DENVER – High-intensity exercise may help patients with anxiety quit smoking, new research shows.

Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.

Effective as CBT

Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).

In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.

The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.

Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.

Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.

The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.

All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.

All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).

The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.

“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
 

Abstinence rate doubled

The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.

Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).

“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”

Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.

Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.

In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
 

Real-world evidence

Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.

It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.

He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.

“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.

Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.

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

DENVER – High-intensity exercise may help patients with anxiety quit smoking, new research shows.

Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.

Effective as CBT

Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).

In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.

The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.

Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.

Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.

The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.

All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.

All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).

The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.

“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
 

Abstinence rate doubled

The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.

Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).

“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”

Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.

Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.

In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
 

Real-world evidence

Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.

It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.

He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.

“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.

Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.

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

DENVER – High-intensity exercise may help patients with anxiety quit smoking, new research shows.

Results from a randomized study of 150 participants reporting symptoms of anxiety showed that among daily smokers who received a personalized, high-intensity aerobic intervention, rates of smoking abstinence were nearly twice as great as for those who received a lower-intensity exercise intervention.

Effective as CBT

Previous research shows that relatively short periods of exercise, lasting as little as 2 weeks, were associated with reductions in anxiety equivalent to 12 weeks of cognitive-behavioral therapy (CBT).

In light of these earlier findings, Dr. Smits and colleagues investigated the effect of an exercise intervention for smoking cessation based on the knowledge that individuals with anxiety disorders are more likely to smoke and less likely to succeed in quitting.

The initial study, which was published in 2016, included 136 smokers with high “anxiety sensitivity,” a heightened sensitivity to normal sensations associated with anxiety, potentially leading to panic attacks or other disorders.

Results showed that participation in the researchers’ Smoking Treatment Enhancement Program (STEP) was associated with significant improvements in prolonged smoking abstinence among those with high anxiety sensitivity but not those with low anxiety.

Building on these results, the new study evaluated the exercise program at a community level at four YMCA centers. This time all participants had high anxiety sensitivity, defined as a score of 23 or higher on the Anxiety Sensitivity Index–3.

The study included 150 adult participants who had high anxiety, were daily smokers, were motivated to quit smoking, and who reported that they did not currently participate in regular moderate exercise.

All participants (67.3% women; mean age, 38.6 years) took part in STEP, which included a 15-week exercise intervention with a personal trainer. Of the participants, 77 individuals were randomly assigned to receive high-intensity aerobic training that targeted 60%-85% of their heart rate reserve (HRR), while the other 73 were assigned to a lower-intensity control group in which training was only targeted to 20%-40% of their HRR.

All participants also received standard behavioral support with phone- or text-based CBT and nicotine replacement therapy (NRT).

The centers’ fitness instructors served as case managers who oversaw the smoking cessation exercise regimens of high-intensity versus low-intensity exercise. A broad array of aerobic exercise options were permitted, with the instructors working with participants to personalize their regimens.

“It’s important to take into consideration patients’ preferences [and] to work with the fitness instructors to find the right activity,” Dr. Smits said. He noted that options may include intense yoga or swimming. “So I think we just need to be creative in thinking about exercise as being more than just running,” he noted.
 

Abstinence rate doubled

The study’s primary endpoint was abstinence, defined as biologically verified 7-day point prevalence abstinence.

Results at 6-month follow-up showed that the primary endpoint was achieved by 27.6% of the higher-intensity intervention group, compared with just 14.8% of the lower-intensity group (odds ratio, 2.2; P = .005).

“It was encouraging to see we roughly doubled the abstinence rate at the 6-month follow-up,” Dr. Smits said. “Those receiving the high-intensity exercise intervention had greater abstinence rates spanning the entire study period versus the standard treatment.”

Of note, declines in anxiety sensitivity, as measured on the Reiss-Epstein-Gursky Anxiety Sensitivity Index, were observed in both groups. However, there was no significant difference in changes between the two groups.

Dr. Smits noted the investigators initially speculated that exercise would improve cessation success in individuals with anxiety sensitivity by providing exposure to the types of sensations that may trigger their anxiety, such as sweating and an accelerated heart rate, providing an opportunity for “extinction training” by desensitizing them to these experiences.

In addition, high-intensity exercise may also mitigate other anxiety symptoms, including panic disorder, pain, depression, overeating, and posttraumatic stress disorder, Dr. Smits said.
 

Real-world evidence

Commenting on the findings, Sahib S. Khalsa, MD, PhD, director of clinical operations at the Laureate Institute for Brain Research and associate professor at the University of Tulsa, Oklahoma, noted that the real-world nature of the study suggests its results are widely applicable.

It is also important to note that both the current and previous studies conducted by the investigators included NRT, “and thus the effects are more likely to be reflective of a grouping of therapies, something that is more reflective of current practice,” said Dr. Khalsa, who was not involved in the research.

He noted that initiating as well as maintaining exercise motivation over longer periods is challenging.

“The study likely addressed this challenge by using fitness instructors, which may be an important criterion for successful deployment of the intervention. We also don’t know whether maintaining an active exercise regimen is critical to maintaining smoking cessation,” Dr. Khalsa added.

Dr. Smits is a consultant for Big Health. Dr. Khalsa has reported no relevant financial relationships.

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

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.

BOSTON – The cost of care for the more than 14 million cases of cellulitis that occur each year in the United States is in the billions of dollars, but there are multiple opportunities, many involving dermatologists, to dramatically reduce these costs, according to an outline of strategies presented at the American Academy of Dermatology 2022 annual meeting in Boston.

“Cellulitis is misdiagnosed about one-third of the time, and that cost is very high,” reported Jennifer L. Adams, MD, assistant professor of dermatology, University of Nebraska, Omaha. She sees opportunities for dermatological consults to help weed through the many cellulitis mimickers, such as venous insufficiency or psoriasiform drug reactions, to prevent unnecessary admissions and ineffective therapy.

“There is a huge need for diagnostic accuracy as a means to deliver more cost-effective care,” Dr. Adams said.

Solving misdiagnosis is only part of the story. Costs of care are also ramped up by unnecessary hospitalizations. According to Dr. Adams, published criteria to triage emergency room patients with cellulitis to outpatient care are not always followed. In one review, 14% of admitted patients had met the criteria for outpatient treatment.

Cellulitis is a common skin infection that causes redness, swelling, and pain in the infected area, most often on the legs and feet.

Unnecessary hospitalizations for misdiagnosed cellulitis, which is associated with an average 4-day hospital stay, “range from $200 million to $500 million in avoidable direct healthcare costs,” Dr. Adams said.

Even for justifiable hospitalizations, there are still opportunities for cost savings. In one study, blood cultures were ordered in 73% of patients even though only 2% produced a finding relevant to care. According to Dr. Adams, most cellulitis cases are caused by the “usual suspects” – group A beta-hemolytic streptococcus, Streptococcus pneumoniae, and Staphylococcus aureus. The exceptions stand out by clinical criteria, such as known neutropenia, history of an animal bite, signs of Systemic Inflammatory Response Syndrome (SIRS), or a purulent appearance.

“Blood cultures are not cost-effective in uncomplicated cellulitis,” Dr. Adams said. She said there are numerous published algorithms to guide clinicians on decision-making in the management of soft tissue infections, including cellulitis, including a much-cited algorithm first published more than 15 years ago and updated in 2014.

Similarly, labs and imaging are commonly ordered with no strong likelihood that they will change management, she said. These types of decisions are also covered in published algorithms.

Strategies to prevent rehospitalization are another area where there is a large opportunity to reduce health care resources consumed by cellulitis. The rehospitalization rate at 30 days is approximately 10%, but many patients have recurrent episodes over years, according to Dr. Adams. The risk factors and the preventative measures have been well described.

“Scrupulous clinical care can reduce recurrence, and it is cost-effective,” said Dr. Adams, referring to control of edema, control of underlying conditions associated with increased risk, such as diabetes, and managing dry skin and erosions with topical agents or even moisturizers. Compression socks are a simple but effective tool, she added.

For patients with repeat episodes of cellulitis over years, Dr. Adams referred to a double-blind trial that associated a twice-daily dose of 250 mg penicillin with a 45% reduction in the risk of cellulitis recurrence over 1 year. At approximately $10 a month for this treatment, she said it is very cost-effective, although she acknowledged that recurrence rates of cellulitis climb back up when the penicillin is stopped.

“I think of this as a bridge while you work on addressing the venous insufficiency or other risk factors for cellulitis,” Dr. Adams said.

For reducing the costs of cellulitis, there is evidence that dermatologists can play a role. Dr. Adams cited a study that evaluated the impact of a dermatologist consultation for suspected cellulitis in the emergency room or within 24 hours of admission. Of 34 patients already prescribed antibiotics for presumed cellulitis, discontinuation was recommended in 82%. Of 39 admissions, pseudocellulitis was identified in 51%.

Extrapolating these data to national rates of cellulitis, there was an estimated savings of up to $200 million annually without any apparent increased risk of adverse outcomes, according to Dr. Adams.

When contacted about his experience, the senior investigator of that study, Arash Mostaghimi, MD, director of the Inpatient Dermatology Consult Service, Brigham and Women’s Hospital, Boston, largely agreed with the premise of Adam’s analysis. In particular, he said, avoiding misdiagnosis of cellulitis offers a major opportunity to lower costs while possibly improving care.

True of national practice and at the local level, “misdiagnosis of noninfectious inflammatory reactions such as cellulitis has substantial cost impacts,” Dr. Mostaghimi said in an interview. Based on evidence, the savings are derived directly from “unnecessary antibiotic exposure as well as inappropriate hospitalization.”

Following publication of his study, he became involved in addressing this issue at his institution.

“At Brigham and Women’s, we collaborated with colleagues in infectious disease and in the emergency department to create cellulitis protocols that identify patients at risk for misdiagnosis and facilitate early dermatology consultation for diagnostic confirmation,” he said.

Although there are algorithms to achieve this goal, he indicated that the expertise of dermatologists can quickly and efficiently differentiate inflammatory skin reactions and expedite appropriate care.

Dr. Adams and Dr. Mostaghimi have reported no relevant financial relationships.

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

BOSTON – The cost of care for the more than 14 million cases of cellulitis that occur each year in the United States is in the billions of dollars, but there are multiple opportunities, many involving dermatologists, to dramatically reduce these costs, according to an outline of strategies presented at the American Academy of Dermatology 2022 annual meeting in Boston.

“Cellulitis is misdiagnosed about one-third of the time, and that cost is very high,” reported Jennifer L. Adams, MD, assistant professor of dermatology, University of Nebraska, Omaha. She sees opportunities for dermatological consults to help weed through the many cellulitis mimickers, such as venous insufficiency or psoriasiform drug reactions, to prevent unnecessary admissions and ineffective therapy.

“There is a huge need for diagnostic accuracy as a means to deliver more cost-effective care,” Dr. Adams said.

Solving misdiagnosis is only part of the story. Costs of care are also ramped up by unnecessary hospitalizations. According to Dr. Adams, published criteria to triage emergency room patients with cellulitis to outpatient care are not always followed. In one review, 14% of admitted patients had met the criteria for outpatient treatment.

Cellulitis is a common skin infection that causes redness, swelling, and pain in the infected area, most often on the legs and feet.

Unnecessary hospitalizations for misdiagnosed cellulitis, which is associated with an average 4-day hospital stay, “range from $200 million to $500 million in avoidable direct healthcare costs,” Dr. Adams said.

Even for justifiable hospitalizations, there are still opportunities for cost savings. In one study, blood cultures were ordered in 73% of patients even though only 2% produced a finding relevant to care. According to Dr. Adams, most cellulitis cases are caused by the “usual suspects” – group A beta-hemolytic streptococcus, Streptococcus pneumoniae, and Staphylococcus aureus. The exceptions stand out by clinical criteria, such as known neutropenia, history of an animal bite, signs of Systemic Inflammatory Response Syndrome (SIRS), or a purulent appearance.

“Blood cultures are not cost-effective in uncomplicated cellulitis,” Dr. Adams said. She said there are numerous published algorithms to guide clinicians on decision-making in the management of soft tissue infections, including cellulitis, including a much-cited algorithm first published more than 15 years ago and updated in 2014.

Similarly, labs and imaging are commonly ordered with no strong likelihood that they will change management, she said. These types of decisions are also covered in published algorithms.

Strategies to prevent rehospitalization are another area where there is a large opportunity to reduce health care resources consumed by cellulitis. The rehospitalization rate at 30 days is approximately 10%, but many patients have recurrent episodes over years, according to Dr. Adams. The risk factors and the preventative measures have been well described.

“Scrupulous clinical care can reduce recurrence, and it is cost-effective,” said Dr. Adams, referring to control of edema, control of underlying conditions associated with increased risk, such as diabetes, and managing dry skin and erosions with topical agents or even moisturizers. Compression socks are a simple but effective tool, she added.

For patients with repeat episodes of cellulitis over years, Dr. Adams referred to a double-blind trial that associated a twice-daily dose of 250 mg penicillin with a 45% reduction in the risk of cellulitis recurrence over 1 year. At approximately $10 a month for this treatment, she said it is very cost-effective, although she acknowledged that recurrence rates of cellulitis climb back up when the penicillin is stopped.

“I think of this as a bridge while you work on addressing the venous insufficiency or other risk factors for cellulitis,” Dr. Adams said.

For reducing the costs of cellulitis, there is evidence that dermatologists can play a role. Dr. Adams cited a study that evaluated the impact of a dermatologist consultation for suspected cellulitis in the emergency room or within 24 hours of admission. Of 34 patients already prescribed antibiotics for presumed cellulitis, discontinuation was recommended in 82%. Of 39 admissions, pseudocellulitis was identified in 51%.

Extrapolating these data to national rates of cellulitis, there was an estimated savings of up to $200 million annually without any apparent increased risk of adverse outcomes, according to Dr. Adams.

When contacted about his experience, the senior investigator of that study, Arash Mostaghimi, MD, director of the Inpatient Dermatology Consult Service, Brigham and Women’s Hospital, Boston, largely agreed with the premise of Adam’s analysis. In particular, he said, avoiding misdiagnosis of cellulitis offers a major opportunity to lower costs while possibly improving care.

True of national practice and at the local level, “misdiagnosis of noninfectious inflammatory reactions such as cellulitis has substantial cost impacts,” Dr. Mostaghimi said in an interview. Based on evidence, the savings are derived directly from “unnecessary antibiotic exposure as well as inappropriate hospitalization.”

Following publication of his study, he became involved in addressing this issue at his institution.

“At Brigham and Women’s, we collaborated with colleagues in infectious disease and in the emergency department to create cellulitis protocols that identify patients at risk for misdiagnosis and facilitate early dermatology consultation for diagnostic confirmation,” he said.

Although there are algorithms to achieve this goal, he indicated that the expertise of dermatologists can quickly and efficiently differentiate inflammatory skin reactions and expedite appropriate care.

Dr. Adams and Dr. Mostaghimi have reported no relevant financial relationships.

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

BOSTON – The cost of care for the more than 14 million cases of cellulitis that occur each year in the United States is in the billions of dollars, but there are multiple opportunities, many involving dermatologists, to dramatically reduce these costs, according to an outline of strategies presented at the American Academy of Dermatology 2022 annual meeting in Boston.

“Cellulitis is misdiagnosed about one-third of the time, and that cost is very high,” reported Jennifer L. Adams, MD, assistant professor of dermatology, University of Nebraska, Omaha. She sees opportunities for dermatological consults to help weed through the many cellulitis mimickers, such as venous insufficiency or psoriasiform drug reactions, to prevent unnecessary admissions and ineffective therapy.

“There is a huge need for diagnostic accuracy as a means to deliver more cost-effective care,” Dr. Adams said.

Solving misdiagnosis is only part of the story. Costs of care are also ramped up by unnecessary hospitalizations. According to Dr. Adams, published criteria to triage emergency room patients with cellulitis to outpatient care are not always followed. In one review, 14% of admitted patients had met the criteria for outpatient treatment.

Cellulitis is a common skin infection that causes redness, swelling, and pain in the infected area, most often on the legs and feet.

Unnecessary hospitalizations for misdiagnosed cellulitis, which is associated with an average 4-day hospital stay, “range from $200 million to $500 million in avoidable direct healthcare costs,” Dr. Adams said.

Even for justifiable hospitalizations, there are still opportunities for cost savings. In one study, blood cultures were ordered in 73% of patients even though only 2% produced a finding relevant to care. According to Dr. Adams, most cellulitis cases are caused by the “usual suspects” – group A beta-hemolytic streptococcus, Streptococcus pneumoniae, and Staphylococcus aureus. The exceptions stand out by clinical criteria, such as known neutropenia, history of an animal bite, signs of Systemic Inflammatory Response Syndrome (SIRS), or a purulent appearance.

“Blood cultures are not cost-effective in uncomplicated cellulitis,” Dr. Adams said. She said there are numerous published algorithms to guide clinicians on decision-making in the management of soft tissue infections, including cellulitis, including a much-cited algorithm first published more than 15 years ago and updated in 2014.

Similarly, labs and imaging are commonly ordered with no strong likelihood that they will change management, she said. These types of decisions are also covered in published algorithms.

Strategies to prevent rehospitalization are another area where there is a large opportunity to reduce health care resources consumed by cellulitis. The rehospitalization rate at 30 days is approximately 10%, but many patients have recurrent episodes over years, according to Dr. Adams. The risk factors and the preventative measures have been well described.

“Scrupulous clinical care can reduce recurrence, and it is cost-effective,” said Dr. Adams, referring to control of edema, control of underlying conditions associated with increased risk, such as diabetes, and managing dry skin and erosions with topical agents or even moisturizers. Compression socks are a simple but effective tool, she added.

For patients with repeat episodes of cellulitis over years, Dr. Adams referred to a double-blind trial that associated a twice-daily dose of 250 mg penicillin with a 45% reduction in the risk of cellulitis recurrence over 1 year. At approximately $10 a month for this treatment, she said it is very cost-effective, although she acknowledged that recurrence rates of cellulitis climb back up when the penicillin is stopped.

“I think of this as a bridge while you work on addressing the venous insufficiency or other risk factors for cellulitis,” Dr. Adams said.

For reducing the costs of cellulitis, there is evidence that dermatologists can play a role. Dr. Adams cited a study that evaluated the impact of a dermatologist consultation for suspected cellulitis in the emergency room or within 24 hours of admission. Of 34 patients already prescribed antibiotics for presumed cellulitis, discontinuation was recommended in 82%. Of 39 admissions, pseudocellulitis was identified in 51%.

Extrapolating these data to national rates of cellulitis, there was an estimated savings of up to $200 million annually without any apparent increased risk of adverse outcomes, according to Dr. Adams.

When contacted about his experience, the senior investigator of that study, Arash Mostaghimi, MD, director of the Inpatient Dermatology Consult Service, Brigham and Women’s Hospital, Boston, largely agreed with the premise of Adam’s analysis. In particular, he said, avoiding misdiagnosis of cellulitis offers a major opportunity to lower costs while possibly improving care.

True of national practice and at the local level, “misdiagnosis of noninfectious inflammatory reactions such as cellulitis has substantial cost impacts,” Dr. Mostaghimi said in an interview. Based on evidence, the savings are derived directly from “unnecessary antibiotic exposure as well as inappropriate hospitalization.”

Following publication of his study, he became involved in addressing this issue at his institution.

“At Brigham and Women’s, we collaborated with colleagues in infectious disease and in the emergency department to create cellulitis protocols that identify patients at risk for misdiagnosis and facilitate early dermatology consultation for diagnostic confirmation,” he said.

Although there are algorithms to achieve this goal, he indicated that the expertise of dermatologists can quickly and efficiently differentiate inflammatory skin reactions and expedite appropriate care.

Dr. Adams and Dr. Mostaghimi have reported no relevant financial relationships.

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

BOSTON – Among atopic dermatitis (AD) patients infected with COVID-19, those who received topical treatments were nearly five times more likely to be hospitalized compared with those on dupilumab monotherapy, results from a global registry demonstrated.

Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.

“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”

On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.

“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”

To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.

Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m², and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.

By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).

To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).

Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.

“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”

She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.

Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”

Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.

BOSTON – Among atopic dermatitis (AD) patients infected with COVID-19, those who received topical treatments were nearly five times more likely to be hospitalized compared with those on dupilumab monotherapy, results from a global registry demonstrated.

Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.

“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”

On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.

“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”

To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.

Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m², and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.

By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).

To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).

Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.

“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”

She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.

Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”

Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.

BOSTON – Among atopic dermatitis (AD) patients infected with COVID-19, those who received topical treatments were nearly five times more likely to be hospitalized compared with those on dupilumab monotherapy, results from a global registry demonstrated.

Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.

“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”

On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.

“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”

To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.

Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m², and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.

By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).

To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).

Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.

“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”

She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.

Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”

Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.

The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.

Semaglutide is currently available as 0.5-mg and 1-mg doses.

Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.

The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.

As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.

Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.

SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.

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

The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.

Semaglutide is currently available as 0.5-mg and 1-mg doses.

Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.

The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.

As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.

Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.

SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.

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

The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.

Semaglutide is currently available as 0.5-mg and 1-mg doses.

Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.

The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.

As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.

Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.

SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.

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

The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.

The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.

Ivan Strba/iStockphoto.com

The bill will now head to the House of Representatives.

According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.

The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.

Despite this, bumpers are still widely sold by retailers.

“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.

A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.

Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.

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

The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.

The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.

Ivan Strba/iStockphoto.com

The bill will now head to the House of Representatives.

According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.

The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.

Despite this, bumpers are still widely sold by retailers.

“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.

A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.

Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.

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

The Senate on Mar. 23 approved a bill to ban the sale of padded crib bumpers, which have been deemed risky by public health experts.

The Safe Cribs Act, introduced by Sen. Rob Portman (R-Ohio) and Sen. Tammy Duckworth (D-Ill.), would prohibit making and distributing bumpers – soft pads made to protect babies from hard sides of cribs – which have been found to increase suffocation risk.

Ivan Strba/iStockphoto.com

The bill will now head to the House of Representatives.

According to data from the Consumer Product Safety Commission, 107 babies died in cribs with bumpers between 1990 and 2016, and 282 nonfatal incidents with bumpers were reported, including near-misses for strangulation and suffocation.

The American Academy of Pediatrics recommends keeping babies’ cribs free of any objects, including bumpers.

Despite this, bumpers are still widely sold by retailers.

“The fact that these deadly products can still be found on shelves across the country is extremely confusing to new parents who don’t believe stores would be selling them if they were truly dangerous to babies,” Sen. Duckworth said in a statement.

A 2020 survey released by Johns Hopkins University found that many parents were unaware of the dangers posed by crib bumpers and assumed they would be removed from stores if found unsafe.

Maryland banned the sale of bumpers in 2013, followed by Ohio in 2017. Chicago became the first city to ban them in 2011.

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

Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.

While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.

“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”

“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”

As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.

The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.

Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).

This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).

Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).

“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”

“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”

Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.

“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.

“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”

“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”

The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.

“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”

Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.

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

Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.

While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.

“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”

“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”

As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.

The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.

Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).

This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).

Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).

“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”

“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”

Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.

“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.

“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”

“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”

The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.

“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”

Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.

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

Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.

While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.

“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”

“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”

As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.

The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.

Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).

This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).

Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).

“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”

“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”

Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.

“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.

“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”

“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”

The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.

“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”

Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.

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

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children.

Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues.

In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL.

The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health.

Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95).

No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted.

However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%).

The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said.

However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

In a related study published in JAMA, Taygen Edwards and colleagues found that prophylactic oral dextrose gel had no significant effect on neurosensory function.

The study, a prospective follow-up of a multicenter randomized trial, included 1,197 later preterm or term infants deemed at risk for neonatal hypoglycemia. The infants (49% of whom were female) were randomized to prophylactic 40% dextrose gel or a placebo, massaged into the buccal mucosa at 1 hour after birth.

The primary outcome was neurosensory impairment at 2 years of age, which was assessed by neurologic examination, parent-reported medical questionnaires, Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), performance-based executive function, Behavior Rating Inventory of Executive Function–Preschool Version, motion coherence thresholds, growth, and body composition.

At 2 years of age, the prevalence of neurosensory impairment was 21% and 19%, respectively, in infants randomized to prophylactic oral dextrose gel and placebo, a nonsignificant difference. No differences between the two groups were noted for cognitive and language delays, or low performance-based overall executive function. However, infants randomized to dextrose gel had significantly higher risk of motor delay compared to placebo (2.5% vs. 0.7%) and significantly lower Bayley-III composite scores for cognitive, language, and motor performance.

No significant differences were noted between the groups in the areas of moderate or severe neurosensory impairment, hearing impairment, cerebral palsy, developmental delay, above-average development, socioemotional and adaptive behavior, questionnaire-based executive function, low visual processing, history of seizures, allergic and infectious diseases, growth, and body composition.

The results are consistent with previous studies on the safety of dextrose gel, the researchers wrote in their discussion. However, the absolute difference of 7% in the primary outcome may be clinically important, they noted. “Caution is warranted before using prophylactic dextrose gel,” they said.

The researchers noted the results of a dose-finding trial that suggested improved scores on language, executive function, and motor skills in unadjusted analysis with higher doses of dextrose gel, but the reason for these findings remains unknown, they said.

The study findings were limited by the potential underpowering to detect small, but significant differences, and possible lack of generalizability because the majority of the participants were children of mothers with diabetes.

The results were strengthened by the high follow-up rate and comprehensive assessments, and highlight the need for additional research with longer follow-up, the researchers said.
 

Findings fuel further exploration

Although hypoglycemia is common in newborns, its management and potential outcomes remain subjects for debate, Paul J. Rozance, MD, of the University of Colorado, Aurora, wrote in an editorial accompanying both studies.

“Often, the same features that increase the risk of hypoglycemia in newborns also increase the risk for poor outcomes independent of hypoglycemia,” he said.

The study by Shah and colleagues was not a randomized trial of a specific management strategy, Dr. Rozance noted. However, the high rate of low educational attainment in children not exposed to dextrose gel emphasizes the need for more effective management of infant hypoglycemia, he said. “The findings also suggest that antenatal conditions that are associated with increased risk of hypoglycemia among newborns are associated with increased risk for impaired neurodevelopment and educational achievement, independent of neonatal hypoglycemia,” he said. The study findings contrast with those of an earlier study showing low academic achievement association with early transient hypoglycemia, which could argue for earlier intervention, he noted.

The study by Edwards and colleagues addressed the potential value of dextrose gel as an early intervention to prevent neonatal hypoglycemia, said Dr. Rozance.

“The 95% CI for the primary outcome of neurosensory impairment included up to a 7% increased risk for neurosensory impairment in the prophylactic dextrose gel group. The 7% increased risk was defined by the investigators as potentially clinically important, and the study may have been underpowered to detect small differences in the primary outcome,” he wrote.

Although the reasons for adverse outcomes in children given prophylactic dextrose gel remain unclear, “incorporation of prophylactic dextrose gel into clinical practice should await further research,” he said.

Regarding such research, Dr. Rozance proposed an “ideal study,” that would “randomize newborns with hypoglycemia to treatment or no treatment, although equipoise and ethical support for such a study are lacking. Another strategy would be to randomize newborns with hypoglycemia to receive low- or high-treatment glucose concentration goals,” he noted.

The relationship between hypoglycemia and impaired neurodevelopment is yet to be determined, but the two studies provide new evidence for the clinical importance and need for management of neonatal hypoglycemia and subsequent neurodevelopmental outcomes, he concluded.

The study by Shah and colleagues was supported by the Health Research Council of New Zealand and the Maurice and Phyllis Paykel Trust. Dr. Shah disclosed a doctoral fellowship from the University of Auckland. The study by Edwards and colleagues was supported by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. Ms. Edwards had no financial conflicts to disclose. Dr. Rozance disclosed receiving a StatStrip from Nova Biomedical for use in his laboratory.

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

COVID-19 continues to be a diminishing issue for U.S. children, as the number of new cases declined for the ninth consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

New cases were down to 29,000 for the week of March 18-24, a drop of 9.3% from the previous week and a full 97.4% lower than the peak reached during the Omicron surge in January, the AAP and CHA said in their weekly COVID report. The most recently infected children brought the total number of COVID-19 cases to just over 12.8 million since the pandemic began.

Other measures of COVID occurrence in children, such as hospital admissions and emergency department visits, also followed recent downward trends, although the sizes of the declines are beginning to decrease. Admissions dropped by 13.3% during the week ending March 26, but that followed declines of 25%, 20%, 26.5% and 24.4% for the 4 previous weeks, data from the Centers for Disease Control and Prevention show.

The slowdown in ED visits started a couple of weeks earlier, but the decline is still ongoing. As of March 25, ED visits with a confirmed COVID diagnosis represented just 0.4% of all visits for children aged 0-11 years, down from 1.1% on Feb. 25 and a peak of 14.3% on Jan. 15. For children aged 12-15, the latest figure is just 0.2%, compared with 0.5% on Feb. 25 and a peak of 14.3% on Jan. 9, the CDC reported on its COVID Data Tracker.

Although he was speaking of the nation as a whole and not specifically of children, Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, recently told the Washington Post that, “unless something changes dramatically,” another major surge isn’t on the horizon.

That sentiment, however, was not entirely shared by Moderna’s chief medical officer, Paul Burton, MD, PhD. In an interview with WebMD, he said that another COVID wave is inevitable and that it’s too soon to dismantle the vaccine infrastructure: “We’ve come so far. We’ve put so much into this to now take our foot off the gas. I think it would be a mistake for public health worldwide.”

Disparities during the Omicron surge

As the country puts Omicron in its rear view mirror, a quick look back at the CDC data shows some differences in how children were affected. At the surge’s peak in early to mid-January, Hispanic children were the most likely to get COVID-19, with incidence highest in the older groups. (See graph.)

At their peak week of Jan. 2-8, Hispanic children aged 16-17 years had a COVID rate of 1,568 cases per 100,000 population, versus 790 per 100,000 for White children, whose peak occurred a week later, from Jan. 9 to 15. Hispanic children aged 5-11 (1,098 per 100,000) and 12-15 (1,269 per 100,000) also had the highest recorded rates of the largest racial/ethnic groups, while Black children had the highest one-week rate, 625 per 100,000, among the 0- to 4-year-olds, according to the CDC.

COVID-19 continues to be a diminishing issue for U.S. children, as the number of new cases declined for the ninth consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

New cases were down to 29,000 for the week of March 18-24, a drop of 9.3% from the previous week and a full 97.4% lower than the peak reached during the Omicron surge in January, the AAP and CHA said in their weekly COVID report. The most recently infected children brought the total number of COVID-19 cases to just over 12.8 million since the pandemic began.

Other measures of COVID occurrence in children, such as hospital admissions and emergency department visits, also followed recent downward trends, although the sizes of the declines are beginning to decrease. Admissions dropped by 13.3% during the week ending March 26, but that followed declines of 25%, 20%, 26.5% and 24.4% for the 4 previous weeks, data from the Centers for Disease Control and Prevention show.

The slowdown in ED visits started a couple of weeks earlier, but the decline is still ongoing. As of March 25, ED visits with a confirmed COVID diagnosis represented just 0.4% of all visits for children aged 0-11 years, down from 1.1% on Feb. 25 and a peak of 14.3% on Jan. 15. For children aged 12-15, the latest figure is just 0.2%, compared with 0.5% on Feb. 25 and a peak of 14.3% on Jan. 9, the CDC reported on its COVID Data Tracker.

Although he was speaking of the nation as a whole and not specifically of children, Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, recently told the Washington Post that, “unless something changes dramatically,” another major surge isn’t on the horizon.

That sentiment, however, was not entirely shared by Moderna’s chief medical officer, Paul Burton, MD, PhD. In an interview with WebMD, he said that another COVID wave is inevitable and that it’s too soon to dismantle the vaccine infrastructure: “We’ve come so far. We’ve put so much into this to now take our foot off the gas. I think it would be a mistake for public health worldwide.”

Disparities during the Omicron surge

As the country puts Omicron in its rear view mirror, a quick look back at the CDC data shows some differences in how children were affected. At the surge’s peak in early to mid-January, Hispanic children were the most likely to get COVID-19, with incidence highest in the older groups. (See graph.)

At their peak week of Jan. 2-8, Hispanic children aged 16-17 years had a COVID rate of 1,568 cases per 100,000 population, versus 790 per 100,000 for White children, whose peak occurred a week later, from Jan. 9 to 15. Hispanic children aged 5-11 (1,098 per 100,000) and 12-15 (1,269 per 100,000) also had the highest recorded rates of the largest racial/ethnic groups, while Black children had the highest one-week rate, 625 per 100,000, among the 0- to 4-year-olds, according to the CDC.

COVID-19 continues to be a diminishing issue for U.S. children, as the number of new cases declined for the ninth consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

New cases were down to 29,000 for the week of March 18-24, a drop of 9.3% from the previous week and a full 97.4% lower than the peak reached during the Omicron surge in January, the AAP and CHA said in their weekly COVID report. The most recently infected children brought the total number of COVID-19 cases to just over 12.8 million since the pandemic began.

Other measures of COVID occurrence in children, such as hospital admissions and emergency department visits, also followed recent downward trends, although the sizes of the declines are beginning to decrease. Admissions dropped by 13.3% during the week ending March 26, but that followed declines of 25%, 20%, 26.5% and 24.4% for the 4 previous weeks, data from the Centers for Disease Control and Prevention show.

The slowdown in ED visits started a couple of weeks earlier, but the decline is still ongoing. As of March 25, ED visits with a confirmed COVID diagnosis represented just 0.4% of all visits for children aged 0-11 years, down from 1.1% on Feb. 25 and a peak of 14.3% on Jan. 15. For children aged 12-15, the latest figure is just 0.2%, compared with 0.5% on Feb. 25 and a peak of 14.3% on Jan. 9, the CDC reported on its COVID Data Tracker.

Although he was speaking of the nation as a whole and not specifically of children, Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, recently told the Washington Post that, “unless something changes dramatically,” another major surge isn’t on the horizon.

That sentiment, however, was not entirely shared by Moderna’s chief medical officer, Paul Burton, MD, PhD. In an interview with WebMD, he said that another COVID wave is inevitable and that it’s too soon to dismantle the vaccine infrastructure: “We’ve come so far. We’ve put so much into this to now take our foot off the gas. I think it would be a mistake for public health worldwide.”

Disparities during the Omicron surge

As the country puts Omicron in its rear view mirror, a quick look back at the CDC data shows some differences in how children were affected. At the surge’s peak in early to mid-January, Hispanic children were the most likely to get COVID-19, with incidence highest in the older groups. (See graph.)

At their peak week of Jan. 2-8, Hispanic children aged 16-17 years had a COVID rate of 1,568 cases per 100,000 population, versus 790 per 100,000 for White children, whose peak occurred a week later, from Jan. 9 to 15. Hispanic children aged 5-11 (1,098 per 100,000) and 12-15 (1,269 per 100,000) also had the highest recorded rates of the largest racial/ethnic groups, while Black children had the highest one-week rate, 625 per 100,000, among the 0- to 4-year-olds, according to the CDC.