Commentary: Risks for Eosinophilic Esophagitis: IBD, Eczema, Diet, and Acid Suppressants, January 2024

Article Type
Changed
Wed, 01/17/2024 - 18:07
Dr Puerta scans the journals so you don't have to!

Cristian Puerta, M.D.
A recent nationwide Swedish population cohort study investigated the link between eosinophilic esophagitis (EoE) and inflammatory bowel disease (IBD), revealing a fourfold increased risk of developing IBD subsequent to an EoE diagnosis.

 

Although there exists a recognized association between IBD and secondary EoE diagnoses, studies focusing on the primary diagnosis of EoE alongside IBD have yielded conflicting results. Dr Amiko Uchida, from the University of Utah Department of Medicine, working with colleagues from the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Stockholm, Sweden, led by Dr Jonas F. Ludvigsson, conducted a comprehensive study spanning 1990-2019 to explore the relationship between these two diseases.

 

Dr Uchida and colleagues assessed the association among Swedish patients diagnosed with biopsy-verified EoE (n = 1587) between 1990 and 2017. These patients were age- and sex-matched with up to five reference individuals from the general population (n = 7808). The primary focus was to discern the relationship between the primary diagnosis of EoE and the subsequent diagnosis of IBD.

 

The study's findings underscore the importance of heightened awareness among healthcare professionals regarding the potential association between EoE and the development of subsequent IBD. Collaborative efforts between physicians, gastroenterologists, and specialists in allergic diseases are crucial to ensure comprehensive care and timely identification of gastrointestinal complications in patients with EoE.

 

These results indicate a potential interplay between EoE and the pathogenesis of IBD, particularly Crohn's disease. In patients with EoE, careful consideration of gastrointestinal symptoms suggestive of IBD, such as abdominal pain, diarrhea, and rectal bleeding, is pivotal, necessitating further evaluation and appropriate monitoring for early detection and management of IBD.

 

Upon diagnosis, clinicians must develop a management plan for this chronic and critical disease. This study aids in planning future screenings for these patients, because one third of those diagnosed with EoE are at risk of developing IBD within a year. Therefore, primary physicians must remain vigilant for the development of gastrointestinal symptoms leading to a diagnosis of Crohn's disease or ulcerative colitis. Additionally, family awareness is crucial owing to observed associations between siblings, suggesting a potential role of genetics or early environmental factors in EoE development and future IBD diagnoses.

 

Further research is necessary to elucidate the shared pathophysiologic mechanisms connecting EoE and IBD. It is important to consider certain details, however; for instance, 31% of all subsequent IBD cases were diagnosed within the first year after an EoE diagnosis, potentially indicating a role of detection bias in these findings. Using a validated nationwide cohort and comparing study individuals with their siblings helped control for potential intrafamilial confounders as well as some environmental confounders, minimizing such biases as selection bias due to socioeconomic status. This strengthens the observed association in this study.

 

These insights into the increased risk for IBD, notably Crohn's disease, among patients with EoE underscore the need for thorough clinical evaluation and vigilant monitoring for gastrointestinal complications in this population.

 

A retrospective study conducted in pediatric patients presenting with an aerodigestive manifestation aimed to assess the factors associated with EoE and the diagnostic role of triple endoscopy. The results suggested a potential association between a family history of eczema and a diet lacking allergenic foods with a future diagnosis of EoE.

 

This study by Sheila Moran and colleagues, led by Dr Christina J. Yang from the Department of Otorhinolaryngology, Head and Neck Surgery at the Albert Einstein College of Medicine, Bronx, New York, aimed to identify preoperative risk factors linked to an EoE diagnosis in children undergoing triple endoscopy. They evaluated 119 pediatric patients aged 0-21 years who underwent triple endoscopy (including flexible bronchoscopy, rigid direct laryngoscopy and bronchoscopy, and esophagoscopy with biopsy) at the Children's Hospital at Montefiore between January 1, 2015, and December 31, 2019.

 

The study underscored the significance of both genetic predisposition and dietary influences in EoE development. Understanding the interplay between familial atopic conditions and dietary choices among pediatric patients with aerodigestive dysfunction is crucial for early identification and implementing preventive strategies against EoE.

 

As clinicians, it's essential to consider rare diseases like EoE when patients present with mixed symptoms, including aerodigestive symptoms, a family history of eczema, and a history of environmental allergies, given the association between these conditions. The potential link between a family history of eczema and increased EoE risk suggests a shared genetic susceptibility among allergic conditions. Therefore, clinicians evaluating children with aerodigestive dysfunction, particularly those with a familial history of eczema, should maintain a high index of suspicion for EoE, prompting vigilant monitoring and appropriate diagnostic assessments.

 

When contemplating advanced procedures, such as triple endoscopy or biopsy sampling, considering the patient's previous medical history and the effect of dietary modifications, such as incorporating or excluding dairy from the diet, warrants further investigation in the context of EoE prevention. Clinicians should consider providing dietary counseling and personalized nutritional plans based on evidence-based approaches to potentially mitigate EoE risk in susceptible pediatric populations.

 

Additionally, it's crucial to consider EoE in minority racial groups and underserved communities and encourage the use of diagnostic tests, such as triple endoscopy, to facilitate early diagnosis. Healthcare providers should contemplate integrating family history assessments, particularly regarding eczema, into the evaluation of children with aerodigestive dysfunction. This information can assist in risk assessment and early identification of individuals at a higher risk of developing EoE, enabling prompt intervention and management.

 

The increasing incidence of EoE across different nations, including the United States, has underscored the need for a deeper understanding of its causes, early diagnosis, and treatment. A novel population-based study conducted in Denmark aimed to explore the relationship between maternal and infant use of antibiotics and acid suppressants in the development of EoE. The study yielded significant results based on a population of 392 cases. Dr Elizabeth T. Jensen, MPH, PhD, from the Department of Epidemiology & Prevention at Wake Forest University School of Medicine, Winston-Salem, North Carolina, conducted a comprehensive study spanning the last 20 years to decipher potential causes contributing to the rising incidence of EoE.

 

Dr Jensen and her colleagues evaluated the association between maternal and infant use of antibiotics and acid suppressants in Denmark. They used pathology, prescription, birth, inpatient, and outpatient health registry data, ensuring complete ascertainment of all EoE cases among Danish residents born between 1997 and 2018. The research obtained a census of cases from a registered sample of approximately 1.4 million children, matching EoE cases to controls using a 1:10 ratio through incidence density sampling. A total of 392 patients with EoE and 3637 control patients were enrolled. The primary outcome of the study focused on the development of EoE, revealing a dose-response association between maternal and infant antibiotic and acid suppressant use and increased EoE risk.

 

This study demonstrated a robust correlation between the dosage of antibiotics and acid suppressants and the development of EoE in offspring during childhood. These findings hold significance because these medications represent some of the most common prescriptions in clinical practice. Pregnancy triggers significant physiologic changes in women, including increased hormonal effects and abdominal pressure on the lower esophageal sphincter, making pregnant individuals more prone to esophageal reflux and necessitating the use of gastric acid suppressants. As clinicians, it's crucial to consider lifestyle modifications and dietary adjustments before resorting to acid suppressants, reserving their use for only when absolutely necessary.

 

Postpregnancy, emphasizing exclusive breastfeeding for the first 6 months and proper feeding techniques can aid in reducing the likelihood of reflux disease in newborns. Acid suppressants have been linked to alterations in infant microbiome colonization, potentially increasing the susceptibility to immunoreactive diseases, such as asthma, atopic dermatitis, and allergic rhinitis. Given that exclusive breastfeeding in the initial 6 months has demonstrated preventive benefits against such diseases, primary physicians play a crucial role in advocating its importance. Although gastric acid suppressants and antibiotics are essential for managing various health conditions, including infections and gastroesophageal reflux disease (GERD), their potential impact on EoE development should not be overlooked.

 

Though this study had a relatively small sample size, the strong population registry of Denmark significantly reduced recall bias. However, cultural differences and over-the-counter access to drugs, such as acid suppressants, in other countries, including the United States, warrant further research to ascertain their effect on EoE development.

 

In light of these findings, clinicians should carefully weigh the risks and benefits of prescribing antibiotics and acid suppressants during pregnancy and infancy. Adherence to evidence-based guidelines and considering alternative treatment options, such as lifestyle modifications, should be prioritized. Prescribing antibiotics only when medically necessary and using nonpharmacologic strategies for managing GERD in infants should be considered to mitigate potential risks associated with these medications.

Author and Disclosure Information

Research Fellow / Lab Manager

Thistlethwaite Lab BSB 4025

Division of Cardiothoracic Surgery

University of California, San Diego

Publications
Topics
Author and Disclosure Information

Research Fellow / Lab Manager

Thistlethwaite Lab BSB 4025

Division of Cardiothoracic Surgery

University of California, San Diego

Author and Disclosure Information

Research Fellow / Lab Manager

Thistlethwaite Lab BSB 4025

Division of Cardiothoracic Surgery

University of California, San Diego

Dr Puerta scans the journals so you don't have to!
Dr Puerta scans the journals so you don't have to!

Cristian Puerta, M.D.
A recent nationwide Swedish population cohort study investigated the link between eosinophilic esophagitis (EoE) and inflammatory bowel disease (IBD), revealing a fourfold increased risk of developing IBD subsequent to an EoE diagnosis.

 

Although there exists a recognized association between IBD and secondary EoE diagnoses, studies focusing on the primary diagnosis of EoE alongside IBD have yielded conflicting results. Dr Amiko Uchida, from the University of Utah Department of Medicine, working with colleagues from the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Stockholm, Sweden, led by Dr Jonas F. Ludvigsson, conducted a comprehensive study spanning 1990-2019 to explore the relationship between these two diseases.

 

Dr Uchida and colleagues assessed the association among Swedish patients diagnosed with biopsy-verified EoE (n = 1587) between 1990 and 2017. These patients were age- and sex-matched with up to five reference individuals from the general population (n = 7808). The primary focus was to discern the relationship between the primary diagnosis of EoE and the subsequent diagnosis of IBD.

 

The study's findings underscore the importance of heightened awareness among healthcare professionals regarding the potential association between EoE and the development of subsequent IBD. Collaborative efforts between physicians, gastroenterologists, and specialists in allergic diseases are crucial to ensure comprehensive care and timely identification of gastrointestinal complications in patients with EoE.

 

These results indicate a potential interplay between EoE and the pathogenesis of IBD, particularly Crohn's disease. In patients with EoE, careful consideration of gastrointestinal symptoms suggestive of IBD, such as abdominal pain, diarrhea, and rectal bleeding, is pivotal, necessitating further evaluation and appropriate monitoring for early detection and management of IBD.

 

Upon diagnosis, clinicians must develop a management plan for this chronic and critical disease. This study aids in planning future screenings for these patients, because one third of those diagnosed with EoE are at risk of developing IBD within a year. Therefore, primary physicians must remain vigilant for the development of gastrointestinal symptoms leading to a diagnosis of Crohn's disease or ulcerative colitis. Additionally, family awareness is crucial owing to observed associations between siblings, suggesting a potential role of genetics or early environmental factors in EoE development and future IBD diagnoses.

 

Further research is necessary to elucidate the shared pathophysiologic mechanisms connecting EoE and IBD. It is important to consider certain details, however; for instance, 31% of all subsequent IBD cases were diagnosed within the first year after an EoE diagnosis, potentially indicating a role of detection bias in these findings. Using a validated nationwide cohort and comparing study individuals with their siblings helped control for potential intrafamilial confounders as well as some environmental confounders, minimizing such biases as selection bias due to socioeconomic status. This strengthens the observed association in this study.

 

These insights into the increased risk for IBD, notably Crohn's disease, among patients with EoE underscore the need for thorough clinical evaluation and vigilant monitoring for gastrointestinal complications in this population.

 

A retrospective study conducted in pediatric patients presenting with an aerodigestive manifestation aimed to assess the factors associated with EoE and the diagnostic role of triple endoscopy. The results suggested a potential association between a family history of eczema and a diet lacking allergenic foods with a future diagnosis of EoE.

 

This study by Sheila Moran and colleagues, led by Dr Christina J. Yang from the Department of Otorhinolaryngology, Head and Neck Surgery at the Albert Einstein College of Medicine, Bronx, New York, aimed to identify preoperative risk factors linked to an EoE diagnosis in children undergoing triple endoscopy. They evaluated 119 pediatric patients aged 0-21 years who underwent triple endoscopy (including flexible bronchoscopy, rigid direct laryngoscopy and bronchoscopy, and esophagoscopy with biopsy) at the Children's Hospital at Montefiore between January 1, 2015, and December 31, 2019.

 

The study underscored the significance of both genetic predisposition and dietary influences in EoE development. Understanding the interplay between familial atopic conditions and dietary choices among pediatric patients with aerodigestive dysfunction is crucial for early identification and implementing preventive strategies against EoE.

 

As clinicians, it's essential to consider rare diseases like EoE when patients present with mixed symptoms, including aerodigestive symptoms, a family history of eczema, and a history of environmental allergies, given the association between these conditions. The potential link between a family history of eczema and increased EoE risk suggests a shared genetic susceptibility among allergic conditions. Therefore, clinicians evaluating children with aerodigestive dysfunction, particularly those with a familial history of eczema, should maintain a high index of suspicion for EoE, prompting vigilant monitoring and appropriate diagnostic assessments.

 

When contemplating advanced procedures, such as triple endoscopy or biopsy sampling, considering the patient's previous medical history and the effect of dietary modifications, such as incorporating or excluding dairy from the diet, warrants further investigation in the context of EoE prevention. Clinicians should consider providing dietary counseling and personalized nutritional plans based on evidence-based approaches to potentially mitigate EoE risk in susceptible pediatric populations.

 

Additionally, it's crucial to consider EoE in minority racial groups and underserved communities and encourage the use of diagnostic tests, such as triple endoscopy, to facilitate early diagnosis. Healthcare providers should contemplate integrating family history assessments, particularly regarding eczema, into the evaluation of children with aerodigestive dysfunction. This information can assist in risk assessment and early identification of individuals at a higher risk of developing EoE, enabling prompt intervention and management.

 

The increasing incidence of EoE across different nations, including the United States, has underscored the need for a deeper understanding of its causes, early diagnosis, and treatment. A novel population-based study conducted in Denmark aimed to explore the relationship between maternal and infant use of antibiotics and acid suppressants in the development of EoE. The study yielded significant results based on a population of 392 cases. Dr Elizabeth T. Jensen, MPH, PhD, from the Department of Epidemiology & Prevention at Wake Forest University School of Medicine, Winston-Salem, North Carolina, conducted a comprehensive study spanning the last 20 years to decipher potential causes contributing to the rising incidence of EoE.

 

Dr Jensen and her colleagues evaluated the association between maternal and infant use of antibiotics and acid suppressants in Denmark. They used pathology, prescription, birth, inpatient, and outpatient health registry data, ensuring complete ascertainment of all EoE cases among Danish residents born between 1997 and 2018. The research obtained a census of cases from a registered sample of approximately 1.4 million children, matching EoE cases to controls using a 1:10 ratio through incidence density sampling. A total of 392 patients with EoE and 3637 control patients were enrolled. The primary outcome of the study focused on the development of EoE, revealing a dose-response association between maternal and infant antibiotic and acid suppressant use and increased EoE risk.

 

This study demonstrated a robust correlation between the dosage of antibiotics and acid suppressants and the development of EoE in offspring during childhood. These findings hold significance because these medications represent some of the most common prescriptions in clinical practice. Pregnancy triggers significant physiologic changes in women, including increased hormonal effects and abdominal pressure on the lower esophageal sphincter, making pregnant individuals more prone to esophageal reflux and necessitating the use of gastric acid suppressants. As clinicians, it's crucial to consider lifestyle modifications and dietary adjustments before resorting to acid suppressants, reserving their use for only when absolutely necessary.

 

Postpregnancy, emphasizing exclusive breastfeeding for the first 6 months and proper feeding techniques can aid in reducing the likelihood of reflux disease in newborns. Acid suppressants have been linked to alterations in infant microbiome colonization, potentially increasing the susceptibility to immunoreactive diseases, such as asthma, atopic dermatitis, and allergic rhinitis. Given that exclusive breastfeeding in the initial 6 months has demonstrated preventive benefits against such diseases, primary physicians play a crucial role in advocating its importance. Although gastric acid suppressants and antibiotics are essential for managing various health conditions, including infections and gastroesophageal reflux disease (GERD), their potential impact on EoE development should not be overlooked.

 

Though this study had a relatively small sample size, the strong population registry of Denmark significantly reduced recall bias. However, cultural differences and over-the-counter access to drugs, such as acid suppressants, in other countries, including the United States, warrant further research to ascertain their effect on EoE development.

 

In light of these findings, clinicians should carefully weigh the risks and benefits of prescribing antibiotics and acid suppressants during pregnancy and infancy. Adherence to evidence-based guidelines and considering alternative treatment options, such as lifestyle modifications, should be prioritized. Prescribing antibiotics only when medically necessary and using nonpharmacologic strategies for managing GERD in infants should be considered to mitigate potential risks associated with these medications.

Cristian Puerta, M.D.
A recent nationwide Swedish population cohort study investigated the link between eosinophilic esophagitis (EoE) and inflammatory bowel disease (IBD), revealing a fourfold increased risk of developing IBD subsequent to an EoE diagnosis.

 

Although there exists a recognized association between IBD and secondary EoE diagnoses, studies focusing on the primary diagnosis of EoE alongside IBD have yielded conflicting results. Dr Amiko Uchida, from the University of Utah Department of Medicine, working with colleagues from the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Stockholm, Sweden, led by Dr Jonas F. Ludvigsson, conducted a comprehensive study spanning 1990-2019 to explore the relationship between these two diseases.

 

Dr Uchida and colleagues assessed the association among Swedish patients diagnosed with biopsy-verified EoE (n = 1587) between 1990 and 2017. These patients were age- and sex-matched with up to five reference individuals from the general population (n = 7808). The primary focus was to discern the relationship between the primary diagnosis of EoE and the subsequent diagnosis of IBD.

 

The study's findings underscore the importance of heightened awareness among healthcare professionals regarding the potential association between EoE and the development of subsequent IBD. Collaborative efforts between physicians, gastroenterologists, and specialists in allergic diseases are crucial to ensure comprehensive care and timely identification of gastrointestinal complications in patients with EoE.

 

These results indicate a potential interplay between EoE and the pathogenesis of IBD, particularly Crohn's disease. In patients with EoE, careful consideration of gastrointestinal symptoms suggestive of IBD, such as abdominal pain, diarrhea, and rectal bleeding, is pivotal, necessitating further evaluation and appropriate monitoring for early detection and management of IBD.

 

Upon diagnosis, clinicians must develop a management plan for this chronic and critical disease. This study aids in planning future screenings for these patients, because one third of those diagnosed with EoE are at risk of developing IBD within a year. Therefore, primary physicians must remain vigilant for the development of gastrointestinal symptoms leading to a diagnosis of Crohn's disease or ulcerative colitis. Additionally, family awareness is crucial owing to observed associations between siblings, suggesting a potential role of genetics or early environmental factors in EoE development and future IBD diagnoses.

 

Further research is necessary to elucidate the shared pathophysiologic mechanisms connecting EoE and IBD. It is important to consider certain details, however; for instance, 31% of all subsequent IBD cases were diagnosed within the first year after an EoE diagnosis, potentially indicating a role of detection bias in these findings. Using a validated nationwide cohort and comparing study individuals with their siblings helped control for potential intrafamilial confounders as well as some environmental confounders, minimizing such biases as selection bias due to socioeconomic status. This strengthens the observed association in this study.

 

These insights into the increased risk for IBD, notably Crohn's disease, among patients with EoE underscore the need for thorough clinical evaluation and vigilant monitoring for gastrointestinal complications in this population.

 

A retrospective study conducted in pediatric patients presenting with an aerodigestive manifestation aimed to assess the factors associated with EoE and the diagnostic role of triple endoscopy. The results suggested a potential association between a family history of eczema and a diet lacking allergenic foods with a future diagnosis of EoE.

 

This study by Sheila Moran and colleagues, led by Dr Christina J. Yang from the Department of Otorhinolaryngology, Head and Neck Surgery at the Albert Einstein College of Medicine, Bronx, New York, aimed to identify preoperative risk factors linked to an EoE diagnosis in children undergoing triple endoscopy. They evaluated 119 pediatric patients aged 0-21 years who underwent triple endoscopy (including flexible bronchoscopy, rigid direct laryngoscopy and bronchoscopy, and esophagoscopy with biopsy) at the Children's Hospital at Montefiore between January 1, 2015, and December 31, 2019.

 

The study underscored the significance of both genetic predisposition and dietary influences in EoE development. Understanding the interplay between familial atopic conditions and dietary choices among pediatric patients with aerodigestive dysfunction is crucial for early identification and implementing preventive strategies against EoE.

 

As clinicians, it's essential to consider rare diseases like EoE when patients present with mixed symptoms, including aerodigestive symptoms, a family history of eczema, and a history of environmental allergies, given the association between these conditions. The potential link between a family history of eczema and increased EoE risk suggests a shared genetic susceptibility among allergic conditions. Therefore, clinicians evaluating children with aerodigestive dysfunction, particularly those with a familial history of eczema, should maintain a high index of suspicion for EoE, prompting vigilant monitoring and appropriate diagnostic assessments.

 

When contemplating advanced procedures, such as triple endoscopy or biopsy sampling, considering the patient's previous medical history and the effect of dietary modifications, such as incorporating or excluding dairy from the diet, warrants further investigation in the context of EoE prevention. Clinicians should consider providing dietary counseling and personalized nutritional plans based on evidence-based approaches to potentially mitigate EoE risk in susceptible pediatric populations.

 

Additionally, it's crucial to consider EoE in minority racial groups and underserved communities and encourage the use of diagnostic tests, such as triple endoscopy, to facilitate early diagnosis. Healthcare providers should contemplate integrating family history assessments, particularly regarding eczema, into the evaluation of children with aerodigestive dysfunction. This information can assist in risk assessment and early identification of individuals at a higher risk of developing EoE, enabling prompt intervention and management.

 

The increasing incidence of EoE across different nations, including the United States, has underscored the need for a deeper understanding of its causes, early diagnosis, and treatment. A novel population-based study conducted in Denmark aimed to explore the relationship between maternal and infant use of antibiotics and acid suppressants in the development of EoE. The study yielded significant results based on a population of 392 cases. Dr Elizabeth T. Jensen, MPH, PhD, from the Department of Epidemiology & Prevention at Wake Forest University School of Medicine, Winston-Salem, North Carolina, conducted a comprehensive study spanning the last 20 years to decipher potential causes contributing to the rising incidence of EoE.

 

Dr Jensen and her colleagues evaluated the association between maternal and infant use of antibiotics and acid suppressants in Denmark. They used pathology, prescription, birth, inpatient, and outpatient health registry data, ensuring complete ascertainment of all EoE cases among Danish residents born between 1997 and 2018. The research obtained a census of cases from a registered sample of approximately 1.4 million children, matching EoE cases to controls using a 1:10 ratio through incidence density sampling. A total of 392 patients with EoE and 3637 control patients were enrolled. The primary outcome of the study focused on the development of EoE, revealing a dose-response association between maternal and infant antibiotic and acid suppressant use and increased EoE risk.

 

This study demonstrated a robust correlation between the dosage of antibiotics and acid suppressants and the development of EoE in offspring during childhood. These findings hold significance because these medications represent some of the most common prescriptions in clinical practice. Pregnancy triggers significant physiologic changes in women, including increased hormonal effects and abdominal pressure on the lower esophageal sphincter, making pregnant individuals more prone to esophageal reflux and necessitating the use of gastric acid suppressants. As clinicians, it's crucial to consider lifestyle modifications and dietary adjustments before resorting to acid suppressants, reserving their use for only when absolutely necessary.

 

Postpregnancy, emphasizing exclusive breastfeeding for the first 6 months and proper feeding techniques can aid in reducing the likelihood of reflux disease in newborns. Acid suppressants have been linked to alterations in infant microbiome colonization, potentially increasing the susceptibility to immunoreactive diseases, such as asthma, atopic dermatitis, and allergic rhinitis. Given that exclusive breastfeeding in the initial 6 months has demonstrated preventive benefits against such diseases, primary physicians play a crucial role in advocating its importance. Although gastric acid suppressants and antibiotics are essential for managing various health conditions, including infections and gastroesophageal reflux disease (GERD), their potential impact on EoE development should not be overlooked.

 

Though this study had a relatively small sample size, the strong population registry of Denmark significantly reduced recall bias. However, cultural differences and over-the-counter access to drugs, such as acid suppressants, in other countries, including the United States, warrant further research to ascertain their effect on EoE development.

 

In light of these findings, clinicians should carefully weigh the risks and benefits of prescribing antibiotics and acid suppressants during pregnancy and infancy. Adherence to evidence-based guidelines and considering alternative treatment options, such as lifestyle modifications, should be prioritized. Prescribing antibiotics only when medically necessary and using nonpharmacologic strategies for managing GERD in infants should be considered to mitigate potential risks associated with these medications.

Publications
Publications
Topics
Article Type
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Article Series
Clinical Edge Journal Scan: Eosinophilic Esophagitis, January 2024
Gate On Date
Fri, 12/29/2023 - 17:15
Un-Gate On Date
Fri, 12/29/2023 - 17:15
Use ProPublica
CFC Schedule Remove Status
Fri, 12/29/2023 - 17:15
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
Activity Salesforce Deliverable ID
403914.1
Activity ID
109899
Product Name
Clinical Edge Journal Scan
Product ID
124
Supporter Name /ID
Takeda Corporate [ 3499 ]

Feedback in Clinical Education

Article Type
Changed
Fri, 12/29/2023 - 12:44

Until relatively recently, becoming a physician was a process in which the student began as an apprentice to an already skilled clinician. Eventually, both university- and hospital-based schools became part of the process, but an apprenticeship component persisted. In 1910, with the release of the Flexner Report, medical education here in the United States was revolutionized with a shift toward a more academic and scientific model already in use in Europe. While the path to becoming a physician grew more rigorous and science based when the students moved from the classroom and laboratory to the clinic and bedside, the process necessarily returned to its old one-on-one mentor-learner roots.

The venerable maxim of “See one — Do one — Teach one” that dominated my residency may still occasionally be whispered in the quiet corners of teaching hospitals, but I suspect concerns about risk management have discouraged its frequent application in hands-on situations. The development of artificial intelligence–driven mannequins may have finally relegated this remnant of an old cowboy (and girl) procedure-acquisition strategy to the dusty closet of medical education history.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

However, when it comes to non–procedure based learning in clinic and hospital settings, the process continues to be one in which the inexperienced are expected to learn by observing their more experienced (sometimes only slightly more experienced) mentors. There may be some mini “lectures” on the fly during rounds explaining the rationale behind what the learner is observing, but “teaching” is still dominated by “Watch this — Try it when it’s your turn — Then we’ll tell you how you did.”

A recent survey in the journal Hospital Pediatrics reviewed in AAP News suggests that there is a problem with feedback, the final step in this three-step process. The investigators surveyed 52 residents and 21 fellows using a scale developed for industrial applications and found that, with the exception of delivery, the fellows scored better than residents in the feedback process. In interviews with a small subgroup of eight residents, the researchers learned that the two consistent impediments to obtaining feedback were 1) that the hectic pace of patient care placed a limit on opportunities (not surprising) and 2) a culture emphasizing “a positive, nurturing environment may have led physicians to avoid giving constructive criticism because it might hurt resident’s feelings.”

I have a friend who has held human resource (HR) positions in two good-sized teaching hospital systems. He certainly agrees with the time limitations component. He has also been involved in several cases in which trainees have accused senior physicians of harassment and unprofessional behavior because learners took issue with the manner in which they had been given feedback on their performance. One wonders if the institution(s) surveyed in this recent study had already experienced similar cases of discontent and have reacted by being so polite that feedback now lacks a feel of authenticity. This was a very small study, and it is hard to know how applicable the findings would be in a national sample, but I suspect there are more than a few teaching institutions in which kid gloves have become fashionable attire.

As my friend pointed out to me, substantial “generational differences” exist in many work places. Different generations may hold competing value systems when it comes to how feedback should be, and should not be, delivered.

None of us were trained in how to deliver a performance evaluation and feedback regardless of whether it was with one or two rushed sentences on a sprint from room to room on morning rounds or a more relaxed sit-down at the end of a rotation. We tend to lean on our own experiences of receiving feedback from our parents, from coaches, and most often from the models we observed as we came up through the hierarchy of medical training.

Feedback is a tightrope we must all walk along, and we must be acutely aware of the background and expectations of the recipients of well-meaning constructive criticism. I found it refreshing to learn that at least one small population of the trainees may be willing, and even eager, to receive honest feedback even though it sometimes may come with a hard edge.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Publications
Topics
Sections

Until relatively recently, becoming a physician was a process in which the student began as an apprentice to an already skilled clinician. Eventually, both university- and hospital-based schools became part of the process, but an apprenticeship component persisted. In 1910, with the release of the Flexner Report, medical education here in the United States was revolutionized with a shift toward a more academic and scientific model already in use in Europe. While the path to becoming a physician grew more rigorous and science based when the students moved from the classroom and laboratory to the clinic and bedside, the process necessarily returned to its old one-on-one mentor-learner roots.

The venerable maxim of “See one — Do one — Teach one” that dominated my residency may still occasionally be whispered in the quiet corners of teaching hospitals, but I suspect concerns about risk management have discouraged its frequent application in hands-on situations. The development of artificial intelligence–driven mannequins may have finally relegated this remnant of an old cowboy (and girl) procedure-acquisition strategy to the dusty closet of medical education history.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

However, when it comes to non–procedure based learning in clinic and hospital settings, the process continues to be one in which the inexperienced are expected to learn by observing their more experienced (sometimes only slightly more experienced) mentors. There may be some mini “lectures” on the fly during rounds explaining the rationale behind what the learner is observing, but “teaching” is still dominated by “Watch this — Try it when it’s your turn — Then we’ll tell you how you did.”

A recent survey in the journal Hospital Pediatrics reviewed in AAP News suggests that there is a problem with feedback, the final step in this three-step process. The investigators surveyed 52 residents and 21 fellows using a scale developed for industrial applications and found that, with the exception of delivery, the fellows scored better than residents in the feedback process. In interviews with a small subgroup of eight residents, the researchers learned that the two consistent impediments to obtaining feedback were 1) that the hectic pace of patient care placed a limit on opportunities (not surprising) and 2) a culture emphasizing “a positive, nurturing environment may have led physicians to avoid giving constructive criticism because it might hurt resident’s feelings.”

I have a friend who has held human resource (HR) positions in two good-sized teaching hospital systems. He certainly agrees with the time limitations component. He has also been involved in several cases in which trainees have accused senior physicians of harassment and unprofessional behavior because learners took issue with the manner in which they had been given feedback on their performance. One wonders if the institution(s) surveyed in this recent study had already experienced similar cases of discontent and have reacted by being so polite that feedback now lacks a feel of authenticity. This was a very small study, and it is hard to know how applicable the findings would be in a national sample, but I suspect there are more than a few teaching institutions in which kid gloves have become fashionable attire.

As my friend pointed out to me, substantial “generational differences” exist in many work places. Different generations may hold competing value systems when it comes to how feedback should be, and should not be, delivered.

None of us were trained in how to deliver a performance evaluation and feedback regardless of whether it was with one or two rushed sentences on a sprint from room to room on morning rounds or a more relaxed sit-down at the end of a rotation. We tend to lean on our own experiences of receiving feedback from our parents, from coaches, and most often from the models we observed as we came up through the hierarchy of medical training.

Feedback is a tightrope we must all walk along, and we must be acutely aware of the background and expectations of the recipients of well-meaning constructive criticism. I found it refreshing to learn that at least one small population of the trainees may be willing, and even eager, to receive honest feedback even though it sometimes may come with a hard edge.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Until relatively recently, becoming a physician was a process in which the student began as an apprentice to an already skilled clinician. Eventually, both university- and hospital-based schools became part of the process, but an apprenticeship component persisted. In 1910, with the release of the Flexner Report, medical education here in the United States was revolutionized with a shift toward a more academic and scientific model already in use in Europe. While the path to becoming a physician grew more rigorous and science based when the students moved from the classroom and laboratory to the clinic and bedside, the process necessarily returned to its old one-on-one mentor-learner roots.

The venerable maxim of “See one — Do one — Teach one” that dominated my residency may still occasionally be whispered in the quiet corners of teaching hospitals, but I suspect concerns about risk management have discouraged its frequent application in hands-on situations. The development of artificial intelligence–driven mannequins may have finally relegated this remnant of an old cowboy (and girl) procedure-acquisition strategy to the dusty closet of medical education history.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

However, when it comes to non–procedure based learning in clinic and hospital settings, the process continues to be one in which the inexperienced are expected to learn by observing their more experienced (sometimes only slightly more experienced) mentors. There may be some mini “lectures” on the fly during rounds explaining the rationale behind what the learner is observing, but “teaching” is still dominated by “Watch this — Try it when it’s your turn — Then we’ll tell you how you did.”

A recent survey in the journal Hospital Pediatrics reviewed in AAP News suggests that there is a problem with feedback, the final step in this three-step process. The investigators surveyed 52 residents and 21 fellows using a scale developed for industrial applications and found that, with the exception of delivery, the fellows scored better than residents in the feedback process. In interviews with a small subgroup of eight residents, the researchers learned that the two consistent impediments to obtaining feedback were 1) that the hectic pace of patient care placed a limit on opportunities (not surprising) and 2) a culture emphasizing “a positive, nurturing environment may have led physicians to avoid giving constructive criticism because it might hurt resident’s feelings.”

I have a friend who has held human resource (HR) positions in two good-sized teaching hospital systems. He certainly agrees with the time limitations component. He has also been involved in several cases in which trainees have accused senior physicians of harassment and unprofessional behavior because learners took issue with the manner in which they had been given feedback on their performance. One wonders if the institution(s) surveyed in this recent study had already experienced similar cases of discontent and have reacted by being so polite that feedback now lacks a feel of authenticity. This was a very small study, and it is hard to know how applicable the findings would be in a national sample, but I suspect there are more than a few teaching institutions in which kid gloves have become fashionable attire.

As my friend pointed out to me, substantial “generational differences” exist in many work places. Different generations may hold competing value systems when it comes to how feedback should be, and should not be, delivered.

None of us were trained in how to deliver a performance evaluation and feedback regardless of whether it was with one or two rushed sentences on a sprint from room to room on morning rounds or a more relaxed sit-down at the end of a rotation. We tend to lean on our own experiences of receiving feedback from our parents, from coaches, and most often from the models we observed as we came up through the hierarchy of medical training.

Feedback is a tightrope we must all walk along, and we must be acutely aware of the background and expectations of the recipients of well-meaning constructive criticism. I found it refreshing to learn that at least one small population of the trainees may be willing, and even eager, to receive honest feedback even though it sometimes may come with a hard edge.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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

Recurrent Bleeding in Small-Intestinal Angiodysplasia Reduced by Thalidomide

Article Type
Changed
Wed, 01/03/2024 - 18:42

In patients with recurrent bleeding due to small-intestinal angiodysplasia (SIA), treatment with thalidomide resulted in a reduction in bleeding, according to results of a new placebo-controlled trial.

At 1 year follow-up, thalidomide doses of 100 mg/day and 50 mg/day outperformed placebo in reducing by at least 50% the number of bleeding episodes, compared with the year prior to treatment, according to the study published online in the New England Journal of Medicine.

SIA, an increasingly recognized cause of repeat obscure gastrointestinal bleeding and iron-deficiency anemia, is a distinct vascular abnormality in the mucosa and submucosa characterized by focal accumulation of ectatic vessels. It is the most common cause of small intestine bleeding, especially among patients older than 50.

There is a high unmet need among patients with SIA for an effective and relatively safe oral medication, given substantial recurrent bleeding risks following endoscopic or surgical procedures, and only observational studies suggest treatment with somatostatin and octreotide, noted senior author Zhizheng Ge, MD, Shanghai Jiao Tong University, Shanghai, China.

SIA is characterized by dilated and tortuous arterial or venous capillaries between thin-walled and immature veins and capillaries without a smooth-muscle layer. Its pathologic process involves chronic hypoxia and vessel sprouting.

Dr. Ge and colleagues postulated that thalidomide’s ability to decrease the expression of proangiogenic factors and angiogenesis would have a long-lasting ameliorating effect on bleeding episodes of angiodysplasia, and thus a continued benefit with respect to bleeding cessation. Their previous small, single-center, open-label, randomized controlled trial of thalidomide for SIA showed a benefit, but it required larger confirmatory trials.

For their current trial, the researchers explored whether a short treatment period, selected to avoid treatment nonadherence, could have a long-term effect. They randomly assigned on a 1:1:1 basis 150 patients with recurrent SIA-related bleeding, defined as at least four episodes during the previous year, to an oral daily dose of 100 mg of thalidomide, 50 mg of thalidomide, or placebo for 4 months.

The patients (median age, 62.2 years; 88% aged 50 years or older) were followed for at least 1 year after treatment. The trial was conducted at 10 sites in China.

The primary endpoint was effective response, defined as a reduction of at least 50% in the number of bleeding episodes in the year following thalidomide treatment, compared with the number in the year before treatment. Bleeding was defined as the presence of overt bleeding or a positive fecal occult blood test.

The percentages of patients with effective response at 1-year follow-up were 68.6% in the 100-mg thalidomide group, 51% in the 50-mg thalidomide group, and 16% in the placebo group.

Among secondary endpoints, the incidence of rebleeding during the 4-month treatment period was 27.5% (14 of 51 patients) in the 100-mg thalidomide group, 42.9% (21 of 49 patients) in the 50-mg thalidomide group, and 90% (45 of 50 patients) in the placebo group. The percentage of patients who received a blood transfusion during the 1-year follow-up period were 17.6% in the 100-mg thalidomide group, 24.5% in the 50-mg thalidomide group, and 62% in the placebo group.

Cessation of bleeding, defined by two consecutive negative fecal occult blood tests on different days, during 1 year of follow-up was observed in 44 patients: 26 (51%) of patients in the 100-mg thalidomide group, 16 (32.7%) in the 50-mg thalidomide group, and 2 (4%) in the placebo group. The authors urge further exploration of the duration of benefit and the efficacy of longer courses of treatment.

Adverse events, all grade 1 or 2, resolved after treatment of symptoms, completion of treatment, or discontinuation of thalidomide or placebo.

 

 

Retreatment May Be Necessary

In an accompanying editorial, Loren Laine, MD, chief of the section of digestive diseases, internal medicine, and medical chief, digestive health, Yale School of Medicine, New Haven, Connecticut, affirmed the authors’ conclusions and commended the quality of evidence they provided.

“Their results suggest that thalidomide may be disease-modifying, with efficacy persisting after discontinuation,” wrote Dr. Laine, also a Yale professor of medicine and digestive diseases.

While thalidomide effectively prevented rebleeding for 42 patients during the year after therapy was stopped, suggesting an alteration of angiodysplasias, rebleeding during the subsequent 3-27 months occurred among 20 of those patients, Dr. Laine noted. That finding, “suggests that retreatment will be needed,” although the appropriate duration of treatment before retreatment and the duration of retreatment remain unclear, he added.

The study’s reliance on bleeding episodes that were defined by positive fecal occult blood tests, which may be clinically unimportant, is a weakness in the trial, Dr. Laine wrote.

Despite the study’s positive findings, clinicians may still prefer somatostatin analogues because of their potential for better safety and, with once-monthly injections versus daily thalidomide pills, their likelihood for better adherence, Dr. Laine wrote. “[They] will reserve thalidomide for use in patients who have continued bleeding or side effects with somatostatin analogues,” he added.

Somatostatin is rarely used in the treatment of SIA bleeding in China, where thalidomide is relatively easy to obtain and is being used clinically, Dr. Ge told this news organization in response to Dr. Laine’s editorial. “The clinical application of thalidomide has been taken up in other [Chinese] hospitals that have seen our research,” he added.

Future research may include randomized controlled trials of somatostatin, since Chinese experience with it is so limited, Dr. Ge said. “We would want to compare efficacy, safety, feasibility and cost-effectiveness between somatostatin and thalidomide,” he added.

The study was supported by grants from the National Natural Science Foundation of China and a grant from the Shanghai Municipal Education Commission, Gaofeng Clinical Medicine. The author disclosures can be found with the original article.

Publications
Topics
Sections

In patients with recurrent bleeding due to small-intestinal angiodysplasia (SIA), treatment with thalidomide resulted in a reduction in bleeding, according to results of a new placebo-controlled trial.

At 1 year follow-up, thalidomide doses of 100 mg/day and 50 mg/day outperformed placebo in reducing by at least 50% the number of bleeding episodes, compared with the year prior to treatment, according to the study published online in the New England Journal of Medicine.

SIA, an increasingly recognized cause of repeat obscure gastrointestinal bleeding and iron-deficiency anemia, is a distinct vascular abnormality in the mucosa and submucosa characterized by focal accumulation of ectatic vessels. It is the most common cause of small intestine bleeding, especially among patients older than 50.

There is a high unmet need among patients with SIA for an effective and relatively safe oral medication, given substantial recurrent bleeding risks following endoscopic or surgical procedures, and only observational studies suggest treatment with somatostatin and octreotide, noted senior author Zhizheng Ge, MD, Shanghai Jiao Tong University, Shanghai, China.

SIA is characterized by dilated and tortuous arterial or venous capillaries between thin-walled and immature veins and capillaries without a smooth-muscle layer. Its pathologic process involves chronic hypoxia and vessel sprouting.

Dr. Ge and colleagues postulated that thalidomide’s ability to decrease the expression of proangiogenic factors and angiogenesis would have a long-lasting ameliorating effect on bleeding episodes of angiodysplasia, and thus a continued benefit with respect to bleeding cessation. Their previous small, single-center, open-label, randomized controlled trial of thalidomide for SIA showed a benefit, but it required larger confirmatory trials.

For their current trial, the researchers explored whether a short treatment period, selected to avoid treatment nonadherence, could have a long-term effect. They randomly assigned on a 1:1:1 basis 150 patients with recurrent SIA-related bleeding, defined as at least four episodes during the previous year, to an oral daily dose of 100 mg of thalidomide, 50 mg of thalidomide, or placebo for 4 months.

The patients (median age, 62.2 years; 88% aged 50 years or older) were followed for at least 1 year after treatment. The trial was conducted at 10 sites in China.

The primary endpoint was effective response, defined as a reduction of at least 50% in the number of bleeding episodes in the year following thalidomide treatment, compared with the number in the year before treatment. Bleeding was defined as the presence of overt bleeding or a positive fecal occult blood test.

The percentages of patients with effective response at 1-year follow-up were 68.6% in the 100-mg thalidomide group, 51% in the 50-mg thalidomide group, and 16% in the placebo group.

Among secondary endpoints, the incidence of rebleeding during the 4-month treatment period was 27.5% (14 of 51 patients) in the 100-mg thalidomide group, 42.9% (21 of 49 patients) in the 50-mg thalidomide group, and 90% (45 of 50 patients) in the placebo group. The percentage of patients who received a blood transfusion during the 1-year follow-up period were 17.6% in the 100-mg thalidomide group, 24.5% in the 50-mg thalidomide group, and 62% in the placebo group.

Cessation of bleeding, defined by two consecutive negative fecal occult blood tests on different days, during 1 year of follow-up was observed in 44 patients: 26 (51%) of patients in the 100-mg thalidomide group, 16 (32.7%) in the 50-mg thalidomide group, and 2 (4%) in the placebo group. The authors urge further exploration of the duration of benefit and the efficacy of longer courses of treatment.

Adverse events, all grade 1 or 2, resolved after treatment of symptoms, completion of treatment, or discontinuation of thalidomide or placebo.

 

 

Retreatment May Be Necessary

In an accompanying editorial, Loren Laine, MD, chief of the section of digestive diseases, internal medicine, and medical chief, digestive health, Yale School of Medicine, New Haven, Connecticut, affirmed the authors’ conclusions and commended the quality of evidence they provided.

“Their results suggest that thalidomide may be disease-modifying, with efficacy persisting after discontinuation,” wrote Dr. Laine, also a Yale professor of medicine and digestive diseases.

While thalidomide effectively prevented rebleeding for 42 patients during the year after therapy was stopped, suggesting an alteration of angiodysplasias, rebleeding during the subsequent 3-27 months occurred among 20 of those patients, Dr. Laine noted. That finding, “suggests that retreatment will be needed,” although the appropriate duration of treatment before retreatment and the duration of retreatment remain unclear, he added.

The study’s reliance on bleeding episodes that were defined by positive fecal occult blood tests, which may be clinically unimportant, is a weakness in the trial, Dr. Laine wrote.

Despite the study’s positive findings, clinicians may still prefer somatostatin analogues because of their potential for better safety and, with once-monthly injections versus daily thalidomide pills, their likelihood for better adherence, Dr. Laine wrote. “[They] will reserve thalidomide for use in patients who have continued bleeding or side effects with somatostatin analogues,” he added.

Somatostatin is rarely used in the treatment of SIA bleeding in China, where thalidomide is relatively easy to obtain and is being used clinically, Dr. Ge told this news organization in response to Dr. Laine’s editorial. “The clinical application of thalidomide has been taken up in other [Chinese] hospitals that have seen our research,” he added.

Future research may include randomized controlled trials of somatostatin, since Chinese experience with it is so limited, Dr. Ge said. “We would want to compare efficacy, safety, feasibility and cost-effectiveness between somatostatin and thalidomide,” he added.

The study was supported by grants from the National Natural Science Foundation of China and a grant from the Shanghai Municipal Education Commission, Gaofeng Clinical Medicine. The author disclosures can be found with the original article.

In patients with recurrent bleeding due to small-intestinal angiodysplasia (SIA), treatment with thalidomide resulted in a reduction in bleeding, according to results of a new placebo-controlled trial.

At 1 year follow-up, thalidomide doses of 100 mg/day and 50 mg/day outperformed placebo in reducing by at least 50% the number of bleeding episodes, compared with the year prior to treatment, according to the study published online in the New England Journal of Medicine.

SIA, an increasingly recognized cause of repeat obscure gastrointestinal bleeding and iron-deficiency anemia, is a distinct vascular abnormality in the mucosa and submucosa characterized by focal accumulation of ectatic vessels. It is the most common cause of small intestine bleeding, especially among patients older than 50.

There is a high unmet need among patients with SIA for an effective and relatively safe oral medication, given substantial recurrent bleeding risks following endoscopic or surgical procedures, and only observational studies suggest treatment with somatostatin and octreotide, noted senior author Zhizheng Ge, MD, Shanghai Jiao Tong University, Shanghai, China.

SIA is characterized by dilated and tortuous arterial or venous capillaries between thin-walled and immature veins and capillaries without a smooth-muscle layer. Its pathologic process involves chronic hypoxia and vessel sprouting.

Dr. Ge and colleagues postulated that thalidomide’s ability to decrease the expression of proangiogenic factors and angiogenesis would have a long-lasting ameliorating effect on bleeding episodes of angiodysplasia, and thus a continued benefit with respect to bleeding cessation. Their previous small, single-center, open-label, randomized controlled trial of thalidomide for SIA showed a benefit, but it required larger confirmatory trials.

For their current trial, the researchers explored whether a short treatment period, selected to avoid treatment nonadherence, could have a long-term effect. They randomly assigned on a 1:1:1 basis 150 patients with recurrent SIA-related bleeding, defined as at least four episodes during the previous year, to an oral daily dose of 100 mg of thalidomide, 50 mg of thalidomide, or placebo for 4 months.

The patients (median age, 62.2 years; 88% aged 50 years or older) were followed for at least 1 year after treatment. The trial was conducted at 10 sites in China.

The primary endpoint was effective response, defined as a reduction of at least 50% in the number of bleeding episodes in the year following thalidomide treatment, compared with the number in the year before treatment. Bleeding was defined as the presence of overt bleeding or a positive fecal occult blood test.

The percentages of patients with effective response at 1-year follow-up were 68.6% in the 100-mg thalidomide group, 51% in the 50-mg thalidomide group, and 16% in the placebo group.

Among secondary endpoints, the incidence of rebleeding during the 4-month treatment period was 27.5% (14 of 51 patients) in the 100-mg thalidomide group, 42.9% (21 of 49 patients) in the 50-mg thalidomide group, and 90% (45 of 50 patients) in the placebo group. The percentage of patients who received a blood transfusion during the 1-year follow-up period were 17.6% in the 100-mg thalidomide group, 24.5% in the 50-mg thalidomide group, and 62% in the placebo group.

Cessation of bleeding, defined by two consecutive negative fecal occult blood tests on different days, during 1 year of follow-up was observed in 44 patients: 26 (51%) of patients in the 100-mg thalidomide group, 16 (32.7%) in the 50-mg thalidomide group, and 2 (4%) in the placebo group. The authors urge further exploration of the duration of benefit and the efficacy of longer courses of treatment.

Adverse events, all grade 1 or 2, resolved after treatment of symptoms, completion of treatment, or discontinuation of thalidomide or placebo.

 

 

Retreatment May Be Necessary

In an accompanying editorial, Loren Laine, MD, chief of the section of digestive diseases, internal medicine, and medical chief, digestive health, Yale School of Medicine, New Haven, Connecticut, affirmed the authors’ conclusions and commended the quality of evidence they provided.

“Their results suggest that thalidomide may be disease-modifying, with efficacy persisting after discontinuation,” wrote Dr. Laine, also a Yale professor of medicine and digestive diseases.

While thalidomide effectively prevented rebleeding for 42 patients during the year after therapy was stopped, suggesting an alteration of angiodysplasias, rebleeding during the subsequent 3-27 months occurred among 20 of those patients, Dr. Laine noted. That finding, “suggests that retreatment will be needed,” although the appropriate duration of treatment before retreatment and the duration of retreatment remain unclear, he added.

The study’s reliance on bleeding episodes that were defined by positive fecal occult blood tests, which may be clinically unimportant, is a weakness in the trial, Dr. Laine wrote.

Despite the study’s positive findings, clinicians may still prefer somatostatin analogues because of their potential for better safety and, with once-monthly injections versus daily thalidomide pills, their likelihood for better adherence, Dr. Laine wrote. “[They] will reserve thalidomide for use in patients who have continued bleeding or side effects with somatostatin analogues,” he added.

Somatostatin is rarely used in the treatment of SIA bleeding in China, where thalidomide is relatively easy to obtain and is being used clinically, Dr. Ge told this news organization in response to Dr. Laine’s editorial. “The clinical application of thalidomide has been taken up in other [Chinese] hospitals that have seen our research,” he added.

Future research may include randomized controlled trials of somatostatin, since Chinese experience with it is so limited, Dr. Ge said. “We would want to compare efficacy, safety, feasibility and cost-effectiveness between somatostatin and thalidomide,” he added.

The study was supported by grants from the National Natural Science Foundation of China and a grant from the Shanghai Municipal Education Commission, Gaofeng Clinical Medicine. The author disclosures can be found with the original article.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE NEW ENGLAND JOURNAL OF 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

Regular Physical Activity Linked to Larger Brain Volume

Article Type
Changed
Tue, 01/02/2024 - 15:23

 

TOPLINE:

Regular moderate to vigorous physical activity predicts larger brain size in key regions, including gray and white matter and the hippocampus, new data suggest. 

METHODOLOGY: 

  • The potential neuroprotective effects of regular physical activity on brain structure are unclear despite reported links between physical activity and reduced dementia risk. 
  • To investigate, researchers analyzed MRI brain scans from 10,125 healthy adults (mean age, 53 years; 52% male) who self-reported their level of physical activity.
  • Moderate to vigorous physical activities, defined as those increasing respiration and pulse rate for at least 10 continuous minutes, was modeled with brain volumes, adjusting for covariates.
  • The threshold for defining physically active (vs nonactive) adults was intentionally set at 2.5 days per week, a level far lower than current guidelines.

TAKEAWAY:

  • Three quarters of the cohort reported engaging in moderate to vigorous physical activity approximately 4 days per week. 
  • Physically active adults tended to be younger, with a higher proportion of White individuals, and with lower rates of hypertension and type 2 diabetes. 
  • After adjusting for multiple factors, increased days of moderate to vigorous activity correlated with larger normalized brain volume in multiple regions including total gray matter; white matter; hippocampus; and frontal, parietal, and occipital lobes. 

IN PRACTICE: 

“We found that even moderate levels of physical activity, such as taking fewer than 4,000 steps a day, can have a positive effect on brain health. This is much less than the often-suggested 10,000 steps, making it a more achievable goal for many people,” co-author David Merrill, MD, with Pacific Brain Health Center, Santa Monica, California, said in a statement. 

SOURCE: 

The study, with first author Cyrus A. Raji, MD, PhD, Washington University School of Medicine, St. Louis, was published online in the Journal of Alzheimer’s Disease.

LIMITATIONS: 

Participants self-reported physical activity in the past 2 weeks, which does not reflect a lifetime of activity levels. The correlation identified between physical activity and brain volumes may not be solely attributable to physical activity alone. 

DISCLOSURES: 

The study received funding from several health centers and foundations. Dr. Raji consults for Brainreader ApS, Neurevolution LLC, Apollo Health, Voxelwise Imaging Technology, and Pacific Neuroscience Foundation and is an editorial board member of the Journal of Alzheimer’s Disease but was not involved in the peer-review process.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

TOPLINE:

Regular moderate to vigorous physical activity predicts larger brain size in key regions, including gray and white matter and the hippocampus, new data suggest. 

METHODOLOGY: 

  • The potential neuroprotective effects of regular physical activity on brain structure are unclear despite reported links between physical activity and reduced dementia risk. 
  • To investigate, researchers analyzed MRI brain scans from 10,125 healthy adults (mean age, 53 years; 52% male) who self-reported their level of physical activity.
  • Moderate to vigorous physical activities, defined as those increasing respiration and pulse rate for at least 10 continuous minutes, was modeled with brain volumes, adjusting for covariates.
  • The threshold for defining physically active (vs nonactive) adults was intentionally set at 2.5 days per week, a level far lower than current guidelines.

TAKEAWAY:

  • Three quarters of the cohort reported engaging in moderate to vigorous physical activity approximately 4 days per week. 
  • Physically active adults tended to be younger, with a higher proportion of White individuals, and with lower rates of hypertension and type 2 diabetes. 
  • After adjusting for multiple factors, increased days of moderate to vigorous activity correlated with larger normalized brain volume in multiple regions including total gray matter; white matter; hippocampus; and frontal, parietal, and occipital lobes. 

IN PRACTICE: 

“We found that even moderate levels of physical activity, such as taking fewer than 4,000 steps a day, can have a positive effect on brain health. This is much less than the often-suggested 10,000 steps, making it a more achievable goal for many people,” co-author David Merrill, MD, with Pacific Brain Health Center, Santa Monica, California, said in a statement. 

SOURCE: 

The study, with first author Cyrus A. Raji, MD, PhD, Washington University School of Medicine, St. Louis, was published online in the Journal of Alzheimer’s Disease.

LIMITATIONS: 

Participants self-reported physical activity in the past 2 weeks, which does not reflect a lifetime of activity levels. The correlation identified between physical activity and brain volumes may not be solely attributable to physical activity alone. 

DISCLOSURES: 

The study received funding from several health centers and foundations. Dr. Raji consults for Brainreader ApS, Neurevolution LLC, Apollo Health, Voxelwise Imaging Technology, and Pacific Neuroscience Foundation and is an editorial board member of the Journal of Alzheimer’s Disease but was not involved in the peer-review process.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Regular moderate to vigorous physical activity predicts larger brain size in key regions, including gray and white matter and the hippocampus, new data suggest. 

METHODOLOGY: 

  • The potential neuroprotective effects of regular physical activity on brain structure are unclear despite reported links between physical activity and reduced dementia risk. 
  • To investigate, researchers analyzed MRI brain scans from 10,125 healthy adults (mean age, 53 years; 52% male) who self-reported their level of physical activity.
  • Moderate to vigorous physical activities, defined as those increasing respiration and pulse rate for at least 10 continuous minutes, was modeled with brain volumes, adjusting for covariates.
  • The threshold for defining physically active (vs nonactive) adults was intentionally set at 2.5 days per week, a level far lower than current guidelines.

TAKEAWAY:

  • Three quarters of the cohort reported engaging in moderate to vigorous physical activity approximately 4 days per week. 
  • Physically active adults tended to be younger, with a higher proportion of White individuals, and with lower rates of hypertension and type 2 diabetes. 
  • After adjusting for multiple factors, increased days of moderate to vigorous activity correlated with larger normalized brain volume in multiple regions including total gray matter; white matter; hippocampus; and frontal, parietal, and occipital lobes. 

IN PRACTICE: 

“We found that even moderate levels of physical activity, such as taking fewer than 4,000 steps a day, can have a positive effect on brain health. This is much less than the often-suggested 10,000 steps, making it a more achievable goal for many people,” co-author David Merrill, MD, with Pacific Brain Health Center, Santa Monica, California, said in a statement. 

SOURCE: 

The study, with first author Cyrus A. Raji, MD, PhD, Washington University School of Medicine, St. Louis, was published online in the Journal of Alzheimer’s Disease.

LIMITATIONS: 

Participants self-reported physical activity in the past 2 weeks, which does not reflect a lifetime of activity levels. The correlation identified between physical activity and brain volumes may not be solely attributable to physical activity alone. 

DISCLOSURES: 

The study received funding from several health centers and foundations. Dr. Raji consults for Brainreader ApS, Neurevolution LLC, Apollo Health, Voxelwise Imaging Technology, and Pacific Neuroscience Foundation and is an editorial board member of the Journal of Alzheimer’s Disease but was not involved in the peer-review process.

A version of this article 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

H pylori Infection Linked to Increased Alzheimer’s Risk

Article Type
Changed
Thu, 01/18/2024 - 11:05
Display Headline
H pylori Infection Linked to Increased Alzheimer’s Risk

 

TOPLINE:

Patients aged 50 years or older with clinically apparent Helicobacter pylori infection (CAHPI) have an 11% increased risk for Alzheimer’s disease (AD), results of a large and lengthy population-based study suggest.

METHODOLOGY: 

  • Researchers identified all cases with a first-time diagnosis of AD and matched each AD case to up to 40 AD-free control cases on the basis of age, sex, cohort entry date, and duration of follow-up.
  • The exposure of interest was CAHPI, defined based on an algorithm using clinical guidelines and recommendations on the management of H pylori (HP) infection, with researchers focusing on infected individuals presenting with symptoms or developing serious complications from the infection.
  • Researchers performed several sensitivity analyses, which included repeating the primary analysis using alternate lag periods, restricting the cohort to participants with AD (not vascular, alcoholic, and unspecified dementia), and using salmonellosis, an infection not previously associated with AD, as a negative control exposure.

TAKEAWAY: 

  • Compared with no exposure to CAHPI, exposure to CAHPI was associated with a moderately increased risk for AD (odds ratio [OR], 1.11; 95% CI, 1.01-1.21), with no major effect modification by demographics or socioeconomic status.
  • The increased risk peaked 7.3-10.8 years after CAHPI onset (OR, 1.24; 95% CI, 1.05-1.47) before decreasing.
  • Sensitivity analyses yielded findings that were overall consistent with those of the primary analysis.
  • The analysis with salmonellosis as a negative control exposure showed no association with the risk for AD (OR, 1.03; 95% CI, 0.82-1.29).

IN PRACTICE:

“These results support the notion of HP infection as a potential modifiable risk factor of AD” and “pave the way for future randomized controlled trials that would assess the impact and cost-effectiveness of population-based targeted interventions such as individualized HP eradication programs, on the development of AD,” the authors write.

SOURCE:

The study was conducted by Antonios Douros, Department of Medicine, and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada, and colleagues. It was published online in Alzheimer’s & Dementia.

LIMITATIONS:

Given the observational nature of the study, residual confounding is possible. Because the exposure definition was on the basis of CAHPI recorded by general practitioners, exposure misclassification due to symptomatic patients not seeking primary care is possible, as is outcome misclassification. The authors can’t rule out the possibility of an association between asymptomatic H pylori infection and AD risk.

DISCLOSURES:

The study received funding from the Canadian Institutes of Health Research. Douros has no relevant conflicts of interest; see paper for disclosures of other authors.

Pauline Anderson has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

TOPLINE:

Patients aged 50 years or older with clinically apparent Helicobacter pylori infection (CAHPI) have an 11% increased risk for Alzheimer’s disease (AD), results of a large and lengthy population-based study suggest.

METHODOLOGY: 

  • Researchers identified all cases with a first-time diagnosis of AD and matched each AD case to up to 40 AD-free control cases on the basis of age, sex, cohort entry date, and duration of follow-up.
  • The exposure of interest was CAHPI, defined based on an algorithm using clinical guidelines and recommendations on the management of H pylori (HP) infection, with researchers focusing on infected individuals presenting with symptoms or developing serious complications from the infection.
  • Researchers performed several sensitivity analyses, which included repeating the primary analysis using alternate lag periods, restricting the cohort to participants with AD (not vascular, alcoholic, and unspecified dementia), and using salmonellosis, an infection not previously associated with AD, as a negative control exposure.

TAKEAWAY: 

  • Compared with no exposure to CAHPI, exposure to CAHPI was associated with a moderately increased risk for AD (odds ratio [OR], 1.11; 95% CI, 1.01-1.21), with no major effect modification by demographics or socioeconomic status.
  • The increased risk peaked 7.3-10.8 years after CAHPI onset (OR, 1.24; 95% CI, 1.05-1.47) before decreasing.
  • Sensitivity analyses yielded findings that were overall consistent with those of the primary analysis.
  • The analysis with salmonellosis as a negative control exposure showed no association with the risk for AD (OR, 1.03; 95% CI, 0.82-1.29).

IN PRACTICE:

“These results support the notion of HP infection as a potential modifiable risk factor of AD” and “pave the way for future randomized controlled trials that would assess the impact and cost-effectiveness of population-based targeted interventions such as individualized HP eradication programs, on the development of AD,” the authors write.

SOURCE:

The study was conducted by Antonios Douros, Department of Medicine, and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada, and colleagues. It was published online in Alzheimer’s & Dementia.

LIMITATIONS:

Given the observational nature of the study, residual confounding is possible. Because the exposure definition was on the basis of CAHPI recorded by general practitioners, exposure misclassification due to symptomatic patients not seeking primary care is possible, as is outcome misclassification. The authors can’t rule out the possibility of an association between asymptomatic H pylori infection and AD risk.

DISCLOSURES:

The study received funding from the Canadian Institutes of Health Research. Douros has no relevant conflicts of interest; see paper for disclosures of other authors.

Pauline Anderson has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Patients aged 50 years or older with clinically apparent Helicobacter pylori infection (CAHPI) have an 11% increased risk for Alzheimer’s disease (AD), results of a large and lengthy population-based study suggest.

METHODOLOGY: 

  • Researchers identified all cases with a first-time diagnosis of AD and matched each AD case to up to 40 AD-free control cases on the basis of age, sex, cohort entry date, and duration of follow-up.
  • The exposure of interest was CAHPI, defined based on an algorithm using clinical guidelines and recommendations on the management of H pylori (HP) infection, with researchers focusing on infected individuals presenting with symptoms or developing serious complications from the infection.
  • Researchers performed several sensitivity analyses, which included repeating the primary analysis using alternate lag periods, restricting the cohort to participants with AD (not vascular, alcoholic, and unspecified dementia), and using salmonellosis, an infection not previously associated with AD, as a negative control exposure.

TAKEAWAY: 

  • Compared with no exposure to CAHPI, exposure to CAHPI was associated with a moderately increased risk for AD (odds ratio [OR], 1.11; 95% CI, 1.01-1.21), with no major effect modification by demographics or socioeconomic status.
  • The increased risk peaked 7.3-10.8 years after CAHPI onset (OR, 1.24; 95% CI, 1.05-1.47) before decreasing.
  • Sensitivity analyses yielded findings that were overall consistent with those of the primary analysis.
  • The analysis with salmonellosis as a negative control exposure showed no association with the risk for AD (OR, 1.03; 95% CI, 0.82-1.29).

IN PRACTICE:

“These results support the notion of HP infection as a potential modifiable risk factor of AD” and “pave the way for future randomized controlled trials that would assess the impact and cost-effectiveness of population-based targeted interventions such as individualized HP eradication programs, on the development of AD,” the authors write.

SOURCE:

The study was conducted by Antonios Douros, Department of Medicine, and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada, and colleagues. It was published online in Alzheimer’s & Dementia.

LIMITATIONS:

Given the observational nature of the study, residual confounding is possible. Because the exposure definition was on the basis of CAHPI recorded by general practitioners, exposure misclassification due to symptomatic patients not seeking primary care is possible, as is outcome misclassification. The authors can’t rule out the possibility of an association between asymptomatic H pylori infection and AD risk.

DISCLOSURES:

The study received funding from the Canadian Institutes of Health Research. Douros has no relevant conflicts of interest; see paper for disclosures of other authors.

Pauline Anderson has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Display Headline
H pylori Infection Linked to Increased Alzheimer’s Risk
Display Headline
H pylori Infection Linked to Increased Alzheimer’s Risk
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

‘World’s Healthiest Arteries’ Found to Be the Most Elastic

Article Type
Changed
Tue, 01/02/2024 - 15:22

The arteries of members of an indigenous community in the Bolivian Amazon, dubbed “the world’s healthiest,” have remarkably low rates of coronary atherosclerosis, compared with those of other populations. These arteries recently were found to be exceptionally elastic and to age more gradually, according to a study presented at the annual scientific sessions of the American Heart Association.

The lead researcher, Michael Gurven, PhD, director of the Integrative Anthropological Sciences Unit at the University of California, Santa Barbara, said in an interview that the study “provides additional evidence that lifestyle modifications can improve arterial health.”

An Ancient Lifestyle

The study focused on the Tsimané or Chimane people, an indigenous community in Bolivia that sustains itself through ancestral practices like slash-and-burn agriculture (mainly involving plantains, rice, sweet cassava, and maize), river fishing, hunting neotropical mammals, and gathering seasonal fruits, honey, and nuts. They are inactive only 10% of their daily time and adhere to a low-fat, low-processed carbohydrate diet.

Over the past decade, numerous studies in this community documented a lower prevalence of arterial hypertension, atrial fibrillation, type 2 diabetes, obesity, smoking, sedentary lifestyle, and more recently, minimal cognitive dysfunction and dementia.

In 2017, Dr. Gurven led a cross-sectional study showing that Tsimané individuals over age 40 years had very low coronary artery calcium scores, which are a marker for coronary atherosclerosis. The finding strongly suggests that healthy lifestyle habits genuinely work in cardiovascular prevention. The mechanisms involved and their evolution with age needed further exploration, however.

The new research, led by Dr. Gurven’s student Tianyu Cao, delved into arterial elasticity, particularly in the carotid and femoral arteries, as a measure of potential arterial stiffening and atherosclerosis. The study included around 500 adults of both sexes.

Aging and Arterial Elasticity

The findings revealed that Tsimané arteries are less rigid than those in various urban and sedentary populations that have been studied previously. For instance, the elasticity of large and small arteries in 491 Tsimané individuals (average age: 55.3 years) was 57%-86% higher than that observed in adult men and women in the United States in the Multi-Ethnic Study of Atherosclerosis.

Similarly, the carotid-femoral pulse wave velocity, a direct indicator of arterial stiffness, was determined in 89 Tsimané individuals (average age: 53.1 years, 54% women). The average value was 6.34 m/s, which is approximately 25% lower than the average for a healthy Brazilian population aged 35-74 years.

Dr. Gurven noted that Tsimané arteries remain more elastic for a longer period than in other populations. However, by age 70 years, the arteries also start to harden. “In other words, Tsimané cannot indefinitely delay arterial aging,” he said.

“The minimal and delayed increase in arterial stiffness related to age could contribute to the very low observed levels of coronary atherosclerosis and dementia in the Tsimané,” wrote the researchers.

Pedro Forcada, MD, a cardiologist and professor at the University Austral in Buenos Aires, who was not involved in the study, emphasized the impact of epigenetics on atherosclerosis and accelerated vascular aging. He referred to the SUPERNOVA phenomenon in Europe and Japan, where exceptionally low arterial stiffness characterizes very long-lived individuals.

“This indicates that we must not only understand accelerated vascular aging but also study protective factors. Lifestyle, according to these recent studies, would play a significant role,” he stated.

Dr. Gurven and Dr. Forcada declared no relevant economic conflicts of interest.

This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

The arteries of members of an indigenous community in the Bolivian Amazon, dubbed “the world’s healthiest,” have remarkably low rates of coronary atherosclerosis, compared with those of other populations. These arteries recently were found to be exceptionally elastic and to age more gradually, according to a study presented at the annual scientific sessions of the American Heart Association.

The lead researcher, Michael Gurven, PhD, director of the Integrative Anthropological Sciences Unit at the University of California, Santa Barbara, said in an interview that the study “provides additional evidence that lifestyle modifications can improve arterial health.”

An Ancient Lifestyle

The study focused on the Tsimané or Chimane people, an indigenous community in Bolivia that sustains itself through ancestral practices like slash-and-burn agriculture (mainly involving plantains, rice, sweet cassava, and maize), river fishing, hunting neotropical mammals, and gathering seasonal fruits, honey, and nuts. They are inactive only 10% of their daily time and adhere to a low-fat, low-processed carbohydrate diet.

Over the past decade, numerous studies in this community documented a lower prevalence of arterial hypertension, atrial fibrillation, type 2 diabetes, obesity, smoking, sedentary lifestyle, and more recently, minimal cognitive dysfunction and dementia.

In 2017, Dr. Gurven led a cross-sectional study showing that Tsimané individuals over age 40 years had very low coronary artery calcium scores, which are a marker for coronary atherosclerosis. The finding strongly suggests that healthy lifestyle habits genuinely work in cardiovascular prevention. The mechanisms involved and their evolution with age needed further exploration, however.

The new research, led by Dr. Gurven’s student Tianyu Cao, delved into arterial elasticity, particularly in the carotid and femoral arteries, as a measure of potential arterial stiffening and atherosclerosis. The study included around 500 adults of both sexes.

Aging and Arterial Elasticity

The findings revealed that Tsimané arteries are less rigid than those in various urban and sedentary populations that have been studied previously. For instance, the elasticity of large and small arteries in 491 Tsimané individuals (average age: 55.3 years) was 57%-86% higher than that observed in adult men and women in the United States in the Multi-Ethnic Study of Atherosclerosis.

Similarly, the carotid-femoral pulse wave velocity, a direct indicator of arterial stiffness, was determined in 89 Tsimané individuals (average age: 53.1 years, 54% women). The average value was 6.34 m/s, which is approximately 25% lower than the average for a healthy Brazilian population aged 35-74 years.

Dr. Gurven noted that Tsimané arteries remain more elastic for a longer period than in other populations. However, by age 70 years, the arteries also start to harden. “In other words, Tsimané cannot indefinitely delay arterial aging,” he said.

“The minimal and delayed increase in arterial stiffness related to age could contribute to the very low observed levels of coronary atherosclerosis and dementia in the Tsimané,” wrote the researchers.

Pedro Forcada, MD, a cardiologist and professor at the University Austral in Buenos Aires, who was not involved in the study, emphasized the impact of epigenetics on atherosclerosis and accelerated vascular aging. He referred to the SUPERNOVA phenomenon in Europe and Japan, where exceptionally low arterial stiffness characterizes very long-lived individuals.

“This indicates that we must not only understand accelerated vascular aging but also study protective factors. Lifestyle, according to these recent studies, would play a significant role,” he stated.

Dr. Gurven and Dr. Forcada declared no relevant economic conflicts of interest.

This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.

The arteries of members of an indigenous community in the Bolivian Amazon, dubbed “the world’s healthiest,” have remarkably low rates of coronary atherosclerosis, compared with those of other populations. These arteries recently were found to be exceptionally elastic and to age more gradually, according to a study presented at the annual scientific sessions of the American Heart Association.

The lead researcher, Michael Gurven, PhD, director of the Integrative Anthropological Sciences Unit at the University of California, Santa Barbara, said in an interview that the study “provides additional evidence that lifestyle modifications can improve arterial health.”

An Ancient Lifestyle

The study focused on the Tsimané or Chimane people, an indigenous community in Bolivia that sustains itself through ancestral practices like slash-and-burn agriculture (mainly involving plantains, rice, sweet cassava, and maize), river fishing, hunting neotropical mammals, and gathering seasonal fruits, honey, and nuts. They are inactive only 10% of their daily time and adhere to a low-fat, low-processed carbohydrate diet.

Over the past decade, numerous studies in this community documented a lower prevalence of arterial hypertension, atrial fibrillation, type 2 diabetes, obesity, smoking, sedentary lifestyle, and more recently, minimal cognitive dysfunction and dementia.

In 2017, Dr. Gurven led a cross-sectional study showing that Tsimané individuals over age 40 years had very low coronary artery calcium scores, which are a marker for coronary atherosclerosis. The finding strongly suggests that healthy lifestyle habits genuinely work in cardiovascular prevention. The mechanisms involved and their evolution with age needed further exploration, however.

The new research, led by Dr. Gurven’s student Tianyu Cao, delved into arterial elasticity, particularly in the carotid and femoral arteries, as a measure of potential arterial stiffening and atherosclerosis. The study included around 500 adults of both sexes.

Aging and Arterial Elasticity

The findings revealed that Tsimané arteries are less rigid than those in various urban and sedentary populations that have been studied previously. For instance, the elasticity of large and small arteries in 491 Tsimané individuals (average age: 55.3 years) was 57%-86% higher than that observed in adult men and women in the United States in the Multi-Ethnic Study of Atherosclerosis.

Similarly, the carotid-femoral pulse wave velocity, a direct indicator of arterial stiffness, was determined in 89 Tsimané individuals (average age: 53.1 years, 54% women). The average value was 6.34 m/s, which is approximately 25% lower than the average for a healthy Brazilian population aged 35-74 years.

Dr. Gurven noted that Tsimané arteries remain more elastic for a longer period than in other populations. However, by age 70 years, the arteries also start to harden. “In other words, Tsimané cannot indefinitely delay arterial aging,” he said.

“The minimal and delayed increase in arterial stiffness related to age could contribute to the very low observed levels of coronary atherosclerosis and dementia in the Tsimané,” wrote the researchers.

Pedro Forcada, MD, a cardiologist and professor at the University Austral in Buenos Aires, who was not involved in the study, emphasized the impact of epigenetics on atherosclerosis and accelerated vascular aging. He referred to the SUPERNOVA phenomenon in Europe and Japan, where exceptionally low arterial stiffness characterizes very long-lived individuals.

“This indicates that we must not only understand accelerated vascular aging but also study protective factors. Lifestyle, according to these recent studies, would play a significant role,” he stated.

Dr. Gurven and Dr. Forcada declared no relevant economic conflicts of interest.

This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM AHA 2023

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

Which Tools Are Best to Streamline In-Office Assessments of Eczema Patients?

Article Type
Changed
Thu, 01/04/2024 - 15:35

The myriad of clinical tools available for assessing patients with atopic dermatitis may leave clinicians wondering how to best incorporate the tools into the daily clinical workflow.

“It can be overwhelming because there are many choices but so little time,” Jonathan I. Silverberg, MD, PhD, MPH, associate professor and director of clinical research in the dermatology department at George Washington University, Washington, DC, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference.

Assessment tools such as the Eczema Area and Severity Index (EASI), the Numeric Rating scale for itch (NRS-itch), and the Dermatology Life Quality Index (DLQI) “all correlate, but they’re all different, and there is value in all of them,” said Dr. Silverberg. “Of course, you’re not going to use all of them, but which ones should you use?”

He favors a structured approach that considers signs, symptoms, and quality of life, a framework that he and Shanthi Narla, MD, proposed in an article published online in Dermatitis. In the United States, he said, the Investigator’s Global Assessment scale (IGA) and BSA are the preferred tools for assessing the clinical severity of AD.

“If you go to Australia and New Zealand, they love EASI, while in Western Europe, they love the SCORAD [SCORing Atopic Dermatitis] tool because they’ve been using it since the 1990s,” Dr. Silverberg said. “So whatever works for you, pick it. But just use something that’s going to work within your practice setting. The IGA and the BSA are the easiest to do and the fastest to do in clinical practice. You’re going to have to document disease severity anyway if you’re going to get systemic therapies approved,” he said, referring to approval for coverage by the patient’s health insurance drug formulary.
 

Several Recommendations

Based on his clinical experience, Dr. Silverberg recommended certain assessment tools as “feasible” to use in daily practice. In the domain of clinical signs, “the IGA and the BSA are the most useful,” he said. “If the patient is gowned up, it probably takes about 30 seconds to do an IGA scale, and a BSA can be done in under a minute, easily.”

In the domain of symptoms, he recommends having the patient or caregiver complete at least one of the following patient-reported outcome measures (PROMs): the NRS-itch, the NRS-pain, the NRS-Sleep Disturbance, the Patient Health Questionnaire-2 (PHQ-2), and either the Patient Global Assessment (PtGA) or the Patient-Reported Global AD Severity (PrtGA).

“Pick one or two that reflect what you can do in clinical practice,” Dr. Silverberg advised. “The NRS-itch is clinically meaningful and takes 10 seconds to do. Or you can just ask the patient, ‘How do you rate your itch? Clear, mild, moderate, or severe?’ A verbal rating scale, like a Likert scale, would also work. Again, this takes 10 seconds to assess. This is not slowing you down in practice; it will speed you up in the long run.”

He favors the NRS scale assessments, “because the 2023 AAD guidelines for AD advocate for open-ended questions,” he said. “I can tell you from personal experience that when you go down that rabbit hole of open-ended questions, you’re never getting out of that exam room. If you ask a patient how AD affects their life, you might as well just plan on a 30- to 40-minute visit. But if you use structured questions, you can get the information you need so dearly to make the right assessments, but you can keep the visit moving efficiently.”

He noted that the NRS-itch or the PtGA and PrtGA tools “each take about 10 seconds to complete. I would argue that you could probably have the patient [complete all of these PROMs], and you’re still in under a minute, and you get incredibly rich information.”

In the quality-of-life domain, Dr. Silverberg recommends that the patient or caregiver complete the DLQI. If there is additional time, he also suggests the Atopic Dermatitis Control Tool (ADCT) to gain further insight on symptomatology.

“The DLQI takes about a minute or minute-and-a-half to complete, while the ADCT takes about a minute,” he said. “It measures overall disease control, and there are some interesting individual questions there, such as how AD bothers them, how it impacts their sleep, how it impacts them emotionally.”

To optimize efficiency, Dr. Silverberg recommends that patients or caregivers complete PROMs prior to the patient encounter by e-mail or on the patient’s online portal the night before. Freely available smart phone applications designed for AD patients can help them track their disease symptoms, such as EczemaWise from the National Eczema Association.

“[The PROMs] can even be completed in the waiting area; a lot of times we’re running behind anyway,” he said. “Even if we’re not, it can be done in a minute or two while they’re filling out their insurance paperwork or whatever. Patient-reported outcomes can also be collected by the medical assistant or nursing while rooming the patient.”

Administering such structured assessments prior to the actual patient encounter “seems counterintuitive because you’re asking seemingly more information, but that doesn’t matter, because you are asking it in an efficient, structured manner, and you are getting the information you need,” he noted. “These tools can also help fill in the gaps of telehealth encounters.”

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies. He has also received grant or research support from Galderma and Pfizer.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

The myriad of clinical tools available for assessing patients with atopic dermatitis may leave clinicians wondering how to best incorporate the tools into the daily clinical workflow.

“It can be overwhelming because there are many choices but so little time,” Jonathan I. Silverberg, MD, PhD, MPH, associate professor and director of clinical research in the dermatology department at George Washington University, Washington, DC, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference.

Assessment tools such as the Eczema Area and Severity Index (EASI), the Numeric Rating scale for itch (NRS-itch), and the Dermatology Life Quality Index (DLQI) “all correlate, but they’re all different, and there is value in all of them,” said Dr. Silverberg. “Of course, you’re not going to use all of them, but which ones should you use?”

He favors a structured approach that considers signs, symptoms, and quality of life, a framework that he and Shanthi Narla, MD, proposed in an article published online in Dermatitis. In the United States, he said, the Investigator’s Global Assessment scale (IGA) and BSA are the preferred tools for assessing the clinical severity of AD.

“If you go to Australia and New Zealand, they love EASI, while in Western Europe, they love the SCORAD [SCORing Atopic Dermatitis] tool because they’ve been using it since the 1990s,” Dr. Silverberg said. “So whatever works for you, pick it. But just use something that’s going to work within your practice setting. The IGA and the BSA are the easiest to do and the fastest to do in clinical practice. You’re going to have to document disease severity anyway if you’re going to get systemic therapies approved,” he said, referring to approval for coverage by the patient’s health insurance drug formulary.
 

Several Recommendations

Based on his clinical experience, Dr. Silverberg recommended certain assessment tools as “feasible” to use in daily practice. In the domain of clinical signs, “the IGA and the BSA are the most useful,” he said. “If the patient is gowned up, it probably takes about 30 seconds to do an IGA scale, and a BSA can be done in under a minute, easily.”

In the domain of symptoms, he recommends having the patient or caregiver complete at least one of the following patient-reported outcome measures (PROMs): the NRS-itch, the NRS-pain, the NRS-Sleep Disturbance, the Patient Health Questionnaire-2 (PHQ-2), and either the Patient Global Assessment (PtGA) or the Patient-Reported Global AD Severity (PrtGA).

“Pick one or two that reflect what you can do in clinical practice,” Dr. Silverberg advised. “The NRS-itch is clinically meaningful and takes 10 seconds to do. Or you can just ask the patient, ‘How do you rate your itch? Clear, mild, moderate, or severe?’ A verbal rating scale, like a Likert scale, would also work. Again, this takes 10 seconds to assess. This is not slowing you down in practice; it will speed you up in the long run.”

He favors the NRS scale assessments, “because the 2023 AAD guidelines for AD advocate for open-ended questions,” he said. “I can tell you from personal experience that when you go down that rabbit hole of open-ended questions, you’re never getting out of that exam room. If you ask a patient how AD affects their life, you might as well just plan on a 30- to 40-minute visit. But if you use structured questions, you can get the information you need so dearly to make the right assessments, but you can keep the visit moving efficiently.”

He noted that the NRS-itch or the PtGA and PrtGA tools “each take about 10 seconds to complete. I would argue that you could probably have the patient [complete all of these PROMs], and you’re still in under a minute, and you get incredibly rich information.”

In the quality-of-life domain, Dr. Silverberg recommends that the patient or caregiver complete the DLQI. If there is additional time, he also suggests the Atopic Dermatitis Control Tool (ADCT) to gain further insight on symptomatology.

“The DLQI takes about a minute or minute-and-a-half to complete, while the ADCT takes about a minute,” he said. “It measures overall disease control, and there are some interesting individual questions there, such as how AD bothers them, how it impacts their sleep, how it impacts them emotionally.”

To optimize efficiency, Dr. Silverberg recommends that patients or caregivers complete PROMs prior to the patient encounter by e-mail or on the patient’s online portal the night before. Freely available smart phone applications designed for AD patients can help them track their disease symptoms, such as EczemaWise from the National Eczema Association.

“[The PROMs] can even be completed in the waiting area; a lot of times we’re running behind anyway,” he said. “Even if we’re not, it can be done in a minute or two while they’re filling out their insurance paperwork or whatever. Patient-reported outcomes can also be collected by the medical assistant or nursing while rooming the patient.”

Administering such structured assessments prior to the actual patient encounter “seems counterintuitive because you’re asking seemingly more information, but that doesn’t matter, because you are asking it in an efficient, structured manner, and you are getting the information you need,” he noted. “These tools can also help fill in the gaps of telehealth encounters.”

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies. He has also received grant or research support from Galderma and Pfizer.

The myriad of clinical tools available for assessing patients with atopic dermatitis may leave clinicians wondering how to best incorporate the tools into the daily clinical workflow.

“It can be overwhelming because there are many choices but so little time,” Jonathan I. Silverberg, MD, PhD, MPH, associate professor and director of clinical research in the dermatology department at George Washington University, Washington, DC, said at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference.

Assessment tools such as the Eczema Area and Severity Index (EASI), the Numeric Rating scale for itch (NRS-itch), and the Dermatology Life Quality Index (DLQI) “all correlate, but they’re all different, and there is value in all of them,” said Dr. Silverberg. “Of course, you’re not going to use all of them, but which ones should you use?”

He favors a structured approach that considers signs, symptoms, and quality of life, a framework that he and Shanthi Narla, MD, proposed in an article published online in Dermatitis. In the United States, he said, the Investigator’s Global Assessment scale (IGA) and BSA are the preferred tools for assessing the clinical severity of AD.

“If you go to Australia and New Zealand, they love EASI, while in Western Europe, they love the SCORAD [SCORing Atopic Dermatitis] tool because they’ve been using it since the 1990s,” Dr. Silverberg said. “So whatever works for you, pick it. But just use something that’s going to work within your practice setting. The IGA and the BSA are the easiest to do and the fastest to do in clinical practice. You’re going to have to document disease severity anyway if you’re going to get systemic therapies approved,” he said, referring to approval for coverage by the patient’s health insurance drug formulary.
 

Several Recommendations

Based on his clinical experience, Dr. Silverberg recommended certain assessment tools as “feasible” to use in daily practice. In the domain of clinical signs, “the IGA and the BSA are the most useful,” he said. “If the patient is gowned up, it probably takes about 30 seconds to do an IGA scale, and a BSA can be done in under a minute, easily.”

In the domain of symptoms, he recommends having the patient or caregiver complete at least one of the following patient-reported outcome measures (PROMs): the NRS-itch, the NRS-pain, the NRS-Sleep Disturbance, the Patient Health Questionnaire-2 (PHQ-2), and either the Patient Global Assessment (PtGA) or the Patient-Reported Global AD Severity (PrtGA).

“Pick one or two that reflect what you can do in clinical practice,” Dr. Silverberg advised. “The NRS-itch is clinically meaningful and takes 10 seconds to do. Or you can just ask the patient, ‘How do you rate your itch? Clear, mild, moderate, or severe?’ A verbal rating scale, like a Likert scale, would also work. Again, this takes 10 seconds to assess. This is not slowing you down in practice; it will speed you up in the long run.”

He favors the NRS scale assessments, “because the 2023 AAD guidelines for AD advocate for open-ended questions,” he said. “I can tell you from personal experience that when you go down that rabbit hole of open-ended questions, you’re never getting out of that exam room. If you ask a patient how AD affects their life, you might as well just plan on a 30- to 40-minute visit. But if you use structured questions, you can get the information you need so dearly to make the right assessments, but you can keep the visit moving efficiently.”

He noted that the NRS-itch or the PtGA and PrtGA tools “each take about 10 seconds to complete. I would argue that you could probably have the patient [complete all of these PROMs], and you’re still in under a minute, and you get incredibly rich information.”

In the quality-of-life domain, Dr. Silverberg recommends that the patient or caregiver complete the DLQI. If there is additional time, he also suggests the Atopic Dermatitis Control Tool (ADCT) to gain further insight on symptomatology.

“The DLQI takes about a minute or minute-and-a-half to complete, while the ADCT takes about a minute,” he said. “It measures overall disease control, and there are some interesting individual questions there, such as how AD bothers them, how it impacts their sleep, how it impacts them emotionally.”

To optimize efficiency, Dr. Silverberg recommends that patients or caregivers complete PROMs prior to the patient encounter by e-mail or on the patient’s online portal the night before. Freely available smart phone applications designed for AD patients can help them track their disease symptoms, such as EczemaWise from the National Eczema Association.

“[The PROMs] can even be completed in the waiting area; a lot of times we’re running behind anyway,” he said. “Even if we’re not, it can be done in a minute or two while they’re filling out their insurance paperwork or whatever. Patient-reported outcomes can also be collected by the medical assistant or nursing while rooming the patient.”

Administering such structured assessments prior to the actual patient encounter “seems counterintuitive because you’re asking seemingly more information, but that doesn’t matter, because you are asking it in an efficient, structured manner, and you are getting the information you need,” he noted. “These tools can also help fill in the gaps of telehealth encounters.”

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies. He has also received grant or research support from Galderma and Pfizer.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM RAD 2023

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

Experimental Topical Drug Shows Promise for Atopic Dermatitis and Plaque Psoriasis

Article Type
Changed
Tue, 01/02/2024 - 15:22

 

An experimental topical phosphodiesterase 4 (PDE4) inhibitor showed superior efficacy to vehicle in patients with mild to moderate atopic dermatitis (AD) and plaque psoriasis, results from a phase 2a study showed.

Dr. Lawrence F. Eichenfield

PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.

Currently Available Treatments

For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.

For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.

An Experimental Alternative

The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.

The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.

The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.

Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.

At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).

Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.

In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.

The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”

Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.

Publications
Topics
Sections

 

An experimental topical phosphodiesterase 4 (PDE4) inhibitor showed superior efficacy to vehicle in patients with mild to moderate atopic dermatitis (AD) and plaque psoriasis, results from a phase 2a study showed.

Dr. Lawrence F. Eichenfield

PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.

Currently Available Treatments

For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.

For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.

An Experimental Alternative

The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.

The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.

The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.

Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.

At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).

Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.

In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.

The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”

Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.

 

An experimental topical phosphodiesterase 4 (PDE4) inhibitor showed superior efficacy to vehicle in patients with mild to moderate atopic dermatitis (AD) and plaque psoriasis, results from a phase 2a study showed.

Dr. Lawrence F. Eichenfield

PDE4 inhibitors are a promising therapeutic target for inflammatory diseases because “they can increase cyclic adenosine monophosphate levels and subsequently reduce the production of proinflammatory cytokines,” lead study author Lawrence F. Eichenfield, MD, of the dermatology department at the University of California, San Diego, and colleagues wrote. The paper was published online in JAMA Dermatology.

Currently Available Treatments

For plaque psoriasis, the FDA approved the topical PDE4 inhibitor roflumilast in 2022. The oral PDE4 inhibitor apremilast has shown to be effective for plaque psoriasis and is well tolerated, and “it has been associated with gastrointestinal adverse events (AEs) such as nausea and diarrhea,” the researchers wrote.

For AD, crisaborole is the only approved topical PDE4 treatment, and it is associated with application site burning and stinging, they wrote.

An Experimental Alternative

The new study tested a topical PDE4 inhibitor known as PF-07038124, which is being developed by Pfizer. It is designed to be “a potent, oxaborole-based PDE4 inhibitor [that shows] immunomodulatory activity in T-cell–based assays, contributing to inhibition of [interleukin]-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis,” the authors wrote.

The phase 2a study was conducted from December 21, 2020, to August 18, 2021. Researchers at 34 sites in four countries randomized 104 patients with mild to moderate AD (70) or plaque psoriasis (34) to receive PF-07038124 as a 0.001% topical ointment or a vehicle only once daily for 6 weeks.

The primary end point was the percent change from baseline in the Eczema Area and Severity Index (EASI) total score among patients with AD and in the Psoriasis Area and Severity Index (PASI) score among patients with plaque psoriasis at week 6. Safety measures of interest included treatment-emergent adverse events.

Overall, the mean age of the 104 patients was 43 years, 52.9%, were women, 3.8% were Asian, 12.5% were Black, and 83.7% were White. Most had moderate disease.

At week 6 in patients with AD, the PF-07038124 group showed statistically significantly greater improvement in the EASI total score, compared with vehicle group (−74.9% vs −35.5% respectively; least squares mean [LSM] difference, −39.4%; 90% CI, −58.8% to−20.1%]; P < .001).

Similarly, at week 6 in patients with plaque psoriasis, the PF-07038124 group demonstrated a significantly greater improvement in the PASI total score, compared with the vehicle group (LSM, −4.8; 90% CI, −6.2 to −3.4] vs 0.1; 90% CI, −1.5 to 1.7), for a difference of −4.9; 90% CI, −7.0 to −2.8; P < .001.

In safety outcomes, treatment-emergent adverse events were reported in 16 people receiving PF-07038124 and 26 people receiving a vehicle. The treatment-related adverse events were reported only in the vehicle groups across all indications, while no patients in the PF-07038124 groups experienced pain or skin reactions at the application sites.

The researchers acknowledged certain limitations of the trial, including its small size and the 6-week treatment period. “Unlike crisaborole, topical PF-07038124 was not associated with application site burning and stinging,” they noted. “To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”

Pfizer supported the study. Dr. Eichenfield reported receiving personal fees from Pfizer during the conduct of the study. He also has received grant support from, is consultant to, and/or is a member of the advisory board for many other pharmaceutical companies. Several other study authors reported similar disclosures.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA DERMATOLOGY

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

Building a Toolkit for the Treatment of Acute Migraine

Article Type
Changed
Tue, 01/02/2024 - 15:21

Selecting a treatment plan to deal with acute migraine attacks can be like putting together a toolkit of possible therapies, individualized for each patient, one expert said.

The toolkit should comprise reliable treatments that patients know are going to work and that act quickly, allowing them to get back to functioning normally in their daily lives, said Jessica Ailani, MD, during a talk at the 17th European Headache Congress held recently in Barcelona, Spain. 

“Everyone with migraine needs acute treatment,” Dr. Ailani, who is a clinical professor of neurology at MedStar Georgetown University Hospital and director of the Georgetown Headache Center, Washington, DC, noted. “Sometimes we can reduce acute treatment with preventative agents, but some disability will remain, so we have to focus on good acute treatment, and this becomes more complex if a person has a lot of comorbidities, which is common in older patients.” 

In selecting suitable treatments for migraine, consideration has to be given to the patient profile, any other conditions they have, speed of onset of the migraine attack, length of the attack, associated symptoms, and side effects of the medications, she said. 
 

A Complex Case

As an example, Dr. Ailani described the process she used to treat one of her patients who had frequent severe migraines and other issues causing difficult decisions when selecting medications — a woman in her late 60s with several other comorbidities.

“This is the kind of case I see on a daily basis and which keeps me up at night,” she said. “Many times in clinical practice, we see complex cases like this, and through the course of a year, we may try every treatment option we have in a patient like this.”

On the first presentation, the patient had a chronic migraine with severe headaches every day. She had a history of previous cervical discectomy with fusion surgery; uncontrolled hypertension, for which she was taking an angiotensin blocker; high cholesterol, for which she was taking a statin; and diabetes with an A1c of 8. She did not smoke or drink alcohol, exercised moderately, and her body mass index was in a good range. 

“Before a patient ever sees a doctor for their migraine, they will have already tried a lot of different things. Most people are already using NSAIDs and acetaminophen, the most commonly used treatments for acute migraine,” Dr. Ailani explains.

Her patient was taking a triptan and the barbiturate, butalbital. Dr. Ailani notes that the triptan is very effective, but in the United States, they are not available over the counter, and the patient is only allowed nine doses per month on her insurance, so she was supplementing with butalbital. 

Over the course of a year, Dr. Ailani got her off the butalbital and started her on onabotulinum toxin A for migraine prevention, which reduced her headache days to about 15 per month (8 severe). She then added the anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, galcanezumab, as another preventative, which further reduced the headache days down to 8-10 days per month (all migraine). 

The attacks are rapid onset and can last multiple days. They come with photophobia and phonophobia and cause her to be bedridden, she noted. 

“I was still worried about this frequency of headache and the fact she was using a triptan for acute treatment when she had uncontrolled hypertension and other cardiovascular risk factors, Dr. Ailani commented. 

She explained that triptans are generally not used in individuals aged over 65 years because of a lack of data in this age group. They are also contraindicated in patients with cardiovascular (CV) disease, and caution is advised in patients with CV risk factors. Noting that migraine is an independent risk factor for stroke in healthy individuals, and this patient already had three other major risk factors for stroke, Dr. Ailani said she did not think a triptan was the best option. 

When triptans do not work, Dr. Ailani said she thinks about dihydroergotamine, which she describes as “a great drug for long-lasting migraine” as it tends to have a sustained response. But it also has vasoconstrictive effects and can increase blood pressure, so it was not suitable for this patient. 

CV risk is also an issue with nonsteroidal anti-inflammatory drugs (NSAIDs), one of the staple treatments for acute migraine.

“NSAIDs are available over the counter, inexpensive, quite effective, and have minimal immediate side effects,” Dr. Ailani said. But long-term adverse events include CV events, particularly in those who already have CV risk factors, and it is now thought that NSAIDs actually carry more CV risk than triptans.

She noted that out of all the NSAIDs, celecoxib carries the lowest CV risk, and in the United States, it is available as a liquid formulation. There is also a study of ketorolac nasal spray showing it to be as effective as sumatriptan nasal spray for acute migraine.

As her patient was still going to the emergency room (ER) quite frequently at this point, Dr. Ailani prescribed ketorolac nasal spray as an emergency rescue medication, which did help to reduce ER visits but did not solve the acute treatment problem.

The next option she tried was the CGRP antagonists or “gepants” because of their good tolerability.

Because her patient had long attacks, Dr. Ailani said her first choice gepant was rimegepant as it has a long half-life.

She noted that in patients who have frequent migraine attacks (> 6 migraine days per month), using rimegepant as needed has been shown to lead to migraine frequency declining over time. “This shows that if we treat acute attacks properly, we can minimize the risk of chronic migraine.”

She pointed out that if a patient has prodrome that is easy to identify or has short attacks, ubrogepant may be a good option, having shown effectiveness in preventing or reducing the onset of the headache in the recently reported PRODROME trial when given the day before migraine starts.

Then there is also zavegepant, which is available as a nasal spray, so it is a good option for patients with nausea and vomiting. Dr. Ailani suggested that zavegepant as a third-generation gepant may be worth trying in patients who have tried the other gepants, as it is a different type of molecule.

For this patient, neither rimegepant nor ubrogepant worked. “We tried treating in the prodrome, when the pain was starting, adding to other treatments, but she is not a ‘gepant’ responder. We have yet to try zavegepant,” she said.

The next consideration was lasmiditan. “This patient is a triptan responder and lasmiditan is a 5HT1 agonist, so it makes sense to try this. Also, it doesn’t have a vasoconstrictor effect as it doesn’t work on the blood vessels, so it is safe for patients with high blood pressure,” Dr. Ailani noted.

She pointed out, however, that lasmiditan has become a rescue medication in her practice because of side effect issues such as dizziness and sleepiness.

But Dr. Ailani said she has learned how to use the medication to minimize the side effects, by increasing the dose slowly and advising patients to take it later in the day.

“We start with 50 mg for a few doses then increase to 100 mg. This seems to build tolerability.”

Her patient has found good relief from lasmiditan 100 mg, but she can’t take it during the day as it makes her sleepy.

As a last resort, Dr. Ailani went back to metoclopramide, which she described as “a tried and tested old-time drug.”

While this does not make the patient sleepy, it has other adverse effects limiting the frequency of its use, she noted. “I ask her to try to limit it to twice a week, and this has been pretty effective. She can function when she uses it.” 

Dr. Ailani also points out that neuromodulation should be in everyone’s tool kit. “So, we added an external combined occipital and trigeminal (eCOT device) neurostimulation device.”

The patient’s tool kit now looks like this:

  • Neuromodulation device and meditation at first sign of an attack.
  • Add metoclopramide 10 mg and acetaminophen 1000 mg.
  • If the attack lasts into the second day, add lasmiditan 100 mg in the evening of the second day (limit 8 days a month).
  • If the patient has a sudden onset severe migraine with nausea and vomiting that might make her go to the ER, add in ketorolac nasal spray (not > 5 days per month).

Dr. Ailani noted that other patients will need different toolkits, and in most cases, it is recommended to think about “situational prevention” for times when migraine attacks are predictable, which may include air travel, high-stress times (holidays, etc.), occasions when alcohol will be consumed, and at times of certain weather triggers.

Dr. Ailani disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

Selecting a treatment plan to deal with acute migraine attacks can be like putting together a toolkit of possible therapies, individualized for each patient, one expert said.

The toolkit should comprise reliable treatments that patients know are going to work and that act quickly, allowing them to get back to functioning normally in their daily lives, said Jessica Ailani, MD, during a talk at the 17th European Headache Congress held recently in Barcelona, Spain. 

“Everyone with migraine needs acute treatment,” Dr. Ailani, who is a clinical professor of neurology at MedStar Georgetown University Hospital and director of the Georgetown Headache Center, Washington, DC, noted. “Sometimes we can reduce acute treatment with preventative agents, but some disability will remain, so we have to focus on good acute treatment, and this becomes more complex if a person has a lot of comorbidities, which is common in older patients.” 

In selecting suitable treatments for migraine, consideration has to be given to the patient profile, any other conditions they have, speed of onset of the migraine attack, length of the attack, associated symptoms, and side effects of the medications, she said. 
 

A Complex Case

As an example, Dr. Ailani described the process she used to treat one of her patients who had frequent severe migraines and other issues causing difficult decisions when selecting medications — a woman in her late 60s with several other comorbidities.

“This is the kind of case I see on a daily basis and which keeps me up at night,” she said. “Many times in clinical practice, we see complex cases like this, and through the course of a year, we may try every treatment option we have in a patient like this.”

On the first presentation, the patient had a chronic migraine with severe headaches every day. She had a history of previous cervical discectomy with fusion surgery; uncontrolled hypertension, for which she was taking an angiotensin blocker; high cholesterol, for which she was taking a statin; and diabetes with an A1c of 8. She did not smoke or drink alcohol, exercised moderately, and her body mass index was in a good range. 

“Before a patient ever sees a doctor for their migraine, they will have already tried a lot of different things. Most people are already using NSAIDs and acetaminophen, the most commonly used treatments for acute migraine,” Dr. Ailani explains.

Her patient was taking a triptan and the barbiturate, butalbital. Dr. Ailani notes that the triptan is very effective, but in the United States, they are not available over the counter, and the patient is only allowed nine doses per month on her insurance, so she was supplementing with butalbital. 

Over the course of a year, Dr. Ailani got her off the butalbital and started her on onabotulinum toxin A for migraine prevention, which reduced her headache days to about 15 per month (8 severe). She then added the anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, galcanezumab, as another preventative, which further reduced the headache days down to 8-10 days per month (all migraine). 

The attacks are rapid onset and can last multiple days. They come with photophobia and phonophobia and cause her to be bedridden, she noted. 

“I was still worried about this frequency of headache and the fact she was using a triptan for acute treatment when she had uncontrolled hypertension and other cardiovascular risk factors, Dr. Ailani commented. 

She explained that triptans are generally not used in individuals aged over 65 years because of a lack of data in this age group. They are also contraindicated in patients with cardiovascular (CV) disease, and caution is advised in patients with CV risk factors. Noting that migraine is an independent risk factor for stroke in healthy individuals, and this patient already had three other major risk factors for stroke, Dr. Ailani said she did not think a triptan was the best option. 

When triptans do not work, Dr. Ailani said she thinks about dihydroergotamine, which she describes as “a great drug for long-lasting migraine” as it tends to have a sustained response. But it also has vasoconstrictive effects and can increase blood pressure, so it was not suitable for this patient. 

CV risk is also an issue with nonsteroidal anti-inflammatory drugs (NSAIDs), one of the staple treatments for acute migraine.

“NSAIDs are available over the counter, inexpensive, quite effective, and have minimal immediate side effects,” Dr. Ailani said. But long-term adverse events include CV events, particularly in those who already have CV risk factors, and it is now thought that NSAIDs actually carry more CV risk than triptans.

She noted that out of all the NSAIDs, celecoxib carries the lowest CV risk, and in the United States, it is available as a liquid formulation. There is also a study of ketorolac nasal spray showing it to be as effective as sumatriptan nasal spray for acute migraine.

As her patient was still going to the emergency room (ER) quite frequently at this point, Dr. Ailani prescribed ketorolac nasal spray as an emergency rescue medication, which did help to reduce ER visits but did not solve the acute treatment problem.

The next option she tried was the CGRP antagonists or “gepants” because of their good tolerability.

Because her patient had long attacks, Dr. Ailani said her first choice gepant was rimegepant as it has a long half-life.

She noted that in patients who have frequent migraine attacks (> 6 migraine days per month), using rimegepant as needed has been shown to lead to migraine frequency declining over time. “This shows that if we treat acute attacks properly, we can minimize the risk of chronic migraine.”

She pointed out that if a patient has prodrome that is easy to identify or has short attacks, ubrogepant may be a good option, having shown effectiveness in preventing or reducing the onset of the headache in the recently reported PRODROME trial when given the day before migraine starts.

Then there is also zavegepant, which is available as a nasal spray, so it is a good option for patients with nausea and vomiting. Dr. Ailani suggested that zavegepant as a third-generation gepant may be worth trying in patients who have tried the other gepants, as it is a different type of molecule.

For this patient, neither rimegepant nor ubrogepant worked. “We tried treating in the prodrome, when the pain was starting, adding to other treatments, but she is not a ‘gepant’ responder. We have yet to try zavegepant,” she said.

The next consideration was lasmiditan. “This patient is a triptan responder and lasmiditan is a 5HT1 agonist, so it makes sense to try this. Also, it doesn’t have a vasoconstrictor effect as it doesn’t work on the blood vessels, so it is safe for patients with high blood pressure,” Dr. Ailani noted.

She pointed out, however, that lasmiditan has become a rescue medication in her practice because of side effect issues such as dizziness and sleepiness.

But Dr. Ailani said she has learned how to use the medication to minimize the side effects, by increasing the dose slowly and advising patients to take it later in the day.

“We start with 50 mg for a few doses then increase to 100 mg. This seems to build tolerability.”

Her patient has found good relief from lasmiditan 100 mg, but she can’t take it during the day as it makes her sleepy.

As a last resort, Dr. Ailani went back to metoclopramide, which she described as “a tried and tested old-time drug.”

While this does not make the patient sleepy, it has other adverse effects limiting the frequency of its use, she noted. “I ask her to try to limit it to twice a week, and this has been pretty effective. She can function when she uses it.” 

Dr. Ailani also points out that neuromodulation should be in everyone’s tool kit. “So, we added an external combined occipital and trigeminal (eCOT device) neurostimulation device.”

The patient’s tool kit now looks like this:

  • Neuromodulation device and meditation at first sign of an attack.
  • Add metoclopramide 10 mg and acetaminophen 1000 mg.
  • If the attack lasts into the second day, add lasmiditan 100 mg in the evening of the second day (limit 8 days a month).
  • If the patient has a sudden onset severe migraine with nausea and vomiting that might make her go to the ER, add in ketorolac nasal spray (not > 5 days per month).

Dr. Ailani noted that other patients will need different toolkits, and in most cases, it is recommended to think about “situational prevention” for times when migraine attacks are predictable, which may include air travel, high-stress times (holidays, etc.), occasions when alcohol will be consumed, and at times of certain weather triggers.

Dr. Ailani disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Selecting a treatment plan to deal with acute migraine attacks can be like putting together a toolkit of possible therapies, individualized for each patient, one expert said.

The toolkit should comprise reliable treatments that patients know are going to work and that act quickly, allowing them to get back to functioning normally in their daily lives, said Jessica Ailani, MD, during a talk at the 17th European Headache Congress held recently in Barcelona, Spain. 

“Everyone with migraine needs acute treatment,” Dr. Ailani, who is a clinical professor of neurology at MedStar Georgetown University Hospital and director of the Georgetown Headache Center, Washington, DC, noted. “Sometimes we can reduce acute treatment with preventative agents, but some disability will remain, so we have to focus on good acute treatment, and this becomes more complex if a person has a lot of comorbidities, which is common in older patients.” 

In selecting suitable treatments for migraine, consideration has to be given to the patient profile, any other conditions they have, speed of onset of the migraine attack, length of the attack, associated symptoms, and side effects of the medications, she said. 
 

A Complex Case

As an example, Dr. Ailani described the process she used to treat one of her patients who had frequent severe migraines and other issues causing difficult decisions when selecting medications — a woman in her late 60s with several other comorbidities.

“This is the kind of case I see on a daily basis and which keeps me up at night,” she said. “Many times in clinical practice, we see complex cases like this, and through the course of a year, we may try every treatment option we have in a patient like this.”

On the first presentation, the patient had a chronic migraine with severe headaches every day. She had a history of previous cervical discectomy with fusion surgery; uncontrolled hypertension, for which she was taking an angiotensin blocker; high cholesterol, for which she was taking a statin; and diabetes with an A1c of 8. She did not smoke or drink alcohol, exercised moderately, and her body mass index was in a good range. 

“Before a patient ever sees a doctor for their migraine, they will have already tried a lot of different things. Most people are already using NSAIDs and acetaminophen, the most commonly used treatments for acute migraine,” Dr. Ailani explains.

Her patient was taking a triptan and the barbiturate, butalbital. Dr. Ailani notes that the triptan is very effective, but in the United States, they are not available over the counter, and the patient is only allowed nine doses per month on her insurance, so she was supplementing with butalbital. 

Over the course of a year, Dr. Ailani got her off the butalbital and started her on onabotulinum toxin A for migraine prevention, which reduced her headache days to about 15 per month (8 severe). She then added the anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, galcanezumab, as another preventative, which further reduced the headache days down to 8-10 days per month (all migraine). 

The attacks are rapid onset and can last multiple days. They come with photophobia and phonophobia and cause her to be bedridden, she noted. 

“I was still worried about this frequency of headache and the fact she was using a triptan for acute treatment when she had uncontrolled hypertension and other cardiovascular risk factors, Dr. Ailani commented. 

She explained that triptans are generally not used in individuals aged over 65 years because of a lack of data in this age group. They are also contraindicated in patients with cardiovascular (CV) disease, and caution is advised in patients with CV risk factors. Noting that migraine is an independent risk factor for stroke in healthy individuals, and this patient already had three other major risk factors for stroke, Dr. Ailani said she did not think a triptan was the best option. 

When triptans do not work, Dr. Ailani said she thinks about dihydroergotamine, which she describes as “a great drug for long-lasting migraine” as it tends to have a sustained response. But it also has vasoconstrictive effects and can increase blood pressure, so it was not suitable for this patient. 

CV risk is also an issue with nonsteroidal anti-inflammatory drugs (NSAIDs), one of the staple treatments for acute migraine.

“NSAIDs are available over the counter, inexpensive, quite effective, and have minimal immediate side effects,” Dr. Ailani said. But long-term adverse events include CV events, particularly in those who already have CV risk factors, and it is now thought that NSAIDs actually carry more CV risk than triptans.

She noted that out of all the NSAIDs, celecoxib carries the lowest CV risk, and in the United States, it is available as a liquid formulation. There is also a study of ketorolac nasal spray showing it to be as effective as sumatriptan nasal spray for acute migraine.

As her patient was still going to the emergency room (ER) quite frequently at this point, Dr. Ailani prescribed ketorolac nasal spray as an emergency rescue medication, which did help to reduce ER visits but did not solve the acute treatment problem.

The next option she tried was the CGRP antagonists or “gepants” because of their good tolerability.

Because her patient had long attacks, Dr. Ailani said her first choice gepant was rimegepant as it has a long half-life.

She noted that in patients who have frequent migraine attacks (> 6 migraine days per month), using rimegepant as needed has been shown to lead to migraine frequency declining over time. “This shows that if we treat acute attacks properly, we can minimize the risk of chronic migraine.”

She pointed out that if a patient has prodrome that is easy to identify or has short attacks, ubrogepant may be a good option, having shown effectiveness in preventing or reducing the onset of the headache in the recently reported PRODROME trial when given the day before migraine starts.

Then there is also zavegepant, which is available as a nasal spray, so it is a good option for patients with nausea and vomiting. Dr. Ailani suggested that zavegepant as a third-generation gepant may be worth trying in patients who have tried the other gepants, as it is a different type of molecule.

For this patient, neither rimegepant nor ubrogepant worked. “We tried treating in the prodrome, when the pain was starting, adding to other treatments, but she is not a ‘gepant’ responder. We have yet to try zavegepant,” she said.

The next consideration was lasmiditan. “This patient is a triptan responder and lasmiditan is a 5HT1 agonist, so it makes sense to try this. Also, it doesn’t have a vasoconstrictor effect as it doesn’t work on the blood vessels, so it is safe for patients with high blood pressure,” Dr. Ailani noted.

She pointed out, however, that lasmiditan has become a rescue medication in her practice because of side effect issues such as dizziness and sleepiness.

But Dr. Ailani said she has learned how to use the medication to minimize the side effects, by increasing the dose slowly and advising patients to take it later in the day.

“We start with 50 mg for a few doses then increase to 100 mg. This seems to build tolerability.”

Her patient has found good relief from lasmiditan 100 mg, but she can’t take it during the day as it makes her sleepy.

As a last resort, Dr. Ailani went back to metoclopramide, which she described as “a tried and tested old-time drug.”

While this does not make the patient sleepy, it has other adverse effects limiting the frequency of its use, she noted. “I ask her to try to limit it to twice a week, and this has been pretty effective. She can function when she uses it.” 

Dr. Ailani also points out that neuromodulation should be in everyone’s tool kit. “So, we added an external combined occipital and trigeminal (eCOT device) neurostimulation device.”

The patient’s tool kit now looks like this:

  • Neuromodulation device and meditation at first sign of an attack.
  • Add metoclopramide 10 mg and acetaminophen 1000 mg.
  • If the attack lasts into the second day, add lasmiditan 100 mg in the evening of the second day (limit 8 days a month).
  • If the patient has a sudden onset severe migraine with nausea and vomiting that might make her go to the ER, add in ketorolac nasal spray (not > 5 days per month).

Dr. Ailani noted that other patients will need different toolkits, and in most cases, it is recommended to think about “situational prevention” for times when migraine attacks are predictable, which may include air travel, high-stress times (holidays, etc.), occasions when alcohol will be consumed, and at times of certain weather triggers.

Dr. Ailani disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE EUROPEAN HEADACHE CONGRESS

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

For Weight Loss With a Low-Carb Diet, Quality Matters

Article Type
Changed
Fri, 01/05/2024 - 13:36

 

TOPLINE:

A high-quality, low-carbohydrate diet (LCD), rich in plant-based proteins and healthy fats, was associated with slower weight gain, while a lower-quality LCD was associated with the reverse.

METHODOLOGY:

  • Prospective cohort study included 123,332 participants from the Nurses’ Health Studies (NHS, 1986-2010 and 1991-2015) and the Health Professionals Follow-up Study (HPFS, 1986-2018).
  • Diets assessed by questionnaires were categorized as: (1) total LCD (TLCD), emphasizing overall lower carbohydrate intake; (2) animal-based LCD (ALCD), emphasizing animal-sourced protein and fat; (3) vegetable-based LCD (VLCD), emphasizing plant-sourced protein and fat; (4) a healthy LCD (HLCD), emphasizing less refined carbohydrates, more plant protein, and healthy fat; and (5) unhealthy LCD (ULCD), emphasizing less healthful carbohydrates, more animal protein, and unhealthy fat.
  • The primary outcome was 4-year reported changes in body weight, divided into quintiles, with Q3 = no change, Q1 = largest decrease, and Q5 = largest increase.

TAKEAWAY:

  • Participants gained a mean of 1.3 kg over each 4-year interval, with gains of 0.8, 1.8, and 0.5 kg for NHS, NHSII, and HPFS, respectively.
  • After adjustment for baseline and concomitant changes in lifestyle and demographic factors, compared with participants with no change in the TLCD score over 4-year intervals, those with the largest increase (Q5) in the TLCD score did not have significant weight change (0.03 kg), while those with the largest decrease (Q1) in the TLCD score had significantly less weight gain (−0.20 kg).
  • Similarly, those following a VLCD with Q5 change, compared with those with stable Q3 adherence, experienced 0.21 kg less weight gain, and those with Q1 change experienced 0.17 kg less weight gain, both significant.
  • Adhering to an ALCD was associated with more weight gain over time, with each 1 standard deviation (SD) increase in ALCD associated with a significant 0.13 kg more weight gain over 4-year intervals.
  • Opposite results were seen for ULCD and HLCD scores, where a 1-SD increase in HLCD and ULCD was associated with a significant 0.36 kg weight loss and 0.39 kg weight gain, respectively, over 4-year intervals.
  • The associations were stronger among individuals with baseline body mass index ≥ 30 kg/m2.

IN PRACTICE:

“The findings of this cohort study underscore the importance of diet quality within LCD patterns for weight management… Overall, the study findings argue against the sole focus of macronutrient quantity for weight management and suggest the crucial role of nutrient quality in maintaining a healthy body weight.”

SOURCE:

This study was conducted by Binkai Liu, MS, of the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, and colleagues. 

The findings were published online in  JAMA Network Open .

LIMITATIONS:

  • Self-reported data.
  • Observational study, potential for residual confounding.
  • No body composition measurement.
  • Study population was mainly White health professionals.

DISCLOSURES:

This study was funded by research grants from the National Institutes of Health, and one coauthor is supported by a postdoctoral fellowship award from the Canadian Institutes of Health Research.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

TOPLINE:

A high-quality, low-carbohydrate diet (LCD), rich in plant-based proteins and healthy fats, was associated with slower weight gain, while a lower-quality LCD was associated with the reverse.

METHODOLOGY:

  • Prospective cohort study included 123,332 participants from the Nurses’ Health Studies (NHS, 1986-2010 and 1991-2015) and the Health Professionals Follow-up Study (HPFS, 1986-2018).
  • Diets assessed by questionnaires were categorized as: (1) total LCD (TLCD), emphasizing overall lower carbohydrate intake; (2) animal-based LCD (ALCD), emphasizing animal-sourced protein and fat; (3) vegetable-based LCD (VLCD), emphasizing plant-sourced protein and fat; (4) a healthy LCD (HLCD), emphasizing less refined carbohydrates, more plant protein, and healthy fat; and (5) unhealthy LCD (ULCD), emphasizing less healthful carbohydrates, more animal protein, and unhealthy fat.
  • The primary outcome was 4-year reported changes in body weight, divided into quintiles, with Q3 = no change, Q1 = largest decrease, and Q5 = largest increase.

TAKEAWAY:

  • Participants gained a mean of 1.3 kg over each 4-year interval, with gains of 0.8, 1.8, and 0.5 kg for NHS, NHSII, and HPFS, respectively.
  • After adjustment for baseline and concomitant changes in lifestyle and demographic factors, compared with participants with no change in the TLCD score over 4-year intervals, those with the largest increase (Q5) in the TLCD score did not have significant weight change (0.03 kg), while those with the largest decrease (Q1) in the TLCD score had significantly less weight gain (−0.20 kg).
  • Similarly, those following a VLCD with Q5 change, compared with those with stable Q3 adherence, experienced 0.21 kg less weight gain, and those with Q1 change experienced 0.17 kg less weight gain, both significant.
  • Adhering to an ALCD was associated with more weight gain over time, with each 1 standard deviation (SD) increase in ALCD associated with a significant 0.13 kg more weight gain over 4-year intervals.
  • Opposite results were seen for ULCD and HLCD scores, where a 1-SD increase in HLCD and ULCD was associated with a significant 0.36 kg weight loss and 0.39 kg weight gain, respectively, over 4-year intervals.
  • The associations were stronger among individuals with baseline body mass index ≥ 30 kg/m2.

IN PRACTICE:

“The findings of this cohort study underscore the importance of diet quality within LCD patterns for weight management… Overall, the study findings argue against the sole focus of macronutrient quantity for weight management and suggest the crucial role of nutrient quality in maintaining a healthy body weight.”

SOURCE:

This study was conducted by Binkai Liu, MS, of the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, and colleagues. 

The findings were published online in  JAMA Network Open .

LIMITATIONS:

  • Self-reported data.
  • Observational study, potential for residual confounding.
  • No body composition measurement.
  • Study population was mainly White health professionals.

DISCLOSURES:

This study was funded by research grants from the National Institutes of Health, and one coauthor is supported by a postdoctoral fellowship award from the Canadian Institutes of Health Research.

A version of this article appeared on Medscape.com.

 

TOPLINE:

A high-quality, low-carbohydrate diet (LCD), rich in plant-based proteins and healthy fats, was associated with slower weight gain, while a lower-quality LCD was associated with the reverse.

METHODOLOGY:

  • Prospective cohort study included 123,332 participants from the Nurses’ Health Studies (NHS, 1986-2010 and 1991-2015) and the Health Professionals Follow-up Study (HPFS, 1986-2018).
  • Diets assessed by questionnaires were categorized as: (1) total LCD (TLCD), emphasizing overall lower carbohydrate intake; (2) animal-based LCD (ALCD), emphasizing animal-sourced protein and fat; (3) vegetable-based LCD (VLCD), emphasizing plant-sourced protein and fat; (4) a healthy LCD (HLCD), emphasizing less refined carbohydrates, more plant protein, and healthy fat; and (5) unhealthy LCD (ULCD), emphasizing less healthful carbohydrates, more animal protein, and unhealthy fat.
  • The primary outcome was 4-year reported changes in body weight, divided into quintiles, with Q3 = no change, Q1 = largest decrease, and Q5 = largest increase.

TAKEAWAY:

  • Participants gained a mean of 1.3 kg over each 4-year interval, with gains of 0.8, 1.8, and 0.5 kg for NHS, NHSII, and HPFS, respectively.
  • After adjustment for baseline and concomitant changes in lifestyle and demographic factors, compared with participants with no change in the TLCD score over 4-year intervals, those with the largest increase (Q5) in the TLCD score did not have significant weight change (0.03 kg), while those with the largest decrease (Q1) in the TLCD score had significantly less weight gain (−0.20 kg).
  • Similarly, those following a VLCD with Q5 change, compared with those with stable Q3 adherence, experienced 0.21 kg less weight gain, and those with Q1 change experienced 0.17 kg less weight gain, both significant.
  • Adhering to an ALCD was associated with more weight gain over time, with each 1 standard deviation (SD) increase in ALCD associated with a significant 0.13 kg more weight gain over 4-year intervals.
  • Opposite results were seen for ULCD and HLCD scores, where a 1-SD increase in HLCD and ULCD was associated with a significant 0.36 kg weight loss and 0.39 kg weight gain, respectively, over 4-year intervals.
  • The associations were stronger among individuals with baseline body mass index ≥ 30 kg/m2.

IN PRACTICE:

“The findings of this cohort study underscore the importance of diet quality within LCD patterns for weight management… Overall, the study findings argue against the sole focus of macronutrient quantity for weight management and suggest the crucial role of nutrient quality in maintaining a healthy body weight.”

SOURCE:

This study was conducted by Binkai Liu, MS, of the department of nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, and colleagues. 

The findings were published online in  JAMA Network Open .

LIMITATIONS:

  • Self-reported data.
  • Observational study, potential for residual confounding.
  • No body composition measurement.
  • Study population was mainly White health professionals.

DISCLOSURES:

This study was funded by research grants from the National Institutes of Health, and one coauthor is supported by a postdoctoral fellowship award from the Canadian Institutes of Health Research.

A version of this article 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