Guidelines

AMSTERDAM – The era of guidelines that recommended treatment with either a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or a glucagonlike peptide-1 (GLP-1) receptor agonist in people with type 2 diabetes mellitus and established cardiovascular disease (CVD) ended with new recommendations from the European Society of Cardiology that call for starting both classes simultaneously.

“A key change is that we removed the ‘and-or’ and the ‘either-or’ terms and recommend using both classes simultaneously in patients who are eligible based on their clinical indications and without contraindications or intolerance,” said Darren K. McGuire, MD, at the annual congress of the European Society of Cardiology.

The society’s new guidelines for managing CVD in patients with diabetes, released on Aug. 25 and presented in several sessions at the Congress, also break with the past by calling for starting treatment with both an SGLT-2 inhibitor and a GLP-1 receptor agonist without regard to a person’s existing level of glucose control, including their current and target hemoglobin A1c levels, and regardless of background therapy, added Dr. McGuire, a cardiologist and professor at the UT Southwestern Medical Center in Dallas and a member of the ESC panel that wrote the new guidelines.

Instead, the new guidance calls for starting both drug classes promptly in people diagnosed with type 2 diabetes and established atherosclerotic CVD.

Both the previous ESC guidelines from 2019 as well as the current Standards of Care for 2023 document from the American Diabetes Association call for using one class or the other, but they hedge on combined treatment as discretionary.
 

Different mechanisms mean additive benefits

“With increasing numbers of patients with type 2 diabetes in trials for SGLT-2 inhibitors or GLP-1 receptor agonists who were also on the other drug class, we’ve done large, stratified analyses that suggest no treatment-effect modification” when people received agents from both drug classes, Dr. McGuire explained in an interview. “While we don’t understand the mechanisms of action of these drugs for CVD, we’ve become very confident that they use different mechanisms” that appear to have at least partially additive effects.

“Their benefits for CVD risk reduction are completely independent of their glucose effects. They are cardiology drugs,” Dr. McGuire added.

The new ESC guidelines highlight two other clinical settings where people with type 2 diabetes should receive an SGLT-2 inhibitor regardless of their existing level of glucose control and any other medical treatment: people with heart failure and people with chronic kidney disease (CKD) based on a depressed estimated glomerular filtration rate and an elevated urine albumin-to-creatinine ratio.

Nephropathy was considered by the ESC’s guideline panel to confer risk that is similar to that of established atherosclerotic CVD, Dr. McGuire said.

The guidelines also, for the first time for ESC recommendations, made treatment with finerenone (Kerendia, Bayer) a class 1 level A recommendation for people with type 2 diabetes and CKD.
 

SCORE2-Diabetes risk estimator

Another major change in the new ESC guideline revision is introduction of a CVD risk calculator intended to estimate the risk among people with type 2 diabetes but without established CVD, heart failure, or CKD.

Called the SCORE2-Diabetes risk estimator, it calculates a person’s 10-year risk for CVD and includes adjustment based on the European region where a person lives; it also tallies different risk levels for women and for men.

The researchers who developed the SCORE2-Diabetes calculator used data from nearly 230,000 people to devise the tool and then validated it with data from an additional 217,000 Europeans with type 2 diabetes.

Key features of the calculator include its use of routinely collected clinical values, such as age, sex, systolic blood pressure, smoking status, serum cholesterol levels, age at diabetes diagnosis, hemoglobin A1c level, and estimated glomerular filtration rate.

“For the first time we have a clear score to categorize risk” in people with type 2 diabetes and identify who needs more aggressive treatment to prevent CVD development,” said Emanuele Di Angelantonio, MD, PhD, deputy director of the cardiovascular epidemiology unit at the University of Cambridge (England).

The guidelines say that people who have a low (< 5%) or moderate (5%-9%) 10-year risk for CVD are possible candidates for metformin treatment. Those with high (10%-19%) or very high (≥ 20%) risk are possible candidates for treatment with metformin and/or an SGLT-2 inhibitor and/or a GLP-1 receptor agonist, said Dr. Di Angelantonio during his talk at the congress on the new risk score.

“The risk score is a good addition” because it estimates future CVD risk better and more systematically than usual practice, which generally relies on no systematic tool, said Naveed Sattar, PhD, professor of metabolic medicine at the University of Glasgow (Scotland) and also a member of the guideline-writing panel.

The new risk score “is a reasonable way” to identify people without CVD but at elevated risk who might benefit from treatment with a relatively expensive drug, such as an SGLT-2 inhibitor, Dr. Sattar said in an interview. “It doesn’t rely on any fancy biomarkers or imaging, and it takes about 30 seconds to calculate. It’s not perfect, but it gets the job done,” and it will increase the number of people with type 2 diabetes who will receive an SGLT-2 inhibitor, he predicted.

Dr. McGuire has been a consultant to Altimmune, Applied Therapeutics, AstraZeneca, Bayer, Boehringer-Ingelheim, Intercept, Lexion, Lilly, Merck, New Amsterdam, and Pfizer. Dr. Di Angelantonio had no disclosures. Dr. Sattar has been a consultant to Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Lilly, Novartis, Novo Nordisk, Pfizer, and Roche Diagnostics.

A version of this article appeared on Medscape.com.

AMSTERDAM – The era of guidelines that recommended treatment with either a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or a glucagonlike peptide-1 (GLP-1) receptor agonist in people with type 2 diabetes mellitus and established cardiovascular disease (CVD) ended with new recommendations from the European Society of Cardiology that call for starting both classes simultaneously.

“A key change is that we removed the ‘and-or’ and the ‘either-or’ terms and recommend using both classes simultaneously in patients who are eligible based on their clinical indications and without contraindications or intolerance,” said Darren K. McGuire, MD, at the annual congress of the European Society of Cardiology.

The society’s new guidelines for managing CVD in patients with diabetes, released on Aug. 25 and presented in several sessions at the Congress, also break with the past by calling for starting treatment with both an SGLT-2 inhibitor and a GLP-1 receptor agonist without regard to a person’s existing level of glucose control, including their current and target hemoglobin A1c levels, and regardless of background therapy, added Dr. McGuire, a cardiologist and professor at the UT Southwestern Medical Center in Dallas and a member of the ESC panel that wrote the new guidelines.

Instead, the new guidance calls for starting both drug classes promptly in people diagnosed with type 2 diabetes and established atherosclerotic CVD.

Both the previous ESC guidelines from 2019 as well as the current Standards of Care for 2023 document from the American Diabetes Association call for using one class or the other, but they hedge on combined treatment as discretionary.
 

Different mechanisms mean additive benefits

“With increasing numbers of patients with type 2 diabetes in trials for SGLT-2 inhibitors or GLP-1 receptor agonists who were also on the other drug class, we’ve done large, stratified analyses that suggest no treatment-effect modification” when people received agents from both drug classes, Dr. McGuire explained in an interview. “While we don’t understand the mechanisms of action of these drugs for CVD, we’ve become very confident that they use different mechanisms” that appear to have at least partially additive effects.

“Their benefits for CVD risk reduction are completely independent of their glucose effects. They are cardiology drugs,” Dr. McGuire added.

The new ESC guidelines highlight two other clinical settings where people with type 2 diabetes should receive an SGLT-2 inhibitor regardless of their existing level of glucose control and any other medical treatment: people with heart failure and people with chronic kidney disease (CKD) based on a depressed estimated glomerular filtration rate and an elevated urine albumin-to-creatinine ratio.

Nephropathy was considered by the ESC’s guideline panel to confer risk that is similar to that of established atherosclerotic CVD, Dr. McGuire said.

The guidelines also, for the first time for ESC recommendations, made treatment with finerenone (Kerendia, Bayer) a class 1 level A recommendation for people with type 2 diabetes and CKD.
 

SCORE2-Diabetes risk estimator

Another major change in the new ESC guideline revision is introduction of a CVD risk calculator intended to estimate the risk among people with type 2 diabetes but without established CVD, heart failure, or CKD.

Called the SCORE2-Diabetes risk estimator, it calculates a person’s 10-year risk for CVD and includes adjustment based on the European region where a person lives; it also tallies different risk levels for women and for men.

The researchers who developed the SCORE2-Diabetes calculator used data from nearly 230,000 people to devise the tool and then validated it with data from an additional 217,000 Europeans with type 2 diabetes.

Key features of the calculator include its use of routinely collected clinical values, such as age, sex, systolic blood pressure, smoking status, serum cholesterol levels, age at diabetes diagnosis, hemoglobin A1c level, and estimated glomerular filtration rate.

“For the first time we have a clear score to categorize risk” in people with type 2 diabetes and identify who needs more aggressive treatment to prevent CVD development,” said Emanuele Di Angelantonio, MD, PhD, deputy director of the cardiovascular epidemiology unit at the University of Cambridge (England).

The guidelines say that people who have a low (< 5%) or moderate (5%-9%) 10-year risk for CVD are possible candidates for metformin treatment. Those with high (10%-19%) or very high (≥ 20%) risk are possible candidates for treatment with metformin and/or an SGLT-2 inhibitor and/or a GLP-1 receptor agonist, said Dr. Di Angelantonio during his talk at the congress on the new risk score.

“The risk score is a good addition” because it estimates future CVD risk better and more systematically than usual practice, which generally relies on no systematic tool, said Naveed Sattar, PhD, professor of metabolic medicine at the University of Glasgow (Scotland) and also a member of the guideline-writing panel.

The new risk score “is a reasonable way” to identify people without CVD but at elevated risk who might benefit from treatment with a relatively expensive drug, such as an SGLT-2 inhibitor, Dr. Sattar said in an interview. “It doesn’t rely on any fancy biomarkers or imaging, and it takes about 30 seconds to calculate. It’s not perfect, but it gets the job done,” and it will increase the number of people with type 2 diabetes who will receive an SGLT-2 inhibitor, he predicted.

Dr. McGuire has been a consultant to Altimmune, Applied Therapeutics, AstraZeneca, Bayer, Boehringer-Ingelheim, Intercept, Lexion, Lilly, Merck, New Amsterdam, and Pfizer. Dr. Di Angelantonio had no disclosures. Dr. Sattar has been a consultant to Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Lilly, Novartis, Novo Nordisk, Pfizer, and Roche Diagnostics.

A version of this article appeared on Medscape.com.

AMSTERDAM – The era of guidelines that recommended treatment with either a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or a glucagonlike peptide-1 (GLP-1) receptor agonist in people with type 2 diabetes mellitus and established cardiovascular disease (CVD) ended with new recommendations from the European Society of Cardiology that call for starting both classes simultaneously.

“A key change is that we removed the ‘and-or’ and the ‘either-or’ terms and recommend using both classes simultaneously in patients who are eligible based on their clinical indications and without contraindications or intolerance,” said Darren K. McGuire, MD, at the annual congress of the European Society of Cardiology.

The society’s new guidelines for managing CVD in patients with diabetes, released on Aug. 25 and presented in several sessions at the Congress, also break with the past by calling for starting treatment with both an SGLT-2 inhibitor and a GLP-1 receptor agonist without regard to a person’s existing level of glucose control, including their current and target hemoglobin A1c levels, and regardless of background therapy, added Dr. McGuire, a cardiologist and professor at the UT Southwestern Medical Center in Dallas and a member of the ESC panel that wrote the new guidelines.

Instead, the new guidance calls for starting both drug classes promptly in people diagnosed with type 2 diabetes and established atherosclerotic CVD.

Both the previous ESC guidelines from 2019 as well as the current Standards of Care for 2023 document from the American Diabetes Association call for using one class or the other, but they hedge on combined treatment as discretionary.
 

Different mechanisms mean additive benefits

“With increasing numbers of patients with type 2 diabetes in trials for SGLT-2 inhibitors or GLP-1 receptor agonists who were also on the other drug class, we’ve done large, stratified analyses that suggest no treatment-effect modification” when people received agents from both drug classes, Dr. McGuire explained in an interview. “While we don’t understand the mechanisms of action of these drugs for CVD, we’ve become very confident that they use different mechanisms” that appear to have at least partially additive effects.

“Their benefits for CVD risk reduction are completely independent of their glucose effects. They are cardiology drugs,” Dr. McGuire added.

The new ESC guidelines highlight two other clinical settings where people with type 2 diabetes should receive an SGLT-2 inhibitor regardless of their existing level of glucose control and any other medical treatment: people with heart failure and people with chronic kidney disease (CKD) based on a depressed estimated glomerular filtration rate and an elevated urine albumin-to-creatinine ratio.

Nephropathy was considered by the ESC’s guideline panel to confer risk that is similar to that of established atherosclerotic CVD, Dr. McGuire said.

The guidelines also, for the first time for ESC recommendations, made treatment with finerenone (Kerendia, Bayer) a class 1 level A recommendation for people with type 2 diabetes and CKD.
 

SCORE2-Diabetes risk estimator

Another major change in the new ESC guideline revision is introduction of a CVD risk calculator intended to estimate the risk among people with type 2 diabetes but without established CVD, heart failure, or CKD.

Called the SCORE2-Diabetes risk estimator, it calculates a person’s 10-year risk for CVD and includes adjustment based on the European region where a person lives; it also tallies different risk levels for women and for men.

The researchers who developed the SCORE2-Diabetes calculator used data from nearly 230,000 people to devise the tool and then validated it with data from an additional 217,000 Europeans with type 2 diabetes.

Key features of the calculator include its use of routinely collected clinical values, such as age, sex, systolic blood pressure, smoking status, serum cholesterol levels, age at diabetes diagnosis, hemoglobin A1c level, and estimated glomerular filtration rate.

“For the first time we have a clear score to categorize risk” in people with type 2 diabetes and identify who needs more aggressive treatment to prevent CVD development,” said Emanuele Di Angelantonio, MD, PhD, deputy director of the cardiovascular epidemiology unit at the University of Cambridge (England).

The guidelines say that people who have a low (< 5%) or moderate (5%-9%) 10-year risk for CVD are possible candidates for metformin treatment. Those with high (10%-19%) or very high (≥ 20%) risk are possible candidates for treatment with metformin and/or an SGLT-2 inhibitor and/or a GLP-1 receptor agonist, said Dr. Di Angelantonio during his talk at the congress on the new risk score.

“The risk score is a good addition” because it estimates future CVD risk better and more systematically than usual practice, which generally relies on no systematic tool, said Naveed Sattar, PhD, professor of metabolic medicine at the University of Glasgow (Scotland) and also a member of the guideline-writing panel.

The new risk score “is a reasonable way” to identify people without CVD but at elevated risk who might benefit from treatment with a relatively expensive drug, such as an SGLT-2 inhibitor, Dr. Sattar said in an interview. “It doesn’t rely on any fancy biomarkers or imaging, and it takes about 30 seconds to calculate. It’s not perfect, but it gets the job done,” and it will increase the number of people with type 2 diabetes who will receive an SGLT-2 inhibitor, he predicted.

Dr. McGuire has been a consultant to Altimmune, Applied Therapeutics, AstraZeneca, Bayer, Boehringer-Ingelheim, Intercept, Lexion, Lilly, Merck, New Amsterdam, and Pfizer. Dr. Di Angelantonio had no disclosures. Dr. Sattar has been a consultant to Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Lilly, Novartis, Novo Nordisk, Pfizer, and Roche Diagnostics.

A version of this article appeared on Medscape.com.

The American Academy of Pediatrics has updated its recommendations on risk assessment, terminology, and other care components for children who are deaf or hard of hearing. The update is the first since 2009.

The AAP’s clinical report was published online in Pediatrics.

Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.

The report details how primary care clinicians can detect changes in hearing status by age.
 

Eliminating terms such as ‘failed’ or ‘impairment’

A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.

The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
 

Birth to 5 a critical time

The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.

Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.

Among recommendations in the update:

• All children should have an objective, evidence-based risk assessment for changes in hearing.
• Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
• A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
• Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
• To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.

Additional recommendations

The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.

They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.

Meningitis and otitis media also are leading causes of a change in hearing.

Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.

She noted that tympanometry is not listed as a method of hearing screening in primary care.

“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.

Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.

“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
 

Development milestones have been adjusted

Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.

She said she wished the guidance included more about hearing loss in older children.

The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.

But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.

“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”

“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.

The report authors and Dr. Lieu report no relevant financial relationships.

The American Academy of Pediatrics has updated its recommendations on risk assessment, terminology, and other care components for children who are deaf or hard of hearing. The update is the first since 2009.

The AAP’s clinical report was published online in Pediatrics.

Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.

The report details how primary care clinicians can detect changes in hearing status by age.
 

Eliminating terms such as ‘failed’ or ‘impairment’

A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.

The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
 

Birth to 5 a critical time

The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.

Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.

Among recommendations in the update:

• All children should have an objective, evidence-based risk assessment for changes in hearing.
• Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
• A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
• Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
• To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.

Additional recommendations

The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.

They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.

Meningitis and otitis media also are leading causes of a change in hearing.

Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.

She noted that tympanometry is not listed as a method of hearing screening in primary care.

“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.

Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.

“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
 

Development milestones have been adjusted

Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.

She said she wished the guidance included more about hearing loss in older children.

The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.

But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.

“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”

“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.

The report authors and Dr. Lieu report no relevant financial relationships.

The American Academy of Pediatrics has updated its recommendations on risk assessment, terminology, and other care components for children who are deaf or hard of hearing. The update is the first since 2009.

The AAP’s clinical report was published online in Pediatrics.

Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.

The report details how primary care clinicians can detect changes in hearing status by age.
 

Eliminating terms such as ‘failed’ or ‘impairment’

A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.

The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
 

Birth to 5 a critical time

The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.

Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.

Among recommendations in the update:

• All children should have an objective, evidence-based risk assessment for changes in hearing.
• Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
• A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
• Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
• To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.

Additional recommendations

The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.

They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.

Meningitis and otitis media also are leading causes of a change in hearing.

Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.

She noted that tympanometry is not listed as a method of hearing screening in primary care.

“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.

Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.

“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
 

Development milestones have been adjusted

Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.

She said she wished the guidance included more about hearing loss in older children.

The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.

But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.

“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”

“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.

The report authors and Dr. Lieu report no relevant financial relationships.

The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.

The consensus-based guidelines also aim to facilitate high-quality randomized controlled trials of various treatment modalities using a standardized nomenclature.

They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview 

“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.

The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.

With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta. 
 

Difficult-to-diagnose conditions

Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.

The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.

Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.

If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.

Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”

Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.

The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
 

Individualized treatment

The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy. 

For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.

The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.

“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”

The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.

No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted. 

For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
 

A starting point for patient management

In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing. 

“We’re looking for them much more,” said Dr. Mukkada.

“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.

“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.

Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.

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

The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.

The consensus-based guidelines also aim to facilitate high-quality randomized controlled trials of various treatment modalities using a standardized nomenclature.

They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview 

“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.

The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.

With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta. 
 

Difficult-to-diagnose conditions

Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.

The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.

Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.

If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.

Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”

Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.

The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
 

Individualized treatment

The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy. 

For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.

The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.

“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”

The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.

No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted. 

For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
 

A starting point for patient management

In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing. 

“We’re looking for them much more,” said Dr. Mukkada.

“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.

“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.

Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.

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

The limited scope and depth of existing literature on childhood eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE) spurred an international group of researchers and clinicians to develop the first clinical practice guidelines for diagnosing and treating these rare conditions.

The consensus-based guidelines also aim to facilitate high-quality randomized controlled trials of various treatment modalities using a standardized nomenclature.

They were developed jointly by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

Non-EoE EGIDs are rare chronic inflammatory disorders of the gastrointestinal tract, estimated at less than 200,000 cases annually in the United States, with unknown long-term consequences, Glenn Furuta, MD, professor of pediatrics at the University of Colorado at Denver and section head of gastroenterology at Children’s Hospital Colorado, both in Aurora, said in an interview 

“There are many unmet needs. Research has been limited and has not progressed at the pace we want it to,” added Dr. Furuta, who is corresponding author of the guidelines.

The guidelines were published online in the Journal of Pediatric Gastroenterology & Nutrition, by lead author Alexandra Papadopoulou, MD, division of gastroenterology and hepatology, first department of pediatrics, University of Athens, and Children’s Hospital Agia Sofia, also in Athens, and colleagues.

With these, we provide guidance for clinicians to better understand the conditions and also how to diagnose and initiate care for patients with these rare diseases, said Dr. Furuta. 
 

Difficult-to-diagnose conditions

Guideline development involved a working group of 26 pediatric gastroenterologists, adult gastroenterologists, allergists/immunologists, and pathologists from 16 countries across five continents. The consensus document includes 34 statements based on available evidence and 41 recommendations based on expert opinion and best clinical practices. In cases where the supporting evidence was weak but agreement was strong, the authors issued conditional recommendations.

The guidelines subdivide the non-EoE EGIDs according to inflammation location: eosinophilic gastritis, eosinophilic duodenitis (EoD), eosinophilic colitis, and eosinophilic enteritis. The latter can be further subdivided into EoD, eosinophilic jejunitis, and eosinophilic ileitis.

Non-EoE EGIDs are hard to diagnose because symptoms are relatively nonspecific and may include abdominal pain, vomiting, diarrhea, and bloody stools, all of which could have any number of underlying causes, Dr. Furuta said.

If you are treating a patient who is not getting better with such symptoms as persisting infections, acid-related problems, significant bleeding leading to anemia, intestinal perforation or obstruction, or low serum protein leading to swelling, then you should think that something else is going on that requires more of an evaluation, Dr. Furuta noted.

Patients with personal or family histories of eosinophilic or allergic disease should raise greater suspicion, Dr. Furuta said. “The next step requires an endoscopy and biopsy.”

Awareness of non-EoE EGIDs has been higher among pediatric gastroenterologists than among those treating adult disease because pediatric gastroenterologists have always obtained biopsies of the intestinal tract, Dr. Furuta noted.

The guidelines recommend that diagnosis of non-EoE EGIDs in children and adolescents must include signs or symptoms of gastrointestinal dysfunction, dense eosinophilic infiltrates found in mucosal or full-thickness biopsies above organ-specific threshold values included in the document, and absence of other diseases associated with GI mucosal eosinophilic inflammation.
 

Individualized treatment

The authors noted that the strength of recommendations varies with the often-modest availability of randomized controlled trial data on treatment efficacy. 

For example, they recommended that systemic steroids be considered to induce remission but only conditionally recommend topical steroids. They conditionally recommend consideration of empiric elimination diets and conditionally recommend against using food allergy testing to guide diet.

The choice of treatment should be individualized on the basis of the affected GI segment, severity of the disease, patient characteristics, and family resources and capabilities, the authors wrote.

“We’ve provided guidance on how to care for patients based on the consensus of experts who have the necessary experience and knowledge base,” Dr. Furuta said. “Our ability to say: ‘Here are the established treatments,’ is lacking, though. We need research studies to verify that our recommended approaches are indeed correct.”

The authors conditionally recommended that treatment goals include achieving symptom resolution, improving gross endoscopic and histologic abnormalities, promoting normal childhood growth and development, and preventing disease complications.

No pediatric study has determined the natural history of non-EoE EGIDs, and no study of maintenance therapy has been conducted, the authors noted. 

For this reason, they conditionally recommended that the clinical decision to continue therapy should be discussed with patients and their parents/caregivers, and those discussions include the benefits and risk of long-term treatment, its cost, and its impact on health-related quality of life.
 

A starting point for patient management

In a comment, Vincent Mukkada, MD, professor of pediatrics at the University of Cincinnati and an attending physician in gastroenterology, hepatology, and nutrition at Cincinnati Children’s Hospital and Medical Center, observed that, though improved awareness among pediatric gastroenterologists may account for some of the increase in GI eosinophil disease, the incidence is also likely growing. 

“We’re looking for them much more,” said Dr. Mukkada.

“But I also think they’re increasing, just like all other atopic diseases. We’re not sure why,” he added.

“The hope is that these guidelines will allow nonsubspecialized gastroenterologists and allergists feel comfortable to at least start on the journey of managing these patients. And, for pediatricians who learn that their patient has received a non-EoE EGID diagnosis, they can go to the summary figures in this one document and very quickly get an overview of the disease and its course,” Dr. Mukkada said.

Guideline development was funded by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. The authors and Dr. Mukkada reported no relevant financial relationships.

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

For comatose adult survivors of out-of-hospital cardiac arrest (OHCA), controlling body temperature to less than 37.5° C is a “reasonable and evidence-based approach,” a new American Heart Association (AHA) scientific advisory suggests.

On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.

The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.

“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.

“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.

“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”

The advisory was published online in Circulation.
 

TTM2 key

The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.

Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.

No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.

Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.

By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.

Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.

“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”

Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”

Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”

No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.

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

For comatose adult survivors of out-of-hospital cardiac arrest (OHCA), controlling body temperature to less than 37.5° C is a “reasonable and evidence-based approach,” a new American Heart Association (AHA) scientific advisory suggests.

On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.

The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.

“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.

“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.

“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”

The advisory was published online in Circulation.
 

TTM2 key

The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.

Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.

No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.

Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.

By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.

Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.

“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”

Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”

Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”

No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.

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

For comatose adult survivors of out-of-hospital cardiac arrest (OHCA), controlling body temperature to less than 37.5° C is a “reasonable and evidence-based approach,” a new American Heart Association (AHA) scientific advisory suggests.

On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.

The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.

“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.

“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.

“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”

The advisory was published online in Circulation.
 

TTM2 key

The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.

Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.

No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.

Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.

By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.

Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.

“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”

Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”

Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”

No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.

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

Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.

The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.

The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.

Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.

“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.

“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
 

Three screening approaches

The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.

The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.

After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.

They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
 

A balancing act

Some physicians view starting screenings at age 45 as a settled argument.

“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”

The epidemiology of CRC is changing rapidly, Dr. Wender said.

“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”

Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.

“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.

Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.

The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
 

Why 50

In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.

Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.

Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.

“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”

One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.

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

Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.

The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.

The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.

Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.

“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.

“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
 

Three screening approaches

The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.

The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.

After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.

They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
 

A balancing act

Some physicians view starting screenings at age 45 as a settled argument.

“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”

The epidemiology of CRC is changing rapidly, Dr. Wender said.

“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”

Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.

“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.

Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.

The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
 

Why 50

In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.

Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.

Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.

“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”

One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.

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

Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.

The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.

The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.

Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.

“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.

“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
 

Three screening approaches

The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.

The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.

After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.

They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
 

A balancing act

Some physicians view starting screenings at age 45 as a settled argument.

“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”

The epidemiology of CRC is changing rapidly, Dr. Wender said.

“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”

Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.

“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.

Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.

The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
 

Why 50

In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.

Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.

Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.

“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”

One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.

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

Stop me if you’ve heard this before. There’s a controversy over blood pressure targets. Some argue for 140/90 mm Hg, others for 130/80 mm Hg, and some super ambitious folks think that we should aim for 120/80 mm Hg. If this sounds familiar, it should. We did it in 2017. It’s unclear what, if anything, we learned from the experience. On the upside, it’s not as bad as it was 100 years ago.

When high blood pressure was a ‘good’ thing

Back then, many believed that you needed higher blood pressure as you got older to push the blood through your progressively stiffened and hardened arteries. Hence the name “essential” hypertension. The concern was that lowering blood pressure would hypoperfuse your organs and be dangerous. In the 1930s, John Hay told an audience at a British Medical Association lecture: “The greatest danger to a man with high blood pressure lies in its discovery, because then some fool is certain to try and reduce it.”

The 1900s were a simpler time when people had fatal strokes in their 50s, and their families were consoled by the knowledge that they had lived a good life.

If our thinking around blood pressure had evolved slightly faster, perhaps President Roosevelt wouldn’t have died of a stroke during World War II as his doctors watched his systolic blood pressure climb above 200 mm Hg and suggested massages and barbiturates to take the edge off.
 

The current controversy

Not that long ago, 180 mm Hg was considered mild hypertension. Now, we are arguing about a systolic blood pressure of 140 versus 130 mm Hg.

The American Academy of Family Physicians takes the view that 140/90 mm Hg is good enough for most people. Their most recent clinical practice guideline, based primarily on two 2020 Cochrane Reviews of blood pressure targets in patients with and without cardiovascular disease, did not find any mortality benefit for a lower blood pressure threshold.

This puts the AAFP guideline in conflict with the 2017 guideline issued jointly by the American College of Cardiology, American Heart Association, and nine other groups, which recommended a target of 130/80 mm Hg for pretty much everyone. Though they say greater than 140/90 mm Hg should be the threshold for low-risk patients or for starting therapy post stroke, we often forget those nuances. The main point of contention is that the AAFP guideline was looking for a mortality benefit, whereas the ACC/AHA/everyone else guideline was looking at preventing cardiovascular events. The latter guideline was driven mainly by the results of the SPRINT trial. ACC/AHA argue for more aggressive targets to prevent the things that cardiologists care about, namely heart attacks.

The AAFP guideline conceded that more aggressive control will result in fewer myocardial infarctions but warn that it comes with more adverse events. Treating 1,000 patients to this lower target would theoretically prevent four MIs, possibly prevent three strokes, but result in 30 adverse events.

In the end, what we are seeing here is not so much a debate over the evidence as a debate over priorities. The AAFP’s main focus is all-cause mortality; the ACC/AHA’s is cardiovascular events. Interventions that don’t improve mortality can be questioned in terms of their cost effectiveness. But you probably don’t want to have a heart attack (even a nonfatal one). And you certainly don’t want to have a stroke. However, lower blood pressure targets inevitably require more medications. Notwithstanding the economic costs, the dangers of polypharmacy, medication interactions, side effects, and syncope leading to falls cannot be ignored. Falls are not benign adverse events, especially in older adults.

The counter argument is that physicians are human and often let things slide. Set the target at 140/90 mm Hg, and many physicians won’t jump on a systolic blood pressure of 144 mm Hg. Set the target at 130 mm Hg, and maybe they’ll be more likely to react. There’s a fine line between permissiveness and complacency.

If you zoom out and look at the multitude of blood pressure guidelines, you start to notice an important fact. There is not much daylight between them. There are subtle differences in what constitutes high risk and different definitions of older (older should be defined as 10 years older than the reader’s current age). But otherwise, the blood pressure targets are not that different.

Does that final 10 mm Hg really matter when barriers to care mean that tens of millions in the United States are unaware they have hypertension? Even among those diagnosed, many are either untreated or inadequately treated.

With this context, perhaps the most insightful thing that can be said about the blood pressure guideline controversy is that it’s not all that controversial. We can likely all agree that we need to be better at treating hypertension and that creative solutions to reach underserved communities are necessary.

Arguing about 140/90 mm Hg or 130/80 mm Hg is less important than acknowledging that we should be aggressive in screening for and treating hypertension. We should acknowledge that beyond a certain point any cardiovascular benefit comes at the cost of hypotension and side effects. That tipping point will be different for different groups, and probably at a higher set point in older patients.

Individualizing care isn’t difficult. We do it all the time. We just shouldn’t be letting people walk around with untreated hypertension. It’s not the 1900s anymore.

Dr. Labos is a cardiologist at Hôpital Notre-Dame, Montreal. He reported no conflicts of interest.

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

Stop me if you’ve heard this before. There’s a controversy over blood pressure targets. Some argue for 140/90 mm Hg, others for 130/80 mm Hg, and some super ambitious folks think that we should aim for 120/80 mm Hg. If this sounds familiar, it should. We did it in 2017. It’s unclear what, if anything, we learned from the experience. On the upside, it’s not as bad as it was 100 years ago.

When high blood pressure was a ‘good’ thing

Back then, many believed that you needed higher blood pressure as you got older to push the blood through your progressively stiffened and hardened arteries. Hence the name “essential” hypertension. The concern was that lowering blood pressure would hypoperfuse your organs and be dangerous. In the 1930s, John Hay told an audience at a British Medical Association lecture: “The greatest danger to a man with high blood pressure lies in its discovery, because then some fool is certain to try and reduce it.”

The 1900s were a simpler time when people had fatal strokes in their 50s, and their families were consoled by the knowledge that they had lived a good life.

If our thinking around blood pressure had evolved slightly faster, perhaps President Roosevelt wouldn’t have died of a stroke during World War II as his doctors watched his systolic blood pressure climb above 200 mm Hg and suggested massages and barbiturates to take the edge off.
 

The current controversy

Not that long ago, 180 mm Hg was considered mild hypertension. Now, we are arguing about a systolic blood pressure of 140 versus 130 mm Hg.

The American Academy of Family Physicians takes the view that 140/90 mm Hg is good enough for most people. Their most recent clinical practice guideline, based primarily on two 2020 Cochrane Reviews of blood pressure targets in patients with and without cardiovascular disease, did not find any mortality benefit for a lower blood pressure threshold.

This puts the AAFP guideline in conflict with the 2017 guideline issued jointly by the American College of Cardiology, American Heart Association, and nine other groups, which recommended a target of 130/80 mm Hg for pretty much everyone. Though they say greater than 140/90 mm Hg should be the threshold for low-risk patients or for starting therapy post stroke, we often forget those nuances. The main point of contention is that the AAFP guideline was looking for a mortality benefit, whereas the ACC/AHA/everyone else guideline was looking at preventing cardiovascular events. The latter guideline was driven mainly by the results of the SPRINT trial. ACC/AHA argue for more aggressive targets to prevent the things that cardiologists care about, namely heart attacks.

The AAFP guideline conceded that more aggressive control will result in fewer myocardial infarctions but warn that it comes with more adverse events. Treating 1,000 patients to this lower target would theoretically prevent four MIs, possibly prevent three strokes, but result in 30 adverse events.

In the end, what we are seeing here is not so much a debate over the evidence as a debate over priorities. The AAFP’s main focus is all-cause mortality; the ACC/AHA’s is cardiovascular events. Interventions that don’t improve mortality can be questioned in terms of their cost effectiveness. But you probably don’t want to have a heart attack (even a nonfatal one). And you certainly don’t want to have a stroke. However, lower blood pressure targets inevitably require more medications. Notwithstanding the economic costs, the dangers of polypharmacy, medication interactions, side effects, and syncope leading to falls cannot be ignored. Falls are not benign adverse events, especially in older adults.

The counter argument is that physicians are human and often let things slide. Set the target at 140/90 mm Hg, and many physicians won’t jump on a systolic blood pressure of 144 mm Hg. Set the target at 130 mm Hg, and maybe they’ll be more likely to react. There’s a fine line between permissiveness and complacency.

If you zoom out and look at the multitude of blood pressure guidelines, you start to notice an important fact. There is not much daylight between them. There are subtle differences in what constitutes high risk and different definitions of older (older should be defined as 10 years older than the reader’s current age). But otherwise, the blood pressure targets are not that different.

Does that final 10 mm Hg really matter when barriers to care mean that tens of millions in the United States are unaware they have hypertension? Even among those diagnosed, many are either untreated or inadequately treated.

With this context, perhaps the most insightful thing that can be said about the blood pressure guideline controversy is that it’s not all that controversial. We can likely all agree that we need to be better at treating hypertension and that creative solutions to reach underserved communities are necessary.

Arguing about 140/90 mm Hg or 130/80 mm Hg is less important than acknowledging that we should be aggressive in screening for and treating hypertension. We should acknowledge that beyond a certain point any cardiovascular benefit comes at the cost of hypotension and side effects. That tipping point will be different for different groups, and probably at a higher set point in older patients.

Individualizing care isn’t difficult. We do it all the time. We just shouldn’t be letting people walk around with untreated hypertension. It’s not the 1900s anymore.

Dr. Labos is a cardiologist at Hôpital Notre-Dame, Montreal. He reported no conflicts of interest.

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

Stop me if you’ve heard this before. There’s a controversy over blood pressure targets. Some argue for 140/90 mm Hg, others for 130/80 mm Hg, and some super ambitious folks think that we should aim for 120/80 mm Hg. If this sounds familiar, it should. We did it in 2017. It’s unclear what, if anything, we learned from the experience. On the upside, it’s not as bad as it was 100 years ago.

When high blood pressure was a ‘good’ thing

Back then, many believed that you needed higher blood pressure as you got older to push the blood through your progressively stiffened and hardened arteries. Hence the name “essential” hypertension. The concern was that lowering blood pressure would hypoperfuse your organs and be dangerous. In the 1930s, John Hay told an audience at a British Medical Association lecture: “The greatest danger to a man with high blood pressure lies in its discovery, because then some fool is certain to try and reduce it.”

The 1900s were a simpler time when people had fatal strokes in their 50s, and their families were consoled by the knowledge that they had lived a good life.

If our thinking around blood pressure had evolved slightly faster, perhaps President Roosevelt wouldn’t have died of a stroke during World War II as his doctors watched his systolic blood pressure climb above 200 mm Hg and suggested massages and barbiturates to take the edge off.
 

The current controversy

Not that long ago, 180 mm Hg was considered mild hypertension. Now, we are arguing about a systolic blood pressure of 140 versus 130 mm Hg.

The American Academy of Family Physicians takes the view that 140/90 mm Hg is good enough for most people. Their most recent clinical practice guideline, based primarily on two 2020 Cochrane Reviews of blood pressure targets in patients with and without cardiovascular disease, did not find any mortality benefit for a lower blood pressure threshold.

This puts the AAFP guideline in conflict with the 2017 guideline issued jointly by the American College of Cardiology, American Heart Association, and nine other groups, which recommended a target of 130/80 mm Hg for pretty much everyone. Though they say greater than 140/90 mm Hg should be the threshold for low-risk patients or for starting therapy post stroke, we often forget those nuances. The main point of contention is that the AAFP guideline was looking for a mortality benefit, whereas the ACC/AHA/everyone else guideline was looking at preventing cardiovascular events. The latter guideline was driven mainly by the results of the SPRINT trial. ACC/AHA argue for more aggressive targets to prevent the things that cardiologists care about, namely heart attacks.

The AAFP guideline conceded that more aggressive control will result in fewer myocardial infarctions but warn that it comes with more adverse events. Treating 1,000 patients to this lower target would theoretically prevent four MIs, possibly prevent three strokes, but result in 30 adverse events.

In the end, what we are seeing here is not so much a debate over the evidence as a debate over priorities. The AAFP’s main focus is all-cause mortality; the ACC/AHA’s is cardiovascular events. Interventions that don’t improve mortality can be questioned in terms of their cost effectiveness. But you probably don’t want to have a heart attack (even a nonfatal one). And you certainly don’t want to have a stroke. However, lower blood pressure targets inevitably require more medications. Notwithstanding the economic costs, the dangers of polypharmacy, medication interactions, side effects, and syncope leading to falls cannot be ignored. Falls are not benign adverse events, especially in older adults.

The counter argument is that physicians are human and often let things slide. Set the target at 140/90 mm Hg, and many physicians won’t jump on a systolic blood pressure of 144 mm Hg. Set the target at 130 mm Hg, and maybe they’ll be more likely to react. There’s a fine line between permissiveness and complacency.

If you zoom out and look at the multitude of blood pressure guidelines, you start to notice an important fact. There is not much daylight between them. There are subtle differences in what constitutes high risk and different definitions of older (older should be defined as 10 years older than the reader’s current age). But otherwise, the blood pressure targets are not that different.

Does that final 10 mm Hg really matter when barriers to care mean that tens of millions in the United States are unaware they have hypertension? Even among those diagnosed, many are either untreated or inadequately treated.

With this context, perhaps the most insightful thing that can be said about the blood pressure guideline controversy is that it’s not all that controversial. We can likely all agree that we need to be better at treating hypertension and that creative solutions to reach underserved communities are necessary.

Arguing about 140/90 mm Hg or 130/80 mm Hg is less important than acknowledging that we should be aggressive in screening for and treating hypertension. We should acknowledge that beyond a certain point any cardiovascular benefit comes at the cost of hypotension and side effects. That tipping point will be different for different groups, and probably at a higher set point in older patients.

Individualizing care isn’t difficult. We do it all the time. We just shouldn’t be letting people walk around with untreated hypertension. It’s not the 1900s anymore.

Dr. Labos is a cardiologist at Hôpital Notre-Dame, Montreal. He reported no conflicts of interest.

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

The European Society of Hypertension has released updated and expanded guidelines for the management of hypertension.

The guidelines, which are endorsed by the European Renal Association and the International Society of Hypertension, were presented during the annual European Meeting on Hypertension and Cardiovascular Protection Meeting in Milan, Italy.

The guidelines consensus document was also published online in the Journal of Hypertension. Giuseppe Mancia, MD, professor emeritus of medicine, University Milano-Bicocca, Italy, and Reinhold Kreutz, MD, PhD, Charité–University Medicine Berlin, were cochairs of the task force that created the document.

“We have tried to provide a simplified message to key topics with these new guidelines,” Dr. Kreutz said in an interview.

“We have confirmed the definition of hypertension and provide clear guidance for blood pressure monitoring and a simplified general strategy targeting similar blood pressure goals for most patients, although the treatment algorithms of how you get there may be different for different patient groups.”

Dr. Kreutz added: “Because hypertension is so prevalent and many patients have comorbidities, it is not easy to have one approach for all, but we have tried to simplify the key messages as much as possible, with a target that is more general to the whole population.”

While there are no major surprises in the guidelines, there are multiple advances and added-value changes, including clear advice on how to measure blood pressure, an upgrade for beta-blockers in the treatment algorithms, and a new definition and treatment recommendations for “true resistant hypertension.”
 

Definition remains unchanged

The definition of hypertension remains unchanged from the previous guidelines – repeated office systolic blood pressure values of ≥ 140 mm Hg and/or diastolic blood pressure values of ≥ 90 mm Hg.

“The definition and classification of hypertension has not changed in these new guidelines,” Dr. Kreutz said. “While there have been suggestions that the definition/target should be changed again, particularly about blood pressure lowering being beneficial at the very low pressure range, after reviewing all the evidence we do not agree with this, and we are standing with the definition of hypertension when intervention is beneficial rather than doing nothing or causing harm.”
 

Clear guidance on measurement

Dr. Kreutz points out that the correct measurement of blood pressure is of key importance, and the new guidelines include a detailed algorithm on how to measure blood pressure. The preferred method is automated cuff-based blood pressure measurement.

“There are still many variations in blood pressure measurement in clinical practice, so we now have clear guidance on how to measure blood pressure in the office but also at home,” he commented.

They have upgraded the use of out-of-office blood pressure measurement, particularly home measurement, as useful in long-term management. “In future, there should be more emphasis on follow-up using technology with remote control and virtual care.”
 

Thresholds for starting treatment

On thresholds for initiating antihypertensive therapy, the guidelines recommend that treatment be initiated for most patients when systolic blood pressure is ≥ 140 mm Hg or diastolic blood pressure is ≥ 90 mm Hg.

The same recommendation is given for patients with grade 1 hypertension (systolic, 140-159 mm Hg; and/or diastolic, 90-99 mm Hg) irrespective of cardiovascular risk, although they add that for patients in the lower blood pressure range who have no hypertension-mediated organ damage and who are at low cardiovascular risk, consideration may be given to starting treatment with lifestyle changes only. If, however, blood pressure control is not achieved within a few months of a lifestyle-based approach alone, drug treatment is necessary.

For older patients (aged 80 or older), the task force recommends initiation of drug treatment at 160 mm Hg systolic, although a lower systolic threshold of 140-160 mm Hg may be considered. The authors note that thresholds for the initiation of drug treatment for very frail patients should be individualized.
 

Blood pressure targets

In the new guidelines, the blood pressure target is the same as in the previous guidelines for the general population of patients with hypertension. The goal is < 140/80 mm Hg for most patients. This accounts for the major portion of the protective effect of blood pressure lowering.

However, the consensus document notes that despite the smaller incremental benefit, an effort should be made to reach a range of 120-129/70-79 mm Hg, but only if treatment is well tolerated to avoid the risk of treatment discontinuation because of adverse events, which might offset, in part or completely, the incremental reduction in cardiovascular outcomes.

Elaborating on this, Dr. Kreutz said, “We should aim for the systolic blood pressure to be within the range of below 140 mm Hg down to 120 mm Hg, with a specific target of around 130 mm Hg for most patients and lower in patients in whom drug treatments are well tolerated and who are at high risk.

“The problem is, if we go for a target of lower that 130 mm Hg, the evidence gets weaker, the benefits diminish, and we risk losing patients because of adverse effects from using so many drugs,” he added. “But in younger and fitter patients, we would recommend the lower the better, but not below 120 mm Hg.”

Dr. Kreutz noted that the new guidelines have tried to simplify recommendations on target pressures. “We have tried to simplify guidance to focus on a target of around 130 for almost all patients. Before, it wasn’t so clear. There were different targets for different groups of patients with various comorbidities or older patients. But now we are saying the range of 120 to 139 is suitable for the vast majority of patients.”

The guidelines do allow slightly higher targets for older and very frail patients.
 

Drug treatments

The guidelines advise that blood pressure lowering be prioritized over the selection of specific antihypertensive drug classes. The use of any of the five major drug classes – angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, calcium blockers, and thiazide/thiazidelike diuretics – and their combinations are recommended as the basis of antihypertensive treatment strategies.

They advise starting with a two-drug combination for most patients. The preferred combinations including a renin-angiotensin blocker (either an ACE inhibitor or an ARB) with a calcium blocker or a thiazide/thiazidelike diuretic, preferably in a single-pill combination to reduce pill burden and improve adherence and outcome.

If blood pressure is not controlled with the initial two-drug combination at the maximum recommended and tolerated dose of the respective components, treatment should be increased to a three-drug combination.

“We can control 60% of patients in the general hypertensive population with dual therapy, and up to 90% with triple therapy,” Dr. Kreutz said. “Only a small percentage need a fourth drug.”

A new feature of the guidelines is the upgrading of beta-blockers in the treatment algorithms.

“Beta-blockers may not have previously been considered as a first choice of antihypertensive medication, but we see that in clinical practice, many patients are actually treated with these drugs because there are so many conditions in which beta-blockers have a compelling evidence-based indication or are believed to be favorable,” he said. “So, we are now positioning beta-blockers as drugs that can be used at any step of the treatment algorithm if there is a guideline directed indication or other conditions for which they are thought to be beneficial.”

The guidelines also recommend that all drugs be given as once-daily preparations and that they be taken preferably in the morning.

“The new TIME study has established that there is no difference in outcome with morning or evening dosing, but we know that adherence is often better when drugs are taken in the morning, and it is not advisable to take diuretics in the evening,” Dr. Kreutz said.
 

‘True resistant hypertension’

The guidelines have introduced a new term, “true resistant hypertension,” defined as systolic blood pressure of ≥ 140 mm Hg or diastolic blood pressure of ≥ 90 mm Hg in the presence of the following conditions: the maximum recommended and tolerated doses of a three-drug combination comprising a renin-angiotensin system blocker (either an ACE inhibitor or an ARB), a calcium blocker, and a thiazide/thiazidelike diuretic were used; inadequate blood pressure control has been confirmed by ambulatory (preferable) or home blood pressure measurement; and various causes of pseudo-resistant hypertension (especially poor medication adherence) and secondary hypertension have been excluded.

“There are many patients who may appear to have resistant hypertension, but we need to screen them carefully to ensure they are adherent to treatment, and then most of these patients are found not to be truly resistant,” Dr. Kreutz explained. “We estimate that only about 5% of patients have true resistant hypertension.”

For these patients with true resistant hypertension, two treatment approaches are recommended.

For those who do not have advanced kidney disease (glomerular filtration rate > 40 mL/min), renal denervation can be considered. This is a new II B recommendation.

Dr. Kreutz noted that studies of renal denervation excluded patients with advanced kidney disease, so there are no data for this group. For these patients, the guidelines suggest that a combination diuretic approach (chlorthalidone with a loop diuretic) could be considered in light of the results of the recent CLICK study.
 

Differences from U.S. guidelines?

Commenting on the new European guidelines for this news organization, Paul Whelton, MD, chair of the most recent American College of Cardiology/American Heart Association hypertension guidelines committee, said: “Publication of these guidelines is important. I congratulate the European task force. It is an enormous amount of time and effort.”

Dr. Whelton, who is Show Chwan Chair in Global Public Health at Tulane University, New Orleans, and president of the World Hypertension League, added: “I would say the changes are incremental rather than major, but that is probably appropriate.”

He welcomed the greater emphasis on out-of-office blood pressure measurement, saying, “That’s where we should be headed.”

Asked how the European guidelines differ from the U.S. guidelines, Dr. Whelton commented: “There are differences, but they are not huge. The major hypertension guidelines across the world are much more alike than they are different.”

He pointed out that both the U.S. and European guidelines aim for a target blood pressure of 130/80 mm Hg for most patients but have different ways of issuing that advice.

“The Europeans recommend a minimum goal of 140/90 mm Hg, and if there are no issues, then press on to get to under 130/80 mm Hg. That’s kind of a two-step process,” he said. “In the U.S., we’ve gone for a more direct approach of just recommending less than 130/80 mm Hg.

“My fear with the European approach is that by saying, get to 140/90 mm Hg first, then move on to 130/80 mm Hg, is that you’re likely to lose people. And doctors could feel that 140/90 is fine.”
 

More effort needed on implementation

Dr. Whelton says that where all hypertension guidelines are lacking is in the implementation of the recommendations.

“We are all falling down on implementation,” he said. “We have a huge burden of illness, and it is a very cost-effective area for management, but still, rates of blood pressure control are very bad. Generally speaking, even with a very conservative target of 140/90, the best countries only have control rates of around 30%, and this can be as low as 8% in some low/middle-income countries.”

Dr. Whelton believes the approach to blood pressure management needs to change.

“We know that the current traditional model of care, where blood pressure is managed by your local doctor, is not working. It is hopeless,” he said. “That is not an indictment of these doctors. It’s just that they have more pressing issues to deal with, so we need to look at other models.”

He suggests that the way forward is through convenient, community-based care delivered by a team in which nonphysicians assist in much of the management and in which reliable, affordable medications are given at the point of care, with patients tracked with electronic health records so as to identify those who are not adhering to their medication regimens.

“We know that using simple protocols will work for the vast majority of people. We don’t need to individualize or complicate this too much. That tends to lose people in the process.”

Dr. Whelton makes the point that it is well known how to diagnose and treat hypertension, yet this is not being done well.

“We are doing these things really badly. In routine care, blood pressure is measured horribly. Nobody would accept a pilot of a plane saying he should be doing all these procedures but he’s too busy and it’s probably okay, but that’s the way blood pressure is often measured in clinical practice,” he added. “And we can’t really do a good job if were not measuring the key variable properly that the diagnosis is based on.”

Dr. Whelton also points out that the medical profession is not making enough effort to have patients reach target levels.

“If you’re in a country where very few people are being treated and very high pressures are common, then of course you have to focus on that group first. But in most of the Western world, we are long past that, so we can move on down the chain. We then get to a lot more people with moderately high blood pressure getting exposed to increases in risk, and while this is not quite as dramatic as those with very high pressures at the individual risk level, because there are so many of them, that’s where a lot of events are occurring,” he says.

“If we get everyone to 140/90 mm Hg, we can probably prevent 60% of blood pressure–related events. But if we can get them all down to 130 mm Hg systolic, then we can prevent 75%-80% of events. It’s often quite easy to get to that target, but patients need help and encouragement.”

Going forward, he concluded, guidelines should pivot to focus more on implementation.

“We all try to make the guidelines as approachable as possible, but they are encyclopedic, and many doctors just continue doing what they are doing. That is our big challenge.”

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

The European Society of Hypertension has released updated and expanded guidelines for the management of hypertension.

The guidelines, which are endorsed by the European Renal Association and the International Society of Hypertension, were presented during the annual European Meeting on Hypertension and Cardiovascular Protection Meeting in Milan, Italy.

The guidelines consensus document was also published online in the Journal of Hypertension. Giuseppe Mancia, MD, professor emeritus of medicine, University Milano-Bicocca, Italy, and Reinhold Kreutz, MD, PhD, Charité–University Medicine Berlin, were cochairs of the task force that created the document.

“We have tried to provide a simplified message to key topics with these new guidelines,” Dr. Kreutz said in an interview.

“We have confirmed the definition of hypertension and provide clear guidance for blood pressure monitoring and a simplified general strategy targeting similar blood pressure goals for most patients, although the treatment algorithms of how you get there may be different for different patient groups.”

Dr. Kreutz added: “Because hypertension is so prevalent and many patients have comorbidities, it is not easy to have one approach for all, but we have tried to simplify the key messages as much as possible, with a target that is more general to the whole population.”

While there are no major surprises in the guidelines, there are multiple advances and added-value changes, including clear advice on how to measure blood pressure, an upgrade for beta-blockers in the treatment algorithms, and a new definition and treatment recommendations for “true resistant hypertension.”
 

Definition remains unchanged

The definition of hypertension remains unchanged from the previous guidelines – repeated office systolic blood pressure values of ≥ 140 mm Hg and/or diastolic blood pressure values of ≥ 90 mm Hg.

“The definition and classification of hypertension has not changed in these new guidelines,” Dr. Kreutz said. “While there have been suggestions that the definition/target should be changed again, particularly about blood pressure lowering being beneficial at the very low pressure range, after reviewing all the evidence we do not agree with this, and we are standing with the definition of hypertension when intervention is beneficial rather than doing nothing or causing harm.”
 

Clear guidance on measurement

Dr. Kreutz points out that the correct measurement of blood pressure is of key importance, and the new guidelines include a detailed algorithm on how to measure blood pressure. The preferred method is automated cuff-based blood pressure measurement.

“There are still many variations in blood pressure measurement in clinical practice, so we now have clear guidance on how to measure blood pressure in the office but also at home,” he commented.

They have upgraded the use of out-of-office blood pressure measurement, particularly home measurement, as useful in long-term management. “In future, there should be more emphasis on follow-up using technology with remote control and virtual care.”
 

Thresholds for starting treatment

On thresholds for initiating antihypertensive therapy, the guidelines recommend that treatment be initiated for most patients when systolic blood pressure is ≥ 140 mm Hg or diastolic blood pressure is ≥ 90 mm Hg.

The same recommendation is given for patients with grade 1 hypertension (systolic, 140-159 mm Hg; and/or diastolic, 90-99 mm Hg) irrespective of cardiovascular risk, although they add that for patients in the lower blood pressure range who have no hypertension-mediated organ damage and who are at low cardiovascular risk, consideration may be given to starting treatment with lifestyle changes only. If, however, blood pressure control is not achieved within a few months of a lifestyle-based approach alone, drug treatment is necessary.

For older patients (aged 80 or older), the task force recommends initiation of drug treatment at 160 mm Hg systolic, although a lower systolic threshold of 140-160 mm Hg may be considered. The authors note that thresholds for the initiation of drug treatment for very frail patients should be individualized.
 

Blood pressure targets

In the new guidelines, the blood pressure target is the same as in the previous guidelines for the general population of patients with hypertension. The goal is < 140/80 mm Hg for most patients. This accounts for the major portion of the protective effect of blood pressure lowering.

However, the consensus document notes that despite the smaller incremental benefit, an effort should be made to reach a range of 120-129/70-79 mm Hg, but only if treatment is well tolerated to avoid the risk of treatment discontinuation because of adverse events, which might offset, in part or completely, the incremental reduction in cardiovascular outcomes.

Elaborating on this, Dr. Kreutz said, “We should aim for the systolic blood pressure to be within the range of below 140 mm Hg down to 120 mm Hg, with a specific target of around 130 mm Hg for most patients and lower in patients in whom drug treatments are well tolerated and who are at high risk.

“The problem is, if we go for a target of lower that 130 mm Hg, the evidence gets weaker, the benefits diminish, and we risk losing patients because of adverse effects from using so many drugs,” he added. “But in younger and fitter patients, we would recommend the lower the better, but not below 120 mm Hg.”

Dr. Kreutz noted that the new guidelines have tried to simplify recommendations on target pressures. “We have tried to simplify guidance to focus on a target of around 130 for almost all patients. Before, it wasn’t so clear. There were different targets for different groups of patients with various comorbidities or older patients. But now we are saying the range of 120 to 139 is suitable for the vast majority of patients.”

The guidelines do allow slightly higher targets for older and very frail patients.
 

Drug treatments

The guidelines advise that blood pressure lowering be prioritized over the selection of specific antihypertensive drug classes. The use of any of the five major drug classes – angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, calcium blockers, and thiazide/thiazidelike diuretics – and their combinations are recommended as the basis of antihypertensive treatment strategies.

They advise starting with a two-drug combination for most patients. The preferred combinations including a renin-angiotensin blocker (either an ACE inhibitor or an ARB) with a calcium blocker or a thiazide/thiazidelike diuretic, preferably in a single-pill combination to reduce pill burden and improve adherence and outcome.

If blood pressure is not controlled with the initial two-drug combination at the maximum recommended and tolerated dose of the respective components, treatment should be increased to a three-drug combination.

“We can control 60% of patients in the general hypertensive population with dual therapy, and up to 90% with triple therapy,” Dr. Kreutz said. “Only a small percentage need a fourth drug.”

A new feature of the guidelines is the upgrading of beta-blockers in the treatment algorithms.

“Beta-blockers may not have previously been considered as a first choice of antihypertensive medication, but we see that in clinical practice, many patients are actually treated with these drugs because there are so many conditions in which beta-blockers have a compelling evidence-based indication or are believed to be favorable,” he said. “So, we are now positioning beta-blockers as drugs that can be used at any step of the treatment algorithm if there is a guideline directed indication or other conditions for which they are thought to be beneficial.”

The guidelines also recommend that all drugs be given as once-daily preparations and that they be taken preferably in the morning.

“The new TIME study has established that there is no difference in outcome with morning or evening dosing, but we know that adherence is often better when drugs are taken in the morning, and it is not advisable to take diuretics in the evening,” Dr. Kreutz said.
 

‘True resistant hypertension’

The guidelines have introduced a new term, “true resistant hypertension,” defined as systolic blood pressure of ≥ 140 mm Hg or diastolic blood pressure of ≥ 90 mm Hg in the presence of the following conditions: the maximum recommended and tolerated doses of a three-drug combination comprising a renin-angiotensin system blocker (either an ACE inhibitor or an ARB), a calcium blocker, and a thiazide/thiazidelike diuretic were used; inadequate blood pressure control has been confirmed by ambulatory (preferable) or home blood pressure measurement; and various causes of pseudo-resistant hypertension (especially poor medication adherence) and secondary hypertension have been excluded.

“There are many patients who may appear to have resistant hypertension, but we need to screen them carefully to ensure they are adherent to treatment, and then most of these patients are found not to be truly resistant,” Dr. Kreutz explained. “We estimate that only about 5% of patients have true resistant hypertension.”

For these patients with true resistant hypertension, two treatment approaches are recommended.

For those who do not have advanced kidney disease (glomerular filtration rate > 40 mL/min), renal denervation can be considered. This is a new II B recommendation.

Dr. Kreutz noted that studies of renal denervation excluded patients with advanced kidney disease, so there are no data for this group. For these patients, the guidelines suggest that a combination diuretic approach (chlorthalidone with a loop diuretic) could be considered in light of the results of the recent CLICK study.
 

Differences from U.S. guidelines?

Commenting on the new European guidelines for this news organization, Paul Whelton, MD, chair of the most recent American College of Cardiology/American Heart Association hypertension guidelines committee, said: “Publication of these guidelines is important. I congratulate the European task force. It is an enormous amount of time and effort.”

Dr. Whelton, who is Show Chwan Chair in Global Public Health at Tulane University, New Orleans, and president of the World Hypertension League, added: “I would say the changes are incremental rather than major, but that is probably appropriate.”

He welcomed the greater emphasis on out-of-office blood pressure measurement, saying, “That’s where we should be headed.”

Asked how the European guidelines differ from the U.S. guidelines, Dr. Whelton commented: “There are differences, but they are not huge. The major hypertension guidelines across the world are much more alike than they are different.”

He pointed out that both the U.S. and European guidelines aim for a target blood pressure of 130/80 mm Hg for most patients but have different ways of issuing that advice.

“The Europeans recommend a minimum goal of 140/90 mm Hg, and if there are no issues, then press on to get to under 130/80 mm Hg. That’s kind of a two-step process,” he said. “In the U.S., we’ve gone for a more direct approach of just recommending less than 130/80 mm Hg.

“My fear with the European approach is that by saying, get to 140/90 mm Hg first, then move on to 130/80 mm Hg, is that you’re likely to lose people. And doctors could feel that 140/90 is fine.”
 

More effort needed on implementation

Dr. Whelton says that where all hypertension guidelines are lacking is in the implementation of the recommendations.

“We are all falling down on implementation,” he said. “We have a huge burden of illness, and it is a very cost-effective area for management, but still, rates of blood pressure control are very bad. Generally speaking, even with a very conservative target of 140/90, the best countries only have control rates of around 30%, and this can be as low as 8% in some low/middle-income countries.”

Dr. Whelton believes the approach to blood pressure management needs to change.

“We know that the current traditional model of care, where blood pressure is managed by your local doctor, is not working. It is hopeless,” he said. “That is not an indictment of these doctors. It’s just that they have more pressing issues to deal with, so we need to look at other models.”

He suggests that the way forward is through convenient, community-based care delivered by a team in which nonphysicians assist in much of the management and in which reliable, affordable medications are given at the point of care, with patients tracked with electronic health records so as to identify those who are not adhering to their medication regimens.

“We know that using simple protocols will work for the vast majority of people. We don’t need to individualize or complicate this too much. That tends to lose people in the process.”

Dr. Whelton makes the point that it is well known how to diagnose and treat hypertension, yet this is not being done well.

“We are doing these things really badly. In routine care, blood pressure is measured horribly. Nobody would accept a pilot of a plane saying he should be doing all these procedures but he’s too busy and it’s probably okay, but that’s the way blood pressure is often measured in clinical practice,” he added. “And we can’t really do a good job if were not measuring the key variable properly that the diagnosis is based on.”

Dr. Whelton also points out that the medical profession is not making enough effort to have patients reach target levels.

“If you’re in a country where very few people are being treated and very high pressures are common, then of course you have to focus on that group first. But in most of the Western world, we are long past that, so we can move on down the chain. We then get to a lot more people with moderately high blood pressure getting exposed to increases in risk, and while this is not quite as dramatic as those with very high pressures at the individual risk level, because there are so many of them, that’s where a lot of events are occurring,” he says.

“If we get everyone to 140/90 mm Hg, we can probably prevent 60% of blood pressure–related events. But if we can get them all down to 130 mm Hg systolic, then we can prevent 75%-80% of events. It’s often quite easy to get to that target, but patients need help and encouragement.”

Going forward, he concluded, guidelines should pivot to focus more on implementation.

“We all try to make the guidelines as approachable as possible, but they are encyclopedic, and many doctors just continue doing what they are doing. That is our big challenge.”

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

The European Society of Hypertension has released updated and expanded guidelines for the management of hypertension.

The guidelines, which are endorsed by the European Renal Association and the International Society of Hypertension, were presented during the annual European Meeting on Hypertension and Cardiovascular Protection Meeting in Milan, Italy.

The guidelines consensus document was also published online in the Journal of Hypertension. Giuseppe Mancia, MD, professor emeritus of medicine, University Milano-Bicocca, Italy, and Reinhold Kreutz, MD, PhD, Charité–University Medicine Berlin, were cochairs of the task force that created the document.

“We have tried to provide a simplified message to key topics with these new guidelines,” Dr. Kreutz said in an interview.

“We have confirmed the definition of hypertension and provide clear guidance for blood pressure monitoring and a simplified general strategy targeting similar blood pressure goals for most patients, although the treatment algorithms of how you get there may be different for different patient groups.”

Dr. Kreutz added: “Because hypertension is so prevalent and many patients have comorbidities, it is not easy to have one approach for all, but we have tried to simplify the key messages as much as possible, with a target that is more general to the whole population.”

While there are no major surprises in the guidelines, there are multiple advances and added-value changes, including clear advice on how to measure blood pressure, an upgrade for beta-blockers in the treatment algorithms, and a new definition and treatment recommendations for “true resistant hypertension.”
 

Definition remains unchanged

The definition of hypertension remains unchanged from the previous guidelines – repeated office systolic blood pressure values of ≥ 140 mm Hg and/or diastolic blood pressure values of ≥ 90 mm Hg.

“The definition and classification of hypertension has not changed in these new guidelines,” Dr. Kreutz said. “While there have been suggestions that the definition/target should be changed again, particularly about blood pressure lowering being beneficial at the very low pressure range, after reviewing all the evidence we do not agree with this, and we are standing with the definition of hypertension when intervention is beneficial rather than doing nothing or causing harm.”
 

Clear guidance on measurement

Dr. Kreutz points out that the correct measurement of blood pressure is of key importance, and the new guidelines include a detailed algorithm on how to measure blood pressure. The preferred method is automated cuff-based blood pressure measurement.

“There are still many variations in blood pressure measurement in clinical practice, so we now have clear guidance on how to measure blood pressure in the office but also at home,” he commented.

They have upgraded the use of out-of-office blood pressure measurement, particularly home measurement, as useful in long-term management. “In future, there should be more emphasis on follow-up using technology with remote control and virtual care.”
 

Thresholds for starting treatment

On thresholds for initiating antihypertensive therapy, the guidelines recommend that treatment be initiated for most patients when systolic blood pressure is ≥ 140 mm Hg or diastolic blood pressure is ≥ 90 mm Hg.

The same recommendation is given for patients with grade 1 hypertension (systolic, 140-159 mm Hg; and/or diastolic, 90-99 mm Hg) irrespective of cardiovascular risk, although they add that for patients in the lower blood pressure range who have no hypertension-mediated organ damage and who are at low cardiovascular risk, consideration may be given to starting treatment with lifestyle changes only. If, however, blood pressure control is not achieved within a few months of a lifestyle-based approach alone, drug treatment is necessary.

For older patients (aged 80 or older), the task force recommends initiation of drug treatment at 160 mm Hg systolic, although a lower systolic threshold of 140-160 mm Hg may be considered. The authors note that thresholds for the initiation of drug treatment for very frail patients should be individualized.
 

Blood pressure targets

In the new guidelines, the blood pressure target is the same as in the previous guidelines for the general population of patients with hypertension. The goal is < 140/80 mm Hg for most patients. This accounts for the major portion of the protective effect of blood pressure lowering.

However, the consensus document notes that despite the smaller incremental benefit, an effort should be made to reach a range of 120-129/70-79 mm Hg, but only if treatment is well tolerated to avoid the risk of treatment discontinuation because of adverse events, which might offset, in part or completely, the incremental reduction in cardiovascular outcomes.

Elaborating on this, Dr. Kreutz said, “We should aim for the systolic blood pressure to be within the range of below 140 mm Hg down to 120 mm Hg, with a specific target of around 130 mm Hg for most patients and lower in patients in whom drug treatments are well tolerated and who are at high risk.

“The problem is, if we go for a target of lower that 130 mm Hg, the evidence gets weaker, the benefits diminish, and we risk losing patients because of adverse effects from using so many drugs,” he added. “But in younger and fitter patients, we would recommend the lower the better, but not below 120 mm Hg.”

Dr. Kreutz noted that the new guidelines have tried to simplify recommendations on target pressures. “We have tried to simplify guidance to focus on a target of around 130 for almost all patients. Before, it wasn’t so clear. There were different targets for different groups of patients with various comorbidities or older patients. But now we are saying the range of 120 to 139 is suitable for the vast majority of patients.”

The guidelines do allow slightly higher targets for older and very frail patients.
 

Drug treatments

The guidelines advise that blood pressure lowering be prioritized over the selection of specific antihypertensive drug classes. The use of any of the five major drug classes – angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, calcium blockers, and thiazide/thiazidelike diuretics – and their combinations are recommended as the basis of antihypertensive treatment strategies.

They advise starting with a two-drug combination for most patients. The preferred combinations including a renin-angiotensin blocker (either an ACE inhibitor or an ARB) with a calcium blocker or a thiazide/thiazidelike diuretic, preferably in a single-pill combination to reduce pill burden and improve adherence and outcome.

If blood pressure is not controlled with the initial two-drug combination at the maximum recommended and tolerated dose of the respective components, treatment should be increased to a three-drug combination.

“We can control 60% of patients in the general hypertensive population with dual therapy, and up to 90% with triple therapy,” Dr. Kreutz said. “Only a small percentage need a fourth drug.”

A new feature of the guidelines is the upgrading of beta-blockers in the treatment algorithms.

“Beta-blockers may not have previously been considered as a first choice of antihypertensive medication, but we see that in clinical practice, many patients are actually treated with these drugs because there are so many conditions in which beta-blockers have a compelling evidence-based indication or are believed to be favorable,” he said. “So, we are now positioning beta-blockers as drugs that can be used at any step of the treatment algorithm if there is a guideline directed indication or other conditions for which they are thought to be beneficial.”

The guidelines also recommend that all drugs be given as once-daily preparations and that they be taken preferably in the morning.

“The new TIME study has established that there is no difference in outcome with morning or evening dosing, but we know that adherence is often better when drugs are taken in the morning, and it is not advisable to take diuretics in the evening,” Dr. Kreutz said.
 

‘True resistant hypertension’

The guidelines have introduced a new term, “true resistant hypertension,” defined as systolic blood pressure of ≥ 140 mm Hg or diastolic blood pressure of ≥ 90 mm Hg in the presence of the following conditions: the maximum recommended and tolerated doses of a three-drug combination comprising a renin-angiotensin system blocker (either an ACE inhibitor or an ARB), a calcium blocker, and a thiazide/thiazidelike diuretic were used; inadequate blood pressure control has been confirmed by ambulatory (preferable) or home blood pressure measurement; and various causes of pseudo-resistant hypertension (especially poor medication adherence) and secondary hypertension have been excluded.

“There are many patients who may appear to have resistant hypertension, but we need to screen them carefully to ensure they are adherent to treatment, and then most of these patients are found not to be truly resistant,” Dr. Kreutz explained. “We estimate that only about 5% of patients have true resistant hypertension.”

For these patients with true resistant hypertension, two treatment approaches are recommended.

For those who do not have advanced kidney disease (glomerular filtration rate > 40 mL/min), renal denervation can be considered. This is a new II B recommendation.

Dr. Kreutz noted that studies of renal denervation excluded patients with advanced kidney disease, so there are no data for this group. For these patients, the guidelines suggest that a combination diuretic approach (chlorthalidone with a loop diuretic) could be considered in light of the results of the recent CLICK study.
 

Differences from U.S. guidelines?

Commenting on the new European guidelines for this news organization, Paul Whelton, MD, chair of the most recent American College of Cardiology/American Heart Association hypertension guidelines committee, said: “Publication of these guidelines is important. I congratulate the European task force. It is an enormous amount of time and effort.”

Dr. Whelton, who is Show Chwan Chair in Global Public Health at Tulane University, New Orleans, and president of the World Hypertension League, added: “I would say the changes are incremental rather than major, but that is probably appropriate.”

He welcomed the greater emphasis on out-of-office blood pressure measurement, saying, “That’s where we should be headed.”

Asked how the European guidelines differ from the U.S. guidelines, Dr. Whelton commented: “There are differences, but they are not huge. The major hypertension guidelines across the world are much more alike than they are different.”

He pointed out that both the U.S. and European guidelines aim for a target blood pressure of 130/80 mm Hg for most patients but have different ways of issuing that advice.

“The Europeans recommend a minimum goal of 140/90 mm Hg, and if there are no issues, then press on to get to under 130/80 mm Hg. That’s kind of a two-step process,” he said. “In the U.S., we’ve gone for a more direct approach of just recommending less than 130/80 mm Hg.

“My fear with the European approach is that by saying, get to 140/90 mm Hg first, then move on to 130/80 mm Hg, is that you’re likely to lose people. And doctors could feel that 140/90 is fine.”
 

More effort needed on implementation

Dr. Whelton says that where all hypertension guidelines are lacking is in the implementation of the recommendations.

“We are all falling down on implementation,” he said. “We have a huge burden of illness, and it is a very cost-effective area for management, but still, rates of blood pressure control are very bad. Generally speaking, even with a very conservative target of 140/90, the best countries only have control rates of around 30%, and this can be as low as 8% in some low/middle-income countries.”

Dr. Whelton believes the approach to blood pressure management needs to change.

“We know that the current traditional model of care, where blood pressure is managed by your local doctor, is not working. It is hopeless,” he said. “That is not an indictment of these doctors. It’s just that they have more pressing issues to deal with, so we need to look at other models.”

He suggests that the way forward is through convenient, community-based care delivered by a team in which nonphysicians assist in much of the management and in which reliable, affordable medications are given at the point of care, with patients tracked with electronic health records so as to identify those who are not adhering to their medication regimens.

“We know that using simple protocols will work for the vast majority of people. We don’t need to individualize or complicate this too much. That tends to lose people in the process.”

Dr. Whelton makes the point that it is well known how to diagnose and treat hypertension, yet this is not being done well.

“We are doing these things really badly. In routine care, blood pressure is measured horribly. Nobody would accept a pilot of a plane saying he should be doing all these procedures but he’s too busy and it’s probably okay, but that’s the way blood pressure is often measured in clinical practice,” he added. “And we can’t really do a good job if were not measuring the key variable properly that the diagnosis is based on.”

Dr. Whelton also points out that the medical profession is not making enough effort to have patients reach target levels.

“If you’re in a country where very few people are being treated and very high pressures are common, then of course you have to focus on that group first. But in most of the Western world, we are long past that, so we can move on down the chain. We then get to a lot more people with moderately high blood pressure getting exposed to increases in risk, and while this is not quite as dramatic as those with very high pressures at the individual risk level, because there are so many of them, that’s where a lot of events are occurring,” he says.

“If we get everyone to 140/90 mm Hg, we can probably prevent 60% of blood pressure–related events. But if we can get them all down to 130 mm Hg systolic, then we can prevent 75%-80% of events. It’s often quite easy to get to that target, but patients need help and encouragement.”

Going forward, he concluded, guidelines should pivot to focus more on implementation.

“We all try to make the guidelines as approachable as possible, but they are encyclopedic, and many doctors just continue doing what they are doing. That is our big challenge.”

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

More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 38^4/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

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

More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 38^4/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

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

More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 38^4/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

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

A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.

A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.

For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.

With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.

Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.

These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.

The scientific statement was published online in Circulation.
 

Evidence gaps and the path forward

“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.

Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.

They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.

The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.

These include the following:

• Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
• Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
• Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
• Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
• Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.

“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.

The research had no commercial funding. No conflicts of interest were reported.

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

A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.

A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.

For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.

With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.

Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.

These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.

The scientific statement was published online in Circulation.
 

Evidence gaps and the path forward

“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.

Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.

They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.

The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.

These include the following:

• Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
• Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
• Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
• Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
• Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.

“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.

The research had no commercial funding. No conflicts of interest were reported.

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

A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.

A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.

For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.

With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.

Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.

These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.

The scientific statement was published online in Circulation.
 

Evidence gaps and the path forward

“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.

Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.

They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.

The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.

These include the following:

• Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
• Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
• Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
• Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
• Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.

“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.

The research had no commercial funding. No conflicts of interest were reported.

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

An expert panel of pain management clinicians has released what they say are the first international guidelines for general practitioners on opioid analgesic deprescribing in adults.

The recommendations describe best practices for stopping opioid therapy and emphasize slow tapering and individualized deprescribing plans tailored to each patient.

Developed by general practitioners, pain specialists, addiction specialists, pharmacists, registered nurses, consumers, and physiotherapists, the guidelines note that deprescribing may not be appropriate for every patient and that stopping abruptly can be associated with an increased risk of overdose.

“Internationally, we were seeing significant harms from opioids but also significant harms from unsolicited and abrupt opioid cessation,” said lead author Aili Langford, PhD, who conducted the study as a doctoral student at the University of Sydney. “It was clear that recommendations to support safe and person-centered opioid deprescribing were required.”

The findings were published online  in the Medical Journal of Australia.
 

Deprescribing plan

The consensus guidelines include 11 recommendations for deprescribing in adult patients who take at least one opioid for any type of pain.

Recommendations include implementing a deprescribing plan when opioids are first prescribed and gradual and individualized deprescribing, with regular monitoring and review.

Clinicians should consider opioid deprescribing in patients who experience no clinically meaningful improvement in function, quality of life, or pain at high risk with opioid therapy, they note. Patients who are at high risk for opioid-related harm are also good candidates for deprescribing.

Stopping opioid therapy is not recommended for patients with severe opioid use disorder (OUD). In those patients, medication-assisted OUD treatment and other evidence-based interventions are recommended.

“Opioids can be effective in pain management,” co-author Carl Schneider, PhD, an associate professor of pharmacy at the University of Sydney, said in a press release. “However, over the longer term, the risk of harms may outweigh the benefits.”
 

A ‘global problem’

Commenting on the guidelines, Orman Trent Hall, DO, assistant professor of addiction medicine, department of psychiatry and behavioral health at the Ohio State University Wexner Medical Center, Columbus, said they are similar to recommendations published by the U.S. Centers for Disease Control and Prevention in 2016 and 2022 but offer additional information that could be helpful.

“This new guideline provides more explicit advice about tapering and withdrawal management, which may be useful to practitioners. The opioid crisis is a global problem, and while individual countries may require local solutions, the new international guideline may offer a framework for approaching this issue,” he said.

The guideline’s emphasis on the potential risks of deprescribing in some patients is also key, Dr. Hall added. Patients who are tapering off opioid therapy may have worsening pain and loss of function that can affect their quality of life.

“Patients may also experience psychological harm and increased risk of opioid use disorder and death by suicide following opioid deprescribing,” Dr. Hall said. “Therefore, it is important for providers to carefully weigh the risks of prescribing and deprescribing and engage patients with person-centered communication and shared decision-making.”

The work was funded by grants from the University of Sydney and the National Health and Medical Research Council. Full disclosures are available in the original article. Dr. Hall has provided expert opinion to the health care consultancy firm Lumanity and Emergent BioSolutions regarding the overdose crisis.

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

An expert panel of pain management clinicians has released what they say are the first international guidelines for general practitioners on opioid analgesic deprescribing in adults.

The recommendations describe best practices for stopping opioid therapy and emphasize slow tapering and individualized deprescribing plans tailored to each patient.

Developed by general practitioners, pain specialists, addiction specialists, pharmacists, registered nurses, consumers, and physiotherapists, the guidelines note that deprescribing may not be appropriate for every patient and that stopping abruptly can be associated with an increased risk of overdose.

“Internationally, we were seeing significant harms from opioids but also significant harms from unsolicited and abrupt opioid cessation,” said lead author Aili Langford, PhD, who conducted the study as a doctoral student at the University of Sydney. “It was clear that recommendations to support safe and person-centered opioid deprescribing were required.”

The findings were published online  in the Medical Journal of Australia.
 

Deprescribing plan

The consensus guidelines include 11 recommendations for deprescribing in adult patients who take at least one opioid for any type of pain.

Recommendations include implementing a deprescribing plan when opioids are first prescribed and gradual and individualized deprescribing, with regular monitoring and review.

Clinicians should consider opioid deprescribing in patients who experience no clinically meaningful improvement in function, quality of life, or pain at high risk with opioid therapy, they note. Patients who are at high risk for opioid-related harm are also good candidates for deprescribing.

Stopping opioid therapy is not recommended for patients with severe opioid use disorder (OUD). In those patients, medication-assisted OUD treatment and other evidence-based interventions are recommended.

“Opioids can be effective in pain management,” co-author Carl Schneider, PhD, an associate professor of pharmacy at the University of Sydney, said in a press release. “However, over the longer term, the risk of harms may outweigh the benefits.”
 

A ‘global problem’

Commenting on the guidelines, Orman Trent Hall, DO, assistant professor of addiction medicine, department of psychiatry and behavioral health at the Ohio State University Wexner Medical Center, Columbus, said they are similar to recommendations published by the U.S. Centers for Disease Control and Prevention in 2016 and 2022 but offer additional information that could be helpful.

“This new guideline provides more explicit advice about tapering and withdrawal management, which may be useful to practitioners. The opioid crisis is a global problem, and while individual countries may require local solutions, the new international guideline may offer a framework for approaching this issue,” he said.

The guideline’s emphasis on the potential risks of deprescribing in some patients is also key, Dr. Hall added. Patients who are tapering off opioid therapy may have worsening pain and loss of function that can affect their quality of life.

“Patients may also experience psychological harm and increased risk of opioid use disorder and death by suicide following opioid deprescribing,” Dr. Hall said. “Therefore, it is important for providers to carefully weigh the risks of prescribing and deprescribing and engage patients with person-centered communication and shared decision-making.”

The work was funded by grants from the University of Sydney and the National Health and Medical Research Council. Full disclosures are available in the original article. Dr. Hall has provided expert opinion to the health care consultancy firm Lumanity and Emergent BioSolutions regarding the overdose crisis.

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

An expert panel of pain management clinicians has released what they say are the first international guidelines for general practitioners on opioid analgesic deprescribing in adults.

The recommendations describe best practices for stopping opioid therapy and emphasize slow tapering and individualized deprescribing plans tailored to each patient.

Developed by general practitioners, pain specialists, addiction specialists, pharmacists, registered nurses, consumers, and physiotherapists, the guidelines note that deprescribing may not be appropriate for every patient and that stopping abruptly can be associated with an increased risk of overdose.

“Internationally, we were seeing significant harms from opioids but also significant harms from unsolicited and abrupt opioid cessation,” said lead author Aili Langford, PhD, who conducted the study as a doctoral student at the University of Sydney. “It was clear that recommendations to support safe and person-centered opioid deprescribing were required.”

The findings were published online  in the Medical Journal of Australia.
 

Deprescribing plan

The consensus guidelines include 11 recommendations for deprescribing in adult patients who take at least one opioid for any type of pain.

Recommendations include implementing a deprescribing plan when opioids are first prescribed and gradual and individualized deprescribing, with regular monitoring and review.

Clinicians should consider opioid deprescribing in patients who experience no clinically meaningful improvement in function, quality of life, or pain at high risk with opioid therapy, they note. Patients who are at high risk for opioid-related harm are also good candidates for deprescribing.

Stopping opioid therapy is not recommended for patients with severe opioid use disorder (OUD). In those patients, medication-assisted OUD treatment and other evidence-based interventions are recommended.

“Opioids can be effective in pain management,” co-author Carl Schneider, PhD, an associate professor of pharmacy at the University of Sydney, said in a press release. “However, over the longer term, the risk of harms may outweigh the benefits.”
 

A ‘global problem’

Commenting on the guidelines, Orman Trent Hall, DO, assistant professor of addiction medicine, department of psychiatry and behavioral health at the Ohio State University Wexner Medical Center, Columbus, said they are similar to recommendations published by the U.S. Centers for Disease Control and Prevention in 2016 and 2022 but offer additional information that could be helpful.

“This new guideline provides more explicit advice about tapering and withdrawal management, which may be useful to practitioners. The opioid crisis is a global problem, and while individual countries may require local solutions, the new international guideline may offer a framework for approaching this issue,” he said.

The guideline’s emphasis on the potential risks of deprescribing in some patients is also key, Dr. Hall added. Patients who are tapering off opioid therapy may have worsening pain and loss of function that can affect their quality of life.

“Patients may also experience psychological harm and increased risk of opioid use disorder and death by suicide following opioid deprescribing,” Dr. Hall said. “Therefore, it is important for providers to carefully weigh the risks of prescribing and deprescribing and engage patients with person-centered communication and shared decision-making.”

The work was funded by grants from the University of Sydney and the National Health and Medical Research Council. Full disclosures are available in the original article. Dr. Hall has provided expert opinion to the health care consultancy firm Lumanity and Emergent BioSolutions regarding the overdose crisis.

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