Clinical Endocrinology News is an independent news source that provides endocrinologists with timely and relevant news and commentary about clinical developments and the impact of health care policy on the endocrinologist's practice. Specialty topics include Diabetes, Lipid & Metabolic Disorders Menopause, Obesity, Osteoporosis, Pediatric Endocrinology, Pituitary, Thyroid & Adrenal Disorders, and Reproductive Endocrinology. Featured content includes Commentaries, Implementin Health Reform, Law & Medicine, and In the Loop, the blog of Clinical Endocrinology News. Clinical Endocrinology News is owned by Frontline Medical Communications.

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FDA gives semaglutide two drug safety–related label changes

Article Type
Changed
Thu, 10/05/2023 - 20:31

The hugely popular weight loss agent semaglutide (approved as Wegovy for weight loss; Ozempic for type 2 diabetes; Novo Nordisk) received a pair of drug safety–related labeling additions from the Food and Drug Administration in late September for the Ozempic formulation.

The FDA added a warning to the drug-interaction section of the Ozempic label that reiterates a warning that is already in place in other label sections, reinforcing the message that the glucagon-like peptide-1 (GLP-1) receptor agonist Ozempic can potentially interact with the action of certain other agents to increase a person’s risk for hypoglycemia.

The added text says: “Ozempic stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving Ozempic in combination with an insulin secretagogue (for instance, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.”

This text was already included in both the “Warning and Precautions” and the “Adverse Reactions” sections of the label. The warning also advises, “The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.”

Reports of ileus episodes after approval

The second addition concerns a new adverse reaction that was identified during the postmarketing experience.

The FDA has received more than 8,500 reports of gastrointestinal issues among patients prescribed glucagon-like peptide-1 (GLP-1) receptor agonists. Ileus is mentioned in 33 cases, including two deaths, associated with semaglutide. The FDA stopped short of saying there is a direct link between the drug and intestinal blockages.

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the FDA stated in its approval of the label update.

The same warning for the risk of intestinal blockages is already listed on the labels for tirzepatide (Mounjaro, Lilly) and semaglutide injection 2.4 mg (Wegovy, Novo Nordisk).

The label change comes after a Louisiana woman filed a lawsuit in August that claims she was “severely injured” after using Mounjaro and Ozempic. She claimed the drug makers failed to disclose risks of vomiting and diarrhea due to inflammation of the stomach lining, as well as the risk of gastroparesis.

*Correction, 10/3/23: An earlier version of this article misstated the semaglutide formulation that received the updates. 

A version of this article first appeared on Medscape.com.

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The hugely popular weight loss agent semaglutide (approved as Wegovy for weight loss; Ozempic for type 2 diabetes; Novo Nordisk) received a pair of drug safety–related labeling additions from the Food and Drug Administration in late September for the Ozempic formulation.

The FDA added a warning to the drug-interaction section of the Ozempic label that reiterates a warning that is already in place in other label sections, reinforcing the message that the glucagon-like peptide-1 (GLP-1) receptor agonist Ozempic can potentially interact with the action of certain other agents to increase a person’s risk for hypoglycemia.

The added text says: “Ozempic stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving Ozempic in combination with an insulin secretagogue (for instance, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.”

This text was already included in both the “Warning and Precautions” and the “Adverse Reactions” sections of the label. The warning also advises, “The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.”

Reports of ileus episodes after approval

The second addition concerns a new adverse reaction that was identified during the postmarketing experience.

The FDA has received more than 8,500 reports of gastrointestinal issues among patients prescribed glucagon-like peptide-1 (GLP-1) receptor agonists. Ileus is mentioned in 33 cases, including two deaths, associated with semaglutide. The FDA stopped short of saying there is a direct link between the drug and intestinal blockages.

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the FDA stated in its approval of the label update.

The same warning for the risk of intestinal blockages is already listed on the labels for tirzepatide (Mounjaro, Lilly) and semaglutide injection 2.4 mg (Wegovy, Novo Nordisk).

The label change comes after a Louisiana woman filed a lawsuit in August that claims she was “severely injured” after using Mounjaro and Ozempic. She claimed the drug makers failed to disclose risks of vomiting and diarrhea due to inflammation of the stomach lining, as well as the risk of gastroparesis.

*Correction, 10/3/23: An earlier version of this article misstated the semaglutide formulation that received the updates. 

A version of this article first appeared on Medscape.com.

The hugely popular weight loss agent semaglutide (approved as Wegovy for weight loss; Ozempic for type 2 diabetes; Novo Nordisk) received a pair of drug safety–related labeling additions from the Food and Drug Administration in late September for the Ozempic formulation.

The FDA added a warning to the drug-interaction section of the Ozempic label that reiterates a warning that is already in place in other label sections, reinforcing the message that the glucagon-like peptide-1 (GLP-1) receptor agonist Ozempic can potentially interact with the action of certain other agents to increase a person’s risk for hypoglycemia.

The added text says: “Ozempic stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving Ozempic in combination with an insulin secretagogue (for instance, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.”

This text was already included in both the “Warning and Precautions” and the “Adverse Reactions” sections of the label. The warning also advises, “The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.”

Reports of ileus episodes after approval

The second addition concerns a new adverse reaction that was identified during the postmarketing experience.

The FDA has received more than 8,500 reports of gastrointestinal issues among patients prescribed glucagon-like peptide-1 (GLP-1) receptor agonists. Ileus is mentioned in 33 cases, including two deaths, associated with semaglutide. The FDA stopped short of saying there is a direct link between the drug and intestinal blockages.

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the FDA stated in its approval of the label update.

The same warning for the risk of intestinal blockages is already listed on the labels for tirzepatide (Mounjaro, Lilly) and semaglutide injection 2.4 mg (Wegovy, Novo Nordisk).

The label change comes after a Louisiana woman filed a lawsuit in August that claims she was “severely injured” after using Mounjaro and Ozempic. She claimed the drug makers failed to disclose risks of vomiting and diarrhea due to inflammation of the stomach lining, as well as the risk of gastroparesis.

*Correction, 10/3/23: An earlier version of this article misstated the semaglutide formulation that received the updates. 

A version of this article first appeared on Medscape.com.

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What potential does AI offer for endocrinology?

Article Type
Changed
Thu, 09/28/2023 - 16:04

While artificial intelligence (AI) appears to be on its way to transforming all fields of medicine, its potential benefits in endocrinology, with its substantial complexity, may be uniquely important. However, hurdles encountered with the latest AI iterations of chatbots underscore the need to proceed with caution.

“In contrast to other medical fields, endocrinology is not connected to a single organ structure; rather, it is a complicated biological system of hormones and metabolites, [intertwined with] various receptors, signaling pathways and intricate feedback mechanisms,” explained the authors of a recent article on the issue in Nature Reviews Endocrinology.

With interconnections that are “often beyond the comprehension and reasoning capabilities of the human brain, AI [is anticipated] to be exceptionally well-suited to tackle this remarkable heterogeneity and complexity,” they wrote.

Since the first regulatory approvals for AI-based technology were granted back in 2015, endocrinology has already been revolutionized by AI-based tools, most notably with AI biosensors for continuous glucose monitoring systems alerting patients of glucose levels, and automated insulin-delivery systems.

AI-based machine learning has also ushered in improved detection and analysis of thyroid nodules and potential malignancies, with algorithms in the analysis of radiological test images enabling detection through a deeper analysis than can be applied with individual specialists.

Likewise, the benefits of AI in imaging extend to osteoporosis.

“Imaging certainly is one of the most promising fields, including (but not limited to) conventional radiography, computed tomography, and magnetic resonance tomography,” explained Hans Peter Dimai, MD, a professor of medicine and endocrinology at the Medical University of Graz (Austria), and the past president of the Austrian Bone and Mineral Society.

“A typical indication is fracture detection, not in terms of replacing expert radiologists or orthopedists but rather in terms of supporting those who are in specialist training,” he said in an interview.

“Particularly the underdiagnosis of vertebral fractures has been an issue in past decades, with dramatic implications for the individual, since the first vertebral fracture would multiply the risk for any future fracture, and therefore requires immediate action from a physician’s side.”

The areas expected to further benefit from AI continue to grow as systems evolve, with advances being reported across a variety of endocrinologic conditions.

Papillary thyroid cancer (PTC): Central lymph node metastasis of papillary thyroid cancer is predictive of tumor recurrence and overall survival in PTC. However, few tests are able to diagnose the metastasis in the cancer with high accuracy. Using a convolutional neural network prediction model built with a deep-learning algorithm, researchers described high diagnostic sensitivity and specificity of a model, as reported in a study published in Feburary. The prediction model, developed using genetic mutations and clinicopathologic factors, showed high prediction efficacy, with validation in subclinical as well as clinical metastasis groups, suggesting broad applicability.

Adrenal tumors: Adrenal incidentalomas, or masses that are incidentally discovered when performing abdominal imaging for other reasons, can be a perplexing clinical challenge. Discovery of these is increasing as imaging technology advances. However, an AI-based machine learning approach utilizing CT is being developed to differentiate between subclinical pheochromocytoma and lipid-poor adenomas. As reported in a 2022 study, the prediction model scoring system used traditional radiological features on CT images to provide for a noninvasive method in assisting in the diagnosis and providing personalized care for people with adrenal tumors.

Osteoporosis – bone mineral density (BMD): In the diagnosis of osteoporosis, the measurement of BMD using dual-energy x-ray absorptiometry (DXA) is the gold standard. However, the availability of DXA devices in many countries is inadequate, leaving an unmet need for alternative approaches. But one AI-based algorithm shows promising diagnostic accuracy, compared with DXA, potentially providing a low-cost screening alternative for the early diagnosis of osteoporosis.  

Osteoporosis – Fracture Risk Assessment Tool (FRAX): In fracture risk and prevention, the free FRAX tool, available online, is the gold standard and recommended in nearly all osteoporosis guidelines. However, several studies on AI-based tools show some benefit over FRAX, including one approach using longitudinal data with conventional spine radiographs, showing predictive accuracy that exceeds FRAX.  

Osteoporosis – treatment: And for the often challenging process of treatment decision-making in osteoporosis, AI-based software, developed from more than 15,000 osteoporosis patients followed over 10 years, shows high accuracy in the prediction of response to treatment in terms of BMD increase, as described in another study. “Our results show that it is feasible to use a combination of electronic medical records–derived information to develop a machine-learning algorithm to predict a BMD response following osteoporosis treatment,” the authors reported. “This alternative approach can aid physicians to select an optimal therapeutic regimen in order to maximize a patient-specific treatment outcome.”
 

 

 

Chatbot wrinkles

The prospects of large language models (LLMs) and ChatGPT unleash the potential to understand and generate text in a similar capacity as humans. Although controversial, they could likewise be compelling.

However, such systems can be vastly more complex than earlier AI-based tools, and some studies are illustrating the kinds of stumbling blocks that need to be overcome.

For instance, in a study published in May, researchers explored the potential of ChatGPT 4.0 to synthesize clinical guidelines for diabetic ketoacidosis from three different sources to reflect the latest evidence and local context.

Such efforts are important but can be very resource-intensive when conducted without the use of AI assistance.

The study’s results showed that, although ChatGPT was able to generate a comprehensive table comparing the guidelines, there were multiple recurrent errors in misreporting and nonreporting, as well as inconsistencies, “rendering the results unreliable,” the authors wrote.

“Although ChatGPT demonstrates the potential for the synthesis of clinical guidelines, the presence of multiple recurrent errors and inconsistencies underscores the need for expert human intervention and validation,” the authors concluded.

Likewise, other research using ChatGPT for use in vitreoretinal diseases, including diabetic retinopathy, further demonstrated disappointing results, with the technology showing the chatbot provided completely accurate responses to only 8 (15.4%) of 52 questions, with some responses containing inappropriate or potentially harmful medical advice.

“For example, in response to ‘How do you get rid of epiretinal membrane?’, the platform described vitrectomy but also included incorrect options of injection therapy and laser therapy,” the authors wrote.

“The study highlights the limitations of using ChatGPT for the adaptation of clinical guidelines without expert human intervention,” they concluded.

And in research published in August that looked at the ability of ChatGPT to interpret guidelines – in this case 26 diagnosis descriptions from the National Comprehensive Cancer Network – results showed that as many as one-third of treatments recommended by the chatbot were at least partially not concordant with information stated in the NCCN guidelines, with recommendations varying based on how the question about treatment was presented.

“Clinicians should advise patients that LLM chatbots are not a reliable source of treatment information,” the authors wrote.
 

Diversity concerns

Among the most prominent concerns about chatbot inaccuracy has been the known lack of racial and ethnic diversity in large databases utilized in developing AI systems, potentially resulting in critical flaws in the information the systems produce.

In an editorial published with the NCCN guideline study, Atul Butte, MD, PhD, from the University of California, San Francisco, noted that the shortcomings should be weighed with the potential benefits.

“There is no doubt that AI and LLMs are not yet perfect, and they carry biases that will need to be addressed,” Dr. Butte wrote. “These algorithms will need to be carefully monitored as they are brought into health systems, [but] this does not alter the potential of how they can improve care for both the haves and have-nots of health care.”

In a comment, Dr. Butte elaborated that, once the system flaws are refined, a key benefit will be the broader application of top standards of care to more patients who may have limited resources.

“It is a privilege to get the very best level of care from the very best centers, but that privilege is not distributable to all right now,” Dr. Butte said.

“The real potential of LLMs and AI will be their ability to be trained from the patient, clinical, and outcomes data from the very best centers, and then used to deliver the best care through digital tools to all patients, especially to those without access to the best care or [those with] limited resources,” he said.

Further commenting on the issue of potential bias with chatbots, Matthew Li, MD, from the University of Alberta, Edmonton, said that awareness of the nature of the problem and need for diversity in data for training and testing AI-systems issues appears to be improving.

“Thanks to much research on this topic in recent years, I think most AI researchers in medicine are at least aware of these challenges now, which was not the case only a few years ago,” he said in an interview.

Across specialties, “the careful deployment of AI tools accounting for issues regarding AI model generalization, biases, and performance drift will be critical for ensuring safe and fair patient care,” Dr. Li noted.

On a broader level is the ongoing general concern of the potential for over-reliance on the technology by clinicians. For example, a recent study showing radiologists across all experience levels reading mammograms were prone to automation bias when being supported by an AI-based system.

“Concerns regarding over-reliance on AI remain,” said Dr. Li, who coauthored a study published in June on the issue.

“Ongoing research into and monitoring of the impact of AI systems as they are developed and deployed will be important to ensure safe patient care moving forward,” he said.

Ultimately, the clinical benefit of AI systems to patients should be the bottom line, Dr. Dimai added.

“In my opinion, the clinical relevance, i.e., the benefit for patients and/or physicians of a to-be-developed AI tool, must be clearly proven before its development starts and first clinical studies are carried out,” he said.

“This is not always the case,” Dr. Dimai said. “In other words, innovation per se should not be the only rationale and driving force for the development of such tools.”

Dr. Li, an associate editor for the journal Radiology: Artificial Intelligence, reports no relevant financial relationships. Dr. Dimai is a member of the key medical advisor team of Image Biopsy Lab.

A version of this article first appeared on Medscape.com.

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While artificial intelligence (AI) appears to be on its way to transforming all fields of medicine, its potential benefits in endocrinology, with its substantial complexity, may be uniquely important. However, hurdles encountered with the latest AI iterations of chatbots underscore the need to proceed with caution.

“In contrast to other medical fields, endocrinology is not connected to a single organ structure; rather, it is a complicated biological system of hormones and metabolites, [intertwined with] various receptors, signaling pathways and intricate feedback mechanisms,” explained the authors of a recent article on the issue in Nature Reviews Endocrinology.

With interconnections that are “often beyond the comprehension and reasoning capabilities of the human brain, AI [is anticipated] to be exceptionally well-suited to tackle this remarkable heterogeneity and complexity,” they wrote.

Since the first regulatory approvals for AI-based technology were granted back in 2015, endocrinology has already been revolutionized by AI-based tools, most notably with AI biosensors for continuous glucose monitoring systems alerting patients of glucose levels, and automated insulin-delivery systems.

AI-based machine learning has also ushered in improved detection and analysis of thyroid nodules and potential malignancies, with algorithms in the analysis of radiological test images enabling detection through a deeper analysis than can be applied with individual specialists.

Likewise, the benefits of AI in imaging extend to osteoporosis.

“Imaging certainly is one of the most promising fields, including (but not limited to) conventional radiography, computed tomography, and magnetic resonance tomography,” explained Hans Peter Dimai, MD, a professor of medicine and endocrinology at the Medical University of Graz (Austria), and the past president of the Austrian Bone and Mineral Society.

“A typical indication is fracture detection, not in terms of replacing expert radiologists or orthopedists but rather in terms of supporting those who are in specialist training,” he said in an interview.

“Particularly the underdiagnosis of vertebral fractures has been an issue in past decades, with dramatic implications for the individual, since the first vertebral fracture would multiply the risk for any future fracture, and therefore requires immediate action from a physician’s side.”

The areas expected to further benefit from AI continue to grow as systems evolve, with advances being reported across a variety of endocrinologic conditions.

Papillary thyroid cancer (PTC): Central lymph node metastasis of papillary thyroid cancer is predictive of tumor recurrence and overall survival in PTC. However, few tests are able to diagnose the metastasis in the cancer with high accuracy. Using a convolutional neural network prediction model built with a deep-learning algorithm, researchers described high diagnostic sensitivity and specificity of a model, as reported in a study published in Feburary. The prediction model, developed using genetic mutations and clinicopathologic factors, showed high prediction efficacy, with validation in subclinical as well as clinical metastasis groups, suggesting broad applicability.

Adrenal tumors: Adrenal incidentalomas, or masses that are incidentally discovered when performing abdominal imaging for other reasons, can be a perplexing clinical challenge. Discovery of these is increasing as imaging technology advances. However, an AI-based machine learning approach utilizing CT is being developed to differentiate between subclinical pheochromocytoma and lipid-poor adenomas. As reported in a 2022 study, the prediction model scoring system used traditional radiological features on CT images to provide for a noninvasive method in assisting in the diagnosis and providing personalized care for people with adrenal tumors.

Osteoporosis – bone mineral density (BMD): In the diagnosis of osteoporosis, the measurement of BMD using dual-energy x-ray absorptiometry (DXA) is the gold standard. However, the availability of DXA devices in many countries is inadequate, leaving an unmet need for alternative approaches. But one AI-based algorithm shows promising diagnostic accuracy, compared with DXA, potentially providing a low-cost screening alternative for the early diagnosis of osteoporosis.  

Osteoporosis – Fracture Risk Assessment Tool (FRAX): In fracture risk and prevention, the free FRAX tool, available online, is the gold standard and recommended in nearly all osteoporosis guidelines. However, several studies on AI-based tools show some benefit over FRAX, including one approach using longitudinal data with conventional spine radiographs, showing predictive accuracy that exceeds FRAX.  

Osteoporosis – treatment: And for the often challenging process of treatment decision-making in osteoporosis, AI-based software, developed from more than 15,000 osteoporosis patients followed over 10 years, shows high accuracy in the prediction of response to treatment in terms of BMD increase, as described in another study. “Our results show that it is feasible to use a combination of electronic medical records–derived information to develop a machine-learning algorithm to predict a BMD response following osteoporosis treatment,” the authors reported. “This alternative approach can aid physicians to select an optimal therapeutic regimen in order to maximize a patient-specific treatment outcome.”
 

 

 

Chatbot wrinkles

The prospects of large language models (LLMs) and ChatGPT unleash the potential to understand and generate text in a similar capacity as humans. Although controversial, they could likewise be compelling.

However, such systems can be vastly more complex than earlier AI-based tools, and some studies are illustrating the kinds of stumbling blocks that need to be overcome.

For instance, in a study published in May, researchers explored the potential of ChatGPT 4.0 to synthesize clinical guidelines for diabetic ketoacidosis from three different sources to reflect the latest evidence and local context.

Such efforts are important but can be very resource-intensive when conducted without the use of AI assistance.

The study’s results showed that, although ChatGPT was able to generate a comprehensive table comparing the guidelines, there were multiple recurrent errors in misreporting and nonreporting, as well as inconsistencies, “rendering the results unreliable,” the authors wrote.

“Although ChatGPT demonstrates the potential for the synthesis of clinical guidelines, the presence of multiple recurrent errors and inconsistencies underscores the need for expert human intervention and validation,” the authors concluded.

Likewise, other research using ChatGPT for use in vitreoretinal diseases, including diabetic retinopathy, further demonstrated disappointing results, with the technology showing the chatbot provided completely accurate responses to only 8 (15.4%) of 52 questions, with some responses containing inappropriate or potentially harmful medical advice.

“For example, in response to ‘How do you get rid of epiretinal membrane?’, the platform described vitrectomy but also included incorrect options of injection therapy and laser therapy,” the authors wrote.

“The study highlights the limitations of using ChatGPT for the adaptation of clinical guidelines without expert human intervention,” they concluded.

And in research published in August that looked at the ability of ChatGPT to interpret guidelines – in this case 26 diagnosis descriptions from the National Comprehensive Cancer Network – results showed that as many as one-third of treatments recommended by the chatbot were at least partially not concordant with information stated in the NCCN guidelines, with recommendations varying based on how the question about treatment was presented.

“Clinicians should advise patients that LLM chatbots are not a reliable source of treatment information,” the authors wrote.
 

Diversity concerns

Among the most prominent concerns about chatbot inaccuracy has been the known lack of racial and ethnic diversity in large databases utilized in developing AI systems, potentially resulting in critical flaws in the information the systems produce.

In an editorial published with the NCCN guideline study, Atul Butte, MD, PhD, from the University of California, San Francisco, noted that the shortcomings should be weighed with the potential benefits.

“There is no doubt that AI and LLMs are not yet perfect, and they carry biases that will need to be addressed,” Dr. Butte wrote. “These algorithms will need to be carefully monitored as they are brought into health systems, [but] this does not alter the potential of how they can improve care for both the haves and have-nots of health care.”

In a comment, Dr. Butte elaborated that, once the system flaws are refined, a key benefit will be the broader application of top standards of care to more patients who may have limited resources.

“It is a privilege to get the very best level of care from the very best centers, but that privilege is not distributable to all right now,” Dr. Butte said.

“The real potential of LLMs and AI will be their ability to be trained from the patient, clinical, and outcomes data from the very best centers, and then used to deliver the best care through digital tools to all patients, especially to those without access to the best care or [those with] limited resources,” he said.

Further commenting on the issue of potential bias with chatbots, Matthew Li, MD, from the University of Alberta, Edmonton, said that awareness of the nature of the problem and need for diversity in data for training and testing AI-systems issues appears to be improving.

“Thanks to much research on this topic in recent years, I think most AI researchers in medicine are at least aware of these challenges now, which was not the case only a few years ago,” he said in an interview.

Across specialties, “the careful deployment of AI tools accounting for issues regarding AI model generalization, biases, and performance drift will be critical for ensuring safe and fair patient care,” Dr. Li noted.

On a broader level is the ongoing general concern of the potential for over-reliance on the technology by clinicians. For example, a recent study showing radiologists across all experience levels reading mammograms were prone to automation bias when being supported by an AI-based system.

“Concerns regarding over-reliance on AI remain,” said Dr. Li, who coauthored a study published in June on the issue.

“Ongoing research into and monitoring of the impact of AI systems as they are developed and deployed will be important to ensure safe patient care moving forward,” he said.

Ultimately, the clinical benefit of AI systems to patients should be the bottom line, Dr. Dimai added.

“In my opinion, the clinical relevance, i.e., the benefit for patients and/or physicians of a to-be-developed AI tool, must be clearly proven before its development starts and first clinical studies are carried out,” he said.

“This is not always the case,” Dr. Dimai said. “In other words, innovation per se should not be the only rationale and driving force for the development of such tools.”

Dr. Li, an associate editor for the journal Radiology: Artificial Intelligence, reports no relevant financial relationships. Dr. Dimai is a member of the key medical advisor team of Image Biopsy Lab.

A version of this article first appeared on Medscape.com.

While artificial intelligence (AI) appears to be on its way to transforming all fields of medicine, its potential benefits in endocrinology, with its substantial complexity, may be uniquely important. However, hurdles encountered with the latest AI iterations of chatbots underscore the need to proceed with caution.

“In contrast to other medical fields, endocrinology is not connected to a single organ structure; rather, it is a complicated biological system of hormones and metabolites, [intertwined with] various receptors, signaling pathways and intricate feedback mechanisms,” explained the authors of a recent article on the issue in Nature Reviews Endocrinology.

With interconnections that are “often beyond the comprehension and reasoning capabilities of the human brain, AI [is anticipated] to be exceptionally well-suited to tackle this remarkable heterogeneity and complexity,” they wrote.

Since the first regulatory approvals for AI-based technology were granted back in 2015, endocrinology has already been revolutionized by AI-based tools, most notably with AI biosensors for continuous glucose monitoring systems alerting patients of glucose levels, and automated insulin-delivery systems.

AI-based machine learning has also ushered in improved detection and analysis of thyroid nodules and potential malignancies, with algorithms in the analysis of radiological test images enabling detection through a deeper analysis than can be applied with individual specialists.

Likewise, the benefits of AI in imaging extend to osteoporosis.

“Imaging certainly is one of the most promising fields, including (but not limited to) conventional radiography, computed tomography, and magnetic resonance tomography,” explained Hans Peter Dimai, MD, a professor of medicine and endocrinology at the Medical University of Graz (Austria), and the past president of the Austrian Bone and Mineral Society.

“A typical indication is fracture detection, not in terms of replacing expert radiologists or orthopedists but rather in terms of supporting those who are in specialist training,” he said in an interview.

“Particularly the underdiagnosis of vertebral fractures has been an issue in past decades, with dramatic implications for the individual, since the first vertebral fracture would multiply the risk for any future fracture, and therefore requires immediate action from a physician’s side.”

The areas expected to further benefit from AI continue to grow as systems evolve, with advances being reported across a variety of endocrinologic conditions.

Papillary thyroid cancer (PTC): Central lymph node metastasis of papillary thyroid cancer is predictive of tumor recurrence and overall survival in PTC. However, few tests are able to diagnose the metastasis in the cancer with high accuracy. Using a convolutional neural network prediction model built with a deep-learning algorithm, researchers described high diagnostic sensitivity and specificity of a model, as reported in a study published in Feburary. The prediction model, developed using genetic mutations and clinicopathologic factors, showed high prediction efficacy, with validation in subclinical as well as clinical metastasis groups, suggesting broad applicability.

Adrenal tumors: Adrenal incidentalomas, or masses that are incidentally discovered when performing abdominal imaging for other reasons, can be a perplexing clinical challenge. Discovery of these is increasing as imaging technology advances. However, an AI-based machine learning approach utilizing CT is being developed to differentiate between subclinical pheochromocytoma and lipid-poor adenomas. As reported in a 2022 study, the prediction model scoring system used traditional radiological features on CT images to provide for a noninvasive method in assisting in the diagnosis and providing personalized care for people with adrenal tumors.

Osteoporosis – bone mineral density (BMD): In the diagnosis of osteoporosis, the measurement of BMD using dual-energy x-ray absorptiometry (DXA) is the gold standard. However, the availability of DXA devices in many countries is inadequate, leaving an unmet need for alternative approaches. But one AI-based algorithm shows promising diagnostic accuracy, compared with DXA, potentially providing a low-cost screening alternative for the early diagnosis of osteoporosis.  

Osteoporosis – Fracture Risk Assessment Tool (FRAX): In fracture risk and prevention, the free FRAX tool, available online, is the gold standard and recommended in nearly all osteoporosis guidelines. However, several studies on AI-based tools show some benefit over FRAX, including one approach using longitudinal data with conventional spine radiographs, showing predictive accuracy that exceeds FRAX.  

Osteoporosis – treatment: And for the often challenging process of treatment decision-making in osteoporosis, AI-based software, developed from more than 15,000 osteoporosis patients followed over 10 years, shows high accuracy in the prediction of response to treatment in terms of BMD increase, as described in another study. “Our results show that it is feasible to use a combination of electronic medical records–derived information to develop a machine-learning algorithm to predict a BMD response following osteoporosis treatment,” the authors reported. “This alternative approach can aid physicians to select an optimal therapeutic regimen in order to maximize a patient-specific treatment outcome.”
 

 

 

Chatbot wrinkles

The prospects of large language models (LLMs) and ChatGPT unleash the potential to understand and generate text in a similar capacity as humans. Although controversial, they could likewise be compelling.

However, such systems can be vastly more complex than earlier AI-based tools, and some studies are illustrating the kinds of stumbling blocks that need to be overcome.

For instance, in a study published in May, researchers explored the potential of ChatGPT 4.0 to synthesize clinical guidelines for diabetic ketoacidosis from three different sources to reflect the latest evidence and local context.

Such efforts are important but can be very resource-intensive when conducted without the use of AI assistance.

The study’s results showed that, although ChatGPT was able to generate a comprehensive table comparing the guidelines, there were multiple recurrent errors in misreporting and nonreporting, as well as inconsistencies, “rendering the results unreliable,” the authors wrote.

“Although ChatGPT demonstrates the potential for the synthesis of clinical guidelines, the presence of multiple recurrent errors and inconsistencies underscores the need for expert human intervention and validation,” the authors concluded.

Likewise, other research using ChatGPT for use in vitreoretinal diseases, including diabetic retinopathy, further demonstrated disappointing results, with the technology showing the chatbot provided completely accurate responses to only 8 (15.4%) of 52 questions, with some responses containing inappropriate or potentially harmful medical advice.

“For example, in response to ‘How do you get rid of epiretinal membrane?’, the platform described vitrectomy but also included incorrect options of injection therapy and laser therapy,” the authors wrote.

“The study highlights the limitations of using ChatGPT for the adaptation of clinical guidelines without expert human intervention,” they concluded.

And in research published in August that looked at the ability of ChatGPT to interpret guidelines – in this case 26 diagnosis descriptions from the National Comprehensive Cancer Network – results showed that as many as one-third of treatments recommended by the chatbot were at least partially not concordant with information stated in the NCCN guidelines, with recommendations varying based on how the question about treatment was presented.

“Clinicians should advise patients that LLM chatbots are not a reliable source of treatment information,” the authors wrote.
 

Diversity concerns

Among the most prominent concerns about chatbot inaccuracy has been the known lack of racial and ethnic diversity in large databases utilized in developing AI systems, potentially resulting in critical flaws in the information the systems produce.

In an editorial published with the NCCN guideline study, Atul Butte, MD, PhD, from the University of California, San Francisco, noted that the shortcomings should be weighed with the potential benefits.

“There is no doubt that AI and LLMs are not yet perfect, and they carry biases that will need to be addressed,” Dr. Butte wrote. “These algorithms will need to be carefully monitored as they are brought into health systems, [but] this does not alter the potential of how they can improve care for both the haves and have-nots of health care.”

In a comment, Dr. Butte elaborated that, once the system flaws are refined, a key benefit will be the broader application of top standards of care to more patients who may have limited resources.

“It is a privilege to get the very best level of care from the very best centers, but that privilege is not distributable to all right now,” Dr. Butte said.

“The real potential of LLMs and AI will be their ability to be trained from the patient, clinical, and outcomes data from the very best centers, and then used to deliver the best care through digital tools to all patients, especially to those without access to the best care or [those with] limited resources,” he said.

Further commenting on the issue of potential bias with chatbots, Matthew Li, MD, from the University of Alberta, Edmonton, said that awareness of the nature of the problem and need for diversity in data for training and testing AI-systems issues appears to be improving.

“Thanks to much research on this topic in recent years, I think most AI researchers in medicine are at least aware of these challenges now, which was not the case only a few years ago,” he said in an interview.

Across specialties, “the careful deployment of AI tools accounting for issues regarding AI model generalization, biases, and performance drift will be critical for ensuring safe and fair patient care,” Dr. Li noted.

On a broader level is the ongoing general concern of the potential for over-reliance on the technology by clinicians. For example, a recent study showing radiologists across all experience levels reading mammograms were prone to automation bias when being supported by an AI-based system.

“Concerns regarding over-reliance on AI remain,” said Dr. Li, who coauthored a study published in June on the issue.

“Ongoing research into and monitoring of the impact of AI systems as they are developed and deployed will be important to ensure safe patient care moving forward,” he said.

Ultimately, the clinical benefit of AI systems to patients should be the bottom line, Dr. Dimai added.

“In my opinion, the clinical relevance, i.e., the benefit for patients and/or physicians of a to-be-developed AI tool, must be clearly proven before its development starts and first clinical studies are carried out,” he said.

“This is not always the case,” Dr. Dimai said. “In other words, innovation per se should not be the only rationale and driving force for the development of such tools.”

Dr. Li, an associate editor for the journal Radiology: Artificial Intelligence, reports no relevant financial relationships. Dr. Dimai is a member of the key medical advisor team of Image Biopsy Lab.

A version of this article first appeared on Medscape.com.

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Hormone replacement therapy for postmenopausal osteoporosis

Article Type
Changed
Thu, 09/28/2023 - 14:05

The actress Sally Field recently described her struggles with postmenopausal osteoporosis – she was given the diagnosis when she was 60 years old despite being physically active and engaging in activities such as biking, hiking, and yoga. As a slim, White woman in her sixth decade of life, she certainly had several risk factors for osteoporosis.

Osteoporosis, a condition associated with weak bones and an increased risk for fracture, is common in women after menopause. It’s defined as a bone mineral density (BMD) T-score of less than or equal to –2.5 on dual-energy x-ray absorptiometry (DXA) scan, occurrence of a spine or hip fracture regardless of BMD, or a BMD T-score between –1 and –2.5, along with a history of certain kinds of fractures or increased fracture risk based on the Fracture Risk Assessment Tool (FRAX).

Massachusetts General Hospital
Dr. Madhusmita Misra


The National Health and Nutrition Examination Survey from 2013 to 2014 reported that 16.5 % of women aged 50 years or older in the U.S. have osteoporosis (vs. only 5% of men of a similar age), with an increasing prevalence with increasing age. For example, the risk for osteoporosis of the hip increases from about 7% in women 50-59 years of age to about 35% in those aged 80 years or older. The risk for postmenopausal osteoporosis is reported to be highest in Asian women (40%), followed by Hispanic (20.5%), non-Hispanic White (17%), and non-Hispanic Black women (8.2%).
 

Why increased fracture risk in postmenopausal women?

The primary cause of postmenopausal osteoporosis is the cessation of estrogen production by the ovaries around the menopausal transition. Estrogen is very important for bone health. It reduces bone loss by reducing levels of receptor activator of NF-kappa B ligand (RANKL) and sclerostin, and it probably also increases bone formation through its effects on sclerostin.

Around menopause, the decrease in estrogen levels results in an increase in RANKL and sclerostin, with a consequent increase in bone loss at a pace that exceeds the rate of bone formation, thereby leading to osteoporosis.

Many factors further increase the risk for osteoporosis and fracture in postmenopausal women. These include a sedentary lifestyle, lower body weight, family history of osteoporosis, smoking, and certain medications and diseases. Medications that adversely affect bone health at this age include (but are not limited to) glucocorticoids such as hydrocortisone, prednisone, and dexamethasone; letrozole; excess thyroid hormone; certain drugs used to treat cancer; immunosuppressive drugs; certain antiseizure medications; proton pump inhibitors (such as omeprazole); sodium-glucose cotransporter 2 inhibitors and certain other drugs used to treat type 2 diabetes; and selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors (used to treat anxiety and depression).

Diseases associated with increased osteoporosis risk include certain genetic conditions affecting bone, a history of early ovarian insufficiency, hyperthyroidism, high levels of cortisol, diabetes, hyperparathyroidism, eating disorders, obesity, calcium and vitamin D deficiency, excess urinary excretion of calcium, malabsorption and certain gastrointestinal surgeries, chronic kidney disease, rheumatoid arthritis, certain types of cancer, and frailty.

Furthermore, older age, low bone density, a previous history of fracture, a family history of hip fracture, smoking, and excessive alcohol intake increase the risk for an osteoporotic fracture in a postmenopausal woman.

Bone density assessment using DXA is recommended in postmenopausal women who are at increased risk for low bone density and fracture. Monitoring of bone density is typically initiated about 5 years after the menopausal transition but should be considered earlier in those at high risk for osteoporosis. Women who are aged 70 or older, and those who have had significant height loss, should also get radiography of the spine to look for vertebral fractures.

Optimal nutrition is important for all postmenopausal women. Weight extremes are to be avoided. Although the use of calcium and vitamin D supplementation in postmenopausal women is still debated, the Institute of Medicine recommends that women 51-70 years of age take 1,000-1,200 mg of calcium and 400-600 IU of vitamin D daily, and that those older than 70 years take 1,000-1,200 mg of calcium and 400-800 IU of vitamin D daily.

Women with low vitamin D levels often require higher doses of vitamin D. It’s very important to avoid smoking and excessive alcohol consumption. Optimizing protein intake and exercises that improve muscle strength and improve balance can reduce the risk for falls, a key contributor to osteoporotic fractures.
 

 

 

Estrogen to prevent fracture risk

Because estrogen deficiency is a key cause of postmenopausal osteoporosis, estrogen replacement therapy has been used to prevent this condition, particularly early in the menopausal transition (51-60 years). Different formulations of estrogen given via oral or transdermal routes have been demonstrated to prevent osteoporosis; transdermal estrogen is often preferred because of a lower risk for blood clots and stroke. Women who have an intact uterus should also receive a progestin preparation either daily or cyclically, because estrogen alone can increase the risk for uterine cancer in the long run. Estrogen replacement has been associated with a 34% reduction in vertebral, hip, and total fractures in women of this age group.

Sally Field did receive hormone replacement therapy, which was helpful for her bones. However, as typically happens, her bone density dropped again when she discontinued hormone replacement. She also had low vitamin D levels, but vitamin D supplementation was not helpful. She received other medical intervention, with recovery back to good bone health.

Raloxifene is a medication that acts on the estrogen receptor, with beneficial effects on bone, and is approved for prevention and treatment of postmenopausal osteoporosis.

Medications that reduce bone loss (antiresorptive drugs), such as bisphosphonates and denosumab, and those that increase bone formation (osteoanabolic drugs), such as teriparatide, abaloparatide, and romosozumab, are used alone or in combination in women whose osteoporosis doesn’t respond to lifestyle and preventive strategies. The osteoanabolic drugs are typically reserved for women at very high risk for fractures, such as those with a BMD T-score ≤ less than or equal to –3, older women with recent fractures, and those with other risk factors. Treatment is typically lifelong.

Postmenopausal osteoporosis can have far-reaching consequences on one’s quality of life, given the risk for fractures that are often associated with hospitalization, surgery, and long periods of rehabilitation (such as fractures of the spine and hip). It’s important to recognize those at greatest risk for this condition; implement bone health monitoring in a timely fashion; and ensure optimal nutrition, calcium and vitamin D supplementation, and exercises that optimize muscle strength and balance. Hormone replacement therapy is a consideration in many women. Some women will require antiresorptive or osteoanabolic drugs to manage this condition. With optimal treatment, older women can live long and productive lives.

Dr. Misra is Chief, Division of Pediatric Endocrinology, Mass General for Children; Associate Director, Harvard Catalyst Translation and Clinical Research Center; Director, Pediatric Endocrine-Sports Endocrine-Neuroendocrine Lab, Mass General Hospital; Professor, department of pediatrics, Harvard Medical School, Boston. She has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Sanofi; Ipsen.

A version of this article first appeared on Medscape.com.

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The actress Sally Field recently described her struggles with postmenopausal osteoporosis – she was given the diagnosis when she was 60 years old despite being physically active and engaging in activities such as biking, hiking, and yoga. As a slim, White woman in her sixth decade of life, she certainly had several risk factors for osteoporosis.

Osteoporosis, a condition associated with weak bones and an increased risk for fracture, is common in women after menopause. It’s defined as a bone mineral density (BMD) T-score of less than or equal to –2.5 on dual-energy x-ray absorptiometry (DXA) scan, occurrence of a spine or hip fracture regardless of BMD, or a BMD T-score between –1 and –2.5, along with a history of certain kinds of fractures or increased fracture risk based on the Fracture Risk Assessment Tool (FRAX).

Massachusetts General Hospital
Dr. Madhusmita Misra


The National Health and Nutrition Examination Survey from 2013 to 2014 reported that 16.5 % of women aged 50 years or older in the U.S. have osteoporosis (vs. only 5% of men of a similar age), with an increasing prevalence with increasing age. For example, the risk for osteoporosis of the hip increases from about 7% in women 50-59 years of age to about 35% in those aged 80 years or older. The risk for postmenopausal osteoporosis is reported to be highest in Asian women (40%), followed by Hispanic (20.5%), non-Hispanic White (17%), and non-Hispanic Black women (8.2%).
 

Why increased fracture risk in postmenopausal women?

The primary cause of postmenopausal osteoporosis is the cessation of estrogen production by the ovaries around the menopausal transition. Estrogen is very important for bone health. It reduces bone loss by reducing levels of receptor activator of NF-kappa B ligand (RANKL) and sclerostin, and it probably also increases bone formation through its effects on sclerostin.

Around menopause, the decrease in estrogen levels results in an increase in RANKL and sclerostin, with a consequent increase in bone loss at a pace that exceeds the rate of bone formation, thereby leading to osteoporosis.

Many factors further increase the risk for osteoporosis and fracture in postmenopausal women. These include a sedentary lifestyle, lower body weight, family history of osteoporosis, smoking, and certain medications and diseases. Medications that adversely affect bone health at this age include (but are not limited to) glucocorticoids such as hydrocortisone, prednisone, and dexamethasone; letrozole; excess thyroid hormone; certain drugs used to treat cancer; immunosuppressive drugs; certain antiseizure medications; proton pump inhibitors (such as omeprazole); sodium-glucose cotransporter 2 inhibitors and certain other drugs used to treat type 2 diabetes; and selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors (used to treat anxiety and depression).

Diseases associated with increased osteoporosis risk include certain genetic conditions affecting bone, a history of early ovarian insufficiency, hyperthyroidism, high levels of cortisol, diabetes, hyperparathyroidism, eating disorders, obesity, calcium and vitamin D deficiency, excess urinary excretion of calcium, malabsorption and certain gastrointestinal surgeries, chronic kidney disease, rheumatoid arthritis, certain types of cancer, and frailty.

Furthermore, older age, low bone density, a previous history of fracture, a family history of hip fracture, smoking, and excessive alcohol intake increase the risk for an osteoporotic fracture in a postmenopausal woman.

Bone density assessment using DXA is recommended in postmenopausal women who are at increased risk for low bone density and fracture. Monitoring of bone density is typically initiated about 5 years after the menopausal transition but should be considered earlier in those at high risk for osteoporosis. Women who are aged 70 or older, and those who have had significant height loss, should also get radiography of the spine to look for vertebral fractures.

Optimal nutrition is important for all postmenopausal women. Weight extremes are to be avoided. Although the use of calcium and vitamin D supplementation in postmenopausal women is still debated, the Institute of Medicine recommends that women 51-70 years of age take 1,000-1,200 mg of calcium and 400-600 IU of vitamin D daily, and that those older than 70 years take 1,000-1,200 mg of calcium and 400-800 IU of vitamin D daily.

Women with low vitamin D levels often require higher doses of vitamin D. It’s very important to avoid smoking and excessive alcohol consumption. Optimizing protein intake and exercises that improve muscle strength and improve balance can reduce the risk for falls, a key contributor to osteoporotic fractures.
 

 

 

Estrogen to prevent fracture risk

Because estrogen deficiency is a key cause of postmenopausal osteoporosis, estrogen replacement therapy has been used to prevent this condition, particularly early in the menopausal transition (51-60 years). Different formulations of estrogen given via oral or transdermal routes have been demonstrated to prevent osteoporosis; transdermal estrogen is often preferred because of a lower risk for blood clots and stroke. Women who have an intact uterus should also receive a progestin preparation either daily or cyclically, because estrogen alone can increase the risk for uterine cancer in the long run. Estrogen replacement has been associated with a 34% reduction in vertebral, hip, and total fractures in women of this age group.

Sally Field did receive hormone replacement therapy, which was helpful for her bones. However, as typically happens, her bone density dropped again when she discontinued hormone replacement. She also had low vitamin D levels, but vitamin D supplementation was not helpful. She received other medical intervention, with recovery back to good bone health.

Raloxifene is a medication that acts on the estrogen receptor, with beneficial effects on bone, and is approved for prevention and treatment of postmenopausal osteoporosis.

Medications that reduce bone loss (antiresorptive drugs), such as bisphosphonates and denosumab, and those that increase bone formation (osteoanabolic drugs), such as teriparatide, abaloparatide, and romosozumab, are used alone or in combination in women whose osteoporosis doesn’t respond to lifestyle and preventive strategies. The osteoanabolic drugs are typically reserved for women at very high risk for fractures, such as those with a BMD T-score ≤ less than or equal to –3, older women with recent fractures, and those with other risk factors. Treatment is typically lifelong.

Postmenopausal osteoporosis can have far-reaching consequences on one’s quality of life, given the risk for fractures that are often associated with hospitalization, surgery, and long periods of rehabilitation (such as fractures of the spine and hip). It’s important to recognize those at greatest risk for this condition; implement bone health monitoring in a timely fashion; and ensure optimal nutrition, calcium and vitamin D supplementation, and exercises that optimize muscle strength and balance. Hormone replacement therapy is a consideration in many women. Some women will require antiresorptive or osteoanabolic drugs to manage this condition. With optimal treatment, older women can live long and productive lives.

Dr. Misra is Chief, Division of Pediatric Endocrinology, Mass General for Children; Associate Director, Harvard Catalyst Translation and Clinical Research Center; Director, Pediatric Endocrine-Sports Endocrine-Neuroendocrine Lab, Mass General Hospital; Professor, department of pediatrics, Harvard Medical School, Boston. She has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Sanofi; Ipsen.

A version of this article first appeared on Medscape.com.

The actress Sally Field recently described her struggles with postmenopausal osteoporosis – she was given the diagnosis when she was 60 years old despite being physically active and engaging in activities such as biking, hiking, and yoga. As a slim, White woman in her sixth decade of life, she certainly had several risk factors for osteoporosis.

Osteoporosis, a condition associated with weak bones and an increased risk for fracture, is common in women after menopause. It’s defined as a bone mineral density (BMD) T-score of less than or equal to –2.5 on dual-energy x-ray absorptiometry (DXA) scan, occurrence of a spine or hip fracture regardless of BMD, or a BMD T-score between –1 and –2.5, along with a history of certain kinds of fractures or increased fracture risk based on the Fracture Risk Assessment Tool (FRAX).

Massachusetts General Hospital
Dr. Madhusmita Misra


The National Health and Nutrition Examination Survey from 2013 to 2014 reported that 16.5 % of women aged 50 years or older in the U.S. have osteoporosis (vs. only 5% of men of a similar age), with an increasing prevalence with increasing age. For example, the risk for osteoporosis of the hip increases from about 7% in women 50-59 years of age to about 35% in those aged 80 years or older. The risk for postmenopausal osteoporosis is reported to be highest in Asian women (40%), followed by Hispanic (20.5%), non-Hispanic White (17%), and non-Hispanic Black women (8.2%).
 

Why increased fracture risk in postmenopausal women?

The primary cause of postmenopausal osteoporosis is the cessation of estrogen production by the ovaries around the menopausal transition. Estrogen is very important for bone health. It reduces bone loss by reducing levels of receptor activator of NF-kappa B ligand (RANKL) and sclerostin, and it probably also increases bone formation through its effects on sclerostin.

Around menopause, the decrease in estrogen levels results in an increase in RANKL and sclerostin, with a consequent increase in bone loss at a pace that exceeds the rate of bone formation, thereby leading to osteoporosis.

Many factors further increase the risk for osteoporosis and fracture in postmenopausal women. These include a sedentary lifestyle, lower body weight, family history of osteoporosis, smoking, and certain medications and diseases. Medications that adversely affect bone health at this age include (but are not limited to) glucocorticoids such as hydrocortisone, prednisone, and dexamethasone; letrozole; excess thyroid hormone; certain drugs used to treat cancer; immunosuppressive drugs; certain antiseizure medications; proton pump inhibitors (such as omeprazole); sodium-glucose cotransporter 2 inhibitors and certain other drugs used to treat type 2 diabetes; and selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors (used to treat anxiety and depression).

Diseases associated with increased osteoporosis risk include certain genetic conditions affecting bone, a history of early ovarian insufficiency, hyperthyroidism, high levels of cortisol, diabetes, hyperparathyroidism, eating disorders, obesity, calcium and vitamin D deficiency, excess urinary excretion of calcium, malabsorption and certain gastrointestinal surgeries, chronic kidney disease, rheumatoid arthritis, certain types of cancer, and frailty.

Furthermore, older age, low bone density, a previous history of fracture, a family history of hip fracture, smoking, and excessive alcohol intake increase the risk for an osteoporotic fracture in a postmenopausal woman.

Bone density assessment using DXA is recommended in postmenopausal women who are at increased risk for low bone density and fracture. Monitoring of bone density is typically initiated about 5 years after the menopausal transition but should be considered earlier in those at high risk for osteoporosis. Women who are aged 70 or older, and those who have had significant height loss, should also get radiography of the spine to look for vertebral fractures.

Optimal nutrition is important for all postmenopausal women. Weight extremes are to be avoided. Although the use of calcium and vitamin D supplementation in postmenopausal women is still debated, the Institute of Medicine recommends that women 51-70 years of age take 1,000-1,200 mg of calcium and 400-600 IU of vitamin D daily, and that those older than 70 years take 1,000-1,200 mg of calcium and 400-800 IU of vitamin D daily.

Women with low vitamin D levels often require higher doses of vitamin D. It’s very important to avoid smoking and excessive alcohol consumption. Optimizing protein intake and exercises that improve muscle strength and improve balance can reduce the risk for falls, a key contributor to osteoporotic fractures.
 

 

 

Estrogen to prevent fracture risk

Because estrogen deficiency is a key cause of postmenopausal osteoporosis, estrogen replacement therapy has been used to prevent this condition, particularly early in the menopausal transition (51-60 years). Different formulations of estrogen given via oral or transdermal routes have been demonstrated to prevent osteoporosis; transdermal estrogen is often preferred because of a lower risk for blood clots and stroke. Women who have an intact uterus should also receive a progestin preparation either daily or cyclically, because estrogen alone can increase the risk for uterine cancer in the long run. Estrogen replacement has been associated with a 34% reduction in vertebral, hip, and total fractures in women of this age group.

Sally Field did receive hormone replacement therapy, which was helpful for her bones. However, as typically happens, her bone density dropped again when she discontinued hormone replacement. She also had low vitamin D levels, but vitamin D supplementation was not helpful. She received other medical intervention, with recovery back to good bone health.

Raloxifene is a medication that acts on the estrogen receptor, with beneficial effects on bone, and is approved for prevention and treatment of postmenopausal osteoporosis.

Medications that reduce bone loss (antiresorptive drugs), such as bisphosphonates and denosumab, and those that increase bone formation (osteoanabolic drugs), such as teriparatide, abaloparatide, and romosozumab, are used alone or in combination in women whose osteoporosis doesn’t respond to lifestyle and preventive strategies. The osteoanabolic drugs are typically reserved for women at very high risk for fractures, such as those with a BMD T-score ≤ less than or equal to –3, older women with recent fractures, and those with other risk factors. Treatment is typically lifelong.

Postmenopausal osteoporosis can have far-reaching consequences on one’s quality of life, given the risk for fractures that are often associated with hospitalization, surgery, and long periods of rehabilitation (such as fractures of the spine and hip). It’s important to recognize those at greatest risk for this condition; implement bone health monitoring in a timely fashion; and ensure optimal nutrition, calcium and vitamin D supplementation, and exercises that optimize muscle strength and balance. Hormone replacement therapy is a consideration in many women. Some women will require antiresorptive or osteoanabolic drugs to manage this condition. With optimal treatment, older women can live long and productive lives.

Dr. Misra is Chief, Division of Pediatric Endocrinology, Mass General for Children; Associate Director, Harvard Catalyst Translation and Clinical Research Center; Director, Pediatric Endocrine-Sports Endocrine-Neuroendocrine Lab, Mass General Hospital; Professor, department of pediatrics, Harvard Medical School, Boston. She has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Sanofi; Ipsen.

A version of this article first appeared on Medscape.com.

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ACP addresses ethical issues for ‘grateful patients’ physician fundraising

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Thu, 09/28/2023 - 10:43

Patients sometimes want to give back to their physician or hospital. In recent years, the practice of soliciting donations from these patients has grown into structured fundraising initiatives at some health care organizations. Some employers mandate clinicians solicit donations, while other doctors participate voluntarily.

But the nation’s second-largest physician group is cautioning its members not to ask their patients for donations to the clinician’s workplace.

“In recent decades, more physician practices have become part of large health systems: these arrangements can offer benefits to care but can also lead to interference in the patient-physician relationship and challenges to the physician’s ethical responsibilities to patients,” said Omar T. Atiq, MD, president of the American College of Physicians.

Grateful patient fundraising (GPF) is largely based on models of charitable giving outside of health care and is relatively new to the industry. Simply defined, it is the solicitation of donations by doctors from current and former patients. Funds may be used for operating costs, clinical research, equipment upgrades, or facility improvements.

In a newly published position paper, the ACP, which represents roughly 161,000 physicians, is clear that clinicians should not try to convert their patients into donors.

“Physicians who directly solicit funds from their own patients do risk interfering with the physician-patient relationship, which is supposed to be based on the patient’s best interests, not the physicians’ interests,” said Stacey A. Tovino, JD, PhD, director of health care law programs at the University of Oklahoma, Norman.

Once involved in fundraising, patients may also develop an unrealistic expectation of what kind of care they should receive, according to the ACP.

Another pitfall clinicians may fall into is the HIPAA Privacy Rule. In 2013, HIPAA was expanded to allow hospital fundraisers to access privileged health information, including demographic, health insurance, treating clinician, and data on outcomes. Dr. Atiq said that, since then, electronic health records have been used as tools to aide fundraising efforts. For instance, some health care organizations have embedded a feature inside EHRs to allow physicians to flag development officers when a patient or family member might be a potential donor. 

Patients may be unaware that hospital fundraising departments have access to their electronic health records, or that they have the right to opt out of fundraising solicitations.

“Physicians should not use or reveal patient information for fundraising,” Dr. Atiq said. “Even acknowledging that a person is under one’s care can make it possible for protected health information to be revealed.”

Data-mining EHRs may be legal, Ms. Tovino said, but it hugs a fine ethical line.

“A patient may not expect that their information will be used for these purposes and may not know how to opt out of having their information used in these ways,” Ms. Tovino said.

A clinician’s employment contract, whether it be a full-time position or for specific admitting privileges, may make it hard for them to push back against expectations to ask patients for money or screen for donors. Metrics or expectations to approach potential donors create ethical snares for clinicians – and it pits them between their patient and place of employment.

“GPF does raise ethical concerns, including those surrounding confidentiality and privacy, and whether physicians are being remunerated or evaluated based on their participation,” Ms. Tovino said.

Asked how doctors can avoid being involved in GPF, Dr. Atiq referred to the ACP ethics manual, which separates clinicians from fundraising.

“Redirecting the patient to discuss donations with institutional administrators provides the appropriate venue and firewall,” he said.

An author of the ACP paper reported a paid position on the board of the Government Employees Health Association.

A version of this article first appeared on Medscape.com.

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Patients sometimes want to give back to their physician or hospital. In recent years, the practice of soliciting donations from these patients has grown into structured fundraising initiatives at some health care organizations. Some employers mandate clinicians solicit donations, while other doctors participate voluntarily.

But the nation’s second-largest physician group is cautioning its members not to ask their patients for donations to the clinician’s workplace.

“In recent decades, more physician practices have become part of large health systems: these arrangements can offer benefits to care but can also lead to interference in the patient-physician relationship and challenges to the physician’s ethical responsibilities to patients,” said Omar T. Atiq, MD, president of the American College of Physicians.

Grateful patient fundraising (GPF) is largely based on models of charitable giving outside of health care and is relatively new to the industry. Simply defined, it is the solicitation of donations by doctors from current and former patients. Funds may be used for operating costs, clinical research, equipment upgrades, or facility improvements.

In a newly published position paper, the ACP, which represents roughly 161,000 physicians, is clear that clinicians should not try to convert their patients into donors.

“Physicians who directly solicit funds from their own patients do risk interfering with the physician-patient relationship, which is supposed to be based on the patient’s best interests, not the physicians’ interests,” said Stacey A. Tovino, JD, PhD, director of health care law programs at the University of Oklahoma, Norman.

Once involved in fundraising, patients may also develop an unrealistic expectation of what kind of care they should receive, according to the ACP.

Another pitfall clinicians may fall into is the HIPAA Privacy Rule. In 2013, HIPAA was expanded to allow hospital fundraisers to access privileged health information, including demographic, health insurance, treating clinician, and data on outcomes. Dr. Atiq said that, since then, electronic health records have been used as tools to aide fundraising efforts. For instance, some health care organizations have embedded a feature inside EHRs to allow physicians to flag development officers when a patient or family member might be a potential donor. 

Patients may be unaware that hospital fundraising departments have access to their electronic health records, or that they have the right to opt out of fundraising solicitations.

“Physicians should not use or reveal patient information for fundraising,” Dr. Atiq said. “Even acknowledging that a person is under one’s care can make it possible for protected health information to be revealed.”

Data-mining EHRs may be legal, Ms. Tovino said, but it hugs a fine ethical line.

“A patient may not expect that their information will be used for these purposes and may not know how to opt out of having their information used in these ways,” Ms. Tovino said.

A clinician’s employment contract, whether it be a full-time position or for specific admitting privileges, may make it hard for them to push back against expectations to ask patients for money or screen for donors. Metrics or expectations to approach potential donors create ethical snares for clinicians – and it pits them between their patient and place of employment.

“GPF does raise ethical concerns, including those surrounding confidentiality and privacy, and whether physicians are being remunerated or evaluated based on their participation,” Ms. Tovino said.

Asked how doctors can avoid being involved in GPF, Dr. Atiq referred to the ACP ethics manual, which separates clinicians from fundraising.

“Redirecting the patient to discuss donations with institutional administrators provides the appropriate venue and firewall,” he said.

An author of the ACP paper reported a paid position on the board of the Government Employees Health Association.

A version of this article first appeared on Medscape.com.

Patients sometimes want to give back to their physician or hospital. In recent years, the practice of soliciting donations from these patients has grown into structured fundraising initiatives at some health care organizations. Some employers mandate clinicians solicit donations, while other doctors participate voluntarily.

But the nation’s second-largest physician group is cautioning its members not to ask their patients for donations to the clinician’s workplace.

“In recent decades, more physician practices have become part of large health systems: these arrangements can offer benefits to care but can also lead to interference in the patient-physician relationship and challenges to the physician’s ethical responsibilities to patients,” said Omar T. Atiq, MD, president of the American College of Physicians.

Grateful patient fundraising (GPF) is largely based on models of charitable giving outside of health care and is relatively new to the industry. Simply defined, it is the solicitation of donations by doctors from current and former patients. Funds may be used for operating costs, clinical research, equipment upgrades, or facility improvements.

In a newly published position paper, the ACP, which represents roughly 161,000 physicians, is clear that clinicians should not try to convert their patients into donors.

“Physicians who directly solicit funds from their own patients do risk interfering with the physician-patient relationship, which is supposed to be based on the patient’s best interests, not the physicians’ interests,” said Stacey A. Tovino, JD, PhD, director of health care law programs at the University of Oklahoma, Norman.

Once involved in fundraising, patients may also develop an unrealistic expectation of what kind of care they should receive, according to the ACP.

Another pitfall clinicians may fall into is the HIPAA Privacy Rule. In 2013, HIPAA was expanded to allow hospital fundraisers to access privileged health information, including demographic, health insurance, treating clinician, and data on outcomes. Dr. Atiq said that, since then, electronic health records have been used as tools to aide fundraising efforts. For instance, some health care organizations have embedded a feature inside EHRs to allow physicians to flag development officers when a patient or family member might be a potential donor. 

Patients may be unaware that hospital fundraising departments have access to their electronic health records, or that they have the right to opt out of fundraising solicitations.

“Physicians should not use or reveal patient information for fundraising,” Dr. Atiq said. “Even acknowledging that a person is under one’s care can make it possible for protected health information to be revealed.”

Data-mining EHRs may be legal, Ms. Tovino said, but it hugs a fine ethical line.

“A patient may not expect that their information will be used for these purposes and may not know how to opt out of having their information used in these ways,” Ms. Tovino said.

A clinician’s employment contract, whether it be a full-time position or for specific admitting privileges, may make it hard for them to push back against expectations to ask patients for money or screen for donors. Metrics or expectations to approach potential donors create ethical snares for clinicians – and it pits them between their patient and place of employment.

“GPF does raise ethical concerns, including those surrounding confidentiality and privacy, and whether physicians are being remunerated or evaluated based on their participation,” Ms. Tovino said.

Asked how doctors can avoid being involved in GPF, Dr. Atiq referred to the ACP ethics manual, which separates clinicians from fundraising.

“Redirecting the patient to discuss donations with institutional administrators provides the appropriate venue and firewall,” he said.

An author of the ACP paper reported a paid position on the board of the Government Employees Health Association.

A version of this article first appeared on Medscape.com.

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Study: Unexpected vaginal bleeding rises after COVID vaccination

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Wed, 10/18/2023 - 22:55

Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

A version of this article first appeared on WebMD.com.

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Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

A version of this article first appeared on WebMD.com.

Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

A version of this article first appeared on WebMD.com.

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LDL cholesterol lowering tied to less risk of first CVD events in patients older than 70

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Thu, 09/28/2023 - 09:06

 

TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

  • Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
  • The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

  • During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
  • After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
  • Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
  • There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

  • Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
  • The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

  • During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
  • After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
  • Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
  • There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

  • Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
  • The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

  • During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
  • After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
  • Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
  • There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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Overburdened: Health care workers more likely to die by suicide

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Wed, 09/27/2023 - 13:04

 

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study.

If you run into a health care provider these days and ask, “How are you doing?” you’re likely to get a response like this one: “You know, hanging in there.” You smile and move on. But it may be time to go a step further. If you ask that next question – “No, really, how are you doing?” Well, you might need to carve out some time.

It’s been a rough few years for those of us in the health care professions. Our lives, dominated by COVID-related concerns at home, were equally dominated by COVID concerns at work. On the job, there were fewer and fewer of us around as exploitation and COVID-related stressors led doctors, nurses, and others to leave the profession entirely or take early retirement. Even now, I’m not sure we’ve recovered. Staffing in the hospitals is still a huge problem, and the persistence of impersonal meetings via teleconference – which not only prevent any sort of human connection but, audaciously, run from one into another without a break – robs us of even the subtle joy of walking from one hallway to another for 5 minutes of reflection before sitting down to view the next hastily cobbled together PowerPoint.

I’m speaking in generalities, of course.

I’m talking about how bad things are now because, in truth, they’ve never been great. And that may be why health care workers – people with jobs focused on serving others – are nevertheless at substantially increased risk for suicide.

Analyses through the years have shown that physicians tend to have higher rates of death from suicide than the general population. There are reasons for this that may not entirely be because of work-related stress. Doctors’ suicide attempts are more often lethal – we know what is likely to work, after all.

But a focus on physicians fails to acknowledge the much larger population of people who work in health care, are less well-compensated, have less autonomy, and do not hold as respected a position in society. And, according to this paper in JAMA, it is those people who may be suffering most of all.

The study is a nationally representative sample based on the 2008 American Community Survey. Records were linked to the National Death Index through 2019.

Survey respondents were classified into five categories of health care worker, as you can see here. And 1,666,000 non–health care workers served as the control group.

Dr. F. Perry Wilson


Let’s take a look at the numbers.

I’m showing you age- and sex-standardized rates of death from suicide, starting with non–health care workers. In this study, physicians have similar rates of death from suicide to the general population. Nurses have higher rates, but health care support workers – nurses’ aides, home health aides – have rates nearly twice that of the general population.

Dr. F. Perry Wilson


Only social and behavioral health workers had rates lower than those in the general population, perhaps because they know how to access life-saving resources.

Of course, these groups differ in a lot of ways – education and income, for example. But even after adjustment for these factors as well as for sex, race, and marital status, the results persist. The only group with even a trend toward lower suicide rates are social and behavioral health workers.

JAMA


There has been much hand-wringing about rates of physician suicide in the past. It is still a very real problem. But this paper finally highlights that there is a lot more to the health care profession than physicians. It’s time we acknowledge and support the people in our profession who seem to be suffering more than any of us: the aides, the techs, the support staff – the overworked and underpaid who have to deal with all the stresses that physicians like me face and then some.

There’s more to suicide risk than just your job; I know that. Family matters. Relationships matter. Medical and psychiatric illnesses matter. But to ignore this problem when it is right here, in our own house so to speak, can’t continue.

Might I suggest we start by asking someone in our profession – whether doctor, nurse, aide, or tech – how they are doing. How they are really doing. And when we are done listening, we use what we hear to advocate for real change.

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.


A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study.

If you run into a health care provider these days and ask, “How are you doing?” you’re likely to get a response like this one: “You know, hanging in there.” You smile and move on. But it may be time to go a step further. If you ask that next question – “No, really, how are you doing?” Well, you might need to carve out some time.

It’s been a rough few years for those of us in the health care professions. Our lives, dominated by COVID-related concerns at home, were equally dominated by COVID concerns at work. On the job, there were fewer and fewer of us around as exploitation and COVID-related stressors led doctors, nurses, and others to leave the profession entirely or take early retirement. Even now, I’m not sure we’ve recovered. Staffing in the hospitals is still a huge problem, and the persistence of impersonal meetings via teleconference – which not only prevent any sort of human connection but, audaciously, run from one into another without a break – robs us of even the subtle joy of walking from one hallway to another for 5 minutes of reflection before sitting down to view the next hastily cobbled together PowerPoint.

I’m speaking in generalities, of course.

I’m talking about how bad things are now because, in truth, they’ve never been great. And that may be why health care workers – people with jobs focused on serving others – are nevertheless at substantially increased risk for suicide.

Analyses through the years have shown that physicians tend to have higher rates of death from suicide than the general population. There are reasons for this that may not entirely be because of work-related stress. Doctors’ suicide attempts are more often lethal – we know what is likely to work, after all.

But a focus on physicians fails to acknowledge the much larger population of people who work in health care, are less well-compensated, have less autonomy, and do not hold as respected a position in society. And, according to this paper in JAMA, it is those people who may be suffering most of all.

The study is a nationally representative sample based on the 2008 American Community Survey. Records were linked to the National Death Index through 2019.

Survey respondents were classified into five categories of health care worker, as you can see here. And 1,666,000 non–health care workers served as the control group.

Dr. F. Perry Wilson


Let’s take a look at the numbers.

I’m showing you age- and sex-standardized rates of death from suicide, starting with non–health care workers. In this study, physicians have similar rates of death from suicide to the general population. Nurses have higher rates, but health care support workers – nurses’ aides, home health aides – have rates nearly twice that of the general population.

Dr. F. Perry Wilson


Only social and behavioral health workers had rates lower than those in the general population, perhaps because they know how to access life-saving resources.

Of course, these groups differ in a lot of ways – education and income, for example. But even after adjustment for these factors as well as for sex, race, and marital status, the results persist. The only group with even a trend toward lower suicide rates are social and behavioral health workers.

JAMA


There has been much hand-wringing about rates of physician suicide in the past. It is still a very real problem. But this paper finally highlights that there is a lot more to the health care profession than physicians. It’s time we acknowledge and support the people in our profession who seem to be suffering more than any of us: the aides, the techs, the support staff – the overworked and underpaid who have to deal with all the stresses that physicians like me face and then some.

There’s more to suicide risk than just your job; I know that. Family matters. Relationships matter. Medical and psychiatric illnesses matter. But to ignore this problem when it is right here, in our own house so to speak, can’t continue.

Might I suggest we start by asking someone in our profession – whether doctor, nurse, aide, or tech – how they are doing. How they are really doing. And when we are done listening, we use what we hear to advocate for real change.

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.


A version of this article appeared on Medscape.com.

 

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study.

If you run into a health care provider these days and ask, “How are you doing?” you’re likely to get a response like this one: “You know, hanging in there.” You smile and move on. But it may be time to go a step further. If you ask that next question – “No, really, how are you doing?” Well, you might need to carve out some time.

It’s been a rough few years for those of us in the health care professions. Our lives, dominated by COVID-related concerns at home, were equally dominated by COVID concerns at work. On the job, there were fewer and fewer of us around as exploitation and COVID-related stressors led doctors, nurses, and others to leave the profession entirely or take early retirement. Even now, I’m not sure we’ve recovered. Staffing in the hospitals is still a huge problem, and the persistence of impersonal meetings via teleconference – which not only prevent any sort of human connection but, audaciously, run from one into another without a break – robs us of even the subtle joy of walking from one hallway to another for 5 minutes of reflection before sitting down to view the next hastily cobbled together PowerPoint.

I’m speaking in generalities, of course.

I’m talking about how bad things are now because, in truth, they’ve never been great. And that may be why health care workers – people with jobs focused on serving others – are nevertheless at substantially increased risk for suicide.

Analyses through the years have shown that physicians tend to have higher rates of death from suicide than the general population. There are reasons for this that may not entirely be because of work-related stress. Doctors’ suicide attempts are more often lethal – we know what is likely to work, after all.

But a focus on physicians fails to acknowledge the much larger population of people who work in health care, are less well-compensated, have less autonomy, and do not hold as respected a position in society. And, according to this paper in JAMA, it is those people who may be suffering most of all.

The study is a nationally representative sample based on the 2008 American Community Survey. Records were linked to the National Death Index through 2019.

Survey respondents were classified into five categories of health care worker, as you can see here. And 1,666,000 non–health care workers served as the control group.

Dr. F. Perry Wilson


Let’s take a look at the numbers.

I’m showing you age- and sex-standardized rates of death from suicide, starting with non–health care workers. In this study, physicians have similar rates of death from suicide to the general population. Nurses have higher rates, but health care support workers – nurses’ aides, home health aides – have rates nearly twice that of the general population.

Dr. F. Perry Wilson


Only social and behavioral health workers had rates lower than those in the general population, perhaps because they know how to access life-saving resources.

Of course, these groups differ in a lot of ways – education and income, for example. But even after adjustment for these factors as well as for sex, race, and marital status, the results persist. The only group with even a trend toward lower suicide rates are social and behavioral health workers.

JAMA


There has been much hand-wringing about rates of physician suicide in the past. It is still a very real problem. But this paper finally highlights that there is a lot more to the health care profession than physicians. It’s time we acknowledge and support the people in our profession who seem to be suffering more than any of us: the aides, the techs, the support staff – the overworked and underpaid who have to deal with all the stresses that physicians like me face and then some.

There’s more to suicide risk than just your job; I know that. Family matters. Relationships matter. Medical and psychiatric illnesses matter. But to ignore this problem when it is right here, in our own house so to speak, can’t continue.

Might I suggest we start by asking someone in our profession – whether doctor, nurse, aide, or tech – how they are doing. How they are really doing. And when we are done listening, we use what we hear to advocate for real change.

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.


A version of this article appeared on Medscape.com.

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How to get paid if your patient passes on

Article Type
Changed
Wed, 09/27/2023 - 12:10

The death of a patient comes with many challenges for physicians, including a range of emotional and professional issues. Beyond those concerns, some physicians and their practices must also consider how to collect on any outstanding bill that might go unpaid after a patient’s death.

“When a patient passes away, obviously there is, unfortunately, a lot of paperwork and stress for families, and it’s a very difficult situation,” says Shikha Jain, MD, an oncologist and associate professor of medicine at the University of Illinois at Chicago. “Talking about finances in that moment can be difficult and uncomfortable, and one thing I’d recommend is that the physicians themselves not get involved.”

Instead, Dr. Jain said, someone in the billing department in the practice or the hospital should take a lead on dealing with any outstanding debts.

“That doctor-patient relationship is a very precious relationship, so you don’t want to mix that financial aspect of providing care with the doctor-patient relationship,” Dr. Jain said. “That’s one thing that’s really important.”

The best approach in such situations is for practices to have a standing policy in place that dictates how to handle bills once a patient has died.

In most cases, the executor of the patient’s will must inform all creditors, including doctors, that the decedent has died, but sometimes there’s a delay.
 

Hoping the doctor’s office writes it off

“Even though the person in charge of the estate is supposed to contact the doctor’s office and let them know when a patient has passed, that doesn’t always happen,” says Hope Wen, head of billing at practice management platform Soundry Health. “It can be very challenging to track down that information, and sometimes they’re just crossing their fingers hoping that the doctor’s office will just write off the balance, which they often do.”

Some offices use a service that compares accounts receivable lists to Social Security death files and state records to identify deaths more quickly. Some physicians might also use a debt collection agency or an attorney who has experience collecting decedent debts and dealing with executors and probate courts.

Once the practice becomes aware that a patient has died, it can no longer send communications to the name and address on file, although it can continue to go through the billing process with the insurer for any bills incurred up to the date of the death.

At that point, the estate becomes responsible for the debt, and all communication must go to the executor of the estate (in some states, this might be called a personal representative). The office can reach out to any contacts on file to see if they are able to identify the executor.

“You want to do that in a compassionate way,” says Jack Brown III, JD, MBA, president of Gulf Coast Collection Bureau. “You’ll tell them you’re sorry for their loss, but you’re wondering who is responsible for the estate. Once you’ve identified that person and gotten their letter of administration from the probate court or a power of attorney, then you can speak with that person as if they were the patient.”

The names of executors are also public record and are available through the probate court (sometimes called the surrogate court) in the county where the decedent lived.

“Even if there’s no will or no executive named, the court will appoint an administrator for the estate, which is usually a family member,” said Robert Bernstein, an estate lawyer in Parsippany, N.J. “Their information will be on file in the court.”
 

 

 

Insurance coverage

Typically, insurance will pay for treatment (after deductibles and copays) up until the date of the patient’s death. But, of course, it can take months for some insurance companies to make their final payments, allowing physicians to know exactly how much they’re owed by that estate. In such cases, it’s important for physicians to know the rules in the decedent’s state for how long they have to file a claim.

Most states require that claims occur within 6-9 months of the person’s death. However, in some states, claimants can continue to file for much longer if the estate has not yet paid out all of its assets.

“Sometimes there is real estate to sell or a business to wind down, and it can take years for the estate to distribute all of the assets,” Mr. Bernstein says. “If it’s a year later and they still haven’t distributed the assets, the physician can still file the claim and should be paid.”

In some cases, especially if the decedent received compassionate, quality care, their family will want to make good on any outstanding debts to the health care providers who took care of their loved ones in their final days. In other cases, especially when a family member has had a long illness, their assets have been depleted over time or were transferred to other family members so that there is little left in the estate itself when the patient dies.

Regardless of other circumstances, the estate alone is responsible for such payments, and family members, including spouses and children, typically have no liability. (Though rarely enforced, some states do have filial responsibility laws that could hold children responsible for their parents’ debts, including unpaid medical bills. In addition, states with community property laws might require a surviving spouse to cover their partner’s debt, even after death.)

The probate process varies from state to state, but in general, the probate system and the executor will gather all existing assets and then notify all creditors about how to submit a claim. Typically, the claim will need to include information about how much is owed and documentation, such as bills and an explanation of benefits to back up the claim. It should be borne in mind that even those who’ve passed away have privacy protections under the Health Insurance Portability and Accountability Act, so practices must be careful as to how much information they’re sharing through their claim.

Once the estate has received all the claims, the executor will follow a priority of claims, starting with secured creditors. Typically, medical bills, especially those incurred in the last 90 days of the decedent’s life, have priority in the probate process, Mr. Brown says.
 

How to minimize losses

In that case, the practice would write off the unpaid debt as a business loss. If there are not enough assets in the estate to pay all claims, the executor will follow a state schedule that apportions those assets that are available.

There are some steps that practices can take to protect themselves from incurring such losses. For example, before beginning treatment, practices might consider asking patients to name a guarantor, who will essentially promise to cover any outstanding debts that the patient incurs.

To be binding, the office will need a signature from both the patient and the guarantor. Some offices may also keep a patient credit card number on file with written authorization that they can use to pay bills that are past due, although this payment method would no longer be valid after a patient dies.

While it’s important for all physicians to document and verify the financial information for their patients, oncologists often must consider an additional layer of fiduciary responsibility when it comes to their patients. Ms. Wen suggests that oncology offices check in with insurance companies to determine whether a patient has exhausted their benefits.

“That can happen with cancer patients, depending on how long they’ve been receiving treatment and what type of treatment they’ve been getting,” she said. “Some of the clinical trials, insurance will pay for them, but they’re really expensive and can get toward that max. So knowing where they are with their insurance coverage is big.”

When time is of the essence, some patients will choose to go forward with a treatment before receiving insurance approval. In those cases, the office must have an additional conversation in which the costs of the treatment are discussed. The office should obtain written confirmation of who will pay if the insurer does not, Ms. Wen said. While it’s the patient’s responsibility to keep track of their insurance benefits, oncology practices and hospitals must also exercise due diligence in monitoring the benefits that are available.

“That’s part of their contract with insurance companies if they’re in network, helping patients understand their benefits,” Ms. Wen saids.

It’s also important for practices to keep clear, consistent records to make it easier to identify outstanding bills and the correct contact information for them. If bills had gone unpaid prior to a patient’s death and the office started legal action and received a judgment, that claim would typically go ahead of other creditors’ claims.

Dr. Jain says that some practices might also consider keeping a financial adviser or social worker on staff who can assist patients and their families with understanding their out-of-pocket costs for treatment.

“Financial toxicity in oncology and medical care is a very real problem,” she says. “At the beginning of the relationship, I recommend that my patients get set up with a financial specialist that can help them navigate that aspect, not only when a patient passes away but during the process of receiving treatment, so they’re not shocked by the bills.”

A version of this article first appeared on Medscape.com.

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The death of a patient comes with many challenges for physicians, including a range of emotional and professional issues. Beyond those concerns, some physicians and their practices must also consider how to collect on any outstanding bill that might go unpaid after a patient’s death.

“When a patient passes away, obviously there is, unfortunately, a lot of paperwork and stress for families, and it’s a very difficult situation,” says Shikha Jain, MD, an oncologist and associate professor of medicine at the University of Illinois at Chicago. “Talking about finances in that moment can be difficult and uncomfortable, and one thing I’d recommend is that the physicians themselves not get involved.”

Instead, Dr. Jain said, someone in the billing department in the practice or the hospital should take a lead on dealing with any outstanding debts.

“That doctor-patient relationship is a very precious relationship, so you don’t want to mix that financial aspect of providing care with the doctor-patient relationship,” Dr. Jain said. “That’s one thing that’s really important.”

The best approach in such situations is for practices to have a standing policy in place that dictates how to handle bills once a patient has died.

In most cases, the executor of the patient’s will must inform all creditors, including doctors, that the decedent has died, but sometimes there’s a delay.
 

Hoping the doctor’s office writes it off

“Even though the person in charge of the estate is supposed to contact the doctor’s office and let them know when a patient has passed, that doesn’t always happen,” says Hope Wen, head of billing at practice management platform Soundry Health. “It can be very challenging to track down that information, and sometimes they’re just crossing their fingers hoping that the doctor’s office will just write off the balance, which they often do.”

Some offices use a service that compares accounts receivable lists to Social Security death files and state records to identify deaths more quickly. Some physicians might also use a debt collection agency or an attorney who has experience collecting decedent debts and dealing with executors and probate courts.

Once the practice becomes aware that a patient has died, it can no longer send communications to the name and address on file, although it can continue to go through the billing process with the insurer for any bills incurred up to the date of the death.

At that point, the estate becomes responsible for the debt, and all communication must go to the executor of the estate (in some states, this might be called a personal representative). The office can reach out to any contacts on file to see if they are able to identify the executor.

“You want to do that in a compassionate way,” says Jack Brown III, JD, MBA, president of Gulf Coast Collection Bureau. “You’ll tell them you’re sorry for their loss, but you’re wondering who is responsible for the estate. Once you’ve identified that person and gotten their letter of administration from the probate court or a power of attorney, then you can speak with that person as if they were the patient.”

The names of executors are also public record and are available through the probate court (sometimes called the surrogate court) in the county where the decedent lived.

“Even if there’s no will or no executive named, the court will appoint an administrator for the estate, which is usually a family member,” said Robert Bernstein, an estate lawyer in Parsippany, N.J. “Their information will be on file in the court.”
 

 

 

Insurance coverage

Typically, insurance will pay for treatment (after deductibles and copays) up until the date of the patient’s death. But, of course, it can take months for some insurance companies to make their final payments, allowing physicians to know exactly how much they’re owed by that estate. In such cases, it’s important for physicians to know the rules in the decedent’s state for how long they have to file a claim.

Most states require that claims occur within 6-9 months of the person’s death. However, in some states, claimants can continue to file for much longer if the estate has not yet paid out all of its assets.

“Sometimes there is real estate to sell or a business to wind down, and it can take years for the estate to distribute all of the assets,” Mr. Bernstein says. “If it’s a year later and they still haven’t distributed the assets, the physician can still file the claim and should be paid.”

In some cases, especially if the decedent received compassionate, quality care, their family will want to make good on any outstanding debts to the health care providers who took care of their loved ones in their final days. In other cases, especially when a family member has had a long illness, their assets have been depleted over time or were transferred to other family members so that there is little left in the estate itself when the patient dies.

Regardless of other circumstances, the estate alone is responsible for such payments, and family members, including spouses and children, typically have no liability. (Though rarely enforced, some states do have filial responsibility laws that could hold children responsible for their parents’ debts, including unpaid medical bills. In addition, states with community property laws might require a surviving spouse to cover their partner’s debt, even after death.)

The probate process varies from state to state, but in general, the probate system and the executor will gather all existing assets and then notify all creditors about how to submit a claim. Typically, the claim will need to include information about how much is owed and documentation, such as bills and an explanation of benefits to back up the claim. It should be borne in mind that even those who’ve passed away have privacy protections under the Health Insurance Portability and Accountability Act, so practices must be careful as to how much information they’re sharing through their claim.

Once the estate has received all the claims, the executor will follow a priority of claims, starting with secured creditors. Typically, medical bills, especially those incurred in the last 90 days of the decedent’s life, have priority in the probate process, Mr. Brown says.
 

How to minimize losses

In that case, the practice would write off the unpaid debt as a business loss. If there are not enough assets in the estate to pay all claims, the executor will follow a state schedule that apportions those assets that are available.

There are some steps that practices can take to protect themselves from incurring such losses. For example, before beginning treatment, practices might consider asking patients to name a guarantor, who will essentially promise to cover any outstanding debts that the patient incurs.

To be binding, the office will need a signature from both the patient and the guarantor. Some offices may also keep a patient credit card number on file with written authorization that they can use to pay bills that are past due, although this payment method would no longer be valid after a patient dies.

While it’s important for all physicians to document and verify the financial information for their patients, oncologists often must consider an additional layer of fiduciary responsibility when it comes to their patients. Ms. Wen suggests that oncology offices check in with insurance companies to determine whether a patient has exhausted their benefits.

“That can happen with cancer patients, depending on how long they’ve been receiving treatment and what type of treatment they’ve been getting,” she said. “Some of the clinical trials, insurance will pay for them, but they’re really expensive and can get toward that max. So knowing where they are with their insurance coverage is big.”

When time is of the essence, some patients will choose to go forward with a treatment before receiving insurance approval. In those cases, the office must have an additional conversation in which the costs of the treatment are discussed. The office should obtain written confirmation of who will pay if the insurer does not, Ms. Wen said. While it’s the patient’s responsibility to keep track of their insurance benefits, oncology practices and hospitals must also exercise due diligence in monitoring the benefits that are available.

“That’s part of their contract with insurance companies if they’re in network, helping patients understand their benefits,” Ms. Wen saids.

It’s also important for practices to keep clear, consistent records to make it easier to identify outstanding bills and the correct contact information for them. If bills had gone unpaid prior to a patient’s death and the office started legal action and received a judgment, that claim would typically go ahead of other creditors’ claims.

Dr. Jain says that some practices might also consider keeping a financial adviser or social worker on staff who can assist patients and their families with understanding their out-of-pocket costs for treatment.

“Financial toxicity in oncology and medical care is a very real problem,” she says. “At the beginning of the relationship, I recommend that my patients get set up with a financial specialist that can help them navigate that aspect, not only when a patient passes away but during the process of receiving treatment, so they’re not shocked by the bills.”

A version of this article first appeared on Medscape.com.

The death of a patient comes with many challenges for physicians, including a range of emotional and professional issues. Beyond those concerns, some physicians and their practices must also consider how to collect on any outstanding bill that might go unpaid after a patient’s death.

“When a patient passes away, obviously there is, unfortunately, a lot of paperwork and stress for families, and it’s a very difficult situation,” says Shikha Jain, MD, an oncologist and associate professor of medicine at the University of Illinois at Chicago. “Talking about finances in that moment can be difficult and uncomfortable, and one thing I’d recommend is that the physicians themselves not get involved.”

Instead, Dr. Jain said, someone in the billing department in the practice or the hospital should take a lead on dealing with any outstanding debts.

“That doctor-patient relationship is a very precious relationship, so you don’t want to mix that financial aspect of providing care with the doctor-patient relationship,” Dr. Jain said. “That’s one thing that’s really important.”

The best approach in such situations is for practices to have a standing policy in place that dictates how to handle bills once a patient has died.

In most cases, the executor of the patient’s will must inform all creditors, including doctors, that the decedent has died, but sometimes there’s a delay.
 

Hoping the doctor’s office writes it off

“Even though the person in charge of the estate is supposed to contact the doctor’s office and let them know when a patient has passed, that doesn’t always happen,” says Hope Wen, head of billing at practice management platform Soundry Health. “It can be very challenging to track down that information, and sometimes they’re just crossing their fingers hoping that the doctor’s office will just write off the balance, which they often do.”

Some offices use a service that compares accounts receivable lists to Social Security death files and state records to identify deaths more quickly. Some physicians might also use a debt collection agency or an attorney who has experience collecting decedent debts and dealing with executors and probate courts.

Once the practice becomes aware that a patient has died, it can no longer send communications to the name and address on file, although it can continue to go through the billing process with the insurer for any bills incurred up to the date of the death.

At that point, the estate becomes responsible for the debt, and all communication must go to the executor of the estate (in some states, this might be called a personal representative). The office can reach out to any contacts on file to see if they are able to identify the executor.

“You want to do that in a compassionate way,” says Jack Brown III, JD, MBA, president of Gulf Coast Collection Bureau. “You’ll tell them you’re sorry for their loss, but you’re wondering who is responsible for the estate. Once you’ve identified that person and gotten their letter of administration from the probate court or a power of attorney, then you can speak with that person as if they were the patient.”

The names of executors are also public record and are available through the probate court (sometimes called the surrogate court) in the county where the decedent lived.

“Even if there’s no will or no executive named, the court will appoint an administrator for the estate, which is usually a family member,” said Robert Bernstein, an estate lawyer in Parsippany, N.J. “Their information will be on file in the court.”
 

 

 

Insurance coverage

Typically, insurance will pay for treatment (after deductibles and copays) up until the date of the patient’s death. But, of course, it can take months for some insurance companies to make their final payments, allowing physicians to know exactly how much they’re owed by that estate. In such cases, it’s important for physicians to know the rules in the decedent’s state for how long they have to file a claim.

Most states require that claims occur within 6-9 months of the person’s death. However, in some states, claimants can continue to file for much longer if the estate has not yet paid out all of its assets.

“Sometimes there is real estate to sell or a business to wind down, and it can take years for the estate to distribute all of the assets,” Mr. Bernstein says. “If it’s a year later and they still haven’t distributed the assets, the physician can still file the claim and should be paid.”

In some cases, especially if the decedent received compassionate, quality care, their family will want to make good on any outstanding debts to the health care providers who took care of their loved ones in their final days. In other cases, especially when a family member has had a long illness, their assets have been depleted over time or were transferred to other family members so that there is little left in the estate itself when the patient dies.

Regardless of other circumstances, the estate alone is responsible for such payments, and family members, including spouses and children, typically have no liability. (Though rarely enforced, some states do have filial responsibility laws that could hold children responsible for their parents’ debts, including unpaid medical bills. In addition, states with community property laws might require a surviving spouse to cover their partner’s debt, even after death.)

The probate process varies from state to state, but in general, the probate system and the executor will gather all existing assets and then notify all creditors about how to submit a claim. Typically, the claim will need to include information about how much is owed and documentation, such as bills and an explanation of benefits to back up the claim. It should be borne in mind that even those who’ve passed away have privacy protections under the Health Insurance Portability and Accountability Act, so practices must be careful as to how much information they’re sharing through their claim.

Once the estate has received all the claims, the executor will follow a priority of claims, starting with secured creditors. Typically, medical bills, especially those incurred in the last 90 days of the decedent’s life, have priority in the probate process, Mr. Brown says.
 

How to minimize losses

In that case, the practice would write off the unpaid debt as a business loss. If there are not enough assets in the estate to pay all claims, the executor will follow a state schedule that apportions those assets that are available.

There are some steps that practices can take to protect themselves from incurring such losses. For example, before beginning treatment, practices might consider asking patients to name a guarantor, who will essentially promise to cover any outstanding debts that the patient incurs.

To be binding, the office will need a signature from both the patient and the guarantor. Some offices may also keep a patient credit card number on file with written authorization that they can use to pay bills that are past due, although this payment method would no longer be valid after a patient dies.

While it’s important for all physicians to document and verify the financial information for their patients, oncologists often must consider an additional layer of fiduciary responsibility when it comes to their patients. Ms. Wen suggests that oncology offices check in with insurance companies to determine whether a patient has exhausted their benefits.

“That can happen with cancer patients, depending on how long they’ve been receiving treatment and what type of treatment they’ve been getting,” she said. “Some of the clinical trials, insurance will pay for them, but they’re really expensive and can get toward that max. So knowing where they are with their insurance coverage is big.”

When time is of the essence, some patients will choose to go forward with a treatment before receiving insurance approval. In those cases, the office must have an additional conversation in which the costs of the treatment are discussed. The office should obtain written confirmation of who will pay if the insurer does not, Ms. Wen said. While it’s the patient’s responsibility to keep track of their insurance benefits, oncology practices and hospitals must also exercise due diligence in monitoring the benefits that are available.

“That’s part of their contract with insurance companies if they’re in network, helping patients understand their benefits,” Ms. Wen saids.

It’s also important for practices to keep clear, consistent records to make it easier to identify outstanding bills and the correct contact information for them. If bills had gone unpaid prior to a patient’s death and the office started legal action and received a judgment, that claim would typically go ahead of other creditors’ claims.

Dr. Jain says that some practices might also consider keeping a financial adviser or social worker on staff who can assist patients and their families with understanding their out-of-pocket costs for treatment.

“Financial toxicity in oncology and medical care is a very real problem,” she says. “At the beginning of the relationship, I recommend that my patients get set up with a financial specialist that can help them navigate that aspect, not only when a patient passes away but during the process of receiving treatment, so they’re not shocked by the bills.”

A version of this article first appeared on Medscape.com.

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People with long COVID have specific blood biomarkers, study says

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Changed
Mon, 10/23/2023 - 13:16

People with long COVID have specific biomarkers in their blood, according to results of a study published in Nature. 

The findings may be a step toward creating blood tests to positively identify people with long COVID so specialized treatments can be employed, researchers said.

 “This is a decisive step forward in the development of valid and reliable blood testing protocols for long COVID,” said David Putrino, PhD., lead author and professor of rehabilitation and human performance and director of the Abilities Research Center at Icahn Mount Sinai Health System, New York.

Researchers from the Icahn School of Medicine at Mount Sinai and Yale School of Medicine looked at blood samples from about 270 people between January 2021 and June 2022. The people had never been infected with COVID, had fully recovered from an infection, or still showed symptoms at least four months after infection.

Using machine learning, the research teams were able to differentiate between people with and without long COVID with 96% accuracy based on distinctive features in the blood samples, according to a news release from Mount Sinai.

People with long COVID had abnormal T-cell activity and low levels of the hormone cortisol. Cortisol helps people feel alert and awake, which would explain why people with long COVID often report fatigue, NBC News said in a report on the study.

“It was one of the findings that most definitively separated the folks with long Covid from the people without long Covid,” Dr. Putrino told NBC News.

The study also found that long COVID appears to reactivate latent viruses including Epstein-Barr and mononucleosis, the study said.

The blood tests could allow doctors to come up with specialized treatments in people who report a wide variety of long COVID symptoms, Dr. Putrino said. 

“There is no ‘silver bullet’ for treating long COVID, because it is an illness that infiltrates complex systems such as the immune and hormonal regulation,” he said.

The Centers for Disease Control and Prevention says about one in five Americans who had COVID still have long COVID. Symptoms include fatigue, brain fog, dizziness, digestive problems, and loss of smell and taste.

A version of this article appeared on WebMD.com.

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People with long COVID have specific biomarkers in their blood, according to results of a study published in Nature. 

The findings may be a step toward creating blood tests to positively identify people with long COVID so specialized treatments can be employed, researchers said.

 “This is a decisive step forward in the development of valid and reliable blood testing protocols for long COVID,” said David Putrino, PhD., lead author and professor of rehabilitation and human performance and director of the Abilities Research Center at Icahn Mount Sinai Health System, New York.

Researchers from the Icahn School of Medicine at Mount Sinai and Yale School of Medicine looked at blood samples from about 270 people between January 2021 and June 2022. The people had never been infected with COVID, had fully recovered from an infection, or still showed symptoms at least four months after infection.

Using machine learning, the research teams were able to differentiate between people with and without long COVID with 96% accuracy based on distinctive features in the blood samples, according to a news release from Mount Sinai.

People with long COVID had abnormal T-cell activity and low levels of the hormone cortisol. Cortisol helps people feel alert and awake, which would explain why people with long COVID often report fatigue, NBC News said in a report on the study.

“It was one of the findings that most definitively separated the folks with long Covid from the people without long Covid,” Dr. Putrino told NBC News.

The study also found that long COVID appears to reactivate latent viruses including Epstein-Barr and mononucleosis, the study said.

The blood tests could allow doctors to come up with specialized treatments in people who report a wide variety of long COVID symptoms, Dr. Putrino said. 

“There is no ‘silver bullet’ for treating long COVID, because it is an illness that infiltrates complex systems such as the immune and hormonal regulation,” he said.

The Centers for Disease Control and Prevention says about one in five Americans who had COVID still have long COVID. Symptoms include fatigue, brain fog, dizziness, digestive problems, and loss of smell and taste.

A version of this article appeared on WebMD.com.

People with long COVID have specific biomarkers in their blood, according to results of a study published in Nature. 

The findings may be a step toward creating blood tests to positively identify people with long COVID so specialized treatments can be employed, researchers said.

 “This is a decisive step forward in the development of valid and reliable blood testing protocols for long COVID,” said David Putrino, PhD., lead author and professor of rehabilitation and human performance and director of the Abilities Research Center at Icahn Mount Sinai Health System, New York.

Researchers from the Icahn School of Medicine at Mount Sinai and Yale School of Medicine looked at blood samples from about 270 people between January 2021 and June 2022. The people had never been infected with COVID, had fully recovered from an infection, or still showed symptoms at least four months after infection.

Using machine learning, the research teams were able to differentiate between people with and without long COVID with 96% accuracy based on distinctive features in the blood samples, according to a news release from Mount Sinai.

People with long COVID had abnormal T-cell activity and low levels of the hormone cortisol. Cortisol helps people feel alert and awake, which would explain why people with long COVID often report fatigue, NBC News said in a report on the study.

“It was one of the findings that most definitively separated the folks with long Covid from the people without long Covid,” Dr. Putrino told NBC News.

The study also found that long COVID appears to reactivate latent viruses including Epstein-Barr and mononucleosis, the study said.

The blood tests could allow doctors to come up with specialized treatments in people who report a wide variety of long COVID symptoms, Dr. Putrino said. 

“There is no ‘silver bullet’ for treating long COVID, because it is an illness that infiltrates complex systems such as the immune and hormonal regulation,” he said.

The Centers for Disease Control and Prevention says about one in five Americans who had COVID still have long COVID. Symptoms include fatigue, brain fog, dizziness, digestive problems, and loss of smell and taste.

A version of this article appeared on WebMD.com.

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EASD 2023: A deeper dive into type 1 and type 2 diabetes

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This year’s annual meeting of the European Association for the Study of Diabetes offers an in-depth look into “disease-modifying and disrupting therapies” in both type 1 and type 2 diabetes.

Noteworthy at the meeting, taking place Oct. 3-6, in Hamburg, Germany, will be final detailed data from the SURMOUNT-4 trial of the “twincretin” tirzepatide (Mounjaro, Lilly) on obesity. The top-line results, announced by the company in July, showed an average 21.1% weight loss at 36 weeks with tirzepatide injections once weekly among adults with overweight or obesity. The drug is approved in the United States and Europe for treating type 2 diabetes, and approval for obesity is expected in the United States later this year.

In addition, a symposium will present a new EASD/American Diabetes Association (ADA) consensus report, Hyperglycaemic Crisis in Adult Patients with Diabetes, scheduled to be simultaneously published in Diabetologia and Diabetes Care on Oct. 6.  

Aside from those, much of the EASD meeting content will feature smaller studies on both type 2 and type 1 diabetes, along with award lectures, symposia, debates, and lots of discussion on hot topics in diabetes and clinical challenges including complications. In essence, it will provide a forum for in-depth follow-up to the jam-packed clinical trial–filled agenda at the ADA meeting in June, said EASD Honorary Secretary Tina Vilsbøll, MD, clinical professor and head of clinic at the Steno Diabetes Center, Copenhagen.

“There were so many large trials at ADA that we just took them in without really having a chance to discuss them. ... There’s so much to discuss with all these new treatments, how do we place them in obesity and diabetes? ... All the data that we have from ADA will make good discussions at EASD,” Dr. Vilsbøll said in an interview.

Indeed, said EASD President Chantal Mathieu, MD, PhD, chair of endocrinology at University Hospital Gasthuisberg Leuven, Belgium, “We always come after ADA. That puts us in a position where we can take deeper dives into the data. ... EASD is a calmer meeting where you can really look at the details.”
 

Type 2 diabetes: Disease modifying in many ways

Dr. Mathieu told this news organization that a unifying theme for much of the EASD meeting’s content is “We are now entering the era of disease-modifying and disease-disrupting therapies” in both diabetes types.

In type 2, this means “getting to the root, which is obesity, so you’ll see a lot of presentations on the incretin system, but you also don’t get type 2 diabetes if you have an iron-clad beta cell. ... So, we also gave a lot of attention to basic translational research that helps us to understand the role of the beta cell in type 2 diabetes.”

In addition to SURMOUNT-4, there will be oral abstract sessions with follow-up data from the SURPASS series of studies of tirzepatide in type 2 diabetes, other abstract sessions, symposia about incretins and obesity, and an oral abstract session on beta cell function in both diabetes types.

Three debates will address controversial questions in the type 2 diabetes arena. In one, speakers will take opposite sides on “Initial combined therapy for type 2 diabetes: Should diabetes follow hypertension?”

In another, speakers will argue over “Is lasting remission of type 2 diabetes feasible in the real-world setting?” That’s an important question, Dr. Vilsbøll said.

“A person might be able to have a remission but go back if they regain the weight. Do we really have remission? How do we define it? Now, suddenly, we have tools to help people go in the right direction. Now we’re in a place where we can actually help our patients with their cravings and their body weight and all that. It’s more fun to discuss when we have the tools.”

A third debate will tackle the question of whether all people with type 2 diabetes and chronic kidney disease should be on [sodium-glucose co-transporter 2] (SGLT2) inhibitors “by default.”

The Minkowski Prize Lecture will address the regulation of energy and glucose metabolism by the dual incretin receptor agonists, while the EASD-Lilly Anniversary Prize Lecture will be about the role of ectopic lipid in insulin resistance and cardiometabolic disease.
 

 

 

Type 1 diabetes: Both disease modifying and disruptive

For type 1 diabetes, “disease-modifying” and “disruptive” approaches on the meeting agenda include new data on immune modulation for people in early stages in order to prevent or delay insulin dependence, islet transplantation including the use of stem cell–derived beta cells, and the latest in technology including automated insulin delivery systems, also known colloquially as the “artificial pancreas.”

Prize lectures about type 1 diabetes will include the Claude Bernard Lecture, on etiologies of autoimmune diabetes, the Albert Renold Lecture, on “disrupted RNA editing as a path to type 1 diabetes,” and the EASD/Novo Nordisk Foundation Diabetes Prize for Excellence Lecture on automated insulin delivery.

Focus on complications: The known and the emerging

The meeting also will focus a great deal on complications of diabetes, including the well-studied cardiovascular disease, neuropathy, nephropathy, retinopathy, and fatty liver disease as well as others that typically receive less attention, such as gastrointestinal problems and cardiomyopathy.

Another debate will address the question “Is it time to reclassify diabetes complications because microvascular and macrovascular classification is no longer sufficient?” And, the Camillo Golgi Lecture will cover “Diabetes Complications: From Classical to Emerging.”

As always, there’s much more on the agenda including pregnancy and diabetes, cystic fibrosis–derived diabetes, mental health in diabetes, COVID-19 and diabetes, hypoglycemia, and hypoglycemia unawareness.  

According to Dr. Vilsbøll, “Clinicians should come and enjoy all the great science we have, interact, and be inspired.”

Dr. Vilsbøll has served on scientific advisory panels, been part of speaker bureaus, and served as a consultant to and/or received research support from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gilead, GSK, Mundipharma, Novo Nordisk, Sanofi, and Sun Pharmaceuticals. Dr. Mathieu serves or has served on the advisory panel for Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Company, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Imcyse, Insulet, Zealand Pharma, Avotres, Mannkind, Sandoz, and Vertex. She has served on the speakers bureau for Novo Nordisk, Sanofi, Eli Lilly and Company, Boehringer Ingelheim, AstraZeneca, and Novartis. Financial compensation for these activities has been received by KU Leuven.
 

A version of this article appeared on Medscape.com.

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This year’s annual meeting of the European Association for the Study of Diabetes offers an in-depth look into “disease-modifying and disrupting therapies” in both type 1 and type 2 diabetes.

Noteworthy at the meeting, taking place Oct. 3-6, in Hamburg, Germany, will be final detailed data from the SURMOUNT-4 trial of the “twincretin” tirzepatide (Mounjaro, Lilly) on obesity. The top-line results, announced by the company in July, showed an average 21.1% weight loss at 36 weeks with tirzepatide injections once weekly among adults with overweight or obesity. The drug is approved in the United States and Europe for treating type 2 diabetes, and approval for obesity is expected in the United States later this year.

In addition, a symposium will present a new EASD/American Diabetes Association (ADA) consensus report, Hyperglycaemic Crisis in Adult Patients with Diabetes, scheduled to be simultaneously published in Diabetologia and Diabetes Care on Oct. 6.  

Aside from those, much of the EASD meeting content will feature smaller studies on both type 2 and type 1 diabetes, along with award lectures, symposia, debates, and lots of discussion on hot topics in diabetes and clinical challenges including complications. In essence, it will provide a forum for in-depth follow-up to the jam-packed clinical trial–filled agenda at the ADA meeting in June, said EASD Honorary Secretary Tina Vilsbøll, MD, clinical professor and head of clinic at the Steno Diabetes Center, Copenhagen.

“There were so many large trials at ADA that we just took them in without really having a chance to discuss them. ... There’s so much to discuss with all these new treatments, how do we place them in obesity and diabetes? ... All the data that we have from ADA will make good discussions at EASD,” Dr. Vilsbøll said in an interview.

Indeed, said EASD President Chantal Mathieu, MD, PhD, chair of endocrinology at University Hospital Gasthuisberg Leuven, Belgium, “We always come after ADA. That puts us in a position where we can take deeper dives into the data. ... EASD is a calmer meeting where you can really look at the details.”
 

Type 2 diabetes: Disease modifying in many ways

Dr. Mathieu told this news organization that a unifying theme for much of the EASD meeting’s content is “We are now entering the era of disease-modifying and disease-disrupting therapies” in both diabetes types.

In type 2, this means “getting to the root, which is obesity, so you’ll see a lot of presentations on the incretin system, but you also don’t get type 2 diabetes if you have an iron-clad beta cell. ... So, we also gave a lot of attention to basic translational research that helps us to understand the role of the beta cell in type 2 diabetes.”

In addition to SURMOUNT-4, there will be oral abstract sessions with follow-up data from the SURPASS series of studies of tirzepatide in type 2 diabetes, other abstract sessions, symposia about incretins and obesity, and an oral abstract session on beta cell function in both diabetes types.

Three debates will address controversial questions in the type 2 diabetes arena. In one, speakers will take opposite sides on “Initial combined therapy for type 2 diabetes: Should diabetes follow hypertension?”

In another, speakers will argue over “Is lasting remission of type 2 diabetes feasible in the real-world setting?” That’s an important question, Dr. Vilsbøll said.

“A person might be able to have a remission but go back if they regain the weight. Do we really have remission? How do we define it? Now, suddenly, we have tools to help people go in the right direction. Now we’re in a place where we can actually help our patients with their cravings and their body weight and all that. It’s more fun to discuss when we have the tools.”

A third debate will tackle the question of whether all people with type 2 diabetes and chronic kidney disease should be on [sodium-glucose co-transporter 2] (SGLT2) inhibitors “by default.”

The Minkowski Prize Lecture will address the regulation of energy and glucose metabolism by the dual incretin receptor agonists, while the EASD-Lilly Anniversary Prize Lecture will be about the role of ectopic lipid in insulin resistance and cardiometabolic disease.
 

 

 

Type 1 diabetes: Both disease modifying and disruptive

For type 1 diabetes, “disease-modifying” and “disruptive” approaches on the meeting agenda include new data on immune modulation for people in early stages in order to prevent or delay insulin dependence, islet transplantation including the use of stem cell–derived beta cells, and the latest in technology including automated insulin delivery systems, also known colloquially as the “artificial pancreas.”

Prize lectures about type 1 diabetes will include the Claude Bernard Lecture, on etiologies of autoimmune diabetes, the Albert Renold Lecture, on “disrupted RNA editing as a path to type 1 diabetes,” and the EASD/Novo Nordisk Foundation Diabetes Prize for Excellence Lecture on automated insulin delivery.

Focus on complications: The known and the emerging

The meeting also will focus a great deal on complications of diabetes, including the well-studied cardiovascular disease, neuropathy, nephropathy, retinopathy, and fatty liver disease as well as others that typically receive less attention, such as gastrointestinal problems and cardiomyopathy.

Another debate will address the question “Is it time to reclassify diabetes complications because microvascular and macrovascular classification is no longer sufficient?” And, the Camillo Golgi Lecture will cover “Diabetes Complications: From Classical to Emerging.”

As always, there’s much more on the agenda including pregnancy and diabetes, cystic fibrosis–derived diabetes, mental health in diabetes, COVID-19 and diabetes, hypoglycemia, and hypoglycemia unawareness.  

According to Dr. Vilsbøll, “Clinicians should come and enjoy all the great science we have, interact, and be inspired.”

Dr. Vilsbøll has served on scientific advisory panels, been part of speaker bureaus, and served as a consultant to and/or received research support from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gilead, GSK, Mundipharma, Novo Nordisk, Sanofi, and Sun Pharmaceuticals. Dr. Mathieu serves or has served on the advisory panel for Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Company, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Imcyse, Insulet, Zealand Pharma, Avotres, Mannkind, Sandoz, and Vertex. She has served on the speakers bureau for Novo Nordisk, Sanofi, Eli Lilly and Company, Boehringer Ingelheim, AstraZeneca, and Novartis. Financial compensation for these activities has been received by KU Leuven.
 

A version of this article appeared on Medscape.com.

This year’s annual meeting of the European Association for the Study of Diabetes offers an in-depth look into “disease-modifying and disrupting therapies” in both type 1 and type 2 diabetes.

Noteworthy at the meeting, taking place Oct. 3-6, in Hamburg, Germany, will be final detailed data from the SURMOUNT-4 trial of the “twincretin” tirzepatide (Mounjaro, Lilly) on obesity. The top-line results, announced by the company in July, showed an average 21.1% weight loss at 36 weeks with tirzepatide injections once weekly among adults with overweight or obesity. The drug is approved in the United States and Europe for treating type 2 diabetes, and approval for obesity is expected in the United States later this year.

In addition, a symposium will present a new EASD/American Diabetes Association (ADA) consensus report, Hyperglycaemic Crisis in Adult Patients with Diabetes, scheduled to be simultaneously published in Diabetologia and Diabetes Care on Oct. 6.  

Aside from those, much of the EASD meeting content will feature smaller studies on both type 2 and type 1 diabetes, along with award lectures, symposia, debates, and lots of discussion on hot topics in diabetes and clinical challenges including complications. In essence, it will provide a forum for in-depth follow-up to the jam-packed clinical trial–filled agenda at the ADA meeting in June, said EASD Honorary Secretary Tina Vilsbøll, MD, clinical professor and head of clinic at the Steno Diabetes Center, Copenhagen.

“There were so many large trials at ADA that we just took them in without really having a chance to discuss them. ... There’s so much to discuss with all these new treatments, how do we place them in obesity and diabetes? ... All the data that we have from ADA will make good discussions at EASD,” Dr. Vilsbøll said in an interview.

Indeed, said EASD President Chantal Mathieu, MD, PhD, chair of endocrinology at University Hospital Gasthuisberg Leuven, Belgium, “We always come after ADA. That puts us in a position where we can take deeper dives into the data. ... EASD is a calmer meeting where you can really look at the details.”
 

Type 2 diabetes: Disease modifying in many ways

Dr. Mathieu told this news organization that a unifying theme for much of the EASD meeting’s content is “We are now entering the era of disease-modifying and disease-disrupting therapies” in both diabetes types.

In type 2, this means “getting to the root, which is obesity, so you’ll see a lot of presentations on the incretin system, but you also don’t get type 2 diabetes if you have an iron-clad beta cell. ... So, we also gave a lot of attention to basic translational research that helps us to understand the role of the beta cell in type 2 diabetes.”

In addition to SURMOUNT-4, there will be oral abstract sessions with follow-up data from the SURPASS series of studies of tirzepatide in type 2 diabetes, other abstract sessions, symposia about incretins and obesity, and an oral abstract session on beta cell function in both diabetes types.

Three debates will address controversial questions in the type 2 diabetes arena. In one, speakers will take opposite sides on “Initial combined therapy for type 2 diabetes: Should diabetes follow hypertension?”

In another, speakers will argue over “Is lasting remission of type 2 diabetes feasible in the real-world setting?” That’s an important question, Dr. Vilsbøll said.

“A person might be able to have a remission but go back if they regain the weight. Do we really have remission? How do we define it? Now, suddenly, we have tools to help people go in the right direction. Now we’re in a place where we can actually help our patients with their cravings and their body weight and all that. It’s more fun to discuss when we have the tools.”

A third debate will tackle the question of whether all people with type 2 diabetes and chronic kidney disease should be on [sodium-glucose co-transporter 2] (SGLT2) inhibitors “by default.”

The Minkowski Prize Lecture will address the regulation of energy and glucose metabolism by the dual incretin receptor agonists, while the EASD-Lilly Anniversary Prize Lecture will be about the role of ectopic lipid in insulin resistance and cardiometabolic disease.
 

 

 

Type 1 diabetes: Both disease modifying and disruptive

For type 1 diabetes, “disease-modifying” and “disruptive” approaches on the meeting agenda include new data on immune modulation for people in early stages in order to prevent or delay insulin dependence, islet transplantation including the use of stem cell–derived beta cells, and the latest in technology including automated insulin delivery systems, also known colloquially as the “artificial pancreas.”

Prize lectures about type 1 diabetes will include the Claude Bernard Lecture, on etiologies of autoimmune diabetes, the Albert Renold Lecture, on “disrupted RNA editing as a path to type 1 diabetes,” and the EASD/Novo Nordisk Foundation Diabetes Prize for Excellence Lecture on automated insulin delivery.

Focus on complications: The known and the emerging

The meeting also will focus a great deal on complications of diabetes, including the well-studied cardiovascular disease, neuropathy, nephropathy, retinopathy, and fatty liver disease as well as others that typically receive less attention, such as gastrointestinal problems and cardiomyopathy.

Another debate will address the question “Is it time to reclassify diabetes complications because microvascular and macrovascular classification is no longer sufficient?” And, the Camillo Golgi Lecture will cover “Diabetes Complications: From Classical to Emerging.”

As always, there’s much more on the agenda including pregnancy and diabetes, cystic fibrosis–derived diabetes, mental health in diabetes, COVID-19 and diabetes, hypoglycemia, and hypoglycemia unawareness.  

According to Dr. Vilsbøll, “Clinicians should come and enjoy all the great science we have, interact, and be inspired.”

Dr. Vilsbøll has served on scientific advisory panels, been part of speaker bureaus, and served as a consultant to and/or received research support from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gilead, GSK, Mundipharma, Novo Nordisk, Sanofi, and Sun Pharmaceuticals. Dr. Mathieu serves or has served on the advisory panel for Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Company, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Imcyse, Insulet, Zealand Pharma, Avotres, Mannkind, Sandoz, and Vertex. She has served on the speakers bureau for Novo Nordisk, Sanofi, Eli Lilly and Company, Boehringer Ingelheim, AstraZeneca, and Novartis. Financial compensation for these activities has been received by KU Leuven.
 

A version of this article appeared on Medscape.com.

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