Is Atopic Dermatitis Linked to Cognitive Impairment Symptoms in Children?

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Thu, 03/07/2024 - 12:49

 

TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

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TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

 

TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

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Study Finds No Increased Cancer Risk With Spironolactone

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Changed
Thu, 03/07/2024 - 11:52

 

TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

  • Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
  • The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
  • Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

  • A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
  • After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
  • The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

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TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

  • Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
  • The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
  • Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

  • A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
  • After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
  • The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Women with daily exposure to spironolactone for dermatologic conditions showed no higher risk of developing breast or gynecologic cancer than that of unexposed women.

METHODOLOGY:

  • Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
  • The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
  • Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.

TAKEAWAY:

  • A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
  • After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
  • The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).

IN PRACTICE:

“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.

SOURCE:

The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.

LIMITATIONS:

The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.

A version of this article appeared on Medscape.com.

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Medicare Pay Bump Provision in Federal Bill Falls Short, Doc Groups Say

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Thu, 03/07/2024 - 11:20

 

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

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Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

 

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

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High-Fiber Gut Microbe Makeover Aids Weight Loss

Article Type
Changed
Thu, 03/07/2024 - 15:03

 

TOPLINE:

A fiber supplement also found in beans and other foods may lead to weight loss and improved insulin sensitivity in people with excess body weight, partly due to changes in the gut microbiota.

METHODOLOGY:

  • In animal studies, resistant starch (RS), a kind of dietary fiber, has shown a potential to reduce body fat along with other metabolic benefits, but human dietary studies of RS have been inconsistent, especially with a high-fat diet.
  • Researchers conducted a crossover, randomized trial to study the effect of RS as a dietary supplement on 37 individuals with overweight or obesity (average age, 33.43 years; 15 women; body mass index > 24 or higher waist circumference).
  • Participants were fed a similar background diet and either 40 g of RS (high-amylose maize) or an energy-matched placebo starch daily for 8 weeks and then switched between the two in a separate 8-week period.
  • The primary outcome was body weight, and the secondary outcomes were visceral and subcutaneous fat mass, waist circumference, lipid profiles, insulin sensitivity, metabolome, and gut microbiome.
  • RS’s impact on gut microbiota composition and function was assessed with metagenomics and metabolomics, and RS-modified gut microbiota’s effect on host body fat and glucose was confirmed by transferring from select average participants to mice.

TAKEAWAY:

  • Participants showed a mean weight loss of 2.8 kg after consuming RS for 8 weeks (P < .001), but there was no significant change in body weight in those on placebo starch.
  • RS improved insulin sensitivity in people to a greater extent than placebo starch (P = .025) and showed a greater reduction in fat mass, waist circumference, and other obesity-related outcomes.
  • The abundance in the gut of the microbe Bifidobacterium adolescentis increased significantly following RS intervention, an increase that exhibited a strong correlation with decreased BMI, suggesting a role of RS in reducing obesity.
  • The levels of pro-inflammatory cytokines, such as serum tumor necrosis factor-alpha and interleukin-1 beta, were significantly lower in participants who consumed RS than in those who had placebo starch.

IN PRACTICE:

“Our study provided an effective dietary recommendation using RS as a supplement (40 g/d with a balanced background diet containing 25%-30% fat), which may help to achieve significant weight loss,” the authors wrote.

SOURCE:

This study was led and corresponded by Huating Li, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China, and University of Hong Kong, Pok Fu Lam, and published online in Nature Metabolism.

LIMITATIONS:

This study was limited by the small sample size and stringent inclusion criteria for participants. The use of database-driven and taxane-based methodology might have led to difficult-to-classify sequences being discarded and strain-level functional diversity being overlooked. The authors also acknowledged the need to validate the findings of this study in larger and more diverse cohorts.

 

 

DISCLOSURES:

This work was supported by the National Key Research and Development Program of China, Shanghai Municipal Key Clinical Specialty, National Natural Science Foundation of China, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

A fiber supplement also found in beans and other foods may lead to weight loss and improved insulin sensitivity in people with excess body weight, partly due to changes in the gut microbiota.

METHODOLOGY:

  • In animal studies, resistant starch (RS), a kind of dietary fiber, has shown a potential to reduce body fat along with other metabolic benefits, but human dietary studies of RS have been inconsistent, especially with a high-fat diet.
  • Researchers conducted a crossover, randomized trial to study the effect of RS as a dietary supplement on 37 individuals with overweight or obesity (average age, 33.43 years; 15 women; body mass index > 24 or higher waist circumference).
  • Participants were fed a similar background diet and either 40 g of RS (high-amylose maize) or an energy-matched placebo starch daily for 8 weeks and then switched between the two in a separate 8-week period.
  • The primary outcome was body weight, and the secondary outcomes were visceral and subcutaneous fat mass, waist circumference, lipid profiles, insulin sensitivity, metabolome, and gut microbiome.
  • RS’s impact on gut microbiota composition and function was assessed with metagenomics and metabolomics, and RS-modified gut microbiota’s effect on host body fat and glucose was confirmed by transferring from select average participants to mice.

TAKEAWAY:

  • Participants showed a mean weight loss of 2.8 kg after consuming RS for 8 weeks (P < .001), but there was no significant change in body weight in those on placebo starch.
  • RS improved insulin sensitivity in people to a greater extent than placebo starch (P = .025) and showed a greater reduction in fat mass, waist circumference, and other obesity-related outcomes.
  • The abundance in the gut of the microbe Bifidobacterium adolescentis increased significantly following RS intervention, an increase that exhibited a strong correlation with decreased BMI, suggesting a role of RS in reducing obesity.
  • The levels of pro-inflammatory cytokines, such as serum tumor necrosis factor-alpha and interleukin-1 beta, were significantly lower in participants who consumed RS than in those who had placebo starch.

IN PRACTICE:

“Our study provided an effective dietary recommendation using RS as a supplement (40 g/d with a balanced background diet containing 25%-30% fat), which may help to achieve significant weight loss,” the authors wrote.

SOURCE:

This study was led and corresponded by Huating Li, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China, and University of Hong Kong, Pok Fu Lam, and published online in Nature Metabolism.

LIMITATIONS:

This study was limited by the small sample size and stringent inclusion criteria for participants. The use of database-driven and taxane-based methodology might have led to difficult-to-classify sequences being discarded and strain-level functional diversity being overlooked. The authors also acknowledged the need to validate the findings of this study in larger and more diverse cohorts.

 

 

DISCLOSURES:

This work was supported by the National Key Research and Development Program of China, Shanghai Municipal Key Clinical Specialty, National Natural Science Foundation of China, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

A fiber supplement also found in beans and other foods may lead to weight loss and improved insulin sensitivity in people with excess body weight, partly due to changes in the gut microbiota.

METHODOLOGY:

  • In animal studies, resistant starch (RS), a kind of dietary fiber, has shown a potential to reduce body fat along with other metabolic benefits, but human dietary studies of RS have been inconsistent, especially with a high-fat diet.
  • Researchers conducted a crossover, randomized trial to study the effect of RS as a dietary supplement on 37 individuals with overweight or obesity (average age, 33.43 years; 15 women; body mass index > 24 or higher waist circumference).
  • Participants were fed a similar background diet and either 40 g of RS (high-amylose maize) or an energy-matched placebo starch daily for 8 weeks and then switched between the two in a separate 8-week period.
  • The primary outcome was body weight, and the secondary outcomes were visceral and subcutaneous fat mass, waist circumference, lipid profiles, insulin sensitivity, metabolome, and gut microbiome.
  • RS’s impact on gut microbiota composition and function was assessed with metagenomics and metabolomics, and RS-modified gut microbiota’s effect on host body fat and glucose was confirmed by transferring from select average participants to mice.

TAKEAWAY:

  • Participants showed a mean weight loss of 2.8 kg after consuming RS for 8 weeks (P < .001), but there was no significant change in body weight in those on placebo starch.
  • RS improved insulin sensitivity in people to a greater extent than placebo starch (P = .025) and showed a greater reduction in fat mass, waist circumference, and other obesity-related outcomes.
  • The abundance in the gut of the microbe Bifidobacterium adolescentis increased significantly following RS intervention, an increase that exhibited a strong correlation with decreased BMI, suggesting a role of RS in reducing obesity.
  • The levels of pro-inflammatory cytokines, such as serum tumor necrosis factor-alpha and interleukin-1 beta, were significantly lower in participants who consumed RS than in those who had placebo starch.

IN PRACTICE:

“Our study provided an effective dietary recommendation using RS as a supplement (40 g/d with a balanced background diet containing 25%-30% fat), which may help to achieve significant weight loss,” the authors wrote.

SOURCE:

This study was led and corresponded by Huating Li, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China, and University of Hong Kong, Pok Fu Lam, and published online in Nature Metabolism.

LIMITATIONS:

This study was limited by the small sample size and stringent inclusion criteria for participants. The use of database-driven and taxane-based methodology might have led to difficult-to-classify sequences being discarded and strain-level functional diversity being overlooked. The authors also acknowledged the need to validate the findings of this study in larger and more diverse cohorts.

 

 

DISCLOSURES:

This work was supported by the National Key Research and Development Program of China, Shanghai Municipal Key Clinical Specialty, National Natural Science Foundation of China, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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Sleep Apnea Hard on the Brain

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Symptoms of sleep apnea, including snorting, gasping, or paused breathing during sleep, are associated with a significantly greater risk for problems with cognition and memory, results from a large study showed.

Data from a representative sample of US adults show that those who reported sleep apnea symptoms were about 50% more likely to also report cognitive issues vs their counterparts without such symptoms.

“For clinicians, these findings suggest a potential benefit of considering sleep apnea as a possible contributing or exacerbating factor in individuals experiencing memory or cognitive problems. This could prompt further evaluation for sleep apnea, particularly in at-risk individuals,” study investigator Dominique Low, MD, MPH, department of neurology, Boston Medical Center, told this news organization.

The findings will be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting on April 17.
 

Need to Raise Awareness

The findings are based on 4257 adults who participated in the 2017-2018 National Health and Nutrition Examination Survey and completed questionnaires covering sleep, memory, cognition, and decision-making abilities.

Those who reported snorting, gasping, or breathing pauses during sleep were categorized as experiencing sleep apnea symptoms. Those who reported memory trouble, periods of confusion, difficulty concentrating, or decision-making problems were classified as having memory or cognitive symptoms.

Overall, 1079 participants reported symptoms of sleep apnea. Compared with people without sleep apnea, those with symptoms were more likely to have cognitive problems (33% vs 20%) and have greater odds of having memory or cognitive symptoms, even after adjusting for age, gender, race, and education (adjusted odds ratio, 2.02; P < .001).

“While the study did not establish a cause-and-effect relationship, the findings suggest the importance of raising awareness about the potential link between sleep and cognitive function. Early identification and treatment may improve overall health and potentially lead to a better quality of life,” Dr. Low said.

Limitations of the study include self-reported data on sleep apnea symptoms and cognitive issues sourced from one survey.
 

Consistent Data

Reached for comment, Matthew Pase, PhD, with the Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia, said the results are similar to earlier work that found a link between obstructive sleep apnea (OSA) and cognition.

For example, in a recent study, the presence of mild to severe OSA, identified using overnight polysomnography in five community-based cohorts with more than 5900 adults, was associated with poorer cognitive test performance, Dr. Pase told this news organization.

“These and other results underscore the importance of healthy sleep for optimal brain health. Future research is needed to test if treating OSA and other sleep disorders can reduce the risk of cognitive impairment,” Dr. Pase said.

Yet, in their latest statement on the topic, reported by this news organization, the US Preventive Services Task Force concluded there remains insufficient evidence to weigh the balance of benefits and harms of screening for OSA among asymptomatic adults and those with unrecognized symptoms.

The study had no specific funding. Dr. Low and Dr. Pase had no relevant disclosures.

A version of this article appeared on Medscape.com.

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Symptoms of sleep apnea, including snorting, gasping, or paused breathing during sleep, are associated with a significantly greater risk for problems with cognition and memory, results from a large study showed.

Data from a representative sample of US adults show that those who reported sleep apnea symptoms were about 50% more likely to also report cognitive issues vs their counterparts without such symptoms.

“For clinicians, these findings suggest a potential benefit of considering sleep apnea as a possible contributing or exacerbating factor in individuals experiencing memory or cognitive problems. This could prompt further evaluation for sleep apnea, particularly in at-risk individuals,” study investigator Dominique Low, MD, MPH, department of neurology, Boston Medical Center, told this news organization.

The findings will be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting on April 17.
 

Need to Raise Awareness

The findings are based on 4257 adults who participated in the 2017-2018 National Health and Nutrition Examination Survey and completed questionnaires covering sleep, memory, cognition, and decision-making abilities.

Those who reported snorting, gasping, or breathing pauses during sleep were categorized as experiencing sleep apnea symptoms. Those who reported memory trouble, periods of confusion, difficulty concentrating, or decision-making problems were classified as having memory or cognitive symptoms.

Overall, 1079 participants reported symptoms of sleep apnea. Compared with people without sleep apnea, those with symptoms were more likely to have cognitive problems (33% vs 20%) and have greater odds of having memory or cognitive symptoms, even after adjusting for age, gender, race, and education (adjusted odds ratio, 2.02; P < .001).

“While the study did not establish a cause-and-effect relationship, the findings suggest the importance of raising awareness about the potential link between sleep and cognitive function. Early identification and treatment may improve overall health and potentially lead to a better quality of life,” Dr. Low said.

Limitations of the study include self-reported data on sleep apnea symptoms and cognitive issues sourced from one survey.
 

Consistent Data

Reached for comment, Matthew Pase, PhD, with the Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia, said the results are similar to earlier work that found a link between obstructive sleep apnea (OSA) and cognition.

For example, in a recent study, the presence of mild to severe OSA, identified using overnight polysomnography in five community-based cohorts with more than 5900 adults, was associated with poorer cognitive test performance, Dr. Pase told this news organization.

“These and other results underscore the importance of healthy sleep for optimal brain health. Future research is needed to test if treating OSA and other sleep disorders can reduce the risk of cognitive impairment,” Dr. Pase said.

Yet, in their latest statement on the topic, reported by this news organization, the US Preventive Services Task Force concluded there remains insufficient evidence to weigh the balance of benefits and harms of screening for OSA among asymptomatic adults and those with unrecognized symptoms.

The study had no specific funding. Dr. Low and Dr. Pase had no relevant disclosures.

A version of this article appeared on Medscape.com.

 



Symptoms of sleep apnea, including snorting, gasping, or paused breathing during sleep, are associated with a significantly greater risk for problems with cognition and memory, results from a large study showed.

Data from a representative sample of US adults show that those who reported sleep apnea symptoms were about 50% more likely to also report cognitive issues vs their counterparts without such symptoms.

“For clinicians, these findings suggest a potential benefit of considering sleep apnea as a possible contributing or exacerbating factor in individuals experiencing memory or cognitive problems. This could prompt further evaluation for sleep apnea, particularly in at-risk individuals,” study investigator Dominique Low, MD, MPH, department of neurology, Boston Medical Center, told this news organization.

The findings will be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting on April 17.
 

Need to Raise Awareness

The findings are based on 4257 adults who participated in the 2017-2018 National Health and Nutrition Examination Survey and completed questionnaires covering sleep, memory, cognition, and decision-making abilities.

Those who reported snorting, gasping, or breathing pauses during sleep were categorized as experiencing sleep apnea symptoms. Those who reported memory trouble, periods of confusion, difficulty concentrating, or decision-making problems were classified as having memory or cognitive symptoms.

Overall, 1079 participants reported symptoms of sleep apnea. Compared with people without sleep apnea, those with symptoms were more likely to have cognitive problems (33% vs 20%) and have greater odds of having memory or cognitive symptoms, even after adjusting for age, gender, race, and education (adjusted odds ratio, 2.02; P < .001).

“While the study did not establish a cause-and-effect relationship, the findings suggest the importance of raising awareness about the potential link between sleep and cognitive function. Early identification and treatment may improve overall health and potentially lead to a better quality of life,” Dr. Low said.

Limitations of the study include self-reported data on sleep apnea symptoms and cognitive issues sourced from one survey.
 

Consistent Data

Reached for comment, Matthew Pase, PhD, with the Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia, said the results are similar to earlier work that found a link between obstructive sleep apnea (OSA) and cognition.

For example, in a recent study, the presence of mild to severe OSA, identified using overnight polysomnography in five community-based cohorts with more than 5900 adults, was associated with poorer cognitive test performance, Dr. Pase told this news organization.

“These and other results underscore the importance of healthy sleep for optimal brain health. Future research is needed to test if treating OSA and other sleep disorders can reduce the risk of cognitive impairment,” Dr. Pase said.

Yet, in their latest statement on the topic, reported by this news organization, the US Preventive Services Task Force concluded there remains insufficient evidence to weigh the balance of benefits and harms of screening for OSA among asymptomatic adults and those with unrecognized symptoms.

The study had no specific funding. Dr. Low and Dr. Pase had no relevant disclosures.

A version of this article appeared on Medscape.com.

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AGA Research Foundation Memorial and Honorary Gifts: A Special Tribute

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Thu, 03/07/2024 - 09:36

 

Did you know you can honor a family member, friend, or colleague whose life has been touched by GI research through a gift to the AGA Research Foundation? Your gift will honor a loved one or yourself and support the AGA Research Awards Program, while giving you a tax benefit.

  • Giving now or later. Any charitable gift can be made in honor or memory of someone.
  • A gift today. An outright gift will help fund the AGA Research Awards Program. Your gift will assist in furthering basic digestive disease research which can ultimately advance research into all digestive diseases. The financial benefits include an income tax deduction and possible elimination of capital gains tax. A cash gift of $5,000 or more qualifies for membership in the AGA Supporter Circle.
  • A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly a percentage of your estate will pass to the AGA Research Foundation in honor of your loved one. A gift in your will of $50,000 or more qualifies for membership in the AGA Legacy Society, which recognizes the foundation’s most generous individual donors.
  • Named commentary section funds. You can support a commentary section in a specific AGA journal to honor or memorialize a loved one. This can be established with a gift of $100,000 over the course of 5 years or through an estate gift. The AGA Institute Publications Committee will work with you to provide name recognition for the commentary section in a specific AGA journal for five years. All content and editing will be conducted by the editorial board of the journal.

Your Next Step

An honorary gift is a wonderful way to acknowledge someone’s vision for the future. To learn more about ways to recognize your honoree, visit our website at www.foundation.gastro.org.

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Did you know you can honor a family member, friend, or colleague whose life has been touched by GI research through a gift to the AGA Research Foundation? Your gift will honor a loved one or yourself and support the AGA Research Awards Program, while giving you a tax benefit.

  • Giving now or later. Any charitable gift can be made in honor or memory of someone.
  • A gift today. An outright gift will help fund the AGA Research Awards Program. Your gift will assist in furthering basic digestive disease research which can ultimately advance research into all digestive diseases. The financial benefits include an income tax deduction and possible elimination of capital gains tax. A cash gift of $5,000 or more qualifies for membership in the AGA Supporter Circle.
  • A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly a percentage of your estate will pass to the AGA Research Foundation in honor of your loved one. A gift in your will of $50,000 or more qualifies for membership in the AGA Legacy Society, which recognizes the foundation’s most generous individual donors.
  • Named commentary section funds. You can support a commentary section in a specific AGA journal to honor or memorialize a loved one. This can be established with a gift of $100,000 over the course of 5 years or through an estate gift. The AGA Institute Publications Committee will work with you to provide name recognition for the commentary section in a specific AGA journal for five years. All content and editing will be conducted by the editorial board of the journal.

Your Next Step

An honorary gift is a wonderful way to acknowledge someone’s vision for the future. To learn more about ways to recognize your honoree, visit our website at www.foundation.gastro.org.

 

Did you know you can honor a family member, friend, or colleague whose life has been touched by GI research through a gift to the AGA Research Foundation? Your gift will honor a loved one or yourself and support the AGA Research Awards Program, while giving you a tax benefit.

  • Giving now or later. Any charitable gift can be made in honor or memory of someone.
  • A gift today. An outright gift will help fund the AGA Research Awards Program. Your gift will assist in furthering basic digestive disease research which can ultimately advance research into all digestive diseases. The financial benefits include an income tax deduction and possible elimination of capital gains tax. A cash gift of $5,000 or more qualifies for membership in the AGA Supporter Circle.
  • A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly a percentage of your estate will pass to the AGA Research Foundation in honor of your loved one. A gift in your will of $50,000 or more qualifies for membership in the AGA Legacy Society, which recognizes the foundation’s most generous individual donors.
  • Named commentary section funds. You can support a commentary section in a specific AGA journal to honor or memorialize a loved one. This can be established with a gift of $100,000 over the course of 5 years or through an estate gift. The AGA Institute Publications Committee will work with you to provide name recognition for the commentary section in a specific AGA journal for five years. All content and editing will be conducted by the editorial board of the journal.

Your Next Step

An honorary gift is a wonderful way to acknowledge someone’s vision for the future. To learn more about ways to recognize your honoree, visit our website at www.foundation.gastro.org.

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No Increase in Autoimmune Risk Seen With GLP-1 Receptor Agonists and SGLT2 Inhibitors

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Thu, 03/07/2024 - 10:02

 

TOPLINE: 

In patients with type 2 diabetes, there was no difference in risk of developing autoimmune disease if prescribed glucagon-like peptide 1 receptor agonists (GLP-1-RAs), sodium-glucose cotransporter-2 (SGLT2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors.

METHODOLOGY:

  • The effect of GLP-1-RAs and SGLT2 inhibitors on autoimmune rheumatic disease (ARD) is understudied, though previous case reports and one study have hinted at increased risk.
  • Researchers used administrative health data from 2014 to 2021 to identify 34,400 patients prescribed GLP-1-RAs and 83,500 patients prescribed SGLT2 inhibitors.
  • They compared patients prescribed GLP-1-RAs or SGLT2 inhibitors with 68,400 patients prescribed DPP-4 inhibitors, which previous studies suggest do not increase ARD risk.
  • Primary outcome was ARD incidence, defined by diagnostic codes.

TAKEAWAY:

  • There were no significant differences in incident ARDs between the three groups.
  • Mean follow-up time was 0.88-1.53 years.
  • The hazard ratio (HR) for developing ARDs with GLP-1-RAs exposure was 0.93 (95% CI, 0.66-1.30) compared with DPP-4 inhibitors.
  • The HR for developing ARDs with SGLT2 inhibitor exposure was 0.97 (95% CI, 0.76-1.24).

IN PRACTICE: 

“Extended longitudinal data are needed to assess risk and benefit with longer-term exposure,” the authors wrote.

SOURCE: 

First author Derin Karacabeyli, MD, of the University of British Columbia, Vancouver, Canada, presented the study in abstract form at the Canadian Rheumatology Association (CRA) 2024 Annual Meeting in Winnipeg on February 29.

LIMITATIONS: 

The study was observational, which could have some residual or unmeasured confounding of data. The researchers relied on diagnostic codes and the average follow-up time was short. 

DISCLOSURES:

The study was funded by the Canadian Institutes of Health Research. The authors had no disclosures.

A version of this article appeared on Medscape.com.

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TOPLINE: 

In patients with type 2 diabetes, there was no difference in risk of developing autoimmune disease if prescribed glucagon-like peptide 1 receptor agonists (GLP-1-RAs), sodium-glucose cotransporter-2 (SGLT2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors.

METHODOLOGY:

  • The effect of GLP-1-RAs and SGLT2 inhibitors on autoimmune rheumatic disease (ARD) is understudied, though previous case reports and one study have hinted at increased risk.
  • Researchers used administrative health data from 2014 to 2021 to identify 34,400 patients prescribed GLP-1-RAs and 83,500 patients prescribed SGLT2 inhibitors.
  • They compared patients prescribed GLP-1-RAs or SGLT2 inhibitors with 68,400 patients prescribed DPP-4 inhibitors, which previous studies suggest do not increase ARD risk.
  • Primary outcome was ARD incidence, defined by diagnostic codes.

TAKEAWAY:

  • There were no significant differences in incident ARDs between the three groups.
  • Mean follow-up time was 0.88-1.53 years.
  • The hazard ratio (HR) for developing ARDs with GLP-1-RAs exposure was 0.93 (95% CI, 0.66-1.30) compared with DPP-4 inhibitors.
  • The HR for developing ARDs with SGLT2 inhibitor exposure was 0.97 (95% CI, 0.76-1.24).

IN PRACTICE: 

“Extended longitudinal data are needed to assess risk and benefit with longer-term exposure,” the authors wrote.

SOURCE: 

First author Derin Karacabeyli, MD, of the University of British Columbia, Vancouver, Canada, presented the study in abstract form at the Canadian Rheumatology Association (CRA) 2024 Annual Meeting in Winnipeg on February 29.

LIMITATIONS: 

The study was observational, which could have some residual or unmeasured confounding of data. The researchers relied on diagnostic codes and the average follow-up time was short. 

DISCLOSURES:

The study was funded by the Canadian Institutes of Health Research. The authors had no disclosures.

A version of this article appeared on Medscape.com.

 

TOPLINE: 

In patients with type 2 diabetes, there was no difference in risk of developing autoimmune disease if prescribed glucagon-like peptide 1 receptor agonists (GLP-1-RAs), sodium-glucose cotransporter-2 (SGLT2) inhibitors, or dipeptidyl peptidase-4 (DPP-4) inhibitors.

METHODOLOGY:

  • The effect of GLP-1-RAs and SGLT2 inhibitors on autoimmune rheumatic disease (ARD) is understudied, though previous case reports and one study have hinted at increased risk.
  • Researchers used administrative health data from 2014 to 2021 to identify 34,400 patients prescribed GLP-1-RAs and 83,500 patients prescribed SGLT2 inhibitors.
  • They compared patients prescribed GLP-1-RAs or SGLT2 inhibitors with 68,400 patients prescribed DPP-4 inhibitors, which previous studies suggest do not increase ARD risk.
  • Primary outcome was ARD incidence, defined by diagnostic codes.

TAKEAWAY:

  • There were no significant differences in incident ARDs between the three groups.
  • Mean follow-up time was 0.88-1.53 years.
  • The hazard ratio (HR) for developing ARDs with GLP-1-RAs exposure was 0.93 (95% CI, 0.66-1.30) compared with DPP-4 inhibitors.
  • The HR for developing ARDs with SGLT2 inhibitor exposure was 0.97 (95% CI, 0.76-1.24).

IN PRACTICE: 

“Extended longitudinal data are needed to assess risk and benefit with longer-term exposure,” the authors wrote.

SOURCE: 

First author Derin Karacabeyli, MD, of the University of British Columbia, Vancouver, Canada, presented the study in abstract form at the Canadian Rheumatology Association (CRA) 2024 Annual Meeting in Winnipeg on February 29.

LIMITATIONS: 

The study was observational, which could have some residual or unmeasured confounding of data. The researchers relied on diagnostic codes and the average follow-up time was short. 

DISCLOSURES:

The study was funded by the Canadian Institutes of Health Research. The authors had no disclosures.

A version of this article appeared on Medscape.com.

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Move Over Sealants, Silver Diamine Fluoride Might Take Your Place

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Wed, 03/06/2024 - 18:02

 

TOPLINE:

Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics

METHODOLOGY:

  • School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
  • Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
  • The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
  • Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
  • Researchers compared the rates of new cavities and fillings between the two groups over time.

TAKEAWAY:

  • Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
  • The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
  • The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
  • Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).

IN PRACTICE:

“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”

SOURCE:

The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.

LIMITATIONS:

The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition. 

DISCLOSURES:

Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.

A version of this article appeared on Medscape.com.

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TOPLINE:

Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics

METHODOLOGY:

  • School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
  • Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
  • The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
  • Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
  • Researchers compared the rates of new cavities and fillings between the two groups over time.

TAKEAWAY:

  • Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
  • The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
  • The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
  • Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).

IN PRACTICE:

“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”

SOURCE:

The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.

LIMITATIONS:

The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition. 

DISCLOSURES:

Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics

METHODOLOGY:

  • School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
  • Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
  • The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
  • Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
  • Researchers compared the rates of new cavities and fillings between the two groups over time.

TAKEAWAY:

  • Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
  • The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
  • The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
  • Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).

IN PRACTICE:

“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”

SOURCE:

The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.

LIMITATIONS:

The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition. 

DISCLOSURES:

Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.

A version of this article appeared on Medscape.com.

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First Denosumab Biosimilar Approved in Two Different Formulations

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Thu, 03/07/2024 - 06:41

 



The US Food and Drug Administration (FDA) has approved the first biosimilar to denosumab, denosumab-bddz (Wyost/Jubbonti).

The biosimilar was also granted interchangeability status, which allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Sandoz announced the approval on March 5, 2024. The lower dosage of denosumab-bddz, marketed as Jubbonti, was also approved by Health Canada in February. 

The FDA approval “is based on robust clinical studies and accompanied by labeling with safety warnings,” according to the press release. Like the reference products Prolia and Xgeva, denosumab-bddz is approved for two indications at separate doses.

Wyost (120-mg/1.7-mL injection) is approved to:

  • Prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
  • Treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
  • Treat hypercalcemia of cancer that is refractory to bisphosphonate therapy

Jubbonti (60-mg/1-mL injection) is approved to:

  • Treat postmenopausal women with osteoporosis who are at high risk for fracture
  • Increase bone mass in men with osteoporosis who are at high risk for fracture
  • Treat glucocorticoid-induced osteoporosis in men and women who are at high risk for fracture
  • Increase bone mass in men who are at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • Increase bone mass in women who are at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer.

Both doses are contraindicated for hypocalcemia and known clinically significant hypersensitivity to denosumab products. Exposure to denosumab products during pregnancy can cause fetal harm, so women of reproductive potential should be advised to use effective contraception during therapy and for at least 5 months after the last dose of denosumab-bddz.

Sandoz did not provide information on US launch details, citing “ongoing patent litigation around these products.”

A version of this article appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has approved the first biosimilar to denosumab, denosumab-bddz (Wyost/Jubbonti).

The biosimilar was also granted interchangeability status, which allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Sandoz announced the approval on March 5, 2024. The lower dosage of denosumab-bddz, marketed as Jubbonti, was also approved by Health Canada in February. 

The FDA approval “is based on robust clinical studies and accompanied by labeling with safety warnings,” according to the press release. Like the reference products Prolia and Xgeva, denosumab-bddz is approved for two indications at separate doses.

Wyost (120-mg/1.7-mL injection) is approved to:

  • Prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
  • Treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
  • Treat hypercalcemia of cancer that is refractory to bisphosphonate therapy

Jubbonti (60-mg/1-mL injection) is approved to:

  • Treat postmenopausal women with osteoporosis who are at high risk for fracture
  • Increase bone mass in men with osteoporosis who are at high risk for fracture
  • Treat glucocorticoid-induced osteoporosis in men and women who are at high risk for fracture
  • Increase bone mass in men who are at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • Increase bone mass in women who are at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer.

Both doses are contraindicated for hypocalcemia and known clinically significant hypersensitivity to denosumab products. Exposure to denosumab products during pregnancy can cause fetal harm, so women of reproductive potential should be advised to use effective contraception during therapy and for at least 5 months after the last dose of denosumab-bddz.

Sandoz did not provide information on US launch details, citing “ongoing patent litigation around these products.”

A version of this article appeared on Medscape.com.

 



The US Food and Drug Administration (FDA) has approved the first biosimilar to denosumab, denosumab-bddz (Wyost/Jubbonti).

The biosimilar was also granted interchangeability status, which allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Sandoz announced the approval on March 5, 2024. The lower dosage of denosumab-bddz, marketed as Jubbonti, was also approved by Health Canada in February. 

The FDA approval “is based on robust clinical studies and accompanied by labeling with safety warnings,” according to the press release. Like the reference products Prolia and Xgeva, denosumab-bddz is approved for two indications at separate doses.

Wyost (120-mg/1.7-mL injection) is approved to:

  • Prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
  • Treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
  • Treat hypercalcemia of cancer that is refractory to bisphosphonate therapy

Jubbonti (60-mg/1-mL injection) is approved to:

  • Treat postmenopausal women with osteoporosis who are at high risk for fracture
  • Increase bone mass in men with osteoporosis who are at high risk for fracture
  • Treat glucocorticoid-induced osteoporosis in men and women who are at high risk for fracture
  • Increase bone mass in men who are at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • Increase bone mass in women who are at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer.

Both doses are contraindicated for hypocalcemia and known clinically significant hypersensitivity to denosumab products. Exposure to denosumab products during pregnancy can cause fetal harm, so women of reproductive potential should be advised to use effective contraception during therapy and for at least 5 months after the last dose of denosumab-bddz.

Sandoz did not provide information on US launch details, citing “ongoing patent litigation around these products.”

A version of this article appeared on Medscape.com.

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AI-Identified Vascular Healing Can Predict Clinical Relapse in Ulcerative Colitis

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Changed
Wed, 03/06/2024 - 17:40

 

An artificial intelligence (AI)–assisted image-enhanced endoscopy system accurately assessed vascular healing and predicted long-term clinical relapse in patients with ulcerative colitis (UC), according to data from the study of a novel investigational tool. 

Clinical relapse was predicted in 3% of patients identified as having vascular healing in all segments compared with 23.9% in those with vascular activity (ie, one or more segments were active), reported Yasuharu Maeda, MD, gastroenterologist from Showa University Northern Yokohama Hospital, Digestive Disease Center, Yokohama, Japan.

In patients with a Mayo Endoscopic Score (MES) ≤ 1, the clinical relapse rate was 3% and 18.6% in the vascular healing and vascular active groups, respectively, he said. 

Endoscopic remission is a crucial treat-to-target goal in patients with UC, and image-enhanced endoscopy is spreading in routine practice as a way to detect inflammation and to predict outcomes, Dr. Maeda said. 

“Image-enhanced vascular findings lead to a stronger correlation with histological activities and long-term prognosis compared with white light endoscopy assessment,” he explained. “It also means that assessment can be done on-site without biopsy, pathologist effort, and associated costs; however, specialist training is required to achieve a high accuracy in outputs.” 

Dr. Maeda presented the data (Abstract OP16) at the annual congress of the European Crohn’s and Colitis Organisation.

Stratifying the Relapse Risk

Dr. Maeda and colleagues developed a novel AI-based narrow-band imaging system, training it by using 8853 images from 167 patients with UC. 

The AI system, EndoBRAIN-UC (Cybernet System Corp, Tokyo), is in use and currently adapted for only one endoscope, the Endocyto CFH290EC (Olympus EMEA, Tokyo), but for the purpose of this study, it was trained on images from five different scopes. 

“By combining narrow-band imaging and AI, we developed a system where we can differentiate between vascular activity and vascular healing. This allows us to predict relapse,” Dr. Maeda said.

In an open-label, prospective cohort study, they tested the system with the aim of assessing the efficacy of AI-identified vascular healing to stratify the relapse risk in 100 patients showing clinical remission of UC (ie, partial MES ≤ 1). 

Patient characteristics were similar between both groups with an average disease duration of 10 years. 

In the vascular healing group (n = 33), the average age was 52 years, 20% were men, 58% had extensive colitis, and 52% had a MES score of 0.

In the vascular active group (n = 67), the average age was 56 years, 32% were men, 61% had extensive colitis, and 25% had a MES score of 0.

Colonoscopy was performed using the AI system to identify mucosa as healing or active for six colorectal segments of each patient. The MES and histologic assessment for these segments were also recorded. Patients were then followed for up to 12 months and assessed for clinical relapse.

The clinical relapse rate was higher in the vascular active group than in the vascular healing group as identified by AI. 

“We only evaluated the diagnostic output of the AI but obtained white light endoscopies and biopsies for contrast studies,” Dr. Maeda noted.

They also looked at whether the endoscopist’s level of experience (ie, trainee or expert) was important but found that clinical relapse predictive values were independent of the endoscopist’s experience. 

 

 

Still in the Early Stages

AI-assisted colonoscopy work is still at an early stage , said session co-moderator, Monika Ferlitsch, MD, head of Internal Medicine Department II, gastroenterology and hepatology, Evangelical Hospital, in Vienna, Austria. 

We now have initial results, but “I suspect it will take 10-20 years for implementation into routine clinical practice,” she said. 

The best outcome for our patients is to be able to predict response to therapy and recurrence rates, “and we see this is possible now with AI. But of course, we need more clinical data to support it,” Dr. Ferlitsch said.

Dr. Maeda and Dr. Ferlitsch have declared no financial disclosures.

A version of this article appeared on Medscape.com.

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An artificial intelligence (AI)–assisted image-enhanced endoscopy system accurately assessed vascular healing and predicted long-term clinical relapse in patients with ulcerative colitis (UC), according to data from the study of a novel investigational tool. 

Clinical relapse was predicted in 3% of patients identified as having vascular healing in all segments compared with 23.9% in those with vascular activity (ie, one or more segments were active), reported Yasuharu Maeda, MD, gastroenterologist from Showa University Northern Yokohama Hospital, Digestive Disease Center, Yokohama, Japan.

In patients with a Mayo Endoscopic Score (MES) ≤ 1, the clinical relapse rate was 3% and 18.6% in the vascular healing and vascular active groups, respectively, he said. 

Endoscopic remission is a crucial treat-to-target goal in patients with UC, and image-enhanced endoscopy is spreading in routine practice as a way to detect inflammation and to predict outcomes, Dr. Maeda said. 

“Image-enhanced vascular findings lead to a stronger correlation with histological activities and long-term prognosis compared with white light endoscopy assessment,” he explained. “It also means that assessment can be done on-site without biopsy, pathologist effort, and associated costs; however, specialist training is required to achieve a high accuracy in outputs.” 

Dr. Maeda presented the data (Abstract OP16) at the annual congress of the European Crohn’s and Colitis Organisation.

Stratifying the Relapse Risk

Dr. Maeda and colleagues developed a novel AI-based narrow-band imaging system, training it by using 8853 images from 167 patients with UC. 

The AI system, EndoBRAIN-UC (Cybernet System Corp, Tokyo), is in use and currently adapted for only one endoscope, the Endocyto CFH290EC (Olympus EMEA, Tokyo), but for the purpose of this study, it was trained on images from five different scopes. 

“By combining narrow-band imaging and AI, we developed a system where we can differentiate between vascular activity and vascular healing. This allows us to predict relapse,” Dr. Maeda said.

In an open-label, prospective cohort study, they tested the system with the aim of assessing the efficacy of AI-identified vascular healing to stratify the relapse risk in 100 patients showing clinical remission of UC (ie, partial MES ≤ 1). 

Patient characteristics were similar between both groups with an average disease duration of 10 years. 

In the vascular healing group (n = 33), the average age was 52 years, 20% were men, 58% had extensive colitis, and 52% had a MES score of 0.

In the vascular active group (n = 67), the average age was 56 years, 32% were men, 61% had extensive colitis, and 25% had a MES score of 0.

Colonoscopy was performed using the AI system to identify mucosa as healing or active for six colorectal segments of each patient. The MES and histologic assessment for these segments were also recorded. Patients were then followed for up to 12 months and assessed for clinical relapse.

The clinical relapse rate was higher in the vascular active group than in the vascular healing group as identified by AI. 

“We only evaluated the diagnostic output of the AI but obtained white light endoscopies and biopsies for contrast studies,” Dr. Maeda noted.

They also looked at whether the endoscopist’s level of experience (ie, trainee or expert) was important but found that clinical relapse predictive values were independent of the endoscopist’s experience. 

 

 

Still in the Early Stages

AI-assisted colonoscopy work is still at an early stage , said session co-moderator, Monika Ferlitsch, MD, head of Internal Medicine Department II, gastroenterology and hepatology, Evangelical Hospital, in Vienna, Austria. 

We now have initial results, but “I suspect it will take 10-20 years for implementation into routine clinical practice,” she said. 

The best outcome for our patients is to be able to predict response to therapy and recurrence rates, “and we see this is possible now with AI. But of course, we need more clinical data to support it,” Dr. Ferlitsch said.

Dr. Maeda and Dr. Ferlitsch have declared no financial disclosures.

A version of this article appeared on Medscape.com.

 

An artificial intelligence (AI)–assisted image-enhanced endoscopy system accurately assessed vascular healing and predicted long-term clinical relapse in patients with ulcerative colitis (UC), according to data from the study of a novel investigational tool. 

Clinical relapse was predicted in 3% of patients identified as having vascular healing in all segments compared with 23.9% in those with vascular activity (ie, one or more segments were active), reported Yasuharu Maeda, MD, gastroenterologist from Showa University Northern Yokohama Hospital, Digestive Disease Center, Yokohama, Japan.

In patients with a Mayo Endoscopic Score (MES) ≤ 1, the clinical relapse rate was 3% and 18.6% in the vascular healing and vascular active groups, respectively, he said. 

Endoscopic remission is a crucial treat-to-target goal in patients with UC, and image-enhanced endoscopy is spreading in routine practice as a way to detect inflammation and to predict outcomes, Dr. Maeda said. 

“Image-enhanced vascular findings lead to a stronger correlation with histological activities and long-term prognosis compared with white light endoscopy assessment,” he explained. “It also means that assessment can be done on-site without biopsy, pathologist effort, and associated costs; however, specialist training is required to achieve a high accuracy in outputs.” 

Dr. Maeda presented the data (Abstract OP16) at the annual congress of the European Crohn’s and Colitis Organisation.

Stratifying the Relapse Risk

Dr. Maeda and colleagues developed a novel AI-based narrow-band imaging system, training it by using 8853 images from 167 patients with UC. 

The AI system, EndoBRAIN-UC (Cybernet System Corp, Tokyo), is in use and currently adapted for only one endoscope, the Endocyto CFH290EC (Olympus EMEA, Tokyo), but for the purpose of this study, it was trained on images from five different scopes. 

“By combining narrow-band imaging and AI, we developed a system where we can differentiate between vascular activity and vascular healing. This allows us to predict relapse,” Dr. Maeda said.

In an open-label, prospective cohort study, they tested the system with the aim of assessing the efficacy of AI-identified vascular healing to stratify the relapse risk in 100 patients showing clinical remission of UC (ie, partial MES ≤ 1). 

Patient characteristics were similar between both groups with an average disease duration of 10 years. 

In the vascular healing group (n = 33), the average age was 52 years, 20% were men, 58% had extensive colitis, and 52% had a MES score of 0.

In the vascular active group (n = 67), the average age was 56 years, 32% were men, 61% had extensive colitis, and 25% had a MES score of 0.

Colonoscopy was performed using the AI system to identify mucosa as healing or active for six colorectal segments of each patient. The MES and histologic assessment for these segments were also recorded. Patients were then followed for up to 12 months and assessed for clinical relapse.

The clinical relapse rate was higher in the vascular active group than in the vascular healing group as identified by AI. 

“We only evaluated the diagnostic output of the AI but obtained white light endoscopies and biopsies for contrast studies,” Dr. Maeda noted.

They also looked at whether the endoscopist’s level of experience (ie, trainee or expert) was important but found that clinical relapse predictive values were independent of the endoscopist’s experience. 

 

 

Still in the Early Stages

AI-assisted colonoscopy work is still at an early stage , said session co-moderator, Monika Ferlitsch, MD, head of Internal Medicine Department II, gastroenterology and hepatology, Evangelical Hospital, in Vienna, Austria. 

We now have initial results, but “I suspect it will take 10-20 years for implementation into routine clinical practice,” she said. 

The best outcome for our patients is to be able to predict response to therapy and recurrence rates, “and we see this is possible now with AI. But of course, we need more clinical data to support it,” Dr. Ferlitsch said.

Dr. Maeda and Dr. Ferlitsch have declared no financial disclosures.

A version of this article appeared on Medscape.com.

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