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Gunshot wound victims are at high risk for readmission
CHICAGO –
A study of individuals at a single institution who were hospitalized and had a prior history of gunshot wound found some patterns of injury that set patients up for a greater likelihood of readmission.
In particular, patients who sustained visceral gunshot wounds were over six times more likely to be readmitted to the hospital, Corbin Pomeranz, MD, a radiology resident at Thomas Jefferson University, Philadelphia, said in an interview at the annual meeting of the Radiological Society of North America. Dr. Pomeranz led the retrospective study that begins to fill a knowledge gap about what happens over the long term to those who sustain gunshot wounds.
“There continues to be profound lack of substantial information related to gun violence, particularly in predicting long-term outcomes,” Dr. Pomeranz and coauthors wrote in the abstract accompanying the presentation.
The researchers performed a single-site retrospective analysis over 3 months in 2018, tapping into an imaging database and looking for inpatient imaging exams that were nonacute, but related to gunshot wounds. From this information, the researchers went back to the original gunshot wound injury imaging, and recorded the pattern of injury, classifying wounds as neurologic, vascular, visceral, musculoskeletal, or involving multiple systems.
The investigators were able to glean additional information including the initial admitting hospital unit, information about interval admissions or surgeries, and demographic data. Regarding the nature of the gunshot injury itself, Dr. Pomeranz and coauthors went back to the earlier imaging studies to note bullet morphology, recording whether the bullet was intact, deformed, or had splintered into shrapnel within injured tissues.
In all, 174 imaging studies involving 110 patients were examined. Men made up 92% of the study population; the average age was 49.7 years. Neurologic and visceral gunshot wounds were moderately correlated with subsequent readmission (r = .436; P less than .001). However, some of this effect was blunted when patient age was controlled for in the statistical analysis.
Patients who were initially admitted to the intensive care unit, and who presumably had more severe injuries, were also more likely to be readmitted (r = .494, P less than .001). Here, “controlling for age had very little effect on the strength of the relationship between these two variables,” noted Dr. Pomeranz and coauthors.
A more elaborate statistical model incorporated several independent variables including age, type of injury, and body region involved, as well as bullet morphology. In this model, visceral injury was the strongest predictor for readmission, with an odds ratio of 6.44.
Dr. Pomeranz said that both the initial gunshot wound and subsequent gaps in care can contribute to readmissions. A patient who has a spinal cord injury may not be reimbursed adequately for supportive cushioning, or an appropriate wheelchair, and so may require admission for decubitus ulcers.
The number of admissions for osteomyelitis, which made up more than half of the subsequent admissions, initially surprised Dr. Pomeranz, until he realized that lack of mobility and sensory losses from gunshot-induced spinal cord injuries could easily lead to nonhealing lower extremity wounds, with osteomyelitis as a sequela.
Several patients were admitted for small bowel obstructions with no interval surgery since treatment for the gunshot wound. These readmissions, said Dr. Pomeranz, were assessed as related to the gunshot wound since it’s extremely rare for a patient with no history of abdominal surgery and no malignancy to have a small bowel obstruction. Exploratory laparotomies are common in the context of abdominal trauma caused by gunshot wounds, and either the gunshot itself or the laparotomy was the likely cause of adhesions.
Dr. Pomeranz acknowledged the many limitations of the study, but pointed out that some will be addressed when he and his coauthors conduct a larger study they have planned to look at readmissions from gunshot wounds at multiple hospitals in the Philadelphia area. The small sample size in the current study meant that the impact of socioeconomic status and other lifestyle and social variables and comorbidities couldn’t be adequately addressed in the statistical analysis. By casting a wider net within the greater Philadelphia area, the investigators should be able to track patients who receive care in more than one hospital system, increasing participant numbers, he said.
“Morbidity and outcomes from gun violence can only be assessed after a firm understanding of injury patterns on imaging,” noted Dr. Pomeranz. He said that interdisciplinary research investigating individual and societal short- and long-term costs of gun violence is sorely needed to inform public policy.
Dr. Pomeranz reported no outside sources of funding and reported that he had no conflicts of interest.
SOURCE: Pomeranz C et al. RSNA 2019, Presentation HP226-SD-THA3.
CHICAGO –
A study of individuals at a single institution who were hospitalized and had a prior history of gunshot wound found some patterns of injury that set patients up for a greater likelihood of readmission.
In particular, patients who sustained visceral gunshot wounds were over six times more likely to be readmitted to the hospital, Corbin Pomeranz, MD, a radiology resident at Thomas Jefferson University, Philadelphia, said in an interview at the annual meeting of the Radiological Society of North America. Dr. Pomeranz led the retrospective study that begins to fill a knowledge gap about what happens over the long term to those who sustain gunshot wounds.
“There continues to be profound lack of substantial information related to gun violence, particularly in predicting long-term outcomes,” Dr. Pomeranz and coauthors wrote in the abstract accompanying the presentation.
The researchers performed a single-site retrospective analysis over 3 months in 2018, tapping into an imaging database and looking for inpatient imaging exams that were nonacute, but related to gunshot wounds. From this information, the researchers went back to the original gunshot wound injury imaging, and recorded the pattern of injury, classifying wounds as neurologic, vascular, visceral, musculoskeletal, or involving multiple systems.
The investigators were able to glean additional information including the initial admitting hospital unit, information about interval admissions or surgeries, and demographic data. Regarding the nature of the gunshot injury itself, Dr. Pomeranz and coauthors went back to the earlier imaging studies to note bullet morphology, recording whether the bullet was intact, deformed, or had splintered into shrapnel within injured tissues.
In all, 174 imaging studies involving 110 patients were examined. Men made up 92% of the study population; the average age was 49.7 years. Neurologic and visceral gunshot wounds were moderately correlated with subsequent readmission (r = .436; P less than .001). However, some of this effect was blunted when patient age was controlled for in the statistical analysis.
Patients who were initially admitted to the intensive care unit, and who presumably had more severe injuries, were also more likely to be readmitted (r = .494, P less than .001). Here, “controlling for age had very little effect on the strength of the relationship between these two variables,” noted Dr. Pomeranz and coauthors.
A more elaborate statistical model incorporated several independent variables including age, type of injury, and body region involved, as well as bullet morphology. In this model, visceral injury was the strongest predictor for readmission, with an odds ratio of 6.44.
Dr. Pomeranz said that both the initial gunshot wound and subsequent gaps in care can contribute to readmissions. A patient who has a spinal cord injury may not be reimbursed adequately for supportive cushioning, or an appropriate wheelchair, and so may require admission for decubitus ulcers.
The number of admissions for osteomyelitis, which made up more than half of the subsequent admissions, initially surprised Dr. Pomeranz, until he realized that lack of mobility and sensory losses from gunshot-induced spinal cord injuries could easily lead to nonhealing lower extremity wounds, with osteomyelitis as a sequela.
Several patients were admitted for small bowel obstructions with no interval surgery since treatment for the gunshot wound. These readmissions, said Dr. Pomeranz, were assessed as related to the gunshot wound since it’s extremely rare for a patient with no history of abdominal surgery and no malignancy to have a small bowel obstruction. Exploratory laparotomies are common in the context of abdominal trauma caused by gunshot wounds, and either the gunshot itself or the laparotomy was the likely cause of adhesions.
Dr. Pomeranz acknowledged the many limitations of the study, but pointed out that some will be addressed when he and his coauthors conduct a larger study they have planned to look at readmissions from gunshot wounds at multiple hospitals in the Philadelphia area. The small sample size in the current study meant that the impact of socioeconomic status and other lifestyle and social variables and comorbidities couldn’t be adequately addressed in the statistical analysis. By casting a wider net within the greater Philadelphia area, the investigators should be able to track patients who receive care in more than one hospital system, increasing participant numbers, he said.
“Morbidity and outcomes from gun violence can only be assessed after a firm understanding of injury patterns on imaging,” noted Dr. Pomeranz. He said that interdisciplinary research investigating individual and societal short- and long-term costs of gun violence is sorely needed to inform public policy.
Dr. Pomeranz reported no outside sources of funding and reported that he had no conflicts of interest.
SOURCE: Pomeranz C et al. RSNA 2019, Presentation HP226-SD-THA3.
CHICAGO –
A study of individuals at a single institution who were hospitalized and had a prior history of gunshot wound found some patterns of injury that set patients up for a greater likelihood of readmission.
In particular, patients who sustained visceral gunshot wounds were over six times more likely to be readmitted to the hospital, Corbin Pomeranz, MD, a radiology resident at Thomas Jefferson University, Philadelphia, said in an interview at the annual meeting of the Radiological Society of North America. Dr. Pomeranz led the retrospective study that begins to fill a knowledge gap about what happens over the long term to those who sustain gunshot wounds.
“There continues to be profound lack of substantial information related to gun violence, particularly in predicting long-term outcomes,” Dr. Pomeranz and coauthors wrote in the abstract accompanying the presentation.
The researchers performed a single-site retrospective analysis over 3 months in 2018, tapping into an imaging database and looking for inpatient imaging exams that were nonacute, but related to gunshot wounds. From this information, the researchers went back to the original gunshot wound injury imaging, and recorded the pattern of injury, classifying wounds as neurologic, vascular, visceral, musculoskeletal, or involving multiple systems.
The investigators were able to glean additional information including the initial admitting hospital unit, information about interval admissions or surgeries, and demographic data. Regarding the nature of the gunshot injury itself, Dr. Pomeranz and coauthors went back to the earlier imaging studies to note bullet morphology, recording whether the bullet was intact, deformed, or had splintered into shrapnel within injured tissues.
In all, 174 imaging studies involving 110 patients were examined. Men made up 92% of the study population; the average age was 49.7 years. Neurologic and visceral gunshot wounds were moderately correlated with subsequent readmission (r = .436; P less than .001). However, some of this effect was blunted when patient age was controlled for in the statistical analysis.
Patients who were initially admitted to the intensive care unit, and who presumably had more severe injuries, were also more likely to be readmitted (r = .494, P less than .001). Here, “controlling for age had very little effect on the strength of the relationship between these two variables,” noted Dr. Pomeranz and coauthors.
A more elaborate statistical model incorporated several independent variables including age, type of injury, and body region involved, as well as bullet morphology. In this model, visceral injury was the strongest predictor for readmission, with an odds ratio of 6.44.
Dr. Pomeranz said that both the initial gunshot wound and subsequent gaps in care can contribute to readmissions. A patient who has a spinal cord injury may not be reimbursed adequately for supportive cushioning, or an appropriate wheelchair, and so may require admission for decubitus ulcers.
The number of admissions for osteomyelitis, which made up more than half of the subsequent admissions, initially surprised Dr. Pomeranz, until he realized that lack of mobility and sensory losses from gunshot-induced spinal cord injuries could easily lead to nonhealing lower extremity wounds, with osteomyelitis as a sequela.
Several patients were admitted for small bowel obstructions with no interval surgery since treatment for the gunshot wound. These readmissions, said Dr. Pomeranz, were assessed as related to the gunshot wound since it’s extremely rare for a patient with no history of abdominal surgery and no malignancy to have a small bowel obstruction. Exploratory laparotomies are common in the context of abdominal trauma caused by gunshot wounds, and either the gunshot itself or the laparotomy was the likely cause of adhesions.
Dr. Pomeranz acknowledged the many limitations of the study, but pointed out that some will be addressed when he and his coauthors conduct a larger study they have planned to look at readmissions from gunshot wounds at multiple hospitals in the Philadelphia area. The small sample size in the current study meant that the impact of socioeconomic status and other lifestyle and social variables and comorbidities couldn’t be adequately addressed in the statistical analysis. By casting a wider net within the greater Philadelphia area, the investigators should be able to track patients who receive care in more than one hospital system, increasing participant numbers, he said.
“Morbidity and outcomes from gun violence can only be assessed after a firm understanding of injury patterns on imaging,” noted Dr. Pomeranz. He said that interdisciplinary research investigating individual and societal short- and long-term costs of gun violence is sorely needed to inform public policy.
Dr. Pomeranz reported no outside sources of funding and reported that he had no conflicts of interest.
SOURCE: Pomeranz C et al. RSNA 2019, Presentation HP226-SD-THA3.
REPORTING FROM RSNA 2019
Effective NASH medications are coming ‘sooner than you think’
SAN ANTONIO – The therapeutic Dark Ages of nonalcoholic steatohepatitis (NASH) are finally drawing to a close.
“NASH-specific therapies are coming soon – sooner than you think,” Naim Alkhouri, MD, predicted at the annual meeting of the American College of Gastroenterology.
And that, he added, has important implications for clinical practice. Physicians are going to need to step up their game with regard to screening and staging patients with nonalcoholic fatty liver disease to identify the right candidates for the coming effective treatments.
The new treatment era in NASH could dawn as soon as the spring of 2020, by which time the Food and Drug Administration is expected to issue a decision on obeticholic acid, an oral FXR agonist for which the agency has granted breakthrough therapy status. Intercept Pharmaceuticals has filed for marketing approval of obeticholic acid for NASH on the strength of the positive 18-month histologic results of the pivotal phase 3 REGENERATE trial, the first-ever successful phase 3 study of a medication for NASH, noted Dr. Alkhouri, a gastroenterologist at the University of Texas, San Antonio, and director of the Metabolic Health Center at the Texas Liver Institute.
At present there are no FDA-approved pharmacotherapies for NASH. The unmet medical need is huge, since NASH is now recognized to be a full-blown, burgeoning epidemic. NASH will soon become the No. 1 indication for liver transplantation in the United States. A full-throttle race is on to find effective therapies targeting the various dimensions of NASH, with more than 70 drugs now in phase 2 studies. These drugs collectively address all four mechanisms of the disease’s development and progression: the metabolic targets, perturbations in the gut-liver axis, liver inflammation, and fibrosis.
Moreover, even as the FDA considers the application for approval of obeticholic acid in NASH, at least four other investigational drugs are in pivotal phase 3 clinical trials. These include elafibranor, aramchol, resmetirom, and cenicriviroc.
Cenicriviroc is a dual CCR 2/5 receptor antagonist that targets the hepatic inflammation and fibrosis dimensions of NASH. It is now being evaluated in the phase 3 AURORA trial on the strength of the earlier positive phase 2b Centaur study, in which patients randomized to cenicriviroc were twice as likely to experience significant improvement in fibrosis as were placebo-treated controls.
Elafibranor, aramchol, and resmetirom employ different mechanisms of action to address the metabolic derangements of NASH. What they share in common is their aim to reduce the influx of free fatty acids from adipose tissue to the liver, and/or to inhibit lipogenesis from carbohydrate building blocks. In so doing, these medications should result in reduced hepatocyte injury and liver inflammation.
Elafibranor is a peroxisome proliferator-activated receptor alpha/delta agonist that achieved significant biopsy-proven reversal of NASH in moderate- or severely affected patients in the phase 2 GOLDEN study. The phase 3 RESOLVE IT trial is underway.
Aramchol is a first-in-class synthetic fatty acid/bile acid conjugate that inhibits stearoyl-CoA desaturate activity. It’s designed to improve insulin resistance and curb accumulation of triglycerides in hepatocytes. In the 52-week, phase 2 ARREST trial, oral aramchol at 600 mg/day was 4.7-fold more likely than was placebo to achieve NASH resolution without worsening of fibrosis. The drug is now in phase 3 in the ARMOR study.
Resmetirom is a selective thyroid hormone receptor–beta agonist. Activation of the beta receptor lowers LDL cholesterol, triglycerides, and liver fat, whereas activation of the alpha receptor has the unwanted effects of promoting bone loss, thyrotoxicosis, and arrhythmias. In phase 2, 75% of patients on high-dose resmetirom achieved at least a 30% reduction in hepatic fat by MRI at week 12, compared with 18% of placebo-treated controls. And 39% of the high-dose resmetirom group showed histologic resolution of NASH on a week-36 liver biopsy, as did a mere 6% of controls. The phase 3 MAESTRO randomized trial is underway.
Obeticholic acid addresses the gut-liver axis abnormalities present in NASH, especially the exuberant bile acid circulation.
Clinical implications of the coming wave of medications
In Dr. Alkhouri’s view, .
“These are the patients with a high chance of progressing to cirrhosis and end-stage liver disease,” the gastroenterologist said.
Patients with earlier-stage nonalcoholic fatty liver disease are best managed via lifestyle changes, with particular emphasis upon 10% weight loss accompanied by exercise. And patients with more advanced disease – NASH with cirrhosis – appear thus far to be beyond the reach of the next-generation therapies.
None of the coming drugs is a cure-all. In the landmark phase 3 REGENERATE trial, for example, the rate of the primary outcome – fibrosis improvement of at least one stage plus no worsening of NASH at 18 months – was 23% in patients randomized to obeticholic acid at 25 mg/day, compared to 12% with placebo.
“These are not like hepatitis C medications, with 97% efficacy, so combination therapy targeting upstream and downstream for NASH is rational,” Dr. Alkhouri observed.
He reported serving on advisory boards for Allergan, Gilead, and Intercept, and receiving research grants from those companies as well as from Galmed, Genfit, and Madrigal.
*This story was updated on 12/5/2019.
SAN ANTONIO – The therapeutic Dark Ages of nonalcoholic steatohepatitis (NASH) are finally drawing to a close.
“NASH-specific therapies are coming soon – sooner than you think,” Naim Alkhouri, MD, predicted at the annual meeting of the American College of Gastroenterology.
And that, he added, has important implications for clinical practice. Physicians are going to need to step up their game with regard to screening and staging patients with nonalcoholic fatty liver disease to identify the right candidates for the coming effective treatments.
The new treatment era in NASH could dawn as soon as the spring of 2020, by which time the Food and Drug Administration is expected to issue a decision on obeticholic acid, an oral FXR agonist for which the agency has granted breakthrough therapy status. Intercept Pharmaceuticals has filed for marketing approval of obeticholic acid for NASH on the strength of the positive 18-month histologic results of the pivotal phase 3 REGENERATE trial, the first-ever successful phase 3 study of a medication for NASH, noted Dr. Alkhouri, a gastroenterologist at the University of Texas, San Antonio, and director of the Metabolic Health Center at the Texas Liver Institute.
At present there are no FDA-approved pharmacotherapies for NASH. The unmet medical need is huge, since NASH is now recognized to be a full-blown, burgeoning epidemic. NASH will soon become the No. 1 indication for liver transplantation in the United States. A full-throttle race is on to find effective therapies targeting the various dimensions of NASH, with more than 70 drugs now in phase 2 studies. These drugs collectively address all four mechanisms of the disease’s development and progression: the metabolic targets, perturbations in the gut-liver axis, liver inflammation, and fibrosis.
Moreover, even as the FDA considers the application for approval of obeticholic acid in NASH, at least four other investigational drugs are in pivotal phase 3 clinical trials. These include elafibranor, aramchol, resmetirom, and cenicriviroc.
Cenicriviroc is a dual CCR 2/5 receptor antagonist that targets the hepatic inflammation and fibrosis dimensions of NASH. It is now being evaluated in the phase 3 AURORA trial on the strength of the earlier positive phase 2b Centaur study, in which patients randomized to cenicriviroc were twice as likely to experience significant improvement in fibrosis as were placebo-treated controls.
Elafibranor, aramchol, and resmetirom employ different mechanisms of action to address the metabolic derangements of NASH. What they share in common is their aim to reduce the influx of free fatty acids from adipose tissue to the liver, and/or to inhibit lipogenesis from carbohydrate building blocks. In so doing, these medications should result in reduced hepatocyte injury and liver inflammation.
Elafibranor is a peroxisome proliferator-activated receptor alpha/delta agonist that achieved significant biopsy-proven reversal of NASH in moderate- or severely affected patients in the phase 2 GOLDEN study. The phase 3 RESOLVE IT trial is underway.
Aramchol is a first-in-class synthetic fatty acid/bile acid conjugate that inhibits stearoyl-CoA desaturate activity. It’s designed to improve insulin resistance and curb accumulation of triglycerides in hepatocytes. In the 52-week, phase 2 ARREST trial, oral aramchol at 600 mg/day was 4.7-fold more likely than was placebo to achieve NASH resolution without worsening of fibrosis. The drug is now in phase 3 in the ARMOR study.
Resmetirom is a selective thyroid hormone receptor–beta agonist. Activation of the beta receptor lowers LDL cholesterol, triglycerides, and liver fat, whereas activation of the alpha receptor has the unwanted effects of promoting bone loss, thyrotoxicosis, and arrhythmias. In phase 2, 75% of patients on high-dose resmetirom achieved at least a 30% reduction in hepatic fat by MRI at week 12, compared with 18% of placebo-treated controls. And 39% of the high-dose resmetirom group showed histologic resolution of NASH on a week-36 liver biopsy, as did a mere 6% of controls. The phase 3 MAESTRO randomized trial is underway.
Obeticholic acid addresses the gut-liver axis abnormalities present in NASH, especially the exuberant bile acid circulation.
Clinical implications of the coming wave of medications
In Dr. Alkhouri’s view, .
“These are the patients with a high chance of progressing to cirrhosis and end-stage liver disease,” the gastroenterologist said.
Patients with earlier-stage nonalcoholic fatty liver disease are best managed via lifestyle changes, with particular emphasis upon 10% weight loss accompanied by exercise. And patients with more advanced disease – NASH with cirrhosis – appear thus far to be beyond the reach of the next-generation therapies.
None of the coming drugs is a cure-all. In the landmark phase 3 REGENERATE trial, for example, the rate of the primary outcome – fibrosis improvement of at least one stage plus no worsening of NASH at 18 months – was 23% in patients randomized to obeticholic acid at 25 mg/day, compared to 12% with placebo.
“These are not like hepatitis C medications, with 97% efficacy, so combination therapy targeting upstream and downstream for NASH is rational,” Dr. Alkhouri observed.
He reported serving on advisory boards for Allergan, Gilead, and Intercept, and receiving research grants from those companies as well as from Galmed, Genfit, and Madrigal.
*This story was updated on 12/5/2019.
SAN ANTONIO – The therapeutic Dark Ages of nonalcoholic steatohepatitis (NASH) are finally drawing to a close.
“NASH-specific therapies are coming soon – sooner than you think,” Naim Alkhouri, MD, predicted at the annual meeting of the American College of Gastroenterology.
And that, he added, has important implications for clinical practice. Physicians are going to need to step up their game with regard to screening and staging patients with nonalcoholic fatty liver disease to identify the right candidates for the coming effective treatments.
The new treatment era in NASH could dawn as soon as the spring of 2020, by which time the Food and Drug Administration is expected to issue a decision on obeticholic acid, an oral FXR agonist for which the agency has granted breakthrough therapy status. Intercept Pharmaceuticals has filed for marketing approval of obeticholic acid for NASH on the strength of the positive 18-month histologic results of the pivotal phase 3 REGENERATE trial, the first-ever successful phase 3 study of a medication for NASH, noted Dr. Alkhouri, a gastroenterologist at the University of Texas, San Antonio, and director of the Metabolic Health Center at the Texas Liver Institute.
At present there are no FDA-approved pharmacotherapies for NASH. The unmet medical need is huge, since NASH is now recognized to be a full-blown, burgeoning epidemic. NASH will soon become the No. 1 indication for liver transplantation in the United States. A full-throttle race is on to find effective therapies targeting the various dimensions of NASH, with more than 70 drugs now in phase 2 studies. These drugs collectively address all four mechanisms of the disease’s development and progression: the metabolic targets, perturbations in the gut-liver axis, liver inflammation, and fibrosis.
Moreover, even as the FDA considers the application for approval of obeticholic acid in NASH, at least four other investigational drugs are in pivotal phase 3 clinical trials. These include elafibranor, aramchol, resmetirom, and cenicriviroc.
Cenicriviroc is a dual CCR 2/5 receptor antagonist that targets the hepatic inflammation and fibrosis dimensions of NASH. It is now being evaluated in the phase 3 AURORA trial on the strength of the earlier positive phase 2b Centaur study, in which patients randomized to cenicriviroc were twice as likely to experience significant improvement in fibrosis as were placebo-treated controls.
Elafibranor, aramchol, and resmetirom employ different mechanisms of action to address the metabolic derangements of NASH. What they share in common is their aim to reduce the influx of free fatty acids from adipose tissue to the liver, and/or to inhibit lipogenesis from carbohydrate building blocks. In so doing, these medications should result in reduced hepatocyte injury and liver inflammation.
Elafibranor is a peroxisome proliferator-activated receptor alpha/delta agonist that achieved significant biopsy-proven reversal of NASH in moderate- or severely affected patients in the phase 2 GOLDEN study. The phase 3 RESOLVE IT trial is underway.
Aramchol is a first-in-class synthetic fatty acid/bile acid conjugate that inhibits stearoyl-CoA desaturate activity. It’s designed to improve insulin resistance and curb accumulation of triglycerides in hepatocytes. In the 52-week, phase 2 ARREST trial, oral aramchol at 600 mg/day was 4.7-fold more likely than was placebo to achieve NASH resolution without worsening of fibrosis. The drug is now in phase 3 in the ARMOR study.
Resmetirom is a selective thyroid hormone receptor–beta agonist. Activation of the beta receptor lowers LDL cholesterol, triglycerides, and liver fat, whereas activation of the alpha receptor has the unwanted effects of promoting bone loss, thyrotoxicosis, and arrhythmias. In phase 2, 75% of patients on high-dose resmetirom achieved at least a 30% reduction in hepatic fat by MRI at week 12, compared with 18% of placebo-treated controls. And 39% of the high-dose resmetirom group showed histologic resolution of NASH on a week-36 liver biopsy, as did a mere 6% of controls. The phase 3 MAESTRO randomized trial is underway.
Obeticholic acid addresses the gut-liver axis abnormalities present in NASH, especially the exuberant bile acid circulation.
Clinical implications of the coming wave of medications
In Dr. Alkhouri’s view, .
“These are the patients with a high chance of progressing to cirrhosis and end-stage liver disease,” the gastroenterologist said.
Patients with earlier-stage nonalcoholic fatty liver disease are best managed via lifestyle changes, with particular emphasis upon 10% weight loss accompanied by exercise. And patients with more advanced disease – NASH with cirrhosis – appear thus far to be beyond the reach of the next-generation therapies.
None of the coming drugs is a cure-all. In the landmark phase 3 REGENERATE trial, for example, the rate of the primary outcome – fibrosis improvement of at least one stage plus no worsening of NASH at 18 months – was 23% in patients randomized to obeticholic acid at 25 mg/day, compared to 12% with placebo.
“These are not like hepatitis C medications, with 97% efficacy, so combination therapy targeting upstream and downstream for NASH is rational,” Dr. Alkhouri observed.
He reported serving on advisory boards for Allergan, Gilead, and Intercept, and receiving research grants from those companies as well as from Galmed, Genfit, and Madrigal.
*This story was updated on 12/5/2019.
REPORTING FROM ACG 2019
Geriatric Psychiatry Fellowship Position
Geriatric Psychiatry Fellowship Position Available effective July 1, 2020
Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center
Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.
Interested applicants can contact Marcelle Shidler, Program Coordinator, at [email protected] or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry
Geriatric Psychiatry Fellowship Position Available effective July 1, 2020
Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center
Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.
Interested applicants can contact Marcelle Shidler, Program Coordinator, at [email protected] or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry
Geriatric Psychiatry Fellowship Position Available effective July 1, 2020
Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center
Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.
Interested applicants can contact Marcelle Shidler, Program Coordinator, at [email protected] or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry
FDA expands use of Toujeo to childhood type 1 diabetes
The Food and Drug Administration has expanded the indication for Toujeo (insulin glargine 300 units/mL injection; Sanofi) to include children as young as 6 years of age with type 1 diabetes.
The FDA first approved Toujeo in 2015 for adults with type 1 and type 2 diabetes, designed as a more potent follow-up to Sanofi’s top-selling insulin glargine (Lantus).
Last month, Sanofi reported positive results from the phase 3 EDITION JUNIOR trial of Toujeo in children and adolescents with type 1 diabetes. These were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston.
In the trial, 463 children and adolescents (aged 6-17 years) treated for type 1 diabetes for at least 1 year and with A1c between 7.5% and 11.0% at screening were randomized to Toujeo or insulin glargine 100 units/mL (Gla-100); participants continued to take their existing mealtime insulin.
The primary endpoint was noninferior reduction in A1c after 26 weeks.
The study met its primary endpoint, confirming a noninferior reduction in A1c with Toujeo versus Gla-100 after 26 weeks (mean reduction, 0.4% vs. 0.4%; difference, 0.004%; 95% confidence interval, –0.17 to 0.18; upper bound was below the prespecified noninferiority margin of 0.3%).
Over 26 weeks, a comparable number of patients in each group experienced one or more hypoglycemic events documented at anytime over 24 hours. Numerically fewer patients taking Toujeo experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking Gla-100.
No unexpected safety concerns were reported based on the established profiles of both products, the company said.
In October 2019, the European Medicines Agency Committee for Medicinal Products for Human Use recommended approval of Toujeo for children age 6 years and older with diabetes.
For more diabetes and endocrinology news, follow us on Twitter and Facebook.
This story first appeared on Medscape.com.
The Food and Drug Administration has expanded the indication for Toujeo (insulin glargine 300 units/mL injection; Sanofi) to include children as young as 6 years of age with type 1 diabetes.
The FDA first approved Toujeo in 2015 for adults with type 1 and type 2 diabetes, designed as a more potent follow-up to Sanofi’s top-selling insulin glargine (Lantus).
Last month, Sanofi reported positive results from the phase 3 EDITION JUNIOR trial of Toujeo in children and adolescents with type 1 diabetes. These were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston.
In the trial, 463 children and adolescents (aged 6-17 years) treated for type 1 diabetes for at least 1 year and with A1c between 7.5% and 11.0% at screening were randomized to Toujeo or insulin glargine 100 units/mL (Gla-100); participants continued to take their existing mealtime insulin.
The primary endpoint was noninferior reduction in A1c after 26 weeks.
The study met its primary endpoint, confirming a noninferior reduction in A1c with Toujeo versus Gla-100 after 26 weeks (mean reduction, 0.4% vs. 0.4%; difference, 0.004%; 95% confidence interval, –0.17 to 0.18; upper bound was below the prespecified noninferiority margin of 0.3%).
Over 26 weeks, a comparable number of patients in each group experienced one or more hypoglycemic events documented at anytime over 24 hours. Numerically fewer patients taking Toujeo experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking Gla-100.
No unexpected safety concerns were reported based on the established profiles of both products, the company said.
In October 2019, the European Medicines Agency Committee for Medicinal Products for Human Use recommended approval of Toujeo for children age 6 years and older with diabetes.
For more diabetes and endocrinology news, follow us on Twitter and Facebook.
This story first appeared on Medscape.com.
The Food and Drug Administration has expanded the indication for Toujeo (insulin glargine 300 units/mL injection; Sanofi) to include children as young as 6 years of age with type 1 diabetes.
The FDA first approved Toujeo in 2015 for adults with type 1 and type 2 diabetes, designed as a more potent follow-up to Sanofi’s top-selling insulin glargine (Lantus).
Last month, Sanofi reported positive results from the phase 3 EDITION JUNIOR trial of Toujeo in children and adolescents with type 1 diabetes. These were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston.
In the trial, 463 children and adolescents (aged 6-17 years) treated for type 1 diabetes for at least 1 year and with A1c between 7.5% and 11.0% at screening were randomized to Toujeo or insulin glargine 100 units/mL (Gla-100); participants continued to take their existing mealtime insulin.
The primary endpoint was noninferior reduction in A1c after 26 weeks.
The study met its primary endpoint, confirming a noninferior reduction in A1c with Toujeo versus Gla-100 after 26 weeks (mean reduction, 0.4% vs. 0.4%; difference, 0.004%; 95% confidence interval, –0.17 to 0.18; upper bound was below the prespecified noninferiority margin of 0.3%).
Over 26 weeks, a comparable number of patients in each group experienced one or more hypoglycemic events documented at anytime over 24 hours. Numerically fewer patients taking Toujeo experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking Gla-100.
No unexpected safety concerns were reported based on the established profiles of both products, the company said.
In October 2019, the European Medicines Agency Committee for Medicinal Products for Human Use recommended approval of Toujeo for children age 6 years and older with diabetes.
For more diabetes and endocrinology news, follow us on Twitter and Facebook.
This story first appeared on Medscape.com.
Extent of insulin rationing in the U.S. is ‘shameful,’ say experts
BUSAN, SOUTH KOREA – The practice of insulin rationing because of cost by people with type 1 diabetes is considerably more common in the United States than in other high-income countries, and is even higher than in some low- and middle-income countries, new data suggest.
Findings from the latest survey conducted by the nonprofit advocacy organization T1International were presented at the International Diabetes Federation Congress 2019 by organization trustee James Elliott, MMSc, of Toronto.
The data were also simultaneously posted on the organization’s website.
The 2018 online survey is an update of T1International’s 2016 survey. It was disseminated through the organization’s website, partner organizations, and social media. The survey questions were developed by people living with type 1 diabetes to ensure they made sense to patients.
A total of 1,478 respondents from 90 countries completed the online survey in 2018.
Overall, 18% reported rationing insulin in the previous year because of cost. About 26% of 627 respondents from the United States reported the practice, compared with 6.5% of 525 respondents from other high-income countries, and 10.9% of 256 respondents from low- and middle-income countries. Rates of rationing suplies for blood glucose testing were even higher.
“The take-home point is that insulin rationing and blood glucose testing rationing is a reality for far more people with diabetes than I think is acknowledged,” said Mr. Elliott.
“One of the key findings is that many people are actually better off living in lower- and middle-income countries than in the United States, which is quite shameful,” Mr. Elliott told Medscape Medical News in an interview.
He advised clinicians to ask patients if they’re insulin rationing, but to be mindful that “not everyone is going to be upfront. There’re a lot of associated stigmas.”
Endocrinologist Irl B. Hirsch, MD, noted that the rationing rate reported for the United States in the survey is similar to that found in a recently published study from Yale University, New Haven, Conn., as reported by Medscape Medical News.
Dr. Hirsch, who is chair of Diabetes Treatment and Teaching at the University of Washington, Seattle, agreed wholeheartedly with Mr. Elliott.
“It is shameful and embarrassing sitting here with colleagues from around the world at IDF. It is time for our elected officials [in the United States] to do something instead of simply talking about it,” Dr. Hirsch said.
Many have no coverage, blood glucose test rationing also common
Overall, 66.2% of survey respondents reported having no financial coverage for diabetes expenses, many instead relying on support from family and friends, charities and nonprofit organizations, donations including online programs such as GoFundMe, and/or assistance from government or pharmaceutical company programs.
By region, the proportions reporting no coverage for diabetes supplies were 79.2% in the United States, 54.0% in other high-income countries, and 59.8% in low- and middle-income countries.
“Many countries still lack any kind of support system to help people with type 1 diabetes survive,” Mr. Elliott noted.
Also asked to comment, Edward W. Gregg, PhD, a professor in the department of epidemiology and biostatistics at Imperial College, London, said: “It’s pretty astounding to me that two thirds of people with type 1 diabetes have no coverage whatsoever for out-of-pocket costs.”
“For as much concern as we have [for the US], it’s really staggering to think about how it must be in the low- and middle-income countries where having to pay for insulin takes away a large proportion of income,” he added.
Rationing of blood glucose testing was considerably more common than insulin rationing, with 33.5% overall reporting having done so in the last year.
The proportion was higher in the United States and in low- and middle-income countries, at 38.6% and 55.5%, respectively, compared with just 17.2% of high-income countries other than the United States.
Mr. Elliott told Medscape Medical News that the recent World Health Organization’s launch of its first-ever insulin prequalification program to expand access to treatment is a “start” and that T1International is pushing to expand that beyond human insulins to also include analogues.
“It’s a tough disease to survive in lower- and middle-income countries. Oftentimes, it’s a death sentence,” Mr. Elliott said.
This story first appeared on Medscape.com.
BUSAN, SOUTH KOREA – The practice of insulin rationing because of cost by people with type 1 diabetes is considerably more common in the United States than in other high-income countries, and is even higher than in some low- and middle-income countries, new data suggest.
Findings from the latest survey conducted by the nonprofit advocacy organization T1International were presented at the International Diabetes Federation Congress 2019 by organization trustee James Elliott, MMSc, of Toronto.
The data were also simultaneously posted on the organization’s website.
The 2018 online survey is an update of T1International’s 2016 survey. It was disseminated through the organization’s website, partner organizations, and social media. The survey questions were developed by people living with type 1 diabetes to ensure they made sense to patients.
A total of 1,478 respondents from 90 countries completed the online survey in 2018.
Overall, 18% reported rationing insulin in the previous year because of cost. About 26% of 627 respondents from the United States reported the practice, compared with 6.5% of 525 respondents from other high-income countries, and 10.9% of 256 respondents from low- and middle-income countries. Rates of rationing suplies for blood glucose testing were even higher.
“The take-home point is that insulin rationing and blood glucose testing rationing is a reality for far more people with diabetes than I think is acknowledged,” said Mr. Elliott.
“One of the key findings is that many people are actually better off living in lower- and middle-income countries than in the United States, which is quite shameful,” Mr. Elliott told Medscape Medical News in an interview.
He advised clinicians to ask patients if they’re insulin rationing, but to be mindful that “not everyone is going to be upfront. There’re a lot of associated stigmas.”
Endocrinologist Irl B. Hirsch, MD, noted that the rationing rate reported for the United States in the survey is similar to that found in a recently published study from Yale University, New Haven, Conn., as reported by Medscape Medical News.
Dr. Hirsch, who is chair of Diabetes Treatment and Teaching at the University of Washington, Seattle, agreed wholeheartedly with Mr. Elliott.
“It is shameful and embarrassing sitting here with colleagues from around the world at IDF. It is time for our elected officials [in the United States] to do something instead of simply talking about it,” Dr. Hirsch said.
Many have no coverage, blood glucose test rationing also common
Overall, 66.2% of survey respondents reported having no financial coverage for diabetes expenses, many instead relying on support from family and friends, charities and nonprofit organizations, donations including online programs such as GoFundMe, and/or assistance from government or pharmaceutical company programs.
By region, the proportions reporting no coverage for diabetes supplies were 79.2% in the United States, 54.0% in other high-income countries, and 59.8% in low- and middle-income countries.
“Many countries still lack any kind of support system to help people with type 1 diabetes survive,” Mr. Elliott noted.
Also asked to comment, Edward W. Gregg, PhD, a professor in the department of epidemiology and biostatistics at Imperial College, London, said: “It’s pretty astounding to me that two thirds of people with type 1 diabetes have no coverage whatsoever for out-of-pocket costs.”
“For as much concern as we have [for the US], it’s really staggering to think about how it must be in the low- and middle-income countries where having to pay for insulin takes away a large proportion of income,” he added.
Rationing of blood glucose testing was considerably more common than insulin rationing, with 33.5% overall reporting having done so in the last year.
The proportion was higher in the United States and in low- and middle-income countries, at 38.6% and 55.5%, respectively, compared with just 17.2% of high-income countries other than the United States.
Mr. Elliott told Medscape Medical News that the recent World Health Organization’s launch of its first-ever insulin prequalification program to expand access to treatment is a “start” and that T1International is pushing to expand that beyond human insulins to also include analogues.
“It’s a tough disease to survive in lower- and middle-income countries. Oftentimes, it’s a death sentence,” Mr. Elliott said.
This story first appeared on Medscape.com.
BUSAN, SOUTH KOREA – The practice of insulin rationing because of cost by people with type 1 diabetes is considerably more common in the United States than in other high-income countries, and is even higher than in some low- and middle-income countries, new data suggest.
Findings from the latest survey conducted by the nonprofit advocacy organization T1International were presented at the International Diabetes Federation Congress 2019 by organization trustee James Elliott, MMSc, of Toronto.
The data were also simultaneously posted on the organization’s website.
The 2018 online survey is an update of T1International’s 2016 survey. It was disseminated through the organization’s website, partner organizations, and social media. The survey questions were developed by people living with type 1 diabetes to ensure they made sense to patients.
A total of 1,478 respondents from 90 countries completed the online survey in 2018.
Overall, 18% reported rationing insulin in the previous year because of cost. About 26% of 627 respondents from the United States reported the practice, compared with 6.5% of 525 respondents from other high-income countries, and 10.9% of 256 respondents from low- and middle-income countries. Rates of rationing suplies for blood glucose testing were even higher.
“The take-home point is that insulin rationing and blood glucose testing rationing is a reality for far more people with diabetes than I think is acknowledged,” said Mr. Elliott.
“One of the key findings is that many people are actually better off living in lower- and middle-income countries than in the United States, which is quite shameful,” Mr. Elliott told Medscape Medical News in an interview.
He advised clinicians to ask patients if they’re insulin rationing, but to be mindful that “not everyone is going to be upfront. There’re a lot of associated stigmas.”
Endocrinologist Irl B. Hirsch, MD, noted that the rationing rate reported for the United States in the survey is similar to that found in a recently published study from Yale University, New Haven, Conn., as reported by Medscape Medical News.
Dr. Hirsch, who is chair of Diabetes Treatment and Teaching at the University of Washington, Seattle, agreed wholeheartedly with Mr. Elliott.
“It is shameful and embarrassing sitting here with colleagues from around the world at IDF. It is time for our elected officials [in the United States] to do something instead of simply talking about it,” Dr. Hirsch said.
Many have no coverage, blood glucose test rationing also common
Overall, 66.2% of survey respondents reported having no financial coverage for diabetes expenses, many instead relying on support from family and friends, charities and nonprofit organizations, donations including online programs such as GoFundMe, and/or assistance from government or pharmaceutical company programs.
By region, the proportions reporting no coverage for diabetes supplies were 79.2% in the United States, 54.0% in other high-income countries, and 59.8% in low- and middle-income countries.
“Many countries still lack any kind of support system to help people with type 1 diabetes survive,” Mr. Elliott noted.
Also asked to comment, Edward W. Gregg, PhD, a professor in the department of epidemiology and biostatistics at Imperial College, London, said: “It’s pretty astounding to me that two thirds of people with type 1 diabetes have no coverage whatsoever for out-of-pocket costs.”
“For as much concern as we have [for the US], it’s really staggering to think about how it must be in the low- and middle-income countries where having to pay for insulin takes away a large proportion of income,” he added.
Rationing of blood glucose testing was considerably more common than insulin rationing, with 33.5% overall reporting having done so in the last year.
The proportion was higher in the United States and in low- and middle-income countries, at 38.6% and 55.5%, respectively, compared with just 17.2% of high-income countries other than the United States.
Mr. Elliott told Medscape Medical News that the recent World Health Organization’s launch of its first-ever insulin prequalification program to expand access to treatment is a “start” and that T1International is pushing to expand that beyond human insulins to also include analogues.
“It’s a tough disease to survive in lower- and middle-income countries. Oftentimes, it’s a death sentence,” Mr. Elliott said.
This story first appeared on Medscape.com.
DoD Explores Virtual Health for Traumatic Brain Injury
NATIONAL HARBOR, MD – As it moves to expand the use of virtual health offerings, the US Department of Defense (DoD) Regional Health Command Europe piloted a virtual health (telehealth) program to treat service members with traumatic brain injury (TBI). Ronald Keen, FNP-C, and Steve Cain, PA, reported on the DoD use of virtual health at the 2019 AMSUS annual meeting in Maryland.
The study, conducted between October 2016 and May 2018, included 15 patients stationed in 4 countries, including Poland, Turkey, and Egypt and 67 total health care encounters. Patients were limited to service members in the direct care system or those who were in remote areas where gaps in care existed in the Tricare Network. The virtual health program was centered at Landstuhl Regional Medical Center in Germany and sought to determine whether virtual health was feasible to treat TBI and whether it would increase patient satisfaction. The multidisciplinary program brought together specialists in 7 different disciplines, including sleep medicine, optometry, behavioral health, and occupational therapy.
According to Keen, the results of the 15-patient pilot were promising. He conservatively estimated a savings of $3,700, and more important, the program saved 322 hours of on-duty time. Health care providers used the program an average 2.8 times, and patients used the system 1.6 times on average. Currently the DoD is requiring active permission from patients to receive a telehealth visit.
NATIONAL HARBOR, MD – As it moves to expand the use of virtual health offerings, the US Department of Defense (DoD) Regional Health Command Europe piloted a virtual health (telehealth) program to treat service members with traumatic brain injury (TBI). Ronald Keen, FNP-C, and Steve Cain, PA, reported on the DoD use of virtual health at the 2019 AMSUS annual meeting in Maryland.
The study, conducted between October 2016 and May 2018, included 15 patients stationed in 4 countries, including Poland, Turkey, and Egypt and 67 total health care encounters. Patients were limited to service members in the direct care system or those who were in remote areas where gaps in care existed in the Tricare Network. The virtual health program was centered at Landstuhl Regional Medical Center in Germany and sought to determine whether virtual health was feasible to treat TBI and whether it would increase patient satisfaction. The multidisciplinary program brought together specialists in 7 different disciplines, including sleep medicine, optometry, behavioral health, and occupational therapy.
According to Keen, the results of the 15-patient pilot were promising. He conservatively estimated a savings of $3,700, and more important, the program saved 322 hours of on-duty time. Health care providers used the program an average 2.8 times, and patients used the system 1.6 times on average. Currently the DoD is requiring active permission from patients to receive a telehealth visit.
NATIONAL HARBOR, MD – As it moves to expand the use of virtual health offerings, the US Department of Defense (DoD) Regional Health Command Europe piloted a virtual health (telehealth) program to treat service members with traumatic brain injury (TBI). Ronald Keen, FNP-C, and Steve Cain, PA, reported on the DoD use of virtual health at the 2019 AMSUS annual meeting in Maryland.
The study, conducted between October 2016 and May 2018, included 15 patients stationed in 4 countries, including Poland, Turkey, and Egypt and 67 total health care encounters. Patients were limited to service members in the direct care system or those who were in remote areas where gaps in care existed in the Tricare Network. The virtual health program was centered at Landstuhl Regional Medical Center in Germany and sought to determine whether virtual health was feasible to treat TBI and whether it would increase patient satisfaction. The multidisciplinary program brought together specialists in 7 different disciplines, including sleep medicine, optometry, behavioral health, and occupational therapy.
According to Keen, the results of the 15-patient pilot were promising. He conservatively estimated a savings of $3,700, and more important, the program saved 322 hours of on-duty time. Health care providers used the program an average 2.8 times, and patients used the system 1.6 times on average. Currently the DoD is requiring active permission from patients to receive a telehealth visit.
Improving Veteran Care With the Mission Act
NATIONAL HARBOR, MD–The US Department of Veterans Affairs (VA) is in the midst of a significant change in the way it will deliver care to veterans. Agency officials remain optimistic that the change will be for the better, and early indications are positive.
The change is being driven by the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (Mission) Act of 2018, a bill that opens health services options for veterans and integrates VA-administered care and care from community-based providers.
“This is change that is enhancing their experience in the system, and this is enhancing their options and the quality of the options in the system,” Jennifer MacDonald, MD, chief consultant to the principal deputy undersecretary for health at the VA, said during a December 3 session at the AMSUS 2019 annual meeting. “We need also for our workforce to understand how important they are to us across this degree of change.”
Dr. MacDonald highlighted integration with community-based care, including a community urgent care provision that allows veterans to access urgent care facilities and receive care without the need for prior authorization.
“The important piece about that is that we are also looking at the way this care has been accessed,” she said. “By and large, what we have seen from the data is that veterans are indeed seeking community urgent care at a site close to home. This may be CVS or Walgreens. It may be a stand-alone urgent care with a bit more functionality than those Minute Clinics tend to have. We are seeing veterans typically access care through those sites for those minor concerns and illnesses.”
However, she noted that this type of access does not alter the role the VA plays in administration of health care services.
“We are seeing them come back to VA for the majority of their care and for their core care–when there are serious issues, when insulin needs to be adjusted for diabetes, when there are heart disease medications that need to be refilled–we are seeing veterans not seek out urgent care, but come to us, and that is exactly what we want,” she said. “We want the continuity of care to continue and we want to help guide people to the right care, right place, right time.”
Dr. MacDonald also highlighted the expansion of a program that provides a stipend to caregivers that allows veterans to avoid institutionalization and remain within the community under that caregiver’s (a family or friend) supervision. This will expand by year’s end to Vietnam War-era veterans and within 2 years, to veterans that fall between the Vietnam War-era and the September 11, 2001, terrorist attacks.
“We wanted to do this equitably across all eras of veterans,” she said. “This now gives us that opportunity.”
Telehealth also plays a key role.
“For the first time ever, VA now has what we term ‘anywhere-to-anywhere’ telehealth under the Mission Act, an enormous opportunity for us,” she said. “Since we stretch … from New York City to Guam, we need the opportunity to provide care where it may be difficult to recruit and retain providers wherever veterans choose to live,” she said. “We believe that we should be able to meet people where they are regardless of where they choose to live. That’s an aspirational vision, but it is one we believe is exceptionally important and indeed we are moving toward that.”
These are just the beginning; the full implementation of the act goes out to 2034.
According to Dr. MacDonald, the agency is working hard to engage both veterans and the workforce to keep tabs on how the implementation is going.
“It’s a fundamental change in the day-to-day business that they’ve been doing, sometimes for years, and so extremely important across this change is that we have set up processes and now a joint operations center and a number of forums to hear directly from our front line and make sure that their issues are our issues in central office, in DC here, and that they feel heard and that they know that when they have needs, those needs are actioned,” she said.
The VA, under the Mission Act, is also working hard to engage health care providers in the community, including making VA training to community partners, including training on opioid use, suicide prevent and military culture.
However, all these change are for naught if the veterans are not on board. But so far, Dr. MacDonald said the early feedback is very positive.
She cited a VFW survey that asked a question about the Mission Act changes so far and whether they would recommend the VA to other veterans. Ninety percent of the respondents answered they would.
“That’s our marker that we are getting somewhere with these changes and the way we do business,” she said. “That is what we want to see continue to increase.”
NATIONAL HARBOR, MD–The US Department of Veterans Affairs (VA) is in the midst of a significant change in the way it will deliver care to veterans. Agency officials remain optimistic that the change will be for the better, and early indications are positive.
The change is being driven by the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (Mission) Act of 2018, a bill that opens health services options for veterans and integrates VA-administered care and care from community-based providers.
“This is change that is enhancing their experience in the system, and this is enhancing their options and the quality of the options in the system,” Jennifer MacDonald, MD, chief consultant to the principal deputy undersecretary for health at the VA, said during a December 3 session at the AMSUS 2019 annual meeting. “We need also for our workforce to understand how important they are to us across this degree of change.”
Dr. MacDonald highlighted integration with community-based care, including a community urgent care provision that allows veterans to access urgent care facilities and receive care without the need for prior authorization.
“The important piece about that is that we are also looking at the way this care has been accessed,” she said. “By and large, what we have seen from the data is that veterans are indeed seeking community urgent care at a site close to home. This may be CVS or Walgreens. It may be a stand-alone urgent care with a bit more functionality than those Minute Clinics tend to have. We are seeing veterans typically access care through those sites for those minor concerns and illnesses.”
However, she noted that this type of access does not alter the role the VA plays in administration of health care services.
“We are seeing them come back to VA for the majority of their care and for their core care–when there are serious issues, when insulin needs to be adjusted for diabetes, when there are heart disease medications that need to be refilled–we are seeing veterans not seek out urgent care, but come to us, and that is exactly what we want,” she said. “We want the continuity of care to continue and we want to help guide people to the right care, right place, right time.”
Dr. MacDonald also highlighted the expansion of a program that provides a stipend to caregivers that allows veterans to avoid institutionalization and remain within the community under that caregiver’s (a family or friend) supervision. This will expand by year’s end to Vietnam War-era veterans and within 2 years, to veterans that fall between the Vietnam War-era and the September 11, 2001, terrorist attacks.
“We wanted to do this equitably across all eras of veterans,” she said. “This now gives us that opportunity.”
Telehealth also plays a key role.
“For the first time ever, VA now has what we term ‘anywhere-to-anywhere’ telehealth under the Mission Act, an enormous opportunity for us,” she said. “Since we stretch … from New York City to Guam, we need the opportunity to provide care where it may be difficult to recruit and retain providers wherever veterans choose to live,” she said. “We believe that we should be able to meet people where they are regardless of where they choose to live. That’s an aspirational vision, but it is one we believe is exceptionally important and indeed we are moving toward that.”
These are just the beginning; the full implementation of the act goes out to 2034.
According to Dr. MacDonald, the agency is working hard to engage both veterans and the workforce to keep tabs on how the implementation is going.
“It’s a fundamental change in the day-to-day business that they’ve been doing, sometimes for years, and so extremely important across this change is that we have set up processes and now a joint operations center and a number of forums to hear directly from our front line and make sure that their issues are our issues in central office, in DC here, and that they feel heard and that they know that when they have needs, those needs are actioned,” she said.
The VA, under the Mission Act, is also working hard to engage health care providers in the community, including making VA training to community partners, including training on opioid use, suicide prevent and military culture.
However, all these change are for naught if the veterans are not on board. But so far, Dr. MacDonald said the early feedback is very positive.
She cited a VFW survey that asked a question about the Mission Act changes so far and whether they would recommend the VA to other veterans. Ninety percent of the respondents answered they would.
“That’s our marker that we are getting somewhere with these changes and the way we do business,” she said. “That is what we want to see continue to increase.”
NATIONAL HARBOR, MD–The US Department of Veterans Affairs (VA) is in the midst of a significant change in the way it will deliver care to veterans. Agency officials remain optimistic that the change will be for the better, and early indications are positive.
The change is being driven by the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (Mission) Act of 2018, a bill that opens health services options for veterans and integrates VA-administered care and care from community-based providers.
“This is change that is enhancing their experience in the system, and this is enhancing their options and the quality of the options in the system,” Jennifer MacDonald, MD, chief consultant to the principal deputy undersecretary for health at the VA, said during a December 3 session at the AMSUS 2019 annual meeting. “We need also for our workforce to understand how important they are to us across this degree of change.”
Dr. MacDonald highlighted integration with community-based care, including a community urgent care provision that allows veterans to access urgent care facilities and receive care without the need for prior authorization.
“The important piece about that is that we are also looking at the way this care has been accessed,” she said. “By and large, what we have seen from the data is that veterans are indeed seeking community urgent care at a site close to home. This may be CVS or Walgreens. It may be a stand-alone urgent care with a bit more functionality than those Minute Clinics tend to have. We are seeing veterans typically access care through those sites for those minor concerns and illnesses.”
However, she noted that this type of access does not alter the role the VA plays in administration of health care services.
“We are seeing them come back to VA for the majority of their care and for their core care–when there are serious issues, when insulin needs to be adjusted for diabetes, when there are heart disease medications that need to be refilled–we are seeing veterans not seek out urgent care, but come to us, and that is exactly what we want,” she said. “We want the continuity of care to continue and we want to help guide people to the right care, right place, right time.”
Dr. MacDonald also highlighted the expansion of a program that provides a stipend to caregivers that allows veterans to avoid institutionalization and remain within the community under that caregiver’s (a family or friend) supervision. This will expand by year’s end to Vietnam War-era veterans and within 2 years, to veterans that fall between the Vietnam War-era and the September 11, 2001, terrorist attacks.
“We wanted to do this equitably across all eras of veterans,” she said. “This now gives us that opportunity.”
Telehealth also plays a key role.
“For the first time ever, VA now has what we term ‘anywhere-to-anywhere’ telehealth under the Mission Act, an enormous opportunity for us,” she said. “Since we stretch … from New York City to Guam, we need the opportunity to provide care where it may be difficult to recruit and retain providers wherever veterans choose to live,” she said. “We believe that we should be able to meet people where they are regardless of where they choose to live. That’s an aspirational vision, but it is one we believe is exceptionally important and indeed we are moving toward that.”
These are just the beginning; the full implementation of the act goes out to 2034.
According to Dr. MacDonald, the agency is working hard to engage both veterans and the workforce to keep tabs on how the implementation is going.
“It’s a fundamental change in the day-to-day business that they’ve been doing, sometimes for years, and so extremely important across this change is that we have set up processes and now a joint operations center and a number of forums to hear directly from our front line and make sure that their issues are our issues in central office, in DC here, and that they feel heard and that they know that when they have needs, those needs are actioned,” she said.
The VA, under the Mission Act, is also working hard to engage health care providers in the community, including making VA training to community partners, including training on opioid use, suicide prevent and military culture.
However, all these change are for naught if the veterans are not on board. But so far, Dr. MacDonald said the early feedback is very positive.
She cited a VFW survey that asked a question about the Mission Act changes so far and whether they would recommend the VA to other veterans. Ninety percent of the respondents answered they would.
“That’s our marker that we are getting somewhere with these changes and the way we do business,” she said. “That is what we want to see continue to increase.”
Survival gains in HR+/HER2– MBC trials yet to be seen in real world
The introduction over the last decade of new systemic therapies for the treatment of hormone receptor positive, HER2-negative metastatic breast cancer has not translated into improved survival in a real-world setting, results of a retrospective study suggest.
Among 2,197 patients who received at least one line of systemic therapy for hormone receptor positive, HER2-negative metastatic breast cancer (HR+/HER2– MBC) from 2003 to 2013, there were no significant differences in median duration of hormonal therapy or median overall survival (OS) for patients treated in any of three time spans during that 10-year period, reported Dan Le, MD, MHA, of BC Cancer, Surrey, B.C., and colleagues.
“Despite the introduction of 9 new adjuvant therapies and 2 new metastatic treatments, survival in the metastatic setting for HR-positive, HER2-negative breast cancer did not improve between 2003 and 2013,” they wrote in a report published in Cancer.
Improvements in adjuvant therapy such as the introduction of cyclin-dependent kinase inhibitors (CDKI) may result in fewer relapses but may also affect the response of relapsed cancers to additional lines of therapy, the authors contended.
“Improved adjuvant therapy means that the cancers that do relapse may have more adverse biology, either intrinsically or because of selective pressure and clonal evolution from exposure to more and better drugs in the adjuvant setting. These factors could, in part, explain the lack of improved survival over time observed in this study,” they wrote.
To see whether significant increases in progression-free survival (PFS) in a clinical trial translated into improved outcomes – including OS – in population-based settings, the investigators identified 2,432 patients with HR+/HER2– MBC from data in the prospective Breast Cancer Outcomes Unit Database of BC Cancer. Of this group, 2,197 received at least one line of systemic therapy after an MBC diagnosis, and 1,752 received first and/or second-line hormonal therapy as well.
The patients were treated in one of three time cohorts: from 2003 through 2005, 2007 through 2009, or 2011 through 2013.
Nine new adjuvant systemic therapies with or without neoadjuvant therapy were approved by BC Cancer during the study period. For the entire decade of the study, the mean survival time was 3.1 years, and the median OS was 2.0 years.
The longest survival for patients diagnosed from 2003 through 2005 was 14.6 years, with 18.1% of these patients living at least 5 years after diagnosis. For patients diagnosed from 2007 through 2009, the longest survival was 10.6 years, with 17.7% of these patients living 5 years or longer post diagnosis. For patients in the most recent cohort (with patients diagnosed after August 2012 excluded), the longest survival was 6.6 years, with 17.3% living at least 5 years after diagnosis.
Overall, patients had a median of 9 months of first-line hormonal treatment, and 6.1 months of second-line hormonal therapy, with nearly identical duration across all three time cohorts.
“Ultimately, it seems likely that the greater the proportion of patients we cure with modern adjuvant therapy, the more challenging it will be to improve outcomes for patients with relapsed disease. This underscores the importance of 1) making continued progress in the adjuvant management of potentially curable breast cancer by first studying new therapeutic agents in the metastatic setting and 2) developing a better understanding of how selective pressure and clonal evolution may lead to more resistant biologic phenotypes in MBC,” the investigators wrote.
No specific study funding was disclosed. No authors disclosed potential conflicts of interest.
SOURCE: Le D et al. Cancer 2019 Nov 21. doi: 10.1002/cncr.32631.
The introduction over the last decade of new systemic therapies for the treatment of hormone receptor positive, HER2-negative metastatic breast cancer has not translated into improved survival in a real-world setting, results of a retrospective study suggest.
Among 2,197 patients who received at least one line of systemic therapy for hormone receptor positive, HER2-negative metastatic breast cancer (HR+/HER2– MBC) from 2003 to 2013, there were no significant differences in median duration of hormonal therapy or median overall survival (OS) for patients treated in any of three time spans during that 10-year period, reported Dan Le, MD, MHA, of BC Cancer, Surrey, B.C., and colleagues.
“Despite the introduction of 9 new adjuvant therapies and 2 new metastatic treatments, survival in the metastatic setting for HR-positive, HER2-negative breast cancer did not improve between 2003 and 2013,” they wrote in a report published in Cancer.
Improvements in adjuvant therapy such as the introduction of cyclin-dependent kinase inhibitors (CDKI) may result in fewer relapses but may also affect the response of relapsed cancers to additional lines of therapy, the authors contended.
“Improved adjuvant therapy means that the cancers that do relapse may have more adverse biology, either intrinsically or because of selective pressure and clonal evolution from exposure to more and better drugs in the adjuvant setting. These factors could, in part, explain the lack of improved survival over time observed in this study,” they wrote.
To see whether significant increases in progression-free survival (PFS) in a clinical trial translated into improved outcomes – including OS – in population-based settings, the investigators identified 2,432 patients with HR+/HER2– MBC from data in the prospective Breast Cancer Outcomes Unit Database of BC Cancer. Of this group, 2,197 received at least one line of systemic therapy after an MBC diagnosis, and 1,752 received first and/or second-line hormonal therapy as well.
The patients were treated in one of three time cohorts: from 2003 through 2005, 2007 through 2009, or 2011 through 2013.
Nine new adjuvant systemic therapies with or without neoadjuvant therapy were approved by BC Cancer during the study period. For the entire decade of the study, the mean survival time was 3.1 years, and the median OS was 2.0 years.
The longest survival for patients diagnosed from 2003 through 2005 was 14.6 years, with 18.1% of these patients living at least 5 years after diagnosis. For patients diagnosed from 2007 through 2009, the longest survival was 10.6 years, with 17.7% of these patients living 5 years or longer post diagnosis. For patients in the most recent cohort (with patients diagnosed after August 2012 excluded), the longest survival was 6.6 years, with 17.3% living at least 5 years after diagnosis.
Overall, patients had a median of 9 months of first-line hormonal treatment, and 6.1 months of second-line hormonal therapy, with nearly identical duration across all three time cohorts.
“Ultimately, it seems likely that the greater the proportion of patients we cure with modern adjuvant therapy, the more challenging it will be to improve outcomes for patients with relapsed disease. This underscores the importance of 1) making continued progress in the adjuvant management of potentially curable breast cancer by first studying new therapeutic agents in the metastatic setting and 2) developing a better understanding of how selective pressure and clonal evolution may lead to more resistant biologic phenotypes in MBC,” the investigators wrote.
No specific study funding was disclosed. No authors disclosed potential conflicts of interest.
SOURCE: Le D et al. Cancer 2019 Nov 21. doi: 10.1002/cncr.32631.
The introduction over the last decade of new systemic therapies for the treatment of hormone receptor positive, HER2-negative metastatic breast cancer has not translated into improved survival in a real-world setting, results of a retrospective study suggest.
Among 2,197 patients who received at least one line of systemic therapy for hormone receptor positive, HER2-negative metastatic breast cancer (HR+/HER2– MBC) from 2003 to 2013, there were no significant differences in median duration of hormonal therapy or median overall survival (OS) for patients treated in any of three time spans during that 10-year period, reported Dan Le, MD, MHA, of BC Cancer, Surrey, B.C., and colleagues.
“Despite the introduction of 9 new adjuvant therapies and 2 new metastatic treatments, survival in the metastatic setting for HR-positive, HER2-negative breast cancer did not improve between 2003 and 2013,” they wrote in a report published in Cancer.
Improvements in adjuvant therapy such as the introduction of cyclin-dependent kinase inhibitors (CDKI) may result in fewer relapses but may also affect the response of relapsed cancers to additional lines of therapy, the authors contended.
“Improved adjuvant therapy means that the cancers that do relapse may have more adverse biology, either intrinsically or because of selective pressure and clonal evolution from exposure to more and better drugs in the adjuvant setting. These factors could, in part, explain the lack of improved survival over time observed in this study,” they wrote.
To see whether significant increases in progression-free survival (PFS) in a clinical trial translated into improved outcomes – including OS – in population-based settings, the investigators identified 2,432 patients with HR+/HER2– MBC from data in the prospective Breast Cancer Outcomes Unit Database of BC Cancer. Of this group, 2,197 received at least one line of systemic therapy after an MBC diagnosis, and 1,752 received first and/or second-line hormonal therapy as well.
The patients were treated in one of three time cohorts: from 2003 through 2005, 2007 through 2009, or 2011 through 2013.
Nine new adjuvant systemic therapies with or without neoadjuvant therapy were approved by BC Cancer during the study period. For the entire decade of the study, the mean survival time was 3.1 years, and the median OS was 2.0 years.
The longest survival for patients diagnosed from 2003 through 2005 was 14.6 years, with 18.1% of these patients living at least 5 years after diagnosis. For patients diagnosed from 2007 through 2009, the longest survival was 10.6 years, with 17.7% of these patients living 5 years or longer post diagnosis. For patients in the most recent cohort (with patients diagnosed after August 2012 excluded), the longest survival was 6.6 years, with 17.3% living at least 5 years after diagnosis.
Overall, patients had a median of 9 months of first-line hormonal treatment, and 6.1 months of second-line hormonal therapy, with nearly identical duration across all three time cohorts.
“Ultimately, it seems likely that the greater the proportion of patients we cure with modern adjuvant therapy, the more challenging it will be to improve outcomes for patients with relapsed disease. This underscores the importance of 1) making continued progress in the adjuvant management of potentially curable breast cancer by first studying new therapeutic agents in the metastatic setting and 2) developing a better understanding of how selective pressure and clonal evolution may lead to more resistant biologic phenotypes in MBC,” the investigators wrote.
No specific study funding was disclosed. No authors disclosed potential conflicts of interest.
SOURCE: Le D et al. Cancer 2019 Nov 21. doi: 10.1002/cncr.32631.
FROM CANCER
Getting a Leg up on the Diagnosis
Three years ago, lesions began appearing on this now 68-year-old woman’s legs. They have grown in size and number, and their roughness disturbs the patient. She has been told the lesions are related to aging, but she has never seen anything like them on her friends or family—and she is worried about what they might mean for her health.
Her primary care provider diagnosed warts and performed cryotherapy on several of the lesions. However, the pain was intolerable and the treatment ineffective. To add insult to injury, each treated spot blistered and took more than a month to heal, leaving behind a pinkish brown blemish.
In all other respects, the patient’s health is excellent.
EXAMINATION
Both legs, from the upper thighs to the tops of the feet, are covered with thousands of uniformly distributed, tiny, keratotic, rough, dry papules. All the lesions are essentially identical: white, with no associated signs of inflammation. The patient’s skin is quite dry in general. Neither her palms nor soles are affected.
What’s the diagnosis?
DISCUSSION
The most common problem seen in dermatology offices worldwide is seborrheic keratosis (SK), a totally benign epidermal excrescence that appears to be related to aging and heredity. Most patients are in their 50s when they first notice an SK, and with a bit of luck, they will only see a few in their lifetime. But some patients develop hundreds of SKs, many of which become quite large (3-5 cm) and unsightly. In certain circumstances, SKs can herald the arrival of an occult carcinoma (the Leser-Trelat sign).
This patient has what some consider a variant of SK, called stucco keratosis. These lesions manifest almost exclusively on the lower legs and feet—perhaps due to the relative lack of sebaceous glands in those areas—and most often on men older than 60. Distressing as they are, stucco keratoses have no pathologic implications.
Grossly and histologically, stucco keratoses are different from ordinary SKs. Each stucco keratosis lesion is essentially identical to the others, with a spiculated surface, white color, and average diameter of 2 to 3 mm. Histologically, they demonstrate a thickened epidermis with focal exophytic upward projections that resemble church spires. The lesions do not extend into the dermis.
Treatment of stucco keratoses is, at best, tedious, painful, and futile. The modalities used are cryotherapy or electrodessication with curettage. For a degree of comfort, use of a loofah after bathing will remove or smooth down a few lesions, but this process must be followed by application of a heavy emollient. Alas, regrowth is a certainty.
TAKE-HOME LEARNING POINTS
- Stucco keratosis is considered a variant of seborrheic keratosis, although they differ in several significant ways.
- The lesions of stucco keratosis are fairly uniform in appearance: white, rough, spiculated, epidermal papules measuring 2 to 3 mm.
- Stucco keratoses affect about 10% of the population (men more often than women) and have no racial predilection or pathologic implications.
- The lesions are found almost exclusively on the legs, from the knees down to and including the dorsa of the feet.
- Treatment is far from satisfactory, for multiple reasons, including resultant pain and scarring.
Three years ago, lesions began appearing on this now 68-year-old woman’s legs. They have grown in size and number, and their roughness disturbs the patient. She has been told the lesions are related to aging, but she has never seen anything like them on her friends or family—and she is worried about what they might mean for her health.
Her primary care provider diagnosed warts and performed cryotherapy on several of the lesions. However, the pain was intolerable and the treatment ineffective. To add insult to injury, each treated spot blistered and took more than a month to heal, leaving behind a pinkish brown blemish.
In all other respects, the patient’s health is excellent.
EXAMINATION
Both legs, from the upper thighs to the tops of the feet, are covered with thousands of uniformly distributed, tiny, keratotic, rough, dry papules. All the lesions are essentially identical: white, with no associated signs of inflammation. The patient’s skin is quite dry in general. Neither her palms nor soles are affected.
What’s the diagnosis?
DISCUSSION
The most common problem seen in dermatology offices worldwide is seborrheic keratosis (SK), a totally benign epidermal excrescence that appears to be related to aging and heredity. Most patients are in their 50s when they first notice an SK, and with a bit of luck, they will only see a few in their lifetime. But some patients develop hundreds of SKs, many of which become quite large (3-5 cm) and unsightly. In certain circumstances, SKs can herald the arrival of an occult carcinoma (the Leser-Trelat sign).
This patient has what some consider a variant of SK, called stucco keratosis. These lesions manifest almost exclusively on the lower legs and feet—perhaps due to the relative lack of sebaceous glands in those areas—and most often on men older than 60. Distressing as they are, stucco keratoses have no pathologic implications.
Grossly and histologically, stucco keratoses are different from ordinary SKs. Each stucco keratosis lesion is essentially identical to the others, with a spiculated surface, white color, and average diameter of 2 to 3 mm. Histologically, they demonstrate a thickened epidermis with focal exophytic upward projections that resemble church spires. The lesions do not extend into the dermis.
Treatment of stucco keratoses is, at best, tedious, painful, and futile. The modalities used are cryotherapy or electrodessication with curettage. For a degree of comfort, use of a loofah after bathing will remove or smooth down a few lesions, but this process must be followed by application of a heavy emollient. Alas, regrowth is a certainty.
TAKE-HOME LEARNING POINTS
- Stucco keratosis is considered a variant of seborrheic keratosis, although they differ in several significant ways.
- The lesions of stucco keratosis are fairly uniform in appearance: white, rough, spiculated, epidermal papules measuring 2 to 3 mm.
- Stucco keratoses affect about 10% of the population (men more often than women) and have no racial predilection or pathologic implications.
- The lesions are found almost exclusively on the legs, from the knees down to and including the dorsa of the feet.
- Treatment is far from satisfactory, for multiple reasons, including resultant pain and scarring.
Three years ago, lesions began appearing on this now 68-year-old woman’s legs. They have grown in size and number, and their roughness disturbs the patient. She has been told the lesions are related to aging, but she has never seen anything like them on her friends or family—and she is worried about what they might mean for her health.
Her primary care provider diagnosed warts and performed cryotherapy on several of the lesions. However, the pain was intolerable and the treatment ineffective. To add insult to injury, each treated spot blistered and took more than a month to heal, leaving behind a pinkish brown blemish.
In all other respects, the patient’s health is excellent.
EXAMINATION
Both legs, from the upper thighs to the tops of the feet, are covered with thousands of uniformly distributed, tiny, keratotic, rough, dry papules. All the lesions are essentially identical: white, with no associated signs of inflammation. The patient’s skin is quite dry in general. Neither her palms nor soles are affected.
What’s the diagnosis?
DISCUSSION
The most common problem seen in dermatology offices worldwide is seborrheic keratosis (SK), a totally benign epidermal excrescence that appears to be related to aging and heredity. Most patients are in their 50s when they first notice an SK, and with a bit of luck, they will only see a few in their lifetime. But some patients develop hundreds of SKs, many of which become quite large (3-5 cm) and unsightly. In certain circumstances, SKs can herald the arrival of an occult carcinoma (the Leser-Trelat sign).
This patient has what some consider a variant of SK, called stucco keratosis. These lesions manifest almost exclusively on the lower legs and feet—perhaps due to the relative lack of sebaceous glands in those areas—and most often on men older than 60. Distressing as they are, stucco keratoses have no pathologic implications.
Grossly and histologically, stucco keratoses are different from ordinary SKs. Each stucco keratosis lesion is essentially identical to the others, with a spiculated surface, white color, and average diameter of 2 to 3 mm. Histologically, they demonstrate a thickened epidermis with focal exophytic upward projections that resemble church spires. The lesions do not extend into the dermis.
Treatment of stucco keratoses is, at best, tedious, painful, and futile. The modalities used are cryotherapy or electrodessication with curettage. For a degree of comfort, use of a loofah after bathing will remove or smooth down a few lesions, but this process must be followed by application of a heavy emollient. Alas, regrowth is a certainty.
TAKE-HOME LEARNING POINTS
- Stucco keratosis is considered a variant of seborrheic keratosis, although they differ in several significant ways.
- The lesions of stucco keratosis are fairly uniform in appearance: white, rough, spiculated, epidermal papules measuring 2 to 3 mm.
- Stucco keratoses affect about 10% of the population (men more often than women) and have no racial predilection or pathologic implications.
- The lesions are found almost exclusively on the legs, from the knees down to and including the dorsa of the feet.
- Treatment is far from satisfactory, for multiple reasons, including resultant pain and scarring.
Is it time for neurologists to manage high blood pressure?
In the Nov. 1, 2019, issue of JAMA Neurology, an editorial argues that it’s time for neurologists to start managing high blood pressure.
It makes some very valid points: that targeting a systolic blood pressure of less than 120 mm Hg results in lower rates of cardiovascular events and all causes of mortality, that poorly controlled hypertension leads to debilitating neurologic conditions, and that high blood pressure is the most common modifiable risk factor for stroke.
All are strong points. I agree with them and definitely believe that more can and should be done to control hypertension.
The editorial then goes on to say that “first and foremost we are charging neurologists with actively diagnosing hypertension and prescribing medications when appropriate.”
Uh, no. I’m not going to be the one managing hypertension, nor should any outpatient neurologist.
Outpatient hypertension treatment has historically been, and should remain, the province of general practitioners, cardiologists, and nephrologists. Too many cooks, as they say, spoils the broth. I don’t want to be in a situation where two (or more) doctors are simultaneously trying to treat the same condition. On that path lies danger.
This doesn’t mean I ignore blood pressure. On the contrary, I take it (myself) at every patient visit, and put it in my note. In most cases I do nothing further, as nothing further needs to be done. On occasion, though, if it’s concerningly high, I’ll write it down for the patient and direct them to call the physician handling it. I also fax a note about it to that office, and if it’s dangerously high will call the doctor myself.
But try to manage it? No. Elevated readings definitely overlap with my world, but treating them shouldn’t.
The article says that, for some chronic patients, neurologists are their de facto internist. Perhaps for a few, but when a patient calls with concerns about a respiratory ailment, gastrointestinal problem, or other nonneurologic issue, I tell them to call their general practitioner. If they don’t have one I’m happy to give them the names and phone numbers of colleagues who practice that field, or even urgent care and emergency department information if needed. Just because I see them for their neurologic problems doesn’t qualify me to practice another branch of medicine.
Beyond the dangers of having more than one doctor involved, as a specialist it’s not practical for me to know the antihypertensive medications – possibly the largest group of agents on the market, – in detail, with their mechanisms of action, side effects, and contraindications. Yes, I do keep a handful in mind, since they’re needed off label for migraines and tremors, but not in the kind of detail a cardiologist would. I have to keep track of enough medications in my specialty as it is.
I wouldn’t try to handle blood pressure any more than I’d expect a nephrologist to treat epilepsy. It’s just looking for trouble.
Even when covering the hospital, I’ll stay out of that arena. This doesn’t mean I ignore blood pressure in such serious conditions as stroke or posterior reversible encephalopathy syndrome. I’m more than happy to provide guidelines and parameters. But as far as choosing the medications and doses? No.
Like driving, we all have to share the road. We may even be focused on the same journey (or patient). But part of practicing medicine and handling traffic is knowing when to stay in your lane.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the Nov. 1, 2019, issue of JAMA Neurology, an editorial argues that it’s time for neurologists to start managing high blood pressure.
It makes some very valid points: that targeting a systolic blood pressure of less than 120 mm Hg results in lower rates of cardiovascular events and all causes of mortality, that poorly controlled hypertension leads to debilitating neurologic conditions, and that high blood pressure is the most common modifiable risk factor for stroke.
All are strong points. I agree with them and definitely believe that more can and should be done to control hypertension.
The editorial then goes on to say that “first and foremost we are charging neurologists with actively diagnosing hypertension and prescribing medications when appropriate.”
Uh, no. I’m not going to be the one managing hypertension, nor should any outpatient neurologist.
Outpatient hypertension treatment has historically been, and should remain, the province of general practitioners, cardiologists, and nephrologists. Too many cooks, as they say, spoils the broth. I don’t want to be in a situation where two (or more) doctors are simultaneously trying to treat the same condition. On that path lies danger.
This doesn’t mean I ignore blood pressure. On the contrary, I take it (myself) at every patient visit, and put it in my note. In most cases I do nothing further, as nothing further needs to be done. On occasion, though, if it’s concerningly high, I’ll write it down for the patient and direct them to call the physician handling it. I also fax a note about it to that office, and if it’s dangerously high will call the doctor myself.
But try to manage it? No. Elevated readings definitely overlap with my world, but treating them shouldn’t.
The article says that, for some chronic patients, neurologists are their de facto internist. Perhaps for a few, but when a patient calls with concerns about a respiratory ailment, gastrointestinal problem, or other nonneurologic issue, I tell them to call their general practitioner. If they don’t have one I’m happy to give them the names and phone numbers of colleagues who practice that field, or even urgent care and emergency department information if needed. Just because I see them for their neurologic problems doesn’t qualify me to practice another branch of medicine.
Beyond the dangers of having more than one doctor involved, as a specialist it’s not practical for me to know the antihypertensive medications – possibly the largest group of agents on the market, – in detail, with their mechanisms of action, side effects, and contraindications. Yes, I do keep a handful in mind, since they’re needed off label for migraines and tremors, but not in the kind of detail a cardiologist would. I have to keep track of enough medications in my specialty as it is.
I wouldn’t try to handle blood pressure any more than I’d expect a nephrologist to treat epilepsy. It’s just looking for trouble.
Even when covering the hospital, I’ll stay out of that arena. This doesn’t mean I ignore blood pressure in such serious conditions as stroke or posterior reversible encephalopathy syndrome. I’m more than happy to provide guidelines and parameters. But as far as choosing the medications and doses? No.
Like driving, we all have to share the road. We may even be focused on the same journey (or patient). But part of practicing medicine and handling traffic is knowing when to stay in your lane.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the Nov. 1, 2019, issue of JAMA Neurology, an editorial argues that it’s time for neurologists to start managing high blood pressure.
It makes some very valid points: that targeting a systolic blood pressure of less than 120 mm Hg results in lower rates of cardiovascular events and all causes of mortality, that poorly controlled hypertension leads to debilitating neurologic conditions, and that high blood pressure is the most common modifiable risk factor for stroke.
All are strong points. I agree with them and definitely believe that more can and should be done to control hypertension.
The editorial then goes on to say that “first and foremost we are charging neurologists with actively diagnosing hypertension and prescribing medications when appropriate.”
Uh, no. I’m not going to be the one managing hypertension, nor should any outpatient neurologist.
Outpatient hypertension treatment has historically been, and should remain, the province of general practitioners, cardiologists, and nephrologists. Too many cooks, as they say, spoils the broth. I don’t want to be in a situation where two (or more) doctors are simultaneously trying to treat the same condition. On that path lies danger.
This doesn’t mean I ignore blood pressure. On the contrary, I take it (myself) at every patient visit, and put it in my note. In most cases I do nothing further, as nothing further needs to be done. On occasion, though, if it’s concerningly high, I’ll write it down for the patient and direct them to call the physician handling it. I also fax a note about it to that office, and if it’s dangerously high will call the doctor myself.
But try to manage it? No. Elevated readings definitely overlap with my world, but treating them shouldn’t.
The article says that, for some chronic patients, neurologists are their de facto internist. Perhaps for a few, but when a patient calls with concerns about a respiratory ailment, gastrointestinal problem, or other nonneurologic issue, I tell them to call their general practitioner. If they don’t have one I’m happy to give them the names and phone numbers of colleagues who practice that field, or even urgent care and emergency department information if needed. Just because I see them for their neurologic problems doesn’t qualify me to practice another branch of medicine.
Beyond the dangers of having more than one doctor involved, as a specialist it’s not practical for me to know the antihypertensive medications – possibly the largest group of agents on the market, – in detail, with their mechanisms of action, side effects, and contraindications. Yes, I do keep a handful in mind, since they’re needed off label for migraines and tremors, but not in the kind of detail a cardiologist would. I have to keep track of enough medications in my specialty as it is.
I wouldn’t try to handle blood pressure any more than I’d expect a nephrologist to treat epilepsy. It’s just looking for trouble.
Even when covering the hospital, I’ll stay out of that arena. This doesn’t mean I ignore blood pressure in such serious conditions as stroke or posterior reversible encephalopathy syndrome. I’m more than happy to provide guidelines and parameters. But as far as choosing the medications and doses? No.
Like driving, we all have to share the road. We may even be focused on the same journey (or patient). But part of practicing medicine and handling traffic is knowing when to stay in your lane.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.