Journal of Clinical Outcomes Management

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

People exposed to high levels of perfluorooctane sulfonic acid (PFOS) – a widely used synthetic chemical – run an increased risk of hepatocellular carcinoma, researchers say.

The correlation does not prove that PFOS causes this cancer, and more research is needed, but in the meantime, people should limit their exposure to it and others in its class, said Jesse Goodrich, PhD, a postdoctoral scholar in environmental medicine at the University of Southern California, Los Angeles.

“If you’re at risk for liver cancer because you have other risk factors, then these chemicals have the potential to kind of send you over the edge,” he told this news organization.

Dr. Goodrich and colleagues published their research online in JHEP Reports.

Dubbed “forever chemicals” because they can take thousands of years to break down, polyfluoroalkyl substances (PFAS) figure in makeup, food packaging, waterproof clothing, nonstick cookware, firefighting foams, and groundwater. They have spread through the atmosphere into rain and can be found in the blood of most Americans. PFOS is one of the most widely used PFAS.

“You can’t really escape them,” Dr. Goodrich said.

Previous research has linked PFAS to infertility, pregnancy complications, learning and behavioral problems in children, immune system issues, and higher cholesterol, as well as other cancers. Some experiments in animals suggested PFAS could cause liver cancer, and others showed a correlation between PFAS serum levels and biomarkers associated with liver cancer. But many of these health effects take a long time to develop.

“It wasn’t until we started to get really highly exposed groups of people that we started, as scientists, to be able to figure out what was going on,” said Dr. Goodrich.
 

High exposure, increased incidence

To measure the relationship between PFAS exposure and the incidence of hepatocellular carcinoma more definitively, Dr. Goodrich and colleagues analyzed data from the Multiethnic Cohort Study, a cohort of more than 200,000 people of African, Latin, Native Hawaiian, Japanese, and European ancestry tracked since the early 1990s in California and Hawaii. About 67,000 participants provided blood samples from 2001 to 2007.

From this cohort, the researchers found 50 people who later developed hepatocellular carcinoma. The researchers matched these patients with 50 controls of similar age at blood collection, sex, race, ethnicity, and study area who did not develop the cancer.

They found that people with more than 54.9 mcg/L of PFOS in their blood before any diagnosis of hepatocellular carcinoma were almost five times more likely to get the cancer (odds ratio 4.5; 95% confidence interval, 1.2-16.0), which was statistically significant (P = .02).

This level of PFOS corresponds to the 90th percentile found in the U.S. National Health and Nutrition Examination Survey (NHANES).

To get some idea of the mechanism by which PFOS might do its damage, the researchers also looked for linkage to levels of metabolites.

They found an overlap among high PFOS levels, hepatocellular carcinoma, and high levels of glucose, butyric acid (a short chain fatty acid), alpha-Ketoisovaleric acid (alpha branched-chain alpha-keto acid), and 7alpha-Hydroxy-3-oxo-4-cholestenoate (a bile acid). These metabolites have been associated in previous studies with metabolic disorders and liver disease.

Similarly, the researchers identified an association among the cancer, PFOS, and alterations in amino acid and glycan biosynthesis pathways.
 

Risk mitigation

The half-life of PFAS in the human body is about 3-7 years, said Dr. Goodrich.

“There’s not much you can do once they’re in there,” he said. “So, the focus needs to be on preventing the exposure in the first place.”

People can limit exposure by avoiding water contaminated with PFAS or filtering it out, Dr. Goodrich said. He recommended avoiding fish from contaminated waterways and nonstick cookware. The Environmental Protection Agency has more detailed recommendations.

But giving patients individualized recommendations is difficult, said Vincent Chen, MD, MS, a clinical instructor in gastroenterology at the University of Michigan, Ann Arbor, who was not involved in the study. Most clinicians don’t know their patients’ PFOS levels.

“It’s not that easy to get a test,” Dr. Chen told this news organization.

People can also mitigate their risk factors for hepatocellular carcinoma, such as a poor diet, a lack of exercise, and smoking, said Dr. Goodrich.

The researchers found that patients with hepatocellular carcinoma were more likely to be overweight and have diabetes, and PFOS was associated with higher fasting glucose levels. This raises the possibility that PFOS increases the risk for hepatocellular carcinoma by causing diabetes and obesity.

Dr. Goodrich and his colleagues tried to address this question by adjusting for baseline body mass index (BMI) and diabetes diagnosis in their statistical analysis.

After adjusting for BMI, they found that the association between PFOS and hepatocellular carcinoma diminished to a threefold risk (OR, 2.90; 95% CI, 0.78-10.00) and was no longer statistically significant (P = .11).

On the other hand, adjusting for diabetes did not change the significance of the relationship between PFOS and the cancer (OR, 5.7; 95% CI, 1.10-30.00; P = .04).

The sample size was probably too small to adequately tease out this relationship, Dr. Chen said. Still, he said, “I thought it was a very, very important study.”

The levels of PFOS found in the blood of Americans has been declining since the 1999-2000 NHANES, Dr. Chen pointed out. But that’s not as reassuring as it sounds.

“The problem is that if you put a regulation limiting the use of one PFAS, what people can do is just substitute with another PFAS or another molecule, which for all we know could be equally harmful,” Dr. Chen said.

Funding was provided by the Southern California Environmental Health Science Center supported by the National Institutes of Health. Dr. Goodrich and Dr. Chen report no relevant financial relationships.

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

People exposed to high levels of perfluorooctane sulfonic acid (PFOS) – a widely used synthetic chemical – run an increased risk of hepatocellular carcinoma, researchers say.

The correlation does not prove that PFOS causes this cancer, and more research is needed, but in the meantime, people should limit their exposure to it and others in its class, said Jesse Goodrich, PhD, a postdoctoral scholar in environmental medicine at the University of Southern California, Los Angeles.

“If you’re at risk for liver cancer because you have other risk factors, then these chemicals have the potential to kind of send you over the edge,” he told this news organization.

Dr. Goodrich and colleagues published their research online in JHEP Reports.

Dubbed “forever chemicals” because they can take thousands of years to break down, polyfluoroalkyl substances (PFAS) figure in makeup, food packaging, waterproof clothing, nonstick cookware, firefighting foams, and groundwater. They have spread through the atmosphere into rain and can be found in the blood of most Americans. PFOS is one of the most widely used PFAS.

“You can’t really escape them,” Dr. Goodrich said.

Previous research has linked PFAS to infertility, pregnancy complications, learning and behavioral problems in children, immune system issues, and higher cholesterol, as well as other cancers. Some experiments in animals suggested PFAS could cause liver cancer, and others showed a correlation between PFAS serum levels and biomarkers associated with liver cancer. But many of these health effects take a long time to develop.

“It wasn’t until we started to get really highly exposed groups of people that we started, as scientists, to be able to figure out what was going on,” said Dr. Goodrich.
 

High exposure, increased incidence

To measure the relationship between PFAS exposure and the incidence of hepatocellular carcinoma more definitively, Dr. Goodrich and colleagues analyzed data from the Multiethnic Cohort Study, a cohort of more than 200,000 people of African, Latin, Native Hawaiian, Japanese, and European ancestry tracked since the early 1990s in California and Hawaii. About 67,000 participants provided blood samples from 2001 to 2007.

From this cohort, the researchers found 50 people who later developed hepatocellular carcinoma. The researchers matched these patients with 50 controls of similar age at blood collection, sex, race, ethnicity, and study area who did not develop the cancer.

They found that people with more than 54.9 mcg/L of PFOS in their blood before any diagnosis of hepatocellular carcinoma were almost five times more likely to get the cancer (odds ratio 4.5; 95% confidence interval, 1.2-16.0), which was statistically significant (P = .02).

This level of PFOS corresponds to the 90th percentile found in the U.S. National Health and Nutrition Examination Survey (NHANES).

To get some idea of the mechanism by which PFOS might do its damage, the researchers also looked for linkage to levels of metabolites.

They found an overlap among high PFOS levels, hepatocellular carcinoma, and high levels of glucose, butyric acid (a short chain fatty acid), alpha-Ketoisovaleric acid (alpha branched-chain alpha-keto acid), and 7alpha-Hydroxy-3-oxo-4-cholestenoate (a bile acid). These metabolites have been associated in previous studies with metabolic disorders and liver disease.

Similarly, the researchers identified an association among the cancer, PFOS, and alterations in amino acid and glycan biosynthesis pathways.
 

Risk mitigation

The half-life of PFAS in the human body is about 3-7 years, said Dr. Goodrich.

“There’s not much you can do once they’re in there,” he said. “So, the focus needs to be on preventing the exposure in the first place.”

People can limit exposure by avoiding water contaminated with PFAS or filtering it out, Dr. Goodrich said. He recommended avoiding fish from contaminated waterways and nonstick cookware. The Environmental Protection Agency has more detailed recommendations.

But giving patients individualized recommendations is difficult, said Vincent Chen, MD, MS, a clinical instructor in gastroenterology at the University of Michigan, Ann Arbor, who was not involved in the study. Most clinicians don’t know their patients’ PFOS levels.

“It’s not that easy to get a test,” Dr. Chen told this news organization.

People can also mitigate their risk factors for hepatocellular carcinoma, such as a poor diet, a lack of exercise, and smoking, said Dr. Goodrich.

The researchers found that patients with hepatocellular carcinoma were more likely to be overweight and have diabetes, and PFOS was associated with higher fasting glucose levels. This raises the possibility that PFOS increases the risk for hepatocellular carcinoma by causing diabetes and obesity.

Dr. Goodrich and his colleagues tried to address this question by adjusting for baseline body mass index (BMI) and diabetes diagnosis in their statistical analysis.

After adjusting for BMI, they found that the association between PFOS and hepatocellular carcinoma diminished to a threefold risk (OR, 2.90; 95% CI, 0.78-10.00) and was no longer statistically significant (P = .11).

On the other hand, adjusting for diabetes did not change the significance of the relationship between PFOS and the cancer (OR, 5.7; 95% CI, 1.10-30.00; P = .04).

The sample size was probably too small to adequately tease out this relationship, Dr. Chen said. Still, he said, “I thought it was a very, very important study.”

The levels of PFOS found in the blood of Americans has been declining since the 1999-2000 NHANES, Dr. Chen pointed out. But that’s not as reassuring as it sounds.

“The problem is that if you put a regulation limiting the use of one PFAS, what people can do is just substitute with another PFAS or another molecule, which for all we know could be equally harmful,” Dr. Chen said.

Funding was provided by the Southern California Environmental Health Science Center supported by the National Institutes of Health. Dr. Goodrich and Dr. Chen report no relevant financial relationships.

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

People exposed to high levels of perfluorooctane sulfonic acid (PFOS) – a widely used synthetic chemical – run an increased risk of hepatocellular carcinoma, researchers say.

The correlation does not prove that PFOS causes this cancer, and more research is needed, but in the meantime, people should limit their exposure to it and others in its class, said Jesse Goodrich, PhD, a postdoctoral scholar in environmental medicine at the University of Southern California, Los Angeles.

“If you’re at risk for liver cancer because you have other risk factors, then these chemicals have the potential to kind of send you over the edge,” he told this news organization.

Dr. Goodrich and colleagues published their research online in JHEP Reports.

Dubbed “forever chemicals” because they can take thousands of years to break down, polyfluoroalkyl substances (PFAS) figure in makeup, food packaging, waterproof clothing, nonstick cookware, firefighting foams, and groundwater. They have spread through the atmosphere into rain and can be found in the blood of most Americans. PFOS is one of the most widely used PFAS.

“You can’t really escape them,” Dr. Goodrich said.

Previous research has linked PFAS to infertility, pregnancy complications, learning and behavioral problems in children, immune system issues, and higher cholesterol, as well as other cancers. Some experiments in animals suggested PFAS could cause liver cancer, and others showed a correlation between PFAS serum levels and biomarkers associated with liver cancer. But many of these health effects take a long time to develop.

“It wasn’t until we started to get really highly exposed groups of people that we started, as scientists, to be able to figure out what was going on,” said Dr. Goodrich.
 

High exposure, increased incidence

To measure the relationship between PFAS exposure and the incidence of hepatocellular carcinoma more definitively, Dr. Goodrich and colleagues analyzed data from the Multiethnic Cohort Study, a cohort of more than 200,000 people of African, Latin, Native Hawaiian, Japanese, and European ancestry tracked since the early 1990s in California and Hawaii. About 67,000 participants provided blood samples from 2001 to 2007.

From this cohort, the researchers found 50 people who later developed hepatocellular carcinoma. The researchers matched these patients with 50 controls of similar age at blood collection, sex, race, ethnicity, and study area who did not develop the cancer.

They found that people with more than 54.9 mcg/L of PFOS in their blood before any diagnosis of hepatocellular carcinoma were almost five times more likely to get the cancer (odds ratio 4.5; 95% confidence interval, 1.2-16.0), which was statistically significant (P = .02).

This level of PFOS corresponds to the 90th percentile found in the U.S. National Health and Nutrition Examination Survey (NHANES).

To get some idea of the mechanism by which PFOS might do its damage, the researchers also looked for linkage to levels of metabolites.

They found an overlap among high PFOS levels, hepatocellular carcinoma, and high levels of glucose, butyric acid (a short chain fatty acid), alpha-Ketoisovaleric acid (alpha branched-chain alpha-keto acid), and 7alpha-Hydroxy-3-oxo-4-cholestenoate (a bile acid). These metabolites have been associated in previous studies with metabolic disorders and liver disease.

Similarly, the researchers identified an association among the cancer, PFOS, and alterations in amino acid and glycan biosynthesis pathways.
 

Risk mitigation

The half-life of PFAS in the human body is about 3-7 years, said Dr. Goodrich.

“There’s not much you can do once they’re in there,” he said. “So, the focus needs to be on preventing the exposure in the first place.”

People can limit exposure by avoiding water contaminated with PFAS or filtering it out, Dr. Goodrich said. He recommended avoiding fish from contaminated waterways and nonstick cookware. The Environmental Protection Agency has more detailed recommendations.

But giving patients individualized recommendations is difficult, said Vincent Chen, MD, MS, a clinical instructor in gastroenterology at the University of Michigan, Ann Arbor, who was not involved in the study. Most clinicians don’t know their patients’ PFOS levels.

“It’s not that easy to get a test,” Dr. Chen told this news organization.

People can also mitigate their risk factors for hepatocellular carcinoma, such as a poor diet, a lack of exercise, and smoking, said Dr. Goodrich.

The researchers found that patients with hepatocellular carcinoma were more likely to be overweight and have diabetes, and PFOS was associated with higher fasting glucose levels. This raises the possibility that PFOS increases the risk for hepatocellular carcinoma by causing diabetes and obesity.

Dr. Goodrich and his colleagues tried to address this question by adjusting for baseline body mass index (BMI) and diabetes diagnosis in their statistical analysis.

After adjusting for BMI, they found that the association between PFOS and hepatocellular carcinoma diminished to a threefold risk (OR, 2.90; 95% CI, 0.78-10.00) and was no longer statistically significant (P = .11).

On the other hand, adjusting for diabetes did not change the significance of the relationship between PFOS and the cancer (OR, 5.7; 95% CI, 1.10-30.00; P = .04).

The sample size was probably too small to adequately tease out this relationship, Dr. Chen said. Still, he said, “I thought it was a very, very important study.”

The levels of PFOS found in the blood of Americans has been declining since the 1999-2000 NHANES, Dr. Chen pointed out. But that’s not as reassuring as it sounds.

“The problem is that if you put a regulation limiting the use of one PFAS, what people can do is just substitute with another PFAS or another molecule, which for all we know could be equally harmful,” Dr. Chen said.

Funding was provided by the Southern California Environmental Health Science Center supported by the National Institutes of Health. Dr. Goodrich and Dr. Chen report no relevant financial relationships.

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

The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

SACRAMENTO – California is trying to ease the pain of vasectomies by making them free for millions of residents.

Federal law and state law require most health insurers to cover prescription contraceptives at no cost to the patient. But those provisions apply to only 18 Food and Drug Administration–approved birth control options for women, so anyone with testicles is out of luck.

California lawmakers are now considering a bill that would expand that requirement to male sterilization and non-prescription birth control, including condoms and contraceptive sponges. If the Contraceptive Equity Act of 2022 passes, commercial insurance plans regulated by the state won’t be allowed to impose out-of-pocket costs, like copays, coinsurance, and deductibles, on those modes of birth control.

“It’s pretty groundbreaking in that way – it’s a whole new framework to think about contraception as something that is relevant for people of all genders,” said Liz McCaman Taylor, a senior attorney with the National Health Law Program, a group that advocates for the health rights of low-income people.

A vasectomy is an outpatient surgical procedure in which the patient’s supply of sperm is cut off from his semen by sealing or snipping the tubes that transport sperm from the testes to the penis. Most men need to recover on the couch with an ice pack for a day or 2, and a test a few months later determines whether the procedure worked.

Because vasectomies are elective procedures and usually not urgent, price can be a deciding factor.

For Nathan Songne, cost was the most stressful part of the procedure. For several years, the 31-year-old had known he didn’t want to have kids biologically. Better to adopt a 4-year-old and skip the diaper stage, he thought. He was adopted by his stepfather as a child and knew he didn’t need to be genetically related to his children to love them.

“My only concern was that I had no idea how much it was going to cost me because nobody told me,” said Mr. Songne, who lives in Mission Viejo, in Orange County. If the procedure cost $1,000, as he expected, he wouldn’t be able to afford it.

Mr. Songne’s insurance, which he gets through his work assembling guitars, covered 70% of the Aug. 8 procedure, leaving him with a bill of just under $200. “Cost did affect my decision, but because it was only $200, it made me feel a lot more relieved about continuing on with the vasectomy.”

There are two hot times of year in the vasectomy business, according to Mary Samplaski, MD, an associate professor of urology at the University of Southern California, Los Angeles. First, she sees an uptick during the March Madness college basketball tournament, when men choose to recover on the couch watching hoops.

The end of the year is also busy, she said, because many patients have finally met their annual insurance deductible and can afford the procedure.

Patients discuss out-of-pocket costs in about 20% of her vasectomy consultations. “It’s obviously a nerve-wracking procedure,” Dr. Samplaski said. “And on top of that, if your copay is high, there’s even less reason to want to do it.”

In April, Jacob Elert comparison-shopped for a vasectomy near his home in Sacramento because his health plan doesn’t cover the procedure. He had hoped to schedule one with his regular urologist, but that would have come with a $1,500 price tag.

Instead, he found a chain of vasectomy clinics where he could get the procedure for $850. Three months later, a test confirmed the vasectomy was a success.

Mr. Elert has no regrets, but had price not been a factor, he would have preferred to go to his regular urologist. “That’s the doctor I trust,” Mr. Elert said. “But it was just way too expensive.”

In November, California voters will decide whether to lock rights to abortion and contraception into the state constitution. But Proposition 1 doesn’t address issues such as cost and coverage, said Amy Moy, a spokesperson for Essential Access Health, a group that runs California’s Title X family planning program.

“The constitutional amendment is kind of the long-term protection, and we are still working to reduce barriers for Californians on the short-term and day-to-day level regardless of their gender,” she said.

SB 523 has sailed through preliminary votes in the state legislature, which faces an end-of-August deadline to act on bills. If the measure passes, it would take effect in 2024, and California would join a handful of states that require plans they regulate to completely cover vasectomies or nonprescription birth control.

The California Association of Health Plans is still evaluating the measure, which may be amended in the final days of the legislative session. But the association generally opposes bills that require additional insurance benefits because they could lead to higher premiums, spokesperson Mary Ellen Grant said.

SB 523 applies to more than 14 million Californians who work for the state, have a student health plan through a university, or have state-regulated commercial health plans. They would become eligible to receive free over-the-counter birth control – such as emergency contraception, condoms, spermicide, and contraceptive sponges – in addition to vasectomies. The bill would not apply to the millions of Californians whose health insurance plans are regulated by the federal government.

The specifics of how the benefit would work, including the frequency and amount of birth control that insurers must cover and whether patients would have to pay upfront and be reimbursed later, would be hammered out after the measure is adopted. Ms. McCaman Taylor said allowing people to simply present their insurance card at a pharmacy counter and walk away with the birth control they need would be preferable.

“We kind of learned from the national experiment with COVID over-the-counter tests that reimbursement wasn’t the best model,” she said. “If people can’t afford to pay out of pocket for it, they’re just not going to get it.”

The California Health Benefits Review Program, which analyzes legislation, projected that roughly 14,200 people with state-regulated commercial insurance would get vasectomies in California in 2022. Eliminating cost sharing would increase the number of vasectomies by 252 in the law’s first year, the program estimated.

It’s a small increase. But that, plus a jump in the use of other contraceptives covered by the bill, particularly condoms, could add up to a big reduction in unintended pregnancies. Roughly 12,300 unplanned pregnancies might be averted each year if the mandate takes effect, a reduction of more than 11%, according to the analysis.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO – California is trying to ease the pain of vasectomies by making them free for millions of residents.

Federal law and state law require most health insurers to cover prescription contraceptives at no cost to the patient. But those provisions apply to only 18 Food and Drug Administration–approved birth control options for women, so anyone with testicles is out of luck.

California lawmakers are now considering a bill that would expand that requirement to male sterilization and non-prescription birth control, including condoms and contraceptive sponges. If the Contraceptive Equity Act of 2022 passes, commercial insurance plans regulated by the state won’t be allowed to impose out-of-pocket costs, like copays, coinsurance, and deductibles, on those modes of birth control.

“It’s pretty groundbreaking in that way – it’s a whole new framework to think about contraception as something that is relevant for people of all genders,” said Liz McCaman Taylor, a senior attorney with the National Health Law Program, a group that advocates for the health rights of low-income people.

A vasectomy is an outpatient surgical procedure in which the patient’s supply of sperm is cut off from his semen by sealing or snipping the tubes that transport sperm from the testes to the penis. Most men need to recover on the couch with an ice pack for a day or 2, and a test a few months later determines whether the procedure worked.

Because vasectomies are elective procedures and usually not urgent, price can be a deciding factor.

For Nathan Songne, cost was the most stressful part of the procedure. For several years, the 31-year-old had known he didn’t want to have kids biologically. Better to adopt a 4-year-old and skip the diaper stage, he thought. He was adopted by his stepfather as a child and knew he didn’t need to be genetically related to his children to love them.

“My only concern was that I had no idea how much it was going to cost me because nobody told me,” said Mr. Songne, who lives in Mission Viejo, in Orange County. If the procedure cost $1,000, as he expected, he wouldn’t be able to afford it.

Mr. Songne’s insurance, which he gets through his work assembling guitars, covered 70% of the Aug. 8 procedure, leaving him with a bill of just under $200. “Cost did affect my decision, but because it was only $200, it made me feel a lot more relieved about continuing on with the vasectomy.”

There are two hot times of year in the vasectomy business, according to Mary Samplaski, MD, an associate professor of urology at the University of Southern California, Los Angeles. First, she sees an uptick during the March Madness college basketball tournament, when men choose to recover on the couch watching hoops.

The end of the year is also busy, she said, because many patients have finally met their annual insurance deductible and can afford the procedure.

Patients discuss out-of-pocket costs in about 20% of her vasectomy consultations. “It’s obviously a nerve-wracking procedure,” Dr. Samplaski said. “And on top of that, if your copay is high, there’s even less reason to want to do it.”

In April, Jacob Elert comparison-shopped for a vasectomy near his home in Sacramento because his health plan doesn’t cover the procedure. He had hoped to schedule one with his regular urologist, but that would have come with a $1,500 price tag.

Instead, he found a chain of vasectomy clinics where he could get the procedure for $850. Three months later, a test confirmed the vasectomy was a success.

Mr. Elert has no regrets, but had price not been a factor, he would have preferred to go to his regular urologist. “That’s the doctor I trust,” Mr. Elert said. “But it was just way too expensive.”

In November, California voters will decide whether to lock rights to abortion and contraception into the state constitution. But Proposition 1 doesn’t address issues such as cost and coverage, said Amy Moy, a spokesperson for Essential Access Health, a group that runs California’s Title X family planning program.

“The constitutional amendment is kind of the long-term protection, and we are still working to reduce barriers for Californians on the short-term and day-to-day level regardless of their gender,” she said.

SB 523 has sailed through preliminary votes in the state legislature, which faces an end-of-August deadline to act on bills. If the measure passes, it would take effect in 2024, and California would join a handful of states that require plans they regulate to completely cover vasectomies or nonprescription birth control.

The California Association of Health Plans is still evaluating the measure, which may be amended in the final days of the legislative session. But the association generally opposes bills that require additional insurance benefits because they could lead to higher premiums, spokesperson Mary Ellen Grant said.

SB 523 applies to more than 14 million Californians who work for the state, have a student health plan through a university, or have state-regulated commercial health plans. They would become eligible to receive free over-the-counter birth control – such as emergency contraception, condoms, spermicide, and contraceptive sponges – in addition to vasectomies. The bill would not apply to the millions of Californians whose health insurance plans are regulated by the federal government.

The specifics of how the benefit would work, including the frequency and amount of birth control that insurers must cover and whether patients would have to pay upfront and be reimbursed later, would be hammered out after the measure is adopted. Ms. McCaman Taylor said allowing people to simply present their insurance card at a pharmacy counter and walk away with the birth control they need would be preferable.

“We kind of learned from the national experiment with COVID over-the-counter tests that reimbursement wasn’t the best model,” she said. “If people can’t afford to pay out of pocket for it, they’re just not going to get it.”

The California Health Benefits Review Program, which analyzes legislation, projected that roughly 14,200 people with state-regulated commercial insurance would get vasectomies in California in 2022. Eliminating cost sharing would increase the number of vasectomies by 252 in the law’s first year, the program estimated.

It’s a small increase. But that, plus a jump in the use of other contraceptives covered by the bill, particularly condoms, could add up to a big reduction in unintended pregnancies. Roughly 12,300 unplanned pregnancies might be averted each year if the mandate takes effect, a reduction of more than 11%, according to the analysis.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO – California is trying to ease the pain of vasectomies by making them free for millions of residents.

Federal law and state law require most health insurers to cover prescription contraceptives at no cost to the patient. But those provisions apply to only 18 Food and Drug Administration–approved birth control options for women, so anyone with testicles is out of luck.

California lawmakers are now considering a bill that would expand that requirement to male sterilization and non-prescription birth control, including condoms and contraceptive sponges. If the Contraceptive Equity Act of 2022 passes, commercial insurance plans regulated by the state won’t be allowed to impose out-of-pocket costs, like copays, coinsurance, and deductibles, on those modes of birth control.

“It’s pretty groundbreaking in that way – it’s a whole new framework to think about contraception as something that is relevant for people of all genders,” said Liz McCaman Taylor, a senior attorney with the National Health Law Program, a group that advocates for the health rights of low-income people.

A vasectomy is an outpatient surgical procedure in which the patient’s supply of sperm is cut off from his semen by sealing or snipping the tubes that transport sperm from the testes to the penis. Most men need to recover on the couch with an ice pack for a day or 2, and a test a few months later determines whether the procedure worked.

Because vasectomies are elective procedures and usually not urgent, price can be a deciding factor.

For Nathan Songne, cost was the most stressful part of the procedure. For several years, the 31-year-old had known he didn’t want to have kids biologically. Better to adopt a 4-year-old and skip the diaper stage, he thought. He was adopted by his stepfather as a child and knew he didn’t need to be genetically related to his children to love them.

“My only concern was that I had no idea how much it was going to cost me because nobody told me,” said Mr. Songne, who lives in Mission Viejo, in Orange County. If the procedure cost $1,000, as he expected, he wouldn’t be able to afford it.

Mr. Songne’s insurance, which he gets through his work assembling guitars, covered 70% of the Aug. 8 procedure, leaving him with a bill of just under $200. “Cost did affect my decision, but because it was only $200, it made me feel a lot more relieved about continuing on with the vasectomy.”

There are two hot times of year in the vasectomy business, according to Mary Samplaski, MD, an associate professor of urology at the University of Southern California, Los Angeles. First, she sees an uptick during the March Madness college basketball tournament, when men choose to recover on the couch watching hoops.

The end of the year is also busy, she said, because many patients have finally met their annual insurance deductible and can afford the procedure.

Patients discuss out-of-pocket costs in about 20% of her vasectomy consultations. “It’s obviously a nerve-wracking procedure,” Dr. Samplaski said. “And on top of that, if your copay is high, there’s even less reason to want to do it.”

In April, Jacob Elert comparison-shopped for a vasectomy near his home in Sacramento because his health plan doesn’t cover the procedure. He had hoped to schedule one with his regular urologist, but that would have come with a $1,500 price tag.

Instead, he found a chain of vasectomy clinics where he could get the procedure for $850. Three months later, a test confirmed the vasectomy was a success.

Mr. Elert has no regrets, but had price not been a factor, he would have preferred to go to his regular urologist. “That’s the doctor I trust,” Mr. Elert said. “But it was just way too expensive.”

In November, California voters will decide whether to lock rights to abortion and contraception into the state constitution. But Proposition 1 doesn’t address issues such as cost and coverage, said Amy Moy, a spokesperson for Essential Access Health, a group that runs California’s Title X family planning program.

“The constitutional amendment is kind of the long-term protection, and we are still working to reduce barriers for Californians on the short-term and day-to-day level regardless of their gender,” she said.

SB 523 has sailed through preliminary votes in the state legislature, which faces an end-of-August deadline to act on bills. If the measure passes, it would take effect in 2024, and California would join a handful of states that require plans they regulate to completely cover vasectomies or nonprescription birth control.

The California Association of Health Plans is still evaluating the measure, which may be amended in the final days of the legislative session. But the association generally opposes bills that require additional insurance benefits because they could lead to higher premiums, spokesperson Mary Ellen Grant said.

SB 523 applies to more than 14 million Californians who work for the state, have a student health plan through a university, or have state-regulated commercial health plans. They would become eligible to receive free over-the-counter birth control – such as emergency contraception, condoms, spermicide, and contraceptive sponges – in addition to vasectomies. The bill would not apply to the millions of Californians whose health insurance plans are regulated by the federal government.

The specifics of how the benefit would work, including the frequency and amount of birth control that insurers must cover and whether patients would have to pay upfront and be reimbursed later, would be hammered out after the measure is adopted. Ms. McCaman Taylor said allowing people to simply present their insurance card at a pharmacy counter and walk away with the birth control they need would be preferable.

“We kind of learned from the national experiment with COVID over-the-counter tests that reimbursement wasn’t the best model,” she said. “If people can’t afford to pay out of pocket for it, they’re just not going to get it.”

The California Health Benefits Review Program, which analyzes legislation, projected that roughly 14,200 people with state-regulated commercial insurance would get vasectomies in California in 2022. Eliminating cost sharing would increase the number of vasectomies by 252 in the law’s first year, the program estimated.

It’s a small increase. But that, plus a jump in the use of other contraceptives covered by the bill, particularly condoms, could add up to a big reduction in unintended pregnancies. Roughly 12,300 unplanned pregnancies might be averted each year if the mandate takes effect, a reduction of more than 11%, according to the analysis.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Children born near fracking and other “unconventional” drilling sites are at two to three times greater risk of developing childhood leukemia, according to new research.

The study, published in the journal Environmental Health Perspectives, compared proximity of homes to unconventional oil and gas development (UOGD) sites and risk of the most common form of childhood leukemia, acute lymphoblastic leukemia (ALL).

Researchers looked at 405 children aged 2-7 diagnosed with ALL in Pennsylvania from 2009 to 2017. These children were compared to a control group of 2,080 without the disease matched on the year of birth.

“Unconventional oil and gas development can both use and release chemicals that have been linked to cancer,” study coauthor Nicole Deziel, PhD, of the Yale School of Public Health, New Haven, Conn., said in a  statement . She noted that the possibility that children living in close proximity to such sites are “exposed to these chemical carcinogens is a major public health concern.”

About 17 million Americans live within a half-mile of active oil and gas production, according to the Oil & Gas Threat Map, Common Dreams reports. That number includes 4 million children.

The Yale study also found that drinking water could be an important pathway of exposure to oil- and gas-related chemicals used in the UOGD methods of extraction.

Researchers used a new metric that measures exposure to contaminated drinking water and distance to a well. They were able to identify UOGD-affected wells that fell within watersheds where children and their families likely obtained their water.

“Previous health studies have found links between proximity to oil and gas drilling and various children’s health outcomes,” said Dr. Deziel. “This study is among the few to focus on drinking water specifically and the first to apply a novel metric designed to capture potential exposure through this pathway.”

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

Children born near fracking and other “unconventional” drilling sites are at two to three times greater risk of developing childhood leukemia, according to new research.

The study, published in the journal Environmental Health Perspectives, compared proximity of homes to unconventional oil and gas development (UOGD) sites and risk of the most common form of childhood leukemia, acute lymphoblastic leukemia (ALL).

Researchers looked at 405 children aged 2-7 diagnosed with ALL in Pennsylvania from 2009 to 2017. These children were compared to a control group of 2,080 without the disease matched on the year of birth.

“Unconventional oil and gas development can both use and release chemicals that have been linked to cancer,” study coauthor Nicole Deziel, PhD, of the Yale School of Public Health, New Haven, Conn., said in a  statement . She noted that the possibility that children living in close proximity to such sites are “exposed to these chemical carcinogens is a major public health concern.”

About 17 million Americans live within a half-mile of active oil and gas production, according to the Oil & Gas Threat Map, Common Dreams reports. That number includes 4 million children.

The Yale study also found that drinking water could be an important pathway of exposure to oil- and gas-related chemicals used in the UOGD methods of extraction.

Researchers used a new metric that measures exposure to contaminated drinking water and distance to a well. They were able to identify UOGD-affected wells that fell within watersheds where children and their families likely obtained their water.

“Previous health studies have found links between proximity to oil and gas drilling and various children’s health outcomes,” said Dr. Deziel. “This study is among the few to focus on drinking water specifically and the first to apply a novel metric designed to capture potential exposure through this pathway.”

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

Children born near fracking and other “unconventional” drilling sites are at two to three times greater risk of developing childhood leukemia, according to new research.

The study, published in the journal Environmental Health Perspectives, compared proximity of homes to unconventional oil and gas development (UOGD) sites and risk of the most common form of childhood leukemia, acute lymphoblastic leukemia (ALL).

Researchers looked at 405 children aged 2-7 diagnosed with ALL in Pennsylvania from 2009 to 2017. These children were compared to a control group of 2,080 without the disease matched on the year of birth.

“Unconventional oil and gas development can both use and release chemicals that have been linked to cancer,” study coauthor Nicole Deziel, PhD, of the Yale School of Public Health, New Haven, Conn., said in a  statement . She noted that the possibility that children living in close proximity to such sites are “exposed to these chemical carcinogens is a major public health concern.”

About 17 million Americans live within a half-mile of active oil and gas production, according to the Oil & Gas Threat Map, Common Dreams reports. That number includes 4 million children.

The Yale study also found that drinking water could be an important pathway of exposure to oil- and gas-related chemicals used in the UOGD methods of extraction.

Researchers used a new metric that measures exposure to contaminated drinking water and distance to a well. They were able to identify UOGD-affected wells that fell within watersheds where children and their families likely obtained their water.

“Previous health studies have found links between proximity to oil and gas drilling and various children’s health outcomes,” said Dr. Deziel. “This study is among the few to focus on drinking water specifically and the first to apply a novel metric designed to capture potential exposure through this pathway.”

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

A 5-minute bout of direct-to-consumer advertising (DTCA) for prescription heart drugs was associated with favorable perceptions of both medication use and pharmaceutical companies, but did not seem to negate intentions to use lifestyle interventions, a survey study shows.

Participants who watched ads for various prescription heart drugs, with or without price disclosure, were more likely to report positive perceptions of drug companies and intentions to take actions such as switching medications.

AlShadsky/Fotolia.com

The ads did not seem to affect intentions to eat healthfully and exercise.

The study was published online in JAMA Health Forum.
 

DTCA ‘unlikely to have an adverse effect’

“Increasing prevalence of DTCA may promote an overreliance on medication over healthy lifestyle choices to manage chronic conditions,” coauthor Yashaswini Singh, MPA, a PhD candidate at the Johns Hopkins University, Baltimore, told this news organization. “Thus, we hypothesized that DTCA exposure would reduce the likelihood of individuals engaging in preventive health behaviors.”

“However,” she said, “our results did not support this hypothesis, suggesting that exposure to DTCA for heart disease medication is unlikely to have an adverse effect on individuals’ intentions to engage in diet and exercise.”

That said, she added, “DTCA of prescription drugs can contribute to rising drug costs due to overprescribing of both inappropriate and brand-name drugs over cheaper generic alternatives. While we do not examine this mechanism in our paper, this remains an important question for future research.”

For the study, the team recruited 2,874 individuals (mean age, 53.8 years; 54% men; 83% White) from a U.S. nationally representative sample of people at high risk of cardiovascular disease, the Ipsos Public Affairs KnowledgePanel.

Participants were randomly assigned to one of three interventions: DTCA for heart disease medications, DTCA for heart disease medications with price disclosure, or nonpharmaceutical advertising (control). Each group watched five 1-minute videos for a total of 5 minutes of advertising exposure.

One group viewed ads for four heart disease medications – two ads for sacubitril/valsartan (Entresto, Novartis) and one each for rivaroxaban (Xarelto, Bayer), evolocumab (Repatha, Amgen), and ticagrelor (Brilinta, AstraZeneca); the second group saw the same ads, but with prices spliced in; and controls watched videos for nondrug products, such as consumer electronics.

Participants then completed a questionnaire to measure medication- and lifestyle-related intentions, as well as health-related beliefs and perceptions. Using a scale of 1 (highly unlikely) to 5 (highly likely), they rated the likelihood of their switching medication, asking a physician or insurer about a medication, searching for the drug online, or taking it as directed. The same scale was used to rate the likelihood of their being more physically active or eating more healthfully.

On a scale of 1 (always disagree) to 5 (always agree), they also related their perceptions of pharmaceutical manufacturers as being competent, innovative, and trustworthy.

To measure the magnitude of DTCA associations, the researchers calculated marginal effects (MEs) of treatment – that is, the difference in probability of an outcome between the treatment and control arms.

They found a positive association between DTCA and medication-related behavioral intentions, including intention to switch medication (ME, 0.004; P = .002) and engage in information-seeking behaviors (ME, 0.02; P = .01).

There was no evidence suggesting that pharmaceutical DTCA discouraged use of nonpharmacologic lifestyle interventions to help manage heart disease. DTCA also was positively associated with consumers’ favorable perceptions of pharmaceutical manufacturers (competence: ME, 0.03; P = .01; innovative: ME, 0.03; P = .008).

No differential associations were seen for price disclosures in DTCA.
 

Questions remain

The authors acknowledged that the study focused on short-term behavioral intentions and that “future research should focus on the long-term effects of advertising in a real-world randomized setting.”

Ms. Singh said additional questions, some of which her team is investigating, include “understanding the interaction between government policies [such as] drug pricing reforms and firms’ advertising decisions; understanding whether observed changes in individuals’ health beliefs translate into actual changes to information-seeking behavior and health care utilization; and whether the demographic, political, and social characteristics of individuals shape their behavioral responses to advertising.”

Johanna Contreras, MD, an advanced heart failure and transplantation cardiologist at Mount Sinai Hospital, New York, said in an interview that the findings don’t surprise her. “The caveat is that this study was an online survey, so it only captured the beliefs and intentions, but not patient demand for the product and use of the product.”

“I do believe DTCA can create positive intentions towards the product ... and could make people more receptive to interventions,” she said. However, the information must be presented in a balanced way.

In addition, she noted, “price is still important. I think people take pricing into account when deciding to proceed with an intervention. If the price is ‘right’ or a little lower than expected, then they will likely consider the product. But if the price is significantly lower, then they may not trust that it is a good product. Generic drugs are an example. Even though they are approved and far cheaper than brand names, patients are often skeptical to take them.”

The study was funded with a grant from the Blue Cross Blue Shield of Illinois Affordability Cures Consortium. Ms. Singh and coauthors disclosed no relevant financial relationships.

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

A 5-minute bout of direct-to-consumer advertising (DTCA) for prescription heart drugs was associated with favorable perceptions of both medication use and pharmaceutical companies, but did not seem to negate intentions to use lifestyle interventions, a survey study shows.

Participants who watched ads for various prescription heart drugs, with or without price disclosure, were more likely to report positive perceptions of drug companies and intentions to take actions such as switching medications.

AlShadsky/Fotolia.com

The ads did not seem to affect intentions to eat healthfully and exercise.

The study was published online in JAMA Health Forum.
 

DTCA ‘unlikely to have an adverse effect’

“Increasing prevalence of DTCA may promote an overreliance on medication over healthy lifestyle choices to manage chronic conditions,” coauthor Yashaswini Singh, MPA, a PhD candidate at the Johns Hopkins University, Baltimore, told this news organization. “Thus, we hypothesized that DTCA exposure would reduce the likelihood of individuals engaging in preventive health behaviors.”

“However,” she said, “our results did not support this hypothesis, suggesting that exposure to DTCA for heart disease medication is unlikely to have an adverse effect on individuals’ intentions to engage in diet and exercise.”

That said, she added, “DTCA of prescription drugs can contribute to rising drug costs due to overprescribing of both inappropriate and brand-name drugs over cheaper generic alternatives. While we do not examine this mechanism in our paper, this remains an important question for future research.”

For the study, the team recruited 2,874 individuals (mean age, 53.8 years; 54% men; 83% White) from a U.S. nationally representative sample of people at high risk of cardiovascular disease, the Ipsos Public Affairs KnowledgePanel.

Participants were randomly assigned to one of three interventions: DTCA for heart disease medications, DTCA for heart disease medications with price disclosure, or nonpharmaceutical advertising (control). Each group watched five 1-minute videos for a total of 5 minutes of advertising exposure.

One group viewed ads for four heart disease medications – two ads for sacubitril/valsartan (Entresto, Novartis) and one each for rivaroxaban (Xarelto, Bayer), evolocumab (Repatha, Amgen), and ticagrelor (Brilinta, AstraZeneca); the second group saw the same ads, but with prices spliced in; and controls watched videos for nondrug products, such as consumer electronics.

Participants then completed a questionnaire to measure medication- and lifestyle-related intentions, as well as health-related beliefs and perceptions. Using a scale of 1 (highly unlikely) to 5 (highly likely), they rated the likelihood of their switching medication, asking a physician or insurer about a medication, searching for the drug online, or taking it as directed. The same scale was used to rate the likelihood of their being more physically active or eating more healthfully.

On a scale of 1 (always disagree) to 5 (always agree), they also related their perceptions of pharmaceutical manufacturers as being competent, innovative, and trustworthy.

To measure the magnitude of DTCA associations, the researchers calculated marginal effects (MEs) of treatment – that is, the difference in probability of an outcome between the treatment and control arms.

They found a positive association between DTCA and medication-related behavioral intentions, including intention to switch medication (ME, 0.004; P = .002) and engage in information-seeking behaviors (ME, 0.02; P = .01).

There was no evidence suggesting that pharmaceutical DTCA discouraged use of nonpharmacologic lifestyle interventions to help manage heart disease. DTCA also was positively associated with consumers’ favorable perceptions of pharmaceutical manufacturers (competence: ME, 0.03; P = .01; innovative: ME, 0.03; P = .008).

No differential associations were seen for price disclosures in DTCA.
 

Questions remain

The authors acknowledged that the study focused on short-term behavioral intentions and that “future research should focus on the long-term effects of advertising in a real-world randomized setting.”

Ms. Singh said additional questions, some of which her team is investigating, include “understanding the interaction between government policies [such as] drug pricing reforms and firms’ advertising decisions; understanding whether observed changes in individuals’ health beliefs translate into actual changes to information-seeking behavior and health care utilization; and whether the demographic, political, and social characteristics of individuals shape their behavioral responses to advertising.”

Johanna Contreras, MD, an advanced heart failure and transplantation cardiologist at Mount Sinai Hospital, New York, said in an interview that the findings don’t surprise her. “The caveat is that this study was an online survey, so it only captured the beliefs and intentions, but not patient demand for the product and use of the product.”

“I do believe DTCA can create positive intentions towards the product ... and could make people more receptive to interventions,” she said. However, the information must be presented in a balanced way.

In addition, she noted, “price is still important. I think people take pricing into account when deciding to proceed with an intervention. If the price is ‘right’ or a little lower than expected, then they will likely consider the product. But if the price is significantly lower, then they may not trust that it is a good product. Generic drugs are an example. Even though they are approved and far cheaper than brand names, patients are often skeptical to take them.”

The study was funded with a grant from the Blue Cross Blue Shield of Illinois Affordability Cures Consortium. Ms. Singh and coauthors disclosed no relevant financial relationships.

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

A 5-minute bout of direct-to-consumer advertising (DTCA) for prescription heart drugs was associated with favorable perceptions of both medication use and pharmaceutical companies, but did not seem to negate intentions to use lifestyle interventions, a survey study shows.

Participants who watched ads for various prescription heart drugs, with or without price disclosure, were more likely to report positive perceptions of drug companies and intentions to take actions such as switching medications.

AlShadsky/Fotolia.com

The ads did not seem to affect intentions to eat healthfully and exercise.

The study was published online in JAMA Health Forum.
 

DTCA ‘unlikely to have an adverse effect’

“Increasing prevalence of DTCA may promote an overreliance on medication over healthy lifestyle choices to manage chronic conditions,” coauthor Yashaswini Singh, MPA, a PhD candidate at the Johns Hopkins University, Baltimore, told this news organization. “Thus, we hypothesized that DTCA exposure would reduce the likelihood of individuals engaging in preventive health behaviors.”

“However,” she said, “our results did not support this hypothesis, suggesting that exposure to DTCA for heart disease medication is unlikely to have an adverse effect on individuals’ intentions to engage in diet and exercise.”

That said, she added, “DTCA of prescription drugs can contribute to rising drug costs due to overprescribing of both inappropriate and brand-name drugs over cheaper generic alternatives. While we do not examine this mechanism in our paper, this remains an important question for future research.”

For the study, the team recruited 2,874 individuals (mean age, 53.8 years; 54% men; 83% White) from a U.S. nationally representative sample of people at high risk of cardiovascular disease, the Ipsos Public Affairs KnowledgePanel.

Participants were randomly assigned to one of three interventions: DTCA for heart disease medications, DTCA for heart disease medications with price disclosure, or nonpharmaceutical advertising (control). Each group watched five 1-minute videos for a total of 5 minutes of advertising exposure.

One group viewed ads for four heart disease medications – two ads for sacubitril/valsartan (Entresto, Novartis) and one each for rivaroxaban (Xarelto, Bayer), evolocumab (Repatha, Amgen), and ticagrelor (Brilinta, AstraZeneca); the second group saw the same ads, but with prices spliced in; and controls watched videos for nondrug products, such as consumer electronics.

Participants then completed a questionnaire to measure medication- and lifestyle-related intentions, as well as health-related beliefs and perceptions. Using a scale of 1 (highly unlikely) to 5 (highly likely), they rated the likelihood of their switching medication, asking a physician or insurer about a medication, searching for the drug online, or taking it as directed. The same scale was used to rate the likelihood of their being more physically active or eating more healthfully.

On a scale of 1 (always disagree) to 5 (always agree), they also related their perceptions of pharmaceutical manufacturers as being competent, innovative, and trustworthy.

To measure the magnitude of DTCA associations, the researchers calculated marginal effects (MEs) of treatment – that is, the difference in probability of an outcome between the treatment and control arms.

They found a positive association between DTCA and medication-related behavioral intentions, including intention to switch medication (ME, 0.004; P = .002) and engage in information-seeking behaviors (ME, 0.02; P = .01).

There was no evidence suggesting that pharmaceutical DTCA discouraged use of nonpharmacologic lifestyle interventions to help manage heart disease. DTCA also was positively associated with consumers’ favorable perceptions of pharmaceutical manufacturers (competence: ME, 0.03; P = .01; innovative: ME, 0.03; P = .008).

No differential associations were seen for price disclosures in DTCA.
 

Questions remain

The authors acknowledged that the study focused on short-term behavioral intentions and that “future research should focus on the long-term effects of advertising in a real-world randomized setting.”

Ms. Singh said additional questions, some of which her team is investigating, include “understanding the interaction between government policies [such as] drug pricing reforms and firms’ advertising decisions; understanding whether observed changes in individuals’ health beliefs translate into actual changes to information-seeking behavior and health care utilization; and whether the demographic, political, and social characteristics of individuals shape their behavioral responses to advertising.”

Johanna Contreras, MD, an advanced heart failure and transplantation cardiologist at Mount Sinai Hospital, New York, said in an interview that the findings don’t surprise her. “The caveat is that this study was an online survey, so it only captured the beliefs and intentions, but not patient demand for the product and use of the product.”

“I do believe DTCA can create positive intentions towards the product ... and could make people more receptive to interventions,” she said. However, the information must be presented in a balanced way.

In addition, she noted, “price is still important. I think people take pricing into account when deciding to proceed with an intervention. If the price is ‘right’ or a little lower than expected, then they will likely consider the product. But if the price is significantly lower, then they may not trust that it is a good product. Generic drugs are an example. Even though they are approved and far cheaper than brand names, patients are often skeptical to take them.”

The study was funded with a grant from the Blue Cross Blue Shield of Illinois Affordability Cures Consortium. Ms. Singh and coauthors disclosed no relevant financial relationships.

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

The U.S. Food and Drug Administration has approved the first oral N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder (MDD) in adults, its manufacturer has announced.

Auvelity (Axsome Therapeutics) is a proprietary extended-release oral tablet containing dextromethorphan (45 mg) and bupropion (105 mg).

It is the “first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week,” the company said in a news release.

“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile,” Maurizio Fava, MD, psychiatrist-in-chief, Massachusetts General Hospital, Boston, added in the release. 
 

‘Milestone’ in depression treatment?

Dr. Fava noted that nearly two-thirds of patients treated with currently available antidepressants fail to respond adequately, and those who do may not achieve clinically meaningful responses for up to 6-8 weeks.

“Given the debilitating nature of depression, the efficacy of Auvelity observed at 1 week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition,” he said.

The company noted the drug was studied in a comprehensive clinical program that included more than 1,100 patients with MDD.

The efficacy of the drug was demonstrated in the GEMINI placebo-controlled study – with confirmatory evidence provided by the ASCEND study, which  compared it with bupropion sustained-release tablets.

Axsome said it expects to launch the new oral medication in the fourth quarter of this year. It is not approved for use in children.

The full prescribing information and medication guide are available online.

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

The U.S. Food and Drug Administration has approved the first oral N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder (MDD) in adults, its manufacturer has announced.

Auvelity (Axsome Therapeutics) is a proprietary extended-release oral tablet containing dextromethorphan (45 mg) and bupropion (105 mg).

It is the “first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week,” the company said in a news release.

“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile,” Maurizio Fava, MD, psychiatrist-in-chief, Massachusetts General Hospital, Boston, added in the release. 
 

‘Milestone’ in depression treatment?

Dr. Fava noted that nearly two-thirds of patients treated with currently available antidepressants fail to respond adequately, and those who do may not achieve clinically meaningful responses for up to 6-8 weeks.

“Given the debilitating nature of depression, the efficacy of Auvelity observed at 1 week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition,” he said.

The company noted the drug was studied in a comprehensive clinical program that included more than 1,100 patients with MDD.

The efficacy of the drug was demonstrated in the GEMINI placebo-controlled study – with confirmatory evidence provided by the ASCEND study, which  compared it with bupropion sustained-release tablets.

Axsome said it expects to launch the new oral medication in the fourth quarter of this year. It is not approved for use in children.

The full prescribing information and medication guide are available online.

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

The U.S. Food and Drug Administration has approved the first oral N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder (MDD) in adults, its manufacturer has announced.

Auvelity (Axsome Therapeutics) is a proprietary extended-release oral tablet containing dextromethorphan (45 mg) and bupropion (105 mg).

It is the “first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week,” the company said in a news release.

“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile,” Maurizio Fava, MD, psychiatrist-in-chief, Massachusetts General Hospital, Boston, added in the release. 
 

‘Milestone’ in depression treatment?

Dr. Fava noted that nearly two-thirds of patients treated with currently available antidepressants fail to respond adequately, and those who do may not achieve clinically meaningful responses for up to 6-8 weeks.

“Given the debilitating nature of depression, the efficacy of Auvelity observed at 1 week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition,” he said.

The company noted the drug was studied in a comprehensive clinical program that included more than 1,100 patients with MDD.

The efficacy of the drug was demonstrated in the GEMINI placebo-controlled study – with confirmatory evidence provided by the ASCEND study, which  compared it with bupropion sustained-release tablets.

Axsome said it expects to launch the new oral medication in the fourth quarter of this year. It is not approved for use in children.

The full prescribing information and medication guide are available online.

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

Many changes in the evolution of the treatment of diabetes have occurred during this year and 2021. Randomized controlled trials have resulted in updated guidelines for the use of glucagonlike peptide-1 receptor agonists (GLP1RAs) and continuous glucose monitoring (CGM) technology. I am hoping my discussion about these major advances in this edition of Highlights will be helpful to those caring for patients with diabetes.

Tirzepatide

The first GLP1RA, exenatide, was released in April 2005. Since then, numerous daily and weekly drugs of this class have been developed. We’ve learned they are effective glucose lowering drugs, and the weekly agents dulaglutide and semaglutide have shown impressive weight reduction properties as well as cardiovascular benefits.

Secondary outcomes have also shown renal benefits to these agents, and studies for primary renal efficacy are pending. Due to all of these properties, the GLP1RAs are recommended as the first injectable for the treatment of type 2 diabetes, prior to insulin initiation.¹

The next generation of these agents are a combination of a GLP1RA and a glucose-dependent insulinotropic polypeptide (GIP). Glucagonlike peptide-1 (GLP-1) stimulates insulin secretion, inhibits glucagon secretion, delays gastric emptying, and has central effects inducing satiety.

We now understand that GIP is the main incretin hormone in those without diabetes, causative of most of the incretin effects. But the insulin response after GIP secretion in type 2 diabetes is strongly reduced. It is now appreciated that this poor effect of GIP can be reduced when used in combination with a GLP1RA. This combination incretin, called by some a “twincretin,” is the basis for the drug tirzepatide which was approved by the Food and Drug Administration in May of 2022.

The data supporting this agent for both diabetes and obesity are impressive. For example, in a 40-week study with a baseline HbA1c of 8.0%, those randomized to tirzepatide at 5 mg, 10 mg, and 15 mg had HbA1c reductions of 1.87%, 1.89%, and 2.07% respectively.² Over 81% at all doses had HbA1c levels less than 6.5% at 40 weeks.

For the 5-mg, 10-mg, and 15-mg doses, weight change from baseline was 7.9%, 9.3%, and 11.0% respectively. Like older GLP1RAs, gastrointestinal side effects were the main problem. For the three doses, 3%, 5%, and 7%, respectively, had to stop the drug, compared with the 3% who stopped taking the placebo. In another study, tirzepatide was noninferior or superior at all three doses compared with semaglutide 1 mg weekly.³

In a population without diabetes, with 40% of patients having prediabetes, weight loss percentages for the three doses were 15.0%, 19.5%, and 20.9% respectively.⁴ Discontinuation percentages due to side effects were 4%-7%. The exciting part is we now have a drug that approaches weight loss from bariatric surgery. The cardiovascular and renal outcome trials are now underway, but the enthusiasm for this drug is clear from the data.

Like other GLP1RAs, the key is to start low and go slowly. It is recommended to start tirzepatide at 2.5 mg four times a week, then increase to 5 mg. Due to gastrointestinal side effects, some patients will do better at the lower dose before increasing. For those switching from another GLP1RA, there are no data to guide us but, in my practice, I start those patients at 5 mg weekly.
 

Continuous glucose monitoring

Data continue to accumulate that this form of glycemic self-monitoring is effective to reduce HbA1c levels and minimize hypoglycemia in both type 1 and type 2 diabetes. The most important change to the 2022 American Diabetes Association (ADA) standards of care is recognizing CGM as level A evidence for those receiving basal insulin without mealtime insulin.⁵ There are four CGMs on the market, but most of the market uses the Dexcom G6 or the Libre 2. Both of these devices will be updated within the next few months to newer generation sensors.

While there are similarities and differences between the two devices, by late 2022 and early 2023 changes to both will reduce the dissimilarities.

The next generation Libre (Libre 3) will be continuous, and “scanning” will no longer be required.  For those unable to get insurance to cover CGM, the Libre will continue to be more affordable than the Dexcom. Alerts will be present on both, but the Dexcom G7 will be approved for both the arm and the abdomen. The Dexcom also can communicate with several automated insulin delivery systems and data can be shared real-time with family members.

For clinicians just starting patients on this technology, my suggestion is to focus on one system so both the provider and staff can become familiar with it. It is key to review downloaded glucose metrics, in addition to the “ambulatory glucose profile,” a graphic overview of daily glycemia where patterns can be identified. It is also helpful to ask for assistance from endocrinologists who have experience with CGMs, in addition to the representatives of the companies.

COVID-19 and new-onset diabetes

From the beginning of the COVID 19 pandemic in 2020, it was clear that stress hyperglycemia and glucose dysregulation was an important observation for those infected. What was not known at the time is that for some, the hyperglycemia continued, and permanent diabetes ensued.

In one study of over 2.7 million U.S. veterans, men infected with COVID-19, but not women, were at a higher risk of new incident diabetes at 120 days after infection compared to no infection (odds ratio for men = 2.56).⁶

Another literature review using meta-analyses and cross-sectional studies concluded new-onset diabetes following COVID-19 infection can have a varied phenotype, with no risk factors, presenting from diabetic ketoacidosis to milder forms of diabetes.⁷

The current thought is that COVID-19 binds to the ACE2 and TMPRSS2 receptors which appear to be located on the beta-cells in the islet, resulting in insulin deficiency, in addition to the insulin resistance that seems to persist after the acute infection. Much more needs to be learned about this, but clinicians need to appreciate this appears to be a new form of diabetes and optimal treatments are not yet clear.

Dr. Hirsch is an endocrinologist, professor of medicine, and diabetes treatment and teaching chair at the University of Washington, Seattle. He has received research grant support from Dexcom and Insulet and has provided consulting to Abbott, Roche, Lifescan, and GWave. You can contact him at [email protected].

References

1. American Diabetes Association Professional Practice Committee. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S125-S143.

2. Rosenstock J et al. Efficacy and safety of a novel GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): A double-blind, randomised, phase 3 trial. Lancet. 2021;398:143-55.

3. Frias JP et al. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385:503-15.

4. Jastreboff AM et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387:205-16.

5. American Diabetes Association Professional Practice Committee. Diabetes technology: Standards of Medical Care in Diabetes–2022. Diabetes Care. 2022;45(Suppl 1):S97-S112.

6. Wander PL et al. The incidence of diabetes in 2,777,768 veterans with and without recent SARS-CoV-2 infection. Diabetes Care 2022;45:782-8.

7. Joshi SC and Pozzilli P. COVID-19 induced diabetes: A novel presentation. Diabetes Res Clin Pract. 2022 Aug 6;191:110034.

Many changes in the evolution of the treatment of diabetes have occurred during this year and 2021. Randomized controlled trials have resulted in updated guidelines for the use of glucagonlike peptide-1 receptor agonists (GLP1RAs) and continuous glucose monitoring (CGM) technology. I am hoping my discussion about these major advances in this edition of Highlights will be helpful to those caring for patients with diabetes.

Tirzepatide

The first GLP1RA, exenatide, was released in April 2005. Since then, numerous daily and weekly drugs of this class have been developed. We’ve learned they are effective glucose lowering drugs, and the weekly agents dulaglutide and semaglutide have shown impressive weight reduction properties as well as cardiovascular benefits.

Secondary outcomes have also shown renal benefits to these agents, and studies for primary renal efficacy are pending. Due to all of these properties, the GLP1RAs are recommended as the first injectable for the treatment of type 2 diabetes, prior to insulin initiation.¹

The next generation of these agents are a combination of a GLP1RA and a glucose-dependent insulinotropic polypeptide (GIP). Glucagonlike peptide-1 (GLP-1) stimulates insulin secretion, inhibits glucagon secretion, delays gastric emptying, and has central effects inducing satiety.

We now understand that GIP is the main incretin hormone in those without diabetes, causative of most of the incretin effects. But the insulin response after GIP secretion in type 2 diabetes is strongly reduced. It is now appreciated that this poor effect of GIP can be reduced when used in combination with a GLP1RA. This combination incretin, called by some a “twincretin,” is the basis for the drug tirzepatide which was approved by the Food and Drug Administration in May of 2022.

The data supporting this agent for both diabetes and obesity are impressive. For example, in a 40-week study with a baseline HbA1c of 8.0%, those randomized to tirzepatide at 5 mg, 10 mg, and 15 mg had HbA1c reductions of 1.87%, 1.89%, and 2.07% respectively.² Over 81% at all doses had HbA1c levels less than 6.5% at 40 weeks.

For the 5-mg, 10-mg, and 15-mg doses, weight change from baseline was 7.9%, 9.3%, and 11.0% respectively. Like older GLP1RAs, gastrointestinal side effects were the main problem. For the three doses, 3%, 5%, and 7%, respectively, had to stop the drug, compared with the 3% who stopped taking the placebo. In another study, tirzepatide was noninferior or superior at all three doses compared with semaglutide 1 mg weekly.³

In a population without diabetes, with 40% of patients having prediabetes, weight loss percentages for the three doses were 15.0%, 19.5%, and 20.9% respectively.⁴ Discontinuation percentages due to side effects were 4%-7%. The exciting part is we now have a drug that approaches weight loss from bariatric surgery. The cardiovascular and renal outcome trials are now underway, but the enthusiasm for this drug is clear from the data.

Like other GLP1RAs, the key is to start low and go slowly. It is recommended to start tirzepatide at 2.5 mg four times a week, then increase to 5 mg. Due to gastrointestinal side effects, some patients will do better at the lower dose before increasing. For those switching from another GLP1RA, there are no data to guide us but, in my practice, I start those patients at 5 mg weekly.
 

Continuous glucose monitoring

Data continue to accumulate that this form of glycemic self-monitoring is effective to reduce HbA1c levels and minimize hypoglycemia in both type 1 and type 2 diabetes. The most important change to the 2022 American Diabetes Association (ADA) standards of care is recognizing CGM as level A evidence for those receiving basal insulin without mealtime insulin.⁵ There are four CGMs on the market, but most of the market uses the Dexcom G6 or the Libre 2. Both of these devices will be updated within the next few months to newer generation sensors.

While there are similarities and differences between the two devices, by late 2022 and early 2023 changes to both will reduce the dissimilarities.

The next generation Libre (Libre 3) will be continuous, and “scanning” will no longer be required.  For those unable to get insurance to cover CGM, the Libre will continue to be more affordable than the Dexcom. Alerts will be present on both, but the Dexcom G7 will be approved for both the arm and the abdomen. The Dexcom also can communicate with several automated insulin delivery systems and data can be shared real-time with family members.

For clinicians just starting patients on this technology, my suggestion is to focus on one system so both the provider and staff can become familiar with it. It is key to review downloaded glucose metrics, in addition to the “ambulatory glucose profile,” a graphic overview of daily glycemia where patterns can be identified. It is also helpful to ask for assistance from endocrinologists who have experience with CGMs, in addition to the representatives of the companies.

COVID-19 and new-onset diabetes

From the beginning of the COVID 19 pandemic in 2020, it was clear that stress hyperglycemia and glucose dysregulation was an important observation for those infected. What was not known at the time is that for some, the hyperglycemia continued, and permanent diabetes ensued.

In one study of over 2.7 million U.S. veterans, men infected with COVID-19, but not women, were at a higher risk of new incident diabetes at 120 days after infection compared to no infection (odds ratio for men = 2.56).⁶

Another literature review using meta-analyses and cross-sectional studies concluded new-onset diabetes following COVID-19 infection can have a varied phenotype, with no risk factors, presenting from diabetic ketoacidosis to milder forms of diabetes.⁷

The current thought is that COVID-19 binds to the ACE2 and TMPRSS2 receptors which appear to be located on the beta-cells in the islet, resulting in insulin deficiency, in addition to the insulin resistance that seems to persist after the acute infection. Much more needs to be learned about this, but clinicians need to appreciate this appears to be a new form of diabetes and optimal treatments are not yet clear.

Dr. Hirsch is an endocrinologist, professor of medicine, and diabetes treatment and teaching chair at the University of Washington, Seattle. He has received research grant support from Dexcom and Insulet and has provided consulting to Abbott, Roche, Lifescan, and GWave. You can contact him at [email protected].

References

1. American Diabetes Association Professional Practice Committee. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S125-S143.

2. Rosenstock J et al. Efficacy and safety of a novel GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): A double-blind, randomised, phase 3 trial. Lancet. 2021;398:143-55.

3. Frias JP et al. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385:503-15.

4. Jastreboff AM et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387:205-16.

5. American Diabetes Association Professional Practice Committee. Diabetes technology: Standards of Medical Care in Diabetes–2022. Diabetes Care. 2022;45(Suppl 1):S97-S112.

6. Wander PL et al. The incidence of diabetes in 2,777,768 veterans with and without recent SARS-CoV-2 infection. Diabetes Care 2022;45:782-8.

7. Joshi SC and Pozzilli P. COVID-19 induced diabetes: A novel presentation. Diabetes Res Clin Pract. 2022 Aug 6;191:110034.

Many changes in the evolution of the treatment of diabetes have occurred during this year and 2021. Randomized controlled trials have resulted in updated guidelines for the use of glucagonlike peptide-1 receptor agonists (GLP1RAs) and continuous glucose monitoring (CGM) technology. I am hoping my discussion about these major advances in this edition of Highlights will be helpful to those caring for patients with diabetes.

Tirzepatide

The first GLP1RA, exenatide, was released in April 2005. Since then, numerous daily and weekly drugs of this class have been developed. We’ve learned they are effective glucose lowering drugs, and the weekly agents dulaglutide and semaglutide have shown impressive weight reduction properties as well as cardiovascular benefits.

Secondary outcomes have also shown renal benefits to these agents, and studies for primary renal efficacy are pending. Due to all of these properties, the GLP1RAs are recommended as the first injectable for the treatment of type 2 diabetes, prior to insulin initiation.¹

The next generation of these agents are a combination of a GLP1RA and a glucose-dependent insulinotropic polypeptide (GIP). Glucagonlike peptide-1 (GLP-1) stimulates insulin secretion, inhibits glucagon secretion, delays gastric emptying, and has central effects inducing satiety.

We now understand that GIP is the main incretin hormone in those without diabetes, causative of most of the incretin effects. But the insulin response after GIP secretion in type 2 diabetes is strongly reduced. It is now appreciated that this poor effect of GIP can be reduced when used in combination with a GLP1RA. This combination incretin, called by some a “twincretin,” is the basis for the drug tirzepatide which was approved by the Food and Drug Administration in May of 2022.

The data supporting this agent for both diabetes and obesity are impressive. For example, in a 40-week study with a baseline HbA1c of 8.0%, those randomized to tirzepatide at 5 mg, 10 mg, and 15 mg had HbA1c reductions of 1.87%, 1.89%, and 2.07% respectively.² Over 81% at all doses had HbA1c levels less than 6.5% at 40 weeks.

For the 5-mg, 10-mg, and 15-mg doses, weight change from baseline was 7.9%, 9.3%, and 11.0% respectively. Like older GLP1RAs, gastrointestinal side effects were the main problem. For the three doses, 3%, 5%, and 7%, respectively, had to stop the drug, compared with the 3% who stopped taking the placebo. In another study, tirzepatide was noninferior or superior at all three doses compared with semaglutide 1 mg weekly.³

In a population without diabetes, with 40% of patients having prediabetes, weight loss percentages for the three doses were 15.0%, 19.5%, and 20.9% respectively.⁴ Discontinuation percentages due to side effects were 4%-7%. The exciting part is we now have a drug that approaches weight loss from bariatric surgery. The cardiovascular and renal outcome trials are now underway, but the enthusiasm for this drug is clear from the data.

Like other GLP1RAs, the key is to start low and go slowly. It is recommended to start tirzepatide at 2.5 mg four times a week, then increase to 5 mg. Due to gastrointestinal side effects, some patients will do better at the lower dose before increasing. For those switching from another GLP1RA, there are no data to guide us but, in my practice, I start those patients at 5 mg weekly.
 

Continuous glucose monitoring

Data continue to accumulate that this form of glycemic self-monitoring is effective to reduce HbA1c levels and minimize hypoglycemia in both type 1 and type 2 diabetes. The most important change to the 2022 American Diabetes Association (ADA) standards of care is recognizing CGM as level A evidence for those receiving basal insulin without mealtime insulin.⁵ There are four CGMs on the market, but most of the market uses the Dexcom G6 or the Libre 2. Both of these devices will be updated within the next few months to newer generation sensors.

While there are similarities and differences between the two devices, by late 2022 and early 2023 changes to both will reduce the dissimilarities.

The next generation Libre (Libre 3) will be continuous, and “scanning” will no longer be required.  For those unable to get insurance to cover CGM, the Libre will continue to be more affordable than the Dexcom. Alerts will be present on both, but the Dexcom G7 will be approved for both the arm and the abdomen. The Dexcom also can communicate with several automated insulin delivery systems and data can be shared real-time with family members.

For clinicians just starting patients on this technology, my suggestion is to focus on one system so both the provider and staff can become familiar with it. It is key to review downloaded glucose metrics, in addition to the “ambulatory glucose profile,” a graphic overview of daily glycemia where patterns can be identified. It is also helpful to ask for assistance from endocrinologists who have experience with CGMs, in addition to the representatives of the companies.

COVID-19 and new-onset diabetes

From the beginning of the COVID 19 pandemic in 2020, it was clear that stress hyperglycemia and glucose dysregulation was an important observation for those infected. What was not known at the time is that for some, the hyperglycemia continued, and permanent diabetes ensued.

In one study of over 2.7 million U.S. veterans, men infected with COVID-19, but not women, were at a higher risk of new incident diabetes at 120 days after infection compared to no infection (odds ratio for men = 2.56).⁶

Another literature review using meta-analyses and cross-sectional studies concluded new-onset diabetes following COVID-19 infection can have a varied phenotype, with no risk factors, presenting from diabetic ketoacidosis to milder forms of diabetes.⁷

The current thought is that COVID-19 binds to the ACE2 and TMPRSS2 receptors which appear to be located on the beta-cells in the islet, resulting in insulin deficiency, in addition to the insulin resistance that seems to persist after the acute infection. Much more needs to be learned about this, but clinicians need to appreciate this appears to be a new form of diabetes and optimal treatments are not yet clear.

Dr. Hirsch is an endocrinologist, professor of medicine, and diabetes treatment and teaching chair at the University of Washington, Seattle. He has received research grant support from Dexcom and Insulet and has provided consulting to Abbott, Roche, Lifescan, and GWave. You can contact him at [email protected].

References

1. American Diabetes Association Professional Practice Committee. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S125-S143.

2. Rosenstock J et al. Efficacy and safety of a novel GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): A double-blind, randomised, phase 3 trial. Lancet. 2021;398:143-55.

3. Frias JP et al. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385:503-15.

4. Jastreboff AM et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387:205-16.

5. American Diabetes Association Professional Practice Committee. Diabetes technology: Standards of Medical Care in Diabetes–2022. Diabetes Care. 2022;45(Suppl 1):S97-S112.

6. Wander PL et al. The incidence of diabetes in 2,777,768 veterans with and without recent SARS-CoV-2 infection. Diabetes Care 2022;45:782-8.

7. Joshi SC and Pozzilli P. COVID-19 induced diabetes: A novel presentation. Diabetes Res Clin Pract. 2022 Aug 6;191:110034.

Difficulty in accessing a family physician is associated with a higher risk for unplanned return visits to the emergency department among patients aged 75 years and older, new data indicate.

In a prospective, observational study that included almost 2,000 patients in this age group, 16% of participants attempted to contact their family physicians before their ED visits. Of this group, more than half reported having difficulty seeing their physicians for urgent problems, more than 40% had difficulty speaking with their family physicians by telephone, and more than one-third had difficulty booking appointments for new health problems.

“Difficulty in accessing primary care was associated with a higher rate of return visits to the ED within an elderly population,” write study author Marc Afilalo, MD, director of the ED at Jewish General Hospital in Montreal, and colleagues. “Therefore, community-based programs that target patient education and improved access to primary care are necessary not only for reducing return visits to the ED, but also for continuity of care and patient satisfaction.”

The study was published in Canadian Family Physician.
 

Comorbidities increased risk

Researchers have estimated that half of Canadians aged 75 years or older use emergency services. Data indicate that the number of unplanned return visits to the ED is associated with increased functional decline and death. But the question of how patient access to primary care services affects unplanned ED return visits has received little attention, according to the investigators.

They conducted a multicenter study at three tertiary adult teaching hospitals in Montreal. From 2012 to 2014, they recruited patients aged 75 years and older who had visited the ED and who lived in their own homes or in an autonomous residence.

Investigators collected data through structured interviews, administrative databases, and medical chart reviews. They followed up with participants at 3 months by telephone. The study’s main outcome was return visit to the ED.

The researchers identified 4,577 patients and included 1,998 in their analysis. Of that total, 33% were 85 or older, 34% lived alone, and 91% had a family physician. Within 3 months, 562 patients (28%) had made 894 return visits to the ED.

Among patients aged 85 years or older (relative risk, 0.80), as well as those whose triage score was less severe (RR, 0.83) and those who were admitted during the index ED visit (RR, 0.76), rates of return ED visits were lower. Among patients who had trouble booking appointments with their family doctors to address new problems (RR, 1.19), as well as those who had made ED visits within the previous 6 months (RR, 1.47) or had a higher Charlson comorbidity index score (RR, 1.06 for every 1-unit increase), rates of return visits were higher.

Factors associated with a higher likelihood of return visits were visits to the ED in the previous 6 months (odds ratio, 2.11), increased Charlson comorbidity index score (OR, 1.41 for every 1-unit increase), and having received help from local community services (OR, 3.00).
 

Primary care access

The study suggests that improvements in primary care access are needed to decrease return visits to the ED, Samir Sinha, MD, DPhil, director of geriatrics at Mount Sinai and the University Health Network Hospitals in Toronto, told this news organization. Dr. Sinha was not involved in the study.

“It reminds us of the importance of having a strong primary care system,” he added. “Of this population, 91% had primary care providers. And what the paper demonstrates is that those who are having trouble accessing their primary care providers are more likely to be readmitted to an ED. We can only imagine how much worse the outcomes are for people who don’t have a primary care provider.”

Patients are frequently advised to visit the ED when they contact their primary care providers, said Mark Rosenberg, PhD, professor of geography and planning and the Canada Research Chair in Aging, Health, and Development at Queens University in Kingston, Ont., said in an interview. He noted that primary care is organized as an appointment-based system. Dr. Rosenberg did not participate in the study.

“If I were to call my primary care provider in the middle of the afternoon and say that I have got chest pains, they are going to simply tell me to go to emergency,” said Dr. Rosenberg. “It is not just older people. Many people end up in the ED because they are told to go to the ED.”
 

Associations with age

“The higher your Charlson comorbidity index, the more multiple, complex health issues you’re dealing with,” said Sinha. He added that the data suggest the frailty of the study population.

The association between age 85 years or older and a lower rate of a return ED visits might mean that the patient did not return to independent living after the ED visit, Dr. Rosenberg speculated. “If it’s a serious health problem, you’re more likely to end up going into long-term care at that stage, and you are not going back to living in the community in your home,” he said. “You’re likely going into some sort of transition care or alternative care.”

People aged 85 years or older who are hospitalized are more likely not to survive their index hospital admission, compared with patients who are aged 75-85 years. There would be no possibility that such patients would revisit the ED in the future, said Dr. Sinha.
 

Expanding primary care

The major solution to decreasing reliance on the ED lies in revamping primary health care so that it offers an expanded level of care and 24/7 access, said Dr. Rosenberg.

Providing continuity of care, identifying problems, and managing them in the community before they become urgent or require a hospitalization are priorities for primary care and will help shift away from return visits to the ED, which should be a last resort for patients, said Dr. Sinha.

Moreover, patients must be able to access primary care in various ways, be it a telephone consultation, a video consultation, or a face-to-face consultation, he added. Face-to-face consultations can take place in a provider’s office or even in a patient’s home when warranted, he said. “What we need to make sure of is that all three types of consultations are available, so that people can actually get the most appropriate care at the time they’re calling.”

The study had no external funding. Dr. Afilalo, Dr. Sinha, and Dr. Rosenberg have disclosed no relevant financial relationships.

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

Difficulty in accessing a family physician is associated with a higher risk for unplanned return visits to the emergency department among patients aged 75 years and older, new data indicate.

In a prospective, observational study that included almost 2,000 patients in this age group, 16% of participants attempted to contact their family physicians before their ED visits. Of this group, more than half reported having difficulty seeing their physicians for urgent problems, more than 40% had difficulty speaking with their family physicians by telephone, and more than one-third had difficulty booking appointments for new health problems.

“Difficulty in accessing primary care was associated with a higher rate of return visits to the ED within an elderly population,” write study author Marc Afilalo, MD, director of the ED at Jewish General Hospital in Montreal, and colleagues. “Therefore, community-based programs that target patient education and improved access to primary care are necessary not only for reducing return visits to the ED, but also for continuity of care and patient satisfaction.”

The study was published in Canadian Family Physician.
 

Comorbidities increased risk

Researchers have estimated that half of Canadians aged 75 years or older use emergency services. Data indicate that the number of unplanned return visits to the ED is associated with increased functional decline and death. But the question of how patient access to primary care services affects unplanned ED return visits has received little attention, according to the investigators.

They conducted a multicenter study at three tertiary adult teaching hospitals in Montreal. From 2012 to 2014, they recruited patients aged 75 years and older who had visited the ED and who lived in their own homes or in an autonomous residence.

Investigators collected data through structured interviews, administrative databases, and medical chart reviews. They followed up with participants at 3 months by telephone. The study’s main outcome was return visit to the ED.

The researchers identified 4,577 patients and included 1,998 in their analysis. Of that total, 33% were 85 or older, 34% lived alone, and 91% had a family physician. Within 3 months, 562 patients (28%) had made 894 return visits to the ED.

Among patients aged 85 years or older (relative risk, 0.80), as well as those whose triage score was less severe (RR, 0.83) and those who were admitted during the index ED visit (RR, 0.76), rates of return ED visits were lower. Among patients who had trouble booking appointments with their family doctors to address new problems (RR, 1.19), as well as those who had made ED visits within the previous 6 months (RR, 1.47) or had a higher Charlson comorbidity index score (RR, 1.06 for every 1-unit increase), rates of return visits were higher.

Factors associated with a higher likelihood of return visits were visits to the ED in the previous 6 months (odds ratio, 2.11), increased Charlson comorbidity index score (OR, 1.41 for every 1-unit increase), and having received help from local community services (OR, 3.00).
 

Primary care access

The study suggests that improvements in primary care access are needed to decrease return visits to the ED, Samir Sinha, MD, DPhil, director of geriatrics at Mount Sinai and the University Health Network Hospitals in Toronto, told this news organization. Dr. Sinha was not involved in the study.

“It reminds us of the importance of having a strong primary care system,” he added. “Of this population, 91% had primary care providers. And what the paper demonstrates is that those who are having trouble accessing their primary care providers are more likely to be readmitted to an ED. We can only imagine how much worse the outcomes are for people who don’t have a primary care provider.”

Patients are frequently advised to visit the ED when they contact their primary care providers, said Mark Rosenberg, PhD, professor of geography and planning and the Canada Research Chair in Aging, Health, and Development at Queens University in Kingston, Ont., said in an interview. He noted that primary care is organized as an appointment-based system. Dr. Rosenberg did not participate in the study.

“If I were to call my primary care provider in the middle of the afternoon and say that I have got chest pains, they are going to simply tell me to go to emergency,” said Dr. Rosenberg. “It is not just older people. Many people end up in the ED because they are told to go to the ED.”
 

Associations with age

“The higher your Charlson comorbidity index, the more multiple, complex health issues you’re dealing with,” said Sinha. He added that the data suggest the frailty of the study population.

The association between age 85 years or older and a lower rate of a return ED visits might mean that the patient did not return to independent living after the ED visit, Dr. Rosenberg speculated. “If it’s a serious health problem, you’re more likely to end up going into long-term care at that stage, and you are not going back to living in the community in your home,” he said. “You’re likely going into some sort of transition care or alternative care.”

People aged 85 years or older who are hospitalized are more likely not to survive their index hospital admission, compared with patients who are aged 75-85 years. There would be no possibility that such patients would revisit the ED in the future, said Dr. Sinha.
 

Expanding primary care

The major solution to decreasing reliance on the ED lies in revamping primary health care so that it offers an expanded level of care and 24/7 access, said Dr. Rosenberg.

Providing continuity of care, identifying problems, and managing them in the community before they become urgent or require a hospitalization are priorities for primary care and will help shift away from return visits to the ED, which should be a last resort for patients, said Dr. Sinha.

Moreover, patients must be able to access primary care in various ways, be it a telephone consultation, a video consultation, or a face-to-face consultation, he added. Face-to-face consultations can take place in a provider’s office or even in a patient’s home when warranted, he said. “What we need to make sure of is that all three types of consultations are available, so that people can actually get the most appropriate care at the time they’re calling.”

The study had no external funding. Dr. Afilalo, Dr. Sinha, and Dr. Rosenberg have disclosed no relevant financial relationships.

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

Difficulty in accessing a family physician is associated with a higher risk for unplanned return visits to the emergency department among patients aged 75 years and older, new data indicate.

In a prospective, observational study that included almost 2,000 patients in this age group, 16% of participants attempted to contact their family physicians before their ED visits. Of this group, more than half reported having difficulty seeing their physicians for urgent problems, more than 40% had difficulty speaking with their family physicians by telephone, and more than one-third had difficulty booking appointments for new health problems.

“Difficulty in accessing primary care was associated with a higher rate of return visits to the ED within an elderly population,” write study author Marc Afilalo, MD, director of the ED at Jewish General Hospital in Montreal, and colleagues. “Therefore, community-based programs that target patient education and improved access to primary care are necessary not only for reducing return visits to the ED, but also for continuity of care and patient satisfaction.”

The study was published in Canadian Family Physician.
 

Comorbidities increased risk

Researchers have estimated that half of Canadians aged 75 years or older use emergency services. Data indicate that the number of unplanned return visits to the ED is associated with increased functional decline and death. But the question of how patient access to primary care services affects unplanned ED return visits has received little attention, according to the investigators.

They conducted a multicenter study at three tertiary adult teaching hospitals in Montreal. From 2012 to 2014, they recruited patients aged 75 years and older who had visited the ED and who lived in their own homes or in an autonomous residence.

Investigators collected data through structured interviews, administrative databases, and medical chart reviews. They followed up with participants at 3 months by telephone. The study’s main outcome was return visit to the ED.

The researchers identified 4,577 patients and included 1,998 in their analysis. Of that total, 33% were 85 or older, 34% lived alone, and 91% had a family physician. Within 3 months, 562 patients (28%) had made 894 return visits to the ED.

Among patients aged 85 years or older (relative risk, 0.80), as well as those whose triage score was less severe (RR, 0.83) and those who were admitted during the index ED visit (RR, 0.76), rates of return ED visits were lower. Among patients who had trouble booking appointments with their family doctors to address new problems (RR, 1.19), as well as those who had made ED visits within the previous 6 months (RR, 1.47) or had a higher Charlson comorbidity index score (RR, 1.06 for every 1-unit increase), rates of return visits were higher.

Factors associated with a higher likelihood of return visits were visits to the ED in the previous 6 months (odds ratio, 2.11), increased Charlson comorbidity index score (OR, 1.41 for every 1-unit increase), and having received help from local community services (OR, 3.00).
 

Primary care access

The study suggests that improvements in primary care access are needed to decrease return visits to the ED, Samir Sinha, MD, DPhil, director of geriatrics at Mount Sinai and the University Health Network Hospitals in Toronto, told this news organization. Dr. Sinha was not involved in the study.

“It reminds us of the importance of having a strong primary care system,” he added. “Of this population, 91% had primary care providers. And what the paper demonstrates is that those who are having trouble accessing their primary care providers are more likely to be readmitted to an ED. We can only imagine how much worse the outcomes are for people who don’t have a primary care provider.”

Patients are frequently advised to visit the ED when they contact their primary care providers, said Mark Rosenberg, PhD, professor of geography and planning and the Canada Research Chair in Aging, Health, and Development at Queens University in Kingston, Ont., said in an interview. He noted that primary care is organized as an appointment-based system. Dr. Rosenberg did not participate in the study.

“If I were to call my primary care provider in the middle of the afternoon and say that I have got chest pains, they are going to simply tell me to go to emergency,” said Dr. Rosenberg. “It is not just older people. Many people end up in the ED because they are told to go to the ED.”
 

Associations with age

“The higher your Charlson comorbidity index, the more multiple, complex health issues you’re dealing with,” said Sinha. He added that the data suggest the frailty of the study population.

The association between age 85 years or older and a lower rate of a return ED visits might mean that the patient did not return to independent living after the ED visit, Dr. Rosenberg speculated. “If it’s a serious health problem, you’re more likely to end up going into long-term care at that stage, and you are not going back to living in the community in your home,” he said. “You’re likely going into some sort of transition care or alternative care.”

People aged 85 years or older who are hospitalized are more likely not to survive their index hospital admission, compared with patients who are aged 75-85 years. There would be no possibility that such patients would revisit the ED in the future, said Dr. Sinha.
 

Expanding primary care

The major solution to decreasing reliance on the ED lies in revamping primary health care so that it offers an expanded level of care and 24/7 access, said Dr. Rosenberg.

Providing continuity of care, identifying problems, and managing them in the community before they become urgent or require a hospitalization are priorities for primary care and will help shift away from return visits to the ED, which should be a last resort for patients, said Dr. Sinha.

Moreover, patients must be able to access primary care in various ways, be it a telephone consultation, a video consultation, or a face-to-face consultation, he added. Face-to-face consultations can take place in a provider’s office or even in a patient’s home when warranted, he said. “What we need to make sure of is that all three types of consultations are available, so that people can actually get the most appropriate care at the time they’re calling.”

The study had no external funding. Dr. Afilalo, Dr. Sinha, and Dr. Rosenberg have disclosed no relevant financial relationships.

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

There’s little doubt long COVID is real. The federal government recognizes long COVID as a condition and said in two reports issued in August that one in five adult COVID-19 survivors have a health condition related to their illness.

COVID-19 can damage multiple organs in the body. Sometimes this damage leads to long COVID; sometimes other reasons are at play. Doctors are beginning to sort it out.

There’s a difference between long COVID and an acute infection with lasting effects, doctors say.

“COVID itself can actually cause prolonged illness, and we don’t really call that long COVID,” said Nisha Viswanathan, MD, a doctor at UCLA Health in Los Angeles. But if symptoms extend beyond 12 weeks, that puts patients in the realm of long COVID.

Symptoms can range from mild to severe and can keep people from resuming their normal lives and jobs. Sometimes they last for months, according to the U.S. Department of Health & Human Services.
 

Multiorgan damage

Lung scarring and other lung problems are common after COVID, said Leora Horwitz, MD, an internal medicine specialist at New York University. Even after a mild case, people can have breathing issues for months, a team at Johns Hopkins Medicine, Baltimore, said in an online briefing. One study published in the journal Radiology found damage in people a full year after a COVID-19 diagnosis.

Some people have persistent heart, kidney, liver, and nervous system problems after COVID-19. A study published in 2020 in JAMA Cardiology found 60% of people who had COVID-19 had ongoing signs of heart inflammation. Nearly a third of people hospitalized for COVID-19 get kidney damage that can become chronic, and some end up needing dialysis or a transplant, said C. John Sperati, MD, a kidney specialist at Johns Hopkins Medicine.

This might be, in part, because SARS-CoV-2, the virus that causes COVID-19, directly infects the cells in many organs.

Nicole Bhave, MD, a cardiologist at University of Michigan Health, Ann Arbor is concerned that COVID-19 appears to increase the risk of heart problems in some people.

“Some of the uptick may just be recognition bias, in that people with symptoms are seeking care,” she said. “But there’s definitely a biological basis by which COVID could tip people over into a new diagnosis of heart failure.”
 

Inflammation

Inflammation is probably a key part of the long-term effects of COVID-19.

Some people have a serious immune reaction to COVID-19 called a cytokine storm, said Nitra Aggarwal Gilotra, MD, a cardiologist at Johns Hopkins Medicine. This release of inflammation-causing molecules called cytokines is meant to attack the invading virus. But it can be so severe that it wreaks havoc on healthy tissues and organs and causes lasting damage – if patients even survive it.

In some people, inflammation can affect the heart, causing myocarditis. Myocarditis symptoms include chest pain, breathlessness, and heart palpitations. Though rare, it can be serious and can raise the risk of other heart problems, including heart failure, down the line.

Long COVID may also trigger an autoimmune condition, said Eline Luning Prak, MD, PhD, a pathologist at the Hospital of the University of Pennsylvania, Philadelphia. Long COVID can share many hallmark symptoms with autoimmune diseases, including fatigue, widespread pain, memory problems, and mood disorders.
 

Blood clots

Studies have shown the overcharged inflammatory response to COVID-19 can cause blood clots. This sometimes overwhelming clotting was an early hallmark of COVID-19 infection, and when clots restrict blood flow in the brain, lungs, kidneys, or limbs, they can cause long-term damage. Some can be deadly. Researchers in Sweden found patients were at risk of deep vein thrombosis – a blood clot usually in the leg – up to 3 months after infection and at higher risk of a blood clot in the lung, called pulmonary embolism, for as long as 3 months.

Viral reservoirs

The virus itself may also linger in a patient’s body, causing continued symptoms and, potentially, new flare-ups. Zoe Swank, PhD, of Harvard Medical School, Boston, and colleagues reported in a preprint study that they found pieces of the SARS-CoV-2 virus in the blood of most patients with long COVID symptoms they tested – some as long as a year after infection. The study has not yet been peer reviewed.

Another team found evidence of the virus in stool up to 7 months later, which suggests the virus hides out in the gut. Other early studies have found bits of viral RNA in the appendix, breast tissue, heart, eyes, and brain.
 

Diabetes

Diabetes is a risk factor for getting severe COVID-19, and multiple studies have shown people can get diabetes both while battling infection and afterward. One study of veterans, published in The Lancet Diabetes and Endocrinology, found COVID-19 survivors were about 40% more likely to get diabetes over the next year.

There are a few ways this might happen. Insulin-producing cells in the pancreas have SARS-CoV-2 receptors – a type of molecular doorway the coronavirus can attach to. Damage to these cells could make the body less able to produce insulin, which in turn can lead to diabetes. The virus could also disrupt the balance in the body or cause inflammation that leads to insulin resistance, which can develop into diabetes, Ziad Al-Aly, MD, of the Veterans Affairs St. Louis Health Care System, and colleagues wrote.
 

Nervous system issues

People who get COVID-19 are also more vulnerable to postural orthostatic tachycardia syndrome (POTS). This affects what’s known as the autonomic nervous system, which regulates blood circulation, and includes those things that happen in your body without your having to think about them, like breathing, heartbeat, and digestion. POTS can cause common long COVID neurologic symptoms, including headaches, fatigue, brain fog, insomnia, and problems thinking and concentrating. “This was a known condition prior to COVID, but it was incredibly rare,” said Dr. Viswanathan. “After COVID, I’ve seen it with increasing frequency.”

Long-term outlook

Lasting issues after COVID-19 are much more likely after a moderate or severe infection. Still, plenty of people are battling them even after a mild illness. “As for why, that’s the billion-dollar question,” said Dr. Horwitz. “It’s well known that viral infections can cause long-term dysregulation. Why that is, we really just don’t know.”

Whether it’s virus hiding out in the body, long-term organ damage, or an autoimmune reaction likely differs from person to person. “I’m believing, increasingly, that it’s a combination of all of these, just based on how different patients are responding to different medications,” said Dr. Viswanathan. “One patient will respond to something beautifully, and another patient won’t at all.”

But it’s clear a significant number of people are facing long-term health struggles because of COVID-19, which has infected at least 580 million people globally and 92 million – likely many more – in the United States, according to Johns Hopkins University.

Even a small increased risk of conditions like heart disease or diabetes translates to a huge number of people, Dr. Horwitz said. “If even 1% of people getting COVID have long-term symptoms, that’s a major public health crisis, because that’s 1% of pretty much everybody in the country.”

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

There’s little doubt long COVID is real. The federal government recognizes long COVID as a condition and said in two reports issued in August that one in five adult COVID-19 survivors have a health condition related to their illness.

COVID-19 can damage multiple organs in the body. Sometimes this damage leads to long COVID; sometimes other reasons are at play. Doctors are beginning to sort it out.

There’s a difference between long COVID and an acute infection with lasting effects, doctors say.

“COVID itself can actually cause prolonged illness, and we don’t really call that long COVID,” said Nisha Viswanathan, MD, a doctor at UCLA Health in Los Angeles. But if symptoms extend beyond 12 weeks, that puts patients in the realm of long COVID.

Symptoms can range from mild to severe and can keep people from resuming their normal lives and jobs. Sometimes they last for months, according to the U.S. Department of Health & Human Services.
 

Multiorgan damage

Lung scarring and other lung problems are common after COVID, said Leora Horwitz, MD, an internal medicine specialist at New York University. Even after a mild case, people can have breathing issues for months, a team at Johns Hopkins Medicine, Baltimore, said in an online briefing. One study published in the journal Radiology found damage in people a full year after a COVID-19 diagnosis.

Some people have persistent heart, kidney, liver, and nervous system problems after COVID-19. A study published in 2020 in JAMA Cardiology found 60% of people who had COVID-19 had ongoing signs of heart inflammation. Nearly a third of people hospitalized for COVID-19 get kidney damage that can become chronic, and some end up needing dialysis or a transplant, said C. John Sperati, MD, a kidney specialist at Johns Hopkins Medicine.

This might be, in part, because SARS-CoV-2, the virus that causes COVID-19, directly infects the cells in many organs.

Nicole Bhave, MD, a cardiologist at University of Michigan Health, Ann Arbor is concerned that COVID-19 appears to increase the risk of heart problems in some people.

“Some of the uptick may just be recognition bias, in that people with symptoms are seeking care,” she said. “But there’s definitely a biological basis by which COVID could tip people over into a new diagnosis of heart failure.”
 

Inflammation

Inflammation is probably a key part of the long-term effects of COVID-19.

Some people have a serious immune reaction to COVID-19 called a cytokine storm, said Nitra Aggarwal Gilotra, MD, a cardiologist at Johns Hopkins Medicine. This release of inflammation-causing molecules called cytokines is meant to attack the invading virus. But it can be so severe that it wreaks havoc on healthy tissues and organs and causes lasting damage – if patients even survive it.

In some people, inflammation can affect the heart, causing myocarditis. Myocarditis symptoms include chest pain, breathlessness, and heart palpitations. Though rare, it can be serious and can raise the risk of other heart problems, including heart failure, down the line.

Long COVID may also trigger an autoimmune condition, said Eline Luning Prak, MD, PhD, a pathologist at the Hospital of the University of Pennsylvania, Philadelphia. Long COVID can share many hallmark symptoms with autoimmune diseases, including fatigue, widespread pain, memory problems, and mood disorders.
 

Blood clots

Studies have shown the overcharged inflammatory response to COVID-19 can cause blood clots. This sometimes overwhelming clotting was an early hallmark of COVID-19 infection, and when clots restrict blood flow in the brain, lungs, kidneys, or limbs, they can cause long-term damage. Some can be deadly. Researchers in Sweden found patients were at risk of deep vein thrombosis – a blood clot usually in the leg – up to 3 months after infection and at higher risk of a blood clot in the lung, called pulmonary embolism, for as long as 3 months.

Viral reservoirs

The virus itself may also linger in a patient’s body, causing continued symptoms and, potentially, new flare-ups. Zoe Swank, PhD, of Harvard Medical School, Boston, and colleagues reported in a preprint study that they found pieces of the SARS-CoV-2 virus in the blood of most patients with long COVID symptoms they tested – some as long as a year after infection. The study has not yet been peer reviewed.

Another team found evidence of the virus in stool up to 7 months later, which suggests the virus hides out in the gut. Other early studies have found bits of viral RNA in the appendix, breast tissue, heart, eyes, and brain.
 

Diabetes

Diabetes is a risk factor for getting severe COVID-19, and multiple studies have shown people can get diabetes both while battling infection and afterward. One study of veterans, published in The Lancet Diabetes and Endocrinology, found COVID-19 survivors were about 40% more likely to get diabetes over the next year.

There are a few ways this might happen. Insulin-producing cells in the pancreas have SARS-CoV-2 receptors – a type of molecular doorway the coronavirus can attach to. Damage to these cells could make the body less able to produce insulin, which in turn can lead to diabetes. The virus could also disrupt the balance in the body or cause inflammation that leads to insulin resistance, which can develop into diabetes, Ziad Al-Aly, MD, of the Veterans Affairs St. Louis Health Care System, and colleagues wrote.
 

Nervous system issues

People who get COVID-19 are also more vulnerable to postural orthostatic tachycardia syndrome (POTS). This affects what’s known as the autonomic nervous system, which regulates blood circulation, and includes those things that happen in your body without your having to think about them, like breathing, heartbeat, and digestion. POTS can cause common long COVID neurologic symptoms, including headaches, fatigue, brain fog, insomnia, and problems thinking and concentrating. “This was a known condition prior to COVID, but it was incredibly rare,” said Dr. Viswanathan. “After COVID, I’ve seen it with increasing frequency.”

Long-term outlook

Lasting issues after COVID-19 are much more likely after a moderate or severe infection. Still, plenty of people are battling them even after a mild illness. “As for why, that’s the billion-dollar question,” said Dr. Horwitz. “It’s well known that viral infections can cause long-term dysregulation. Why that is, we really just don’t know.”

Whether it’s virus hiding out in the body, long-term organ damage, or an autoimmune reaction likely differs from person to person. “I’m believing, increasingly, that it’s a combination of all of these, just based on how different patients are responding to different medications,” said Dr. Viswanathan. “One patient will respond to something beautifully, and another patient won’t at all.”

But it’s clear a significant number of people are facing long-term health struggles because of COVID-19, which has infected at least 580 million people globally and 92 million – likely many more – in the United States, according to Johns Hopkins University.

Even a small increased risk of conditions like heart disease or diabetes translates to a huge number of people, Dr. Horwitz said. “If even 1% of people getting COVID have long-term symptoms, that’s a major public health crisis, because that’s 1% of pretty much everybody in the country.”

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

There’s little doubt long COVID is real. The federal government recognizes long COVID as a condition and said in two reports issued in August that one in five adult COVID-19 survivors have a health condition related to their illness.

COVID-19 can damage multiple organs in the body. Sometimes this damage leads to long COVID; sometimes other reasons are at play. Doctors are beginning to sort it out.

There’s a difference between long COVID and an acute infection with lasting effects, doctors say.

“COVID itself can actually cause prolonged illness, and we don’t really call that long COVID,” said Nisha Viswanathan, MD, a doctor at UCLA Health in Los Angeles. But if symptoms extend beyond 12 weeks, that puts patients in the realm of long COVID.

Symptoms can range from mild to severe and can keep people from resuming their normal lives and jobs. Sometimes they last for months, according to the U.S. Department of Health & Human Services.
 

Multiorgan damage

Lung scarring and other lung problems are common after COVID, said Leora Horwitz, MD, an internal medicine specialist at New York University. Even after a mild case, people can have breathing issues for months, a team at Johns Hopkins Medicine, Baltimore, said in an online briefing. One study published in the journal Radiology found damage in people a full year after a COVID-19 diagnosis.

Some people have persistent heart, kidney, liver, and nervous system problems after COVID-19. A study published in 2020 in JAMA Cardiology found 60% of people who had COVID-19 had ongoing signs of heart inflammation. Nearly a third of people hospitalized for COVID-19 get kidney damage that can become chronic, and some end up needing dialysis or a transplant, said C. John Sperati, MD, a kidney specialist at Johns Hopkins Medicine.

This might be, in part, because SARS-CoV-2, the virus that causes COVID-19, directly infects the cells in many organs.

Nicole Bhave, MD, a cardiologist at University of Michigan Health, Ann Arbor is concerned that COVID-19 appears to increase the risk of heart problems in some people.

“Some of the uptick may just be recognition bias, in that people with symptoms are seeking care,” she said. “But there’s definitely a biological basis by which COVID could tip people over into a new diagnosis of heart failure.”
 

Inflammation

Inflammation is probably a key part of the long-term effects of COVID-19.

Some people have a serious immune reaction to COVID-19 called a cytokine storm, said Nitra Aggarwal Gilotra, MD, a cardiologist at Johns Hopkins Medicine. This release of inflammation-causing molecules called cytokines is meant to attack the invading virus. But it can be so severe that it wreaks havoc on healthy tissues and organs and causes lasting damage – if patients even survive it.

In some people, inflammation can affect the heart, causing myocarditis. Myocarditis symptoms include chest pain, breathlessness, and heart palpitations. Though rare, it can be serious and can raise the risk of other heart problems, including heart failure, down the line.

Long COVID may also trigger an autoimmune condition, said Eline Luning Prak, MD, PhD, a pathologist at the Hospital of the University of Pennsylvania, Philadelphia. Long COVID can share many hallmark symptoms with autoimmune diseases, including fatigue, widespread pain, memory problems, and mood disorders.
 

Blood clots

Studies have shown the overcharged inflammatory response to COVID-19 can cause blood clots. This sometimes overwhelming clotting was an early hallmark of COVID-19 infection, and when clots restrict blood flow in the brain, lungs, kidneys, or limbs, they can cause long-term damage. Some can be deadly. Researchers in Sweden found patients were at risk of deep vein thrombosis – a blood clot usually in the leg – up to 3 months after infection and at higher risk of a blood clot in the lung, called pulmonary embolism, for as long as 3 months.

Viral reservoirs

The virus itself may also linger in a patient’s body, causing continued symptoms and, potentially, new flare-ups. Zoe Swank, PhD, of Harvard Medical School, Boston, and colleagues reported in a preprint study that they found pieces of the SARS-CoV-2 virus in the blood of most patients with long COVID symptoms they tested – some as long as a year after infection. The study has not yet been peer reviewed.

Another team found evidence of the virus in stool up to 7 months later, which suggests the virus hides out in the gut. Other early studies have found bits of viral RNA in the appendix, breast tissue, heart, eyes, and brain.
 

Diabetes

Diabetes is a risk factor for getting severe COVID-19, and multiple studies have shown people can get diabetes both while battling infection and afterward. One study of veterans, published in The Lancet Diabetes and Endocrinology, found COVID-19 survivors were about 40% more likely to get diabetes over the next year.

There are a few ways this might happen. Insulin-producing cells in the pancreas have SARS-CoV-2 receptors – a type of molecular doorway the coronavirus can attach to. Damage to these cells could make the body less able to produce insulin, which in turn can lead to diabetes. The virus could also disrupt the balance in the body or cause inflammation that leads to insulin resistance, which can develop into diabetes, Ziad Al-Aly, MD, of the Veterans Affairs St. Louis Health Care System, and colleagues wrote.
 

Nervous system issues

People who get COVID-19 are also more vulnerable to postural orthostatic tachycardia syndrome (POTS). This affects what’s known as the autonomic nervous system, which regulates blood circulation, and includes those things that happen in your body without your having to think about them, like breathing, heartbeat, and digestion. POTS can cause common long COVID neurologic symptoms, including headaches, fatigue, brain fog, insomnia, and problems thinking and concentrating. “This was a known condition prior to COVID, but it was incredibly rare,” said Dr. Viswanathan. “After COVID, I’ve seen it with increasing frequency.”

Long-term outlook

Lasting issues after COVID-19 are much more likely after a moderate or severe infection. Still, plenty of people are battling them even after a mild illness. “As for why, that’s the billion-dollar question,” said Dr. Horwitz. “It’s well known that viral infections can cause long-term dysregulation. Why that is, we really just don’t know.”

Whether it’s virus hiding out in the body, long-term organ damage, or an autoimmune reaction likely differs from person to person. “I’m believing, increasingly, that it’s a combination of all of these, just based on how different patients are responding to different medications,” said Dr. Viswanathan. “One patient will respond to something beautifully, and another patient won’t at all.”

But it’s clear a significant number of people are facing long-term health struggles because of COVID-19, which has infected at least 580 million people globally and 92 million – likely many more – in the United States, according to Johns Hopkins University.

Even a small increased risk of conditions like heart disease or diabetes translates to a huge number of people, Dr. Horwitz said. “If even 1% of people getting COVID have long-term symptoms, that’s a major public health crisis, because that’s 1% of pretty much everybody in the country.”

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