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AURORA, COLO. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.

The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.

You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?

This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.

“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”

When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.

“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”

Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.

“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
 

Starting point

Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.

“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”

Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.

Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.

Women who experience preeclampsia have two to four times the risk for coronary heart disease.

Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
 

More questions

Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.

Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.

“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.

Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.

She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
 

Follow-up care

“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”

For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.

Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.

“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”

No relevant financial relationships were reported.

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

AURORA, COLO. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.

The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.

You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?

This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.

“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”

When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.

“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”

Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.

“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
 

Starting point

Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.

“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”

Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.

Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.

Women who experience preeclampsia have two to four times the risk for coronary heart disease.

Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
 

More questions

Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.

Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.

“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.

Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.

She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
 

Follow-up care

“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”

For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.

Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.

“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”

No relevant financial relationships were reported.

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

AURORA, COLO. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.

The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.

You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?

This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.

“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”

When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.

“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”

Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.

“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
 

Starting point

Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.

“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”

Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.

Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.

Women who experience preeclampsia have two to four times the risk for coronary heart disease.

Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
 

More questions

Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.

Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.

“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.

Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.

She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
 

Follow-up care

“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”

For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.

Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.

“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”

No relevant financial relationships were reported.

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

Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.

“The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), said in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”

As of early May, there were 15 oncology drugs on the official Food and Drug Administration drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.

Factors blamed for the current shortages include expanded demand, supply shortages, limited manufacturing capacity, and low profit margins for generic therapies.

Dr. Knudsen emphasized that several of the oncology drugs now in short supply do not have an effective alternative. “As first-line treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer, and leukemia often experienced by pediatric cancer patients, the shortage could lead to delays in treatment that could result in worse outcomes,” she said.

The ACS has listed the following oncology drugs and supportive agents as being in short supply: carboplatin injection used to treat triple negative breast cancer, ovarian, head, and neck cancers; fludarabine phosphate injection used for treating B-cell chronic lymphocytic leukemia; dacarbazine injection for treatment of skin cancer; amifostine injection; azacitidine injection; capecitabine tablets; cisplatin injection; cytarabine injection; dexamethasone sodium phosphate injection; hydrocortisone sodium succinate injection; leucovorin calcium lyophilized powder for injection; Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) injection; methotrexate injection; pentostatin injection; and streptozocin (Zanosar) sterile powder.

Many of these drugs, such as cisplatin, are used in multiple regimens, so the issue is not limited to one specific cancer type.

In addition to these drugs, many products used in cancer care such as intravenous saline solutions are also in short supply, the ACS noted.
 

Two decades of shortages

Drug shortages in the United States have been a chronic problem for more than 2 decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.

The report further noted that the first quarter of 2023 marked the highest number of ongoing shortages by quarter since early 2018, with 301 active shortages as of March 31. For some drugs, the problem has become chronic, as more than 15 critical drug products have been in short supply for more than a decade, and 20 have been in shortage since at least 2015.

A 2022 survey of oncology pharmacists at 68 organizations nationwide showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

Dr. Knudsen noted that the FDA is largely limited to working directly with the manufacturer on whatever issue is causing the shortage, as well as working with other manufacturers of the same product to urge them to ramp up production. 

“ACS CAN is urging Congress to look at longer-term solutions that change the fundamental underpinnings of the shortages,” she said. “In the meantime, we urge the industry to work with medical practitioners to help identify alternatives where possible to ensure that cancer patients’ treatments are not delayed.”
 

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

Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.

“The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), said in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”

As of early May, there were 15 oncology drugs on the official Food and Drug Administration drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.

Factors blamed for the current shortages include expanded demand, supply shortages, limited manufacturing capacity, and low profit margins for generic therapies.

Dr. Knudsen emphasized that several of the oncology drugs now in short supply do not have an effective alternative. “As first-line treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer, and leukemia often experienced by pediatric cancer patients, the shortage could lead to delays in treatment that could result in worse outcomes,” she said.

The ACS has listed the following oncology drugs and supportive agents as being in short supply: carboplatin injection used to treat triple negative breast cancer, ovarian, head, and neck cancers; fludarabine phosphate injection used for treating B-cell chronic lymphocytic leukemia; dacarbazine injection for treatment of skin cancer; amifostine injection; azacitidine injection; capecitabine tablets; cisplatin injection; cytarabine injection; dexamethasone sodium phosphate injection; hydrocortisone sodium succinate injection; leucovorin calcium lyophilized powder for injection; Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) injection; methotrexate injection; pentostatin injection; and streptozocin (Zanosar) sterile powder.

Many of these drugs, such as cisplatin, are used in multiple regimens, so the issue is not limited to one specific cancer type.

In addition to these drugs, many products used in cancer care such as intravenous saline solutions are also in short supply, the ACS noted.
 

Two decades of shortages

Drug shortages in the United States have been a chronic problem for more than 2 decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.

The report further noted that the first quarter of 2023 marked the highest number of ongoing shortages by quarter since early 2018, with 301 active shortages as of March 31. For some drugs, the problem has become chronic, as more than 15 critical drug products have been in short supply for more than a decade, and 20 have been in shortage since at least 2015.

A 2022 survey of oncology pharmacists at 68 organizations nationwide showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

Dr. Knudsen noted that the FDA is largely limited to working directly with the manufacturer on whatever issue is causing the shortage, as well as working with other manufacturers of the same product to urge them to ramp up production. 

“ACS CAN is urging Congress to look at longer-term solutions that change the fundamental underpinnings of the shortages,” she said. “In the meantime, we urge the industry to work with medical practitioners to help identify alternatives where possible to ensure that cancer patients’ treatments are not delayed.”
 

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

Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.

“The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), said in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”

As of early May, there were 15 oncology drugs on the official Food and Drug Administration drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.

Factors blamed for the current shortages include expanded demand, supply shortages, limited manufacturing capacity, and low profit margins for generic therapies.

Dr. Knudsen emphasized that several of the oncology drugs now in short supply do not have an effective alternative. “As first-line treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer, and leukemia often experienced by pediatric cancer patients, the shortage could lead to delays in treatment that could result in worse outcomes,” she said.

The ACS has listed the following oncology drugs and supportive agents as being in short supply: carboplatin injection used to treat triple negative breast cancer, ovarian, head, and neck cancers; fludarabine phosphate injection used for treating B-cell chronic lymphocytic leukemia; dacarbazine injection for treatment of skin cancer; amifostine injection; azacitidine injection; capecitabine tablets; cisplatin injection; cytarabine injection; dexamethasone sodium phosphate injection; hydrocortisone sodium succinate injection; leucovorin calcium lyophilized powder for injection; Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) injection; methotrexate injection; pentostatin injection; and streptozocin (Zanosar) sterile powder.

Many of these drugs, such as cisplatin, are used in multiple regimens, so the issue is not limited to one specific cancer type.

In addition to these drugs, many products used in cancer care such as intravenous saline solutions are also in short supply, the ACS noted.
 

Two decades of shortages

Drug shortages in the United States have been a chronic problem for more than 2 decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.

The report further noted that the first quarter of 2023 marked the highest number of ongoing shortages by quarter since early 2018, with 301 active shortages as of March 31. For some drugs, the problem has become chronic, as more than 15 critical drug products have been in short supply for more than a decade, and 20 have been in shortage since at least 2015.

A 2022 survey of oncology pharmacists at 68 organizations nationwide showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

Dr. Knudsen noted that the FDA is largely limited to working directly with the manufacturer on whatever issue is causing the shortage, as well as working with other manufacturers of the same product to urge them to ramp up production. 

“ACS CAN is urging Congress to look at longer-term solutions that change the fundamental underpinnings of the shortages,” she said. “In the meantime, we urge the industry to work with medical practitioners to help identify alternatives where possible to ensure that cancer patients’ treatments are not delayed.”
 

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

The American Academy of Physical Medicine and Rehabilitation (AAPM&R) has issued new consensus guidance on the assessment and treatment of neurologic sequelae in patients with long COVID, also known as postacute sequelae of SARS-CoV-2 infection (PASC).

The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.

Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.

Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.

“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.

According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.

“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.

Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.

The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.

She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”

Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.

While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.

The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.

Experts also recommend clinicians do the following:

• Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
• Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
• Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
• Work with physical, occupational, and speech therapists to increase function and independence.
• Refer patients to counseling and community resources for risk factor modification.

The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.

The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.

“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”

The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.

The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.

For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.

The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
 

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

The American Academy of Physical Medicine and Rehabilitation (AAPM&R) has issued new consensus guidance on the assessment and treatment of neurologic sequelae in patients with long COVID, also known as postacute sequelae of SARS-CoV-2 infection (PASC).

The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.

Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.

Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.

“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.

According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.

“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.

Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.

The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.

She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”

Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.

While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.

The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.

Experts also recommend clinicians do the following:

• Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
• Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
• Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
• Work with physical, occupational, and speech therapists to increase function and independence.
• Refer patients to counseling and community resources for risk factor modification.

The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.

The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.

“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”

The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.

The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.

For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.

The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
 

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

The American Academy of Physical Medicine and Rehabilitation (AAPM&R) has issued new consensus guidance on the assessment and treatment of neurologic sequelae in patients with long COVID, also known as postacute sequelae of SARS-CoV-2 infection (PASC).

The new recommendations, which were published online in Physical Medicine & Rehabilitation, are the result of a collaboration between experts from a variety of medical specialties at 41 long COVID clinics across the United States.

Because physical medicine specialists treat individuals with disability and functional impairments, the AAPM&R was among the first organizations to initiate guidance for the assessment and treatment of long COVID and issued its first consensus statement that addressed long COVID–related fatigue in 2021.

Even though the number of COVID cases and hospitalizations has declined from the peak, long COVID continues to be a major public health issue, Steven R. Flanagan, MD, AAPM&R president-elect and Howard A. Rusk Professor of Rehabilitation Medicine at NYU Langone Health, New York, told reporters attending a press briefing.

“There is some evidence that some of the antivirals may actually help reduce the incidence but not everybody gets them,” said Dr. Flanagan. “In our own clinic here, we continue to see many, many people with problems associated with long COVID,” he added.

According to the consensus guidelines, about 80% of patients hospitalized with acute COVID-19 have neurological symptoms. But these symptoms are not just limited to people who had severe illness, said Leslie Rydberg, MD, coauthor of the neurology long COVID guidance statement.

“What we know is that many people with mild or moderate COVID infection end up with neurologic sequelae that last longer than 4 weeks,” said Dr. Rydberg, the Henry and Monika Betts Medical Student Education Chair and assistant residency program director at Shirley Ryan AbilityLab, Chicago.

Dr. Rydberg added that patients who have symptoms for longer than a month after the initial infection should be evaluated. Although the definition of what constitutes PASC is evolving, the guidance states that the literature indicates that it should be defined as the persistence of symptoms 4 weeks beyond the initial infection.

The most common neurological symptoms are headache, weakness, muscular pain, nerve pain, tremors, peripheral nerve issues, sleep issues, and cognitive effects, Dr. Rydberg told reporters.

She added that “identifying patients with progressive or ominous ‘red flag’ neurological symptoms is essential for emergent triaging.”

Among the red flags are sudden or progressive weakness or sudden or progressive sensory changes, because those could indicate an acute neurologic condition – either due to long COVID or other illnesses – such as a stroke or a problem with the spinal cord, Guillain-Barré syndrome, or myopathy.

While those signs and symptoms would likely be flagged by most clinicians, some of the emergent or urgent signs – such as upper motor neuron changes on physical exam – are more subtle, said Dr. Rydberg.

The new guidance spells out steps for initial evaluation, including identification of red flag symptoms, and also provides treatment recommendations.

Experts also recommend clinicians do the following:

• Treat underlying medical conditions such as pain, psychiatric, cardiovascular, respiratory, and other conditions that may be contributing to neurologic symptoms.
• Consider polypharmacy reduction, looking especially closely at medications with a known impact on neurologic symptoms.
• Urge patients to get regular physical activity, as tolerated, while avoiding overuse syndrome.
• Work with physical, occupational, and speech therapists to increase function and independence.
• Refer patients to counseling and community resources for risk factor modification.

The treatment recommendations are more in-depth for specific long-COVID conditions including headache, cranial neuropathies, sleep disturbances, and neuropathies.

The guidance includes a special statement on the importance of ensuring equitable access to care. Underserved, marginalized, and socioeconomically disadvantaged communities had notably higher rates of infection, hospitalization, and death with less access to rehabilitation services before the pandemic, said Monica Verduzco-Gutierrez, MD, chair of the department of rehabilitation medicine at Long School of Medicine, UT Health San Antonio, and a guideline coauthor.

“We know that these communities have been historically underserved, that there’s already access issues, and that they’re disproportionately impacted by the pandemic,” said Dr. Verduzco-Gutierrez. “This continues as patients develop PASC, or long COVID,” she said, adding that these individuals are still less likely to receive rehabilitation services. “This can lead to poorer outcomes and widened disparities.”

The AAPM&R PASC Multi-Disciplinary Collaborative has previously issued consensus guidance on fatigue, breathing discomfort and respiratory distress, cognitive symptoms, cardiovascular complications, pediatrics, and autonomic dysfunction, and will be publishing guidance on mental health soon.

The collaborative is also putting together a compilation of all the guidance – “a ‘greatest hits’ if you like,” said Dr. Verduzco-Gutierrez.

For clinicians who are unaccustomed to caring for patients with long COVID, the hope is that this new guidance will help them manage the condition, Dr. Rydberg said.

The guidance was written with the support of the AAPM&R. Dr. Verduzco-Gutierrez and two coauthors have disclosed grants, contracts, or honoraria from various funding sources, some paid to their institutions and some personal reimbursement for activities related to PASC and broader areas of research and expertise. However, none of the authors have any conflicts relative to the work on the guidance.
 

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

Physical activity has been tied to a significantly decreased risk of Parkinson’s disease (PD) in women, results of a large, long-term prospective study show.

Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.

The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.

This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.

“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.

The study was published online in Neurology.
 

Direct protective effect?

Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.

The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.

To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.

The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.

In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.

Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.

Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.

The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.

In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).

The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”

Analyses that included 15-year and 20-year lag times had similar findings.

Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.

“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.

Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.

Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.

The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
 

Robust evidence

In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.

“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.

The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.

Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.

Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.

Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”

Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”

The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.

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

Physical activity has been tied to a significantly decreased risk of Parkinson’s disease (PD) in women, results of a large, long-term prospective study show.

Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.

The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.

This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.

“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.

The study was published online in Neurology.
 

Direct protective effect?

Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.

The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.

To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.

The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.

In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.

Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.

Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.

The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.

In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).

The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”

Analyses that included 15-year and 20-year lag times had similar findings.

Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.

“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.

Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.

Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.

The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
 

Robust evidence

In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.

“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.

The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.

Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.

Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.

Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”

Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”

The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.

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

Physical activity has been tied to a significantly decreased risk of Parkinson’s disease (PD) in women, results of a large, long-term prospective study show.

Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.

The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.

This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.

“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.

The study was published online in Neurology.
 

Direct protective effect?

Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.

The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.

To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.

The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.

In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.

Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.

Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.

The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.

In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).

The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”

Analyses that included 15-year and 20-year lag times had similar findings.

Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.

“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.

Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.

Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.

The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
 

Robust evidence

In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.

“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.

The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.

Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.

Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.

Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”

Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”

The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.

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

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

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

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

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

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

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

Using age-specific thresholds for troponin measurement would more accurately diagnose myocardial injury when assessing patients for suspected myocardial infarction, a study suggests.
 

The study shows that the 99th percentile for the upper reference limit (used to define myocardial injury) for high-sensitivity (hs)–troponin T in the new analysis matched those reported by manufacturers. However, the same threshold for hs–troponin I was lower than was manufacturer-reported levels when considering the whole population.

And for both hs–troponin T and hs–troponin I, there were significant differences in 99th percentile levels by age.

“Our data suggest that some cases of myocardial injury may be missed in the whole population by using current non–age specific thresholds of troponin I,” lead author, John McEvoy, MB, University of Galway (Ireland), said in an interview. “If the non–age specific threshold was lowered to that in our cohort, then we would pick up more people with myocardial injury.”

“However,” Dr. McEvoy added, “if age-specific thresholds were deployed, then our data suggest that thresholds used to diagnose myocardial injury would need to be higher in older adults, somewhat lower in middle-aged individuals and much lower in younger people.”

The study was published online in the Journal of the American College of Cardiology.  

The authors explain that the 99th percentile upper–reference limit threshold is the common benchmark of abnormality for all troponin assays. Five high-sensitivity cardiac troponin assays have been cleared by the Food and Drug Administration for clinical use and allow for earlier diagnosis of MI.

However, there has been variability in the approach used to define the 99th percentile upper reference limits for these assays, with definitions of healthy reference populations differing and the various assays available are not standardized or harmonized. So troponin concentrations at 99th percentiles do not align across assays, and the generalizability of manufacturer-reported reference upper reference limits for hs-troponin assays to the U.S. adult population is unknown.

They note that though sex-specific 99th percentile upper reference limits for hs-troponin have been recommended since 2018, age-specific thresholds are not yet endorsed, and whether thresholds differ by race or ethnicity is also controversial.

They aimed to investigate these issues using stored serum samples from adults aged 18 or older who participated in the 1999-2004 National Health and Nutrition Examination Survey (NHANES).

Dr. McEvoy described the NHANES database as “the gold standard cohort for representation of the U.S. adult population,” noting that other studies conducted by the manufacturers of the troponin tests have often used convenience samples from patients attending hospital clinics and blood donors, which he said were not representative of the whole population.

For the study, the researchers estimated that the 99th percentile upper reference limit for four hs-troponin assays (one troponin T and three troponin I) in a strictly defined healthy reference subgroup of 2,746 individuals from the NHANES cohort.

Results showed that the NHANES 99th percentile upper reference limit for hs–troponin T (19 ng/L) matched the manufacturer-reported level (19 ng/L). But, the NHANES upper reference levels for three troponin I assays were lower than were levels stated by the manufacturers.

The NHANES levels were 13 ng/L for the Abbott hs–troponin I assay (manufacturer: 28 ng/L); 5 ng/L for the Ortho hs–troponin I assay (manufacturer: 11 ng/L); and 37 ng/L for the Siemens hs–troponin I assay (manufacturer: 46.5 ng/L).

Furthermore, the 99th percentile upper reference limits for all four hs-troponin assays were statistically significantly lower in healthy adults younger than 40 years, compared with healthy adults older than 60 years.

There were also significant differences in upper reference limits by sex, but none by race/ethnicity.

Dr. McEvoy explained that NHANES is a very well phenotyped database with information on individuals’ health, body mass index, and other biomarkers. “This allows us to define a completely healthy subgroup of people, which could explain why the 99th percentile threshold for hs–troponin I was lower than previously reported from other cohorts,” he added.

Though there may be concern that such a healthy subgroup would mean the sample is enriched with younger people, whereas the typical person having their troponin measured would be older, Dr. McEvoy pointed out that there were more than 400 people older than 60 years in the healthy group. “This is probably the biggest cohort of super healthy older U.S. adults ever sampled in this regard,” he commented.

Dr. McEvoy said that the overall results from the study suggested that different thresholds might need to be considered for troponin I. “This could lead to threshold levels used to diagnose myocardial injury being cut in the population as a whole.”

But, he said a more important message was the need for age-specific thresholds.

“We found that troponin levels track with age. Even in individuals who age in a very healthy way, their troponin levels are greater than in younger people. This is the first time this has been shown with such clear statistical significance,” Dr. McEvoy said. “We think this data provides a compelling case for the use of age-specific cut-offs.”

He explained that, if age-specific thresholds were used to diagnose myocardial injury, the cut point from the current data would be higher than it would be from current manufacturers’ recommendations in those older than 60 years, so fewer people in this age group would be labeled as having myocardial injury.

“Our results suggest that, at present, we are seeing more false positives in older people leading to more unnecessary tests.” Using age-specific cut off points will reduce the number of false positives in older people. Dr. McEvoy noted a similar change in the way D-Dimer blood tests have been used to diagnose pulmonary embolism in recent years.

Using age-specific cut-offs for hs-troponin would also reduce the number of false negatives in younger people, Dr. McEvoy added.
 

Further studies needed?

In an accompanying editorial, Cian McCarthy, MB, Austin Vyas, and James Januzzi, MD, of Massachusetts General Hospital, Boston, note that though there are substantial shortcomings to using the 99th percentile upper reference limit of troponins for the diagnosis of cardiac injury, they believe this measurement should persist as a central component of the MI diagnostic criteria, with the caveat that this is only one component of the definition of MI and does not alone define it.

“Cardiac troponin measurement is one of the most commonly utilized blood tests in hospital-based settings, and yet important questions remain about what exactly is a normal value for this test,” the editorialists comment.

They say this new study emphasizes the importance of age and sex in interpretation of troponin levels.

“Although the use of such cut-offs may further complicate MI diagnostic criteria, this is superseded by the benefits of improved diagnostic accuracy in younger and female patients (a critical health equity step) while reducing MI overdiagnosis in the elderly, with the resultant harms that might follow, adverse psychosocial patient impact, and unnecessary health care expenditure from cascade testing,” they write.

They conclude that further large studies derived from healthy cohorts should be conducted to answer this question in a definitive fashion.

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

Using age-specific thresholds for troponin measurement would more accurately diagnose myocardial injury when assessing patients for suspected myocardial infarction, a study suggests.
 

The study shows that the 99th percentile for the upper reference limit (used to define myocardial injury) for high-sensitivity (hs)–troponin T in the new analysis matched those reported by manufacturers. However, the same threshold for hs–troponin I was lower than was manufacturer-reported levels when considering the whole population.

And for both hs–troponin T and hs–troponin I, there were significant differences in 99th percentile levels by age.

“Our data suggest that some cases of myocardial injury may be missed in the whole population by using current non–age specific thresholds of troponin I,” lead author, John McEvoy, MB, University of Galway (Ireland), said in an interview. “If the non–age specific threshold was lowered to that in our cohort, then we would pick up more people with myocardial injury.”

“However,” Dr. McEvoy added, “if age-specific thresholds were deployed, then our data suggest that thresholds used to diagnose myocardial injury would need to be higher in older adults, somewhat lower in middle-aged individuals and much lower in younger people.”

The study was published online in the Journal of the American College of Cardiology.  

The authors explain that the 99th percentile upper–reference limit threshold is the common benchmark of abnormality for all troponin assays. Five high-sensitivity cardiac troponin assays have been cleared by the Food and Drug Administration for clinical use and allow for earlier diagnosis of MI.

However, there has been variability in the approach used to define the 99th percentile upper reference limits for these assays, with definitions of healthy reference populations differing and the various assays available are not standardized or harmonized. So troponin concentrations at 99th percentiles do not align across assays, and the generalizability of manufacturer-reported reference upper reference limits for hs-troponin assays to the U.S. adult population is unknown.

They note that though sex-specific 99th percentile upper reference limits for hs-troponin have been recommended since 2018, age-specific thresholds are not yet endorsed, and whether thresholds differ by race or ethnicity is also controversial.

They aimed to investigate these issues using stored serum samples from adults aged 18 or older who participated in the 1999-2004 National Health and Nutrition Examination Survey (NHANES).

Dr. McEvoy described the NHANES database as “the gold standard cohort for representation of the U.S. adult population,” noting that other studies conducted by the manufacturers of the troponin tests have often used convenience samples from patients attending hospital clinics and blood donors, which he said were not representative of the whole population.

For the study, the researchers estimated that the 99th percentile upper reference limit for four hs-troponin assays (one troponin T and three troponin I) in a strictly defined healthy reference subgroup of 2,746 individuals from the NHANES cohort.

Results showed that the NHANES 99th percentile upper reference limit for hs–troponin T (19 ng/L) matched the manufacturer-reported level (19 ng/L). But, the NHANES upper reference levels for three troponin I assays were lower than were levels stated by the manufacturers.

The NHANES levels were 13 ng/L for the Abbott hs–troponin I assay (manufacturer: 28 ng/L); 5 ng/L for the Ortho hs–troponin I assay (manufacturer: 11 ng/L); and 37 ng/L for the Siemens hs–troponin I assay (manufacturer: 46.5 ng/L).

Furthermore, the 99th percentile upper reference limits for all four hs-troponin assays were statistically significantly lower in healthy adults younger than 40 years, compared with healthy adults older than 60 years.

There were also significant differences in upper reference limits by sex, but none by race/ethnicity.

Dr. McEvoy explained that NHANES is a very well phenotyped database with information on individuals’ health, body mass index, and other biomarkers. “This allows us to define a completely healthy subgroup of people, which could explain why the 99th percentile threshold for hs–troponin I was lower than previously reported from other cohorts,” he added.

Though there may be concern that such a healthy subgroup would mean the sample is enriched with younger people, whereas the typical person having their troponin measured would be older, Dr. McEvoy pointed out that there were more than 400 people older than 60 years in the healthy group. “This is probably the biggest cohort of super healthy older U.S. adults ever sampled in this regard,” he commented.

Dr. McEvoy said that the overall results from the study suggested that different thresholds might need to be considered for troponin I. “This could lead to threshold levels used to diagnose myocardial injury being cut in the population as a whole.”

But, he said a more important message was the need for age-specific thresholds.

“We found that troponin levels track with age. Even in individuals who age in a very healthy way, their troponin levels are greater than in younger people. This is the first time this has been shown with such clear statistical significance,” Dr. McEvoy said. “We think this data provides a compelling case for the use of age-specific cut-offs.”

He explained that, if age-specific thresholds were used to diagnose myocardial injury, the cut point from the current data would be higher than it would be from current manufacturers’ recommendations in those older than 60 years, so fewer people in this age group would be labeled as having myocardial injury.

“Our results suggest that, at present, we are seeing more false positives in older people leading to more unnecessary tests.” Using age-specific cut off points will reduce the number of false positives in older people. Dr. McEvoy noted a similar change in the way D-Dimer blood tests have been used to diagnose pulmonary embolism in recent years.

Using age-specific cut-offs for hs-troponin would also reduce the number of false negatives in younger people, Dr. McEvoy added.
 

Further studies needed?

In an accompanying editorial, Cian McCarthy, MB, Austin Vyas, and James Januzzi, MD, of Massachusetts General Hospital, Boston, note that though there are substantial shortcomings to using the 99th percentile upper reference limit of troponins for the diagnosis of cardiac injury, they believe this measurement should persist as a central component of the MI diagnostic criteria, with the caveat that this is only one component of the definition of MI and does not alone define it.

“Cardiac troponin measurement is one of the most commonly utilized blood tests in hospital-based settings, and yet important questions remain about what exactly is a normal value for this test,” the editorialists comment.

They say this new study emphasizes the importance of age and sex in interpretation of troponin levels.

“Although the use of such cut-offs may further complicate MI diagnostic criteria, this is superseded by the benefits of improved diagnostic accuracy in younger and female patients (a critical health equity step) while reducing MI overdiagnosis in the elderly, with the resultant harms that might follow, adverse psychosocial patient impact, and unnecessary health care expenditure from cascade testing,” they write.

They conclude that further large studies derived from healthy cohorts should be conducted to answer this question in a definitive fashion.

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

Using age-specific thresholds for troponin measurement would more accurately diagnose myocardial injury when assessing patients for suspected myocardial infarction, a study suggests.
 

The study shows that the 99th percentile for the upper reference limit (used to define myocardial injury) for high-sensitivity (hs)–troponin T in the new analysis matched those reported by manufacturers. However, the same threshold for hs–troponin I was lower than was manufacturer-reported levels when considering the whole population.

And for both hs–troponin T and hs–troponin I, there were significant differences in 99th percentile levels by age.

“Our data suggest that some cases of myocardial injury may be missed in the whole population by using current non–age specific thresholds of troponin I,” lead author, John McEvoy, MB, University of Galway (Ireland), said in an interview. “If the non–age specific threshold was lowered to that in our cohort, then we would pick up more people with myocardial injury.”

“However,” Dr. McEvoy added, “if age-specific thresholds were deployed, then our data suggest that thresholds used to diagnose myocardial injury would need to be higher in older adults, somewhat lower in middle-aged individuals and much lower in younger people.”

The study was published online in the Journal of the American College of Cardiology.  

The authors explain that the 99th percentile upper–reference limit threshold is the common benchmark of abnormality for all troponin assays. Five high-sensitivity cardiac troponin assays have been cleared by the Food and Drug Administration for clinical use and allow for earlier diagnosis of MI.

However, there has been variability in the approach used to define the 99th percentile upper reference limits for these assays, with definitions of healthy reference populations differing and the various assays available are not standardized or harmonized. So troponin concentrations at 99th percentiles do not align across assays, and the generalizability of manufacturer-reported reference upper reference limits for hs-troponin assays to the U.S. adult population is unknown.

They note that though sex-specific 99th percentile upper reference limits for hs-troponin have been recommended since 2018, age-specific thresholds are not yet endorsed, and whether thresholds differ by race or ethnicity is also controversial.

They aimed to investigate these issues using stored serum samples from adults aged 18 or older who participated in the 1999-2004 National Health and Nutrition Examination Survey (NHANES).

Dr. McEvoy described the NHANES database as “the gold standard cohort for representation of the U.S. adult population,” noting that other studies conducted by the manufacturers of the troponin tests have often used convenience samples from patients attending hospital clinics and blood donors, which he said were not representative of the whole population.

For the study, the researchers estimated that the 99th percentile upper reference limit for four hs-troponin assays (one troponin T and three troponin I) in a strictly defined healthy reference subgroup of 2,746 individuals from the NHANES cohort.

Results showed that the NHANES 99th percentile upper reference limit for hs–troponin T (19 ng/L) matched the manufacturer-reported level (19 ng/L). But, the NHANES upper reference levels for three troponin I assays were lower than were levels stated by the manufacturers.

The NHANES levels were 13 ng/L for the Abbott hs–troponin I assay (manufacturer: 28 ng/L); 5 ng/L for the Ortho hs–troponin I assay (manufacturer: 11 ng/L); and 37 ng/L for the Siemens hs–troponin I assay (manufacturer: 46.5 ng/L).

Furthermore, the 99th percentile upper reference limits for all four hs-troponin assays were statistically significantly lower in healthy adults younger than 40 years, compared with healthy adults older than 60 years.

There were also significant differences in upper reference limits by sex, but none by race/ethnicity.

Dr. McEvoy explained that NHANES is a very well phenotyped database with information on individuals’ health, body mass index, and other biomarkers. “This allows us to define a completely healthy subgroup of people, which could explain why the 99th percentile threshold for hs–troponin I was lower than previously reported from other cohorts,” he added.

Though there may be concern that such a healthy subgroup would mean the sample is enriched with younger people, whereas the typical person having their troponin measured would be older, Dr. McEvoy pointed out that there were more than 400 people older than 60 years in the healthy group. “This is probably the biggest cohort of super healthy older U.S. adults ever sampled in this regard,” he commented.

Dr. McEvoy said that the overall results from the study suggested that different thresholds might need to be considered for troponin I. “This could lead to threshold levels used to diagnose myocardial injury being cut in the population as a whole.”

But, he said a more important message was the need for age-specific thresholds.

“We found that troponin levels track with age. Even in individuals who age in a very healthy way, their troponin levels are greater than in younger people. This is the first time this has been shown with such clear statistical significance,” Dr. McEvoy said. “We think this data provides a compelling case for the use of age-specific cut-offs.”

He explained that, if age-specific thresholds were used to diagnose myocardial injury, the cut point from the current data would be higher than it would be from current manufacturers’ recommendations in those older than 60 years, so fewer people in this age group would be labeled as having myocardial injury.

“Our results suggest that, at present, we are seeing more false positives in older people leading to more unnecessary tests.” Using age-specific cut off points will reduce the number of false positives in older people. Dr. McEvoy noted a similar change in the way D-Dimer blood tests have been used to diagnose pulmonary embolism in recent years.

Using age-specific cut-offs for hs-troponin would also reduce the number of false negatives in younger people, Dr. McEvoy added.
 

Further studies needed?

In an accompanying editorial, Cian McCarthy, MB, Austin Vyas, and James Januzzi, MD, of Massachusetts General Hospital, Boston, note that though there are substantial shortcomings to using the 99th percentile upper reference limit of troponins for the diagnosis of cardiac injury, they believe this measurement should persist as a central component of the MI diagnostic criteria, with the caveat that this is only one component of the definition of MI and does not alone define it.

“Cardiac troponin measurement is one of the most commonly utilized blood tests in hospital-based settings, and yet important questions remain about what exactly is a normal value for this test,” the editorialists comment.

They say this new study emphasizes the importance of age and sex in interpretation of troponin levels.

“Although the use of such cut-offs may further complicate MI diagnostic criteria, this is superseded by the benefits of improved diagnostic accuracy in younger and female patients (a critical health equity step) while reducing MI overdiagnosis in the elderly, with the resultant harms that might follow, adverse psychosocial patient impact, and unnecessary health care expenditure from cascade testing,” they write.

They conclude that further large studies derived from healthy cohorts should be conducted to answer this question in a definitive fashion.

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

Many of the persistent problems that breast cancer survivors experience after treatment are not part of the conversation with oncologists during treatment, said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.

Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.

Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.

In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.

In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.

Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.

Shift to primary care

As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.

A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
 

Delivering the three P’s

The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .

The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.

The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.

The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.

Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.

To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.

For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.

Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.

However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.

During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
 

Engaging a patient’s partner early can be helpful

If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.

“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”

“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.

Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.

Many of the persistent problems that breast cancer survivors experience after treatment are not part of the conversation with oncologists during treatment, said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.

Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.

Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.

In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.

In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.

Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.

Shift to primary care

As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.

A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
 

Delivering the three P’s

The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .

The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.

The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.

The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.

Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.

To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.

For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.

Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.

However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.

During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
 

Engaging a patient’s partner early can be helpful

If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.

“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”

“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.

Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.

Many of the persistent problems that breast cancer survivors experience after treatment are not part of the conversation with oncologists during treatment, said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.

Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.

Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.

In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.

In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.

Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.

Shift to primary care

As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.

A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
 

Delivering the three P’s

The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .

The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.

The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.

The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.

Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.

To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.

For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.

Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.

However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.

During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
 

Engaging a patient’s partner early can be helpful

If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.

“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”

“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.

Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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

DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.

“The combination therapy [balloon and liraglutide] resulted in an additional weight loss compared to the two single treatments,” said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.

“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.

Allurion Technologies

“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.

The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m².

The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.

The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”

Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”

“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
 

Average 40-lb weight loss with balloon and liraglutide

For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.

During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.

Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”

Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.

Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m². After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m² respectively.

After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m².

Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.

When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”

Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).

Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.

The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.

“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”

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

DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.

“The combination therapy [balloon and liraglutide] resulted in an additional weight loss compared to the two single treatments,” said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.

“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.

Allurion Technologies

“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.

The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m².

The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.

The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”

Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”

“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
 

Average 40-lb weight loss with balloon and liraglutide

For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.

During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.

Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”

Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.

Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m². After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m² respectively.

After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m².

Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.

When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”

Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).

Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.

The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.

“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”

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

DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.

“The combination therapy [balloon and liraglutide] resulted in an additional weight loss compared to the two single treatments,” said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.

“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.

Allurion Technologies

“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.

The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m².

The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.

The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”

Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”

“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
 

Average 40-lb weight loss with balloon and liraglutide

For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.

During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.

Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”

Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.

Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m². After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m² respectively.

After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m².

Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.

When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”

Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).

Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.

The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.

“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”

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

Self-reported, regular Internet use, but not overuse, in older adults is linked to a lower dementia risk, new research suggests.

Investigators followed more than 18,000 older individuals and found that regular Internet use was associated with about a 50% reduction in dementia risk, compared with their counterparts who did not use the Internet regularly.

They also found that longer duration of regular Internet use was associated with a reduced risk of dementia, although excessive daily Internet usage appeared to adversely affect dementia risk.

“Online engagement can develop and maintain cognitive reserve – resiliency against physiological damage to the brain – and increased cognitive reserve can, in turn, compensate for brain aging and reduce the risk of dementia,” study investigator Gawon Cho, a doctoral candidate at New York University School of Global Public Health, said in an interview.

The study was published online in the Journal of the American Geriatrics Society.
 

Unexamined benefits

Prior research has shown that older adult Internet users have “better overall cognitive performance, verbal reasoning, and memory,” compared with nonusers, the authors note.

However, because this body of research consists of cross-sectional analyses and longitudinal studies with brief follow-up periods, the long-term cognitive benefits of Internet usage remain “unexamined.”

In addition, despite “extensive evidence of a disproportionately high burden of dementia in people of color, individuals without higher education, and adults who experienced other socioeconomic hardships, little is known about whether the Internet has exacerbated population-level disparities in cognitive health,” the investigators add.

Another question concerns whether excessive Internet usage may actually be detrimental to neurocognitive outcomes. However, “existing evidence on the adverse effects of Internet usage is concentrated in younger populations whose brains are still undergoing maturation.”

Ms. Cho said the motivation for the study was the lack of longitudinal studies on this topic, especially those with sufficient follow-up periods. In addition, she said, there is insufficient evidence about how changes in Internet usage in older age are associated with prospective dementia risk.

For the study, investigators turned to participants in the Health and Retirement Study, an ongoing longitudinal survey of a nationally representative sample of U.S.-based older adults (aged ≥ 50 years).

All participants (n = 18,154; 47.36% male; median age, 55.17 years) were dementia-free, community-dwelling older adults who completed a 2002 baseline cognitive assessment and were asked about Internet usage every 2 years thereafter.

Participants were followed from 2002 to 2018 for a maximum of 17.1 years (median, 7.9 years), which is the longest follow-up period to date. Of the total sample, 64.76% were regular Internet users.

The study’s primary outcome was incident dementia, based on performance on the Modified Telephone Interview for Cognitive Status (TICS-M), which was administered every 2 years.

The exposure examined in the study was cumulative Internet usage in late adulthood, defined as “the number of biennial waves where participants used the Internet regularly during the first three waves.”

In addition, participants were asked how many hours they spent using the Internet during the past week for activities other than viewing television shows or movies.

The researchers also investigated whether the link between Internet usage and dementia risk varied by educational attainment, race-ethnicity, sex, and generational cohort.

Covariates included baseline TICS-M score, health, age, household income, marital status, and region of residence.
 

U-shaped curve

More than half of the sample (52.96%) showed no changes in Internet use from baseline during the study period, while one-fifth (20.54%) did show changes in use.

Investigators found a robust link between Internet usage and lower dementia risk (cause-specific hazard ratio, 0.57 [95% CI, 0.46-0.71]) – a finding that remained even after adjusting for self-selection into baseline usage (csHR, 0.54 [0.41-0.72]) and signs of cognitive decline at baseline (csHR, 0.62 [0.46-0.85]).

Each additional wave of regular Internet usage was associated with a 21% decrease in the risk of dementia (95% CI, 13%-29%), wherein additional regular periods were associated with reduced dementia risk (csHR, 0.80 [95% CI, 0.68-0.95]).

“The difference in risk between regular and nonregular users did not vary by educational attainment, race-ethnicity, sex, and generation,” the investigators note.

A U-shaped association was found between daily hours of online engagement, wherein the lowest risk was observed in those with 0.1-2 hours of usage (compared with 0 hours of usage). The risk increased in a “monotonic fashion” after 2 hours, with 6.1-8 hours of usage showing the highest risk.

This finding was not considered statistically significant, but the “consistent U-shaped trend offers a preliminary suggestion that excessive online engagement may have adverse cognitive effects on older adults,” the investigators note.

“Among older adults, regular Internet users may experience a lower risk of dementia compared to nonregular users, and longer periods of regular Internet usage in late adulthood may help reduce the risks of subsequent dementia incidence,” said Ms. Cho. “Nonetheless, using the Internet excessively daily may negatively affect the risk of dementia in older adults.”
 

Bidirectional relationship?

Commenting for this article, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that some risk factors for Alzheimer’s or other dementias can’t be changed, while others are modifiable, “either at a personal or a population level.”

She called the current research “important” because it “identifies a potentially modifiable factor that may influence dementia risk.”

However, cautioned Dr. Sexton, who was not involved with the study, the findings cannot establish cause and effect. In fact, the relationship may be bidirectional.

“It may be that regular Internet usage is associated with increased cognitive stimulation, and in turn reduced risk of dementia; or it may be that individuals with lower risk of dementia are more likely to engage in regular Internet usage,” she said. Thus, “interventional studies are able to shed more light on causation.”

The Health and Retirement Study is sponsored by the National Institute on Aging and is conducted by the University of Michigan, Ann Arbor. Ms. Cho, her coauthors, and Dr. Sexton have disclosed no relevant financial relationships.

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

Self-reported, regular Internet use, but not overuse, in older adults is linked to a lower dementia risk, new research suggests.

Investigators followed more than 18,000 older individuals and found that regular Internet use was associated with about a 50% reduction in dementia risk, compared with their counterparts who did not use the Internet regularly.

They also found that longer duration of regular Internet use was associated with a reduced risk of dementia, although excessive daily Internet usage appeared to adversely affect dementia risk.

“Online engagement can develop and maintain cognitive reserve – resiliency against physiological damage to the brain – and increased cognitive reserve can, in turn, compensate for brain aging and reduce the risk of dementia,” study investigator Gawon Cho, a doctoral candidate at New York University School of Global Public Health, said in an interview.

The study was published online in the Journal of the American Geriatrics Society.
 

Unexamined benefits

Prior research has shown that older adult Internet users have “better overall cognitive performance, verbal reasoning, and memory,” compared with nonusers, the authors note.

However, because this body of research consists of cross-sectional analyses and longitudinal studies with brief follow-up periods, the long-term cognitive benefits of Internet usage remain “unexamined.”

In addition, despite “extensive evidence of a disproportionately high burden of dementia in people of color, individuals without higher education, and adults who experienced other socioeconomic hardships, little is known about whether the Internet has exacerbated population-level disparities in cognitive health,” the investigators add.

Another question concerns whether excessive Internet usage may actually be detrimental to neurocognitive outcomes. However, “existing evidence on the adverse effects of Internet usage is concentrated in younger populations whose brains are still undergoing maturation.”

Ms. Cho said the motivation for the study was the lack of longitudinal studies on this topic, especially those with sufficient follow-up periods. In addition, she said, there is insufficient evidence about how changes in Internet usage in older age are associated with prospective dementia risk.

For the study, investigators turned to participants in the Health and Retirement Study, an ongoing longitudinal survey of a nationally representative sample of U.S.-based older adults (aged ≥ 50 years).

All participants (n = 18,154; 47.36% male; median age, 55.17 years) were dementia-free, community-dwelling older adults who completed a 2002 baseline cognitive assessment and were asked about Internet usage every 2 years thereafter.

Participants were followed from 2002 to 2018 for a maximum of 17.1 years (median, 7.9 years), which is the longest follow-up period to date. Of the total sample, 64.76% were regular Internet users.

The study’s primary outcome was incident dementia, based on performance on the Modified Telephone Interview for Cognitive Status (TICS-M), which was administered every 2 years.

The exposure examined in the study was cumulative Internet usage in late adulthood, defined as “the number of biennial waves where participants used the Internet regularly during the first three waves.”

In addition, participants were asked how many hours they spent using the Internet during the past week for activities other than viewing television shows or movies.

The researchers also investigated whether the link between Internet usage and dementia risk varied by educational attainment, race-ethnicity, sex, and generational cohort.

Covariates included baseline TICS-M score, health, age, household income, marital status, and region of residence.
 

U-shaped curve

More than half of the sample (52.96%) showed no changes in Internet use from baseline during the study period, while one-fifth (20.54%) did show changes in use.

Investigators found a robust link between Internet usage and lower dementia risk (cause-specific hazard ratio, 0.57 [95% CI, 0.46-0.71]) – a finding that remained even after adjusting for self-selection into baseline usage (csHR, 0.54 [0.41-0.72]) and signs of cognitive decline at baseline (csHR, 0.62 [0.46-0.85]).

Each additional wave of regular Internet usage was associated with a 21% decrease in the risk of dementia (95% CI, 13%-29%), wherein additional regular periods were associated with reduced dementia risk (csHR, 0.80 [95% CI, 0.68-0.95]).

“The difference in risk between regular and nonregular users did not vary by educational attainment, race-ethnicity, sex, and generation,” the investigators note.

A U-shaped association was found between daily hours of online engagement, wherein the lowest risk was observed in those with 0.1-2 hours of usage (compared with 0 hours of usage). The risk increased in a “monotonic fashion” after 2 hours, with 6.1-8 hours of usage showing the highest risk.

This finding was not considered statistically significant, but the “consistent U-shaped trend offers a preliminary suggestion that excessive online engagement may have adverse cognitive effects on older adults,” the investigators note.

“Among older adults, regular Internet users may experience a lower risk of dementia compared to nonregular users, and longer periods of regular Internet usage in late adulthood may help reduce the risks of subsequent dementia incidence,” said Ms. Cho. “Nonetheless, using the Internet excessively daily may negatively affect the risk of dementia in older adults.”
 

Bidirectional relationship?

Commenting for this article, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that some risk factors for Alzheimer’s or other dementias can’t be changed, while others are modifiable, “either at a personal or a population level.”

She called the current research “important” because it “identifies a potentially modifiable factor that may influence dementia risk.”

However, cautioned Dr. Sexton, who was not involved with the study, the findings cannot establish cause and effect. In fact, the relationship may be bidirectional.

“It may be that regular Internet usage is associated with increased cognitive stimulation, and in turn reduced risk of dementia; or it may be that individuals with lower risk of dementia are more likely to engage in regular Internet usage,” she said. Thus, “interventional studies are able to shed more light on causation.”

The Health and Retirement Study is sponsored by the National Institute on Aging and is conducted by the University of Michigan, Ann Arbor. Ms. Cho, her coauthors, and Dr. Sexton have disclosed no relevant financial relationships.

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

Self-reported, regular Internet use, but not overuse, in older adults is linked to a lower dementia risk, new research suggests.

Investigators followed more than 18,000 older individuals and found that regular Internet use was associated with about a 50% reduction in dementia risk, compared with their counterparts who did not use the Internet regularly.

They also found that longer duration of regular Internet use was associated with a reduced risk of dementia, although excessive daily Internet usage appeared to adversely affect dementia risk.

“Online engagement can develop and maintain cognitive reserve – resiliency against physiological damage to the brain – and increased cognitive reserve can, in turn, compensate for brain aging and reduce the risk of dementia,” study investigator Gawon Cho, a doctoral candidate at New York University School of Global Public Health, said in an interview.

The study was published online in the Journal of the American Geriatrics Society.
 

Unexamined benefits

Prior research has shown that older adult Internet users have “better overall cognitive performance, verbal reasoning, and memory,” compared with nonusers, the authors note.

However, because this body of research consists of cross-sectional analyses and longitudinal studies with brief follow-up periods, the long-term cognitive benefits of Internet usage remain “unexamined.”

In addition, despite “extensive evidence of a disproportionately high burden of dementia in people of color, individuals without higher education, and adults who experienced other socioeconomic hardships, little is known about whether the Internet has exacerbated population-level disparities in cognitive health,” the investigators add.

Another question concerns whether excessive Internet usage may actually be detrimental to neurocognitive outcomes. However, “existing evidence on the adverse effects of Internet usage is concentrated in younger populations whose brains are still undergoing maturation.”

Ms. Cho said the motivation for the study was the lack of longitudinal studies on this topic, especially those with sufficient follow-up periods. In addition, she said, there is insufficient evidence about how changes in Internet usage in older age are associated with prospective dementia risk.

For the study, investigators turned to participants in the Health and Retirement Study, an ongoing longitudinal survey of a nationally representative sample of U.S.-based older adults (aged ≥ 50 years).

All participants (n = 18,154; 47.36% male; median age, 55.17 years) were dementia-free, community-dwelling older adults who completed a 2002 baseline cognitive assessment and were asked about Internet usage every 2 years thereafter.

Participants were followed from 2002 to 2018 for a maximum of 17.1 years (median, 7.9 years), which is the longest follow-up period to date. Of the total sample, 64.76% were regular Internet users.

The study’s primary outcome was incident dementia, based on performance on the Modified Telephone Interview for Cognitive Status (TICS-M), which was administered every 2 years.

The exposure examined in the study was cumulative Internet usage in late adulthood, defined as “the number of biennial waves where participants used the Internet regularly during the first three waves.”

In addition, participants were asked how many hours they spent using the Internet during the past week for activities other than viewing television shows or movies.

The researchers also investigated whether the link between Internet usage and dementia risk varied by educational attainment, race-ethnicity, sex, and generational cohort.

Covariates included baseline TICS-M score, health, age, household income, marital status, and region of residence.
 

U-shaped curve

More than half of the sample (52.96%) showed no changes in Internet use from baseline during the study period, while one-fifth (20.54%) did show changes in use.

Investigators found a robust link between Internet usage and lower dementia risk (cause-specific hazard ratio, 0.57 [95% CI, 0.46-0.71]) – a finding that remained even after adjusting for self-selection into baseline usage (csHR, 0.54 [0.41-0.72]) and signs of cognitive decline at baseline (csHR, 0.62 [0.46-0.85]).

Each additional wave of regular Internet usage was associated with a 21% decrease in the risk of dementia (95% CI, 13%-29%), wherein additional regular periods were associated with reduced dementia risk (csHR, 0.80 [95% CI, 0.68-0.95]).

“The difference in risk between regular and nonregular users did not vary by educational attainment, race-ethnicity, sex, and generation,” the investigators note.

A U-shaped association was found between daily hours of online engagement, wherein the lowest risk was observed in those with 0.1-2 hours of usage (compared with 0 hours of usage). The risk increased in a “monotonic fashion” after 2 hours, with 6.1-8 hours of usage showing the highest risk.

This finding was not considered statistically significant, but the “consistent U-shaped trend offers a preliminary suggestion that excessive online engagement may have adverse cognitive effects on older adults,” the investigators note.

“Among older adults, regular Internet users may experience a lower risk of dementia compared to nonregular users, and longer periods of regular Internet usage in late adulthood may help reduce the risks of subsequent dementia incidence,” said Ms. Cho. “Nonetheless, using the Internet excessively daily may negatively affect the risk of dementia in older adults.”
 

Bidirectional relationship?

Commenting for this article, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that some risk factors for Alzheimer’s or other dementias can’t be changed, while others are modifiable, “either at a personal or a population level.”

She called the current research “important” because it “identifies a potentially modifiable factor that may influence dementia risk.”

However, cautioned Dr. Sexton, who was not involved with the study, the findings cannot establish cause and effect. In fact, the relationship may be bidirectional.

“It may be that regular Internet usage is associated with increased cognitive stimulation, and in turn reduced risk of dementia; or it may be that individuals with lower risk of dementia are more likely to engage in regular Internet usage,” she said. Thus, “interventional studies are able to shed more light on causation.”

The Health and Retirement Study is sponsored by the National Institute on Aging and is conducted by the University of Michigan, Ann Arbor. Ms. Cho, her coauthors, and Dr. Sexton have disclosed no relevant financial relationships.

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