Clinician Reviews

While the increased risk of cancer in patients with metabolic syndrome is well established by research, the authors of a new study delve deeper by examining metabolic syndrome trajectories.

The new research finds that adults with persistent metabolic syndrome that worsens over time are at increased risk for any type of cancer.

The conditions that make up metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, and colleagues.

However, a single assessment of metabolic syndrome at one point in time is inadequate to show an association with cancer risk over time, they said. In the current study, the researchers used models to examine the association between trajectory patterns of metabolic syndrome over time and the risk of overall and specific cancer types. They also examined the impact of chronic inflammation concurrent with metabolic syndrome.
 

What We Know About Metabolic Syndrome and Cancer Risk

A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.

More recently, a 2020 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.

In addition, a 2022 study by some of the current study researchers of the same Chinese cohort focused on the role of inflammation in combination with metabolic syndrome on colorectal cancer specifically, and found an increased risk for cancer when both metabolic syndrome and inflammation were present.

However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.

“There is emerging evidence that even normal weight individuals who are metabolically unhealthy may be at an elevated cancer risk, and we need better metrics to define the underlying metabolic dysfunction in obesity,” Sheetal Hardikar, MBBS, PhD, MPH, an investigator at the Huntsman Cancer Institute, University of Utah, said in an interview.

Dr. Hardikar, who serves as assistant professor in the department of population health sciences at the University of Utah, was not involved in the current study. She and her colleagues published a research paper on data from the National Health and Nutrition Examination Survey in 2023 that showed an increased risk of obesity-related cancer.
 

What New Study Adds to Related Research

Previous studies have consistently reported an approximately 30% increased risk of cancer with metabolic syndrome, Dr. Hardikar said. “What is unique about this study is the examination of metabolic syndrome trajectories over four years, and not just the presence of metabolic syndrome at one point in time,” she said.

In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).

The average age of the participants was 49 years; the mean body mass index ranged from approximately 22 kg/m² in the low-stable group to approximately 28 kg/m² in the elevated-increasing group.

The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.

Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.

The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
 

What Are the Limitations of This Research?

The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.

Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.

Using the International Diabetes Federation criteria was another limitation, because it prevented the assessment of cancer risk in normal weight individuals with metabolic dysfunction, Dr. Hardikar noted.
 

Does Metabolic Syndrome Cause Cancer?

“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, noted in a statement on the study.

More research is needed to assess the impact of these interventions on cancer risk. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he continued.

“Current evidence based on this study and many other reports strongly suggests an increased risk for cancer associated with metabolic syndrome,” Dr. Hardikar said in an interview. The data serve as a reminder to clinicians to look beyond BMI as the only measure of obesity, and to consider metabolic factors together to identify individuals at increased risk for cancer, she said.

“We must continue to educate patients about obesity and all the chronic conditions it may lead to, but we cannot ignore this emerging phenotype of being of normal weight but metabolically unhealthy,” Dr. Hardikar emphasized.
 

What Additional Research is Needed?

Looking ahead, “we need well-designed interventions to test causality for metabolic syndrome and cancer risk, though the evidence from the observational studies is very strong,” Dr. Hardikar said.

In addition, a consensus is needed to better define metabolic dysfunction,and to explore cancer risk in normal weight but metabolically unhealthy individuals, she said.

The study was supported by the National Key Research and Development Program of China. The researchers and Dr. Hardikar had no financial conflicts to disclose.

While the increased risk of cancer in patients with metabolic syndrome is well established by research, the authors of a new study delve deeper by examining metabolic syndrome trajectories.

The new research finds that adults with persistent metabolic syndrome that worsens over time are at increased risk for any type of cancer.

The conditions that make up metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, and colleagues.

However, a single assessment of metabolic syndrome at one point in time is inadequate to show an association with cancer risk over time, they said. In the current study, the researchers used models to examine the association between trajectory patterns of metabolic syndrome over time and the risk of overall and specific cancer types. They also examined the impact of chronic inflammation concurrent with metabolic syndrome.
 

What We Know About Metabolic Syndrome and Cancer Risk

A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.

More recently, a 2020 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.

In addition, a 2022 study by some of the current study researchers of the same Chinese cohort focused on the role of inflammation in combination with metabolic syndrome on colorectal cancer specifically, and found an increased risk for cancer when both metabolic syndrome and inflammation were present.

However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.

“There is emerging evidence that even normal weight individuals who are metabolically unhealthy may be at an elevated cancer risk, and we need better metrics to define the underlying metabolic dysfunction in obesity,” Sheetal Hardikar, MBBS, PhD, MPH, an investigator at the Huntsman Cancer Institute, University of Utah, said in an interview.

Dr. Hardikar, who serves as assistant professor in the department of population health sciences at the University of Utah, was not involved in the current study. She and her colleagues published a research paper on data from the National Health and Nutrition Examination Survey in 2023 that showed an increased risk of obesity-related cancer.
 

What New Study Adds to Related Research

Previous studies have consistently reported an approximately 30% increased risk of cancer with metabolic syndrome, Dr. Hardikar said. “What is unique about this study is the examination of metabolic syndrome trajectories over four years, and not just the presence of metabolic syndrome at one point in time,” she said.

In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).

The average age of the participants was 49 years; the mean body mass index ranged from approximately 22 kg/m² in the low-stable group to approximately 28 kg/m² in the elevated-increasing group.

The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.

Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.

The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
 

What Are the Limitations of This Research?

The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.

Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.

Using the International Diabetes Federation criteria was another limitation, because it prevented the assessment of cancer risk in normal weight individuals with metabolic dysfunction, Dr. Hardikar noted.
 

Does Metabolic Syndrome Cause Cancer?

“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, noted in a statement on the study.

More research is needed to assess the impact of these interventions on cancer risk. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he continued.

“Current evidence based on this study and many other reports strongly suggests an increased risk for cancer associated with metabolic syndrome,” Dr. Hardikar said in an interview. The data serve as a reminder to clinicians to look beyond BMI as the only measure of obesity, and to consider metabolic factors together to identify individuals at increased risk for cancer, she said.

“We must continue to educate patients about obesity and all the chronic conditions it may lead to, but we cannot ignore this emerging phenotype of being of normal weight but metabolically unhealthy,” Dr. Hardikar emphasized.
 

What Additional Research is Needed?

Looking ahead, “we need well-designed interventions to test causality for metabolic syndrome and cancer risk, though the evidence from the observational studies is very strong,” Dr. Hardikar said.

In addition, a consensus is needed to better define metabolic dysfunction,and to explore cancer risk in normal weight but metabolically unhealthy individuals, she said.

The study was supported by the National Key Research and Development Program of China. The researchers and Dr. Hardikar had no financial conflicts to disclose.

While the increased risk of cancer in patients with metabolic syndrome is well established by research, the authors of a new study delve deeper by examining metabolic syndrome trajectories.

The new research finds that adults with persistent metabolic syndrome that worsens over time are at increased risk for any type of cancer.

The conditions that make up metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, and colleagues.

However, a single assessment of metabolic syndrome at one point in time is inadequate to show an association with cancer risk over time, they said. In the current study, the researchers used models to examine the association between trajectory patterns of metabolic syndrome over time and the risk of overall and specific cancer types. They also examined the impact of chronic inflammation concurrent with metabolic syndrome.
 

What We Know About Metabolic Syndrome and Cancer Risk

A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.

More recently, a 2020 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.

In addition, a 2022 study by some of the current study researchers of the same Chinese cohort focused on the role of inflammation in combination with metabolic syndrome on colorectal cancer specifically, and found an increased risk for cancer when both metabolic syndrome and inflammation were present.

However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.

“There is emerging evidence that even normal weight individuals who are metabolically unhealthy may be at an elevated cancer risk, and we need better metrics to define the underlying metabolic dysfunction in obesity,” Sheetal Hardikar, MBBS, PhD, MPH, an investigator at the Huntsman Cancer Institute, University of Utah, said in an interview.

Dr. Hardikar, who serves as assistant professor in the department of population health sciences at the University of Utah, was not involved in the current study. She and her colleagues published a research paper on data from the National Health and Nutrition Examination Survey in 2023 that showed an increased risk of obesity-related cancer.
 

What New Study Adds to Related Research

Previous studies have consistently reported an approximately 30% increased risk of cancer with metabolic syndrome, Dr. Hardikar said. “What is unique about this study is the examination of metabolic syndrome trajectories over four years, and not just the presence of metabolic syndrome at one point in time,” she said.

In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).

The average age of the participants was 49 years; the mean body mass index ranged from approximately 22 kg/m² in the low-stable group to approximately 28 kg/m² in the elevated-increasing group.

The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.

Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.

The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
 

What Are the Limitations of This Research?

The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.

Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.

Using the International Diabetes Federation criteria was another limitation, because it prevented the assessment of cancer risk in normal weight individuals with metabolic dysfunction, Dr. Hardikar noted.
 

Does Metabolic Syndrome Cause Cancer?

“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, noted in a statement on the study.

More research is needed to assess the impact of these interventions on cancer risk. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he continued.

“Current evidence based on this study and many other reports strongly suggests an increased risk for cancer associated with metabolic syndrome,” Dr. Hardikar said in an interview. The data serve as a reminder to clinicians to look beyond BMI as the only measure of obesity, and to consider metabolic factors together to identify individuals at increased risk for cancer, she said.

“We must continue to educate patients about obesity and all the chronic conditions it may lead to, but we cannot ignore this emerging phenotype of being of normal weight but metabolically unhealthy,” Dr. Hardikar emphasized.
 

What Additional Research is Needed?

Looking ahead, “we need well-designed interventions to test causality for metabolic syndrome and cancer risk, though the evidence from the observational studies is very strong,” Dr. Hardikar said.

In addition, a consensus is needed to better define metabolic dysfunction,and to explore cancer risk in normal weight but metabolically unhealthy individuals, she said.

The study was supported by the National Key Research and Development Program of China. The researchers and Dr. Hardikar had no financial conflicts to disclose.

Sublingual immunotherapy (SLIT) is as safe and effective for high-risk older children and adolescents as oral immunotherapy (OIT) is for infants and preschoolers, according to new research.

Preliminary data from a study of more than 180 pediatric patients with multiple food allergies showed that while most patients had mild symptoms, none experienced a severe grade 4 reaction during the buildup and maintenance phase of SLIT.

In addition, 70% of those tested at the end of the treatment protocol were able to tolerate 300 mg of their allergen, a success rate nearly as high as that for OIT.

The study was published in The Journal of Allergy and Clinical Immunology: In Practice.

SLIT has been used successfully in the treatment of environmental allergens such as grass and tree pollen and dust mites. In this study, researchers decided to test SLIT’s effectiveness and safety in the treatment of food allergies in older children.

“We knew that OIT is very effective and safe in infants and toddlers, but there was literature illustrating that for older, school-age kids and adolescents, OIT is not safe enough, as those older age groups tend to have higher risk of severe reaction during treatment,” senior author Edmond Chan, MD, clinical professor of allergy at the University of British Columbia and pediatric allergist at BC Children’s Hospital, both in Vancouver, British Columbia, Canada, told this news organization. “With that knowledge, we decided to explore SLIT as another first-phase therapy for the older kids.”

The investigators recruited 188 high-risk older children aged 4-18 years for multifood SLIT. Most (61.7%) participants had multiple food allergies. Approximately 68% were male, and the population’s median age was 11.3 years.

Nearly half (48.4%) of participants had atopic dermatitis, 45.2% had asthma, 58.0% had allergic rhinitis, and 2.66% had preexisting eosinophilic esophagitis.

Most (75.0%) of the children were classified as higher risk, and 23 had a history of a grade 3 or 4 reaction before beginning SLIT.

Of the 188 children who were initially enrolled in the study, 173 (92.0%) finished their SLIT buildup phase.

Because the study started when COVID-19 pandemic restrictions were in place, the SLIT protocol mandated that patients be seen virtually. The patients’ caregivers learned how to mix and administer the required doses at home using recipes specially developed by the research team that used products bought at the grocery store.

A wide variety of food allergens were treated, including peanut, other legumes, tree nuts, sesame, other seeds, egg, cow’s milk, fish, wheat, shrimp, and other allergens.

The children built up to 2-mg protein SLIT maintenance over the course of three to five visits under nurse supervision.

After 1-2 years of daily SLIT maintenance, patients were offered a low-dose oral food challenge (OFC; cumulative dose: 300 mg of protein) with the goal of bypassing OIT buildup.

Nearly all patients (93.1%) had symptoms during SLIT buildup, but most were mild grade 1 (52.1%) or 2 (40.4%) reactions. Only one patient had a grade 3 reaction. None of the patients experienced a severe grade 4 reaction.

The most common grade 1 reaction was oral itch, an expected symptom of SLIT, which occurred in 82.7% of the patients.

Four patients (2.10%) received epinephrine during buildup and went to the emergency department. All these patients returned to continue SLIT without further need for epinephrine.

To test the effectiveness of SLIT, the researchers performed 50 low-dose OFCs in 20 patients. Of these food challenges, 35 (70%) were successful, and patients were asked to start daily 300-mg OIT maintenance, thus bypassing OIT buildup.

An additional nine OFCs that were unsuccessful were counseled to self-escalate from 80 mg or higher to 300 mg at home with medical guidance as needed.

“Our preliminary data of 20 patients and 50 low-dose oral food challenges suggest that an initial phase of 1-2 years of 2-mg daily SLIT therapy may be a safe and effective way to bypass the OIT buildup phase without the need for dozens of in-person visits with an allergist,” said Dr. Chan.

“So now we have the best of both worlds. We harness the safety of SLIT for the first 1-2 years, with the effectiveness of OIT for the remainder of the treatment period,” he said.
 

Adds to Evidence

Commenting on the study for this news organization, Julia Upton, MD, associate professor of pediatrics at the University of Toronto, Toronto, Ontario, Canada, said, “This study adds to the evidence that consistent, low exposure to food drives meaningful desensitization far above the daily dose.” Upton did not participate in the research.

“Prior prospective studies in SLIT demonstrated that small single-digit-milligram doses and time greatly increased the threshold of reaction. This real-world report suggests that a way to utilize that threshold increase is by switching to a commonly used maintenance dose of OIT,” said Dr. Upton.

“Although few patients have been assessed for the 300-mg challenge, this study is notable for the age group of 4-18 years, and that many of the patients had reacted to low doses in the past. It also shows that many families are capable of diluting and mixing their own immunotherapy solutions with store-bought foods under the guidance of an experienced allergy clinic,” she added.

“Overall, evidence is building that by various routes, initial small amounts with minimal updoses, plus the tincture of time, may be preferred to multiple frequent updosing from multiple perspectives, including safety, feasibility, cost, and medical resources. It will also be important to understand the preferences and goals of the patient and family as various regimens become more available,” Dr. Upton concluded.

The study was funded by BC Children’s Hospital Foundation. Dr. Chan reported receiving research support from DVB Technologies; has been a member of advisory boards for Pfizer, Miravo, Medexus, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi, Genzyme, Bausch Health, Avir Pharma, AstraZeneca, ALK, and Alladapt; and was a colead of the CSACI OIT guidelines. Dr. Upton reported research support/grants from Novartis, Regeneron, Sanofi, ALK Abello, DBV Technologies, CIHR, and SickKids Food Allergy and Anaphylaxis Program and fees from Pfizer, ALK Abello, Bausch Health, Astra Zeneca, and Pharming. She serves as an associate editor for Allergy, Asthma & Clinical Immunology and is on the Board of Directors of Canadian Society of Allergy and Clinical Immunology and the Healthcare Advisory Board of Food Allergy Canada.

A version of this article appeared on Medscape.com .

Sublingual immunotherapy (SLIT) is as safe and effective for high-risk older children and adolescents as oral immunotherapy (OIT) is for infants and preschoolers, according to new research.

Preliminary data from a study of more than 180 pediatric patients with multiple food allergies showed that while most patients had mild symptoms, none experienced a severe grade 4 reaction during the buildup and maintenance phase of SLIT.

In addition, 70% of those tested at the end of the treatment protocol were able to tolerate 300 mg of their allergen, a success rate nearly as high as that for OIT.

The study was published in The Journal of Allergy and Clinical Immunology: In Practice.

SLIT has been used successfully in the treatment of environmental allergens such as grass and tree pollen and dust mites. In this study, researchers decided to test SLIT’s effectiveness and safety in the treatment of food allergies in older children.

“We knew that OIT is very effective and safe in infants and toddlers, but there was literature illustrating that for older, school-age kids and adolescents, OIT is not safe enough, as those older age groups tend to have higher risk of severe reaction during treatment,” senior author Edmond Chan, MD, clinical professor of allergy at the University of British Columbia and pediatric allergist at BC Children’s Hospital, both in Vancouver, British Columbia, Canada, told this news organization. “With that knowledge, we decided to explore SLIT as another first-phase therapy for the older kids.”

The investigators recruited 188 high-risk older children aged 4-18 years for multifood SLIT. Most (61.7%) participants had multiple food allergies. Approximately 68% were male, and the population’s median age was 11.3 years.

Nearly half (48.4%) of participants had atopic dermatitis, 45.2% had asthma, 58.0% had allergic rhinitis, and 2.66% had preexisting eosinophilic esophagitis.

Most (75.0%) of the children were classified as higher risk, and 23 had a history of a grade 3 or 4 reaction before beginning SLIT.

Of the 188 children who were initially enrolled in the study, 173 (92.0%) finished their SLIT buildup phase.

Because the study started when COVID-19 pandemic restrictions were in place, the SLIT protocol mandated that patients be seen virtually. The patients’ caregivers learned how to mix and administer the required doses at home using recipes specially developed by the research team that used products bought at the grocery store.

A wide variety of food allergens were treated, including peanut, other legumes, tree nuts, sesame, other seeds, egg, cow’s milk, fish, wheat, shrimp, and other allergens.

The children built up to 2-mg protein SLIT maintenance over the course of three to five visits under nurse supervision.

After 1-2 years of daily SLIT maintenance, patients were offered a low-dose oral food challenge (OFC; cumulative dose: 300 mg of protein) with the goal of bypassing OIT buildup.

Nearly all patients (93.1%) had symptoms during SLIT buildup, but most were mild grade 1 (52.1%) or 2 (40.4%) reactions. Only one patient had a grade 3 reaction. None of the patients experienced a severe grade 4 reaction.

The most common grade 1 reaction was oral itch, an expected symptom of SLIT, which occurred in 82.7% of the patients.

Four patients (2.10%) received epinephrine during buildup and went to the emergency department. All these patients returned to continue SLIT without further need for epinephrine.

To test the effectiveness of SLIT, the researchers performed 50 low-dose OFCs in 20 patients. Of these food challenges, 35 (70%) were successful, and patients were asked to start daily 300-mg OIT maintenance, thus bypassing OIT buildup.

An additional nine OFCs that were unsuccessful were counseled to self-escalate from 80 mg or higher to 300 mg at home with medical guidance as needed.

“Our preliminary data of 20 patients and 50 low-dose oral food challenges suggest that an initial phase of 1-2 years of 2-mg daily SLIT therapy may be a safe and effective way to bypass the OIT buildup phase without the need for dozens of in-person visits with an allergist,” said Dr. Chan.

“So now we have the best of both worlds. We harness the safety of SLIT for the first 1-2 years, with the effectiveness of OIT for the remainder of the treatment period,” he said.
 

Adds to Evidence

Commenting on the study for this news organization, Julia Upton, MD, associate professor of pediatrics at the University of Toronto, Toronto, Ontario, Canada, said, “This study adds to the evidence that consistent, low exposure to food drives meaningful desensitization far above the daily dose.” Upton did not participate in the research.

“Prior prospective studies in SLIT demonstrated that small single-digit-milligram doses and time greatly increased the threshold of reaction. This real-world report suggests that a way to utilize that threshold increase is by switching to a commonly used maintenance dose of OIT,” said Dr. Upton.

“Although few patients have been assessed for the 300-mg challenge, this study is notable for the age group of 4-18 years, and that many of the patients had reacted to low doses in the past. It also shows that many families are capable of diluting and mixing their own immunotherapy solutions with store-bought foods under the guidance of an experienced allergy clinic,” she added.

“Overall, evidence is building that by various routes, initial small amounts with minimal updoses, plus the tincture of time, may be preferred to multiple frequent updosing from multiple perspectives, including safety, feasibility, cost, and medical resources. It will also be important to understand the preferences and goals of the patient and family as various regimens become more available,” Dr. Upton concluded.

The study was funded by BC Children’s Hospital Foundation. Dr. Chan reported receiving research support from DVB Technologies; has been a member of advisory boards for Pfizer, Miravo, Medexus, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi, Genzyme, Bausch Health, Avir Pharma, AstraZeneca, ALK, and Alladapt; and was a colead of the CSACI OIT guidelines. Dr. Upton reported research support/grants from Novartis, Regeneron, Sanofi, ALK Abello, DBV Technologies, CIHR, and SickKids Food Allergy and Anaphylaxis Program and fees from Pfizer, ALK Abello, Bausch Health, Astra Zeneca, and Pharming. She serves as an associate editor for Allergy, Asthma & Clinical Immunology and is on the Board of Directors of Canadian Society of Allergy and Clinical Immunology and the Healthcare Advisory Board of Food Allergy Canada.

A version of this article appeared on Medscape.com .

Sublingual immunotherapy (SLIT) is as safe and effective for high-risk older children and adolescents as oral immunotherapy (OIT) is for infants and preschoolers, according to new research.

Preliminary data from a study of more than 180 pediatric patients with multiple food allergies showed that while most patients had mild symptoms, none experienced a severe grade 4 reaction during the buildup and maintenance phase of SLIT.

In addition, 70% of those tested at the end of the treatment protocol were able to tolerate 300 mg of their allergen, a success rate nearly as high as that for OIT.

The study was published in The Journal of Allergy and Clinical Immunology: In Practice.

SLIT has been used successfully in the treatment of environmental allergens such as grass and tree pollen and dust mites. In this study, researchers decided to test SLIT’s effectiveness and safety in the treatment of food allergies in older children.

“We knew that OIT is very effective and safe in infants and toddlers, but there was literature illustrating that for older, school-age kids and adolescents, OIT is not safe enough, as those older age groups tend to have higher risk of severe reaction during treatment,” senior author Edmond Chan, MD, clinical professor of allergy at the University of British Columbia and pediatric allergist at BC Children’s Hospital, both in Vancouver, British Columbia, Canada, told this news organization. “With that knowledge, we decided to explore SLIT as another first-phase therapy for the older kids.”

The investigators recruited 188 high-risk older children aged 4-18 years for multifood SLIT. Most (61.7%) participants had multiple food allergies. Approximately 68% were male, and the population’s median age was 11.3 years.

Nearly half (48.4%) of participants had atopic dermatitis, 45.2% had asthma, 58.0% had allergic rhinitis, and 2.66% had preexisting eosinophilic esophagitis.

Most (75.0%) of the children were classified as higher risk, and 23 had a history of a grade 3 or 4 reaction before beginning SLIT.

Of the 188 children who were initially enrolled in the study, 173 (92.0%) finished their SLIT buildup phase.

Because the study started when COVID-19 pandemic restrictions were in place, the SLIT protocol mandated that patients be seen virtually. The patients’ caregivers learned how to mix and administer the required doses at home using recipes specially developed by the research team that used products bought at the grocery store.

A wide variety of food allergens were treated, including peanut, other legumes, tree nuts, sesame, other seeds, egg, cow’s milk, fish, wheat, shrimp, and other allergens.

The children built up to 2-mg protein SLIT maintenance over the course of three to five visits under nurse supervision.

After 1-2 years of daily SLIT maintenance, patients were offered a low-dose oral food challenge (OFC; cumulative dose: 300 mg of protein) with the goal of bypassing OIT buildup.

Nearly all patients (93.1%) had symptoms during SLIT buildup, but most were mild grade 1 (52.1%) or 2 (40.4%) reactions. Only one patient had a grade 3 reaction. None of the patients experienced a severe grade 4 reaction.

The most common grade 1 reaction was oral itch, an expected symptom of SLIT, which occurred in 82.7% of the patients.

Four patients (2.10%) received epinephrine during buildup and went to the emergency department. All these patients returned to continue SLIT without further need for epinephrine.

To test the effectiveness of SLIT, the researchers performed 50 low-dose OFCs in 20 patients. Of these food challenges, 35 (70%) were successful, and patients were asked to start daily 300-mg OIT maintenance, thus bypassing OIT buildup.

An additional nine OFCs that were unsuccessful were counseled to self-escalate from 80 mg or higher to 300 mg at home with medical guidance as needed.

“Our preliminary data of 20 patients and 50 low-dose oral food challenges suggest that an initial phase of 1-2 years of 2-mg daily SLIT therapy may be a safe and effective way to bypass the OIT buildup phase without the need for dozens of in-person visits with an allergist,” said Dr. Chan.

“So now we have the best of both worlds. We harness the safety of SLIT for the first 1-2 years, with the effectiveness of OIT for the remainder of the treatment period,” he said.
 

Adds to Evidence

Commenting on the study for this news organization, Julia Upton, MD, associate professor of pediatrics at the University of Toronto, Toronto, Ontario, Canada, said, “This study adds to the evidence that consistent, low exposure to food drives meaningful desensitization far above the daily dose.” Upton did not participate in the research.

“Prior prospective studies in SLIT demonstrated that small single-digit-milligram doses and time greatly increased the threshold of reaction. This real-world report suggests that a way to utilize that threshold increase is by switching to a commonly used maintenance dose of OIT,” said Dr. Upton.

“Although few patients have been assessed for the 300-mg challenge, this study is notable for the age group of 4-18 years, and that many of the patients had reacted to low doses in the past. It also shows that many families are capable of diluting and mixing their own immunotherapy solutions with store-bought foods under the guidance of an experienced allergy clinic,” she added.

“Overall, evidence is building that by various routes, initial small amounts with minimal updoses, plus the tincture of time, may be preferred to multiple frequent updosing from multiple perspectives, including safety, feasibility, cost, and medical resources. It will also be important to understand the preferences and goals of the patient and family as various regimens become more available,” Dr. Upton concluded.

The study was funded by BC Children’s Hospital Foundation. Dr. Chan reported receiving research support from DVB Technologies; has been a member of advisory boards for Pfizer, Miravo, Medexus, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi, Genzyme, Bausch Health, Avir Pharma, AstraZeneca, ALK, and Alladapt; and was a colead of the CSACI OIT guidelines. Dr. Upton reported research support/grants from Novartis, Regeneron, Sanofi, ALK Abello, DBV Technologies, CIHR, and SickKids Food Allergy and Anaphylaxis Program and fees from Pfizer, ALK Abello, Bausch Health, Astra Zeneca, and Pharming. She serves as an associate editor for Allergy, Asthma & Clinical Immunology and is on the Board of Directors of Canadian Society of Allergy and Clinical Immunology and the Healthcare Advisory Board of Food Allergy Canada.

A version of this article appeared on Medscape.com .

SAN DIEGO — Just weeks after the American Academy of Dermatology (AAD) published its updated acne management guidelines, a dermatologist who helped write the recommendations provided colleagues with insight into recently approved topical therapies, the importance of multimodal therapy, and a controversial report linking benzoyl peroxide (BP) to the carcinogen benzene.

In regard to topical treatments, the guidelines make a “strong” recommendation for topical retinoids based on “moderate” evidence, Andrea L. Zaenglein, MD, professor of dermatology and pediatrics, Penn State University, Hershey, Pennsylvania, said at the annual meeting of the American Academy of Dermatology. The recommendation was based on a pooled analysis of four randomized controlled trials that found patients with acne who used the medications were more likely to have improvement via the Investigator Global Assessment (IGA) scale at 12 weeks than were those treated with a vehicle (risk ratio [RR], 1.57; 1.21-2.04).

The updated guidelines were published on January 30 in the Journal of the American Academy of Dermatology. The previous guidelines were issued in 2016.

“We have four current retinoids that we use: adapalene, tretinoin, tazarotene, and trifarotene,” Dr. Zaenglein said. “Typically, when we think about retinoids, we think of adapalene as being more tolerable and tazarotene as being more effective. But we also know that they can work to prevent and treat scarring, and they work against comedonal lesions and inflammatory lesions.”

Newer concentrations include tretinoin 0.05% lotion, tazarotene 0.045% lotion, and trifarotene 0.005% cream. She noted that this trifarotene concentration can be helpful for moderate truncal acne and also referred to evidence that whey protein appears to exacerbate that condition. “I always ask teenage kids about that: Are they using those protein powders?”
 

Recommendations for ‘Multimodal Therapy,’ Especially With Antibiotics

Dr. Zaenglein highlighted a “good practice statement” in the new guidelines that says, “when managing acne with topical medications, we recommend multimodal therapy combining multiple mechanisms of action.”

Topical antibiotics are effective treatments on their own and include erythromycin, clindamycin, and minocycline (Minocin), she said. But the guidelines, which refer to evidence supporting them as “moderate,” do not recommend them as monotherapy because of the risk for antibiotic resistance.

The oral retinoid isotretinoin may be appropriate in conjunction with topical medications, she said, “and we also recommend fixed combination products because they’re associated with increased adherence.”

Dermatologists are familiar with several of these products because “we’ve been using them for years and years,” she said. The guidelines note that “compared to vehicle at 12 weeks, a greater proportion of patients treated with combined BP and topical retinoid achieved IGA success in three RCTs (RR, 2.19; 1.77-2.72).”

Dr. Zaenglein noted that the guidelines recommend that patients taking antibiotics also use benzoyl peroxide, which has “moderate” evidence regarding preventing the development of antibiotic resistance. “Lower strengths tend to be less irritating, and over-the-counter formulations are readily available,” she said, adding that colleagues should make sure to warn patients about the risk of bleaching clothes and towels with BP.

Now, there’s a newly approved treatment, the first fixed-dose triple combination therapy for acne, she said. It combines 1.2% clindamycin, 3.1% benzoyl peroxide, and 0.15% adapalene (Cabtreo) and is Food and Drug Administration (FDA)-approved for treating acne in patients ages 12 and up.

The new AAD guidelines note that “potential adverse effect profiles of the fixed-dose combinations generally reflect those of the individual agents in summation. Some fixed-dose combination products may be less expensive than prescribing their individual components separately.” The evidence supporting fixed-dose combinations in conjunction with benzoyl peroxide is considered “moderate.”

Dapsone gel, 7.5% (Aczone) is another option for acne. “It’s a topical so you don’t need to do G6PD [glucose-6-phosphate dehydrogenase] testing,” Dr. Zaenglein said. “It’s well tolerated, and mean total lesions fell by 48.9% vs 43.2% for vehicle,” in a 2018 study, which she said also found that females benefited more than males from this treatment.

Clascoterone 1% cream (Winlevi), approved in 2020, is appropriate for males and females aged 12 and up, Dr. Zaenglein said. She noted that it’s the only topical anti-androgen that can be used in males. However, while it has a “high” level of evidence because of phase 3 clinical trials showing benefits in moderate to severe acne, the AAD guidelines only conditionally recommend this option because the high price of clascoterone “may impact equitable acne treatment access.” The price listed on the website GoodRx (accessed on March 12) lists drugstore prices for a single 60-gram tube as ranging from $590 to $671.

“One of the harder things is trying to figure out where clascoterone fits in our kind of standard combination therapy,” she said. “Much like other hormonal therapies, it works better over the long term.”

Two more topical options per the AAD guidelines are salicylic acid, based on one randomized controlled trial, and azelaic acid (Azelex, Finacea), based on three randomized controlled trials. Both of these recommendations are conditional because of limited evidence: Evidence is considered “low” for salicylic acid and “moderate” for azelaic acid, the guidelines say, and azelaic acid “may be particularly helpful for patients with sensitive skin or darker skin types due to its lightening effect on dyspigmentation.”

As for risk for topical treatments during pregnancy/lactation, the guidelines note that topical therapies other than topical retinoids are “preferred” during pregnancy. Tazarotene is contraindicated during pregnancy, and salicylic acid should be used only in limited areas of exposure. There are no data for dapsone and clascoterone during pregnancy/lactation, and minocycline is “not recommended.”

The guideline authors noted that “available evidence is insufficient to develop a recommendation on the use of topical glycolic acid, sulfur, sodium sulfacetamide, and resorcinol for acne treatment or to make recommendations that compare topical BP, retinoids, antibiotics, and their combinations directly against each other.”
 

Could BP Post a Risk From Benzene?

Dr. Zaenglein highlighted a recently released report by Valisure, an independent laboratory, which reported finding high levels of the cancer-causing chemical benzene in several acne treatments, including brands such as Clearasil. “They didn’t release all of the ones that they evaluated, but there were a lot ... that we commonly recommend for our patients,” she said.

On March 6, CBS News reported that Valisure “ran tests at various temperatures over 18 days and found some products ‘can form over 800 times the conditionally restricted FDA concentration limit of two parts per million (ppm) for benzene’ in 2 weeks at 50° C (122° F),” but that benzene levels “at room temperature were more modest, ranging from about one to 24 parts per million.”

Dr. Zaenglein said she’s not ready to urge patients to discontinue BP, although in light of the findings, “I will tell them to store it at room temperature or lower.”

For now, it’s important to wait for independent verification of the results, she said. “And then it’s up to the manufacturers to reevaluate the stability of their benzoyl peroxide products with heat.”

Dr. Zaenglein disclosed relationships with AbbVie, Arcutis, Biofrontera, Galderma, and Incyte (grants/research funding), Church & Dwight (consulting fees), and UCB (consulting honoraria).

A version of this article appeared on Medscape.com.

SAN DIEGO — Just weeks after the American Academy of Dermatology (AAD) published its updated acne management guidelines, a dermatologist who helped write the recommendations provided colleagues with insight into recently approved topical therapies, the importance of multimodal therapy, and a controversial report linking benzoyl peroxide (BP) to the carcinogen benzene.

In regard to topical treatments, the guidelines make a “strong” recommendation for topical retinoids based on “moderate” evidence, Andrea L. Zaenglein, MD, professor of dermatology and pediatrics, Penn State University, Hershey, Pennsylvania, said at the annual meeting of the American Academy of Dermatology. The recommendation was based on a pooled analysis of four randomized controlled trials that found patients with acne who used the medications were more likely to have improvement via the Investigator Global Assessment (IGA) scale at 12 weeks than were those treated with a vehicle (risk ratio [RR], 1.57; 1.21-2.04).

The updated guidelines were published on January 30 in the Journal of the American Academy of Dermatology. The previous guidelines were issued in 2016.

“We have four current retinoids that we use: adapalene, tretinoin, tazarotene, and trifarotene,” Dr. Zaenglein said. “Typically, when we think about retinoids, we think of adapalene as being more tolerable and tazarotene as being more effective. But we also know that they can work to prevent and treat scarring, and they work against comedonal lesions and inflammatory lesions.”

Newer concentrations include tretinoin 0.05% lotion, tazarotene 0.045% lotion, and trifarotene 0.005% cream. She noted that this trifarotene concentration can be helpful for moderate truncal acne and also referred to evidence that whey protein appears to exacerbate that condition. “I always ask teenage kids about that: Are they using those protein powders?”
 

Recommendations for ‘Multimodal Therapy,’ Especially With Antibiotics

Dr. Zaenglein highlighted a “good practice statement” in the new guidelines that says, “when managing acne with topical medications, we recommend multimodal therapy combining multiple mechanisms of action.”

Topical antibiotics are effective treatments on their own and include erythromycin, clindamycin, and minocycline (Minocin), she said. But the guidelines, which refer to evidence supporting them as “moderate,” do not recommend them as monotherapy because of the risk for antibiotic resistance.

The oral retinoid isotretinoin may be appropriate in conjunction with topical medications, she said, “and we also recommend fixed combination products because they’re associated with increased adherence.”

Dermatologists are familiar with several of these products because “we’ve been using them for years and years,” she said. The guidelines note that “compared to vehicle at 12 weeks, a greater proportion of patients treated with combined BP and topical retinoid achieved IGA success in three RCTs (RR, 2.19; 1.77-2.72).”

Dr. Zaenglein noted that the guidelines recommend that patients taking antibiotics also use benzoyl peroxide, which has “moderate” evidence regarding preventing the development of antibiotic resistance. “Lower strengths tend to be less irritating, and over-the-counter formulations are readily available,” she said, adding that colleagues should make sure to warn patients about the risk of bleaching clothes and towels with BP.

Now, there’s a newly approved treatment, the first fixed-dose triple combination therapy for acne, she said. It combines 1.2% clindamycin, 3.1% benzoyl peroxide, and 0.15% adapalene (Cabtreo) and is Food and Drug Administration (FDA)-approved for treating acne in patients ages 12 and up.

The new AAD guidelines note that “potential adverse effect profiles of the fixed-dose combinations generally reflect those of the individual agents in summation. Some fixed-dose combination products may be less expensive than prescribing their individual components separately.” The evidence supporting fixed-dose combinations in conjunction with benzoyl peroxide is considered “moderate.”

Dapsone gel, 7.5% (Aczone) is another option for acne. “It’s a topical so you don’t need to do G6PD [glucose-6-phosphate dehydrogenase] testing,” Dr. Zaenglein said. “It’s well tolerated, and mean total lesions fell by 48.9% vs 43.2% for vehicle,” in a 2018 study, which she said also found that females benefited more than males from this treatment.

Clascoterone 1% cream (Winlevi), approved in 2020, is appropriate for males and females aged 12 and up, Dr. Zaenglein said. She noted that it’s the only topical anti-androgen that can be used in males. However, while it has a “high” level of evidence because of phase 3 clinical trials showing benefits in moderate to severe acne, the AAD guidelines only conditionally recommend this option because the high price of clascoterone “may impact equitable acne treatment access.” The price listed on the website GoodRx (accessed on March 12) lists drugstore prices for a single 60-gram tube as ranging from $590 to $671.

“One of the harder things is trying to figure out where clascoterone fits in our kind of standard combination therapy,” she said. “Much like other hormonal therapies, it works better over the long term.”

Two more topical options per the AAD guidelines are salicylic acid, based on one randomized controlled trial, and azelaic acid (Azelex, Finacea), based on three randomized controlled trials. Both of these recommendations are conditional because of limited evidence: Evidence is considered “low” for salicylic acid and “moderate” for azelaic acid, the guidelines say, and azelaic acid “may be particularly helpful for patients with sensitive skin or darker skin types due to its lightening effect on dyspigmentation.”

As for risk for topical treatments during pregnancy/lactation, the guidelines note that topical therapies other than topical retinoids are “preferred” during pregnancy. Tazarotene is contraindicated during pregnancy, and salicylic acid should be used only in limited areas of exposure. There are no data for dapsone and clascoterone during pregnancy/lactation, and minocycline is “not recommended.”

The guideline authors noted that “available evidence is insufficient to develop a recommendation on the use of topical glycolic acid, sulfur, sodium sulfacetamide, and resorcinol for acne treatment or to make recommendations that compare topical BP, retinoids, antibiotics, and their combinations directly against each other.”
 

Could BP Post a Risk From Benzene?

Dr. Zaenglein highlighted a recently released report by Valisure, an independent laboratory, which reported finding high levels of the cancer-causing chemical benzene in several acne treatments, including brands such as Clearasil. “They didn’t release all of the ones that they evaluated, but there were a lot ... that we commonly recommend for our patients,” she said.

On March 6, CBS News reported that Valisure “ran tests at various temperatures over 18 days and found some products ‘can form over 800 times the conditionally restricted FDA concentration limit of two parts per million (ppm) for benzene’ in 2 weeks at 50° C (122° F),” but that benzene levels “at room temperature were more modest, ranging from about one to 24 parts per million.”

Dr. Zaenglein said she’s not ready to urge patients to discontinue BP, although in light of the findings, “I will tell them to store it at room temperature or lower.”

For now, it’s important to wait for independent verification of the results, she said. “And then it’s up to the manufacturers to reevaluate the stability of their benzoyl peroxide products with heat.”

Dr. Zaenglein disclosed relationships with AbbVie, Arcutis, Biofrontera, Galderma, and Incyte (grants/research funding), Church & Dwight (consulting fees), and UCB (consulting honoraria).

A version of this article appeared on Medscape.com.

SAN DIEGO — Just weeks after the American Academy of Dermatology (AAD) published its updated acne management guidelines, a dermatologist who helped write the recommendations provided colleagues with insight into recently approved topical therapies, the importance of multimodal therapy, and a controversial report linking benzoyl peroxide (BP) to the carcinogen benzene.

In regard to topical treatments, the guidelines make a “strong” recommendation for topical retinoids based on “moderate” evidence, Andrea L. Zaenglein, MD, professor of dermatology and pediatrics, Penn State University, Hershey, Pennsylvania, said at the annual meeting of the American Academy of Dermatology. The recommendation was based on a pooled analysis of four randomized controlled trials that found patients with acne who used the medications were more likely to have improvement via the Investigator Global Assessment (IGA) scale at 12 weeks than were those treated with a vehicle (risk ratio [RR], 1.57; 1.21-2.04).

The updated guidelines were published on January 30 in the Journal of the American Academy of Dermatology. The previous guidelines were issued in 2016.

“We have four current retinoids that we use: adapalene, tretinoin, tazarotene, and trifarotene,” Dr. Zaenglein said. “Typically, when we think about retinoids, we think of adapalene as being more tolerable and tazarotene as being more effective. But we also know that they can work to prevent and treat scarring, and they work against comedonal lesions and inflammatory lesions.”

Newer concentrations include tretinoin 0.05% lotion, tazarotene 0.045% lotion, and trifarotene 0.005% cream. She noted that this trifarotene concentration can be helpful for moderate truncal acne and also referred to evidence that whey protein appears to exacerbate that condition. “I always ask teenage kids about that: Are they using those protein powders?”
 

Recommendations for ‘Multimodal Therapy,’ Especially With Antibiotics

Dr. Zaenglein highlighted a “good practice statement” in the new guidelines that says, “when managing acne with topical medications, we recommend multimodal therapy combining multiple mechanisms of action.”

Topical antibiotics are effective treatments on their own and include erythromycin, clindamycin, and minocycline (Minocin), she said. But the guidelines, which refer to evidence supporting them as “moderate,” do not recommend them as monotherapy because of the risk for antibiotic resistance.

The oral retinoid isotretinoin may be appropriate in conjunction with topical medications, she said, “and we also recommend fixed combination products because they’re associated with increased adherence.”

Dermatologists are familiar with several of these products because “we’ve been using them for years and years,” she said. The guidelines note that “compared to vehicle at 12 weeks, a greater proportion of patients treated with combined BP and topical retinoid achieved IGA success in three RCTs (RR, 2.19; 1.77-2.72).”

Dr. Zaenglein noted that the guidelines recommend that patients taking antibiotics also use benzoyl peroxide, which has “moderate” evidence regarding preventing the development of antibiotic resistance. “Lower strengths tend to be less irritating, and over-the-counter formulations are readily available,” she said, adding that colleagues should make sure to warn patients about the risk of bleaching clothes and towels with BP.

Now, there’s a newly approved treatment, the first fixed-dose triple combination therapy for acne, she said. It combines 1.2% clindamycin, 3.1% benzoyl peroxide, and 0.15% adapalene (Cabtreo) and is Food and Drug Administration (FDA)-approved for treating acne in patients ages 12 and up.

The new AAD guidelines note that “potential adverse effect profiles of the fixed-dose combinations generally reflect those of the individual agents in summation. Some fixed-dose combination products may be less expensive than prescribing their individual components separately.” The evidence supporting fixed-dose combinations in conjunction with benzoyl peroxide is considered “moderate.”

Dapsone gel, 7.5% (Aczone) is another option for acne. “It’s a topical so you don’t need to do G6PD [glucose-6-phosphate dehydrogenase] testing,” Dr. Zaenglein said. “It’s well tolerated, and mean total lesions fell by 48.9% vs 43.2% for vehicle,” in a 2018 study, which she said also found that females benefited more than males from this treatment.

Clascoterone 1% cream (Winlevi), approved in 2020, is appropriate for males and females aged 12 and up, Dr. Zaenglein said. She noted that it’s the only topical anti-androgen that can be used in males. However, while it has a “high” level of evidence because of phase 3 clinical trials showing benefits in moderate to severe acne, the AAD guidelines only conditionally recommend this option because the high price of clascoterone “may impact equitable acne treatment access.” The price listed on the website GoodRx (accessed on March 12) lists drugstore prices for a single 60-gram tube as ranging from $590 to $671.

“One of the harder things is trying to figure out where clascoterone fits in our kind of standard combination therapy,” she said. “Much like other hormonal therapies, it works better over the long term.”

Two more topical options per the AAD guidelines are salicylic acid, based on one randomized controlled trial, and azelaic acid (Azelex, Finacea), based on three randomized controlled trials. Both of these recommendations are conditional because of limited evidence: Evidence is considered “low” for salicylic acid and “moderate” for azelaic acid, the guidelines say, and azelaic acid “may be particularly helpful for patients with sensitive skin or darker skin types due to its lightening effect on dyspigmentation.”

As for risk for topical treatments during pregnancy/lactation, the guidelines note that topical therapies other than topical retinoids are “preferred” during pregnancy. Tazarotene is contraindicated during pregnancy, and salicylic acid should be used only in limited areas of exposure. There are no data for dapsone and clascoterone during pregnancy/lactation, and minocycline is “not recommended.”

The guideline authors noted that “available evidence is insufficient to develop a recommendation on the use of topical glycolic acid, sulfur, sodium sulfacetamide, and resorcinol for acne treatment or to make recommendations that compare topical BP, retinoids, antibiotics, and their combinations directly against each other.”
 

Could BP Post a Risk From Benzene?

Dr. Zaenglein highlighted a recently released report by Valisure, an independent laboratory, which reported finding high levels of the cancer-causing chemical benzene in several acne treatments, including brands such as Clearasil. “They didn’t release all of the ones that they evaluated, but there were a lot ... that we commonly recommend for our patients,” she said.

On March 6, CBS News reported that Valisure “ran tests at various temperatures over 18 days and found some products ‘can form over 800 times the conditionally restricted FDA concentration limit of two parts per million (ppm) for benzene’ in 2 weeks at 50° C (122° F),” but that benzene levels “at room temperature were more modest, ranging from about one to 24 parts per million.”

Dr. Zaenglein said she’s not ready to urge patients to discontinue BP, although in light of the findings, “I will tell them to store it at room temperature or lower.”

For now, it’s important to wait for independent verification of the results, she said. “And then it’s up to the manufacturers to reevaluate the stability of their benzoyl peroxide products with heat.”

Dr. Zaenglein disclosed relationships with AbbVie, Arcutis, Biofrontera, Galderma, and Incyte (grants/research funding), Church & Dwight (consulting fees), and UCB (consulting honoraria).

A version of this article appeared on Medscape.com.

Semaglutide improved metabolic dysfunction–associated steatotic liver disease (MASLD) among people living with HIV, and in some cases resolved it completely, according to results from the SLIM LIVER study presented by the AIDS Clinical Trials Group (ACTG) at this year’s Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver.

Furthermore, although muscle volume decreased with weight loss, participants did not experience significant changes in muscle quality or physical function.
 

‘A First’

SLIM LIVER is the first study evaluating semaglutide as a treatment of MASLD among people living with HIV.

The phase 2b, single-arm pilot study enrolled adults living with HIV who were virally suppressed and had central adiposity, insulin resistance or prediabetes, and steatotic liver disease.

Participants self-injected semaglutide weekly at increasing doses until they reached a 1-mg dose at week 4. At 24 weeks, the study team assessed changes in participants’ intra-hepatic triglyceride content using magnetic resonance imaging-proton density fat fraction.

The primary analysis results from SLIM LIVER were reported in an oral presentation, “Semaglutide Reduces Metabolic-Associated Steatotic Liver Disease in People With HIV: The SLIM LIVER Study,” on March 5 by Jordan E. Lake, MD, MSc, of UTHealth Houston.

A subgroup analysis of the study was provided in a poster, “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER Study,” presented on March 4 by Grace L. Ditzenberger, PT, DPT, of the University of Colorado Anschutz Medical Campus in Aurora.

In the primary analysis, the median age of the 49 participants was 52 years, 43% were women (cisgender and transgender), the mean body mass index was 35, 39% were Hispanic and 33% were Black/African American, and 82% were taking antiretroviral therapy that included an integrase inhibitor.

Liver fat was reduced by an average of 31%, with 29% of participants experiencing a complete resolution (5% or less liver fat) of MASLD. They also experienced weight loss, reduced fasting blood glucose, and reduced fasting triglycerides, consistent with effects observed in studies of semaglutide in people without HIV.

The sub-analysis of the 46 participants for whom muscle measurements were available showed that muscle volume (measured in the psoas) decreased but with no significant change in physical function.

Semaglutide was generally well tolerated, with an adverse event profile similar to that seen in individuals without HIV.

The most common adverse events were gastrointestinal (ie, nausea, diarrhea, vomiting, and abdominal pain). Two participants experienced more significant adverse events possibly related to semaglutide but were able to continue in the study.

All participants completed the full 24 weeks of therapy at the originally prescribed dose.
 

Potential Impact

“Even at the low dose of 1 mg every week, most participants lost significant weight, and weight loss was closely associated with improvements in MASLD,” Dr. Lake said. “Additional research will assess the secondary effects of semaglutide on systemic inflammation and metabolism and determine whether semaglutide may have unique risks or benefits for people living with HIV.”

“These findings have the potential to have a significant impact on the health and quality of life of people living with HIV,” added ACTG Chair Judith Currier, MD, MSc, University of California Los Angeles.

The SLIM LIVER study was sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), with additional funding from UTHealth Houston McGovern School of Medicine. ACTG is a clinical trials network focused on HIV and other infectious diseases, funded by NIAID and collaborating institutes of the US National Institutes of Health.

No conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

Semaglutide improved metabolic dysfunction–associated steatotic liver disease (MASLD) among people living with HIV, and in some cases resolved it completely, according to results from the SLIM LIVER study presented by the AIDS Clinical Trials Group (ACTG) at this year’s Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver.

Furthermore, although muscle volume decreased with weight loss, participants did not experience significant changes in muscle quality or physical function.
 

‘A First’

SLIM LIVER is the first study evaluating semaglutide as a treatment of MASLD among people living with HIV.

The phase 2b, single-arm pilot study enrolled adults living with HIV who were virally suppressed and had central adiposity, insulin resistance or prediabetes, and steatotic liver disease.

Participants self-injected semaglutide weekly at increasing doses until they reached a 1-mg dose at week 4. At 24 weeks, the study team assessed changes in participants’ intra-hepatic triglyceride content using magnetic resonance imaging-proton density fat fraction.

The primary analysis results from SLIM LIVER were reported in an oral presentation, “Semaglutide Reduces Metabolic-Associated Steatotic Liver Disease in People With HIV: The SLIM LIVER Study,” on March 5 by Jordan E. Lake, MD, MSc, of UTHealth Houston.

A subgroup analysis of the study was provided in a poster, “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER Study,” presented on March 4 by Grace L. Ditzenberger, PT, DPT, of the University of Colorado Anschutz Medical Campus in Aurora.

In the primary analysis, the median age of the 49 participants was 52 years, 43% were women (cisgender and transgender), the mean body mass index was 35, 39% were Hispanic and 33% were Black/African American, and 82% were taking antiretroviral therapy that included an integrase inhibitor.

Liver fat was reduced by an average of 31%, with 29% of participants experiencing a complete resolution (5% or less liver fat) of MASLD. They also experienced weight loss, reduced fasting blood glucose, and reduced fasting triglycerides, consistent with effects observed in studies of semaglutide in people without HIV.

The sub-analysis of the 46 participants for whom muscle measurements were available showed that muscle volume (measured in the psoas) decreased but with no significant change in physical function.

Semaglutide was generally well tolerated, with an adverse event profile similar to that seen in individuals without HIV.

The most common adverse events were gastrointestinal (ie, nausea, diarrhea, vomiting, and abdominal pain). Two participants experienced more significant adverse events possibly related to semaglutide but were able to continue in the study.

All participants completed the full 24 weeks of therapy at the originally prescribed dose.
 

Potential Impact

“Even at the low dose of 1 mg every week, most participants lost significant weight, and weight loss was closely associated with improvements in MASLD,” Dr. Lake said. “Additional research will assess the secondary effects of semaglutide on systemic inflammation and metabolism and determine whether semaglutide may have unique risks or benefits for people living with HIV.”

“These findings have the potential to have a significant impact on the health and quality of life of people living with HIV,” added ACTG Chair Judith Currier, MD, MSc, University of California Los Angeles.

The SLIM LIVER study was sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), with additional funding from UTHealth Houston McGovern School of Medicine. ACTG is a clinical trials network focused on HIV and other infectious diseases, funded by NIAID and collaborating institutes of the US National Institutes of Health.

No conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

Semaglutide improved metabolic dysfunction–associated steatotic liver disease (MASLD) among people living with HIV, and in some cases resolved it completely, according to results from the SLIM LIVER study presented by the AIDS Clinical Trials Group (ACTG) at this year’s Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver.

Furthermore, although muscle volume decreased with weight loss, participants did not experience significant changes in muscle quality or physical function.
 

‘A First’

SLIM LIVER is the first study evaluating semaglutide as a treatment of MASLD among people living with HIV.

The phase 2b, single-arm pilot study enrolled adults living with HIV who were virally suppressed and had central adiposity, insulin resistance or prediabetes, and steatotic liver disease.

Participants self-injected semaglutide weekly at increasing doses until they reached a 1-mg dose at week 4. At 24 weeks, the study team assessed changes in participants’ intra-hepatic triglyceride content using magnetic resonance imaging-proton density fat fraction.

The primary analysis results from SLIM LIVER were reported in an oral presentation, “Semaglutide Reduces Metabolic-Associated Steatotic Liver Disease in People With HIV: The SLIM LIVER Study,” on March 5 by Jordan E. Lake, MD, MSc, of UTHealth Houston.

A subgroup analysis of the study was provided in a poster, “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER Study,” presented on March 4 by Grace L. Ditzenberger, PT, DPT, of the University of Colorado Anschutz Medical Campus in Aurora.

In the primary analysis, the median age of the 49 participants was 52 years, 43% were women (cisgender and transgender), the mean body mass index was 35, 39% were Hispanic and 33% were Black/African American, and 82% were taking antiretroviral therapy that included an integrase inhibitor.

Liver fat was reduced by an average of 31%, with 29% of participants experiencing a complete resolution (5% or less liver fat) of MASLD. They also experienced weight loss, reduced fasting blood glucose, and reduced fasting triglycerides, consistent with effects observed in studies of semaglutide in people without HIV.

The sub-analysis of the 46 participants for whom muscle measurements were available showed that muscle volume (measured in the psoas) decreased but with no significant change in physical function.

Semaglutide was generally well tolerated, with an adverse event profile similar to that seen in individuals without HIV.

The most common adverse events were gastrointestinal (ie, nausea, diarrhea, vomiting, and abdominal pain). Two participants experienced more significant adverse events possibly related to semaglutide but were able to continue in the study.

All participants completed the full 24 weeks of therapy at the originally prescribed dose.
 

Potential Impact

“Even at the low dose of 1 mg every week, most participants lost significant weight, and weight loss was closely associated with improvements in MASLD,” Dr. Lake said. “Additional research will assess the secondary effects of semaglutide on systemic inflammation and metabolism and determine whether semaglutide may have unique risks or benefits for people living with HIV.”

“These findings have the potential to have a significant impact on the health and quality of life of people living with HIV,” added ACTG Chair Judith Currier, MD, MSc, University of California Los Angeles.

The SLIM LIVER study was sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), with additional funding from UTHealth Houston McGovern School of Medicine. ACTG is a clinical trials network focused on HIV and other infectious diseases, funded by NIAID and collaborating institutes of the US National Institutes of Health.

No conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A multicomponent strategy of nurse-led communication, home blood pressure monitoring, evidence-based treatment algorithms, and electronic health record tools improved systolic blood pressure (SBP) and non–high-density lipoprotein (non-HDL) cholesterol levels in people living with HIV.

METHODOLOGY:

• Investigators assessed if EXTRA-CVD, a nurse-led multicomponent intervention for preventing cardiovascular diseases (CVD), could effectively improve SBP and non-HDL cholesterol levels in people living with HIV whose viral replication has been controlled effectively using antiretroviral therapy.
• They recruited 297 individuals (median age, 59 years; 20.9% women) from three academic HIV clinics in the United States with an HIV-1 viral load < 200 copies/mL who were diagnosed with both hypertension and hypercholesterolemia.
• Participants were randomly assigned to either the EXTRA-CVD intervention group or a control group comprising individuals who received general prevention education.
• SBP (the primary outcome) was calculated as the mean of two SBP measurements obtained 1 minute apart, and non-HDL cholesterol (the secondary outcome) was calculated as total cholesterol minus HDL cholesterol.

TAKEAWAY:

• Participants in the intervention vs control group reported having significantly lower SBP as early as 4 months after the nurse-led strategy (mean difference, −6.4 mm Hg; P = .002), with the improvements sustaining until 12 months (mean difference, −4.2 mm Hg; P = .04).
• At 12 months, participants in the intervention group showed a 16.9-mg/dL (P < .001) reduction in non-HDL cholesterol levels compared with those in the control group.
• The nurse-led strategy led to a greater reduction in SBP in women with HIV vs men living with HIV (5.9 mm Hg greater SBP difference at 12 months), with the difference being clinically meaningful but not statistically significant.
• This nurse-led strategy did not increase the risk for adverse events in people living with HIV.

IN PRACTICE:

“Although the EXTRA-CVD intervention was limited to BP and cholesterol, nurse-led case management might be beneficial for a range of other primary care conditions in HIV clinics. If HIV clinics choose to implement EXTRA-CVD, they might consider adding staff trained in other chronic comorbidities and/or health promotion activities,” the authors noted.

SOURCE:

This study was led by Christopher T. Longenecker, MD, University of Washington School of Medicine, Seattle, and published online on March 5, 2024, in JAMA Network Open.

LIMITATIONS:

Because this trial was conducted at well-resourced, major academic HIV clinics, the results may not be applicable to other populations, such as smaller community-based clinics or HIV care outside the United States. The sensitivity analyses performed in this study may not have fully accounted for the bias introduced by the differential attrition in the intervention group.

DISCLOSURES:

This study was supported by grants from the National Institutes of Health (NIH). The authors declared receiving grants and personal fees from or having other ties with the NIH and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A multicomponent strategy of nurse-led communication, home blood pressure monitoring, evidence-based treatment algorithms, and electronic health record tools improved systolic blood pressure (SBP) and non–high-density lipoprotein (non-HDL) cholesterol levels in people living with HIV.

METHODOLOGY:

• Investigators assessed if EXTRA-CVD, a nurse-led multicomponent intervention for preventing cardiovascular diseases (CVD), could effectively improve SBP and non-HDL cholesterol levels in people living with HIV whose viral replication has been controlled effectively using antiretroviral therapy.
• They recruited 297 individuals (median age, 59 years; 20.9% women) from three academic HIV clinics in the United States with an HIV-1 viral load < 200 copies/mL who were diagnosed with both hypertension and hypercholesterolemia.
• Participants were randomly assigned to either the EXTRA-CVD intervention group or a control group comprising individuals who received general prevention education.
• SBP (the primary outcome) was calculated as the mean of two SBP measurements obtained 1 minute apart, and non-HDL cholesterol (the secondary outcome) was calculated as total cholesterol minus HDL cholesterol.

TAKEAWAY:

• Participants in the intervention vs control group reported having significantly lower SBP as early as 4 months after the nurse-led strategy (mean difference, −6.4 mm Hg; P = .002), with the improvements sustaining until 12 months (mean difference, −4.2 mm Hg; P = .04).
• At 12 months, participants in the intervention group showed a 16.9-mg/dL (P < .001) reduction in non-HDL cholesterol levels compared with those in the control group.
• The nurse-led strategy led to a greater reduction in SBP in women with HIV vs men living with HIV (5.9 mm Hg greater SBP difference at 12 months), with the difference being clinically meaningful but not statistically significant.
• This nurse-led strategy did not increase the risk for adverse events in people living with HIV.

IN PRACTICE:

“Although the EXTRA-CVD intervention was limited to BP and cholesterol, nurse-led case management might be beneficial for a range of other primary care conditions in HIV clinics. If HIV clinics choose to implement EXTRA-CVD, they might consider adding staff trained in other chronic comorbidities and/or health promotion activities,” the authors noted.

SOURCE:

This study was led by Christopher T. Longenecker, MD, University of Washington School of Medicine, Seattle, and published online on March 5, 2024, in JAMA Network Open.

LIMITATIONS:

Because this trial was conducted at well-resourced, major academic HIV clinics, the results may not be applicable to other populations, such as smaller community-based clinics or HIV care outside the United States. The sensitivity analyses performed in this study may not have fully accounted for the bias introduced by the differential attrition in the intervention group.

DISCLOSURES:

This study was supported by grants from the National Institutes of Health (NIH). The authors declared receiving grants and personal fees from or having other ties with the NIH and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A multicomponent strategy of nurse-led communication, home blood pressure monitoring, evidence-based treatment algorithms, and electronic health record tools improved systolic blood pressure (SBP) and non–high-density lipoprotein (non-HDL) cholesterol levels in people living with HIV.

METHODOLOGY:

• Investigators assessed if EXTRA-CVD, a nurse-led multicomponent intervention for preventing cardiovascular diseases (CVD), could effectively improve SBP and non-HDL cholesterol levels in people living with HIV whose viral replication has been controlled effectively using antiretroviral therapy.
• They recruited 297 individuals (median age, 59 years; 20.9% women) from three academic HIV clinics in the United States with an HIV-1 viral load < 200 copies/mL who were diagnosed with both hypertension and hypercholesterolemia.
• Participants were randomly assigned to either the EXTRA-CVD intervention group or a control group comprising individuals who received general prevention education.
• SBP (the primary outcome) was calculated as the mean of two SBP measurements obtained 1 minute apart, and non-HDL cholesterol (the secondary outcome) was calculated as total cholesterol minus HDL cholesterol.

TAKEAWAY:

• Participants in the intervention vs control group reported having significantly lower SBP as early as 4 months after the nurse-led strategy (mean difference, −6.4 mm Hg; P = .002), with the improvements sustaining until 12 months (mean difference, −4.2 mm Hg; P = .04).
• At 12 months, participants in the intervention group showed a 16.9-mg/dL (P < .001) reduction in non-HDL cholesterol levels compared with those in the control group.
• The nurse-led strategy led to a greater reduction in SBP in women with HIV vs men living with HIV (5.9 mm Hg greater SBP difference at 12 months), with the difference being clinically meaningful but not statistically significant.
• This nurse-led strategy did not increase the risk for adverse events in people living with HIV.

IN PRACTICE:

“Although the EXTRA-CVD intervention was limited to BP and cholesterol, nurse-led case management might be beneficial for a range of other primary care conditions in HIV clinics. If HIV clinics choose to implement EXTRA-CVD, they might consider adding staff trained in other chronic comorbidities and/or health promotion activities,” the authors noted.

SOURCE:

This study was led by Christopher T. Longenecker, MD, University of Washington School of Medicine, Seattle, and published online on March 5, 2024, in JAMA Network Open.

LIMITATIONS:

Because this trial was conducted at well-resourced, major academic HIV clinics, the results may not be applicable to other populations, such as smaller community-based clinics or HIV care outside the United States. The sensitivity analyses performed in this study may not have fully accounted for the bias introduced by the differential attrition in the intervention group.

DISCLOSURES:

This study was supported by grants from the National Institutes of Health (NIH). The authors declared receiving grants and personal fees from or having other ties with the NIH and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher dietary niacin intake is associated with a lower risk for all-cause mortality among people with metabolic dysfunction-associated steatotic liver disease (MASLD), but there is no connection between niacin consumption and cardiovascular disease (CVD) mortality, a recent study suggested.

METHODOLOGY:

• Researchers analyzed data from the National Health and Nutrition Examination Survey (2003-2018) for 4315 adults with MASLD (mean age, 52.5 years; 55%, men; 67%, non-Hispanic White).
• Dietary niacin intake levels were based on two 24-hour dietary recall interviews to report the types and quantities of foods that participants consumed in the 24 hours prior to the interviews.
• Participants were categorized by tertile of dietary niacin intake: Tertile 1 (n = 1440), < 18.4 mg; tertile 2 (n = 1441), 18.5-26.6 mg; and tertile 3 (n = 1434), > 26.7 mg.

TAKEAWAY:

• During a median follow-up of 8.8 years, 566 deaths occurred, of which 197 were attributed to CVD.
• Compared with participants with a niacin intake of 18.4 mg or lower (the lowest tertile), the multivariable-adjusted hazard ratios (HRs) for participants with a niacin intake of 26.7 mg or higher (the highest tertile) were 0.70 for all-cause mortality and 0.65 for CVD mortality.
• For the subgroup with diabetes compared with the reference group (the first tertile), the HR of all-cause mortality in the third tertile was 0.82.
• When the subgroup without diabetes was compared with the reference group, the HR of all-cause mortality in the third tertile was 0.58, suggesting a significant interaction between niacin and diabetes with the risk of all-cause mortality.
• An inverse association between dietary niacin intake and all-cause mortality was seen in sensitivity analyses, when excluding a participant who died within 2 years of follow-up.

IN PRACTICE:

“Higher dietary niacin intake was associated with a lower risk of all-cause mortality,” but not CVD, among individuals with MASLD, and “the dose-response association…needs to be further investigated to determine optimal intake level,” the authors wrote.

SOURCE:

The study, led by Jie Pan, MD, Sun Yat-sen University, Guangzhou, China, was published online in JAMA Network Open.

LIMITATIONS:

Physical activity data were missing and could not be adjusted for. The National Death Index used by the researchers has only “modest” ability to accurately classify CVD mortality, and the dietary data were subject to recall bias.

DISCLOSURES:

One author was supported by a grant from the National Nature Science Foundation of China. No other conflicts of interest were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher dietary niacin intake is associated with a lower risk for all-cause mortality among people with metabolic dysfunction-associated steatotic liver disease (MASLD), but there is no connection between niacin consumption and cardiovascular disease (CVD) mortality, a recent study suggested.

METHODOLOGY:

• Researchers analyzed data from the National Health and Nutrition Examination Survey (2003-2018) for 4315 adults with MASLD (mean age, 52.5 years; 55%, men; 67%, non-Hispanic White).
• Dietary niacin intake levels were based on two 24-hour dietary recall interviews to report the types and quantities of foods that participants consumed in the 24 hours prior to the interviews.
• Participants were categorized by tertile of dietary niacin intake: Tertile 1 (n = 1440), < 18.4 mg; tertile 2 (n = 1441), 18.5-26.6 mg; and tertile 3 (n = 1434), > 26.7 mg.

TAKEAWAY:

• During a median follow-up of 8.8 years, 566 deaths occurred, of which 197 were attributed to CVD.
• Compared with participants with a niacin intake of 18.4 mg or lower (the lowest tertile), the multivariable-adjusted hazard ratios (HRs) for participants with a niacin intake of 26.7 mg or higher (the highest tertile) were 0.70 for all-cause mortality and 0.65 for CVD mortality.
• For the subgroup with diabetes compared with the reference group (the first tertile), the HR of all-cause mortality in the third tertile was 0.82.
• When the subgroup without diabetes was compared with the reference group, the HR of all-cause mortality in the third tertile was 0.58, suggesting a significant interaction between niacin and diabetes with the risk of all-cause mortality.
• An inverse association between dietary niacin intake and all-cause mortality was seen in sensitivity analyses, when excluding a participant who died within 2 years of follow-up.

IN PRACTICE:

“Higher dietary niacin intake was associated with a lower risk of all-cause mortality,” but not CVD, among individuals with MASLD, and “the dose-response association…needs to be further investigated to determine optimal intake level,” the authors wrote.

SOURCE:

The study, led by Jie Pan, MD, Sun Yat-sen University, Guangzhou, China, was published online in JAMA Network Open.

LIMITATIONS:

Physical activity data were missing and could not be adjusted for. The National Death Index used by the researchers has only “modest” ability to accurately classify CVD mortality, and the dietary data were subject to recall bias.

DISCLOSURES:

One author was supported by a grant from the National Nature Science Foundation of China. No other conflicts of interest were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher dietary niacin intake is associated with a lower risk for all-cause mortality among people with metabolic dysfunction-associated steatotic liver disease (MASLD), but there is no connection between niacin consumption and cardiovascular disease (CVD) mortality, a recent study suggested.

METHODOLOGY:

• Researchers analyzed data from the National Health and Nutrition Examination Survey (2003-2018) for 4315 adults with MASLD (mean age, 52.5 years; 55%, men; 67%, non-Hispanic White).
• Dietary niacin intake levels were based on two 24-hour dietary recall interviews to report the types and quantities of foods that participants consumed in the 24 hours prior to the interviews.
• Participants were categorized by tertile of dietary niacin intake: Tertile 1 (n = 1440), < 18.4 mg; tertile 2 (n = 1441), 18.5-26.6 mg; and tertile 3 (n = 1434), > 26.7 mg.

TAKEAWAY:

• During a median follow-up of 8.8 years, 566 deaths occurred, of which 197 were attributed to CVD.
• Compared with participants with a niacin intake of 18.4 mg or lower (the lowest tertile), the multivariable-adjusted hazard ratios (HRs) for participants with a niacin intake of 26.7 mg or higher (the highest tertile) were 0.70 for all-cause mortality and 0.65 for CVD mortality.
• For the subgroup with diabetes compared with the reference group (the first tertile), the HR of all-cause mortality in the third tertile was 0.82.
• When the subgroup without diabetes was compared with the reference group, the HR of all-cause mortality in the third tertile was 0.58, suggesting a significant interaction between niacin and diabetes with the risk of all-cause mortality.
• An inverse association between dietary niacin intake and all-cause mortality was seen in sensitivity analyses, when excluding a participant who died within 2 years of follow-up.

IN PRACTICE:

“Higher dietary niacin intake was associated with a lower risk of all-cause mortality,” but not CVD, among individuals with MASLD, and “the dose-response association…needs to be further investigated to determine optimal intake level,” the authors wrote.

SOURCE:

The study, led by Jie Pan, MD, Sun Yat-sen University, Guangzhou, China, was published online in JAMA Network Open.

LIMITATIONS:

Physical activity data were missing and could not be adjusted for. The National Death Index used by the researchers has only “modest” ability to accurately classify CVD mortality, and the dietary data were subject to recall bias.

DISCLOSURES:

One author was supported by a grant from the National Nature Science Foundation of China. No other conflicts of interest were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Hypertension prevalence remained stable in the United States at 30% after guidelines updated in 2017 lowered the threshold for the condition, while antihypertensive medication use rose about 3%, new research from the Centers for Disease Control and Prevention (CDC) shows.

METHODOLOGY:

• Researchers analyzed data from the Behavioral Risk Factor Surveillance System, a telephone survey of US adults aged 18 years and older.
• Self-reported diagnosed hypertension was defined as an affirmative response to the question, “Have you ever been told by a doctor, nurse, or other health professional that you have high blood pressure?”
• To determine treatment, respondents who answered the first question affirmatively were then asked, “Are you currently taking medicine for your high blood pressure?”
• Hypertension and treatment were assessed by age group (18-44, 45-64, and > 65 years), sex, race, ethnicity, level of education, and state of residence.

TAKEAWAY:

• The final analytic samples for 2017, 2019, and 2021 included 425,417, 392,100, and 410,318 participants, respectively.
• From 2017 to 2021, the overall age-standardized prevalence of hypertension did not change, remaining at almost exactly 30%.
• The age-standardized prevalence of antihypertensive medication use among individuals with hypertension increased by 3.1 percentage points, from 59.8% to 62.9%.
• Increases in medication use were seen in most sociodemographic groups; for example, in 2021, the prevalence was higher among women than among men (68.5% vs 59.4%), among adults aged ≥ 65 years than among those aged 18-44 years (92.5% vs 42.5%), and among Black patients than among White patients (71.3% vs 62%).
• Increases in medication use were also seen by state; use increased in 11 states, ranging from 52.2% in Utah to 72.8% in Mississippi in 2021, and did not decrease significantly in any state.

IN PRACTICE:

“These findings can be used to increase awareness of hypertension and promote lifestyle modifications and antihypertensive medication use to optimize blood pressure control and reduce disparities in prevalence and control,” the authors wrote.

SOURCE:

The study was led by Ahlia Sekkarie, PhD, of CDC’s Division for Heart Disease and Stroke Prevention, and published online in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The study had several limitations. The findings were based on self-report. Median response rates of less than 50% could lead to under- or overestimates of prevalence. Parts of the population, such as those in long-term care facilities or without a telephone, were not included in the analysis. Some demographic categories had small sample sizes; therefore, prevalence changes might not be detectable.

DISCLOSURES:

No specific funding was reported. The authors reported no potential conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Hypertension prevalence remained stable in the United States at 30% after guidelines updated in 2017 lowered the threshold for the condition, while antihypertensive medication use rose about 3%, new research from the Centers for Disease Control and Prevention (CDC) shows.

METHODOLOGY:

• Researchers analyzed data from the Behavioral Risk Factor Surveillance System, a telephone survey of US adults aged 18 years and older.
• Self-reported diagnosed hypertension was defined as an affirmative response to the question, “Have you ever been told by a doctor, nurse, or other health professional that you have high blood pressure?”
• To determine treatment, respondents who answered the first question affirmatively were then asked, “Are you currently taking medicine for your high blood pressure?”
• Hypertension and treatment were assessed by age group (18-44, 45-64, and > 65 years), sex, race, ethnicity, level of education, and state of residence.

TAKEAWAY:

• The final analytic samples for 2017, 2019, and 2021 included 425,417, 392,100, and 410,318 participants, respectively.
• From 2017 to 2021, the overall age-standardized prevalence of hypertension did not change, remaining at almost exactly 30%.
• The age-standardized prevalence of antihypertensive medication use among individuals with hypertension increased by 3.1 percentage points, from 59.8% to 62.9%.
• Increases in medication use were seen in most sociodemographic groups; for example, in 2021, the prevalence was higher among women than among men (68.5% vs 59.4%), among adults aged ≥ 65 years than among those aged 18-44 years (92.5% vs 42.5%), and among Black patients than among White patients (71.3% vs 62%).
• Increases in medication use were also seen by state; use increased in 11 states, ranging from 52.2% in Utah to 72.8% in Mississippi in 2021, and did not decrease significantly in any state.

IN PRACTICE:

“These findings can be used to increase awareness of hypertension and promote lifestyle modifications and antihypertensive medication use to optimize blood pressure control and reduce disparities in prevalence and control,” the authors wrote.

SOURCE:

The study was led by Ahlia Sekkarie, PhD, of CDC’s Division for Heart Disease and Stroke Prevention, and published online in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The study had several limitations. The findings were based on self-report. Median response rates of less than 50% could lead to under- or overestimates of prevalence. Parts of the population, such as those in long-term care facilities or without a telephone, were not included in the analysis. Some demographic categories had small sample sizes; therefore, prevalence changes might not be detectable.

DISCLOSURES:

No specific funding was reported. The authors reported no potential conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Hypertension prevalence remained stable in the United States at 30% after guidelines updated in 2017 lowered the threshold for the condition, while antihypertensive medication use rose about 3%, new research from the Centers for Disease Control and Prevention (CDC) shows.

METHODOLOGY:

• Researchers analyzed data from the Behavioral Risk Factor Surveillance System, a telephone survey of US adults aged 18 years and older.
• Self-reported diagnosed hypertension was defined as an affirmative response to the question, “Have you ever been told by a doctor, nurse, or other health professional that you have high blood pressure?”
• To determine treatment, respondents who answered the first question affirmatively were then asked, “Are you currently taking medicine for your high blood pressure?”
• Hypertension and treatment were assessed by age group (18-44, 45-64, and > 65 years), sex, race, ethnicity, level of education, and state of residence.

TAKEAWAY:

• The final analytic samples for 2017, 2019, and 2021 included 425,417, 392,100, and 410,318 participants, respectively.
• From 2017 to 2021, the overall age-standardized prevalence of hypertension did not change, remaining at almost exactly 30%.
• The age-standardized prevalence of antihypertensive medication use among individuals with hypertension increased by 3.1 percentage points, from 59.8% to 62.9%.
• Increases in medication use were seen in most sociodemographic groups; for example, in 2021, the prevalence was higher among women than among men (68.5% vs 59.4%), among adults aged ≥ 65 years than among those aged 18-44 years (92.5% vs 42.5%), and among Black patients than among White patients (71.3% vs 62%).
• Increases in medication use were also seen by state; use increased in 11 states, ranging from 52.2% in Utah to 72.8% in Mississippi in 2021, and did not decrease significantly in any state.

IN PRACTICE:

“These findings can be used to increase awareness of hypertension and promote lifestyle modifications and antihypertensive medication use to optimize blood pressure control and reduce disparities in prevalence and control,” the authors wrote.

SOURCE:

The study was led by Ahlia Sekkarie, PhD, of CDC’s Division for Heart Disease and Stroke Prevention, and published online in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The study had several limitations. The findings were based on self-report. Median response rates of less than 50% could lead to under- or overestimates of prevalence. Parts of the population, such as those in long-term care facilities or without a telephone, were not included in the analysis. Some demographic categories had small sample sizes; therefore, prevalence changes might not be detectable.

DISCLOSURES:

No specific funding was reported. The authors reported no potential conflicts of interest.

A version of this article appeared on Medscape.com.

A new position statement from the International Diabetes Federation advises using a 1-hour 75-g oral glucose tolerance test (OGTT) to improve identification of people at risk of developing type 2 diabetes.

“There are many, many people who may appear ‘normal’ if you use A1c or fasting glucose, but if you do a glucose tolerance test, they may have an abnormality after a glucose load. …The 1-hour plasma glucose has been found to be a more sensitive biomarker for the earlier identification of these high-risk individuals,” lead author Michael Bergman, MD, professor of medicine and population health at New York University Grossman School of Medicine, New York City, told this news organization in an interview.

Dr. Bergman presented the document, written by a 22-member international expert panel, on March 6, 2024, at the annual Advanced Technologies & Treatments for Diabetes meeting. It was simultaneously published in Diabetes Research and Clinical Practice.

This is the International Diabetes Federation’s (IDF’s) proposed screening algorithm for “intermediate hyperglycemia” and type 2 diabetes:

• At-risk high-risk individuals are first screened with a validated questionnaire such as the FINDRISK or the American Diabetes Association’s (ADA’s) risk screening tool.
• People identified as high risk should undergo laboratory screening with a 1-hour 75-g OGTT (although a 2-hour OGTT, fasting glucose, or A1c, as currently recommended by several organizations, is still considered acceptable).
• People with a 1-hour plasma glucose value at or above 155 mg (8.6 mmol/L) are considered to have intermediate hyperglycemia and should be prescribed lifestyle intervention and referred to a diabetes prevention program.
• Those with a 1-hour value greater than or equal to 209 mg/dL (11.6 mmol/L) are considered to have type 2 diabetes and should have a repeat test to confirm the diagnosis, with referral for further evaluation and treatment.

The new guidance is based on increasing evidence that the 1-hour test is a better predictor than other tests, including the 2-hour OGTT, of progression to type 2 diabetes and its associated complications, in a variety of populations. The document cites data showing that a plasma glucose of 155 mg/dl or greater on the 1-hour post-75-g test can identify people with undiagnosed type 2 diabetes or who are at increased risk but who have “normal” glucose tolerance as defined by an A1c < 5.7% (38.8 mmol/mol), a fasting plasma glucose < 100 mg/dL (5.6 mmol/L), or a 2-hour value below 140 mg/dL (7.8 mmol/L).

However, even though a 1-hour test may be more convenient than the traditional 2-hour test, incorporating OGTT into busy clinical practice may still pose logistical problems and may not improve ultimate outcomes, Elizabeth Selvin, PhD, MPH, of the Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, told this news organization. “I worry that emphasizing a burdensome test is not going to improve diabetes screening or diabetes prevention. Doing more 1-hour glucose screening is not going to get more people into diabetes prevention programs.”

When an audience member raised the logistics concern during the session Q&A, Dr. Bergman replied, “It’s no different than recommending colonoscopy or a mammogram. … I tell patients that we want to learn more about what is going on before we make a firm diagnosis. … I’ve done more than a hundred 1-hour glucose tolerance tests and have not seen one patient who refused because of inconvenience. Everything depends on the way we discuss things with patients.”
 

Recommendation Based on Emerging Evidence

“Intermediate hyperglycemia” is the World Health Organization’s term to refer to either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). These conditions are often called “prediabetes,” especially in the United States, but that term has been controversial because not everyone with IFG and IGT will go on to develop type 2 diabetes, said Dr. Bergman, who is also director of the NYU Langone Diabetes Prevention Program.

“With ‘prediabetes’ you’re labeling someone with a disease they may not develop. It’s not normal, but it’s not diabetes, so it’s an intermediate state,” he explained.

The statement provides a detailed summary of the data from 19 studies supporting use of a 1-hour plasma glucose of ≥ 155 mg/dL (8.6 mmol/L) to diagnose intermediate hyperglycemia and type 2 diabetes, including links between that level of glycemia and worsened metabolic and atherogenic profiles, risk for microvascular and macrovascular complications and mortality, and identification of risks for obstructive sleep apnea, cystic fibrosis-related diabetes mellitus, fatty liver disease, and premature mortality.

One major problem with current testing, Dr. Bergman said, is that “there is a huge disconnect between A1c and glucose values. … Only about 30% of individuals with an abnormal A1c will have an abnormal fasting glucose, and the inverse is also true. There’s a big mismatch between the two.”

Current guidelines suggest using both A1c and fasting glucose, but Dr. Bergman said that even then “you’re still missing about 20-30% who have IGT. … Part of the problem is that the criteria we use for defining abnormal fasting and 2-hour levels are too high. … 140 [mg/dL] for the 2-hour is too high and 100 [mg/dL] fasting is too high. … And that’s one of the reasons why many people progress to type 2 diabetes, because we’re using screening thresholds that are nonphysiologic.”

But Dr. Selvin disagrees, pointing to her own work showing that “using a combination of fasting glucose and A1c for screening does an excellent job at identifying high-risk individuals.”

She’s also unconvinced by other data cited in the paper. “I am deeply skeptical about 1-hour glucose being more prognostic than all other glycemic tests. … Associations of glucose tests with incident diabetes are inherently a circular analysis since diabetes is defined by elevations in those same tests. It is helpful to look at progression of diabetes, but these analyses are not simple and doing them well, especially with head-to-head comparisons against different glycemic tests, is hard,” she said.

In her view, “lifestyle interventions and weight loss should be recommended in at-risk individuals, including those with overweight and obesity, hypertension, metabolic syndrome, etc., regardless of 1-hour glucose test results.”

She added, “If we want to prevent diabetes, we need to focus on preventing weight gain and obesity and managing cardiometabolic risk factors. Lifestyle interventions are not effective unless they are intensive and patients are highly adherent. We need to make lifestyle interventions available and affordable for patients. That is the big barrier. I don’t think more screening with 1-hour glucose is going to help.”

Dr. Bergman pointed out that the International Diabetes Federation represents more than 100 countries, including many that are middle- and low-income. “They need a simple, cost-effective tool for screening effectively. A1c is more expensive, and fasting glucose alone will underestimate disease prevalence. So, the IDF felt, after doing a fairly comprehensive due diligence, that the data warranted recommendation of the 1-hour glucose.”

He’s hoping other organizations like the ADA and the World Health Organization will sign on to bring this guidance into the primary care arena. This news organization reached out to ADA for comment, but their representative hadn’t responded by press time.

Dr. Bergman had no disclosures. Dr. Selvin was supported by the National Institutes of Health.

A version of this article appeared on Medscape.com.

A new position statement from the International Diabetes Federation advises using a 1-hour 75-g oral glucose tolerance test (OGTT) to improve identification of people at risk of developing type 2 diabetes.

“There are many, many people who may appear ‘normal’ if you use A1c or fasting glucose, but if you do a glucose tolerance test, they may have an abnormality after a glucose load. …The 1-hour plasma glucose has been found to be a more sensitive biomarker for the earlier identification of these high-risk individuals,” lead author Michael Bergman, MD, professor of medicine and population health at New York University Grossman School of Medicine, New York City, told this news organization in an interview.

Dr. Bergman presented the document, written by a 22-member international expert panel, on March 6, 2024, at the annual Advanced Technologies & Treatments for Diabetes meeting. It was simultaneously published in Diabetes Research and Clinical Practice.

This is the International Diabetes Federation’s (IDF’s) proposed screening algorithm for “intermediate hyperglycemia” and type 2 diabetes:

• At-risk high-risk individuals are first screened with a validated questionnaire such as the FINDRISK or the American Diabetes Association’s (ADA’s) risk screening tool.
• People identified as high risk should undergo laboratory screening with a 1-hour 75-g OGTT (although a 2-hour OGTT, fasting glucose, or A1c, as currently recommended by several organizations, is still considered acceptable).
• People with a 1-hour plasma glucose value at or above 155 mg (8.6 mmol/L) are considered to have intermediate hyperglycemia and should be prescribed lifestyle intervention and referred to a diabetes prevention program.
• Those with a 1-hour value greater than or equal to 209 mg/dL (11.6 mmol/L) are considered to have type 2 diabetes and should have a repeat test to confirm the diagnosis, with referral for further evaluation and treatment.

The new guidance is based on increasing evidence that the 1-hour test is a better predictor than other tests, including the 2-hour OGTT, of progression to type 2 diabetes and its associated complications, in a variety of populations. The document cites data showing that a plasma glucose of 155 mg/dl or greater on the 1-hour post-75-g test can identify people with undiagnosed type 2 diabetes or who are at increased risk but who have “normal” glucose tolerance as defined by an A1c < 5.7% (38.8 mmol/mol), a fasting plasma glucose < 100 mg/dL (5.6 mmol/L), or a 2-hour value below 140 mg/dL (7.8 mmol/L).

However, even though a 1-hour test may be more convenient than the traditional 2-hour test, incorporating OGTT into busy clinical practice may still pose logistical problems and may not improve ultimate outcomes, Elizabeth Selvin, PhD, MPH, of the Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, told this news organization. “I worry that emphasizing a burdensome test is not going to improve diabetes screening or diabetes prevention. Doing more 1-hour glucose screening is not going to get more people into diabetes prevention programs.”

When an audience member raised the logistics concern during the session Q&A, Dr. Bergman replied, “It’s no different than recommending colonoscopy or a mammogram. … I tell patients that we want to learn more about what is going on before we make a firm diagnosis. … I’ve done more than a hundred 1-hour glucose tolerance tests and have not seen one patient who refused because of inconvenience. Everything depends on the way we discuss things with patients.”
 

Recommendation Based on Emerging Evidence

“Intermediate hyperglycemia” is the World Health Organization’s term to refer to either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). These conditions are often called “prediabetes,” especially in the United States, but that term has been controversial because not everyone with IFG and IGT will go on to develop type 2 diabetes, said Dr. Bergman, who is also director of the NYU Langone Diabetes Prevention Program.

“With ‘prediabetes’ you’re labeling someone with a disease they may not develop. It’s not normal, but it’s not diabetes, so it’s an intermediate state,” he explained.

The statement provides a detailed summary of the data from 19 studies supporting use of a 1-hour plasma glucose of ≥ 155 mg/dL (8.6 mmol/L) to diagnose intermediate hyperglycemia and type 2 diabetes, including links between that level of glycemia and worsened metabolic and atherogenic profiles, risk for microvascular and macrovascular complications and mortality, and identification of risks for obstructive sleep apnea, cystic fibrosis-related diabetes mellitus, fatty liver disease, and premature mortality.

One major problem with current testing, Dr. Bergman said, is that “there is a huge disconnect between A1c and glucose values. … Only about 30% of individuals with an abnormal A1c will have an abnormal fasting glucose, and the inverse is also true. There’s a big mismatch between the two.”

Current guidelines suggest using both A1c and fasting glucose, but Dr. Bergman said that even then “you’re still missing about 20-30% who have IGT. … Part of the problem is that the criteria we use for defining abnormal fasting and 2-hour levels are too high. … 140 [mg/dL] for the 2-hour is too high and 100 [mg/dL] fasting is too high. … And that’s one of the reasons why many people progress to type 2 diabetes, because we’re using screening thresholds that are nonphysiologic.”

But Dr. Selvin disagrees, pointing to her own work showing that “using a combination of fasting glucose and A1c for screening does an excellent job at identifying high-risk individuals.”

She’s also unconvinced by other data cited in the paper. “I am deeply skeptical about 1-hour glucose being more prognostic than all other glycemic tests. … Associations of glucose tests with incident diabetes are inherently a circular analysis since diabetes is defined by elevations in those same tests. It is helpful to look at progression of diabetes, but these analyses are not simple and doing them well, especially with head-to-head comparisons against different glycemic tests, is hard,” she said.

In her view, “lifestyle interventions and weight loss should be recommended in at-risk individuals, including those with overweight and obesity, hypertension, metabolic syndrome, etc., regardless of 1-hour glucose test results.”

She added, “If we want to prevent diabetes, we need to focus on preventing weight gain and obesity and managing cardiometabolic risk factors. Lifestyle interventions are not effective unless they are intensive and patients are highly adherent. We need to make lifestyle interventions available and affordable for patients. That is the big barrier. I don’t think more screening with 1-hour glucose is going to help.”

Dr. Bergman pointed out that the International Diabetes Federation represents more than 100 countries, including many that are middle- and low-income. “They need a simple, cost-effective tool for screening effectively. A1c is more expensive, and fasting glucose alone will underestimate disease prevalence. So, the IDF felt, after doing a fairly comprehensive due diligence, that the data warranted recommendation of the 1-hour glucose.”

He’s hoping other organizations like the ADA and the World Health Organization will sign on to bring this guidance into the primary care arena. This news organization reached out to ADA for comment, but their representative hadn’t responded by press time.

Dr. Bergman had no disclosures. Dr. Selvin was supported by the National Institutes of Health.

A version of this article appeared on Medscape.com.

A new position statement from the International Diabetes Federation advises using a 1-hour 75-g oral glucose tolerance test (OGTT) to improve identification of people at risk of developing type 2 diabetes.

“There are many, many people who may appear ‘normal’ if you use A1c or fasting glucose, but if you do a glucose tolerance test, they may have an abnormality after a glucose load. …The 1-hour plasma glucose has been found to be a more sensitive biomarker for the earlier identification of these high-risk individuals,” lead author Michael Bergman, MD, professor of medicine and population health at New York University Grossman School of Medicine, New York City, told this news organization in an interview.

Dr. Bergman presented the document, written by a 22-member international expert panel, on March 6, 2024, at the annual Advanced Technologies & Treatments for Diabetes meeting. It was simultaneously published in Diabetes Research and Clinical Practice.

This is the International Diabetes Federation’s (IDF’s) proposed screening algorithm for “intermediate hyperglycemia” and type 2 diabetes:

• At-risk high-risk individuals are first screened with a validated questionnaire such as the FINDRISK or the American Diabetes Association’s (ADA’s) risk screening tool.
• People identified as high risk should undergo laboratory screening with a 1-hour 75-g OGTT (although a 2-hour OGTT, fasting glucose, or A1c, as currently recommended by several organizations, is still considered acceptable).
• People with a 1-hour plasma glucose value at or above 155 mg (8.6 mmol/L) are considered to have intermediate hyperglycemia and should be prescribed lifestyle intervention and referred to a diabetes prevention program.
• Those with a 1-hour value greater than or equal to 209 mg/dL (11.6 mmol/L) are considered to have type 2 diabetes and should have a repeat test to confirm the diagnosis, with referral for further evaluation and treatment.

The new guidance is based on increasing evidence that the 1-hour test is a better predictor than other tests, including the 2-hour OGTT, of progression to type 2 diabetes and its associated complications, in a variety of populations. The document cites data showing that a plasma glucose of 155 mg/dl or greater on the 1-hour post-75-g test can identify people with undiagnosed type 2 diabetes or who are at increased risk but who have “normal” glucose tolerance as defined by an A1c < 5.7% (38.8 mmol/mol), a fasting plasma glucose < 100 mg/dL (5.6 mmol/L), or a 2-hour value below 140 mg/dL (7.8 mmol/L).

However, even though a 1-hour test may be more convenient than the traditional 2-hour test, incorporating OGTT into busy clinical practice may still pose logistical problems and may not improve ultimate outcomes, Elizabeth Selvin, PhD, MPH, of the Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, told this news organization. “I worry that emphasizing a burdensome test is not going to improve diabetes screening or diabetes prevention. Doing more 1-hour glucose screening is not going to get more people into diabetes prevention programs.”

When an audience member raised the logistics concern during the session Q&A, Dr. Bergman replied, “It’s no different than recommending colonoscopy or a mammogram. … I tell patients that we want to learn more about what is going on before we make a firm diagnosis. … I’ve done more than a hundred 1-hour glucose tolerance tests and have not seen one patient who refused because of inconvenience. Everything depends on the way we discuss things with patients.”
 

Recommendation Based on Emerging Evidence

“Intermediate hyperglycemia” is the World Health Organization’s term to refer to either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). These conditions are often called “prediabetes,” especially in the United States, but that term has been controversial because not everyone with IFG and IGT will go on to develop type 2 diabetes, said Dr. Bergman, who is also director of the NYU Langone Diabetes Prevention Program.

“With ‘prediabetes’ you’re labeling someone with a disease they may not develop. It’s not normal, but it’s not diabetes, so it’s an intermediate state,” he explained.

The statement provides a detailed summary of the data from 19 studies supporting use of a 1-hour plasma glucose of ≥ 155 mg/dL (8.6 mmol/L) to diagnose intermediate hyperglycemia and type 2 diabetes, including links between that level of glycemia and worsened metabolic and atherogenic profiles, risk for microvascular and macrovascular complications and mortality, and identification of risks for obstructive sleep apnea, cystic fibrosis-related diabetes mellitus, fatty liver disease, and premature mortality.

One major problem with current testing, Dr. Bergman said, is that “there is a huge disconnect between A1c and glucose values. … Only about 30% of individuals with an abnormal A1c will have an abnormal fasting glucose, and the inverse is also true. There’s a big mismatch between the two.”

Current guidelines suggest using both A1c and fasting glucose, but Dr. Bergman said that even then “you’re still missing about 20-30% who have IGT. … Part of the problem is that the criteria we use for defining abnormal fasting and 2-hour levels are too high. … 140 [mg/dL] for the 2-hour is too high and 100 [mg/dL] fasting is too high. … And that’s one of the reasons why many people progress to type 2 diabetes, because we’re using screening thresholds that are nonphysiologic.”

But Dr. Selvin disagrees, pointing to her own work showing that “using a combination of fasting glucose and A1c for screening does an excellent job at identifying high-risk individuals.”

She’s also unconvinced by other data cited in the paper. “I am deeply skeptical about 1-hour glucose being more prognostic than all other glycemic tests. … Associations of glucose tests with incident diabetes are inherently a circular analysis since diabetes is defined by elevations in those same tests. It is helpful to look at progression of diabetes, but these analyses are not simple and doing them well, especially with head-to-head comparisons against different glycemic tests, is hard,” she said.

In her view, “lifestyle interventions and weight loss should be recommended in at-risk individuals, including those with overweight and obesity, hypertension, metabolic syndrome, etc., regardless of 1-hour glucose test results.”

She added, “If we want to prevent diabetes, we need to focus on preventing weight gain and obesity and managing cardiometabolic risk factors. Lifestyle interventions are not effective unless they are intensive and patients are highly adherent. We need to make lifestyle interventions available and affordable for patients. That is the big barrier. I don’t think more screening with 1-hour glucose is going to help.”

Dr. Bergman pointed out that the International Diabetes Federation represents more than 100 countries, including many that are middle- and low-income. “They need a simple, cost-effective tool for screening effectively. A1c is more expensive, and fasting glucose alone will underestimate disease prevalence. So, the IDF felt, after doing a fairly comprehensive due diligence, that the data warranted recommendation of the 1-hour glucose.”

He’s hoping other organizations like the ADA and the World Health Organization will sign on to bring this guidance into the primary care arena. This news organization reached out to ADA for comment, but their representative hadn’t responded by press time.

Dr. Bergman had no disclosures. Dr. Selvin was supported by the National Institutes of Health.

A version of this article appeared on Medscape.com.