Federal Practitioner

Survivors of childhood cancers are at increased risk for prescription opioid misuse compared with their peers, a review of a claims database revealed.

Among more than 8,000 patients age 21 or younger who had completed treatment for hematologic, central nervous system, bone, or gonadal cancers, survivors were significantly more likely than were their peers to have an opioid prescription, longer duration of prescription, and higher daily doses of opioids, and to have opioid prescriptions overlapping for a week or more, reported Xu Ji, PhD, of Emory University in Atlanta.

Teenage and young adult patients were at higher risk than were patients younger than 12, and the risk was highest among patients who had been treated for bone malignancies, as well as those who had undergone any hematopoietic stem cell transplant.

“These findings suggest that health care providers who regularly see survivors should explore nonopioid options to help prevent opioid misuse, and screen for potential misuse in those who actually receive opioids,” she said in an oral abstract presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.

“This is a really important topic, and something that’s probably been underinvestigated and underexplored in our patient population,” said session comoderator Sheri Spunt, MD, Endowed Professor of Pediatric Cancer at Stanford (Calif.) University.
 

Database review

Dr. Ji and colleagues used the IBM MarketScan Commercial Claims and Encounters database from 2009 to 2018 to examine prescription opioid use, potential misuse, and substance use disorders in pediatric cancer survivors in the first year after completion of therapy, and to identify factors associated with risk for misuse or substance use disorders. Specifically, the period of interest was the first year after completion of all treatments, including surgery, chemotherapy, radiation, and stem cell transplant (Abstract 2015).

They looked at deidentified records on any opioid prescription and for treatment of any opioid use or substance use disorder (alcohol, psychotherapeutic drugs, marijuana, or illicit drug use disorders).

They defined indicators of potential misuse as either prescriptions for long-acting or extended-release opioids for acute pain conditions; opioid and benzodiazepine prescriptions overlapping by a week or more; opioid prescriptions overlapping by a week or more; high daily opioid dosage (prescribed daily dose of 100 or greater morphine milligram equivalent [MME]; and/or opioid dose escalation (an increase of at least 50% in mean MMEs per month twice consecutively within 1 year).

They compared outcomes between a total of 8,635 survivors and 44,175 controls, matched on a 1:5 basis with survivors by age, sex, and region, and continuous enrollment during the 1-year posttherapy period.

In each of three age categories – 0 to 11 years, 12 to 17 years, and 18 years and older – survivors were significantly more likely to have received an opioid prescription, at 15% for the youngest survivors vs. 2% of controls, 25% vs. 8% for 12- to 17-year-olds, and 28% vs. 12% for those 18 and older (P < .01 for all three comparisons).

Survivors were also significantly more likely to have any indicator of potential misuse (1.6% vs. 0.1%, 4.6% vs. 0.5%, and 7.4% vs. 1.2%, respectively, P < .001 for all) and both the youngest and oldest groups (but not 12- to 17-year-olds) were significantly more like to have opioid or substance use disorder (0.4% vs. 0% for 0-11 years, 5.76% vs. 4.2% for 18 years and older, P < .001 for both).

Among patients with any opioid prescription, survivors were significantly more likely than were controls of any age to have indicators for potential misuse. For example, 13% of survivors aged 18 years and older had prescriptions for high opioid doses, compared with 5% of controls, and 12% had prescription overlap, vs. 2%.

Compared with patients with leukemia, patients treated for bone malignancies had a 6% greater risk for having any indicator of misuse, while patients with other malignancies were at slightly lower risk for misuse than those who completed leukemia therapy.

Patients who received any stem cell transplant had an 8.4% greater risk for misuse compared with patients who had surgery only.
 

Opioids pre- and posttreatment?

“Being someone who takes care of a lot of bone cancer patients, I do see patients with these issues,” Dr. Spunt said.

Audience member Jack H. Staddon, MD, PhD, of the Billings (Montana) Clinic, noted the possibility that opioid use during treatment may have been carried on into the posttreatment period, and asked whether use of narcotics during treatment was an independent risk factor for posttreatment narcotic use or misuse.

The researchers plan to investigate this question in future studies, Dr. Ji replied.

They did not report a study funding source. Dr. Ji and coauthors and Dr. Staddon reported no relevant disclosures.

Survivors of childhood cancers are at increased risk for prescription opioid misuse compared with their peers, a review of a claims database revealed.

Among more than 8,000 patients age 21 or younger who had completed treatment for hematologic, central nervous system, bone, or gonadal cancers, survivors were significantly more likely than were their peers to have an opioid prescription, longer duration of prescription, and higher daily doses of opioids, and to have opioid prescriptions overlapping for a week or more, reported Xu Ji, PhD, of Emory University in Atlanta.

Teenage and young adult patients were at higher risk than were patients younger than 12, and the risk was highest among patients who had been treated for bone malignancies, as well as those who had undergone any hematopoietic stem cell transplant.

“These findings suggest that health care providers who regularly see survivors should explore nonopioid options to help prevent opioid misuse, and screen for potential misuse in those who actually receive opioids,” she said in an oral abstract presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.

“This is a really important topic, and something that’s probably been underinvestigated and underexplored in our patient population,” said session comoderator Sheri Spunt, MD, Endowed Professor of Pediatric Cancer at Stanford (Calif.) University.
 

Database review

Dr. Ji and colleagues used the IBM MarketScan Commercial Claims and Encounters database from 2009 to 2018 to examine prescription opioid use, potential misuse, and substance use disorders in pediatric cancer survivors in the first year after completion of therapy, and to identify factors associated with risk for misuse or substance use disorders. Specifically, the period of interest was the first year after completion of all treatments, including surgery, chemotherapy, radiation, and stem cell transplant (Abstract 2015).

They looked at deidentified records on any opioid prescription and for treatment of any opioid use or substance use disorder (alcohol, psychotherapeutic drugs, marijuana, or illicit drug use disorders).

They defined indicators of potential misuse as either prescriptions for long-acting or extended-release opioids for acute pain conditions; opioid and benzodiazepine prescriptions overlapping by a week or more; opioid prescriptions overlapping by a week or more; high daily opioid dosage (prescribed daily dose of 100 or greater morphine milligram equivalent [MME]; and/or opioid dose escalation (an increase of at least 50% in mean MMEs per month twice consecutively within 1 year).

They compared outcomes between a total of 8,635 survivors and 44,175 controls, matched on a 1:5 basis with survivors by age, sex, and region, and continuous enrollment during the 1-year posttherapy period.

In each of three age categories – 0 to 11 years, 12 to 17 years, and 18 years and older – survivors were significantly more likely to have received an opioid prescription, at 15% for the youngest survivors vs. 2% of controls, 25% vs. 8% for 12- to 17-year-olds, and 28% vs. 12% for those 18 and older (P < .01 for all three comparisons).

Survivors were also significantly more likely to have any indicator of potential misuse (1.6% vs. 0.1%, 4.6% vs. 0.5%, and 7.4% vs. 1.2%, respectively, P < .001 for all) and both the youngest and oldest groups (but not 12- to 17-year-olds) were significantly more like to have opioid or substance use disorder (0.4% vs. 0% for 0-11 years, 5.76% vs. 4.2% for 18 years and older, P < .001 for both).

Among patients with any opioid prescription, survivors were significantly more likely than were controls of any age to have indicators for potential misuse. For example, 13% of survivors aged 18 years and older had prescriptions for high opioid doses, compared with 5% of controls, and 12% had prescription overlap, vs. 2%.

Compared with patients with leukemia, patients treated for bone malignancies had a 6% greater risk for having any indicator of misuse, while patients with other malignancies were at slightly lower risk for misuse than those who completed leukemia therapy.

Patients who received any stem cell transplant had an 8.4% greater risk for misuse compared with patients who had surgery only.
 

Opioids pre- and posttreatment?

“Being someone who takes care of a lot of bone cancer patients, I do see patients with these issues,” Dr. Spunt said.

Audience member Jack H. Staddon, MD, PhD, of the Billings (Montana) Clinic, noted the possibility that opioid use during treatment may have been carried on into the posttreatment period, and asked whether use of narcotics during treatment was an independent risk factor for posttreatment narcotic use or misuse.

The researchers plan to investigate this question in future studies, Dr. Ji replied.

They did not report a study funding source. Dr. Ji and coauthors and Dr. Staddon reported no relevant disclosures.

Survivors of childhood cancers are at increased risk for prescription opioid misuse compared with their peers, a review of a claims database revealed.

Among more than 8,000 patients age 21 or younger who had completed treatment for hematologic, central nervous system, bone, or gonadal cancers, survivors were significantly more likely than were their peers to have an opioid prescription, longer duration of prescription, and higher daily doses of opioids, and to have opioid prescriptions overlapping for a week or more, reported Xu Ji, PhD, of Emory University in Atlanta.

Teenage and young adult patients were at higher risk than were patients younger than 12, and the risk was highest among patients who had been treated for bone malignancies, as well as those who had undergone any hematopoietic stem cell transplant.

“These findings suggest that health care providers who regularly see survivors should explore nonopioid options to help prevent opioid misuse, and screen for potential misuse in those who actually receive opioids,” she said in an oral abstract presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.

“This is a really important topic, and something that’s probably been underinvestigated and underexplored in our patient population,” said session comoderator Sheri Spunt, MD, Endowed Professor of Pediatric Cancer at Stanford (Calif.) University.
 

Database review

Dr. Ji and colleagues used the IBM MarketScan Commercial Claims and Encounters database from 2009 to 2018 to examine prescription opioid use, potential misuse, and substance use disorders in pediatric cancer survivors in the first year after completion of therapy, and to identify factors associated with risk for misuse or substance use disorders. Specifically, the period of interest was the first year after completion of all treatments, including surgery, chemotherapy, radiation, and stem cell transplant (Abstract 2015).

They looked at deidentified records on any opioid prescription and for treatment of any opioid use or substance use disorder (alcohol, psychotherapeutic drugs, marijuana, or illicit drug use disorders).

They defined indicators of potential misuse as either prescriptions for long-acting or extended-release opioids for acute pain conditions; opioid and benzodiazepine prescriptions overlapping by a week or more; opioid prescriptions overlapping by a week or more; high daily opioid dosage (prescribed daily dose of 100 or greater morphine milligram equivalent [MME]; and/or opioid dose escalation (an increase of at least 50% in mean MMEs per month twice consecutively within 1 year).

They compared outcomes between a total of 8,635 survivors and 44,175 controls, matched on a 1:5 basis with survivors by age, sex, and region, and continuous enrollment during the 1-year posttherapy period.

In each of three age categories – 0 to 11 years, 12 to 17 years, and 18 years and older – survivors were significantly more likely to have received an opioid prescription, at 15% for the youngest survivors vs. 2% of controls, 25% vs. 8% for 12- to 17-year-olds, and 28% vs. 12% for those 18 and older (P < .01 for all three comparisons).

Survivors were also significantly more likely to have any indicator of potential misuse (1.6% vs. 0.1%, 4.6% vs. 0.5%, and 7.4% vs. 1.2%, respectively, P < .001 for all) and both the youngest and oldest groups (but not 12- to 17-year-olds) were significantly more like to have opioid or substance use disorder (0.4% vs. 0% for 0-11 years, 5.76% vs. 4.2% for 18 years and older, P < .001 for both).

Among patients with any opioid prescription, survivors were significantly more likely than were controls of any age to have indicators for potential misuse. For example, 13% of survivors aged 18 years and older had prescriptions for high opioid doses, compared with 5% of controls, and 12% had prescription overlap, vs. 2%.

Compared with patients with leukemia, patients treated for bone malignancies had a 6% greater risk for having any indicator of misuse, while patients with other malignancies were at slightly lower risk for misuse than those who completed leukemia therapy.

Patients who received any stem cell transplant had an 8.4% greater risk for misuse compared with patients who had surgery only.
 

Opioids pre- and posttreatment?

“Being someone who takes care of a lot of bone cancer patients, I do see patients with these issues,” Dr. Spunt said.

Audience member Jack H. Staddon, MD, PhD, of the Billings (Montana) Clinic, noted the possibility that opioid use during treatment may have been carried on into the posttreatment period, and asked whether use of narcotics during treatment was an independent risk factor for posttreatment narcotic use or misuse.

The researchers plan to investigate this question in future studies, Dr. Ji replied.

They did not report a study funding source. Dr. Ji and coauthors and Dr. Staddon reported no relevant disclosures.

As the number of elderly patients with cancer continues to rise – and geriatricians remain in short supply – primary care providers and community oncologists need to incorporate formal geriatric assessment into routine practice, a geriatric oncologist said during a presentation at the American College of Physicians annual Internal Medicine meeting.

A 2020 ASCO survey, which the speaker, Grant R. Williams, MD, coauthored, found that 9 out of 10 community oncologists assessed at least some older patients differently than younger patients. But only 1 out of 3 did so in a formal manner, Dr. Williams, director of the cancer and aging program at the University of Alabama at Birmingham, said during presentation at virtual meeting.

In most cases, informal geriatric assessment considers only the tip of the ‘geriatric oncology iceberg,’ including chronological age, performance status, tumor characteristics, and organ function, Dr. Williams noted.

In contrast, formal geriatric assessment dives deeper, measuring a series of additional outcome-associated factors: polypharmacy, comorbidities, falls, psychosocial dysfunction, social support, sarcopenia, nutritional deficits, cognitive impairment, and functional issues.

“All these other factors under the surface are critically important to developing a personalized and individualized cancer treatment plan for older adults,” Dr. Williams said.

He went on to explain that elderly cancer patients can be sorted into three broad categories: fit, vulnerable, and frail. Fit and frail patients are relatively easy to identify, but most elderly patients fall into the vulnerable category, Dr. Williams noted.

“It’s really more challenging to identify those individuals across the spectrum than those at the extremes,” Dr. Williams said, noting that formal geriatric assessment can detect problems not found routinely.
 

Formal geriatric assessment’s value

Geriatric assessment can be used for risk modeling and making life-expectancy calculations. It can also be used as an interventional tool, guiding cancer treatment selection, he said. Furthermore, it can open doors to general health interventions, such as occupational therapy, to reduce fall risk.

Beneficial interventions identified by geriatric assessment have been shown to improve function, reduce chemotherapy toxicities, improve quality of life, and extend survival, Dr. Williams noted.

Formal geriatric assessment may be particularly useful for primary care providers considering referral to an oncologist, he said.

“I think performing a geriatric assessment [prior to referral] would be a great idea. And that’s twofold: Even before you send them to the oncologist, it gives you an idea of how they may tolerate treatment, and frankly, it may give you an idea that they don’t need a referral to the oncologist if they’re particularly frail,” noted Dr. Williams.
 

Alternatives to formal assessments

When asked how providers can incorporate formal assessments into a busy day at the clinic, Dr. Williams encouraged the use of abbreviated formal assessments, then adding further testing if needed.

“Given known time and support staff restraints, modified geriatric assessment tools have been developed that are either mostly or completely patient-reported,” he said in an interview, referring to the Cancer and Aging Research Group (CARG) Geriatric Assessment and the Cancer and Aging Resilience Evaluation (CARE), respectively.

“[These assessments] can easily be completed before clinical visits or while in the waiting room,” Dr. Williams noted. “The additional objective tests, such as Timed Up and Go, and Mental Status Exam, can be completed if deemed necessary based on these initial assessments.”

Martine Extermann, MD, PhD, provided her suggestions in an interview for what physicians can do to get better outcomes for this patient group.

Courtesy Dr. Extermann

Gerontology remains a practice gap

Oncologists who don’t perform geriatric assessments are probably missing more than they think, Dr. Extermann said in an interview.

“Many oncologists don’t fully realize the importance of [geriatric assessment] yet,” Dr. Extermann said. “They kind of think that their internal medicine training will carry through, and they’ll be able to identify everything; actually, we know very well we miss half of what is found by geriatric assessment clinically.”

Gerontology remains a practice gap, Dr. Extermann said, not only within oncology, but across specialties.

“One of the big problems with the U.S. health care system is we don’t have enough geriatricians, and the reason we don’t have enough geriatricians is because we don’t pay them,” she said.

“Geriatrics is the only specialty where you do more training to be paid less, because Medicare doesn’t reimburse geriatric assessment, [and] it doesn’t reimburse geriatric consultation. [This] doesn’t motivate universities to create geriatric clinics and geriatric programs because they will lose money, basically, doing that. If we want to really solve the problem, we have to solve the reimbursement problem up front,” she explained.

Dr. Williams disclosed financial relationships with Carevive Health Systems, Cardinal Health, the National Cancer Institute, and the American Cancer Society. Dr. Extermann reported no conflicts of interest.
 

As the number of elderly patients with cancer continues to rise – and geriatricians remain in short supply – primary care providers and community oncologists need to incorporate formal geriatric assessment into routine practice, a geriatric oncologist said during a presentation at the American College of Physicians annual Internal Medicine meeting.

A 2020 ASCO survey, which the speaker, Grant R. Williams, MD, coauthored, found that 9 out of 10 community oncologists assessed at least some older patients differently than younger patients. But only 1 out of 3 did so in a formal manner, Dr. Williams, director of the cancer and aging program at the University of Alabama at Birmingham, said during presentation at virtual meeting.

In most cases, informal geriatric assessment considers only the tip of the ‘geriatric oncology iceberg,’ including chronological age, performance status, tumor characteristics, and organ function, Dr. Williams noted.

In contrast, formal geriatric assessment dives deeper, measuring a series of additional outcome-associated factors: polypharmacy, comorbidities, falls, psychosocial dysfunction, social support, sarcopenia, nutritional deficits, cognitive impairment, and functional issues.

“All these other factors under the surface are critically important to developing a personalized and individualized cancer treatment plan for older adults,” Dr. Williams said.

He went on to explain that elderly cancer patients can be sorted into three broad categories: fit, vulnerable, and frail. Fit and frail patients are relatively easy to identify, but most elderly patients fall into the vulnerable category, Dr. Williams noted.

“It’s really more challenging to identify those individuals across the spectrum than those at the extremes,” Dr. Williams said, noting that formal geriatric assessment can detect problems not found routinely.
 

Formal geriatric assessment’s value

Geriatric assessment can be used for risk modeling and making life-expectancy calculations. It can also be used as an interventional tool, guiding cancer treatment selection, he said. Furthermore, it can open doors to general health interventions, such as occupational therapy, to reduce fall risk.

Beneficial interventions identified by geriatric assessment have been shown to improve function, reduce chemotherapy toxicities, improve quality of life, and extend survival, Dr. Williams noted.

Formal geriatric assessment may be particularly useful for primary care providers considering referral to an oncologist, he said.

“I think performing a geriatric assessment [prior to referral] would be a great idea. And that’s twofold: Even before you send them to the oncologist, it gives you an idea of how they may tolerate treatment, and frankly, it may give you an idea that they don’t need a referral to the oncologist if they’re particularly frail,” noted Dr. Williams.
 

Alternatives to formal assessments

When asked how providers can incorporate formal assessments into a busy day at the clinic, Dr. Williams encouraged the use of abbreviated formal assessments, then adding further testing if needed.

“Given known time and support staff restraints, modified geriatric assessment tools have been developed that are either mostly or completely patient-reported,” he said in an interview, referring to the Cancer and Aging Research Group (CARG) Geriatric Assessment and the Cancer and Aging Resilience Evaluation (CARE), respectively.

“[These assessments] can easily be completed before clinical visits or while in the waiting room,” Dr. Williams noted. “The additional objective tests, such as Timed Up and Go, and Mental Status Exam, can be completed if deemed necessary based on these initial assessments.”

Martine Extermann, MD, PhD, provided her suggestions in an interview for what physicians can do to get better outcomes for this patient group.

Courtesy Dr. Extermann

Gerontology remains a practice gap

Oncologists who don’t perform geriatric assessments are probably missing more than they think, Dr. Extermann said in an interview.

“Many oncologists don’t fully realize the importance of [geriatric assessment] yet,” Dr. Extermann said. “They kind of think that their internal medicine training will carry through, and they’ll be able to identify everything; actually, we know very well we miss half of what is found by geriatric assessment clinically.”

Gerontology remains a practice gap, Dr. Extermann said, not only within oncology, but across specialties.

“One of the big problems with the U.S. health care system is we don’t have enough geriatricians, and the reason we don’t have enough geriatricians is because we don’t pay them,” she said.

“Geriatrics is the only specialty where you do more training to be paid less, because Medicare doesn’t reimburse geriatric assessment, [and] it doesn’t reimburse geriatric consultation. [This] doesn’t motivate universities to create geriatric clinics and geriatric programs because they will lose money, basically, doing that. If we want to really solve the problem, we have to solve the reimbursement problem up front,” she explained.

Dr. Williams disclosed financial relationships with Carevive Health Systems, Cardinal Health, the National Cancer Institute, and the American Cancer Society. Dr. Extermann reported no conflicts of interest.
 

As the number of elderly patients with cancer continues to rise – and geriatricians remain in short supply – primary care providers and community oncologists need to incorporate formal geriatric assessment into routine practice, a geriatric oncologist said during a presentation at the American College of Physicians annual Internal Medicine meeting.

A 2020 ASCO survey, which the speaker, Grant R. Williams, MD, coauthored, found that 9 out of 10 community oncologists assessed at least some older patients differently than younger patients. But only 1 out of 3 did so in a formal manner, Dr. Williams, director of the cancer and aging program at the University of Alabama at Birmingham, said during presentation at virtual meeting.

In most cases, informal geriatric assessment considers only the tip of the ‘geriatric oncology iceberg,’ including chronological age, performance status, tumor characteristics, and organ function, Dr. Williams noted.

In contrast, formal geriatric assessment dives deeper, measuring a series of additional outcome-associated factors: polypharmacy, comorbidities, falls, psychosocial dysfunction, social support, sarcopenia, nutritional deficits, cognitive impairment, and functional issues.

“All these other factors under the surface are critically important to developing a personalized and individualized cancer treatment plan for older adults,” Dr. Williams said.

He went on to explain that elderly cancer patients can be sorted into three broad categories: fit, vulnerable, and frail. Fit and frail patients are relatively easy to identify, but most elderly patients fall into the vulnerable category, Dr. Williams noted.

“It’s really more challenging to identify those individuals across the spectrum than those at the extremes,” Dr. Williams said, noting that formal geriatric assessment can detect problems not found routinely.
 

Formal geriatric assessment’s value

Geriatric assessment can be used for risk modeling and making life-expectancy calculations. It can also be used as an interventional tool, guiding cancer treatment selection, he said. Furthermore, it can open doors to general health interventions, such as occupational therapy, to reduce fall risk.

Beneficial interventions identified by geriatric assessment have been shown to improve function, reduce chemotherapy toxicities, improve quality of life, and extend survival, Dr. Williams noted.

Formal geriatric assessment may be particularly useful for primary care providers considering referral to an oncologist, he said.

“I think performing a geriatric assessment [prior to referral] would be a great idea. And that’s twofold: Even before you send them to the oncologist, it gives you an idea of how they may tolerate treatment, and frankly, it may give you an idea that they don’t need a referral to the oncologist if they’re particularly frail,” noted Dr. Williams.
 

Alternatives to formal assessments

When asked how providers can incorporate formal assessments into a busy day at the clinic, Dr. Williams encouraged the use of abbreviated formal assessments, then adding further testing if needed.

“Given known time and support staff restraints, modified geriatric assessment tools have been developed that are either mostly or completely patient-reported,” he said in an interview, referring to the Cancer and Aging Research Group (CARG) Geriatric Assessment and the Cancer and Aging Resilience Evaluation (CARE), respectively.

“[These assessments] can easily be completed before clinical visits or while in the waiting room,” Dr. Williams noted. “The additional objective tests, such as Timed Up and Go, and Mental Status Exam, can be completed if deemed necessary based on these initial assessments.”

Martine Extermann, MD, PhD, provided her suggestions in an interview for what physicians can do to get better outcomes for this patient group.

Courtesy Dr. Extermann

Gerontology remains a practice gap

Oncologists who don’t perform geriatric assessments are probably missing more than they think, Dr. Extermann said in an interview.

“Many oncologists don’t fully realize the importance of [geriatric assessment] yet,” Dr. Extermann said. “They kind of think that their internal medicine training will carry through, and they’ll be able to identify everything; actually, we know very well we miss half of what is found by geriatric assessment clinically.”

Gerontology remains a practice gap, Dr. Extermann said, not only within oncology, but across specialties.

“One of the big problems with the U.S. health care system is we don’t have enough geriatricians, and the reason we don’t have enough geriatricians is because we don’t pay them,” she said.

“Geriatrics is the only specialty where you do more training to be paid less, because Medicare doesn’t reimburse geriatric assessment, [and] it doesn’t reimburse geriatric consultation. [This] doesn’t motivate universities to create geriatric clinics and geriatric programs because they will lose money, basically, doing that. If we want to really solve the problem, we have to solve the reimbursement problem up front,” she explained.

Dr. Williams disclosed financial relationships with Carevive Health Systems, Cardinal Health, the National Cancer Institute, and the American Cancer Society. Dr. Extermann reported no conflicts of interest.
 

Whether they realize it or not, hospitalists treating patients during the COVID-19 pandemic have been in a combat-like situation, with challenges and stresses similar to those faced by soldiers in a war zone.

And now, as the pandemic shows signs of subsiding, they’re about to emerge from this fight, which poses a whole new set of challenges, according a retired U.S. Army general who spoke May 4 at SHM Converge, the annual conference of the Society of Hospital Medicine.

Lt. Gen. (Ret.) Mark Hertling, DBA, said during his keynote speech that clinicians and soldiers – the only two professions that routinely have to navigate through life and death situations – must lead during all phases of combat.

“This is a period where you’re going to experience some things that you may or may not be ready for,” he said. “These are the same kind of issues soldiers face when redeploying from a combat zone.”

To help draw the comparison between hospitalists during the COVID-19 era and troops during a war, Lt. Gen. Hertling showed a photo of a U.S. paratrooper who’d just dropped into northern Iraq, carrying a backpack engorged with gear. He was on one knee with his face downcast as he seemed to be taking a moment to reflect on the enormity, complexity, and danger of the crisis into which he was about to plunge. He was, Lt. Gen. Hertling said, likely pondering the mission, his family he left behind, and concerns about making mistakes in front of his comrades.

Then he showed a picture of a health care worker in a hospital corridor slumped on the floor with his or her back against the wall, knees up, and hands loosely clasped, looking exhausted and dazed. Health care workers also have carried a load that has seemed unbearable.

“You can certainly see that they are experiencing an emotional trauma at the very start of the pandemic,” he said. “The things you have carried over the last year-plus as the pandemic has raged will be with you in good and sometimes bad ways, and you need to address those things.”

Lt. Gen. Hertling described several issues – mirroring those seen in combat – that clinicians will take away from the COVID-19 experience and must grapple with as the closing chapters of the pandemic play out:
 

A sense of teamwork in a crisis

While it’s not unusual, he said, for physicians not to get along well with administrators, and for nurses sometimes not to trust doctors, the COVID-19 crisis created a sense of effective teamwork.

“They have built trust because they see a common mission and a common requirement,” he said.
 

A sense of loss

“You have lost patients, you probably have lost comrades, and some of you are having this associated survivor’s guilt – why did you survive and so many of your patients, perhaps a lot of your friends, did not?”

At memorial services for fallen soldiers, Lt. Gen. Hertling would bring a laminated card with the soldier’s picture and put it in a box with the words “Make It Matter” on it.

“That was our code for ensuring that every one of these individual soldiers who sacrificed their lives for the organization, we would carry on their legacy and make their sacrifice matter,” he said. “That’s one of the few ways you can overcome survivor’s guilt.”
 

Sense of accomplishment

Lt. Gen. Hertling said hospitalists, pushed to the extreme, were able to do things they never thought they were capable of.

“You have to relish in that, and you have to write those things down so you can go back and think about the things you did in a crisis environment to help,” he said.

In the post-pandemic era, health care workers should reflect on what they have seen, learned, and experienced, to help set a new standard and to establish ways to eliminate “bureaucratic morasses,” which seemed more possible than ever because the urgency of the moment demanded it.

Lt. Gen. Hertling also said hospitalists should take time to make a plan to handle personal, professional, team, and organizational requirements. For instance, health care workers should get a physical to take stock of how their bodies reacted to the stress of the pandemic. He said they should also recognize the difference between posttraumatic stress, which is to be expected, and posttraumatic stress disorder (PTSD), which is less common.

“It’s only at the extreme that it becomes a dysfunction and you have to address it with the help of others,” he said. Hospitalists should examine the state of their emotional and spiritual relationships – with family and friends as well as with God or other figures important to them spiritually.

Professionally, hospitalists should review professional accomplishments and shortcomings and make changes based on those assessments, he said. It’s also a good time to assess leadership issues – recall who the contributors were and who could have done more. Hospitalists should also consider contributing post-pandemic articles to the Journal of Hospital Medicine, he said.

Lt. Gen. Hertling concluded by suggesting that hospitalists seek feedback on themselves and their own leadership qualities, from their team members.

“Really press the issue,” he said, “and get a good critique on how you can improve personally and professionally in terms of your leadership approach.”

Whether they realize it or not, hospitalists treating patients during the COVID-19 pandemic have been in a combat-like situation, with challenges and stresses similar to those faced by soldiers in a war zone.

And now, as the pandemic shows signs of subsiding, they’re about to emerge from this fight, which poses a whole new set of challenges, according a retired U.S. Army general who spoke May 4 at SHM Converge, the annual conference of the Society of Hospital Medicine.

Lt. Gen. (Ret.) Mark Hertling, DBA, said during his keynote speech that clinicians and soldiers – the only two professions that routinely have to navigate through life and death situations – must lead during all phases of combat.

“This is a period where you’re going to experience some things that you may or may not be ready for,” he said. “These are the same kind of issues soldiers face when redeploying from a combat zone.”

To help draw the comparison between hospitalists during the COVID-19 era and troops during a war, Lt. Gen. Hertling showed a photo of a U.S. paratrooper who’d just dropped into northern Iraq, carrying a backpack engorged with gear. He was on one knee with his face downcast as he seemed to be taking a moment to reflect on the enormity, complexity, and danger of the crisis into which he was about to plunge. He was, Lt. Gen. Hertling said, likely pondering the mission, his family he left behind, and concerns about making mistakes in front of his comrades.

Then he showed a picture of a health care worker in a hospital corridor slumped on the floor with his or her back against the wall, knees up, and hands loosely clasped, looking exhausted and dazed. Health care workers also have carried a load that has seemed unbearable.

“You can certainly see that they are experiencing an emotional trauma at the very start of the pandemic,” he said. “The things you have carried over the last year-plus as the pandemic has raged will be with you in good and sometimes bad ways, and you need to address those things.”

Lt. Gen. Hertling described several issues – mirroring those seen in combat – that clinicians will take away from the COVID-19 experience and must grapple with as the closing chapters of the pandemic play out:
 

A sense of teamwork in a crisis

While it’s not unusual, he said, for physicians not to get along well with administrators, and for nurses sometimes not to trust doctors, the COVID-19 crisis created a sense of effective teamwork.

“They have built trust because they see a common mission and a common requirement,” he said.
 

A sense of loss

“You have lost patients, you probably have lost comrades, and some of you are having this associated survivor’s guilt – why did you survive and so many of your patients, perhaps a lot of your friends, did not?”

At memorial services for fallen soldiers, Lt. Gen. Hertling would bring a laminated card with the soldier’s picture and put it in a box with the words “Make It Matter” on it.

“That was our code for ensuring that every one of these individual soldiers who sacrificed their lives for the organization, we would carry on their legacy and make their sacrifice matter,” he said. “That’s one of the few ways you can overcome survivor’s guilt.”
 

Sense of accomplishment

Lt. Gen. Hertling said hospitalists, pushed to the extreme, were able to do things they never thought they were capable of.

“You have to relish in that, and you have to write those things down so you can go back and think about the things you did in a crisis environment to help,” he said.

In the post-pandemic era, health care workers should reflect on what they have seen, learned, and experienced, to help set a new standard and to establish ways to eliminate “bureaucratic morasses,” which seemed more possible than ever because the urgency of the moment demanded it.

Lt. Gen. Hertling also said hospitalists should take time to make a plan to handle personal, professional, team, and organizational requirements. For instance, health care workers should get a physical to take stock of how their bodies reacted to the stress of the pandemic. He said they should also recognize the difference between posttraumatic stress, which is to be expected, and posttraumatic stress disorder (PTSD), which is less common.

“It’s only at the extreme that it becomes a dysfunction and you have to address it with the help of others,” he said. Hospitalists should examine the state of their emotional and spiritual relationships – with family and friends as well as with God or other figures important to them spiritually.

Professionally, hospitalists should review professional accomplishments and shortcomings and make changes based on those assessments, he said. It’s also a good time to assess leadership issues – recall who the contributors were and who could have done more. Hospitalists should also consider contributing post-pandemic articles to the Journal of Hospital Medicine, he said.

Lt. Gen. Hertling concluded by suggesting that hospitalists seek feedback on themselves and their own leadership qualities, from their team members.

“Really press the issue,” he said, “and get a good critique on how you can improve personally and professionally in terms of your leadership approach.”

Whether they realize it or not, hospitalists treating patients during the COVID-19 pandemic have been in a combat-like situation, with challenges and stresses similar to those faced by soldiers in a war zone.

And now, as the pandemic shows signs of subsiding, they’re about to emerge from this fight, which poses a whole new set of challenges, according a retired U.S. Army general who spoke May 4 at SHM Converge, the annual conference of the Society of Hospital Medicine.

Lt. Gen. (Ret.) Mark Hertling, DBA, said during his keynote speech that clinicians and soldiers – the only two professions that routinely have to navigate through life and death situations – must lead during all phases of combat.

“This is a period where you’re going to experience some things that you may or may not be ready for,” he said. “These are the same kind of issues soldiers face when redeploying from a combat zone.”

To help draw the comparison between hospitalists during the COVID-19 era and troops during a war, Lt. Gen. Hertling showed a photo of a U.S. paratrooper who’d just dropped into northern Iraq, carrying a backpack engorged with gear. He was on one knee with his face downcast as he seemed to be taking a moment to reflect on the enormity, complexity, and danger of the crisis into which he was about to plunge. He was, Lt. Gen. Hertling said, likely pondering the mission, his family he left behind, and concerns about making mistakes in front of his comrades.

Then he showed a picture of a health care worker in a hospital corridor slumped on the floor with his or her back against the wall, knees up, and hands loosely clasped, looking exhausted and dazed. Health care workers also have carried a load that has seemed unbearable.

“You can certainly see that they are experiencing an emotional trauma at the very start of the pandemic,” he said. “The things you have carried over the last year-plus as the pandemic has raged will be with you in good and sometimes bad ways, and you need to address those things.”

Lt. Gen. Hertling described several issues – mirroring those seen in combat – that clinicians will take away from the COVID-19 experience and must grapple with as the closing chapters of the pandemic play out:
 

A sense of teamwork in a crisis

While it’s not unusual, he said, for physicians not to get along well with administrators, and for nurses sometimes not to trust doctors, the COVID-19 crisis created a sense of effective teamwork.

“They have built trust because they see a common mission and a common requirement,” he said.
 

A sense of loss

“You have lost patients, you probably have lost comrades, and some of you are having this associated survivor’s guilt – why did you survive and so many of your patients, perhaps a lot of your friends, did not?”

At memorial services for fallen soldiers, Lt. Gen. Hertling would bring a laminated card with the soldier’s picture and put it in a box with the words “Make It Matter” on it.

“That was our code for ensuring that every one of these individual soldiers who sacrificed their lives for the organization, we would carry on their legacy and make their sacrifice matter,” he said. “That’s one of the few ways you can overcome survivor’s guilt.”
 

Sense of accomplishment

Lt. Gen. Hertling said hospitalists, pushed to the extreme, were able to do things they never thought they were capable of.

“You have to relish in that, and you have to write those things down so you can go back and think about the things you did in a crisis environment to help,” he said.

In the post-pandemic era, health care workers should reflect on what they have seen, learned, and experienced, to help set a new standard and to establish ways to eliminate “bureaucratic morasses,” which seemed more possible than ever because the urgency of the moment demanded it.

Lt. Gen. Hertling also said hospitalists should take time to make a plan to handle personal, professional, team, and organizational requirements. For instance, health care workers should get a physical to take stock of how their bodies reacted to the stress of the pandemic. He said they should also recognize the difference between posttraumatic stress, which is to be expected, and posttraumatic stress disorder (PTSD), which is less common.

“It’s only at the extreme that it becomes a dysfunction and you have to address it with the help of others,” he said. Hospitalists should examine the state of their emotional and spiritual relationships – with family and friends as well as with God or other figures important to them spiritually.

Professionally, hospitalists should review professional accomplishments and shortcomings and make changes based on those assessments, he said. It’s also a good time to assess leadership issues – recall who the contributors were and who could have done more. Hospitalists should also consider contributing post-pandemic articles to the Journal of Hospital Medicine, he said.

Lt. Gen. Hertling concluded by suggesting that hospitalists seek feedback on themselves and their own leadership qualities, from their team members.

“Really press the issue,” he said, “and get a good critique on how you can improve personally and professionally in terms of your leadership approach.”

The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.

“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.

“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.

The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.

“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial (Lancet Diabetes Endocrinol 2021 Apr 29; doi: 10.1016/S2213-8587[21]00109-1).

Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.

For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.

Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.


 

Risk rises from BMI of 23 kg/m²

In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).

The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).

In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m² (adjusted HR 1.10).

“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.

The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).

In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).

“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.

Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.

Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.

Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”

Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.

“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.

Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.

The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.

Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.

The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.

“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.

“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.

The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.

“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial (Lancet Diabetes Endocrinol 2021 Apr 29; doi: 10.1016/S2213-8587[21]00109-1).

Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.

For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.

Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.


 

Risk rises from BMI of 23 kg/m²

In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).

The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).

In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m² (adjusted HR 1.10).

“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.

The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).

In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).

“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.

Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.

Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.

Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”

Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.

“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.

Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.

The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.

Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.

The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.

“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.

“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.

The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.

“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial (Lancet Diabetes Endocrinol 2021 Apr 29; doi: 10.1016/S2213-8587[21]00109-1).

Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.

For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.

Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.


 

Risk rises from BMI of 23 kg/m²

In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).

The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).

In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m² (adjusted HR 1.10).

“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.

The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).

In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).

“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.

Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.

Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.

Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”

Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.

“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.

Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.

The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.

Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.

Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m² or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.

“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m² or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.

“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m² or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.

“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.

The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.

Serious mental health hit

In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.

Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.

The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%). 

Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).

In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.

Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).

The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.

Call to action

More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.

More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.

Nearly half (49%) of parents of children younger than 18 years say their child received help from a mental health professional since the start of the pandemic; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.

More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.

“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.

“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.

Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.

For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).

Resiliency a finite resource

Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.

“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.

He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.

“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.

The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.

“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.

“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.

While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.

“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.

“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.

“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.

Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.

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

Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.

The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.

Serious mental health hit

In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.

Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.

The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%). 

Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).

In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.

Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).

The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.

Call to action

More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.

More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.

Nearly half (49%) of parents of children younger than 18 years say their child received help from a mental health professional since the start of the pandemic; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.

More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.

“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.

“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.

Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.

For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).

Resiliency a finite resource

Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.

“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.

He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.

“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.

The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.

“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.

“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.

While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.

“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.

“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.

“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.

Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.

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

Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.

The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.

Serious mental health hit

In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.

Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.

The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%). 

Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).

In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.

Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).

The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.

Call to action

More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.

More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.

Nearly half (49%) of parents of children younger than 18 years say their child received help from a mental health professional since the start of the pandemic; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.

More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.

“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.

“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.

Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.

For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).

Resiliency a finite resource

Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.

“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.

He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.

“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.

The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.

“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.

“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.

While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.

“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.

“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.

“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.

Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.

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

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

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

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

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

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

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

The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

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

The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

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

The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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