Oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) offers a safe and effective strategy for treating patients with complicated urinary tract infections, according to a new study.

“No new oral antibiotic alternative has emerged to treat these conditions in more than 25 years,” corresponding author Angela K. Talley, MD, said in an interview. The new research was published in the New England Journal of Medicine.

Courtesy Spero Therapeutics

Patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), are often hospitalized and treated with intravenous therapy because of the lack of oral options, especially in cases of antibiotic-resistant pathogens, explained Dr. Talley, of Spero Therapeutics.

In their new phase 3, double-blind randomized trial, the researchers evaluated the safety and effectiveness of oral TBP-PI-HBr, compared with intravenous ertapenem in hospitalized patients with cUTIs or AP. Oral tebipenem is an investigational carbapenem with demonstrated activity against uropathogenic Enterobacterales, and it has shown effectiveness in animal models, the researchers noted in their paper.
 

Methods and results

The researchers randomized 1,372 adult patients. The microbiologic intent-to-treat population included 449 patients who received TBP-PI-HBr (600 mg every 8 hours) and 419 who received ertapenem (1 g every 24 hours) for 7-10 days or up to 14 days for patients with bacteremia.

The primary endpoint was a composite of clinical cure and favorable microbiologic response, assessed at a test-of-cure visit on day 19. Clinical cure was defined as “complete resolution or clinically significant alleviation of baseline signs and symptoms of complicated urinary tract infection or acute pyelonephritis and no new symptoms, such that no further antimicrobial therapy was warranted,” the researchers wrote. Microbiologic response was defined as a reduction to less than 103 CFU per milliliter in uropathogen levels from baseline at day 19.

Overall, the clinical response occurred in 58.8% of patients who received TBP-PI-HBr and 61.6% of those who received ertapenem at the test-of-cure visit.

Clinical cure rates were similar in the TBP-PI-HBr and ertapenem groups (93.1% vs. 93.6%) at the test-of-cure visit.

Both treatment groups showed similar responses to Enterobacterales pathogens at the test-of-cure visit (62.7% for TBP-PI-HBr and 65.2% for ertapenem).

Among patients with bacteremia at baseline, overall response rates were 72.3% and 66.0% for TBP-PI-HBr and ertapenem, respectively, at the test-of-cure visit, and 93.6% and 96.2%, respectively, at the end-of-treatment visit on or around day 25.

The overall incidence of adverse events was approximately 26% in both treatment groups. Most adverse events were mild or moderate in severity and did not limit treatment, the researchers wrote.

The mean age of the patients was 58.1 years; 46.1% were aged 65 and older, and 11.5% had bacteremia at baseline.

The study findings were limited by several factors, including the mandated 7- to 10-day course of antibiotics, which may not reflect the standard of care in other settings in the United States. The study’s trial sites were located in the United States, South Africa, and Europe. The study population was primarily White and from Central and Eastern Europe. Other limitations included the randomization of patients before confirming the baseline pathogen, although this was done to limit potential confounding from previous antibiotics, the researchers noted.
 

Safety and efficacy support application for approval

“To our knowledge, this is the first head-to-head evaluation of an IV vs. an oral drug for the treatment of cUTI and acute pyelonephritis,” Dr. Talley said in an interview.  

“The findings demonstrate that almost all patients in the study achieved complete resolution of the signs and symptoms of their infection,” she said.

TBP-PI-HBr has not been approved by the Food and Drug Administration, but a new drug application that included data from the current study was submitted to the FDA and is currently under review, Dr. Talley noted.

As for additional research, the current study was conducted in hospitalized patients, and the use of TBP-PI-HBr in the outpatient setting has not yet been evaluated, she said.
 

Approval and use of oral carbapenem will change practice

The current study is very important because it provides a viable and effective alternative form of antibiotic delivery for the patients with complicated UTI, Noel N. Deep, MD, emphasized in an interview.

“Currently these patients have to be treated with IV carbapenem antibiotics either in a hospital or through a home health nurse,” Dr. Deep, a general internist in group practice in Antigo, Wisc., explained.

Current IV strategies also carry the inherent risk associated with the insertion of an IV catheter that is left in place for several days or replaced periodically. “The oral antibiotic eliminates these risks and higher health care costs and provides a safer and equally efficacious option,” Dr. Deep said.

In the current study, “I was definitely surprised at the effectiveness of the oral carbapenem,” Dr. Deep said. “I am absolutely delighted with this new treatment option that physicians can now add to their armamentarium [assuming FDA approval] as we provide care to our patients,” he said.

If approved, TBP-PI-HBr will definitely change the treatment spectrum for the multidrug-resistant bacterial UTIs, said Dr. Deep. “Carbapenems have continued to be effective and low antibiotic resistance to carbapenems has been recorded.”

As for additional research, “I would like to see studies done in other ethnicities and different countries to ascertain the effectiveness of this antibiotic in those populations and against other bacterial strains with potentially different resistance mechanisms,” Dr. Deep said.

The study was supported by Spero Therapeutics and the Department of Health and Human Services. Lead author Paul B. Eckburg, MD, of Stanford (Calif.) University, and Dr. Talley are employees of Spero Therapeutics. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.

Oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) offers a safe and effective strategy for treating patients with complicated urinary tract infections, according to a new study.

“No new oral antibiotic alternative has emerged to treat these conditions in more than 25 years,” corresponding author Angela K. Talley, MD, said in an interview. The new research was published in the New England Journal of Medicine.

Courtesy Spero Therapeutics

Patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), are often hospitalized and treated with intravenous therapy because of the lack of oral options, especially in cases of antibiotic-resistant pathogens, explained Dr. Talley, of Spero Therapeutics.

In their new phase 3, double-blind randomized trial, the researchers evaluated the safety and effectiveness of oral TBP-PI-HBr, compared with intravenous ertapenem in hospitalized patients with cUTIs or AP. Oral tebipenem is an investigational carbapenem with demonstrated activity against uropathogenic Enterobacterales, and it has shown effectiveness in animal models, the researchers noted in their paper.
 

Methods and results

The researchers randomized 1,372 adult patients. The microbiologic intent-to-treat population included 449 patients who received TBP-PI-HBr (600 mg every 8 hours) and 419 who received ertapenem (1 g every 24 hours) for 7-10 days or up to 14 days for patients with bacteremia.

The primary endpoint was a composite of clinical cure and favorable microbiologic response, assessed at a test-of-cure visit on day 19. Clinical cure was defined as “complete resolution or clinically significant alleviation of baseline signs and symptoms of complicated urinary tract infection or acute pyelonephritis and no new symptoms, such that no further antimicrobial therapy was warranted,” the researchers wrote. Microbiologic response was defined as a reduction to less than 103 CFU per milliliter in uropathogen levels from baseline at day 19.

Overall, the clinical response occurred in 58.8% of patients who received TBP-PI-HBr and 61.6% of those who received ertapenem at the test-of-cure visit.

Clinical cure rates were similar in the TBP-PI-HBr and ertapenem groups (93.1% vs. 93.6%) at the test-of-cure visit.

Both treatment groups showed similar responses to Enterobacterales pathogens at the test-of-cure visit (62.7% for TBP-PI-HBr and 65.2% for ertapenem).

Among patients with bacteremia at baseline, overall response rates were 72.3% and 66.0% for TBP-PI-HBr and ertapenem, respectively, at the test-of-cure visit, and 93.6% and 96.2%, respectively, at the end-of-treatment visit on or around day 25.

The overall incidence of adverse events was approximately 26% in both treatment groups. Most adverse events were mild or moderate in severity and did not limit treatment, the researchers wrote.

The mean age of the patients was 58.1 years; 46.1% were aged 65 and older, and 11.5% had bacteremia at baseline.

The study findings were limited by several factors, including the mandated 7- to 10-day course of antibiotics, which may not reflect the standard of care in other settings in the United States. The study’s trial sites were located in the United States, South Africa, and Europe. The study population was primarily White and from Central and Eastern Europe. Other limitations included the randomization of patients before confirming the baseline pathogen, although this was done to limit potential confounding from previous antibiotics, the researchers noted.
 

Safety and efficacy support application for approval

“To our knowledge, this is the first head-to-head evaluation of an IV vs. an oral drug for the treatment of cUTI and acute pyelonephritis,” Dr. Talley said in an interview.  

“The findings demonstrate that almost all patients in the study achieved complete resolution of the signs and symptoms of their infection,” she said.

TBP-PI-HBr has not been approved by the Food and Drug Administration, but a new drug application that included data from the current study was submitted to the FDA and is currently under review, Dr. Talley noted.

As for additional research, the current study was conducted in hospitalized patients, and the use of TBP-PI-HBr in the outpatient setting has not yet been evaluated, she said.
 

Approval and use of oral carbapenem will change practice

The current study is very important because it provides a viable and effective alternative form of antibiotic delivery for the patients with complicated UTI, Noel N. Deep, MD, emphasized in an interview.

“Currently these patients have to be treated with IV carbapenem antibiotics either in a hospital or through a home health nurse,” Dr. Deep, a general internist in group practice in Antigo, Wisc., explained.

Current IV strategies also carry the inherent risk associated with the insertion of an IV catheter that is left in place for several days or replaced periodically. “The oral antibiotic eliminates these risks and higher health care costs and provides a safer and equally efficacious option,” Dr. Deep said.

In the current study, “I was definitely surprised at the effectiveness of the oral carbapenem,” Dr. Deep said. “I am absolutely delighted with this new treatment option that physicians can now add to their armamentarium [assuming FDA approval] as we provide care to our patients,” he said.

If approved, TBP-PI-HBr will definitely change the treatment spectrum for the multidrug-resistant bacterial UTIs, said Dr. Deep. “Carbapenems have continued to be effective and low antibiotic resistance to carbapenems has been recorded.”

As for additional research, “I would like to see studies done in other ethnicities and different countries to ascertain the effectiveness of this antibiotic in those populations and against other bacterial strains with potentially different resistance mechanisms,” Dr. Deep said.

The study was supported by Spero Therapeutics and the Department of Health and Human Services. Lead author Paul B. Eckburg, MD, of Stanford (Calif.) University, and Dr. Talley are employees of Spero Therapeutics. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.

Oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) offers a safe and effective strategy for treating patients with complicated urinary tract infections, according to a new study.

“No new oral antibiotic alternative has emerged to treat these conditions in more than 25 years,” corresponding author Angela K. Talley, MD, said in an interview. The new research was published in the New England Journal of Medicine.

Courtesy Spero Therapeutics

Patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), are often hospitalized and treated with intravenous therapy because of the lack of oral options, especially in cases of antibiotic-resistant pathogens, explained Dr. Talley, of Spero Therapeutics.

In their new phase 3, double-blind randomized trial, the researchers evaluated the safety and effectiveness of oral TBP-PI-HBr, compared with intravenous ertapenem in hospitalized patients with cUTIs or AP. Oral tebipenem is an investigational carbapenem with demonstrated activity against uropathogenic Enterobacterales, and it has shown effectiveness in animal models, the researchers noted in their paper.
 

Methods and results

The researchers randomized 1,372 adult patients. The microbiologic intent-to-treat population included 449 patients who received TBP-PI-HBr (600 mg every 8 hours) and 419 who received ertapenem (1 g every 24 hours) for 7-10 days or up to 14 days for patients with bacteremia.

The primary endpoint was a composite of clinical cure and favorable microbiologic response, assessed at a test-of-cure visit on day 19. Clinical cure was defined as “complete resolution or clinically significant alleviation of baseline signs and symptoms of complicated urinary tract infection or acute pyelonephritis and no new symptoms, such that no further antimicrobial therapy was warranted,” the researchers wrote. Microbiologic response was defined as a reduction to less than 103 CFU per milliliter in uropathogen levels from baseline at day 19.

Overall, the clinical response occurred in 58.8% of patients who received TBP-PI-HBr and 61.6% of those who received ertapenem at the test-of-cure visit.

Clinical cure rates were similar in the TBP-PI-HBr and ertapenem groups (93.1% vs. 93.6%) at the test-of-cure visit.

Both treatment groups showed similar responses to Enterobacterales pathogens at the test-of-cure visit (62.7% for TBP-PI-HBr and 65.2% for ertapenem).

Among patients with bacteremia at baseline, overall response rates were 72.3% and 66.0% for TBP-PI-HBr and ertapenem, respectively, at the test-of-cure visit, and 93.6% and 96.2%, respectively, at the end-of-treatment visit on or around day 25.

The overall incidence of adverse events was approximately 26% in both treatment groups. Most adverse events were mild or moderate in severity and did not limit treatment, the researchers wrote.

The mean age of the patients was 58.1 years; 46.1% were aged 65 and older, and 11.5% had bacteremia at baseline.

The study findings were limited by several factors, including the mandated 7- to 10-day course of antibiotics, which may not reflect the standard of care in other settings in the United States. The study’s trial sites were located in the United States, South Africa, and Europe. The study population was primarily White and from Central and Eastern Europe. Other limitations included the randomization of patients before confirming the baseline pathogen, although this was done to limit potential confounding from previous antibiotics, the researchers noted.
 

Safety and efficacy support application for approval

“To our knowledge, this is the first head-to-head evaluation of an IV vs. an oral drug for the treatment of cUTI and acute pyelonephritis,” Dr. Talley said in an interview.  

“The findings demonstrate that almost all patients in the study achieved complete resolution of the signs and symptoms of their infection,” she said.

TBP-PI-HBr has not been approved by the Food and Drug Administration, but a new drug application that included data from the current study was submitted to the FDA and is currently under review, Dr. Talley noted.

As for additional research, the current study was conducted in hospitalized patients, and the use of TBP-PI-HBr in the outpatient setting has not yet been evaluated, she said.
 

Approval and use of oral carbapenem will change practice

The current study is very important because it provides a viable and effective alternative form of antibiotic delivery for the patients with complicated UTI, Noel N. Deep, MD, emphasized in an interview.

“Currently these patients have to be treated with IV carbapenem antibiotics either in a hospital or through a home health nurse,” Dr. Deep, a general internist in group practice in Antigo, Wisc., explained.

Current IV strategies also carry the inherent risk associated with the insertion of an IV catheter that is left in place for several days or replaced periodically. “The oral antibiotic eliminates these risks and higher health care costs and provides a safer and equally efficacious option,” Dr. Deep said.

In the current study, “I was definitely surprised at the effectiveness of the oral carbapenem,” Dr. Deep said. “I am absolutely delighted with this new treatment option that physicians can now add to their armamentarium [assuming FDA approval] as we provide care to our patients,” he said.

If approved, TBP-PI-HBr will definitely change the treatment spectrum for the multidrug-resistant bacterial UTIs, said Dr. Deep. “Carbapenems have continued to be effective and low antibiotic resistance to carbapenems has been recorded.”

As for additional research, “I would like to see studies done in other ethnicities and different countries to ascertain the effectiveness of this antibiotic in those populations and against other bacterial strains with potentially different resistance mechanisms,” Dr. Deep said.

The study was supported by Spero Therapeutics and the Department of Health and Human Services. Lead author Paul B. Eckburg, MD, of Stanford (Calif.) University, and Dr. Talley are employees of Spero Therapeutics. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.

A new study suggests that overgrowth of the amygdala in infants during the first 6-12 months of life is tied to a later diagnosis of autism spectrum disorder (ASD).

“The faster the amygdala grew in infancy, the more social difficulties the child showed when diagnosed with autism a year later,” first author Mark Shen, PhD, assistant professor of psychiatry and neuroscience, University of North Carolina, Chapel Hill, told this news organization.

The study was published online  in the American Journal of Psychiatry.
 

Unique to autism

The amygdala plays a key role in processing memory, emotional responses, and decisionmaking. 

It’s long been known that the amygdala is abnormally large in school-aged children with ASD, but until now, it was not known precisely when aberrant amygdala growth happens, what the clinical consequences may be, and whether amygdala overgrowth is unique to autism.

To investigate, Dr. Shen and colleagues evaluated 1,099 longitudinal MRI scans obtained during natural sleep at 6, 12, and 24 months of age in 408 infants in the Infant Brain Imaging Study (IBIS) Network.

The cohort included 58 infants at high likelihood of developing ASD who were later diagnosed with the disorder, 212 infants at high likelihood of ASD who did not develop ASD, 109 typically-developing control infants, and 29 infants with fragile X syndrome.

At 6 months, infants who developed ASD had typically sized amygdala volumes but showed significantly faster amygdala growth between 6 and 24 months, such that by 12 months the ASD group had significantly larger amygdala volume (Cohen’s d = 0.56), compared with all other groups.

Amygdala growth rate between 6 and 12 months was significantly associated with greater social deficits at 24 months when the children were diagnosed with ASD.

“We found that the amygdala grows too rapidly between 6 and 12 months of age, during a presymptomatic period in autism, prior to when the diagnostic symptoms of autism (social difficulties and repetitive behaviors) are evident and lead to the later diagnosis of autism,” Dr. Shen said in an interview.

This brain growth pattern appears to be unique to autism, as babies with the genetic disorder fragile X syndrome – another neurodevelopmental condition – showed a markedly different brain growth pattern: no differences in amygdala growth but enlargement of a different brain structure, the caudate, which was linked to increased repetitive behaviors, the investigators found.
 

Earlier intervention

Prior research has shown that children who are later diagnosed with ASD often display problems in infancy with how they attend to visual stimuli in their surroundings.

These early problems with processing visual and sensory information may put increased stress on the amygdala, potentially leading to amygdala hyperactivity, deficits in pruning dendritic connections, and overgrowth, Dr. Shen and colleagues hypothesize.

Amygdala overgrowth has also been linked to chronic stress in studies of other psychiatric conditions, such as depression and anxiety, and may provide a clue to understanding this observation in infants who later develop autism.

“This research suggests that an optimal time to begin supports for children who are at the highest likelihood of developing autism may be during the first year of life: to improve early precursors to social development, such as sensory processing, in babies even before social difficulties arise,” Dr. Shen said.

Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said, “What makes this study important is the finding of abnormally increased amygdala growth rate in autism using a longitudinal design that focuses on earlier development.”

“While we are typically used to understanding brain structure as abnormally decreasing over time in certain disorders like Alzheimer’s disease, this study challenges us to understand that too much brain volume growth can also be abnormal in specific conditions,” Dr. Raji added.

This research was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Environmental Health Sciences, and National Institute of Mental Health, along with Autism Speaks and the Simons Foundation. Dr. Shen and Dr. Raji have disclosed no relevant financial relationships.

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

A new study suggests that overgrowth of the amygdala in infants during the first 6-12 months of life is tied to a later diagnosis of autism spectrum disorder (ASD).

“The faster the amygdala grew in infancy, the more social difficulties the child showed when diagnosed with autism a year later,” first author Mark Shen, PhD, assistant professor of psychiatry and neuroscience, University of North Carolina, Chapel Hill, told this news organization.

The study was published online  in the American Journal of Psychiatry.
 

Unique to autism

The amygdala plays a key role in processing memory, emotional responses, and decisionmaking. 

It’s long been known that the amygdala is abnormally large in school-aged children with ASD, but until now, it was not known precisely when aberrant amygdala growth happens, what the clinical consequences may be, and whether amygdala overgrowth is unique to autism.

To investigate, Dr. Shen and colleagues evaluated 1,099 longitudinal MRI scans obtained during natural sleep at 6, 12, and 24 months of age in 408 infants in the Infant Brain Imaging Study (IBIS) Network.

The cohort included 58 infants at high likelihood of developing ASD who were later diagnosed with the disorder, 212 infants at high likelihood of ASD who did not develop ASD, 109 typically-developing control infants, and 29 infants with fragile X syndrome.

At 6 months, infants who developed ASD had typically sized amygdala volumes but showed significantly faster amygdala growth between 6 and 24 months, such that by 12 months the ASD group had significantly larger amygdala volume (Cohen’s d = 0.56), compared with all other groups.

Amygdala growth rate between 6 and 12 months was significantly associated with greater social deficits at 24 months when the children were diagnosed with ASD.

“We found that the amygdala grows too rapidly between 6 and 12 months of age, during a presymptomatic period in autism, prior to when the diagnostic symptoms of autism (social difficulties and repetitive behaviors) are evident and lead to the later diagnosis of autism,” Dr. Shen said in an interview.

This brain growth pattern appears to be unique to autism, as babies with the genetic disorder fragile X syndrome – another neurodevelopmental condition – showed a markedly different brain growth pattern: no differences in amygdala growth but enlargement of a different brain structure, the caudate, which was linked to increased repetitive behaviors, the investigators found.
 

Earlier intervention

Prior research has shown that children who are later diagnosed with ASD often display problems in infancy with how they attend to visual stimuli in their surroundings.

These early problems with processing visual and sensory information may put increased stress on the amygdala, potentially leading to amygdala hyperactivity, deficits in pruning dendritic connections, and overgrowth, Dr. Shen and colleagues hypothesize.

Amygdala overgrowth has also been linked to chronic stress in studies of other psychiatric conditions, such as depression and anxiety, and may provide a clue to understanding this observation in infants who later develop autism.

“This research suggests that an optimal time to begin supports for children who are at the highest likelihood of developing autism may be during the first year of life: to improve early precursors to social development, such as sensory processing, in babies even before social difficulties arise,” Dr. Shen said.

Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said, “What makes this study important is the finding of abnormally increased amygdala growth rate in autism using a longitudinal design that focuses on earlier development.”

“While we are typically used to understanding brain structure as abnormally decreasing over time in certain disorders like Alzheimer’s disease, this study challenges us to understand that too much brain volume growth can also be abnormal in specific conditions,” Dr. Raji added.

This research was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Environmental Health Sciences, and National Institute of Mental Health, along with Autism Speaks and the Simons Foundation. Dr. Shen and Dr. Raji have disclosed no relevant financial relationships.

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

A new study suggests that overgrowth of the amygdala in infants during the first 6-12 months of life is tied to a later diagnosis of autism spectrum disorder (ASD).

“The faster the amygdala grew in infancy, the more social difficulties the child showed when diagnosed with autism a year later,” first author Mark Shen, PhD, assistant professor of psychiatry and neuroscience, University of North Carolina, Chapel Hill, told this news organization.

The study was published online  in the American Journal of Psychiatry.
 

Unique to autism

The amygdala plays a key role in processing memory, emotional responses, and decisionmaking. 

It’s long been known that the amygdala is abnormally large in school-aged children with ASD, but until now, it was not known precisely when aberrant amygdala growth happens, what the clinical consequences may be, and whether amygdala overgrowth is unique to autism.

To investigate, Dr. Shen and colleagues evaluated 1,099 longitudinal MRI scans obtained during natural sleep at 6, 12, and 24 months of age in 408 infants in the Infant Brain Imaging Study (IBIS) Network.

The cohort included 58 infants at high likelihood of developing ASD who were later diagnosed with the disorder, 212 infants at high likelihood of ASD who did not develop ASD, 109 typically-developing control infants, and 29 infants with fragile X syndrome.

At 6 months, infants who developed ASD had typically sized amygdala volumes but showed significantly faster amygdala growth between 6 and 24 months, such that by 12 months the ASD group had significantly larger amygdala volume (Cohen’s d = 0.56), compared with all other groups.

Amygdala growth rate between 6 and 12 months was significantly associated with greater social deficits at 24 months when the children were diagnosed with ASD.

“We found that the amygdala grows too rapidly between 6 and 12 months of age, during a presymptomatic period in autism, prior to when the diagnostic symptoms of autism (social difficulties and repetitive behaviors) are evident and lead to the later diagnosis of autism,” Dr. Shen said in an interview.

This brain growth pattern appears to be unique to autism, as babies with the genetic disorder fragile X syndrome – another neurodevelopmental condition – showed a markedly different brain growth pattern: no differences in amygdala growth but enlargement of a different brain structure, the caudate, which was linked to increased repetitive behaviors, the investigators found.
 

Earlier intervention

Prior research has shown that children who are later diagnosed with ASD often display problems in infancy with how they attend to visual stimuli in their surroundings.

These early problems with processing visual and sensory information may put increased stress on the amygdala, potentially leading to amygdala hyperactivity, deficits in pruning dendritic connections, and overgrowth, Dr. Shen and colleagues hypothesize.

Amygdala overgrowth has also been linked to chronic stress in studies of other psychiatric conditions, such as depression and anxiety, and may provide a clue to understanding this observation in infants who later develop autism.

“This research suggests that an optimal time to begin supports for children who are at the highest likelihood of developing autism may be during the first year of life: to improve early precursors to social development, such as sensory processing, in babies even before social difficulties arise,” Dr. Shen said.

Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said, “What makes this study important is the finding of abnormally increased amygdala growth rate in autism using a longitudinal design that focuses on earlier development.”

“While we are typically used to understanding brain structure as abnormally decreasing over time in certain disorders like Alzheimer’s disease, this study challenges us to understand that too much brain volume growth can also be abnormal in specific conditions,” Dr. Raji added.

This research was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Environmental Health Sciences, and National Institute of Mental Health, along with Autism Speaks and the Simons Foundation. Dr. Shen and Dr. Raji have disclosed no relevant financial relationships.

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

I’d do anything for weight loss (but I won’t do that)

Weight loss isn’t a multibillion-dollar industry for nothing. How many people step onto the scale in the morning and sigh, wishing they could lose that last 10 pounds?

Alcohol also isn’t a multibillion-dollar industry for nothing. If there’s one thing more universal than wishing you could lose weight, it’s drinking to forget your woes about being unable to lose weight.

© Ljupco Smokovski/Fotolia.com

Naturally, and unfortunately for those of us who rather enjoy a good beer, one of the best ways to lose weight is to stop drinking. Alcohol is almost the definition of empty calories. So, which wins out: The unstoppable force of wanting to lose weight, or the immovable object of alcohol? According to a survey from DrugAbuse.com, it’s alcohol, and it’s not even close.

Even in a state with as health conscious a reputation as California, not only are people not willing to give up alcohol to lose weight, they’re willing to gain a noticeable amount of weight in order to continue drinking. It’s 14 pounds for Californians, which is in the middle of the road for America, which overall averaged 13 pounds to keep drinking. Hawaiians, South Dakotans, Utahns, and Vermonters were at the bottom, willing to add only 8 pounds to keep booze in their diet. At the other end of the scale, willing to add 28 whole pounds to keep the beer flowing, is humble little Rhode Island, followed by Wyoming at 23 pounds, Maryland at 22, and Tennessee at 21.

Obviously, that’s a lot of weight to gain, but to drive home the exact quantity of just how much weight, KRON-TV noted that adding the U.S. average of 13 pounds to your body is the equivalent of strapping 224 slices of bacon to yourself, which, to us, is just the poorest choice of comparison. If there’s one thing we’re less willing to give up than alcohol, it’s probably bacon. Or if you’re feeling especially ambitious, you could go for bacon-scented beer from the Waffle House. Now that’s a drink.
 

This looks like a job for the ‘magnetic slime robot’

What’s that? While you were in the process of gaining 14 pounds so you could keep drinking alcohol you swallowed something that you shouldn’t have? Did you swallow a lot of aggression?

openclipart/freesvg

You swallowed a what? An ear bud? But how did you manage that? No, never mind, we don’t really want to hear about your personal life. Lucky for you, though, today’s LOTME phrase that pays is “magnetic turd” and it’s just the thing for the busy executive/child with a foreign object stuck in their … whatever.

Yes, we said magnetic turd. Or, if you prefer, a “magnetic slime robot.” The black-brown–colored blob/robot/turd in question is an investigational substance that can be controlled magnetically to move through very narrow spaces and encircle small objects that have been accidentally swallowed, its cocreator, Li Zhang of the Chinese University of Hong Kong, told the Guardian.

It’s made by combining the polymer polyvinyl alcohol with borax and particles of neodymium magnet. And since those neodymium particles are not particularly friendly to humans, Dr. Zhang and the research team coated the slime with silica to seal in the toxicity. The slime has the consistency of custard and exhibits “visco-elastic properties,” Dr. Zhang said, meaning that “sometimes it behaves like a solid, sometimes it behaves like a liquid.”

We could go on, telling you about the substance’s self-healing ability and electrical conductivity and how it does look very, very turd-like. Instead, we offer this link to the team’s really freaky video.

We’re going to be seeing that in our nightmares.
 

Fish: More than meets the fry?

When you think of fish, intelligence isn’t usually the first thing to pop into your head. Their short memory spans, which can be as little as 3 seconds, probably don’t help their cause.

Taken/Pixabay

Recently, though, it has become apparent that fish can be trained to do simple math problems like adding and subtracting. Research conducted in Germany has shown that cichlids – tropical fish often found in home aquariums – and stingrays can observe small quantities and know how many things are there without actually counting, kind of like how a human can look at a bowl of apples and know about how many are in it.

Fish, once thought to be not very smart, may be on the same level of intelligence as birds, suggested Vera Schluessel, PhD, of the University of Bonn’s Institute of Zoology, and associates.

“Successful fish showed abilities far above chance level, specifically in the stingrays. Again, this raises the question of what abilities fish may be capable of if being asked the ‘right’ question,” the researchers said in Scientific Reports.

They tried to teach the cichlids and stingrays how to add and subtract by recognizing colors: Blue meant to add one and yellow meant to subtract one. Gates were set up and when the fish chose a correct answer, they were rewarded with food. Although it took many sessions for the fish to completely catch on, they did figure it out eventually.

If fish are smarter than we thought, maybe we can stop paying for math tutors for our kids and just have the family goldfish do it.
 

For earthworms, not all plastics are created equal

Everything living on the earth has to deal with pollution in some way, including earthworms. Not only have they have adapted to eating plastics found in soil, they have preferences.

Piqsels

The earthworm is a little creature with a big job. The materials and minerals they munch on as they go through the earth get recycled through their tiny bodies to create more fertile soil for things to grow – making them the hidden heroes of every garden. But what about soil that’s full of microscopic plastic pieces? Well, turns out earthworms will eat that too, investigators from Nankai University in Tianjin, China, reported in Environmental Science & Technology.

The researchers looked at how these eating machines were digesting the plastic and found that they actually have preferences. Soils with bio-based polylactic acid (PLA) or petroleum-derived polyethylene terephthalate (PET) particles were a hit. Another test showed that the worms broke the PLA particles down into smaller fragments than the PET ones. So at least the “healthier” option agreed with them more. More work is needed, however, to determine if the worms are being harmed by all the waste they’re digesting.

So what does this mean for the evolution or even survival of this unsung hero of the planet? Scientists still need to dig into that question. No pun intended.

I’d do anything for weight loss (but I won’t do that)

Weight loss isn’t a multibillion-dollar industry for nothing. How many people step onto the scale in the morning and sigh, wishing they could lose that last 10 pounds?

Alcohol also isn’t a multibillion-dollar industry for nothing. If there’s one thing more universal than wishing you could lose weight, it’s drinking to forget your woes about being unable to lose weight.

© Ljupco Smokovski/Fotolia.com

Naturally, and unfortunately for those of us who rather enjoy a good beer, one of the best ways to lose weight is to stop drinking. Alcohol is almost the definition of empty calories. So, which wins out: The unstoppable force of wanting to lose weight, or the immovable object of alcohol? According to a survey from DrugAbuse.com, it’s alcohol, and it’s not even close.

Even in a state with as health conscious a reputation as California, not only are people not willing to give up alcohol to lose weight, they’re willing to gain a noticeable amount of weight in order to continue drinking. It’s 14 pounds for Californians, which is in the middle of the road for America, which overall averaged 13 pounds to keep drinking. Hawaiians, South Dakotans, Utahns, and Vermonters were at the bottom, willing to add only 8 pounds to keep booze in their diet. At the other end of the scale, willing to add 28 whole pounds to keep the beer flowing, is humble little Rhode Island, followed by Wyoming at 23 pounds, Maryland at 22, and Tennessee at 21.

Obviously, that’s a lot of weight to gain, but to drive home the exact quantity of just how much weight, KRON-TV noted that adding the U.S. average of 13 pounds to your body is the equivalent of strapping 224 slices of bacon to yourself, which, to us, is just the poorest choice of comparison. If there’s one thing we’re less willing to give up than alcohol, it’s probably bacon. Or if you’re feeling especially ambitious, you could go for bacon-scented beer from the Waffle House. Now that’s a drink.
 

This looks like a job for the ‘magnetic slime robot’

What’s that? While you were in the process of gaining 14 pounds so you could keep drinking alcohol you swallowed something that you shouldn’t have? Did you swallow a lot of aggression?

openclipart/freesvg

You swallowed a what? An ear bud? But how did you manage that? No, never mind, we don’t really want to hear about your personal life. Lucky for you, though, today’s LOTME phrase that pays is “magnetic turd” and it’s just the thing for the busy executive/child with a foreign object stuck in their … whatever.

Yes, we said magnetic turd. Or, if you prefer, a “magnetic slime robot.” The black-brown–colored blob/robot/turd in question is an investigational substance that can be controlled magnetically to move through very narrow spaces and encircle small objects that have been accidentally swallowed, its cocreator, Li Zhang of the Chinese University of Hong Kong, told the Guardian.

It’s made by combining the polymer polyvinyl alcohol with borax and particles of neodymium magnet. And since those neodymium particles are not particularly friendly to humans, Dr. Zhang and the research team coated the slime with silica to seal in the toxicity. The slime has the consistency of custard and exhibits “visco-elastic properties,” Dr. Zhang said, meaning that “sometimes it behaves like a solid, sometimes it behaves like a liquid.”

We could go on, telling you about the substance’s self-healing ability and electrical conductivity and how it does look very, very turd-like. Instead, we offer this link to the team’s really freaky video.

We’re going to be seeing that in our nightmares.
 

Fish: More than meets the fry?

When you think of fish, intelligence isn’t usually the first thing to pop into your head. Their short memory spans, which can be as little as 3 seconds, probably don’t help their cause.

Taken/Pixabay

Recently, though, it has become apparent that fish can be trained to do simple math problems like adding and subtracting. Research conducted in Germany has shown that cichlids – tropical fish often found in home aquariums – and stingrays can observe small quantities and know how many things are there without actually counting, kind of like how a human can look at a bowl of apples and know about how many are in it.

Fish, once thought to be not very smart, may be on the same level of intelligence as birds, suggested Vera Schluessel, PhD, of the University of Bonn’s Institute of Zoology, and associates.

“Successful fish showed abilities far above chance level, specifically in the stingrays. Again, this raises the question of what abilities fish may be capable of if being asked the ‘right’ question,” the researchers said in Scientific Reports.

They tried to teach the cichlids and stingrays how to add and subtract by recognizing colors: Blue meant to add one and yellow meant to subtract one. Gates were set up and when the fish chose a correct answer, they were rewarded with food. Although it took many sessions for the fish to completely catch on, they did figure it out eventually.

If fish are smarter than we thought, maybe we can stop paying for math tutors for our kids and just have the family goldfish do it.
 

For earthworms, not all plastics are created equal

Everything living on the earth has to deal with pollution in some way, including earthworms. Not only have they have adapted to eating plastics found in soil, they have preferences.

Piqsels

The earthworm is a little creature with a big job. The materials and minerals they munch on as they go through the earth get recycled through their tiny bodies to create more fertile soil for things to grow – making them the hidden heroes of every garden. But what about soil that’s full of microscopic plastic pieces? Well, turns out earthworms will eat that too, investigators from Nankai University in Tianjin, China, reported in Environmental Science & Technology.

The researchers looked at how these eating machines were digesting the plastic and found that they actually have preferences. Soils with bio-based polylactic acid (PLA) or petroleum-derived polyethylene terephthalate (PET) particles were a hit. Another test showed that the worms broke the PLA particles down into smaller fragments than the PET ones. So at least the “healthier” option agreed with them more. More work is needed, however, to determine if the worms are being harmed by all the waste they’re digesting.

So what does this mean for the evolution or even survival of this unsung hero of the planet? Scientists still need to dig into that question. No pun intended.

I’d do anything for weight loss (but I won’t do that)

Weight loss isn’t a multibillion-dollar industry for nothing. How many people step onto the scale in the morning and sigh, wishing they could lose that last 10 pounds?

Alcohol also isn’t a multibillion-dollar industry for nothing. If there’s one thing more universal than wishing you could lose weight, it’s drinking to forget your woes about being unable to lose weight.

© Ljupco Smokovski/Fotolia.com

Naturally, and unfortunately for those of us who rather enjoy a good beer, one of the best ways to lose weight is to stop drinking. Alcohol is almost the definition of empty calories. So, which wins out: The unstoppable force of wanting to lose weight, or the immovable object of alcohol? According to a survey from DrugAbuse.com, it’s alcohol, and it’s not even close.

Even in a state with as health conscious a reputation as California, not only are people not willing to give up alcohol to lose weight, they’re willing to gain a noticeable amount of weight in order to continue drinking. It’s 14 pounds for Californians, which is in the middle of the road for America, which overall averaged 13 pounds to keep drinking. Hawaiians, South Dakotans, Utahns, and Vermonters were at the bottom, willing to add only 8 pounds to keep booze in their diet. At the other end of the scale, willing to add 28 whole pounds to keep the beer flowing, is humble little Rhode Island, followed by Wyoming at 23 pounds, Maryland at 22, and Tennessee at 21.

Obviously, that’s a lot of weight to gain, but to drive home the exact quantity of just how much weight, KRON-TV noted that adding the U.S. average of 13 pounds to your body is the equivalent of strapping 224 slices of bacon to yourself, which, to us, is just the poorest choice of comparison. If there’s one thing we’re less willing to give up than alcohol, it’s probably bacon. Or if you’re feeling especially ambitious, you could go for bacon-scented beer from the Waffle House. Now that’s a drink.
 

This looks like a job for the ‘magnetic slime robot’

What’s that? While you were in the process of gaining 14 pounds so you could keep drinking alcohol you swallowed something that you shouldn’t have? Did you swallow a lot of aggression?

openclipart/freesvg

You swallowed a what? An ear bud? But how did you manage that? No, never mind, we don’t really want to hear about your personal life. Lucky for you, though, today’s LOTME phrase that pays is “magnetic turd” and it’s just the thing for the busy executive/child with a foreign object stuck in their … whatever.

Yes, we said magnetic turd. Or, if you prefer, a “magnetic slime robot.” The black-brown–colored blob/robot/turd in question is an investigational substance that can be controlled magnetically to move through very narrow spaces and encircle small objects that have been accidentally swallowed, its cocreator, Li Zhang of the Chinese University of Hong Kong, told the Guardian.

It’s made by combining the polymer polyvinyl alcohol with borax and particles of neodymium magnet. And since those neodymium particles are not particularly friendly to humans, Dr. Zhang and the research team coated the slime with silica to seal in the toxicity. The slime has the consistency of custard and exhibits “visco-elastic properties,” Dr. Zhang said, meaning that “sometimes it behaves like a solid, sometimes it behaves like a liquid.”

We could go on, telling you about the substance’s self-healing ability and electrical conductivity and how it does look very, very turd-like. Instead, we offer this link to the team’s really freaky video.

We’re going to be seeing that in our nightmares.
 

Fish: More than meets the fry?

When you think of fish, intelligence isn’t usually the first thing to pop into your head. Their short memory spans, which can be as little as 3 seconds, probably don’t help their cause.

Taken/Pixabay

Recently, though, it has become apparent that fish can be trained to do simple math problems like adding and subtracting. Research conducted in Germany has shown that cichlids – tropical fish often found in home aquariums – and stingrays can observe small quantities and know how many things are there without actually counting, kind of like how a human can look at a bowl of apples and know about how many are in it.

Fish, once thought to be not very smart, may be on the same level of intelligence as birds, suggested Vera Schluessel, PhD, of the University of Bonn’s Institute of Zoology, and associates.

“Successful fish showed abilities far above chance level, specifically in the stingrays. Again, this raises the question of what abilities fish may be capable of if being asked the ‘right’ question,” the researchers said in Scientific Reports.

They tried to teach the cichlids and stingrays how to add and subtract by recognizing colors: Blue meant to add one and yellow meant to subtract one. Gates were set up and when the fish chose a correct answer, they were rewarded with food. Although it took many sessions for the fish to completely catch on, they did figure it out eventually.

If fish are smarter than we thought, maybe we can stop paying for math tutors for our kids and just have the family goldfish do it.
 

For earthworms, not all plastics are created equal

Everything living on the earth has to deal with pollution in some way, including earthworms. Not only have they have adapted to eating plastics found in soil, they have preferences.

Piqsels

The earthworm is a little creature with a big job. The materials and minerals they munch on as they go through the earth get recycled through their tiny bodies to create more fertile soil for things to grow – making them the hidden heroes of every garden. But what about soil that’s full of microscopic plastic pieces? Well, turns out earthworms will eat that too, investigators from Nankai University in Tianjin, China, reported in Environmental Science & Technology.

The researchers looked at how these eating machines were digesting the plastic and found that they actually have preferences. Soils with bio-based polylactic acid (PLA) or petroleum-derived polyethylene terephthalate (PET) particles were a hit. Another test showed that the worms broke the PLA particles down into smaller fragments than the PET ones. So at least the “healthier” option agreed with them more. More work is needed, however, to determine if the worms are being harmed by all the waste they’re digesting.

So what does this mean for the evolution or even survival of this unsung hero of the planet? Scientists still need to dig into that question. No pun intended.

An artificial intelligence (AI)–based predictive tool may be able to identify type 1 diabetes in children earlier, before they are diagnosed as a result of potentially fatal diabetic ketoacidosis (DKA), suggests a new U.K. study.

The tool was developed by Julia Townson, PhD, senior trial manager in children and young people at Cardiff University, U.K., and colleagues.

Her team had previously shown that children who develop type 1 diabetes have a different pattern of contact with primary care in the 6 months leading up to their diagnosis.

Symptoms of type 1 diabetes include going to the toilet more and being thirsty, tired, and thin, but GPs can still miss these signs.

So they tested different combinations of factors from GP records – such as urinary tract infections or bedwetting, being prescribed antibiotics or family history of type 1 diabetes – in approximately 1 million children in Wales, more than 2,000 of whom had been diagnosed with type 1 diabetes, to train the predictive tool.

In a separate study of around 1.5 million children in England, they found that the algorithm could identify type 1 diabetes in 75% of affected children 11 days earlier than without the tool, if it was set up as an alert at every one in 10 general practice consultations.

Dr. Townson presented her research at the recent Diabetes UK Professional Conference 2022.
 

One-quarter of kids diagnosed with type 1 diabetes are in DKA

During her presentation, Dr. Townson explained that, in the U.K., approximately 25% of children with type 1 diabetes are diagnosed while they are in DKA, a figure that has remained unchanged for 25 years.

“We know that delayed- and misdiagnosis are the most common reasons for a child presenting in DKA at diagnosis,” she said. “And of course, the reason why it’s so important to prevent presentation in DKA is because of the considerable morbidity and potentially mortality associated with it.”

Indeed, with a simple internet search, Dr. Townson was able to identify four children who lost their lives to DKA in the past 8 years in the U.K.

“It’s encouraging to see that this research could save many families a potentially traumatic trip to the hospital by helping family doctors diagnose type 1 diabetes more rapidly,” Conor McKeever, research communications manager at the type 1 diabetes charity JDRF, told this news organization.

“This approach could go hand-in-hand with population screening, which has the potential to identify people at high risk of developing type 1 diabetes before they experience any symptoms,” he added. The hope is that “far fewer families experience DKA at the start of their type 1 diabetes journey.”

“Finding a way to catch the condition and treat it early could help to avoid emergency hospital treatment and save lives,” agreed Lucy Chambers, PhD, head of research communications at Diabetes UK, which funded the research.
 

How to integrate tool into GP systems

“We are now looking to see how this tool might work with primary care computer systems,” Dr. Townson said. She said in an interview that they are exploring “how it could be ‘bolted’ on to the GP’s software system.”

“It works on many different levels, but one level is frequency of consultations in relation to the frequency of previous consultations, so it needs to be able to ‘look’ through the electronic health records, at the time of the consultation, to come up with a predictive score.”

Dr. Townson said it is not clear how “easy it will be to integrate it into current systems, and I do not know of any other machine learning applications which have been used like this in primary care.”

“But we are hopeful, and we have started to contact companies who are involved in providing these systems.”

The research was funded by Diabetes UK, and the Clinical Trials Unit was funded by Health and Care Research Wales. No relevant financial relationships were declared.

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

An artificial intelligence (AI)–based predictive tool may be able to identify type 1 diabetes in children earlier, before they are diagnosed as a result of potentially fatal diabetic ketoacidosis (DKA), suggests a new U.K. study.

The tool was developed by Julia Townson, PhD, senior trial manager in children and young people at Cardiff University, U.K., and colleagues.

Her team had previously shown that children who develop type 1 diabetes have a different pattern of contact with primary care in the 6 months leading up to their diagnosis.

Symptoms of type 1 diabetes include going to the toilet more and being thirsty, tired, and thin, but GPs can still miss these signs.

So they tested different combinations of factors from GP records – such as urinary tract infections or bedwetting, being prescribed antibiotics or family history of type 1 diabetes – in approximately 1 million children in Wales, more than 2,000 of whom had been diagnosed with type 1 diabetes, to train the predictive tool.

In a separate study of around 1.5 million children in England, they found that the algorithm could identify type 1 diabetes in 75% of affected children 11 days earlier than without the tool, if it was set up as an alert at every one in 10 general practice consultations.

Dr. Townson presented her research at the recent Diabetes UK Professional Conference 2022.
 

One-quarter of kids diagnosed with type 1 diabetes are in DKA

During her presentation, Dr. Townson explained that, in the U.K., approximately 25% of children with type 1 diabetes are diagnosed while they are in DKA, a figure that has remained unchanged for 25 years.

“We know that delayed- and misdiagnosis are the most common reasons for a child presenting in DKA at diagnosis,” she said. “And of course, the reason why it’s so important to prevent presentation in DKA is because of the considerable morbidity and potentially mortality associated with it.”

Indeed, with a simple internet search, Dr. Townson was able to identify four children who lost their lives to DKA in the past 8 years in the U.K.

“It’s encouraging to see that this research could save many families a potentially traumatic trip to the hospital by helping family doctors diagnose type 1 diabetes more rapidly,” Conor McKeever, research communications manager at the type 1 diabetes charity JDRF, told this news organization.

“This approach could go hand-in-hand with population screening, which has the potential to identify people at high risk of developing type 1 diabetes before they experience any symptoms,” he added. The hope is that “far fewer families experience DKA at the start of their type 1 diabetes journey.”

“Finding a way to catch the condition and treat it early could help to avoid emergency hospital treatment and save lives,” agreed Lucy Chambers, PhD, head of research communications at Diabetes UK, which funded the research.
 

How to integrate tool into GP systems

“We are now looking to see how this tool might work with primary care computer systems,” Dr. Townson said. She said in an interview that they are exploring “how it could be ‘bolted’ on to the GP’s software system.”

“It works on many different levels, but one level is frequency of consultations in relation to the frequency of previous consultations, so it needs to be able to ‘look’ through the electronic health records, at the time of the consultation, to come up with a predictive score.”

Dr. Townson said it is not clear how “easy it will be to integrate it into current systems, and I do not know of any other machine learning applications which have been used like this in primary care.”

“But we are hopeful, and we have started to contact companies who are involved in providing these systems.”

The research was funded by Diabetes UK, and the Clinical Trials Unit was funded by Health and Care Research Wales. No relevant financial relationships were declared.

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

An artificial intelligence (AI)–based predictive tool may be able to identify type 1 diabetes in children earlier, before they are diagnosed as a result of potentially fatal diabetic ketoacidosis (DKA), suggests a new U.K. study.

The tool was developed by Julia Townson, PhD, senior trial manager in children and young people at Cardiff University, U.K., and colleagues.

Her team had previously shown that children who develop type 1 diabetes have a different pattern of contact with primary care in the 6 months leading up to their diagnosis.

Symptoms of type 1 diabetes include going to the toilet more and being thirsty, tired, and thin, but GPs can still miss these signs.

So they tested different combinations of factors from GP records – such as urinary tract infections or bedwetting, being prescribed antibiotics or family history of type 1 diabetes – in approximately 1 million children in Wales, more than 2,000 of whom had been diagnosed with type 1 diabetes, to train the predictive tool.

In a separate study of around 1.5 million children in England, they found that the algorithm could identify type 1 diabetes in 75% of affected children 11 days earlier than without the tool, if it was set up as an alert at every one in 10 general practice consultations.

Dr. Townson presented her research at the recent Diabetes UK Professional Conference 2022.
 

One-quarter of kids diagnosed with type 1 diabetes are in DKA

During her presentation, Dr. Townson explained that, in the U.K., approximately 25% of children with type 1 diabetes are diagnosed while they are in DKA, a figure that has remained unchanged for 25 years.

“We know that delayed- and misdiagnosis are the most common reasons for a child presenting in DKA at diagnosis,” she said. “And of course, the reason why it’s so important to prevent presentation in DKA is because of the considerable morbidity and potentially mortality associated with it.”

Indeed, with a simple internet search, Dr. Townson was able to identify four children who lost their lives to DKA in the past 8 years in the U.K.

“It’s encouraging to see that this research could save many families a potentially traumatic trip to the hospital by helping family doctors diagnose type 1 diabetes more rapidly,” Conor McKeever, research communications manager at the type 1 diabetes charity JDRF, told this news organization.

“This approach could go hand-in-hand with population screening, which has the potential to identify people at high risk of developing type 1 diabetes before they experience any symptoms,” he added. The hope is that “far fewer families experience DKA at the start of their type 1 diabetes journey.”

“Finding a way to catch the condition and treat it early could help to avoid emergency hospital treatment and save lives,” agreed Lucy Chambers, PhD, head of research communications at Diabetes UK, which funded the research.
 

How to integrate tool into GP systems

“We are now looking to see how this tool might work with primary care computer systems,” Dr. Townson said. She said in an interview that they are exploring “how it could be ‘bolted’ on to the GP’s software system.”

“It works on many different levels, but one level is frequency of consultations in relation to the frequency of previous consultations, so it needs to be able to ‘look’ through the electronic health records, at the time of the consultation, to come up with a predictive score.”

Dr. Townson said it is not clear how “easy it will be to integrate it into current systems, and I do not know of any other machine learning applications which have been used like this in primary care.”

“But we are hopeful, and we have started to contact companies who are involved in providing these systems.”

The research was funded by Diabetes UK, and the Clinical Trials Unit was funded by Health and Care Research Wales. No relevant financial relationships were declared.

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

SEATTLE – A novel treatment for amyotrophic lateral sclerosis (ALS) that targets brain cell energy production to promote remyelination showed signs of efficacy in a phase 2 trial, though it did not meet its primary endpoint, which was the change in the summated motor unit index (MUNIX) from baseline to week 36.

The drug, CNM-Au8, is being developed by Clene, and would represent a novel mechanism of action. “This is a brand-new approach. We used it complementary with riluzole and it was well tolerated, so I see this as an add-on therapy. I think if we can show some more positivity and longer-term results, it’s going to be a game changer for ALS,” Matthew Kiernan, MBBS, PhD, said in an interview. Dr. Kiernan presented the results at the 2022 annual meeting of the American Academy of Neurology.

Jim Kling/MDedge News

Riluzole (Rilutek), which received Food and Drug Administration approval in 1995, inhibits glutamate release to counter excitotoxicity, which is believed to play a role in ALS, Huntington’s disease, ischemia, and other acute and chronic neurodegenerative diseases. The other FDA-approved agent for ALS is the neuroprotective agent and free-radical scavenger edaravone (Radicava), approved in 2017.

CNM-Au8 is made up of catalytically active gold nanocrystals that cross the blood-brain barrier, but lacks the toxicity associated with other synthetic gold compounds, according to the company. The formulation is also being investigated for the treatment of Parkinson’s disease and multiple sclerosis. Basic research has shown that it stabilizes mitochondria and reduces accumulation of the TDP-43 protein, which is linked to spread of ALS through the brain, Dr. Kiernan said during his presentation.

The treatment is well tolerated. “Normally in an ALS trial, we see about a 25% dropout rate. There were no dropouts on the active compound in the clinical trial. There are less deaths, so improved survival,” said Dr. Kiernan, the Bushell chair of neurology at the University of Sydney and codirector of the Brain and Mind Center in Sydney.
 

Good safety signal

The fact that the trial missed its primary endpoint isn’t too concerning, according to Nicholas Johnson, MD, who comoderated the session where the study was presented. “ALS clinical trials are incredibly difficult to conduct, especially a phase 2 learning-phase clinical trial. At this phase, I’m much more buoyed by the fact that they have a good safety signal, and that they’re willing to move forward to that phase 3 clinical trial,” Dr. Johnson said in an interview. He is vice chair of research at Virginia Commonwealth University, Richmond.

A phase 3 clinical trial is in development in the United States and Europe. The drug also is included as part of the HEALEY ALS Platform Trial, which is testing multiple ALS therapies simultaneously. “The results from that should be available by the second half of this year and it will also inform us as to what the approach should be,” said Dr. Kiernan.

Dr. Johnson also was enthusiastic. “I’m excited to see the results in terms of the primary endpoints for that next phase 3 clinical trial,” he said.
 

Ongoing research

In September 2021, Clene announced a second expanded access program for people with ALS.

The study included a 36-week double-blind treatment period followed by long-term, open-label follow-up. Twenty-three patients received 30 mg CNM-Au8, and 22 received placebo. In the first 36 weeks, the treatment group was more likely to have no disease progression, defined as death, tracheostomy, noninvasive ventilation, or a gastronomy tube (P = .0125). The researchers compared the probability of experiencing a less than 6-point decline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale. At 12 weeks, it was about 85% in both groups. At 24 weeks, it was about 60% to 50% in favor of the CNM-Au8 group, and at 36 weeks it was about 50% to 20% (P = .0350).

At 36 weeks, quality of life as measured by the ALS Specific Quality of Life–Short Form was better in the treatment group at 36 weeks (mean change, 0.9; P = .0177).

Survival was better in the treatment group at 96 weeks than the mortality derived from a European Network for the Cure of ALS prediction model (hazard ratio [HR], 0.2974; P = .0068). This benefit also was experienced by patients who received drug throughout the study (HR, 0.36; 95% confidence interval [CI], 0.12-1.1) and those who started out on placebo and converted to active drug during the open-label period (HR, 0.24; 95% CI, 0.064-0.88).

The study was funded by Clene and FightMND. Dr. Kiernan and Dr. Johnson have no relevant financial disclosures.

SEATTLE – A novel treatment for amyotrophic lateral sclerosis (ALS) that targets brain cell energy production to promote remyelination showed signs of efficacy in a phase 2 trial, though it did not meet its primary endpoint, which was the change in the summated motor unit index (MUNIX) from baseline to week 36.

The drug, CNM-Au8, is being developed by Clene, and would represent a novel mechanism of action. “This is a brand-new approach. We used it complementary with riluzole and it was well tolerated, so I see this as an add-on therapy. I think if we can show some more positivity and longer-term results, it’s going to be a game changer for ALS,” Matthew Kiernan, MBBS, PhD, said in an interview. Dr. Kiernan presented the results at the 2022 annual meeting of the American Academy of Neurology.

Jim Kling/MDedge News

Riluzole (Rilutek), which received Food and Drug Administration approval in 1995, inhibits glutamate release to counter excitotoxicity, which is believed to play a role in ALS, Huntington’s disease, ischemia, and other acute and chronic neurodegenerative diseases. The other FDA-approved agent for ALS is the neuroprotective agent and free-radical scavenger edaravone (Radicava), approved in 2017.

CNM-Au8 is made up of catalytically active gold nanocrystals that cross the blood-brain barrier, but lacks the toxicity associated with other synthetic gold compounds, according to the company. The formulation is also being investigated for the treatment of Parkinson’s disease and multiple sclerosis. Basic research has shown that it stabilizes mitochondria and reduces accumulation of the TDP-43 protein, which is linked to spread of ALS through the brain, Dr. Kiernan said during his presentation.

The treatment is well tolerated. “Normally in an ALS trial, we see about a 25% dropout rate. There were no dropouts on the active compound in the clinical trial. There are less deaths, so improved survival,” said Dr. Kiernan, the Bushell chair of neurology at the University of Sydney and codirector of the Brain and Mind Center in Sydney.
 

Good safety signal

The fact that the trial missed its primary endpoint isn’t too concerning, according to Nicholas Johnson, MD, who comoderated the session where the study was presented. “ALS clinical trials are incredibly difficult to conduct, especially a phase 2 learning-phase clinical trial. At this phase, I’m much more buoyed by the fact that they have a good safety signal, and that they’re willing to move forward to that phase 3 clinical trial,” Dr. Johnson said in an interview. He is vice chair of research at Virginia Commonwealth University, Richmond.

A phase 3 clinical trial is in development in the United States and Europe. The drug also is included as part of the HEALEY ALS Platform Trial, which is testing multiple ALS therapies simultaneously. “The results from that should be available by the second half of this year and it will also inform us as to what the approach should be,” said Dr. Kiernan.

Dr. Johnson also was enthusiastic. “I’m excited to see the results in terms of the primary endpoints for that next phase 3 clinical trial,” he said.
 

Ongoing research

In September 2021, Clene announced a second expanded access program for people with ALS.

The study included a 36-week double-blind treatment period followed by long-term, open-label follow-up. Twenty-three patients received 30 mg CNM-Au8, and 22 received placebo. In the first 36 weeks, the treatment group was more likely to have no disease progression, defined as death, tracheostomy, noninvasive ventilation, or a gastronomy tube (P = .0125). The researchers compared the probability of experiencing a less than 6-point decline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale. At 12 weeks, it was about 85% in both groups. At 24 weeks, it was about 60% to 50% in favor of the CNM-Au8 group, and at 36 weeks it was about 50% to 20% (P = .0350).

At 36 weeks, quality of life as measured by the ALS Specific Quality of Life–Short Form was better in the treatment group at 36 weeks (mean change, 0.9; P = .0177).

Survival was better in the treatment group at 96 weeks than the mortality derived from a European Network for the Cure of ALS prediction model (hazard ratio [HR], 0.2974; P = .0068). This benefit also was experienced by patients who received drug throughout the study (HR, 0.36; 95% confidence interval [CI], 0.12-1.1) and those who started out on placebo and converted to active drug during the open-label period (HR, 0.24; 95% CI, 0.064-0.88).

The study was funded by Clene and FightMND. Dr. Kiernan and Dr. Johnson have no relevant financial disclosures.

SEATTLE – A novel treatment for amyotrophic lateral sclerosis (ALS) that targets brain cell energy production to promote remyelination showed signs of efficacy in a phase 2 trial, though it did not meet its primary endpoint, which was the change in the summated motor unit index (MUNIX) from baseline to week 36.

The drug, CNM-Au8, is being developed by Clene, and would represent a novel mechanism of action. “This is a brand-new approach. We used it complementary with riluzole and it was well tolerated, so I see this as an add-on therapy. I think if we can show some more positivity and longer-term results, it’s going to be a game changer for ALS,” Matthew Kiernan, MBBS, PhD, said in an interview. Dr. Kiernan presented the results at the 2022 annual meeting of the American Academy of Neurology.

Jim Kling/MDedge News

Riluzole (Rilutek), which received Food and Drug Administration approval in 1995, inhibits glutamate release to counter excitotoxicity, which is believed to play a role in ALS, Huntington’s disease, ischemia, and other acute and chronic neurodegenerative diseases. The other FDA-approved agent for ALS is the neuroprotective agent and free-radical scavenger edaravone (Radicava), approved in 2017.

CNM-Au8 is made up of catalytically active gold nanocrystals that cross the blood-brain barrier, but lacks the toxicity associated with other synthetic gold compounds, according to the company. The formulation is also being investigated for the treatment of Parkinson’s disease and multiple sclerosis. Basic research has shown that it stabilizes mitochondria and reduces accumulation of the TDP-43 protein, which is linked to spread of ALS through the brain, Dr. Kiernan said during his presentation.

The treatment is well tolerated. “Normally in an ALS trial, we see about a 25% dropout rate. There were no dropouts on the active compound in the clinical trial. There are less deaths, so improved survival,” said Dr. Kiernan, the Bushell chair of neurology at the University of Sydney and codirector of the Brain and Mind Center in Sydney.
 

Good safety signal

The fact that the trial missed its primary endpoint isn’t too concerning, according to Nicholas Johnson, MD, who comoderated the session where the study was presented. “ALS clinical trials are incredibly difficult to conduct, especially a phase 2 learning-phase clinical trial. At this phase, I’m much more buoyed by the fact that they have a good safety signal, and that they’re willing to move forward to that phase 3 clinical trial,” Dr. Johnson said in an interview. He is vice chair of research at Virginia Commonwealth University, Richmond.

A phase 3 clinical trial is in development in the United States and Europe. The drug also is included as part of the HEALEY ALS Platform Trial, which is testing multiple ALS therapies simultaneously. “The results from that should be available by the second half of this year and it will also inform us as to what the approach should be,” said Dr. Kiernan.

Dr. Johnson also was enthusiastic. “I’m excited to see the results in terms of the primary endpoints for that next phase 3 clinical trial,” he said.
 

Ongoing research

In September 2021, Clene announced a second expanded access program for people with ALS.

The study included a 36-week double-blind treatment period followed by long-term, open-label follow-up. Twenty-three patients received 30 mg CNM-Au8, and 22 received placebo. In the first 36 weeks, the treatment group was more likely to have no disease progression, defined as death, tracheostomy, noninvasive ventilation, or a gastronomy tube (P = .0125). The researchers compared the probability of experiencing a less than 6-point decline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale. At 12 weeks, it was about 85% in both groups. At 24 weeks, it was about 60% to 50% in favor of the CNM-Au8 group, and at 36 weeks it was about 50% to 20% (P = .0350).

At 36 weeks, quality of life as measured by the ALS Specific Quality of Life–Short Form was better in the treatment group at 36 weeks (mean change, 0.9; P = .0177).

Survival was better in the treatment group at 96 weeks than the mortality derived from a European Network for the Cure of ALS prediction model (hazard ratio [HR], 0.2974; P = .0068). This benefit also was experienced by patients who received drug throughout the study (HR, 0.36; 95% confidence interval [CI], 0.12-1.1) and those who started out on placebo and converted to active drug during the open-label period (HR, 0.24; 95% CI, 0.064-0.88).

The study was funded by Clene and FightMND. Dr. Kiernan and Dr. Johnson have no relevant financial disclosures.

The rates of infection involving cardiac implanted electronic devices (CIEDs), like pacemakers and cardioverter defibrillators (ICDs), are substantial, but only a minority of patients in the United States receive the guideline-directed recommendation of device removal, according to data from a Medicare population.

The study was conducted on the hypothesis that adherence to guidelines were low, “but we were surprised by how low the extraction rates turned out to be,” Sean D. Pokorney, MD, an electrophysiologist at the Duke Clinical Research Institute, Durham, N.C., reported at the annual scientific sessions of the American College of Cardiology.

The major U.S. and European guidelines are uniform in recommending complete extraction for a CIED infection. The American Heart Association and the Heart Rhythm Society and two out of the three other guidelines cited by Dr. Pokorney not only recommend extraction but specify prompt extraction.

Neither complete extraction nor prompt extraction are typical.

Of the 11,619 CIED infection cases identified in the Medicare database, 18.2% underwent extraction within 30 days of diagnosis. Only 13% were extracted within 6 days.
 

Lack of extraction may cause avoidable mortality

The result is likely to be avoidable mortality. Among those with extraction within 30 days, 80% were still alive 1 year later. Survival at 1 year fell to 67.6% in those without an extraction within this time frame.

This translated to a 22% lower rate of death at 1 year (hazard ratio, 0.78; P = .008) in those who underwent extraction within 30 days.

For those in whom the device was extracted within 7 days, the associated HR for death at 1 year was more than 40% lower (HR, 0.59; P < .001), reported Dr. Pokorney, who characterized these reductions as occurring in “a dose-response fashion.”

The very high risk of relapse despite antibiotics is the reason that “there is a class 1 indication for complete hardware removal,” Dr. Pokorney. He cited five studies that addressed this question. With partial device removal or medical therapy alone, relapse was consistently 50% or greater. In one study, it was 67%. In another it was 100%.

With complete removal, the rate of infection relapse was 1% or lower in four. In the fifth, the rate was 4.2%.

Infections can occur early or late after implantation, but cases accumulate over time. In the Medicare data sample, infection rates climbed from 0.3% at 1 year to 0.6% at 2 years and then to 1.1% at 3 years, Dr. Pokorney reported.

Other studies have also shown a steady increase in the proportion of implanted devices associated with infection over time. In a cohort study conducted in Olmstead County, Minnesota, the cumulative probability of a CIED infection reached 6.2% after 15 years and 11.7% after 25 years. While about half of these were infections localized to the device pocket, the others were potentially life-threatening systemic infections, according to Dr. Pokorney, who cited this study.

In his analysis of the Medicare data, all fee-for-service patients receiving a first CIED implant over a period of 14 years were included. The 14-year period ended just before the COVID-19 epidemic.

The more than 11,000 CIED infections were identified in 1,065,549 total CIED patients. Most (72%) had received a pacemaker. Of the others , more than half received an ICD and the others received a cardiac resynchronization device. The median age was 78 years.
 

Female and Black patients even less likely to undergo extraction

About half (49.1%) of the overall study population was female, but females represented only about 40% of those who developed an infection. Blacks represented just under 8% of the population but nearly 16% of the CIED infections. Both females and Blacks were significantly less likely than the overall study population to undergo extraction for their infection (P < .001 for both).

Perhaps predictably, patients with comorbidities were more likely to develop CIED infections. For example, 87% of those with infection, versus only 64.9% of the overall population, were in heart failure at the time of implantation. Diabetes (68.3% vs. 49.3%), ischemic heart disease (91.9% vs. 79.4%), renal disease (70.5% vs. 37.9%), and chronic obstructive pulmonary disease (70.6% vs. 55.0%) were also more common at baseline in those who went on to a CIED infection than in the overall population.

Based on the evidence that there is a large unmet need to improve adherence to the guidelines, Dr. Pokorney called for care pathways and other quality initiatives to address the problem.

The reasons that so many patients are not undergoing prompt device extraction at the time of infection is unclear, but Dr. Pokorney offered some hypotheses.

“There appears to be a false belief in the efficacy of antibiotics for treating CIED infections,” Dr. Pokorney said.
 

Comorbidities shouldn’t delay extraction

It is also possible that clinicians are concerned about performing extractions in patients with multiple comorbidities. If clinicians are delaying extractions for this reason, Dr. Pokorney suggested this behavior is misdirected given the fact that delays appear to increase mortality risk.

Several experts, including Rachel Lambert, MD, an electrophysiologist and professor of medicine at Yale University, New Haven, Conn., agreed that these data deserve a response.

“I was not surprised by the mortality data, but I was surprised at this low extraction rate,” said Dr. Lambert, who concurs with the guidelines. She indicated this study provides teeth to prompt action.

“It is great to have these data about the increased mortality risk to back up the guidelines,” she said.

More information is needed to understand exactly why CIED infection is not now leading to guideline-directed care. Dr. Pokorney said: “Where do we go from here is a key question.”

While several different types of initiatives might be needed, Dr. Pokorney called for regionalization of care to address the fact that not every center that places CIEDs has the capability to perform extractions.

“Extraction is not available at every center, and it probably should not be available at every center, so mechanisms are need to get patients with infection to the specialized centers that provide care,” he said.

Dr. Pokorney has financial relationships with Boston Scientific, Bristol-Myers Squibb, Gilead, Janssen, Medtronic, Pfizer, and Philips. Dr. Lambert reported financial relationships with Abbott, Amgen, and Medtronic.

The rates of infection involving cardiac implanted electronic devices (CIEDs), like pacemakers and cardioverter defibrillators (ICDs), are substantial, but only a minority of patients in the United States receive the guideline-directed recommendation of device removal, according to data from a Medicare population.

The study was conducted on the hypothesis that adherence to guidelines were low, “but we were surprised by how low the extraction rates turned out to be,” Sean D. Pokorney, MD, an electrophysiologist at the Duke Clinical Research Institute, Durham, N.C., reported at the annual scientific sessions of the American College of Cardiology.

The major U.S. and European guidelines are uniform in recommending complete extraction for a CIED infection. The American Heart Association and the Heart Rhythm Society and two out of the three other guidelines cited by Dr. Pokorney not only recommend extraction but specify prompt extraction.

Neither complete extraction nor prompt extraction are typical.

Of the 11,619 CIED infection cases identified in the Medicare database, 18.2% underwent extraction within 30 days of diagnosis. Only 13% were extracted within 6 days.
 

Lack of extraction may cause avoidable mortality

The result is likely to be avoidable mortality. Among those with extraction within 30 days, 80% were still alive 1 year later. Survival at 1 year fell to 67.6% in those without an extraction within this time frame.

This translated to a 22% lower rate of death at 1 year (hazard ratio, 0.78; P = .008) in those who underwent extraction within 30 days.

For those in whom the device was extracted within 7 days, the associated HR for death at 1 year was more than 40% lower (HR, 0.59; P < .001), reported Dr. Pokorney, who characterized these reductions as occurring in “a dose-response fashion.”

The very high risk of relapse despite antibiotics is the reason that “there is a class 1 indication for complete hardware removal,” Dr. Pokorney. He cited five studies that addressed this question. With partial device removal or medical therapy alone, relapse was consistently 50% or greater. In one study, it was 67%. In another it was 100%.

With complete removal, the rate of infection relapse was 1% or lower in four. In the fifth, the rate was 4.2%.

Infections can occur early or late after implantation, but cases accumulate over time. In the Medicare data sample, infection rates climbed from 0.3% at 1 year to 0.6% at 2 years and then to 1.1% at 3 years, Dr. Pokorney reported.

Other studies have also shown a steady increase in the proportion of implanted devices associated with infection over time. In a cohort study conducted in Olmstead County, Minnesota, the cumulative probability of a CIED infection reached 6.2% after 15 years and 11.7% after 25 years. While about half of these were infections localized to the device pocket, the others were potentially life-threatening systemic infections, according to Dr. Pokorney, who cited this study.

In his analysis of the Medicare data, all fee-for-service patients receiving a first CIED implant over a period of 14 years were included. The 14-year period ended just before the COVID-19 epidemic.

The more than 11,000 CIED infections were identified in 1,065,549 total CIED patients. Most (72%) had received a pacemaker. Of the others , more than half received an ICD and the others received a cardiac resynchronization device. The median age was 78 years.
 

Female and Black patients even less likely to undergo extraction

About half (49.1%) of the overall study population was female, but females represented only about 40% of those who developed an infection. Blacks represented just under 8% of the population but nearly 16% of the CIED infections. Both females and Blacks were significantly less likely than the overall study population to undergo extraction for their infection (P < .001 for both).

Perhaps predictably, patients with comorbidities were more likely to develop CIED infections. For example, 87% of those with infection, versus only 64.9% of the overall population, were in heart failure at the time of implantation. Diabetes (68.3% vs. 49.3%), ischemic heart disease (91.9% vs. 79.4%), renal disease (70.5% vs. 37.9%), and chronic obstructive pulmonary disease (70.6% vs. 55.0%) were also more common at baseline in those who went on to a CIED infection than in the overall population.

Based on the evidence that there is a large unmet need to improve adherence to the guidelines, Dr. Pokorney called for care pathways and other quality initiatives to address the problem.

The reasons that so many patients are not undergoing prompt device extraction at the time of infection is unclear, but Dr. Pokorney offered some hypotheses.

“There appears to be a false belief in the efficacy of antibiotics for treating CIED infections,” Dr. Pokorney said.
 

Comorbidities shouldn’t delay extraction

It is also possible that clinicians are concerned about performing extractions in patients with multiple comorbidities. If clinicians are delaying extractions for this reason, Dr. Pokorney suggested this behavior is misdirected given the fact that delays appear to increase mortality risk.

Several experts, including Rachel Lambert, MD, an electrophysiologist and professor of medicine at Yale University, New Haven, Conn., agreed that these data deserve a response.

“I was not surprised by the mortality data, but I was surprised at this low extraction rate,” said Dr. Lambert, who concurs with the guidelines. She indicated this study provides teeth to prompt action.

“It is great to have these data about the increased mortality risk to back up the guidelines,” she said.

More information is needed to understand exactly why CIED infection is not now leading to guideline-directed care. Dr. Pokorney said: “Where do we go from here is a key question.”

While several different types of initiatives might be needed, Dr. Pokorney called for regionalization of care to address the fact that not every center that places CIEDs has the capability to perform extractions.

“Extraction is not available at every center, and it probably should not be available at every center, so mechanisms are need to get patients with infection to the specialized centers that provide care,” he said.

Dr. Pokorney has financial relationships with Boston Scientific, Bristol-Myers Squibb, Gilead, Janssen, Medtronic, Pfizer, and Philips. Dr. Lambert reported financial relationships with Abbott, Amgen, and Medtronic.

The rates of infection involving cardiac implanted electronic devices (CIEDs), like pacemakers and cardioverter defibrillators (ICDs), are substantial, but only a minority of patients in the United States receive the guideline-directed recommendation of device removal, according to data from a Medicare population.

The study was conducted on the hypothesis that adherence to guidelines were low, “but we were surprised by how low the extraction rates turned out to be,” Sean D. Pokorney, MD, an electrophysiologist at the Duke Clinical Research Institute, Durham, N.C., reported at the annual scientific sessions of the American College of Cardiology.

The major U.S. and European guidelines are uniform in recommending complete extraction for a CIED infection. The American Heart Association and the Heart Rhythm Society and two out of the three other guidelines cited by Dr. Pokorney not only recommend extraction but specify prompt extraction.

Neither complete extraction nor prompt extraction are typical.

Of the 11,619 CIED infection cases identified in the Medicare database, 18.2% underwent extraction within 30 days of diagnosis. Only 13% were extracted within 6 days.
 

Lack of extraction may cause avoidable mortality

The result is likely to be avoidable mortality. Among those with extraction within 30 days, 80% were still alive 1 year later. Survival at 1 year fell to 67.6% in those without an extraction within this time frame.

This translated to a 22% lower rate of death at 1 year (hazard ratio, 0.78; P = .008) in those who underwent extraction within 30 days.

For those in whom the device was extracted within 7 days, the associated HR for death at 1 year was more than 40% lower (HR, 0.59; P < .001), reported Dr. Pokorney, who characterized these reductions as occurring in “a dose-response fashion.”

The very high risk of relapse despite antibiotics is the reason that “there is a class 1 indication for complete hardware removal,” Dr. Pokorney. He cited five studies that addressed this question. With partial device removal or medical therapy alone, relapse was consistently 50% or greater. In one study, it was 67%. In another it was 100%.

With complete removal, the rate of infection relapse was 1% or lower in four. In the fifth, the rate was 4.2%.

Infections can occur early or late after implantation, but cases accumulate over time. In the Medicare data sample, infection rates climbed from 0.3% at 1 year to 0.6% at 2 years and then to 1.1% at 3 years, Dr. Pokorney reported.

Other studies have also shown a steady increase in the proportion of implanted devices associated with infection over time. In a cohort study conducted in Olmstead County, Minnesota, the cumulative probability of a CIED infection reached 6.2% after 15 years and 11.7% after 25 years. While about half of these were infections localized to the device pocket, the others were potentially life-threatening systemic infections, according to Dr. Pokorney, who cited this study.

In his analysis of the Medicare data, all fee-for-service patients receiving a first CIED implant over a period of 14 years were included. The 14-year period ended just before the COVID-19 epidemic.

The more than 11,000 CIED infections were identified in 1,065,549 total CIED patients. Most (72%) had received a pacemaker. Of the others , more than half received an ICD and the others received a cardiac resynchronization device. The median age was 78 years.
 

Female and Black patients even less likely to undergo extraction

About half (49.1%) of the overall study population was female, but females represented only about 40% of those who developed an infection. Blacks represented just under 8% of the population but nearly 16% of the CIED infections. Both females and Blacks were significantly less likely than the overall study population to undergo extraction for their infection (P < .001 for both).

Perhaps predictably, patients with comorbidities were more likely to develop CIED infections. For example, 87% of those with infection, versus only 64.9% of the overall population, were in heart failure at the time of implantation. Diabetes (68.3% vs. 49.3%), ischemic heart disease (91.9% vs. 79.4%), renal disease (70.5% vs. 37.9%), and chronic obstructive pulmonary disease (70.6% vs. 55.0%) were also more common at baseline in those who went on to a CIED infection than in the overall population.

Based on the evidence that there is a large unmet need to improve adherence to the guidelines, Dr. Pokorney called for care pathways and other quality initiatives to address the problem.

The reasons that so many patients are not undergoing prompt device extraction at the time of infection is unclear, but Dr. Pokorney offered some hypotheses.

“There appears to be a false belief in the efficacy of antibiotics for treating CIED infections,” Dr. Pokorney said.
 

Comorbidities shouldn’t delay extraction

It is also possible that clinicians are concerned about performing extractions in patients with multiple comorbidities. If clinicians are delaying extractions for this reason, Dr. Pokorney suggested this behavior is misdirected given the fact that delays appear to increase mortality risk.

Several experts, including Rachel Lambert, MD, an electrophysiologist and professor of medicine at Yale University, New Haven, Conn., agreed that these data deserve a response.

“I was not surprised by the mortality data, but I was surprised at this low extraction rate,” said Dr. Lambert, who concurs with the guidelines. She indicated this study provides teeth to prompt action.

“It is great to have these data about the increased mortality risk to back up the guidelines,” she said.

More information is needed to understand exactly why CIED infection is not now leading to guideline-directed care. Dr. Pokorney said: “Where do we go from here is a key question.”

While several different types of initiatives might be needed, Dr. Pokorney called for regionalization of care to address the fact that not every center that places CIEDs has the capability to perform extractions.

“Extraction is not available at every center, and it probably should not be available at every center, so mechanisms are need to get patients with infection to the specialized centers that provide care,” he said.

Dr. Pokorney has financial relationships with Boston Scientific, Bristol-Myers Squibb, Gilead, Janssen, Medtronic, Pfizer, and Philips. Dr. Lambert reported financial relationships with Abbott, Amgen, and Medtronic.

Physical fitness has been linked to a lower risk of Alzheimer’s disease, but even moderate levels of cardiorespiratory fitness offer some protection, new findings suggest. “One exciting finding of this study is that as people’s fitness improved, their risk of Alzheimer’s disease decreased – it was not an all-or-nothing proposition,” study investigator Edward Zamrini, MD, of the Washington DC VA Medical Center, said in a news release.

The findings suggest that people can work toward making incremental changes and improvements in their physical fitness, which may help decrease their risk of dementia, Dr. Zamrini added.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Effective prevention strategy

Using the Veterans Health Administration database, Dr. Zamrini and colleagues identified 649,605 veterans (mean age, 61 years) free of Alzheimer’s disease and related disorders (ADRD) when they completed standardized exercise treadmill tests between 2000 and 2017.

They divided participants into five age-specific fitness groups, from least fit to most fit, based on peak metabolic equivalents (METs) achieved during the treadmill test: lowest-fit (METs, ±3.8), low-fit (METs, ±5.8), moderate-fit (METs, ±7.5), fit (METs, ±9.2), and highest-fit (METs, ±11.7).

In unadjusted analysis, veterans with the lowest cardiorespiratory fitness developed ADRD at a rate of 9.5 cases per 1,000 person-years, compared with a rate of 6.4 cases per 1,000 person-years for the most fit group (P < .001).

After adjusting for factors that could affect risk of ADRD, compared with the lowest-fit group, the highest-fit and fit groups were 33% and 26% less likely to develop ADRD, respectively, while the moderate-fit and low-fit groups were 20% and 13% less likely to develop the disease, respectively.

The next vital sign?

Commenting on the study, Shaheen E. Lakhan, MD, PhD, a neurologist in Boston, noted that “for decades and with increasing body of support from studies like this, we have known that preventing dementia is based on healthy behaviors for the brain including a proper diet (NASH and/or Mediterranean), exercise regimen (aerobic/cardio more than anaerobic/weight-lifting), sleep hygiene, and social and intellectual engagements.”

“Frankly, what’s good for the body is good for the brain,” said Dr. Lakhan.

“It should be noted that the measure studied here is cardiorespiratory fitness, which has been associated with heart disease and resulting death, death from any cause, and now brain health,” Dr. Lakhan said.

“This powerful predictor may in fact be the next vital sign, after your heart rate and blood pressure, from which your primary care provider can make a personalized treatment plan,” he added.

“Accelerating this process, the ability to measure cardiorespiratory fitness traditionally from huge stationary machines down to wearables like a watch or ring, or even your iPhone or Android, is just on the horizon,” Dr. Lakhan said.

“Instead of tracking just your weight, shape, and BMI, personal fitness may be tailored to optimizing this indicator and further empowering individuals to take charge of their health,” he said.

The study was supported by the National Institute on Aging, the National Institutes of Health, the U.S. Department of Veterans Affairs, the Washington DC VA Medical Center, and George Washington University. Dr. Zamrini and Dr. Lakhan have disclosed no relevant financial relationships.

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

Physical fitness has been linked to a lower risk of Alzheimer’s disease, but even moderate levels of cardiorespiratory fitness offer some protection, new findings suggest. “One exciting finding of this study is that as people’s fitness improved, their risk of Alzheimer’s disease decreased – it was not an all-or-nothing proposition,” study investigator Edward Zamrini, MD, of the Washington DC VA Medical Center, said in a news release.

The findings suggest that people can work toward making incremental changes and improvements in their physical fitness, which may help decrease their risk of dementia, Dr. Zamrini added.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Effective prevention strategy

Using the Veterans Health Administration database, Dr. Zamrini and colleagues identified 649,605 veterans (mean age, 61 years) free of Alzheimer’s disease and related disorders (ADRD) when they completed standardized exercise treadmill tests between 2000 and 2017.

They divided participants into five age-specific fitness groups, from least fit to most fit, based on peak metabolic equivalents (METs) achieved during the treadmill test: lowest-fit (METs, ±3.8), low-fit (METs, ±5.8), moderate-fit (METs, ±7.5), fit (METs, ±9.2), and highest-fit (METs, ±11.7).

In unadjusted analysis, veterans with the lowest cardiorespiratory fitness developed ADRD at a rate of 9.5 cases per 1,000 person-years, compared with a rate of 6.4 cases per 1,000 person-years for the most fit group (P < .001).

After adjusting for factors that could affect risk of ADRD, compared with the lowest-fit group, the highest-fit and fit groups were 33% and 26% less likely to develop ADRD, respectively, while the moderate-fit and low-fit groups were 20% and 13% less likely to develop the disease, respectively.

The next vital sign?

Commenting on the study, Shaheen E. Lakhan, MD, PhD, a neurologist in Boston, noted that “for decades and with increasing body of support from studies like this, we have known that preventing dementia is based on healthy behaviors for the brain including a proper diet (NASH and/or Mediterranean), exercise regimen (aerobic/cardio more than anaerobic/weight-lifting), sleep hygiene, and social and intellectual engagements.”

“Frankly, what’s good for the body is good for the brain,” said Dr. Lakhan.

“It should be noted that the measure studied here is cardiorespiratory fitness, which has been associated with heart disease and resulting death, death from any cause, and now brain health,” Dr. Lakhan said.

“This powerful predictor may in fact be the next vital sign, after your heart rate and blood pressure, from which your primary care provider can make a personalized treatment plan,” he added.

“Accelerating this process, the ability to measure cardiorespiratory fitness traditionally from huge stationary machines down to wearables like a watch or ring, or even your iPhone or Android, is just on the horizon,” Dr. Lakhan said.

“Instead of tracking just your weight, shape, and BMI, personal fitness may be tailored to optimizing this indicator and further empowering individuals to take charge of their health,” he said.

The study was supported by the National Institute on Aging, the National Institutes of Health, the U.S. Department of Veterans Affairs, the Washington DC VA Medical Center, and George Washington University. Dr. Zamrini and Dr. Lakhan have disclosed no relevant financial relationships.

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

Physical fitness has been linked to a lower risk of Alzheimer’s disease, but even moderate levels of cardiorespiratory fitness offer some protection, new findings suggest. “One exciting finding of this study is that as people’s fitness improved, their risk of Alzheimer’s disease decreased – it was not an all-or-nothing proposition,” study investigator Edward Zamrini, MD, of the Washington DC VA Medical Center, said in a news release.

The findings suggest that people can work toward making incremental changes and improvements in their physical fitness, which may help decrease their risk of dementia, Dr. Zamrini added.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Effective prevention strategy

Using the Veterans Health Administration database, Dr. Zamrini and colleagues identified 649,605 veterans (mean age, 61 years) free of Alzheimer’s disease and related disorders (ADRD) when they completed standardized exercise treadmill tests between 2000 and 2017.

They divided participants into five age-specific fitness groups, from least fit to most fit, based on peak metabolic equivalents (METs) achieved during the treadmill test: lowest-fit (METs, ±3.8), low-fit (METs, ±5.8), moderate-fit (METs, ±7.5), fit (METs, ±9.2), and highest-fit (METs, ±11.7).

In unadjusted analysis, veterans with the lowest cardiorespiratory fitness developed ADRD at a rate of 9.5 cases per 1,000 person-years, compared with a rate of 6.4 cases per 1,000 person-years for the most fit group (P < .001).

After adjusting for factors that could affect risk of ADRD, compared with the lowest-fit group, the highest-fit and fit groups were 33% and 26% less likely to develop ADRD, respectively, while the moderate-fit and low-fit groups were 20% and 13% less likely to develop the disease, respectively.

The next vital sign?

Commenting on the study, Shaheen E. Lakhan, MD, PhD, a neurologist in Boston, noted that “for decades and with increasing body of support from studies like this, we have known that preventing dementia is based on healthy behaviors for the brain including a proper diet (NASH and/or Mediterranean), exercise regimen (aerobic/cardio more than anaerobic/weight-lifting), sleep hygiene, and social and intellectual engagements.”

“Frankly, what’s good for the body is good for the brain,” said Dr. Lakhan.

“It should be noted that the measure studied here is cardiorespiratory fitness, which has been associated with heart disease and resulting death, death from any cause, and now brain health,” Dr. Lakhan said.

“This powerful predictor may in fact be the next vital sign, after your heart rate and blood pressure, from which your primary care provider can make a personalized treatment plan,” he added.

“Accelerating this process, the ability to measure cardiorespiratory fitness traditionally from huge stationary machines down to wearables like a watch or ring, or even your iPhone or Android, is just on the horizon,” Dr. Lakhan said.

“Instead of tracking just your weight, shape, and BMI, personal fitness may be tailored to optimizing this indicator and further empowering individuals to take charge of their health,” he said.

The study was supported by the National Institute on Aging, the National Institutes of Health, the U.S. Department of Veterans Affairs, the Washington DC VA Medical Center, and George Washington University. Dr. Zamrini and Dr. Lakhan have disclosed no relevant financial relationships.

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

A dose-response relationship exists between number of years playing hockey and risk and severity of chronic traumatic encephalopathy (CTE), new research suggests. Early results from a study that examined donor brains showed that each additional year of ice hockey play increased the risk for CTE by 23%.

This information should be on the “radar” of all clinicians, said coinvestigator Jesse Mez, MD, associate professor of neurology at Boston University. “When they’re talking to kids and families and parents about playing contact sports, they should discuss the benefits as well as the risks so all that information can be taken into consideration.”

Dr. Mez noted that clinicians should also consider the amount of hockey played when assessing patients for thinking and memory trouble later in life. “CTE could be in the differential diagnosis,” he said.

The study findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Football data

CTE is a neurodegenerative disease associated with repetitive hits to the head. In previous research, the investigators showed that the more that athletes play American football, the more likely they are to develop CTE.

“Hockey, like football, involves repetitive head impacts as part of the game,” said Dr. Mez. “So we hypothesized that we would see a similar type of dose-response relationship in hockey.”

From two brain banks – the Veterans Affairs–Boston University–Concussion Legacy Foundation and the Framingham Heart Study – the researchers accessed 74 consecutive brains from donors who had played ice hockey. They collected information about hockey play during “pretty comprehensive” interviews with next of kin, Dr. Mez reported.

The study participants ranged in age from 13 to 91 years. The cause of death varied; most died with end-stage dementia and neurodegenerative disease, but some died of cardiovascular disease, and others from accidents.

For 9% of the individuals, the highest level of play was a youth league; 34% had reached the high school level, 30% reached the juniors/college level, and 26% played professionally. In addition, 46% played another contact sport – including 43% who played American football.

Primary outcomes included evidence of CTE from stage 0 (no CTE) to stage IV and severity of CTE, which was defined by the amount of neurofibrillary tangle (NFT) burden in 11 brain regions. For this burden, the score ranged from 0 (absent) to 3 (severe) in each region for a total range of 0-33.

Dr. Mez noted that, in CTE, tau protein accumulates abnormally. “It typically begins in the cortex in the frontal lobe and then spreads to other parts of the brain, including to the medial temporal structures, and is widespread by stage IV.”

The researchers estimated the association of duration of ice hockey play in years with each neuropathologic outcome and adjusted for age at death and duration of football play.
 

Consistent findings

Results showed that, of the 74 donors, 40 (54%) had CTE. Each additional year of hockey play corresponded to increased chances for having CTE (odds ratio, 1.23; 95% confidence interval, 11%-36%; P < .01). This increase in risk is similar to that which was found with football players, Dr. Mez noted. This was somewhat surprising, as hockey involves fewer “hits” than football.

“Hits are not as quintessential to the game of hockey as they are in football, where contacts occur with nearly every play,” he said. “In football, you have several hundred impacts over the course of a season.”

Researchers also found a 15% increase in odds for increasing one CTE stage (95% CI, 8%-22%; P < .01), and a .03 standard deviation increase in cumulative NFT burden (95% CI, 0.01-0.05; P < .01).

Dr. Mez noted that the fact that the results were consistent across different outcomes “improves the validity” of the findings.

In a sensitivity analysis that excluded participants who also played football, estimates “were pretty similar” to those in the full analysis, said Dr. Mez.

The investigators have not yet examined the effect of level of hockey play, such as professionally or at the college level, on CTE risk. However, in football players, they found that level of play is another “valuable predictor of CTE pathology,” Dr. Mez said, adding that level of play, position played, and years of play “are all probably contributing” to CTE risk.

Asking about years of play is useful in a clinical setting. “It’s very easy for a clinician to ask patients how many years of hockey they played,” said Dr. Mez.

Overall, the new results are important, as “millions of individuals” play contact sports, whether that is hockey, football, or European soccer, he added. “And for all sports, there seems to be this relationship between more play and risk of this disease.”
 

‘Skewed’ population?

Commenting on the findings, Frank Conidi, MD, director, Florida Center for Health and Sports Neurology, Port St. Lucie, said he was surprised the investigators found a 23% per year increase in risk for CTE among hockey players.

Dr. Conidi has played hockey himself and works with the Florida Panthers of the National Hockey League. In his practice, he treats retired professional football players who have neurodegenerative disorders. From his experience, the number of repetitive direct head impacts in football is significantly higher than in hockey. “Most of the forces seen in hockey are from hits to the body, where the force is transferred to the head,” said Dr. Conidi, who was not involved with the research.

He noted differences in the way hockey is played around the world. In European countries, for example, the ice surface is relatively large and the emphasis tends to be more on skill than hitting.

“It would have been interesting to have the study group analyze the data based on where the athlete grew up,” he said. Dr. Conidi would also like to know when the participants played hockey. “The game is vastly different now than it was in the 1970s, ‘80s, and early ‘90s, when there was more fighting, less protective gear, and more hitting in general.”

As is the case for most studies of CTE in athletes, the study population is “skewed” because the participants likely had neurocognitive and other problems that led to their decision to donate their brain, said Dr. Conidi.

He also doesn’t believe the study should be the sole factor in a decision to continue or stop playing hockey. “We are still in the infancy stages of understanding the effects of high-impact sports on athletes’ brains.”

The study received funding from the National Institute of Neurological Diseases and Stroke and the National Institute on Aging. Dr. Mez and Dr. Conidi have reported no relevant financial relationships.

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

A dose-response relationship exists between number of years playing hockey and risk and severity of chronic traumatic encephalopathy (CTE), new research suggests. Early results from a study that examined donor brains showed that each additional year of ice hockey play increased the risk for CTE by 23%.

This information should be on the “radar” of all clinicians, said coinvestigator Jesse Mez, MD, associate professor of neurology at Boston University. “When they’re talking to kids and families and parents about playing contact sports, they should discuss the benefits as well as the risks so all that information can be taken into consideration.”

Dr. Mez noted that clinicians should also consider the amount of hockey played when assessing patients for thinking and memory trouble later in life. “CTE could be in the differential diagnosis,” he said.

The study findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Football data

CTE is a neurodegenerative disease associated with repetitive hits to the head. In previous research, the investigators showed that the more that athletes play American football, the more likely they are to develop CTE.

“Hockey, like football, involves repetitive head impacts as part of the game,” said Dr. Mez. “So we hypothesized that we would see a similar type of dose-response relationship in hockey.”

From two brain banks – the Veterans Affairs–Boston University–Concussion Legacy Foundation and the Framingham Heart Study – the researchers accessed 74 consecutive brains from donors who had played ice hockey. They collected information about hockey play during “pretty comprehensive” interviews with next of kin, Dr. Mez reported.

The study participants ranged in age from 13 to 91 years. The cause of death varied; most died with end-stage dementia and neurodegenerative disease, but some died of cardiovascular disease, and others from accidents.

For 9% of the individuals, the highest level of play was a youth league; 34% had reached the high school level, 30% reached the juniors/college level, and 26% played professionally. In addition, 46% played another contact sport – including 43% who played American football.

Primary outcomes included evidence of CTE from stage 0 (no CTE) to stage IV and severity of CTE, which was defined by the amount of neurofibrillary tangle (NFT) burden in 11 brain regions. For this burden, the score ranged from 0 (absent) to 3 (severe) in each region for a total range of 0-33.

Dr. Mez noted that, in CTE, tau protein accumulates abnormally. “It typically begins in the cortex in the frontal lobe and then spreads to other parts of the brain, including to the medial temporal structures, and is widespread by stage IV.”

The researchers estimated the association of duration of ice hockey play in years with each neuropathologic outcome and adjusted for age at death and duration of football play.
 

Consistent findings

Results showed that, of the 74 donors, 40 (54%) had CTE. Each additional year of hockey play corresponded to increased chances for having CTE (odds ratio, 1.23; 95% confidence interval, 11%-36%; P < .01). This increase in risk is similar to that which was found with football players, Dr. Mez noted. This was somewhat surprising, as hockey involves fewer “hits” than football.

“Hits are not as quintessential to the game of hockey as they are in football, where contacts occur with nearly every play,” he said. “In football, you have several hundred impacts over the course of a season.”

Researchers also found a 15% increase in odds for increasing one CTE stage (95% CI, 8%-22%; P < .01), and a .03 standard deviation increase in cumulative NFT burden (95% CI, 0.01-0.05; P < .01).

Dr. Mez noted that the fact that the results were consistent across different outcomes “improves the validity” of the findings.

In a sensitivity analysis that excluded participants who also played football, estimates “were pretty similar” to those in the full analysis, said Dr. Mez.

The investigators have not yet examined the effect of level of hockey play, such as professionally or at the college level, on CTE risk. However, in football players, they found that level of play is another “valuable predictor of CTE pathology,” Dr. Mez said, adding that level of play, position played, and years of play “are all probably contributing” to CTE risk.

Asking about years of play is useful in a clinical setting. “It’s very easy for a clinician to ask patients how many years of hockey they played,” said Dr. Mez.

Overall, the new results are important, as “millions of individuals” play contact sports, whether that is hockey, football, or European soccer, he added. “And for all sports, there seems to be this relationship between more play and risk of this disease.”
 

‘Skewed’ population?

Commenting on the findings, Frank Conidi, MD, director, Florida Center for Health and Sports Neurology, Port St. Lucie, said he was surprised the investigators found a 23% per year increase in risk for CTE among hockey players.

Dr. Conidi has played hockey himself and works with the Florida Panthers of the National Hockey League. In his practice, he treats retired professional football players who have neurodegenerative disorders. From his experience, the number of repetitive direct head impacts in football is significantly higher than in hockey. “Most of the forces seen in hockey are from hits to the body, where the force is transferred to the head,” said Dr. Conidi, who was not involved with the research.

He noted differences in the way hockey is played around the world. In European countries, for example, the ice surface is relatively large and the emphasis tends to be more on skill than hitting.

“It would have been interesting to have the study group analyze the data based on where the athlete grew up,” he said. Dr. Conidi would also like to know when the participants played hockey. “The game is vastly different now than it was in the 1970s, ‘80s, and early ‘90s, when there was more fighting, less protective gear, and more hitting in general.”

As is the case for most studies of CTE in athletes, the study population is “skewed” because the participants likely had neurocognitive and other problems that led to their decision to donate their brain, said Dr. Conidi.

He also doesn’t believe the study should be the sole factor in a decision to continue or stop playing hockey. “We are still in the infancy stages of understanding the effects of high-impact sports on athletes’ brains.”

The study received funding from the National Institute of Neurological Diseases and Stroke and the National Institute on Aging. Dr. Mez and Dr. Conidi have reported no relevant financial relationships.

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

A dose-response relationship exists between number of years playing hockey and risk and severity of chronic traumatic encephalopathy (CTE), new research suggests. Early results from a study that examined donor brains showed that each additional year of ice hockey play increased the risk for CTE by 23%.

This information should be on the “radar” of all clinicians, said coinvestigator Jesse Mez, MD, associate professor of neurology at Boston University. “When they’re talking to kids and families and parents about playing contact sports, they should discuss the benefits as well as the risks so all that information can be taken into consideration.”

Dr. Mez noted that clinicians should also consider the amount of hockey played when assessing patients for thinking and memory trouble later in life. “CTE could be in the differential diagnosis,” he said.

The study findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

Football data

CTE is a neurodegenerative disease associated with repetitive hits to the head. In previous research, the investigators showed that the more that athletes play American football, the more likely they are to develop CTE.

“Hockey, like football, involves repetitive head impacts as part of the game,” said Dr. Mez. “So we hypothesized that we would see a similar type of dose-response relationship in hockey.”

From two brain banks – the Veterans Affairs–Boston University–Concussion Legacy Foundation and the Framingham Heart Study – the researchers accessed 74 consecutive brains from donors who had played ice hockey. They collected information about hockey play during “pretty comprehensive” interviews with next of kin, Dr. Mez reported.

The study participants ranged in age from 13 to 91 years. The cause of death varied; most died with end-stage dementia and neurodegenerative disease, but some died of cardiovascular disease, and others from accidents.

For 9% of the individuals, the highest level of play was a youth league; 34% had reached the high school level, 30% reached the juniors/college level, and 26% played professionally. In addition, 46% played another contact sport – including 43% who played American football.

Primary outcomes included evidence of CTE from stage 0 (no CTE) to stage IV and severity of CTE, which was defined by the amount of neurofibrillary tangle (NFT) burden in 11 brain regions. For this burden, the score ranged from 0 (absent) to 3 (severe) in each region for a total range of 0-33.

Dr. Mez noted that, in CTE, tau protein accumulates abnormally. “It typically begins in the cortex in the frontal lobe and then spreads to other parts of the brain, including to the medial temporal structures, and is widespread by stage IV.”

The researchers estimated the association of duration of ice hockey play in years with each neuropathologic outcome and adjusted for age at death and duration of football play.
 

Consistent findings

Results showed that, of the 74 donors, 40 (54%) had CTE. Each additional year of hockey play corresponded to increased chances for having CTE (odds ratio, 1.23; 95% confidence interval, 11%-36%; P < .01). This increase in risk is similar to that which was found with football players, Dr. Mez noted. This was somewhat surprising, as hockey involves fewer “hits” than football.

“Hits are not as quintessential to the game of hockey as they are in football, where contacts occur with nearly every play,” he said. “In football, you have several hundred impacts over the course of a season.”

Researchers also found a 15% increase in odds for increasing one CTE stage (95% CI, 8%-22%; P < .01), and a .03 standard deviation increase in cumulative NFT burden (95% CI, 0.01-0.05; P < .01).

Dr. Mez noted that the fact that the results were consistent across different outcomes “improves the validity” of the findings.

In a sensitivity analysis that excluded participants who also played football, estimates “were pretty similar” to those in the full analysis, said Dr. Mez.

The investigators have not yet examined the effect of level of hockey play, such as professionally or at the college level, on CTE risk. However, in football players, they found that level of play is another “valuable predictor of CTE pathology,” Dr. Mez said, adding that level of play, position played, and years of play “are all probably contributing” to CTE risk.

Asking about years of play is useful in a clinical setting. “It’s very easy for a clinician to ask patients how many years of hockey they played,” said Dr. Mez.

Overall, the new results are important, as “millions of individuals” play contact sports, whether that is hockey, football, or European soccer, he added. “And for all sports, there seems to be this relationship between more play and risk of this disease.”
 

‘Skewed’ population?

Commenting on the findings, Frank Conidi, MD, director, Florida Center for Health and Sports Neurology, Port St. Lucie, said he was surprised the investigators found a 23% per year increase in risk for CTE among hockey players.

Dr. Conidi has played hockey himself and works with the Florida Panthers of the National Hockey League. In his practice, he treats retired professional football players who have neurodegenerative disorders. From his experience, the number of repetitive direct head impacts in football is significantly higher than in hockey. “Most of the forces seen in hockey are from hits to the body, where the force is transferred to the head,” said Dr. Conidi, who was not involved with the research.

He noted differences in the way hockey is played around the world. In European countries, for example, the ice surface is relatively large and the emphasis tends to be more on skill than hitting.

“It would have been interesting to have the study group analyze the data based on where the athlete grew up,” he said. Dr. Conidi would also like to know when the participants played hockey. “The game is vastly different now than it was in the 1970s, ‘80s, and early ‘90s, when there was more fighting, less protective gear, and more hitting in general.”

As is the case for most studies of CTE in athletes, the study population is “skewed” because the participants likely had neurocognitive and other problems that led to their decision to donate their brain, said Dr. Conidi.

He also doesn’t believe the study should be the sole factor in a decision to continue or stop playing hockey. “We are still in the infancy stages of understanding the effects of high-impact sports on athletes’ brains.”

The study received funding from the National Institute of Neurological Diseases and Stroke and the National Institute on Aging. Dr. Mez and Dr. Conidi have reported no relevant financial relationships.

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

The first comprehensive guidelines to manage pregnant women with anorexia nervosa (AN) have been released.

Pregnant women with AN are at greater risk of poor outcomes, including stillbirth, underweight infant, or pre-term birth, yet there are no clear guidelines on the management of the condition.

“Anorexia in pregnancy has been an overlooked area of clinical care, as many believed only women in remission become pregnant, and it is clear that is not the case,” lead author Megan Galbally, MBBS, PhD, professor and director, Centre of Women’s and Children’s Mental Health at Monash University School of Clinical Sciences, Melbourne, told this news organization.

“There are great opportunities to support women in their mental health and give them and their babies a healthier start to parenthood and life,” said Dr. Galbally.

“For instance, reducing the likelihood of prematurity or low birth weight at birth that can be associated with anorexia in pregnancy has extraordinary benefits for that child for lifelong health and well-being,” she added.

The guidelines were published online in Lancet Psychiatry.
 

Spike in cases

Dr. Galbally noted that during her 20 years of working in perinatal mental health within tertiary maternity services, she only ever saw an occasional pregnant woman with current AN.

In contrast, over the last 3 to 4 years, there has been a “steep increase in women presenting in pregnancy with very low body mass index (BMI) and current anorexia nervosa requiring treatment in pregnancy,” Dr. Galbally said.

Despite the complexity of managing AN in pregnancy, few studies are available to guide care. In a systematic literature review, the researchers identified only eight studies that addressed the management of AN in pregnancy. These studies were case studies or case reports examining narrow aspects of management.

Digging deeper, the researchers conducted a state-of-the-art research review in relevant disciplines and areas of expertise for managing anorexia nervosa in pregnancy. They synthesized their findings into “recommendations and principles” for multidisciplinary care of pregnant women with AN.

The researchers note that AN in pregnancy is associated with increased risks of pregnancy complications and poorer outcomes for infants, and measures such as BMI are less accurate in pregnancy for assessing severity or change in anorexia nervosa.

Anorexia affects pregnancy and neonatal outcomes through low calorie intake, nutritional and vitamin deficiencies, stress, fasting, low body mass, and poor placentation and uteroplacental function.

The authors note that managing AN in pregnancy requires multidisciplinary care that considers the substantial physiological changes for women and requirements for monitoring fetal growth and development.

At a minimum, they recommend monitoring the following:

• Sodium, potassium, magnesium, phosphate, and chloride concentration
• Iron status, vitamin D and bone mineral density, blood sugar concentration (fasting or random), and A1c
• Liver function (including bilirubin, aspartate transaminase, alanine aminotransferase, and gamma-glutamyl transferase) and bone marrow function (including full blood examination, white cell count, neutrophil count, platelets, and hemoglobin)
• Inflammatory markers (C-reactive protein and erythrocyte sedimentation rate)
• Cardiac function (electrocardiogram and echocardiogram)
• Blood pressure and heart rate (lying and standing) and body temperature

“There are considerable risks for women and their unborn child in managing moderate to severe AN in pregnancy,” said Dr. Galbally.

“While we have provided some recommendations, it still requires considerable adaptation to individual presentations and circumstances, and this is best done with a maternity service that manages other high-risk pregnancies such as through maternal-fetal medicine teams,” she said.

“While this area of clinical care can be new to high-risk pregnancy teams, it is clearly important that high-risk pregnancy services and mental health work together to improve care for women with anorexia in pregnancy,” Dr. Galbally added.
 

A nightmare, a dream come true

Reached for comment, Kamryn T. Eddy, PhD, co-director, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, said, “for many with anorexia nervosa, pregnancy realizes their greatest nightmare and dream come true, both at once.”

“The physical demands of pregnancy can be taxing, and for those with anorexia nervosa, closer clinical management makes sense and may help to support patients who are at risk for return to or worsening of symptoms with the increased nutritional needs and weight gain that occur in pregnancy,” Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston, told this news organization.

“At the same time, the desire to have a child can be a strong motivator for patients to make the changes needed to recover, and for some, the transition to mother can also help in recovery by broadening the range of things that influence their self-worth,” Dr. Eddy added.

This research had no specific funding. Dr. Galbally and Dr. Eddy report no relevant conflicts of interest.

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

The first comprehensive guidelines to manage pregnant women with anorexia nervosa (AN) have been released.

Pregnant women with AN are at greater risk of poor outcomes, including stillbirth, underweight infant, or pre-term birth, yet there are no clear guidelines on the management of the condition.

“Anorexia in pregnancy has been an overlooked area of clinical care, as many believed only women in remission become pregnant, and it is clear that is not the case,” lead author Megan Galbally, MBBS, PhD, professor and director, Centre of Women’s and Children’s Mental Health at Monash University School of Clinical Sciences, Melbourne, told this news organization.

“There are great opportunities to support women in their mental health and give them and their babies a healthier start to parenthood and life,” said Dr. Galbally.

“For instance, reducing the likelihood of prematurity or low birth weight at birth that can be associated with anorexia in pregnancy has extraordinary benefits for that child for lifelong health and well-being,” she added.

The guidelines were published online in Lancet Psychiatry.
 

Spike in cases

Dr. Galbally noted that during her 20 years of working in perinatal mental health within tertiary maternity services, she only ever saw an occasional pregnant woman with current AN.

In contrast, over the last 3 to 4 years, there has been a “steep increase in women presenting in pregnancy with very low body mass index (BMI) and current anorexia nervosa requiring treatment in pregnancy,” Dr. Galbally said.

Despite the complexity of managing AN in pregnancy, few studies are available to guide care. In a systematic literature review, the researchers identified only eight studies that addressed the management of AN in pregnancy. These studies were case studies or case reports examining narrow aspects of management.

Digging deeper, the researchers conducted a state-of-the-art research review in relevant disciplines and areas of expertise for managing anorexia nervosa in pregnancy. They synthesized their findings into “recommendations and principles” for multidisciplinary care of pregnant women with AN.

The researchers note that AN in pregnancy is associated with increased risks of pregnancy complications and poorer outcomes for infants, and measures such as BMI are less accurate in pregnancy for assessing severity or change in anorexia nervosa.

Anorexia affects pregnancy and neonatal outcomes through low calorie intake, nutritional and vitamin deficiencies, stress, fasting, low body mass, and poor placentation and uteroplacental function.

The authors note that managing AN in pregnancy requires multidisciplinary care that considers the substantial physiological changes for women and requirements for monitoring fetal growth and development.

At a minimum, they recommend monitoring the following:

• Sodium, potassium, magnesium, phosphate, and chloride concentration
• Iron status, vitamin D and bone mineral density, blood sugar concentration (fasting or random), and A1c
• Liver function (including bilirubin, aspartate transaminase, alanine aminotransferase, and gamma-glutamyl transferase) and bone marrow function (including full blood examination, white cell count, neutrophil count, platelets, and hemoglobin)
• Inflammatory markers (C-reactive protein and erythrocyte sedimentation rate)
• Cardiac function (electrocardiogram and echocardiogram)
• Blood pressure and heart rate (lying and standing) and body temperature

“There are considerable risks for women and their unborn child in managing moderate to severe AN in pregnancy,” said Dr. Galbally.

“While we have provided some recommendations, it still requires considerable adaptation to individual presentations and circumstances, and this is best done with a maternity service that manages other high-risk pregnancies such as through maternal-fetal medicine teams,” she said.

“While this area of clinical care can be new to high-risk pregnancy teams, it is clearly important that high-risk pregnancy services and mental health work together to improve care for women with anorexia in pregnancy,” Dr. Galbally added.
 

A nightmare, a dream come true

Reached for comment, Kamryn T. Eddy, PhD, co-director, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, said, “for many with anorexia nervosa, pregnancy realizes their greatest nightmare and dream come true, both at once.”

“The physical demands of pregnancy can be taxing, and for those with anorexia nervosa, closer clinical management makes sense and may help to support patients who are at risk for return to or worsening of symptoms with the increased nutritional needs and weight gain that occur in pregnancy,” Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston, told this news organization.

“At the same time, the desire to have a child can be a strong motivator for patients to make the changes needed to recover, and for some, the transition to mother can also help in recovery by broadening the range of things that influence their self-worth,” Dr. Eddy added.

This research had no specific funding. Dr. Galbally and Dr. Eddy report no relevant conflicts of interest.

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

The first comprehensive guidelines to manage pregnant women with anorexia nervosa (AN) have been released.

Pregnant women with AN are at greater risk of poor outcomes, including stillbirth, underweight infant, or pre-term birth, yet there are no clear guidelines on the management of the condition.

“Anorexia in pregnancy has been an overlooked area of clinical care, as many believed only women in remission become pregnant, and it is clear that is not the case,” lead author Megan Galbally, MBBS, PhD, professor and director, Centre of Women’s and Children’s Mental Health at Monash University School of Clinical Sciences, Melbourne, told this news organization.

“There are great opportunities to support women in their mental health and give them and their babies a healthier start to parenthood and life,” said Dr. Galbally.

“For instance, reducing the likelihood of prematurity or low birth weight at birth that can be associated with anorexia in pregnancy has extraordinary benefits for that child for lifelong health and well-being,” she added.

The guidelines were published online in Lancet Psychiatry.
 

Spike in cases

Dr. Galbally noted that during her 20 years of working in perinatal mental health within tertiary maternity services, she only ever saw an occasional pregnant woman with current AN.

In contrast, over the last 3 to 4 years, there has been a “steep increase in women presenting in pregnancy with very low body mass index (BMI) and current anorexia nervosa requiring treatment in pregnancy,” Dr. Galbally said.

Despite the complexity of managing AN in pregnancy, few studies are available to guide care. In a systematic literature review, the researchers identified only eight studies that addressed the management of AN in pregnancy. These studies were case studies or case reports examining narrow aspects of management.

Digging deeper, the researchers conducted a state-of-the-art research review in relevant disciplines and areas of expertise for managing anorexia nervosa in pregnancy. They synthesized their findings into “recommendations and principles” for multidisciplinary care of pregnant women with AN.

The researchers note that AN in pregnancy is associated with increased risks of pregnancy complications and poorer outcomes for infants, and measures such as BMI are less accurate in pregnancy for assessing severity or change in anorexia nervosa.

Anorexia affects pregnancy and neonatal outcomes through low calorie intake, nutritional and vitamin deficiencies, stress, fasting, low body mass, and poor placentation and uteroplacental function.

The authors note that managing AN in pregnancy requires multidisciplinary care that considers the substantial physiological changes for women and requirements for monitoring fetal growth and development.

At a minimum, they recommend monitoring the following:

• Sodium, potassium, magnesium, phosphate, and chloride concentration
• Iron status, vitamin D and bone mineral density, blood sugar concentration (fasting or random), and A1c
• Liver function (including bilirubin, aspartate transaminase, alanine aminotransferase, and gamma-glutamyl transferase) and bone marrow function (including full blood examination, white cell count, neutrophil count, platelets, and hemoglobin)
• Inflammatory markers (C-reactive protein and erythrocyte sedimentation rate)
• Cardiac function (electrocardiogram and echocardiogram)
• Blood pressure and heart rate (lying and standing) and body temperature

“There are considerable risks for women and their unborn child in managing moderate to severe AN in pregnancy,” said Dr. Galbally.

“While we have provided some recommendations, it still requires considerable adaptation to individual presentations and circumstances, and this is best done with a maternity service that manages other high-risk pregnancies such as through maternal-fetal medicine teams,” she said.

“While this area of clinical care can be new to high-risk pregnancy teams, it is clearly important that high-risk pregnancy services and mental health work together to improve care for women with anorexia in pregnancy,” Dr. Galbally added.
 

A nightmare, a dream come true

Reached for comment, Kamryn T. Eddy, PhD, co-director, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, said, “for many with anorexia nervosa, pregnancy realizes their greatest nightmare and dream come true, both at once.”

“The physical demands of pregnancy can be taxing, and for those with anorexia nervosa, closer clinical management makes sense and may help to support patients who are at risk for return to or worsening of symptoms with the increased nutritional needs and weight gain that occur in pregnancy,” Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston, told this news organization.

“At the same time, the desire to have a child can be a strong motivator for patients to make the changes needed to recover, and for some, the transition to mother can also help in recovery by broadening the range of things that influence their self-worth,” Dr. Eddy added.

This research had no specific funding. Dr. Galbally and Dr. Eddy report no relevant conflicts of interest.

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

The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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

The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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

The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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