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Which patients are most likely to have a positive RNS test for myasthenia gravis?
AUSTIN, TEX. – , according to research presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine.
Low-frequency RNS is a common test that neurologists perform to evaluate a patient for myasthenia gravis. The effects of various clinical factors on the diagnostic yield of this test are unknown, however.
Myasthenia gravis is “mostly a clinical diagnosis,” study first author Tingting Hua, a medical student at the University of Missouri in Columbia, said in an interview. “RNS is just one of the helpful diagnostic tests for it. If we can find out in what kind of populations of patients this test is more helpful, maybe that would help cut down unnecessary tests in patients for whom it’s not necessarily helpful.”
Ms. Hua and her colleagues conducted research to assess the effects of clinical, serologic, and demographic factors on the diagnostic yield of RNS. They retrospectively analyzed patients with an established diagnosis of myasthenia gravis and at least 1 year of follow-up. The variables that the investigators examined were demographic characteristics, MGFA class, RNS study results, antibody test results, thymoma status, and treatments received.
Ms. Hua and her colleagues included 65 patients in their analysis. Thirty-one patients were female. Fifty-five patients were white, eight were black, and two were categorized as “unknown.” Of this population, 32 patients (49.2%) were in MGFA Class I, 14 (21.5%) were in MGFA Class IIa, 13 (20.0%) were in MGFA Class IIb, and the remaining 6 (9.2%) were in MGFA Classes IIIa through V. Twenty-seven patients (42%) had positive RNS studies. Twenty-one patients (32%) were seropositive for myasthenia gravis antibodies.
Eleven patients underwent RNS in an inpatient setting, and 54 were tested in an outpatient setting. Acetylcholine receptor (AChR) binding antibody titer ranged from 0.12 nmol/L to 118 nmol/L. The RNS results were significantly more likely to be positive for seropositive patients, compared with seronegative patients. Patients with MGFA Class III or higher also had higher likelihood of positive RNS results, compared with patients in lower classes. Finally, the diagnostic yield was highest for patients with MGFA Class III or higher who were tested in an inpatient setting.
The study was supported by a Missouri School of Medicine Summer Research Fellowship.
SOURCE: Hua T et al. AANEM 2019, Abstract 9.
AUSTIN, TEX. – , according to research presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine.
Low-frequency RNS is a common test that neurologists perform to evaluate a patient for myasthenia gravis. The effects of various clinical factors on the diagnostic yield of this test are unknown, however.
Myasthenia gravis is “mostly a clinical diagnosis,” study first author Tingting Hua, a medical student at the University of Missouri in Columbia, said in an interview. “RNS is just one of the helpful diagnostic tests for it. If we can find out in what kind of populations of patients this test is more helpful, maybe that would help cut down unnecessary tests in patients for whom it’s not necessarily helpful.”
Ms. Hua and her colleagues conducted research to assess the effects of clinical, serologic, and demographic factors on the diagnostic yield of RNS. They retrospectively analyzed patients with an established diagnosis of myasthenia gravis and at least 1 year of follow-up. The variables that the investigators examined were demographic characteristics, MGFA class, RNS study results, antibody test results, thymoma status, and treatments received.
Ms. Hua and her colleagues included 65 patients in their analysis. Thirty-one patients were female. Fifty-five patients were white, eight were black, and two were categorized as “unknown.” Of this population, 32 patients (49.2%) were in MGFA Class I, 14 (21.5%) were in MGFA Class IIa, 13 (20.0%) were in MGFA Class IIb, and the remaining 6 (9.2%) were in MGFA Classes IIIa through V. Twenty-seven patients (42%) had positive RNS studies. Twenty-one patients (32%) were seropositive for myasthenia gravis antibodies.
Eleven patients underwent RNS in an inpatient setting, and 54 were tested in an outpatient setting. Acetylcholine receptor (AChR) binding antibody titer ranged from 0.12 nmol/L to 118 nmol/L. The RNS results were significantly more likely to be positive for seropositive patients, compared with seronegative patients. Patients with MGFA Class III or higher also had higher likelihood of positive RNS results, compared with patients in lower classes. Finally, the diagnostic yield was highest for patients with MGFA Class III or higher who were tested in an inpatient setting.
The study was supported by a Missouri School of Medicine Summer Research Fellowship.
SOURCE: Hua T et al. AANEM 2019, Abstract 9.
AUSTIN, TEX. – , according to research presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine.
Low-frequency RNS is a common test that neurologists perform to evaluate a patient for myasthenia gravis. The effects of various clinical factors on the diagnostic yield of this test are unknown, however.
Myasthenia gravis is “mostly a clinical diagnosis,” study first author Tingting Hua, a medical student at the University of Missouri in Columbia, said in an interview. “RNS is just one of the helpful diagnostic tests for it. If we can find out in what kind of populations of patients this test is more helpful, maybe that would help cut down unnecessary tests in patients for whom it’s not necessarily helpful.”
Ms. Hua and her colleagues conducted research to assess the effects of clinical, serologic, and demographic factors on the diagnostic yield of RNS. They retrospectively analyzed patients with an established diagnosis of myasthenia gravis and at least 1 year of follow-up. The variables that the investigators examined were demographic characteristics, MGFA class, RNS study results, antibody test results, thymoma status, and treatments received.
Ms. Hua and her colleagues included 65 patients in their analysis. Thirty-one patients were female. Fifty-five patients were white, eight were black, and two were categorized as “unknown.” Of this population, 32 patients (49.2%) were in MGFA Class I, 14 (21.5%) were in MGFA Class IIa, 13 (20.0%) were in MGFA Class IIb, and the remaining 6 (9.2%) were in MGFA Classes IIIa through V. Twenty-seven patients (42%) had positive RNS studies. Twenty-one patients (32%) were seropositive for myasthenia gravis antibodies.
Eleven patients underwent RNS in an inpatient setting, and 54 were tested in an outpatient setting. Acetylcholine receptor (AChR) binding antibody titer ranged from 0.12 nmol/L to 118 nmol/L. The RNS results were significantly more likely to be positive for seropositive patients, compared with seronegative patients. Patients with MGFA Class III or higher also had higher likelihood of positive RNS results, compared with patients in lower classes. Finally, the diagnostic yield was highest for patients with MGFA Class III or higher who were tested in an inpatient setting.
The study was supported by a Missouri School of Medicine Summer Research Fellowship.
SOURCE: Hua T et al. AANEM 2019, Abstract 9.
REPORTING FROM AANEM 2019
Neurologists consider flu shot safe in most patients with autoimmune neuromuscular disorders
AUSTIN, TEX. – (CIDP), according to a survey presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. They are more conservative in recommending immunization for patients with a history of Guillain-Barré syndrome, however. Temporally associated disease relapses may be a risk factor for relapse with subsequent immunization, according to the investigators.
Influenza vaccination of patients with autoimmune neuromuscular disorders such as myasthenia gravis, CIDP, or Guillain-Barré syndrome is controversial, and no clear guideline helps clinicians to decide whether vaccination for such patients is appropriate. Tess Litchman, a medical student at Yale University, New Haven, Conn., and colleagues conducted a web-based survey of neurologists throughout the United States to examine current practices for recommending influenza vaccination for patients with myasthenia gravis, CIDP, and Guillain-Barré syndrome.
The researchers received 184 survey responses, with the highest proportions of responses coming from California (8.8%), Connecticut (8.8%), and Texas (8.3%). On average, respondents had been in practice for 15.5 years. Their reported practice specialties were neuromuscular medicine in 50%, general neurology in 20%, mixed specialties in 20%, and other in 10%.
Across practice settings, neurologists followed 6,448 patients with myasthenia gravis, 2,310 patients with CIDP, and 1,907 patients with Guillain-Barré syndrome. Approximately 83% of respondents reported recommending influenza vaccination for all of their patients with myasthenia gravis, 59% reported recommending vaccination for all of their patients with CIDP, and 43% of respondents reported recommending vaccination for all of their patients with Guillain-Barré syndrome. About 2%, 8%, and 15% of respondents reported that they do not recommend influenza vaccination for any of their patients with myasthenia gravis, CIDP, and Guillain-Barré syndrome, respectively.
A temporal association between disease relapse and influenza vaccination was reported in 1.5% of patients with myasthenia gravis, 3.7% of patients with CIDP, and 8.7% of patients with Guillain-Barré syndrome. Recurrent relapses occurred in 87% (26 of 30) of patients with myasthenia gravis, 92% (23 of 25) of patients with CIDP, and 74% (26 of 35) of patients with Guillain-Barré syndrome who received another influenza vaccination.
“According to existing guidelines per the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, all patients with myasthenia gravis and CIDP should be vaccinated, and patients with Guillain-Barré syndrome who did not develop the syndrome due to a flu shot should be vaccinated,” said Richard J. Nowak, MD, director of the program in clinical and translational neuromuscular research at Yale and one of the senior investigators on the study. “This survey demonstrates that clearer guidelines and education from a professional academic neurology society is an unmet need and would be helpful to better inform the neurology community about the possible risks and benefits of immunization in myasthenia gravis, CIDP, and Guillain-Barré syndrome patients. We hope to utilize these initial results to stimulate a larger scale study, and identify whether this topic represents a knowledge gap in the community or an area in which we can improve on the best-practice standard.”
Dr. Nowak had no relevant disclosures. The study was supported by the department of neurology at Yale University; there was no external funding.
SOURCE: Litchman T et al. AANEM 2019, Abstract 16.
AUSTIN, TEX. – (CIDP), according to a survey presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. They are more conservative in recommending immunization for patients with a history of Guillain-Barré syndrome, however. Temporally associated disease relapses may be a risk factor for relapse with subsequent immunization, according to the investigators.
Influenza vaccination of patients with autoimmune neuromuscular disorders such as myasthenia gravis, CIDP, or Guillain-Barré syndrome is controversial, and no clear guideline helps clinicians to decide whether vaccination for such patients is appropriate. Tess Litchman, a medical student at Yale University, New Haven, Conn., and colleagues conducted a web-based survey of neurologists throughout the United States to examine current practices for recommending influenza vaccination for patients with myasthenia gravis, CIDP, and Guillain-Barré syndrome.
The researchers received 184 survey responses, with the highest proportions of responses coming from California (8.8%), Connecticut (8.8%), and Texas (8.3%). On average, respondents had been in practice for 15.5 years. Their reported practice specialties were neuromuscular medicine in 50%, general neurology in 20%, mixed specialties in 20%, and other in 10%.
Across practice settings, neurologists followed 6,448 patients with myasthenia gravis, 2,310 patients with CIDP, and 1,907 patients with Guillain-Barré syndrome. Approximately 83% of respondents reported recommending influenza vaccination for all of their patients with myasthenia gravis, 59% reported recommending vaccination for all of their patients with CIDP, and 43% of respondents reported recommending vaccination for all of their patients with Guillain-Barré syndrome. About 2%, 8%, and 15% of respondents reported that they do not recommend influenza vaccination for any of their patients with myasthenia gravis, CIDP, and Guillain-Barré syndrome, respectively.
A temporal association between disease relapse and influenza vaccination was reported in 1.5% of patients with myasthenia gravis, 3.7% of patients with CIDP, and 8.7% of patients with Guillain-Barré syndrome. Recurrent relapses occurred in 87% (26 of 30) of patients with myasthenia gravis, 92% (23 of 25) of patients with CIDP, and 74% (26 of 35) of patients with Guillain-Barré syndrome who received another influenza vaccination.
“According to existing guidelines per the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, all patients with myasthenia gravis and CIDP should be vaccinated, and patients with Guillain-Barré syndrome who did not develop the syndrome due to a flu shot should be vaccinated,” said Richard J. Nowak, MD, director of the program in clinical and translational neuromuscular research at Yale and one of the senior investigators on the study. “This survey demonstrates that clearer guidelines and education from a professional academic neurology society is an unmet need and would be helpful to better inform the neurology community about the possible risks and benefits of immunization in myasthenia gravis, CIDP, and Guillain-Barré syndrome patients. We hope to utilize these initial results to stimulate a larger scale study, and identify whether this topic represents a knowledge gap in the community or an area in which we can improve on the best-practice standard.”
Dr. Nowak had no relevant disclosures. The study was supported by the department of neurology at Yale University; there was no external funding.
SOURCE: Litchman T et al. AANEM 2019, Abstract 16.
AUSTIN, TEX. – (CIDP), according to a survey presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. They are more conservative in recommending immunization for patients with a history of Guillain-Barré syndrome, however. Temporally associated disease relapses may be a risk factor for relapse with subsequent immunization, according to the investigators.
Influenza vaccination of patients with autoimmune neuromuscular disorders such as myasthenia gravis, CIDP, or Guillain-Barré syndrome is controversial, and no clear guideline helps clinicians to decide whether vaccination for such patients is appropriate. Tess Litchman, a medical student at Yale University, New Haven, Conn., and colleagues conducted a web-based survey of neurologists throughout the United States to examine current practices for recommending influenza vaccination for patients with myasthenia gravis, CIDP, and Guillain-Barré syndrome.
The researchers received 184 survey responses, with the highest proportions of responses coming from California (8.8%), Connecticut (8.8%), and Texas (8.3%). On average, respondents had been in practice for 15.5 years. Their reported practice specialties were neuromuscular medicine in 50%, general neurology in 20%, mixed specialties in 20%, and other in 10%.
Across practice settings, neurologists followed 6,448 patients with myasthenia gravis, 2,310 patients with CIDP, and 1,907 patients with Guillain-Barré syndrome. Approximately 83% of respondents reported recommending influenza vaccination for all of their patients with myasthenia gravis, 59% reported recommending vaccination for all of their patients with CIDP, and 43% of respondents reported recommending vaccination for all of their patients with Guillain-Barré syndrome. About 2%, 8%, and 15% of respondents reported that they do not recommend influenza vaccination for any of their patients with myasthenia gravis, CIDP, and Guillain-Barré syndrome, respectively.
A temporal association between disease relapse and influenza vaccination was reported in 1.5% of patients with myasthenia gravis, 3.7% of patients with CIDP, and 8.7% of patients with Guillain-Barré syndrome. Recurrent relapses occurred in 87% (26 of 30) of patients with myasthenia gravis, 92% (23 of 25) of patients with CIDP, and 74% (26 of 35) of patients with Guillain-Barré syndrome who received another influenza vaccination.
“According to existing guidelines per the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, all patients with myasthenia gravis and CIDP should be vaccinated, and patients with Guillain-Barré syndrome who did not develop the syndrome due to a flu shot should be vaccinated,” said Richard J. Nowak, MD, director of the program in clinical and translational neuromuscular research at Yale and one of the senior investigators on the study. “This survey demonstrates that clearer guidelines and education from a professional academic neurology society is an unmet need and would be helpful to better inform the neurology community about the possible risks and benefits of immunization in myasthenia gravis, CIDP, and Guillain-Barré syndrome patients. We hope to utilize these initial results to stimulate a larger scale study, and identify whether this topic represents a knowledge gap in the community or an area in which we can improve on the best-practice standard.”
Dr. Nowak had no relevant disclosures. The study was supported by the department of neurology at Yale University; there was no external funding.
SOURCE: Litchman T et al. AANEM 2019, Abstract 16.
REPORTING FROM AANEM 2019
Eureka Challenge Winners Help Lighten the Load of Life With Alzheimer Disease
Mobile applications and other tech solutions that target the specific needs of patients with Alzheimer and their caregivers won the day in the first Eureka prize competition, sponsored by the National Institute on Aging.
The Improving Care for People with Alzheimer’s Disease and Related Dementias Using Technology (iCare-AD/ADRD) Challenge received 33 applications for mobile device applications or web-based methods to help users coordinate and navigate life with dementia. The judging was based on creativity and innovation, rationale and potential impact, value to relevant stakeholders, usability, and functionality and feasibility.
First place, with $250,000, went to MapHabit for mobile software that provides behavior prompts with customizable picture-and-keyword visual maps to help people with activities of daily living. The platform has different interfaces for users: people with impaired memory, caregiver, or long-term care community manager. Simple commands, such as “take a shower,” are scheduled, with feedback provided to caregivers. The system takes advantage of the brain’s habit (procedural) memory system, the researchers say, rather than the hippocampal (declarative) memory system that is damaged early in AD.
A team from University of California, Los Angeles, won second prize of $100,000 for their web-based Dementia Care Software system, which helps coordinate complex medical and social services. The software, which can be integrated into any of the leading electronic health record systems, has already been used in support of the UCLA Alzheimer’s and Dementia Care Program, a nurse-practitioner co-management approach that includes structured needs assessment, individualized dementia care plans, and round-the-clock access for assistance and advice. The researchers say more than 2,600 patients with dementia have participated in the program so far.
Caregiver411, developed by researchers from North Carolina Agricultural and Technical State University, won the third-place prize of $50,000. The mobile app helps people make informed decisions by, for instance, capturing the care recipient’s stage of AD in order to provide targeted recommendations. Dementia caregivers can obtain tailored resources related to mental, emotional, physical, social, legal, and financial concerns. The app also gives them a forum for social connections and family chat groups through a messaging center.
The Eureka Challenge is part of the 21st Century Cures Act, signed into law in 2016, designed to help accelerate medical product development with innovations incorporating the perspectives of patients. More detailed project descriptions are available at www.nia.nih.gov/challenge-prize.
Mobile applications and other tech solutions that target the specific needs of patients with Alzheimer and their caregivers won the day in the first Eureka prize competition, sponsored by the National Institute on Aging.
The Improving Care for People with Alzheimer’s Disease and Related Dementias Using Technology (iCare-AD/ADRD) Challenge received 33 applications for mobile device applications or web-based methods to help users coordinate and navigate life with dementia. The judging was based on creativity and innovation, rationale and potential impact, value to relevant stakeholders, usability, and functionality and feasibility.
First place, with $250,000, went to MapHabit for mobile software that provides behavior prompts with customizable picture-and-keyword visual maps to help people with activities of daily living. The platform has different interfaces for users: people with impaired memory, caregiver, or long-term care community manager. Simple commands, such as “take a shower,” are scheduled, with feedback provided to caregivers. The system takes advantage of the brain’s habit (procedural) memory system, the researchers say, rather than the hippocampal (declarative) memory system that is damaged early in AD.
A team from University of California, Los Angeles, won second prize of $100,000 for their web-based Dementia Care Software system, which helps coordinate complex medical and social services. The software, which can be integrated into any of the leading electronic health record systems, has already been used in support of the UCLA Alzheimer’s and Dementia Care Program, a nurse-practitioner co-management approach that includes structured needs assessment, individualized dementia care plans, and round-the-clock access for assistance and advice. The researchers say more than 2,600 patients with dementia have participated in the program so far.
Caregiver411, developed by researchers from North Carolina Agricultural and Technical State University, won the third-place prize of $50,000. The mobile app helps people make informed decisions by, for instance, capturing the care recipient’s stage of AD in order to provide targeted recommendations. Dementia caregivers can obtain tailored resources related to mental, emotional, physical, social, legal, and financial concerns. The app also gives them a forum for social connections and family chat groups through a messaging center.
The Eureka Challenge is part of the 21st Century Cures Act, signed into law in 2016, designed to help accelerate medical product development with innovations incorporating the perspectives of patients. More detailed project descriptions are available at www.nia.nih.gov/challenge-prize.
Mobile applications and other tech solutions that target the specific needs of patients with Alzheimer and their caregivers won the day in the first Eureka prize competition, sponsored by the National Institute on Aging.
The Improving Care for People with Alzheimer’s Disease and Related Dementias Using Technology (iCare-AD/ADRD) Challenge received 33 applications for mobile device applications or web-based methods to help users coordinate and navigate life with dementia. The judging was based on creativity and innovation, rationale and potential impact, value to relevant stakeholders, usability, and functionality and feasibility.
First place, with $250,000, went to MapHabit for mobile software that provides behavior prompts with customizable picture-and-keyword visual maps to help people with activities of daily living. The platform has different interfaces for users: people with impaired memory, caregiver, or long-term care community manager. Simple commands, such as “take a shower,” are scheduled, with feedback provided to caregivers. The system takes advantage of the brain’s habit (procedural) memory system, the researchers say, rather than the hippocampal (declarative) memory system that is damaged early in AD.
A team from University of California, Los Angeles, won second prize of $100,000 for their web-based Dementia Care Software system, which helps coordinate complex medical and social services. The software, which can be integrated into any of the leading electronic health record systems, has already been used in support of the UCLA Alzheimer’s and Dementia Care Program, a nurse-practitioner co-management approach that includes structured needs assessment, individualized dementia care plans, and round-the-clock access for assistance and advice. The researchers say more than 2,600 patients with dementia have participated in the program so far.
Caregiver411, developed by researchers from North Carolina Agricultural and Technical State University, won the third-place prize of $50,000. The mobile app helps people make informed decisions by, for instance, capturing the care recipient’s stage of AD in order to provide targeted recommendations. Dementia caregivers can obtain tailored resources related to mental, emotional, physical, social, legal, and financial concerns. The app also gives them a forum for social connections and family chat groups through a messaging center.
The Eureka Challenge is part of the 21st Century Cures Act, signed into law in 2016, designed to help accelerate medical product development with innovations incorporating the perspectives of patients. More detailed project descriptions are available at www.nia.nih.gov/challenge-prize.
Concussion effects may linger on MRI 1 year after athletes resume play
Among athletes with concussion, the effects of the injury on brain physiology may persist when they return to play and 1 year later.
MRI measures from 24 athletes with concussion significantly differed from those of controls at various time points and changed over time, according to a study published in Neurology. “Different aspects of brain physiology have different patterns of long-term recovery,” the researchers wrote.
While guidelines for safe return to play mainly rely on the resolution of symptoms, “the findings in this study indicate that more research is needed ... to better understand optimal recovery time from a biological standpoint,” wrote first author Nathan W. Churchill, PhD, a researcher at St. Michael’s Hospital in Toronto, and colleagues.
The study provides “evidence of incomplete or ongoing recovery” when athletes return to play, which could entail “a potential risk for long-term sequelae, given the evidence of worse outcomes if a second concussion occurs before recovery is complete,” according to the investigators. In addition,
To examine whether concussion-related brain changes dissipate by 1 year after athletes receive medical clearance to return to play, Dr. Churchill and colleagues analyzed MRI data from 24 college athletes with concussion and 122 control athletes without concussion.
Athletes with concussion were scanned within 1 week of the injury, at return to play a median of 27 days after the concussion, and 1 year after return to play. Control athletes were scanned before the start of the season. Participants’ sports included volleyball, hockey, soccer, football, rugby, basketball, lacrosse, and water polo. The participants had a mean age of about 20 years, and about half were women.
Athletes with concussion had elevated mean diffusivity within 1 week of injury, at return to play, and 1 year later, compared with controls. In athletes with concussion, cerebral blood flow was elevated soon after concussion, normal at return to play, and decreased 1 year later, relative to controls. Global functional connectivity increased and white matter fractional anisotropy decreased near the time of injury and at return to play, but these measures did not significantly differ from those of controls at 1 year.
The study did not capture MRI changes between return to play and 1 year later. In addition, MRI changes might be influenced by a lack of training before resuming play, as well as by exertion and subconcussive impacts after returning to play, the authors noted.
The Canadian Institutes of Health Research, the Canadian Institute for Military and Veterans Health Research, and Siemens Healthineers Canada supported the study. Siemens makes the MRI equipment used in the study. Dr. Churchill and colleagues had no relevant disclosures.
SOURCE: Churchill NW et al. Neurology. 2019 Oct 16. doi: 10.1212/WNL.0000000000008523.
Among athletes with concussion, the effects of the injury on brain physiology may persist when they return to play and 1 year later.
MRI measures from 24 athletes with concussion significantly differed from those of controls at various time points and changed over time, according to a study published in Neurology. “Different aspects of brain physiology have different patterns of long-term recovery,” the researchers wrote.
While guidelines for safe return to play mainly rely on the resolution of symptoms, “the findings in this study indicate that more research is needed ... to better understand optimal recovery time from a biological standpoint,” wrote first author Nathan W. Churchill, PhD, a researcher at St. Michael’s Hospital in Toronto, and colleagues.
The study provides “evidence of incomplete or ongoing recovery” when athletes return to play, which could entail “a potential risk for long-term sequelae, given the evidence of worse outcomes if a second concussion occurs before recovery is complete,” according to the investigators. In addition,
To examine whether concussion-related brain changes dissipate by 1 year after athletes receive medical clearance to return to play, Dr. Churchill and colleagues analyzed MRI data from 24 college athletes with concussion and 122 control athletes without concussion.
Athletes with concussion were scanned within 1 week of the injury, at return to play a median of 27 days after the concussion, and 1 year after return to play. Control athletes were scanned before the start of the season. Participants’ sports included volleyball, hockey, soccer, football, rugby, basketball, lacrosse, and water polo. The participants had a mean age of about 20 years, and about half were women.
Athletes with concussion had elevated mean diffusivity within 1 week of injury, at return to play, and 1 year later, compared with controls. In athletes with concussion, cerebral blood flow was elevated soon after concussion, normal at return to play, and decreased 1 year later, relative to controls. Global functional connectivity increased and white matter fractional anisotropy decreased near the time of injury and at return to play, but these measures did not significantly differ from those of controls at 1 year.
The study did not capture MRI changes between return to play and 1 year later. In addition, MRI changes might be influenced by a lack of training before resuming play, as well as by exertion and subconcussive impacts after returning to play, the authors noted.
The Canadian Institutes of Health Research, the Canadian Institute for Military and Veterans Health Research, and Siemens Healthineers Canada supported the study. Siemens makes the MRI equipment used in the study. Dr. Churchill and colleagues had no relevant disclosures.
SOURCE: Churchill NW et al. Neurology. 2019 Oct 16. doi: 10.1212/WNL.0000000000008523.
Among athletes with concussion, the effects of the injury on brain physiology may persist when they return to play and 1 year later.
MRI measures from 24 athletes with concussion significantly differed from those of controls at various time points and changed over time, according to a study published in Neurology. “Different aspects of brain physiology have different patterns of long-term recovery,” the researchers wrote.
While guidelines for safe return to play mainly rely on the resolution of symptoms, “the findings in this study indicate that more research is needed ... to better understand optimal recovery time from a biological standpoint,” wrote first author Nathan W. Churchill, PhD, a researcher at St. Michael’s Hospital in Toronto, and colleagues.
The study provides “evidence of incomplete or ongoing recovery” when athletes return to play, which could entail “a potential risk for long-term sequelae, given the evidence of worse outcomes if a second concussion occurs before recovery is complete,” according to the investigators. In addition,
To examine whether concussion-related brain changes dissipate by 1 year after athletes receive medical clearance to return to play, Dr. Churchill and colleagues analyzed MRI data from 24 college athletes with concussion and 122 control athletes without concussion.
Athletes with concussion were scanned within 1 week of the injury, at return to play a median of 27 days after the concussion, and 1 year after return to play. Control athletes were scanned before the start of the season. Participants’ sports included volleyball, hockey, soccer, football, rugby, basketball, lacrosse, and water polo. The participants had a mean age of about 20 years, and about half were women.
Athletes with concussion had elevated mean diffusivity within 1 week of injury, at return to play, and 1 year later, compared with controls. In athletes with concussion, cerebral blood flow was elevated soon after concussion, normal at return to play, and decreased 1 year later, relative to controls. Global functional connectivity increased and white matter fractional anisotropy decreased near the time of injury and at return to play, but these measures did not significantly differ from those of controls at 1 year.
The study did not capture MRI changes between return to play and 1 year later. In addition, MRI changes might be influenced by a lack of training before resuming play, as well as by exertion and subconcussive impacts after returning to play, the authors noted.
The Canadian Institutes of Health Research, the Canadian Institute for Military and Veterans Health Research, and Siemens Healthineers Canada supported the study. Siemens makes the MRI equipment used in the study. Dr. Churchill and colleagues had no relevant disclosures.
SOURCE: Churchill NW et al. Neurology. 2019 Oct 16. doi: 10.1212/WNL.0000000000008523.
FROM NEUROLOGY
Key clinical point: Among athletes with concussion, the effects of the injury on brain physiology may persist when they return to play and 1 year later.
Major finding: Athletes with concussion had elevated mean diffusivity within 1 week of injury, at return to play, and 1 year later, compared with controls. In athletes with concussion, cerebral blood flow was elevated soon after concussion, normal at return to play, and decreased 1 year later. Global functional connectivity increased and white matter fractional anisotropy decreased near the time of injury and at return to play, but these measures did not significantly differ from those of controls at 1 year.
Study details: An observational study of 24 college athletes with concussion.
Disclosures: The study was supported by the Canadian Institutes of Health Research, the Canadian Institute for Military and Veterans Health Research, and Siemens Healthineers Canada. Siemens makes the MRI equipment used in the study. The researchers had no relevant disclosures.
Source: Churchill NW et al. Neurology. 2019 Oct 16. doi: 10.1212/WNL.0000000000008523.
In utero Zika exposure can have delayed consequences
WASHINGTON – Evidence continues to mount that infants born to moms infected with Zika virus during pregnancy can have neurodevelopmental abnormalities as they age even if they showed no defects at birth, based on follow-up of 890 Colombian children tracked by epidemiologists from the U.S. Centers for Disease Control and Prevention.
Among the 890 neonates born to mothers apparently infected with Zika during pregnancy and followed for up to 2 years, 40 of the 852 (5%) without a detectable birth defect at delivery went on to show some type of neurodevelopmental sequelae during up to 24 months of age, Margaret Honein, PhD, said at an annual scientific meeting on infectious diseases.
In addition, among the children without birth defects at delivery who received follow-up examinations out to about 2 years, the incidence of “alerts” for possible neurodevelopmental issues was 15%-20% for each of the four domains studied (gross motor, fine motor, hearing and language, and personal and social functions), said Dr. Honein, an epidemiologist and chief of the birth defects branch of the CDC. In contrast, 17 of the 38 children (45%) followed who had identifiable birth defects at delivery also showed neurodevelopmental abnormalities when reexamined as long as 2 years after birth. These possible neurodevelopmental abnormalities, designated as alerts, were identified in comparison with a contemporaneous cohort of children born to uninfected mothers in the same regions of Colombia and assessed by the CDC researchers.
This cohort of children born to mothers who became infected with Zika virus during the 2016 Colombian epidemic will not undergo any planned, additional follow-up beyond the initial 2 years, Dr. Honein noted.
The findings she reported were consistent with observations from a much smaller cohort of 70 infants born to Colombian mothers infected with Zika virus while pregnant who had a normal head circumference and a normal clinical examination at delivery. When assessed once or twice 4-18 months after birth, these 70 infants showed an overall greater than one standard deviation (z-score) drop in their scores on the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA) metric by 12 months after birth and continuing out to 18 months, said Sarah B. Mulkey, MD, a fetal-neonatal neurologist at Children’s National Health System in Washington. These deficits were especially pronounced in the mobility and social cognition domains of the four-domain WIDEA metric. The social cognition domain is an important predictor of later problems with executive function and other neurologic disorders, Dr. Mulkey said while reporting her findings in a separate talk at the meeting. She acknowledged that the analysis was flawed by comparing the WIDEA outcomes of the Zika virus–exposed children to healthy children from either inner-city Chicago or Canada. Dr. Mulkey said that she and her associates plan to characterize a population of Zika virus–unexposed children in Colombia to use for future comparisons.
The study reported by Dr. Honein involved an enhanced surveillance program launched by the CDC in 2016 in three regions of Colombia and included 1,190 pregnancies accompanied by Zika symptoms in the mother and with a reported pregnancy outcome, including 1,185 live births. Nearly half of the Zika infections occurred during the first trimester, and 34% occurred during the second trimester. However, fewer than a third of the pregnant women underwent some type of laboratory testing to confirm their infection, either by serology or by a DNA-based assay, and of these 28% had a positive finding. Dr. Honein cautioned that many of the specimens that tested negative for Zika virus may have been false negatives.
The birth defects identified among the infants born from an apparently affected pregnancy included brain abnormalities, eye anomalies, and microcephaly, with 5% of the 1,185 live births showing one or more of these outcomes. The neurodevelopmental deficits identified during follow-up of 890 of the children out to 2 years included seizures; abnormalities of tone, movement, or swallowing; and impairments of vision or hearing.
WASHINGTON – Evidence continues to mount that infants born to moms infected with Zika virus during pregnancy can have neurodevelopmental abnormalities as they age even if they showed no defects at birth, based on follow-up of 890 Colombian children tracked by epidemiologists from the U.S. Centers for Disease Control and Prevention.
Among the 890 neonates born to mothers apparently infected with Zika during pregnancy and followed for up to 2 years, 40 of the 852 (5%) without a detectable birth defect at delivery went on to show some type of neurodevelopmental sequelae during up to 24 months of age, Margaret Honein, PhD, said at an annual scientific meeting on infectious diseases.
In addition, among the children without birth defects at delivery who received follow-up examinations out to about 2 years, the incidence of “alerts” for possible neurodevelopmental issues was 15%-20% for each of the four domains studied (gross motor, fine motor, hearing and language, and personal and social functions), said Dr. Honein, an epidemiologist and chief of the birth defects branch of the CDC. In contrast, 17 of the 38 children (45%) followed who had identifiable birth defects at delivery also showed neurodevelopmental abnormalities when reexamined as long as 2 years after birth. These possible neurodevelopmental abnormalities, designated as alerts, were identified in comparison with a contemporaneous cohort of children born to uninfected mothers in the same regions of Colombia and assessed by the CDC researchers.
This cohort of children born to mothers who became infected with Zika virus during the 2016 Colombian epidemic will not undergo any planned, additional follow-up beyond the initial 2 years, Dr. Honein noted.
The findings she reported were consistent with observations from a much smaller cohort of 70 infants born to Colombian mothers infected with Zika virus while pregnant who had a normal head circumference and a normal clinical examination at delivery. When assessed once or twice 4-18 months after birth, these 70 infants showed an overall greater than one standard deviation (z-score) drop in their scores on the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA) metric by 12 months after birth and continuing out to 18 months, said Sarah B. Mulkey, MD, a fetal-neonatal neurologist at Children’s National Health System in Washington. These deficits were especially pronounced in the mobility and social cognition domains of the four-domain WIDEA metric. The social cognition domain is an important predictor of later problems with executive function and other neurologic disorders, Dr. Mulkey said while reporting her findings in a separate talk at the meeting. She acknowledged that the analysis was flawed by comparing the WIDEA outcomes of the Zika virus–exposed children to healthy children from either inner-city Chicago or Canada. Dr. Mulkey said that she and her associates plan to characterize a population of Zika virus–unexposed children in Colombia to use for future comparisons.
The study reported by Dr. Honein involved an enhanced surveillance program launched by the CDC in 2016 in three regions of Colombia and included 1,190 pregnancies accompanied by Zika symptoms in the mother and with a reported pregnancy outcome, including 1,185 live births. Nearly half of the Zika infections occurred during the first trimester, and 34% occurred during the second trimester. However, fewer than a third of the pregnant women underwent some type of laboratory testing to confirm their infection, either by serology or by a DNA-based assay, and of these 28% had a positive finding. Dr. Honein cautioned that many of the specimens that tested negative for Zika virus may have been false negatives.
The birth defects identified among the infants born from an apparently affected pregnancy included brain abnormalities, eye anomalies, and microcephaly, with 5% of the 1,185 live births showing one or more of these outcomes. The neurodevelopmental deficits identified during follow-up of 890 of the children out to 2 years included seizures; abnormalities of tone, movement, or swallowing; and impairments of vision or hearing.
WASHINGTON – Evidence continues to mount that infants born to moms infected with Zika virus during pregnancy can have neurodevelopmental abnormalities as they age even if they showed no defects at birth, based on follow-up of 890 Colombian children tracked by epidemiologists from the U.S. Centers for Disease Control and Prevention.
Among the 890 neonates born to mothers apparently infected with Zika during pregnancy and followed for up to 2 years, 40 of the 852 (5%) without a detectable birth defect at delivery went on to show some type of neurodevelopmental sequelae during up to 24 months of age, Margaret Honein, PhD, said at an annual scientific meeting on infectious diseases.
In addition, among the children without birth defects at delivery who received follow-up examinations out to about 2 years, the incidence of “alerts” for possible neurodevelopmental issues was 15%-20% for each of the four domains studied (gross motor, fine motor, hearing and language, and personal and social functions), said Dr. Honein, an epidemiologist and chief of the birth defects branch of the CDC. In contrast, 17 of the 38 children (45%) followed who had identifiable birth defects at delivery also showed neurodevelopmental abnormalities when reexamined as long as 2 years after birth. These possible neurodevelopmental abnormalities, designated as alerts, were identified in comparison with a contemporaneous cohort of children born to uninfected mothers in the same regions of Colombia and assessed by the CDC researchers.
This cohort of children born to mothers who became infected with Zika virus during the 2016 Colombian epidemic will not undergo any planned, additional follow-up beyond the initial 2 years, Dr. Honein noted.
The findings she reported were consistent with observations from a much smaller cohort of 70 infants born to Colombian mothers infected with Zika virus while pregnant who had a normal head circumference and a normal clinical examination at delivery. When assessed once or twice 4-18 months after birth, these 70 infants showed an overall greater than one standard deviation (z-score) drop in their scores on the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA) metric by 12 months after birth and continuing out to 18 months, said Sarah B. Mulkey, MD, a fetal-neonatal neurologist at Children’s National Health System in Washington. These deficits were especially pronounced in the mobility and social cognition domains of the four-domain WIDEA metric. The social cognition domain is an important predictor of later problems with executive function and other neurologic disorders, Dr. Mulkey said while reporting her findings in a separate talk at the meeting. She acknowledged that the analysis was flawed by comparing the WIDEA outcomes of the Zika virus–exposed children to healthy children from either inner-city Chicago or Canada. Dr. Mulkey said that she and her associates plan to characterize a population of Zika virus–unexposed children in Colombia to use for future comparisons.
The study reported by Dr. Honein involved an enhanced surveillance program launched by the CDC in 2016 in three regions of Colombia and included 1,190 pregnancies accompanied by Zika symptoms in the mother and with a reported pregnancy outcome, including 1,185 live births. Nearly half of the Zika infections occurred during the first trimester, and 34% occurred during the second trimester. However, fewer than a third of the pregnant women underwent some type of laboratory testing to confirm their infection, either by serology or by a DNA-based assay, and of these 28% had a positive finding. Dr. Honein cautioned that many of the specimens that tested negative for Zika virus may have been false negatives.
The birth defects identified among the infants born from an apparently affected pregnancy included brain abnormalities, eye anomalies, and microcephaly, with 5% of the 1,185 live births showing one or more of these outcomes. The neurodevelopmental deficits identified during follow-up of 890 of the children out to 2 years included seizures; abnormalities of tone, movement, or swallowing; and impairments of vision or hearing.
REPORTING FROM ID WEEK 2019
Minimize blood pressure peaks, variability after stroke reperfusion
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
REPORTING FROM ANA 2019
Neurologists publish consensus statement on stridor in MSA
The statement was published Oct. 1 in Neurology. In addition to reviewing the literature on the topic and providing recommendations, the authors described several areas for future research.
MSA is a rare neurodegenerative disorder that entails autonomic failure, cerebellar ataxia, and parkinsonism. Laryngeal stridor has a high positive predictive value in the diagnosis of MSA, but consensus about its definition and clinical implications had not been established previously. The Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) delle Scienze Neurologiche di Bologna (Italy) convened a consensus conference of experts in 2017 to determine diagnostic criteria for stridor in MSA, define its prognostic value, suggest treatment options, and indicate subjects for future research. The neurologists reviewed studies of any design that reported original data. They based their statements on 34 published articles, most of which were class III or IV.
The authors defined stridor in MSA as “a strained, high-pitched, harsh respiratory sound, mainly inspiratory, caused by laryngeal dysfunction leading to narrowing of the rima glottidis.” Stridor may occur exclusively during sleep or during sleep and wakefulness. It may be recognized during a clinical examination, through witness report, or through an audio recording. Neurologists may consider laryngoscopy to exclude mechanical lesions or functional vocal cord abnormalities related to other neurologic conditions, wrote the authors. Drug-induced sleep endoscopy and video polysomnography also may be considered.
Whether stridor, or certain features of stridor, affects survival in MSA is uncertain. “Stridor within 3 years of motor or autonomic symptom onset may shorten survival,” according to the statement. “However, identification of stridor onset may be difficult.” Moreover, stridor during wakefulness is considered to reflect a more advanced stage of disease, compared with stridor during sleep. Although stridor can be distressing for the patient and his or her caregivers, its influence on health-related quality of life has yet to be determined, according to the statement.
Continuous positive airway pressure (CPAP) during sleep can be a useful symptomatic treatment and should be considered a first-line therapy for stridor, wrote the authors. Tracheostomy, another effective symptomatic treatment, bypasses upper-airway obstruction at the larynx. “Persistent and severe stridor may require tracheostomy,” according to the statement. It is not certain whether CPAP improves survival in patients with MSA and stridor, and tracheostomy may improve survival. The literature contains insufficient evidence about whether minimally invasive procedures or botulinum toxin injections are effective symptomatic treatments for stridor, wrote the authors.
During their review of the literature, the authors identified what they considered to be several research gaps. The diagnosis of stridor remains challenging, and investigators should develop a questionnaire for detecting stridor, they wrote. A smartphone application also could be developed to recognize stridor automatically. “The relationship between stridor and other breathing disorders (i.e., central apneas and breathing rate abnormalities) and their respective contributions to disease prognosis and survival should be determined through a multicenter prospective study,” according to the statement. Finally, randomized controlled trials comparing CPAP and tracheostomy for various degrees of stridor could guide physicians’ choice of treatment.
The IRCCS funded the study. One of the authors is a section editor for Neurology, and other authors reported receiving honoraria from various companies such as Novartis, Sanofi, and UCB.
The statement was published Oct. 1 in Neurology. In addition to reviewing the literature on the topic and providing recommendations, the authors described several areas for future research.
MSA is a rare neurodegenerative disorder that entails autonomic failure, cerebellar ataxia, and parkinsonism. Laryngeal stridor has a high positive predictive value in the diagnosis of MSA, but consensus about its definition and clinical implications had not been established previously. The Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) delle Scienze Neurologiche di Bologna (Italy) convened a consensus conference of experts in 2017 to determine diagnostic criteria for stridor in MSA, define its prognostic value, suggest treatment options, and indicate subjects for future research. The neurologists reviewed studies of any design that reported original data. They based their statements on 34 published articles, most of which were class III or IV.
The authors defined stridor in MSA as “a strained, high-pitched, harsh respiratory sound, mainly inspiratory, caused by laryngeal dysfunction leading to narrowing of the rima glottidis.” Stridor may occur exclusively during sleep or during sleep and wakefulness. It may be recognized during a clinical examination, through witness report, or through an audio recording. Neurologists may consider laryngoscopy to exclude mechanical lesions or functional vocal cord abnormalities related to other neurologic conditions, wrote the authors. Drug-induced sleep endoscopy and video polysomnography also may be considered.
Whether stridor, or certain features of stridor, affects survival in MSA is uncertain. “Stridor within 3 years of motor or autonomic symptom onset may shorten survival,” according to the statement. “However, identification of stridor onset may be difficult.” Moreover, stridor during wakefulness is considered to reflect a more advanced stage of disease, compared with stridor during sleep. Although stridor can be distressing for the patient and his or her caregivers, its influence on health-related quality of life has yet to be determined, according to the statement.
Continuous positive airway pressure (CPAP) during sleep can be a useful symptomatic treatment and should be considered a first-line therapy for stridor, wrote the authors. Tracheostomy, another effective symptomatic treatment, bypasses upper-airway obstruction at the larynx. “Persistent and severe stridor may require tracheostomy,” according to the statement. It is not certain whether CPAP improves survival in patients with MSA and stridor, and tracheostomy may improve survival. The literature contains insufficient evidence about whether minimally invasive procedures or botulinum toxin injections are effective symptomatic treatments for stridor, wrote the authors.
During their review of the literature, the authors identified what they considered to be several research gaps. The diagnosis of stridor remains challenging, and investigators should develop a questionnaire for detecting stridor, they wrote. A smartphone application also could be developed to recognize stridor automatically. “The relationship between stridor and other breathing disorders (i.e., central apneas and breathing rate abnormalities) and their respective contributions to disease prognosis and survival should be determined through a multicenter prospective study,” according to the statement. Finally, randomized controlled trials comparing CPAP and tracheostomy for various degrees of stridor could guide physicians’ choice of treatment.
The IRCCS funded the study. One of the authors is a section editor for Neurology, and other authors reported receiving honoraria from various companies such as Novartis, Sanofi, and UCB.
The statement was published Oct. 1 in Neurology. In addition to reviewing the literature on the topic and providing recommendations, the authors described several areas for future research.
MSA is a rare neurodegenerative disorder that entails autonomic failure, cerebellar ataxia, and parkinsonism. Laryngeal stridor has a high positive predictive value in the diagnosis of MSA, but consensus about its definition and clinical implications had not been established previously. The Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) delle Scienze Neurologiche di Bologna (Italy) convened a consensus conference of experts in 2017 to determine diagnostic criteria for stridor in MSA, define its prognostic value, suggest treatment options, and indicate subjects for future research. The neurologists reviewed studies of any design that reported original data. They based their statements on 34 published articles, most of which were class III or IV.
The authors defined stridor in MSA as “a strained, high-pitched, harsh respiratory sound, mainly inspiratory, caused by laryngeal dysfunction leading to narrowing of the rima glottidis.” Stridor may occur exclusively during sleep or during sleep and wakefulness. It may be recognized during a clinical examination, through witness report, or through an audio recording. Neurologists may consider laryngoscopy to exclude mechanical lesions or functional vocal cord abnormalities related to other neurologic conditions, wrote the authors. Drug-induced sleep endoscopy and video polysomnography also may be considered.
Whether stridor, or certain features of stridor, affects survival in MSA is uncertain. “Stridor within 3 years of motor or autonomic symptom onset may shorten survival,” according to the statement. “However, identification of stridor onset may be difficult.” Moreover, stridor during wakefulness is considered to reflect a more advanced stage of disease, compared with stridor during sleep. Although stridor can be distressing for the patient and his or her caregivers, its influence on health-related quality of life has yet to be determined, according to the statement.
Continuous positive airway pressure (CPAP) during sleep can be a useful symptomatic treatment and should be considered a first-line therapy for stridor, wrote the authors. Tracheostomy, another effective symptomatic treatment, bypasses upper-airway obstruction at the larynx. “Persistent and severe stridor may require tracheostomy,” according to the statement. It is not certain whether CPAP improves survival in patients with MSA and stridor, and tracheostomy may improve survival. The literature contains insufficient evidence about whether minimally invasive procedures or botulinum toxin injections are effective symptomatic treatments for stridor, wrote the authors.
During their review of the literature, the authors identified what they considered to be several research gaps. The diagnosis of stridor remains challenging, and investigators should develop a questionnaire for detecting stridor, they wrote. A smartphone application also could be developed to recognize stridor automatically. “The relationship between stridor and other breathing disorders (i.e., central apneas and breathing rate abnormalities) and their respective contributions to disease prognosis and survival should be determined through a multicenter prospective study,” according to the statement. Finally, randomized controlled trials comparing CPAP and tracheostomy for various degrees of stridor could guide physicians’ choice of treatment.
The IRCCS funded the study. One of the authors is a section editor for Neurology, and other authors reported receiving honoraria from various companies such as Novartis, Sanofi, and UCB.
FROM NEUROLOGY
MRI saves money, better than CT in acute stroke
ST. LOUIS – , according to a review from Johns Hopkins University, Baltimore.
MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”
Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.
The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.
Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.
A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.
The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.
Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.
Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.
The average age for stroke admissions at Hopkins is 55 years, with as many men as women.
There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.
ST. LOUIS – , according to a review from Johns Hopkins University, Baltimore.
MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”
Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.
The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.
Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.
A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.
The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.
Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.
Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.
The average age for stroke admissions at Hopkins is 55 years, with as many men as women.
There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.
ST. LOUIS – , according to a review from Johns Hopkins University, Baltimore.
MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”
Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.
The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.
Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.
A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.
The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.
Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.
Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.
The average age for stroke admissions at Hopkins is 55 years, with as many men as women.
There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.
REPORTING FROM ANA 2019
Key clinical point: Getting an MRI first for suspected stroke, instead of a CT, saves money by avoiding unnecessary admissions and might lead to better outcomes.
Major finding: An MRI-first approach at a busy ED in downtown Baltimore would have saved $888,138 in 1 year.
Study details: Review of 320 patients with suspected ischemic strokes.
Disclosures: There was no industry funding, and the senior investigator did not have any relevant disclosures.
Source: Sherry E et al. ANA 2019. Abstract M123.
Retraining Working Memory to Reduce PTSD Symptoms
Working memory (WM)—the function that allows us to temporarily store information and use it for cognitive tasks like learning, reasoning, and comprehension—is thought to play an important role in managing anxiety and intrusive symptoms of posttraumatic stress disorder (PTSD). Researchers have found inefficient filtering of threatening material from WM and increased storage of task-irrelevant threat distractors are associated with elevated anxiety. Thus, veterans with high levels of anxiety may disproportionately allocate cognitive resources toward threatening stimuli, and have trouble keeping threatening thoughts from entering WM and staying there. People with PTSD also have been shown to have problems using WM in emotional contexts, making it hard for them to deal with stressful situations in work and personal life. Some research has suggested that WM training that incorporates affective stimuli may increase the ability to use WM in emotional contexts. In a pilot study, researchers from Medical College of Wisconsin and University of Wisconsin-Milwaukee expanded on that possibility by testing 2 kinds of WM training in 21 veterans with elevated PTSD symptoms.
Participants completed a pretest, 15 sessions of at-home computerized training, a posttest, and a 1-month follow-up session. The computerized tests included tasks to measure WM capacity, such as solving math questions while trying to remember a set of unrelated numbers. The participants were then assigned to active emotional WM training (n-back) or control emotional WM training (1-back). The n-back training involved constant updating of information stored in WM and shifting between visual and auditory stimuli using 8 different faces and 8 different negative words. The training sessions started at the 1-back level and increased in difficulty level by level with performance with > 95% accuracy, or were scaled back with performance with < 75% accuracy. The control training was the same but consisted only of 1 level.
Overall, the researchers say, contrary to their hypothesis, they did not find a significant difference in results from the 2 groups. But they did find that both trainings had an overall “significant and sizable” impact on PTSD symptoms in both groups: 73% of the n-back group and 60% of the 1-back group had a reduction of ≥ 10 points on the PTSD Checklist total scores, which the researchers say is considered a clinically meaningful change. Moreover, both groups showed a clinically meaningful reduction in symptoms at follow-up: 55% and 40%, respectively.
It was interesting, the researchers say, that both groups showed improvement, especially with the 1-back intervention, which they had used as a “minimally effective” control condition. They also note that, anecdotally, the participants found both interventions “quite challenging.” It may be that in this population even the 1-back intervention is enough to detectably reduce symptoms, the researchers say. They were also encouraged to see that the n-back condition (marginally) outperformed the 1-back condition in improving reexperiencing symptoms, theoretically the most relevant training target of WM-focused intervention. The researchers believe that their study yields useful pilot data, suggesting that n-back training can have a clinical impact primarily by reducing reexperiencing symptoms, which are highly likely to indicate the presence of impaired WM functioning.
Working memory (WM)—the function that allows us to temporarily store information and use it for cognitive tasks like learning, reasoning, and comprehension—is thought to play an important role in managing anxiety and intrusive symptoms of posttraumatic stress disorder (PTSD). Researchers have found inefficient filtering of threatening material from WM and increased storage of task-irrelevant threat distractors are associated with elevated anxiety. Thus, veterans with high levels of anxiety may disproportionately allocate cognitive resources toward threatening stimuli, and have trouble keeping threatening thoughts from entering WM and staying there. People with PTSD also have been shown to have problems using WM in emotional contexts, making it hard for them to deal with stressful situations in work and personal life. Some research has suggested that WM training that incorporates affective stimuli may increase the ability to use WM in emotional contexts. In a pilot study, researchers from Medical College of Wisconsin and University of Wisconsin-Milwaukee expanded on that possibility by testing 2 kinds of WM training in 21 veterans with elevated PTSD symptoms.
Participants completed a pretest, 15 sessions of at-home computerized training, a posttest, and a 1-month follow-up session. The computerized tests included tasks to measure WM capacity, such as solving math questions while trying to remember a set of unrelated numbers. The participants were then assigned to active emotional WM training (n-back) or control emotional WM training (1-back). The n-back training involved constant updating of information stored in WM and shifting between visual and auditory stimuli using 8 different faces and 8 different negative words. The training sessions started at the 1-back level and increased in difficulty level by level with performance with > 95% accuracy, or were scaled back with performance with < 75% accuracy. The control training was the same but consisted only of 1 level.
Overall, the researchers say, contrary to their hypothesis, they did not find a significant difference in results from the 2 groups. But they did find that both trainings had an overall “significant and sizable” impact on PTSD symptoms in both groups: 73% of the n-back group and 60% of the 1-back group had a reduction of ≥ 10 points on the PTSD Checklist total scores, which the researchers say is considered a clinically meaningful change. Moreover, both groups showed a clinically meaningful reduction in symptoms at follow-up: 55% and 40%, respectively.
It was interesting, the researchers say, that both groups showed improvement, especially with the 1-back intervention, which they had used as a “minimally effective” control condition. They also note that, anecdotally, the participants found both interventions “quite challenging.” It may be that in this population even the 1-back intervention is enough to detectably reduce symptoms, the researchers say. They were also encouraged to see that the n-back condition (marginally) outperformed the 1-back condition in improving reexperiencing symptoms, theoretically the most relevant training target of WM-focused intervention. The researchers believe that their study yields useful pilot data, suggesting that n-back training can have a clinical impact primarily by reducing reexperiencing symptoms, which are highly likely to indicate the presence of impaired WM functioning.
Working memory (WM)—the function that allows us to temporarily store information and use it for cognitive tasks like learning, reasoning, and comprehension—is thought to play an important role in managing anxiety and intrusive symptoms of posttraumatic stress disorder (PTSD). Researchers have found inefficient filtering of threatening material from WM and increased storage of task-irrelevant threat distractors are associated with elevated anxiety. Thus, veterans with high levels of anxiety may disproportionately allocate cognitive resources toward threatening stimuli, and have trouble keeping threatening thoughts from entering WM and staying there. People with PTSD also have been shown to have problems using WM in emotional contexts, making it hard for them to deal with stressful situations in work and personal life. Some research has suggested that WM training that incorporates affective stimuli may increase the ability to use WM in emotional contexts. In a pilot study, researchers from Medical College of Wisconsin and University of Wisconsin-Milwaukee expanded on that possibility by testing 2 kinds of WM training in 21 veterans with elevated PTSD symptoms.
Participants completed a pretest, 15 sessions of at-home computerized training, a posttest, and a 1-month follow-up session. The computerized tests included tasks to measure WM capacity, such as solving math questions while trying to remember a set of unrelated numbers. The participants were then assigned to active emotional WM training (n-back) or control emotional WM training (1-back). The n-back training involved constant updating of information stored in WM and shifting between visual and auditory stimuli using 8 different faces and 8 different negative words. The training sessions started at the 1-back level and increased in difficulty level by level with performance with > 95% accuracy, or were scaled back with performance with < 75% accuracy. The control training was the same but consisted only of 1 level.
Overall, the researchers say, contrary to their hypothesis, they did not find a significant difference in results from the 2 groups. But they did find that both trainings had an overall “significant and sizable” impact on PTSD symptoms in both groups: 73% of the n-back group and 60% of the 1-back group had a reduction of ≥ 10 points on the PTSD Checklist total scores, which the researchers say is considered a clinically meaningful change. Moreover, both groups showed a clinically meaningful reduction in symptoms at follow-up: 55% and 40%, respectively.
It was interesting, the researchers say, that both groups showed improvement, especially with the 1-back intervention, which they had used as a “minimally effective” control condition. They also note that, anecdotally, the participants found both interventions “quite challenging.” It may be that in this population even the 1-back intervention is enough to detectably reduce symptoms, the researchers say. They were also encouraged to see that the n-back condition (marginally) outperformed the 1-back condition in improving reexperiencing symptoms, theoretically the most relevant training target of WM-focused intervention. The researchers believe that their study yields useful pilot data, suggesting that n-back training can have a clinical impact primarily by reducing reexperiencing symptoms, which are highly likely to indicate the presence of impaired WM functioning.
FDA approves Reyvow for acute migraine treatment
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.