News

TOPLINE:

A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.

METHODOLOGY:

• Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
• 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
• 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
• PPI and H2RA use, dementia incidence, and cognitive changes were tracked.

TAKEAWAY:

• In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
• PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
• No associations were found between H2RA use and cognitive endpoints.

IN PRACTICE:

“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.

STUDY DETAILS:

The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.

LIMITATIONS:

Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.

DISCLOSURES:

Dr. Mehta has disclosed no relevant conflicts of interest.

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

TOPLINE:

A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.

METHODOLOGY:

• Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
• 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
• 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
• PPI and H2RA use, dementia incidence, and cognitive changes were tracked.

TAKEAWAY:

• In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
• PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
• No associations were found between H2RA use and cognitive endpoints.

IN PRACTICE:

“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.

STUDY DETAILS:

The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.

LIMITATIONS:

Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.

DISCLOSURES:

Dr. Mehta has disclosed no relevant conflicts of interest.

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

TOPLINE:

A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.

METHODOLOGY:

• Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
• 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
• 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
• PPI and H2RA use, dementia incidence, and cognitive changes were tracked.

TAKEAWAY:

• In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
• PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
• No associations were found between H2RA use and cognitive endpoints.

IN PRACTICE:

“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.

STUDY DETAILS:

The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.

LIMITATIONS:

Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.

DISCLOSURES:

Dr. Mehta has disclosed no relevant conflicts of interest.

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

TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

TOPLINE:

The less U.S. patients pay out of pocket for drugs that often have high copays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) agonists, the more adherent they are.

METHODOLOGY:

• Review of 90,041 U.S. adults who started a GLP-1 agonist (n = 39,149) or SGLT2 inhibitor (n = 50,892) in 2014-2020.
• Participants had type 2 diabetes, heart failure, or both.
• Data are from Clinformatics Data Mart, including both commercial and Medicare health insurance plans.
• Primary outcome: 12-month adherence to prescribed GLP-1 agonist or SGLT2 inhibitor.

TAKEAWAYS:

• U.S. adults with a lower drug copay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher copay.
• These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.
• After full adjustment, patients with a high copay (≥ $50/month) were, after 12 months, 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a low copay (< $10/month) for these agents.

IN PRACTICE:

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” say the authors.

STUDY DETAILS:

The study was led by Utibe R. Essien, MD, from the University of California, Los Angeles, and Balvindar Singh, MD, PhD, from the University of Pittsburgh, and included several authors from other U.S. centers.

LIMITATIONS:

Study could not exclude residual confounding.

Generalizability uncertain for those without health insurance or with public insurance.

Study did not have information on patient preferences associated with medication use, including specific reasons for poor adherence.

Possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities.

Study could not assess how copayments influenced initial prescription receipt or abandonment at the pharmacy, nor other factors including possible price inflation.
 

DISCLOSURES:

The study received no commercial funding. One author (not a lead author) is an advisor to several drug companies, including ones that market SGLT2 inhibitors or GLP-1 agonists.

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

TOPLINE:

The less U.S. patients pay out of pocket for drugs that often have high copays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) agonists, the more adherent they are.

METHODOLOGY:

• Review of 90,041 U.S. adults who started a GLP-1 agonist (n = 39,149) or SGLT2 inhibitor (n = 50,892) in 2014-2020.
• Participants had type 2 diabetes, heart failure, or both.
• Data are from Clinformatics Data Mart, including both commercial and Medicare health insurance plans.
• Primary outcome: 12-month adherence to prescribed GLP-1 agonist or SGLT2 inhibitor.

TAKEAWAYS:

• U.S. adults with a lower drug copay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher copay.
• These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.
• After full adjustment, patients with a high copay (≥ $50/month) were, after 12 months, 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a low copay (< $10/month) for these agents.

IN PRACTICE:

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” say the authors.

STUDY DETAILS:

The study was led by Utibe R. Essien, MD, from the University of California, Los Angeles, and Balvindar Singh, MD, PhD, from the University of Pittsburgh, and included several authors from other U.S. centers.

LIMITATIONS:

Study could not exclude residual confounding.

Generalizability uncertain for those without health insurance or with public insurance.

Study did not have information on patient preferences associated with medication use, including specific reasons for poor adherence.

Possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities.

Study could not assess how copayments influenced initial prescription receipt or abandonment at the pharmacy, nor other factors including possible price inflation.
 

DISCLOSURES:

The study received no commercial funding. One author (not a lead author) is an advisor to several drug companies, including ones that market SGLT2 inhibitors or GLP-1 agonists.

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

TOPLINE:

The less U.S. patients pay out of pocket for drugs that often have high copays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) agonists, the more adherent they are.

METHODOLOGY:

• Review of 90,041 U.S. adults who started a GLP-1 agonist (n = 39,149) or SGLT2 inhibitor (n = 50,892) in 2014-2020.
• Participants had type 2 diabetes, heart failure, or both.
• Data are from Clinformatics Data Mart, including both commercial and Medicare health insurance plans.
• Primary outcome: 12-month adherence to prescribed GLP-1 agonist or SGLT2 inhibitor.

TAKEAWAYS:

• U.S. adults with a lower drug copay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher copay.
• These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.
• After full adjustment, patients with a high copay (≥ $50/month) were, after 12 months, 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a low copay (< $10/month) for these agents.

IN PRACTICE:

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” say the authors.

STUDY DETAILS:

The study was led by Utibe R. Essien, MD, from the University of California, Los Angeles, and Balvindar Singh, MD, PhD, from the University of Pittsburgh, and included several authors from other U.S. centers.

LIMITATIONS:

Study could not exclude residual confounding.

Generalizability uncertain for those without health insurance or with public insurance.

Study did not have information on patient preferences associated with medication use, including specific reasons for poor adherence.

Possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities.

Study could not assess how copayments influenced initial prescription receipt or abandonment at the pharmacy, nor other factors including possible price inflation.
 

DISCLOSURES:

The study received no commercial funding. One author (not a lead author) is an advisor to several drug companies, including ones that market SGLT2 inhibitors or GLP-1 agonists.

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

Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

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

Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

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

Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

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

Complications from sickle cell disease (SCD) can affect education and life opportunities, and these complications have been associated with social determinants of health such as socioeconomic status, depression, health literacy, and level of education, according to Kelly M. Harris, PhD, of Washington University in St. Louis, and colleagues.

Pain is a hallmark of SCD, and “the current climate around pain management and opioid use has specific implications for individuals with [SCD], especially youth,” Dr. Harris said in an interview.

In a study published in JAMA Network Open, the researchers analyzed 2,264 participants (average age, 27.9 years; 56.2% were female) in the Sickle Cell Disease Implementation Consortium a study that includes patient assessment, treatment, and creation of a longitudinal registry.

The participants completed the Adult Sickle Cell Quality of Life Measurement Information System to provide data on the frequency and severity of pain episodes related to SCD over the past 12 months. Multivariable regression analysis was used to examine the associations of education, employment, and mental health with pain frequency and severity.

Overall, 79.8% of participants reported severe pain, and 47.8% reported more than four episodes of pain in the past year.

Notably, 20% of the participants were diagnosed with depression, and increased pain frequency was significantly associated with depression, although no significant association appeared between pain severity and depression, the researchers said.

A total of 47% of the participants reported using pain medication and 49% reported using hydroxyurea. In addition, 628 participants (28.0%) underwent regular blood transfusions.

Neither education level nor income was associated with increased pain frequency or severity. Age younger than 18 years was significantly associated with both pain frequency and severity, as was daily used of pain medication. Unemployment and female sex also were associated with increased pain frequency.

The findings were limited by several factors including the cross-sectional design that prevents conclusions of causality, and by the reliance on patient reports of depression, which likely led to underreporting, the researchers noted.

However, the results are consistent with previous studies suggesting that pain and negative feelings were associated with reduced quality of life in SCD patients, especially younger patients, and support the need to screen SCD patients for depression, especially those who report more severe and/or more frequent pain, they said.
 

Take a comprehensive approach to a complex condition

“When treating pain, we cannot just rely on medication,” Dr. Harris said. “It is important that providers consider the full experiences of patients and pursue holistic and comprehensive treatment approaches to reducing pain. Screening for depression should be a regular practice, particularly for patients experiencing frequent and/or severe pain.

“Racial discrimination, stigma, and bias impact pain diagnosis and treatment for individuals with SCD,” said Dr. Harris. “Increasing awareness of the associations between depression and pain frequency and severity ... may help address these barriers.”
 

Data highlight treatment gaps

Alexander A. Boucher, MD, a member of the division of pediatric hematology and oncology at the University of Minnesota, Minneapolis, noted the researchers included patients as young as midadolescence, with a majority being under 35 years old. “The 18- to 30-year-old range is an especially high-risk age window for increased acute health care utilization, even compared with other chronic adolescent/young adult conditions. “The demographics in the study group also reasonably approximate those for young adults with SCD in urban centers. By taking a multicenter approach across a several-state region, I believe the findings offer better generalizability, since health care access and mental health access can vary state-by-state,” and the current results show a more standard experience.

“It was a bit surprising that female [sex] maintained such an association with pain across the different components of the study,” and that the pain peak was in the 25- to 34-year-old age range, said Dr. Boucher. However, anecdotally, the late teens and early 20s “can be laden with mental health concerns due to the life transitions that accompany most people at that time. The note that hydroxyurea use was associated with more pain and depression symptoms was interesting, and serves as a reminder that what is happening to the red blood cells and in the blood vessels, such as red blood cell breakdown, sickling, and vaso-occlusion are only a part of what causes pain, and hydroxyurea is not likely to play a role in mitigating mental health aspects of pain.”

The findings that overall pain frequency and related pain medication use were associated with higher depression rates “may in part reflect a blind spot for physicians and medical teams, who often resort back to physical pain-based heuristics.” Physicians may misunderstand chronic pain and its management and look for quick fixes for pain out of uncertainty or urgency, said Dr. Boucher. “This serves to diminish the perspectives of patients as people first (not embodiments of a disease) and can lead to missed opportunities to tackle mental health challenges.”
 

Barriers and limitations

There are barriers to mental health screening in hematology care,” Dr. Boucher said. First, most hematologists are not experts in mental health and while they may have some from their medical training in these disorders, it can be difficult to maintain the level of health literacy needed to stay up to date on treatments. Second, depression screening may not be part of regular patient intake and the Patient Health Questionnaire–2 or PHQ-9 offer only short-term (2-week) snapshots of depression.

“Perhaps most critically, even if we do successfully screen, the access to mental health specialists is severely limited, just as it is across the medical landscape, so intervention opportunities may be suboptimal,” said Dr. Boucher. The problem is magnified if, as the current study suggests, the rates of depression in SCD are approximately three times greater than the population overall.

In the current study, “the fact that only half of those who self-reported depression symptoms actually had depression documented as a diagnosis in their medical records suggests that we are missing a lot of patients affected by mental health disturbances.”

This study is limited in measurement of the contribution of social determinants of health, he said, as they were primarily focused on employment status and income. The study does not describe other factors like support systems, housing, and transportation.

“I would like to see studies that not only identify associated drivers of pain, but also offer evidence for successful interventions,” Dr. Boucher said, and these studies should include patient-centered interventions versus disease-centered interventions.
 

Undertreatment persists

Other concerns with sickle cell anemia include the underuse of hydroxyurea to reduce complications associated with the disease such as pain, stroke, and even early death. Another recent study in JAMA Network Open suggested that use of hydroxyurea remained low in children and youth despite the issuing of guidelines, and that underserved populations were especially affected. In that study, the researchers found that the patients’ annual days’ supply of hydroxyurea in New York state did not change significantly after the guideline update.

SCD also has been associated with increased risk of other poor outcomes, such as stillbirth and increased risk of poor COVID-19–related outcomes and COVID-19–related deaths.

The study by Dr. Harris and colleagues was supported by the National Institutes of Health through the National Heart, Lung, and Blood Institute and the National Institute on Minority Health and Health Disparities. Dr. Harris had no financial conflicts to disclose. The hydroxyurea study was supported by the Agency for Healthcare Research and Quality and the NHLBI. The researchers had no financial conflicts to disclose. Dr. Boucher disclosed conducting research with SCL Behring, but had no relevant financial conflicts.

Complications from sickle cell disease (SCD) can affect education and life opportunities, and these complications have been associated with social determinants of health such as socioeconomic status, depression, health literacy, and level of education, according to Kelly M. Harris, PhD, of Washington University in St. Louis, and colleagues.

Pain is a hallmark of SCD, and “the current climate around pain management and opioid use has specific implications for individuals with [SCD], especially youth,” Dr. Harris said in an interview.

In a study published in JAMA Network Open, the researchers analyzed 2,264 participants (average age, 27.9 years; 56.2% were female) in the Sickle Cell Disease Implementation Consortium a study that includes patient assessment, treatment, and creation of a longitudinal registry.

The participants completed the Adult Sickle Cell Quality of Life Measurement Information System to provide data on the frequency and severity of pain episodes related to SCD over the past 12 months. Multivariable regression analysis was used to examine the associations of education, employment, and mental health with pain frequency and severity.

Overall, 79.8% of participants reported severe pain, and 47.8% reported more than four episodes of pain in the past year.

Notably, 20% of the participants were diagnosed with depression, and increased pain frequency was significantly associated with depression, although no significant association appeared between pain severity and depression, the researchers said.

A total of 47% of the participants reported using pain medication and 49% reported using hydroxyurea. In addition, 628 participants (28.0%) underwent regular blood transfusions.

Neither education level nor income was associated with increased pain frequency or severity. Age younger than 18 years was significantly associated with both pain frequency and severity, as was daily used of pain medication. Unemployment and female sex also were associated with increased pain frequency.

The findings were limited by several factors including the cross-sectional design that prevents conclusions of causality, and by the reliance on patient reports of depression, which likely led to underreporting, the researchers noted.

However, the results are consistent with previous studies suggesting that pain and negative feelings were associated with reduced quality of life in SCD patients, especially younger patients, and support the need to screen SCD patients for depression, especially those who report more severe and/or more frequent pain, they said.
 

Take a comprehensive approach to a complex condition

“When treating pain, we cannot just rely on medication,” Dr. Harris said. “It is important that providers consider the full experiences of patients and pursue holistic and comprehensive treatment approaches to reducing pain. Screening for depression should be a regular practice, particularly for patients experiencing frequent and/or severe pain.

“Racial discrimination, stigma, and bias impact pain diagnosis and treatment for individuals with SCD,” said Dr. Harris. “Increasing awareness of the associations between depression and pain frequency and severity ... may help address these barriers.”
 

Data highlight treatment gaps

Alexander A. Boucher, MD, a member of the division of pediatric hematology and oncology at the University of Minnesota, Minneapolis, noted the researchers included patients as young as midadolescence, with a majority being under 35 years old. “The 18- to 30-year-old range is an especially high-risk age window for increased acute health care utilization, even compared with other chronic adolescent/young adult conditions. “The demographics in the study group also reasonably approximate those for young adults with SCD in urban centers. By taking a multicenter approach across a several-state region, I believe the findings offer better generalizability, since health care access and mental health access can vary state-by-state,” and the current results show a more standard experience.

“It was a bit surprising that female [sex] maintained such an association with pain across the different components of the study,” and that the pain peak was in the 25- to 34-year-old age range, said Dr. Boucher. However, anecdotally, the late teens and early 20s “can be laden with mental health concerns due to the life transitions that accompany most people at that time. The note that hydroxyurea use was associated with more pain and depression symptoms was interesting, and serves as a reminder that what is happening to the red blood cells and in the blood vessels, such as red blood cell breakdown, sickling, and vaso-occlusion are only a part of what causes pain, and hydroxyurea is not likely to play a role in mitigating mental health aspects of pain.”

The findings that overall pain frequency and related pain medication use were associated with higher depression rates “may in part reflect a blind spot for physicians and medical teams, who often resort back to physical pain-based heuristics.” Physicians may misunderstand chronic pain and its management and look for quick fixes for pain out of uncertainty or urgency, said Dr. Boucher. “This serves to diminish the perspectives of patients as people first (not embodiments of a disease) and can lead to missed opportunities to tackle mental health challenges.”
 

Barriers and limitations

There are barriers to mental health screening in hematology care,” Dr. Boucher said. First, most hematologists are not experts in mental health and while they may have some from their medical training in these disorders, it can be difficult to maintain the level of health literacy needed to stay up to date on treatments. Second, depression screening may not be part of regular patient intake and the Patient Health Questionnaire–2 or PHQ-9 offer only short-term (2-week) snapshots of depression.

“Perhaps most critically, even if we do successfully screen, the access to mental health specialists is severely limited, just as it is across the medical landscape, so intervention opportunities may be suboptimal,” said Dr. Boucher. The problem is magnified if, as the current study suggests, the rates of depression in SCD are approximately three times greater than the population overall.

In the current study, “the fact that only half of those who self-reported depression symptoms actually had depression documented as a diagnosis in their medical records suggests that we are missing a lot of patients affected by mental health disturbances.”

This study is limited in measurement of the contribution of social determinants of health, he said, as they were primarily focused on employment status and income. The study does not describe other factors like support systems, housing, and transportation.

“I would like to see studies that not only identify associated drivers of pain, but also offer evidence for successful interventions,” Dr. Boucher said, and these studies should include patient-centered interventions versus disease-centered interventions.
 

Undertreatment persists

Other concerns with sickle cell anemia include the underuse of hydroxyurea to reduce complications associated with the disease such as pain, stroke, and even early death. Another recent study in JAMA Network Open suggested that use of hydroxyurea remained low in children and youth despite the issuing of guidelines, and that underserved populations were especially affected. In that study, the researchers found that the patients’ annual days’ supply of hydroxyurea in New York state did not change significantly after the guideline update.

SCD also has been associated with increased risk of other poor outcomes, such as stillbirth and increased risk of poor COVID-19–related outcomes and COVID-19–related deaths.

The study by Dr. Harris and colleagues was supported by the National Institutes of Health through the National Heart, Lung, and Blood Institute and the National Institute on Minority Health and Health Disparities. Dr. Harris had no financial conflicts to disclose. The hydroxyurea study was supported by the Agency for Healthcare Research and Quality and the NHLBI. The researchers had no financial conflicts to disclose. Dr. Boucher disclosed conducting research with SCL Behring, but had no relevant financial conflicts.

Complications from sickle cell disease (SCD) can affect education and life opportunities, and these complications have been associated with social determinants of health such as socioeconomic status, depression, health literacy, and level of education, according to Kelly M. Harris, PhD, of Washington University in St. Louis, and colleagues.

Pain is a hallmark of SCD, and “the current climate around pain management and opioid use has specific implications for individuals with [SCD], especially youth,” Dr. Harris said in an interview.

In a study published in JAMA Network Open, the researchers analyzed 2,264 participants (average age, 27.9 years; 56.2% were female) in the Sickle Cell Disease Implementation Consortium a study that includes patient assessment, treatment, and creation of a longitudinal registry.

The participants completed the Adult Sickle Cell Quality of Life Measurement Information System to provide data on the frequency and severity of pain episodes related to SCD over the past 12 months. Multivariable regression analysis was used to examine the associations of education, employment, and mental health with pain frequency and severity.

Overall, 79.8% of participants reported severe pain, and 47.8% reported more than four episodes of pain in the past year.

Notably, 20% of the participants were diagnosed with depression, and increased pain frequency was significantly associated with depression, although no significant association appeared between pain severity and depression, the researchers said.

A total of 47% of the participants reported using pain medication and 49% reported using hydroxyurea. In addition, 628 participants (28.0%) underwent regular blood transfusions.

Neither education level nor income was associated with increased pain frequency or severity. Age younger than 18 years was significantly associated with both pain frequency and severity, as was daily used of pain medication. Unemployment and female sex also were associated with increased pain frequency.

The findings were limited by several factors including the cross-sectional design that prevents conclusions of causality, and by the reliance on patient reports of depression, which likely led to underreporting, the researchers noted.

However, the results are consistent with previous studies suggesting that pain and negative feelings were associated with reduced quality of life in SCD patients, especially younger patients, and support the need to screen SCD patients for depression, especially those who report more severe and/or more frequent pain, they said.
 

Take a comprehensive approach to a complex condition

“When treating pain, we cannot just rely on medication,” Dr. Harris said. “It is important that providers consider the full experiences of patients and pursue holistic and comprehensive treatment approaches to reducing pain. Screening for depression should be a regular practice, particularly for patients experiencing frequent and/or severe pain.

“Racial discrimination, stigma, and bias impact pain diagnosis and treatment for individuals with SCD,” said Dr. Harris. “Increasing awareness of the associations between depression and pain frequency and severity ... may help address these barriers.”
 

Data highlight treatment gaps

Alexander A. Boucher, MD, a member of the division of pediatric hematology and oncology at the University of Minnesota, Minneapolis, noted the researchers included patients as young as midadolescence, with a majority being under 35 years old. “The 18- to 30-year-old range is an especially high-risk age window for increased acute health care utilization, even compared with other chronic adolescent/young adult conditions. “The demographics in the study group also reasonably approximate those for young adults with SCD in urban centers. By taking a multicenter approach across a several-state region, I believe the findings offer better generalizability, since health care access and mental health access can vary state-by-state,” and the current results show a more standard experience.

“It was a bit surprising that female [sex] maintained such an association with pain across the different components of the study,” and that the pain peak was in the 25- to 34-year-old age range, said Dr. Boucher. However, anecdotally, the late teens and early 20s “can be laden with mental health concerns due to the life transitions that accompany most people at that time. The note that hydroxyurea use was associated with more pain and depression symptoms was interesting, and serves as a reminder that what is happening to the red blood cells and in the blood vessels, such as red blood cell breakdown, sickling, and vaso-occlusion are only a part of what causes pain, and hydroxyurea is not likely to play a role in mitigating mental health aspects of pain.”

The findings that overall pain frequency and related pain medication use were associated with higher depression rates “may in part reflect a blind spot for physicians and medical teams, who often resort back to physical pain-based heuristics.” Physicians may misunderstand chronic pain and its management and look for quick fixes for pain out of uncertainty or urgency, said Dr. Boucher. “This serves to diminish the perspectives of patients as people first (not embodiments of a disease) and can lead to missed opportunities to tackle mental health challenges.”
 

Barriers and limitations

There are barriers to mental health screening in hematology care,” Dr. Boucher said. First, most hematologists are not experts in mental health and while they may have some from their medical training in these disorders, it can be difficult to maintain the level of health literacy needed to stay up to date on treatments. Second, depression screening may not be part of regular patient intake and the Patient Health Questionnaire–2 or PHQ-9 offer only short-term (2-week) snapshots of depression.

“Perhaps most critically, even if we do successfully screen, the access to mental health specialists is severely limited, just as it is across the medical landscape, so intervention opportunities may be suboptimal,” said Dr. Boucher. The problem is magnified if, as the current study suggests, the rates of depression in SCD are approximately three times greater than the population overall.

In the current study, “the fact that only half of those who self-reported depression symptoms actually had depression documented as a diagnosis in their medical records suggests that we are missing a lot of patients affected by mental health disturbances.”

This study is limited in measurement of the contribution of social determinants of health, he said, as they were primarily focused on employment status and income. The study does not describe other factors like support systems, housing, and transportation.

“I would like to see studies that not only identify associated drivers of pain, but also offer evidence for successful interventions,” Dr. Boucher said, and these studies should include patient-centered interventions versus disease-centered interventions.
 

Undertreatment persists

Other concerns with sickle cell anemia include the underuse of hydroxyurea to reduce complications associated with the disease such as pain, stroke, and even early death. Another recent study in JAMA Network Open suggested that use of hydroxyurea remained low in children and youth despite the issuing of guidelines, and that underserved populations were especially affected. In that study, the researchers found that the patients’ annual days’ supply of hydroxyurea in New York state did not change significantly after the guideline update.

SCD also has been associated with increased risk of other poor outcomes, such as stillbirth and increased risk of poor COVID-19–related outcomes and COVID-19–related deaths.

The study by Dr. Harris and colleagues was supported by the National Institutes of Health through the National Heart, Lung, and Blood Institute and the National Institute on Minority Health and Health Disparities. Dr. Harris had no financial conflicts to disclose. The hydroxyurea study was supported by the Agency for Healthcare Research and Quality and the NHLBI. The researchers had no financial conflicts to disclose. Dr. Boucher disclosed conducting research with SCL Behring, but had no relevant financial conflicts.

TOPLINE:

Vortioxetine significantly improves depressive symptoms, cognitive performance, functioning, and quality of life at 12 weeks in patients with both major depressive disorder (MDD) and early-stage dementia.

METHODOLOGY:

• The multicenter MEMORY study included 82 subjects with MDD and early-stage dementia, mean age 70.3 years, mostly female (66%) and White (95%).
• Vortioxetine, a modulator of 5-hydroxytryptamine receptor activity and an inhibitor of the 5-HT transporter, initiated at 5 mg/day (recommended starting dose in older adults) with the dose up-titrated to 10 mg/day after a week and flexible dosing thereafter.
• Depression was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), and cognition with the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test.

TAKEAWAY:

• There was significant and clinically meaningful improvement in the severity of depressive symptoms, as measured by MADRS total score (the primary outcome), at all assessment time points (P < .0001).
• Improvements in depressive symptoms were irrespective of dementia type.
• There were also significant improvements in DSST total score (P < .0001) and in daily functioning and health-related quality of life (HRQoL).
• Vortioxetine was well tolerated; side effects, including nausea and abdominal pain, were mostly mild to moderate.

IN PRACTICE:

“Vortioxetine demonstrated effectiveness in clinically significantly improving depressive symptoms, cognitive performance, daily and global functioning, and HRQoL in patients with MDD and comorbid early-stage dementia treated for 12 weeks” the researchers noted. 

STUDY DETAILS:

The study was conducted by Michael Cronquist Christensen from pharmaceutical company H. Lundbeck, Valby, Denmark, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The study is open label and lacked a control group. Learning effects were possible, which could contribute to improved cognitive performance, although significant improvement on the RAVLT was not observed until week 4, suggesting earning effects were minimal.
 

DISCLOSURES:

The study was funded by H. Lundbeck. Mr. Christensen is an employee of H. Lundbeck.

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

TOPLINE:

Vortioxetine significantly improves depressive symptoms, cognitive performance, functioning, and quality of life at 12 weeks in patients with both major depressive disorder (MDD) and early-stage dementia.

METHODOLOGY:

• The multicenter MEMORY study included 82 subjects with MDD and early-stage dementia, mean age 70.3 years, mostly female (66%) and White (95%).
• Vortioxetine, a modulator of 5-hydroxytryptamine receptor activity and an inhibitor of the 5-HT transporter, initiated at 5 mg/day (recommended starting dose in older adults) with the dose up-titrated to 10 mg/day after a week and flexible dosing thereafter.
• Depression was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), and cognition with the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test.

TAKEAWAY:

• There was significant and clinically meaningful improvement in the severity of depressive symptoms, as measured by MADRS total score (the primary outcome), at all assessment time points (P < .0001).
• Improvements in depressive symptoms were irrespective of dementia type.
• There were also significant improvements in DSST total score (P < .0001) and in daily functioning and health-related quality of life (HRQoL).
• Vortioxetine was well tolerated; side effects, including nausea and abdominal pain, were mostly mild to moderate.

IN PRACTICE:

“Vortioxetine demonstrated effectiveness in clinically significantly improving depressive symptoms, cognitive performance, daily and global functioning, and HRQoL in patients with MDD and comorbid early-stage dementia treated for 12 weeks” the researchers noted. 

STUDY DETAILS:

The study was conducted by Michael Cronquist Christensen from pharmaceutical company H. Lundbeck, Valby, Denmark, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The study is open label and lacked a control group. Learning effects were possible, which could contribute to improved cognitive performance, although significant improvement on the RAVLT was not observed until week 4, suggesting earning effects were minimal.
 

DISCLOSURES:

The study was funded by H. Lundbeck. Mr. Christensen is an employee of H. Lundbeck.

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

TOPLINE:

Vortioxetine significantly improves depressive symptoms, cognitive performance, functioning, and quality of life at 12 weeks in patients with both major depressive disorder (MDD) and early-stage dementia.

METHODOLOGY:

• The multicenter MEMORY study included 82 subjects with MDD and early-stage dementia, mean age 70.3 years, mostly female (66%) and White (95%).
• Vortioxetine, a modulator of 5-hydroxytryptamine receptor activity and an inhibitor of the 5-HT transporter, initiated at 5 mg/day (recommended starting dose in older adults) with the dose up-titrated to 10 mg/day after a week and flexible dosing thereafter.
• Depression was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), and cognition with the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test.

TAKEAWAY:

• There was significant and clinically meaningful improvement in the severity of depressive symptoms, as measured by MADRS total score (the primary outcome), at all assessment time points (P < .0001).
• Improvements in depressive symptoms were irrespective of dementia type.
• There were also significant improvements in DSST total score (P < .0001) and in daily functioning and health-related quality of life (HRQoL).
• Vortioxetine was well tolerated; side effects, including nausea and abdominal pain, were mostly mild to moderate.

IN PRACTICE:

“Vortioxetine demonstrated effectiveness in clinically significantly improving depressive symptoms, cognitive performance, daily and global functioning, and HRQoL in patients with MDD and comorbid early-stage dementia treated for 12 weeks” the researchers noted. 

STUDY DETAILS:

The study was conducted by Michael Cronquist Christensen from pharmaceutical company H. Lundbeck, Valby, Denmark, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The study is open label and lacked a control group. Learning effects were possible, which could contribute to improved cognitive performance, although significant improvement on the RAVLT was not observed until week 4, suggesting earning effects were minimal.
 

DISCLOSURES:

The study was funded by H. Lundbeck. Mr. Christensen is an employee of H. Lundbeck.

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

TOPLINE:

Therapists’ oxytocin levels significantly affect the association between patients’ negative emotions and reduction in their depressive symptoms.

METHODOLOGY:

• Evidence suggests patient experiences of negative emotions predict outcomes of psychotherapy for major depressive disorder (MDD), but mechanisms remain unclear.
• Researchers used a mediation model based on the role of oxytocin (OT) in attachment relationships, such as between parent and infant.
• They collected 435 oxytocin samples pre- and post-session from therapists of 62 patients receiving psychotherapy for MDD.
• Hamilton Rating Scale for Depression (HRSD) was administered to patients before sessions, and patients reported their in-session emotions.

TAKEAWAY:

• Higher negative emotion levels of patients predicted higher therapist oxytocin levels on the post-session assessment, when controlling for the pre-session oxytocin (“a” path [same-session path between negative affect and OT levels]: 0.11; standard error, 0.05; P = 03; 95% confidence interval, 0.003-0.20)
• Higher therapist oxytocin levels predicted lower depression severity in the next session (“b” path [time-lagged association between post-session OT levels and depression severity]: –0.97; SE, 0.34; P = .005; 95 % CI, –1.57 to –0.22)
• An increase in therapists’ oxytocin in response to patients’ negative emotions may represent activation of the therapists’ caregiving system signaling the emergence of a healthy therapeutic interaction.

IN PRACTICE:

“The findings suggest that therapists’ oxytocin responses could potentially serve as a biomarker of an effective therapeutic process,” the researchers write.

STUDY DETAILS:

The study was conducted by Hadar Fisher, department of psychology, University of Haifa, Israel, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The sample size, while one of the largest in studies looking at oxytocin in psychotherapy, still has limited statistical power. The study used post-session retrospective self-reports to measure negative emotions, which focused on patients’ experiences rather than expression of these emotions.

DISCLOSURES:

The study was supported by a grant from the Israeli Science Foundation. The authors report no competing interests.

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

TOPLINE:

Therapists’ oxytocin levels significantly affect the association between patients’ negative emotions and reduction in their depressive symptoms.

METHODOLOGY:

• Evidence suggests patient experiences of negative emotions predict outcomes of psychotherapy for major depressive disorder (MDD), but mechanisms remain unclear.
• Researchers used a mediation model based on the role of oxytocin (OT) in attachment relationships, such as between parent and infant.
• They collected 435 oxytocin samples pre- and post-session from therapists of 62 patients receiving psychotherapy for MDD.
• Hamilton Rating Scale for Depression (HRSD) was administered to patients before sessions, and patients reported their in-session emotions.

TAKEAWAY:

• Higher negative emotion levels of patients predicted higher therapist oxytocin levels on the post-session assessment, when controlling for the pre-session oxytocin (“a” path [same-session path between negative affect and OT levels]: 0.11; standard error, 0.05; P = 03; 95% confidence interval, 0.003-0.20)
• Higher therapist oxytocin levels predicted lower depression severity in the next session (“b” path [time-lagged association between post-session OT levels and depression severity]: –0.97; SE, 0.34; P = .005; 95 % CI, –1.57 to –0.22)
• An increase in therapists’ oxytocin in response to patients’ negative emotions may represent activation of the therapists’ caregiving system signaling the emergence of a healthy therapeutic interaction.

IN PRACTICE:

“The findings suggest that therapists’ oxytocin responses could potentially serve as a biomarker of an effective therapeutic process,” the researchers write.

STUDY DETAILS:

The study was conducted by Hadar Fisher, department of psychology, University of Haifa, Israel, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The sample size, while one of the largest in studies looking at oxytocin in psychotherapy, still has limited statistical power. The study used post-session retrospective self-reports to measure negative emotions, which focused on patients’ experiences rather than expression of these emotions.

DISCLOSURES:

The study was supported by a grant from the Israeli Science Foundation. The authors report no competing interests.

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

TOPLINE:

Therapists’ oxytocin levels significantly affect the association between patients’ negative emotions and reduction in their depressive symptoms.

METHODOLOGY:

• Evidence suggests patient experiences of negative emotions predict outcomes of psychotherapy for major depressive disorder (MDD), but mechanisms remain unclear.
• Researchers used a mediation model based on the role of oxytocin (OT) in attachment relationships, such as between parent and infant.
• They collected 435 oxytocin samples pre- and post-session from therapists of 62 patients receiving psychotherapy for MDD.
• Hamilton Rating Scale for Depression (HRSD) was administered to patients before sessions, and patients reported their in-session emotions.

TAKEAWAY:

• Higher negative emotion levels of patients predicted higher therapist oxytocin levels on the post-session assessment, when controlling for the pre-session oxytocin (“a” path [same-session path between negative affect and OT levels]: 0.11; standard error, 0.05; P = 03; 95% confidence interval, 0.003-0.20)
• Higher therapist oxytocin levels predicted lower depression severity in the next session (“b” path [time-lagged association between post-session OT levels and depression severity]: –0.97; SE, 0.34; P = .005; 95 % CI, –1.57 to –0.22)
• An increase in therapists’ oxytocin in response to patients’ negative emotions may represent activation of the therapists’ caregiving system signaling the emergence of a healthy therapeutic interaction.

IN PRACTICE:

“The findings suggest that therapists’ oxytocin responses could potentially serve as a biomarker of an effective therapeutic process,” the researchers write.

STUDY DETAILS:

The study was conducted by Hadar Fisher, department of psychology, University of Haifa, Israel, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS:

The sample size, while one of the largest in studies looking at oxytocin in psychotherapy, still has limited statistical power. The study used post-session retrospective self-reports to measure negative emotions, which focused on patients’ experiences rather than expression of these emotions.

DISCLOSURES:

The study was supported by a grant from the Israeli Science Foundation. The authors report no competing interests.

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

Observation should be considered the first-line treatment of choice in appropriately selected primary spontaneous pneumothorax patients, according to a review comparing observation alone with aspiration or chest tube placement.

Observation was the dominant choice, based on economic modeling showing it to offer both the highest utility and the lowest cost, according to the review, published in CHEST, which encompassed 20 years of relevant publications.

While current guidelines are shifting toward either aspiration or observation and away from recommending chest tube placement, chest tube placement remains quite common in physicians’ clinical practices, Gilgamesh Eamer, MD, MSc, FRCSC, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues wrote. They pointed to recent studies suggesting equivalent or improved outcomes with simple observation in appropriately selected patients. The authors asked, “What management strategy derives the most utility for patients given the cost and morbidity of chest tube placement, hospital admission, surgical intervention and the risk of recurrence of primary spontaneous pneumothorax.”

Primary spontaneous pneumothorax, which leads to progressive pulmonary collapse and respiratory compromise, is thought to be attributable to rupture of air-containing blisters (or bullae) formed under the visceral pleura of the lung, according to the researchers. They stated that, while prior systematic reviews have examined various primary spontaneous pneumothorax management techniques, no reviews encompass more recently published high-quality studies comparing aspiration to other interventions such as observation or Heimlich valve devices.

The authors identified 22 articles for systematic review and meta-analysis after screening an initial list of 5,179 potentially relevant articles (Jan. 1, 2000 to April 10, 2020). They compared observation, needle aspiration, and chest tube placement, and created an economic model for these three treatment pathways based on Canadian medical cost data. The primary outcome measure was resolution following the initial intervention. Secondary outcomes included primary spontaneous pneumothorax recurrence, length of hospital stay, and treatment complications.

The analysis revealed that, compared with observation, chest tube and aspiration had higher resolution without additional intervention (relative risk for chest tube, 0.81; P < .01; RR for aspiration, 0.73; P < .01). Compared with a chest tube, observation and aspiration had shorter length of stay (mean difference for observation, 5.17; P < .01): (MD for aspiration, 2.72; P < .01).

Two-year recurrence rates did not differ between management strategies. Cost utility modeling found a cost of $14,658 (Canadian dollars [CAD] with 1.2535 = 1 US dollar) for chest tube placement, $13,126 CAD for aspiration, and $6,408 CAD for observation.

The utility (a measure including both quantity and quality of life) for each management arm was 0.77 for CT placement, 0.79 for aspiration, and 0.82 for observation. “The observation arm dominates the other two arms meaning it results in a more desirable (higher) utility with lower cost and results in a negative ICER [incremental cost-effectiveness ratio],” the authors stated.

They observed further that it is not typical for a medical intervention to improve patient outcomes, compared with standard care, and at the same time to bring costs down. “Given this, and the increasing evidence that observation is safe and effective in appropriately selected patients presenting with primary spontaneous pneumothorax,” they concluded that “observation should be considered in all patients presenting with primary spontaneous pneumothorax who meet predefined criteria.” They added that, because aspiration is favored over chest tube placement, it should be considered second-line therapy in well-selected primary spontaneous pneumothorax patients presenting with recurrence or who have failed a trial of observation.

“This review sheds light on ‘less is better’ for primary spontaneous pneumothorax management,” commented Dharani K. Narendra, MD, of the department of medicine, Baylor College of Medicine, Houston. “It allows clinicians to utilize a ‘wait approach’ versus invasive treatment. Interestingly, recurrence was lower in the observation group.” She said further, in an interview, “In general we assume that if no intervention is done, there is higher chance of recurrence. However, this meta-analysis reveals that is not the case; there is no difference in recurrence of pneumothorax in all groups and fewer complications in the observation group. The invasive treatments such as aspiration or chest tube are risky as they have more complications like pain, bleeding, injury to surrounding structures, etc.”

Neither Dr. Eamer nor Dr. Narendra reported any conflicts of interest. The study was self-funded.

Observation should be considered the first-line treatment of choice in appropriately selected primary spontaneous pneumothorax patients, according to a review comparing observation alone with aspiration or chest tube placement.

Observation was the dominant choice, based on economic modeling showing it to offer both the highest utility and the lowest cost, according to the review, published in CHEST, which encompassed 20 years of relevant publications.

While current guidelines are shifting toward either aspiration or observation and away from recommending chest tube placement, chest tube placement remains quite common in physicians’ clinical practices, Gilgamesh Eamer, MD, MSc, FRCSC, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues wrote. They pointed to recent studies suggesting equivalent or improved outcomes with simple observation in appropriately selected patients. The authors asked, “What management strategy derives the most utility for patients given the cost and morbidity of chest tube placement, hospital admission, surgical intervention and the risk of recurrence of primary spontaneous pneumothorax.”

Primary spontaneous pneumothorax, which leads to progressive pulmonary collapse and respiratory compromise, is thought to be attributable to rupture of air-containing blisters (or bullae) formed under the visceral pleura of the lung, according to the researchers. They stated that, while prior systematic reviews have examined various primary spontaneous pneumothorax management techniques, no reviews encompass more recently published high-quality studies comparing aspiration to other interventions such as observation or Heimlich valve devices.

The authors identified 22 articles for systematic review and meta-analysis after screening an initial list of 5,179 potentially relevant articles (Jan. 1, 2000 to April 10, 2020). They compared observation, needle aspiration, and chest tube placement, and created an economic model for these three treatment pathways based on Canadian medical cost data. The primary outcome measure was resolution following the initial intervention. Secondary outcomes included primary spontaneous pneumothorax recurrence, length of hospital stay, and treatment complications.

The analysis revealed that, compared with observation, chest tube and aspiration had higher resolution without additional intervention (relative risk for chest tube, 0.81; P < .01; RR for aspiration, 0.73; P < .01). Compared with a chest tube, observation and aspiration had shorter length of stay (mean difference for observation, 5.17; P < .01): (MD for aspiration, 2.72; P < .01).

Two-year recurrence rates did not differ between management strategies. Cost utility modeling found a cost of $14,658 (Canadian dollars [CAD] with 1.2535 = 1 US dollar) for chest tube placement, $13,126 CAD for aspiration, and $6,408 CAD for observation.

The utility (a measure including both quantity and quality of life) for each management arm was 0.77 for CT placement, 0.79 for aspiration, and 0.82 for observation. “The observation arm dominates the other two arms meaning it results in a more desirable (higher) utility with lower cost and results in a negative ICER [incremental cost-effectiveness ratio],” the authors stated.

They observed further that it is not typical for a medical intervention to improve patient outcomes, compared with standard care, and at the same time to bring costs down. “Given this, and the increasing evidence that observation is safe and effective in appropriately selected patients presenting with primary spontaneous pneumothorax,” they concluded that “observation should be considered in all patients presenting with primary spontaneous pneumothorax who meet predefined criteria.” They added that, because aspiration is favored over chest tube placement, it should be considered second-line therapy in well-selected primary spontaneous pneumothorax patients presenting with recurrence or who have failed a trial of observation.

“This review sheds light on ‘less is better’ for primary spontaneous pneumothorax management,” commented Dharani K. Narendra, MD, of the department of medicine, Baylor College of Medicine, Houston. “It allows clinicians to utilize a ‘wait approach’ versus invasive treatment. Interestingly, recurrence was lower in the observation group.” She said further, in an interview, “In general we assume that if no intervention is done, there is higher chance of recurrence. However, this meta-analysis reveals that is not the case; there is no difference in recurrence of pneumothorax in all groups and fewer complications in the observation group. The invasive treatments such as aspiration or chest tube are risky as they have more complications like pain, bleeding, injury to surrounding structures, etc.”

Neither Dr. Eamer nor Dr. Narendra reported any conflicts of interest. The study was self-funded.

Observation should be considered the first-line treatment of choice in appropriately selected primary spontaneous pneumothorax patients, according to a review comparing observation alone with aspiration or chest tube placement.

Observation was the dominant choice, based on economic modeling showing it to offer both the highest utility and the lowest cost, according to the review, published in CHEST, which encompassed 20 years of relevant publications.

While current guidelines are shifting toward either aspiration or observation and away from recommending chest tube placement, chest tube placement remains quite common in physicians’ clinical practices, Gilgamesh Eamer, MD, MSc, FRCSC, of Children’s Hospital of Eastern Ontario, Ottawa, and colleagues wrote. They pointed to recent studies suggesting equivalent or improved outcomes with simple observation in appropriately selected patients. The authors asked, “What management strategy derives the most utility for patients given the cost and morbidity of chest tube placement, hospital admission, surgical intervention and the risk of recurrence of primary spontaneous pneumothorax.”

Primary spontaneous pneumothorax, which leads to progressive pulmonary collapse and respiratory compromise, is thought to be attributable to rupture of air-containing blisters (or bullae) formed under the visceral pleura of the lung, according to the researchers. They stated that, while prior systematic reviews have examined various primary spontaneous pneumothorax management techniques, no reviews encompass more recently published high-quality studies comparing aspiration to other interventions such as observation or Heimlich valve devices.

The authors identified 22 articles for systematic review and meta-analysis after screening an initial list of 5,179 potentially relevant articles (Jan. 1, 2000 to April 10, 2020). They compared observation, needle aspiration, and chest tube placement, and created an economic model for these three treatment pathways based on Canadian medical cost data. The primary outcome measure was resolution following the initial intervention. Secondary outcomes included primary spontaneous pneumothorax recurrence, length of hospital stay, and treatment complications.

The analysis revealed that, compared with observation, chest tube and aspiration had higher resolution without additional intervention (relative risk for chest tube, 0.81; P < .01; RR for aspiration, 0.73; P < .01). Compared with a chest tube, observation and aspiration had shorter length of stay (mean difference for observation, 5.17; P < .01): (MD for aspiration, 2.72; P < .01).

Two-year recurrence rates did not differ between management strategies. Cost utility modeling found a cost of $14,658 (Canadian dollars [CAD] with 1.2535 = 1 US dollar) for chest tube placement, $13,126 CAD for aspiration, and $6,408 CAD for observation.

The utility (a measure including both quantity and quality of life) for each management arm was 0.77 for CT placement, 0.79 for aspiration, and 0.82 for observation. “The observation arm dominates the other two arms meaning it results in a more desirable (higher) utility with lower cost and results in a negative ICER [incremental cost-effectiveness ratio],” the authors stated.

They observed further that it is not typical for a medical intervention to improve patient outcomes, compared with standard care, and at the same time to bring costs down. “Given this, and the increasing evidence that observation is safe and effective in appropriately selected patients presenting with primary spontaneous pneumothorax,” they concluded that “observation should be considered in all patients presenting with primary spontaneous pneumothorax who meet predefined criteria.” They added that, because aspiration is favored over chest tube placement, it should be considered second-line therapy in well-selected primary spontaneous pneumothorax patients presenting with recurrence or who have failed a trial of observation.

“This review sheds light on ‘less is better’ for primary spontaneous pneumothorax management,” commented Dharani K. Narendra, MD, of the department of medicine, Baylor College of Medicine, Houston. “It allows clinicians to utilize a ‘wait approach’ versus invasive treatment. Interestingly, recurrence was lower in the observation group.” She said further, in an interview, “In general we assume that if no intervention is done, there is higher chance of recurrence. However, this meta-analysis reveals that is not the case; there is no difference in recurrence of pneumothorax in all groups and fewer complications in the observation group. The invasive treatments such as aspiration or chest tube are risky as they have more complications like pain, bleeding, injury to surrounding structures, etc.”

Neither Dr. Eamer nor Dr. Narendra reported any conflicts of interest. The study was self-funded.

Prescriptions for desiccated thyroid extract (DTE) to treat newly diagnosed hypothyroidism nearly doubled between 2010 and 2020 in the United States, while prescribing of first-line levothyroxine monotherapy dropped, new research has found.

Nationwide MarketScan claims data reveal that, among first-time thyroid hormone prescriptions, those for DTE rose from 5.4% in 2010 to 10.2% in 2020. At the same time, prescriptions for first-line levothyroxine dropped from 91.8% to 87.2%. Prescriptions for liothyronine (LT3), primarily in combination with levothyroxine, remained at about 2% throughout the decade.

The nonlevothyroxine therapies were more commonly prescribed in the West and Southwestern United States, while levothyroxine monotherapy was more frequent in the Northwest and upper Midwest, and also in states with higher densities of primary care physicians and endocrinologists.

The magnitude of this shift in first-line treatment was unexpected.

“We were frankly quite surprised to see that difference in just 10 years,” lead author Matthew Ettleson, MD, of the University of Chicago, said in an interview.

Asked to comment, session moderator Elizabeth N. Pearce, MD, professor of medicine at Boston University Medical Center, said she also found the dramatic shift to DTE surprising.

“It’s unclear why since there hasn’t been a shift in the science or in the guidelines over the last decade. ... I think we need to understand better what is driving this, who the patients are who are seeking it out, and which providers are the primary drivers of these prescriptions,” she said.

Dr. Ettleson presented the findings at the annual meeting of the Endocrine Society. The results were simultaneously published in the Journal of Clinical Endocrinology and Metabolism.
 

Why the increase in desiccated thyroid extract?

Current guidelines by the American Thyroid Association recommend levothyroxine, a synthetic form of thyroxine (T4) monotherapy, as the standard of care for treating hypothyroidism. However, approximately 10%-20% of levothyroxine-treated patients report bothersome symptoms despite normalization of thyroid-stimulating hormone (TSH) levels.

In 2021, the ATA, along with European and British thyroid societies, issued a consensus statement noting that new trials of triiodothyronine (T3)/T4 combination therapy were “justified.”

However, the MarketScan data were gathered before that statement came out, which doesn’t mention desiccated thyroid extract, “so that’s a bit of a head-scratcher,” Ettleson said.

He said one possibility may be the existence of online materials saying negative things about levothyroxine, so that “people who are just learning about hypothyroidism might already be primed to think about alternative treatments.” Moreover, some patients may view DTE as more “natural” than levothyroxine.

Dr. Ettleson also noted that the distinct geographic variation “didn’t seem random. ... So not only was there a doubling overall but there’s a variation in practice patterns across the country. I don’t have an explanation for that, but I think it’s important to recognize in the medical community that there are these big differences.”
 

Endocrinologists not as keen to prescribe DTE or T3

Residence in a state with higher endocrinologist density (3.0/100,000 population) was associated with a decreased likelihood of receiving T3 (adjusted odds ratio, 0.33; P < .001) or DTE therapy (aOR, 0.18; P < .001).

Residence in large central metro zones was associated with an increased likelihood of receiving T3 (aOR, 1.32; P < .001) or DTE therapy (aOR, 1.05; P < .008, respectively).

Dr. Pearce observed: “I don’t see DTE in Boston. It’s mostly in the South and Southwest.”

She said she doubted that endocrinologists were the primary prescribers of DTE, as many endocrinologists are “wary” of the pig thyroid–derived product because its T4 to T3 ratio is about 4:1, in contrast to the ratio in humans of 13-14:1.

Thus, DTE contains a much higher proportion of the active hormone T3. It is also much shorter acting, with a half-life of a few hours, compared to a few days for T4, she explained.

“We don’t really know what long-term safety effects are but it’s probably a less physiologic way of dosing thyroid hormone than ... either levothyroxine or levothyroxine in combination with a lower T3 proportion,” she said.
 

Just trying to understand

Dr. Ettleson emphasized that the goal of his research wasn’t to reverse the trend but to better understand it.

Nonetheless, he also noted, “now that we know there are more patients taking DTE, we need to start looking at rates of atrial fibrillation, fracture, heart failure, and other possible outcomes in this population and compare them with levothyroxine and nonthyroid populations to make sure that it is as safe as levothyroxine.”

“There are no data to suggest increased risk, especially if TSH is monitored and stays in the normal range, but there’s very little data for over 5 or 10 years on DTE-treated patients. We need the data,” he emphasized.

Meanwhile, he’s working on a survey of endocrinologists and non-endocrinologists to ask if they’ve prescribed DTE, and if so, why, and whether it’s because patients asked for it. “There’s a lot more work to be done, but I think it’s exciting. It’s important to see how patients are being treated in the real world ... and understand why it’s happening and what the outcomes are.”

Dr. Ettleson and Dr. Pearce have reported no relevant financial relationships.

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

Prescriptions for desiccated thyroid extract (DTE) to treat newly diagnosed hypothyroidism nearly doubled between 2010 and 2020 in the United States, while prescribing of first-line levothyroxine monotherapy dropped, new research has found.

Nationwide MarketScan claims data reveal that, among first-time thyroid hormone prescriptions, those for DTE rose from 5.4% in 2010 to 10.2% in 2020. At the same time, prescriptions for first-line levothyroxine dropped from 91.8% to 87.2%. Prescriptions for liothyronine (LT3), primarily in combination with levothyroxine, remained at about 2% throughout the decade.

The nonlevothyroxine therapies were more commonly prescribed in the West and Southwestern United States, while levothyroxine monotherapy was more frequent in the Northwest and upper Midwest, and also in states with higher densities of primary care physicians and endocrinologists.

The magnitude of this shift in first-line treatment was unexpected.

“We were frankly quite surprised to see that difference in just 10 years,” lead author Matthew Ettleson, MD, of the University of Chicago, said in an interview.

Asked to comment, session moderator Elizabeth N. Pearce, MD, professor of medicine at Boston University Medical Center, said she also found the dramatic shift to DTE surprising.

“It’s unclear why since there hasn’t been a shift in the science or in the guidelines over the last decade. ... I think we need to understand better what is driving this, who the patients are who are seeking it out, and which providers are the primary drivers of these prescriptions,” she said.

Dr. Ettleson presented the findings at the annual meeting of the Endocrine Society. The results were simultaneously published in the Journal of Clinical Endocrinology and Metabolism.
 

Why the increase in desiccated thyroid extract?

Current guidelines by the American Thyroid Association recommend levothyroxine, a synthetic form of thyroxine (T4) monotherapy, as the standard of care for treating hypothyroidism. However, approximately 10%-20% of levothyroxine-treated patients report bothersome symptoms despite normalization of thyroid-stimulating hormone (TSH) levels.

In 2021, the ATA, along with European and British thyroid societies, issued a consensus statement noting that new trials of triiodothyronine (T3)/T4 combination therapy were “justified.”

However, the MarketScan data were gathered before that statement came out, which doesn’t mention desiccated thyroid extract, “so that’s a bit of a head-scratcher,” Ettleson said.

He said one possibility may be the existence of online materials saying negative things about levothyroxine, so that “people who are just learning about hypothyroidism might already be primed to think about alternative treatments.” Moreover, some patients may view DTE as more “natural” than levothyroxine.

Dr. Ettleson also noted that the distinct geographic variation “didn’t seem random. ... So not only was there a doubling overall but there’s a variation in practice patterns across the country. I don’t have an explanation for that, but I think it’s important to recognize in the medical community that there are these big differences.”
 

Endocrinologists not as keen to prescribe DTE or T3

Residence in a state with higher endocrinologist density (3.0/100,000 population) was associated with a decreased likelihood of receiving T3 (adjusted odds ratio, 0.33; P < .001) or DTE therapy (aOR, 0.18; P < .001).

Residence in large central metro zones was associated with an increased likelihood of receiving T3 (aOR, 1.32; P < .001) or DTE therapy (aOR, 1.05; P < .008, respectively).

Dr. Pearce observed: “I don’t see DTE in Boston. It’s mostly in the South and Southwest.”

She said she doubted that endocrinologists were the primary prescribers of DTE, as many endocrinologists are “wary” of the pig thyroid–derived product because its T4 to T3 ratio is about 4:1, in contrast to the ratio in humans of 13-14:1.

Thus, DTE contains a much higher proportion of the active hormone T3. It is also much shorter acting, with a half-life of a few hours, compared to a few days for T4, she explained.

“We don’t really know what long-term safety effects are but it’s probably a less physiologic way of dosing thyroid hormone than ... either levothyroxine or levothyroxine in combination with a lower T3 proportion,” she said.
 

Just trying to understand

Dr. Ettleson emphasized that the goal of his research wasn’t to reverse the trend but to better understand it.

Nonetheless, he also noted, “now that we know there are more patients taking DTE, we need to start looking at rates of atrial fibrillation, fracture, heart failure, and other possible outcomes in this population and compare them with levothyroxine and nonthyroid populations to make sure that it is as safe as levothyroxine.”

“There are no data to suggest increased risk, especially if TSH is monitored and stays in the normal range, but there’s very little data for over 5 or 10 years on DTE-treated patients. We need the data,” he emphasized.

Meanwhile, he’s working on a survey of endocrinologists and non-endocrinologists to ask if they’ve prescribed DTE, and if so, why, and whether it’s because patients asked for it. “There’s a lot more work to be done, but I think it’s exciting. It’s important to see how patients are being treated in the real world ... and understand why it’s happening and what the outcomes are.”

Dr. Ettleson and Dr. Pearce have reported no relevant financial relationships.

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

Prescriptions for desiccated thyroid extract (DTE) to treat newly diagnosed hypothyroidism nearly doubled between 2010 and 2020 in the United States, while prescribing of first-line levothyroxine monotherapy dropped, new research has found.

Nationwide MarketScan claims data reveal that, among first-time thyroid hormone prescriptions, those for DTE rose from 5.4% in 2010 to 10.2% in 2020. At the same time, prescriptions for first-line levothyroxine dropped from 91.8% to 87.2%. Prescriptions for liothyronine (LT3), primarily in combination with levothyroxine, remained at about 2% throughout the decade.

The nonlevothyroxine therapies were more commonly prescribed in the West and Southwestern United States, while levothyroxine monotherapy was more frequent in the Northwest and upper Midwest, and also in states with higher densities of primary care physicians and endocrinologists.

The magnitude of this shift in first-line treatment was unexpected.

“We were frankly quite surprised to see that difference in just 10 years,” lead author Matthew Ettleson, MD, of the University of Chicago, said in an interview.

Asked to comment, session moderator Elizabeth N. Pearce, MD, professor of medicine at Boston University Medical Center, said she also found the dramatic shift to DTE surprising.

“It’s unclear why since there hasn’t been a shift in the science or in the guidelines over the last decade. ... I think we need to understand better what is driving this, who the patients are who are seeking it out, and which providers are the primary drivers of these prescriptions,” she said.

Dr. Ettleson presented the findings at the annual meeting of the Endocrine Society. The results were simultaneously published in the Journal of Clinical Endocrinology and Metabolism.
 

Why the increase in desiccated thyroid extract?

Current guidelines by the American Thyroid Association recommend levothyroxine, a synthetic form of thyroxine (T4) monotherapy, as the standard of care for treating hypothyroidism. However, approximately 10%-20% of levothyroxine-treated patients report bothersome symptoms despite normalization of thyroid-stimulating hormone (TSH) levels.

In 2021, the ATA, along with European and British thyroid societies, issued a consensus statement noting that new trials of triiodothyronine (T3)/T4 combination therapy were “justified.”

However, the MarketScan data were gathered before that statement came out, which doesn’t mention desiccated thyroid extract, “so that’s a bit of a head-scratcher,” Ettleson said.

He said one possibility may be the existence of online materials saying negative things about levothyroxine, so that “people who are just learning about hypothyroidism might already be primed to think about alternative treatments.” Moreover, some patients may view DTE as more “natural” than levothyroxine.

Dr. Ettleson also noted that the distinct geographic variation “didn’t seem random. ... So not only was there a doubling overall but there’s a variation in practice patterns across the country. I don’t have an explanation for that, but I think it’s important to recognize in the medical community that there are these big differences.”
 

Endocrinologists not as keen to prescribe DTE or T3

Residence in a state with higher endocrinologist density (3.0/100,000 population) was associated with a decreased likelihood of receiving T3 (adjusted odds ratio, 0.33; P < .001) or DTE therapy (aOR, 0.18; P < .001).

Residence in large central metro zones was associated with an increased likelihood of receiving T3 (aOR, 1.32; P < .001) or DTE therapy (aOR, 1.05; P < .008, respectively).

Dr. Pearce observed: “I don’t see DTE in Boston. It’s mostly in the South and Southwest.”

She said she doubted that endocrinologists were the primary prescribers of DTE, as many endocrinologists are “wary” of the pig thyroid–derived product because its T4 to T3 ratio is about 4:1, in contrast to the ratio in humans of 13-14:1.

Thus, DTE contains a much higher proportion of the active hormone T3. It is also much shorter acting, with a half-life of a few hours, compared to a few days for T4, she explained.

“We don’t really know what long-term safety effects are but it’s probably a less physiologic way of dosing thyroid hormone than ... either levothyroxine or levothyroxine in combination with a lower T3 proportion,” she said.
 

Just trying to understand

Dr. Ettleson emphasized that the goal of his research wasn’t to reverse the trend but to better understand it.

Nonetheless, he also noted, “now that we know there are more patients taking DTE, we need to start looking at rates of atrial fibrillation, fracture, heart failure, and other possible outcomes in this population and compare them with levothyroxine and nonthyroid populations to make sure that it is as safe as levothyroxine.”

“There are no data to suggest increased risk, especially if TSH is monitored and stays in the normal range, but there’s very little data for over 5 or 10 years on DTE-treated patients. We need the data,” he emphasized.

Meanwhile, he’s working on a survey of endocrinologists and non-endocrinologists to ask if they’ve prescribed DTE, and if so, why, and whether it’s because patients asked for it. “There’s a lot more work to be done, but I think it’s exciting. It’s important to see how patients are being treated in the real world ... and understand why it’s happening and what the outcomes are.”

Dr. Ettleson and Dr. Pearce have reported no relevant financial relationships.

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

TOPLINE:

Downregulation of plasma exosome-derived apolipoproteins APOA1, APOB, and APOC1 indicates DR-TB status and lipid metabolism regulation in pathogenesis. 

METHODOLOGY:

Group case-controlled study assessed 17 drug resistant tuberculosis (DR-TB) and 33 non–drug resistant TB (NDR-TB) patients at The Fourth People’s Hospital of Taiyuan, China, from November 2018 to March 2019.

Plasma exosome purity and quality was determined by transmission electron microscopy, nanoparticle tracking analysis, and Western blot markers.

Proteins purified from plasma exosomes were characterized by SDS-Page with Western blotting and liquid chromatography coupled with tandem mass spectrometry techniques.

Functional proteomic differential analysis was achieved using the UniProt-GOA, Kyoto Encyclopedia of Genes and Genomes (KEGG), and STRING databases.

TAKEAWAYS:

DR-TB patients tended to be older than NDR-TB patients.

Isolated plasma exosomes were morphologically characterized as being “close to pure.”

Differential gene expression analysis revealed 16 upregulated and 10 downregulated proteins from DR-TB compared with NDR-TB patient-derived plasma exosomes.

Protein-protein interaction modeling suggests that downregulated apolipoproteins APOA1, APOB, and APOC1 have a role in mediating DR-TB development through their functions in lipid metabolism and protein transport.

IN PRACTICE:

Key apolipoproteins “may be involved in the pathogenesis of DR-TB via accelerating the formation of foamy macrophages and reducing the cellular uptake of anti-TB drugs.” 

STUDY DETAILS:

The study led by Mingrui Wu of Shanxi (China) Medical University and colleagues was published in the July 2023 issue of Tuberculosis.

LIMITATIONS:

This study is limited by an enrollment bias of at least twice as many men to women patients for both DR-TB and NDR-TB categories, reporting of some incomplete data collection characterizing the study population, and small sample size, which did not permit stratified analysis of the five types of DR-TB.

DISCLOSURES:

The authors report no relevant financial relationships.
 

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

TOPLINE:

Downregulation of plasma exosome-derived apolipoproteins APOA1, APOB, and APOC1 indicates DR-TB status and lipid metabolism regulation in pathogenesis. 

METHODOLOGY:

Group case-controlled study assessed 17 drug resistant tuberculosis (DR-TB) and 33 non–drug resistant TB (NDR-TB) patients at The Fourth People’s Hospital of Taiyuan, China, from November 2018 to March 2019.

Plasma exosome purity and quality was determined by transmission electron microscopy, nanoparticle tracking analysis, and Western blot markers.

Proteins purified from plasma exosomes were characterized by SDS-Page with Western blotting and liquid chromatography coupled with tandem mass spectrometry techniques.

Functional proteomic differential analysis was achieved using the UniProt-GOA, Kyoto Encyclopedia of Genes and Genomes (KEGG), and STRING databases.

TAKEAWAYS:

DR-TB patients tended to be older than NDR-TB patients.

Isolated plasma exosomes were morphologically characterized as being “close to pure.”

Differential gene expression analysis revealed 16 upregulated and 10 downregulated proteins from DR-TB compared with NDR-TB patient-derived plasma exosomes.

Protein-protein interaction modeling suggests that downregulated apolipoproteins APOA1, APOB, and APOC1 have a role in mediating DR-TB development through their functions in lipid metabolism and protein transport.

IN PRACTICE:

Key apolipoproteins “may be involved in the pathogenesis of DR-TB via accelerating the formation of foamy macrophages and reducing the cellular uptake of anti-TB drugs.” 

STUDY DETAILS:

The study led by Mingrui Wu of Shanxi (China) Medical University and colleagues was published in the July 2023 issue of Tuberculosis.

LIMITATIONS:

This study is limited by an enrollment bias of at least twice as many men to women patients for both DR-TB and NDR-TB categories, reporting of some incomplete data collection characterizing the study population, and small sample size, which did not permit stratified analysis of the five types of DR-TB.

DISCLOSURES:

The authors report no relevant financial relationships.
 

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

TOPLINE:

Downregulation of plasma exosome-derived apolipoproteins APOA1, APOB, and APOC1 indicates DR-TB status and lipid metabolism regulation in pathogenesis. 

METHODOLOGY:

Group case-controlled study assessed 17 drug resistant tuberculosis (DR-TB) and 33 non–drug resistant TB (NDR-TB) patients at The Fourth People’s Hospital of Taiyuan, China, from November 2018 to March 2019.

Plasma exosome purity and quality was determined by transmission electron microscopy, nanoparticle tracking analysis, and Western blot markers.

Proteins purified from plasma exosomes were characterized by SDS-Page with Western blotting and liquid chromatography coupled with tandem mass spectrometry techniques.

Functional proteomic differential analysis was achieved using the UniProt-GOA, Kyoto Encyclopedia of Genes and Genomes (KEGG), and STRING databases.

TAKEAWAYS:

DR-TB patients tended to be older than NDR-TB patients.

Isolated plasma exosomes were morphologically characterized as being “close to pure.”

Differential gene expression analysis revealed 16 upregulated and 10 downregulated proteins from DR-TB compared with NDR-TB patient-derived plasma exosomes.

Protein-protein interaction modeling suggests that downregulated apolipoproteins APOA1, APOB, and APOC1 have a role in mediating DR-TB development through their functions in lipid metabolism and protein transport.

IN PRACTICE:

Key apolipoproteins “may be involved in the pathogenesis of DR-TB via accelerating the formation of foamy macrophages and reducing the cellular uptake of anti-TB drugs.” 

STUDY DETAILS:

The study led by Mingrui Wu of Shanxi (China) Medical University and colleagues was published in the July 2023 issue of Tuberculosis.

LIMITATIONS:

This study is limited by an enrollment bias of at least twice as many men to women patients for both DR-TB and NDR-TB categories, reporting of some incomplete data collection characterizing the study population, and small sample size, which did not permit stratified analysis of the five types of DR-TB.

DISCLOSURES:

The authors report no relevant financial relationships.
 

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