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Drug reduces oral mucositis without affecting tumor control
A small molecule can provide a “clinically meaningful reduction” in severe oral mucositis without affecting tumor control in head and neck cancer, according to an investigator from a phase 2 trial.
The molecule, GC4419 (avasopasem manganese), is designed to convert superoxide to hydrogen peroxide and oxygen, thereby protecting normal tissue from damage associated with radiotherapy.
Investigators tested GC4419 in a phase 2 trial of patients with locally advanced oral cavity or oropharynx cancer who received intensity-modulated radiotherapy plus cisplatin. Initial results from this trial were published in December (J Clin Oncol. 2019 Dec 1;37[34]:3256-65).
Carryn M. Anderson, MD, of University of Iowa Hospitals & Clinics in Iowa City, presented updated results at the Multidisciplinary Head and Neck Cancer Symposium, sponsored by the American Society for Radiation Oncology.
The trial (NCT02508389) enrolled 223 patients scheduled to be treated with intensity-modulated radiotherapy (60-72 Gy or greater than 50 Gy to more than two oral sites) plus cisplatin (weekly or every 3 weeks).
The patients were randomized to receive 30 mg of GC4419 (n = 73), 90 mg of GC4419 (n = 76), or placebo (n = 74) intravenously over 60 minutes prior to each radiotherapy fraction. Baseline patient and tumor characteristics were well balanced among the treatment arms.
Efficacy and safety
The study’s primary endpoint was the duration of severe oral mucositis. When compared with placebo, the 90-mg dose of GC4419 conferred a 92% reduction in median days of severe oral mucositis (P = .024).
The 90-mg dose of GC4419 also reduced the incidence of severe oral mucositis by 34% (P = .009) and the rate of grade 4 oral mucositis by 47% (P = .045) when compared with placebo.
“GC4419, particularly the 90-mg dosage, provides a clinically meaningful reduction in severe oral mucositis duration, incidence, and severity,” Dr. Anderson noted.
“Safety was comparable across study arms,” she added. “The most frequent adverse events were those already expected with cisplatin and radiation, and those were not worsened in any way by the addition of this drug.”
Adverse events expected with GC4419 were “mild and transient,” according to Dr. Anderson. These events included syncope, hypotension/orthostasis, and oral/facial paresthesia.
Grade 3 syncope occurred in 4% of patients in the placebo arm, 4% in the 30-mg arm, and 6% in the 90-mg arm. Grade 3 hypotension/orthostasis occurred in 6%, 4%, and 4%, respectively. Grade 1 oral/facial paresthesia occurred in 15%, 10%, and 19%, respectively.
Long-term outcomes
“The 1- and 2-year tumor control is similar with utilization of [GC4419], and this is consistent with the drug’s known mechanism and previous animal models,” Dr. Anderson said.
At 1 and 2 years, there were no significant differences between the treatment arms with regard to locoregional control, distant metastasis, progression-free survival, or overall survival.
The 1-year progression-free survival was 82% in the placebo arm, 86% in the 30-mg arm, and 80% in the 90-mg arm. The 1-year overall survival was 93%, 91%, and 88%, respectively.
The 2-year progression-free survival was 77% in the placebo arm, 76% in the 30-mg arm, and 77% in the 90-mg arm. The 1-year overall survival was 87%, 85%, and 86%, respectively.
From trials to practice
Despite the favorable results of this trial, meeting attendees expressed concerns that the administration of GC4419 may not be feasible in real-life because it is labor- and resource-intensive.
“Methodologically, the study was excellent,” said attendee Shahid Iqbal, MBBS, a consultant clinical oncologist at Newcastle upon Tyne Hospitals NHS Foundation Trust in the United Kingdom, who was not involved in this trial.
Dr. Iqbal noted that this placebo-controlled trial had a “very reasonable number of patients in each arm,” the 90-mg dose of GC4419 was “effective,” and the drug had “no adverse impact on survival.”
“However, in my personal opinion, this intravenous infusion on a daily basis is not feasible in real life,” Dr. Iqbal said. “I cannot see this becoming a standard of care in National Health Service UK. This is simply not cost-effective at all.”
Although she didn’t address costs, Dr. Anderson did acknowledge that administering GC4419 is labor intensive.
“But we are hopeful that, if this drug ultimately makes it to [Food and Drug Administration] approval, the efficacy benefits we are showing will make the work flow changes worthwhile,” she said. “We certainly have shown that, in this study, 44 institutions could make that happen. At the University of Iowa, we found it easiest to institute an infusion space within the department of radiation oncology rather than relying on our medical oncology colleagues to let us borrow a chair.”
GC4419 is now under investigation in a phase 3 trial (NCT03689712) and has received fast track and breakthrough therapy designations from the FDA.
The phase 2 trial was sponsored by Galera Therapeutics. Dr. Anderson is an uncompensated research adviser to the company. Dr. Iqbal has no relevant conflicts of interest.
SOURCE: Anderson CM et al. Head and Neck Cancer Symposium. Abstract LBA 2.
A small molecule can provide a “clinically meaningful reduction” in severe oral mucositis without affecting tumor control in head and neck cancer, according to an investigator from a phase 2 trial.
The molecule, GC4419 (avasopasem manganese), is designed to convert superoxide to hydrogen peroxide and oxygen, thereby protecting normal tissue from damage associated with radiotherapy.
Investigators tested GC4419 in a phase 2 trial of patients with locally advanced oral cavity or oropharynx cancer who received intensity-modulated radiotherapy plus cisplatin. Initial results from this trial were published in December (J Clin Oncol. 2019 Dec 1;37[34]:3256-65).
Carryn M. Anderson, MD, of University of Iowa Hospitals & Clinics in Iowa City, presented updated results at the Multidisciplinary Head and Neck Cancer Symposium, sponsored by the American Society for Radiation Oncology.
The trial (NCT02508389) enrolled 223 patients scheduled to be treated with intensity-modulated radiotherapy (60-72 Gy or greater than 50 Gy to more than two oral sites) plus cisplatin (weekly or every 3 weeks).
The patients were randomized to receive 30 mg of GC4419 (n = 73), 90 mg of GC4419 (n = 76), or placebo (n = 74) intravenously over 60 minutes prior to each radiotherapy fraction. Baseline patient and tumor characteristics were well balanced among the treatment arms.
Efficacy and safety
The study’s primary endpoint was the duration of severe oral mucositis. When compared with placebo, the 90-mg dose of GC4419 conferred a 92% reduction in median days of severe oral mucositis (P = .024).
The 90-mg dose of GC4419 also reduced the incidence of severe oral mucositis by 34% (P = .009) and the rate of grade 4 oral mucositis by 47% (P = .045) when compared with placebo.
“GC4419, particularly the 90-mg dosage, provides a clinically meaningful reduction in severe oral mucositis duration, incidence, and severity,” Dr. Anderson noted.
“Safety was comparable across study arms,” she added. “The most frequent adverse events were those already expected with cisplatin and radiation, and those were not worsened in any way by the addition of this drug.”
Adverse events expected with GC4419 were “mild and transient,” according to Dr. Anderson. These events included syncope, hypotension/orthostasis, and oral/facial paresthesia.
Grade 3 syncope occurred in 4% of patients in the placebo arm, 4% in the 30-mg arm, and 6% in the 90-mg arm. Grade 3 hypotension/orthostasis occurred in 6%, 4%, and 4%, respectively. Grade 1 oral/facial paresthesia occurred in 15%, 10%, and 19%, respectively.
Long-term outcomes
“The 1- and 2-year tumor control is similar with utilization of [GC4419], and this is consistent with the drug’s known mechanism and previous animal models,” Dr. Anderson said.
At 1 and 2 years, there were no significant differences between the treatment arms with regard to locoregional control, distant metastasis, progression-free survival, or overall survival.
The 1-year progression-free survival was 82% in the placebo arm, 86% in the 30-mg arm, and 80% in the 90-mg arm. The 1-year overall survival was 93%, 91%, and 88%, respectively.
The 2-year progression-free survival was 77% in the placebo arm, 76% in the 30-mg arm, and 77% in the 90-mg arm. The 1-year overall survival was 87%, 85%, and 86%, respectively.
From trials to practice
Despite the favorable results of this trial, meeting attendees expressed concerns that the administration of GC4419 may not be feasible in real-life because it is labor- and resource-intensive.
“Methodologically, the study was excellent,” said attendee Shahid Iqbal, MBBS, a consultant clinical oncologist at Newcastle upon Tyne Hospitals NHS Foundation Trust in the United Kingdom, who was not involved in this trial.
Dr. Iqbal noted that this placebo-controlled trial had a “very reasonable number of patients in each arm,” the 90-mg dose of GC4419 was “effective,” and the drug had “no adverse impact on survival.”
“However, in my personal opinion, this intravenous infusion on a daily basis is not feasible in real life,” Dr. Iqbal said. “I cannot see this becoming a standard of care in National Health Service UK. This is simply not cost-effective at all.”
Although she didn’t address costs, Dr. Anderson did acknowledge that administering GC4419 is labor intensive.
“But we are hopeful that, if this drug ultimately makes it to [Food and Drug Administration] approval, the efficacy benefits we are showing will make the work flow changes worthwhile,” she said. “We certainly have shown that, in this study, 44 institutions could make that happen. At the University of Iowa, we found it easiest to institute an infusion space within the department of radiation oncology rather than relying on our medical oncology colleagues to let us borrow a chair.”
GC4419 is now under investigation in a phase 3 trial (NCT03689712) and has received fast track and breakthrough therapy designations from the FDA.
The phase 2 trial was sponsored by Galera Therapeutics. Dr. Anderson is an uncompensated research adviser to the company. Dr. Iqbal has no relevant conflicts of interest.
SOURCE: Anderson CM et al. Head and Neck Cancer Symposium. Abstract LBA 2.
A small molecule can provide a “clinically meaningful reduction” in severe oral mucositis without affecting tumor control in head and neck cancer, according to an investigator from a phase 2 trial.
The molecule, GC4419 (avasopasem manganese), is designed to convert superoxide to hydrogen peroxide and oxygen, thereby protecting normal tissue from damage associated with radiotherapy.
Investigators tested GC4419 in a phase 2 trial of patients with locally advanced oral cavity or oropharynx cancer who received intensity-modulated radiotherapy plus cisplatin. Initial results from this trial were published in December (J Clin Oncol. 2019 Dec 1;37[34]:3256-65).
Carryn M. Anderson, MD, of University of Iowa Hospitals & Clinics in Iowa City, presented updated results at the Multidisciplinary Head and Neck Cancer Symposium, sponsored by the American Society for Radiation Oncology.
The trial (NCT02508389) enrolled 223 patients scheduled to be treated with intensity-modulated radiotherapy (60-72 Gy or greater than 50 Gy to more than two oral sites) plus cisplatin (weekly or every 3 weeks).
The patients were randomized to receive 30 mg of GC4419 (n = 73), 90 mg of GC4419 (n = 76), or placebo (n = 74) intravenously over 60 minutes prior to each radiotherapy fraction. Baseline patient and tumor characteristics were well balanced among the treatment arms.
Efficacy and safety
The study’s primary endpoint was the duration of severe oral mucositis. When compared with placebo, the 90-mg dose of GC4419 conferred a 92% reduction in median days of severe oral mucositis (P = .024).
The 90-mg dose of GC4419 also reduced the incidence of severe oral mucositis by 34% (P = .009) and the rate of grade 4 oral mucositis by 47% (P = .045) when compared with placebo.
“GC4419, particularly the 90-mg dosage, provides a clinically meaningful reduction in severe oral mucositis duration, incidence, and severity,” Dr. Anderson noted.
“Safety was comparable across study arms,” she added. “The most frequent adverse events were those already expected with cisplatin and radiation, and those were not worsened in any way by the addition of this drug.”
Adverse events expected with GC4419 were “mild and transient,” according to Dr. Anderson. These events included syncope, hypotension/orthostasis, and oral/facial paresthesia.
Grade 3 syncope occurred in 4% of patients in the placebo arm, 4% in the 30-mg arm, and 6% in the 90-mg arm. Grade 3 hypotension/orthostasis occurred in 6%, 4%, and 4%, respectively. Grade 1 oral/facial paresthesia occurred in 15%, 10%, and 19%, respectively.
Long-term outcomes
“The 1- and 2-year tumor control is similar with utilization of [GC4419], and this is consistent with the drug’s known mechanism and previous animal models,” Dr. Anderson said.
At 1 and 2 years, there were no significant differences between the treatment arms with regard to locoregional control, distant metastasis, progression-free survival, or overall survival.
The 1-year progression-free survival was 82% in the placebo arm, 86% in the 30-mg arm, and 80% in the 90-mg arm. The 1-year overall survival was 93%, 91%, and 88%, respectively.
The 2-year progression-free survival was 77% in the placebo arm, 76% in the 30-mg arm, and 77% in the 90-mg arm. The 1-year overall survival was 87%, 85%, and 86%, respectively.
From trials to practice
Despite the favorable results of this trial, meeting attendees expressed concerns that the administration of GC4419 may not be feasible in real-life because it is labor- and resource-intensive.
“Methodologically, the study was excellent,” said attendee Shahid Iqbal, MBBS, a consultant clinical oncologist at Newcastle upon Tyne Hospitals NHS Foundation Trust in the United Kingdom, who was not involved in this trial.
Dr. Iqbal noted that this placebo-controlled trial had a “very reasonable number of patients in each arm,” the 90-mg dose of GC4419 was “effective,” and the drug had “no adverse impact on survival.”
“However, in my personal opinion, this intravenous infusion on a daily basis is not feasible in real life,” Dr. Iqbal said. “I cannot see this becoming a standard of care in National Health Service UK. This is simply not cost-effective at all.”
Although she didn’t address costs, Dr. Anderson did acknowledge that administering GC4419 is labor intensive.
“But we are hopeful that, if this drug ultimately makes it to [Food and Drug Administration] approval, the efficacy benefits we are showing will make the work flow changes worthwhile,” she said. “We certainly have shown that, in this study, 44 institutions could make that happen. At the University of Iowa, we found it easiest to institute an infusion space within the department of radiation oncology rather than relying on our medical oncology colleagues to let us borrow a chair.”
GC4419 is now under investigation in a phase 3 trial (NCT03689712) and has received fast track and breakthrough therapy designations from the FDA.
The phase 2 trial was sponsored by Galera Therapeutics. Dr. Anderson is an uncompensated research adviser to the company. Dr. Iqbal has no relevant conflicts of interest.
SOURCE: Anderson CM et al. Head and Neck Cancer Symposium. Abstract LBA 2.
REPORTING FROM HEAD AND NECK CANCERS SYMPOSIUM 2020
Know the 15% rule in scleroderma
MAUI, HAWAII – The 15% rule in scleroderma is a handy tool that raises awareness of the disease’s associated prevalence of various severe organ complications so clinicians can screen appropriately, Janet Pope, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Dr. Pope and colleagues in the Canadian Scleroderma Research Group developed the 15% rule because they recognized that scleroderma is rare enough that most physicians practicing outside of a few specialized centers don’t see many affected patients. The systemic autoimmune disease is marked by numerous possible expressions of vascular inflammation and malfunction, fibrosis, and autoimmunity in different organ systems.
“A lot of clinicians do not know how common this stuff is,” according to Dr. Pope, professor of medicine at the University of Western Ontario and head of the division of rheumatology at St. Joseph’s Health Center in London, Ont.
Basically, the 15% rule holds that, at any given time, a patient with scleroderma has roughly a 15% chance – or one in six – of having any of an extensive array of severe organ complications. That means a 15% chance of having prevalent clinically significant pulmonary hypertension as defined by a systolic pulmonary artery pressure of 45 mm Hg or more on Doppler echocardiography, a 15% likelihood of interstitial lung disease or clinically significant pulmonary fibrosis as suggested by a forced vital capacity less than 70% of predicted, a 15% prevalence of Sjögren’s syndrome, a 15% likelihood of having pulmonary artery hypertension upon right heart catheterization, a 15% chance of inflammatory arthritis, and a one-in-six chance of having a myopathy or myositis. Also, diastolic dysfunction, 15%. Ditto symptomatic arrhythmias.
“It’s a good little rule of thumb,” Dr. Pope commented.
The odds of having a current digital ulcer on any given day? Again, about 15%. In addition, scleroderma patients have a 15% lifetime risk of developing a complicated digital ulcer requiring hospitalization and/or amputation, she continued.
And while the prevalence of scleroderma renal crisis in the overall population with scleroderma is low, at 3%, in the subgroup with diffuse cutaneous systemic sclerosis, it climbs to 12%-15%.
Every rule has its exceptions. The 15% rule doesn’t apply to Raynaud’s phenomenon, which is present in nearly all patients with scleroderma, nor to gastroesophageal reflux disease or dysphagia, present in roughly 80% of patients.
Dr. Pope and coinvestigators developed the 15% rule pertaining to the prevalence of serious organ complications in scleroderma by conducting a systematic review of 69 published studies, each including a minimum of 50 scleroderma patients. The detailed results of the systematic review have been published.
Dr. Pope reported receiving research grants from and/or serving as a consultant to more than a dozen pharmaceutical companies.
MAUI, HAWAII – The 15% rule in scleroderma is a handy tool that raises awareness of the disease’s associated prevalence of various severe organ complications so clinicians can screen appropriately, Janet Pope, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Dr. Pope and colleagues in the Canadian Scleroderma Research Group developed the 15% rule because they recognized that scleroderma is rare enough that most physicians practicing outside of a few specialized centers don’t see many affected patients. The systemic autoimmune disease is marked by numerous possible expressions of vascular inflammation and malfunction, fibrosis, and autoimmunity in different organ systems.
“A lot of clinicians do not know how common this stuff is,” according to Dr. Pope, professor of medicine at the University of Western Ontario and head of the division of rheumatology at St. Joseph’s Health Center in London, Ont.
Basically, the 15% rule holds that, at any given time, a patient with scleroderma has roughly a 15% chance – or one in six – of having any of an extensive array of severe organ complications. That means a 15% chance of having prevalent clinically significant pulmonary hypertension as defined by a systolic pulmonary artery pressure of 45 mm Hg or more on Doppler echocardiography, a 15% likelihood of interstitial lung disease or clinically significant pulmonary fibrosis as suggested by a forced vital capacity less than 70% of predicted, a 15% prevalence of Sjögren’s syndrome, a 15% likelihood of having pulmonary artery hypertension upon right heart catheterization, a 15% chance of inflammatory arthritis, and a one-in-six chance of having a myopathy or myositis. Also, diastolic dysfunction, 15%. Ditto symptomatic arrhythmias.
“It’s a good little rule of thumb,” Dr. Pope commented.
The odds of having a current digital ulcer on any given day? Again, about 15%. In addition, scleroderma patients have a 15% lifetime risk of developing a complicated digital ulcer requiring hospitalization and/or amputation, she continued.
And while the prevalence of scleroderma renal crisis in the overall population with scleroderma is low, at 3%, in the subgroup with diffuse cutaneous systemic sclerosis, it climbs to 12%-15%.
Every rule has its exceptions. The 15% rule doesn’t apply to Raynaud’s phenomenon, which is present in nearly all patients with scleroderma, nor to gastroesophageal reflux disease or dysphagia, present in roughly 80% of patients.
Dr. Pope and coinvestigators developed the 15% rule pertaining to the prevalence of serious organ complications in scleroderma by conducting a systematic review of 69 published studies, each including a minimum of 50 scleroderma patients. The detailed results of the systematic review have been published.
Dr. Pope reported receiving research grants from and/or serving as a consultant to more than a dozen pharmaceutical companies.
MAUI, HAWAII – The 15% rule in scleroderma is a handy tool that raises awareness of the disease’s associated prevalence of various severe organ complications so clinicians can screen appropriately, Janet Pope, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Dr. Pope and colleagues in the Canadian Scleroderma Research Group developed the 15% rule because they recognized that scleroderma is rare enough that most physicians practicing outside of a few specialized centers don’t see many affected patients. The systemic autoimmune disease is marked by numerous possible expressions of vascular inflammation and malfunction, fibrosis, and autoimmunity in different organ systems.
“A lot of clinicians do not know how common this stuff is,” according to Dr. Pope, professor of medicine at the University of Western Ontario and head of the division of rheumatology at St. Joseph’s Health Center in London, Ont.
Basically, the 15% rule holds that, at any given time, a patient with scleroderma has roughly a 15% chance – or one in six – of having any of an extensive array of severe organ complications. That means a 15% chance of having prevalent clinically significant pulmonary hypertension as defined by a systolic pulmonary artery pressure of 45 mm Hg or more on Doppler echocardiography, a 15% likelihood of interstitial lung disease or clinically significant pulmonary fibrosis as suggested by a forced vital capacity less than 70% of predicted, a 15% prevalence of Sjögren’s syndrome, a 15% likelihood of having pulmonary artery hypertension upon right heart catheterization, a 15% chance of inflammatory arthritis, and a one-in-six chance of having a myopathy or myositis. Also, diastolic dysfunction, 15%. Ditto symptomatic arrhythmias.
“It’s a good little rule of thumb,” Dr. Pope commented.
The odds of having a current digital ulcer on any given day? Again, about 15%. In addition, scleroderma patients have a 15% lifetime risk of developing a complicated digital ulcer requiring hospitalization and/or amputation, she continued.
And while the prevalence of scleroderma renal crisis in the overall population with scleroderma is low, at 3%, in the subgroup with diffuse cutaneous systemic sclerosis, it climbs to 12%-15%.
Every rule has its exceptions. The 15% rule doesn’t apply to Raynaud’s phenomenon, which is present in nearly all patients with scleroderma, nor to gastroesophageal reflux disease or dysphagia, present in roughly 80% of patients.
Dr. Pope and coinvestigators developed the 15% rule pertaining to the prevalence of serious organ complications in scleroderma by conducting a systematic review of 69 published studies, each including a minimum of 50 scleroderma patients. The detailed results of the systematic review have been published.
Dr. Pope reported receiving research grants from and/or serving as a consultant to more than a dozen pharmaceutical companies.
REPORTING FROM RWCS 2020
Internal Medicine 2020 canceled
The American College of Physicians has recently joined the list of medical-specialty organizations to have canceled an upcoming meeting because of the ongoing COVID-19 (coronavirus disease) outbreak.
according to a statement from the organization.
“ACP’s decision is based on recent reports from the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) of rapidly escalating concerns about the Coronavirus Disease 2019 (COVID-19), and in recognition of the vital role of internal medicine physicians in diagnosing, managing, and caring for their patients and communities on the front lines,” according to the announcement.
The ACP is offering a refund to those who have already registered to attend the meeting.
The organization has included responses on its website to a number of frequently asked questions related to the cancellation. One response notes that ACP is offering paid registrants an opportunity to apply their meeting registration credit toward a 30-hour CME package, “which will be made available as soon as possible.” This package, named ACP CME 30, “will comprise curated, online lectures originally scheduled for live presentation at Internal Medicine Meeting 2020.”
The American College of Physicians has recently joined the list of medical-specialty organizations to have canceled an upcoming meeting because of the ongoing COVID-19 (coronavirus disease) outbreak.
according to a statement from the organization.
“ACP’s decision is based on recent reports from the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) of rapidly escalating concerns about the Coronavirus Disease 2019 (COVID-19), and in recognition of the vital role of internal medicine physicians in diagnosing, managing, and caring for their patients and communities on the front lines,” according to the announcement.
The ACP is offering a refund to those who have already registered to attend the meeting.
The organization has included responses on its website to a number of frequently asked questions related to the cancellation. One response notes that ACP is offering paid registrants an opportunity to apply their meeting registration credit toward a 30-hour CME package, “which will be made available as soon as possible.” This package, named ACP CME 30, “will comprise curated, online lectures originally scheduled for live presentation at Internal Medicine Meeting 2020.”
The American College of Physicians has recently joined the list of medical-specialty organizations to have canceled an upcoming meeting because of the ongoing COVID-19 (coronavirus disease) outbreak.
according to a statement from the organization.
“ACP’s decision is based on recent reports from the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) of rapidly escalating concerns about the Coronavirus Disease 2019 (COVID-19), and in recognition of the vital role of internal medicine physicians in diagnosing, managing, and caring for their patients and communities on the front lines,” according to the announcement.
The ACP is offering a refund to those who have already registered to attend the meeting.
The organization has included responses on its website to a number of frequently asked questions related to the cancellation. One response notes that ACP is offering paid registrants an opportunity to apply their meeting registration credit toward a 30-hour CME package, “which will be made available as soon as possible.” This package, named ACP CME 30, “will comprise curated, online lectures originally scheduled for live presentation at Internal Medicine Meeting 2020.”
American Headache Society updates guideline on neuroimaging for migraine
Migraine with atypical features may require neuroimaging, according to the guideline. These include an unusual aura; change in clinical features; a first or worst migraine; a migraine that presents with brainstem aura, confusion, or motor manifestation; migraine accompaniments in later life; headaches that are side-locked or posttraumatic; and aura that presents without headache.
Assessing the evidence
The recommendation to avoid MRI or CT in otherwise neurologically normal patients with migraine carried a grade A recommendation from the American Headache Society, while the specific considerations for neuroimaging was based on consensus and carried a grade C recommendation, according to lead author Randolph W. Evans, MD, of the department of neurology at Baylor College of Medicine in Houston, and colleagues.
The recommendations, published in the journal Headache (2020 Feb;60(2):318-36), came from a systematic review of 23 studies of adults at least 18 years old who underwent MRI or CT during outpatient treatment for migraine between 1973 and 2018. Ten studies looked at CT neuroimaging in patients with migraine, nine studies examined MRI neuroimaging alone in patients with migraine, and four studies contained adults with headache or migraine who underwent either MRI or CT. The majority of studies analyzed were retrospective or cross-sectional in nature, while four studies were prospective observational studies.
Dr. Evans and colleagues noted that neuroimaging for patients with suspected migraine is ordered for a variety of reasons, such as excluding conditions that aren’t migraine, diagnostic certainty, cognitive bias, practice workflow, medicolegal concerns, addressing patient and family anxiety, and addressing clinician anxiety. Neuroimaging also can be costly, they said, adding up to an estimated $1 billion annually according to one study, and can lead to additional testing from findings that may not be clinically significant.
Good advice, with caveats
In an interview, Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews, said that while he generally does not like broad guideline recommendations, the recommendation made by the American Headache Society to avoid neuroimaging in patients with a normal neurological examination without any atypical features and red flags “takes most of the important factors into consideration and will work almost all the time.” The recommendation made by consensus for specific considerations of neuroimaging was issued by top headache specialists in the United States who reviewed the data, and it is unlikely a patient with a migraine as diagnosed by the International Classification of Headache Disorders with a normal neurological examination would have a significant abnormality that would appear with imaging, Dr. Rapoport said.
“If everyone caring for migraine patients knew these recommendations, and used them unless the patients fit the exclusions mentioned, we would have more efficient clinical practice and save lots of money on unnecessary scanning,” he said.
However, Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles, founder of the New England Center for Headache, and past president of The International Headache Society, said that not all clinicians will be convinced by the American Headache Society’s recommendations.
“Various third parties often jump on society recommendations or guidelines and prevent smart clinicians from doing what they need to do when they want to disregard the recommendation or guideline,” he explained. “More importantly, if a physician feels the need to think out of the box and image a patient without a clear reason, and the patient cannot pay for the scan when a medical insurance company refuses to authorize it, there can be a bad result if the patient does not get the study.”
Dr. Rapoport noted that the guideline does not address situations where neuroimaging may not pick up conditions that lead to migraine, such as a subarachnoid or subdural hemorrhage, reversible cerebral vasoconstriction syndrome, or early aspects of low cerebrospinal fluid pressure syndrome. Anxiety on the part of the patient or the clinician is another area that can be addressed by future research, he said.
“If the clinician does a good job of explaining the odds of anything significant being found with a typical migraine history and normal examination, and the patient says [they] need an MRI with contrast to be sure, it will be difficult to dissuade them,” said Dr. Rapoport. “If you don’t order one, they will find a way to get one. If it is abnormal, you could be in trouble. Also, if the clinician has no good reason to do a scan but has anxiety about what is being missed, it will probably get done.”
There was no funding source for the guidelines. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, and consultancies for a variety of pharmaceutical companies, agencies, institutions, publishers, and other organizations.
Migraine with atypical features may require neuroimaging, according to the guideline. These include an unusual aura; change in clinical features; a first or worst migraine; a migraine that presents with brainstem aura, confusion, or motor manifestation; migraine accompaniments in later life; headaches that are side-locked or posttraumatic; and aura that presents without headache.
Assessing the evidence
The recommendation to avoid MRI or CT in otherwise neurologically normal patients with migraine carried a grade A recommendation from the American Headache Society, while the specific considerations for neuroimaging was based on consensus and carried a grade C recommendation, according to lead author Randolph W. Evans, MD, of the department of neurology at Baylor College of Medicine in Houston, and colleagues.
The recommendations, published in the journal Headache (2020 Feb;60(2):318-36), came from a systematic review of 23 studies of adults at least 18 years old who underwent MRI or CT during outpatient treatment for migraine between 1973 and 2018. Ten studies looked at CT neuroimaging in patients with migraine, nine studies examined MRI neuroimaging alone in patients with migraine, and four studies contained adults with headache or migraine who underwent either MRI or CT. The majority of studies analyzed were retrospective or cross-sectional in nature, while four studies were prospective observational studies.
Dr. Evans and colleagues noted that neuroimaging for patients with suspected migraine is ordered for a variety of reasons, such as excluding conditions that aren’t migraine, diagnostic certainty, cognitive bias, practice workflow, medicolegal concerns, addressing patient and family anxiety, and addressing clinician anxiety. Neuroimaging also can be costly, they said, adding up to an estimated $1 billion annually according to one study, and can lead to additional testing from findings that may not be clinically significant.
Good advice, with caveats
In an interview, Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews, said that while he generally does not like broad guideline recommendations, the recommendation made by the American Headache Society to avoid neuroimaging in patients with a normal neurological examination without any atypical features and red flags “takes most of the important factors into consideration and will work almost all the time.” The recommendation made by consensus for specific considerations of neuroimaging was issued by top headache specialists in the United States who reviewed the data, and it is unlikely a patient with a migraine as diagnosed by the International Classification of Headache Disorders with a normal neurological examination would have a significant abnormality that would appear with imaging, Dr. Rapoport said.
“If everyone caring for migraine patients knew these recommendations, and used them unless the patients fit the exclusions mentioned, we would have more efficient clinical practice and save lots of money on unnecessary scanning,” he said.
However, Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles, founder of the New England Center for Headache, and past president of The International Headache Society, said that not all clinicians will be convinced by the American Headache Society’s recommendations.
“Various third parties often jump on society recommendations or guidelines and prevent smart clinicians from doing what they need to do when they want to disregard the recommendation or guideline,” he explained. “More importantly, if a physician feels the need to think out of the box and image a patient without a clear reason, and the patient cannot pay for the scan when a medical insurance company refuses to authorize it, there can be a bad result if the patient does not get the study.”
Dr. Rapoport noted that the guideline does not address situations where neuroimaging may not pick up conditions that lead to migraine, such as a subarachnoid or subdural hemorrhage, reversible cerebral vasoconstriction syndrome, or early aspects of low cerebrospinal fluid pressure syndrome. Anxiety on the part of the patient or the clinician is another area that can be addressed by future research, he said.
“If the clinician does a good job of explaining the odds of anything significant being found with a typical migraine history and normal examination, and the patient says [they] need an MRI with contrast to be sure, it will be difficult to dissuade them,” said Dr. Rapoport. “If you don’t order one, they will find a way to get one. If it is abnormal, you could be in trouble. Also, if the clinician has no good reason to do a scan but has anxiety about what is being missed, it will probably get done.”
There was no funding source for the guidelines. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, and consultancies for a variety of pharmaceutical companies, agencies, institutions, publishers, and other organizations.
Migraine with atypical features may require neuroimaging, according to the guideline. These include an unusual aura; change in clinical features; a first or worst migraine; a migraine that presents with brainstem aura, confusion, or motor manifestation; migraine accompaniments in later life; headaches that are side-locked or posttraumatic; and aura that presents without headache.
Assessing the evidence
The recommendation to avoid MRI or CT in otherwise neurologically normal patients with migraine carried a grade A recommendation from the American Headache Society, while the specific considerations for neuroimaging was based on consensus and carried a grade C recommendation, according to lead author Randolph W. Evans, MD, of the department of neurology at Baylor College of Medicine in Houston, and colleagues.
The recommendations, published in the journal Headache (2020 Feb;60(2):318-36), came from a systematic review of 23 studies of adults at least 18 years old who underwent MRI or CT during outpatient treatment for migraine between 1973 and 2018. Ten studies looked at CT neuroimaging in patients with migraine, nine studies examined MRI neuroimaging alone in patients with migraine, and four studies contained adults with headache or migraine who underwent either MRI or CT. The majority of studies analyzed were retrospective or cross-sectional in nature, while four studies were prospective observational studies.
Dr. Evans and colleagues noted that neuroimaging for patients with suspected migraine is ordered for a variety of reasons, such as excluding conditions that aren’t migraine, diagnostic certainty, cognitive bias, practice workflow, medicolegal concerns, addressing patient and family anxiety, and addressing clinician anxiety. Neuroimaging also can be costly, they said, adding up to an estimated $1 billion annually according to one study, and can lead to additional testing from findings that may not be clinically significant.
Good advice, with caveats
In an interview, Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews, said that while he generally does not like broad guideline recommendations, the recommendation made by the American Headache Society to avoid neuroimaging in patients with a normal neurological examination without any atypical features and red flags “takes most of the important factors into consideration and will work almost all the time.” The recommendation made by consensus for specific considerations of neuroimaging was issued by top headache specialists in the United States who reviewed the data, and it is unlikely a patient with a migraine as diagnosed by the International Classification of Headache Disorders with a normal neurological examination would have a significant abnormality that would appear with imaging, Dr. Rapoport said.
“If everyone caring for migraine patients knew these recommendations, and used them unless the patients fit the exclusions mentioned, we would have more efficient clinical practice and save lots of money on unnecessary scanning,” he said.
However, Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles, founder of the New England Center for Headache, and past president of The International Headache Society, said that not all clinicians will be convinced by the American Headache Society’s recommendations.
“Various third parties often jump on society recommendations or guidelines and prevent smart clinicians from doing what they need to do when they want to disregard the recommendation or guideline,” he explained. “More importantly, if a physician feels the need to think out of the box and image a patient without a clear reason, and the patient cannot pay for the scan when a medical insurance company refuses to authorize it, there can be a bad result if the patient does not get the study.”
Dr. Rapoport noted that the guideline does not address situations where neuroimaging may not pick up conditions that lead to migraine, such as a subarachnoid or subdural hemorrhage, reversible cerebral vasoconstriction syndrome, or early aspects of low cerebrospinal fluid pressure syndrome. Anxiety on the part of the patient or the clinician is another area that can be addressed by future research, he said.
“If the clinician does a good job of explaining the odds of anything significant being found with a typical migraine history and normal examination, and the patient says [they] need an MRI with contrast to be sure, it will be difficult to dissuade them,” said Dr. Rapoport. “If you don’t order one, they will find a way to get one. If it is abnormal, you could be in trouble. Also, if the clinician has no good reason to do a scan but has anxiety about what is being missed, it will probably get done.”
There was no funding source for the guidelines. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, and consultancies for a variety of pharmaceutical companies, agencies, institutions, publishers, and other organizations.
FROM HEADACHE
More postpartum weight gain with dolutegravir-based ART
Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.
The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.
Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.
Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m2), postpartum weight for the dolutegravir group was significantly higher.
Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).
Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).
The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.
Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.
Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.
Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.
“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.
The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.
SOURCE: Jao J et al. CROI 2020, Poster 00772.
Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.
The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.
Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.
Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m2), postpartum weight for the dolutegravir group was significantly higher.
Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).
Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).
The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.
Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.
Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.
Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.
“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.
The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.
SOURCE: Jao J et al. CROI 2020, Poster 00772.
Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.
The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.
Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.
Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m2), postpartum weight for the dolutegravir group was significantly higher.
Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).
Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).
The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.
Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.
Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.
Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.
“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.
The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.
SOURCE: Jao J et al. CROI 2020, Poster 00772.
FROM CROI 2020
Endocrine Society meeting canceled because of novel coronavirus
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.
The Endocrine Society has canceled its annual scientific meeting because of concerns about the novel coronavirus.
The conference was scheduled to take place March 28-31 in San Francisco. The announcement comes the same day as the American College of Cardiology/World Congress of Cardiology joint conference, scheduled for March 27-30 in Chicago, was also canceled.
“This is an unprecedented public health emergency that is clearly impacting not only the city of San Francisco, but many nations around the world. As such, it is with a very heavy heart that I am reporting to you that out of an abundance of caution, the board of directors has decided to cancel ENDO 2020,” Endocrine Society president E. Dale Abel, MD, PhD, said in a news release.
The Endocrine Society has canceled its annual meeting only twice before in its 104-year history, both during World War II. This year, more than 9,000 people were expected to attend the meeting. “Like you, ENDO is one of the highlights of my professional life each year, and I am sure that you are just as disappointed as I am to hear this news,” Dr. Abel said.
As recently as last week, the society’s board of directors had still hoped that the meeting could take place, but over the weekend it consulted with the San Francisco Department of Public Health, which has recommended canceling or postponing all nonessential gatherings.
The society also has been following reports from the U.S. Centers for Disease Control and Prevention and the World Health Organization.
Moreover, Dr. Abel said, “To add to our concerns, institutions across the world are restricting travel, making it impossible for many who have registered for ENDO 2020 to attend and enjoy the meeting.”
The concerns extend even further, as attendance could take health care providers away from where they’re needed most during the emergency.
“By holding the meeting, we might not only put attendees at risk, but we may also displace health care workers during a public health crisis. This could occur because of the need to self-quarantine upon your return home or, in a worse scenario, contribute to spreading the virus to our attendees’ hometowns,” he said.
Meeting registrants will be contacted soon with refund information. Dr. Abel gave a “special thank you” to the annual meeting steering committee and staff, “who have poured so much into this meeting.”
The society is currently “exploring ways in which we might be able to deliver to our registrants content from ENDO 2020 in various venues in the coming year.”
This article first appeared on Medscape.com.
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.
The Endocrine Society has canceled its annual scientific meeting because of concerns about the novel coronavirus.
The conference was scheduled to take place March 28-31 in San Francisco. The announcement comes the same day as the American College of Cardiology/World Congress of Cardiology joint conference, scheduled for March 27-30 in Chicago, was also canceled.
“This is an unprecedented public health emergency that is clearly impacting not only the city of San Francisco, but many nations around the world. As such, it is with a very heavy heart that I am reporting to you that out of an abundance of caution, the board of directors has decided to cancel ENDO 2020,” Endocrine Society president E. Dale Abel, MD, PhD, said in a news release.
The Endocrine Society has canceled its annual meeting only twice before in its 104-year history, both during World War II. This year, more than 9,000 people were expected to attend the meeting. “Like you, ENDO is one of the highlights of my professional life each year, and I am sure that you are just as disappointed as I am to hear this news,” Dr. Abel said.
As recently as last week, the society’s board of directors had still hoped that the meeting could take place, but over the weekend it consulted with the San Francisco Department of Public Health, which has recommended canceling or postponing all nonessential gatherings.
The society also has been following reports from the U.S. Centers for Disease Control and Prevention and the World Health Organization.
Moreover, Dr. Abel said, “To add to our concerns, institutions across the world are restricting travel, making it impossible for many who have registered for ENDO 2020 to attend and enjoy the meeting.”
The concerns extend even further, as attendance could take health care providers away from where they’re needed most during the emergency.
“By holding the meeting, we might not only put attendees at risk, but we may also displace health care workers during a public health crisis. This could occur because of the need to self-quarantine upon your return home or, in a worse scenario, contribute to spreading the virus to our attendees’ hometowns,” he said.
Meeting registrants will be contacted soon with refund information. Dr. Abel gave a “special thank you” to the annual meeting steering committee and staff, “who have poured so much into this meeting.”
The society is currently “exploring ways in which we might be able to deliver to our registrants content from ENDO 2020 in various venues in the coming year.”
This article first appeared on Medscape.com.
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.
The Endocrine Society has canceled its annual scientific meeting because of concerns about the novel coronavirus.
The conference was scheduled to take place March 28-31 in San Francisco. The announcement comes the same day as the American College of Cardiology/World Congress of Cardiology joint conference, scheduled for March 27-30 in Chicago, was also canceled.
“This is an unprecedented public health emergency that is clearly impacting not only the city of San Francisco, but many nations around the world. As such, it is with a very heavy heart that I am reporting to you that out of an abundance of caution, the board of directors has decided to cancel ENDO 2020,” Endocrine Society president E. Dale Abel, MD, PhD, said in a news release.
The Endocrine Society has canceled its annual meeting only twice before in its 104-year history, both during World War II. This year, more than 9,000 people were expected to attend the meeting. “Like you, ENDO is one of the highlights of my professional life each year, and I am sure that you are just as disappointed as I am to hear this news,” Dr. Abel said.
As recently as last week, the society’s board of directors had still hoped that the meeting could take place, but over the weekend it consulted with the San Francisco Department of Public Health, which has recommended canceling or postponing all nonessential gatherings.
The society also has been following reports from the U.S. Centers for Disease Control and Prevention and the World Health Organization.
Moreover, Dr. Abel said, “To add to our concerns, institutions across the world are restricting travel, making it impossible for many who have registered for ENDO 2020 to attend and enjoy the meeting.”
The concerns extend even further, as attendance could take health care providers away from where they’re needed most during the emergency.
“By holding the meeting, we might not only put attendees at risk, but we may also displace health care workers during a public health crisis. This could occur because of the need to self-quarantine upon your return home or, in a worse scenario, contribute to spreading the virus to our attendees’ hometowns,” he said.
Meeting registrants will be contacted soon with refund information. Dr. Abel gave a “special thank you” to the annual meeting steering committee and staff, “who have poured so much into this meeting.”
The society is currently “exploring ways in which we might be able to deliver to our registrants content from ENDO 2020 in various venues in the coming year.”
This article first appeared on Medscape.com.
Coronavirus outbreak prompts cancellation of AAD annual meeting
The American Academy of Dermatology annual meeting is the latest large medical conference to be canceled because of the coronavirus disease 2019 (COVID-19) outbreak.
“After carefully weighing the emerging facts, as well as our duties to the Academy, our members, other meeting attendees, and the local communities we as dermatologists serve, the AAD has made the difficult but necessary decision to cancel the AAD 2020 Annual Meeting in Denver,” AAD President George Hruza, MD, said in an announcement posted on the AAD’s website late on March 9. “We also want to respect our physicians’ need to be available to and healthy for their own patients, communities, and countries,” he added.
Earlier in the day, the American College of Cardiology announced that its annual meeting would be canceled, as did the Society of Gynecologic Oncology.
In his statement, Dr. Hruza said that the AAD is looking into “virtual meeting options” to provide content that was scheduled to be presented at the meeting.
Updates on those plans will be posted on the AAD’s website at www.aad.org.
The American Academy of Dermatology annual meeting is the latest large medical conference to be canceled because of the coronavirus disease 2019 (COVID-19) outbreak.
“After carefully weighing the emerging facts, as well as our duties to the Academy, our members, other meeting attendees, and the local communities we as dermatologists serve, the AAD has made the difficult but necessary decision to cancel the AAD 2020 Annual Meeting in Denver,” AAD President George Hruza, MD, said in an announcement posted on the AAD’s website late on March 9. “We also want to respect our physicians’ need to be available to and healthy for their own patients, communities, and countries,” he added.
Earlier in the day, the American College of Cardiology announced that its annual meeting would be canceled, as did the Society of Gynecologic Oncology.
In his statement, Dr. Hruza said that the AAD is looking into “virtual meeting options” to provide content that was scheduled to be presented at the meeting.
Updates on those plans will be posted on the AAD’s website at www.aad.org.
The American Academy of Dermatology annual meeting is the latest large medical conference to be canceled because of the coronavirus disease 2019 (COVID-19) outbreak.
“After carefully weighing the emerging facts, as well as our duties to the Academy, our members, other meeting attendees, and the local communities we as dermatologists serve, the AAD has made the difficult but necessary decision to cancel the AAD 2020 Annual Meeting in Denver,” AAD President George Hruza, MD, said in an announcement posted on the AAD’s website late on March 9. “We also want to respect our physicians’ need to be available to and healthy for their own patients, communities, and countries,” he added.
Earlier in the day, the American College of Cardiology announced that its annual meeting would be canceled, as did the Society of Gynecologic Oncology.
In his statement, Dr. Hruza said that the AAD is looking into “virtual meeting options” to provide content that was scheduled to be presented at the meeting.
Updates on those plans will be posted on the AAD’s website at www.aad.org.
British Society for Rheumatology cancels annual conference
The British Society for Rheumatology (BSR) has canceled its annual conference that was scheduled to take place April 20-22 in Glasgow.
“After careful monitoring of the COVID-19 (coronavirus) situation ... [and] in light of increasing demands on health services, our Board of Trustees felt it was no longer appropriate to host a large-scale event nor to take medical professionals away from where they may be needed most in the coming weeks,” the organization announced on its website.
The BSR said that it will soon have more information available for people affected, including “details of how we will showcase some of the content that would have been celebrated at the event.”
The British Society for Rheumatology (BSR) has canceled its annual conference that was scheduled to take place April 20-22 in Glasgow.
“After careful monitoring of the COVID-19 (coronavirus) situation ... [and] in light of increasing demands on health services, our Board of Trustees felt it was no longer appropriate to host a large-scale event nor to take medical professionals away from where they may be needed most in the coming weeks,” the organization announced on its website.
The BSR said that it will soon have more information available for people affected, including “details of how we will showcase some of the content that would have been celebrated at the event.”
The British Society for Rheumatology (BSR) has canceled its annual conference that was scheduled to take place April 20-22 in Glasgow.
“After careful monitoring of the COVID-19 (coronavirus) situation ... [and] in light of increasing demands on health services, our Board of Trustees felt it was no longer appropriate to host a large-scale event nor to take medical professionals away from where they may be needed most in the coming weeks,” the organization announced on its website.
The BSR said that it will soon have more information available for people affected, including “details of how we will showcase some of the content that would have been celebrated at the event.”
Supreme Court to rule on Louisiana abortion rules by end of summer
The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.
Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.
During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.
“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”
Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.
“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”
During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”
Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.
“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”
Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.
Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.
During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.
“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.
The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.
“We’re not going to solve this at oral argument,” he said.
A decision by the Supreme Court is expected by August 2020.
The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.
Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.
During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.
“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”
Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.
“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”
During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”
Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.
“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”
Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.
Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.
During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.
“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.
The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.
“We’re not going to solve this at oral argument,” he said.
A decision by the Supreme Court is expected by August 2020.
The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.
Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.
During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.
“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”
Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.
“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”
During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”
Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.
“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”
Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.
Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.
During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.
“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.
The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.
“We’re not going to solve this at oral argument,” he said.
A decision by the Supreme Court is expected by August 2020.
Hyperlipidemia occurs earlier in patients with MS
WEST PALM BEACH, FLA. – Onset of hyperlipidemia tends to occur earlier in patients with multiple sclerosis (MS), compared with matched controls, according to new research. Among females and African Americans, the effect of MS on age of hyperlipidemia onset may be especially pronounced, said Diane Krill, PhD, professor of biological sciences at Point Park University, Pittsburgh, and colleagues.
Many patients with MS have hyperlipidemia, and adverse lipid profiles correlate with physical and cognitive impairment in this population. “There is evidence of endothelial dysfunction and inflammation in both MS and hyperlipidemia, but the timing of onset of hyperlipidemia is not known,” the researchers said at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
To assess whether patients with MS have hyperlipidemia diagnosed at an earlier age, relative to matched controls, Dr. Krill and colleagues analyzed data from the Cleveland Clinic health system. They included in their analyses patients with at least two hyperlipidemia diagnoses and at least five encounters with a primary care physician. They matched each patient with MS to four patients without MS using variables such as birth year, sex, race, and year of first encounter. In all, the study included 669 patients with MS and 2,676 controls. The investigators examined age of hyperlipidemia onset using multivariable Cox proportional hazard models that adjusted for sex, race, smoking, and body mass index.
Patients with MS had a 20% increased risk for earlier onset of hyperlipidemia, relative to matched controls. The effect was greater among females (hazard ratio, 1.22) and African Americans (HR, 1.42). Patients with MS have earlier onset of hyperlipidemia “irrespective of the relationship with age of MS onset,” Dr. Krill and colleagues noted. “Additional research is warranted to further characterize the temporal relationships between MS and hyperlipidemia, as well as considerations for timing of disease-modifying therapies.”
The researchers had no relevant disclosures.
SOURCE: Krill D et al. ACTRIMS Forum 2020, Abstract P085.
WEST PALM BEACH, FLA. – Onset of hyperlipidemia tends to occur earlier in patients with multiple sclerosis (MS), compared with matched controls, according to new research. Among females and African Americans, the effect of MS on age of hyperlipidemia onset may be especially pronounced, said Diane Krill, PhD, professor of biological sciences at Point Park University, Pittsburgh, and colleagues.
Many patients with MS have hyperlipidemia, and adverse lipid profiles correlate with physical and cognitive impairment in this population. “There is evidence of endothelial dysfunction and inflammation in both MS and hyperlipidemia, but the timing of onset of hyperlipidemia is not known,” the researchers said at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
To assess whether patients with MS have hyperlipidemia diagnosed at an earlier age, relative to matched controls, Dr. Krill and colleagues analyzed data from the Cleveland Clinic health system. They included in their analyses patients with at least two hyperlipidemia diagnoses and at least five encounters with a primary care physician. They matched each patient with MS to four patients without MS using variables such as birth year, sex, race, and year of first encounter. In all, the study included 669 patients with MS and 2,676 controls. The investigators examined age of hyperlipidemia onset using multivariable Cox proportional hazard models that adjusted for sex, race, smoking, and body mass index.
Patients with MS had a 20% increased risk for earlier onset of hyperlipidemia, relative to matched controls. The effect was greater among females (hazard ratio, 1.22) and African Americans (HR, 1.42). Patients with MS have earlier onset of hyperlipidemia “irrespective of the relationship with age of MS onset,” Dr. Krill and colleagues noted. “Additional research is warranted to further characterize the temporal relationships between MS and hyperlipidemia, as well as considerations for timing of disease-modifying therapies.”
The researchers had no relevant disclosures.
SOURCE: Krill D et al. ACTRIMS Forum 2020, Abstract P085.
WEST PALM BEACH, FLA. – Onset of hyperlipidemia tends to occur earlier in patients with multiple sclerosis (MS), compared with matched controls, according to new research. Among females and African Americans, the effect of MS on age of hyperlipidemia onset may be especially pronounced, said Diane Krill, PhD, professor of biological sciences at Point Park University, Pittsburgh, and colleagues.
Many patients with MS have hyperlipidemia, and adverse lipid profiles correlate with physical and cognitive impairment in this population. “There is evidence of endothelial dysfunction and inflammation in both MS and hyperlipidemia, but the timing of onset of hyperlipidemia is not known,” the researchers said at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
To assess whether patients with MS have hyperlipidemia diagnosed at an earlier age, relative to matched controls, Dr. Krill and colleagues analyzed data from the Cleveland Clinic health system. They included in their analyses patients with at least two hyperlipidemia diagnoses and at least five encounters with a primary care physician. They matched each patient with MS to four patients without MS using variables such as birth year, sex, race, and year of first encounter. In all, the study included 669 patients with MS and 2,676 controls. The investigators examined age of hyperlipidemia onset using multivariable Cox proportional hazard models that adjusted for sex, race, smoking, and body mass index.
Patients with MS had a 20% increased risk for earlier onset of hyperlipidemia, relative to matched controls. The effect was greater among females (hazard ratio, 1.22) and African Americans (HR, 1.42). Patients with MS have earlier onset of hyperlipidemia “irrespective of the relationship with age of MS onset,” Dr. Krill and colleagues noted. “Additional research is warranted to further characterize the temporal relationships between MS and hyperlipidemia, as well as considerations for timing of disease-modifying therapies.”
The researchers had no relevant disclosures.
SOURCE: Krill D et al. ACTRIMS Forum 2020, Abstract P085.
REPORTING FROM ACTRIMS FORUM 2020