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Younger age of type 2 diabetes onset linked to dementia risk
, new findings suggest.
Moreover, the new data from the prospective Atherosclerosis Risk in Communities (ARIC) cohort also suggest that the previously identified increased risk for dementia among people with prediabetes appears to be entirely explained by the subset who go on to develop type 2 diabetes.
“Our findings suggest that preventing prediabetes progression, especially in younger individuals, may be an important way to reduce the dementia burden,” wrote PhD student Jiaqi Hu of Johns Hopkins University, Baltimore, and colleagues. Their article was published online in Diabetologia.
The result builds on previous findings linking dysglycemia and cognitive decline, the study’s lead author, Elizabeth Selvin, PhD, of the Bloomberg School of Public Health at Johns Hopkins, said in an interview.
“Our prior work in the ARIC study suggests that improving glucose control could help prevent dementia in later life,” she said. 
Other studies have also linked higher A1c levels and diabetes in midlife to increased rates of cognitive decline. In addition, Dr. Selvin noted, “There is growing evidence that focusing on vascular health, especially focusing on diabetes and blood pressure, in midlife can stave off dementia in later life.”
This new study is the first to examine the effect of diabetes in the relationship between prediabetes and dementia, as well as the age of diabetes onset on subsequent dementia.
Prediabetes linked to dementia via diabetes development
Of the 11,656 ARIC participants without diabetes at baseline during 1990-1992 (age 46-70 years), 20.0% had prediabetes (defined as A1c 5.7%-6.4% or 39-46 mmol/mol). During a median follow-up of 15.9 years, 3,143 participants developed diabetes. The proportions of patients who developed diabetes were 44.6% among those with prediabetes at baseline versus 22.5% of those without.
Dementia developed in 2,247 participants over a median follow-up of 24.7 years. The cumulative incidence of dementia was 23.9% among those who developed diabetes versus 20.5% among those who did not.
After adjustment for demographics and for the Alzheimer’s disease–linked apolipoprotein E (APOE) gene, prediabetes was significantly associated with incident dementia (hazard ratio [HR], 1.19). However, significance disappeared after adjustment for incident diabetes (HR, 1.09), the researchers reported.
Younger age at diabetes diagnosis raises dementia risk
Age at diabetes diagnosis made a difference in dementia risk. With adjustments for lifestyle, demographic, and clinical factors, those diagnosed with diabetes before age 60 years had a nearly threefold increased risk for dementia compared with those who never developed diabetes (HR, 2.92; P < .001).
The dementia risk was also significantly increased, although to a lesser degree, among those aged 60-69 years at diabetes diagnosis (HR, 1.73; P < .001) and age 70-79 years at diabetes diagnosis (HR, 1.23; P < .001). The relationship was not significant for those aged 80 years and older (HR, 1.13).
“Prevention efforts in people with diabetes diagnosed younger than 65 years should be a high priority,” the authors urged.
Taken together, the data suggest that prolonged exposure to hyperglycemia plays a major role in dementia development.
“Putative mechanisms include acute and chronic hyperglycemia, glucose toxicity, insulin resistance, and microvascular dysfunction of the central nervous system. ... Glucose toxicity and microvascular dysfunction are associated with increased inflammatory and oxidative stress, leading to increased blood–brain permeability,” the researchers wrote.
Dr. Selvin said that her group is pursuing further work in this area using continuous glucose monitoring. “We plan to look at ... how glycemic control and different patterns of glucose in older adults may be linked to cognitive decline and other neurocognitive outcomes.”
The researchers reported no relevant financial relationships. Dr. Selvin has reported being on the advisory board for Diabetologia; she had no role in peer review of the manuscript.
A version of this article first appeared on Medscape.com.
, new findings suggest.
Moreover, the new data from the prospective Atherosclerosis Risk in Communities (ARIC) cohort also suggest that the previously identified increased risk for dementia among people with prediabetes appears to be entirely explained by the subset who go on to develop type 2 diabetes.
“Our findings suggest that preventing prediabetes progression, especially in younger individuals, may be an important way to reduce the dementia burden,” wrote PhD student Jiaqi Hu of Johns Hopkins University, Baltimore, and colleagues. Their article was published online in Diabetologia.
The result builds on previous findings linking dysglycemia and cognitive decline, the study’s lead author, Elizabeth Selvin, PhD, of the Bloomberg School of Public Health at Johns Hopkins, said in an interview.
“Our prior work in the ARIC study suggests that improving glucose control could help prevent dementia in later life,” she said.
Other studies have also linked higher A1c levels and diabetes in midlife to increased rates of cognitive decline. In addition, Dr. Selvin noted, “There is growing evidence that focusing on vascular health, especially focusing on diabetes and blood pressure, in midlife can stave off dementia in later life.”
This new study is the first to examine the effect of diabetes in the relationship between prediabetes and dementia, as well as the age of diabetes onset on subsequent dementia.
Prediabetes linked to dementia via diabetes development
Of the 11,656 ARIC participants without diabetes at baseline during 1990-1992 (age 46-70 years), 20.0% had prediabetes (defined as A1c 5.7%-6.4% or 39-46 mmol/mol). During a median follow-up of 15.9 years, 3,143 participants developed diabetes. The proportions of patients who developed diabetes were 44.6% among those with prediabetes at baseline versus 22.5% of those without.
Dementia developed in 2,247 participants over a median follow-up of 24.7 years. The cumulative incidence of dementia was 23.9% among those who developed diabetes versus 20.5% among those who did not.
After adjustment for demographics and for the Alzheimer’s disease–linked apolipoprotein E (APOE) gene, prediabetes was significantly associated with incident dementia (hazard ratio [HR], 1.19). However, significance disappeared after adjustment for incident diabetes (HR, 1.09), the researchers reported.
Younger age at diabetes diagnosis raises dementia risk
Age at diabetes diagnosis made a difference in dementia risk. With adjustments for lifestyle, demographic, and clinical factors, those diagnosed with diabetes before age 60 years had a nearly threefold increased risk for dementia compared with those who never developed diabetes (HR, 2.92; P < .001).
The dementia risk was also significantly increased, although to a lesser degree, among those aged 60-69 years at diabetes diagnosis (HR, 1.73; P < .001) and age 70-79 years at diabetes diagnosis (HR, 1.23; P < .001). The relationship was not significant for those aged 80 years and older (HR, 1.13).
“Prevention efforts in people with diabetes diagnosed younger than 65 years should be a high priority,” the authors urged.
Taken together, the data suggest that prolonged exposure to hyperglycemia plays a major role in dementia development.
“Putative mechanisms include acute and chronic hyperglycemia, glucose toxicity, insulin resistance, and microvascular dysfunction of the central nervous system. ... Glucose toxicity and microvascular dysfunction are associated with increased inflammatory and oxidative stress, leading to increased blood–brain permeability,” the researchers wrote.
Dr. Selvin said that her group is pursuing further work in this area using continuous glucose monitoring. “We plan to look at ... how glycemic control and different patterns of glucose in older adults may be linked to cognitive decline and other neurocognitive outcomes.”
The researchers reported no relevant financial relationships. Dr. Selvin has reported being on the advisory board for Diabetologia; she had no role in peer review of the manuscript.
A version of this article first appeared on Medscape.com.
, new findings suggest.
Moreover, the new data from the prospective Atherosclerosis Risk in Communities (ARIC) cohort also suggest that the previously identified increased risk for dementia among people with prediabetes appears to be entirely explained by the subset who go on to develop type 2 diabetes.
“Our findings suggest that preventing prediabetes progression, especially in younger individuals, may be an important way to reduce the dementia burden,” wrote PhD student Jiaqi Hu of Johns Hopkins University, Baltimore, and colleagues. Their article was published online in Diabetologia.
The result builds on previous findings linking dysglycemia and cognitive decline, the study’s lead author, Elizabeth Selvin, PhD, of the Bloomberg School of Public Health at Johns Hopkins, said in an interview.
“Our prior work in the ARIC study suggests that improving glucose control could help prevent dementia in later life,” she said.
Other studies have also linked higher A1c levels and diabetes in midlife to increased rates of cognitive decline. In addition, Dr. Selvin noted, “There is growing evidence that focusing on vascular health, especially focusing on diabetes and blood pressure, in midlife can stave off dementia in later life.”
This new study is the first to examine the effect of diabetes in the relationship between prediabetes and dementia, as well as the age of diabetes onset on subsequent dementia.
Prediabetes linked to dementia via diabetes development
Of the 11,656 ARIC participants without diabetes at baseline during 1990-1992 (age 46-70 years), 20.0% had prediabetes (defined as A1c 5.7%-6.4% or 39-46 mmol/mol). During a median follow-up of 15.9 years, 3,143 participants developed diabetes. The proportions of patients who developed diabetes were 44.6% among those with prediabetes at baseline versus 22.5% of those without.
Dementia developed in 2,247 participants over a median follow-up of 24.7 years. The cumulative incidence of dementia was 23.9% among those who developed diabetes versus 20.5% among those who did not.
After adjustment for demographics and for the Alzheimer’s disease–linked apolipoprotein E (APOE) gene, prediabetes was significantly associated with incident dementia (hazard ratio [HR], 1.19). However, significance disappeared after adjustment for incident diabetes (HR, 1.09), the researchers reported.
Younger age at diabetes diagnosis raises dementia risk
Age at diabetes diagnosis made a difference in dementia risk. With adjustments for lifestyle, demographic, and clinical factors, those diagnosed with diabetes before age 60 years had a nearly threefold increased risk for dementia compared with those who never developed diabetes (HR, 2.92; P < .001).
The dementia risk was also significantly increased, although to a lesser degree, among those aged 60-69 years at diabetes diagnosis (HR, 1.73; P < .001) and age 70-79 years at diabetes diagnosis (HR, 1.23; P < .001). The relationship was not significant for those aged 80 years and older (HR, 1.13).
“Prevention efforts in people with diabetes diagnosed younger than 65 years should be a high priority,” the authors urged.
Taken together, the data suggest that prolonged exposure to hyperglycemia plays a major role in dementia development.
“Putative mechanisms include acute and chronic hyperglycemia, glucose toxicity, insulin resistance, and microvascular dysfunction of the central nervous system. ... Glucose toxicity and microvascular dysfunction are associated with increased inflammatory and oxidative stress, leading to increased blood–brain permeability,” the researchers wrote.
Dr. Selvin said that her group is pursuing further work in this area using continuous glucose monitoring. “We plan to look at ... how glycemic control and different patterns of glucose in older adults may be linked to cognitive decline and other neurocognitive outcomes.”
The researchers reported no relevant financial relationships. Dr. Selvin has reported being on the advisory board for Diabetologia; she had no role in peer review of the manuscript.
A version of this article first appeared on Medscape.com.
FROM DIABETOLOGIA
Could love hormone help psychological symptoms in AVD?
.
Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.
It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.
Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.
“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.
“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.
The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.
“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.
“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.
However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.
“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.
In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
Eightfold increase in plasma oxytocin levels in patients vs. control persons
The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.
All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.
Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.
In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.
The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).
The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.
The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.
“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.
Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.
A version of this article first appeared on Medscape.com.
.
Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.
It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.
Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.
“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.
“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.
The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.
“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.
“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.
However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.
“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.
In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
Eightfold increase in plasma oxytocin levels in patients vs. control persons
The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.
All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.
Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.
In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.
The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).
The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.
The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.
“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.
Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.
A version of this article first appeared on Medscape.com.
.
Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.
It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.
Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.
“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.
“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.
The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.
“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.
“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.
However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.
“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.
In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
Eightfold increase in plasma oxytocin levels in patients vs. control persons
The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.
All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.
Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.
In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.
The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).
The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.
The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.
“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.
Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.
A version of this article first appeared on Medscape.com.
FROM THE LANCET DIABETES & ENDOCRINOLOGY
FDA clears iLet bionic pancreas insulin delivery system
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.
TransCon PTH nears U.S. approval for hypoparathyroidism?
SEATTLE –
Findings from 110-week phase 2 data for the once-daily investigational parathyroid hormone (PTH) replacement drug were recently presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Overall, the drug was associated with independence from conventional calcium and active vitamin D therapy in most patients at 110 weeks, with no discontinuations due to adverse effects.
“Patients with hypoparathyroidism have low serum calcium levels and struggle with quality of life and biochemical abnormalities. The data from the TransCon PTH studies seem to show that a lot of these abnormalities can be reversed,” presenter Mishaela R. Rubin, MD, said in an interview.
Other PTH replacement therapies such as Nupara (now discontinued) and teriparatide (off-label) have been used in some patients with hypoparathyroidism.
However, “[TransCon PTH] is delivered in such a way as to have a prolonged half-life, so that’s kind of a special benefit that it has,” added Dr. Rubin of the division of endocrinology and metabolic bone disease, department of medicine, Columbia University, New York.
Asked to comment, session moderator Thanh Hoang, DO, of Walter Reed National Military Medical Center, Silver Spring, Md., said: “I think it’s a very promising medication because right now we don’t have a lot of options ... I think it would help a lot of patients.”
Approval denied, company addressing concerns
On May 1, the Food and Drug Administration issued a complete response letter, signaling denial of approval for the TransCon PTH, citing concerns related to manufacturing control of the product’s drug/device combination product, but not about the product’s safety and efficacy, according to an Ascendis statement.
The company is now working with the FDA to address these issues and is awaiting a European Union decision later this year.
The FDA did not request that the company conduct further clinical trials of TransCon PTH, which now include published 26-week phase 2 and phase 3 data along with the current longer-term phase 2 data presented at AACE.
“The company has said that they’re hopeful the issues will be addressable and that the FDA did not have any concerns about safety,” Dr. Rubin said in an interview.
Calcium normalized, bone turnover improved
Dr. Rubin presented long-term efficacy and safety data from the Phase 2 PaTH Forward trial, which involved 57 of the initial 59 participants who completed week 110 of an open-label extension of the trial.
During the first 4 weeks, patients had been randomized to TransCon PTH at fixed doses of 15 µg/day, 18 µg/day, 21 µg/day, or placebo. After week 4, all patients switched to TransCon PTH titrated to doses of 6-60 µg/day along with conventional therapy, with the goal of maintaining normocalcemia.
Participants were a mean age of 50 years, 81% were women, and 92% were White. Causes of hypoparathyroidism were neck surgery in 80%, autoimmune disease in 2%, and idiopathic disease in 19%. Disease duration was 12 years (range 1-39), and all were taking conventional therapy including calcium and active vitamin D (calcitriol or alfacaldiol).
At 110 weeks, all 57 patients were able to stop taking active vitamin D, and 53 of the 57 (93%) patients achieved independence from conventional therapy, defined as taking 0 µg/day of active vitamin D and no more than 600 mg/day of calcium (the dietary supplement dose). A total of 44 (77%) patients were not taking any calcium or active vitamin D.
“This really establishes the durability up to 2 years of keeping people off conventional therapy,” Dr. Rubin said during her presentation.
There was an initial uptick to 9.4 mg/dL in mean serum calcium, as some participants were still taking active vitamin D, but that dropped to 8.9 mg/dL by week 26. Mean 24-hour urine calcium dropped from 428 mg/day at baseline to 173 mg/day by week 26. Both serum calcium and urine calcium remained in the normal range through week 110 in all patients, at 8.6 mg/dL and 167 mg/day, respectively.
“This is a really important outcome because we know that high urine calcium in these patients sets them at risk for going on to develop nephrocalcinosis, nephrolithiasis, and ultimately, chronic kidney disease,” Dr. Rubin said.
Serum levels of two bone formation markers peaked at 12 weeks after initiation of TransCon PTH. Both trended downward thereafter through week 110 to levels approximating those of age- and sex-matched controls.
“Both markers started off low, consistent with hypoparathyroidism, but with initiation of TransCon PTH we see a robust increase in bone turnover markers, almost as if the bone is ‘waking up,’ if you will. And this is consistent with calcium being mobilized from the skeleton and going into the circulation,” Dr. Rubin explained.
Bone mineral density assessed by dual-energy x-ray absorptiometry normalized, primarily in the first 26 weeks. For lumbar spine L1-L4, mean Z-scores dropped from 1.6 to 1.0 at 26 weeks and down to 0.7 by week 100. For total hip, those values were 1.0, 0.6, and 0.4, respectively. The values approached age- and sex-matched norms, Dr. Rubin noted, to “perhaps where their skeleton would be if they hadn’t had hypoparathyroidism.”
Overall 56 of the 57 (94.9%) patients reported treatment-emergent adverse events, of which 25 (42.4%) were treatment related and none were deemed serious. There were no treatment-emergent adverse events related to hypercalcemia or hypocalcemia leading to health care visits or hospitalization, none leading to discontinuation of study drug, and none to death.
“So overall, a reassuring safety profile,” Dr. Rubin said. “We look forward to presenting the next 2 years’ worth of data to the end of the open-label extension study.”
Dr. Rubin is a paid researcher for Ascendis, which funded the study. Dr. Hoang has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE –
Findings from 110-week phase 2 data for the once-daily investigational parathyroid hormone (PTH) replacement drug were recently presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Overall, the drug was associated with independence from conventional calcium and active vitamin D therapy in most patients at 110 weeks, with no discontinuations due to adverse effects.
“Patients with hypoparathyroidism have low serum calcium levels and struggle with quality of life and biochemical abnormalities. The data from the TransCon PTH studies seem to show that a lot of these abnormalities can be reversed,” presenter Mishaela R. Rubin, MD, said in an interview.
Other PTH replacement therapies such as Nupara (now discontinued) and teriparatide (off-label) have been used in some patients with hypoparathyroidism.
However, “[TransCon PTH] is delivered in such a way as to have a prolonged half-life, so that’s kind of a special benefit that it has,” added Dr. Rubin of the division of endocrinology and metabolic bone disease, department of medicine, Columbia University, New York.
Asked to comment, session moderator Thanh Hoang, DO, of Walter Reed National Military Medical Center, Silver Spring, Md., said: “I think it’s a very promising medication because right now we don’t have a lot of options ... I think it would help a lot of patients.”
Approval denied, company addressing concerns
On May 1, the Food and Drug Administration issued a complete response letter, signaling denial of approval for the TransCon PTH, citing concerns related to manufacturing control of the product’s drug/device combination product, but not about the product’s safety and efficacy, according to an Ascendis statement.
The company is now working with the FDA to address these issues and is awaiting a European Union decision later this year.
The FDA did not request that the company conduct further clinical trials of TransCon PTH, which now include published 26-week phase 2 and phase 3 data along with the current longer-term phase 2 data presented at AACE.
“The company has said that they’re hopeful the issues will be addressable and that the FDA did not have any concerns about safety,” Dr. Rubin said in an interview.
Calcium normalized, bone turnover improved
Dr. Rubin presented long-term efficacy and safety data from the Phase 2 PaTH Forward trial, which involved 57 of the initial 59 participants who completed week 110 of an open-label extension of the trial.
During the first 4 weeks, patients had been randomized to TransCon PTH at fixed doses of 15 µg/day, 18 µg/day, 21 µg/day, or placebo. After week 4, all patients switched to TransCon PTH titrated to doses of 6-60 µg/day along with conventional therapy, with the goal of maintaining normocalcemia.
Participants were a mean age of 50 years, 81% were women, and 92% were White. Causes of hypoparathyroidism were neck surgery in 80%, autoimmune disease in 2%, and idiopathic disease in 19%. Disease duration was 12 years (range 1-39), and all were taking conventional therapy including calcium and active vitamin D (calcitriol or alfacaldiol).
At 110 weeks, all 57 patients were able to stop taking active vitamin D, and 53 of the 57 (93%) patients achieved independence from conventional therapy, defined as taking 0 µg/day of active vitamin D and no more than 600 mg/day of calcium (the dietary supplement dose). A total of 44 (77%) patients were not taking any calcium or active vitamin D.
“This really establishes the durability up to 2 years of keeping people off conventional therapy,” Dr. Rubin said during her presentation.
There was an initial uptick to 9.4 mg/dL in mean serum calcium, as some participants were still taking active vitamin D, but that dropped to 8.9 mg/dL by week 26. Mean 24-hour urine calcium dropped from 428 mg/day at baseline to 173 mg/day by week 26. Both serum calcium and urine calcium remained in the normal range through week 110 in all patients, at 8.6 mg/dL and 167 mg/day, respectively.
“This is a really important outcome because we know that high urine calcium in these patients sets them at risk for going on to develop nephrocalcinosis, nephrolithiasis, and ultimately, chronic kidney disease,” Dr. Rubin said.
Serum levels of two bone formation markers peaked at 12 weeks after initiation of TransCon PTH. Both trended downward thereafter through week 110 to levels approximating those of age- and sex-matched controls.
“Both markers started off low, consistent with hypoparathyroidism, but with initiation of TransCon PTH we see a robust increase in bone turnover markers, almost as if the bone is ‘waking up,’ if you will. And this is consistent with calcium being mobilized from the skeleton and going into the circulation,” Dr. Rubin explained.
Bone mineral density assessed by dual-energy x-ray absorptiometry normalized, primarily in the first 26 weeks. For lumbar spine L1-L4, mean Z-scores dropped from 1.6 to 1.0 at 26 weeks and down to 0.7 by week 100. For total hip, those values were 1.0, 0.6, and 0.4, respectively. The values approached age- and sex-matched norms, Dr. Rubin noted, to “perhaps where their skeleton would be if they hadn’t had hypoparathyroidism.”
Overall 56 of the 57 (94.9%) patients reported treatment-emergent adverse events, of which 25 (42.4%) were treatment related and none were deemed serious. There were no treatment-emergent adverse events related to hypercalcemia or hypocalcemia leading to health care visits or hospitalization, none leading to discontinuation of study drug, and none to death.
“So overall, a reassuring safety profile,” Dr. Rubin said. “We look forward to presenting the next 2 years’ worth of data to the end of the open-label extension study.”
Dr. Rubin is a paid researcher for Ascendis, which funded the study. Dr. Hoang has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE –
Findings from 110-week phase 2 data for the once-daily investigational parathyroid hormone (PTH) replacement drug were recently presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Overall, the drug was associated with independence from conventional calcium and active vitamin D therapy in most patients at 110 weeks, with no discontinuations due to adverse effects.
“Patients with hypoparathyroidism have low serum calcium levels and struggle with quality of life and biochemical abnormalities. The data from the TransCon PTH studies seem to show that a lot of these abnormalities can be reversed,” presenter Mishaela R. Rubin, MD, said in an interview.
Other PTH replacement therapies such as Nupara (now discontinued) and teriparatide (off-label) have been used in some patients with hypoparathyroidism.
However, “[TransCon PTH] is delivered in such a way as to have a prolonged half-life, so that’s kind of a special benefit that it has,” added Dr. Rubin of the division of endocrinology and metabolic bone disease, department of medicine, Columbia University, New York.
Asked to comment, session moderator Thanh Hoang, DO, of Walter Reed National Military Medical Center, Silver Spring, Md., said: “I think it’s a very promising medication because right now we don’t have a lot of options ... I think it would help a lot of patients.”
Approval denied, company addressing concerns
On May 1, the Food and Drug Administration issued a complete response letter, signaling denial of approval for the TransCon PTH, citing concerns related to manufacturing control of the product’s drug/device combination product, but not about the product’s safety and efficacy, according to an Ascendis statement.
The company is now working with the FDA to address these issues and is awaiting a European Union decision later this year.
The FDA did not request that the company conduct further clinical trials of TransCon PTH, which now include published 26-week phase 2 and phase 3 data along with the current longer-term phase 2 data presented at AACE.
“The company has said that they’re hopeful the issues will be addressable and that the FDA did not have any concerns about safety,” Dr. Rubin said in an interview.
Calcium normalized, bone turnover improved
Dr. Rubin presented long-term efficacy and safety data from the Phase 2 PaTH Forward trial, which involved 57 of the initial 59 participants who completed week 110 of an open-label extension of the trial.
During the first 4 weeks, patients had been randomized to TransCon PTH at fixed doses of 15 µg/day, 18 µg/day, 21 µg/day, or placebo. After week 4, all patients switched to TransCon PTH titrated to doses of 6-60 µg/day along with conventional therapy, with the goal of maintaining normocalcemia.
Participants were a mean age of 50 years, 81% were women, and 92% were White. Causes of hypoparathyroidism were neck surgery in 80%, autoimmune disease in 2%, and idiopathic disease in 19%. Disease duration was 12 years (range 1-39), and all were taking conventional therapy including calcium and active vitamin D (calcitriol or alfacaldiol).
At 110 weeks, all 57 patients were able to stop taking active vitamin D, and 53 of the 57 (93%) patients achieved independence from conventional therapy, defined as taking 0 µg/day of active vitamin D and no more than 600 mg/day of calcium (the dietary supplement dose). A total of 44 (77%) patients were not taking any calcium or active vitamin D.
“This really establishes the durability up to 2 years of keeping people off conventional therapy,” Dr. Rubin said during her presentation.
There was an initial uptick to 9.4 mg/dL in mean serum calcium, as some participants were still taking active vitamin D, but that dropped to 8.9 mg/dL by week 26. Mean 24-hour urine calcium dropped from 428 mg/day at baseline to 173 mg/day by week 26. Both serum calcium and urine calcium remained in the normal range through week 110 in all patients, at 8.6 mg/dL and 167 mg/day, respectively.
“This is a really important outcome because we know that high urine calcium in these patients sets them at risk for going on to develop nephrocalcinosis, nephrolithiasis, and ultimately, chronic kidney disease,” Dr. Rubin said.
Serum levels of two bone formation markers peaked at 12 weeks after initiation of TransCon PTH. Both trended downward thereafter through week 110 to levels approximating those of age- and sex-matched controls.
“Both markers started off low, consistent with hypoparathyroidism, but with initiation of TransCon PTH we see a robust increase in bone turnover markers, almost as if the bone is ‘waking up,’ if you will. And this is consistent with calcium being mobilized from the skeleton and going into the circulation,” Dr. Rubin explained.
Bone mineral density assessed by dual-energy x-ray absorptiometry normalized, primarily in the first 26 weeks. For lumbar spine L1-L4, mean Z-scores dropped from 1.6 to 1.0 at 26 weeks and down to 0.7 by week 100. For total hip, those values were 1.0, 0.6, and 0.4, respectively. The values approached age- and sex-matched norms, Dr. Rubin noted, to “perhaps where their skeleton would be if they hadn’t had hypoparathyroidism.”
Overall 56 of the 57 (94.9%) patients reported treatment-emergent adverse events, of which 25 (42.4%) were treatment related and none were deemed serious. There were no treatment-emergent adverse events related to hypercalcemia or hypocalcemia leading to health care visits or hospitalization, none leading to discontinuation of study drug, and none to death.
“So overall, a reassuring safety profile,” Dr. Rubin said. “We look forward to presenting the next 2 years’ worth of data to the end of the open-label extension study.”
Dr. Rubin is a paid researcher for Ascendis, which funded the study. Dr. Hoang has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT AACE 2023
Noninvasive skin test may aid in Cushing diagnosis
SEATTLE – new research suggests.
Tissue accumulation of AGEs – harmful compounds formed by glycation of macromolecules – has been implicated in aging, diabetes, and cardiovascular disease. Now, in a new single-center prospective study, a group of 208 patients with endogenous hypercortisolism was found to have significantly higher median tissue AGE levels than 103 reference subjects without hypercortisolism.
The findings were presented at the annual meeting of the American Association of Clinical Endocrinology by Rashi Sandooja, MD, an endocrinology fellow at the Mayo Clinic, Rochester, Minn.
“Diagnosis of endogenous hypercortisolism can be quite challenging. Often patients can have nonspecific symptoms with biochemical testing being equivocal. In these situations, new biomarkers of hypercortisolism such as AGE measurement could potentially be useful,” Dr. Sandooja said in an interview.
“After proper validation, it could help clinicians in cases which may not be straightforward and could serve as an additional” instrument in the toolkit to reach a conclusive diagnosis, she added.
Asked to comment, session moderator Anupam Kotwal, MD, said in an interview: “I think it’s very exciting data. ... I envision its use in mild autonomous cortisol secretion, where there are not a lot of overt Cushing features but they may have a small adrenal mass. ... It might be used to guide care when there’s not a clear-cut answer.”
However, he cautioned that more validation is needed to determine the correlates of AGEs by different etiologies and magnitudes of cortisol excess.
Moreover, “skin can become thin in hypercortisolism, so is [the reader device] just detecting it more with skin testing? I think a blood test for validation would be a very good next step,” added Dr. Kotwal, who is an assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha.
More work will be needed
Future directions for research should include adding a longitudinal arm and looking at the impact on AGE after patients undergo curative surgery and achieve remission, Dr. Sandooja explained.
“It will be interesting to see if AGE levels continue to be persistently high or decrease after patients achieve sustained remission of hypercortisolism. We are also interested in whether AGE measurement at baseline, prior to surgery may be associated with glucocorticoid withdrawal, myopathy, and metabolic outcomes following the surgery.”
Dr. Kotwal observed: “If the answer is clear for Cushing disease, I don’t know what extra information this would give. Maybe they would monitor people more closely afterward. It would be useful to see, but I think the first low-hanging fruit is use it in a way to guide the care of patients where we’re unclear as to whether initial treatment of this [mild autonomous cortisol secretion] is going to improve their outcomes.”
But, he added, “keeping in mind issues of skin ... we don’t want to distract clinicians and patients from using the tried and tested methods of characterizing Cushing syndrome. I’m always hesitant to bring something into practice before there is a little more information on how it can be used.”
Dr. Sandooja and Dr. Kotwal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SEATTLE – new research suggests.
Tissue accumulation of AGEs – harmful compounds formed by glycation of macromolecules – has been implicated in aging, diabetes, and cardiovascular disease. Now, in a new single-center prospective study, a group of 208 patients with endogenous hypercortisolism was found to have significantly higher median tissue AGE levels than 103 reference subjects without hypercortisolism.
The findings were presented at the annual meeting of the American Association of Clinical Endocrinology by Rashi Sandooja, MD, an endocrinology fellow at the Mayo Clinic, Rochester, Minn.
“Diagnosis of endogenous hypercortisolism can be quite challenging. Often patients can have nonspecific symptoms with biochemical testing being equivocal. In these situations, new biomarkers of hypercortisolism such as AGE measurement could potentially be useful,” Dr. Sandooja said in an interview.
“After proper validation, it could help clinicians in cases which may not be straightforward and could serve as an additional” instrument in the toolkit to reach a conclusive diagnosis, she added.
Asked to comment, session moderator Anupam Kotwal, MD, said in an interview: “I think it’s very exciting data. ... I envision its use in mild autonomous cortisol secretion, where there are not a lot of overt Cushing features but they may have a small adrenal mass. ... It might be used to guide care when there’s not a clear-cut answer.”
However, he cautioned that more validation is needed to determine the correlates of AGEs by different etiologies and magnitudes of cortisol excess.
Moreover, “skin can become thin in hypercortisolism, so is [the reader device] just detecting it more with skin testing? I think a blood test for validation would be a very good next step,” added Dr. Kotwal, who is an assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha.
More work will be needed
Future directions for research should include adding a longitudinal arm and looking at the impact on AGE after patients undergo curative surgery and achieve remission, Dr. Sandooja explained.
“It will be interesting to see if AGE levels continue to be persistently high or decrease after patients achieve sustained remission of hypercortisolism. We are also interested in whether AGE measurement at baseline, prior to surgery may be associated with glucocorticoid withdrawal, myopathy, and metabolic outcomes following the surgery.”
Dr. Kotwal observed: “If the answer is clear for Cushing disease, I don’t know what extra information this would give. Maybe they would monitor people more closely afterward. It would be useful to see, but I think the first low-hanging fruit is use it in a way to guide the care of patients where we’re unclear as to whether initial treatment of this [mild autonomous cortisol secretion] is going to improve their outcomes.”
But, he added, “keeping in mind issues of skin ... we don’t want to distract clinicians and patients from using the tried and tested methods of characterizing Cushing syndrome. I’m always hesitant to bring something into practice before there is a little more information on how it can be used.”
Dr. Sandooja and Dr. Kotwal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SEATTLE – new research suggests.
Tissue accumulation of AGEs – harmful compounds formed by glycation of macromolecules – has been implicated in aging, diabetes, and cardiovascular disease. Now, in a new single-center prospective study, a group of 208 patients with endogenous hypercortisolism was found to have significantly higher median tissue AGE levels than 103 reference subjects without hypercortisolism.
The findings were presented at the annual meeting of the American Association of Clinical Endocrinology by Rashi Sandooja, MD, an endocrinology fellow at the Mayo Clinic, Rochester, Minn.
“Diagnosis of endogenous hypercortisolism can be quite challenging. Often patients can have nonspecific symptoms with biochemical testing being equivocal. In these situations, new biomarkers of hypercortisolism such as AGE measurement could potentially be useful,” Dr. Sandooja said in an interview.
“After proper validation, it could help clinicians in cases which may not be straightforward and could serve as an additional” instrument in the toolkit to reach a conclusive diagnosis, she added.
Asked to comment, session moderator Anupam Kotwal, MD, said in an interview: “I think it’s very exciting data. ... I envision its use in mild autonomous cortisol secretion, where there are not a lot of overt Cushing features but they may have a small adrenal mass. ... It might be used to guide care when there’s not a clear-cut answer.”
However, he cautioned that more validation is needed to determine the correlates of AGEs by different etiologies and magnitudes of cortisol excess.
Moreover, “skin can become thin in hypercortisolism, so is [the reader device] just detecting it more with skin testing? I think a blood test for validation would be a very good next step,” added Dr. Kotwal, who is an assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha.
More work will be needed
Future directions for research should include adding a longitudinal arm and looking at the impact on AGE after patients undergo curative surgery and achieve remission, Dr. Sandooja explained.
“It will be interesting to see if AGE levels continue to be persistently high or decrease after patients achieve sustained remission of hypercortisolism. We are also interested in whether AGE measurement at baseline, prior to surgery may be associated with glucocorticoid withdrawal, myopathy, and metabolic outcomes following the surgery.”
Dr. Kotwal observed: “If the answer is clear for Cushing disease, I don’t know what extra information this would give. Maybe they would monitor people more closely afterward. It would be useful to see, but I think the first low-hanging fruit is use it in a way to guide the care of patients where we’re unclear as to whether initial treatment of this [mild autonomous cortisol secretion] is going to improve their outcomes.”
But, he added, “keeping in mind issues of skin ... we don’t want to distract clinicians and patients from using the tried and tested methods of characterizing Cushing syndrome. I’m always hesitant to bring something into practice before there is a little more information on how it can be used.”
Dr. Sandooja and Dr. Kotwal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AACE 2023
New protocol could cut fasting period to detect insulinomas
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT AACE 2023
Sulfonylureas as street drugs: Hidden hypoglycemia cause
SEATTLE – .
“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.
Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.
“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
Similar cases go back nearly two decades
Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”
Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.
The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
Persistent hypoglycemia led to the source
In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.
Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?
Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.
She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
Ocreotide: A ‘unique antidote’
In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.
“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.
However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”
Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SEATTLE – .
“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.
Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.
“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
Similar cases go back nearly two decades
Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”
Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.
The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
Persistent hypoglycemia led to the source
In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.
Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?
Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.
She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
Ocreotide: A ‘unique antidote’
In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.
“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.
However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”
Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SEATTLE – .
“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.
Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.
“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
Similar cases go back nearly two decades
Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”
Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.
The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
Persistent hypoglycemia led to the source
In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.
Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?
Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.
She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
Ocreotide: A ‘unique antidote’
In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.
“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.
However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”
Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AACE 2023
New AACE type 2 diabetes algorithm individualizes care
SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.
The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.
Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.
lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.
Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
Eleven separate algorithms with text and graphics
Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”
Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.
Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.
Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”
And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.
Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.
Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.
“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.
The end of the document includes a full page of each graphic, meant for wall posting.
Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.
“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.
Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”
“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.
Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.
A version of this article originally appeared on Medscape.com.
SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.
The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.
Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.
lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.
Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
Eleven separate algorithms with text and graphics
Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”
Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.
Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.
Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”
And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.
Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.
Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.
“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.
The end of the document includes a full page of each graphic, meant for wall posting.
Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.
“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.
Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”
“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.
Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.
A version of this article originally appeared on Medscape.com.
SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.
The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.
Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.
lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.
Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
Eleven separate algorithms with text and graphics
Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”
Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.
Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.
Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”
And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.
Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.
Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.
“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.
The end of the document includes a full page of each graphic, meant for wall posting.
Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.
“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.
Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”
“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.
Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.
A version of this article originally appeared on Medscape.com.
AT AACE 2023
New AACE statement tries to fight weight bias and stigma
SEATTLE –
Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.
The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.
Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.
Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.
Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.
To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.
“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.
The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.
Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.
“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.
Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”
However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.
Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.
But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”
Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”
In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”
Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.
A version of this article originally appeared on Medscape.com.
SEATTLE –
Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.
The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.
Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.
Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.
Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.
To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.
“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.
The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.
Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.
“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.
Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”
However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.
Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.
But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”
Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”
In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”
Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.
A version of this article originally appeared on Medscape.com.
SEATTLE –
Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.
The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.
Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.
Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.
Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.
To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.
“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.
The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.
Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.
“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.
Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”
However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.
Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.
But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”
Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”
In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”
Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.
A version of this article originally appeared on Medscape.com.
AT AACE 2023
Radiofrequency ablation successful in small thyroid cancers
SEATTLE –
RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.
Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.
“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.
Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.
Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”
But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”
He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
An alternative to waiting vs. surgery?
The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.
Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.
For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.
The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.
Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.
All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.
No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.
Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.
Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”
Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”
Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE –
RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.
Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.
“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.
Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.
Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”
But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”
He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
An alternative to waiting vs. surgery?
The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.
Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.
For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.
The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.
Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.
All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.
No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.
Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.
Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”
Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”
Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE –
RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.
Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.
“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.
Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.
Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”
But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”
He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
An alternative to waiting vs. surgery?
The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.
Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.
For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.
The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.
Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.
All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.
No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.
Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.
Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”
Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”
Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT AACE 2023