Psychotropic med use tied to ‘striking’ post-COVID dementia risk

Article Type
Changed

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research
Dr. Liron Sinvani


“Our study highlights the potential interaction between baseline neuropsychiatric disease, psychotropic medications, COVID-19, and dementia,” Dr. Sinvani added.

The findings were published online March 18 in Frontiers in Medicine.
 

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Publications
Topics
Sections

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research
Dr. Liron Sinvani


“Our study highlights the potential interaction between baseline neuropsychiatric disease, psychotropic medications, COVID-19, and dementia,” Dr. Sinvani added.

The findings were published online March 18 in Frontiers in Medicine.
 

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Older adults taking psychotropic medication before contracting COVID-19 are at increased risk of dementia in the year following the illness, new research suggests.

Results from a large study of more than 1,700 patients who had been hospitalized with COVID showed a greater than twofold increased risk for post-COVID dementia in those taking antipsychotics and mood stabilizers/anticonvulsants – medications often used to treat schizophrenia, psychosis, bipolar disorder, and seizures.

“We know that pre-existing psychiatric illness is associated with poor COVID-19 outcomes, but our study is the first to show an association with certain psychiatric medications and dementia,” co-investigator Liron Sinvani, MD, the Feinstein Institutes for Medical Research, Manhasset, New York, said in an interview.

Feinstein Institutes for Medical Research
Dr. Liron Sinvani


“Our study highlights the potential interaction between baseline neuropsychiatric disease, psychotropic medications, COVID-19, and dementia,” Dr. Sinvani added.

The findings were published online March 18 in Frontiers in Medicine.
 

‘Striking’ dementia rate

Using electronic health records, the researchers evaluated pre-COVID psychotropic medication use and post-COVID dementia onset in 1,755 adults aged 65 and older. All were hospitalized with COVID-19 at Northwell Health between March 1 and April 20, 2020.

A “striking” 13% of the participants (n = 223) developed dementia within 1-year of follow-up, the investigators report.

Among the 438 patients (25%) exposed to at least one psychotropic medication before COVID-19, 105 (24%) developed dementia in the year following COVID versus 118 of 1,317 (9%) patients with no pre-COVID exposure to psychotropic medication (odds ratio, 3.2; 95% confidence interval, 2.37-4.32).

Both pre-COVID psychotropic medication use (OR, 2.7; 95% CI, 1.8-4.0, P < .001) and delirium (OR, 3.0; 95% CI, 1.9-4.6, P < .001) were significantly associated with post-COVID dementia at 1 year.

In a sensitivity analysis in the subset of 423 patients with at least one documented neurologic or psychiatric diagnosis at the time of COVID admission, and after adjusting for confounding factors, pre-COVID psychotropic medication use remained significantly linked to post-COVID dementia onset (OR, 3.09; 95% CI, 1.5-6.6, P = .002).

Drug classes most strongly associated with 1-year post-COVID dementia onset were antipsychotics (OR, 2.8, 95% CI, 1.7-4.4, P < .001) and mood stabilizers/anticonvulsants (OR, 2.4, 95% CI, 1.39-4.02, P = .001).

In a further exploratory analysis, the psychotropics valproic acid (multiple brands) and haloperidol (Haldol) had the largest association with post-COVID dementia.

Antidepressants as a class were not associated with post-COVID dementia, but the potential effects of two commonly prescribed antidepressants in older adults, mirtazapine (Remeron) and escitalopram (Lexapro), “warrant further investigation,” the researchers note.
 

Predictive risk marker?

“This research shows that psychotropic medications can be considered a predictive risk marker for post-COVID dementia. In patients taking psychotropic medications, COVID-19 could have accelerated progression of dementia after hospitalization,” lead author Yun Freudenberg-Hua, MD, the Feinstein Institutes, said in a news release.

It is unclear why psychotropic medications may raise the risk for dementia onset after COVID, the investigators note.

“It is intuitive that psychotropic medications indicate pre-existing neuropsychiatric conditions in which COVID-19 occurs. It is possible that psychotropic medications may potentiate the neurostructural changes that have been found in the brain of those who have recovered from COVID-19,” they write.

The sensitivity analysis in patients with documented neurologic and psychiatric diagnoses supports this interpretation. 

COVID-19 may also accelerate the underlying brain disorders for which psychotropic medications were prescribed, leading to the greater incidence of post-COVID dementia, the researchers write.

“It is important to note that this study is in no way recommending people should stop taking antipsychotics but simply that clinicians need to factor in a patient’s medication history while considering post-COVID aftereffects,” Dr. Freudenberg-Hua said.

“Given that the number of patients with dementia is projected to triple in the next 30 years, these findings have significant public health implications,” Dr. Sinvani added.

She noted that “care partners and health care professionals” should look for early signs of dementia, such as forgetfulness and depressive symptoms, in their patients.

“Future studies must continue to evaluate these associations, which are key for potential future interventions to prevent dementia,” Dr. Sinvani said.

The study was funded by the National Institutes of Health. Dr. Freudenberg-Hua co-owns stock and stock options from Regeneron Pharmaceuticals. Dr. Sinvani has disclosed no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM FRONTIERS IN MEDICINE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Surgery in CJD patients a potential risk factor for transmission

Article Type
Changed

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

Publications
Topics
Sections

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

About one in six patients with Creutzfeldt-Jakob disease (CJD) undergo surgery, raising the risk of iatrogenic transmission of this rare but universally fatal prion disease.

In a retrospective analysis, researchers found that 26 of 121 (21%) patients with probable or definite CJD at four U.S. academic medical centers underwent a total of 55 procedures.

These included high-risk procedures for two patients with neuropathologically proven CJD. One underwent ophthalmic artery aneurysm clipping for unruptured aneurysm, and the other underwent diagnostic brain biopsy.

“The findings were definitely surprising to me and my team – particularly the high frequency with which patients with an irreversible and particularly transmissible neurologic disease underwent invasive medical procedures either just before or shortly after the emergence of symptoms later attributed to CJD,” study investigator Gregory Day, MD, with the Mayo Clinic, Jacksonville, Fla., said in an interview.

The study was published online March 9, 2022, in JAMA Network Open.
 

Poor infection control

The investigators noted that the majority of CJD cases are sporadic or are inherited, but research shows that prion transmission can occur via contaminated tissues or reusable medical equipment.

While the risk of iatrogenic transmission is highest following procedures involving the central nervous system, where prion burden is highest, experimental models suggest CJD transmission can occur after contact with other tissues, including nasal mucosa, lung, lymph nodes, and spleen, the researchers noted.

“If these models are accurate, surgical procedures involving these tissues may pose a risk to patients,” the investigators wrote.

To determine the potential scope of this problem, the researchers examined the frequency of invasive procedures performed in patients with CJD at four tertiary care centers.

“In several cases, these procedures were done with clear indications [such as] fixation or joint replacement following a fracture. In several others, however, the procedures were unlikely to help the patient. For instance, a hip replacement for walking difficulties that were actually due to changes in the brain due to CJD,” Dr. Day said.

“Even more surprising was the low frequency with which appropriate surgical precautions/infection control procedures were used in patients with established diagnoses of CJD,” he noted.

Only one procedure was performed with sterilization techniques adequate to prevent CJD.

Dr. Day said the findings aren’t necessarily cause for immediate alarm, but they do highlight an area for potential improvement, including better screening of patients who have new and unexplained symptoms before proceeding with surgery, especially surgery of the central nervous system, where prion burden is high.

Another potential solution is to develop and support program surveillance and to work with public health organizations such the Centers for Disease Control and Prevention and the National Prion Disease Pathology Surveillance Center to elicit a surgical history in patients diagnosed with prion disease.

“Active nationwide surveillance is needed to determine the true scope of this potential problem and to develop strategies to mitigate the potential risk of iatrogenic prion transmission to future patients,” Dr. Day said.
 

True prevalence unknown

The authors of an invited commentary noted that, while most CJD infections occur sporadically, iatrogenic transmission is possible. Approximately 500 such cases have been reported worldwide to date.

“Yet, reported transmission from surgical procedures remains rare, with fewer than 10 confirmed CJD cases described in the literature, although the true prevalence is difficult to quantify as confirmed diagnosis requires autopsy,” wrote Beatrice Sun, MD, and Joseph Forrester, MD, with the department of surgery, Stanford (Calif.) University.

They noted that, over a 15-year period, 19 suspected iatrogenic CJD exposures were reported to the CDC – two from ophthalmology procedures, and 17 from neurosurgical procedures.

In all 19 cases, the diagnosis of CJD was unknown before the intervention, and all surgical instruments underwent normal decontamination protocols, which are inadequate to eradicate prion disease.

For patients with suspected or confirmed CJD, the World Health Organization has published infection control guidelines to prevent transmission of spongiform encephalopathies.

The guidelines recommend proper communication with all staff involved in the surgical procedure and the sterilization of supplies to be aware of potential exposure; minimizing the number of staff in the operating room; using single-use equipment whenever possible and disposing of it by incineration; using protective coverings for all nondisposable equipment; and scheduling such procedures at the end of the day to allow adequate time for decontamination.

Funding for the study was provided by the National Institutes of Health. Dr. Day owns stock in ANI Pharmaceuticals; serves as a consultant for Parabon Nanolabs, as a topic editor (dementia) for DynaMed, and as the clinical director of the Anti-NMDA Receptor Encephalitis Foundation (uncompensated). Dr. Forrester reported receiving unrestricted research funding from Varian and has received grant funding from the Surgical Infections Society.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA NETWORK OPEN

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Psychedelics’ interaction with psych meds: More questions than answers

Article Type
Changed

Psychedelics, including psilocybin and MDMA, are promising for a variety of psychiatric disorders, but there are few data showing how these drugs interact with traditional psychiatric medications, new research shows.

“Despite prolific psychedelic research and public interest, I was surprised to see little clinical research on how psilocybin and common psychiatric treatments interact,” study investigator Aryan Sarparast, MD, department of psychiatry, Oregon Health and Science University, Portland, told this news organization.

The review was published online March 7, 2022, in Psychopharmacology.
 

Need for RCTs

The Food and Drug Administration recently granted breakthrough therapy designation to psilocybin-assisted psychotherapy for major depression and treatment-resistant depression and to MDMA-assisted psychotherapy for PTSD.

The investigators assessed the volume of available research on interactions between psychedelics and traditional psychiatric medications, such as antidepressants.

They found 40 studies dating back to 1958, including 26 randomized controlled trials, 11 case reports, and 3 epidemiologic studies.

Only one randomized clinical trial evaluated the interaction between psilocybin and the most common psychiatric treatment, SSRIs, said Dr. Sarparast.

However, this study is “reassuring and overlaps with our hypothesis that there is a low risk of psilocybin and most psychiatric drugs causing harm when combined,” he noted.

Yet all of the clinical trials exclusively included young healthy adults, who were often recruited from university campuses. “We don’t have data on what happens when a depressed person on an SSRI takes psilocybin,” said Dr. Sarparast.

He added that he is concerned that the lack of evidence on drug-drug interactions will lead some providers to require patients to be tapered off existing traditional psychiatric medications before initiation of psilocybin therapy.

This may force vulnerable patients to choose between their existing therapy and psilocybin.

In addition, patients who opt for the “DIY method” of tapering risk mental health relapse and medication withdrawal effects. “That’s a very, very tough place to be,” Dr. Sarparast said.

Ideally, Dr. Sarparast would like to see a study in which depressed patients who have been receiving long-term antidepressant treatment are randomly assigned to received low, medium, and high doses of psilocybin. “This would clarify a lot of question marks.”
 

Evidence gap

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said: “The point in this article is very well taken. Indeed, more research is needed” on potential interactions between psychedelics and traditional psychiatric medications.

“Before we embark on completing research and development for psychedelics – or, for that matter, any psychoactive substance – we should endeavor to identify what the potential safety and toxicity concerns are when they are coprescribed with other prescribed medications, over-the-counter medications, and other substances (e.g., marijuana) that people take,” Dr. McIntyre said.

A case in point – a 2017 study conducted by McIntyre and colleagues revealed “significant drug-drug interactions with cannabis, which never receives that much attention.”

Also weighing in, Albert Garcia-Romeu, PhD, assistant professor of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, confirmed that there is “an evidence gap” on psilocybin’s and other psychedelic drugs’ interactions with other medications.

“This has not been formally studied for a number of reasons, but mainly because psilocybin has primarily been considered a drug of abuse. Psilocybin has only recently started to be looked at as a potential medication, and as such, research on drug-drug interactions is still limited, but growing,” Dr. Garcia-Romeu told this news organization.

He noted that studies are underway to better understand potential interactions between psilocybin and other medications.

“This will allow us to better understand how psilocybin should be used medically and what types of interactions could occur with other drugs or medications,” Dr. Garcia-Romeu added.

The study had no specific funding. Dr. Sarparast, Dr. McIntyre, and Dr. Garcia-Romeu reported no relevant financial relationships.

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

Publications
Topics
Sections

Psychedelics, including psilocybin and MDMA, are promising for a variety of psychiatric disorders, but there are few data showing how these drugs interact with traditional psychiatric medications, new research shows.

“Despite prolific psychedelic research and public interest, I was surprised to see little clinical research on how psilocybin and common psychiatric treatments interact,” study investigator Aryan Sarparast, MD, department of psychiatry, Oregon Health and Science University, Portland, told this news organization.

The review was published online March 7, 2022, in Psychopharmacology.
 

Need for RCTs

The Food and Drug Administration recently granted breakthrough therapy designation to psilocybin-assisted psychotherapy for major depression and treatment-resistant depression and to MDMA-assisted psychotherapy for PTSD.

The investigators assessed the volume of available research on interactions between psychedelics and traditional psychiatric medications, such as antidepressants.

They found 40 studies dating back to 1958, including 26 randomized controlled trials, 11 case reports, and 3 epidemiologic studies.

Only one randomized clinical trial evaluated the interaction between psilocybin and the most common psychiatric treatment, SSRIs, said Dr. Sarparast.

However, this study is “reassuring and overlaps with our hypothesis that there is a low risk of psilocybin and most psychiatric drugs causing harm when combined,” he noted.

Yet all of the clinical trials exclusively included young healthy adults, who were often recruited from university campuses. “We don’t have data on what happens when a depressed person on an SSRI takes psilocybin,” said Dr. Sarparast.

He added that he is concerned that the lack of evidence on drug-drug interactions will lead some providers to require patients to be tapered off existing traditional psychiatric medications before initiation of psilocybin therapy.

This may force vulnerable patients to choose between their existing therapy and psilocybin.

In addition, patients who opt for the “DIY method” of tapering risk mental health relapse and medication withdrawal effects. “That’s a very, very tough place to be,” Dr. Sarparast said.

Ideally, Dr. Sarparast would like to see a study in which depressed patients who have been receiving long-term antidepressant treatment are randomly assigned to received low, medium, and high doses of psilocybin. “This would clarify a lot of question marks.”
 

Evidence gap

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said: “The point in this article is very well taken. Indeed, more research is needed” on potential interactions between psychedelics and traditional psychiatric medications.

“Before we embark on completing research and development for psychedelics – or, for that matter, any psychoactive substance – we should endeavor to identify what the potential safety and toxicity concerns are when they are coprescribed with other prescribed medications, over-the-counter medications, and other substances (e.g., marijuana) that people take,” Dr. McIntyre said.

A case in point – a 2017 study conducted by McIntyre and colleagues revealed “significant drug-drug interactions with cannabis, which never receives that much attention.”

Also weighing in, Albert Garcia-Romeu, PhD, assistant professor of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, confirmed that there is “an evidence gap” on psilocybin’s and other psychedelic drugs’ interactions with other medications.

“This has not been formally studied for a number of reasons, but mainly because psilocybin has primarily been considered a drug of abuse. Psilocybin has only recently started to be looked at as a potential medication, and as such, research on drug-drug interactions is still limited, but growing,” Dr. Garcia-Romeu told this news organization.

He noted that studies are underway to better understand potential interactions between psilocybin and other medications.

“This will allow us to better understand how psilocybin should be used medically and what types of interactions could occur with other drugs or medications,” Dr. Garcia-Romeu added.

The study had no specific funding. Dr. Sarparast, Dr. McIntyre, and Dr. Garcia-Romeu reported no relevant financial relationships.

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

Psychedelics, including psilocybin and MDMA, are promising for a variety of psychiatric disorders, but there are few data showing how these drugs interact with traditional psychiatric medications, new research shows.

“Despite prolific psychedelic research and public interest, I was surprised to see little clinical research on how psilocybin and common psychiatric treatments interact,” study investigator Aryan Sarparast, MD, department of psychiatry, Oregon Health and Science University, Portland, told this news organization.

The review was published online March 7, 2022, in Psychopharmacology.
 

Need for RCTs

The Food and Drug Administration recently granted breakthrough therapy designation to psilocybin-assisted psychotherapy for major depression and treatment-resistant depression and to MDMA-assisted psychotherapy for PTSD.

The investigators assessed the volume of available research on interactions between psychedelics and traditional psychiatric medications, such as antidepressants.

They found 40 studies dating back to 1958, including 26 randomized controlled trials, 11 case reports, and 3 epidemiologic studies.

Only one randomized clinical trial evaluated the interaction between psilocybin and the most common psychiatric treatment, SSRIs, said Dr. Sarparast.

However, this study is “reassuring and overlaps with our hypothesis that there is a low risk of psilocybin and most psychiatric drugs causing harm when combined,” he noted.

Yet all of the clinical trials exclusively included young healthy adults, who were often recruited from university campuses. “We don’t have data on what happens when a depressed person on an SSRI takes psilocybin,” said Dr. Sarparast.

He added that he is concerned that the lack of evidence on drug-drug interactions will lead some providers to require patients to be tapered off existing traditional psychiatric medications before initiation of psilocybin therapy.

This may force vulnerable patients to choose between their existing therapy and psilocybin.

In addition, patients who opt for the “DIY method” of tapering risk mental health relapse and medication withdrawal effects. “That’s a very, very tough place to be,” Dr. Sarparast said.

Ideally, Dr. Sarparast would like to see a study in which depressed patients who have been receiving long-term antidepressant treatment are randomly assigned to received low, medium, and high doses of psilocybin. “This would clarify a lot of question marks.”
 

Evidence gap

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said: “The point in this article is very well taken. Indeed, more research is needed” on potential interactions between psychedelics and traditional psychiatric medications.

“Before we embark on completing research and development for psychedelics – or, for that matter, any psychoactive substance – we should endeavor to identify what the potential safety and toxicity concerns are when they are coprescribed with other prescribed medications, over-the-counter medications, and other substances (e.g., marijuana) that people take,” Dr. McIntyre said.

A case in point – a 2017 study conducted by McIntyre and colleagues revealed “significant drug-drug interactions with cannabis, which never receives that much attention.”

Also weighing in, Albert Garcia-Romeu, PhD, assistant professor of psychiatry and behavioral sciences, Johns Hopkins University, Baltimore, confirmed that there is “an evidence gap” on psilocybin’s and other psychedelic drugs’ interactions with other medications.

“This has not been formally studied for a number of reasons, but mainly because psilocybin has primarily been considered a drug of abuse. Psilocybin has only recently started to be looked at as a potential medication, and as such, research on drug-drug interactions is still limited, but growing,” Dr. Garcia-Romeu told this news organization.

He noted that studies are underway to better understand potential interactions between psilocybin and other medications.

“This will allow us to better understand how psilocybin should be used medically and what types of interactions could occur with other drugs or medications,” Dr. Garcia-Romeu added.

The study had no specific funding. Dr. Sarparast, Dr. McIntyre, and Dr. Garcia-Romeu reported no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM PSYCHOPHARMACOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Cancer survivors: Move more, sit less for a longer life, study says

Article Type
Changed

Cancer survivors who spend more than 8 hours of the day sitting are five times more likely to die over the ensuing years than their peers who spend less time sitting. Being physically active, on the other hand, lowers the risk of early death, new research shows.

What’s “alarming” is that so many cancer survivors have a sedentary lifestyle, Chao Cao and Lin Yang, PhD, with Alberta Health Services in Calgary, who worked on the study, said in an interview.

The American Cancer Society recommends that cancer survivors follow the same physical activity guidance as the general population. The target is 150-300 minutes of moderate activity or 75-150 minutes of vigorous activity each week (or a combination of these).

“Getting to or exceeding the upper limit of 300 minutes is ideal,” Mr. Cao and Dr. Yang say.

Yet in their study of more than 1,500 cancer survivors, more than half (57%) were inactive, reporting no weekly leisure-time physical activity in the past week.

About 16% were “insufficiently” active, or getting less than 150 minutes per week. Meanwhile, 28% were active, achieving more than 150 minutes of weekly physical activity.

Digging deeper, the researchers found that more than one-third of cancer survivors reported sitting for 6-8 hours each day, and one-quarter reported sitting for more than 8 hours per day.

Over the course of up to 9 years, 293 of the cancer survivors died – 114 from cancer, 41 from heart diseases, and 138 from other causes.

After accounting for things that might influence the results, the risk of dying from any cause or cancer was about 65% lower in cancer survivors who were physically active, relative to their inactive peers.

Sitting for long periods was especially risky, according to the study in JAMA Oncology.

Compared with cancer survivors who sat for less than 4 hours each day, cancer survivors who reported sitting for more than 8 hours a day had nearly twice the risk of dying from any cause and more than twice the risk of dying from cancer.

Cancer survivors who sat for more than 8 hours a day, and were inactive or not active enough, had as much as five times the risk of death from any cause or cancer.

“Be active and sit less, move more, and move frequently,” advise Mr. Cao and Dr. Yang. “Avoiding prolonged sitting is essential for most cancer survivors to reduce excess mortality risks.”

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

Publications
Topics
Sections

Cancer survivors who spend more than 8 hours of the day sitting are five times more likely to die over the ensuing years than their peers who spend less time sitting. Being physically active, on the other hand, lowers the risk of early death, new research shows.

What’s “alarming” is that so many cancer survivors have a sedentary lifestyle, Chao Cao and Lin Yang, PhD, with Alberta Health Services in Calgary, who worked on the study, said in an interview.

The American Cancer Society recommends that cancer survivors follow the same physical activity guidance as the general population. The target is 150-300 minutes of moderate activity or 75-150 minutes of vigorous activity each week (or a combination of these).

“Getting to or exceeding the upper limit of 300 minutes is ideal,” Mr. Cao and Dr. Yang say.

Yet in their study of more than 1,500 cancer survivors, more than half (57%) were inactive, reporting no weekly leisure-time physical activity in the past week.

About 16% were “insufficiently” active, or getting less than 150 minutes per week. Meanwhile, 28% were active, achieving more than 150 minutes of weekly physical activity.

Digging deeper, the researchers found that more than one-third of cancer survivors reported sitting for 6-8 hours each day, and one-quarter reported sitting for more than 8 hours per day.

Over the course of up to 9 years, 293 of the cancer survivors died – 114 from cancer, 41 from heart diseases, and 138 from other causes.

After accounting for things that might influence the results, the risk of dying from any cause or cancer was about 65% lower in cancer survivors who were physically active, relative to their inactive peers.

Sitting for long periods was especially risky, according to the study in JAMA Oncology.

Compared with cancer survivors who sat for less than 4 hours each day, cancer survivors who reported sitting for more than 8 hours a day had nearly twice the risk of dying from any cause and more than twice the risk of dying from cancer.

Cancer survivors who sat for more than 8 hours a day, and were inactive or not active enough, had as much as five times the risk of death from any cause or cancer.

“Be active and sit less, move more, and move frequently,” advise Mr. Cao and Dr. Yang. “Avoiding prolonged sitting is essential for most cancer survivors to reduce excess mortality risks.”

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

Cancer survivors who spend more than 8 hours of the day sitting are five times more likely to die over the ensuing years than their peers who spend less time sitting. Being physically active, on the other hand, lowers the risk of early death, new research shows.

What’s “alarming” is that so many cancer survivors have a sedentary lifestyle, Chao Cao and Lin Yang, PhD, with Alberta Health Services in Calgary, who worked on the study, said in an interview.

The American Cancer Society recommends that cancer survivors follow the same physical activity guidance as the general population. The target is 150-300 minutes of moderate activity or 75-150 minutes of vigorous activity each week (or a combination of these).

“Getting to or exceeding the upper limit of 300 minutes is ideal,” Mr. Cao and Dr. Yang say.

Yet in their study of more than 1,500 cancer survivors, more than half (57%) were inactive, reporting no weekly leisure-time physical activity in the past week.

About 16% were “insufficiently” active, or getting less than 150 minutes per week. Meanwhile, 28% were active, achieving more than 150 minutes of weekly physical activity.

Digging deeper, the researchers found that more than one-third of cancer survivors reported sitting for 6-8 hours each day, and one-quarter reported sitting for more than 8 hours per day.

Over the course of up to 9 years, 293 of the cancer survivors died – 114 from cancer, 41 from heart diseases, and 138 from other causes.

After accounting for things that might influence the results, the risk of dying from any cause or cancer was about 65% lower in cancer survivors who were physically active, relative to their inactive peers.

Sitting for long periods was especially risky, according to the study in JAMA Oncology.

Compared with cancer survivors who sat for less than 4 hours each day, cancer survivors who reported sitting for more than 8 hours a day had nearly twice the risk of dying from any cause and more than twice the risk of dying from cancer.

Cancer survivors who sat for more than 8 hours a day, and were inactive or not active enough, had as much as five times the risk of death from any cause or cancer.

“Be active and sit less, move more, and move frequently,” advise Mr. Cao and Dr. Yang. “Avoiding prolonged sitting is essential for most cancer survivors to reduce excess mortality risks.”

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA ONCOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Few new cancer drugs replace current standards of care

Article Type
Changed

Only about 1 in 7 new cancer drugs approved in the U.S. displace existing standards of care, a new analysis shows.

Of more than 200 agents evaluated, most (42%) received approval as second-, third-, or later-line therapies.

“While there is justified enthusiasm for the high volume of new cancer drug approvals in oncology and malignant hematology, these approvals must be evaluated in the context of their use,” the authors note in a report published online March 15 in JAMA Network Open. Later-line drugs may, for instance, “benefit patients with few alternatives but also add to cost of care and further delay palliative and comfort services” compared to first-line therapies, which may alter “the treatment paradigm for a certain indication.”

The U.S. Food and Drug Administration approves several new cancer drugs each month, but it’s not clear how many transform the treatment landscape.

To investigate, David Benjamin, MD, with the Division of Hematology and Oncology, University of California, Irvine, and colleagues evaluated all 207 cancer drugs approved in the U.S. between May 1, 2016 and May 31, 2021.

The researchers found that only 28 drugs (14%) displaced the prior first-line standard of care for an indication.

Examples of these cancer drugs include alectinib for anaplastic lymphoma kinase rearrangement–positive metastatic non–small cell lung cancer (NSCLC), osimertinib for epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution NSCLC, atezolizumab plus bevacizumab for unresectable or metastatic hepatocellular carcinoma, and cabozantinib for advanced kidney cancer.

A total of 32 drugs (15%) were approved as first-line alternatives or new drugs. These drugs were approved for use in the first-line setting but did not necessarily replace the standard of care at the time of approval or were first-of-their-class therapies.

Examples of these drug approvals include apalutamide for nonmetastatic castrate-resistant prostate cancer, tepotinib for metastatic MET exon 14-skipping NSCLC, and avapritinib for unresectable or metastatic gastrointestinal stromal tumor with platelet-derived growth factor receptor alpha exon 18 variant, including D842V variant.

A total of 61 drugs (29%) were approved as add-on therapies for use in combination with a previously approved therapy or in the adjuvant or maintenance settings. These drugs “can only increase the cost of care,” the study team says.

Most new approvals (n = 86) were for use in second-, third- or later-line settings, often for patients for whom other treatment options had been exhausted.

The authors highlight disparities among approvals based on tumor type. Lung-related tumors received the most approvals (n = 37), followed by genitourinary tumors (n = 28), leukemia (n = 25), lymphoma (n = 22), breast cancer (n = 19), and gastrointestinal cancers (n = 14).

The authors note that cancer drugs considered new standards of care or approved as first-line setting alternatives could “provide market competition and work to lower cancer drug prices.”

The study was funded by a grant from Arnold Ventures.

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

Publications
Topics
Sections

Only about 1 in 7 new cancer drugs approved in the U.S. displace existing standards of care, a new analysis shows.

Of more than 200 agents evaluated, most (42%) received approval as second-, third-, or later-line therapies.

“While there is justified enthusiasm for the high volume of new cancer drug approvals in oncology and malignant hematology, these approvals must be evaluated in the context of their use,” the authors note in a report published online March 15 in JAMA Network Open. Later-line drugs may, for instance, “benefit patients with few alternatives but also add to cost of care and further delay palliative and comfort services” compared to first-line therapies, which may alter “the treatment paradigm for a certain indication.”

The U.S. Food and Drug Administration approves several new cancer drugs each month, but it’s not clear how many transform the treatment landscape.

To investigate, David Benjamin, MD, with the Division of Hematology and Oncology, University of California, Irvine, and colleagues evaluated all 207 cancer drugs approved in the U.S. between May 1, 2016 and May 31, 2021.

The researchers found that only 28 drugs (14%) displaced the prior first-line standard of care for an indication.

Examples of these cancer drugs include alectinib for anaplastic lymphoma kinase rearrangement–positive metastatic non–small cell lung cancer (NSCLC), osimertinib for epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution NSCLC, atezolizumab plus bevacizumab for unresectable or metastatic hepatocellular carcinoma, and cabozantinib for advanced kidney cancer.

A total of 32 drugs (15%) were approved as first-line alternatives or new drugs. These drugs were approved for use in the first-line setting but did not necessarily replace the standard of care at the time of approval or were first-of-their-class therapies.

Examples of these drug approvals include apalutamide for nonmetastatic castrate-resistant prostate cancer, tepotinib for metastatic MET exon 14-skipping NSCLC, and avapritinib for unresectable or metastatic gastrointestinal stromal tumor with platelet-derived growth factor receptor alpha exon 18 variant, including D842V variant.

A total of 61 drugs (29%) were approved as add-on therapies for use in combination with a previously approved therapy or in the adjuvant or maintenance settings. These drugs “can only increase the cost of care,” the study team says.

Most new approvals (n = 86) were for use in second-, third- or later-line settings, often for patients for whom other treatment options had been exhausted.

The authors highlight disparities among approvals based on tumor type. Lung-related tumors received the most approvals (n = 37), followed by genitourinary tumors (n = 28), leukemia (n = 25), lymphoma (n = 22), breast cancer (n = 19), and gastrointestinal cancers (n = 14).

The authors note that cancer drugs considered new standards of care or approved as first-line setting alternatives could “provide market competition and work to lower cancer drug prices.”

The study was funded by a grant from Arnold Ventures.

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

Only about 1 in 7 new cancer drugs approved in the U.S. displace existing standards of care, a new analysis shows.

Of more than 200 agents evaluated, most (42%) received approval as second-, third-, or later-line therapies.

“While there is justified enthusiasm for the high volume of new cancer drug approvals in oncology and malignant hematology, these approvals must be evaluated in the context of their use,” the authors note in a report published online March 15 in JAMA Network Open. Later-line drugs may, for instance, “benefit patients with few alternatives but also add to cost of care and further delay palliative and comfort services” compared to first-line therapies, which may alter “the treatment paradigm for a certain indication.”

The U.S. Food and Drug Administration approves several new cancer drugs each month, but it’s not clear how many transform the treatment landscape.

To investigate, David Benjamin, MD, with the Division of Hematology and Oncology, University of California, Irvine, and colleagues evaluated all 207 cancer drugs approved in the U.S. between May 1, 2016 and May 31, 2021.

The researchers found that only 28 drugs (14%) displaced the prior first-line standard of care for an indication.

Examples of these cancer drugs include alectinib for anaplastic lymphoma kinase rearrangement–positive metastatic non–small cell lung cancer (NSCLC), osimertinib for epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution NSCLC, atezolizumab plus bevacizumab for unresectable or metastatic hepatocellular carcinoma, and cabozantinib for advanced kidney cancer.

A total of 32 drugs (15%) were approved as first-line alternatives or new drugs. These drugs were approved for use in the first-line setting but did not necessarily replace the standard of care at the time of approval or were first-of-their-class therapies.

Examples of these drug approvals include apalutamide for nonmetastatic castrate-resistant prostate cancer, tepotinib for metastatic MET exon 14-skipping NSCLC, and avapritinib for unresectable or metastatic gastrointestinal stromal tumor with platelet-derived growth factor receptor alpha exon 18 variant, including D842V variant.

A total of 61 drugs (29%) were approved as add-on therapies for use in combination with a previously approved therapy or in the adjuvant or maintenance settings. These drugs “can only increase the cost of care,” the study team says.

Most new approvals (n = 86) were for use in second-, third- or later-line settings, often for patients for whom other treatment options had been exhausted.

The authors highlight disparities among approvals based on tumor type. Lung-related tumors received the most approvals (n = 37), followed by genitourinary tumors (n = 28), leukemia (n = 25), lymphoma (n = 22), breast cancer (n = 19), and gastrointestinal cancers (n = 14).

The authors note that cancer drugs considered new standards of care or approved as first-line setting alternatives could “provide market competition and work to lower cancer drug prices.”

The study was funded by a grant from Arnold Ventures.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA NETWORK OPEN

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Jury is out on universal screening for eating disorders

Article Type
Changed

There is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults, the U.S. Preventive Services Task Force says in their first-ever statement on the topic.

Eating disorders (binge eating disorder, bulimia nervosa, and anorexia nervosa) can cause “serious harms to physical and psychosocial health and take a tremendous toll on individuals and families,” task force member Lori Pbert, PhD, told this news organization.

“Screening for eating disorders has the potential to improve health by leading to early detection and effective treatment,” said Dr. Pbert, with the department of population and quantitative health sciences, University of Massachusetts, Worcester.

However, a “deep dive” into the available literature failed to turn up adequate evidence to recommend for or against routine screening for eating disorders for children and adolescents aged 10 years and older and for adults who have no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder, Dr. Pbert said.

The task force, therefore, issued an “I” statement (insufficient evidence), meaning it cannot at this time recommend for or against screening for eating disorders.

An “I” statement is “fundamentally a call for more research,” Dr. Pbert noted.

Adolescents and adults who have signs and symptoms of an eating disorder – which include rapid weight loss; weight gain or pronounced deviation from growth trajectory; pubertal delay; bradycardia; oligomenorrhea; and amenorrhea – are not included in this recommendation.

The USPSTF recommendation statement and accompanying evidence report were published online March 15 in JAMA.
 

Clinical judgment key

In the absence of evidence, clinicians should use their judgment when determining whether or not to screen an individual patient for an eating disorder, Dr. Pbert advised.

One thing to consider is whether the patient is in a group at higher risk for eating disorders, such as athletes, females, young adults aged 18-29, and transgender individuals.

Another is whether the patient reports engaging in unhealthy weight control behaviors, such as fasting or skipping meals, Dr. Pbert said.

Importantly, any patient who has signs or symptoms of an eating disorder or is expressing concerns about their eating should be assessed and referred for appropriate care, Dr. Pbert said.

“The good news is that eating disorders can be treated,” she said.

Several organizations currently recommend screening in the context of monitoring changes in weight and other vital signs or signs and symptoms to determine whether a patient might have an eating disorder.

Dr. Pbert said it’s important to recognize that the USPSTF statement “doesn’t really conflict” with the recommendations of other organizations. “We all agree that patients who present with signs or symptoms of an eating disorder should be assessed further.”
 

Evidence gaps

The authors of an invited commentary in JAMA) say the task force has identified several “notable deficiencies” in the available data on screening for eating disorders.

Dr. Evelyn Attia

“Directing attention to rigorous research to close this evidence gap will be important to find optimal approaches to identify patients with these complex disorders and improve their health outcomes,” write Evelyn Attia, MD, with Weill Cornell Medicine in New York, and Angela Guarda, MD, with Johns Hopkins University, Baltimore.

This “I” statement, they say, “highlights the need to prioritize research aimed at closing the evidence gap identified by USPSTF in a timely manner and underscores the need for new studies that address screening for eating disorders, treatment trials that enroll screen-detected populations from primary care settings, and screening in specific populations.

“Research on screening in primary care also should be paired with development and assessment of early brief intervention strategies for those individuals who screen positive, especially adolescents,” Dr. Attia and Dr. Guarda say.

Members of the USPSTF have disclosed no relevant financial relationships. Dr. Attia has received research support from the National Institute of Mental Health and the Hilda & Preston David Foundation; royalties from UpToDate; and has served as a clinical advisor to Equip Health. Dr. Guarda has received support from the Stephen and Jean Robinson Fund and research funding from the Klarman Family Foundation.

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

Publications
Topics
Sections

There is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults, the U.S. Preventive Services Task Force says in their first-ever statement on the topic.

Eating disorders (binge eating disorder, bulimia nervosa, and anorexia nervosa) can cause “serious harms to physical and psychosocial health and take a tremendous toll on individuals and families,” task force member Lori Pbert, PhD, told this news organization.

“Screening for eating disorders has the potential to improve health by leading to early detection and effective treatment,” said Dr. Pbert, with the department of population and quantitative health sciences, University of Massachusetts, Worcester.

However, a “deep dive” into the available literature failed to turn up adequate evidence to recommend for or against routine screening for eating disorders for children and adolescents aged 10 years and older and for adults who have no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder, Dr. Pbert said.

The task force, therefore, issued an “I” statement (insufficient evidence), meaning it cannot at this time recommend for or against screening for eating disorders.

An “I” statement is “fundamentally a call for more research,” Dr. Pbert noted.

Adolescents and adults who have signs and symptoms of an eating disorder – which include rapid weight loss; weight gain or pronounced deviation from growth trajectory; pubertal delay; bradycardia; oligomenorrhea; and amenorrhea – are not included in this recommendation.

The USPSTF recommendation statement and accompanying evidence report were published online March 15 in JAMA.
 

Clinical judgment key

In the absence of evidence, clinicians should use their judgment when determining whether or not to screen an individual patient for an eating disorder, Dr. Pbert advised.

One thing to consider is whether the patient is in a group at higher risk for eating disorders, such as athletes, females, young adults aged 18-29, and transgender individuals.

Another is whether the patient reports engaging in unhealthy weight control behaviors, such as fasting or skipping meals, Dr. Pbert said.

Importantly, any patient who has signs or symptoms of an eating disorder or is expressing concerns about their eating should be assessed and referred for appropriate care, Dr. Pbert said.

“The good news is that eating disorders can be treated,” she said.

Several organizations currently recommend screening in the context of monitoring changes in weight and other vital signs or signs and symptoms to determine whether a patient might have an eating disorder.

Dr. Pbert said it’s important to recognize that the USPSTF statement “doesn’t really conflict” with the recommendations of other organizations. “We all agree that patients who present with signs or symptoms of an eating disorder should be assessed further.”
 

Evidence gaps

The authors of an invited commentary in JAMA) say the task force has identified several “notable deficiencies” in the available data on screening for eating disorders.

Dr. Evelyn Attia

“Directing attention to rigorous research to close this evidence gap will be important to find optimal approaches to identify patients with these complex disorders and improve their health outcomes,” write Evelyn Attia, MD, with Weill Cornell Medicine in New York, and Angela Guarda, MD, with Johns Hopkins University, Baltimore.

This “I” statement, they say, “highlights the need to prioritize research aimed at closing the evidence gap identified by USPSTF in a timely manner and underscores the need for new studies that address screening for eating disorders, treatment trials that enroll screen-detected populations from primary care settings, and screening in specific populations.

“Research on screening in primary care also should be paired with development and assessment of early brief intervention strategies for those individuals who screen positive, especially adolescents,” Dr. Attia and Dr. Guarda say.

Members of the USPSTF have disclosed no relevant financial relationships. Dr. Attia has received research support from the National Institute of Mental Health and the Hilda & Preston David Foundation; royalties from UpToDate; and has served as a clinical advisor to Equip Health. Dr. Guarda has received support from the Stephen and Jean Robinson Fund and research funding from the Klarman Family Foundation.

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

There is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults, the U.S. Preventive Services Task Force says in their first-ever statement on the topic.

Eating disorders (binge eating disorder, bulimia nervosa, and anorexia nervosa) can cause “serious harms to physical and psychosocial health and take a tremendous toll on individuals and families,” task force member Lori Pbert, PhD, told this news organization.

“Screening for eating disorders has the potential to improve health by leading to early detection and effective treatment,” said Dr. Pbert, with the department of population and quantitative health sciences, University of Massachusetts, Worcester.

However, a “deep dive” into the available literature failed to turn up adequate evidence to recommend for or against routine screening for eating disorders for children and adolescents aged 10 years and older and for adults who have no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder, Dr. Pbert said.

The task force, therefore, issued an “I” statement (insufficient evidence), meaning it cannot at this time recommend for or against screening for eating disorders.

An “I” statement is “fundamentally a call for more research,” Dr. Pbert noted.

Adolescents and adults who have signs and symptoms of an eating disorder – which include rapid weight loss; weight gain or pronounced deviation from growth trajectory; pubertal delay; bradycardia; oligomenorrhea; and amenorrhea – are not included in this recommendation.

The USPSTF recommendation statement and accompanying evidence report were published online March 15 in JAMA.
 

Clinical judgment key

In the absence of evidence, clinicians should use their judgment when determining whether or not to screen an individual patient for an eating disorder, Dr. Pbert advised.

One thing to consider is whether the patient is in a group at higher risk for eating disorders, such as athletes, females, young adults aged 18-29, and transgender individuals.

Another is whether the patient reports engaging in unhealthy weight control behaviors, such as fasting or skipping meals, Dr. Pbert said.

Importantly, any patient who has signs or symptoms of an eating disorder or is expressing concerns about their eating should be assessed and referred for appropriate care, Dr. Pbert said.

“The good news is that eating disorders can be treated,” she said.

Several organizations currently recommend screening in the context of monitoring changes in weight and other vital signs or signs and symptoms to determine whether a patient might have an eating disorder.

Dr. Pbert said it’s important to recognize that the USPSTF statement “doesn’t really conflict” with the recommendations of other organizations. “We all agree that patients who present with signs or symptoms of an eating disorder should be assessed further.”
 

Evidence gaps

The authors of an invited commentary in JAMA) say the task force has identified several “notable deficiencies” in the available data on screening for eating disorders.

Dr. Evelyn Attia

“Directing attention to rigorous research to close this evidence gap will be important to find optimal approaches to identify patients with these complex disorders and improve their health outcomes,” write Evelyn Attia, MD, with Weill Cornell Medicine in New York, and Angela Guarda, MD, with Johns Hopkins University, Baltimore.

This “I” statement, they say, “highlights the need to prioritize research aimed at closing the evidence gap identified by USPSTF in a timely manner and underscores the need for new studies that address screening for eating disorders, treatment trials that enroll screen-detected populations from primary care settings, and screening in specific populations.

“Research on screening in primary care also should be paired with development and assessment of early brief intervention strategies for those individuals who screen positive, especially adolescents,” Dr. Attia and Dr. Guarda say.

Members of the USPSTF have disclosed no relevant financial relationships. Dr. Attia has received research support from the National Institute of Mental Health and the Hilda & Preston David Foundation; royalties from UpToDate; and has served as a clinical advisor to Equip Health. Dr. Guarda has received support from the Stephen and Jean Robinson Fund and research funding from the Klarman Family Foundation.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

‘Vast majority’ of COVID patients wake up after mechanical ventilation

Article Type
Changed

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

Publications
Topics
Sections

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM ANNALS OF NEUROLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

FDA approves upadacitinib for ulcerative colitis

Article Type
Changed

The Food and Drug Administration has approved upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who do not respond adequately to or can’t tolerate anti–tumor necrosis factor (TNF) agents.

It marks the first FDA approval for the selective Janus kinase (JAK) inhibitor in gastroenterology and is supported by efficacy and safety data from three phase 3 randomized, double-blind, placebo-controlled clinical studies.

In clinical trials, upadacitinib achieved the primary endpoints of clinical remission, per modified Mayo Score, at 8 and 52 weeks.

In addition, a greater proportion of patients who received upadacitinib achieved clinical response as early as the second week of treatment and steroid-free clinical remission at 1 year, as well as key endoscopic and histologic improvement endpoints at 8 and 52 weeks.

“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” Maria T. Abreu, MD, director, Crohn’s and Colitis Center, University of Miami Health System, said in a news release issued by AbbVie.

Upadacitinib has been shown to “rapidly control symptoms,” said Dr. Abreu, adding, “I believe these types of improvements can make a positive difference for my patients.”

Upadacitinib is also approved in the United States to treat adults with moderate to severe rheumatoid arthritis, moderate to severe atopic dermatitis, and active psoriatic arthritis.

Overall, the safety profile observed in patients with UC who were treated with upadacitinib was generally similar to the safety profile in patients with rheumatoid arthritis and atopic dermatitis.

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

Publications
Topics
Sections

The Food and Drug Administration has approved upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who do not respond adequately to or can’t tolerate anti–tumor necrosis factor (TNF) agents.

It marks the first FDA approval for the selective Janus kinase (JAK) inhibitor in gastroenterology and is supported by efficacy and safety data from three phase 3 randomized, double-blind, placebo-controlled clinical studies.

In clinical trials, upadacitinib achieved the primary endpoints of clinical remission, per modified Mayo Score, at 8 and 52 weeks.

In addition, a greater proportion of patients who received upadacitinib achieved clinical response as early as the second week of treatment and steroid-free clinical remission at 1 year, as well as key endoscopic and histologic improvement endpoints at 8 and 52 weeks.

“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” Maria T. Abreu, MD, director, Crohn’s and Colitis Center, University of Miami Health System, said in a news release issued by AbbVie.

Upadacitinib has been shown to “rapidly control symptoms,” said Dr. Abreu, adding, “I believe these types of improvements can make a positive difference for my patients.”

Upadacitinib is also approved in the United States to treat adults with moderate to severe rheumatoid arthritis, moderate to severe atopic dermatitis, and active psoriatic arthritis.

Overall, the safety profile observed in patients with UC who were treated with upadacitinib was generally similar to the safety profile in patients with rheumatoid arthritis and atopic dermatitis.

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

The Food and Drug Administration has approved upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who do not respond adequately to or can’t tolerate anti–tumor necrosis factor (TNF) agents.

It marks the first FDA approval for the selective Janus kinase (JAK) inhibitor in gastroenterology and is supported by efficacy and safety data from three phase 3 randomized, double-blind, placebo-controlled clinical studies.

In clinical trials, upadacitinib achieved the primary endpoints of clinical remission, per modified Mayo Score, at 8 and 52 weeks.

In addition, a greater proportion of patients who received upadacitinib achieved clinical response as early as the second week of treatment and steroid-free clinical remission at 1 year, as well as key endoscopic and histologic improvement endpoints at 8 and 52 weeks.

“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” Maria T. Abreu, MD, director, Crohn’s and Colitis Center, University of Miami Health System, said in a news release issued by AbbVie.

Upadacitinib has been shown to “rapidly control symptoms,” said Dr. Abreu, adding, “I believe these types of improvements can make a positive difference for my patients.”

Upadacitinib is also approved in the United States to treat adults with moderate to severe rheumatoid arthritis, moderate to severe atopic dermatitis, and active psoriatic arthritis.

Overall, the safety profile observed in patients with UC who were treated with upadacitinib was generally similar to the safety profile in patients with rheumatoid arthritis and atopic dermatitis.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Relax. The dog-tor will see you now

Article Type
Changed

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

Publications
Topics
Sections

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM PLOS ONE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

FDA clears once-weekly transdermal patch for Alzheimer’s

Article Type
Changed

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

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

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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

Issue
Neurology Reviews - 30(4)
Publications
Topics
Sections

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

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

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

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

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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

Issue
Neurology Reviews - 30(4)
Issue
Neurology Reviews - 30(4)
Publications
Publications
Topics
Article Type
Sections
Citation Override
Publish date: March 16, 2022
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article