Diabetes Hub contains news and clinical review articles for physicians seeking the most up-to-date information on the rapidly evolving options for treating and preventing Type 2 Diabetes in at-risk patients. The Diabetes Hub is powered by Frontline Medical Communications.

Theme
medstat_dbh
Top Sections
Video
dbh
Main menu
Diabetes Hub
Unpublish
Specialty Focus
Diabetes
Hypertension
Altmetric
DSM Affiliated
Display in offset block
Enable Disqus
Display Author and Disclosure Link
Publication Type
Clinical
Slot System
Top 25
Disable Sticky Ads
Disable Ad Block Mitigation
Featured Buckets Admin
Show Ads on this Publication's Homepage
Consolidated Pub
Show Article Page Numbers on TOC
Use larger logo size
Off
publication_blueconic_enabled
Off
Show More Destinations Menu
Disable Adhesion on Publication
Off
Restore Menu Label on Mobile Navigation
Disable Facebook Pixel from Publication
Exclude this publication from publication selection on articles and quiz
Challenge Center
Disable Inline Native ads

Diabetes in seniors increases dementia risk

Article Type
Changed
Tue, 05/03/2022 - 15:38
Display Headline
Diabetes in seniors increases dementia risk

A diagnosis of diabetes in later life is associated with an increased risk of dementia, particularly in individuals with preexisting vascular disease.

A population-based matched cohort study in 225,045 seniors newly diagnosed with diabetes and 668,070 without found a 16% higher risk of dementia among those with diabetes.

Ingram Pub.l

The association remained after adjustment for hypertension, coronary artery disease, cardiovascular disease, peripheral vascular disease and chronic kidney disease.

There is a growing body of evidence pointing to a link between diabetes and dementia, with their shared cardiometabolic risk factors suggesting dementia may be yet another vascular complication of diabetes, wrote Dr. Nisha Nigil Haroon of the University of Toronto.

“We hypothesized that exposure to even short-term hyperglycemia in late life can trigger or accelerate cognitive decline and therefore that incident diabetes is a risk factor for dementia after accounting for differences in cardiovascular disease and other common risk factors,” wrote Dr. Haroon and her colleagues.

The risk of dementia was slightly higher in men with diabetes (hazard ratio, 1.20; 95% confidence interval, 1.17-1.22) than in women (HR 1.14; 95% CI, 1.12–1.16) compared with healthy controls, according to a paper published online July 27 in Diabetes Care.

Previous cardiovascular disease doubled the risk of dementia in patients with diabetes, while hospitalization or emergency department visits for hypoglycaemia were associated with a 73% increase in dementia risk. Patients with chronic kidney disease or prior vascular disease were at increased dementia risk (Diabetes Care 2015, July 27 [doi: 10.2337/dc15-0491]).

There was a 1% increase in the risk of dementia per year following the diagnosis of diabetes, such that patients who had had diabetes for 10 years had a nearly 30% higher incidence of dementia. The median age of the cohort was 73 years.

“This is of serious concern given the aging population, increasing prevalence of diabetes, and the limited effective treatment currently available for dementia,” the authors wrote.

They also found that many commonly used vascular and antidiabetic medications did not impact the risk of dementia, except statins and calcium-channel blockers.

“Although such treatments have been postulated to be protective against dementia, numerous trials have failed to identify any beneficial role of glucose-, blood pressure–, or lipid-lowering agents on cognitive decline, as suggested by previous observational data,” they noted.

Insulin use was associated with a 74% greater risk of developing dementia.

Recent immigrants or South Asian or Chinese ethnicity had a reduced risk of dementia, and hypertension also seemed to lower the risk by 5%.

The authors found that individuals with diabetes living in the lowest income areas were 17% more likely to develop dementia than were those in the wealthiest area.

“Impaired health literacy, poorer self-management, and adverse health behaviors, such as smoking, have been linked to low income and could explain this association,” reported Dr. Haroon and her coauthors.

The Canadian Institutes of Health Research, the Heart and Stroke Foundation of Ontario, the Canadian Institutes of Health Research, the University of Toronto, and the Ontario Ministry of Health and Long-Term Care supported the study. One author reported an unrestricted grant from Amgen, but there were no other conflicts of interest declared.

References

Click for Credit Link
Author and Disclosure Information

Publications
Topics
Legacy Keywords
Diabetes, dementia
Click for Credit Link
Click for Credit Link
Author and Disclosure Information

Author and Disclosure Information

A diagnosis of diabetes in later life is associated with an increased risk of dementia, particularly in individuals with preexisting vascular disease.

A population-based matched cohort study in 225,045 seniors newly diagnosed with diabetes and 668,070 without found a 16% higher risk of dementia among those with diabetes.

Ingram Pub.l

The association remained after adjustment for hypertension, coronary artery disease, cardiovascular disease, peripheral vascular disease and chronic kidney disease.

There is a growing body of evidence pointing to a link between diabetes and dementia, with their shared cardiometabolic risk factors suggesting dementia may be yet another vascular complication of diabetes, wrote Dr. Nisha Nigil Haroon of the University of Toronto.

“We hypothesized that exposure to even short-term hyperglycemia in late life can trigger or accelerate cognitive decline and therefore that incident diabetes is a risk factor for dementia after accounting for differences in cardiovascular disease and other common risk factors,” wrote Dr. Haroon and her colleagues.

The risk of dementia was slightly higher in men with diabetes (hazard ratio, 1.20; 95% confidence interval, 1.17-1.22) than in women (HR 1.14; 95% CI, 1.12–1.16) compared with healthy controls, according to a paper published online July 27 in Diabetes Care.

Previous cardiovascular disease doubled the risk of dementia in patients with diabetes, while hospitalization or emergency department visits for hypoglycaemia were associated with a 73% increase in dementia risk. Patients with chronic kidney disease or prior vascular disease were at increased dementia risk (Diabetes Care 2015, July 27 [doi: 10.2337/dc15-0491]).

There was a 1% increase in the risk of dementia per year following the diagnosis of diabetes, such that patients who had had diabetes for 10 years had a nearly 30% higher incidence of dementia. The median age of the cohort was 73 years.

“This is of serious concern given the aging population, increasing prevalence of diabetes, and the limited effective treatment currently available for dementia,” the authors wrote.

They also found that many commonly used vascular and antidiabetic medications did not impact the risk of dementia, except statins and calcium-channel blockers.

“Although such treatments have been postulated to be protective against dementia, numerous trials have failed to identify any beneficial role of glucose-, blood pressure–, or lipid-lowering agents on cognitive decline, as suggested by previous observational data,” they noted.

Insulin use was associated with a 74% greater risk of developing dementia.

Recent immigrants or South Asian or Chinese ethnicity had a reduced risk of dementia, and hypertension also seemed to lower the risk by 5%.

The authors found that individuals with diabetes living in the lowest income areas were 17% more likely to develop dementia than were those in the wealthiest area.

“Impaired health literacy, poorer self-management, and adverse health behaviors, such as smoking, have been linked to low income and could explain this association,” reported Dr. Haroon and her coauthors.

The Canadian Institutes of Health Research, the Heart and Stroke Foundation of Ontario, the Canadian Institutes of Health Research, the University of Toronto, and the Ontario Ministry of Health and Long-Term Care supported the study. One author reported an unrestricted grant from Amgen, but there were no other conflicts of interest declared.

A diagnosis of diabetes in later life is associated with an increased risk of dementia, particularly in individuals with preexisting vascular disease.

A population-based matched cohort study in 225,045 seniors newly diagnosed with diabetes and 668,070 without found a 16% higher risk of dementia among those with diabetes.

Ingram Pub.l

The association remained after adjustment for hypertension, coronary artery disease, cardiovascular disease, peripheral vascular disease and chronic kidney disease.

There is a growing body of evidence pointing to a link between diabetes and dementia, with their shared cardiometabolic risk factors suggesting dementia may be yet another vascular complication of diabetes, wrote Dr. Nisha Nigil Haroon of the University of Toronto.

“We hypothesized that exposure to even short-term hyperglycemia in late life can trigger or accelerate cognitive decline and therefore that incident diabetes is a risk factor for dementia after accounting for differences in cardiovascular disease and other common risk factors,” wrote Dr. Haroon and her colleagues.

The risk of dementia was slightly higher in men with diabetes (hazard ratio, 1.20; 95% confidence interval, 1.17-1.22) than in women (HR 1.14; 95% CI, 1.12–1.16) compared with healthy controls, according to a paper published online July 27 in Diabetes Care.

Previous cardiovascular disease doubled the risk of dementia in patients with diabetes, while hospitalization or emergency department visits for hypoglycaemia were associated with a 73% increase in dementia risk. Patients with chronic kidney disease or prior vascular disease were at increased dementia risk (Diabetes Care 2015, July 27 [doi: 10.2337/dc15-0491]).

There was a 1% increase in the risk of dementia per year following the diagnosis of diabetes, such that patients who had had diabetes for 10 years had a nearly 30% higher incidence of dementia. The median age of the cohort was 73 years.

“This is of serious concern given the aging population, increasing prevalence of diabetes, and the limited effective treatment currently available for dementia,” the authors wrote.

They also found that many commonly used vascular and antidiabetic medications did not impact the risk of dementia, except statins and calcium-channel blockers.

“Although such treatments have been postulated to be protective against dementia, numerous trials have failed to identify any beneficial role of glucose-, blood pressure–, or lipid-lowering agents on cognitive decline, as suggested by previous observational data,” they noted.

Insulin use was associated with a 74% greater risk of developing dementia.

Recent immigrants or South Asian or Chinese ethnicity had a reduced risk of dementia, and hypertension also seemed to lower the risk by 5%.

The authors found that individuals with diabetes living in the lowest income areas were 17% more likely to develop dementia than were those in the wealthiest area.

“Impaired health literacy, poorer self-management, and adverse health behaviors, such as smoking, have been linked to low income and could explain this association,” reported Dr. Haroon and her coauthors.

The Canadian Institutes of Health Research, the Heart and Stroke Foundation of Ontario, the Canadian Institutes of Health Research, the University of Toronto, and the Ontario Ministry of Health and Long-Term Care supported the study. One author reported an unrestricted grant from Amgen, but there were no other conflicts of interest declared.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Diabetes in seniors increases dementia risk
Display Headline
Diabetes in seniors increases dementia risk
Legacy Keywords
Diabetes, dementia
Legacy Keywords
Diabetes, dementia
Article Source

FROM DIABETES CARE

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Even short-term hyperglycemia in late life can trigger or accelerate cognitive decline and incident diabetes is a risk factor for dementia after adjustment for differences in cardiovascular disease and other common risk factors.

Major finding: Individuals diagnosed with diabetes later in life have a 16% higher risk of dementia than do those without diabetes.

Data source: A population-based matched cohort study in 225,045 seniors newly diagnosed with diabetes and 668,070 nondiabetic controls.

Disclosures: The Canadian Institutes of Health Research, the Heart and Stroke Foundation of Ontario, the Canadian Institutes of Health Research, the University of Toronto, and the Ontario Ministry of Health and Long-Term Care supported the study. One author reported an unrestricted grant from Amgen, but there were no other conflicts of interest declared.

Study: Most young adults with diabetes neglect eye exams

Article Type
Changed
Tue, 05/03/2022 - 15:38
Display Headline
Study: Most young adults with diabetes neglect eye exams

Adults younger than 40 years old who have diabetes were much less likely to have recently seen an eye doctor than were older adults during 2012-2013, especially if they had been diagnosed less than 5 years earlier, according to a report from the National Center for Health Statistics.

Among adults aged 18-39 years who had been diagnosed with diabetes in the previous 5 years, 31% had seen an eye doctor in the previous year, compared with 49% of adults aged 40-64 and about 67% of adults 65 and older. About 44% of 18- to 39-year-olds diagnosed 5-10 years earlier reported seeing an eye doctor recently, and just under 43% of 18- to 39-year olds diagnosed more than 10 years prior reported seeing an eye doctor in the past year, the researchers noted.

Adults aged 40-64 years who had been diagnosed more than 10 years prior were significantly more likely to have seen an eye doctor recently (58%) than were those diagnosed between 5 and 10 years earlier (53%). In adults 65 and older, between 66% and 67% had seen an eye doctor recently in all diagnosis groups, according to the report.

“Among adults with diabetes, both age and years since diagnosis may play a role in visiting an eye doctor in the past 12 months. However, the findings here show that the association between years since diagnosis and visiting an eye doctor in the past year may only hold for certain age groups, specifically adults aged 40-64,” wrote the NCHS researchers.

The NCHS used data collected for the 2012-2013 National Health Interview Survey.

[email protected]

References

Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Adults younger than 40 years old who have diabetes were much less likely to have recently seen an eye doctor than were older adults during 2012-2013, especially if they had been diagnosed less than 5 years earlier, according to a report from the National Center for Health Statistics.

Among adults aged 18-39 years who had been diagnosed with diabetes in the previous 5 years, 31% had seen an eye doctor in the previous year, compared with 49% of adults aged 40-64 and about 67% of adults 65 and older. About 44% of 18- to 39-year-olds diagnosed 5-10 years earlier reported seeing an eye doctor recently, and just under 43% of 18- to 39-year olds diagnosed more than 10 years prior reported seeing an eye doctor in the past year, the researchers noted.

Adults aged 40-64 years who had been diagnosed more than 10 years prior were significantly more likely to have seen an eye doctor recently (58%) than were those diagnosed between 5 and 10 years earlier (53%). In adults 65 and older, between 66% and 67% had seen an eye doctor recently in all diagnosis groups, according to the report.

“Among adults with diabetes, both age and years since diagnosis may play a role in visiting an eye doctor in the past 12 months. However, the findings here show that the association between years since diagnosis and visiting an eye doctor in the past year may only hold for certain age groups, specifically adults aged 40-64,” wrote the NCHS researchers.

The NCHS used data collected for the 2012-2013 National Health Interview Survey.

[email protected]

Adults younger than 40 years old who have diabetes were much less likely to have recently seen an eye doctor than were older adults during 2012-2013, especially if they had been diagnosed less than 5 years earlier, according to a report from the National Center for Health Statistics.

Among adults aged 18-39 years who had been diagnosed with diabetes in the previous 5 years, 31% had seen an eye doctor in the previous year, compared with 49% of adults aged 40-64 and about 67% of adults 65 and older. About 44% of 18- to 39-year-olds diagnosed 5-10 years earlier reported seeing an eye doctor recently, and just under 43% of 18- to 39-year olds diagnosed more than 10 years prior reported seeing an eye doctor in the past year, the researchers noted.

Adults aged 40-64 years who had been diagnosed more than 10 years prior were significantly more likely to have seen an eye doctor recently (58%) than were those diagnosed between 5 and 10 years earlier (53%). In adults 65 and older, between 66% and 67% had seen an eye doctor recently in all diagnosis groups, according to the report.

“Among adults with diabetes, both age and years since diagnosis may play a role in visiting an eye doctor in the past 12 months. However, the findings here show that the association between years since diagnosis and visiting an eye doctor in the past year may only hold for certain age groups, specifically adults aged 40-64,” wrote the NCHS researchers.

The NCHS used data collected for the 2012-2013 National Health Interview Survey.

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
Study: Most young adults with diabetes neglect eye exams
Display Headline
Study: Most young adults with diabetes neglect eye exams
Article Source

PURLs Copyright

Inside the Article

Fungal foot infections risk secondary infection in diabetic patients

Article Type
Changed
Tue, 05/03/2022 - 15:38
Display Headline
Fungal foot infections risk secondary infection in diabetic patients

VANCOUVER – Fungal foot infections in diabetic patients are often ignored and are far more than a cosmetic problem.

In patients with diabetes, tinea pedis and onychomycosis triple the likelihood of secondary bacterial infections including gram-negative intertrigo, cellulitis, and osteomyelitis. Further, they boost up to fivefold the risk of life- and limb-threatening gangrene, Dr. Manuela Papini said at the World Congress of Dermatology.

Courtesy CDC/Dr. Libero Ajello

Her own work (G Ital Dermatol Venereol. 2013 Dec;148(6):603-8), as well as that of others, indicates tinea pedis and onychomycosis in diabetic patients often goes undiagnosed, ignored, or inadequately treated.

In her own experience, four out of five diabetic patients with a fungal foot infection are unaware of it, she said. Moreover, half of those with a diagnosed fungal foot infection remain untreated or insufficiently treated, added Dr. Papini, a dermatologist at the University of Perugia (Italy).

Fungal infections of the foot are three times more common among diabetic individuals than the general population. The reasons for this disparity included impaired peripheral circulation, an immunocompromised state, autonomic neuropathy, and the inability to maintain good foot hygiene because of obesity, impaired vision, or advanced age.

The causative organisms of fungal infections in diabetic patients are the same as those seen in the general population. So are the recommended first-line treatments. But treatment response is generally poor – much worse than in nondiabetics. Adherence to antifungal medication also is a real problem in diabetic patients, due in large part to the high prevalence of comorbid conditions and resultant polypharmacy.

“Most diabetic patients say their large pill burden is an issue, and they think onychomycosis is the least important of their problems,” she explained.

Photodynamic therapy and laser treatments show promise, but the supporting data aren’t yet sufficient to warrant their introduction into clinical practice, according to Dr. Papini.

As for contemporary therapy, she noted that the British Association of Dermatologists, in its current onychomycosis treatment guidelines, reserves its A-strength recommendations for two oral drugs given daily for 12 weeks: terbinafine and itraconazole, although itraconazole can alternatively be used as pulse therapy for 3-6 months. Topical therapies are advised only for superficial white onychomycosis and early distal lateral subungual onychomycosis (Br J Dermatol. 2014 Nov;171(5):937-58).

A systematic review of the published literature on treatment of diabetic fungal foot infections concluded that there is good evidence that oral terbinafine is as safe and effective as itraconazole for treating onychomycosis. The authors, however, found that there is no evidence to guide treatment of tinea pedis in the diabetic population (J Foot Ankle Res. 2011 Dec 4;4:26).

In the nondiabetic population, the first-line treatment for tinea pedis is typically a topical antifungal. A good option in diabetic patients is luliconazole (Luzu), which is active against Trichophyton rubrum – the most common causative organism – and has the advantage of simplicity: the regimen is once-daily treatment for 2 weeks, much shorter than for many other topical antifungals, Dr. Papini observed.

Until new and better treatments come along, she continued, the key to preventing relapse of fungal foot infections in diabetic patients is to choose the simplest and most effective therapy, stress to patients the importance of completing the treatment course, and provide instruction in self-inspection and disinfection of shoes and socks.

Dr. Papini reported having no financial conflicts of interest.

[email protected]

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
diabetes, onychomycosis, tinea pedis
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

VANCOUVER – Fungal foot infections in diabetic patients are often ignored and are far more than a cosmetic problem.

In patients with diabetes, tinea pedis and onychomycosis triple the likelihood of secondary bacterial infections including gram-negative intertrigo, cellulitis, and osteomyelitis. Further, they boost up to fivefold the risk of life- and limb-threatening gangrene, Dr. Manuela Papini said at the World Congress of Dermatology.

Courtesy CDC/Dr. Libero Ajello

Her own work (G Ital Dermatol Venereol. 2013 Dec;148(6):603-8), as well as that of others, indicates tinea pedis and onychomycosis in diabetic patients often goes undiagnosed, ignored, or inadequately treated.

In her own experience, four out of five diabetic patients with a fungal foot infection are unaware of it, she said. Moreover, half of those with a diagnosed fungal foot infection remain untreated or insufficiently treated, added Dr. Papini, a dermatologist at the University of Perugia (Italy).

Fungal infections of the foot are three times more common among diabetic individuals than the general population. The reasons for this disparity included impaired peripheral circulation, an immunocompromised state, autonomic neuropathy, and the inability to maintain good foot hygiene because of obesity, impaired vision, or advanced age.

The causative organisms of fungal infections in diabetic patients are the same as those seen in the general population. So are the recommended first-line treatments. But treatment response is generally poor – much worse than in nondiabetics. Adherence to antifungal medication also is a real problem in diabetic patients, due in large part to the high prevalence of comorbid conditions and resultant polypharmacy.

“Most diabetic patients say their large pill burden is an issue, and they think onychomycosis is the least important of their problems,” she explained.

Photodynamic therapy and laser treatments show promise, but the supporting data aren’t yet sufficient to warrant their introduction into clinical practice, according to Dr. Papini.

As for contemporary therapy, she noted that the British Association of Dermatologists, in its current onychomycosis treatment guidelines, reserves its A-strength recommendations for two oral drugs given daily for 12 weeks: terbinafine and itraconazole, although itraconazole can alternatively be used as pulse therapy for 3-6 months. Topical therapies are advised only for superficial white onychomycosis and early distal lateral subungual onychomycosis (Br J Dermatol. 2014 Nov;171(5):937-58).

A systematic review of the published literature on treatment of diabetic fungal foot infections concluded that there is good evidence that oral terbinafine is as safe and effective as itraconazole for treating onychomycosis. The authors, however, found that there is no evidence to guide treatment of tinea pedis in the diabetic population (J Foot Ankle Res. 2011 Dec 4;4:26).

In the nondiabetic population, the first-line treatment for tinea pedis is typically a topical antifungal. A good option in diabetic patients is luliconazole (Luzu), which is active against Trichophyton rubrum – the most common causative organism – and has the advantage of simplicity: the regimen is once-daily treatment for 2 weeks, much shorter than for many other topical antifungals, Dr. Papini observed.

Until new and better treatments come along, she continued, the key to preventing relapse of fungal foot infections in diabetic patients is to choose the simplest and most effective therapy, stress to patients the importance of completing the treatment course, and provide instruction in self-inspection and disinfection of shoes and socks.

Dr. Papini reported having no financial conflicts of interest.

[email protected]

VANCOUVER – Fungal foot infections in diabetic patients are often ignored and are far more than a cosmetic problem.

In patients with diabetes, tinea pedis and onychomycosis triple the likelihood of secondary bacterial infections including gram-negative intertrigo, cellulitis, and osteomyelitis. Further, they boost up to fivefold the risk of life- and limb-threatening gangrene, Dr. Manuela Papini said at the World Congress of Dermatology.

Courtesy CDC/Dr. Libero Ajello

Her own work (G Ital Dermatol Venereol. 2013 Dec;148(6):603-8), as well as that of others, indicates tinea pedis and onychomycosis in diabetic patients often goes undiagnosed, ignored, or inadequately treated.

In her own experience, four out of five diabetic patients with a fungal foot infection are unaware of it, she said. Moreover, half of those with a diagnosed fungal foot infection remain untreated or insufficiently treated, added Dr. Papini, a dermatologist at the University of Perugia (Italy).

Fungal infections of the foot are three times more common among diabetic individuals than the general population. The reasons for this disparity included impaired peripheral circulation, an immunocompromised state, autonomic neuropathy, and the inability to maintain good foot hygiene because of obesity, impaired vision, or advanced age.

The causative organisms of fungal infections in diabetic patients are the same as those seen in the general population. So are the recommended first-line treatments. But treatment response is generally poor – much worse than in nondiabetics. Adherence to antifungal medication also is a real problem in diabetic patients, due in large part to the high prevalence of comorbid conditions and resultant polypharmacy.

“Most diabetic patients say their large pill burden is an issue, and they think onychomycosis is the least important of their problems,” she explained.

Photodynamic therapy and laser treatments show promise, but the supporting data aren’t yet sufficient to warrant their introduction into clinical practice, according to Dr. Papini.

As for contemporary therapy, she noted that the British Association of Dermatologists, in its current onychomycosis treatment guidelines, reserves its A-strength recommendations for two oral drugs given daily for 12 weeks: terbinafine and itraconazole, although itraconazole can alternatively be used as pulse therapy for 3-6 months. Topical therapies are advised only for superficial white onychomycosis and early distal lateral subungual onychomycosis (Br J Dermatol. 2014 Nov;171(5):937-58).

A systematic review of the published literature on treatment of diabetic fungal foot infections concluded that there is good evidence that oral terbinafine is as safe and effective as itraconazole for treating onychomycosis. The authors, however, found that there is no evidence to guide treatment of tinea pedis in the diabetic population (J Foot Ankle Res. 2011 Dec 4;4:26).

In the nondiabetic population, the first-line treatment for tinea pedis is typically a topical antifungal. A good option in diabetic patients is luliconazole (Luzu), which is active against Trichophyton rubrum – the most common causative organism – and has the advantage of simplicity: the regimen is once-daily treatment for 2 weeks, much shorter than for many other topical antifungals, Dr. Papini observed.

Until new and better treatments come along, she continued, the key to preventing relapse of fungal foot infections in diabetic patients is to choose the simplest and most effective therapy, stress to patients the importance of completing the treatment course, and provide instruction in self-inspection and disinfection of shoes and socks.

Dr. Papini reported having no financial conflicts of interest.

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
Fungal foot infections risk secondary infection in diabetic patients
Display Headline
Fungal foot infections risk secondary infection in diabetic patients
Legacy Keywords
diabetes, onychomycosis, tinea pedis
Legacy Keywords
diabetes, onychomycosis, tinea pedis
Sections
Article Source

EXPERT ANALYSIS FROM WCD 2015

PURLs Copyright

Inside the Article

Weighted CMDS score predicts 15-year diabetes risk

Article Type
Changed
Tue, 05/03/2022 - 15:38
Display Headline
Weighted CMDS score predicts 15-year diabetes risk

A modified version of the cardiometabolic disease staging (CMDS) scoring system can be effectively used in a clinical setting to identify patients who are at an elevated risk for developing diabetes, according to a study published in the Journal of Clinical Endocrinology & Metabolism.

“To enhance the application of the CMDS system in clinical settings, we sought to develop a weighted scoring system based on risk factor components in the CMDS system for the prediction of future diabetes by separate identification and weighting of those risk components,” said Dr. Fangjian Guo of the University of Texas Medical Branch, Galveston, and Dr. W. Timothy Garvey of the University of Alabama, Birmingham.

©donskarpo/thinkstockphotos.com

The CMDS scoring method involves these measures:

• Fasting blood glucose of at least 100 mg/dL.

• Two-hour glucose from oral glucose tolerance test (OGTT) of at least 140 mg/dL.

• Waist circumference of 102 cm for men and 88 cm for women.

• Blood pressure (systolic of at least 130 mm Hg and/or diastolic of at least 85 mm Hg) or use of antihypertensive medication.

• HDL cholesterol under 40 mg/dL in men and under 50 mg/dL in women.

• Fasting triglycerides of at least 150 mg/dL or use of antihyperlipidemia medication.

Dr. Guo and Dr. Garvey used data from the CARDIA study and the ARIC study for their investigation.

CARDIA is a large, ongoing population study of 5,115 black and white adults, age 18-30 years, recruited from 1985 to 1986, with follow-up examinations conducted in seven visits over the next 25 years.

ARIC is an ongoing prospective cohort study of 15,792 men and women recruited at age 46-64 years in 1987 from either Mississippi, North Carolina, Minnesota, or Maryland, with follow-ups every 3 years.

The CMDS score was derived based on “verified incident diabetes cases from the CARDIA study” and was validated “in participants from the ARIC study,” after which the researchers “fitted Cox models and derived CMDS scores for diabetes accordingly,” the researchers wrote (J Clin Endocrinol Metab. 2015 Aug 4 doi: 10.1210/jc.2015-2691).

Overall, weighted diabetes CMDS scores were derived for 2,857 subjects and were validated in 6,425 subjects from the ARIC study. Scores in each of the six subcategories carried integer values that, when totaled, equaled a maximum of 100 per subject.

Weighted CMDS scores of 10 or lower were found to indicate a low 15-year risk of diabetes rate: 11% for both black men and women, 5% for white women, and 3% for white men. Weighted CMDS scores of 11-20 indicate a 15% risk for black men and women, 7% for white women, and 6% for white men. Scores of 21-30 indicated a 20% risk for black men and women, 11% for white women, and 10% for white men. Scores of 31-40 indicated a 27% risk for black men and women, 18% for white women, and 16% for white men. Scores of 41-50 indicated a 36% risk for black men and women, 26% for white women, and 25% for white men.

Fifteen-year diabetes-risk rates increased in the higher CMDS score brackets. In the 51-60 range, black men and women have a 47% risk, compared with 39% for white women and 38% for white men. Scores of 61-70 indicated a 59% risk for black men and women, 54% for white women, and 55% for white men. In the final score bracket of 71 and higher, the risk is greater than 59% for black men and women, greater than 54% for white women, and greater than 55% for white men.

“The main strength of this study is the development and validation of a weighted diabetes algorithm using data from two large prospective national cohorts,” Dr. Guo and Dr. Garvey noted, adding that “incident diabetes in the CARDIA study was based on rigorous measures of fasting glucose and 2-hour OGTT glucose, such that the ascertained diabetes cases provide a solid basis for the development of our weighted CMDS scoring system.”

Limitations of the study include the fact that blood glucose measures were not available for ARIC participants after the fourth visit and that diabetes cases were based on hospital records and self-reports. Furthermore, both CARDIA and ARIC looked exclusively at black and white subjects, meaning that other minority groups – particularly Asians – were not included.

This study was supported by the merit review program of the Department of Veterans Affairs, National Institutes of Health, and the UAB Diabetes Research Center. Dr. Guo is supported by an institutional training grant from the Eunice Kennedy Shriver National Institute of Child Health & Human Development at the NIH.

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
CMDS, diabetes, weighted, score, black, white, risk
Author and Disclosure Information

Author and Disclosure Information

A modified version of the cardiometabolic disease staging (CMDS) scoring system can be effectively used in a clinical setting to identify patients who are at an elevated risk for developing diabetes, according to a study published in the Journal of Clinical Endocrinology & Metabolism.

“To enhance the application of the CMDS system in clinical settings, we sought to develop a weighted scoring system based on risk factor components in the CMDS system for the prediction of future diabetes by separate identification and weighting of those risk components,” said Dr. Fangjian Guo of the University of Texas Medical Branch, Galveston, and Dr. W. Timothy Garvey of the University of Alabama, Birmingham.

©donskarpo/thinkstockphotos.com

The CMDS scoring method involves these measures:

• Fasting blood glucose of at least 100 mg/dL.

• Two-hour glucose from oral glucose tolerance test (OGTT) of at least 140 mg/dL.

• Waist circumference of 102 cm for men and 88 cm for women.

• Blood pressure (systolic of at least 130 mm Hg and/or diastolic of at least 85 mm Hg) or use of antihypertensive medication.

• HDL cholesterol under 40 mg/dL in men and under 50 mg/dL in women.

• Fasting triglycerides of at least 150 mg/dL or use of antihyperlipidemia medication.

Dr. Guo and Dr. Garvey used data from the CARDIA study and the ARIC study for their investigation.

CARDIA is a large, ongoing population study of 5,115 black and white adults, age 18-30 years, recruited from 1985 to 1986, with follow-up examinations conducted in seven visits over the next 25 years.

ARIC is an ongoing prospective cohort study of 15,792 men and women recruited at age 46-64 years in 1987 from either Mississippi, North Carolina, Minnesota, or Maryland, with follow-ups every 3 years.

The CMDS score was derived based on “verified incident diabetes cases from the CARDIA study” and was validated “in participants from the ARIC study,” after which the researchers “fitted Cox models and derived CMDS scores for diabetes accordingly,” the researchers wrote (J Clin Endocrinol Metab. 2015 Aug 4 doi: 10.1210/jc.2015-2691).

Overall, weighted diabetes CMDS scores were derived for 2,857 subjects and were validated in 6,425 subjects from the ARIC study. Scores in each of the six subcategories carried integer values that, when totaled, equaled a maximum of 100 per subject.

Weighted CMDS scores of 10 or lower were found to indicate a low 15-year risk of diabetes rate: 11% for both black men and women, 5% for white women, and 3% for white men. Weighted CMDS scores of 11-20 indicate a 15% risk for black men and women, 7% for white women, and 6% for white men. Scores of 21-30 indicated a 20% risk for black men and women, 11% for white women, and 10% for white men. Scores of 31-40 indicated a 27% risk for black men and women, 18% for white women, and 16% for white men. Scores of 41-50 indicated a 36% risk for black men and women, 26% for white women, and 25% for white men.

Fifteen-year diabetes-risk rates increased in the higher CMDS score brackets. In the 51-60 range, black men and women have a 47% risk, compared with 39% for white women and 38% for white men. Scores of 61-70 indicated a 59% risk for black men and women, 54% for white women, and 55% for white men. In the final score bracket of 71 and higher, the risk is greater than 59% for black men and women, greater than 54% for white women, and greater than 55% for white men.

“The main strength of this study is the development and validation of a weighted diabetes algorithm using data from two large prospective national cohorts,” Dr. Guo and Dr. Garvey noted, adding that “incident diabetes in the CARDIA study was based on rigorous measures of fasting glucose and 2-hour OGTT glucose, such that the ascertained diabetes cases provide a solid basis for the development of our weighted CMDS scoring system.”

Limitations of the study include the fact that blood glucose measures were not available for ARIC participants after the fourth visit and that diabetes cases were based on hospital records and self-reports. Furthermore, both CARDIA and ARIC looked exclusively at black and white subjects, meaning that other minority groups – particularly Asians – were not included.

This study was supported by the merit review program of the Department of Veterans Affairs, National Institutes of Health, and the UAB Diabetes Research Center. Dr. Guo is supported by an institutional training grant from the Eunice Kennedy Shriver National Institute of Child Health & Human Development at the NIH.

A modified version of the cardiometabolic disease staging (CMDS) scoring system can be effectively used in a clinical setting to identify patients who are at an elevated risk for developing diabetes, according to a study published in the Journal of Clinical Endocrinology & Metabolism.

“To enhance the application of the CMDS system in clinical settings, we sought to develop a weighted scoring system based on risk factor components in the CMDS system for the prediction of future diabetes by separate identification and weighting of those risk components,” said Dr. Fangjian Guo of the University of Texas Medical Branch, Galveston, and Dr. W. Timothy Garvey of the University of Alabama, Birmingham.

©donskarpo/thinkstockphotos.com

The CMDS scoring method involves these measures:

• Fasting blood glucose of at least 100 mg/dL.

• Two-hour glucose from oral glucose tolerance test (OGTT) of at least 140 mg/dL.

• Waist circumference of 102 cm for men and 88 cm for women.

• Blood pressure (systolic of at least 130 mm Hg and/or diastolic of at least 85 mm Hg) or use of antihypertensive medication.

• HDL cholesterol under 40 mg/dL in men and under 50 mg/dL in women.

• Fasting triglycerides of at least 150 mg/dL or use of antihyperlipidemia medication.

Dr. Guo and Dr. Garvey used data from the CARDIA study and the ARIC study for their investigation.

CARDIA is a large, ongoing population study of 5,115 black and white adults, age 18-30 years, recruited from 1985 to 1986, with follow-up examinations conducted in seven visits over the next 25 years.

ARIC is an ongoing prospective cohort study of 15,792 men and women recruited at age 46-64 years in 1987 from either Mississippi, North Carolina, Minnesota, or Maryland, with follow-ups every 3 years.

The CMDS score was derived based on “verified incident diabetes cases from the CARDIA study” and was validated “in participants from the ARIC study,” after which the researchers “fitted Cox models and derived CMDS scores for diabetes accordingly,” the researchers wrote (J Clin Endocrinol Metab. 2015 Aug 4 doi: 10.1210/jc.2015-2691).

Overall, weighted diabetes CMDS scores were derived for 2,857 subjects and were validated in 6,425 subjects from the ARIC study. Scores in each of the six subcategories carried integer values that, when totaled, equaled a maximum of 100 per subject.

Weighted CMDS scores of 10 or lower were found to indicate a low 15-year risk of diabetes rate: 11% for both black men and women, 5% for white women, and 3% for white men. Weighted CMDS scores of 11-20 indicate a 15% risk for black men and women, 7% for white women, and 6% for white men. Scores of 21-30 indicated a 20% risk for black men and women, 11% for white women, and 10% for white men. Scores of 31-40 indicated a 27% risk for black men and women, 18% for white women, and 16% for white men. Scores of 41-50 indicated a 36% risk for black men and women, 26% for white women, and 25% for white men.

Fifteen-year diabetes-risk rates increased in the higher CMDS score brackets. In the 51-60 range, black men and women have a 47% risk, compared with 39% for white women and 38% for white men. Scores of 61-70 indicated a 59% risk for black men and women, 54% for white women, and 55% for white men. In the final score bracket of 71 and higher, the risk is greater than 59% for black men and women, greater than 54% for white women, and greater than 55% for white men.

“The main strength of this study is the development and validation of a weighted diabetes algorithm using data from two large prospective national cohorts,” Dr. Guo and Dr. Garvey noted, adding that “incident diabetes in the CARDIA study was based on rigorous measures of fasting glucose and 2-hour OGTT glucose, such that the ascertained diabetes cases provide a solid basis for the development of our weighted CMDS scoring system.”

Limitations of the study include the fact that blood glucose measures were not available for ARIC participants after the fourth visit and that diabetes cases were based on hospital records and self-reports. Furthermore, both CARDIA and ARIC looked exclusively at black and white subjects, meaning that other minority groups – particularly Asians – were not included.

This study was supported by the merit review program of the Department of Veterans Affairs, National Institutes of Health, and the UAB Diabetes Research Center. Dr. Guo is supported by an institutional training grant from the Eunice Kennedy Shriver National Institute of Child Health & Human Development at the NIH.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Weighted CMDS score predicts 15-year diabetes risk
Display Headline
Weighted CMDS score predicts 15-year diabetes risk
Legacy Keywords
CMDS, diabetes, weighted, score, black, white, risk
Legacy Keywords
CMDS, diabetes, weighted, score, black, white, risk
Article Source

FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

PURLs Copyright

Inside the Article

Vitals

Key clinical point: The cardiometabolic disease staging (CMDS) scoring system can be used as an effective quantitative measure for predicting an individual’s chances of developing diabetes.

Major finding: CMDS scores that were adjusted according to age and race of each subject were more accurate in predicting risk of developing diabetes within 15 years; black men and women aged 61 years and older were most susceptible.

Data source: CARDIA, an ongoing population-based study of 5,115 black and white adults recruited during 1985-1986, and ARIC, an ongoing prospective cohort study of 15,792 men and women aged 45-64 years recruited in 1987.

Disclosures: This study was supported by the merit review program of the Department of Veterans Affairs, National Institutes of Health, and the UAB Diabetes Research Center. Dr. Guo is supported by an institutional training grant from the Eunice Kennedy Shriver National Institute of Child Health & Human Development at the NIH.

For diabetic patients, LRYGB safety comparable to other common procedures

Article Type
Changed
Tue, 05/03/2022 - 15:39
Display Headline
For diabetic patients, LRYGB safety comparable to other common procedures

CHICAGO – Laparoscopic Roux-en-Y gastric bypass (LRYGB) in diabetic patients has comparable short-term morbidity and mortality with other common surgical procedures and may circumvent the need for many of them, a NSQIP database analysis shows.

Thirty-day mortality for LRYGB was 3 per 1,000 patients, or approximately one-tenth that of coronary artery bypass graft (0.3% vs. 2.8%).

Dr. Matthew Davis

“This is significant to us moving forward from the point of meeting patients earlier on in their life and approaching the idea of bariatric surgery because the earlier intervention of bariatric surgery, which may have the chance of curing their diabetes, may eliminate the need for higher-risk procedures such as a cardiac bypass down the road,” study author Dr. Matthew Davis said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

Similarly, total knee arthroplasty had a complication rate nearly five times that of LRYGB (16.7% vs. 3.4%) and comparable mortality (both 0.3%).

“Being that morbid obesity, or obesity in general, is a significant risk factor for osteoarthritis, which is the number-one indication for total knee [arthroplasty], again, we can potentially perform one surgery to eliminate the need for a further surgery that does show to have a higher complication rate,” he said.

Five randomized controlled trials have shown the remarkable effects of bariatric surgery on type 2 diabetes mellitus, including better glycemic control, cardiovascular risk factor modification, and the potential for long-term remission. The safety profile of metabolic diabetes surgery, however, has been a matter of concern among patients and physicians, said Dr. Davis of the Bariatric & Metabolic Institute at the Cleveland Clinic.

To explore short-term metabolic diabetes surgery outcomes, the investigators used the American College of Surgeons’ NSQIP dataset to identify 16,509 diabetic patients who underwent LRYGB from January 2007 to December 2012 and compare them with patients undergoing seven other common surgical procedures: coronary artery bypass graft (n = 2,868), infrainguinal bypass (n = 10,454), laparoscopic partial colectomy (n = 5,511), laparoscopic cholecystectomy (n = 15,306), laparoscopic appendectomy (n = 4,537), laparoscopic hysterectomy (n = 2,309), and total knee arthroplasty (n = 9,184).

Patients undergoing open or revisional bariatric surgery were excluded. Also excluded were sleeve gastrectomy cases because data were not available for the entire study period and gastric banding because its effect on diabetes is not as significant as gastric bypass, he said.

One-third (37.4%) of patients used insulin, 79% had hypertension, and 71.5% were women. The average body mass index was 46.5 kg/m2 and the average age was 50 years.

The 30-day composite complication rate was defined as the presence of any of nine postoperative adverse events: stroke, myocardial infarction, pulmonary embolism, acute renal failure, septic shock, deep vein thrombosis, pneumonia, sepsis, and need for transfusion.

The most frequent adverse event with LRYGB was need for transfusion, which occurred in 1.22% of patients, Dr. Davis said. Rates for the other eight complications in ascending order were: stroke (0.05%), MI (0.16%), pulmonary embolism (0.22%), acute renal failure (0.22%), septic shock (0.30%), deep vein thrombosis (0.36%), pneumonia (0.66%), and sepsis (0.81%).

The 30-day complication rate for LRYGB was comparable with that for laparoscopic cholecystectomy (3.7%) and laparoscopic hysterectomy. Complication rates were significantly higher, however, for CABG (46.6%), infrainguinal bypass (23.6%), laparoscopic partial colectomy (12%), laparoscopic appendectomy (4.5%), and total knee arthroplasty (16.7%), according to Dr. Davis.

Among LRYGB patients, the mean length of stay was 2.6 days, and 6.7% were readmitted, 2.5% underwent reoperation, and 0.3% died.

In contrast, the average length of stay was 6 days for laparoscopic partial colectomy, with readmission, reoperation, and mortality rates of 9.4%, 3.8%, and 1.8%, respectively.

“Compared with laparoscopic colectomy, gastric bypass superseded in all categories with morbidity and mortality,” he said.

Limitations of the study were the lack of information on sleeve gastrectomy and long-term safety outcomes, and nonsimilar baseline characteristics for comparator groups.

Session comoderator Dr. Konstantin Umanskiy of the University of Chicago said that the results highlight the dramatic improvements achieved in bariatric surgery through centers of excellence and could serve to invigorate efforts to bring this model to colorectal surgery. An initiative by the 144-member Consortium for Optimizing the Surgical Treatment of Rectal Cancer (OSTRICH) to establish a U.S. Rectal Cancer Centers of Excellence program was endorsed last year by the American College of Surgeons and the Commission on Cancer.

The investigators and Dr. Umanskiy reported having no conflicts of interest.

[email protected]

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
gastric bypass, obesity, LRYGB, diabetes, ACS NSQIP
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

CHICAGO – Laparoscopic Roux-en-Y gastric bypass (LRYGB) in diabetic patients has comparable short-term morbidity and mortality with other common surgical procedures and may circumvent the need for many of them, a NSQIP database analysis shows.

Thirty-day mortality for LRYGB was 3 per 1,000 patients, or approximately one-tenth that of coronary artery bypass graft (0.3% vs. 2.8%).

Dr. Matthew Davis

“This is significant to us moving forward from the point of meeting patients earlier on in their life and approaching the idea of bariatric surgery because the earlier intervention of bariatric surgery, which may have the chance of curing their diabetes, may eliminate the need for higher-risk procedures such as a cardiac bypass down the road,” study author Dr. Matthew Davis said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

Similarly, total knee arthroplasty had a complication rate nearly five times that of LRYGB (16.7% vs. 3.4%) and comparable mortality (both 0.3%).

“Being that morbid obesity, or obesity in general, is a significant risk factor for osteoarthritis, which is the number-one indication for total knee [arthroplasty], again, we can potentially perform one surgery to eliminate the need for a further surgery that does show to have a higher complication rate,” he said.

Five randomized controlled trials have shown the remarkable effects of bariatric surgery on type 2 diabetes mellitus, including better glycemic control, cardiovascular risk factor modification, and the potential for long-term remission. The safety profile of metabolic diabetes surgery, however, has been a matter of concern among patients and physicians, said Dr. Davis of the Bariatric & Metabolic Institute at the Cleveland Clinic.

To explore short-term metabolic diabetes surgery outcomes, the investigators used the American College of Surgeons’ NSQIP dataset to identify 16,509 diabetic patients who underwent LRYGB from January 2007 to December 2012 and compare them with patients undergoing seven other common surgical procedures: coronary artery bypass graft (n = 2,868), infrainguinal bypass (n = 10,454), laparoscopic partial colectomy (n = 5,511), laparoscopic cholecystectomy (n = 15,306), laparoscopic appendectomy (n = 4,537), laparoscopic hysterectomy (n = 2,309), and total knee arthroplasty (n = 9,184).

Patients undergoing open or revisional bariatric surgery were excluded. Also excluded were sleeve gastrectomy cases because data were not available for the entire study period and gastric banding because its effect on diabetes is not as significant as gastric bypass, he said.

One-third (37.4%) of patients used insulin, 79% had hypertension, and 71.5% were women. The average body mass index was 46.5 kg/m2 and the average age was 50 years.

The 30-day composite complication rate was defined as the presence of any of nine postoperative adverse events: stroke, myocardial infarction, pulmonary embolism, acute renal failure, septic shock, deep vein thrombosis, pneumonia, sepsis, and need for transfusion.

The most frequent adverse event with LRYGB was need for transfusion, which occurred in 1.22% of patients, Dr. Davis said. Rates for the other eight complications in ascending order were: stroke (0.05%), MI (0.16%), pulmonary embolism (0.22%), acute renal failure (0.22%), septic shock (0.30%), deep vein thrombosis (0.36%), pneumonia (0.66%), and sepsis (0.81%).

The 30-day complication rate for LRYGB was comparable with that for laparoscopic cholecystectomy (3.7%) and laparoscopic hysterectomy. Complication rates were significantly higher, however, for CABG (46.6%), infrainguinal bypass (23.6%), laparoscopic partial colectomy (12%), laparoscopic appendectomy (4.5%), and total knee arthroplasty (16.7%), according to Dr. Davis.

Among LRYGB patients, the mean length of stay was 2.6 days, and 6.7% were readmitted, 2.5% underwent reoperation, and 0.3% died.

In contrast, the average length of stay was 6 days for laparoscopic partial colectomy, with readmission, reoperation, and mortality rates of 9.4%, 3.8%, and 1.8%, respectively.

“Compared with laparoscopic colectomy, gastric bypass superseded in all categories with morbidity and mortality,” he said.

Limitations of the study were the lack of information on sleeve gastrectomy and long-term safety outcomes, and nonsimilar baseline characteristics for comparator groups.

Session comoderator Dr. Konstantin Umanskiy of the University of Chicago said that the results highlight the dramatic improvements achieved in bariatric surgery through centers of excellence and could serve to invigorate efforts to bring this model to colorectal surgery. An initiative by the 144-member Consortium for Optimizing the Surgical Treatment of Rectal Cancer (OSTRICH) to establish a U.S. Rectal Cancer Centers of Excellence program was endorsed last year by the American College of Surgeons and the Commission on Cancer.

The investigators and Dr. Umanskiy reported having no conflicts of interest.

[email protected]

CHICAGO – Laparoscopic Roux-en-Y gastric bypass (LRYGB) in diabetic patients has comparable short-term morbidity and mortality with other common surgical procedures and may circumvent the need for many of them, a NSQIP database analysis shows.

Thirty-day mortality for LRYGB was 3 per 1,000 patients, or approximately one-tenth that of coronary artery bypass graft (0.3% vs. 2.8%).

Dr. Matthew Davis

“This is significant to us moving forward from the point of meeting patients earlier on in their life and approaching the idea of bariatric surgery because the earlier intervention of bariatric surgery, which may have the chance of curing their diabetes, may eliminate the need for higher-risk procedures such as a cardiac bypass down the road,” study author Dr. Matthew Davis said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

Similarly, total knee arthroplasty had a complication rate nearly five times that of LRYGB (16.7% vs. 3.4%) and comparable mortality (both 0.3%).

“Being that morbid obesity, or obesity in general, is a significant risk factor for osteoarthritis, which is the number-one indication for total knee [arthroplasty], again, we can potentially perform one surgery to eliminate the need for a further surgery that does show to have a higher complication rate,” he said.

Five randomized controlled trials have shown the remarkable effects of bariatric surgery on type 2 diabetes mellitus, including better glycemic control, cardiovascular risk factor modification, and the potential for long-term remission. The safety profile of metabolic diabetes surgery, however, has been a matter of concern among patients and physicians, said Dr. Davis of the Bariatric & Metabolic Institute at the Cleveland Clinic.

To explore short-term metabolic diabetes surgery outcomes, the investigators used the American College of Surgeons’ NSQIP dataset to identify 16,509 diabetic patients who underwent LRYGB from January 2007 to December 2012 and compare them with patients undergoing seven other common surgical procedures: coronary artery bypass graft (n = 2,868), infrainguinal bypass (n = 10,454), laparoscopic partial colectomy (n = 5,511), laparoscopic cholecystectomy (n = 15,306), laparoscopic appendectomy (n = 4,537), laparoscopic hysterectomy (n = 2,309), and total knee arthroplasty (n = 9,184).

Patients undergoing open or revisional bariatric surgery were excluded. Also excluded were sleeve gastrectomy cases because data were not available for the entire study period and gastric banding because its effect on diabetes is not as significant as gastric bypass, he said.

One-third (37.4%) of patients used insulin, 79% had hypertension, and 71.5% were women. The average body mass index was 46.5 kg/m2 and the average age was 50 years.

The 30-day composite complication rate was defined as the presence of any of nine postoperative adverse events: stroke, myocardial infarction, pulmonary embolism, acute renal failure, septic shock, deep vein thrombosis, pneumonia, sepsis, and need for transfusion.

The most frequent adverse event with LRYGB was need for transfusion, which occurred in 1.22% of patients, Dr. Davis said. Rates for the other eight complications in ascending order were: stroke (0.05%), MI (0.16%), pulmonary embolism (0.22%), acute renal failure (0.22%), septic shock (0.30%), deep vein thrombosis (0.36%), pneumonia (0.66%), and sepsis (0.81%).

The 30-day complication rate for LRYGB was comparable with that for laparoscopic cholecystectomy (3.7%) and laparoscopic hysterectomy. Complication rates were significantly higher, however, for CABG (46.6%), infrainguinal bypass (23.6%), laparoscopic partial colectomy (12%), laparoscopic appendectomy (4.5%), and total knee arthroplasty (16.7%), according to Dr. Davis.

Among LRYGB patients, the mean length of stay was 2.6 days, and 6.7% were readmitted, 2.5% underwent reoperation, and 0.3% died.

In contrast, the average length of stay was 6 days for laparoscopic partial colectomy, with readmission, reoperation, and mortality rates of 9.4%, 3.8%, and 1.8%, respectively.

“Compared with laparoscopic colectomy, gastric bypass superseded in all categories with morbidity and mortality,” he said.

Limitations of the study were the lack of information on sleeve gastrectomy and long-term safety outcomes, and nonsimilar baseline characteristics for comparator groups.

Session comoderator Dr. Konstantin Umanskiy of the University of Chicago said that the results highlight the dramatic improvements achieved in bariatric surgery through centers of excellence and could serve to invigorate efforts to bring this model to colorectal surgery. An initiative by the 144-member Consortium for Optimizing the Surgical Treatment of Rectal Cancer (OSTRICH) to establish a U.S. Rectal Cancer Centers of Excellence program was endorsed last year by the American College of Surgeons and the Commission on Cancer.

The investigators and Dr. Umanskiy reported having no conflicts of interest.

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
For diabetic patients, LRYGB safety comparable to other common procedures
Display Headline
For diabetic patients, LRYGB safety comparable to other common procedures
Legacy Keywords
gastric bypass, obesity, LRYGB, diabetes, ACS NSQIP
Legacy Keywords
gastric bypass, obesity, LRYGB, diabetes, ACS NSQIP
Sections
Article Source

AT THE ACS NSQIP NATIONAL CONFERENCE

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Laparoscopic Roux-en-Y gastric bypass in patients with diabetes is as safe as other common procedures.

Major finding: At 30 days, LRYGB mortality was 0.3% and the composite complication rate was 3.4%.

Data source: Retrospective study in 16,509 diabetic patients who underwent Roux-en-Y gastric bypass and 50,169 patients who had other surgical procedures.

Disclosures: The investigators and Dr. Umanskiy reported having no conflicts of interest.

Skipping breakfast incites hyperglycemic response in type 2 diabetes patients

Article Type
Changed
Tue, 05/03/2022 - 15:39
Display Headline
Skipping breakfast incites hyperglycemic response in type 2 diabetes patients

When type 2 diabetes patients skipped breakfast, they had higher levels of glucagon and free fatty acids (FFA), and reduced levels of insulin, C-peptide, and intact glucagonlike peptide-1 (iGLP-1) after meals, compared with when they ate breakfast, according to a randomized, open-label, cross-over-within-subject clinical trial.

A total of 22 overweight or obese people who had type 2 diabetes completed the study. Patients could not be taking GLP-1 analogs, anorectic drugs, steroids, or oral hypoglycemic agents, other than metformin. Seven of the patients had a history of hypertension and were treated with ACE inhibitors and/or calcium antagonists, wrote Dr. Daniela Jakubowicz of the Diabetes Unit in Hospital de Clinicas in Caracas, Venezuela.

At the Diabetes Unit, the patients participated in 2 full days of testing, separated by a washout period of 2-4 weeks. On one of the days, patients consumed three meals, including breakfast. On the other testing day, patients fasted until 1:30 p.m., consuming only lunch and dinner. All patients ate each of their meals during the same scheduled times; all meals contained identical macronutrient content and composition.

©MattZ90/thinkstockimages.com

Areas under the curve of data values for tested measures during an early response interval (0-30 minutes after eating a meal) and 0-180 minutes after eating a meal were calculated by the trapezoidal rule. These calculations were used as an estimate of response to meal consumption.

Plasma levels for glucose, insulin, C-peptide, and iGLP-1 were, respectively, 16.5%, 45%, 50%, and 33% higher before lunch, on the day that patients consumed breakfast, than they were on the day that they skipped breakfast.

The plasma FFA level was 1,787.1% higher for study participants on the day when they fasted until lunch than it was on the day when they ate breakfast. During tests taken 60-180 minutes after consumption of breakfast, patients’ glucagon levels were 12.5% lower than those of patients who fasted before lunch.

On the day that patients skipped breakfast, insulin was 17% lower after lunch and 7.9% lower after dinner, compared with the amounts of insulin found on the day that patients ate breakfast; iGLP-1 was also lower after dinner (16.5%) on the day that patients skipped breakfast.

After lunch and dinner, glucagon levels were 9.7% and 11.5% higher, respectively, on the day that patients refrained from eating breakfast than on the day that patients ate breakfast. Following lunch and dinner on the day that patients skipped breakfast, FFA values were higher (41.1% and 29.6%, respectively).

“We showed that the deleterious effects of breakfast omission triggering hyperglycemic response occurred after lunch and dinner, but the exact duration of this effect is not known,” wrote Dr. Jakubowicz and her colleagues. “In addition, the role of insulin sensitivity, suppression of hepatic glucose production, gastric emptying, and clock gene expression remain undefined.”

Read the full study in Diabetes Care (doi:10.2337/dc15-0761).

[email protected]

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
breakfast, type 2 diabetes
Author and Disclosure Information

Author and Disclosure Information

When type 2 diabetes patients skipped breakfast, they had higher levels of glucagon and free fatty acids (FFA), and reduced levels of insulin, C-peptide, and intact glucagonlike peptide-1 (iGLP-1) after meals, compared with when they ate breakfast, according to a randomized, open-label, cross-over-within-subject clinical trial.

A total of 22 overweight or obese people who had type 2 diabetes completed the study. Patients could not be taking GLP-1 analogs, anorectic drugs, steroids, or oral hypoglycemic agents, other than metformin. Seven of the patients had a history of hypertension and were treated with ACE inhibitors and/or calcium antagonists, wrote Dr. Daniela Jakubowicz of the Diabetes Unit in Hospital de Clinicas in Caracas, Venezuela.

At the Diabetes Unit, the patients participated in 2 full days of testing, separated by a washout period of 2-4 weeks. On one of the days, patients consumed three meals, including breakfast. On the other testing day, patients fasted until 1:30 p.m., consuming only lunch and dinner. All patients ate each of their meals during the same scheduled times; all meals contained identical macronutrient content and composition.

©MattZ90/thinkstockimages.com

Areas under the curve of data values for tested measures during an early response interval (0-30 minutes after eating a meal) and 0-180 minutes after eating a meal were calculated by the trapezoidal rule. These calculations were used as an estimate of response to meal consumption.

Plasma levels for glucose, insulin, C-peptide, and iGLP-1 were, respectively, 16.5%, 45%, 50%, and 33% higher before lunch, on the day that patients consumed breakfast, than they were on the day that they skipped breakfast.

The plasma FFA level was 1,787.1% higher for study participants on the day when they fasted until lunch than it was on the day when they ate breakfast. During tests taken 60-180 minutes after consumption of breakfast, patients’ glucagon levels were 12.5% lower than those of patients who fasted before lunch.

On the day that patients skipped breakfast, insulin was 17% lower after lunch and 7.9% lower after dinner, compared with the amounts of insulin found on the day that patients ate breakfast; iGLP-1 was also lower after dinner (16.5%) on the day that patients skipped breakfast.

After lunch and dinner, glucagon levels were 9.7% and 11.5% higher, respectively, on the day that patients refrained from eating breakfast than on the day that patients ate breakfast. Following lunch and dinner on the day that patients skipped breakfast, FFA values were higher (41.1% and 29.6%, respectively).

“We showed that the deleterious effects of breakfast omission triggering hyperglycemic response occurred after lunch and dinner, but the exact duration of this effect is not known,” wrote Dr. Jakubowicz and her colleagues. “In addition, the role of insulin sensitivity, suppression of hepatic glucose production, gastric emptying, and clock gene expression remain undefined.”

Read the full study in Diabetes Care (doi:10.2337/dc15-0761).

[email protected]

When type 2 diabetes patients skipped breakfast, they had higher levels of glucagon and free fatty acids (FFA), and reduced levels of insulin, C-peptide, and intact glucagonlike peptide-1 (iGLP-1) after meals, compared with when they ate breakfast, according to a randomized, open-label, cross-over-within-subject clinical trial.

A total of 22 overweight or obese people who had type 2 diabetes completed the study. Patients could not be taking GLP-1 analogs, anorectic drugs, steroids, or oral hypoglycemic agents, other than metformin. Seven of the patients had a history of hypertension and were treated with ACE inhibitors and/or calcium antagonists, wrote Dr. Daniela Jakubowicz of the Diabetes Unit in Hospital de Clinicas in Caracas, Venezuela.

At the Diabetes Unit, the patients participated in 2 full days of testing, separated by a washout period of 2-4 weeks. On one of the days, patients consumed three meals, including breakfast. On the other testing day, patients fasted until 1:30 p.m., consuming only lunch and dinner. All patients ate each of their meals during the same scheduled times; all meals contained identical macronutrient content and composition.

©MattZ90/thinkstockimages.com

Areas under the curve of data values for tested measures during an early response interval (0-30 minutes after eating a meal) and 0-180 minutes after eating a meal were calculated by the trapezoidal rule. These calculations were used as an estimate of response to meal consumption.

Plasma levels for glucose, insulin, C-peptide, and iGLP-1 were, respectively, 16.5%, 45%, 50%, and 33% higher before lunch, on the day that patients consumed breakfast, than they were on the day that they skipped breakfast.

The plasma FFA level was 1,787.1% higher for study participants on the day when they fasted until lunch than it was on the day when they ate breakfast. During tests taken 60-180 minutes after consumption of breakfast, patients’ glucagon levels were 12.5% lower than those of patients who fasted before lunch.

On the day that patients skipped breakfast, insulin was 17% lower after lunch and 7.9% lower after dinner, compared with the amounts of insulin found on the day that patients ate breakfast; iGLP-1 was also lower after dinner (16.5%) on the day that patients skipped breakfast.

After lunch and dinner, glucagon levels were 9.7% and 11.5% higher, respectively, on the day that patients refrained from eating breakfast than on the day that patients ate breakfast. Following lunch and dinner on the day that patients skipped breakfast, FFA values were higher (41.1% and 29.6%, respectively).

“We showed that the deleterious effects of breakfast omission triggering hyperglycemic response occurred after lunch and dinner, but the exact duration of this effect is not known,” wrote Dr. Jakubowicz and her colleagues. “In addition, the role of insulin sensitivity, suppression of hepatic glucose production, gastric emptying, and clock gene expression remain undefined.”

Read the full study in Diabetes Care (doi:10.2337/dc15-0761).

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
Skipping breakfast incites hyperglycemic response in type 2 diabetes patients
Display Headline
Skipping breakfast incites hyperglycemic response in type 2 diabetes patients
Legacy Keywords
breakfast, type 2 diabetes
Legacy Keywords
breakfast, type 2 diabetes
Article Source

FROM DIABETES CARE

PURLs Copyright

Inside the Article

NICE recommends empagliflozin in combo therapy for type 2 diabetes

Article Type
Changed
Tue, 05/03/2022 - 15:39
Display Headline
NICE recommends empagliflozin in combo therapy for type 2 diabetes

The National Institute for Health and Care Excellence (NICE) has issued guidance on the clinical and cost-effectiveness of empagliflozin in combination therapy for treatment of type 2 diabetes.

The guideline, released in March, is for advanced-practice nurses, nurses, physician assistants, and physicians, according to a summary by the National Guideline Clearinghouse (NGC).

The summary lists recommendations by NICE for treatment of type 2 diabetes as follows:

• Empagliflozin in a dual-therapy regimen in combination with metformin, only if a sulfonylurea is contraindicated or not tolerated, or if the person is at significant risk of hypoglycemia or its consequences.

• Empagliflozin in a triple-therapy regimen, in combination with metformin and a sulfonylurea or metformin and a thiazolidinedione.

• Empagliflozin in combination with insulin with or without other antidiabetic drugs.

According to the summary, the most commonly reported adverse reactions for empagliflozin are hypoglycemia in combination with insulin or a sulfonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria.

As for the cost-effectiveness, an appraisal committee independent of NICE “concluded that the very small differences in costs and quality-adjusted life years between empagliflozin (10 mg and 25 mg) and its key comparators showed that empagliflozin was a cost-effective use of National Health Service resources as dual therapy in combination with metformin, triple therapy in combination with metformin and either a sulfonylurea or a thiazolidinedione, and as an add-on treatment to insulin.”

[email protected]

References

Author and Disclosure Information

Publications
Topics
Sections
Author and Disclosure Information

Author and Disclosure Information

The National Institute for Health and Care Excellence (NICE) has issued guidance on the clinical and cost-effectiveness of empagliflozin in combination therapy for treatment of type 2 diabetes.

The guideline, released in March, is for advanced-practice nurses, nurses, physician assistants, and physicians, according to a summary by the National Guideline Clearinghouse (NGC).

The summary lists recommendations by NICE for treatment of type 2 diabetes as follows:

• Empagliflozin in a dual-therapy regimen in combination with metformin, only if a sulfonylurea is contraindicated or not tolerated, or if the person is at significant risk of hypoglycemia or its consequences.

• Empagliflozin in a triple-therapy regimen, in combination with metformin and a sulfonylurea or metformin and a thiazolidinedione.

• Empagliflozin in combination with insulin with or without other antidiabetic drugs.

According to the summary, the most commonly reported adverse reactions for empagliflozin are hypoglycemia in combination with insulin or a sulfonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria.

As for the cost-effectiveness, an appraisal committee independent of NICE “concluded that the very small differences in costs and quality-adjusted life years between empagliflozin (10 mg and 25 mg) and its key comparators showed that empagliflozin was a cost-effective use of National Health Service resources as dual therapy in combination with metformin, triple therapy in combination with metformin and either a sulfonylurea or a thiazolidinedione, and as an add-on treatment to insulin.”

[email protected]

The National Institute for Health and Care Excellence (NICE) has issued guidance on the clinical and cost-effectiveness of empagliflozin in combination therapy for treatment of type 2 diabetes.

The guideline, released in March, is for advanced-practice nurses, nurses, physician assistants, and physicians, according to a summary by the National Guideline Clearinghouse (NGC).

The summary lists recommendations by NICE for treatment of type 2 diabetes as follows:

• Empagliflozin in a dual-therapy regimen in combination with metformin, only if a sulfonylurea is contraindicated or not tolerated, or if the person is at significant risk of hypoglycemia or its consequences.

• Empagliflozin in a triple-therapy regimen, in combination with metformin and a sulfonylurea or metformin and a thiazolidinedione.

• Empagliflozin in combination with insulin with or without other antidiabetic drugs.

According to the summary, the most commonly reported adverse reactions for empagliflozin are hypoglycemia in combination with insulin or a sulfonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria.

As for the cost-effectiveness, an appraisal committee independent of NICE “concluded that the very small differences in costs and quality-adjusted life years between empagliflozin (10 mg and 25 mg) and its key comparators showed that empagliflozin was a cost-effective use of National Health Service resources as dual therapy in combination with metformin, triple therapy in combination with metformin and either a sulfonylurea or a thiazolidinedione, and as an add-on treatment to insulin.”

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
NICE recommends empagliflozin in combo therapy for type 2 diabetes
Display Headline
NICE recommends empagliflozin in combo therapy for type 2 diabetes
Sections
Article Source

PURLs Copyright

Inside the Article

NICE advises on how to maintain, achieve healthy weight

Article Type
Changed
Fri, 01/18/2019 - 15:06
Display Headline
NICE advises on how to maintain, achieve healthy weight

The National Institute for Health and Care Excellence (NICE) has issued a new guideline on maintaining a healthy weight and preventing excess weight gain.

This guideline replaces section 1.1.1 of NICE’s guideline on obesity, CG43 (2006).

©wragg/iStockphoto.com

The guideline, for those who educate people on how to maintain a healthy weight or prevent excess weight gain, comprises the following recommendations:

• Encourage people to make changes in line with existing advice.

• Encourage physical activity habits to avoid low energy expenditure.

• Encourage dietary habits that reduce the risk of excess energy intake.

• Provide further advice for parents and carers of children and young people.

• Encourage adults to limit the amount of alcohol they drink.

• Encourage self-monitoring.

• Clearly communicate the benefits of maintaining a healthy weight.

• Clearly communicate the benefits of gradual improvements to physical activity and dietary habits.

• Tailor messages for specific groups.

• Ensure activities are integrated with the local strategic approach to obesity.

[email protected]

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
weight, NICE, National Institute for Health Care Excellence
Sections
Author and Disclosure Information

Author and Disclosure Information

The National Institute for Health and Care Excellence (NICE) has issued a new guideline on maintaining a healthy weight and preventing excess weight gain.

This guideline replaces section 1.1.1 of NICE’s guideline on obesity, CG43 (2006).

©wragg/iStockphoto.com

The guideline, for those who educate people on how to maintain a healthy weight or prevent excess weight gain, comprises the following recommendations:

• Encourage people to make changes in line with existing advice.

• Encourage physical activity habits to avoid low energy expenditure.

• Encourage dietary habits that reduce the risk of excess energy intake.

• Provide further advice for parents and carers of children and young people.

• Encourage adults to limit the amount of alcohol they drink.

• Encourage self-monitoring.

• Clearly communicate the benefits of maintaining a healthy weight.

• Clearly communicate the benefits of gradual improvements to physical activity and dietary habits.

• Tailor messages for specific groups.

• Ensure activities are integrated with the local strategic approach to obesity.

[email protected]

The National Institute for Health and Care Excellence (NICE) has issued a new guideline on maintaining a healthy weight and preventing excess weight gain.

This guideline replaces section 1.1.1 of NICE’s guideline on obesity, CG43 (2006).

©wragg/iStockphoto.com

The guideline, for those who educate people on how to maintain a healthy weight or prevent excess weight gain, comprises the following recommendations:

• Encourage people to make changes in line with existing advice.

• Encourage physical activity habits to avoid low energy expenditure.

• Encourage dietary habits that reduce the risk of excess energy intake.

• Provide further advice for parents and carers of children and young people.

• Encourage adults to limit the amount of alcohol they drink.

• Encourage self-monitoring.

• Clearly communicate the benefits of maintaining a healthy weight.

• Clearly communicate the benefits of gradual improvements to physical activity and dietary habits.

• Tailor messages for specific groups.

• Ensure activities are integrated with the local strategic approach to obesity.

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
NICE advises on how to maintain, achieve healthy weight
Display Headline
NICE advises on how to maintain, achieve healthy weight
Legacy Keywords
weight, NICE, National Institute for Health Care Excellence
Legacy Keywords
weight, NICE, National Institute for Health Care Excellence
Sections
Article Source

PURLs Copyright

Inside the Article

Orbera intragastric balloon approved for weight loss in obese adults

Article Type
Changed
Fri, 01/18/2019 - 15:06
Display Headline
Orbera intragastric balloon approved for weight loss in obese adults

Another endoscopically delivered intragastric balloon indicated as a weight loss aid in obese adults has been approved by the Food and Drug Administration.

The Orbera intragastric balloon has been approved as a treatment for weight loss, in obese adults, with a body mass index between 30 and 40 kg/m2, the manufacturer, Apollo Endosurgery, announced on Aug. 6. It is intended for obese adults who are considering invasive surgery or for whom invasive surgery is not appropriate, when diet and exercise or pharmaceutical interventions have not worked, the statement said.

Courtesy Orbera Weight Loss
The Orbera intragastric balloon is filled with saline.

During a 20- to 30-minute procedure, the deflated Orbera silicone balloon is placed in the stomach via an endoscopic procedure under a mild sedative, where it is then filled with saline until it is about the size of a grapefruit, according to the company. The patient usually can go home on the same day; the balloon is deflated and removed 6 months later. The company will provide patients with an individualized weight-loss program for patients for 1 year, starting from the time of balloon placement.

The approval of this device follows the approval of the ReShape intragastric balloon for obese adults, for up to 6 months, announced by the FDA on July 28. ReShape was the first such device to be approved in the United States.

The results of the pivotal U.S. 12-month multicenter trial of the Orbera balloon in more than 250 obese adults with a BMI of 30-40 kg/m2 were reported at the Digestive Disease Week meeting in May, by Dr. Barham K. Abu Dayyeh of the Mayo Clinic in Rochester, Minn. For more than 2 years, patients were randomized to a 12-month behavioral modification program, with or without endoscopic placement of the balloon, which was removed at 6 months. Eighteen patients withdrew before treatment; 215 patients were evaluable at 6 months, 206 at 9 months, and 191 at 12 months.

At 6 months, the mean percent total body weight loss was about 10% in the balloon group, vs. 4% in the control group, a significant difference (P less than .001). In addition, the total body weight loss was significantly higher in the balloon group at 3, 6, 9, and 12 months, and the mean percent of excess weight loss at 6 months was better in the balloon group than in the control group (about 40% vs. 13%; P less than .001), he said at the meeting. The majority of excess weight loss achieved at 6 months was also maintained at 12 months.

Serious adverse events were reported in 7% of controls and almost 10% of the balloon group, which included eight early removals for intolerance, one gastric outlet obstruction, one laryngospasm during placement, one case of severe abdominal cramping, and one case of severe dehydration. Early device removals occurred in 22% of patients, 15 for symptoms and 13 at subject request, Dr. Abu Dayyeh said. There were no deaths during the study.

The Orbera balloon has been available in more than 80 countries, according to the manufacturer.

More information is available on the FDA website.

[email protected]

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
intragastric, balloon, weight, loss, obesity, ReShape, FDA
Author and Disclosure Information

Author and Disclosure Information

Related Articles

Another endoscopically delivered intragastric balloon indicated as a weight loss aid in obese adults has been approved by the Food and Drug Administration.

The Orbera intragastric balloon has been approved as a treatment for weight loss, in obese adults, with a body mass index between 30 and 40 kg/m2, the manufacturer, Apollo Endosurgery, announced on Aug. 6. It is intended for obese adults who are considering invasive surgery or for whom invasive surgery is not appropriate, when diet and exercise or pharmaceutical interventions have not worked, the statement said.

Courtesy Orbera Weight Loss
The Orbera intragastric balloon is filled with saline.

During a 20- to 30-minute procedure, the deflated Orbera silicone balloon is placed in the stomach via an endoscopic procedure under a mild sedative, where it is then filled with saline until it is about the size of a grapefruit, according to the company. The patient usually can go home on the same day; the balloon is deflated and removed 6 months later. The company will provide patients with an individualized weight-loss program for patients for 1 year, starting from the time of balloon placement.

The approval of this device follows the approval of the ReShape intragastric balloon for obese adults, for up to 6 months, announced by the FDA on July 28. ReShape was the first such device to be approved in the United States.

The results of the pivotal U.S. 12-month multicenter trial of the Orbera balloon in more than 250 obese adults with a BMI of 30-40 kg/m2 were reported at the Digestive Disease Week meeting in May, by Dr. Barham K. Abu Dayyeh of the Mayo Clinic in Rochester, Minn. For more than 2 years, patients were randomized to a 12-month behavioral modification program, with or without endoscopic placement of the balloon, which was removed at 6 months. Eighteen patients withdrew before treatment; 215 patients were evaluable at 6 months, 206 at 9 months, and 191 at 12 months.

At 6 months, the mean percent total body weight loss was about 10% in the balloon group, vs. 4% in the control group, a significant difference (P less than .001). In addition, the total body weight loss was significantly higher in the balloon group at 3, 6, 9, and 12 months, and the mean percent of excess weight loss at 6 months was better in the balloon group than in the control group (about 40% vs. 13%; P less than .001), he said at the meeting. The majority of excess weight loss achieved at 6 months was also maintained at 12 months.

Serious adverse events were reported in 7% of controls and almost 10% of the balloon group, which included eight early removals for intolerance, one gastric outlet obstruction, one laryngospasm during placement, one case of severe abdominal cramping, and one case of severe dehydration. Early device removals occurred in 22% of patients, 15 for symptoms and 13 at subject request, Dr. Abu Dayyeh said. There were no deaths during the study.

The Orbera balloon has been available in more than 80 countries, according to the manufacturer.

More information is available on the FDA website.

[email protected]

Another endoscopically delivered intragastric balloon indicated as a weight loss aid in obese adults has been approved by the Food and Drug Administration.

The Orbera intragastric balloon has been approved as a treatment for weight loss, in obese adults, with a body mass index between 30 and 40 kg/m2, the manufacturer, Apollo Endosurgery, announced on Aug. 6. It is intended for obese adults who are considering invasive surgery or for whom invasive surgery is not appropriate, when diet and exercise or pharmaceutical interventions have not worked, the statement said.

Courtesy Orbera Weight Loss
The Orbera intragastric balloon is filled with saline.

During a 20- to 30-minute procedure, the deflated Orbera silicone balloon is placed in the stomach via an endoscopic procedure under a mild sedative, where it is then filled with saline until it is about the size of a grapefruit, according to the company. The patient usually can go home on the same day; the balloon is deflated and removed 6 months later. The company will provide patients with an individualized weight-loss program for patients for 1 year, starting from the time of balloon placement.

The approval of this device follows the approval of the ReShape intragastric balloon for obese adults, for up to 6 months, announced by the FDA on July 28. ReShape was the first such device to be approved in the United States.

The results of the pivotal U.S. 12-month multicenter trial of the Orbera balloon in more than 250 obese adults with a BMI of 30-40 kg/m2 were reported at the Digestive Disease Week meeting in May, by Dr. Barham K. Abu Dayyeh of the Mayo Clinic in Rochester, Minn. For more than 2 years, patients were randomized to a 12-month behavioral modification program, with or without endoscopic placement of the balloon, which was removed at 6 months. Eighteen patients withdrew before treatment; 215 patients were evaluable at 6 months, 206 at 9 months, and 191 at 12 months.

At 6 months, the mean percent total body weight loss was about 10% in the balloon group, vs. 4% in the control group, a significant difference (P less than .001). In addition, the total body weight loss was significantly higher in the balloon group at 3, 6, 9, and 12 months, and the mean percent of excess weight loss at 6 months was better in the balloon group than in the control group (about 40% vs. 13%; P less than .001), he said at the meeting. The majority of excess weight loss achieved at 6 months was also maintained at 12 months.

Serious adverse events were reported in 7% of controls and almost 10% of the balloon group, which included eight early removals for intolerance, one gastric outlet obstruction, one laryngospasm during placement, one case of severe abdominal cramping, and one case of severe dehydration. Early device removals occurred in 22% of patients, 15 for symptoms and 13 at subject request, Dr. Abu Dayyeh said. There were no deaths during the study.

The Orbera balloon has been available in more than 80 countries, according to the manufacturer.

More information is available on the FDA website.

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
Orbera intragastric balloon approved for weight loss in obese adults
Display Headline
Orbera intragastric balloon approved for weight loss in obese adults
Legacy Keywords
intragastric, balloon, weight, loss, obesity, ReShape, FDA
Legacy Keywords
intragastric, balloon, weight, loss, obesity, ReShape, FDA
Article Source

PURLs Copyright

Inside the Article

Laparoscopic sleeve gastrectomy: Comorbidity benefits fade with time

Avoid a rush to judgment
Article Type
Changed
Fri, 01/18/2019 - 15:06
Display Headline
Laparoscopic sleeve gastrectomy: Comorbidity benefits fade with time

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

[email protected]

References

Body

Laparoscopic sleeve gastrectomy [has evolved] very quickly during the last several years into the dominant procedure in use despite a complete void of information about the longer-term effects. [The investigators try] to address this ... but clearly raise more issues than they can answer.

Dr. Anita P. Courcoulas

It is unclear whether current studies will address critical questions about the long-term outcomes of bariatric surgery, including the sustainability of weight loss and comorbidity control and long-term complication rates. The answers will likely be generated over time not only by ... large-scale efforts but also by thoughtful inference that will be made through pooled analyses of data like that from [this study] and from many other disparate randomized and nonrandomized studies of bariatric surgery. It will take time, patience, and a willingness to avoid a rush to judgment. In the meantime, clinicians and prospective patients will need to discuss and weigh the evidence in a dynamic exchange driven not always by final conclusions but by the most current available data.

Dr. Anita Courcoulas is professor of surgery and chief of the section of minimally invasive bariatric and general surgery at the University of Pittsburgh. She reported receiving grants from Nutrisystem, Ethicon, and Covidien and serving as a project consultant for Ethicon and Apollo Endosurgery. She made her comments in an editorial that accompanied the study.

Author and Disclosure Information

Publications
Topics
Author and Disclosure Information

Author and Disclosure Information

Body

Laparoscopic sleeve gastrectomy [has evolved] very quickly during the last several years into the dominant procedure in use despite a complete void of information about the longer-term effects. [The investigators try] to address this ... but clearly raise more issues than they can answer.

Dr. Anita P. Courcoulas

It is unclear whether current studies will address critical questions about the long-term outcomes of bariatric surgery, including the sustainability of weight loss and comorbidity control and long-term complication rates. The answers will likely be generated over time not only by ... large-scale efforts but also by thoughtful inference that will be made through pooled analyses of data like that from [this study] and from many other disparate randomized and nonrandomized studies of bariatric surgery. It will take time, patience, and a willingness to avoid a rush to judgment. In the meantime, clinicians and prospective patients will need to discuss and weigh the evidence in a dynamic exchange driven not always by final conclusions but by the most current available data.

Dr. Anita Courcoulas is professor of surgery and chief of the section of minimally invasive bariatric and general surgery at the University of Pittsburgh. She reported receiving grants from Nutrisystem, Ethicon, and Covidien and serving as a project consultant for Ethicon and Apollo Endosurgery. She made her comments in an editorial that accompanied the study.

Body

Laparoscopic sleeve gastrectomy [has evolved] very quickly during the last several years into the dominant procedure in use despite a complete void of information about the longer-term effects. [The investigators try] to address this ... but clearly raise more issues than they can answer.

Dr. Anita P. Courcoulas

It is unclear whether current studies will address critical questions about the long-term outcomes of bariatric surgery, including the sustainability of weight loss and comorbidity control and long-term complication rates. The answers will likely be generated over time not only by ... large-scale efforts but also by thoughtful inference that will be made through pooled analyses of data like that from [this study] and from many other disparate randomized and nonrandomized studies of bariatric surgery. It will take time, patience, and a willingness to avoid a rush to judgment. In the meantime, clinicians and prospective patients will need to discuss and weigh the evidence in a dynamic exchange driven not always by final conclusions but by the most current available data.

Dr. Anita Courcoulas is professor of surgery and chief of the section of minimally invasive bariatric and general surgery at the University of Pittsburgh. She reported receiving grants from Nutrisystem, Ethicon, and Covidien and serving as a project consultant for Ethicon and Apollo Endosurgery. She made her comments in an editorial that accompanied the study.

Title
Avoid a rush to judgment
Avoid a rush to judgment

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

[email protected]

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

[email protected]

References

References

Publications
Publications
Topics
Article Type
Display Headline
Laparoscopic sleeve gastrectomy: Comorbidity benefits fade with time
Display Headline
Laparoscopic sleeve gastrectomy: Comorbidity benefits fade with time
Article Source

FROM JAMA SURGERY

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Laparoscopic sleeve gastrectomy (LSG) might not be the best surgical choice for bariatric patients with significant hyperlipidemia.

Major finding: One year after LSG, patients lost, on average, 76.8% of their excess weight. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%.

Data source: Retrospective study of 443 Israeli laparoscopic sleeve gastrectomies.

Disclosures: The investigators had no disclosures.