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Critics say hospital price transparency proposal ‘misses the mark’
A proposal by the Centers for Medicare & Medicaid Services to require full price transparency, including the disclosure of both list prices and payer-negotiated prices, is already receiving pushback.
Rick Pollack, president and CEO of the American Hospital Association, said in a statement that “mandating disclosure of negotiated rates between insurers and hospitals is the wrong approach,” adding that it “could seriously limit the choices available to patients in the private market and fuel anticompetitive behavior among commercial health insurers in an already highly concentrated insurance industry.”
The requirement for hospital price transparency was posted online July 29 as part of the proposed annual update to the hospital outpatient prospective payment system (OPPS) for 2020. It is scheduled for publication in the Federal Register on Aug. 9.
CMS is proposing, beginning in calendar year 2020, that hospitals make publicly available their “standard charges,” defined as the gross – or list – price of for all services provided by the hospital, as well as payer-specific negotiated prices. To allow for price comparisons, prices would be posted on the Internet in a machine-readable file that includes common billing or accounting codes and a description of the item of service being delivered.
Additionally, hospitals must make payer-specific negotiated prices for “shoppable” services, defined as services that can be scheduled in advance – such as x-rays, outpatient visits, imaging and laboratory tests, or bundled services like a cesarean delivery with pre- and postdelivery care – in a consumer-friendly manner.
“As deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” CMS Administrator Seema Verma said during a July 29 press conference. “In fact, a recent poll showed that the majority of Americans have tried to get pricing information before getting care, but have found it challenging to find that information.”
She noted that patients may see prices that range from 150% of Medicare rates to more than 400% for the same service.
Hospitals will need to display at least 300 shoppable services, including 70 that are CMS selected and 230 that are hospital selected, according to a fact sheet outlining this and other proposed OPPS updates for 2020.
“If a hospital does not provide one or more of the 70 CMS selected shoppable services, the hospital must select additional shoppable services such that the total number of shoppable services is at least 300,” the fact sheet states.
Information on pricing will be required to be updated at least annually.
CMS is including enforcement tools as part of the proposal, including fines to hospitals for noncompliance.
“Price transparency creates a marketplace where providers compete on the basis of cost and quality that will lower cost,” Ms. Verma said.
However, that notion has been challenged by America’s Health Insurance Plans (AHIP).
Matt Eyles, president and CEO of AHIP said in a statement that “multiple experts, including the Federal Trade Commission, agree that disclosing privately negotiated rates will make it harder to bargain for lower rates, creating a floor, not a ceiling, for the prices that hospitals would be willing to accept. Publicly disclosing competitively negotiated, proprietary rates will push prices and premiums higher, not lower, for consumers, patients, and taxpayers.”
Mr. Pollack of the American Hospital Association agreed. “While we support transparency, [this] proposal misses the mark, exceeds the Administration’s legal authority, and should be abandoned.”
Ms. Verma said she believed the agency had legal authority to impose this requirement and is not worried about possible lawsuits that could challenge this provision.
“This administration is not afraid of those things,” she said. “We are not about protecting the status quo when it doesn’t work for patients.”
A proposal by the Centers for Medicare & Medicaid Services to require full price transparency, including the disclosure of both list prices and payer-negotiated prices, is already receiving pushback.
Rick Pollack, president and CEO of the American Hospital Association, said in a statement that “mandating disclosure of negotiated rates between insurers and hospitals is the wrong approach,” adding that it “could seriously limit the choices available to patients in the private market and fuel anticompetitive behavior among commercial health insurers in an already highly concentrated insurance industry.”
The requirement for hospital price transparency was posted online July 29 as part of the proposed annual update to the hospital outpatient prospective payment system (OPPS) for 2020. It is scheduled for publication in the Federal Register on Aug. 9.
CMS is proposing, beginning in calendar year 2020, that hospitals make publicly available their “standard charges,” defined as the gross – or list – price of for all services provided by the hospital, as well as payer-specific negotiated prices. To allow for price comparisons, prices would be posted on the Internet in a machine-readable file that includes common billing or accounting codes and a description of the item of service being delivered.
Additionally, hospitals must make payer-specific negotiated prices for “shoppable” services, defined as services that can be scheduled in advance – such as x-rays, outpatient visits, imaging and laboratory tests, or bundled services like a cesarean delivery with pre- and postdelivery care – in a consumer-friendly manner.
“As deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” CMS Administrator Seema Verma said during a July 29 press conference. “In fact, a recent poll showed that the majority of Americans have tried to get pricing information before getting care, but have found it challenging to find that information.”
She noted that patients may see prices that range from 150% of Medicare rates to more than 400% for the same service.
Hospitals will need to display at least 300 shoppable services, including 70 that are CMS selected and 230 that are hospital selected, according to a fact sheet outlining this and other proposed OPPS updates for 2020.
“If a hospital does not provide one or more of the 70 CMS selected shoppable services, the hospital must select additional shoppable services such that the total number of shoppable services is at least 300,” the fact sheet states.
Information on pricing will be required to be updated at least annually.
CMS is including enforcement tools as part of the proposal, including fines to hospitals for noncompliance.
“Price transparency creates a marketplace where providers compete on the basis of cost and quality that will lower cost,” Ms. Verma said.
However, that notion has been challenged by America’s Health Insurance Plans (AHIP).
Matt Eyles, president and CEO of AHIP said in a statement that “multiple experts, including the Federal Trade Commission, agree that disclosing privately negotiated rates will make it harder to bargain for lower rates, creating a floor, not a ceiling, for the prices that hospitals would be willing to accept. Publicly disclosing competitively negotiated, proprietary rates will push prices and premiums higher, not lower, for consumers, patients, and taxpayers.”
Mr. Pollack of the American Hospital Association agreed. “While we support transparency, [this] proposal misses the mark, exceeds the Administration’s legal authority, and should be abandoned.”
Ms. Verma said she believed the agency had legal authority to impose this requirement and is not worried about possible lawsuits that could challenge this provision.
“This administration is not afraid of those things,” she said. “We are not about protecting the status quo when it doesn’t work for patients.”
A proposal by the Centers for Medicare & Medicaid Services to require full price transparency, including the disclosure of both list prices and payer-negotiated prices, is already receiving pushback.
Rick Pollack, president and CEO of the American Hospital Association, said in a statement that “mandating disclosure of negotiated rates between insurers and hospitals is the wrong approach,” adding that it “could seriously limit the choices available to patients in the private market and fuel anticompetitive behavior among commercial health insurers in an already highly concentrated insurance industry.”
The requirement for hospital price transparency was posted online July 29 as part of the proposed annual update to the hospital outpatient prospective payment system (OPPS) for 2020. It is scheduled for publication in the Federal Register on Aug. 9.
CMS is proposing, beginning in calendar year 2020, that hospitals make publicly available their “standard charges,” defined as the gross – or list – price of for all services provided by the hospital, as well as payer-specific negotiated prices. To allow for price comparisons, prices would be posted on the Internet in a machine-readable file that includes common billing or accounting codes and a description of the item of service being delivered.
Additionally, hospitals must make payer-specific negotiated prices for “shoppable” services, defined as services that can be scheduled in advance – such as x-rays, outpatient visits, imaging and laboratory tests, or bundled services like a cesarean delivery with pre- and postdelivery care – in a consumer-friendly manner.
“As deductibles rise and with 29 million uninsured, patients have the right to know the price of health care services so they can shop around for the best deal,” CMS Administrator Seema Verma said during a July 29 press conference. “In fact, a recent poll showed that the majority of Americans have tried to get pricing information before getting care, but have found it challenging to find that information.”
She noted that patients may see prices that range from 150% of Medicare rates to more than 400% for the same service.
Hospitals will need to display at least 300 shoppable services, including 70 that are CMS selected and 230 that are hospital selected, according to a fact sheet outlining this and other proposed OPPS updates for 2020.
“If a hospital does not provide one or more of the 70 CMS selected shoppable services, the hospital must select additional shoppable services such that the total number of shoppable services is at least 300,” the fact sheet states.
Information on pricing will be required to be updated at least annually.
CMS is including enforcement tools as part of the proposal, including fines to hospitals for noncompliance.
“Price transparency creates a marketplace where providers compete on the basis of cost and quality that will lower cost,” Ms. Verma said.
However, that notion has been challenged by America’s Health Insurance Plans (AHIP).
Matt Eyles, president and CEO of AHIP said in a statement that “multiple experts, including the Federal Trade Commission, agree that disclosing privately negotiated rates will make it harder to bargain for lower rates, creating a floor, not a ceiling, for the prices that hospitals would be willing to accept. Publicly disclosing competitively negotiated, proprietary rates will push prices and premiums higher, not lower, for consumers, patients, and taxpayers.”
Mr. Pollack of the American Hospital Association agreed. “While we support transparency, [this] proposal misses the mark, exceeds the Administration’s legal authority, and should be abandoned.”
Ms. Verma said she believed the agency had legal authority to impose this requirement and is not worried about possible lawsuits that could challenge this provision.
“This administration is not afraid of those things,” she said. “We are not about protecting the status quo when it doesn’t work for patients.”
Key clinical point: CMS proposes complete transparency in hospital prices.
Major finding: Hospitals would be required to make public the list prices, as well as all payer-negotiated prices.
Study details: CMS asserts that the disclosure of pricing data will lead to reduced prices through market competition.
Disclosures: CMS, as issuer of the proposed rule, makes no disclosures.
Source: Proposed rule updating the hospital outpatient prospective payment system for 2020.
Timing, volume of transfusion may not matter in children with severe anemia
Trial results suggest African children with uncomplicated, severe anemia may not require immediate blood transfusion, and the volume of transfusion may only matter in the context of fever.
The TRACT trial showed no significant differences in 28-day mortality or other clinical outcomes between children who received immediate transfusions and those who did not.
Similarly, there was no significant difference in 28-day mortality among children who received transfusions of 20 mL/kg and those who received transfusions of 30 mL/kg. There was evidence to suggest a higher transfusion volume may benefit children without fevers, but this was an exploratory endpoint. The findings were published in the New England Journal of Medicine.
These results suggest “there is no credible reason to transfuse immediately or to transfuse a higher volume of blood, at least in pediatric populations in regions such as these two sub-Saharan countries [Uganda and Malawi],” Julie R. Ingelfinger, MD, of Massachusetts General Hospital in Boston, wrote in an accompanying editorial, also published in the New England Journal of Medicine (2019;381:475-6).
“The possible effect of higher volume transfusion in patients with fever may trigger additional and potentially useful studies,” she added.
Immediate transfusion
One goal of the TRACT trial was to determine if blood transfusion is the best treatment for children with severe anemia. With this in mind, Kathryn Maitland, MD, PhD, of Imperial College London and colleagues evaluated 1,565 Ugandan and Malawian children with uncomplicated, severe anemia. The patients’ median age was 26 months, and 984 (62.9%) had malaria.
The children were randomized to immediate transfusion (n = 778) or no immediate transfusion (n = 787). Children who did not have an immediate transfusion (control group) could receive a transfusion if they exhibited new signs of clinical severity or had their hemoglobin decrease to below 4 g/dL.
All children in the immediate-transfusion group received a transfusion, as did 386 (49.0%) in the control group. The median time to transfusion was 1.3 hours in the immediate group and 24.9 hours in the control group. The mean total blood volume transfused per child was 314 plus or minus 228 mL and 142 plus or minus 224, respectively. The follow-up period was 180 days, and 4.5% of patients (n = 71) were lost to follow-up.
The researchers found no significant difference between the treatment groups with regard to mortality, other clinical outcomes, or the cost of care.
The 28-day mortality rate was 0.9% in the immediate-transfusion group and 1.7% in the control group (hazard ratio, 0.54; 95% confidence interval, 0.22-1.36; P = .19). The 180-day mortality was 4.5% and 6.0%, respectively (HR, 0.75; 95% CI, 0.48-1.15).
Transfusion volume
To assess the effects of transfusion volume, Dr. Maitland and colleagues evaluated 3,196 Ugandan and Malawian children with severe anemia. The median age of the children was 37 months, and 2,050 (64.1%) had malaria.
The children received a transfusion of 30 mL/kg (n = 1,592) or 20 mL/kg (n = 1,596) at a median of 1.2 hours after randomization. Some children – 197 in the 30-mL/kg group and 300 in the 20-mL/kg group – received additional transfusions. The mean volume of total blood transfused per child was 475 plus or minus 385 mL, and 353 plus or minus 348 mL, respectively.
Overall, there was no significant between-group difference with regard to mortality. The 28-day mortality rate was 3.4% in the 30 mL/kg group and 4.5% in the 20 mL/kg group (HR = 0.76; 95% CI, 0.54 to 1.08; P = .12).
However, the 28-day mortality rate did differ according to the presence of fever at screening. The mortality rate was lower in the 30 mL/kg group for children without fevers (HR = 0.43; 95% CI, 0.27 to 0.69) but higher in the 30 mL/kg group for febrile children (HR = 1.91; 95% CI, 1.04 to 3.49).
For other outcomes, including readmissions and serious adverse events, the researchers found no significant between-group differences.
This trial was supported by a grant from the United Kingdom Medical Research Council through a concordat with the Department for International Development. One researcher has a Wellcome Senior Research Fellowship, and another is a National Institute for Health Research Senior Investigator. Dr. Ingelfinger is a deputy editor at the New England Journal of Medicine. No other relevant conflicts of interest were reported.
SOURCES: Maitland K et al. N Engl J Med. 2019;381:407-19. Maitland K et al. N Engl J Med. 2019;381:420-31.
Trial results suggest African children with uncomplicated, severe anemia may not require immediate blood transfusion, and the volume of transfusion may only matter in the context of fever.
The TRACT trial showed no significant differences in 28-day mortality or other clinical outcomes between children who received immediate transfusions and those who did not.
Similarly, there was no significant difference in 28-day mortality among children who received transfusions of 20 mL/kg and those who received transfusions of 30 mL/kg. There was evidence to suggest a higher transfusion volume may benefit children without fevers, but this was an exploratory endpoint. The findings were published in the New England Journal of Medicine.
These results suggest “there is no credible reason to transfuse immediately or to transfuse a higher volume of blood, at least in pediatric populations in regions such as these two sub-Saharan countries [Uganda and Malawi],” Julie R. Ingelfinger, MD, of Massachusetts General Hospital in Boston, wrote in an accompanying editorial, also published in the New England Journal of Medicine (2019;381:475-6).
“The possible effect of higher volume transfusion in patients with fever may trigger additional and potentially useful studies,” she added.
Immediate transfusion
One goal of the TRACT trial was to determine if blood transfusion is the best treatment for children with severe anemia. With this in mind, Kathryn Maitland, MD, PhD, of Imperial College London and colleagues evaluated 1,565 Ugandan and Malawian children with uncomplicated, severe anemia. The patients’ median age was 26 months, and 984 (62.9%) had malaria.
The children were randomized to immediate transfusion (n = 778) or no immediate transfusion (n = 787). Children who did not have an immediate transfusion (control group) could receive a transfusion if they exhibited new signs of clinical severity or had their hemoglobin decrease to below 4 g/dL.
All children in the immediate-transfusion group received a transfusion, as did 386 (49.0%) in the control group. The median time to transfusion was 1.3 hours in the immediate group and 24.9 hours in the control group. The mean total blood volume transfused per child was 314 plus or minus 228 mL and 142 plus or minus 224, respectively. The follow-up period was 180 days, and 4.5% of patients (n = 71) were lost to follow-up.
The researchers found no significant difference between the treatment groups with regard to mortality, other clinical outcomes, or the cost of care.
The 28-day mortality rate was 0.9% in the immediate-transfusion group and 1.7% in the control group (hazard ratio, 0.54; 95% confidence interval, 0.22-1.36; P = .19). The 180-day mortality was 4.5% and 6.0%, respectively (HR, 0.75; 95% CI, 0.48-1.15).
Transfusion volume
To assess the effects of transfusion volume, Dr. Maitland and colleagues evaluated 3,196 Ugandan and Malawian children with severe anemia. The median age of the children was 37 months, and 2,050 (64.1%) had malaria.
The children received a transfusion of 30 mL/kg (n = 1,592) or 20 mL/kg (n = 1,596) at a median of 1.2 hours after randomization. Some children – 197 in the 30-mL/kg group and 300 in the 20-mL/kg group – received additional transfusions. The mean volume of total blood transfused per child was 475 plus or minus 385 mL, and 353 plus or minus 348 mL, respectively.
Overall, there was no significant between-group difference with regard to mortality. The 28-day mortality rate was 3.4% in the 30 mL/kg group and 4.5% in the 20 mL/kg group (HR = 0.76; 95% CI, 0.54 to 1.08; P = .12).
However, the 28-day mortality rate did differ according to the presence of fever at screening. The mortality rate was lower in the 30 mL/kg group for children without fevers (HR = 0.43; 95% CI, 0.27 to 0.69) but higher in the 30 mL/kg group for febrile children (HR = 1.91; 95% CI, 1.04 to 3.49).
For other outcomes, including readmissions and serious adverse events, the researchers found no significant between-group differences.
This trial was supported by a grant from the United Kingdom Medical Research Council through a concordat with the Department for International Development. One researcher has a Wellcome Senior Research Fellowship, and another is a National Institute for Health Research Senior Investigator. Dr. Ingelfinger is a deputy editor at the New England Journal of Medicine. No other relevant conflicts of interest were reported.
SOURCES: Maitland K et al. N Engl J Med. 2019;381:407-19. Maitland K et al. N Engl J Med. 2019;381:420-31.
Trial results suggest African children with uncomplicated, severe anemia may not require immediate blood transfusion, and the volume of transfusion may only matter in the context of fever.
The TRACT trial showed no significant differences in 28-day mortality or other clinical outcomes between children who received immediate transfusions and those who did not.
Similarly, there was no significant difference in 28-day mortality among children who received transfusions of 20 mL/kg and those who received transfusions of 30 mL/kg. There was evidence to suggest a higher transfusion volume may benefit children without fevers, but this was an exploratory endpoint. The findings were published in the New England Journal of Medicine.
These results suggest “there is no credible reason to transfuse immediately or to transfuse a higher volume of blood, at least in pediatric populations in regions such as these two sub-Saharan countries [Uganda and Malawi],” Julie R. Ingelfinger, MD, of Massachusetts General Hospital in Boston, wrote in an accompanying editorial, also published in the New England Journal of Medicine (2019;381:475-6).
“The possible effect of higher volume transfusion in patients with fever may trigger additional and potentially useful studies,” she added.
Immediate transfusion
One goal of the TRACT trial was to determine if blood transfusion is the best treatment for children with severe anemia. With this in mind, Kathryn Maitland, MD, PhD, of Imperial College London and colleagues evaluated 1,565 Ugandan and Malawian children with uncomplicated, severe anemia. The patients’ median age was 26 months, and 984 (62.9%) had malaria.
The children were randomized to immediate transfusion (n = 778) or no immediate transfusion (n = 787). Children who did not have an immediate transfusion (control group) could receive a transfusion if they exhibited new signs of clinical severity or had their hemoglobin decrease to below 4 g/dL.
All children in the immediate-transfusion group received a transfusion, as did 386 (49.0%) in the control group. The median time to transfusion was 1.3 hours in the immediate group and 24.9 hours in the control group. The mean total blood volume transfused per child was 314 plus or minus 228 mL and 142 plus or minus 224, respectively. The follow-up period was 180 days, and 4.5% of patients (n = 71) were lost to follow-up.
The researchers found no significant difference between the treatment groups with regard to mortality, other clinical outcomes, or the cost of care.
The 28-day mortality rate was 0.9% in the immediate-transfusion group and 1.7% in the control group (hazard ratio, 0.54; 95% confidence interval, 0.22-1.36; P = .19). The 180-day mortality was 4.5% and 6.0%, respectively (HR, 0.75; 95% CI, 0.48-1.15).
Transfusion volume
To assess the effects of transfusion volume, Dr. Maitland and colleagues evaluated 3,196 Ugandan and Malawian children with severe anemia. The median age of the children was 37 months, and 2,050 (64.1%) had malaria.
The children received a transfusion of 30 mL/kg (n = 1,592) or 20 mL/kg (n = 1,596) at a median of 1.2 hours after randomization. Some children – 197 in the 30-mL/kg group and 300 in the 20-mL/kg group – received additional transfusions. The mean volume of total blood transfused per child was 475 plus or minus 385 mL, and 353 plus or minus 348 mL, respectively.
Overall, there was no significant between-group difference with regard to mortality. The 28-day mortality rate was 3.4% in the 30 mL/kg group and 4.5% in the 20 mL/kg group (HR = 0.76; 95% CI, 0.54 to 1.08; P = .12).
However, the 28-day mortality rate did differ according to the presence of fever at screening. The mortality rate was lower in the 30 mL/kg group for children without fevers (HR = 0.43; 95% CI, 0.27 to 0.69) but higher in the 30 mL/kg group for febrile children (HR = 1.91; 95% CI, 1.04 to 3.49).
For other outcomes, including readmissions and serious adverse events, the researchers found no significant between-group differences.
This trial was supported by a grant from the United Kingdom Medical Research Council through a concordat with the Department for International Development. One researcher has a Wellcome Senior Research Fellowship, and another is a National Institute for Health Research Senior Investigator. Dr. Ingelfinger is a deputy editor at the New England Journal of Medicine. No other relevant conflicts of interest were reported.
SOURCES: Maitland K et al. N Engl J Med. 2019;381:407-19. Maitland K et al. N Engl J Med. 2019;381:420-31.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: The 28-day mortality was 0.9% in patients who had immediate transfusions and 1.7% in those who did not (hazard ratio, 0.54; P = .19). The 28-day mortality rate was 3.4% in patients who received transfusions of 30 mL/kg and 4.5% in those who received transfusions of 20 mL/kg (HR, 0.76; P = .12). However, the mortality rate was lower in the 30-mL/kg group for children without fevers (HR, 0.43) and higher in the 30-mL/kg group for febrile children (HR, 1.91).
Study details: A phase 3 trial of African children with severe anemia who were randomized to immediate transfusion (n = 778) or no immediate transfusion (n = 787) and transfusions of 30 mL/kg (n = 1,592) or 20 mL/kg (n = 1,596)
Disclosures: The trial was supported by a grant from the United Kingdom Medical Research Council through a concordat with the Department for International Development. One researcher has a Wellcome Senior Research Fellowship, and another is a National Institute for Health Research Senior Investigator.
Sources: Maitland K et al. N Engl J Med. 2019;381:407-19. Maitland K et al. N Engl J Med. 2019;381:420-31.
ICYMI: Ibrutinib/rituximab combo improves CLL survival
Patients with previously untreated chronic lymphocytic leukemia (CLL) aged 70 years or younger who received ibrutinib/rituximab therapy experienced significantly greater progression-free survival, compared with those who received standard chemotherapy with fludarabine, cyclophosphamide, and rituximab (89.4% vs. 72.9% at 3 years; hazard ratio, 0.35; 95% confidence interval, 0.22-0.56; P less than .001), according to results from a randomized, phase 3 trial published in the New England Journal of Medicine (2019;381:432-43).
We first reported on the results of this trial when they were presented at the annual meeting of the American Society of Hematology. Find our coverage at the link below.
Patients with previously untreated chronic lymphocytic leukemia (CLL) aged 70 years or younger who received ibrutinib/rituximab therapy experienced significantly greater progression-free survival, compared with those who received standard chemotherapy with fludarabine, cyclophosphamide, and rituximab (89.4% vs. 72.9% at 3 years; hazard ratio, 0.35; 95% confidence interval, 0.22-0.56; P less than .001), according to results from a randomized, phase 3 trial published in the New England Journal of Medicine (2019;381:432-43).
We first reported on the results of this trial when they were presented at the annual meeting of the American Society of Hematology. Find our coverage at the link below.
Patients with previously untreated chronic lymphocytic leukemia (CLL) aged 70 years or younger who received ibrutinib/rituximab therapy experienced significantly greater progression-free survival, compared with those who received standard chemotherapy with fludarabine, cyclophosphamide, and rituximab (89.4% vs. 72.9% at 3 years; hazard ratio, 0.35; 95% confidence interval, 0.22-0.56; P less than .001), according to results from a randomized, phase 3 trial published in the New England Journal of Medicine (2019;381:432-43).
We first reported on the results of this trial when they were presented at the annual meeting of the American Society of Hematology. Find our coverage at the link below.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Hemoglobin levels are associated with long-term dementia risk
This U-shaped association “may relate to differences in white matter integrity and cerebral perfusion,” the researchers wrote in Neurology.
“With around 10% of people over age 65 having anemia in the Americas and Europe and up to 45% in African and southeast Asian countries, these results could have important implications for the burden of dementia,” said study author M. Arfan Ikram, MD, PhD, in a news release. Dr. Ikram is a professor of epidemiology at Erasmus Medical Center in Rotterdam, the Netherlands.
Prior studies have found that low hemoglobin levels are associated with adverse health outcomes, such as coronary heart disease, stroke, and mortality, but data about the relationship between hemoglobin levels and dementia risk have been limited.
A population-based cohort study
To examine the long-term association of hemoglobin levels and anemia with risk of dementia, Dr. Ikram and coauthors analyzed data from the Rotterdam Study, an ongoing population-based cohort study in the Netherlands that started in 1990. Their analysis included data from 12,305 participants without dementia who had serum hemoglobin measured at baseline (mean age, 64.6 years; 57.7% women).
During a mean follow-up of 12.1 years, 1,520 participants developed dementia, 1,194 of whom had Alzheimer’s disease.
“Both low and high hemoglobin levels were associated with increased dementia risk,” the authors wrote. Compared with participants in the middle quintile of hemoglobin levels (8.57-8.99 mmol/L), participants in the lowest quintile (less than 8.11 mmol/L) had a hazard ratio of dementia of 1.29, and participants in the highest quintile (greater than 9.40 mmol/L) had an HR of 1.20.
About 6% of the participants had anemia – that is, a hemoglobin level of less than 8.1 mmol/L for men and less than 7.5 mmol/L for women. Anemia was associated with a 34% increased risk of dementia and a 41% increased risk of Alzheimer’s disease.
Of the 745 people with anemia, 128 developed dementia, compared with 1,392 of the 11,560 people who did not have anemia (17% vs. 12%).
A U-shaped association
The researchers also examined hemoglobin in relation to vascular brain disease, structural connectivity, and global cerebral perfusion among 5,267 participants without dementia who had brain MRI. White matter hyperintensity volume and hemoglobin had a U-shaped association, similar to that for dementia and hemoglobin. In addition, hemoglobin inversely correlated to cerebral perfusion.
The results remained consistent after adjustment for factors such as smoking, high blood pressure, high cholesterol, and alcohol use.
A limitation of the study is that the participants lived in the Netherlands and were primarily of European descent, so the results may not apply to other populations, the authors wrote.
Dr. Ikram noted that the study does not prove that low or high hemoglobin levels cause dementia. “More research is needed to determine whether hemoglobin levels play a direct role in this increased risk or whether these associations can be explained by underlying issues or other vascular or metabolic changes.”
The study was supported by the Netherlands Cardiovascular Research Initiative; Erasmus Medical Centre; Erasmus University Rotterdam; Netherlands Organization for Scientific Research; Netherlands Organization for Health Research and Development; Research Institute for Diseases in the Elderly; Netherlands Genomic Initiative; Dutch Ministry of Education, Culture, and Science; Dutch Ministry of Health, Welfare, and Sports; European Commission; Municipality of Rotterdam; Netherlands Consortium for Healthy Aging; and Dutch Heart Foundation. The authors reported no relevant disclosures.
SOURCE: Ikram MA et al. Neurology. 2019 Jul 31. doi: 10.1212/WNL.0000000000008003.
This U-shaped association “may relate to differences in white matter integrity and cerebral perfusion,” the researchers wrote in Neurology.
“With around 10% of people over age 65 having anemia in the Americas and Europe and up to 45% in African and southeast Asian countries, these results could have important implications for the burden of dementia,” said study author M. Arfan Ikram, MD, PhD, in a news release. Dr. Ikram is a professor of epidemiology at Erasmus Medical Center in Rotterdam, the Netherlands.
Prior studies have found that low hemoglobin levels are associated with adverse health outcomes, such as coronary heart disease, stroke, and mortality, but data about the relationship between hemoglobin levels and dementia risk have been limited.
A population-based cohort study
To examine the long-term association of hemoglobin levels and anemia with risk of dementia, Dr. Ikram and coauthors analyzed data from the Rotterdam Study, an ongoing population-based cohort study in the Netherlands that started in 1990. Their analysis included data from 12,305 participants without dementia who had serum hemoglobin measured at baseline (mean age, 64.6 years; 57.7% women).
During a mean follow-up of 12.1 years, 1,520 participants developed dementia, 1,194 of whom had Alzheimer’s disease.
“Both low and high hemoglobin levels were associated with increased dementia risk,” the authors wrote. Compared with participants in the middle quintile of hemoglobin levels (8.57-8.99 mmol/L), participants in the lowest quintile (less than 8.11 mmol/L) had a hazard ratio of dementia of 1.29, and participants in the highest quintile (greater than 9.40 mmol/L) had an HR of 1.20.
About 6% of the participants had anemia – that is, a hemoglobin level of less than 8.1 mmol/L for men and less than 7.5 mmol/L for women. Anemia was associated with a 34% increased risk of dementia and a 41% increased risk of Alzheimer’s disease.
Of the 745 people with anemia, 128 developed dementia, compared with 1,392 of the 11,560 people who did not have anemia (17% vs. 12%).
A U-shaped association
The researchers also examined hemoglobin in relation to vascular brain disease, structural connectivity, and global cerebral perfusion among 5,267 participants without dementia who had brain MRI. White matter hyperintensity volume and hemoglobin had a U-shaped association, similar to that for dementia and hemoglobin. In addition, hemoglobin inversely correlated to cerebral perfusion.
The results remained consistent after adjustment for factors such as smoking, high blood pressure, high cholesterol, and alcohol use.
A limitation of the study is that the participants lived in the Netherlands and were primarily of European descent, so the results may not apply to other populations, the authors wrote.
Dr. Ikram noted that the study does not prove that low or high hemoglobin levels cause dementia. “More research is needed to determine whether hemoglobin levels play a direct role in this increased risk or whether these associations can be explained by underlying issues or other vascular or metabolic changes.”
The study was supported by the Netherlands Cardiovascular Research Initiative; Erasmus Medical Centre; Erasmus University Rotterdam; Netherlands Organization for Scientific Research; Netherlands Organization for Health Research and Development; Research Institute for Diseases in the Elderly; Netherlands Genomic Initiative; Dutch Ministry of Education, Culture, and Science; Dutch Ministry of Health, Welfare, and Sports; European Commission; Municipality of Rotterdam; Netherlands Consortium for Healthy Aging; and Dutch Heart Foundation. The authors reported no relevant disclosures.
SOURCE: Ikram MA et al. Neurology. 2019 Jul 31. doi: 10.1212/WNL.0000000000008003.
This U-shaped association “may relate to differences in white matter integrity and cerebral perfusion,” the researchers wrote in Neurology.
“With around 10% of people over age 65 having anemia in the Americas and Europe and up to 45% in African and southeast Asian countries, these results could have important implications for the burden of dementia,” said study author M. Arfan Ikram, MD, PhD, in a news release. Dr. Ikram is a professor of epidemiology at Erasmus Medical Center in Rotterdam, the Netherlands.
Prior studies have found that low hemoglobin levels are associated with adverse health outcomes, such as coronary heart disease, stroke, and mortality, but data about the relationship between hemoglobin levels and dementia risk have been limited.
A population-based cohort study
To examine the long-term association of hemoglobin levels and anemia with risk of dementia, Dr. Ikram and coauthors analyzed data from the Rotterdam Study, an ongoing population-based cohort study in the Netherlands that started in 1990. Their analysis included data from 12,305 participants without dementia who had serum hemoglobin measured at baseline (mean age, 64.6 years; 57.7% women).
During a mean follow-up of 12.1 years, 1,520 participants developed dementia, 1,194 of whom had Alzheimer’s disease.
“Both low and high hemoglobin levels were associated with increased dementia risk,” the authors wrote. Compared with participants in the middle quintile of hemoglobin levels (8.57-8.99 mmol/L), participants in the lowest quintile (less than 8.11 mmol/L) had a hazard ratio of dementia of 1.29, and participants in the highest quintile (greater than 9.40 mmol/L) had an HR of 1.20.
About 6% of the participants had anemia – that is, a hemoglobin level of less than 8.1 mmol/L for men and less than 7.5 mmol/L for women. Anemia was associated with a 34% increased risk of dementia and a 41% increased risk of Alzheimer’s disease.
Of the 745 people with anemia, 128 developed dementia, compared with 1,392 of the 11,560 people who did not have anemia (17% vs. 12%).
A U-shaped association
The researchers also examined hemoglobin in relation to vascular brain disease, structural connectivity, and global cerebral perfusion among 5,267 participants without dementia who had brain MRI. White matter hyperintensity volume and hemoglobin had a U-shaped association, similar to that for dementia and hemoglobin. In addition, hemoglobin inversely correlated to cerebral perfusion.
The results remained consistent after adjustment for factors such as smoking, high blood pressure, high cholesterol, and alcohol use.
A limitation of the study is that the participants lived in the Netherlands and were primarily of European descent, so the results may not apply to other populations, the authors wrote.
Dr. Ikram noted that the study does not prove that low or high hemoglobin levels cause dementia. “More research is needed to determine whether hemoglobin levels play a direct role in this increased risk or whether these associations can be explained by underlying issues or other vascular or metabolic changes.”
The study was supported by the Netherlands Cardiovascular Research Initiative; Erasmus Medical Centre; Erasmus University Rotterdam; Netherlands Organization for Scientific Research; Netherlands Organization for Health Research and Development; Research Institute for Diseases in the Elderly; Netherlands Genomic Initiative; Dutch Ministry of Education, Culture, and Science; Dutch Ministry of Health, Welfare, and Sports; European Commission; Municipality of Rotterdam; Netherlands Consortium for Healthy Aging; and Dutch Heart Foundation. The authors reported no relevant disclosures.
SOURCE: Ikram MA et al. Neurology. 2019 Jul 31. doi: 10.1212/WNL.0000000000008003.
FROM NEUROLOGY
Key clinical point: Adults with low levels of hemoglobin and adults with high levels of hemoglobin may have an increased risk of dementia.
Major finding: Compared with participants in the middle quintile of hemoglobin levels (8.57-8.99 mmol/L), participants in the lowest quintile (less than 8.11 mmol/L) had a hazard ratio of dementia of 1.29, and participants in the highest quintile (greater than 9.40 mmol/L) had an HR of 1.20.
Study details: An analysis of data from 12,305 participants in the Rotterdam Study, a population-based cohort study in the Netherlands, who were followed up for an average of 12 years.
Disclosures: The study was supported by the Netherlands Cardiovascular Research Initiative; Erasmus Medical Centre; Erasmus University Rotterdam; Netherlands Organization for Scientific Research; Netherlands Organization for Health Research and Development; Research Institute for Diseases in the Elderly; Netherlands Genomic Initiative; Dutch Ministry of Education, Culture, and Science; Dutch Ministry of Health, Welfare, and Sports; European Commission; Municipality of Rotterdam; Netherlands Consortium for Healthy Aging; and Dutch Heart Foundation. The authors reported no relevant disclosures.
Source: Ikram MA et al. Neurology. 2019 Jul 31. doi: 10.1212/WNL.0000000000008003.
Predatory journals and HULLK’s prostate
The incredible HULLK
HULLK TYPE OF RNA THAT CONTROLS GROWTH OF PROSTATE CANCER CELLS. HULLK IS STRONGEST RNA THERE IS. HULLK SMASH CANCER!
Is everyone’s favorite not-so-jolly green giant the key to crushing prostate cancer? Not exactly: HULLK is a noncoding type of RNA. Which means, instead of coding a protein, it helps regulate cellular processes.
Cancer researchers from the University of Virginia found there was more HULLK in tumors from patients with advanced prostate cancer. They also found that decreasing the incredible RNA slows tumor cell growth.
In other words, we need a little more Bruce Banner, a little less HULLK.
The scientists who identified HULLK are hopeful that it can function as a biomarker and a therapeutic target in the future, and could be an integral discovery on the way to curing prostate cancer. HULLK LIKE.
Trading places with Sigmund Freud
Sometimes, it can be helpful to talk to someone about your problems. We’re not really going out on a limb here. That is, after all, pretty much the basis of psychotherapy.
But what if that someone else was really you, disguised as Sigmund Freud?
That was the premise for a recent study involving body swapping and immersive virtual reality. The investigators scanned each subject to create a 3D avatar that functioned as an online representation and moved as he or she moved during the experiment. In virtual reality, the subject’s avatar sat across a table from Sigmund Freud, who was the variable element in the study.
For the control group, Freud responded with prescripted questions and comments about the subject’s problem. The other group, however, was able to swap virtual bodies and respond to their own bodies as Freud. In other words, they could have a conversation with themselves, but it looked like they were talking to Freud.
A week after the virtual conversations, more than 80% of those in the body-swapping group experienced some sort of change with respect to their problem, compared with less than 50% of controls.
“We found that those in the body-swapping group got better knowledge, understanding, control, and new ideas about their problem, compared to the control group,” one of the investigators said.
We’re just wondering about their choice of Freud. It kind of makes sense, because that was his line of work; but would another person have been even more helpful?
How about Dr. Phil? Or maybe Oprah? Seems like Dwayne “the Rock” Johnson is everywhere else, so why not virtual reality? It would be hard to go wrong with some type of Kardashian, right?
Cue the ‘Jaws’ music
Doctors with freshly written studies beware, for you are not alone. Lurking in the undergrowth, stalking your every move, are the predatory journals. They’ve come for you. And they pose a danger not only to you, but to the entire field of medical literature.
However, there’s no need to fear, as you have a guide through the great Serengeti of the publication process: a new guideline on avoiding predatory journals from the American Medical Writers Association, European Medical Writers Association, and International Society for Medical Publication Professionals.
According to the guideline, some telltale characteristics of these journals include a lack of information, poorly made websites, a lack of indexing in a recognized system, promises of unrealistically quick peer review, and an insatiable thirst for your blood. We may have made that last one up.
The guideline authors call for all medical authors to conduct research while submitting to journals, and only submit to those journals that conduct a full peer review process and that genuinely seek to contribute to medical literature.
Failure to do so may result in a damaged reputation, being unwittingly appointed to an editorial board, losing your paper, or having your liver eaten by an eagle day after day until Hercules finally frees you from your torture.
We may have made that one up as well.
The incredible HULLK
HULLK TYPE OF RNA THAT CONTROLS GROWTH OF PROSTATE CANCER CELLS. HULLK IS STRONGEST RNA THERE IS. HULLK SMASH CANCER!
Is everyone’s favorite not-so-jolly green giant the key to crushing prostate cancer? Not exactly: HULLK is a noncoding type of RNA. Which means, instead of coding a protein, it helps regulate cellular processes.
Cancer researchers from the University of Virginia found there was more HULLK in tumors from patients with advanced prostate cancer. They also found that decreasing the incredible RNA slows tumor cell growth.
In other words, we need a little more Bruce Banner, a little less HULLK.
The scientists who identified HULLK are hopeful that it can function as a biomarker and a therapeutic target in the future, and could be an integral discovery on the way to curing prostate cancer. HULLK LIKE.
Trading places with Sigmund Freud
Sometimes, it can be helpful to talk to someone about your problems. We’re not really going out on a limb here. That is, after all, pretty much the basis of psychotherapy.
But what if that someone else was really you, disguised as Sigmund Freud?
That was the premise for a recent study involving body swapping and immersive virtual reality. The investigators scanned each subject to create a 3D avatar that functioned as an online representation and moved as he or she moved during the experiment. In virtual reality, the subject’s avatar sat across a table from Sigmund Freud, who was the variable element in the study.
For the control group, Freud responded with prescripted questions and comments about the subject’s problem. The other group, however, was able to swap virtual bodies and respond to their own bodies as Freud. In other words, they could have a conversation with themselves, but it looked like they were talking to Freud.
A week after the virtual conversations, more than 80% of those in the body-swapping group experienced some sort of change with respect to their problem, compared with less than 50% of controls.
“We found that those in the body-swapping group got better knowledge, understanding, control, and new ideas about their problem, compared to the control group,” one of the investigators said.
We’re just wondering about their choice of Freud. It kind of makes sense, because that was his line of work; but would another person have been even more helpful?
How about Dr. Phil? Or maybe Oprah? Seems like Dwayne “the Rock” Johnson is everywhere else, so why not virtual reality? It would be hard to go wrong with some type of Kardashian, right?
Cue the ‘Jaws’ music
Doctors with freshly written studies beware, for you are not alone. Lurking in the undergrowth, stalking your every move, are the predatory journals. They’ve come for you. And they pose a danger not only to you, but to the entire field of medical literature.
However, there’s no need to fear, as you have a guide through the great Serengeti of the publication process: a new guideline on avoiding predatory journals from the American Medical Writers Association, European Medical Writers Association, and International Society for Medical Publication Professionals.
According to the guideline, some telltale characteristics of these journals include a lack of information, poorly made websites, a lack of indexing in a recognized system, promises of unrealistically quick peer review, and an insatiable thirst for your blood. We may have made that last one up.
The guideline authors call for all medical authors to conduct research while submitting to journals, and only submit to those journals that conduct a full peer review process and that genuinely seek to contribute to medical literature.
Failure to do so may result in a damaged reputation, being unwittingly appointed to an editorial board, losing your paper, or having your liver eaten by an eagle day after day until Hercules finally frees you from your torture.
We may have made that one up as well.
The incredible HULLK
HULLK TYPE OF RNA THAT CONTROLS GROWTH OF PROSTATE CANCER CELLS. HULLK IS STRONGEST RNA THERE IS. HULLK SMASH CANCER!
Is everyone’s favorite not-so-jolly green giant the key to crushing prostate cancer? Not exactly: HULLK is a noncoding type of RNA. Which means, instead of coding a protein, it helps regulate cellular processes.
Cancer researchers from the University of Virginia found there was more HULLK in tumors from patients with advanced prostate cancer. They also found that decreasing the incredible RNA slows tumor cell growth.
In other words, we need a little more Bruce Banner, a little less HULLK.
The scientists who identified HULLK are hopeful that it can function as a biomarker and a therapeutic target in the future, and could be an integral discovery on the way to curing prostate cancer. HULLK LIKE.
Trading places with Sigmund Freud
Sometimes, it can be helpful to talk to someone about your problems. We’re not really going out on a limb here. That is, after all, pretty much the basis of psychotherapy.
But what if that someone else was really you, disguised as Sigmund Freud?
That was the premise for a recent study involving body swapping and immersive virtual reality. The investigators scanned each subject to create a 3D avatar that functioned as an online representation and moved as he or she moved during the experiment. In virtual reality, the subject’s avatar sat across a table from Sigmund Freud, who was the variable element in the study.
For the control group, Freud responded with prescripted questions and comments about the subject’s problem. The other group, however, was able to swap virtual bodies and respond to their own bodies as Freud. In other words, they could have a conversation with themselves, but it looked like they were talking to Freud.
A week after the virtual conversations, more than 80% of those in the body-swapping group experienced some sort of change with respect to their problem, compared with less than 50% of controls.
“We found that those in the body-swapping group got better knowledge, understanding, control, and new ideas about their problem, compared to the control group,” one of the investigators said.
We’re just wondering about their choice of Freud. It kind of makes sense, because that was his line of work; but would another person have been even more helpful?
How about Dr. Phil? Or maybe Oprah? Seems like Dwayne “the Rock” Johnson is everywhere else, so why not virtual reality? It would be hard to go wrong with some type of Kardashian, right?
Cue the ‘Jaws’ music
Doctors with freshly written studies beware, for you are not alone. Lurking in the undergrowth, stalking your every move, are the predatory journals. They’ve come for you. And they pose a danger not only to you, but to the entire field of medical literature.
However, there’s no need to fear, as you have a guide through the great Serengeti of the publication process: a new guideline on avoiding predatory journals from the American Medical Writers Association, European Medical Writers Association, and International Society for Medical Publication Professionals.
According to the guideline, some telltale characteristics of these journals include a lack of information, poorly made websites, a lack of indexing in a recognized system, promises of unrealistically quick peer review, and an insatiable thirst for your blood. We may have made that last one up.
The guideline authors call for all medical authors to conduct research while submitting to journals, and only submit to those journals that conduct a full peer review process and that genuinely seek to contribute to medical literature.
Failure to do so may result in a damaged reputation, being unwittingly appointed to an editorial board, losing your paper, or having your liver eaten by an eagle day after day until Hercules finally frees you from your torture.
We may have made that one up as well.
GLP-1 agonists, SGLT2 inhibitors offer more options in diabetes management
ORLANDO – The big news in diabetes management this year is “happy cardiologists and nephrologists.”
According to Christine Kessler, MN, ANP-C, CNS, BC-ADM, FAANP, founder of Metabolic Medicine Associates in King George, Va., these specialists are happy because the American College of Cardiology and the American Diabetes Association both recently updated their respective societies’ guidelines to include evidence that treating patients with type 2 diabetes with glucagonlike peptide-1 (GLP-1) agonists, sodium-glucose cotransporter 2 (SGLT2) inhibitors, or metformin can lower risk of cardiovascular disease and chronic kidney disease.
“Finally, the ACC is aligned with the ADA,” Ms. Kessler said in her presentation. “This is amazing, and it’s good news.”
Recent innovations in diabetes management technology, such as continuous glucose monitors, are also helping to make diabetes management easier. “If you’re not using some of this technology in your primary care practice, it’s coming to you, and it’s amazing the data it can provide to us,” said Ms. Kessler at the Cardiovascular & Respiratory Summit by Global Academy for Medical Education.
In endocrinology, diabetes is thought of in terms of macrovascular and microvascular disease, she said. Macrovascular disease is cardiovascular disease and stroke, while microvascular disease is nephropathy, neuropathy, and retinopathy. Diabetes is a cardiovascular risk factor and puts patients at higher risk for cardiovascular death, all-cause mortality, and hospitalization because of myocardial infarction or stroke, compared with patients who do not have type 2 diabetes. There is also a higher risk of kidney disease, nerve damage, blindness, nonalcoholic fatty liver disease, depression, complications during pregnancy, periodontal disease, and erectile dysfunction, said Ms. Kessler, who also is a nurse practitioner and researcher.
However, including getting enough sleep, dietary interventions that target weight loss and blood glucose control, and increasing physical activity that has cardiopulmonary benefits. Clinicians should also treat underlying conditions that contribute to increased cardiovascular risk, such as obesity, dyslipidemia, hypertension, and nonalcoholic fatty liver disease.
Addressing insulin resistance and hyperglycemia are also important, but patients must avoid hypoglycemia. “Any patient with diabetes, we don’t want to drive them there because that’s a cardiac risk,” said Ms. Kessler. The endothelial microvascular and macrovascular damage is believed to be caused by glycemic swings, she added.
For pharmacologic therapy, patients with type 2 diabetes should stay on metformin if they are already on the drug, and it can even be used in cases where patients have reduced kidney function, with a glomerular filtration rate (GFR) between 30 and 60 mL/min per 1.73 m2, with a lower dose used between 30 and 45 mL/min per 1.73 m2. To treat patients with atherosclerotic cardiovascular disease, recent evidence has shown GLP-1 agonists are beneficial and can also promote appetite satiety, prandial support, and reduce a patient’s weight, but the drug is expensive, and about 15% of patients will not see therapeutic benefit while on the medication, said Ms. Kessler. Clinicians should also watch for increased risk of pancreatitis while patients use GLP-1 agonists, and it should not be prescribed in patients with a history of thyroid medullary cancer or multiple endocrine neoplasia type 2 (MEN2).
SGLT2 inhibitors can benefit type 1 diabetes and type 2 diabetes patients with heart failure and diabetic kidney disease, but should be the second or third choice in therapy. The dosage of SGLT2 inhibitors should be cut in half when used with insulin and sulfonylurea, and the drug can also increase LDL cholesterol.
Ms. Kessler noted that while GLP-1 agonists and SGLT2 inhibitors prevent or reduce cardiovascular risk, they are not currently approved to treat cardiovascular disease.
Ms. Kessler reports being an advisor and speaker for Novo Nordisk on the subject of obesity. Global Academy for Medical Education and this news organization are owned by the same parent company.
ORLANDO – The big news in diabetes management this year is “happy cardiologists and nephrologists.”
According to Christine Kessler, MN, ANP-C, CNS, BC-ADM, FAANP, founder of Metabolic Medicine Associates in King George, Va., these specialists are happy because the American College of Cardiology and the American Diabetes Association both recently updated their respective societies’ guidelines to include evidence that treating patients with type 2 diabetes with glucagonlike peptide-1 (GLP-1) agonists, sodium-glucose cotransporter 2 (SGLT2) inhibitors, or metformin can lower risk of cardiovascular disease and chronic kidney disease.
“Finally, the ACC is aligned with the ADA,” Ms. Kessler said in her presentation. “This is amazing, and it’s good news.”
Recent innovations in diabetes management technology, such as continuous glucose monitors, are also helping to make diabetes management easier. “If you’re not using some of this technology in your primary care practice, it’s coming to you, and it’s amazing the data it can provide to us,” said Ms. Kessler at the Cardiovascular & Respiratory Summit by Global Academy for Medical Education.
In endocrinology, diabetes is thought of in terms of macrovascular and microvascular disease, she said. Macrovascular disease is cardiovascular disease and stroke, while microvascular disease is nephropathy, neuropathy, and retinopathy. Diabetes is a cardiovascular risk factor and puts patients at higher risk for cardiovascular death, all-cause mortality, and hospitalization because of myocardial infarction or stroke, compared with patients who do not have type 2 diabetes. There is also a higher risk of kidney disease, nerve damage, blindness, nonalcoholic fatty liver disease, depression, complications during pregnancy, periodontal disease, and erectile dysfunction, said Ms. Kessler, who also is a nurse practitioner and researcher.
However, including getting enough sleep, dietary interventions that target weight loss and blood glucose control, and increasing physical activity that has cardiopulmonary benefits. Clinicians should also treat underlying conditions that contribute to increased cardiovascular risk, such as obesity, dyslipidemia, hypertension, and nonalcoholic fatty liver disease.
Addressing insulin resistance and hyperglycemia are also important, but patients must avoid hypoglycemia. “Any patient with diabetes, we don’t want to drive them there because that’s a cardiac risk,” said Ms. Kessler. The endothelial microvascular and macrovascular damage is believed to be caused by glycemic swings, she added.
For pharmacologic therapy, patients with type 2 diabetes should stay on metformin if they are already on the drug, and it can even be used in cases where patients have reduced kidney function, with a glomerular filtration rate (GFR) between 30 and 60 mL/min per 1.73 m2, with a lower dose used between 30 and 45 mL/min per 1.73 m2. To treat patients with atherosclerotic cardiovascular disease, recent evidence has shown GLP-1 agonists are beneficial and can also promote appetite satiety, prandial support, and reduce a patient’s weight, but the drug is expensive, and about 15% of patients will not see therapeutic benefit while on the medication, said Ms. Kessler. Clinicians should also watch for increased risk of pancreatitis while patients use GLP-1 agonists, and it should not be prescribed in patients with a history of thyroid medullary cancer or multiple endocrine neoplasia type 2 (MEN2).
SGLT2 inhibitors can benefit type 1 diabetes and type 2 diabetes patients with heart failure and diabetic kidney disease, but should be the second or third choice in therapy. The dosage of SGLT2 inhibitors should be cut in half when used with insulin and sulfonylurea, and the drug can also increase LDL cholesterol.
Ms. Kessler noted that while GLP-1 agonists and SGLT2 inhibitors prevent or reduce cardiovascular risk, they are not currently approved to treat cardiovascular disease.
Ms. Kessler reports being an advisor and speaker for Novo Nordisk on the subject of obesity. Global Academy for Medical Education and this news organization are owned by the same parent company.
ORLANDO – The big news in diabetes management this year is “happy cardiologists and nephrologists.”
According to Christine Kessler, MN, ANP-C, CNS, BC-ADM, FAANP, founder of Metabolic Medicine Associates in King George, Va., these specialists are happy because the American College of Cardiology and the American Diabetes Association both recently updated their respective societies’ guidelines to include evidence that treating patients with type 2 diabetes with glucagonlike peptide-1 (GLP-1) agonists, sodium-glucose cotransporter 2 (SGLT2) inhibitors, or metformin can lower risk of cardiovascular disease and chronic kidney disease.
“Finally, the ACC is aligned with the ADA,” Ms. Kessler said in her presentation. “This is amazing, and it’s good news.”
Recent innovations in diabetes management technology, such as continuous glucose monitors, are also helping to make diabetes management easier. “If you’re not using some of this technology in your primary care practice, it’s coming to you, and it’s amazing the data it can provide to us,” said Ms. Kessler at the Cardiovascular & Respiratory Summit by Global Academy for Medical Education.
In endocrinology, diabetes is thought of in terms of macrovascular and microvascular disease, she said. Macrovascular disease is cardiovascular disease and stroke, while microvascular disease is nephropathy, neuropathy, and retinopathy. Diabetes is a cardiovascular risk factor and puts patients at higher risk for cardiovascular death, all-cause mortality, and hospitalization because of myocardial infarction or stroke, compared with patients who do not have type 2 diabetes. There is also a higher risk of kidney disease, nerve damage, blindness, nonalcoholic fatty liver disease, depression, complications during pregnancy, periodontal disease, and erectile dysfunction, said Ms. Kessler, who also is a nurse practitioner and researcher.
However, including getting enough sleep, dietary interventions that target weight loss and blood glucose control, and increasing physical activity that has cardiopulmonary benefits. Clinicians should also treat underlying conditions that contribute to increased cardiovascular risk, such as obesity, dyslipidemia, hypertension, and nonalcoholic fatty liver disease.
Addressing insulin resistance and hyperglycemia are also important, but patients must avoid hypoglycemia. “Any patient with diabetes, we don’t want to drive them there because that’s a cardiac risk,” said Ms. Kessler. The endothelial microvascular and macrovascular damage is believed to be caused by glycemic swings, she added.
For pharmacologic therapy, patients with type 2 diabetes should stay on metformin if they are already on the drug, and it can even be used in cases where patients have reduced kidney function, with a glomerular filtration rate (GFR) between 30 and 60 mL/min per 1.73 m2, with a lower dose used between 30 and 45 mL/min per 1.73 m2. To treat patients with atherosclerotic cardiovascular disease, recent evidence has shown GLP-1 agonists are beneficial and can also promote appetite satiety, prandial support, and reduce a patient’s weight, but the drug is expensive, and about 15% of patients will not see therapeutic benefit while on the medication, said Ms. Kessler. Clinicians should also watch for increased risk of pancreatitis while patients use GLP-1 agonists, and it should not be prescribed in patients with a history of thyroid medullary cancer or multiple endocrine neoplasia type 2 (MEN2).
SGLT2 inhibitors can benefit type 1 diabetes and type 2 diabetes patients with heart failure and diabetic kidney disease, but should be the second or third choice in therapy. The dosage of SGLT2 inhibitors should be cut in half when used with insulin and sulfonylurea, and the drug can also increase LDL cholesterol.
Ms. Kessler noted that while GLP-1 agonists and SGLT2 inhibitors prevent or reduce cardiovascular risk, they are not currently approved to treat cardiovascular disease.
Ms. Kessler reports being an advisor and speaker for Novo Nordisk on the subject of obesity. Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM CARPS 2019
Endocrine Society advises on diabetes care for older adults
according to a new guideline on diabetes care for older adults issued by the Endocrine Society.
“The prevalence of diabetes in the United States is projected to increase dramatically during the next 3 decades as the population ages, the numbers of higher-risk minority groups increase, and people with diabetes live longer because of decreasing rates of cardiovascular deaths,” wrote Derek LeRoith, MD, of Icahn School of Medicine at Mount Sinai, New York, and his writing committee colleagues. They said their goal was to provide health care providers with guidance for the management of type 1 or type 2 diabetes in older patients, with a focus on simplifying medication regimens and management strategies to avoid “unnecessary and/or harmful adverse effects.”
The guideline, published in the Journal of Clinical Endocrinology & Metabolism, is based mainly on evidence from controlled trials in two systematic reviews that specifically focused on adults aged 65 years and older. The guideline addresses six areas of consideration for this patient population:
- Role of the endocrinologist and diabetes care specialist.
- Screening for diabetes and prediabetes, and diabetes prevention.
- Assessment of older patients with diabetes.
- Treatment of hyperglycemia.
- Treating complications of diabetes.
- Special settings and populations.
Partnerships and screening
The guideline recommends that primary care providers partner with an endocrinologist or diabetes specialist in the care of patients aged 65 and older with newly diagnosed diabetes, and that the specialist take primary responsibility for diabetes care of patients with type 1 diabetes or those who need more complex intervention to achieve treatment goals.
Screening for diabetes in adults aged 65 years and older using fasting plasma glucose and/or hemoglobin A1c should occur every 2 years, but that schedule should be adjusted based on shared decision making with the patient, the committee said. Providers are advised to assess the patient’s overall health and personal values before settling on treatment goals and strategies. The writing group also recommends periodic cognitive screening and that medication regimens be simplified as much as possible.
Tackling hyperglycemia
For treatment of hyperglycemia, the guideline recommends outpatient strategies to minimize hypoglycemia and periodic or continuous glucose monitoring. The strategies include lifestyle modifications as a first-line intervention for ambulatory patients, as well as nutritional assessment. A high-protein diet is recommended for older patients with frailty, but no restrictions on diet are advised for patients who cannot meet glycemic targets with lifestyle modification and who are at risk for malnutrition.
Metformin is the first-choice recommendation for patients with diabetes aged 65 and older who need medical management in addition to lifestyle modification, but it is not recommended for individuals with impaired kidney function or gastrointestinal intolerance, according to the guideline. Oral and injectable drugs and/or insulin are recommended if metformin and lifestyle changes are insufficient to meet glycemic targets, the writers noted.
Managing complications
Hypertension is among the diabetes-related complications that need to be managed in older adults, and the guideline recommends a target blood pressure of 140/90 mm Hg, but other targets – based on patient-provider shared decision making – may be considered for patients in high-risk groups.
The guideline calls for management of hyperlipidemia with statin therapy and “use of an annual lipid profile to achieve the recommended levels for reducing absolute cardiovascular disease events and all-cause mortality.” The committee does not specify low-density lipoprotein cholesterol targets because of insufficient evidence, but recommends alternative treatments, including ezetimibe or proprotein convertase subtilisin/kexin type 9 inhibitors, if statin therapy is not enough to help the patients meet goals. The writers also advocate fish oil and/or fenofibrate for patients with fasting triglycerides of more than 500 mg/dL.
To manage congestive heart failure in older patients with diabetes, the guideline recommends following standard clinical practice guidelines for the condition, and cautious use of oral hypoglycemic agents, including glinides, rosiglitazone, pioglitazone, and dipeptidyl peptidase–4 inhibitors. The writers noted that low-dose aspirin is recommended for patients with diabetes with a history of atherosclerotic cardiovascular disease.
The committee also recommends an annual comprehensive eye exam for patients with diabetes aged 65 years and older to identify retinal disease and suggests that actions, such as physical therapy and reduced use of sedatives, be taken to minimize the risk of falls in patients with neuropathy or problems with balance and gait.
Older patients with diabetes also should be screened annually for chronic kidney disease, and the dosage of diabetes medications should be adjusted to minimize side effects in patients with kidney problems.
Tailoring care to setting
Finally, the guideline addresses special settings and populations, including managing diabetes in hospitals or nursing homes, or in patients who are transitioning to homes or long-term care facilities. Recommendations in this category include simplifying medications for older adults with terminal illness or severe comorbidities, as well as setting glycemic targets as part of a hospital discharge plan.
“The most important aspect of successful transition is effective, detailed, and thorough bidirectional communication between the discharging and receiving teams of health care providers,” the writers emphasized.
The guideline is cosponsored by the European Society of Endocrinology, the Gerontological Society of America, and the Obesity Society. The chair of the committee had no relevant financial conflicts to disclose, and at least 50% of the committee members were free of relevant conflicts of interest.
SOURCE: LeRoith D et al. J Clin Endocrinol Metab. 2019;104:1520-74.
according to a new guideline on diabetes care for older adults issued by the Endocrine Society.
“The prevalence of diabetes in the United States is projected to increase dramatically during the next 3 decades as the population ages, the numbers of higher-risk minority groups increase, and people with diabetes live longer because of decreasing rates of cardiovascular deaths,” wrote Derek LeRoith, MD, of Icahn School of Medicine at Mount Sinai, New York, and his writing committee colleagues. They said their goal was to provide health care providers with guidance for the management of type 1 or type 2 diabetes in older patients, with a focus on simplifying medication regimens and management strategies to avoid “unnecessary and/or harmful adverse effects.”
The guideline, published in the Journal of Clinical Endocrinology & Metabolism, is based mainly on evidence from controlled trials in two systematic reviews that specifically focused on adults aged 65 years and older. The guideline addresses six areas of consideration for this patient population:
- Role of the endocrinologist and diabetes care specialist.
- Screening for diabetes and prediabetes, and diabetes prevention.
- Assessment of older patients with diabetes.
- Treatment of hyperglycemia.
- Treating complications of diabetes.
- Special settings and populations.
Partnerships and screening
The guideline recommends that primary care providers partner with an endocrinologist or diabetes specialist in the care of patients aged 65 and older with newly diagnosed diabetes, and that the specialist take primary responsibility for diabetes care of patients with type 1 diabetes or those who need more complex intervention to achieve treatment goals.
Screening for diabetes in adults aged 65 years and older using fasting plasma glucose and/or hemoglobin A1c should occur every 2 years, but that schedule should be adjusted based on shared decision making with the patient, the committee said. Providers are advised to assess the patient’s overall health and personal values before settling on treatment goals and strategies. The writing group also recommends periodic cognitive screening and that medication regimens be simplified as much as possible.
Tackling hyperglycemia
For treatment of hyperglycemia, the guideline recommends outpatient strategies to minimize hypoglycemia and periodic or continuous glucose monitoring. The strategies include lifestyle modifications as a first-line intervention for ambulatory patients, as well as nutritional assessment. A high-protein diet is recommended for older patients with frailty, but no restrictions on diet are advised for patients who cannot meet glycemic targets with lifestyle modification and who are at risk for malnutrition.
Metformin is the first-choice recommendation for patients with diabetes aged 65 and older who need medical management in addition to lifestyle modification, but it is not recommended for individuals with impaired kidney function or gastrointestinal intolerance, according to the guideline. Oral and injectable drugs and/or insulin are recommended if metformin and lifestyle changes are insufficient to meet glycemic targets, the writers noted.
Managing complications
Hypertension is among the diabetes-related complications that need to be managed in older adults, and the guideline recommends a target blood pressure of 140/90 mm Hg, but other targets – based on patient-provider shared decision making – may be considered for patients in high-risk groups.
The guideline calls for management of hyperlipidemia with statin therapy and “use of an annual lipid profile to achieve the recommended levels for reducing absolute cardiovascular disease events and all-cause mortality.” The committee does not specify low-density lipoprotein cholesterol targets because of insufficient evidence, but recommends alternative treatments, including ezetimibe or proprotein convertase subtilisin/kexin type 9 inhibitors, if statin therapy is not enough to help the patients meet goals. The writers also advocate fish oil and/or fenofibrate for patients with fasting triglycerides of more than 500 mg/dL.
To manage congestive heart failure in older patients with diabetes, the guideline recommends following standard clinical practice guidelines for the condition, and cautious use of oral hypoglycemic agents, including glinides, rosiglitazone, pioglitazone, and dipeptidyl peptidase–4 inhibitors. The writers noted that low-dose aspirin is recommended for patients with diabetes with a history of atherosclerotic cardiovascular disease.
The committee also recommends an annual comprehensive eye exam for patients with diabetes aged 65 years and older to identify retinal disease and suggests that actions, such as physical therapy and reduced use of sedatives, be taken to minimize the risk of falls in patients with neuropathy or problems with balance and gait.
Older patients with diabetes also should be screened annually for chronic kidney disease, and the dosage of diabetes medications should be adjusted to minimize side effects in patients with kidney problems.
Tailoring care to setting
Finally, the guideline addresses special settings and populations, including managing diabetes in hospitals or nursing homes, or in patients who are transitioning to homes or long-term care facilities. Recommendations in this category include simplifying medications for older adults with terminal illness or severe comorbidities, as well as setting glycemic targets as part of a hospital discharge plan.
“The most important aspect of successful transition is effective, detailed, and thorough bidirectional communication between the discharging and receiving teams of health care providers,” the writers emphasized.
The guideline is cosponsored by the European Society of Endocrinology, the Gerontological Society of America, and the Obesity Society. The chair of the committee had no relevant financial conflicts to disclose, and at least 50% of the committee members were free of relevant conflicts of interest.
SOURCE: LeRoith D et al. J Clin Endocrinol Metab. 2019;104:1520-74.
according to a new guideline on diabetes care for older adults issued by the Endocrine Society.
“The prevalence of diabetes in the United States is projected to increase dramatically during the next 3 decades as the population ages, the numbers of higher-risk minority groups increase, and people with diabetes live longer because of decreasing rates of cardiovascular deaths,” wrote Derek LeRoith, MD, of Icahn School of Medicine at Mount Sinai, New York, and his writing committee colleagues. They said their goal was to provide health care providers with guidance for the management of type 1 or type 2 diabetes in older patients, with a focus on simplifying medication regimens and management strategies to avoid “unnecessary and/or harmful adverse effects.”
The guideline, published in the Journal of Clinical Endocrinology & Metabolism, is based mainly on evidence from controlled trials in two systematic reviews that specifically focused on adults aged 65 years and older. The guideline addresses six areas of consideration for this patient population:
- Role of the endocrinologist and diabetes care specialist.
- Screening for diabetes and prediabetes, and diabetes prevention.
- Assessment of older patients with diabetes.
- Treatment of hyperglycemia.
- Treating complications of diabetes.
- Special settings and populations.
Partnerships and screening
The guideline recommends that primary care providers partner with an endocrinologist or diabetes specialist in the care of patients aged 65 and older with newly diagnosed diabetes, and that the specialist take primary responsibility for diabetes care of patients with type 1 diabetes or those who need more complex intervention to achieve treatment goals.
Screening for diabetes in adults aged 65 years and older using fasting plasma glucose and/or hemoglobin A1c should occur every 2 years, but that schedule should be adjusted based on shared decision making with the patient, the committee said. Providers are advised to assess the patient’s overall health and personal values before settling on treatment goals and strategies. The writing group also recommends periodic cognitive screening and that medication regimens be simplified as much as possible.
Tackling hyperglycemia
For treatment of hyperglycemia, the guideline recommends outpatient strategies to minimize hypoglycemia and periodic or continuous glucose monitoring. The strategies include lifestyle modifications as a first-line intervention for ambulatory patients, as well as nutritional assessment. A high-protein diet is recommended for older patients with frailty, but no restrictions on diet are advised for patients who cannot meet glycemic targets with lifestyle modification and who are at risk for malnutrition.
Metformin is the first-choice recommendation for patients with diabetes aged 65 and older who need medical management in addition to lifestyle modification, but it is not recommended for individuals with impaired kidney function or gastrointestinal intolerance, according to the guideline. Oral and injectable drugs and/or insulin are recommended if metformin and lifestyle changes are insufficient to meet glycemic targets, the writers noted.
Managing complications
Hypertension is among the diabetes-related complications that need to be managed in older adults, and the guideline recommends a target blood pressure of 140/90 mm Hg, but other targets – based on patient-provider shared decision making – may be considered for patients in high-risk groups.
The guideline calls for management of hyperlipidemia with statin therapy and “use of an annual lipid profile to achieve the recommended levels for reducing absolute cardiovascular disease events and all-cause mortality.” The committee does not specify low-density lipoprotein cholesterol targets because of insufficient evidence, but recommends alternative treatments, including ezetimibe or proprotein convertase subtilisin/kexin type 9 inhibitors, if statin therapy is not enough to help the patients meet goals. The writers also advocate fish oil and/or fenofibrate for patients with fasting triglycerides of more than 500 mg/dL.
To manage congestive heart failure in older patients with diabetes, the guideline recommends following standard clinical practice guidelines for the condition, and cautious use of oral hypoglycemic agents, including glinides, rosiglitazone, pioglitazone, and dipeptidyl peptidase–4 inhibitors. The writers noted that low-dose aspirin is recommended for patients with diabetes with a history of atherosclerotic cardiovascular disease.
The committee also recommends an annual comprehensive eye exam for patients with diabetes aged 65 years and older to identify retinal disease and suggests that actions, such as physical therapy and reduced use of sedatives, be taken to minimize the risk of falls in patients with neuropathy or problems with balance and gait.
Older patients with diabetes also should be screened annually for chronic kidney disease, and the dosage of diabetes medications should be adjusted to minimize side effects in patients with kidney problems.
Tailoring care to setting
Finally, the guideline addresses special settings and populations, including managing diabetes in hospitals or nursing homes, or in patients who are transitioning to homes or long-term care facilities. Recommendations in this category include simplifying medications for older adults with terminal illness or severe comorbidities, as well as setting glycemic targets as part of a hospital discharge plan.
“The most important aspect of successful transition is effective, detailed, and thorough bidirectional communication between the discharging and receiving teams of health care providers,” the writers emphasized.
The guideline is cosponsored by the European Society of Endocrinology, the Gerontological Society of America, and the Obesity Society. The chair of the committee had no relevant financial conflicts to disclose, and at least 50% of the committee members were free of relevant conflicts of interest.
SOURCE: LeRoith D et al. J Clin Endocrinol Metab. 2019;104:1520-74.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
FDA approves darolutamide for nonmetastatic CRPC
The Food and Drug Administration has approved darolutamide for nonmetastatic, castration-resistant prostate cancer.
The approval was based on improved metastasis-free survival (MFS) in the randomized ARAMIS trial of 1,509 patients with nonmetastatic, castration-resistant prostate cancer.
Median MFS was 40.4 months (95% confidence interval, 34.3 months to not reached) for patients treated with darolutamide, compared with 18.4 months (95% CI, 15.5-22.3 months) for those receiving placebo (hazard ratio, 0.41; 95% CI, 0.34-0.50; P less than .0001), according to the FDA.
MFS is defined as the time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
In ARAMIS, patients were randomized 2:1 to receive either 600 mg darolutamide orally twice daily (n = 955) or matching placebo (n = 554). All patients received a gonadotropin-releasing hormone analog concurrently or had a previous bilateral orchiectomy. Twelve patients with previous seizure histories were treated on the darolutamide arm.
Overall survival data is not yet mature, the FDA said.
The most common adverse reactions in patients who received darolutamide were fatigue, extremity pain, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common on the darolutamide arm, while seizure incidence was similar in the two arms (0.2%).
The recommended darolutamide dose is 600 mg (two 300-mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy, the FDA said.
Darolutamide is marketed as Nubeqa by Bayer HealthCare Pharmaceuticals.
The Food and Drug Administration has approved darolutamide for nonmetastatic, castration-resistant prostate cancer.
The approval was based on improved metastasis-free survival (MFS) in the randomized ARAMIS trial of 1,509 patients with nonmetastatic, castration-resistant prostate cancer.
Median MFS was 40.4 months (95% confidence interval, 34.3 months to not reached) for patients treated with darolutamide, compared with 18.4 months (95% CI, 15.5-22.3 months) for those receiving placebo (hazard ratio, 0.41; 95% CI, 0.34-0.50; P less than .0001), according to the FDA.
MFS is defined as the time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
In ARAMIS, patients were randomized 2:1 to receive either 600 mg darolutamide orally twice daily (n = 955) or matching placebo (n = 554). All patients received a gonadotropin-releasing hormone analog concurrently or had a previous bilateral orchiectomy. Twelve patients with previous seizure histories were treated on the darolutamide arm.
Overall survival data is not yet mature, the FDA said.
The most common adverse reactions in patients who received darolutamide were fatigue, extremity pain, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common on the darolutamide arm, while seizure incidence was similar in the two arms (0.2%).
The recommended darolutamide dose is 600 mg (two 300-mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy, the FDA said.
Darolutamide is marketed as Nubeqa by Bayer HealthCare Pharmaceuticals.
The Food and Drug Administration has approved darolutamide for nonmetastatic, castration-resistant prostate cancer.
The approval was based on improved metastasis-free survival (MFS) in the randomized ARAMIS trial of 1,509 patients with nonmetastatic, castration-resistant prostate cancer.
Median MFS was 40.4 months (95% confidence interval, 34.3 months to not reached) for patients treated with darolutamide, compared with 18.4 months (95% CI, 15.5-22.3 months) for those receiving placebo (hazard ratio, 0.41; 95% CI, 0.34-0.50; P less than .0001), according to the FDA.
MFS is defined as the time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
In ARAMIS, patients were randomized 2:1 to receive either 600 mg darolutamide orally twice daily (n = 955) or matching placebo (n = 554). All patients received a gonadotropin-releasing hormone analog concurrently or had a previous bilateral orchiectomy. Twelve patients with previous seizure histories were treated on the darolutamide arm.
Overall survival data is not yet mature, the FDA said.
The most common adverse reactions in patients who received darolutamide were fatigue, extremity pain, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common on the darolutamide arm, while seizure incidence was similar in the two arms (0.2%).
The recommended darolutamide dose is 600 mg (two 300-mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy, the FDA said.
Darolutamide is marketed as Nubeqa by Bayer HealthCare Pharmaceuticals.
Higher dietary vitamin A linked to lower SCC risk
in a large prospective study published in JAMA Dermatology.
There was also an inverse association between intake of carotenoids and risk of cutaneous SCC over the follow-up period of 26-28 years. The results of the study support “the protective role of vitamin A against SCC development,” wrote Jongwoo Kim, MD, of Brown University, Providence, R.I., and Inje University, Seoul, South Korea, and coauthors. “Our data further support the contention that supplemental and dietary vitamin A may be beneficial in preventing SCC,” they added.
The study evaluated intake of vitamin A and carotenoids and SCC risk with data from the Health Professionals Follow-Up Study (1986-2012) of 48,400 men, and the Nurses’ Health Study (1984-2012) of 75,170 women. Participants in those studies completed questionnaires based on lifestyle and medical history. Only white participants were included, because of the low number of SCC cases and low SCC risk in nonwhite participants, and participants who did not report diet and those who had a history of melanoma, SCC, or other cancer diagnoses at baseline were excluded.
Over the follow-up of 26-28 years, a total of 3,978 SCC cases were confirmed using pathological records. The investigators used different quintiles based on the median total amount of vitamin A intake. Using quintile 1 (lowest intake) as a reference, the pooled multivariate hazard ratios of vitamin A intake were 0.97, 0.97, 0.93, and 0.83 for quintiles 2, 3, 4, and 5, respectively (P less than .001 for the trend, in order of increasing quintiles).
In addition, they reported that greater intakes of retinol and several carotenoids were also significantly associated with a lower SCC risk.
The results were “generally consistent between men and women,” and “the inverse associations appeared to be more prominent among those with moles and those with burn or blistering sunburn reaction as children or adolescents,” they wrote.
The large sample size, prospective design, and confirmation of SCC cases by histology are among the strengths of the study, while a key limitation of the study was the homogeneous nature of the study population, which “may limit the generalizability of our findings,” the authors wrote.
The study was funded by the National Institutes of Health and Inje University (South Korea). One author reported serving as a consultant for AbbVie, Amgen, the Centers for Disease Control and Prevention, Janssen, Merck, Novartis, and Pfizer; and as a compensated investigator for Amgen, Regeneron, and Sanofi. Dr. Kim and the remaining three authors reported no disclosures.
SOURCE: Kim J et al. JAMA Dermatol. 2019 Jul 31. doi: 10.1001/jamadermatol.2019.1937.
in a large prospective study published in JAMA Dermatology.
There was also an inverse association between intake of carotenoids and risk of cutaneous SCC over the follow-up period of 26-28 years. The results of the study support “the protective role of vitamin A against SCC development,” wrote Jongwoo Kim, MD, of Brown University, Providence, R.I., and Inje University, Seoul, South Korea, and coauthors. “Our data further support the contention that supplemental and dietary vitamin A may be beneficial in preventing SCC,” they added.
The study evaluated intake of vitamin A and carotenoids and SCC risk with data from the Health Professionals Follow-Up Study (1986-2012) of 48,400 men, and the Nurses’ Health Study (1984-2012) of 75,170 women. Participants in those studies completed questionnaires based on lifestyle and medical history. Only white participants were included, because of the low number of SCC cases and low SCC risk in nonwhite participants, and participants who did not report diet and those who had a history of melanoma, SCC, or other cancer diagnoses at baseline were excluded.
Over the follow-up of 26-28 years, a total of 3,978 SCC cases were confirmed using pathological records. The investigators used different quintiles based on the median total amount of vitamin A intake. Using quintile 1 (lowest intake) as a reference, the pooled multivariate hazard ratios of vitamin A intake were 0.97, 0.97, 0.93, and 0.83 for quintiles 2, 3, 4, and 5, respectively (P less than .001 for the trend, in order of increasing quintiles).
In addition, they reported that greater intakes of retinol and several carotenoids were also significantly associated with a lower SCC risk.
The results were “generally consistent between men and women,” and “the inverse associations appeared to be more prominent among those with moles and those with burn or blistering sunburn reaction as children or adolescents,” they wrote.
The large sample size, prospective design, and confirmation of SCC cases by histology are among the strengths of the study, while a key limitation of the study was the homogeneous nature of the study population, which “may limit the generalizability of our findings,” the authors wrote.
The study was funded by the National Institutes of Health and Inje University (South Korea). One author reported serving as a consultant for AbbVie, Amgen, the Centers for Disease Control and Prevention, Janssen, Merck, Novartis, and Pfizer; and as a compensated investigator for Amgen, Regeneron, and Sanofi. Dr. Kim and the remaining three authors reported no disclosures.
SOURCE: Kim J et al. JAMA Dermatol. 2019 Jul 31. doi: 10.1001/jamadermatol.2019.1937.
in a large prospective study published in JAMA Dermatology.
There was also an inverse association between intake of carotenoids and risk of cutaneous SCC over the follow-up period of 26-28 years. The results of the study support “the protective role of vitamin A against SCC development,” wrote Jongwoo Kim, MD, of Brown University, Providence, R.I., and Inje University, Seoul, South Korea, and coauthors. “Our data further support the contention that supplemental and dietary vitamin A may be beneficial in preventing SCC,” they added.
The study evaluated intake of vitamin A and carotenoids and SCC risk with data from the Health Professionals Follow-Up Study (1986-2012) of 48,400 men, and the Nurses’ Health Study (1984-2012) of 75,170 women. Participants in those studies completed questionnaires based on lifestyle and medical history. Only white participants were included, because of the low number of SCC cases and low SCC risk in nonwhite participants, and participants who did not report diet and those who had a history of melanoma, SCC, or other cancer diagnoses at baseline were excluded.
Over the follow-up of 26-28 years, a total of 3,978 SCC cases were confirmed using pathological records. The investigators used different quintiles based on the median total amount of vitamin A intake. Using quintile 1 (lowest intake) as a reference, the pooled multivariate hazard ratios of vitamin A intake were 0.97, 0.97, 0.93, and 0.83 for quintiles 2, 3, 4, and 5, respectively (P less than .001 for the trend, in order of increasing quintiles).
In addition, they reported that greater intakes of retinol and several carotenoids were also significantly associated with a lower SCC risk.
The results were “generally consistent between men and women,” and “the inverse associations appeared to be more prominent among those with moles and those with burn or blistering sunburn reaction as children or adolescents,” they wrote.
The large sample size, prospective design, and confirmation of SCC cases by histology are among the strengths of the study, while a key limitation of the study was the homogeneous nature of the study population, which “may limit the generalizability of our findings,” the authors wrote.
The study was funded by the National Institutes of Health and Inje University (South Korea). One author reported serving as a consultant for AbbVie, Amgen, the Centers for Disease Control and Prevention, Janssen, Merck, Novartis, and Pfizer; and as a compensated investigator for Amgen, Regeneron, and Sanofi. Dr. Kim and the remaining three authors reported no disclosures.
SOURCE: Kim J et al. JAMA Dermatol. 2019 Jul 31. doi: 10.1001/jamadermatol.2019.1937.
FROM JAMA DERMATOLOGY
Short-course azithromycin no benefit in pediatric asthma admissions
SEATTLE – Adding a 3-day course of azithromycin to treatment regimens of children hospitalized with asthma did not shorten length of stay or bring other benefits in a randomized, blinded trial of more than 150 youngsters at The Children’s Hospital at Montefiore, New York.
In recent years, some pediatricians at Montefiore had begun giving short-course azithromycin to hospitalized children who were not recovering as quickly as they had hoped, spurred by outpatient reports of reduced exacerbations and other benefits with long-term azithromycin (e.g., Lancet. 2017 Aug 12;390(10095):659-68).
“We had no evidence for doing that at all” in the hospital, and it might be going on elsewhere, said senior investigator Alyssa Silver, MD, assistant professor of pediatrics at Montefiore and Albert Einstein College of Medicine, New York. She and her colleagues, including primary investigator Lindsey Douglas, MD, assistant professor of pediatrics at the Icahn School of Medicine at Mount Sinai, New York, took a closer look.
The negative results mean that “we can stop doing this, giving kids unnecessary things. Word is starting to get out” at Montefiore. “People are not using it as much,” she said at Pediatric Hospital Medicine, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The team had expected azithromycin to shorten length of stay (LOS) by about half a day, due to its anti-inflammatory effects, but that’s not what was found when they randomized 80 children aged 4-12 years with persistent asthma to oral azithromycin 10 mg/kg per day for 3 days within 12 hours of admission, and 79 to placebo.
LOS was 1.86 days in the placebo arm, and 1.69 days in the azithromycin group (P = .23). One placebo child was transferred to the pediatric ICU, versus none in the azithromycin arm (P = .50). The study was stopped short of its 214 subject enrollment goal because of futility, but even so, it was well powered to detect a difference in LOS, the primary outcome, Dr. Silver said.
At 1 week phone follow-up, 7 placebo children and 11 in the azithromycin arm had persistent asthma symptoms (P = .42), and 1 placebo child and 2 azithromycin children had been readmitted (P greater than .99). There were no differences in days of school missed, or work days missed among parents and guardians.
At one month, 23 placebo and 18 azithromycin children had persistent asthma symptoms (P = .5); 7 placebo and 6 azithromycin children had returned to the ED (P = .75).
In short, “we really found no difference” with short-course azithromycin. “Clinicians should consider [these] data before prescribing azithromycin [to] children hospitalized with asthma,” Dr. Silver and her team concluded.
Subjects were an average of about 7 years old, and about two-thirds were boys. They were not on azithromycin or other antibiotics prior to admission. About half had been admitted in the previous year, and about a quarter had at least one previous pediatric ICU admission. Over two-thirds had been on daily asthma medications. There were about 2 days of symptoms prior to admission.
There was no external funding, and Dr. Silver had no disclosures.
SEATTLE – Adding a 3-day course of azithromycin to treatment regimens of children hospitalized with asthma did not shorten length of stay or bring other benefits in a randomized, blinded trial of more than 150 youngsters at The Children’s Hospital at Montefiore, New York.
In recent years, some pediatricians at Montefiore had begun giving short-course azithromycin to hospitalized children who were not recovering as quickly as they had hoped, spurred by outpatient reports of reduced exacerbations and other benefits with long-term azithromycin (e.g., Lancet. 2017 Aug 12;390(10095):659-68).
“We had no evidence for doing that at all” in the hospital, and it might be going on elsewhere, said senior investigator Alyssa Silver, MD, assistant professor of pediatrics at Montefiore and Albert Einstein College of Medicine, New York. She and her colleagues, including primary investigator Lindsey Douglas, MD, assistant professor of pediatrics at the Icahn School of Medicine at Mount Sinai, New York, took a closer look.
The negative results mean that “we can stop doing this, giving kids unnecessary things. Word is starting to get out” at Montefiore. “People are not using it as much,” she said at Pediatric Hospital Medicine, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The team had expected azithromycin to shorten length of stay (LOS) by about half a day, due to its anti-inflammatory effects, but that’s not what was found when they randomized 80 children aged 4-12 years with persistent asthma to oral azithromycin 10 mg/kg per day for 3 days within 12 hours of admission, and 79 to placebo.
LOS was 1.86 days in the placebo arm, and 1.69 days in the azithromycin group (P = .23). One placebo child was transferred to the pediatric ICU, versus none in the azithromycin arm (P = .50). The study was stopped short of its 214 subject enrollment goal because of futility, but even so, it was well powered to detect a difference in LOS, the primary outcome, Dr. Silver said.
At 1 week phone follow-up, 7 placebo children and 11 in the azithromycin arm had persistent asthma symptoms (P = .42), and 1 placebo child and 2 azithromycin children had been readmitted (P greater than .99). There were no differences in days of school missed, or work days missed among parents and guardians.
At one month, 23 placebo and 18 azithromycin children had persistent asthma symptoms (P = .5); 7 placebo and 6 azithromycin children had returned to the ED (P = .75).
In short, “we really found no difference” with short-course azithromycin. “Clinicians should consider [these] data before prescribing azithromycin [to] children hospitalized with asthma,” Dr. Silver and her team concluded.
Subjects were an average of about 7 years old, and about two-thirds were boys. They were not on azithromycin or other antibiotics prior to admission. About half had been admitted in the previous year, and about a quarter had at least one previous pediatric ICU admission. Over two-thirds had been on daily asthma medications. There were about 2 days of symptoms prior to admission.
There was no external funding, and Dr. Silver had no disclosures.
SEATTLE – Adding a 3-day course of azithromycin to treatment regimens of children hospitalized with asthma did not shorten length of stay or bring other benefits in a randomized, blinded trial of more than 150 youngsters at The Children’s Hospital at Montefiore, New York.
In recent years, some pediatricians at Montefiore had begun giving short-course azithromycin to hospitalized children who were not recovering as quickly as they had hoped, spurred by outpatient reports of reduced exacerbations and other benefits with long-term azithromycin (e.g., Lancet. 2017 Aug 12;390(10095):659-68).
“We had no evidence for doing that at all” in the hospital, and it might be going on elsewhere, said senior investigator Alyssa Silver, MD, assistant professor of pediatrics at Montefiore and Albert Einstein College of Medicine, New York. She and her colleagues, including primary investigator Lindsey Douglas, MD, assistant professor of pediatrics at the Icahn School of Medicine at Mount Sinai, New York, took a closer look.
The negative results mean that “we can stop doing this, giving kids unnecessary things. Word is starting to get out” at Montefiore. “People are not using it as much,” she said at Pediatric Hospital Medicine, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The team had expected azithromycin to shorten length of stay (LOS) by about half a day, due to its anti-inflammatory effects, but that’s not what was found when they randomized 80 children aged 4-12 years with persistent asthma to oral azithromycin 10 mg/kg per day for 3 days within 12 hours of admission, and 79 to placebo.
LOS was 1.86 days in the placebo arm, and 1.69 days in the azithromycin group (P = .23). One placebo child was transferred to the pediatric ICU, versus none in the azithromycin arm (P = .50). The study was stopped short of its 214 subject enrollment goal because of futility, but even so, it was well powered to detect a difference in LOS, the primary outcome, Dr. Silver said.
At 1 week phone follow-up, 7 placebo children and 11 in the azithromycin arm had persistent asthma symptoms (P = .42), and 1 placebo child and 2 azithromycin children had been readmitted (P greater than .99). There were no differences in days of school missed, or work days missed among parents and guardians.
At one month, 23 placebo and 18 azithromycin children had persistent asthma symptoms (P = .5); 7 placebo and 6 azithromycin children had returned to the ED (P = .75).
In short, “we really found no difference” with short-course azithromycin. “Clinicians should consider [these] data before prescribing azithromycin [to] children hospitalized with asthma,” Dr. Silver and her team concluded.
Subjects were an average of about 7 years old, and about two-thirds were boys. They were not on azithromycin or other antibiotics prior to admission. About half had been admitted in the previous year, and about a quarter had at least one previous pediatric ICU admission. Over two-thirds had been on daily asthma medications. There were about 2 days of symptoms prior to admission.
There was no external funding, and Dr. Silver had no disclosures.
REPORTING FROM PHM 2019