. By contrast, there was much more variation in the responses regarding the influence of various side effects in their decision-making based on personal preferences, beliefs, and previous experiences.
This paper is one part of research funded by the Patient-Centered Outcomes Research Institute (PCORI) examining the effects of second-line glucose-lowering medications in patients with type 2 diabetes who are at moderate, rather than high, cardiovascular risk. The main paper, looking at prespecified cardiovascular outcomes, is scheduled to be published soon, Dr. McCoy said.
She’s now planning a follow-up study to look at actual outcomes for the second-line drugs based on the patients’ preferences. “We don’t have the evidence necessarily to tell our patients what is best given their specific preferences ... The question is, if our patients tell us what they want, how would that change what we recommend to them?”
The study was funded by PCORI. Dr. McCoy received support from the National Institutes of Health and AARP. She also served as a consultant to Emmi (Wolters Kluwer) for developing patient education materials related to prediabetes and diabetes. Dr. Low Wang received research support from Dexcom Inc, Virta Health, and CellResearch Corp within the past 24 months.
A version of this article appeared on Medscape.com.
Hypocalcemia Risk Warning Added to Osteoporosis Drug
The US Food and Drug Administration (FDA) has added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) about increased risk for severe hypocalcemia in patients with advanced chronic kidney disease (CKD).
Denosumab is a monoclonal antibody, indicated for the treatment of postmenopausal women with osteoporosis who are at increased risk for fracture for whom other treatments aren’t effective or can’t be tolerated. It’s also indicated to increase bone mass in men with osteoporosis at high risk for fracture, treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, increase bone mass in men at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer, and increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
This new warning updates a November 2022 alert based on preliminary evidence for a “substantial risk” for hypocalcemia in patients with CKD on dialysis.
Upon further examination of the data from two trials including more than 500,000 denosumab-treated women with CKD, the FDA concluded that severe hypocalcemia appears to be more common in those with CKD who also have mineral and bone disorder (CKD-MBD). And, for patients with advanced CKD taking denosumab, “severe hypocalcemia resulted in serious harm, including hospitalization, life-threatening events, and death.”
Most of the severe hypocalcemia events occurred 2-10 weeks after denosumab injection, with the greatest risk during weeks 2-5.
The new warning advises healthcare professionals to assess patients’ kidney function before prescribing denosumab, and for those with advanced CKD, “consider the risk of severe hypocalcemia with Prolia in the context of other available treatments for osteoporosis.”
If the drug is still being considered for those patients for initial or continued use, calcium blood levels should be checked, and patients should be evaluated for CKD-MBD. Prior to prescribing denosumab in these patients, CKD-MBD should be properly managed, hypocalcemia corrected, and patients supplemented with calcium and activated vitamin D to decrease the risk for severe hypocalcemia and associated complications.
“Treatment with denosumab in patients with advanced CKD, including those on dialysis, and particularly patients with diagnosed CKD-MBD should involve a health care provider with expertise in the diagnosis and management of CKD-MBD,” the FDA advises.
Once denosumab is administered, close monitoring of blood calcium levels and prompt hypocalcemia management is essential to prevent complications including seizures or arrythmias. Patients should be advised to promptly report symptoms that could be consistent with hypocalcemia, including confusion, seizures, irregular heartbeat, fainting, muscle spasms or weakness, face twitching, tingling, or numbness anywhere in the body.
In 2022, an estimated 2.2 million Prolia prefilled syringes were sold by the manufacturer to US healthcare settings.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) about increased risk for severe hypocalcemia in patients with advanced chronic kidney disease (CKD).
Denosumab is a monoclonal antibody, indicated for the treatment of postmenopausal women with osteoporosis who are at increased risk for fracture for whom other treatments aren’t effective or can’t be tolerated. It’s also indicated to increase bone mass in men with osteoporosis at high risk for fracture, treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, increase bone mass in men at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer, and increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
This new warning updates a November 2022 alert based on preliminary evidence for a “substantial risk” for hypocalcemia in patients with CKD on dialysis.
Upon further examination of the data from two trials including more than 500,000 denosumab-treated women with CKD, the FDA concluded that severe hypocalcemia appears to be more common in those with CKD who also have mineral and bone disorder (CKD-MBD). And, for patients with advanced CKD taking denosumab, “severe hypocalcemia resulted in serious harm, including hospitalization, life-threatening events, and death.”
Most of the severe hypocalcemia events occurred 2-10 weeks after denosumab injection, with the greatest risk during weeks 2-5.
The new warning advises healthcare professionals to assess patients’ kidney function before prescribing denosumab, and for those with advanced CKD, “consider the risk of severe hypocalcemia with Prolia in the context of other available treatments for osteoporosis.”
If the drug is still being considered for those patients for initial or continued use, calcium blood levels should be checked, and patients should be evaluated for CKD-MBD. Prior to prescribing denosumab in these patients, CKD-MBD should be properly managed, hypocalcemia corrected, and patients supplemented with calcium and activated vitamin D to decrease the risk for severe hypocalcemia and associated complications.
“Treatment with denosumab in patients with advanced CKD, including those on dialysis, and particularly patients with diagnosed CKD-MBD should involve a health care provider with expertise in the diagnosis and management of CKD-MBD,” the FDA advises.
Once denosumab is administered, close monitoring of blood calcium levels and prompt hypocalcemia management is essential to prevent complications including seizures or arrythmias. Patients should be advised to promptly report symptoms that could be consistent with hypocalcemia, including confusion, seizures, irregular heartbeat, fainting, muscle spasms or weakness, face twitching, tingling, or numbness anywhere in the body.
In 2022, an estimated 2.2 million Prolia prefilled syringes were sold by the manufacturer to US healthcare settings.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) about increased risk for severe hypocalcemia in patients with advanced chronic kidney disease (CKD).
Denosumab is a monoclonal antibody, indicated for the treatment of postmenopausal women with osteoporosis who are at increased risk for fracture for whom other treatments aren’t effective or can’t be tolerated. It’s also indicated to increase bone mass in men with osteoporosis at high risk for fracture, treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, increase bone mass in men at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer, and increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
This new warning updates a November 2022 alert based on preliminary evidence for a “substantial risk” for hypocalcemia in patients with CKD on dialysis.
Upon further examination of the data from two trials including more than 500,000 denosumab-treated women with CKD, the FDA concluded that severe hypocalcemia appears to be more common in those with CKD who also have mineral and bone disorder (CKD-MBD). And, for patients with advanced CKD taking denosumab, “severe hypocalcemia resulted in serious harm, including hospitalization, life-threatening events, and death.”
Most of the severe hypocalcemia events occurred 2-10 weeks after denosumab injection, with the greatest risk during weeks 2-5.
The new warning advises healthcare professionals to assess patients’ kidney function before prescribing denosumab, and for those with advanced CKD, “consider the risk of severe hypocalcemia with Prolia in the context of other available treatments for osteoporosis.”
If the drug is still being considered for those patients for initial or continued use, calcium blood levels should be checked, and patients should be evaluated for CKD-MBD. Prior to prescribing denosumab in these patients, CKD-MBD should be properly managed, hypocalcemia corrected, and patients supplemented with calcium and activated vitamin D to decrease the risk for severe hypocalcemia and associated complications.
“Treatment with denosumab in patients with advanced CKD, including those on dialysis, and particularly patients with diagnosed CKD-MBD should involve a health care provider with expertise in the diagnosis and management of CKD-MBD,” the FDA advises.
Once denosumab is administered, close monitoring of blood calcium levels and prompt hypocalcemia management is essential to prevent complications including seizures or arrythmias. Patients should be advised to promptly report symptoms that could be consistent with hypocalcemia, including confusion, seizures, irregular heartbeat, fainting, muscle spasms or weakness, face twitching, tingling, or numbness anywhere in the body.
In 2022, an estimated 2.2 million Prolia prefilled syringes were sold by the manufacturer to US healthcare settings.
A version of this article appeared on Medscape.com.