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Plant-based diets not always healthy; quality is key
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Osteoporosis drugs may extend life after fracture
Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.
The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.
“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.
The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.
Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”
“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.
“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.
“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.
Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.
He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.
“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.
But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
‘Denosumab is a more potent antiresorptive than bisphosphonates’
Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.
Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.
Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.
After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.
Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.
Similar results were found for hip and vertebral fractures analyzed individually.
Women had a lower mortality risk than men.
Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.
Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”
The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.
The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.
“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.
The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.
Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”
“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.
“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.
“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.
Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.
He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.
“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.
But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
‘Denosumab is a more potent antiresorptive than bisphosphonates’
Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.
Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.
Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.
After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.
Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.
Similar results were found for hip and vertebral fractures analyzed individually.
Women had a lower mortality risk than men.
Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.
Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”
The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.
The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.
“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.
The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.
Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”
“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.
“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.
“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.
Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.
He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.
“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.
But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
‘Denosumab is a more potent antiresorptive than bisphosphonates’
Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.
Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.
Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.
After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.
Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.
Similar results were found for hip and vertebral fractures analyzed individually.
Women had a lower mortality risk than men.
Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.
Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”
The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Tooth loss and diabetes together hasten mental decline
most specifically in those 65-74 years of age, new findings suggest.
The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.
“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.
Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”
Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.
The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.
The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.
Diabetes, edentulism, and cognitive decline
The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.
They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.
Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”
The condition of having no teeth is known as edentulism.
The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).
Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).
In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).
Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).
“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
Study limitations: Better data needed
The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.
“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.
Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.
Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”
The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
most specifically in those 65-74 years of age, new findings suggest.
The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.
“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.
Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”
Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.
The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.
The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.
Diabetes, edentulism, and cognitive decline
The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.
They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.
Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”
The condition of having no teeth is known as edentulism.
The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).
Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).
In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).
Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).
“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
Study limitations: Better data needed
The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.
“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.
Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.
Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”
The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
most specifically in those 65-74 years of age, new findings suggest.
The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.
“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.
Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”
Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.
The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.
The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.
Diabetes, edentulism, and cognitive decline
The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.
They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.
Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”
The condition of having no teeth is known as edentulism.
The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).
Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).
In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).
Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).
“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
Study limitations: Better data needed
The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.
“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.
Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.
Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”
The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF DENTAL RESEARCH
Holy smoke: Air pollution link to bone damage confirmed
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
FROM ECLINICALMEDICINE
Artificial pancreas ‘superior’ in young kids with type 1 diabetes
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
High caffeine levels may lower body fat, type 2 diabetes risks
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BMJ MEDICINE
Treat together: Tackle heart disease and obesity simultaneously
say the authors of a new state-of-the-art review.
“CVD and obesity are common conditions that frequently coexist. We cannot treat one of these conditions while ignoring the other,” Rosana G. Bianchettin, MD, of the division of cardiovascular diseases, Mayo Clinic, Rochester, Minn., and colleagues wrote in their review, recently published in the Journal of the American College of Cardiology.
The review outlines, for example, how obesity can impair common imaging tests used to diagnose heart disease, potentially reducing their accuracy.
And cardiac procedures such as percutaneous coronary intervention, open heart surgery, and revascularization all involve greater risk in the setting of obesity, while procedures such as valve replacement and heart transplantation carry a greater likelihood of failure.
Obesity can also alter drug pharmacokinetics and pharmacodynamics.
Weight reduction is an important part of the management of patients with cardiovascular disease and obesity, and “cardiac rehabilitation programs represent a potential opportunity for structured interventions,” the authors noted. However, “when other measures are insufficient, bariatric surgery can improve outcomes.”
They also advised against relying solely on body mass index (BMI) to assess adiposity: “It is prudent to investigate a range of complementary ... parameters alongside standard BMI calculations (accounting for age, race, and sex), including measures of central obesity, such as waist circumference, waist-to-hip ratio, and weight-to-height ratio.”
Excess fat acts as filter and can skew diagnostic results
“Obesity affects nearly all the diagnostic tests used in cardiology, such as ECG, CT scan, MRI, and echocardiogram,” senior author Francisco Lopez-Jimenez, MD, director of preventive cardiology at Mayo Clinic, explained in a statement.
The review includes a detailed table of these key obesity-related challenges. With electrocardiograms, for example, obesity can cause displacement of the heart, increased cardiac workload, and widening of the distance between the heart and the recording electrodes.
Obesity also lowers the sensitivity of exercise echocardiography, and use of CT coronary angiogram is completely precluded in people with a BMI above 40 kg/m2. In interventional radiology, there may be poor visualization of target areas.
“Excess fat acts as a kind of filter and can skew test readings to under- or overdiagnosis,” noted Dr. Lopez-Jimenez.
Therapeutic challenges: Drugs may work differently
A longer table in the review summarizes the therapeutic challenges involved in lifestyle modification, pharmacology, cardiac procedures, and other therapeutic measures for people with the two conditions.
Obesity can limit a person’s ability to exercise, for example, and smoking cessation may promote overeating and further weight gain.
Moreover, “tailoring pharmacotherapy is difficult because of unique pharmacokinetic and pharmacodynamic factors in people with obesity that alter distribution, metabolism, and elimination of drugs. Each drug also has special properties that must be considered when it is administrated,” the authors wrote.
Examples include the higher volume of distribution of lipophilic drugs in those with increased fat mass, alterations in liver metabolism, and difficulties with anticoagulant dosing.
Cardiac rehabilitation is an intervention opportunity
Although cardiac rehabilitation is “a cornerstone in secondary prevention” for people who have experienced a cardiac event, only 8% of such programs include formal in-house behavioral weight-loss programs.
But that could be remedied and expanded with the use of options such as home-based rehabilitation and telephone counseling, particularly in rural communities, Dr. Bianchettin and colleagues said.
“Motivated individuals will benefit from multicomponent approaches and should be encouraged to set specific, proximal, shared goals with their health care professional. A multitude of tools are available to support self-monitoring (e.g., smartphone applications, food diaries), and scheduled regular follow-up and feedback on progress can help to maintain motivation,” they wrote.
The bottom line, said Dr. Lopez-Jimenez: “Obesity is an important risk factor to address in patients with heart disease and it requires us to do something. ... The patient needs to know that their clinician can help them lose weight. Overall, weight-loss solutions come down to finding the right therapy for the patient.”
Dr. Bianchettin reported no relevant financial relationships. Dr. Lopez-Jimenez has reported conducting research related to 3D body assessment with Select Research, Mayo Clinic, and may benefit in the future if the technology is commercialized; he has not received any relevant monetary, financial, or other type of compensation to date, in relationship to this arrangement. He is a member of the scientific advisory board for Novo Nordisk.
A version of this article first appeared on Medscape.com.
say the authors of a new state-of-the-art review.
“CVD and obesity are common conditions that frequently coexist. We cannot treat one of these conditions while ignoring the other,” Rosana G. Bianchettin, MD, of the division of cardiovascular diseases, Mayo Clinic, Rochester, Minn., and colleagues wrote in their review, recently published in the Journal of the American College of Cardiology.
The review outlines, for example, how obesity can impair common imaging tests used to diagnose heart disease, potentially reducing their accuracy.
And cardiac procedures such as percutaneous coronary intervention, open heart surgery, and revascularization all involve greater risk in the setting of obesity, while procedures such as valve replacement and heart transplantation carry a greater likelihood of failure.
Obesity can also alter drug pharmacokinetics and pharmacodynamics.
Weight reduction is an important part of the management of patients with cardiovascular disease and obesity, and “cardiac rehabilitation programs represent a potential opportunity for structured interventions,” the authors noted. However, “when other measures are insufficient, bariatric surgery can improve outcomes.”
They also advised against relying solely on body mass index (BMI) to assess adiposity: “It is prudent to investigate a range of complementary ... parameters alongside standard BMI calculations (accounting for age, race, and sex), including measures of central obesity, such as waist circumference, waist-to-hip ratio, and weight-to-height ratio.”
Excess fat acts as filter and can skew diagnostic results
“Obesity affects nearly all the diagnostic tests used in cardiology, such as ECG, CT scan, MRI, and echocardiogram,” senior author Francisco Lopez-Jimenez, MD, director of preventive cardiology at Mayo Clinic, explained in a statement.
The review includes a detailed table of these key obesity-related challenges. With electrocardiograms, for example, obesity can cause displacement of the heart, increased cardiac workload, and widening of the distance between the heart and the recording electrodes.
Obesity also lowers the sensitivity of exercise echocardiography, and use of CT coronary angiogram is completely precluded in people with a BMI above 40 kg/m2. In interventional radiology, there may be poor visualization of target areas.
“Excess fat acts as a kind of filter and can skew test readings to under- or overdiagnosis,” noted Dr. Lopez-Jimenez.
Therapeutic challenges: Drugs may work differently
A longer table in the review summarizes the therapeutic challenges involved in lifestyle modification, pharmacology, cardiac procedures, and other therapeutic measures for people with the two conditions.
Obesity can limit a person’s ability to exercise, for example, and smoking cessation may promote overeating and further weight gain.
Moreover, “tailoring pharmacotherapy is difficult because of unique pharmacokinetic and pharmacodynamic factors in people with obesity that alter distribution, metabolism, and elimination of drugs. Each drug also has special properties that must be considered when it is administrated,” the authors wrote.
Examples include the higher volume of distribution of lipophilic drugs in those with increased fat mass, alterations in liver metabolism, and difficulties with anticoagulant dosing.
Cardiac rehabilitation is an intervention opportunity
Although cardiac rehabilitation is “a cornerstone in secondary prevention” for people who have experienced a cardiac event, only 8% of such programs include formal in-house behavioral weight-loss programs.
But that could be remedied and expanded with the use of options such as home-based rehabilitation and telephone counseling, particularly in rural communities, Dr. Bianchettin and colleagues said.
“Motivated individuals will benefit from multicomponent approaches and should be encouraged to set specific, proximal, shared goals with their health care professional. A multitude of tools are available to support self-monitoring (e.g., smartphone applications, food diaries), and scheduled regular follow-up and feedback on progress can help to maintain motivation,” they wrote.
The bottom line, said Dr. Lopez-Jimenez: “Obesity is an important risk factor to address in patients with heart disease and it requires us to do something. ... The patient needs to know that their clinician can help them lose weight. Overall, weight-loss solutions come down to finding the right therapy for the patient.”
Dr. Bianchettin reported no relevant financial relationships. Dr. Lopez-Jimenez has reported conducting research related to 3D body assessment with Select Research, Mayo Clinic, and may benefit in the future if the technology is commercialized; he has not received any relevant monetary, financial, or other type of compensation to date, in relationship to this arrangement. He is a member of the scientific advisory board for Novo Nordisk.
A version of this article first appeared on Medscape.com.
say the authors of a new state-of-the-art review.
“CVD and obesity are common conditions that frequently coexist. We cannot treat one of these conditions while ignoring the other,” Rosana G. Bianchettin, MD, of the division of cardiovascular diseases, Mayo Clinic, Rochester, Minn., and colleagues wrote in their review, recently published in the Journal of the American College of Cardiology.
The review outlines, for example, how obesity can impair common imaging tests used to diagnose heart disease, potentially reducing their accuracy.
And cardiac procedures such as percutaneous coronary intervention, open heart surgery, and revascularization all involve greater risk in the setting of obesity, while procedures such as valve replacement and heart transplantation carry a greater likelihood of failure.
Obesity can also alter drug pharmacokinetics and pharmacodynamics.
Weight reduction is an important part of the management of patients with cardiovascular disease and obesity, and “cardiac rehabilitation programs represent a potential opportunity for structured interventions,” the authors noted. However, “when other measures are insufficient, bariatric surgery can improve outcomes.”
They also advised against relying solely on body mass index (BMI) to assess adiposity: “It is prudent to investigate a range of complementary ... parameters alongside standard BMI calculations (accounting for age, race, and sex), including measures of central obesity, such as waist circumference, waist-to-hip ratio, and weight-to-height ratio.”
Excess fat acts as filter and can skew diagnostic results
“Obesity affects nearly all the diagnostic tests used in cardiology, such as ECG, CT scan, MRI, and echocardiogram,” senior author Francisco Lopez-Jimenez, MD, director of preventive cardiology at Mayo Clinic, explained in a statement.
The review includes a detailed table of these key obesity-related challenges. With electrocardiograms, for example, obesity can cause displacement of the heart, increased cardiac workload, and widening of the distance between the heart and the recording electrodes.
Obesity also lowers the sensitivity of exercise echocardiography, and use of CT coronary angiogram is completely precluded in people with a BMI above 40 kg/m2. In interventional radiology, there may be poor visualization of target areas.
“Excess fat acts as a kind of filter and can skew test readings to under- or overdiagnosis,” noted Dr. Lopez-Jimenez.
Therapeutic challenges: Drugs may work differently
A longer table in the review summarizes the therapeutic challenges involved in lifestyle modification, pharmacology, cardiac procedures, and other therapeutic measures for people with the two conditions.
Obesity can limit a person’s ability to exercise, for example, and smoking cessation may promote overeating and further weight gain.
Moreover, “tailoring pharmacotherapy is difficult because of unique pharmacokinetic and pharmacodynamic factors in people with obesity that alter distribution, metabolism, and elimination of drugs. Each drug also has special properties that must be considered when it is administrated,” the authors wrote.
Examples include the higher volume of distribution of lipophilic drugs in those with increased fat mass, alterations in liver metabolism, and difficulties with anticoagulant dosing.
Cardiac rehabilitation is an intervention opportunity
Although cardiac rehabilitation is “a cornerstone in secondary prevention” for people who have experienced a cardiac event, only 8% of such programs include formal in-house behavioral weight-loss programs.
But that could be remedied and expanded with the use of options such as home-based rehabilitation and telephone counseling, particularly in rural communities, Dr. Bianchettin and colleagues said.
“Motivated individuals will benefit from multicomponent approaches and should be encouraged to set specific, proximal, shared goals with their health care professional. A multitude of tools are available to support self-monitoring (e.g., smartphone applications, food diaries), and scheduled regular follow-up and feedback on progress can help to maintain motivation,” they wrote.
The bottom line, said Dr. Lopez-Jimenez: “Obesity is an important risk factor to address in patients with heart disease and it requires us to do something. ... The patient needs to know that their clinician can help them lose weight. Overall, weight-loss solutions come down to finding the right therapy for the patient.”
Dr. Bianchettin reported no relevant financial relationships. Dr. Lopez-Jimenez has reported conducting research related to 3D body assessment with Select Research, Mayo Clinic, and may benefit in the future if the technology is commercialized; he has not received any relevant monetary, financial, or other type of compensation to date, in relationship to this arrangement. He is a member of the scientific advisory board for Novo Nordisk.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
New documentary highlights human toll of high insulin cost
A new documentary premiering at the 2023 South by Southwest (SXSW) Festival illustrates the human consequences of insulin’s high cost in the United States. Its creators hope that it will help spur action toward overall prescription pricing reform.
Pay or Die: A Documentary is scheduled to premiere March 11. It will be shown twice more during the festival, which runs from March 10 to 19 in Austin, Texas. The documentary was co-created and directed by filmmaker and cinematographer Scott Alexander Ruderman, who has type 1 diabetes, and his partner, producer and journalist Rachael Dyer. One of the executive producers is Sarah Silverman, a comic, actor, producer, and health care reform advocate.
The 90-minute film follows three human stories: A mother and young daughter who both have type 1 diabetes and become homeless after spending their rent money on insulin, a young adult diagnosed during the COVID-19 pandemic, and a mother whose 26-year-old son died from diabetic ketoacidosis (DKA) after his insulin was rationed.
“As an Australian now living in the U.S. and seeing how the health care system works here, especially for people with type 1 diabetes like Scott, and how access to insulin is a life-or-death situation, has been very eye-opening for me. I’m also half Canadian, and both are countries where access to health care is a human right, not a business,” Ms. Dyer said in an interview.
In response to the March 1 announcement from Eli Lilly about its insulin price cut, the film’s team told this news organization: “While we commend Eli Lilly in taking this first step and hope that Novo Nordisk and Sanofi [the two other major insulin manufacturers] follow suit, it is important to remember that the key issue is not about these companies voluntarily slashing prices; it’s about changing laws so the insulin manufacturers do not have the ability to raise the prices again.
“This is the life-or-death issue that we focus on in our documentary Pay or Die. It’s also important to note that insulin is just one of the many expensive prescription drugs in the U.S., which is why we need to call for reform. Affordable medication needs to be a basic human right within reach for all Americans.”
Physician perspective: Good news on insulin, but broader issues
The film features four physicians. One, Mayo Clinic oncologist/hematologist S. Vincent Rajkumar, MD, has spoken and published widely on insulin prices specifically and U.S. drug costs more broadly.
The other three are Joslin Clinic endocrinologist Elizabeth Halprin, MD, Massachusetts General Hospital internist Leigh Simmons, MD, and New York University physician and essayist Danielle Ofri, MD, PhD.
In an interview after the Lilly announcement, Dr. Rajkumar said, “I think this is very, very good news for patients. ... The fact that they’re doing it means they’re listening to us and listening to patients, which is good. And I do hope that other insulin manufacturers do the same shortly.”
However, he added, “for prescription drug prices and particularly cancer drug prices, there’s more reform that’s needed, and that’s at the policy level. ... The goal of the film was to use insulin to highlight the prescription drug price problem in the U.S.”
‘Then life changed’
The filmmaker, Mr. Ruderman, was diagnosed at age 19, during his freshman year in college. He spent several days hospitalized with DKA, and “then life changed,” he said in an interview. He went into photography first and later filmmaking, always with the uneasy knowledge that he could lose access to insulin at any time.
The impetus for the film came after he and Ms. Dyer walked into a pharmacy while visiting Canada in 2018 and discovered how much cheaper insulin was compared to the United States – roughly $20 per vial, compared to $300 in the U.S.
“When Rachael [Dyer] and I came back to the U.S., we were actually quite shocked about how many people are struggling to afford their medication ... the uninsured, those aging off their parents’ health insurance. So that was really the kickoff to us going into the field for the last 4 years making this documentary.”
As a freelancer, Mr. Ruderman has been personally paying for expensive “premium” health insurance that covers the pump and glucose monitors he uses. He buys insulin overseas as often as possible.
“Fortunately, I haven’t been in a situation where I’ve had to ration my insulin, but the fear is instilled in me. What if there’s a month when I can’t afford it? What am I going to do?” (Note: The writer of this article is in the same situation, which could be alleviated by Lilly’s action.)
Timing is everything
To be sure, even before Lilly’s announcement, some progress had been made since work on the film began.
The issue of insulin pricing has received wide media attention. More than 20 states have passed copay caps on insulin, and a new law capping the cost of insulin for Medicare beneficiaries at $35/month went into effect in January 2023. President Biden mentioned insulin during his State of the Union address, and Georgia Senator Raphael Warnock made the issue a centerpiece of his campaign.
But there have also been losses, including the failure thus far to pass a nationwide copay cap.
These recent developments make this a good time for the film’s debut, producer Yael Melamede said in an interview. “There’s a lot happening in the space, but also a lot of incredible disappointments along the way, so we are really interested in getting this film out now.”
Ms. Melamede, who owns a film production company, said, “I’ve done a lot of films that have some issue advocacy side to them. I love this film because it’s grounded in the stories of real people. ... We feel this is a perfect catalyst to keep the energy going and for people to say this is super-important and not get distracted.”
While the film doesn’t advocate for specific policies, there is a “call to action” at the end that points viewers to resources on the website for writing to their members of Congress along with additional ways to become personally involved.
Ms. Dyer told this news organization, “This film is not only focusing on type 1 diabetes. That is obviously the crux of the issue, but it is a broader health care message for everyone wanting to make a change for health care in this country, the richest country in the world.”
At SXSW, Pay or Die will be competing with seven other films in the documentary feature competition, and it is eligible to win other awards.
Several other activities at the festival will address the topics of diabetes and U.S. health care costs, including a panel discussion titled Crushing: The Burden of Diabetes on Patients, featuring musician and actor Nick Jonas, who has type 1 diabetes, and a representative from the continuous glucose monitor manufacturer Dexcom.
Another panel, Young and Uninsured: Pay or Die, will include Dr. Rajkumar, Mr. Ruderman, Texas Representative James Talarico, who is advancing an insulin cap bill in that state, and Nicole Smith-Holt, the Minnesota mother of the young man who died because he couldn’t afford his insulin.
Mr. Ruderman, Ms. Dyer, Ms. Melamede, and Dr. Rajkumar have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A new documentary premiering at the 2023 South by Southwest (SXSW) Festival illustrates the human consequences of insulin’s high cost in the United States. Its creators hope that it will help spur action toward overall prescription pricing reform.
Pay or Die: A Documentary is scheduled to premiere March 11. It will be shown twice more during the festival, which runs from March 10 to 19 in Austin, Texas. The documentary was co-created and directed by filmmaker and cinematographer Scott Alexander Ruderman, who has type 1 diabetes, and his partner, producer and journalist Rachael Dyer. One of the executive producers is Sarah Silverman, a comic, actor, producer, and health care reform advocate.
The 90-minute film follows three human stories: A mother and young daughter who both have type 1 diabetes and become homeless after spending their rent money on insulin, a young adult diagnosed during the COVID-19 pandemic, and a mother whose 26-year-old son died from diabetic ketoacidosis (DKA) after his insulin was rationed.
“As an Australian now living in the U.S. and seeing how the health care system works here, especially for people with type 1 diabetes like Scott, and how access to insulin is a life-or-death situation, has been very eye-opening for me. I’m also half Canadian, and both are countries where access to health care is a human right, not a business,” Ms. Dyer said in an interview.
In response to the March 1 announcement from Eli Lilly about its insulin price cut, the film’s team told this news organization: “While we commend Eli Lilly in taking this first step and hope that Novo Nordisk and Sanofi [the two other major insulin manufacturers] follow suit, it is important to remember that the key issue is not about these companies voluntarily slashing prices; it’s about changing laws so the insulin manufacturers do not have the ability to raise the prices again.
“This is the life-or-death issue that we focus on in our documentary Pay or Die. It’s also important to note that insulin is just one of the many expensive prescription drugs in the U.S., which is why we need to call for reform. Affordable medication needs to be a basic human right within reach for all Americans.”
Physician perspective: Good news on insulin, but broader issues
The film features four physicians. One, Mayo Clinic oncologist/hematologist S. Vincent Rajkumar, MD, has spoken and published widely on insulin prices specifically and U.S. drug costs more broadly.
The other three are Joslin Clinic endocrinologist Elizabeth Halprin, MD, Massachusetts General Hospital internist Leigh Simmons, MD, and New York University physician and essayist Danielle Ofri, MD, PhD.
In an interview after the Lilly announcement, Dr. Rajkumar said, “I think this is very, very good news for patients. ... The fact that they’re doing it means they’re listening to us and listening to patients, which is good. And I do hope that other insulin manufacturers do the same shortly.”
However, he added, “for prescription drug prices and particularly cancer drug prices, there’s more reform that’s needed, and that’s at the policy level. ... The goal of the film was to use insulin to highlight the prescription drug price problem in the U.S.”
‘Then life changed’
The filmmaker, Mr. Ruderman, was diagnosed at age 19, during his freshman year in college. He spent several days hospitalized with DKA, and “then life changed,” he said in an interview. He went into photography first and later filmmaking, always with the uneasy knowledge that he could lose access to insulin at any time.
The impetus for the film came after he and Ms. Dyer walked into a pharmacy while visiting Canada in 2018 and discovered how much cheaper insulin was compared to the United States – roughly $20 per vial, compared to $300 in the U.S.
“When Rachael [Dyer] and I came back to the U.S., we were actually quite shocked about how many people are struggling to afford their medication ... the uninsured, those aging off their parents’ health insurance. So that was really the kickoff to us going into the field for the last 4 years making this documentary.”
As a freelancer, Mr. Ruderman has been personally paying for expensive “premium” health insurance that covers the pump and glucose monitors he uses. He buys insulin overseas as often as possible.
“Fortunately, I haven’t been in a situation where I’ve had to ration my insulin, but the fear is instilled in me. What if there’s a month when I can’t afford it? What am I going to do?” (Note: The writer of this article is in the same situation, which could be alleviated by Lilly’s action.)
Timing is everything
To be sure, even before Lilly’s announcement, some progress had been made since work on the film began.
The issue of insulin pricing has received wide media attention. More than 20 states have passed copay caps on insulin, and a new law capping the cost of insulin for Medicare beneficiaries at $35/month went into effect in January 2023. President Biden mentioned insulin during his State of the Union address, and Georgia Senator Raphael Warnock made the issue a centerpiece of his campaign.
But there have also been losses, including the failure thus far to pass a nationwide copay cap.
These recent developments make this a good time for the film’s debut, producer Yael Melamede said in an interview. “There’s a lot happening in the space, but also a lot of incredible disappointments along the way, so we are really interested in getting this film out now.”
Ms. Melamede, who owns a film production company, said, “I’ve done a lot of films that have some issue advocacy side to them. I love this film because it’s grounded in the stories of real people. ... We feel this is a perfect catalyst to keep the energy going and for people to say this is super-important and not get distracted.”
While the film doesn’t advocate for specific policies, there is a “call to action” at the end that points viewers to resources on the website for writing to their members of Congress along with additional ways to become personally involved.
Ms. Dyer told this news organization, “This film is not only focusing on type 1 diabetes. That is obviously the crux of the issue, but it is a broader health care message for everyone wanting to make a change for health care in this country, the richest country in the world.”
At SXSW, Pay or Die will be competing with seven other films in the documentary feature competition, and it is eligible to win other awards.
Several other activities at the festival will address the topics of diabetes and U.S. health care costs, including a panel discussion titled Crushing: The Burden of Diabetes on Patients, featuring musician and actor Nick Jonas, who has type 1 diabetes, and a representative from the continuous glucose monitor manufacturer Dexcom.
Another panel, Young and Uninsured: Pay or Die, will include Dr. Rajkumar, Mr. Ruderman, Texas Representative James Talarico, who is advancing an insulin cap bill in that state, and Nicole Smith-Holt, the Minnesota mother of the young man who died because he couldn’t afford his insulin.
Mr. Ruderman, Ms. Dyer, Ms. Melamede, and Dr. Rajkumar have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A new documentary premiering at the 2023 South by Southwest (SXSW) Festival illustrates the human consequences of insulin’s high cost in the United States. Its creators hope that it will help spur action toward overall prescription pricing reform.
Pay or Die: A Documentary is scheduled to premiere March 11. It will be shown twice more during the festival, which runs from March 10 to 19 in Austin, Texas. The documentary was co-created and directed by filmmaker and cinematographer Scott Alexander Ruderman, who has type 1 diabetes, and his partner, producer and journalist Rachael Dyer. One of the executive producers is Sarah Silverman, a comic, actor, producer, and health care reform advocate.
The 90-minute film follows three human stories: A mother and young daughter who both have type 1 diabetes and become homeless after spending their rent money on insulin, a young adult diagnosed during the COVID-19 pandemic, and a mother whose 26-year-old son died from diabetic ketoacidosis (DKA) after his insulin was rationed.
“As an Australian now living in the U.S. and seeing how the health care system works here, especially for people with type 1 diabetes like Scott, and how access to insulin is a life-or-death situation, has been very eye-opening for me. I’m also half Canadian, and both are countries where access to health care is a human right, not a business,” Ms. Dyer said in an interview.
In response to the March 1 announcement from Eli Lilly about its insulin price cut, the film’s team told this news organization: “While we commend Eli Lilly in taking this first step and hope that Novo Nordisk and Sanofi [the two other major insulin manufacturers] follow suit, it is important to remember that the key issue is not about these companies voluntarily slashing prices; it’s about changing laws so the insulin manufacturers do not have the ability to raise the prices again.
“This is the life-or-death issue that we focus on in our documentary Pay or Die. It’s also important to note that insulin is just one of the many expensive prescription drugs in the U.S., which is why we need to call for reform. Affordable medication needs to be a basic human right within reach for all Americans.”
Physician perspective: Good news on insulin, but broader issues
The film features four physicians. One, Mayo Clinic oncologist/hematologist S. Vincent Rajkumar, MD, has spoken and published widely on insulin prices specifically and U.S. drug costs more broadly.
The other three are Joslin Clinic endocrinologist Elizabeth Halprin, MD, Massachusetts General Hospital internist Leigh Simmons, MD, and New York University physician and essayist Danielle Ofri, MD, PhD.
In an interview after the Lilly announcement, Dr. Rajkumar said, “I think this is very, very good news for patients. ... The fact that they’re doing it means they’re listening to us and listening to patients, which is good. And I do hope that other insulin manufacturers do the same shortly.”
However, he added, “for prescription drug prices and particularly cancer drug prices, there’s more reform that’s needed, and that’s at the policy level. ... The goal of the film was to use insulin to highlight the prescription drug price problem in the U.S.”
‘Then life changed’
The filmmaker, Mr. Ruderman, was diagnosed at age 19, during his freshman year in college. He spent several days hospitalized with DKA, and “then life changed,” he said in an interview. He went into photography first and later filmmaking, always with the uneasy knowledge that he could lose access to insulin at any time.
The impetus for the film came after he and Ms. Dyer walked into a pharmacy while visiting Canada in 2018 and discovered how much cheaper insulin was compared to the United States – roughly $20 per vial, compared to $300 in the U.S.
“When Rachael [Dyer] and I came back to the U.S., we were actually quite shocked about how many people are struggling to afford their medication ... the uninsured, those aging off their parents’ health insurance. So that was really the kickoff to us going into the field for the last 4 years making this documentary.”
As a freelancer, Mr. Ruderman has been personally paying for expensive “premium” health insurance that covers the pump and glucose monitors he uses. He buys insulin overseas as often as possible.
“Fortunately, I haven’t been in a situation where I’ve had to ration my insulin, but the fear is instilled in me. What if there’s a month when I can’t afford it? What am I going to do?” (Note: The writer of this article is in the same situation, which could be alleviated by Lilly’s action.)
Timing is everything
To be sure, even before Lilly’s announcement, some progress had been made since work on the film began.
The issue of insulin pricing has received wide media attention. More than 20 states have passed copay caps on insulin, and a new law capping the cost of insulin for Medicare beneficiaries at $35/month went into effect in January 2023. President Biden mentioned insulin during his State of the Union address, and Georgia Senator Raphael Warnock made the issue a centerpiece of his campaign.
But there have also been losses, including the failure thus far to pass a nationwide copay cap.
These recent developments make this a good time for the film’s debut, producer Yael Melamede said in an interview. “There’s a lot happening in the space, but also a lot of incredible disappointments along the way, so we are really interested in getting this film out now.”
Ms. Melamede, who owns a film production company, said, “I’ve done a lot of films that have some issue advocacy side to them. I love this film because it’s grounded in the stories of real people. ... We feel this is a perfect catalyst to keep the energy going and for people to say this is super-important and not get distracted.”
While the film doesn’t advocate for specific policies, there is a “call to action” at the end that points viewers to resources on the website for writing to their members of Congress along with additional ways to become personally involved.
Ms. Dyer told this news organization, “This film is not only focusing on type 1 diabetes. That is obviously the crux of the issue, but it is a broader health care message for everyone wanting to make a change for health care in this country, the richest country in the world.”
At SXSW, Pay or Die will be competing with seven other films in the documentary feature competition, and it is eligible to win other awards.
Several other activities at the festival will address the topics of diabetes and U.S. health care costs, including a panel discussion titled Crushing: The Burden of Diabetes on Patients, featuring musician and actor Nick Jonas, who has type 1 diabetes, and a representative from the continuous glucose monitor manufacturer Dexcom.
Another panel, Young and Uninsured: Pay or Die, will include Dr. Rajkumar, Mr. Ruderman, Texas Representative James Talarico, who is advancing an insulin cap bill in that state, and Nicole Smith-Holt, the Minnesota mother of the young man who died because he couldn’t afford his insulin.
Mr. Ruderman, Ms. Dyer, Ms. Melamede, and Dr. Rajkumar have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Troubling trend as both diabetes types rise among U.S. youth
The incidence of type 1 and type 2 diabetes continues to rise among children and adolescents in the United States, new data from the SEARCH for Diabetes in Youth study show.
The SEARCH data demonstrate an increase in the youth population aged 0-19 diagnosed with type 1 or type 2 diabetes in five representative U.S. centers. Between 2002 and 2018, the annual incidence rose by about 2% per year for type 1 diabetes and 5% per year for type 2 diabetes. The rates of increase for both types were greater among non-White than White youth.
These increases “will result in an expanding population of young adults at risk of developing early complications of diabetes whose health care needs will exceed those of their peers,” write Lynne E. Wagenknecht, DrPH, of Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues in their article, recently published in The Lancet Diabetes & Endocrinology.
In an accompanying editorial, Jonathan E. Shaw, MD, and Dianna J. Magliano, PhD, both at the Baker Heart and Diabetes Institute, Melbourne, write that one of the most “concerning findings” was a 7%-9% annual increase in the incidence of type 2 diabetes among Hispanic, Asian, and Pacific Islander populations.
“This is a health care crisis in the making. ...Youth and young-adult-onset type 2 diabetes are growing problems leading to poor outcomes and to widening social inequality, adversely affecting a population that might already be disadvantaged. Better information about its natural history, prevention, and management is urgently needed,” they write.
Upward trends in both diabetes types
Overall, 18,169 children and adolescents with type 1 diabetes and 5,293 with type 2 diabetes were identified over the 17-year study period in SEARCH. After adjustment for age, sex, and race/ethnicity, there was a significant increase in type 1 diabetes incidence from 19.5 cases/100,000 population in 2002-2003 to 22.2/100,000 in 2017-2018, a 2.02% annual increase.
The upward trend was even greater for type 2 diabetes, from 9.0/100,000 in 2002-2003 to 17.9/100,000 in 2017-2018, a 5.31% annual increase.
The annual rate of increase in type 1 diabetes was highest among Asian/Pacific Islander youth (4.84%), followed by Hispanic (4.14%) and Black youth (2.93%): All significantly rose over the 17 years.
For type 2 diabetes, significant annual rates of increase were also highest for Asian/Pacific Islanders (8.92%), followed by Hispanic (7.17%) and Black youth (5.99%).
Among youth aged 15-19 years, the overall incidence of type 2 diabetes exceeded that of type 1 diabetes (19.7 vs. 14.6/100,000).
The incidence of type 2 diabetes may be rising because of increased rates of obesity, as well as increased screening of at-risk youth, the authors say.
And, the editorialists note, obesity is also a risk factor for type 1 diabetes.
Peak incidence of type 1 diabetes occurred at age 10 years, while for type 2 diabetes, the peak was at 16 years. There were also seasonal peaks, occurring in January for type 1 diabetes and in August for type 2 diabetes. Those seasonal patterns have been previously reported; they are possibly because of increased viral infections and decreased sun exposure for the former, and increased physical exams in preparation for school in the latter, the authors speculate.
Dr. Shaw and Dr. Magliano note that the reduced incidence after age 16 years “might simply reflect a failure to diagnose,” suggesting that there will likely be an upturn in incidence in the subsequent decade.
The editorialists also point out: “Not only does the long duration of diabetes that youth-onset leads to cause a large burden of fatal and nonfatal complications, but it magnifies intergenerational effects.”
“When type 2 diabetes is already present before pregnancy, birth outcomes are worse, and the long-term metabolic health of the offspring is adversely affected. This does not bode well for the epidemic of diabetes and its complications.”
The study was funded by the Centers for Disease Control and Prevention and National Institutes of Health. The authors and Dr. Magliano have reported no relevant financial relationships. Dr. Shaw has reported receiving honoraria for lectures and for advisory boards and grants from AstraZeneca, Boehringer Ingelheim, Pfizer, Eli Lilly, Sanofi, Roche, Mylan, and Zuellig Pharma.
A version of this article originally appeared on Medscape.com.
The incidence of type 1 and type 2 diabetes continues to rise among children and adolescents in the United States, new data from the SEARCH for Diabetes in Youth study show.
The SEARCH data demonstrate an increase in the youth population aged 0-19 diagnosed with type 1 or type 2 diabetes in five representative U.S. centers. Between 2002 and 2018, the annual incidence rose by about 2% per year for type 1 diabetes and 5% per year for type 2 diabetes. The rates of increase for both types were greater among non-White than White youth.
These increases “will result in an expanding population of young adults at risk of developing early complications of diabetes whose health care needs will exceed those of their peers,” write Lynne E. Wagenknecht, DrPH, of Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues in their article, recently published in The Lancet Diabetes & Endocrinology.
In an accompanying editorial, Jonathan E. Shaw, MD, and Dianna J. Magliano, PhD, both at the Baker Heart and Diabetes Institute, Melbourne, write that one of the most “concerning findings” was a 7%-9% annual increase in the incidence of type 2 diabetes among Hispanic, Asian, and Pacific Islander populations.
“This is a health care crisis in the making. ...Youth and young-adult-onset type 2 diabetes are growing problems leading to poor outcomes and to widening social inequality, adversely affecting a population that might already be disadvantaged. Better information about its natural history, prevention, and management is urgently needed,” they write.
Upward trends in both diabetes types
Overall, 18,169 children and adolescents with type 1 diabetes and 5,293 with type 2 diabetes were identified over the 17-year study period in SEARCH. After adjustment for age, sex, and race/ethnicity, there was a significant increase in type 1 diabetes incidence from 19.5 cases/100,000 population in 2002-2003 to 22.2/100,000 in 2017-2018, a 2.02% annual increase.
The upward trend was even greater for type 2 diabetes, from 9.0/100,000 in 2002-2003 to 17.9/100,000 in 2017-2018, a 5.31% annual increase.
The annual rate of increase in type 1 diabetes was highest among Asian/Pacific Islander youth (4.84%), followed by Hispanic (4.14%) and Black youth (2.93%): All significantly rose over the 17 years.
For type 2 diabetes, significant annual rates of increase were also highest for Asian/Pacific Islanders (8.92%), followed by Hispanic (7.17%) and Black youth (5.99%).
Among youth aged 15-19 years, the overall incidence of type 2 diabetes exceeded that of type 1 diabetes (19.7 vs. 14.6/100,000).
The incidence of type 2 diabetes may be rising because of increased rates of obesity, as well as increased screening of at-risk youth, the authors say.
And, the editorialists note, obesity is also a risk factor for type 1 diabetes.
Peak incidence of type 1 diabetes occurred at age 10 years, while for type 2 diabetes, the peak was at 16 years. There were also seasonal peaks, occurring in January for type 1 diabetes and in August for type 2 diabetes. Those seasonal patterns have been previously reported; they are possibly because of increased viral infections and decreased sun exposure for the former, and increased physical exams in preparation for school in the latter, the authors speculate.
Dr. Shaw and Dr. Magliano note that the reduced incidence after age 16 years “might simply reflect a failure to diagnose,” suggesting that there will likely be an upturn in incidence in the subsequent decade.
The editorialists also point out: “Not only does the long duration of diabetes that youth-onset leads to cause a large burden of fatal and nonfatal complications, but it magnifies intergenerational effects.”
“When type 2 diabetes is already present before pregnancy, birth outcomes are worse, and the long-term metabolic health of the offspring is adversely affected. This does not bode well for the epidemic of diabetes and its complications.”
The study was funded by the Centers for Disease Control and Prevention and National Institutes of Health. The authors and Dr. Magliano have reported no relevant financial relationships. Dr. Shaw has reported receiving honoraria for lectures and for advisory boards and grants from AstraZeneca, Boehringer Ingelheim, Pfizer, Eli Lilly, Sanofi, Roche, Mylan, and Zuellig Pharma.
A version of this article originally appeared on Medscape.com.
The incidence of type 1 and type 2 diabetes continues to rise among children and adolescents in the United States, new data from the SEARCH for Diabetes in Youth study show.
The SEARCH data demonstrate an increase in the youth population aged 0-19 diagnosed with type 1 or type 2 diabetes in five representative U.S. centers. Between 2002 and 2018, the annual incidence rose by about 2% per year for type 1 diabetes and 5% per year for type 2 diabetes. The rates of increase for both types were greater among non-White than White youth.
These increases “will result in an expanding population of young adults at risk of developing early complications of diabetes whose health care needs will exceed those of their peers,” write Lynne E. Wagenknecht, DrPH, of Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues in their article, recently published in The Lancet Diabetes & Endocrinology.
In an accompanying editorial, Jonathan E. Shaw, MD, and Dianna J. Magliano, PhD, both at the Baker Heart and Diabetes Institute, Melbourne, write that one of the most “concerning findings” was a 7%-9% annual increase in the incidence of type 2 diabetes among Hispanic, Asian, and Pacific Islander populations.
“This is a health care crisis in the making. ...Youth and young-adult-onset type 2 diabetes are growing problems leading to poor outcomes and to widening social inequality, adversely affecting a population that might already be disadvantaged. Better information about its natural history, prevention, and management is urgently needed,” they write.
Upward trends in both diabetes types
Overall, 18,169 children and adolescents with type 1 diabetes and 5,293 with type 2 diabetes were identified over the 17-year study period in SEARCH. After adjustment for age, sex, and race/ethnicity, there was a significant increase in type 1 diabetes incidence from 19.5 cases/100,000 population in 2002-2003 to 22.2/100,000 in 2017-2018, a 2.02% annual increase.
The upward trend was even greater for type 2 diabetes, from 9.0/100,000 in 2002-2003 to 17.9/100,000 in 2017-2018, a 5.31% annual increase.
The annual rate of increase in type 1 diabetes was highest among Asian/Pacific Islander youth (4.84%), followed by Hispanic (4.14%) and Black youth (2.93%): All significantly rose over the 17 years.
For type 2 diabetes, significant annual rates of increase were also highest for Asian/Pacific Islanders (8.92%), followed by Hispanic (7.17%) and Black youth (5.99%).
Among youth aged 15-19 years, the overall incidence of type 2 diabetes exceeded that of type 1 diabetes (19.7 vs. 14.6/100,000).
The incidence of type 2 diabetes may be rising because of increased rates of obesity, as well as increased screening of at-risk youth, the authors say.
And, the editorialists note, obesity is also a risk factor for type 1 diabetes.
Peak incidence of type 1 diabetes occurred at age 10 years, while for type 2 diabetes, the peak was at 16 years. There were also seasonal peaks, occurring in January for type 1 diabetes and in August for type 2 diabetes. Those seasonal patterns have been previously reported; they are possibly because of increased viral infections and decreased sun exposure for the former, and increased physical exams in preparation for school in the latter, the authors speculate.
Dr. Shaw and Dr. Magliano note that the reduced incidence after age 16 years “might simply reflect a failure to diagnose,” suggesting that there will likely be an upturn in incidence in the subsequent decade.
The editorialists also point out: “Not only does the long duration of diabetes that youth-onset leads to cause a large burden of fatal and nonfatal complications, but it magnifies intergenerational effects.”
“When type 2 diabetes is already present before pregnancy, birth outcomes are worse, and the long-term metabolic health of the offspring is adversely affected. This does not bode well for the epidemic of diabetes and its complications.”
The study was funded by the Centers for Disease Control and Prevention and National Institutes of Health. The authors and Dr. Magliano have reported no relevant financial relationships. Dr. Shaw has reported receiving honoraria for lectures and for advisory boards and grants from AstraZeneca, Boehringer Ingelheim, Pfizer, Eli Lilly, Sanofi, Roche, Mylan, and Zuellig Pharma.
A version of this article originally appeared on Medscape.com.
FROM THE LANCET DIABETES & ENDOCRINOLOGY
Two FDA clearances add diabetes technology options
Two diabetes management devices that aid in the precision of insulin delivery have been recently cleared by the Food and Drug Administration.
On March 2, the FDA cleared the Android version of Bigfoot Biomedical’s Unity Mobile App for use with its system of smart pen caps that are compatible with different disposable insulin pens for administering both long-acting and rapid-acting insulin.
The system, which has been compatible with iOS devices since May 2021, is “the first and only FDA-cleared smart injection system that turns CGM [continuous glucose monitoring] data into dosing recommendations displayed right on the pen cap for people using multiple daily [insulin] injection therapy,” according to a company statement.
The Bigfoot app allows users to input and review provider treatment recommendations, displays current glucose ranges, and delivers real-time alerts.
Once it is commercially launched, the Android phone application will be available via the Google Play Store. “Given that 41% of U.S. smartphone users choose Android devices, this clearance enables expanded access to a large group of people with diabetes,” the company said.
On March 6, the FDA cleared the Abbott FreeStyle Libre 2 and FreeStyle Libre 3 devices as “integrated” CGM sensors. This means that they can now be used as components in automated insulin delivery systems, along with insulin pumps and connectivity software.
Abbott is working with insulin pump manufacturers Insulet and Tandem in the United States for integration with the FreeStyle Libre versions 2 and 3. Outside the United States, the Libre 3 is already authorized to work with mylife Loop from Ypsomed and CamDiab in Germany. Further launches are expected in the United Kingdom, Switzerland, and the Netherlands later this year.
The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors have been cleared for use by patients as young as age 2 years and for up to 15 days, in contrast to the previous versions, which were available for patients as young as 4 years for use up to 14 days. The FDA has cleared all Libre sensors – 2 and 3, current and future versions – for use by pregnant women with any type of diabetes.
The modified sensors will be available in the United States later this year and will eventually replace the Libre sensors in current use, the company said in a statement.
“The FreeStyle Libre portfolio is still the most affordable CGM on the market,” an Abbott representative said in an interview.
A version of this article first appeared on Medscape.com.
Two diabetes management devices that aid in the precision of insulin delivery have been recently cleared by the Food and Drug Administration.
On March 2, the FDA cleared the Android version of Bigfoot Biomedical’s Unity Mobile App for use with its system of smart pen caps that are compatible with different disposable insulin pens for administering both long-acting and rapid-acting insulin.
The system, which has been compatible with iOS devices since May 2021, is “the first and only FDA-cleared smart injection system that turns CGM [continuous glucose monitoring] data into dosing recommendations displayed right on the pen cap for people using multiple daily [insulin] injection therapy,” according to a company statement.
The Bigfoot app allows users to input and review provider treatment recommendations, displays current glucose ranges, and delivers real-time alerts.
Once it is commercially launched, the Android phone application will be available via the Google Play Store. “Given that 41% of U.S. smartphone users choose Android devices, this clearance enables expanded access to a large group of people with diabetes,” the company said.
On March 6, the FDA cleared the Abbott FreeStyle Libre 2 and FreeStyle Libre 3 devices as “integrated” CGM sensors. This means that they can now be used as components in automated insulin delivery systems, along with insulin pumps and connectivity software.
Abbott is working with insulin pump manufacturers Insulet and Tandem in the United States for integration with the FreeStyle Libre versions 2 and 3. Outside the United States, the Libre 3 is already authorized to work with mylife Loop from Ypsomed and CamDiab in Germany. Further launches are expected in the United Kingdom, Switzerland, and the Netherlands later this year.
The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors have been cleared for use by patients as young as age 2 years and for up to 15 days, in contrast to the previous versions, which were available for patients as young as 4 years for use up to 14 days. The FDA has cleared all Libre sensors – 2 and 3, current and future versions – for use by pregnant women with any type of diabetes.
The modified sensors will be available in the United States later this year and will eventually replace the Libre sensors in current use, the company said in a statement.
“The FreeStyle Libre portfolio is still the most affordable CGM on the market,” an Abbott representative said in an interview.
A version of this article first appeared on Medscape.com.
Two diabetes management devices that aid in the precision of insulin delivery have been recently cleared by the Food and Drug Administration.
On March 2, the FDA cleared the Android version of Bigfoot Biomedical’s Unity Mobile App for use with its system of smart pen caps that are compatible with different disposable insulin pens for administering both long-acting and rapid-acting insulin.
The system, which has been compatible with iOS devices since May 2021, is “the first and only FDA-cleared smart injection system that turns CGM [continuous glucose monitoring] data into dosing recommendations displayed right on the pen cap for people using multiple daily [insulin] injection therapy,” according to a company statement.
The Bigfoot app allows users to input and review provider treatment recommendations, displays current glucose ranges, and delivers real-time alerts.
Once it is commercially launched, the Android phone application will be available via the Google Play Store. “Given that 41% of U.S. smartphone users choose Android devices, this clearance enables expanded access to a large group of people with diabetes,” the company said.
On March 6, the FDA cleared the Abbott FreeStyle Libre 2 and FreeStyle Libre 3 devices as “integrated” CGM sensors. This means that they can now be used as components in automated insulin delivery systems, along with insulin pumps and connectivity software.
Abbott is working with insulin pump manufacturers Insulet and Tandem in the United States for integration with the FreeStyle Libre versions 2 and 3. Outside the United States, the Libre 3 is already authorized to work with mylife Loop from Ypsomed and CamDiab in Germany. Further launches are expected in the United Kingdom, Switzerland, and the Netherlands later this year.
The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors have been cleared for use by patients as young as age 2 years and for up to 15 days, in contrast to the previous versions, which were available for patients as young as 4 years for use up to 14 days. The FDA has cleared all Libre sensors – 2 and 3, current and future versions – for use by pregnant women with any type of diabetes.
The modified sensors will be available in the United States later this year and will eventually replace the Libre sensors in current use, the company said in a statement.
“The FreeStyle Libre portfolio is still the most affordable CGM on the market,” an Abbott representative said in an interview.
A version of this article first appeared on Medscape.com.