Clinician Reviews

A healthier lifestyle mitigated the impact of genetic factors on the risk of thyroid cancer, in a study based on data from more than 260,000 individuals.

Thyroid cancer has increased globally in recent years and ranks 9th among 36 cancers worldwide, at a considerable cost to health care systems, wrote Xiuming Feng of Guangxi Medical University, Nanning, Guangxi, China, and colleagues.

SciePro/Science Source

Both genetic and lifestyle factors are related to thyroid cancer; previous research suggests a heritability of about 50%, but data on the impact of modifiable lifestyle factors on thyroid cancer are limited, the researchers said.

In a prospective cohort study published in JAMA Network Open, the researchers used data from the UK Biobank and recruited adults aged 40-69 years during March 2006–October 2010. The final study population included 264,956 individuals of European descent. The median age of the participants was 57 years, and 52% were women.

Data on lifestyle behaviors were collected using interviews and questionnaires. The researchers constructed a total lifestyle score based on five variables: diet, physical activity, weight, smoking, and alcohol consumption. Each variable was assigned a score of 0 or 1, with 1 being favorable lifestyle behavior. Lifestyle was divided into three categories: unfavorable (scores 0-1), intermediate (score 2), and favorable (scores 3-5).

Each individual’s polygenic risk score (PRS) was categorized as low, intermediate, or high based on a meta–genome-wide association study of three cohorts.

The main outcome was the development of thyroid cancer.

The researchers identified 423 incident thyroid cancer cases over a median follow-up of 11.1 years.

Overall, higher PRSs were significantly associated with thyroid cancer (hazard ratio, 2.25; 95% confidence interval [CI], 1.91-2.64; P < .00001) as was an unfavorable lifestyle score (HR, 1.93; 95% CI, 1.50-2.49; P < .001 for trend).

An unfavorable lifestyle was significantly associated with thyroid cancer in the highest PRS group, and individuals with high PRS and unfavorable lifestyle had a nearly fivefold increased risk of thyroid cancer (HR, 4.89; 95% CI, 3.03-7.91; P < .001). By extension, “Adherence to a healthier lifestyle could decrease the incidence of thyroid cancer in individuals with a higher PRS,” the researchers wrote in their discussion.

The findings were limited by several factors, including the availability of only baseline lifestyle data, and lack of data on iodine intake, radiation exposure, experience, and family history, the researchers noted. Other limitations include the potential lack of generalizability to populations other than the individuals of European descent in the current study, they said.

However, the study is the first known to address the association among lifestyle, genetic factors, and risk of thyroid cancer, and was strengthened by the large study population, and the results suggest that lifestyle interventions may help reduce the risk of thyroid cancer in those with a genetic predisposition, they concluded.

Healthy living can make a difference

The incidence of thyroid cancer has increased annually, and exploring the possible risk factors could prevent the occurrence of thyroid cancer, corresponding author Xiaobo Yang, PhD, said in an interview.

Previous studies have reported that thyroid cancer is related to genetics and lifestyle, said Dr. Yang. “However, whether healthy lifestyle was associated with thyroid cancer risk and could attenuate the impact of genetic variants on thyroid cancer remains equivocal; therefore, it is crucial to determine the associations between genetic and lifestyle with thyroid cancer,” he said.

“To our surprise, we found that adherence to healthier lifestyle also could reduce the risk of thyroid cancer in those with high genetic predispositions,” said Dr. Yang. “The findings highlight the potential role of lifestyle interventions on thyroid cancer, especially in those with high genetic risk, because the heritability of thyroid cancer was very high, approximately 50%,” he said. “More attention should be paid to the role of healthier lifestyle in the prevention of cancer,” he added.

“Adherence to a healthier lifestyle could decrease the risk of thyroid cancer, which is the important message for clinicians,” said Dr. Yang. “It is not too soon to comment on implications for clinical practice, because many studies have maintained the consistent comment that healthier lifestyle could prevent the occurrence of cancer,” he said.

The relationship between sex-specific lifestyle factors such as smoking and alcohol use and thyroid cancer remains uncertain, and more research is needed to validate these associations, Dr. Yang said. More research also is needed to confirm the complex mechanism between lifestyle and genetics in thyroid cancer, he added.

The study was supported by the National Key R&D Program of China and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

A healthier lifestyle mitigated the impact of genetic factors on the risk of thyroid cancer, in a study based on data from more than 260,000 individuals.

Thyroid cancer has increased globally in recent years and ranks 9th among 36 cancers worldwide, at a considerable cost to health care systems, wrote Xiuming Feng of Guangxi Medical University, Nanning, Guangxi, China, and colleagues.

SciePro/Science Source

Both genetic and lifestyle factors are related to thyroid cancer; previous research suggests a heritability of about 50%, but data on the impact of modifiable lifestyle factors on thyroid cancer are limited, the researchers said.

In a prospective cohort study published in JAMA Network Open, the researchers used data from the UK Biobank and recruited adults aged 40-69 years during March 2006–October 2010. The final study population included 264,956 individuals of European descent. The median age of the participants was 57 years, and 52% were women.

Data on lifestyle behaviors were collected using interviews and questionnaires. The researchers constructed a total lifestyle score based on five variables: diet, physical activity, weight, smoking, and alcohol consumption. Each variable was assigned a score of 0 or 1, with 1 being favorable lifestyle behavior. Lifestyle was divided into three categories: unfavorable (scores 0-1), intermediate (score 2), and favorable (scores 3-5).

Each individual’s polygenic risk score (PRS) was categorized as low, intermediate, or high based on a meta–genome-wide association study of three cohorts.

The main outcome was the development of thyroid cancer.

The researchers identified 423 incident thyroid cancer cases over a median follow-up of 11.1 years.

Overall, higher PRSs were significantly associated with thyroid cancer (hazard ratio, 2.25; 95% confidence interval [CI], 1.91-2.64; P < .00001) as was an unfavorable lifestyle score (HR, 1.93; 95% CI, 1.50-2.49; P < .001 for trend).

An unfavorable lifestyle was significantly associated with thyroid cancer in the highest PRS group, and individuals with high PRS and unfavorable lifestyle had a nearly fivefold increased risk of thyroid cancer (HR, 4.89; 95% CI, 3.03-7.91; P < .001). By extension, “Adherence to a healthier lifestyle could decrease the incidence of thyroid cancer in individuals with a higher PRS,” the researchers wrote in their discussion.

The findings were limited by several factors, including the availability of only baseline lifestyle data, and lack of data on iodine intake, radiation exposure, experience, and family history, the researchers noted. Other limitations include the potential lack of generalizability to populations other than the individuals of European descent in the current study, they said.

However, the study is the first known to address the association among lifestyle, genetic factors, and risk of thyroid cancer, and was strengthened by the large study population, and the results suggest that lifestyle interventions may help reduce the risk of thyroid cancer in those with a genetic predisposition, they concluded.

Healthy living can make a difference

The incidence of thyroid cancer has increased annually, and exploring the possible risk factors could prevent the occurrence of thyroid cancer, corresponding author Xiaobo Yang, PhD, said in an interview.

Previous studies have reported that thyroid cancer is related to genetics and lifestyle, said Dr. Yang. “However, whether healthy lifestyle was associated with thyroid cancer risk and could attenuate the impact of genetic variants on thyroid cancer remains equivocal; therefore, it is crucial to determine the associations between genetic and lifestyle with thyroid cancer,” he said.

“To our surprise, we found that adherence to healthier lifestyle also could reduce the risk of thyroid cancer in those with high genetic predispositions,” said Dr. Yang. “The findings highlight the potential role of lifestyle interventions on thyroid cancer, especially in those with high genetic risk, because the heritability of thyroid cancer was very high, approximately 50%,” he said. “More attention should be paid to the role of healthier lifestyle in the prevention of cancer,” he added.

“Adherence to a healthier lifestyle could decrease the risk of thyroid cancer, which is the important message for clinicians,” said Dr. Yang. “It is not too soon to comment on implications for clinical practice, because many studies have maintained the consistent comment that healthier lifestyle could prevent the occurrence of cancer,” he said.

The relationship between sex-specific lifestyle factors such as smoking and alcohol use and thyroid cancer remains uncertain, and more research is needed to validate these associations, Dr. Yang said. More research also is needed to confirm the complex mechanism between lifestyle and genetics in thyroid cancer, he added.

The study was supported by the National Key R&D Program of China and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

A healthier lifestyle mitigated the impact of genetic factors on the risk of thyroid cancer, in a study based on data from more than 260,000 individuals.

Thyroid cancer has increased globally in recent years and ranks 9th among 36 cancers worldwide, at a considerable cost to health care systems, wrote Xiuming Feng of Guangxi Medical University, Nanning, Guangxi, China, and colleagues.

SciePro/Science Source

Both genetic and lifestyle factors are related to thyroid cancer; previous research suggests a heritability of about 50%, but data on the impact of modifiable lifestyle factors on thyroid cancer are limited, the researchers said.

In a prospective cohort study published in JAMA Network Open, the researchers used data from the UK Biobank and recruited adults aged 40-69 years during March 2006–October 2010. The final study population included 264,956 individuals of European descent. The median age of the participants was 57 years, and 52% were women.

Data on lifestyle behaviors were collected using interviews and questionnaires. The researchers constructed a total lifestyle score based on five variables: diet, physical activity, weight, smoking, and alcohol consumption. Each variable was assigned a score of 0 or 1, with 1 being favorable lifestyle behavior. Lifestyle was divided into three categories: unfavorable (scores 0-1), intermediate (score 2), and favorable (scores 3-5).

Each individual’s polygenic risk score (PRS) was categorized as low, intermediate, or high based on a meta–genome-wide association study of three cohorts.

The main outcome was the development of thyroid cancer.

The researchers identified 423 incident thyroid cancer cases over a median follow-up of 11.1 years.

Overall, higher PRSs were significantly associated with thyroid cancer (hazard ratio, 2.25; 95% confidence interval [CI], 1.91-2.64; P < .00001) as was an unfavorable lifestyle score (HR, 1.93; 95% CI, 1.50-2.49; P < .001 for trend).

An unfavorable lifestyle was significantly associated with thyroid cancer in the highest PRS group, and individuals with high PRS and unfavorable lifestyle had a nearly fivefold increased risk of thyroid cancer (HR, 4.89; 95% CI, 3.03-7.91; P < .001). By extension, “Adherence to a healthier lifestyle could decrease the incidence of thyroid cancer in individuals with a higher PRS,” the researchers wrote in their discussion.

The findings were limited by several factors, including the availability of only baseline lifestyle data, and lack of data on iodine intake, radiation exposure, experience, and family history, the researchers noted. Other limitations include the potential lack of generalizability to populations other than the individuals of European descent in the current study, they said.

However, the study is the first known to address the association among lifestyle, genetic factors, and risk of thyroid cancer, and was strengthened by the large study population, and the results suggest that lifestyle interventions may help reduce the risk of thyroid cancer in those with a genetic predisposition, they concluded.

Healthy living can make a difference

The incidence of thyroid cancer has increased annually, and exploring the possible risk factors could prevent the occurrence of thyroid cancer, corresponding author Xiaobo Yang, PhD, said in an interview.

Previous studies have reported that thyroid cancer is related to genetics and lifestyle, said Dr. Yang. “However, whether healthy lifestyle was associated with thyroid cancer risk and could attenuate the impact of genetic variants on thyroid cancer remains equivocal; therefore, it is crucial to determine the associations between genetic and lifestyle with thyroid cancer,” he said.

“To our surprise, we found that adherence to healthier lifestyle also could reduce the risk of thyroid cancer in those with high genetic predispositions,” said Dr. Yang. “The findings highlight the potential role of lifestyle interventions on thyroid cancer, especially in those with high genetic risk, because the heritability of thyroid cancer was very high, approximately 50%,” he said. “More attention should be paid to the role of healthier lifestyle in the prevention of cancer,” he added.

“Adherence to a healthier lifestyle could decrease the risk of thyroid cancer, which is the important message for clinicians,” said Dr. Yang. “It is not too soon to comment on implications for clinical practice, because many studies have maintained the consistent comment that healthier lifestyle could prevent the occurrence of cancer,” he said.

The relationship between sex-specific lifestyle factors such as smoking and alcohol use and thyroid cancer remains uncertain, and more research is needed to validate these associations, Dr. Yang said. More research also is needed to confirm the complex mechanism between lifestyle and genetics in thyroid cancer, he added.

The study was supported by the National Key R&D Program of China and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes – 2023.

The document, long considered the gold standard for care of the more than 100 million Americans living with diabetes and prediabetes, was published as a supplement in Diabetes Care. The guidelines are also accessible to doctors via an app; last year’s standards were accessed more than 4 million times.

The standards now advise a blood pressure target for people with diabetes of less than 130/80 mm Hg, and low-density lipoprotein (LDL) cholesterol targets of below 70 mg/dL or no greater than 55 mg/dL, depending on the individual’s cardiovascular risk.

Courtesy Joslin Diabetes Center

“In this year’s version of the ADA Standards of Care – the longstanding guidelines for diabetes management globally – you’ll see information that really speaks to how we can more aggressively treat diabetes and reduce complications in a variety of different ways,” ADA Chief Scientific and Medical Officer Robert A. Gabbay, MD, PhD, said in an interview.

Other changes for 2023 include a new emphasis on weight loss as a goal of therapy for type 2 diabetes; guidance for screening and assessing peripheral arterial disease in an effort to prevent amputations; use of finerenone in people with diabetes and chronic kidney disease; use of approved point-of-care A1c tests; and guidance on screening for food insecurity, along with an elevated role for community health workers.

“The management of type 2 diabetes is not just about glucose,” Dr. Gabbay emphasized, noting that the ADA Standards have increasingly focused on cardiorenal risk as well as weight management. “We need to think about all those things, not just one. We have better tools now that have been helpful in being able to move forward with this.”
 

New targets in cardiovascular disease and risk management

As it has been for the past 6 years, the section on cardiovascular disease and risk management is also endorsed by the American College of Cardiology.

The new definition of hypertension in people with diabetes is ≥ 130 mm Hg systolic or ≥ 80 mm Hg diastolic blood pressure, repeated on two measurements at different times. Among individuals with established cardiovascular disease, hypertension can be diagnosed with one measurement of ≥ 180/110 mm Hg.

The goal of treatment is now less than 130/80 mm Hg if it can be reached safely.

In 2012, easing of the systolic target to 140 mm Hg by the ADA caused some controversy.

But, as Dr. Gabbay explained: “The evidence wasn’t there 10 years ago. We stuck to the evidence at that time, although there was a belief that lower was better. Over the past decade, a number of studies have made it quite clear that there is benefit to a lower target. That’s why we staked out the ground on this.”

The new Standards of Care also has new lipid targets. For people with diabetes aged 40-75 years at increased cardiovascular risk, including those with one or more atherosclerotic risk factors, high-intensity statin therapy is recommended to reduce LDL cholesterol by 50% or more from baseline and to a target of less than 70 mg/dL, in contrast to the previous target of 100 mg/dL.  

To achieve that goal, the document advises to consider adding ezetimibe or a PCSK9 inhibitor to maximally tolerated statin therapy.

For people with diabetes aged 40-75 who have established cardiovascular disease, treatment with high-intensity statin therapy is recommended with the target of a 50% or greater reduction from baseline and an LDL cholesterol level of 55 mg/dL or lower, in contrast to the previous 70 mg/dL.

“That is a lower goal than previously recommended, and based on strong evidence in the literature,” Dr. Gabbay noted.

Here, a stronger recommendation is made for ezetimibe or a PCSK9 inhibitor added to maximal statins.

And for people with diabetes older than 75 years, those already on statins should continue taking them. For those who aren’t, it may be reasonable to initiate moderate-intensity statin therapy after discussion of the benefits and risks.

Another new recommendation based on recent trial data is use of a sodium–glucose cotransporter 2 (SGLT2) inhibitor in people with diabetes and heart failure with preserved, as well as reduced, ejection fraction.
 

Kidney disease guidance updated: SGLT2 inhibitors, finerenone

Another recommendation calls for the addition of finerenone for people with type 2 diabetes who have chronic kidney disease (CKD) with albuminuria and have been treated with the maximum tolerated doses of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) to improve cardiovascular outcomes as well as reduce the risk of CKD progression.

The threshold for initiating an SGLT2 inhibitor for kidney protection has changed to an estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m² and urinary albumin ≥ 200 mg/g creatinine (previously ≥ 25 mL/min/1.73 m² and ≥ 300 mg/g, respectively). An SGLT2 inhibitor may also be beneficial in people with a urinary albumin of normal to ≥ 200 mg/g creatinine, but supporting data have not yet been published.

Referral to a nephrologist is advised for individuals with increasing urinary albumin levels or continued decreasing eGFR or eGFR < 30 mL/min/1.73 m².
 

Weight loss, point-of-care testing, food insecurity assessment 

Other changes for 2023 include fresh emphasis on supporting weight loss of up to 15% with the new twincretin tirzepatide (Mounjaro) – approved in the United States in May for type 2 diabetes – added as a glucose-lowering drug with weight loss potential.

A novel section was added with guidance for peripheral arterial disease screening.

And a new recommendation advises use of point-of-care A1c testing for diabetes screening and diagnosis using only tests approved by the Food and Drug Administration.

Also introduced for 2023 is guidance to use community health workers to support the management of diabetes and cardiovascular risk factors, particularly in underserved areas and health systems.

“Community health workers can be a link to help people navigate and engage with the health system for better outcomes,” said Dr. Gabbay.

He added that these professionals are among those who can also assist with screening for food insecurity, another new recommendation. “We talk about screening for food insecurity and tools to use. That shouldn’t be something only dietitians do.”

Dr. Gabbay said he’d like to see more clinicians partner with community health workers. “We’d like to see more of that ... They should be considered part of the health care team,” he said.

Dr. Gabbay has reported serving on advisory boards for Lark, Health Reveal, Sweetch, StartUp Health, Vida Health, and Onduo.

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

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes – 2023.

The document, long considered the gold standard for care of the more than 100 million Americans living with diabetes and prediabetes, was published as a supplement in Diabetes Care. The guidelines are also accessible to doctors via an app; last year’s standards were accessed more than 4 million times.

The standards now advise a blood pressure target for people with diabetes of less than 130/80 mm Hg, and low-density lipoprotein (LDL) cholesterol targets of below 70 mg/dL or no greater than 55 mg/dL, depending on the individual’s cardiovascular risk.

Courtesy Joslin Diabetes Center

“In this year’s version of the ADA Standards of Care – the longstanding guidelines for diabetes management globally – you’ll see information that really speaks to how we can more aggressively treat diabetes and reduce complications in a variety of different ways,” ADA Chief Scientific and Medical Officer Robert A. Gabbay, MD, PhD, said in an interview.

Other changes for 2023 include a new emphasis on weight loss as a goal of therapy for type 2 diabetes; guidance for screening and assessing peripheral arterial disease in an effort to prevent amputations; use of finerenone in people with diabetes and chronic kidney disease; use of approved point-of-care A1c tests; and guidance on screening for food insecurity, along with an elevated role for community health workers.

“The management of type 2 diabetes is not just about glucose,” Dr. Gabbay emphasized, noting that the ADA Standards have increasingly focused on cardiorenal risk as well as weight management. “We need to think about all those things, not just one. We have better tools now that have been helpful in being able to move forward with this.”
 

New targets in cardiovascular disease and risk management

As it has been for the past 6 years, the section on cardiovascular disease and risk management is also endorsed by the American College of Cardiology.

The new definition of hypertension in people with diabetes is ≥ 130 mm Hg systolic or ≥ 80 mm Hg diastolic blood pressure, repeated on two measurements at different times. Among individuals with established cardiovascular disease, hypertension can be diagnosed with one measurement of ≥ 180/110 mm Hg.

The goal of treatment is now less than 130/80 mm Hg if it can be reached safely.

In 2012, easing of the systolic target to 140 mm Hg by the ADA caused some controversy.

But, as Dr. Gabbay explained: “The evidence wasn’t there 10 years ago. We stuck to the evidence at that time, although there was a belief that lower was better. Over the past decade, a number of studies have made it quite clear that there is benefit to a lower target. That’s why we staked out the ground on this.”

The new Standards of Care also has new lipid targets. For people with diabetes aged 40-75 years at increased cardiovascular risk, including those with one or more atherosclerotic risk factors, high-intensity statin therapy is recommended to reduce LDL cholesterol by 50% or more from baseline and to a target of less than 70 mg/dL, in contrast to the previous target of 100 mg/dL.  

To achieve that goal, the document advises to consider adding ezetimibe or a PCSK9 inhibitor to maximally tolerated statin therapy.

For people with diabetes aged 40-75 who have established cardiovascular disease, treatment with high-intensity statin therapy is recommended with the target of a 50% or greater reduction from baseline and an LDL cholesterol level of 55 mg/dL or lower, in contrast to the previous 70 mg/dL.

“That is a lower goal than previously recommended, and based on strong evidence in the literature,” Dr. Gabbay noted.

Here, a stronger recommendation is made for ezetimibe or a PCSK9 inhibitor added to maximal statins.

And for people with diabetes older than 75 years, those already on statins should continue taking them. For those who aren’t, it may be reasonable to initiate moderate-intensity statin therapy after discussion of the benefits and risks.

Another new recommendation based on recent trial data is use of a sodium–glucose cotransporter 2 (SGLT2) inhibitor in people with diabetes and heart failure with preserved, as well as reduced, ejection fraction.
 

Kidney disease guidance updated: SGLT2 inhibitors, finerenone

Another recommendation calls for the addition of finerenone for people with type 2 diabetes who have chronic kidney disease (CKD) with albuminuria and have been treated with the maximum tolerated doses of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) to improve cardiovascular outcomes as well as reduce the risk of CKD progression.

The threshold for initiating an SGLT2 inhibitor for kidney protection has changed to an estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m² and urinary albumin ≥ 200 mg/g creatinine (previously ≥ 25 mL/min/1.73 m² and ≥ 300 mg/g, respectively). An SGLT2 inhibitor may also be beneficial in people with a urinary albumin of normal to ≥ 200 mg/g creatinine, but supporting data have not yet been published.

Referral to a nephrologist is advised for individuals with increasing urinary albumin levels or continued decreasing eGFR or eGFR < 30 mL/min/1.73 m².
 

Weight loss, point-of-care testing, food insecurity assessment 

Other changes for 2023 include fresh emphasis on supporting weight loss of up to 15% with the new twincretin tirzepatide (Mounjaro) – approved in the United States in May for type 2 diabetes – added as a glucose-lowering drug with weight loss potential.

A novel section was added with guidance for peripheral arterial disease screening.

And a new recommendation advises use of point-of-care A1c testing for diabetes screening and diagnosis using only tests approved by the Food and Drug Administration.

Also introduced for 2023 is guidance to use community health workers to support the management of diabetes and cardiovascular risk factors, particularly in underserved areas and health systems.

“Community health workers can be a link to help people navigate and engage with the health system for better outcomes,” said Dr. Gabbay.

He added that these professionals are among those who can also assist with screening for food insecurity, another new recommendation. “We talk about screening for food insecurity and tools to use. That shouldn’t be something only dietitians do.”

Dr. Gabbay said he’d like to see more clinicians partner with community health workers. “We’d like to see more of that ... They should be considered part of the health care team,” he said.

Dr. Gabbay has reported serving on advisory boards for Lark, Health Reveal, Sweetch, StartUp Health, Vida Health, and Onduo.

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

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes – 2023.

The document, long considered the gold standard for care of the more than 100 million Americans living with diabetes and prediabetes, was published as a supplement in Diabetes Care. The guidelines are also accessible to doctors via an app; last year’s standards were accessed more than 4 million times.

The standards now advise a blood pressure target for people with diabetes of less than 130/80 mm Hg, and low-density lipoprotein (LDL) cholesterol targets of below 70 mg/dL or no greater than 55 mg/dL, depending on the individual’s cardiovascular risk.

Courtesy Joslin Diabetes Center

“In this year’s version of the ADA Standards of Care – the longstanding guidelines for diabetes management globally – you’ll see information that really speaks to how we can more aggressively treat diabetes and reduce complications in a variety of different ways,” ADA Chief Scientific and Medical Officer Robert A. Gabbay, MD, PhD, said in an interview.

Other changes for 2023 include a new emphasis on weight loss as a goal of therapy for type 2 diabetes; guidance for screening and assessing peripheral arterial disease in an effort to prevent amputations; use of finerenone in people with diabetes and chronic kidney disease; use of approved point-of-care A1c tests; and guidance on screening for food insecurity, along with an elevated role for community health workers.

“The management of type 2 diabetes is not just about glucose,” Dr. Gabbay emphasized, noting that the ADA Standards have increasingly focused on cardiorenal risk as well as weight management. “We need to think about all those things, not just one. We have better tools now that have been helpful in being able to move forward with this.”
 

New targets in cardiovascular disease and risk management

As it has been for the past 6 years, the section on cardiovascular disease and risk management is also endorsed by the American College of Cardiology.

The new definition of hypertension in people with diabetes is ≥ 130 mm Hg systolic or ≥ 80 mm Hg diastolic blood pressure, repeated on two measurements at different times. Among individuals with established cardiovascular disease, hypertension can be diagnosed with one measurement of ≥ 180/110 mm Hg.

The goal of treatment is now less than 130/80 mm Hg if it can be reached safely.

In 2012, easing of the systolic target to 140 mm Hg by the ADA caused some controversy.

But, as Dr. Gabbay explained: “The evidence wasn’t there 10 years ago. We stuck to the evidence at that time, although there was a belief that lower was better. Over the past decade, a number of studies have made it quite clear that there is benefit to a lower target. That’s why we staked out the ground on this.”

The new Standards of Care also has new lipid targets. For people with diabetes aged 40-75 years at increased cardiovascular risk, including those with one or more atherosclerotic risk factors, high-intensity statin therapy is recommended to reduce LDL cholesterol by 50% or more from baseline and to a target of less than 70 mg/dL, in contrast to the previous target of 100 mg/dL.  

To achieve that goal, the document advises to consider adding ezetimibe or a PCSK9 inhibitor to maximally tolerated statin therapy.

For people with diabetes aged 40-75 who have established cardiovascular disease, treatment with high-intensity statin therapy is recommended with the target of a 50% or greater reduction from baseline and an LDL cholesterol level of 55 mg/dL or lower, in contrast to the previous 70 mg/dL.

“That is a lower goal than previously recommended, and based on strong evidence in the literature,” Dr. Gabbay noted.

Here, a stronger recommendation is made for ezetimibe or a PCSK9 inhibitor added to maximal statins.

And for people with diabetes older than 75 years, those already on statins should continue taking them. For those who aren’t, it may be reasonable to initiate moderate-intensity statin therapy after discussion of the benefits and risks.

Another new recommendation based on recent trial data is use of a sodium–glucose cotransporter 2 (SGLT2) inhibitor in people with diabetes and heart failure with preserved, as well as reduced, ejection fraction.
 

Kidney disease guidance updated: SGLT2 inhibitors, finerenone

Another recommendation calls for the addition of finerenone for people with type 2 diabetes who have chronic kidney disease (CKD) with albuminuria and have been treated with the maximum tolerated doses of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) to improve cardiovascular outcomes as well as reduce the risk of CKD progression.

The threshold for initiating an SGLT2 inhibitor for kidney protection has changed to an estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m² and urinary albumin ≥ 200 mg/g creatinine (previously ≥ 25 mL/min/1.73 m² and ≥ 300 mg/g, respectively). An SGLT2 inhibitor may also be beneficial in people with a urinary albumin of normal to ≥ 200 mg/g creatinine, but supporting data have not yet been published.

Referral to a nephrologist is advised for individuals with increasing urinary albumin levels or continued decreasing eGFR or eGFR < 30 mL/min/1.73 m².
 

Weight loss, point-of-care testing, food insecurity assessment 

Other changes for 2023 include fresh emphasis on supporting weight loss of up to 15% with the new twincretin tirzepatide (Mounjaro) – approved in the United States in May for type 2 diabetes – added as a glucose-lowering drug with weight loss potential.

A novel section was added with guidance for peripheral arterial disease screening.

And a new recommendation advises use of point-of-care A1c testing for diabetes screening and diagnosis using only tests approved by the Food and Drug Administration.

Also introduced for 2023 is guidance to use community health workers to support the management of diabetes and cardiovascular risk factors, particularly in underserved areas and health systems.

“Community health workers can be a link to help people navigate and engage with the health system for better outcomes,” said Dr. Gabbay.

He added that these professionals are among those who can also assist with screening for food insecurity, another new recommendation. “We talk about screening for food insecurity and tools to use. That shouldn’t be something only dietitians do.”

Dr. Gabbay said he’d like to see more clinicians partner with community health workers. “We’d like to see more of that ... They should be considered part of the health care team,” he said.

Dr. Gabbay has reported serving on advisory boards for Lark, Health Reveal, Sweetch, StartUp Health, Vida Health, and Onduo.

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

It was the last monoclonal antibody treatment standing. But less than 10 months after the U.S. Food and Drug Administration gave bebtelovimab its emergency use authorization (EUA) to fight COVID-19, it earlier this month de-authorized it, just as it had for other monoclonal antibody treatments, and for the same reason: The treatments were outwitted by the viral mutations.
 

Bebtelovimab couldn’t neutralize the Omicron subvariants BQ.1 and BQ.1.1, the cause of nearly 60% of COVID cases nationally as of November 30.

Next on the chopping block, some predict, will be Evusheld, the combination of tixagevimab and cilgavimab given as a preventive monoclonal antibody to people who are immunocompromised and at high risk of contracting COVID and to those who can’t take the vaccine. In October, the FDA warned that Evusheld was not neutralizing circulating COVID variants.

As the options for treating and preventing COVID decline, will companies rally quickly to develop new ones, or cut their losses in developing treatments that may work for only a few months, given the speed of viral mutations?

But although monoclonal antibody treatments are off the table, at least for now, antiviral drugs – including Paxlovid – are still very much available, and some say underused.

Others suggest it’s time to resurrect interest in convalescent plasma, a treatment used early in the pandemic before drugs or vaccines were here and still authorized for use in those who are immunosuppressed or receiving immunosuppressive treatment.

And on the prevention front, staying up to date with booster vaccines, masking, and taking other precautions should be stressed more, others say, regardless of the number of treatment options, and especially now, as cases rise and people gather for the winter holidays.
 

‘A major setback’

The bebtelovimab de-authorization was “a major setback,” but an understandable one, said Arturo Casadevall, MD, PhD, professor and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Monoclonal antibodies are great drugs. We are in an unfortunate situation in that they are vulnerable to changes in the virus” and can’t offer long-lasting protection.

Supplies of bebtelovimab will be retained, according to the FDA, in case variants susceptible to it return.

“What happened to bebtelovimab is no surprise,” agreed Amesh Adalja, MD, senior scholar at Johns Hopkins Center for Health Security. “This is what is going to happen when you are targeting a virus that mutates a lot.”

Monoclonal antibodies work by binding to the spike protein on the virus surface to prevent it from entering cells.

However, Dr. Adalja doesn’t view the disappearance of monoclonal antibody treatments as a major setback. Monoclonal antibodies were not the primary way COVID was treated, he said.

While he does believe it’s important that more monoclonal antibody treatments be developed, “I think it’s important to remember we still have Paxlovid while everyone is lamenting the loss of bebtelovimab.’’
 

Antivirals: What’s here, what’s coming

Compared with monoclonal antibodies, “Paxlovid remains a much easier drug to give,” Dr. Adalja told this news organization, because it is taken orally, not intravenously.

And it’s effective. In a recent study, researchers found that adults diagnosed with COVID given Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within the next 30 days than those not given it. Another study shows it could also reduce a person’s risk of developing long COVID by 26%.

Paxlovid is underused, Dr. Adalja said, partly because the rebound potential got more press than the effectiveness. When a celebrity got rebound from Paxlovid, he said, that would make the news, overshadowing the research on its effectiveness.

Besides Paxlovid, the antivirals remdesivir (Veklury), given intravenously for 3 days, and molnupiravir (Lagevrio), taken orally, are also still available. Antivirals work by targeting specific parts of the virus to prevent it from multiplying.

In the lab, remdesivir, molnupiravir, and another antiviral, nirmatrelvir, all appear to be effective against both BQ.1.1 (a BA.5 subvariant) and XBB (a BA.2 subvariant), both rapidly rising in the United States, according to a report last week in the New England Journal of Medicine.

The researchers also tested several monoclonal antibodies and found they did not neutralize either of the subvariants BQ.1.1 and XBB.

A new oral antiviral, Xocova (ensitrelvir fumaric acid), from Japanese manufacturer Shionogi, received emergency approval in Japan on November 22. It’s taken once a day for 5 days. The goal is to expand access to it globally, according to the company.

Pardes Biosciences launched a phase 2 trial in September for its oral antiviral drug (PBI-0451), under study as a treatment and preventive for COVID. It expects data by the first quarter of 2023.

Pfizer, which makes Paxlovid, has partnered with Clear Creek Bio to develop another oral antiviral COVID drug.
 

Other approaches

A receptor protein known as ACE2 (angiotensin-converting enzyme 2) is the main “doorway” that SARS-CoV-2 uses to enter and infect cells.

Dana-Farber Cancer Institute scientists are developing a “decoy” drug that works by mimicking the ACE2 receptor on the surface of cells; when the virus tries to bind to it, the spike protein is destroyed. Human trials have not yet started.

Other researchers are investigating whether an already-approved drug used to treat a liver disease, Actigall (UDCA/ursodeoxycholic acid), could protect against COVID infection by reducing ACE2.

So far, the researchers have found in early research that people taking UDCA for liver conditions were less likely than those not taking the drug to have severe COVID. They also found that UDCA reduced SARS-CoV-2 infection in human lungs maintained outside the body.
 

Monoclonal antibody treatments?

After the FDA decision to withdraw the bebtelovimab EUA, which Eli Lilly said it agreed with, the company issued a statement, promising it wasn’t giving up on monoclonal antibody treatments.

“Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants,” it read in part.

AstraZeneca, which makes Evusheld, is also continuing to work on monoclonal antibody development. According to a spokesperson, “We are also developing a new long-acting antibody combination – AZD5156 – which has been shown in the lab to neutralize emerging new variants and all known variants to date. We are working to accelerate the development of AZD5156 to make it available at the end of 2023.”

The AstraZeneca spokesperson said he could share no more information about what the combination would include.
 

A convalescent plasma comeback?

Although Paxlovid can help, there are many contraindications to it, such as drug-drug interactions, Dr. Casadevall told this news organization. And now that the monoclonal antibody treatments have been paused, convalescent plasma “is the only antibody-based therapy that is reliably available. Convalescent plasma includes thousands of different antibodies.”

With his colleagues, Dr. Casadevall evaluated plasma samples from 740 patients. Some had received booster vaccines and been infected with Omicron, others had received boosters and not been infected, and still others had not been vaccinated and became infected.

In a report (not yet peer-reviewed), they found the plasma from those who had been infected or boosted within the past 6 months neutralized the new Omicron variants BQ.1.1, XBB.1, and BF.7.
 

A push for boosters, masks

To get through the coming months, taking precautions like masking and distancing and staying up to date on booster vaccinations, especially for older adults, can make a difference, other experts say.

In a Twitter thread in early December, Peter Hotez, MD, PhD, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, Houston, urged people to take COVID seriously as holiday parties and gatherings occur.

“The single most impactful thing you can do is get your bivalent booster,” he tweeted, as well as give your kids the booster, citing preliminary research that the bivalent mRNA booster broadens immunity against the Omicron subvariants.

For seniors, he said, ‘‘if you get breakthrough COVID, [it’s] really important to get Paxlovid.” Masks will help not only for COVID but also influenza, respiratory syncytial virus (RSV), and other conditions.

Mitigation measures have largely been abandoned, according to Eric Topol, MD, director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape. In an op-ed in the Los Angeles Times, and on his Twitter feed, he reminds people about masking and urges people to get the bivalent booster.

According to the Centers for Disease Control and Prevention, as of Dec. 8, only 13.5% of people aged 5 and older have gotten an updated booster, despite research that shows an increase in antibodies to BQ.1.1. Recent research has found that the bivalent booster increases antibodies to BQ.1.1 by up to 10-fold, Dr. Topol said.

Dr. Adalja is on advisory boards for Shionogi, GSK, and Pardes. Dr. Casadevall reports no relevant financial relationships.

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

It was the last monoclonal antibody treatment standing. But less than 10 months after the U.S. Food and Drug Administration gave bebtelovimab its emergency use authorization (EUA) to fight COVID-19, it earlier this month de-authorized it, just as it had for other monoclonal antibody treatments, and for the same reason: The treatments were outwitted by the viral mutations.
 

Bebtelovimab couldn’t neutralize the Omicron subvariants BQ.1 and BQ.1.1, the cause of nearly 60% of COVID cases nationally as of November 30.

Next on the chopping block, some predict, will be Evusheld, the combination of tixagevimab and cilgavimab given as a preventive monoclonal antibody to people who are immunocompromised and at high risk of contracting COVID and to those who can’t take the vaccine. In October, the FDA warned that Evusheld was not neutralizing circulating COVID variants.

As the options for treating and preventing COVID decline, will companies rally quickly to develop new ones, or cut their losses in developing treatments that may work for only a few months, given the speed of viral mutations?

But although monoclonal antibody treatments are off the table, at least for now, antiviral drugs – including Paxlovid – are still very much available, and some say underused.

Others suggest it’s time to resurrect interest in convalescent plasma, a treatment used early in the pandemic before drugs or vaccines were here and still authorized for use in those who are immunosuppressed or receiving immunosuppressive treatment.

And on the prevention front, staying up to date with booster vaccines, masking, and taking other precautions should be stressed more, others say, regardless of the number of treatment options, and especially now, as cases rise and people gather for the winter holidays.
 

‘A major setback’

The bebtelovimab de-authorization was “a major setback,” but an understandable one, said Arturo Casadevall, MD, PhD, professor and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Monoclonal antibodies are great drugs. We are in an unfortunate situation in that they are vulnerable to changes in the virus” and can’t offer long-lasting protection.

Supplies of bebtelovimab will be retained, according to the FDA, in case variants susceptible to it return.

“What happened to bebtelovimab is no surprise,” agreed Amesh Adalja, MD, senior scholar at Johns Hopkins Center for Health Security. “This is what is going to happen when you are targeting a virus that mutates a lot.”

Monoclonal antibodies work by binding to the spike protein on the virus surface to prevent it from entering cells.

However, Dr. Adalja doesn’t view the disappearance of monoclonal antibody treatments as a major setback. Monoclonal antibodies were not the primary way COVID was treated, he said.

While he does believe it’s important that more monoclonal antibody treatments be developed, “I think it’s important to remember we still have Paxlovid while everyone is lamenting the loss of bebtelovimab.’’
 

Antivirals: What’s here, what’s coming

Compared with monoclonal antibodies, “Paxlovid remains a much easier drug to give,” Dr. Adalja told this news organization, because it is taken orally, not intravenously.

And it’s effective. In a recent study, researchers found that adults diagnosed with COVID given Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within the next 30 days than those not given it. Another study shows it could also reduce a person’s risk of developing long COVID by 26%.

Paxlovid is underused, Dr. Adalja said, partly because the rebound potential got more press than the effectiveness. When a celebrity got rebound from Paxlovid, he said, that would make the news, overshadowing the research on its effectiveness.

Besides Paxlovid, the antivirals remdesivir (Veklury), given intravenously for 3 days, and molnupiravir (Lagevrio), taken orally, are also still available. Antivirals work by targeting specific parts of the virus to prevent it from multiplying.

In the lab, remdesivir, molnupiravir, and another antiviral, nirmatrelvir, all appear to be effective against both BQ.1.1 (a BA.5 subvariant) and XBB (a BA.2 subvariant), both rapidly rising in the United States, according to a report last week in the New England Journal of Medicine.

The researchers also tested several monoclonal antibodies and found they did not neutralize either of the subvariants BQ.1.1 and XBB.

A new oral antiviral, Xocova (ensitrelvir fumaric acid), from Japanese manufacturer Shionogi, received emergency approval in Japan on November 22. It’s taken once a day for 5 days. The goal is to expand access to it globally, according to the company.

Pardes Biosciences launched a phase 2 trial in September for its oral antiviral drug (PBI-0451), under study as a treatment and preventive for COVID. It expects data by the first quarter of 2023.

Pfizer, which makes Paxlovid, has partnered with Clear Creek Bio to develop another oral antiviral COVID drug.
 

Other approaches

A receptor protein known as ACE2 (angiotensin-converting enzyme 2) is the main “doorway” that SARS-CoV-2 uses to enter and infect cells.

Dana-Farber Cancer Institute scientists are developing a “decoy” drug that works by mimicking the ACE2 receptor on the surface of cells; when the virus tries to bind to it, the spike protein is destroyed. Human trials have not yet started.

Other researchers are investigating whether an already-approved drug used to treat a liver disease, Actigall (UDCA/ursodeoxycholic acid), could protect against COVID infection by reducing ACE2.

So far, the researchers have found in early research that people taking UDCA for liver conditions were less likely than those not taking the drug to have severe COVID. They also found that UDCA reduced SARS-CoV-2 infection in human lungs maintained outside the body.
 

Monoclonal antibody treatments?

After the FDA decision to withdraw the bebtelovimab EUA, which Eli Lilly said it agreed with, the company issued a statement, promising it wasn’t giving up on monoclonal antibody treatments.

“Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants,” it read in part.

AstraZeneca, which makes Evusheld, is also continuing to work on monoclonal antibody development. According to a spokesperson, “We are also developing a new long-acting antibody combination – AZD5156 – which has been shown in the lab to neutralize emerging new variants and all known variants to date. We are working to accelerate the development of AZD5156 to make it available at the end of 2023.”

The AstraZeneca spokesperson said he could share no more information about what the combination would include.
 

A convalescent plasma comeback?

Although Paxlovid can help, there are many contraindications to it, such as drug-drug interactions, Dr. Casadevall told this news organization. And now that the monoclonal antibody treatments have been paused, convalescent plasma “is the only antibody-based therapy that is reliably available. Convalescent plasma includes thousands of different antibodies.”

With his colleagues, Dr. Casadevall evaluated plasma samples from 740 patients. Some had received booster vaccines and been infected with Omicron, others had received boosters and not been infected, and still others had not been vaccinated and became infected.

In a report (not yet peer-reviewed), they found the plasma from those who had been infected or boosted within the past 6 months neutralized the new Omicron variants BQ.1.1, XBB.1, and BF.7.
 

A push for boosters, masks

To get through the coming months, taking precautions like masking and distancing and staying up to date on booster vaccinations, especially for older adults, can make a difference, other experts say.

In a Twitter thread in early December, Peter Hotez, MD, PhD, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, Houston, urged people to take COVID seriously as holiday parties and gatherings occur.

“The single most impactful thing you can do is get your bivalent booster,” he tweeted, as well as give your kids the booster, citing preliminary research that the bivalent mRNA booster broadens immunity against the Omicron subvariants.

For seniors, he said, ‘‘if you get breakthrough COVID, [it’s] really important to get Paxlovid.” Masks will help not only for COVID but also influenza, respiratory syncytial virus (RSV), and other conditions.

Mitigation measures have largely been abandoned, according to Eric Topol, MD, director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape. In an op-ed in the Los Angeles Times, and on his Twitter feed, he reminds people about masking and urges people to get the bivalent booster.

According to the Centers for Disease Control and Prevention, as of Dec. 8, only 13.5% of people aged 5 and older have gotten an updated booster, despite research that shows an increase in antibodies to BQ.1.1. Recent research has found that the bivalent booster increases antibodies to BQ.1.1 by up to 10-fold, Dr. Topol said.

Dr. Adalja is on advisory boards for Shionogi, GSK, and Pardes. Dr. Casadevall reports no relevant financial relationships.

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

It was the last monoclonal antibody treatment standing. But less than 10 months after the U.S. Food and Drug Administration gave bebtelovimab its emergency use authorization (EUA) to fight COVID-19, it earlier this month de-authorized it, just as it had for other monoclonal antibody treatments, and for the same reason: The treatments were outwitted by the viral mutations.
 

Bebtelovimab couldn’t neutralize the Omicron subvariants BQ.1 and BQ.1.1, the cause of nearly 60% of COVID cases nationally as of November 30.

Next on the chopping block, some predict, will be Evusheld, the combination of tixagevimab and cilgavimab given as a preventive monoclonal antibody to people who are immunocompromised and at high risk of contracting COVID and to those who can’t take the vaccine. In October, the FDA warned that Evusheld was not neutralizing circulating COVID variants.

As the options for treating and preventing COVID decline, will companies rally quickly to develop new ones, or cut their losses in developing treatments that may work for only a few months, given the speed of viral mutations?

But although monoclonal antibody treatments are off the table, at least for now, antiviral drugs – including Paxlovid – are still very much available, and some say underused.

Others suggest it’s time to resurrect interest in convalescent plasma, a treatment used early in the pandemic before drugs or vaccines were here and still authorized for use in those who are immunosuppressed or receiving immunosuppressive treatment.

And on the prevention front, staying up to date with booster vaccines, masking, and taking other precautions should be stressed more, others say, regardless of the number of treatment options, and especially now, as cases rise and people gather for the winter holidays.
 

‘A major setback’

The bebtelovimab de-authorization was “a major setback,” but an understandable one, said Arturo Casadevall, MD, PhD, professor and chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Monoclonal antibodies are great drugs. We are in an unfortunate situation in that they are vulnerable to changes in the virus” and can’t offer long-lasting protection.

Supplies of bebtelovimab will be retained, according to the FDA, in case variants susceptible to it return.

“What happened to bebtelovimab is no surprise,” agreed Amesh Adalja, MD, senior scholar at Johns Hopkins Center for Health Security. “This is what is going to happen when you are targeting a virus that mutates a lot.”

Monoclonal antibodies work by binding to the spike protein on the virus surface to prevent it from entering cells.

However, Dr. Adalja doesn’t view the disappearance of monoclonal antibody treatments as a major setback. Monoclonal antibodies were not the primary way COVID was treated, he said.

While he does believe it’s important that more monoclonal antibody treatments be developed, “I think it’s important to remember we still have Paxlovid while everyone is lamenting the loss of bebtelovimab.’’
 

Antivirals: What’s here, what’s coming

Compared with monoclonal antibodies, “Paxlovid remains a much easier drug to give,” Dr. Adalja told this news organization, because it is taken orally, not intravenously.

And it’s effective. In a recent study, researchers found that adults diagnosed with COVID given Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within the next 30 days than those not given it. Another study shows it could also reduce a person’s risk of developing long COVID by 26%.

Paxlovid is underused, Dr. Adalja said, partly because the rebound potential got more press than the effectiveness. When a celebrity got rebound from Paxlovid, he said, that would make the news, overshadowing the research on its effectiveness.

Besides Paxlovid, the antivirals remdesivir (Veklury), given intravenously for 3 days, and molnupiravir (Lagevrio), taken orally, are also still available. Antivirals work by targeting specific parts of the virus to prevent it from multiplying.

In the lab, remdesivir, molnupiravir, and another antiviral, nirmatrelvir, all appear to be effective against both BQ.1.1 (a BA.5 subvariant) and XBB (a BA.2 subvariant), both rapidly rising in the United States, according to a report last week in the New England Journal of Medicine.

The researchers also tested several monoclonal antibodies and found they did not neutralize either of the subvariants BQ.1.1 and XBB.

A new oral antiviral, Xocova (ensitrelvir fumaric acid), from Japanese manufacturer Shionogi, received emergency approval in Japan on November 22. It’s taken once a day for 5 days. The goal is to expand access to it globally, according to the company.

Pardes Biosciences launched a phase 2 trial in September for its oral antiviral drug (PBI-0451), under study as a treatment and preventive for COVID. It expects data by the first quarter of 2023.

Pfizer, which makes Paxlovid, has partnered with Clear Creek Bio to develop another oral antiviral COVID drug.
 

Other approaches

A receptor protein known as ACE2 (angiotensin-converting enzyme 2) is the main “doorway” that SARS-CoV-2 uses to enter and infect cells.

Dana-Farber Cancer Institute scientists are developing a “decoy” drug that works by mimicking the ACE2 receptor on the surface of cells; when the virus tries to bind to it, the spike protein is destroyed. Human trials have not yet started.

Other researchers are investigating whether an already-approved drug used to treat a liver disease, Actigall (UDCA/ursodeoxycholic acid), could protect against COVID infection by reducing ACE2.

So far, the researchers have found in early research that people taking UDCA for liver conditions were less likely than those not taking the drug to have severe COVID. They also found that UDCA reduced SARS-CoV-2 infection in human lungs maintained outside the body.
 

Monoclonal antibody treatments?

After the FDA decision to withdraw the bebtelovimab EUA, which Eli Lilly said it agreed with, the company issued a statement, promising it wasn’t giving up on monoclonal antibody treatments.

“Lilly will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants,” it read in part.

AstraZeneca, which makes Evusheld, is also continuing to work on monoclonal antibody development. According to a spokesperson, “We are also developing a new long-acting antibody combination – AZD5156 – which has been shown in the lab to neutralize emerging new variants and all known variants to date. We are working to accelerate the development of AZD5156 to make it available at the end of 2023.”

The AstraZeneca spokesperson said he could share no more information about what the combination would include.
 

A convalescent plasma comeback?

Although Paxlovid can help, there are many contraindications to it, such as drug-drug interactions, Dr. Casadevall told this news organization. And now that the monoclonal antibody treatments have been paused, convalescent plasma “is the only antibody-based therapy that is reliably available. Convalescent plasma includes thousands of different antibodies.”

With his colleagues, Dr. Casadevall evaluated plasma samples from 740 patients. Some had received booster vaccines and been infected with Omicron, others had received boosters and not been infected, and still others had not been vaccinated and became infected.

In a report (not yet peer-reviewed), they found the plasma from those who had been infected or boosted within the past 6 months neutralized the new Omicron variants BQ.1.1, XBB.1, and BF.7.
 

A push for boosters, masks

To get through the coming months, taking precautions like masking and distancing and staying up to date on booster vaccinations, especially for older adults, can make a difference, other experts say.

In a Twitter thread in early December, Peter Hotez, MD, PhD, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, Houston, urged people to take COVID seriously as holiday parties and gatherings occur.

“The single most impactful thing you can do is get your bivalent booster,” he tweeted, as well as give your kids the booster, citing preliminary research that the bivalent mRNA booster broadens immunity against the Omicron subvariants.

For seniors, he said, ‘‘if you get breakthrough COVID, [it’s] really important to get Paxlovid.” Masks will help not only for COVID but also influenza, respiratory syncytial virus (RSV), and other conditions.

Mitigation measures have largely been abandoned, according to Eric Topol, MD, director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape. In an op-ed in the Los Angeles Times, and on his Twitter feed, he reminds people about masking and urges people to get the bivalent booster.

According to the Centers for Disease Control and Prevention, as of Dec. 8, only 13.5% of people aged 5 and older have gotten an updated booster, despite research that shows an increase in antibodies to BQ.1.1. Recent research has found that the bivalent booster increases antibodies to BQ.1.1 by up to 10-fold, Dr. Topol said.

Dr. Adalja is on advisory boards for Shionogi, GSK, and Pardes. Dr. Casadevall reports no relevant financial relationships.

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

The notion that the reason people with obesity are not losing weight is that they aren’t sufficiently incentivized to do so is toxic.
 

It denies the impact of the thousands of genes and dozens of hormones involved in our individual levels of hunger, cravings, and fullness. It denies the torrential current of our ultraprocessed and calorific food environment. It denies the constant push of food advertising and the role food has taken on as the star of even the smallest of events and celebrations. It denies the role of food as a seminal pleasure in a world that, even for those possessing great degrees of privilege is challenging, let alone for those facing tremendous and varied difficulties. And of course, it upholds the hateful notion that, if people just wanted it badly enough, they’d manage their weight, the corollary of which is that people with obesity are unmotivated and lazy. 

Yet the notion that, if people want it badly enough, they’d make it happen, is incredibly commonplace. It’s so commonplace that NBC aired their prime-time televised reality show The Biggest Loser from 2004 through 2016, featuring people with obesity competing for a $500,000 prize during a 30-week–long orgy of fat-shaming, victim-blaming, hugely restrictive eating, and injury. It’s also so commonplace that studies are still being conducted exploring the impact of paying people to lose weight.

The most recent of these – “Effectiveness of Goal-Directed and Outcome-Based Financial Incentives for Weight Loss in Primary Care Patients With Obesity Living in Socioeconomically Disadvantaged Neighborhoods: A Randomized Clinical Trial” – examined the effects of randomly assigning participants whose annual household incomes were less than $40,000 to either a free year of Weight Watchers and the provisions of basic weight loss advice (exercise, track your food, eat healthfully, et cetera) or to an incentivized program that would see them earning up to $750 over 6 months, with dollars being awarded for such things as attendance in education sessions, keeping a food diary, recording their weight, and obtaining a certain amount of exercise or for weight loss.

Resultswise – though you might not have gathered it from the conclusion of the paper, which states that incentives were more effective at 12 months – the average incentivized participant lost roughly 6 pounds more than those given only resources. It should also be mentioned that over half of the incentivized group did not complete the study.

That these sorts of studies are still being conducted is depressing. Medicine and academia need to actively stop promoting harmful stereotypes when it comes to the genesis of a chronic noncommunicable disease that is not caused by a lack of desire, needing the right incentive, but is rather caused by the interaction of millions of years of evolution during extreme dietary insecurity with a modern-day food environment and culture that constantly offers, provides, and encourages consumption. This is especially true now that there are effective antiobesity medications whose success underwrites the notion that it’s physiology, rather than a lack of wanting it enough, that gets in the way of sustained success.

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

The notion that the reason people with obesity are not losing weight is that they aren’t sufficiently incentivized to do so is toxic.
 

It denies the impact of the thousands of genes and dozens of hormones involved in our individual levels of hunger, cravings, and fullness. It denies the torrential current of our ultraprocessed and calorific food environment. It denies the constant push of food advertising and the role food has taken on as the star of even the smallest of events and celebrations. It denies the role of food as a seminal pleasure in a world that, even for those possessing great degrees of privilege is challenging, let alone for those facing tremendous and varied difficulties. And of course, it upholds the hateful notion that, if people just wanted it badly enough, they’d manage their weight, the corollary of which is that people with obesity are unmotivated and lazy. 

Yet the notion that, if people want it badly enough, they’d make it happen, is incredibly commonplace. It’s so commonplace that NBC aired their prime-time televised reality show The Biggest Loser from 2004 through 2016, featuring people with obesity competing for a $500,000 prize during a 30-week–long orgy of fat-shaming, victim-blaming, hugely restrictive eating, and injury. It’s also so commonplace that studies are still being conducted exploring the impact of paying people to lose weight.

The most recent of these – “Effectiveness of Goal-Directed and Outcome-Based Financial Incentives for Weight Loss in Primary Care Patients With Obesity Living in Socioeconomically Disadvantaged Neighborhoods: A Randomized Clinical Trial” – examined the effects of randomly assigning participants whose annual household incomes were less than $40,000 to either a free year of Weight Watchers and the provisions of basic weight loss advice (exercise, track your food, eat healthfully, et cetera) or to an incentivized program that would see them earning up to $750 over 6 months, with dollars being awarded for such things as attendance in education sessions, keeping a food diary, recording their weight, and obtaining a certain amount of exercise or for weight loss.

Resultswise – though you might not have gathered it from the conclusion of the paper, which states that incentives were more effective at 12 months – the average incentivized participant lost roughly 6 pounds more than those given only resources. It should also be mentioned that over half of the incentivized group did not complete the study.

That these sorts of studies are still being conducted is depressing. Medicine and academia need to actively stop promoting harmful stereotypes when it comes to the genesis of a chronic noncommunicable disease that is not caused by a lack of desire, needing the right incentive, but is rather caused by the interaction of millions of years of evolution during extreme dietary insecurity with a modern-day food environment and culture that constantly offers, provides, and encourages consumption. This is especially true now that there are effective antiobesity medications whose success underwrites the notion that it’s physiology, rather than a lack of wanting it enough, that gets in the way of sustained success.

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

The notion that the reason people with obesity are not losing weight is that they aren’t sufficiently incentivized to do so is toxic.
 

It denies the impact of the thousands of genes and dozens of hormones involved in our individual levels of hunger, cravings, and fullness. It denies the torrential current of our ultraprocessed and calorific food environment. It denies the constant push of food advertising and the role food has taken on as the star of even the smallest of events and celebrations. It denies the role of food as a seminal pleasure in a world that, even for those possessing great degrees of privilege is challenging, let alone for those facing tremendous and varied difficulties. And of course, it upholds the hateful notion that, if people just wanted it badly enough, they’d manage their weight, the corollary of which is that people with obesity are unmotivated and lazy. 

Yet the notion that, if people want it badly enough, they’d make it happen, is incredibly commonplace. It’s so commonplace that NBC aired their prime-time televised reality show The Biggest Loser from 2004 through 2016, featuring people with obesity competing for a $500,000 prize during a 30-week–long orgy of fat-shaming, victim-blaming, hugely restrictive eating, and injury. It’s also so commonplace that studies are still being conducted exploring the impact of paying people to lose weight.

The most recent of these – “Effectiveness of Goal-Directed and Outcome-Based Financial Incentives for Weight Loss in Primary Care Patients With Obesity Living in Socioeconomically Disadvantaged Neighborhoods: A Randomized Clinical Trial” – examined the effects of randomly assigning participants whose annual household incomes were less than $40,000 to either a free year of Weight Watchers and the provisions of basic weight loss advice (exercise, track your food, eat healthfully, et cetera) or to an incentivized program that would see them earning up to $750 over 6 months, with dollars being awarded for such things as attendance in education sessions, keeping a food diary, recording their weight, and obtaining a certain amount of exercise or for weight loss.

Resultswise – though you might not have gathered it from the conclusion of the paper, which states that incentives were more effective at 12 months – the average incentivized participant lost roughly 6 pounds more than those given only resources. It should also be mentioned that over half of the incentivized group did not complete the study.

That these sorts of studies are still being conducted is depressing. Medicine and academia need to actively stop promoting harmful stereotypes when it comes to the genesis of a chronic noncommunicable disease that is not caused by a lack of desire, needing the right incentive, but is rather caused by the interaction of millions of years of evolution during extreme dietary insecurity with a modern-day food environment and culture that constantly offers, provides, and encourages consumption. This is especially true now that there are effective antiobesity medications whose success underwrites the notion that it’s physiology, rather than a lack of wanting it enough, that gets in the way of sustained success.

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

Eating a low-carbohydrate, high-fat (LCHF) diet, instead of a high-carbohydrate, low-fat diet (HCLF), leads to significant improvements in type 2 diabetes (T2D), a new study finds.

This was true regardless of an individual’s calorie intake, in the randomized controlled trial published in the Annals of Internal Medicine.

Patients with T2D who ate a low-carb, high-fat diet (LCHF) lost more weight and saw greater improvements in both glycemic control and insulin resistance than those who ate a high-carb, low-fat diet (HCLF), reported lead author Camilla Dalby Hansen, MD, of University of Southern Denmark, Odense, and colleagues, suggesting that this is an effective, nonpharmaceutical treatment option for T2D.

The trial enrolled 185 patients with T2D, for whom low-calorie diets are often recommended to induce weight loss and improve glycemic control.

The trouble with this common recommendation, the investigators wrote, is that it induces hunger, so few patients stick to it.

“Therefore, calorie-unrestricted diets may be a better alternative to achieve long-term maintenance,” Dr. Hansen and colleagues wrote, noting that this approach “is not widely investigated.”
 

Study methods and results

In the new study, participants were randomized in a 2:1 ratio to follow the LCHF or HCLF diet for 6 months, with no restriction on calorie intake. Patients were evaluated at baseline, 3 months, 6 months, and 9 months (3 months after discontinuation). Parameters included glycemic control, serum lipid levels, and metabolic markers. The final analysis included 165 patients.

While patients in both groups lost weight, those in the LCHF group lost, on average, about 8 pounds more than the HCLF group, a significant difference. While the LCHF diet was associated with greater improvements in glycemic control (HbA1c) than the HCLF diet, it also led to slightly greater increases in LDL levels. In both groups, HDL levels increased, and triglycerides decreased, without significant differences between groups.

The above changes were not sustained 3 months after finishing the diet.

“I believe we have sufficient data to include LCHF as one of the diet options for people with type 2 diabetes,” Dr. Hansen said in a written comment, considering all available data.

Although the diet did lead to significant clinical benefits, she predicted that some patients would still struggle with adherence in the real world.

“The LCHF diet can be difficult for some people to follow,” Dr. Hansen said. “It is a bit more expensive, and it can be difficult to comply to in social gatherings, simply because our society is not suited for this type of diet.”
 

The magic of unrestricted calories

Jay H. Shubrook, DO, diabetologist and professor at Touro University of California, Vallejo, offered a similar view.

“When you start to fiddle with the diet, it affects not only the person, but all the people they eat with, because eating is a communal experience,” Dr. Shubrook said, in an interview.

Still, he said the present study is “a big deal,” because T2D is a “noncommunicable pandemic,” and “anything we could do that disrupts this process is very important.”

While some may struggle to follow the LCHF diet, Dr. Shubrook predicted better long-term adherence than the low-calorie diet usually recommended.

“What’s magic about this study is because it wasn’t calorie restricted, I think it made it a little bit more flexible for people to continue,” Dr. Shubrook said.

He added that he thinks patients will need a fair amount of coaching and education about food choices in order to lose weight on a diet without calorie restrictions.
 

Not the first study of its kind

In a written comment, Jeff Volek, PhD, RD, professor at the Ohio State University, Columbus, called the present study “another important piece of work, demonstrating yet again, that a low-carbohydrate eating pattern is superior to a high-carbohydrate approach in people with insulin resistance.”

Yet Dr. Volek, who has conducted numerous studies on low-carbohydrate diets, also said there is “little here that is new or surprising.”

He went on to admonish Dr. Hansen and colleagues for failing to recognize those who have already broken ground in this area.

“Unfortunately, these authors do not give credit to the many researchers who have published extensively on low-carbohydrate diets in the past, and instead make claims about being the first to study a calorie unrestricted low-carb diet in individuals with T2D, which is clearly not the case,” Dr. Volek said. “There is a large body of literature showing similar findings with better control over diet, larger cohorts, longer follow-up, and more comprehensive biomarker assessment.”

He noted that data supporting low-carb diets for T2D have been sufficient since at least 2019, when the American Diabetes Association updated their guidance on the subject.

Citing a paper published in Diabetes Care, he said, “Low-carbohydrate eating patterns, especially very-low-carbohydrate eating patterns, have been shown to reduce A1C and the need for antihyperglycemic medications.”

The study was funded by Novo Nordisk Foundation, Danish Diabetes Academy, Odense University Hospital, and others. The investigators disclosed additional relationships with Eli Lilly, Amgen, UCB, and others. Dr. Shubrook disclosed relationships with Abbot, AstraZeneca, Bayer, and others.

Eating a low-carbohydrate, high-fat (LCHF) diet, instead of a high-carbohydrate, low-fat diet (HCLF), leads to significant improvements in type 2 diabetes (T2D), a new study finds.

This was true regardless of an individual’s calorie intake, in the randomized controlled trial published in the Annals of Internal Medicine.

Patients with T2D who ate a low-carb, high-fat diet (LCHF) lost more weight and saw greater improvements in both glycemic control and insulin resistance than those who ate a high-carb, low-fat diet (HCLF), reported lead author Camilla Dalby Hansen, MD, of University of Southern Denmark, Odense, and colleagues, suggesting that this is an effective, nonpharmaceutical treatment option for T2D.

The trial enrolled 185 patients with T2D, for whom low-calorie diets are often recommended to induce weight loss and improve glycemic control.

The trouble with this common recommendation, the investigators wrote, is that it induces hunger, so few patients stick to it.

“Therefore, calorie-unrestricted diets may be a better alternative to achieve long-term maintenance,” Dr. Hansen and colleagues wrote, noting that this approach “is not widely investigated.”
 

Study methods and results

In the new study, participants were randomized in a 2:1 ratio to follow the LCHF or HCLF diet for 6 months, with no restriction on calorie intake. Patients were evaluated at baseline, 3 months, 6 months, and 9 months (3 months after discontinuation). Parameters included glycemic control, serum lipid levels, and metabolic markers. The final analysis included 165 patients.

While patients in both groups lost weight, those in the LCHF group lost, on average, about 8 pounds more than the HCLF group, a significant difference. While the LCHF diet was associated with greater improvements in glycemic control (HbA1c) than the HCLF diet, it also led to slightly greater increases in LDL levels. In both groups, HDL levels increased, and triglycerides decreased, without significant differences between groups.

The above changes were not sustained 3 months after finishing the diet.

“I believe we have sufficient data to include LCHF as one of the diet options for people with type 2 diabetes,” Dr. Hansen said in a written comment, considering all available data.

Although the diet did lead to significant clinical benefits, she predicted that some patients would still struggle with adherence in the real world.

“The LCHF diet can be difficult for some people to follow,” Dr. Hansen said. “It is a bit more expensive, and it can be difficult to comply to in social gatherings, simply because our society is not suited for this type of diet.”
 

The magic of unrestricted calories

Jay H. Shubrook, DO, diabetologist and professor at Touro University of California, Vallejo, offered a similar view.

“When you start to fiddle with the diet, it affects not only the person, but all the people they eat with, because eating is a communal experience,” Dr. Shubrook said, in an interview.

Still, he said the present study is “a big deal,” because T2D is a “noncommunicable pandemic,” and “anything we could do that disrupts this process is very important.”

While some may struggle to follow the LCHF diet, Dr. Shubrook predicted better long-term adherence than the low-calorie diet usually recommended.

“What’s magic about this study is because it wasn’t calorie restricted, I think it made it a little bit more flexible for people to continue,” Dr. Shubrook said.

He added that he thinks patients will need a fair amount of coaching and education about food choices in order to lose weight on a diet without calorie restrictions.
 

Not the first study of its kind

In a written comment, Jeff Volek, PhD, RD, professor at the Ohio State University, Columbus, called the present study “another important piece of work, demonstrating yet again, that a low-carbohydrate eating pattern is superior to a high-carbohydrate approach in people with insulin resistance.”

Yet Dr. Volek, who has conducted numerous studies on low-carbohydrate diets, also said there is “little here that is new or surprising.”

He went on to admonish Dr. Hansen and colleagues for failing to recognize those who have already broken ground in this area.

“Unfortunately, these authors do not give credit to the many researchers who have published extensively on low-carbohydrate diets in the past, and instead make claims about being the first to study a calorie unrestricted low-carb diet in individuals with T2D, which is clearly not the case,” Dr. Volek said. “There is a large body of literature showing similar findings with better control over diet, larger cohorts, longer follow-up, and more comprehensive biomarker assessment.”

He noted that data supporting low-carb diets for T2D have been sufficient since at least 2019, when the American Diabetes Association updated their guidance on the subject.

Citing a paper published in Diabetes Care, he said, “Low-carbohydrate eating patterns, especially very-low-carbohydrate eating patterns, have been shown to reduce A1C and the need for antihyperglycemic medications.”

The study was funded by Novo Nordisk Foundation, Danish Diabetes Academy, Odense University Hospital, and others. The investigators disclosed additional relationships with Eli Lilly, Amgen, UCB, and others. Dr. Shubrook disclosed relationships with Abbot, AstraZeneca, Bayer, and others.

Eating a low-carbohydrate, high-fat (LCHF) diet, instead of a high-carbohydrate, low-fat diet (HCLF), leads to significant improvements in type 2 diabetes (T2D), a new study finds.

This was true regardless of an individual’s calorie intake, in the randomized controlled trial published in the Annals of Internal Medicine.

Patients with T2D who ate a low-carb, high-fat diet (LCHF) lost more weight and saw greater improvements in both glycemic control and insulin resistance than those who ate a high-carb, low-fat diet (HCLF), reported lead author Camilla Dalby Hansen, MD, of University of Southern Denmark, Odense, and colleagues, suggesting that this is an effective, nonpharmaceutical treatment option for T2D.

The trial enrolled 185 patients with T2D, for whom low-calorie diets are often recommended to induce weight loss and improve glycemic control.

The trouble with this common recommendation, the investigators wrote, is that it induces hunger, so few patients stick to it.

“Therefore, calorie-unrestricted diets may be a better alternative to achieve long-term maintenance,” Dr. Hansen and colleagues wrote, noting that this approach “is not widely investigated.”
 

Study methods and results

In the new study, participants were randomized in a 2:1 ratio to follow the LCHF or HCLF diet for 6 months, with no restriction on calorie intake. Patients were evaluated at baseline, 3 months, 6 months, and 9 months (3 months after discontinuation). Parameters included glycemic control, serum lipid levels, and metabolic markers. The final analysis included 165 patients.

While patients in both groups lost weight, those in the LCHF group lost, on average, about 8 pounds more than the HCLF group, a significant difference. While the LCHF diet was associated with greater improvements in glycemic control (HbA1c) than the HCLF diet, it also led to slightly greater increases in LDL levels. In both groups, HDL levels increased, and triglycerides decreased, without significant differences between groups.

The above changes were not sustained 3 months after finishing the diet.

“I believe we have sufficient data to include LCHF as one of the diet options for people with type 2 diabetes,” Dr. Hansen said in a written comment, considering all available data.

Although the diet did lead to significant clinical benefits, she predicted that some patients would still struggle with adherence in the real world.

“The LCHF diet can be difficult for some people to follow,” Dr. Hansen said. “It is a bit more expensive, and it can be difficult to comply to in social gatherings, simply because our society is not suited for this type of diet.”
 

The magic of unrestricted calories

Jay H. Shubrook, DO, diabetologist and professor at Touro University of California, Vallejo, offered a similar view.

“When you start to fiddle with the diet, it affects not only the person, but all the people they eat with, because eating is a communal experience,” Dr. Shubrook said, in an interview.

Still, he said the present study is “a big deal,” because T2D is a “noncommunicable pandemic,” and “anything we could do that disrupts this process is very important.”

While some may struggle to follow the LCHF diet, Dr. Shubrook predicted better long-term adherence than the low-calorie diet usually recommended.

“What’s magic about this study is because it wasn’t calorie restricted, I think it made it a little bit more flexible for people to continue,” Dr. Shubrook said.

He added that he thinks patients will need a fair amount of coaching and education about food choices in order to lose weight on a diet without calorie restrictions.
 

Not the first study of its kind

In a written comment, Jeff Volek, PhD, RD, professor at the Ohio State University, Columbus, called the present study “another important piece of work, demonstrating yet again, that a low-carbohydrate eating pattern is superior to a high-carbohydrate approach in people with insulin resistance.”

Yet Dr. Volek, who has conducted numerous studies on low-carbohydrate diets, also said there is “little here that is new or surprising.”

He went on to admonish Dr. Hansen and colleagues for failing to recognize those who have already broken ground in this area.

“Unfortunately, these authors do not give credit to the many researchers who have published extensively on low-carbohydrate diets in the past, and instead make claims about being the first to study a calorie unrestricted low-carb diet in individuals with T2D, which is clearly not the case,” Dr. Volek said. “There is a large body of literature showing similar findings with better control over diet, larger cohorts, longer follow-up, and more comprehensive biomarker assessment.”

He noted that data supporting low-carb diets for T2D have been sufficient since at least 2019, when the American Diabetes Association updated their guidance on the subject.

Citing a paper published in Diabetes Care, he said, “Low-carbohydrate eating patterns, especially very-low-carbohydrate eating patterns, have been shown to reduce A1C and the need for antihyperglycemic medications.”

The study was funded by Novo Nordisk Foundation, Danish Diabetes Academy, Odense University Hospital, and others. The investigators disclosed additional relationships with Eli Lilly, Amgen, UCB, and others. Dr. Shubrook disclosed relationships with Abbot, AstraZeneca, Bayer, and others.

The randomized, placebo-controlled CLEAR Outcomes trial has shown a significant reduction in risk for a composite cardiovascular (CV) endpoint among its patients treated with the lipid-lowering agent bempedoic acid (Nexletol), the drug’s owner, Esperion, announced today.

The trial marks the first time an ATP-citrate lyase inhibitor has shown significant and “clinically meaningful” benefit for patients not adequately managed with standard lipid-modifying agents, Esperion president and CEO Sheldon Koenig said in a press release.

The brief statement provided only top-line results, without P values or other evidence of the magnitude of benefit in the active-therapy group. The company expects to present more complete results “at a key medical conference in the first quarter of 2023.”

CLEAR Outcomes had entered 14,014 patients with a history of or at high risk for CV disease events, elevated low-density lipoprotein cholesterol (LDL-C) levels, and demonstrated intolerance to at least two statins.

They were randomly assigned to bempedoic acid 180 mg once daily or placebo and followed for the primary endpoint of CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. The trial, conducted in 32 countries, launched in December 2016.  

Bempedoic acid is currently approved for adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease on maximally tolerated statins who require additional LDL-C lowering, the company states.

Concomitant use of bempedoic acid with simvastatin or pravastatin, the press release says, may lead to increased statin concentrations and risk for “simvastatin- or pravastatin-related myopathy.” Therefore, “use with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided.”

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

The randomized, placebo-controlled CLEAR Outcomes trial has shown a significant reduction in risk for a composite cardiovascular (CV) endpoint among its patients treated with the lipid-lowering agent bempedoic acid (Nexletol), the drug’s owner, Esperion, announced today.

The trial marks the first time an ATP-citrate lyase inhibitor has shown significant and “clinically meaningful” benefit for patients not adequately managed with standard lipid-modifying agents, Esperion president and CEO Sheldon Koenig said in a press release.

The brief statement provided only top-line results, without P values or other evidence of the magnitude of benefit in the active-therapy group. The company expects to present more complete results “at a key medical conference in the first quarter of 2023.”

CLEAR Outcomes had entered 14,014 patients with a history of or at high risk for CV disease events, elevated low-density lipoprotein cholesterol (LDL-C) levels, and demonstrated intolerance to at least two statins.

They were randomly assigned to bempedoic acid 180 mg once daily or placebo and followed for the primary endpoint of CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. The trial, conducted in 32 countries, launched in December 2016.  

Bempedoic acid is currently approved for adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease on maximally tolerated statins who require additional LDL-C lowering, the company states.

Concomitant use of bempedoic acid with simvastatin or pravastatin, the press release says, may lead to increased statin concentrations and risk for “simvastatin- or pravastatin-related myopathy.” Therefore, “use with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided.”

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

The randomized, placebo-controlled CLEAR Outcomes trial has shown a significant reduction in risk for a composite cardiovascular (CV) endpoint among its patients treated with the lipid-lowering agent bempedoic acid (Nexletol), the drug’s owner, Esperion, announced today.

The trial marks the first time an ATP-citrate lyase inhibitor has shown significant and “clinically meaningful” benefit for patients not adequately managed with standard lipid-modifying agents, Esperion president and CEO Sheldon Koenig said in a press release.

The brief statement provided only top-line results, without P values or other evidence of the magnitude of benefit in the active-therapy group. The company expects to present more complete results “at a key medical conference in the first quarter of 2023.”

CLEAR Outcomes had entered 14,014 patients with a history of or at high risk for CV disease events, elevated low-density lipoprotein cholesterol (LDL-C) levels, and demonstrated intolerance to at least two statins.

They were randomly assigned to bempedoic acid 180 mg once daily or placebo and followed for the primary endpoint of CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. The trial, conducted in 32 countries, launched in December 2016.  

Bempedoic acid is currently approved for adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease on maximally tolerated statins who require additional LDL-C lowering, the company states.

Concomitant use of bempedoic acid with simvastatin or pravastatin, the press release says, may lead to increased statin concentrations and risk for “simvastatin- or pravastatin-related myopathy.” Therefore, “use with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided.”

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

CHICAGO – A smartphone app that delivers nutritional cognitive behavioral therapy (CBT) to people with type 2 diabetes produced an average 0.29 percentage point drop in hemoglobin A1c during 180 days of use compared with controls, and an average 0.37 percentage point reduction in A1c compared with baseline values in a randomized, pivotal trial with 669 adults.

Use of the app for 180 days also significantly linked with a reduced need for additional medications, reduced weight and blood pressure, and improved patient-reported outcomes, and it led to fewer adverse effects than seen in control subjects, Marc P. Bonaca, MD, reported at the American Heart Association scientific sessions.

Mitchel L. Zoler/MDedge News

The findings also showed a clear dose-response relationship: The more CBT lessons a person completed with the app, the greater the A1c reduction.

The results suggest that the app, called BT-001, “potentially provides a scalable treatment option for patients with type 2 diabetes,” concluded Dr. Bonaca.

On the basis of the results from this trial, also called BT-001, the company developing the app, Better Therapeutics, announced in September 2022 that it had filed a classification request with the Food and Drug Administration that would allow marketing authorization for the BT-001 app. Better Therapeutics envisions that once authorized by the FDA, the app would be available to people with type 2 diabetes by prescriptions written by health care providers and that the cost for the app would be covered by health insurance, explained a company spokesperson.
 

A ‘modest positive impact’

“CBT is an empirically supported psychotherapy for a variety of emotional disorders, and it has been adapted to target specific emotional distress in the context of chronic illness,” said Amit Shapira, PhD, a clinical psychologist at the Joslin Diabetes Center in Boston who has not been involved in the BT-001 studies. A CBT protocol designed for diabetes, CBT for Adherence and Depression, “has been shown to have a positive impact on depression symptoms and glycemic control in adults with type 2 diabetes,” Dr. Shapira said in an interview.

Based on published results, the BT-001 app “seems to have a modest positive impact on glycemic control, especially among people who completed more than 10 [lesson] modules.” The evidence appears to suggest that the app “might be a good supplement to working with a behavioral health counselor.”

The BT-001 trial enrolled 669 adults with type 2 diabetes for an average of 11 years and an A1c of 7%-10.9% with an average level of 8.2%. Participants had to be on a stable medication regimen for at least 3 months but not using insulin, and their treatment regimens could undergo adjustment during the trial. At baseline, each subject was on an average of 2.1 antidiabetes medications, including 90% on metformin and 42% on a sulfonylurea. The researchers also highlighted that the enrolled cohort of people with type 2 diabetes had a demographic profile that was “generally representative” of U.S. adults with type 2 diabetes.

The researchers told the 326 people who were randomized to the active intervention group to use the app but subjects were free to determine their frequency of use. The app introduced a new lesson module weekly that took 10-20 minutes to complete, and each weekly lesson came with associated exercises aimed at practicing skills related to behavioral beliefs.

The study’s primary efficacy endpoint was the average change from baseline in A1c compared with the 343 control participants after 90 days of app use, and 610 of the 669 enrolled participants (91%) had paired baseline and 90-day measurements. At 90 days, people in the app group had an average 0.28 percentage point decrease in their A1c compared with an average 0.11 percentage point increase among the controls, a between-group difference of 0.39 percentage points. Both the reduction from baseline with app use and the reduction relative to the controls were significant. These results appeared in an article published online in in Diabetes Care.

At the scientific sessions, Dr. Bonaca presented additional outcome data after 180 days of app use. He reported an average 0.37 percentage point reduction from baseline in A1c among app users and a 0.08 percentage point decrease from baseline among the controls, for a net 0.29 percentage point incremental decline with the app, a significant difference. At 180 days, 50% of the people in the app group had an A1c decline from baseline of at least 0.4 percentage points compared with 34% of the controls, a significant difference.


 

A dose-response relationship

Notably, app use showed a clear dose-response pattern. During 180 days of app availability, people who used the app fewer than 10 times had an average reduction from baseline in their A1c of less than 0.1 percentage points. Among those who used the app 10-20 times (a subgroup with roughly one-third of the people randomized to app use) average A1c reduction increased to about 0.4 percentage points, and among those who used the app more than 20 times, also one-third of the intervention group, the average A1c reduction from baseline was about 0.6 percentage points.

“It would be interesting to learn more about the adults who engaged with the app” and had a higher use rate “to provide more targeted care” with the app to people who match the profiles of those who were more likely to use the app during the trial, said Dr. Shapira.

Dr. Bonaca, a cardiologist and vascular medicine specialist and executive director of CPC Clinical Research and CPC Community Health, an academic research organization created by and affiliated with the University of Colorado Anschutz Medical Campus in Aurora, Colo., reported several other 180-day outcomes in the BT-001 trial:

• A 33% relative decrease in the percentage of subjects who needed during the study an additional antidiabetes medication or increased dosages of their baseline medications, which occurred at a rate of 21% among the controls and 14% among those who used the app.
• An average weight loss from baseline of 5.5 pounds using the app compared with an average 1.9 pound decrease among controls, a significant difference.
• A decline in average systolic blood pressure of 4.7 mm Hg with app use compared with a 1.8 mm Hg average decline among the controls, a significant difference.
• Significant incremental average improvements in a self-reported Short Form-12 physical component score with the app compared with controls, and increased average improvement in the PHQ9 self-reported measure of depression in app users compared with controls.
• Significantly fewer treatment-emergent adverse effects, and significantly fewer serious treatment-emergent adverse effects among the app users compared with the controls.

‘Ready for clinical use’

Based on these findings, “in my view the app is ready for [routine] clinical use,” declared Judith Hsia, MD, a cardiologist and professor of medicine at the University of Colorado in Aurora, and with Dr. Bonaca a co-lead investigator for the study.

The BT-001 app can serve as “an addition to the toolkit of diabetes treatments,” Dr. Hsia said in an interview. One key advantage of the app is that, once approved, it could be available to many more people with type 2 diabetes than would be able to receive CBT directly from a therapist. Another potential plus for the CBT app is that “the effects should be durable in contrast to medications,” which must be taken on an ongoing basis to maintain effectiveness. In addition, the safety profile “is favorable compared with drug therapies, which should appeal to health care providers,” said Dr. Hsia, chief science officer for CPC Clinical Research.

However, Dr. Shapira cited the issue that therapeutic apps “raise privacy and licensing liability concerns.”

The BT-001 trial was sponsored by Better Therapeutics, the company developing the app. CPC Clinical Research receives research and consulting funding from numerous companies. Dr. Bonaca has been a consultant to Audentes, and is a stockholder of Medtronic and Pfizer. Dr. Shapira had no disclosures. Dr. Hsia is a stockholder of AstraZeneca.

CHICAGO – A smartphone app that delivers nutritional cognitive behavioral therapy (CBT) to people with type 2 diabetes produced an average 0.29 percentage point drop in hemoglobin A1c during 180 days of use compared with controls, and an average 0.37 percentage point reduction in A1c compared with baseline values in a randomized, pivotal trial with 669 adults.

Use of the app for 180 days also significantly linked with a reduced need for additional medications, reduced weight and blood pressure, and improved patient-reported outcomes, and it led to fewer adverse effects than seen in control subjects, Marc P. Bonaca, MD, reported at the American Heart Association scientific sessions.

Mitchel L. Zoler/MDedge News

The findings also showed a clear dose-response relationship: The more CBT lessons a person completed with the app, the greater the A1c reduction.

The results suggest that the app, called BT-001, “potentially provides a scalable treatment option for patients with type 2 diabetes,” concluded Dr. Bonaca.

On the basis of the results from this trial, also called BT-001, the company developing the app, Better Therapeutics, announced in September 2022 that it had filed a classification request with the Food and Drug Administration that would allow marketing authorization for the BT-001 app. Better Therapeutics envisions that once authorized by the FDA, the app would be available to people with type 2 diabetes by prescriptions written by health care providers and that the cost for the app would be covered by health insurance, explained a company spokesperson.
 

A ‘modest positive impact’

“CBT is an empirically supported psychotherapy for a variety of emotional disorders, and it has been adapted to target specific emotional distress in the context of chronic illness,” said Amit Shapira, PhD, a clinical psychologist at the Joslin Diabetes Center in Boston who has not been involved in the BT-001 studies. A CBT protocol designed for diabetes, CBT for Adherence and Depression, “has been shown to have a positive impact on depression symptoms and glycemic control in adults with type 2 diabetes,” Dr. Shapira said in an interview.

Based on published results, the BT-001 app “seems to have a modest positive impact on glycemic control, especially among people who completed more than 10 [lesson] modules.” The evidence appears to suggest that the app “might be a good supplement to working with a behavioral health counselor.”

The BT-001 trial enrolled 669 adults with type 2 diabetes for an average of 11 years and an A1c of 7%-10.9% with an average level of 8.2%. Participants had to be on a stable medication regimen for at least 3 months but not using insulin, and their treatment regimens could undergo adjustment during the trial. At baseline, each subject was on an average of 2.1 antidiabetes medications, including 90% on metformin and 42% on a sulfonylurea. The researchers also highlighted that the enrolled cohort of people with type 2 diabetes had a demographic profile that was “generally representative” of U.S. adults with type 2 diabetes.

The researchers told the 326 people who were randomized to the active intervention group to use the app but subjects were free to determine their frequency of use. The app introduced a new lesson module weekly that took 10-20 minutes to complete, and each weekly lesson came with associated exercises aimed at practicing skills related to behavioral beliefs.

The study’s primary efficacy endpoint was the average change from baseline in A1c compared with the 343 control participants after 90 days of app use, and 610 of the 669 enrolled participants (91%) had paired baseline and 90-day measurements. At 90 days, people in the app group had an average 0.28 percentage point decrease in their A1c compared with an average 0.11 percentage point increase among the controls, a between-group difference of 0.39 percentage points. Both the reduction from baseline with app use and the reduction relative to the controls were significant. These results appeared in an article published online in in Diabetes Care.

At the scientific sessions, Dr. Bonaca presented additional outcome data after 180 days of app use. He reported an average 0.37 percentage point reduction from baseline in A1c among app users and a 0.08 percentage point decrease from baseline among the controls, for a net 0.29 percentage point incremental decline with the app, a significant difference. At 180 days, 50% of the people in the app group had an A1c decline from baseline of at least 0.4 percentage points compared with 34% of the controls, a significant difference.


 

A dose-response relationship

Notably, app use showed a clear dose-response pattern. During 180 days of app availability, people who used the app fewer than 10 times had an average reduction from baseline in their A1c of less than 0.1 percentage points. Among those who used the app 10-20 times (a subgroup with roughly one-third of the people randomized to app use) average A1c reduction increased to about 0.4 percentage points, and among those who used the app more than 20 times, also one-third of the intervention group, the average A1c reduction from baseline was about 0.6 percentage points.

“It would be interesting to learn more about the adults who engaged with the app” and had a higher use rate “to provide more targeted care” with the app to people who match the profiles of those who were more likely to use the app during the trial, said Dr. Shapira.

Dr. Bonaca, a cardiologist and vascular medicine specialist and executive director of CPC Clinical Research and CPC Community Health, an academic research organization created by and affiliated with the University of Colorado Anschutz Medical Campus in Aurora, Colo., reported several other 180-day outcomes in the BT-001 trial:

• A 33% relative decrease in the percentage of subjects who needed during the study an additional antidiabetes medication or increased dosages of their baseline medications, which occurred at a rate of 21% among the controls and 14% among those who used the app.
• An average weight loss from baseline of 5.5 pounds using the app compared with an average 1.9 pound decrease among controls, a significant difference.
• A decline in average systolic blood pressure of 4.7 mm Hg with app use compared with a 1.8 mm Hg average decline among the controls, a significant difference.
• Significant incremental average improvements in a self-reported Short Form-12 physical component score with the app compared with controls, and increased average improvement in the PHQ9 self-reported measure of depression in app users compared with controls.
• Significantly fewer treatment-emergent adverse effects, and significantly fewer serious treatment-emergent adverse effects among the app users compared with the controls.

‘Ready for clinical use’

Based on these findings, “in my view the app is ready for [routine] clinical use,” declared Judith Hsia, MD, a cardiologist and professor of medicine at the University of Colorado in Aurora, and with Dr. Bonaca a co-lead investigator for the study.

The BT-001 app can serve as “an addition to the toolkit of diabetes treatments,” Dr. Hsia said in an interview. One key advantage of the app is that, once approved, it could be available to many more people with type 2 diabetes than would be able to receive CBT directly from a therapist. Another potential plus for the CBT app is that “the effects should be durable in contrast to medications,” which must be taken on an ongoing basis to maintain effectiveness. In addition, the safety profile “is favorable compared with drug therapies, which should appeal to health care providers,” said Dr. Hsia, chief science officer for CPC Clinical Research.

However, Dr. Shapira cited the issue that therapeutic apps “raise privacy and licensing liability concerns.”

The BT-001 trial was sponsored by Better Therapeutics, the company developing the app. CPC Clinical Research receives research and consulting funding from numerous companies. Dr. Bonaca has been a consultant to Audentes, and is a stockholder of Medtronic and Pfizer. Dr. Shapira had no disclosures. Dr. Hsia is a stockholder of AstraZeneca.

CHICAGO – A smartphone app that delivers nutritional cognitive behavioral therapy (CBT) to people with type 2 diabetes produced an average 0.29 percentage point drop in hemoglobin A1c during 180 days of use compared with controls, and an average 0.37 percentage point reduction in A1c compared with baseline values in a randomized, pivotal trial with 669 adults.

Use of the app for 180 days also significantly linked with a reduced need for additional medications, reduced weight and blood pressure, and improved patient-reported outcomes, and it led to fewer adverse effects than seen in control subjects, Marc P. Bonaca, MD, reported at the American Heart Association scientific sessions.

Mitchel L. Zoler/MDedge News

The findings also showed a clear dose-response relationship: The more CBT lessons a person completed with the app, the greater the A1c reduction.

The results suggest that the app, called BT-001, “potentially provides a scalable treatment option for patients with type 2 diabetes,” concluded Dr. Bonaca.

On the basis of the results from this trial, also called BT-001, the company developing the app, Better Therapeutics, announced in September 2022 that it had filed a classification request with the Food and Drug Administration that would allow marketing authorization for the BT-001 app. Better Therapeutics envisions that once authorized by the FDA, the app would be available to people with type 2 diabetes by prescriptions written by health care providers and that the cost for the app would be covered by health insurance, explained a company spokesperson.
 

A ‘modest positive impact’

“CBT is an empirically supported psychotherapy for a variety of emotional disorders, and it has been adapted to target specific emotional distress in the context of chronic illness,” said Amit Shapira, PhD, a clinical psychologist at the Joslin Diabetes Center in Boston who has not been involved in the BT-001 studies. A CBT protocol designed for diabetes, CBT for Adherence and Depression, “has been shown to have a positive impact on depression symptoms and glycemic control in adults with type 2 diabetes,” Dr. Shapira said in an interview.

Based on published results, the BT-001 app “seems to have a modest positive impact on glycemic control, especially among people who completed more than 10 [lesson] modules.” The evidence appears to suggest that the app “might be a good supplement to working with a behavioral health counselor.”

The BT-001 trial enrolled 669 adults with type 2 diabetes for an average of 11 years and an A1c of 7%-10.9% with an average level of 8.2%. Participants had to be on a stable medication regimen for at least 3 months but not using insulin, and their treatment regimens could undergo adjustment during the trial. At baseline, each subject was on an average of 2.1 antidiabetes medications, including 90% on metformin and 42% on a sulfonylurea. The researchers also highlighted that the enrolled cohort of people with type 2 diabetes had a demographic profile that was “generally representative” of U.S. adults with type 2 diabetes.

The researchers told the 326 people who were randomized to the active intervention group to use the app but subjects were free to determine their frequency of use. The app introduced a new lesson module weekly that took 10-20 minutes to complete, and each weekly lesson came with associated exercises aimed at practicing skills related to behavioral beliefs.

The study’s primary efficacy endpoint was the average change from baseline in A1c compared with the 343 control participants after 90 days of app use, and 610 of the 669 enrolled participants (91%) had paired baseline and 90-day measurements. At 90 days, people in the app group had an average 0.28 percentage point decrease in their A1c compared with an average 0.11 percentage point increase among the controls, a between-group difference of 0.39 percentage points. Both the reduction from baseline with app use and the reduction relative to the controls were significant. These results appeared in an article published online in in Diabetes Care.

At the scientific sessions, Dr. Bonaca presented additional outcome data after 180 days of app use. He reported an average 0.37 percentage point reduction from baseline in A1c among app users and a 0.08 percentage point decrease from baseline among the controls, for a net 0.29 percentage point incremental decline with the app, a significant difference. At 180 days, 50% of the people in the app group had an A1c decline from baseline of at least 0.4 percentage points compared with 34% of the controls, a significant difference.


 

A dose-response relationship

Notably, app use showed a clear dose-response pattern. During 180 days of app availability, people who used the app fewer than 10 times had an average reduction from baseline in their A1c of less than 0.1 percentage points. Among those who used the app 10-20 times (a subgroup with roughly one-third of the people randomized to app use) average A1c reduction increased to about 0.4 percentage points, and among those who used the app more than 20 times, also one-third of the intervention group, the average A1c reduction from baseline was about 0.6 percentage points.

“It would be interesting to learn more about the adults who engaged with the app” and had a higher use rate “to provide more targeted care” with the app to people who match the profiles of those who were more likely to use the app during the trial, said Dr. Shapira.

Dr. Bonaca, a cardiologist and vascular medicine specialist and executive director of CPC Clinical Research and CPC Community Health, an academic research organization created by and affiliated with the University of Colorado Anschutz Medical Campus in Aurora, Colo., reported several other 180-day outcomes in the BT-001 trial:

• A 33% relative decrease in the percentage of subjects who needed during the study an additional antidiabetes medication or increased dosages of their baseline medications, which occurred at a rate of 21% among the controls and 14% among those who used the app.
• An average weight loss from baseline of 5.5 pounds using the app compared with an average 1.9 pound decrease among controls, a significant difference.
• A decline in average systolic blood pressure of 4.7 mm Hg with app use compared with a 1.8 mm Hg average decline among the controls, a significant difference.
• Significant incremental average improvements in a self-reported Short Form-12 physical component score with the app compared with controls, and increased average improvement in the PHQ9 self-reported measure of depression in app users compared with controls.
• Significantly fewer treatment-emergent adverse effects, and significantly fewer serious treatment-emergent adverse effects among the app users compared with the controls.

‘Ready for clinical use’

Based on these findings, “in my view the app is ready for [routine] clinical use,” declared Judith Hsia, MD, a cardiologist and professor of medicine at the University of Colorado in Aurora, and with Dr. Bonaca a co-lead investigator for the study.

The BT-001 app can serve as “an addition to the toolkit of diabetes treatments,” Dr. Hsia said in an interview. One key advantage of the app is that, once approved, it could be available to many more people with type 2 diabetes than would be able to receive CBT directly from a therapist. Another potential plus for the CBT app is that “the effects should be durable in contrast to medications,” which must be taken on an ongoing basis to maintain effectiveness. In addition, the safety profile “is favorable compared with drug therapies, which should appeal to health care providers,” said Dr. Hsia, chief science officer for CPC Clinical Research.

However, Dr. Shapira cited the issue that therapeutic apps “raise privacy and licensing liability concerns.”

The BT-001 trial was sponsored by Better Therapeutics, the company developing the app. CPC Clinical Research receives research and consulting funding from numerous companies. Dr. Bonaca has been a consultant to Audentes, and is a stockholder of Medtronic and Pfizer. Dr. Shapira had no disclosures. Dr. Hsia is a stockholder of AstraZeneca.

A new generation of treatments appears to have caused U.S. melanoma mortality rates to plunge between 2013 and 2017 for the first time in 4 decades, a new study finds, although the dip appeared to stabilize over the next 2 years.

“This data is very encouraging and represents the real-world effectiveness of these newer therapies, which include immunotherapies and targeted therapies,” hematologist/oncologist Navkirat Kahlon, MD, MPH, of Seacoast Cancer Center and Massachusetts General Brigham Wentworth-Douglass Hospital, Dover, N.H., one of the study authors, said in an interview. In clinical trials, these new treatments “have been very effective ... so the timing as well as magnitude of drop seen in melanoma-specific population mortality was not at all surprising. But it’s still very exciting.”

The report, published in JAMA Network Open, tracked mortality rates for the deadliest form of skin cancer from 1975 to 2019. The researchers launched the study to better understand outcomes in cutaneous melanoma following the rise of new therapies that now provide options in addition to chemotherapy. “With the use of novel therapies, the survival of these patients has increased from a few weeks or months to many years in clinical trials,” Dr. Kahlon said. “Given the magnitude of benefit compared to traditional chemotherapy in clinical trials, we decided to see if the real-world U.S. population is deriving the same benefit.”

New drugs introduced in recent years include immunotherapy agents such as ipilimumab and targeted therapies such as vemurafenib.

The researchers analyzed age-adjusted melanoma outcome data from the Surveillance, Epidemiology, and End Results (SEER) database. In 1975, the long-term melanoma mortality rate for melanoma was 2.07 per 100,000 people (95% confidence interval [CI], 2.00-2.13). It rose to 2.65 (95% CI, 2.58-2.65) in 1988 and 2.67 (95% CI, 2.61-2.72) in 2013, then fell to 2.09 (95% CI, 2.05-2.14) in 2017 and 2.01 (95% CI, 1.97-2.06) in 2019.

Per the analysis, the rate grew at an annual percentage change (APC) of 1.65% (95% CI, 1.30%-2.00%, P < .001) from 1975 to 1988 and remained stable from 1988 to 2013 (P = .85). Then it fell by an APC of 6.28% (95% CI, –8.52% to –3.97%, P < .001) from 2013 to 2017. There was no statistically significant difference between 2017 and 2019, although “the trend was downward,” the authors noted.

“Our study didn’t study the parameters that can answer the question about how many more years of life patients are getting or how many lives aren’t lost,” Dr. Kahlon said in the interview. “But looking at other studies and clinical trial data, the prognosis of these patients with a historical median overall survival of a few weeks to months has improved to many months to years.”

But why do melanoma mortality rates remain roughly about the same as they were in 1975? “The incidence of melanoma has continued to rise,” she said. “Also, over time, we have become better at collecting more accurate information, so the [rate] in 1975 could potentially be an underestimated rate.”

In an interview, dermatologist Adewole “Ade” Adamson, MD, MPP, of the University of Texas at Austin, noted that a 2020 study examined melanoma death rates in Whites – who are most affected by melanoma – and found similar trends from 2013 to 2016. “Nothing about these [new] findings surprises me as they have been shown before. However, these confirmatory findings are reassuring because they show the powerful effect of novel treatments at a population level.”

A new generation of treatments appears to have caused U.S. melanoma mortality rates to plunge between 2013 and 2017 for the first time in 4 decades, a new study finds, although the dip appeared to stabilize over the next 2 years.

“This data is very encouraging and represents the real-world effectiveness of these newer therapies, which include immunotherapies and targeted therapies,” hematologist/oncologist Navkirat Kahlon, MD, MPH, of Seacoast Cancer Center and Massachusetts General Brigham Wentworth-Douglass Hospital, Dover, N.H., one of the study authors, said in an interview. In clinical trials, these new treatments “have been very effective ... so the timing as well as magnitude of drop seen in melanoma-specific population mortality was not at all surprising. But it’s still very exciting.”

The report, published in JAMA Network Open, tracked mortality rates for the deadliest form of skin cancer from 1975 to 2019. The researchers launched the study to better understand outcomes in cutaneous melanoma following the rise of new therapies that now provide options in addition to chemotherapy. “With the use of novel therapies, the survival of these patients has increased from a few weeks or months to many years in clinical trials,” Dr. Kahlon said. “Given the magnitude of benefit compared to traditional chemotherapy in clinical trials, we decided to see if the real-world U.S. population is deriving the same benefit.”

New drugs introduced in recent years include immunotherapy agents such as ipilimumab and targeted therapies such as vemurafenib.

The researchers analyzed age-adjusted melanoma outcome data from the Surveillance, Epidemiology, and End Results (SEER) database. In 1975, the long-term melanoma mortality rate for melanoma was 2.07 per 100,000 people (95% confidence interval [CI], 2.00-2.13). It rose to 2.65 (95% CI, 2.58-2.65) in 1988 and 2.67 (95% CI, 2.61-2.72) in 2013, then fell to 2.09 (95% CI, 2.05-2.14) in 2017 and 2.01 (95% CI, 1.97-2.06) in 2019.

Per the analysis, the rate grew at an annual percentage change (APC) of 1.65% (95% CI, 1.30%-2.00%, P < .001) from 1975 to 1988 and remained stable from 1988 to 2013 (P = .85). Then it fell by an APC of 6.28% (95% CI, –8.52% to –3.97%, P < .001) from 2013 to 2017. There was no statistically significant difference between 2017 and 2019, although “the trend was downward,” the authors noted.

“Our study didn’t study the parameters that can answer the question about how many more years of life patients are getting or how many lives aren’t lost,” Dr. Kahlon said in the interview. “But looking at other studies and clinical trial data, the prognosis of these patients with a historical median overall survival of a few weeks to months has improved to many months to years.”

But why do melanoma mortality rates remain roughly about the same as they were in 1975? “The incidence of melanoma has continued to rise,” she said. “Also, over time, we have become better at collecting more accurate information, so the [rate] in 1975 could potentially be an underestimated rate.”

In an interview, dermatologist Adewole “Ade” Adamson, MD, MPP, of the University of Texas at Austin, noted that a 2020 study examined melanoma death rates in Whites – who are most affected by melanoma – and found similar trends from 2013 to 2016. “Nothing about these [new] findings surprises me as they have been shown before. However, these confirmatory findings are reassuring because they show the powerful effect of novel treatments at a population level.”

A new generation of treatments appears to have caused U.S. melanoma mortality rates to plunge between 2013 and 2017 for the first time in 4 decades, a new study finds, although the dip appeared to stabilize over the next 2 years.

“This data is very encouraging and represents the real-world effectiveness of these newer therapies, which include immunotherapies and targeted therapies,” hematologist/oncologist Navkirat Kahlon, MD, MPH, of Seacoast Cancer Center and Massachusetts General Brigham Wentworth-Douglass Hospital, Dover, N.H., one of the study authors, said in an interview. In clinical trials, these new treatments “have been very effective ... so the timing as well as magnitude of drop seen in melanoma-specific population mortality was not at all surprising. But it’s still very exciting.”

The report, published in JAMA Network Open, tracked mortality rates for the deadliest form of skin cancer from 1975 to 2019. The researchers launched the study to better understand outcomes in cutaneous melanoma following the rise of new therapies that now provide options in addition to chemotherapy. “With the use of novel therapies, the survival of these patients has increased from a few weeks or months to many years in clinical trials,” Dr. Kahlon said. “Given the magnitude of benefit compared to traditional chemotherapy in clinical trials, we decided to see if the real-world U.S. population is deriving the same benefit.”

New drugs introduced in recent years include immunotherapy agents such as ipilimumab and targeted therapies such as vemurafenib.

The researchers analyzed age-adjusted melanoma outcome data from the Surveillance, Epidemiology, and End Results (SEER) database. In 1975, the long-term melanoma mortality rate for melanoma was 2.07 per 100,000 people (95% confidence interval [CI], 2.00-2.13). It rose to 2.65 (95% CI, 2.58-2.65) in 1988 and 2.67 (95% CI, 2.61-2.72) in 2013, then fell to 2.09 (95% CI, 2.05-2.14) in 2017 and 2.01 (95% CI, 1.97-2.06) in 2019.

Per the analysis, the rate grew at an annual percentage change (APC) of 1.65% (95% CI, 1.30%-2.00%, P < .001) from 1975 to 1988 and remained stable from 1988 to 2013 (P = .85). Then it fell by an APC of 6.28% (95% CI, –8.52% to –3.97%, P < .001) from 2013 to 2017. There was no statistically significant difference between 2017 and 2019, although “the trend was downward,” the authors noted.

“Our study didn’t study the parameters that can answer the question about how many more years of life patients are getting or how many lives aren’t lost,” Dr. Kahlon said in the interview. “But looking at other studies and clinical trial data, the prognosis of these patients with a historical median overall survival of a few weeks to months has improved to many months to years.”

But why do melanoma mortality rates remain roughly about the same as they were in 1975? “The incidence of melanoma has continued to rise,” she said. “Also, over time, we have become better at collecting more accurate information, so the [rate] in 1975 could potentially be an underestimated rate.”

In an interview, dermatologist Adewole “Ade” Adamson, MD, MPP, of the University of Texas at Austin, noted that a 2020 study examined melanoma death rates in Whites – who are most affected by melanoma – and found similar trends from 2013 to 2016. “Nothing about these [new] findings surprises me as they have been shown before. However, these confirmatory findings are reassuring because they show the powerful effect of novel treatments at a population level.”

Allowing people with type 2 diabetes to try agents from three different classes of antidiabetes drugs showed they usually find a clear preference, often the drug that gives them the best glycemic control and least bothersome adverse effects, according to secondary findings from a randomized study of patients in the United Kingdom.

“This is the first study in which the same patient has tried three different types of glucose-lowering drug, enabling them to directly compare them and then choose which one is best for them,” Andrew Hattersley, BMBCh, DM, the study’s principal investigator, said in a written statement. “We’ve shown that going with the patients’ choice results in better glucose control and fewer side effects than any other approach. When it’s not clear which drug is best to use, then patients should try before they choose. Surprisingly, that approach has never been tried before.”

Mitchel L. Zoler/MDedge News

These secondary results from the TriMaster study were recently published in Nature Medicine and presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in September, as reported by this news organization.

TriMaster enrolled adults aged 30-80 years with a clinical diagnosis of type 2 diabetes for at least 12 months. Their glycemia was inadequately controlled despite treatment with metformin alone or two classes of oral glucose-lowering therapy that did not include an agent from any of the three classes tested in the study: dipeptidyl peptidase–4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, and thiazolidinediones. The people taking two different drug classes at entry were most often taking metformin and a sulfonylurea.
 

Do BMI and renal function affect treatment response?

TriMaster tested two hypotheses. Firstly, would people with a body mass index of more than 30 kg/m² have greater glucose lowering with the thiazolidinedione pioglitazone (Actos) than with the DPP-4 inhibitor sitagliptin (Januvia), compared to people with a lower BMI?

Secondly, would people with an estimated glomerular filtration rate (eGFR) of 60-90 mL/min/1.73 m² have greater glucose lowering with sitagliptin than with the SGLT2 inhibitor canagliflozin (Invokana), compared with people with higher levels of renal function? The metric for both hypotheses was change in A1c levels from baseline.

The study included 525 adults with type 2 diabetes in a double-blind, three-way crossover trial that assigned each participant a random order of serial 16-week trials of treatment with sitagliptin 100 mg once daily, canagliflozin 100 mg once daily, and pioglitazone 30 mg once daily, with each agent added to the preexisting background regimen.

Analysis showed that for second- or third-line therapy in people with type 2 diabetes “simple predefined stratification using BMI and renal function can determine the choice of the drug most likely to be effective for glucose lowering,” the researchers concluded.

Among those with a BMI of more than 30 kg/m², patients achieved a lower A1c on pioglitazone, compared with sitagliptin, while those with a lower BMI had their best A1c response on sitagliptin. Patients with impaired renal function (eGFR 60-90 mL/min/1.73 m²) had better A1c lowering with sitagliptin, while those with a higher eGFR had better A1c lowering with canagliflozin.

These results appeared in a second article published in Nature Medicine, and the researchers also presented these findings at the EASD 2021 annual meeting, as reported by this news organization at the time.
 

Patients identified the agent they liked best

Dr. Hattersley and associates used the TriMaster study to also address the secondary question of which of the three tested agents patients preferred, focusing on the 457 patients who provided information on their treatment preference.

The results showed that patient preference varied: Twenty-four percent liked pioglitazone best, 33% preferred sitagliptin, and 37% said canagliflozin was their favorite, with 6% having no preference. These numbers barely budged when participants learned how well each agent worked for them in terms of reducing their A1c and lowering their BMI.

The findings also showed good correlation between patient preferences and their A1c and adverse-effect responses. The agents that patients identified as their favorites were also the drugs that lowered their A1c the most 53% of the time before they got any feedback on which one gave them their best glycemic control. Once they had this feedback, 70% preferred the most effective agent, with the results likely reflecting that patients feel better when they have improved glucose levels as well as the education patients received that lower A1c levels are better.

Patients also tended to understandably favor the agents that caused the fewest and mildest adverse effects: Sixty-eight percent of the patients who identified a favorite drug picked the one that gave them the best adverse-effect profile.

In an interview at the EASD 2022 annual meeting, Dr. Hattersley promoted the study’s design as a best-practice approach to deciding which drug to next give a person with type 2 diabetes who needs additional glycemic control.

“Whenever you’re not sure how to balance adverse effects and positive effects the best person to decide is the one who experiences the effects,” he said. “Patients had overwhelming positivity about being able to choose their drug. Do it when you’re not certain which drug to prescribe,” suggested Dr. Hattersley, a professor and diabetologist at the University of Exeter, England. “We can’t know which drug a patient might prefer.”

But he stressed cautioning patients to return for treatment adjustment sooner than 4 months if they can’t tolerate a new drug they’re trying.

TriMaster received no commercial funding. Dr. Hattersley has reported no relevant financial relationships.

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

Allowing people with type 2 diabetes to try agents from three different classes of antidiabetes drugs showed they usually find a clear preference, often the drug that gives them the best glycemic control and least bothersome adverse effects, according to secondary findings from a randomized study of patients in the United Kingdom.

“This is the first study in which the same patient has tried three different types of glucose-lowering drug, enabling them to directly compare them and then choose which one is best for them,” Andrew Hattersley, BMBCh, DM, the study’s principal investigator, said in a written statement. “We’ve shown that going with the patients’ choice results in better glucose control and fewer side effects than any other approach. When it’s not clear which drug is best to use, then patients should try before they choose. Surprisingly, that approach has never been tried before.”

Mitchel L. Zoler/MDedge News

These secondary results from the TriMaster study were recently published in Nature Medicine and presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in September, as reported by this news organization.

TriMaster enrolled adults aged 30-80 years with a clinical diagnosis of type 2 diabetes for at least 12 months. Their glycemia was inadequately controlled despite treatment with metformin alone or two classes of oral glucose-lowering therapy that did not include an agent from any of the three classes tested in the study: dipeptidyl peptidase–4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, and thiazolidinediones. The people taking two different drug classes at entry were most often taking metformin and a sulfonylurea.
 

Do BMI and renal function affect treatment response?

TriMaster tested two hypotheses. Firstly, would people with a body mass index of more than 30 kg/m² have greater glucose lowering with the thiazolidinedione pioglitazone (Actos) than with the DPP-4 inhibitor sitagliptin (Januvia), compared to people with a lower BMI?

Secondly, would people with an estimated glomerular filtration rate (eGFR) of 60-90 mL/min/1.73 m² have greater glucose lowering with sitagliptin than with the SGLT2 inhibitor canagliflozin (Invokana), compared with people with higher levels of renal function? The metric for both hypotheses was change in A1c levels from baseline.

The study included 525 adults with type 2 diabetes in a double-blind, three-way crossover trial that assigned each participant a random order of serial 16-week trials of treatment with sitagliptin 100 mg once daily, canagliflozin 100 mg once daily, and pioglitazone 30 mg once daily, with each agent added to the preexisting background regimen.

Analysis showed that for second- or third-line therapy in people with type 2 diabetes “simple predefined stratification using BMI and renal function can determine the choice of the drug most likely to be effective for glucose lowering,” the researchers concluded.

Among those with a BMI of more than 30 kg/m², patients achieved a lower A1c on pioglitazone, compared with sitagliptin, while those with a lower BMI had their best A1c response on sitagliptin. Patients with impaired renal function (eGFR 60-90 mL/min/1.73 m²) had better A1c lowering with sitagliptin, while those with a higher eGFR had better A1c lowering with canagliflozin.

These results appeared in a second article published in Nature Medicine, and the researchers also presented these findings at the EASD 2021 annual meeting, as reported by this news organization at the time.
 

Patients identified the agent they liked best

Dr. Hattersley and associates used the TriMaster study to also address the secondary question of which of the three tested agents patients preferred, focusing on the 457 patients who provided information on their treatment preference.

The results showed that patient preference varied: Twenty-four percent liked pioglitazone best, 33% preferred sitagliptin, and 37% said canagliflozin was their favorite, with 6% having no preference. These numbers barely budged when participants learned how well each agent worked for them in terms of reducing their A1c and lowering their BMI.

The findings also showed good correlation between patient preferences and their A1c and adverse-effect responses. The agents that patients identified as their favorites were also the drugs that lowered their A1c the most 53% of the time before they got any feedback on which one gave them their best glycemic control. Once they had this feedback, 70% preferred the most effective agent, with the results likely reflecting that patients feel better when they have improved glucose levels as well as the education patients received that lower A1c levels are better.

Patients also tended to understandably favor the agents that caused the fewest and mildest adverse effects: Sixty-eight percent of the patients who identified a favorite drug picked the one that gave them the best adverse-effect profile.

In an interview at the EASD 2022 annual meeting, Dr. Hattersley promoted the study’s design as a best-practice approach to deciding which drug to next give a person with type 2 diabetes who needs additional glycemic control.

“Whenever you’re not sure how to balance adverse effects and positive effects the best person to decide is the one who experiences the effects,” he said. “Patients had overwhelming positivity about being able to choose their drug. Do it when you’re not certain which drug to prescribe,” suggested Dr. Hattersley, a professor and diabetologist at the University of Exeter, England. “We can’t know which drug a patient might prefer.”

But he stressed cautioning patients to return for treatment adjustment sooner than 4 months if they can’t tolerate a new drug they’re trying.

TriMaster received no commercial funding. Dr. Hattersley has reported no relevant financial relationships.

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

Allowing people with type 2 diabetes to try agents from three different classes of antidiabetes drugs showed they usually find a clear preference, often the drug that gives them the best glycemic control and least bothersome adverse effects, according to secondary findings from a randomized study of patients in the United Kingdom.

“This is the first study in which the same patient has tried three different types of glucose-lowering drug, enabling them to directly compare them and then choose which one is best for them,” Andrew Hattersley, BMBCh, DM, the study’s principal investigator, said in a written statement. “We’ve shown that going with the patients’ choice results in better glucose control and fewer side effects than any other approach. When it’s not clear which drug is best to use, then patients should try before they choose. Surprisingly, that approach has never been tried before.”

Mitchel L. Zoler/MDedge News

These secondary results from the TriMaster study were recently published in Nature Medicine and presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in September, as reported by this news organization.

TriMaster enrolled adults aged 30-80 years with a clinical diagnosis of type 2 diabetes for at least 12 months. Their glycemia was inadequately controlled despite treatment with metformin alone or two classes of oral glucose-lowering therapy that did not include an agent from any of the three classes tested in the study: dipeptidyl peptidase–4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, and thiazolidinediones. The people taking two different drug classes at entry were most often taking metformin and a sulfonylurea.
 

Do BMI and renal function affect treatment response?

TriMaster tested two hypotheses. Firstly, would people with a body mass index of more than 30 kg/m² have greater glucose lowering with the thiazolidinedione pioglitazone (Actos) than with the DPP-4 inhibitor sitagliptin (Januvia), compared to people with a lower BMI?

Secondly, would people with an estimated glomerular filtration rate (eGFR) of 60-90 mL/min/1.73 m² have greater glucose lowering with sitagliptin than with the SGLT2 inhibitor canagliflozin (Invokana), compared with people with higher levels of renal function? The metric for both hypotheses was change in A1c levels from baseline.

The study included 525 adults with type 2 diabetes in a double-blind, three-way crossover trial that assigned each participant a random order of serial 16-week trials of treatment with sitagliptin 100 mg once daily, canagliflozin 100 mg once daily, and pioglitazone 30 mg once daily, with each agent added to the preexisting background regimen.

Analysis showed that for second- or third-line therapy in people with type 2 diabetes “simple predefined stratification using BMI and renal function can determine the choice of the drug most likely to be effective for glucose lowering,” the researchers concluded.

Among those with a BMI of more than 30 kg/m², patients achieved a lower A1c on pioglitazone, compared with sitagliptin, while those with a lower BMI had their best A1c response on sitagliptin. Patients with impaired renal function (eGFR 60-90 mL/min/1.73 m²) had better A1c lowering with sitagliptin, while those with a higher eGFR had better A1c lowering with canagliflozin.

These results appeared in a second article published in Nature Medicine, and the researchers also presented these findings at the EASD 2021 annual meeting, as reported by this news organization at the time.
 

Patients identified the agent they liked best

Dr. Hattersley and associates used the TriMaster study to also address the secondary question of which of the three tested agents patients preferred, focusing on the 457 patients who provided information on their treatment preference.

The results showed that patient preference varied: Twenty-four percent liked pioglitazone best, 33% preferred sitagliptin, and 37% said canagliflozin was their favorite, with 6% having no preference. These numbers barely budged when participants learned how well each agent worked for them in terms of reducing their A1c and lowering their BMI.

The findings also showed good correlation between patient preferences and their A1c and adverse-effect responses. The agents that patients identified as their favorites were also the drugs that lowered their A1c the most 53% of the time before they got any feedback on which one gave them their best glycemic control. Once they had this feedback, 70% preferred the most effective agent, with the results likely reflecting that patients feel better when they have improved glucose levels as well as the education patients received that lower A1c levels are better.

Patients also tended to understandably favor the agents that caused the fewest and mildest adverse effects: Sixty-eight percent of the patients who identified a favorite drug picked the one that gave them the best adverse-effect profile.

In an interview at the EASD 2022 annual meeting, Dr. Hattersley promoted the study’s design as a best-practice approach to deciding which drug to next give a person with type 2 diabetes who needs additional glycemic control.

“Whenever you’re not sure how to balance adverse effects and positive effects the best person to decide is the one who experiences the effects,” he said. “Patients had overwhelming positivity about being able to choose their drug. Do it when you’re not certain which drug to prescribe,” suggested Dr. Hattersley, a professor and diabetologist at the University of Exeter, England. “We can’t know which drug a patient might prefer.”

But he stressed cautioning patients to return for treatment adjustment sooner than 4 months if they can’t tolerate a new drug they’re trying.

TriMaster received no commercial funding. Dr. Hattersley has reported no relevant financial relationships.

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

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

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

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

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

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

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