Marcia Frellick

Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.

The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.

Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
 

Three Comparisons

Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.

The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.

Among the results were the following:

• The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
• Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
• There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.

Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.

“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.

The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.

Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.

Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.

The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.

Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
 

Three Comparisons

Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.

The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.

Among the results were the following:

• The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
• Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
• There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.

Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.

“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.

The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.

Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.

Treatment for chronic hypertension in pregnancy with labetalol showed no significant differences in maternal or neonatal outcomes, compared with treatment with nifedipine, new research indicates.

The open-label, multicenter, randomized CHAP (Chronic Hypertension in Pregnancy) trial showed that treating mild chronic hypertension was better than delaying treatment until severe hypertension developed, but still unclear was whether, or to what extent, the choice of first-line treatment affected outcomes.

Researchers, led by Ayodeji A. Sanusi, MD, MPH, with the Division of Maternal and Fetal Medicine at the University of Alabama at Birmingham, conducted a secondary analysis of CHAP to compare the primary treatments. Mild chronic hypertension in the study was defined as blood pressure of 140-159/90-104 mmHg before 20 weeks of gestation.
 

Three Comparisons

Three comparisons were performed in 2292 participants based on medications prescribed at enrollment: 720 (31.4%) received labetalol; 417 (18.2%) initially received nifedipine; and 1155 (50.4%) had standard care. Labetalol was compared with standard care; nifedipine was compared with standard care; and labetalol was compared with nifedipine.

The primary outcome was occurrence of superimposed preeclampsia with severe features; preterm birth before 35 weeks of gestation; placental abruption; or fetal or neonatal death. The key secondary outcome was a small-for-gestational age neonate. Researchers also compared adverse effects between groups.

Among the results were the following:

• The primary outcome occurred in 30.1% in the labetalol group; 31.2% in the nifedipine group; and 37% in the standard care group.
• Risk of the primary outcome was lower among those receiving treatment. For labetalol vs standard care, the adjusted relative risk (RR) was 0.82; 95% confidence interval (CI), 0.72-0.94. For nifedipine vs standard care, the adjusted RR was 0.84; 95% CI, 0.71-0.99. There was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR, 0.98; 95% CI, 0.82-1.18).
• There were no significant differences in numbers of small-for-gestational age neonates or serious adverse events between those who received labetalol and those using nifedipine.

Any adverse events were significantly more common with nifedipine, compared with labetalol (35.7% vs 28.3%, P = .009), and with nifedipine, compared with standard care (35.7% vs 26.3%, P = .0003). Adverse event rates were not significantly higher with labetalol when compared with standard care (28.3% vs 26.3%, P = .34). The most frequently reported adverse events were headache, medication intolerance, dizziness, nausea, dyspepsia, neonatal jaundice, and vomiting.

“Thus, labetalol compared with nifedipine appeared to have fewer adverse events and to be better tolerated,” the authors write. They note that labetalol, a third-generation mixed alpha- and beta-adrenergic antagonist, is contraindicated for those who have obstructive pulmonary disease and nifedipine, a dihydropyridine calcium channel blocker, is contraindicated in people with tachycardia.

The authors write that their results align with other studies that have not found differences between labetalol and nifedipine. “[O]ur findings support the use of either labetalol or nifedipine as initial first-line agents for the management of mild chronic hypertension in pregnancy to reduce the risk of adverse maternal and other perinatal outcomes with no increased risk of fetal harm,” the authors write.

Dr. Sanusi reports no relevant financial relationships. Full coauthor disclosures are available with the full text of the paper.

An algorithm using two well-known tests has shown strong accuracy (91%) in predicting whether an older driver can pass an on-road driving evaluation according to a new study published in the Journal of the American Medical Directors Association .

The Fit2Drive algorithm combines the Mini-Mental State Exam (MMSE), a 30-point dementia screening tool that has been found in several studies to have an association with driving ability, and the Trails B test, which gauges cognitive flexibility and set-shifting (task switching), considered to be measures of executive functioning.
 

Algorithm Available for Providers

The algorithm is clinically available and providers can fill in patients’ information and results of the two tests at the Fit2Drive website. Results may help physicians with often-difficult conversations with older patients about driving when they present with cognitive concerns.

Families report it is one of the most difficult conversations they have with a loved one and doctors are often asked to be part of the conversation. This is particularly difficult when, often, little objective information is available. In the past, a clinical rule of thumb has been that people diagnosed with Alzheimer’s disease or related dementias (ADRD) will usually be able to drive for 3 years after diagnosis.

“[T]he anger, tears, and frustration on the part of the individual patient and the lack of objective data to guide provider recommendations are the driving forces behind our effort to develop a highly accurate, evidence-based predictor of the ability to pass an on-road driving test,” the authors write. They added that the goal of the study was to identify the smallest number of cognitive test results that could predict likelihood of passing an on-road driver evaluation.

A number of tests were evaluated for the algorithm, but the combination of Trails B in seconds and MMSE using the highest scores of the serial 7s (counting back from 100 by 7s) or WORLD spelled backward accounted for the highest correlation with passing the on-road driving test, according to the authors, led by Ruth Tappen, EdD, FN, with the Christine E. Lynn College of Nursing at Florida Atlantic University, in Boca Raton.

A receiver operator characteristic (ROC) analysis was conducted on the linear combination of the two assessments.

“Because an ROC of 0.70 is considered to be the minimal requirement [for predictive value], 0.80 is considered good, and higher than 0.90 is excellent, these findings [with 91% area under the curve] suggest excellent accuracy using these two cognitive tests in this population,” the authors write.

For this analysis, researchers included 412 older drivers (179 men and 233 women) with an average age of 80. T he study was conducted at the Florida Atlantic University’s Memory Center and Clinical Research Unit. Participants included those who received a driving evaluation at the Memory Center and agreed to have their results included in the Driving Repository, and community-based older drivers who volunteered to participate.
 

Limitations of the Study

There were marginal differences between sexes on the measures, but they were not significant. The sample was composed of relatively well-educated people, primarily of European American ethnic origin, which is a consideration in generalizing the results.

Among other limitations are that physical and sensory factors, in addition to cognitive issues, may affect an individual’s ability to drive safely and are not included in the algorithm. Sensory disabilities, including reduced visual acuity caused by binocular field vision loss, contrast sensitivity, glare sensitivity, and other conditions, may affect driving ability as well as the ability to fully rotate the head and neck. Medical conditions affecting the cardiovascular, neurological, and orthopedic systems can also influence driving ability.

“Future studies should involve more diverse samples and a greater variety of driving challenges, including school zones and multilane highways, which are not included in the study,” the authors write.

The study received grant support from the State of Florida Department of Health and the Ed and Ethel Moore Alzheimer’s Disease Research Program.

An algorithm using two well-known tests has shown strong accuracy (91%) in predicting whether an older driver can pass an on-road driving evaluation according to a new study published in the Journal of the American Medical Directors Association .

The Fit2Drive algorithm combines the Mini-Mental State Exam (MMSE), a 30-point dementia screening tool that has been found in several studies to have an association with driving ability, and the Trails B test, which gauges cognitive flexibility and set-shifting (task switching), considered to be measures of executive functioning.
 

Algorithm Available for Providers

The algorithm is clinically available and providers can fill in patients’ information and results of the two tests at the Fit2Drive website. Results may help physicians with often-difficult conversations with older patients about driving when they present with cognitive concerns.

Families report it is one of the most difficult conversations they have with a loved one and doctors are often asked to be part of the conversation. This is particularly difficult when, often, little objective information is available. In the past, a clinical rule of thumb has been that people diagnosed with Alzheimer’s disease or related dementias (ADRD) will usually be able to drive for 3 years after diagnosis.

“[T]he anger, tears, and frustration on the part of the individual patient and the lack of objective data to guide provider recommendations are the driving forces behind our effort to develop a highly accurate, evidence-based predictor of the ability to pass an on-road driving test,” the authors write. They added that the goal of the study was to identify the smallest number of cognitive test results that could predict likelihood of passing an on-road driver evaluation.

A number of tests were evaluated for the algorithm, but the combination of Trails B in seconds and MMSE using the highest scores of the serial 7s (counting back from 100 by 7s) or WORLD spelled backward accounted for the highest correlation with passing the on-road driving test, according to the authors, led by Ruth Tappen, EdD, FN, with the Christine E. Lynn College of Nursing at Florida Atlantic University, in Boca Raton.

A receiver operator characteristic (ROC) analysis was conducted on the linear combination of the two assessments.

“Because an ROC of 0.70 is considered to be the minimal requirement [for predictive value], 0.80 is considered good, and higher than 0.90 is excellent, these findings [with 91% area under the curve] suggest excellent accuracy using these two cognitive tests in this population,” the authors write.

For this analysis, researchers included 412 older drivers (179 men and 233 women) with an average age of 80. T he study was conducted at the Florida Atlantic University’s Memory Center and Clinical Research Unit. Participants included those who received a driving evaluation at the Memory Center and agreed to have their results included in the Driving Repository, and community-based older drivers who volunteered to participate.
 

Limitations of the Study

There were marginal differences between sexes on the measures, but they were not significant. The sample was composed of relatively well-educated people, primarily of European American ethnic origin, which is a consideration in generalizing the results.

Among other limitations are that physical and sensory factors, in addition to cognitive issues, may affect an individual’s ability to drive safely and are not included in the algorithm. Sensory disabilities, including reduced visual acuity caused by binocular field vision loss, contrast sensitivity, glare sensitivity, and other conditions, may affect driving ability as well as the ability to fully rotate the head and neck. Medical conditions affecting the cardiovascular, neurological, and orthopedic systems can also influence driving ability.

“Future studies should involve more diverse samples and a greater variety of driving challenges, including school zones and multilane highways, which are not included in the study,” the authors write.

The study received grant support from the State of Florida Department of Health and the Ed and Ethel Moore Alzheimer’s Disease Research Program.

An algorithm using two well-known tests has shown strong accuracy (91%) in predicting whether an older driver can pass an on-road driving evaluation according to a new study published in the Journal of the American Medical Directors Association .

The Fit2Drive algorithm combines the Mini-Mental State Exam (MMSE), a 30-point dementia screening tool that has been found in several studies to have an association with driving ability, and the Trails B test, which gauges cognitive flexibility and set-shifting (task switching), considered to be measures of executive functioning.
 

Algorithm Available for Providers

The algorithm is clinically available and providers can fill in patients’ information and results of the two tests at the Fit2Drive website. Results may help physicians with often-difficult conversations with older patients about driving when they present with cognitive concerns.

Families report it is one of the most difficult conversations they have with a loved one and doctors are often asked to be part of the conversation. This is particularly difficult when, often, little objective information is available. In the past, a clinical rule of thumb has been that people diagnosed with Alzheimer’s disease or related dementias (ADRD) will usually be able to drive for 3 years after diagnosis.

“[T]he anger, tears, and frustration on the part of the individual patient and the lack of objective data to guide provider recommendations are the driving forces behind our effort to develop a highly accurate, evidence-based predictor of the ability to pass an on-road driving test,” the authors write. They added that the goal of the study was to identify the smallest number of cognitive test results that could predict likelihood of passing an on-road driver evaluation.

A number of tests were evaluated for the algorithm, but the combination of Trails B in seconds and MMSE using the highest scores of the serial 7s (counting back from 100 by 7s) or WORLD spelled backward accounted for the highest correlation with passing the on-road driving test, according to the authors, led by Ruth Tappen, EdD, FN, with the Christine E. Lynn College of Nursing at Florida Atlantic University, in Boca Raton.

A receiver operator characteristic (ROC) analysis was conducted on the linear combination of the two assessments.

“Because an ROC of 0.70 is considered to be the minimal requirement [for predictive value], 0.80 is considered good, and higher than 0.90 is excellent, these findings [with 91% area under the curve] suggest excellent accuracy using these two cognitive tests in this population,” the authors write.

For this analysis, researchers included 412 older drivers (179 men and 233 women) with an average age of 80. T he study was conducted at the Florida Atlantic University’s Memory Center and Clinical Research Unit. Participants included those who received a driving evaluation at the Memory Center and agreed to have their results included in the Driving Repository, and community-based older drivers who volunteered to participate.
 

Limitations of the Study

There were marginal differences between sexes on the measures, but they were not significant. The sample was composed of relatively well-educated people, primarily of European American ethnic origin, which is a consideration in generalizing the results.

Among other limitations are that physical and sensory factors, in addition to cognitive issues, may affect an individual’s ability to drive safely and are not included in the algorithm. Sensory disabilities, including reduced visual acuity caused by binocular field vision loss, contrast sensitivity, glare sensitivity, and other conditions, may affect driving ability as well as the ability to fully rotate the head and neck. Medical conditions affecting the cardiovascular, neurological, and orthopedic systems can also influence driving ability.

“Future studies should involve more diverse samples and a greater variety of driving challenges, including school zones and multilane highways, which are not included in the study,” the authors write.

The study received grant support from the State of Florida Department of Health and the Ed and Ethel Moore Alzheimer’s Disease Research Program.

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

At the same time the Medicare population is growing, the number of family practice (FP) physicians and the number of procedures they perform are decreasing, according to a new analysis in Annals of Family Medicine.

“The reasons might represent a changing scope of family practice, increasing referrals, shifting tasks to [physician assistants] and [nurse practitioners], or some combination,” wrote the authors, led by Robert McKenna, DMSc, MPH, PA-C, with Marshall B. Ketchum University, Fullerton, California. But understanding the reasons may be important to improve training programs.

The Council of Academic Family Medicine (CAFM) in 2014 addressed variability in how FPs perform procedures with a consensus statement on 44 procedures FPs should be competent to perform after a family medicine residency and 24 more for which residency programs should offer training.

Researchers wanted to see how often the procedures were being done so they performed a retrospective, observational study of the Medicare Part B cohort to understand how often FPs report CAFM-recommended procedures in an outpatient setting. They used data from 2014 to 2021, the most recent years for which data were available, and modified the list of procedures for Medicare beneficiaries to match with Current Procedural Terminology codes.
 

Procedures Dropped by a Third in 8 Years

For the 8 years ending in 2021, there was a 33% decrease in outpatient procedures filed and a 36% decrease in the number of FPs who filed them, according to the paper. However, the number of FPs who treat Medicare beneficiaries has remained relatively stable. Almost all procedures performed were for the skin; musculoskeletal; eyes, ears, nose, and throat; and pulmonary categories.

There was a 17% decrease in every category of modified CAFM procedures between 2014 and 2019 before the pandemic.

Concurrently, the U.S. Bureau of Labor Statistics reported a 7% decrease in clinically active FPs from 2013 to 2022; 100,940 FPs were employed clinically in 2022. The Association of American Medical Colleges estimates a shortage of 17,800-48,000 primary care physicians by 2034.

“In 2021, the number of Medicare Part B claims by FPs for all [modified] CAFM outpatient procedures was reported by 12% of these clinicians and represented less than 1% of all CPT claims submitted,” the researchers wrote.

“Meanwhile, the 17% of Americans aged [at least] 65 years is projected to represent 20% of the U.S. population by 2030,” the authors pointed out.

The reasons for the decrease in procedures need further study, the authors said. From 2010 to 2020, there was a 30% and 47% increase in the employment of PAs and NPs, respectively, across all specialties, many employed in primary care. And 42% and 56% of family physicians reported working with PAs and NPs, respectively, from 2014 to 2018, according to the paper.

One explanation is a shifting of roles. “NPs and PAs might increasingly serve as proceduralists, freeing FPs to focus on other aspects of their practice such as complex chronic disease management or annual wellness visits,” the authors wrote.

It’s also possible that more Medicare-eligible Americans are being referred to various specialists such as urologists, gynecologists, and cardiologists, they speculated, adding that, “because demographic trends show an increasingly older population, family medicine training programs might need to adjust to meet this change.”

Among the limitations of the data are that publicly available Medicare data are limited to the approximately 60% of beneficiaries who are traditional Part B enrollees. Those enrolled in Medicare Advantage plans were excluded.

The work was supported in part by a Small Research Grant from the American Academy of Physician Associates in 2022. The authors reported no relevant financial relationships.

At the same time the Medicare population is growing, the number of family practice (FP) physicians and the number of procedures they perform are decreasing, according to a new analysis in Annals of Family Medicine.

“The reasons might represent a changing scope of family practice, increasing referrals, shifting tasks to [physician assistants] and [nurse practitioners], or some combination,” wrote the authors, led by Robert McKenna, DMSc, MPH, PA-C, with Marshall B. Ketchum University, Fullerton, California. But understanding the reasons may be important to improve training programs.

The Council of Academic Family Medicine (CAFM) in 2014 addressed variability in how FPs perform procedures with a consensus statement on 44 procedures FPs should be competent to perform after a family medicine residency and 24 more for which residency programs should offer training.

Researchers wanted to see how often the procedures were being done so they performed a retrospective, observational study of the Medicare Part B cohort to understand how often FPs report CAFM-recommended procedures in an outpatient setting. They used data from 2014 to 2021, the most recent years for which data were available, and modified the list of procedures for Medicare beneficiaries to match with Current Procedural Terminology codes.
 

Procedures Dropped by a Third in 8 Years

For the 8 years ending in 2021, there was a 33% decrease in outpatient procedures filed and a 36% decrease in the number of FPs who filed them, according to the paper. However, the number of FPs who treat Medicare beneficiaries has remained relatively stable. Almost all procedures performed were for the skin; musculoskeletal; eyes, ears, nose, and throat; and pulmonary categories.

There was a 17% decrease in every category of modified CAFM procedures between 2014 and 2019 before the pandemic.

Concurrently, the U.S. Bureau of Labor Statistics reported a 7% decrease in clinically active FPs from 2013 to 2022; 100,940 FPs were employed clinically in 2022. The Association of American Medical Colleges estimates a shortage of 17,800-48,000 primary care physicians by 2034.

“In 2021, the number of Medicare Part B claims by FPs for all [modified] CAFM outpatient procedures was reported by 12% of these clinicians and represented less than 1% of all CPT claims submitted,” the researchers wrote.

“Meanwhile, the 17% of Americans aged [at least] 65 years is projected to represent 20% of the U.S. population by 2030,” the authors pointed out.

The reasons for the decrease in procedures need further study, the authors said. From 2010 to 2020, there was a 30% and 47% increase in the employment of PAs and NPs, respectively, across all specialties, many employed in primary care. And 42% and 56% of family physicians reported working with PAs and NPs, respectively, from 2014 to 2018, according to the paper.

One explanation is a shifting of roles. “NPs and PAs might increasingly serve as proceduralists, freeing FPs to focus on other aspects of their practice such as complex chronic disease management or annual wellness visits,” the authors wrote.

It’s also possible that more Medicare-eligible Americans are being referred to various specialists such as urologists, gynecologists, and cardiologists, they speculated, adding that, “because demographic trends show an increasingly older population, family medicine training programs might need to adjust to meet this change.”

Among the limitations of the data are that publicly available Medicare data are limited to the approximately 60% of beneficiaries who are traditional Part B enrollees. Those enrolled in Medicare Advantage plans were excluded.

The work was supported in part by a Small Research Grant from the American Academy of Physician Associates in 2022. The authors reported no relevant financial relationships.

At the same time the Medicare population is growing, the number of family practice (FP) physicians and the number of procedures they perform are decreasing, according to a new analysis in Annals of Family Medicine.

“The reasons might represent a changing scope of family practice, increasing referrals, shifting tasks to [physician assistants] and [nurse practitioners], or some combination,” wrote the authors, led by Robert McKenna, DMSc, MPH, PA-C, with Marshall B. Ketchum University, Fullerton, California. But understanding the reasons may be important to improve training programs.

The Council of Academic Family Medicine (CAFM) in 2014 addressed variability in how FPs perform procedures with a consensus statement on 44 procedures FPs should be competent to perform after a family medicine residency and 24 more for which residency programs should offer training.

Researchers wanted to see how often the procedures were being done so they performed a retrospective, observational study of the Medicare Part B cohort to understand how often FPs report CAFM-recommended procedures in an outpatient setting. They used data from 2014 to 2021, the most recent years for which data were available, and modified the list of procedures for Medicare beneficiaries to match with Current Procedural Terminology codes.
 

Procedures Dropped by a Third in 8 Years

For the 8 years ending in 2021, there was a 33% decrease in outpatient procedures filed and a 36% decrease in the number of FPs who filed them, according to the paper. However, the number of FPs who treat Medicare beneficiaries has remained relatively stable. Almost all procedures performed were for the skin; musculoskeletal; eyes, ears, nose, and throat; and pulmonary categories.

There was a 17% decrease in every category of modified CAFM procedures between 2014 and 2019 before the pandemic.

Concurrently, the U.S. Bureau of Labor Statistics reported a 7% decrease in clinically active FPs from 2013 to 2022; 100,940 FPs were employed clinically in 2022. The Association of American Medical Colleges estimates a shortage of 17,800-48,000 primary care physicians by 2034.

“In 2021, the number of Medicare Part B claims by FPs for all [modified] CAFM outpatient procedures was reported by 12% of these clinicians and represented less than 1% of all CPT claims submitted,” the researchers wrote.

“Meanwhile, the 17% of Americans aged [at least] 65 years is projected to represent 20% of the U.S. population by 2030,” the authors pointed out.

The reasons for the decrease in procedures need further study, the authors said. From 2010 to 2020, there was a 30% and 47% increase in the employment of PAs and NPs, respectively, across all specialties, many employed in primary care. And 42% and 56% of family physicians reported working with PAs and NPs, respectively, from 2014 to 2018, according to the paper.

One explanation is a shifting of roles. “NPs and PAs might increasingly serve as proceduralists, freeing FPs to focus on other aspects of their practice such as complex chronic disease management or annual wellness visits,” the authors wrote.

It’s also possible that more Medicare-eligible Americans are being referred to various specialists such as urologists, gynecologists, and cardiologists, they speculated, adding that, “because demographic trends show an increasingly older population, family medicine training programs might need to adjust to meet this change.”

Among the limitations of the data are that publicly available Medicare data are limited to the approximately 60% of beneficiaries who are traditional Part B enrollees. Those enrolled in Medicare Advantage plans were excluded.

The work was supported in part by a Small Research Grant from the American Academy of Physician Associates in 2022. The authors reported no relevant financial relationships.

The U.S. Preventive Services Task Force (USPSTF) is recommending that clinicians provide comprehensive, intensive behavioral interventions for children 6 years and older who have a high body mass index (BMI) at or above the 95th percentile (for age and sex) or refer those patients to an appropriate provider.

One in five children (19.7%) and adolescents ages 2-19 in the United States are at or above this range, based on Centers for Disease Control and Prevention growth charts from 2000, the task force wrote in its statement. The rate of BMI increase nearly doubled in this age group during the COVID pandemic, compared with prepandemic levels.

Publishing their recommendations in JAMA, the task force, with lead author Wanda K. Nicholson, MD, MPH, MBA, with the Milken Institute of Public Health, George Washington University, Washington, D.C., also noted that the prevalence of high BMI increases with age and rates are higher among children from lower-income families. Rates are also higher in Hispanic/Latino, Native American/Alaska Native and non-Hispanic Black children.
 

At Least 26 Hours of Interventions

It is important that children and adolescents 6 years or older with a high BMI receive intensive interventions for at least 26 contact hours for up to a year, as evidence showed that was the threshold for weight loss, the task force said.

Based on its evidence review, the USPSTF assigned this recommendation a B grade indicating “moderate certainty ... of moderate net benefit.” The task force analyzed 50 randomized clinical trials (RCTs) (n = 8,798) that examined behavioral interventions. They also analyzed eight trials that assessed pharmacotherapy interventions: liraglutide (three RCTs), semaglutide (one RCT), orlistat (two RCTs) and phentermine/topiramate (two RCTs). Five trials included behavioral counseling with the medication or placebo.

These new recommendations also reaffirm the task force’s 2010 and 2023 recommendations.

Effective interventions had multiple components. They included interventions targeting both the parent and child (separately, together or both); group sessions; information about healthy eating, information on reading food labels, and safe exercising; and interventions for encouraging behavioral changes, such as monitoring food intake and problem solving, changing physical activity behaviors, and goal setting.

These types of interventions are often delivered by multidisciplinary teams, including pediatricians, exercise physiologists or physical therapists, dietitians, psychologists, social workers, or other behavioral specialists.
 

Personalizing Treatment for Optimal Benefit

“The time to prevent and intervene on childhood obesity is now, and the need to start with ILT [intensive lifestyle therapy] is clear,” Roohi Y. Kharofa, MD, with the department of pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, and colleagues wrote in a related editorial.

However, the editorialists noted it will be important to personalize the level of interventions as ILT won’t be enough for some to prevent serious outcomes. For such patients, bariatric surgery or pharmacotherapy may need to be considered as well.
 

Ways to Reach the 26 Hours

Dr. Kharofa and coauthors pointed out that, while the threshold of at least 26 contact hours is associated with significant improvement in BMI (mean BMI difference, –0.8; 95% CI, –1.2 to –0.4), and while it’s important to now have an evidence-based threshold, the number may be disheartening given limits on clinicians, staff, and resources. The key may be prescribing physical activity sessions outside the health system.

For patients not interested in group sports or burdened by participation fees, collaboration with local community organizations, such as the YMCA or the Boys & Girls Club, could be arranged, the authors suggested.

“The inability to attain 26 hours should not deter patients or practitioners from participating in, referring to, or implementing obesity interventions. Rather, clinical teams and families should work together to maximize intervention dose using clinical and community programs synergistically,” they wrote.

They noted that the USPSTF in this 2024 update found “inadequate evidence on the benefits of pharmacotherapy in youth with obesity, encouraging clinicians to use ILT as the primary intervention.”
 

What About Medications?

New since the previous USPSTF review, several new medications have been approved for weight loss in pediatric populations, Elizabeth A. O’Connor, PhD, with The Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, and colleagues noted in their updated evidence report.

They noted that the 2023 Clinical Practice Guideline developed by the American Academy of Pediatrics states that clinicians “may offer children ages 8 through 11 years of age with obesity weight loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment.”

However, Dr. O’Connor and coauthors wrote, the evidence base for each agent is limited and there is no information in the literature supporting their findings on harms of medication use beyond 17 months.

“For pharmacotherapy, when evidence was available on weight maintenance after discontinuation, weight rebounded quickly after medication use ended,” the authors wrote. “This suggests that long-term use is required for weight maintenance and underscores the need for evidence about potential harms from long-term use.”
 

Changes in Investment, Food, Government Priorities Are Needed

In a separate accompanying editorial, Thomas N. Robinson, MD, MPH, with Stanford University’s Center for Healthy Weight and General Pediatrics Department in Palo Alto, California, and Sarah C. Armstrong, MD, with the Duke Center for Childhood Obesity Research, Chapel Hill, North Carolina, wrote that experience to date has shown that current approaches aren’t working and, in fact, pediatric obesity rates are worsening.

“After nearly 15 years of authoritative, evidence-backed USPSTF recommendations for effective interventions for children with high BMI, it is long past time to implement them,” they wrote.

But changes will need to go far beyond clinicians’ offices and priorities must change at local, state, and federal levels, Dr. Robinson and Dr. Armstrong wrote. A shift in priorities is needed to make screening and behavioral interventions available to all children and teens with obesity.

Public policies, they wrote, must address larger issues, such as food content and availability of healthy foods, transportation innovations, and ways to make active lifestyles available equitably.

The authors said that strategies may include taxing sugary drinks, regulating marketing of unhealthful foods, crafting legislation to regulate the nutritional content of school meals, and creating policies to reduce poverty and address social drivers of health.

“A synergistic combination of effective clinical care, as recommended by the USPSTF, and public policy interventions is critically needed to turn the tide on childhood obesity,” Dr. Robinson and Dr. Armstrong wrote.

The full recommendation statement is available at the USPSTF website or the JAMA website.

One coauthor of the recommendation statement reported receiving publications and federal grand funding to his institution for the relationship between obesity and the potential effect of nutrition policy interventions on cardiovascular disease and cancer and for a meta-analysis of the effect of dietary counseling for weight loss. The authors of the evidence report had no relevant conflicts of interest. Dr. Kharofa reported receiving grants from Rhythm Pharmaceuticals outside the submitted work. Dr. Robinson has served on the scientific advisory board of WW International (through December 2022). Dr. Armstrong has served as chair of the Section on Obesity, American Academy of Pediatrics; and is a coauthor of the Clinical Practice Guidelines for the Evaluation and Treatment of Children and Adolescents with Obesity.
 

The U.S. Preventive Services Task Force (USPSTF) is recommending that clinicians provide comprehensive, intensive behavioral interventions for children 6 years and older who have a high body mass index (BMI) at or above the 95th percentile (for age and sex) or refer those patients to an appropriate provider.

One in five children (19.7%) and adolescents ages 2-19 in the United States are at or above this range, based on Centers for Disease Control and Prevention growth charts from 2000, the task force wrote in its statement. The rate of BMI increase nearly doubled in this age group during the COVID pandemic, compared with prepandemic levels.

Publishing their recommendations in JAMA, the task force, with lead author Wanda K. Nicholson, MD, MPH, MBA, with the Milken Institute of Public Health, George Washington University, Washington, D.C., also noted that the prevalence of high BMI increases with age and rates are higher among children from lower-income families. Rates are also higher in Hispanic/Latino, Native American/Alaska Native and non-Hispanic Black children.
 

At Least 26 Hours of Interventions

It is important that children and adolescents 6 years or older with a high BMI receive intensive interventions for at least 26 contact hours for up to a year, as evidence showed that was the threshold for weight loss, the task force said.

Based on its evidence review, the USPSTF assigned this recommendation a B grade indicating “moderate certainty ... of moderate net benefit.” The task force analyzed 50 randomized clinical trials (RCTs) (n = 8,798) that examined behavioral interventions. They also analyzed eight trials that assessed pharmacotherapy interventions: liraglutide (three RCTs), semaglutide (one RCT), orlistat (two RCTs) and phentermine/topiramate (two RCTs). Five trials included behavioral counseling with the medication or placebo.

These new recommendations also reaffirm the task force’s 2010 and 2023 recommendations.

Effective interventions had multiple components. They included interventions targeting both the parent and child (separately, together or both); group sessions; information about healthy eating, information on reading food labels, and safe exercising; and interventions for encouraging behavioral changes, such as monitoring food intake and problem solving, changing physical activity behaviors, and goal setting.

These types of interventions are often delivered by multidisciplinary teams, including pediatricians, exercise physiologists or physical therapists, dietitians, psychologists, social workers, or other behavioral specialists.
 

Personalizing Treatment for Optimal Benefit

“The time to prevent and intervene on childhood obesity is now, and the need to start with ILT [intensive lifestyle therapy] is clear,” Roohi Y. Kharofa, MD, with the department of pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, and colleagues wrote in a related editorial.

However, the editorialists noted it will be important to personalize the level of interventions as ILT won’t be enough for some to prevent serious outcomes. For such patients, bariatric surgery or pharmacotherapy may need to be considered as well.
 

Ways to Reach the 26 Hours

Dr. Kharofa and coauthors pointed out that, while the threshold of at least 26 contact hours is associated with significant improvement in BMI (mean BMI difference, –0.8; 95% CI, –1.2 to –0.4), and while it’s important to now have an evidence-based threshold, the number may be disheartening given limits on clinicians, staff, and resources. The key may be prescribing physical activity sessions outside the health system.

For patients not interested in group sports or burdened by participation fees, collaboration with local community organizations, such as the YMCA or the Boys & Girls Club, could be arranged, the authors suggested.

“The inability to attain 26 hours should not deter patients or practitioners from participating in, referring to, or implementing obesity interventions. Rather, clinical teams and families should work together to maximize intervention dose using clinical and community programs synergistically,” they wrote.

They noted that the USPSTF in this 2024 update found “inadequate evidence on the benefits of pharmacotherapy in youth with obesity, encouraging clinicians to use ILT as the primary intervention.”
 

What About Medications?

New since the previous USPSTF review, several new medications have been approved for weight loss in pediatric populations, Elizabeth A. O’Connor, PhD, with The Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, and colleagues noted in their updated evidence report.

They noted that the 2023 Clinical Practice Guideline developed by the American Academy of Pediatrics states that clinicians “may offer children ages 8 through 11 years of age with obesity weight loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment.”

However, Dr. O’Connor and coauthors wrote, the evidence base for each agent is limited and there is no information in the literature supporting their findings on harms of medication use beyond 17 months.

“For pharmacotherapy, when evidence was available on weight maintenance after discontinuation, weight rebounded quickly after medication use ended,” the authors wrote. “This suggests that long-term use is required for weight maintenance and underscores the need for evidence about potential harms from long-term use.”
 

Changes in Investment, Food, Government Priorities Are Needed

In a separate accompanying editorial, Thomas N. Robinson, MD, MPH, with Stanford University’s Center for Healthy Weight and General Pediatrics Department in Palo Alto, California, and Sarah C. Armstrong, MD, with the Duke Center for Childhood Obesity Research, Chapel Hill, North Carolina, wrote that experience to date has shown that current approaches aren’t working and, in fact, pediatric obesity rates are worsening.

“After nearly 15 years of authoritative, evidence-backed USPSTF recommendations for effective interventions for children with high BMI, it is long past time to implement them,” they wrote.

But changes will need to go far beyond clinicians’ offices and priorities must change at local, state, and federal levels, Dr. Robinson and Dr. Armstrong wrote. A shift in priorities is needed to make screening and behavioral interventions available to all children and teens with obesity.

Public policies, they wrote, must address larger issues, such as food content and availability of healthy foods, transportation innovations, and ways to make active lifestyles available equitably.

The authors said that strategies may include taxing sugary drinks, regulating marketing of unhealthful foods, crafting legislation to regulate the nutritional content of school meals, and creating policies to reduce poverty and address social drivers of health.

“A synergistic combination of effective clinical care, as recommended by the USPSTF, and public policy interventions is critically needed to turn the tide on childhood obesity,” Dr. Robinson and Dr. Armstrong wrote.

The full recommendation statement is available at the USPSTF website or the JAMA website.

One coauthor of the recommendation statement reported receiving publications and federal grand funding to his institution for the relationship between obesity and the potential effect of nutrition policy interventions on cardiovascular disease and cancer and for a meta-analysis of the effect of dietary counseling for weight loss. The authors of the evidence report had no relevant conflicts of interest. Dr. Kharofa reported receiving grants from Rhythm Pharmaceuticals outside the submitted work. Dr. Robinson has served on the scientific advisory board of WW International (through December 2022). Dr. Armstrong has served as chair of the Section on Obesity, American Academy of Pediatrics; and is a coauthor of the Clinical Practice Guidelines for the Evaluation and Treatment of Children and Adolescents with Obesity.
 

The U.S. Preventive Services Task Force (USPSTF) is recommending that clinicians provide comprehensive, intensive behavioral interventions for children 6 years and older who have a high body mass index (BMI) at or above the 95th percentile (for age and sex) or refer those patients to an appropriate provider.

One in five children (19.7%) and adolescents ages 2-19 in the United States are at or above this range, based on Centers for Disease Control and Prevention growth charts from 2000, the task force wrote in its statement. The rate of BMI increase nearly doubled in this age group during the COVID pandemic, compared with prepandemic levels.

Publishing their recommendations in JAMA, the task force, with lead author Wanda K. Nicholson, MD, MPH, MBA, with the Milken Institute of Public Health, George Washington University, Washington, D.C., also noted that the prevalence of high BMI increases with age and rates are higher among children from lower-income families. Rates are also higher in Hispanic/Latino, Native American/Alaska Native and non-Hispanic Black children.
 

At Least 26 Hours of Interventions

It is important that children and adolescents 6 years or older with a high BMI receive intensive interventions for at least 26 contact hours for up to a year, as evidence showed that was the threshold for weight loss, the task force said.

Based on its evidence review, the USPSTF assigned this recommendation a B grade indicating “moderate certainty ... of moderate net benefit.” The task force analyzed 50 randomized clinical trials (RCTs) (n = 8,798) that examined behavioral interventions. They also analyzed eight trials that assessed pharmacotherapy interventions: liraglutide (three RCTs), semaglutide (one RCT), orlistat (two RCTs) and phentermine/topiramate (two RCTs). Five trials included behavioral counseling with the medication or placebo.

These new recommendations also reaffirm the task force’s 2010 and 2023 recommendations.

Effective interventions had multiple components. They included interventions targeting both the parent and child (separately, together or both); group sessions; information about healthy eating, information on reading food labels, and safe exercising; and interventions for encouraging behavioral changes, such as monitoring food intake and problem solving, changing physical activity behaviors, and goal setting.

These types of interventions are often delivered by multidisciplinary teams, including pediatricians, exercise physiologists or physical therapists, dietitians, psychologists, social workers, or other behavioral specialists.
 

Personalizing Treatment for Optimal Benefit

“The time to prevent and intervene on childhood obesity is now, and the need to start with ILT [intensive lifestyle therapy] is clear,” Roohi Y. Kharofa, MD, with the department of pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, and colleagues wrote in a related editorial.

However, the editorialists noted it will be important to personalize the level of interventions as ILT won’t be enough for some to prevent serious outcomes. For such patients, bariatric surgery or pharmacotherapy may need to be considered as well.
 

Ways to Reach the 26 Hours

Dr. Kharofa and coauthors pointed out that, while the threshold of at least 26 contact hours is associated with significant improvement in BMI (mean BMI difference, –0.8; 95% CI, –1.2 to –0.4), and while it’s important to now have an evidence-based threshold, the number may be disheartening given limits on clinicians, staff, and resources. The key may be prescribing physical activity sessions outside the health system.

For patients not interested in group sports or burdened by participation fees, collaboration with local community organizations, such as the YMCA or the Boys & Girls Club, could be arranged, the authors suggested.

“The inability to attain 26 hours should not deter patients or practitioners from participating in, referring to, or implementing obesity interventions. Rather, clinical teams and families should work together to maximize intervention dose using clinical and community programs synergistically,” they wrote.

They noted that the USPSTF in this 2024 update found “inadequate evidence on the benefits of pharmacotherapy in youth with obesity, encouraging clinicians to use ILT as the primary intervention.”
 

What About Medications?

New since the previous USPSTF review, several new medications have been approved for weight loss in pediatric populations, Elizabeth A. O’Connor, PhD, with The Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, and colleagues noted in their updated evidence report.

They noted that the 2023 Clinical Practice Guideline developed by the American Academy of Pediatrics states that clinicians “may offer children ages 8 through 11 years of age with obesity weight loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment.”

However, Dr. O’Connor and coauthors wrote, the evidence base for each agent is limited and there is no information in the literature supporting their findings on harms of medication use beyond 17 months.

“For pharmacotherapy, when evidence was available on weight maintenance after discontinuation, weight rebounded quickly after medication use ended,” the authors wrote. “This suggests that long-term use is required for weight maintenance and underscores the need for evidence about potential harms from long-term use.”
 

Changes in Investment, Food, Government Priorities Are Needed

In a separate accompanying editorial, Thomas N. Robinson, MD, MPH, with Stanford University’s Center for Healthy Weight and General Pediatrics Department in Palo Alto, California, and Sarah C. Armstrong, MD, with the Duke Center for Childhood Obesity Research, Chapel Hill, North Carolina, wrote that experience to date has shown that current approaches aren’t working and, in fact, pediatric obesity rates are worsening.

“After nearly 15 years of authoritative, evidence-backed USPSTF recommendations for effective interventions for children with high BMI, it is long past time to implement them,” they wrote.

But changes will need to go far beyond clinicians’ offices and priorities must change at local, state, and federal levels, Dr. Robinson and Dr. Armstrong wrote. A shift in priorities is needed to make screening and behavioral interventions available to all children and teens with obesity.

Public policies, they wrote, must address larger issues, such as food content and availability of healthy foods, transportation innovations, and ways to make active lifestyles available equitably.

The authors said that strategies may include taxing sugary drinks, regulating marketing of unhealthful foods, crafting legislation to regulate the nutritional content of school meals, and creating policies to reduce poverty and address social drivers of health.

“A synergistic combination of effective clinical care, as recommended by the USPSTF, and public policy interventions is critically needed to turn the tide on childhood obesity,” Dr. Robinson and Dr. Armstrong wrote.

The full recommendation statement is available at the USPSTF website or the JAMA website.

One coauthor of the recommendation statement reported receiving publications and federal grand funding to his institution for the relationship between obesity and the potential effect of nutrition policy interventions on cardiovascular disease and cancer and for a meta-analysis of the effect of dietary counseling for weight loss. The authors of the evidence report had no relevant conflicts of interest. Dr. Kharofa reported receiving grants from Rhythm Pharmaceuticals outside the submitted work. Dr. Robinson has served on the scientific advisory board of WW International (through December 2022). Dr. Armstrong has served as chair of the Section on Obesity, American Academy of Pediatrics; and is a coauthor of the Clinical Practice Guidelines for the Evaluation and Treatment of Children and Adolescents with Obesity.
 

CHICAGO — One of the more recent developments in sunscreen technology is the addition of iron oxide to mineral sunscreens.

Iron oxide is “an excellent pigment” that absorbs and blocks visible light, which is particularly important in individuals with Fitzpatrick skin types III-VI, Zoe D. Draelos, MD, consulting professor of dermatology at Duke University, Durham, North Carolina, said at the Pigmentation Disorders Exchange symposium.

Susan C. Taylor, MD, professor of dermatology at the University of Pennsylvania, Philadelphia, who spoke at the conference, also recommended tinted sunscreen with iron oxide for patients with skin of color. “It still needs to be broad spectrum,” she said, “and at least an SPF [Sun Protection Factor] 30.”

When blended with mineral sunscreens, iron oxide can reduce transmission of visible light by 90% and can protect patients from hyperpigmentation. Iron oxide comes in different colors blended together for various degrees of tinting.

Dr. Taylor noted that iron oxide is listed under the inactive ingredients. “The literature indicates a 3% concentration to aim for, but we don’t know the concentration in most of the products,” she added.

During her presentation, Dr. Draelos noted that inorganic sunscreens, such as zinc oxide and titanium oxides, are highly effective but make the skin white and pasty. To address this issue, many companies are now grinding these materials into such small particles that they are transparent.

“That’s great, except the smaller the particle is, the less UV [ultraviolet] radiation it reflects and that lowers the [SPF],” she said.

In addition to providing photoprotection, sunscreens in general provide protection from nanoparticles in tobacco and combustion, such as traffic exhaust, which can harm skin over time. “Moisturizers and sunscreens are the best way to protect against pollution and tobacco nanoparticle damage, which can contribute to inflammation,” she noted. They create a film over the skin and trap the nanoparticles.
 

Start the Patient Visit With a Photoprotection Talk

At the meeting, Dr. Taylor recommended that for all patients with hypopigmentation and hyperpigmentation disorders, “treatment really begins with photoprotection.”

She acknowledged that photoprotection discussions, including the basics of seeking shade, wearing protective clothing, and avoiding midday sun, often come at the end of the patient visit but she urged dermatologists to make that the first topic instead.

Dr. Taylor said a question often asked of patients of color about prolonged sun exposure — whether their skin turns bright red after too much sun — may get a negative reply. The better question is whether the patient has experienced tender skin after too much sun — which can signify a sunburn, she said.

Dr. Draelos reported no relevant financial relationships. Dr. Taylor reported financial relationships and grant support from multiple pharmaceutical companies.

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

CHICAGO — One of the more recent developments in sunscreen technology is the addition of iron oxide to mineral sunscreens.

Iron oxide is “an excellent pigment” that absorbs and blocks visible light, which is particularly important in individuals with Fitzpatrick skin types III-VI, Zoe D. Draelos, MD, consulting professor of dermatology at Duke University, Durham, North Carolina, said at the Pigmentation Disorders Exchange symposium.

Susan C. Taylor, MD, professor of dermatology at the University of Pennsylvania, Philadelphia, who spoke at the conference, also recommended tinted sunscreen with iron oxide for patients with skin of color. “It still needs to be broad spectrum,” she said, “and at least an SPF [Sun Protection Factor] 30.”

When blended with mineral sunscreens, iron oxide can reduce transmission of visible light by 90% and can protect patients from hyperpigmentation. Iron oxide comes in different colors blended together for various degrees of tinting.

Dr. Taylor noted that iron oxide is listed under the inactive ingredients. “The literature indicates a 3% concentration to aim for, but we don’t know the concentration in most of the products,” she added.

During her presentation, Dr. Draelos noted that inorganic sunscreens, such as zinc oxide and titanium oxides, are highly effective but make the skin white and pasty. To address this issue, many companies are now grinding these materials into such small particles that they are transparent.

“That’s great, except the smaller the particle is, the less UV [ultraviolet] radiation it reflects and that lowers the [SPF],” she said.

In addition to providing photoprotection, sunscreens in general provide protection from nanoparticles in tobacco and combustion, such as traffic exhaust, which can harm skin over time. “Moisturizers and sunscreens are the best way to protect against pollution and tobacco nanoparticle damage, which can contribute to inflammation,” she noted. They create a film over the skin and trap the nanoparticles.
 

Start the Patient Visit With a Photoprotection Talk

At the meeting, Dr. Taylor recommended that for all patients with hypopigmentation and hyperpigmentation disorders, “treatment really begins with photoprotection.”

She acknowledged that photoprotection discussions, including the basics of seeking shade, wearing protective clothing, and avoiding midday sun, often come at the end of the patient visit but she urged dermatologists to make that the first topic instead.

Dr. Taylor said a question often asked of patients of color about prolonged sun exposure — whether their skin turns bright red after too much sun — may get a negative reply. The better question is whether the patient has experienced tender skin after too much sun — which can signify a sunburn, she said.

Dr. Draelos reported no relevant financial relationships. Dr. Taylor reported financial relationships and grant support from multiple pharmaceutical companies.

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

CHICAGO — One of the more recent developments in sunscreen technology is the addition of iron oxide to mineral sunscreens.

Iron oxide is “an excellent pigment” that absorbs and blocks visible light, which is particularly important in individuals with Fitzpatrick skin types III-VI, Zoe D. Draelos, MD, consulting professor of dermatology at Duke University, Durham, North Carolina, said at the Pigmentation Disorders Exchange symposium.

Susan C. Taylor, MD, professor of dermatology at the University of Pennsylvania, Philadelphia, who spoke at the conference, also recommended tinted sunscreen with iron oxide for patients with skin of color. “It still needs to be broad spectrum,” she said, “and at least an SPF [Sun Protection Factor] 30.”

When blended with mineral sunscreens, iron oxide can reduce transmission of visible light by 90% and can protect patients from hyperpigmentation. Iron oxide comes in different colors blended together for various degrees of tinting.

Dr. Taylor noted that iron oxide is listed under the inactive ingredients. “The literature indicates a 3% concentration to aim for, but we don’t know the concentration in most of the products,” she added.

During her presentation, Dr. Draelos noted that inorganic sunscreens, such as zinc oxide and titanium oxides, are highly effective but make the skin white and pasty. To address this issue, many companies are now grinding these materials into such small particles that they are transparent.

“That’s great, except the smaller the particle is, the less UV [ultraviolet] radiation it reflects and that lowers the [SPF],” she said.

In addition to providing photoprotection, sunscreens in general provide protection from nanoparticles in tobacco and combustion, such as traffic exhaust, which can harm skin over time. “Moisturizers and sunscreens are the best way to protect against pollution and tobacco nanoparticle damage, which can contribute to inflammation,” she noted. They create a film over the skin and trap the nanoparticles.
 

Start the Patient Visit With a Photoprotection Talk

At the meeting, Dr. Taylor recommended that for all patients with hypopigmentation and hyperpigmentation disorders, “treatment really begins with photoprotection.”

She acknowledged that photoprotection discussions, including the basics of seeking shade, wearing protective clothing, and avoiding midday sun, often come at the end of the patient visit but she urged dermatologists to make that the first topic instead.

Dr. Taylor said a question often asked of patients of color about prolonged sun exposure — whether their skin turns bright red after too much sun — may get a negative reply. The better question is whether the patient has experienced tender skin after too much sun — which can signify a sunburn, she said.

Dr. Draelos reported no relevant financial relationships. Dr. Taylor reported financial relationships and grant support from multiple pharmaceutical companies.

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

Using combined genetic testing in early childhood may decrease the misdiagnosis rate for Global Development Delay (GDD) and may help identify intervention targets, a new study suggests.

Researchers, led by Jiamei Zhang, MS, Department of Rehabilitation Medicine, Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China, in a multicenter, prospective cohort study enrolled patients ages 12 to 60 months with GDD from six centers in China from July 2020 through August 2023. Participants underwent trio whole exome sequencing (trio-WES) paired with copy number variation sequencing (CNV-seq).

“To the best of our knowledge, this study represents the largest prospective examination of combined genetic testing methods in a GDD cohort,” the authors reported in JAMA Network Open.

GDD is a common neurodevelopmental disorder, marked by cognitive impairment, and affects about 1% of children, the paper states. Most children with GDD develop intellectual disability (ID) after 5 years of age, with implications for quality of life, their physical abilities, and social functioning. Early and accurate diagnosis followed by appropriately targeted treatment is critical, but lacking. Researchers note that there is lack of consensus among health care professionals on whether genetic testing is necessary.

Genetics are known to play a significant role in pathogenesis of GDD, but definitive biomarkers have been elusive.
 

Positive Detection Rate of 61%

In this study, the combined use of trio-WES with CNV-seq in children with early-stage GDD resulted in a positive detection rate of 61%, a significant improvement over performing individual tests, “enhancing the positive detection rate by 18%-40%,” the researchers wrote. The combined approach also saves families time and costs, they note, while leading to more comprehensive genetic analysis and fewer missed diagnoses.

The combined approach also addressed the limitations of trio-WES and CNV-seq used alone, the authors wrote. Because of technological constraints, trio-WES may miss 55% of CNV variations, and CNV-seq has a missed diagnosis rate of 3%.

The study included 434 patients with GDD (60% male; average age, 25 months) with diverse degrees of cognitive impairment: mild (23%); moderate (32%); severe (28%); and profound (17%).

Three characteristics were linked with higher likelihood of having genetic variants: Craniofacial abnormalities (odds ratio [OR], 2.27; 95% confidence interval [CI], 1.45-3.56); moderate or severe cognitive impairment (OR, 1.69; 95% CI, 1.05-2.70); and age between 12 and 24 months (OR, 1.57; 95% CI, 1.05-2.35).
 

Dopaminergic Pathway Promising for Treatment

Researchers also discovered that GDD-related genes were primarily enriched in lysosome, dopaminergic synapse, and lysine degradation pathways. Dopaminergic synapse emerged as a significant pathway linked with GDD.

“In this cohort study, our findings support the correlation between dopaminergic synapse and cognitive impairment, as substantiated by prior research and animal models. Therefore, targeting the dopaminergic pathway holds promise for treating GDD and ID,” the authors wrote.

However, the authors note in the limitations that they used only a subset of 100 patients with GDD to measure dopamine concentration.

“Expanding the sample size and conducting in vivo and in vitro experiments are necessary steps to verify whether dopamine can be targeted for clinical precision medical intervention in patients with GDD,” they wrote.

The authors reported no relevant financial relationships.

Using combined genetic testing in early childhood may decrease the misdiagnosis rate for Global Development Delay (GDD) and may help identify intervention targets, a new study suggests.

Researchers, led by Jiamei Zhang, MS, Department of Rehabilitation Medicine, Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China, in a multicenter, prospective cohort study enrolled patients ages 12 to 60 months with GDD from six centers in China from July 2020 through August 2023. Participants underwent trio whole exome sequencing (trio-WES) paired with copy number variation sequencing (CNV-seq).

“To the best of our knowledge, this study represents the largest prospective examination of combined genetic testing methods in a GDD cohort,” the authors reported in JAMA Network Open.

GDD is a common neurodevelopmental disorder, marked by cognitive impairment, and affects about 1% of children, the paper states. Most children with GDD develop intellectual disability (ID) after 5 years of age, with implications for quality of life, their physical abilities, and social functioning. Early and accurate diagnosis followed by appropriately targeted treatment is critical, but lacking. Researchers note that there is lack of consensus among health care professionals on whether genetic testing is necessary.

Genetics are known to play a significant role in pathogenesis of GDD, but definitive biomarkers have been elusive.
 

Positive Detection Rate of 61%

In this study, the combined use of trio-WES with CNV-seq in children with early-stage GDD resulted in a positive detection rate of 61%, a significant improvement over performing individual tests, “enhancing the positive detection rate by 18%-40%,” the researchers wrote. The combined approach also saves families time and costs, they note, while leading to more comprehensive genetic analysis and fewer missed diagnoses.

The combined approach also addressed the limitations of trio-WES and CNV-seq used alone, the authors wrote. Because of technological constraints, trio-WES may miss 55% of CNV variations, and CNV-seq has a missed diagnosis rate of 3%.

The study included 434 patients with GDD (60% male; average age, 25 months) with diverse degrees of cognitive impairment: mild (23%); moderate (32%); severe (28%); and profound (17%).

Three characteristics were linked with higher likelihood of having genetic variants: Craniofacial abnormalities (odds ratio [OR], 2.27; 95% confidence interval [CI], 1.45-3.56); moderate or severe cognitive impairment (OR, 1.69; 95% CI, 1.05-2.70); and age between 12 and 24 months (OR, 1.57; 95% CI, 1.05-2.35).
 

Dopaminergic Pathway Promising for Treatment

Researchers also discovered that GDD-related genes were primarily enriched in lysosome, dopaminergic synapse, and lysine degradation pathways. Dopaminergic synapse emerged as a significant pathway linked with GDD.

“In this cohort study, our findings support the correlation between dopaminergic synapse and cognitive impairment, as substantiated by prior research and animal models. Therefore, targeting the dopaminergic pathway holds promise for treating GDD and ID,” the authors wrote.

However, the authors note in the limitations that they used only a subset of 100 patients with GDD to measure dopamine concentration.

“Expanding the sample size and conducting in vivo and in vitro experiments are necessary steps to verify whether dopamine can be targeted for clinical precision medical intervention in patients with GDD,” they wrote.

The authors reported no relevant financial relationships.

Using combined genetic testing in early childhood may decrease the misdiagnosis rate for Global Development Delay (GDD) and may help identify intervention targets, a new study suggests.

Researchers, led by Jiamei Zhang, MS, Department of Rehabilitation Medicine, Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China, in a multicenter, prospective cohort study enrolled patients ages 12 to 60 months with GDD from six centers in China from July 2020 through August 2023. Participants underwent trio whole exome sequencing (trio-WES) paired with copy number variation sequencing (CNV-seq).

“To the best of our knowledge, this study represents the largest prospective examination of combined genetic testing methods in a GDD cohort,” the authors reported in JAMA Network Open.

GDD is a common neurodevelopmental disorder, marked by cognitive impairment, and affects about 1% of children, the paper states. Most children with GDD develop intellectual disability (ID) after 5 years of age, with implications for quality of life, their physical abilities, and social functioning. Early and accurate diagnosis followed by appropriately targeted treatment is critical, but lacking. Researchers note that there is lack of consensus among health care professionals on whether genetic testing is necessary.

Genetics are known to play a significant role in pathogenesis of GDD, but definitive biomarkers have been elusive.
 

Positive Detection Rate of 61%

In this study, the combined use of trio-WES with CNV-seq in children with early-stage GDD resulted in a positive detection rate of 61%, a significant improvement over performing individual tests, “enhancing the positive detection rate by 18%-40%,” the researchers wrote. The combined approach also saves families time and costs, they note, while leading to more comprehensive genetic analysis and fewer missed diagnoses.

The combined approach also addressed the limitations of trio-WES and CNV-seq used alone, the authors wrote. Because of technological constraints, trio-WES may miss 55% of CNV variations, and CNV-seq has a missed diagnosis rate of 3%.

The study included 434 patients with GDD (60% male; average age, 25 months) with diverse degrees of cognitive impairment: mild (23%); moderate (32%); severe (28%); and profound (17%).

Three characteristics were linked with higher likelihood of having genetic variants: Craniofacial abnormalities (odds ratio [OR], 2.27; 95% confidence interval [CI], 1.45-3.56); moderate or severe cognitive impairment (OR, 1.69; 95% CI, 1.05-2.70); and age between 12 and 24 months (OR, 1.57; 95% CI, 1.05-2.35).
 

Dopaminergic Pathway Promising for Treatment

Researchers also discovered that GDD-related genes were primarily enriched in lysosome, dopaminergic synapse, and lysine degradation pathways. Dopaminergic synapse emerged as a significant pathway linked with GDD.

“In this cohort study, our findings support the correlation between dopaminergic synapse and cognitive impairment, as substantiated by prior research and animal models. Therefore, targeting the dopaminergic pathway holds promise for treating GDD and ID,” the authors wrote.

However, the authors note in the limitations that they used only a subset of 100 patients with GDD to measure dopamine concentration.

“Expanding the sample size and conducting in vivo and in vitro experiments are necessary steps to verify whether dopamine can be targeted for clinical precision medical intervention in patients with GDD,” they wrote.

The authors reported no relevant financial relationships.

Fewer than half (42%) of obstetricians/gynecologists in the latest Medscape survey said they were satisfied with their average $352,000/year pay, putting them in the bottom 20% of specialties for pay satisfaction.

The $352,000 listed in the Medscape Ob/Gyn Compensation Report 2024 put the specialty in the middle of physicians overall. Orthopedists made the most at $558,000, followed by plastic surgeons at $536,000. Endocrinologists/diabetes specialists made the least at $256,000.
 

Ob.Gyn. Pay Rose 4%

Ob.gyns.’ pay overall was up 4% this year and the specialty was one of 10 in the survey that saw an increase.

There were contrasts in satisfaction among the specialties: Public health and preventive medicine physicians had the highest rate of satisfaction with pay (65% were satisfied) though they made new the least among physicians ($263,000). Those least satisfied with their pay were infectious disease physicians with only 34% saying they were satisfied.

There was also a contrast between what ob.gyns. thought about all physicians’ pay and what they thought of their own pay. While 68% said they thought physicians were underpaid, only 58% said that about their own specialty.

Elizabeth Woodcock, a healthcare consultant with Woodcock and Associates in Atlanta, Georgia, said this may be a mindset of self-deprecation, where pay is concerned.

“I think their response is a function of their lens — ‘I feel fortunate to have a job, to care for my patients, to be paid for this work,’ ” Ms. Woodcock said in the survey report.
 

Most Billings, Most Pay

“As a rule of thumb, the specialists who generate the most gross billings to commercial payers are more likely to receive the highest compensation,” said Jeff Decker, president of AMN Healthcare’s physician solutions division.

Louise P. King, MD, JD, associate professor of obstetrics and gynecology at Harvard Medical School in Boston, said lower reimbursement for procedures drives her reimbursement as a gynecological surgeon.

“Ob.gyns. — who are primarily surgical and have the highest malpractice risks and costs of almost the entire profession — earn far less than other surgeons,” she said.

The reasons for that are complex, she said, but she explained in a commentary in Obstetrics and Gynecology that “insurers reimburse procedures for women at a lower rate than similar procedures for men, although there is no medically justifiable reason for this disparity.”

She says that doubly affects female gynecological surgeons, who make up a disproportionately high number of surgeons in the field and serve mostly female patients.
 

Implications for Patient Care

Lower reimbursement also has implications for patient care, she says. Lower reimbursement for gynecological surgeries pushes many obstetrics and gynecological surgeons to perform fewer surgeries and more obstetric services, “resulting in a high prevalence of low-volume gynecologic surgeons, a metric that is closely tied to higher complication rates,” said Dr. King.

She added that as a gynecological surgeon, because of the lower reimbursement for services, “I have less access to [operating room] time and supports like midlevel clinicians.”

Fifty-three percent of ob.gyns. reported they have a chance for an incentive bonus and the average was $40,000; this is compared with the highest bonuses — $142,000, which were for dermatologists, followed by orthopedists at $102,000.

Ob.gyns. were also asked about whether they supplemented their income with additional work and 39% this year, about the same percentage as last year, said they did. The percentage is similar to the number of physicians who say they supplement their income. In most cases, for all physicians, the outside work is usually within the medical field.

Ms. Woodcock, Mr. Decker, and Dr. King report no relevant financial disclosures.

Fewer than half (42%) of obstetricians/gynecologists in the latest Medscape survey said they were satisfied with their average $352,000/year pay, putting them in the bottom 20% of specialties for pay satisfaction.

The $352,000 listed in the Medscape Ob/Gyn Compensation Report 2024 put the specialty in the middle of physicians overall. Orthopedists made the most at $558,000, followed by plastic surgeons at $536,000. Endocrinologists/diabetes specialists made the least at $256,000.
 

Ob.Gyn. Pay Rose 4%

Ob.gyns.’ pay overall was up 4% this year and the specialty was one of 10 in the survey that saw an increase.

There were contrasts in satisfaction among the specialties: Public health and preventive medicine physicians had the highest rate of satisfaction with pay (65% were satisfied) though they made new the least among physicians ($263,000). Those least satisfied with their pay were infectious disease physicians with only 34% saying they were satisfied.

There was also a contrast between what ob.gyns. thought about all physicians’ pay and what they thought of their own pay. While 68% said they thought physicians were underpaid, only 58% said that about their own specialty.

Elizabeth Woodcock, a healthcare consultant with Woodcock and Associates in Atlanta, Georgia, said this may be a mindset of self-deprecation, where pay is concerned.

“I think their response is a function of their lens — ‘I feel fortunate to have a job, to care for my patients, to be paid for this work,’ ” Ms. Woodcock said in the survey report.
 

Most Billings, Most Pay

“As a rule of thumb, the specialists who generate the most gross billings to commercial payers are more likely to receive the highest compensation,” said Jeff Decker, president of AMN Healthcare’s physician solutions division.

Louise P. King, MD, JD, associate professor of obstetrics and gynecology at Harvard Medical School in Boston, said lower reimbursement for procedures drives her reimbursement as a gynecological surgeon.

“Ob.gyns. — who are primarily surgical and have the highest malpractice risks and costs of almost the entire profession — earn far less than other surgeons,” she said.

The reasons for that are complex, she said, but she explained in a commentary in Obstetrics and Gynecology that “insurers reimburse procedures for women at a lower rate than similar procedures for men, although there is no medically justifiable reason for this disparity.”

She says that doubly affects female gynecological surgeons, who make up a disproportionately high number of surgeons in the field and serve mostly female patients.
 

Implications for Patient Care

Lower reimbursement also has implications for patient care, she says. Lower reimbursement for gynecological surgeries pushes many obstetrics and gynecological surgeons to perform fewer surgeries and more obstetric services, “resulting in a high prevalence of low-volume gynecologic surgeons, a metric that is closely tied to higher complication rates,” said Dr. King.

She added that as a gynecological surgeon, because of the lower reimbursement for services, “I have less access to [operating room] time and supports like midlevel clinicians.”

Fifty-three percent of ob.gyns. reported they have a chance for an incentive bonus and the average was $40,000; this is compared with the highest bonuses — $142,000, which were for dermatologists, followed by orthopedists at $102,000.

Ob.gyns. were also asked about whether they supplemented their income with additional work and 39% this year, about the same percentage as last year, said they did. The percentage is similar to the number of physicians who say they supplement their income. In most cases, for all physicians, the outside work is usually within the medical field.

Ms. Woodcock, Mr. Decker, and Dr. King report no relevant financial disclosures.

Fewer than half (42%) of obstetricians/gynecologists in the latest Medscape survey said they were satisfied with their average $352,000/year pay, putting them in the bottom 20% of specialties for pay satisfaction.

The $352,000 listed in the Medscape Ob/Gyn Compensation Report 2024 put the specialty in the middle of physicians overall. Orthopedists made the most at $558,000, followed by plastic surgeons at $536,000. Endocrinologists/diabetes specialists made the least at $256,000.
 

Ob.Gyn. Pay Rose 4%

Ob.gyns.’ pay overall was up 4% this year and the specialty was one of 10 in the survey that saw an increase.

There were contrasts in satisfaction among the specialties: Public health and preventive medicine physicians had the highest rate of satisfaction with pay (65% were satisfied) though they made new the least among physicians ($263,000). Those least satisfied with their pay were infectious disease physicians with only 34% saying they were satisfied.

There was also a contrast between what ob.gyns. thought about all physicians’ pay and what they thought of their own pay. While 68% said they thought physicians were underpaid, only 58% said that about their own specialty.

Elizabeth Woodcock, a healthcare consultant with Woodcock and Associates in Atlanta, Georgia, said this may be a mindset of self-deprecation, where pay is concerned.

“I think their response is a function of their lens — ‘I feel fortunate to have a job, to care for my patients, to be paid for this work,’ ” Ms. Woodcock said in the survey report.
 

Most Billings, Most Pay

“As a rule of thumb, the specialists who generate the most gross billings to commercial payers are more likely to receive the highest compensation,” said Jeff Decker, president of AMN Healthcare’s physician solutions division.

Louise P. King, MD, JD, associate professor of obstetrics and gynecology at Harvard Medical School in Boston, said lower reimbursement for procedures drives her reimbursement as a gynecological surgeon.

“Ob.gyns. — who are primarily surgical and have the highest malpractice risks and costs of almost the entire profession — earn far less than other surgeons,” she said.

The reasons for that are complex, she said, but she explained in a commentary in Obstetrics and Gynecology that “insurers reimburse procedures for women at a lower rate than similar procedures for men, although there is no medically justifiable reason for this disparity.”

She says that doubly affects female gynecological surgeons, who make up a disproportionately high number of surgeons in the field and serve mostly female patients.
 

Implications for Patient Care

Lower reimbursement also has implications for patient care, she says. Lower reimbursement for gynecological surgeries pushes many obstetrics and gynecological surgeons to perform fewer surgeries and more obstetric services, “resulting in a high prevalence of low-volume gynecologic surgeons, a metric that is closely tied to higher complication rates,” said Dr. King.

She added that as a gynecological surgeon, because of the lower reimbursement for services, “I have less access to [operating room] time and supports like midlevel clinicians.”

Fifty-three percent of ob.gyns. reported they have a chance for an incentive bonus and the average was $40,000; this is compared with the highest bonuses — $142,000, which were for dermatologists, followed by orthopedists at $102,000.

Ob.gyns. were also asked about whether they supplemented their income with additional work and 39% this year, about the same percentage as last year, said they did. The percentage is similar to the number of physicians who say they supplement their income. In most cases, for all physicians, the outside work is usually within the medical field.

Ms. Woodcock, Mr. Decker, and Dr. King report no relevant financial disclosures.

About one in six children (17%) between 3 and 17 years have a disability, which may affect their ability to make decisions when they transition to adulthood.

Typically, at age 18, a young adult assumes rights such as the legal right to make medical decisions (including reproductive decisions), and mental health, financial, and education decisions.

The American Academy of Pediatrics (AAP) recently issued a policy statement in Pediatrics to help pediatricians help young people with Intellectual and/or Developmental Disabilities (IDD) and their families with alternative ways to make those decisions if necessary .
 

Several Options in the Continuum

The AAP describes a continuum of decision-making for youth with IDD from fully autonomous decisions to decisions made by an appointed guardian.

Highlighting an array of options is one way this paper is helpful, said Matthew Siegel, MD, chief of clinical enterprise with the Department of Psychiatry & Behavioral Sciences at Boston Children’s Hospital in Massachusetts. “I suspect that for a lot of practitioners what they’re aware of is guardianship or no guardianship.” These authors highlight that the options are more nuanced, he said.

Pediatricians have widely different ideas about what their role should be in facilitating decision-making in the transition period, he said, so this paper helps clarify what advocacy and discussion are needed.

The paper, written by first author Renee M. Turchi, MD, MPH, and colleagues on behalf of the Council on Children with Disabilities’ Committee on Medical Liability and Risk Management, states that, “The goal should always be the least restrictive decision-making that balances autonomy with safety and supports.”
 

One Alternative Is Supported Decision-Making

Supported decision-making is one alternative to guardianship. Authors explain that under that framework, a patient can choose a trusted support person and create an agreement with that person on what kinds of decisions the person needs help with and how much assistance is needed. The individual makes the final decision, not the support person.

Authors explain the benefits of that approach: “Individuals with IDD who use supported decision-making report increased confidence in themselves and their decision-making, improved decision-making skills, increased engagement with their community, and perceived more control of their lives,” the authors wrote.

Another option for people with IDD might be, rather than formally naming a substitute decision-maker, allowing a parent or caregiver access to their electronic health record or allowing that person to have independent discussions with their physician.

With guardianship, also called conservatorship in some states, a court requires clear and convincing evidence that the youth is not competent to make his or her own decisions. The court may order evaluations by many professionals, including pediatricians.
 

State-Specific Legal Information Is Available

Many states have recently enacted laws surrounding supported decision-making and guardianship. The authors reference a national resource center website that details the legislation for each state and points to resources and tools for pediatricians, families, and patients.

“Historically, pediatricians have rarely discussed the legal aspects of transition to adult-oriented services with the youth with IDD and subsequently, their families,” the authors wrote.
 

Discussions Should Start Early

Ideally, the authors wrote, the discussions about what level of supports might be necessary in the transition to adulthood should start at age 12-14 and include the youth, teachers, parents, and the medical team.

That’s earlier than some of the previous guidance, Dr. Siegel said, and it will be important to evaluate future evidence on the best age to start planning “both from a cognitive development standpoint and from a practicality standpoint.”

The authors point out that the needs for level of support may change and “pediatricians can reevaluate the decision-making arrangement as part of the annual physical/mental examinations to align with the youth’s desires, needs, and decision-making abilities over time.”

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

About one in six children (17%) between 3 and 17 years have a disability, which may affect their ability to make decisions when they transition to adulthood.

Typically, at age 18, a young adult assumes rights such as the legal right to make medical decisions (including reproductive decisions), and mental health, financial, and education decisions.

The American Academy of Pediatrics (AAP) recently issued a policy statement in Pediatrics to help pediatricians help young people with Intellectual and/or Developmental Disabilities (IDD) and their families with alternative ways to make those decisions if necessary .
 

Several Options in the Continuum

The AAP describes a continuum of decision-making for youth with IDD from fully autonomous decisions to decisions made by an appointed guardian.

Highlighting an array of options is one way this paper is helpful, said Matthew Siegel, MD, chief of clinical enterprise with the Department of Psychiatry & Behavioral Sciences at Boston Children’s Hospital in Massachusetts. “I suspect that for a lot of practitioners what they’re aware of is guardianship or no guardianship.” These authors highlight that the options are more nuanced, he said.

Pediatricians have widely different ideas about what their role should be in facilitating decision-making in the transition period, he said, so this paper helps clarify what advocacy and discussion are needed.

The paper, written by first author Renee M. Turchi, MD, MPH, and colleagues on behalf of the Council on Children with Disabilities’ Committee on Medical Liability and Risk Management, states that, “The goal should always be the least restrictive decision-making that balances autonomy with safety and supports.”
 

One Alternative Is Supported Decision-Making

Supported decision-making is one alternative to guardianship. Authors explain that under that framework, a patient can choose a trusted support person and create an agreement with that person on what kinds of decisions the person needs help with and how much assistance is needed. The individual makes the final decision, not the support person.

Authors explain the benefits of that approach: “Individuals with IDD who use supported decision-making report increased confidence in themselves and their decision-making, improved decision-making skills, increased engagement with their community, and perceived more control of their lives,” the authors wrote.

Another option for people with IDD might be, rather than formally naming a substitute decision-maker, allowing a parent or caregiver access to their electronic health record or allowing that person to have independent discussions with their physician.

With guardianship, also called conservatorship in some states, a court requires clear and convincing evidence that the youth is not competent to make his or her own decisions. The court may order evaluations by many professionals, including pediatricians.
 

State-Specific Legal Information Is Available

Many states have recently enacted laws surrounding supported decision-making and guardianship. The authors reference a national resource center website that details the legislation for each state and points to resources and tools for pediatricians, families, and patients.

“Historically, pediatricians have rarely discussed the legal aspects of transition to adult-oriented services with the youth with IDD and subsequently, their families,” the authors wrote.
 

Discussions Should Start Early

Ideally, the authors wrote, the discussions about what level of supports might be necessary in the transition to adulthood should start at age 12-14 and include the youth, teachers, parents, and the medical team.

That’s earlier than some of the previous guidance, Dr. Siegel said, and it will be important to evaluate future evidence on the best age to start planning “both from a cognitive development standpoint and from a practicality standpoint.”

The authors point out that the needs for level of support may change and “pediatricians can reevaluate the decision-making arrangement as part of the annual physical/mental examinations to align with the youth’s desires, needs, and decision-making abilities over time.”

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

About one in six children (17%) between 3 and 17 years have a disability, which may affect their ability to make decisions when they transition to adulthood.

Typically, at age 18, a young adult assumes rights such as the legal right to make medical decisions (including reproductive decisions), and mental health, financial, and education decisions.

The American Academy of Pediatrics (AAP) recently issued a policy statement in Pediatrics to help pediatricians help young people with Intellectual and/or Developmental Disabilities (IDD) and their families with alternative ways to make those decisions if necessary .
 

Several Options in the Continuum

The AAP describes a continuum of decision-making for youth with IDD from fully autonomous decisions to decisions made by an appointed guardian.

Highlighting an array of options is one way this paper is helpful, said Matthew Siegel, MD, chief of clinical enterprise with the Department of Psychiatry & Behavioral Sciences at Boston Children’s Hospital in Massachusetts. “I suspect that for a lot of practitioners what they’re aware of is guardianship or no guardianship.” These authors highlight that the options are more nuanced, he said.

Pediatricians have widely different ideas about what their role should be in facilitating decision-making in the transition period, he said, so this paper helps clarify what advocacy and discussion are needed.

The paper, written by first author Renee M. Turchi, MD, MPH, and colleagues on behalf of the Council on Children with Disabilities’ Committee on Medical Liability and Risk Management, states that, “The goal should always be the least restrictive decision-making that balances autonomy with safety and supports.”
 

One Alternative Is Supported Decision-Making

Supported decision-making is one alternative to guardianship. Authors explain that under that framework, a patient can choose a trusted support person and create an agreement with that person on what kinds of decisions the person needs help with and how much assistance is needed. The individual makes the final decision, not the support person.

Authors explain the benefits of that approach: “Individuals with IDD who use supported decision-making report increased confidence in themselves and their decision-making, improved decision-making skills, increased engagement with their community, and perceived more control of their lives,” the authors wrote.

Another option for people with IDD might be, rather than formally naming a substitute decision-maker, allowing a parent or caregiver access to their electronic health record or allowing that person to have independent discussions with their physician.

With guardianship, also called conservatorship in some states, a court requires clear and convincing evidence that the youth is not competent to make his or her own decisions. The court may order evaluations by many professionals, including pediatricians.
 

State-Specific Legal Information Is Available

Many states have recently enacted laws surrounding supported decision-making and guardianship. The authors reference a national resource center website that details the legislation for each state and points to resources and tools for pediatricians, families, and patients.

“Historically, pediatricians have rarely discussed the legal aspects of transition to adult-oriented services with the youth with IDD and subsequently, their families,” the authors wrote.
 

Discussions Should Start Early

Ideally, the authors wrote, the discussions about what level of supports might be necessary in the transition to adulthood should start at age 12-14 and include the youth, teachers, parents, and the medical team.

That’s earlier than some of the previous guidance, Dr. Siegel said, and it will be important to evaluate future evidence on the best age to start planning “both from a cognitive development standpoint and from a practicality standpoint.”

The authors point out that the needs for level of support may change and “pediatricians can reevaluate the decision-making arrangement as part of the annual physical/mental examinations to align with the youth’s desires, needs, and decision-making abilities over time.”

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

Patients at least 75 years old saw a reduced risk of overall cardiovascular incidence with statin therapy without increased risk of severe adverse effects in a study published in Annals of Internal Medicine.

“Of note, the benefits and safety of statin therapy were consistently found in adults aged 85 years or older,” wrote the authors, led by Wanchun Xu, a PhD student with the Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, in the Special Administrative Region, China.

Geriatrician Jerry H. Gurwitz, MD, the Dr. John Meyers Professor in Primary Care Medicine at UMass Chan Medical School in Boston, said he found the results of this trial “remarkable,” but is awaiting the results of the much-anticipated randomized, controlled PREVENTABLE trial years from now for more definitive evidence.
 

Little Consensus on Statins for This Age Group

Prescribing statins for primary prevention of CVD in the most senior patient groups has been controversial. There is little consensus as patients in this age group have been underrepresented in randomized controlled trials.

Major guidelines for use of statins in the primary prevention of CVD, including the US Preventive Services Task Force, exclude specific guidance for statin use in patients older than 75, citing insufficient evidence.

Ms. Xu and colleagues used territory-wide electronic health records in a sequential target trial emulation comparing matched cohorts that did or did not start statins. There were 42,680 matched person-trials in the group of patients aged 75-84 years and 5,390 matched person-trials in the 85 and older group. The average follow-up was 5.3 years and people with CVDs at baseline, such as coronary heart disease, were excluded. Patients who met indications for statin initiation from January 2008 to December 2015 were included.

Risk Reduction Seen in Both Senior Groups

Of the 42,680 matched person-trials in the 75-84 age group, 9676 developed cardiovascular disease; of the 5390 in the 85-plus group, 1600 developed CVD.

In the younger cohort, the 5-year reduced risk for overall CVD incidence when statin therapy was initiated was 1.20% (95% CI, 0.57%-1.82%) in the intention-to-treat (ITT) analysis; 5.00% (95% CI, 1.11%-8.89%) in the per protocol (PP) analysis.

Reduced risk for overall CVD incidence in the 85-and-older group when statins were initiated was 4.44% in the ITT analysis (95% CI, 1.40%-7.48%); and 12.50% in the PP analysis (95% CI, 4.33%-20.66%). There was no significantly increased risk for liver dysfunction or myopathies in either age group, the authors stated.

One of the biggest strengths of the study is the use of population-based data over a long period. One of the limitations was that the researchers were not able to measure lifestyle factors such as diet and physical activity in their analysis.

Dr. Gurwitz, who has done drug research in older adults for decades, said “the results are very compelling,” and in the oldest group “almost too compelling. Wow.”

Numbers Needed to Treat Are Strikingly Low

He noted that the authors thoroughly acknowledge limitations of the trial. But he also pointed to the impressive number needed to treat reported by the researchers.

The authors stated: “[O]n the basis of the estimated absolute risk reduction in the PP analysis, the number needed to treat [NNT] to prevent 1 CVD event in 5 years was 20 (95% CI, 11-90) in those aged 75-84 years and 8 (95% CI, 5-23) in those aged 85 years or older.”

For perspective, he said, “Sometimes you’re seeing numbers needed to treat for vaccinations of 400 to prevent one hospitalization. They are using real-world information and they are seeing this remarkable effect. If it’s that good in the real world, it’s going to be even better in a clinical trial. That’s why I have some reservations about whether it’s really that good.”

Dr. Gurwitz said, “I’m not ready to start an 87-year-old on statin therapy who hasn’t been on it before for primary prevention, despite the results of this very well done study.” He will await the findings of PREVENTABLE, which aims to enroll 20,000 people at least 75 years old to look at statin use. But in the meantime, he will discuss the Xu et al. results and other evidence with patients if they request statins and may prescribe them as part of shared decision making.

He said the question of whether to use statins in primary prevention is similar to the question of whether to use aspirin as primary prevention for CVD in older adults.

Originally, “Most of us thought, yes, it’s probably a good thing,” he said, but now “there have been a lot of deprescribing efforts to get older people off of aspirin.

“In the United States, believe it or not, 48% of people 75 and older are on statins already,” Dr. Gurwitz said. “Maybe that’s good,” he said, but added physicians won’t know for sure until PREVENTABLE results are in.

“If I didn’t already know the PREVENTABLE trial was going on, and it was never going to happen, I would find this [Xu et al. study] very influential,” Dr. Gurwitz said. “I’m willing to wait.”

The study was funded by the Health and Medical Research Fund, Health Bureau, the Government of Hong Kong Special Administrative Region, China, and the National Natural Science Foundation of China. Coauthors reported grants from the Kerry Group Kuok Foundation, the Malaysian College of Family Physicians, and the International Association of Chinese Nephrologists in Hong Kong. Dr. Gurwitz reported no relevant financial relationships.

Patients at least 75 years old saw a reduced risk of overall cardiovascular incidence with statin therapy without increased risk of severe adverse effects in a study published in Annals of Internal Medicine.

“Of note, the benefits and safety of statin therapy were consistently found in adults aged 85 years or older,” wrote the authors, led by Wanchun Xu, a PhD student with the Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, in the Special Administrative Region, China.

Geriatrician Jerry H. Gurwitz, MD, the Dr. John Meyers Professor in Primary Care Medicine at UMass Chan Medical School in Boston, said he found the results of this trial “remarkable,” but is awaiting the results of the much-anticipated randomized, controlled PREVENTABLE trial years from now for more definitive evidence.
 

Little Consensus on Statins for This Age Group

Prescribing statins for primary prevention of CVD in the most senior patient groups has been controversial. There is little consensus as patients in this age group have been underrepresented in randomized controlled trials.

Major guidelines for use of statins in the primary prevention of CVD, including the US Preventive Services Task Force, exclude specific guidance for statin use in patients older than 75, citing insufficient evidence.

Ms. Xu and colleagues used territory-wide electronic health records in a sequential target trial emulation comparing matched cohorts that did or did not start statins. There were 42,680 matched person-trials in the group of patients aged 75-84 years and 5,390 matched person-trials in the 85 and older group. The average follow-up was 5.3 years and people with CVDs at baseline, such as coronary heart disease, were excluded. Patients who met indications for statin initiation from January 2008 to December 2015 were included.

Risk Reduction Seen in Both Senior Groups

Of the 42,680 matched person-trials in the 75-84 age group, 9676 developed cardiovascular disease; of the 5390 in the 85-plus group, 1600 developed CVD.

In the younger cohort, the 5-year reduced risk for overall CVD incidence when statin therapy was initiated was 1.20% (95% CI, 0.57%-1.82%) in the intention-to-treat (ITT) analysis; 5.00% (95% CI, 1.11%-8.89%) in the per protocol (PP) analysis.

Reduced risk for overall CVD incidence in the 85-and-older group when statins were initiated was 4.44% in the ITT analysis (95% CI, 1.40%-7.48%); and 12.50% in the PP analysis (95% CI, 4.33%-20.66%). There was no significantly increased risk for liver dysfunction or myopathies in either age group, the authors stated.

One of the biggest strengths of the study is the use of population-based data over a long period. One of the limitations was that the researchers were not able to measure lifestyle factors such as diet and physical activity in their analysis.

Dr. Gurwitz, who has done drug research in older adults for decades, said “the results are very compelling,” and in the oldest group “almost too compelling. Wow.”

Numbers Needed to Treat Are Strikingly Low

He noted that the authors thoroughly acknowledge limitations of the trial. But he also pointed to the impressive number needed to treat reported by the researchers.

The authors stated: “[O]n the basis of the estimated absolute risk reduction in the PP analysis, the number needed to treat [NNT] to prevent 1 CVD event in 5 years was 20 (95% CI, 11-90) in those aged 75-84 years and 8 (95% CI, 5-23) in those aged 85 years or older.”

For perspective, he said, “Sometimes you’re seeing numbers needed to treat for vaccinations of 400 to prevent one hospitalization. They are using real-world information and they are seeing this remarkable effect. If it’s that good in the real world, it’s going to be even better in a clinical trial. That’s why I have some reservations about whether it’s really that good.”

Dr. Gurwitz said, “I’m not ready to start an 87-year-old on statin therapy who hasn’t been on it before for primary prevention, despite the results of this very well done study.” He will await the findings of PREVENTABLE, which aims to enroll 20,000 people at least 75 years old to look at statin use. But in the meantime, he will discuss the Xu et al. results and other evidence with patients if they request statins and may prescribe them as part of shared decision making.

He said the question of whether to use statins in primary prevention is similar to the question of whether to use aspirin as primary prevention for CVD in older adults.

Originally, “Most of us thought, yes, it’s probably a good thing,” he said, but now “there have been a lot of deprescribing efforts to get older people off of aspirin.

“In the United States, believe it or not, 48% of people 75 and older are on statins already,” Dr. Gurwitz said. “Maybe that’s good,” he said, but added physicians won’t know for sure until PREVENTABLE results are in.

“If I didn’t already know the PREVENTABLE trial was going on, and it was never going to happen, I would find this [Xu et al. study] very influential,” Dr. Gurwitz said. “I’m willing to wait.”

The study was funded by the Health and Medical Research Fund, Health Bureau, the Government of Hong Kong Special Administrative Region, China, and the National Natural Science Foundation of China. Coauthors reported grants from the Kerry Group Kuok Foundation, the Malaysian College of Family Physicians, and the International Association of Chinese Nephrologists in Hong Kong. Dr. Gurwitz reported no relevant financial relationships.

Patients at least 75 years old saw a reduced risk of overall cardiovascular incidence with statin therapy without increased risk of severe adverse effects in a study published in Annals of Internal Medicine.

“Of note, the benefits and safety of statin therapy were consistently found in adults aged 85 years or older,” wrote the authors, led by Wanchun Xu, a PhD student with the Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, in the Special Administrative Region, China.

Geriatrician Jerry H. Gurwitz, MD, the Dr. John Meyers Professor in Primary Care Medicine at UMass Chan Medical School in Boston, said he found the results of this trial “remarkable,” but is awaiting the results of the much-anticipated randomized, controlled PREVENTABLE trial years from now for more definitive evidence.
 

Little Consensus on Statins for This Age Group

Prescribing statins for primary prevention of CVD in the most senior patient groups has been controversial. There is little consensus as patients in this age group have been underrepresented in randomized controlled trials.

Major guidelines for use of statins in the primary prevention of CVD, including the US Preventive Services Task Force, exclude specific guidance for statin use in patients older than 75, citing insufficient evidence.

Ms. Xu and colleagues used territory-wide electronic health records in a sequential target trial emulation comparing matched cohorts that did or did not start statins. There were 42,680 matched person-trials in the group of patients aged 75-84 years and 5,390 matched person-trials in the 85 and older group. The average follow-up was 5.3 years and people with CVDs at baseline, such as coronary heart disease, were excluded. Patients who met indications for statin initiation from January 2008 to December 2015 were included.

Risk Reduction Seen in Both Senior Groups

Of the 42,680 matched person-trials in the 75-84 age group, 9676 developed cardiovascular disease; of the 5390 in the 85-plus group, 1600 developed CVD.

In the younger cohort, the 5-year reduced risk for overall CVD incidence when statin therapy was initiated was 1.20% (95% CI, 0.57%-1.82%) in the intention-to-treat (ITT) analysis; 5.00% (95% CI, 1.11%-8.89%) in the per protocol (PP) analysis.

Reduced risk for overall CVD incidence in the 85-and-older group when statins were initiated was 4.44% in the ITT analysis (95% CI, 1.40%-7.48%); and 12.50% in the PP analysis (95% CI, 4.33%-20.66%). There was no significantly increased risk for liver dysfunction or myopathies in either age group, the authors stated.

One of the biggest strengths of the study is the use of population-based data over a long period. One of the limitations was that the researchers were not able to measure lifestyle factors such as diet and physical activity in their analysis.

Dr. Gurwitz, who has done drug research in older adults for decades, said “the results are very compelling,” and in the oldest group “almost too compelling. Wow.”

Numbers Needed to Treat Are Strikingly Low

He noted that the authors thoroughly acknowledge limitations of the trial. But he also pointed to the impressive number needed to treat reported by the researchers.

The authors stated: “[O]n the basis of the estimated absolute risk reduction in the PP analysis, the number needed to treat [NNT] to prevent 1 CVD event in 5 years was 20 (95% CI, 11-90) in those aged 75-84 years and 8 (95% CI, 5-23) in those aged 85 years or older.”

For perspective, he said, “Sometimes you’re seeing numbers needed to treat for vaccinations of 400 to prevent one hospitalization. They are using real-world information and they are seeing this remarkable effect. If it’s that good in the real world, it’s going to be even better in a clinical trial. That’s why I have some reservations about whether it’s really that good.”

Dr. Gurwitz said, “I’m not ready to start an 87-year-old on statin therapy who hasn’t been on it before for primary prevention, despite the results of this very well done study.” He will await the findings of PREVENTABLE, which aims to enroll 20,000 people at least 75 years old to look at statin use. But in the meantime, he will discuss the Xu et al. results and other evidence with patients if they request statins and may prescribe them as part of shared decision making.

He said the question of whether to use statins in primary prevention is similar to the question of whether to use aspirin as primary prevention for CVD in older adults.

Originally, “Most of us thought, yes, it’s probably a good thing,” he said, but now “there have been a lot of deprescribing efforts to get older people off of aspirin.

“In the United States, believe it or not, 48% of people 75 and older are on statins already,” Dr. Gurwitz said. “Maybe that’s good,” he said, but added physicians won’t know for sure until PREVENTABLE results are in.

“If I didn’t already know the PREVENTABLE trial was going on, and it was never going to happen, I would find this [Xu et al. study] very influential,” Dr. Gurwitz said. “I’m willing to wait.”

The study was funded by the Health and Medical Research Fund, Health Bureau, the Government of Hong Kong Special Administrative Region, China, and the National Natural Science Foundation of China. Coauthors reported grants from the Kerry Group Kuok Foundation, the Malaysian College of Family Physicians, and the International Association of Chinese Nephrologists in Hong Kong. Dr. Gurwitz reported no relevant financial relationships.