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Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

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

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

TOPLINE:

Cancer surgery poses an elevated risk for venous thromboembolism, which can vary depending on the type of cancer and the timing of surgery, a study suggested.

METHODOLOGY:

• Both major surgery and cancer increase the risk for venous thromboembolism, which can lead to severe illness and death. Research showed that approximately 2% of patients who have cancer surgery experience clinically significant venous thromboembolism, which accounts for about half of the deaths that occur immediately after surgery.
• The American Society of Clinical Oncology and European Association of Urology guidelines recommend an extended 28-day prophylaxis for patients undergoing cancer surgery. These guidelines also provide specific estimates of the excess risk for thromboembolic events for each disease.
• This retrospective study included data on 432,218 patients (median age, 67 years) from Swedish nationwide registers who underwent major surgery for eight types of cancer (bladder, breast, colorectal, gynecologic, lung, prostate, gastroesophageal, and kidney or upper tract urothelial cancer) from 1998 to 2016.
• The researchers matched the patients with 4,009,343 cancer-free individuals from the general population in a 1:10 ratio.
• The primary outcome was the incidence of venous thromboembolic events, including subsegmental pulmonary embolism and deep venous thromboembolism in the calf, within 1 year after the surgery.

TAKEAWAY:

• The researchers found an increased absolute risk for pulmonary embolism at 1 year following cancer surgery, with the highest increase in patients with bladder cancer (a 2.69 percentage point difference), followed by lung (a 2.61 percentage point difference), gastroesophageal (2.13), colorectal (1.57), kidney or upper urinary tract (1.38), gynecologic (1.32), breast (0.59), and prostate cancer (0.57).
• The increased 1-year absolute risk for deep vein thrombosis (in percentage points) was highest for the bladder (a 4.67 percentage point difference), followed by gastroesophageal (2.19), colorectal (2.15), upper urinary tract (2.14), gynecologic (2.02), lung (1.40), breast (1.36), and prostate cancer (0.75).
• The temporal trends showed that the risk for pulmonary embolism and deep vein thrombosis peaked immediately after surgery and plateaued within 120 days for most cancers. At 30 days after surgery, the risk for pulmonary embolism following cancer surgery was 10- to 30-fold times higher than with no surgery for all cancers aside from breast cancer (hazard ratio, 5.18). The researchers observed a similar elevated risk for deep vein thrombosis 30 days following surgery.
• The risk for pulmonary embolism and deep vein thrombosis remained significant at 1 year for all cancer types, except prostate.

IN PRACTICE:

“The marked variation in the occurrence patterns of postoperative venous thromboembolic events indicates a need for a more tailored approach to prophylaxis,” the authors noted, advocating for individualized venous thromboembolism risk evaluation and prophylaxis regimens.

SOURCE:

This study, led by Johan Björklund, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

The information regarding treatments other than surgery that might be linked to an elevated risk for venous thromboembolism was not available. Additionally, changes in clinical practices and diagnostics over time could affect both the occurrence and detection of outcomes. Adoption of minimally invasive surgical techniques, increased use of thromboprophylaxis over time, improved diagnostic capabilities, and a trend toward operating on older patients with more comorbidities over time may have influenced outcomes.

DISCLOSURES: 

The work was funded by the Karolinska Institute and the Swedish Cancer Society. Two study authors reported receiving personal or consulting fees. Other authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Cancer surgery poses an elevated risk for venous thromboembolism, which can vary depending on the type of cancer and the timing of surgery, a study suggested.

METHODOLOGY:

• Both major surgery and cancer increase the risk for venous thromboembolism, which can lead to severe illness and death. Research showed that approximately 2% of patients who have cancer surgery experience clinically significant venous thromboembolism, which accounts for about half of the deaths that occur immediately after surgery.
• The American Society of Clinical Oncology and European Association of Urology guidelines recommend an extended 28-day prophylaxis for patients undergoing cancer surgery. These guidelines also provide specific estimates of the excess risk for thromboembolic events for each disease.
• This retrospective study included data on 432,218 patients (median age, 67 years) from Swedish nationwide registers who underwent major surgery for eight types of cancer (bladder, breast, colorectal, gynecologic, lung, prostate, gastroesophageal, and kidney or upper tract urothelial cancer) from 1998 to 2016.
• The researchers matched the patients with 4,009,343 cancer-free individuals from the general population in a 1:10 ratio.
• The primary outcome was the incidence of venous thromboembolic events, including subsegmental pulmonary embolism and deep venous thromboembolism in the calf, within 1 year after the surgery.

TAKEAWAY:

• The researchers found an increased absolute risk for pulmonary embolism at 1 year following cancer surgery, with the highest increase in patients with bladder cancer (a 2.69 percentage point difference), followed by lung (a 2.61 percentage point difference), gastroesophageal (2.13), colorectal (1.57), kidney or upper urinary tract (1.38), gynecologic (1.32), breast (0.59), and prostate cancer (0.57).
• The increased 1-year absolute risk for deep vein thrombosis (in percentage points) was highest for the bladder (a 4.67 percentage point difference), followed by gastroesophageal (2.19), colorectal (2.15), upper urinary tract (2.14), gynecologic (2.02), lung (1.40), breast (1.36), and prostate cancer (0.75).
• The temporal trends showed that the risk for pulmonary embolism and deep vein thrombosis peaked immediately after surgery and plateaued within 120 days for most cancers. At 30 days after surgery, the risk for pulmonary embolism following cancer surgery was 10- to 30-fold times higher than with no surgery for all cancers aside from breast cancer (hazard ratio, 5.18). The researchers observed a similar elevated risk for deep vein thrombosis 30 days following surgery.
• The risk for pulmonary embolism and deep vein thrombosis remained significant at 1 year for all cancer types, except prostate.

IN PRACTICE:

“The marked variation in the occurrence patterns of postoperative venous thromboembolic events indicates a need for a more tailored approach to prophylaxis,” the authors noted, advocating for individualized venous thromboembolism risk evaluation and prophylaxis regimens.

SOURCE:

This study, led by Johan Björklund, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

The information regarding treatments other than surgery that might be linked to an elevated risk for venous thromboembolism was not available. Additionally, changes in clinical practices and diagnostics over time could affect both the occurrence and detection of outcomes. Adoption of minimally invasive surgical techniques, increased use of thromboprophylaxis over time, improved diagnostic capabilities, and a trend toward operating on older patients with more comorbidities over time may have influenced outcomes.

DISCLOSURES: 

The work was funded by the Karolinska Institute and the Swedish Cancer Society. Two study authors reported receiving personal or consulting fees. Other authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Cancer surgery poses an elevated risk for venous thromboembolism, which can vary depending on the type of cancer and the timing of surgery, a study suggested.

METHODOLOGY:

• Both major surgery and cancer increase the risk for venous thromboembolism, which can lead to severe illness and death. Research showed that approximately 2% of patients who have cancer surgery experience clinically significant venous thromboembolism, which accounts for about half of the deaths that occur immediately after surgery.
• The American Society of Clinical Oncology and European Association of Urology guidelines recommend an extended 28-day prophylaxis for patients undergoing cancer surgery. These guidelines also provide specific estimates of the excess risk for thromboembolic events for each disease.
• This retrospective study included data on 432,218 patients (median age, 67 years) from Swedish nationwide registers who underwent major surgery for eight types of cancer (bladder, breast, colorectal, gynecologic, lung, prostate, gastroesophageal, and kidney or upper tract urothelial cancer) from 1998 to 2016.
• The researchers matched the patients with 4,009,343 cancer-free individuals from the general population in a 1:10 ratio.
• The primary outcome was the incidence of venous thromboembolic events, including subsegmental pulmonary embolism and deep venous thromboembolism in the calf, within 1 year after the surgery.

TAKEAWAY:

• The researchers found an increased absolute risk for pulmonary embolism at 1 year following cancer surgery, with the highest increase in patients with bladder cancer (a 2.69 percentage point difference), followed by lung (a 2.61 percentage point difference), gastroesophageal (2.13), colorectal (1.57), kidney or upper urinary tract (1.38), gynecologic (1.32), breast (0.59), and prostate cancer (0.57).
• The increased 1-year absolute risk for deep vein thrombosis (in percentage points) was highest for the bladder (a 4.67 percentage point difference), followed by gastroesophageal (2.19), colorectal (2.15), upper urinary tract (2.14), gynecologic (2.02), lung (1.40), breast (1.36), and prostate cancer (0.75).
• The temporal trends showed that the risk for pulmonary embolism and deep vein thrombosis peaked immediately after surgery and plateaued within 120 days for most cancers. At 30 days after surgery, the risk for pulmonary embolism following cancer surgery was 10- to 30-fold times higher than with no surgery for all cancers aside from breast cancer (hazard ratio, 5.18). The researchers observed a similar elevated risk for deep vein thrombosis 30 days following surgery.
• The risk for pulmonary embolism and deep vein thrombosis remained significant at 1 year for all cancer types, except prostate.

IN PRACTICE:

“The marked variation in the occurrence patterns of postoperative venous thromboembolic events indicates a need for a more tailored approach to prophylaxis,” the authors noted, advocating for individualized venous thromboembolism risk evaluation and prophylaxis regimens.

SOURCE:

This study, led by Johan Björklund, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

The information regarding treatments other than surgery that might be linked to an elevated risk for venous thromboembolism was not available. Additionally, changes in clinical practices and diagnostics over time could affect both the occurrence and detection of outcomes. Adoption of minimally invasive surgical techniques, increased use of thromboprophylaxis over time, improved diagnostic capabilities, and a trend toward operating on older patients with more comorbidities over time may have influenced outcomes.

DISCLOSURES: 

The work was funded by the Karolinska Institute and the Swedish Cancer Society. Two study authors reported receiving personal or consulting fees. Other authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued a reminder to healthcare professionals regarding the potential serious adverse reactions associated with Paxlovid when administered in combination with specific immunosuppressants.

These immunosuppressants, encompassing calcineurin inhibitors (tacrolimus and ciclosporin) and mTOR inhibitors (everolimus and sirolimus), possess a narrow safe dosage range. They are recognized for their role in diminishing the activity of the immune system and are typically prescribed for autoimmune conditions and organ transplant recipients.

The highlighted risk arises due to drug-drug interactions, which can compromise the body’s ability to eliminate these medicines effectively.

Paxlovid, also known as nirmatrelvir with ritonavir, is an antiviral medication used to treat COVID-19 in adults who do not require supplemental oxygen and who are at an increased risk of progressing to severe COVID-19. It should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.

Conditional marketing authorization for Paxlovid was granted across the European Union (EU) on January 28, 2022, and subsequently transitioned to full marketing authorization on February 24, 2023.

Developed by Pfizer, Paxlovid exhibited an 89% reduction in the risk for hospitalization or death among unvaccinated individuals in a phase 2-3 clinical trial. This led the National Institutes of Health to prioritize Paxlovid over other COVID-19 treatments. Subsequent real-world studies have affirmed its effectiveness, even among the vaccinated.

When combining Paxlovid with tacrolimus, ciclosporin, everolimus, or sirolimus, healthcare professionals need to actively monitor their blood levels. This proactive approach is essential to mitigate the risk for drug-drug interactions and potential serious reactions. They should collaborate with a multidisciplinary team of specialists to navigate the complexities of administering these medications concurrently.

Further, Paxlovid must not be coadministered with medications highly reliant on CYP3A liver enzymes for elimination, such as the immunosuppressant voclosporin. When administered together, there is a risk for these drugs interfering with each other’s metabolism, potentially leading to altered blood levels, reduced effectiveness, or an increased risk for adverse reactions.

After a thorough review, PRAC has highlighted potential serious adverse reactions, including fatal cases, due to drug interactions between Paxlovid and specified immunosuppressants. Thus, it issued a direct healthcare professional communication (DHPC) to emphasize the recognized risk for these interactions, as previously outlined in Paxlovid’s product information.

The DHPC for Paxlovid will undergo further evaluation by EMA’s Committee for Medicinal Products for Human Use and, upon adoption, will be disseminated to healthcare professionals. The communication plan will include publication on the DHPCs page and in national registers across EU Member States.

A version of this article appeared on Medscape.com.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued a reminder to healthcare professionals regarding the potential serious adverse reactions associated with Paxlovid when administered in combination with specific immunosuppressants.

These immunosuppressants, encompassing calcineurin inhibitors (tacrolimus and ciclosporin) and mTOR inhibitors (everolimus and sirolimus), possess a narrow safe dosage range. They are recognized for their role in diminishing the activity of the immune system and are typically prescribed for autoimmune conditions and organ transplant recipients.

The highlighted risk arises due to drug-drug interactions, which can compromise the body’s ability to eliminate these medicines effectively.

Paxlovid, also known as nirmatrelvir with ritonavir, is an antiviral medication used to treat COVID-19 in adults who do not require supplemental oxygen and who are at an increased risk of progressing to severe COVID-19. It should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.

Conditional marketing authorization for Paxlovid was granted across the European Union (EU) on January 28, 2022, and subsequently transitioned to full marketing authorization on February 24, 2023.

Developed by Pfizer, Paxlovid exhibited an 89% reduction in the risk for hospitalization or death among unvaccinated individuals in a phase 2-3 clinical trial. This led the National Institutes of Health to prioritize Paxlovid over other COVID-19 treatments. Subsequent real-world studies have affirmed its effectiveness, even among the vaccinated.

When combining Paxlovid with tacrolimus, ciclosporin, everolimus, or sirolimus, healthcare professionals need to actively monitor their blood levels. This proactive approach is essential to mitigate the risk for drug-drug interactions and potential serious reactions. They should collaborate with a multidisciplinary team of specialists to navigate the complexities of administering these medications concurrently.

Further, Paxlovid must not be coadministered with medications highly reliant on CYP3A liver enzymes for elimination, such as the immunosuppressant voclosporin. When administered together, there is a risk for these drugs interfering with each other’s metabolism, potentially leading to altered blood levels, reduced effectiveness, or an increased risk for adverse reactions.

After a thorough review, PRAC has highlighted potential serious adverse reactions, including fatal cases, due to drug interactions between Paxlovid and specified immunosuppressants. Thus, it issued a direct healthcare professional communication (DHPC) to emphasize the recognized risk for these interactions, as previously outlined in Paxlovid’s product information.

The DHPC for Paxlovid will undergo further evaluation by EMA’s Committee for Medicinal Products for Human Use and, upon adoption, will be disseminated to healthcare professionals. The communication plan will include publication on the DHPCs page and in national registers across EU Member States.

A version of this article appeared on Medscape.com.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued a reminder to healthcare professionals regarding the potential serious adverse reactions associated with Paxlovid when administered in combination with specific immunosuppressants.

These immunosuppressants, encompassing calcineurin inhibitors (tacrolimus and ciclosporin) and mTOR inhibitors (everolimus and sirolimus), possess a narrow safe dosage range. They are recognized for their role in diminishing the activity of the immune system and are typically prescribed for autoimmune conditions and organ transplant recipients.

The highlighted risk arises due to drug-drug interactions, which can compromise the body’s ability to eliminate these medicines effectively.

Paxlovid, also known as nirmatrelvir with ritonavir, is an antiviral medication used to treat COVID-19 in adults who do not require supplemental oxygen and who are at an increased risk of progressing to severe COVID-19. It should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.

Conditional marketing authorization for Paxlovid was granted across the European Union (EU) on January 28, 2022, and subsequently transitioned to full marketing authorization on February 24, 2023.

Developed by Pfizer, Paxlovid exhibited an 89% reduction in the risk for hospitalization or death among unvaccinated individuals in a phase 2-3 clinical trial. This led the National Institutes of Health to prioritize Paxlovid over other COVID-19 treatments. Subsequent real-world studies have affirmed its effectiveness, even among the vaccinated.

When combining Paxlovid with tacrolimus, ciclosporin, everolimus, or sirolimus, healthcare professionals need to actively monitor their blood levels. This proactive approach is essential to mitigate the risk for drug-drug interactions and potential serious reactions. They should collaborate with a multidisciplinary team of specialists to navigate the complexities of administering these medications concurrently.

Further, Paxlovid must not be coadministered with medications highly reliant on CYP3A liver enzymes for elimination, such as the immunosuppressant voclosporin. When administered together, there is a risk for these drugs interfering with each other’s metabolism, potentially leading to altered blood levels, reduced effectiveness, or an increased risk for adverse reactions.

After a thorough review, PRAC has highlighted potential serious adverse reactions, including fatal cases, due to drug interactions between Paxlovid and specified immunosuppressants. Thus, it issued a direct healthcare professional communication (DHPC) to emphasize the recognized risk for these interactions, as previously outlined in Paxlovid’s product information.

The DHPC for Paxlovid will undergo further evaluation by EMA’s Committee for Medicinal Products for Human Use and, upon adoption, will be disseminated to healthcare professionals. The communication plan will include publication on the DHPCs page and in national registers across EU Member States.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

A version of this article appeared on Medscape.com.

Obesity and diabetes increase the risk for complications following joint surgeries like total hip replacement, but can semaglutide and related drugs help?

The question has massive implications. More than 450,000 total hip arthroplasty (THA) procedures are performed annually in the United States, with the number expected to grow to 850,000 by 2030. Obesity is the leading reason for the increase. Semaglutide and other glucagon-like peptide 1 (GLP-1) receptor agonists can lead to dramatic and rapid weight loss, in addition to controlling diabetes, so researchers have wondered if the medications might improve outcomes in patients undergoing joint surgery. 

Two studies presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) sought to answer the question — but reached different conclusions. 

One study of THA patients taking semaglutide found fewer 90-day readmissions for diabetes and fewer prosthetic joint infections at the 2-year mark. Another found similar outcomes on the need for revision surgery, infections, and many other postsurgery metrics in people who took the GLP-1 receptor agonist and those who did not. Neither study had outside funding.
 

Study: Fewer Infections, Readmissions

For their study, Matthew Magruder, MD, a third-year orthopedic resident at Maimonides Medical Center’s Department of Orthopaedic Surgery and Rehabilitation in New York City, and his colleagues used an administrative claim database (PearlDiver) to identify THA patients who underwent the surgery between January 1, 2020, to October 31, 2021, when semaglutide was approved for the treatment of diabetes but not yet for obesity. The researchers found 9465 patients who had had a primary THA, of whom 1653 had received a prescription for semaglutide.

In total, 84.9% of those on semaglutide had obesity, as did 85.2% of those not on the medication.

Dr. Magruder’s group looked at medical complications such as deep vein thrombosis, myocardial infarction, hypoglycemia, and pulmonary embolism within 90 days of surgery, implant-related complications 2 years after the procedure, rates of readmission within 90 days of the procedure, length of stay in the hospital, and costs of care. 

They found that patients taking semaglutide were less likely to be readmitted to the hospital within 90 days of THA (6.2% vs 8.8%; P <.01) and experienced fewer joint infections (1.6% vs 2.9%; P <.01). No significant differences were found in the other outcomes.

Among the potential concerns involving the use of GLP-1 receptor agonists in patients undergoing surgery are their potential to cause hypoglycemia and the risk for aspiration during anesthesia. But those issues did not emerge in the analysis.

“We concluded that this was preliminary evidence that using semaglutide at the time of surgery was safe and potentially effective at reducing complications,” said Dr. Magruder, whose team published their findings in The Journal of Arthroplasty.
 

Study: Semaglutide Has No Effect on Postop Complications

In another study presented at the AAOS meeting, researchers found that rates of complications after THA were similar in patients with obesity who took semaglutide and those who did not. That information could be helpful for clinicians who have been reluctant to perform THA procedures in patients who also have had bariatric surgery, said Daniel E. Pereira, MD, a resident at Washington University in St. Louis and the first author of the study.

A recent retrospective review found that patients who had bariatric surgery have worse implant survivorship and higher rates of dislocation than do those with a naturally low or high body mass index (BMI). 

Pereira and his colleagues used a national database, with deidentified patient records, originally finding 42,410 patients. After matching, they evaluated 616 in each cohort: those who took semaglutide and those who did not. The average age was 62.7 years; average BMI was 35.5. 

Both groups had a similar risk for a range of complications including revision surgery, infection of the new joint and surgical site, opioid-related disorders, pulmonary embolism, deep vein thrombosis, and mortality. 

“We didn’t observe anything significant [between groups] in terms of the complications,” said David Momtaz, MPH, a fourth-year medical student at the University of Texas Health Science Center at San Antonio, who helped conduct the research. 

Dr. Pereira said he hoped the results would end the hesitation he observes, partly due to a lack of research, among some physicians about prescribing semaglutide before THA in appropriate patients. “Our preliminary evidence suggests there is no need to withhold THA in patients who successfully lost weight on semaglutide,” he said.
 

Expert Perspective: Not Unexpected

Peter Hanson, MD, an orthopedic surgeon and orthopedic medical director at Sharp Grossmont Hospital in La Mesa, California, who specializes in hip and knee replacement, said he was unsurprised by the findings. 

The patients he has observed on GLP-1 receptor agonists lose weight, he said, and a few even to the point of not needing a replacement. A recent study found that every 1% decrease in weight was associated with a 2% reduced risk for knee replacement in those with knee osteoarthritis or at risk for it, and every 1% drop in weight was associated with a 3% reduced risk for THA.

“I always advise my overweight patient to lose at least 30 pounds, even if their BMI is less than 40, like many in these studies,” Dr. Hanson said. If a patient’s doctor prescribes semaglutide or another GLP-1 receptor agonist, “I am very supportive, and we postpone surgery until the weight loss is maximized,” he added.

Drs. Magruder, Pereira, Momtaz, and Hanson have no disclosures.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

Dupuytren contracture can be treated with three invasive methods, but new data from a randomized controlled trial show better 2-year success rates for surgery than for needle fasciotomy and collagenase injection, despite retreatments.

The common hereditary disorder affects the palmar fascia in middle-aged and older people, more often men. The disease typically affects the ring and little fingers and they may curl toward the palm. The disease can’t be cured, but can be eased.

Findings of the study, led by Mikko Petteri Räisänen, MD, with the Department of Orthopedics, Traumatology and Hand Surgery, Kuopio University Hospital, Kuopio, and Tampere University, Tampere, both in Finland, were published online in Annals of Internal Medicine.
 

Initially, Outcomes Similar

Initially, in the multisite, randomized controlled, outcome assessor–blinded, superiority trial, the outcomes were similar among the treatments, the authors write, but at 2 years only the surgery group maintained the success rate.

The primary outcome was more than 50% contracture release and patients reaching the patient-acceptable symptom state. Secondary outcomes included hand function, pain, patient satisfaction, quality of life, finger flexion, residual contracture angle, risk for retreatment, and serious adverse events.

A total of 292 (97%) and 284 (94%) patients completed the 3-month and 2-year follow ups, respectively.

Success rates at 3 months were similar: 71% (95% CI, 62%-80%) for surgery; 73% (95% CI, 64%-82%) for needle fasciotomy; and 73% (95% CI, 64%-82%) for collagenase injection.

At 2 Years, Surgery Superior

At 2 years, however, surgery had superior success rates. Surgery success rates vs needle fasciotomy were 78% vs 50% (adjusted risk difference, 0.30; 95% CI, 0.17-0.43).

Surgery success rates vs collagenase injection were 78% vs 65% (aRD, 0.13; 95% CI, 0.01-0.26).

“Secondary analyses paralleled with the primary analysis,” the authors write.

Patients may choose surgery despite initial morbidity which includes potential time off work and higher costs than the other options if the long-term outcome is better, the authors write.

“Collagenase is likely a viable alternative to needle fasciotomy only if its costs are substantially reduced,” the authors write.

A strength of the study is its generalizability, as researchers recruited patients in a setting with universal healthcare where few people seek care outside public hospitals.

Another strength of the trial is that the blinded outcome assessors measured the contracture angles with the participant’s hand covered by a rubber glove and patients were instructed not to reveal their treatment group to the assessor.

Some Physicians Offer Noninvasive Treatments First

Family physician Shannon Scott, DO, medical director of the Midwestern University Multispecialty Clinic in Scottsdale, Arizona, treats many patients with the contracture.

In her practice, patients come to her seeking noninvasive options first. But if they are not satisfied with their hand function after noninvasive treatments such as osteopathic manipulative treatment, physical therapy, and a home exercise program, the next steps are the choices compared in the study. The findings of this randomized controlled trial, she says, will help her in counseling patients choosing among those options.

“What’s important for me as a family physician to understand is more about the path that led to this decision” to seek more invasive treatment and whether the patients in the study had first completed a course of noninvasive care, Dr. Scott says.

The condition, especially in the population most affected — older adults — can greatly affect activities of daily living, she noted. Patients may also often have other conditions contributing to the symptoms of Dupuytren contracture in the neck, arm, or shoulder, for instance, that limit range of motion or cause pain. Addressing those symptoms noninvasively may help relieve the contracture, she says.

Asking patients about their goals is essential, Dr. Scott says. “What patients are looking for is function and the definition for one patient may be different than the level of function for another. Many patients get to a desired level of function with nonsurgical options first.”

A First for the Comparison

Dawn LaPorte, MD, a hand surgeon at Johns Hopkins Medicine in Baltimore, Maryland, who also was not part of the study, says although surgery was thought to have better long-term success rates, this is the first time the data have been able to show that at 2 years.

She added that the results are particularly striking because the endpoint was a 50% release when surgeons hope for a complete release. Even with the 50% release outcome at 2 years, surgery had better success.

She noted that the authors plan to look at outcomes at 5 and 10 years, but, she says, “the fact that surgery is already significantly better at 2 years really says a lot.”

Treatments Have Tradeoffs

She says the conclusions may change the discussions physicians have with patients.

Collagenase injections are an office procedure, and there’s no anesthesia. “There’s usually no lost time from work, and they can use their hand pretty normally the following day,” Dr. LaPorte says. One downside, compared with surgery, is that there may be a more frequent recurrence rate. Patients may have a skin tear that usually heals over a couple of weeks, she added.

Additionally, “the collagenase drug is very expensive,” she notes, so preapproval is important so that the patient doesn’t have to pay out of pocket.

Needle fasciotomy can also be done in the office without anesthesia. There’s less time off work than with surgery.

“With both that and the injection, they should see release of the contracture right away,” Dr. LaPorte says, but the concern is a quicker recurrence rate.

While surgery isn’t a cure, she says, and there is a lower recurrence rate, it typically means time off work, anesthesia, and an incision to heal, and may mean postoperative therapy.

The study was funded by the Research Council of Finland. Disclosures are available with the full text.

Dr. LaPorte and Dr. Scott report no relevant financial relationships.

Dupuytren contracture can be treated with three invasive methods, but new data from a randomized controlled trial show better 2-year success rates for surgery than for needle fasciotomy and collagenase injection, despite retreatments.

The common hereditary disorder affects the palmar fascia in middle-aged and older people, more often men. The disease typically affects the ring and little fingers and they may curl toward the palm. The disease can’t be cured, but can be eased.

Findings of the study, led by Mikko Petteri Räisänen, MD, with the Department of Orthopedics, Traumatology and Hand Surgery, Kuopio University Hospital, Kuopio, and Tampere University, Tampere, both in Finland, were published online in Annals of Internal Medicine.
 

Initially, Outcomes Similar

Initially, in the multisite, randomized controlled, outcome assessor–blinded, superiority trial, the outcomes were similar among the treatments, the authors write, but at 2 years only the surgery group maintained the success rate.

The primary outcome was more than 50% contracture release and patients reaching the patient-acceptable symptom state. Secondary outcomes included hand function, pain, patient satisfaction, quality of life, finger flexion, residual contracture angle, risk for retreatment, and serious adverse events.

A total of 292 (97%) and 284 (94%) patients completed the 3-month and 2-year follow ups, respectively.

Success rates at 3 months were similar: 71% (95% CI, 62%-80%) for surgery; 73% (95% CI, 64%-82%) for needle fasciotomy; and 73% (95% CI, 64%-82%) for collagenase injection.

At 2 Years, Surgery Superior

At 2 years, however, surgery had superior success rates. Surgery success rates vs needle fasciotomy were 78% vs 50% (adjusted risk difference, 0.30; 95% CI, 0.17-0.43).

Surgery success rates vs collagenase injection were 78% vs 65% (aRD, 0.13; 95% CI, 0.01-0.26).

“Secondary analyses paralleled with the primary analysis,” the authors write.

Patients may choose surgery despite initial morbidity which includes potential time off work and higher costs than the other options if the long-term outcome is better, the authors write.

“Collagenase is likely a viable alternative to needle fasciotomy only if its costs are substantially reduced,” the authors write.

A strength of the study is its generalizability, as researchers recruited patients in a setting with universal healthcare where few people seek care outside public hospitals.

Another strength of the trial is that the blinded outcome assessors measured the contracture angles with the participant’s hand covered by a rubber glove and patients were instructed not to reveal their treatment group to the assessor.

Some Physicians Offer Noninvasive Treatments First

Family physician Shannon Scott, DO, medical director of the Midwestern University Multispecialty Clinic in Scottsdale, Arizona, treats many patients with the contracture.

In her practice, patients come to her seeking noninvasive options first. But if they are not satisfied with their hand function after noninvasive treatments such as osteopathic manipulative treatment, physical therapy, and a home exercise program, the next steps are the choices compared in the study. The findings of this randomized controlled trial, she says, will help her in counseling patients choosing among those options.

“What’s important for me as a family physician to understand is more about the path that led to this decision” to seek more invasive treatment and whether the patients in the study had first completed a course of noninvasive care, Dr. Scott says.

The condition, especially in the population most affected — older adults — can greatly affect activities of daily living, she noted. Patients may also often have other conditions contributing to the symptoms of Dupuytren contracture in the neck, arm, or shoulder, for instance, that limit range of motion or cause pain. Addressing those symptoms noninvasively may help relieve the contracture, she says.

Asking patients about their goals is essential, Dr. Scott says. “What patients are looking for is function and the definition for one patient may be different than the level of function for another. Many patients get to a desired level of function with nonsurgical options first.”

A First for the Comparison

Dawn LaPorte, MD, a hand surgeon at Johns Hopkins Medicine in Baltimore, Maryland, who also was not part of the study, says although surgery was thought to have better long-term success rates, this is the first time the data have been able to show that at 2 years.

She added that the results are particularly striking because the endpoint was a 50% release when surgeons hope for a complete release. Even with the 50% release outcome at 2 years, surgery had better success.

She noted that the authors plan to look at outcomes at 5 and 10 years, but, she says, “the fact that surgery is already significantly better at 2 years really says a lot.”

Treatments Have Tradeoffs

She says the conclusions may change the discussions physicians have with patients.

Collagenase injections are an office procedure, and there’s no anesthesia. “There’s usually no lost time from work, and they can use their hand pretty normally the following day,” Dr. LaPorte says. One downside, compared with surgery, is that there may be a more frequent recurrence rate. Patients may have a skin tear that usually heals over a couple of weeks, she added.

Additionally, “the collagenase drug is very expensive,” she notes, so preapproval is important so that the patient doesn’t have to pay out of pocket.

Needle fasciotomy can also be done in the office without anesthesia. There’s less time off work than with surgery.

“With both that and the injection, they should see release of the contracture right away,” Dr. LaPorte says, but the concern is a quicker recurrence rate.

While surgery isn’t a cure, she says, and there is a lower recurrence rate, it typically means time off work, anesthesia, and an incision to heal, and may mean postoperative therapy.

The study was funded by the Research Council of Finland. Disclosures are available with the full text.

Dr. LaPorte and Dr. Scott report no relevant financial relationships.

Dupuytren contracture can be treated with three invasive methods, but new data from a randomized controlled trial show better 2-year success rates for surgery than for needle fasciotomy and collagenase injection, despite retreatments.

The common hereditary disorder affects the palmar fascia in middle-aged and older people, more often men. The disease typically affects the ring and little fingers and they may curl toward the palm. The disease can’t be cured, but can be eased.

Findings of the study, led by Mikko Petteri Räisänen, MD, with the Department of Orthopedics, Traumatology and Hand Surgery, Kuopio University Hospital, Kuopio, and Tampere University, Tampere, both in Finland, were published online in Annals of Internal Medicine.
 

Initially, Outcomes Similar

Initially, in the multisite, randomized controlled, outcome assessor–blinded, superiority trial, the outcomes were similar among the treatments, the authors write, but at 2 years only the surgery group maintained the success rate.

The primary outcome was more than 50% contracture release and patients reaching the patient-acceptable symptom state. Secondary outcomes included hand function, pain, patient satisfaction, quality of life, finger flexion, residual contracture angle, risk for retreatment, and serious adverse events.

A total of 292 (97%) and 284 (94%) patients completed the 3-month and 2-year follow ups, respectively.

Success rates at 3 months were similar: 71% (95% CI, 62%-80%) for surgery; 73% (95% CI, 64%-82%) for needle fasciotomy; and 73% (95% CI, 64%-82%) for collagenase injection.

At 2 Years, Surgery Superior

At 2 years, however, surgery had superior success rates. Surgery success rates vs needle fasciotomy were 78% vs 50% (adjusted risk difference, 0.30; 95% CI, 0.17-0.43).

Surgery success rates vs collagenase injection were 78% vs 65% (aRD, 0.13; 95% CI, 0.01-0.26).

“Secondary analyses paralleled with the primary analysis,” the authors write.

Patients may choose surgery despite initial morbidity which includes potential time off work and higher costs than the other options if the long-term outcome is better, the authors write.

“Collagenase is likely a viable alternative to needle fasciotomy only if its costs are substantially reduced,” the authors write.

A strength of the study is its generalizability, as researchers recruited patients in a setting with universal healthcare where few people seek care outside public hospitals.

Another strength of the trial is that the blinded outcome assessors measured the contracture angles with the participant’s hand covered by a rubber glove and patients were instructed not to reveal their treatment group to the assessor.

Some Physicians Offer Noninvasive Treatments First

Family physician Shannon Scott, DO, medical director of the Midwestern University Multispecialty Clinic in Scottsdale, Arizona, treats many patients with the contracture.

In her practice, patients come to her seeking noninvasive options first. But if they are not satisfied with their hand function after noninvasive treatments such as osteopathic manipulative treatment, physical therapy, and a home exercise program, the next steps are the choices compared in the study. The findings of this randomized controlled trial, she says, will help her in counseling patients choosing among those options.

“What’s important for me as a family physician to understand is more about the path that led to this decision” to seek more invasive treatment and whether the patients in the study had first completed a course of noninvasive care, Dr. Scott says.

The condition, especially in the population most affected — older adults — can greatly affect activities of daily living, she noted. Patients may also often have other conditions contributing to the symptoms of Dupuytren contracture in the neck, arm, or shoulder, for instance, that limit range of motion or cause pain. Addressing those symptoms noninvasively may help relieve the contracture, she says.

Asking patients about their goals is essential, Dr. Scott says. “What patients are looking for is function and the definition for one patient may be different than the level of function for another. Many patients get to a desired level of function with nonsurgical options first.”

A First for the Comparison

Dawn LaPorte, MD, a hand surgeon at Johns Hopkins Medicine in Baltimore, Maryland, who also was not part of the study, says although surgery was thought to have better long-term success rates, this is the first time the data have been able to show that at 2 years.

She added that the results are particularly striking because the endpoint was a 50% release when surgeons hope for a complete release. Even with the 50% release outcome at 2 years, surgery had better success.

She noted that the authors plan to look at outcomes at 5 and 10 years, but, she says, “the fact that surgery is already significantly better at 2 years really says a lot.”

Treatments Have Tradeoffs

She says the conclusions may change the discussions physicians have with patients.

Collagenase injections are an office procedure, and there’s no anesthesia. “There’s usually no lost time from work, and they can use their hand pretty normally the following day,” Dr. LaPorte says. One downside, compared with surgery, is that there may be a more frequent recurrence rate. Patients may have a skin tear that usually heals over a couple of weeks, she added.

Additionally, “the collagenase drug is very expensive,” she notes, so preapproval is important so that the patient doesn’t have to pay out of pocket.

Needle fasciotomy can also be done in the office without anesthesia. There’s less time off work than with surgery.

“With both that and the injection, they should see release of the contracture right away,” Dr. LaPorte says, but the concern is a quicker recurrence rate.

While surgery isn’t a cure, she says, and there is a lower recurrence rate, it typically means time off work, anesthesia, and an incision to heal, and may mean postoperative therapy.

The study was funded by the Research Council of Finland. Disclosures are available with the full text.

Dr. LaPorte and Dr. Scott report no relevant financial relationships.

TOPLINE:

Adolescents with severe obesity who undergo bariatric surgery may have a continuing need for mental health treatment and an increased risk for alcohol use disorder after the procedure.

METHODOLOGY:

• Researchers evaluated the long-term effects of bariatric surgery on the mental health of 1554 adolescents (75% women) with severe obesity who underwent bariatric surgery in Sweden between 2007 and 2017.
• At the time of surgery, the mean age was 19.0 years, and the mean body mass index was 43.7.
• A general population reference group of 15,540 adolescents was created by matching 10 comparators each to adolescents in the surgery group by age, sex, and country of residence.
• Information on psychiatric healthcare use and filled psychiatric drug prescriptions for 5 years before surgery and the first 10 years after surgery were obtained from national registers.
• The number of visits for self-harm and substance use disorder and the number of filled prescriptions for any psychiatric drug, antidepressants, and anxiolytics were other outcomes of interest.

TAKEAWAY:

• At 5 years before surgery, the prevalence of psychiatric healthcare visits (prevalence difference [Δ], 3.7%) and of psychiatric drug use (Δ, 6.2%) was higher in the surgery vs reference group.
• The preoperative trajectories continued and grew post-surgery, with the differences in psychiatric healthcare visits (Δ, ~12%) and psychiatric drug use (Δ, 20.4%) between the groups peaking at 9 and 10 years post surgery, respectively.
• A low prevalence of healthcare visits for substance use disorder in both groups grew to about 5% of adolescents in the surgery group after 10 years, driven primarily by alcohol use, compared with about 1% of adolescents in the reference group (Δ, 4.3%).
• Surgery is an obesity treatment, leading to sustainable weight loss, cardiometabolic health, and physical quality of life, but mental health improvements cannot be expected at the group level.

IN PRACTICE:

“Adolescent patients should be informed of the increased risk for alcohol use disorder and that they might continue needing mental health treatment,” the authors wrote.

SOURCE:

Gustaf Bruze, PhD, from the Department of Medicine, Clinical Epidemiology Division, Karolinska Institutet, Solna, and Kajsa Jarvholm, PhD, from the Department of Psychology, Lund University, Lund, Sweden, led this study, which was published online in The Lancet Child & Adolescent Health.

LIMITATIONS:

The findings may have limited generalizability to other settings, as the study was performed in Sweden with a predominantly White population undergoing Roux-en-Y gastric bypass in a universally accessible healthcare system. Moreover, there was a shortage of nonsurgically treated adolescents with severe obesity for comparison. Patients undergoing surgery may have easier access to healthcare than the general population, which could account for an increase in healthcare visits.

DISCLOSURES:

This study was supported by the Swedish Research Council and the Swedish Research Council for Health, Working Life, and Welfare. Two authors were the current or previous director of the Scandinavian Obesity Surgery Registry. Several authors declared receiving personal fees, participating in advisory boards and educational activities, and having other ties with Ethicon Johnson & Johnson, and Novo Nordisk.

A version of this article appeared on Medscape.com.

TOPLINE:

Adolescents with severe obesity who undergo bariatric surgery may have a continuing need for mental health treatment and an increased risk for alcohol use disorder after the procedure.

METHODOLOGY:

• Researchers evaluated the long-term effects of bariatric surgery on the mental health of 1554 adolescents (75% women) with severe obesity who underwent bariatric surgery in Sweden between 2007 and 2017.
• At the time of surgery, the mean age was 19.0 years, and the mean body mass index was 43.7.
• A general population reference group of 15,540 adolescents was created by matching 10 comparators each to adolescents in the surgery group by age, sex, and country of residence.
• Information on psychiatric healthcare use and filled psychiatric drug prescriptions for 5 years before surgery and the first 10 years after surgery were obtained from national registers.
• The number of visits for self-harm and substance use disorder and the number of filled prescriptions for any psychiatric drug, antidepressants, and anxiolytics were other outcomes of interest.

TAKEAWAY:

• At 5 years before surgery, the prevalence of psychiatric healthcare visits (prevalence difference [Δ], 3.7%) and of psychiatric drug use (Δ, 6.2%) was higher in the surgery vs reference group.
• The preoperative trajectories continued and grew post-surgery, with the differences in psychiatric healthcare visits (Δ, ~12%) and psychiatric drug use (Δ, 20.4%) between the groups peaking at 9 and 10 years post surgery, respectively.
• A low prevalence of healthcare visits for substance use disorder in both groups grew to about 5% of adolescents in the surgery group after 10 years, driven primarily by alcohol use, compared with about 1% of adolescents in the reference group (Δ, 4.3%).
• Surgery is an obesity treatment, leading to sustainable weight loss, cardiometabolic health, and physical quality of life, but mental health improvements cannot be expected at the group level.

IN PRACTICE:

“Adolescent patients should be informed of the increased risk for alcohol use disorder and that they might continue needing mental health treatment,” the authors wrote.

SOURCE:

Gustaf Bruze, PhD, from the Department of Medicine, Clinical Epidemiology Division, Karolinska Institutet, Solna, and Kajsa Jarvholm, PhD, from the Department of Psychology, Lund University, Lund, Sweden, led this study, which was published online in The Lancet Child & Adolescent Health.

LIMITATIONS:

The findings may have limited generalizability to other settings, as the study was performed in Sweden with a predominantly White population undergoing Roux-en-Y gastric bypass in a universally accessible healthcare system. Moreover, there was a shortage of nonsurgically treated adolescents with severe obesity for comparison. Patients undergoing surgery may have easier access to healthcare than the general population, which could account for an increase in healthcare visits.

DISCLOSURES:

This study was supported by the Swedish Research Council and the Swedish Research Council for Health, Working Life, and Welfare. Two authors were the current or previous director of the Scandinavian Obesity Surgery Registry. Several authors declared receiving personal fees, participating in advisory boards and educational activities, and having other ties with Ethicon Johnson & Johnson, and Novo Nordisk.

A version of this article appeared on Medscape.com.

TOPLINE:

Adolescents with severe obesity who undergo bariatric surgery may have a continuing need for mental health treatment and an increased risk for alcohol use disorder after the procedure.

METHODOLOGY:

• Researchers evaluated the long-term effects of bariatric surgery on the mental health of 1554 adolescents (75% women) with severe obesity who underwent bariatric surgery in Sweden between 2007 and 2017.
• At the time of surgery, the mean age was 19.0 years, and the mean body mass index was 43.7.
• A general population reference group of 15,540 adolescents was created by matching 10 comparators each to adolescents in the surgery group by age, sex, and country of residence.
• Information on psychiatric healthcare use and filled psychiatric drug prescriptions for 5 years before surgery and the first 10 years after surgery were obtained from national registers.
• The number of visits for self-harm and substance use disorder and the number of filled prescriptions for any psychiatric drug, antidepressants, and anxiolytics were other outcomes of interest.

TAKEAWAY:

• At 5 years before surgery, the prevalence of psychiatric healthcare visits (prevalence difference [Δ], 3.7%) and of psychiatric drug use (Δ, 6.2%) was higher in the surgery vs reference group.
• The preoperative trajectories continued and grew post-surgery, with the differences in psychiatric healthcare visits (Δ, ~12%) and psychiatric drug use (Δ, 20.4%) between the groups peaking at 9 and 10 years post surgery, respectively.
• A low prevalence of healthcare visits for substance use disorder in both groups grew to about 5% of adolescents in the surgery group after 10 years, driven primarily by alcohol use, compared with about 1% of adolescents in the reference group (Δ, 4.3%).
• Surgery is an obesity treatment, leading to sustainable weight loss, cardiometabolic health, and physical quality of life, but mental health improvements cannot be expected at the group level.

IN PRACTICE:

“Adolescent patients should be informed of the increased risk for alcohol use disorder and that they might continue needing mental health treatment,” the authors wrote.

SOURCE:

Gustaf Bruze, PhD, from the Department of Medicine, Clinical Epidemiology Division, Karolinska Institutet, Solna, and Kajsa Jarvholm, PhD, from the Department of Psychology, Lund University, Lund, Sweden, led this study, which was published online in The Lancet Child & Adolescent Health.

LIMITATIONS:

The findings may have limited generalizability to other settings, as the study was performed in Sweden with a predominantly White population undergoing Roux-en-Y gastric bypass in a universally accessible healthcare system. Moreover, there was a shortage of nonsurgically treated adolescents with severe obesity for comparison. Patients undergoing surgery may have easier access to healthcare than the general population, which could account for an increase in healthcare visits.

DISCLOSURES:

This study was supported by the Swedish Research Council and the Swedish Research Council for Health, Working Life, and Welfare. Two authors were the current or previous director of the Scandinavian Obesity Surgery Registry. Several authors declared receiving personal fees, participating in advisory boards and educational activities, and having other ties with Ethicon Johnson & Johnson, and Novo Nordisk.

A version of this article appeared on Medscape.com.