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Dapagliflozin approved for reducing HF hospitalization in diabetes
The Food And Drug Administration has approved the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors, according to a statement from AstraZeneca.
The approval was based on results from the DECLARE-TIMI 58 cardiovascular outcomes trial, which evaluated dapagliflozin in more than 17,000 patients with type 2 diabetes and cardiovascular risk factors or cardiovascular disease. They showed that dapagliflozin significantly reduced the risk of the primary composite endpoint of hospitalization for heart failure by 27%, compared with placebo (2.5% vs. 3.3%; HR, 0.73; 95% confidence interval, 0.61-0.88).
The drug is an oral, once-daily SGLT2 inhibitor initially approved as a monotherapy or combination therapy for glycemic control in adults with type 2 diabetes. It has additional benefits of weight loss and reduction in blood pressure in concert with diet and exercise in the same population.
“,” Ruud Dobber, PhD, executive vice president of the company’s biopharmaceuticals business unit, said in the statement. “This is promising news for the 30 million people living with type 2 diabetes in the U.S., as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. [Dapagliflozin] now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure.”
In September, the agency granted dapagliflozin a Fast Track designation to reduce the risk of cardiovascular death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction or preserved ejection fraction, based on the phase 3 DAPA-HF and DELIVER trials. It also gave the drug Fast Track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease based on the phase 3 DAPA-CKD trial, the statement noted.
The Food And Drug Administration has approved the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors, according to a statement from AstraZeneca.
The approval was based on results from the DECLARE-TIMI 58 cardiovascular outcomes trial, which evaluated dapagliflozin in more than 17,000 patients with type 2 diabetes and cardiovascular risk factors or cardiovascular disease. They showed that dapagliflozin significantly reduced the risk of the primary composite endpoint of hospitalization for heart failure by 27%, compared with placebo (2.5% vs. 3.3%; HR, 0.73; 95% confidence interval, 0.61-0.88).
The drug is an oral, once-daily SGLT2 inhibitor initially approved as a monotherapy or combination therapy for glycemic control in adults with type 2 diabetes. It has additional benefits of weight loss and reduction in blood pressure in concert with diet and exercise in the same population.
“,” Ruud Dobber, PhD, executive vice president of the company’s biopharmaceuticals business unit, said in the statement. “This is promising news for the 30 million people living with type 2 diabetes in the U.S., as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. [Dapagliflozin] now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure.”
In September, the agency granted dapagliflozin a Fast Track designation to reduce the risk of cardiovascular death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction or preserved ejection fraction, based on the phase 3 DAPA-HF and DELIVER trials. It also gave the drug Fast Track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease based on the phase 3 DAPA-CKD trial, the statement noted.
The Food And Drug Administration has approved the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors, according to a statement from AstraZeneca.
The approval was based on results from the DECLARE-TIMI 58 cardiovascular outcomes trial, which evaluated dapagliflozin in more than 17,000 patients with type 2 diabetes and cardiovascular risk factors or cardiovascular disease. They showed that dapagliflozin significantly reduced the risk of the primary composite endpoint of hospitalization for heart failure by 27%, compared with placebo (2.5% vs. 3.3%; HR, 0.73; 95% confidence interval, 0.61-0.88).
The drug is an oral, once-daily SGLT2 inhibitor initially approved as a monotherapy or combination therapy for glycemic control in adults with type 2 diabetes. It has additional benefits of weight loss and reduction in blood pressure in concert with diet and exercise in the same population.
“,” Ruud Dobber, PhD, executive vice president of the company’s biopharmaceuticals business unit, said in the statement. “This is promising news for the 30 million people living with type 2 diabetes in the U.S., as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. [Dapagliflozin] now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure.”
In September, the agency granted dapagliflozin a Fast Track designation to reduce the risk of cardiovascular death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction or preserved ejection fraction, based on the phase 3 DAPA-HF and DELIVER trials. It also gave the drug Fast Track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease based on the phase 3 DAPA-CKD trial, the statement noted.
Certain diabetes drugs may thwart dementia
COPENHAGEN – Selected antidiabetes medications appear to blunt the increased risk of dementia associated with type 2 diabetes, according to a Danish national case control registry study.
This benefit applies to the newer antidiabetic agents – specifically, the dipeptidyl peptidase 4 (DPP4) inhibitors, the glucagon-like peptide 1 (GLP1) analogs, and the sodium-glucose transport protein 2 (SGLT2) inhibitors – and metformin as well, Merete Osler, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.
In contrast, neither insulin nor the sulfonylureas showed any signal of a protective effect against development of dementia. In fact, the use of sulfonylureas was associated with a small but statistically significant 7% increased risk, added Dr. Osler, of the University of Copenhagen.
Elsewhere at the meeting, investigators tapped a Swedish national registry to demonstrate that individuals with type 1 diabetes have a sharply reduced risk of developing schizophrenia.
Type 2 diabetes medications and dementia
Dr. Osler and colleagues are among several groups of investigators who have previously shown that patients with type 2 diabetes have an increased risk of dementia.
“This has raised the question of the role of dysregulated glucose metabolism in the development of this neurodegenerative disorder, and the possible effect of antidiabetic medications,” she noted.
To further explore this issue, which links two great ongoing global epidemics, Dr. Osler and coinvestigators conducted a nested case-control study including all 176,250 patients with type 2 diabetes in the comprehensive Danish National Diabetes Register for 1995-2012. The 11,619 patients with type 2 diabetes who received a dementia diagnosis were matched with 46,476 type 2 diabetes patients without dementia. The objective was to determine associations between dementia and ever-use and cumulative dose of antidiabetes drugs, alone and in combination, in logistic regression analyses adjusted for demographics, comorbid conditions, marital status, diabetic complications, and year of dementia diagnosis.
Patients who had ever used metformin had an adjusted 6% reduction in the likelihood of dementia compared with metformin nonusers, a modest but statistically significant difference. Those on a DPP4 inhibitor had a 20% reduction in risk. The GLP1 analogs were associated with a 42% decrease in risk. So were the SGLT2 inhibitors. A dose-response relationship was evident: The higher the cumulative exposure to these agents, the lower the odds of dementia.
Combination therapy is common in type 2 diabetes, so the investigators scrutinized the impact of a variety of multidrug combinations. Combinations including a DPP4 inhibitor or GLP1 analog were also associated with significantly reduced dementia risk.
Records of glycemic control in the form of hemoglobin A1c values were available on only 1,446 type 2 diabetic dementia patients and 4,003 matched controls. An analysis that incorporated this variable showed that the observed anti-dementia effect of selected diabetes drugs was independent of glycemic control, according to Dr. Osler.
The protective effect appeared to extend to both Alzheimer’s disease and vascular dementias, although firm conclusions can’t be drawn on this score because the study was insufficiently powered to address that issue.
Dr. Osler noted that the Danish study confirms a recent Taiwanese study showing an apparent protective effect against dementia for metformin in patients with type 2 diabetes (Aging Dis. 2019 Feb 1;10(1):37-48).
“Ours is the first study on the newer diabetic drugs, so our results need to be confirmed,” she pointed out.
If confirmed, however, it would warrant exploration of these drugs more generally as potential interventions to prevent dementia. That could open a whole new chapter in the remarkable story of the SGLT2 inhibitors, a class of drugs originally developed for treatment of type 2 diabetes but which in major randomized clinical trials later proved to be so effective in the treatment of heart failure that they are now considered cardiology drugs first.
Asked if she thinks these antidiabetes agents have a general neuroprotective effect or, instead, that the observed reduced risk of dementia is a function of patients being treated better early on with modern drugs, the psychiatrist replied, “I think it might be a combination of both, especially because we find different risk estimates between the drugs.”
Dr. Osler reported having no financial conflicts of interest regarding the study, which was funded by the Danish Diabetes Foundation, the Danish Medical Association, and several other foundations.
The full study details were published online shortly before her presentation at ECNP 2019 (Eur J Endocrinol. 2019 Aug 1. pii: EJE-19-0259.R1. doi: 10.1530/EJE-19-0259).
Type 1 diabetes and schizophrenia risk
Kristina Melkersson, MD, PhD, presented a cohort study that utilized Swedish national registries to examine the relationship between type 1 diabetes and schizophrenia. The study comprised 1,745,977 individuals, of whom 10,117 had type 1 diabetes, who were followed for a median of 9.7 and maximum of 18 years from their 13th birthday. During follow-up, 1,280 individuals were diagnosed with schizophrenia and 649 others with schizoaffective disorder. The adjusted risk of schizophrenia was 70% lower in patients with type 1 diabetes. However, there was no difference in the risk of schizoaffective disorder in the type 1 diabetic versus nondiabetic subjects.
The Swedish data confirm the findings of an earlier Finnish national study showing that the risk of schizophrenia is reduced in patients with type 1 diabetes (Arch Gen Psychiatry. 2007 Aug;64(8):894-9). These findings raise the intriguing possibility that autoimmunity somehow figures into the etiology of the psychiatric disorder. Other investigators have previously reported a reduced prevalence of rheumatoid arthritis in patients with schizophrenia, noted Dr. Melkersson of the Karolinska Institute in Stockholm.
She reported having no financial conflicts regarding her study.
SOURCE: Osler M. ECNP Abstract P180. Melkersson K. Abstract 81.
COPENHAGEN – Selected antidiabetes medications appear to blunt the increased risk of dementia associated with type 2 diabetes, according to a Danish national case control registry study.
This benefit applies to the newer antidiabetic agents – specifically, the dipeptidyl peptidase 4 (DPP4) inhibitors, the glucagon-like peptide 1 (GLP1) analogs, and the sodium-glucose transport protein 2 (SGLT2) inhibitors – and metformin as well, Merete Osler, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.
In contrast, neither insulin nor the sulfonylureas showed any signal of a protective effect against development of dementia. In fact, the use of sulfonylureas was associated with a small but statistically significant 7% increased risk, added Dr. Osler, of the University of Copenhagen.
Elsewhere at the meeting, investigators tapped a Swedish national registry to demonstrate that individuals with type 1 diabetes have a sharply reduced risk of developing schizophrenia.
Type 2 diabetes medications and dementia
Dr. Osler and colleagues are among several groups of investigators who have previously shown that patients with type 2 diabetes have an increased risk of dementia.
“This has raised the question of the role of dysregulated glucose metabolism in the development of this neurodegenerative disorder, and the possible effect of antidiabetic medications,” she noted.
To further explore this issue, which links two great ongoing global epidemics, Dr. Osler and coinvestigators conducted a nested case-control study including all 176,250 patients with type 2 diabetes in the comprehensive Danish National Diabetes Register for 1995-2012. The 11,619 patients with type 2 diabetes who received a dementia diagnosis were matched with 46,476 type 2 diabetes patients without dementia. The objective was to determine associations between dementia and ever-use and cumulative dose of antidiabetes drugs, alone and in combination, in logistic regression analyses adjusted for demographics, comorbid conditions, marital status, diabetic complications, and year of dementia diagnosis.
Patients who had ever used metformin had an adjusted 6% reduction in the likelihood of dementia compared with metformin nonusers, a modest but statistically significant difference. Those on a DPP4 inhibitor had a 20% reduction in risk. The GLP1 analogs were associated with a 42% decrease in risk. So were the SGLT2 inhibitors. A dose-response relationship was evident: The higher the cumulative exposure to these agents, the lower the odds of dementia.
Combination therapy is common in type 2 diabetes, so the investigators scrutinized the impact of a variety of multidrug combinations. Combinations including a DPP4 inhibitor or GLP1 analog were also associated with significantly reduced dementia risk.
Records of glycemic control in the form of hemoglobin A1c values were available on only 1,446 type 2 diabetic dementia patients and 4,003 matched controls. An analysis that incorporated this variable showed that the observed anti-dementia effect of selected diabetes drugs was independent of glycemic control, according to Dr. Osler.
The protective effect appeared to extend to both Alzheimer’s disease and vascular dementias, although firm conclusions can’t be drawn on this score because the study was insufficiently powered to address that issue.
Dr. Osler noted that the Danish study confirms a recent Taiwanese study showing an apparent protective effect against dementia for metformin in patients with type 2 diabetes (Aging Dis. 2019 Feb 1;10(1):37-48).
“Ours is the first study on the newer diabetic drugs, so our results need to be confirmed,” she pointed out.
If confirmed, however, it would warrant exploration of these drugs more generally as potential interventions to prevent dementia. That could open a whole new chapter in the remarkable story of the SGLT2 inhibitors, a class of drugs originally developed for treatment of type 2 diabetes but which in major randomized clinical trials later proved to be so effective in the treatment of heart failure that they are now considered cardiology drugs first.
Asked if she thinks these antidiabetes agents have a general neuroprotective effect or, instead, that the observed reduced risk of dementia is a function of patients being treated better early on with modern drugs, the psychiatrist replied, “I think it might be a combination of both, especially because we find different risk estimates between the drugs.”
Dr. Osler reported having no financial conflicts of interest regarding the study, which was funded by the Danish Diabetes Foundation, the Danish Medical Association, and several other foundations.
The full study details were published online shortly before her presentation at ECNP 2019 (Eur J Endocrinol. 2019 Aug 1. pii: EJE-19-0259.R1. doi: 10.1530/EJE-19-0259).
Type 1 diabetes and schizophrenia risk
Kristina Melkersson, MD, PhD, presented a cohort study that utilized Swedish national registries to examine the relationship between type 1 diabetes and schizophrenia. The study comprised 1,745,977 individuals, of whom 10,117 had type 1 diabetes, who were followed for a median of 9.7 and maximum of 18 years from their 13th birthday. During follow-up, 1,280 individuals were diagnosed with schizophrenia and 649 others with schizoaffective disorder. The adjusted risk of schizophrenia was 70% lower in patients with type 1 diabetes. However, there was no difference in the risk of schizoaffective disorder in the type 1 diabetic versus nondiabetic subjects.
The Swedish data confirm the findings of an earlier Finnish national study showing that the risk of schizophrenia is reduced in patients with type 1 diabetes (Arch Gen Psychiatry. 2007 Aug;64(8):894-9). These findings raise the intriguing possibility that autoimmunity somehow figures into the etiology of the psychiatric disorder. Other investigators have previously reported a reduced prevalence of rheumatoid arthritis in patients with schizophrenia, noted Dr. Melkersson of the Karolinska Institute in Stockholm.
She reported having no financial conflicts regarding her study.
SOURCE: Osler M. ECNP Abstract P180. Melkersson K. Abstract 81.
COPENHAGEN – Selected antidiabetes medications appear to blunt the increased risk of dementia associated with type 2 diabetes, according to a Danish national case control registry study.
This benefit applies to the newer antidiabetic agents – specifically, the dipeptidyl peptidase 4 (DPP4) inhibitors, the glucagon-like peptide 1 (GLP1) analogs, and the sodium-glucose transport protein 2 (SGLT2) inhibitors – and metformin as well, Merete Osler, MD, PhD, reported at the annual congress of the European College of Neuropsychopharmacology.
In contrast, neither insulin nor the sulfonylureas showed any signal of a protective effect against development of dementia. In fact, the use of sulfonylureas was associated with a small but statistically significant 7% increased risk, added Dr. Osler, of the University of Copenhagen.
Elsewhere at the meeting, investigators tapped a Swedish national registry to demonstrate that individuals with type 1 diabetes have a sharply reduced risk of developing schizophrenia.
Type 2 diabetes medications and dementia
Dr. Osler and colleagues are among several groups of investigators who have previously shown that patients with type 2 diabetes have an increased risk of dementia.
“This has raised the question of the role of dysregulated glucose metabolism in the development of this neurodegenerative disorder, and the possible effect of antidiabetic medications,” she noted.
To further explore this issue, which links two great ongoing global epidemics, Dr. Osler and coinvestigators conducted a nested case-control study including all 176,250 patients with type 2 diabetes in the comprehensive Danish National Diabetes Register for 1995-2012. The 11,619 patients with type 2 diabetes who received a dementia diagnosis were matched with 46,476 type 2 diabetes patients without dementia. The objective was to determine associations between dementia and ever-use and cumulative dose of antidiabetes drugs, alone and in combination, in logistic regression analyses adjusted for demographics, comorbid conditions, marital status, diabetic complications, and year of dementia diagnosis.
Patients who had ever used metformin had an adjusted 6% reduction in the likelihood of dementia compared with metformin nonusers, a modest but statistically significant difference. Those on a DPP4 inhibitor had a 20% reduction in risk. The GLP1 analogs were associated with a 42% decrease in risk. So were the SGLT2 inhibitors. A dose-response relationship was evident: The higher the cumulative exposure to these agents, the lower the odds of dementia.
Combination therapy is common in type 2 diabetes, so the investigators scrutinized the impact of a variety of multidrug combinations. Combinations including a DPP4 inhibitor or GLP1 analog were also associated with significantly reduced dementia risk.
Records of glycemic control in the form of hemoglobin A1c values were available on only 1,446 type 2 diabetic dementia patients and 4,003 matched controls. An analysis that incorporated this variable showed that the observed anti-dementia effect of selected diabetes drugs was independent of glycemic control, according to Dr. Osler.
The protective effect appeared to extend to both Alzheimer’s disease and vascular dementias, although firm conclusions can’t be drawn on this score because the study was insufficiently powered to address that issue.
Dr. Osler noted that the Danish study confirms a recent Taiwanese study showing an apparent protective effect against dementia for metformin in patients with type 2 diabetes (Aging Dis. 2019 Feb 1;10(1):37-48).
“Ours is the first study on the newer diabetic drugs, so our results need to be confirmed,” she pointed out.
If confirmed, however, it would warrant exploration of these drugs more generally as potential interventions to prevent dementia. That could open a whole new chapter in the remarkable story of the SGLT2 inhibitors, a class of drugs originally developed for treatment of type 2 diabetes but which in major randomized clinical trials later proved to be so effective in the treatment of heart failure that they are now considered cardiology drugs first.
Asked if she thinks these antidiabetes agents have a general neuroprotective effect or, instead, that the observed reduced risk of dementia is a function of patients being treated better early on with modern drugs, the psychiatrist replied, “I think it might be a combination of both, especially because we find different risk estimates between the drugs.”
Dr. Osler reported having no financial conflicts of interest regarding the study, which was funded by the Danish Diabetes Foundation, the Danish Medical Association, and several other foundations.
The full study details were published online shortly before her presentation at ECNP 2019 (Eur J Endocrinol. 2019 Aug 1. pii: EJE-19-0259.R1. doi: 10.1530/EJE-19-0259).
Type 1 diabetes and schizophrenia risk
Kristina Melkersson, MD, PhD, presented a cohort study that utilized Swedish national registries to examine the relationship between type 1 diabetes and schizophrenia. The study comprised 1,745,977 individuals, of whom 10,117 had type 1 diabetes, who were followed for a median of 9.7 and maximum of 18 years from their 13th birthday. During follow-up, 1,280 individuals were diagnosed with schizophrenia and 649 others with schizoaffective disorder. The adjusted risk of schizophrenia was 70% lower in patients with type 1 diabetes. However, there was no difference in the risk of schizoaffective disorder in the type 1 diabetic versus nondiabetic subjects.
The Swedish data confirm the findings of an earlier Finnish national study showing that the risk of schizophrenia is reduced in patients with type 1 diabetes (Arch Gen Psychiatry. 2007 Aug;64(8):894-9). These findings raise the intriguing possibility that autoimmunity somehow figures into the etiology of the psychiatric disorder. Other investigators have previously reported a reduced prevalence of rheumatoid arthritis in patients with schizophrenia, noted Dr. Melkersson of the Karolinska Institute in Stockholm.
She reported having no financial conflicts regarding her study.
SOURCE: Osler M. ECNP Abstract P180. Melkersson K. Abstract 81.
REPORTING FROM ECNP 2019
Research on pediatric firearms deaths is underfunded
new research has found.
For the period 2008-2017, an average of $88 million per year was granted to study motor vehicle crashes, the leading cause of death in this age group. Cancer, the third leading cause of mortality, received on average $335 million per year. However, research into mortality from firearms, the second leading cause of death in this age group, received $12 million total during the entire research period across a total of 32 research grants.
This translates to $26,136 in research funding per death for the 33,577 deaths of children and adolescents in motor vehicle crashes from 2008-2017, $195,508 per death from cancer (17,111 deaths recorded), and just $597 per death from firearm injury (20,719 deaths recorded).
Pediatric firearm injury prevention “is substantially underfunded in relation to the magnitude of the public health problem,” Rebecca Cunningham, MD, from the University of Michigan, Ann Arbor, and colleagues wrote in the October 2019 issue of Health Affairs.
“According to our analysis, federal funding for this leading cause of pediatric mortality is 3.3 percent of what would be needed for it to be commensurate with the funding for other common causes of pediatric death,” the authors continued.
Dr. Cunningham and colleagues said that the “lack of an evidence base for firearm safety prevention has likely contributed to the lack of progress on, and recent increase in, firearm deaths among children and adolescents since 2013.”
They did note that there was an increase in federal research funding following the shooting in Newtown, Conn., with an increase from $136,224 in 2012 to $4.5 million in 2017, but it clearly is not enough.
“Our analysis, using other major diseases and the country’s history of federal funding as a guide, demonstrates that approximately $37 million per year over the next decade is needed to realize a reduction in pediatric firearm mortality that is comparable to that observed for other pediatric causes of death,” the authors state.
The group also suggests the development of a group similar to the National Highway Traffic Safety Administration that is focused specifically on firearm safety that could “begin to address the large gaps in foundational epidemiological and multidisciplinary behavioral research that the nation needs. It could have a transformational impact on the reduction of firearm injuries among children and adolescents parallel to what has been seen for other major causes of pediatric death in the U.S.”
SOURCE: Cunningham R et al. Health Affairs. 2019. doi: 10.1377/hlthaff.2019.00476.
new research has found.
For the period 2008-2017, an average of $88 million per year was granted to study motor vehicle crashes, the leading cause of death in this age group. Cancer, the third leading cause of mortality, received on average $335 million per year. However, research into mortality from firearms, the second leading cause of death in this age group, received $12 million total during the entire research period across a total of 32 research grants.
This translates to $26,136 in research funding per death for the 33,577 deaths of children and adolescents in motor vehicle crashes from 2008-2017, $195,508 per death from cancer (17,111 deaths recorded), and just $597 per death from firearm injury (20,719 deaths recorded).
Pediatric firearm injury prevention “is substantially underfunded in relation to the magnitude of the public health problem,” Rebecca Cunningham, MD, from the University of Michigan, Ann Arbor, and colleagues wrote in the October 2019 issue of Health Affairs.
“According to our analysis, federal funding for this leading cause of pediatric mortality is 3.3 percent of what would be needed for it to be commensurate with the funding for other common causes of pediatric death,” the authors continued.
Dr. Cunningham and colleagues said that the “lack of an evidence base for firearm safety prevention has likely contributed to the lack of progress on, and recent increase in, firearm deaths among children and adolescents since 2013.”
They did note that there was an increase in federal research funding following the shooting in Newtown, Conn., with an increase from $136,224 in 2012 to $4.5 million in 2017, but it clearly is not enough.
“Our analysis, using other major diseases and the country’s history of federal funding as a guide, demonstrates that approximately $37 million per year over the next decade is needed to realize a reduction in pediatric firearm mortality that is comparable to that observed for other pediatric causes of death,” the authors state.
The group also suggests the development of a group similar to the National Highway Traffic Safety Administration that is focused specifically on firearm safety that could “begin to address the large gaps in foundational epidemiological and multidisciplinary behavioral research that the nation needs. It could have a transformational impact on the reduction of firearm injuries among children and adolescents parallel to what has been seen for other major causes of pediatric death in the U.S.”
SOURCE: Cunningham R et al. Health Affairs. 2019. doi: 10.1377/hlthaff.2019.00476.
new research has found.
For the period 2008-2017, an average of $88 million per year was granted to study motor vehicle crashes, the leading cause of death in this age group. Cancer, the third leading cause of mortality, received on average $335 million per year. However, research into mortality from firearms, the second leading cause of death in this age group, received $12 million total during the entire research period across a total of 32 research grants.
This translates to $26,136 in research funding per death for the 33,577 deaths of children and adolescents in motor vehicle crashes from 2008-2017, $195,508 per death from cancer (17,111 deaths recorded), and just $597 per death from firearm injury (20,719 deaths recorded).
Pediatric firearm injury prevention “is substantially underfunded in relation to the magnitude of the public health problem,” Rebecca Cunningham, MD, from the University of Michigan, Ann Arbor, and colleagues wrote in the October 2019 issue of Health Affairs.
“According to our analysis, federal funding for this leading cause of pediatric mortality is 3.3 percent of what would be needed for it to be commensurate with the funding for other common causes of pediatric death,” the authors continued.
Dr. Cunningham and colleagues said that the “lack of an evidence base for firearm safety prevention has likely contributed to the lack of progress on, and recent increase in, firearm deaths among children and adolescents since 2013.”
They did note that there was an increase in federal research funding following the shooting in Newtown, Conn., with an increase from $136,224 in 2012 to $4.5 million in 2017, but it clearly is not enough.
“Our analysis, using other major diseases and the country’s history of federal funding as a guide, demonstrates that approximately $37 million per year over the next decade is needed to realize a reduction in pediatric firearm mortality that is comparable to that observed for other pediatric causes of death,” the authors state.
The group also suggests the development of a group similar to the National Highway Traffic Safety Administration that is focused specifically on firearm safety that could “begin to address the large gaps in foundational epidemiological and multidisciplinary behavioral research that the nation needs. It could have a transformational impact on the reduction of firearm injuries among children and adolescents parallel to what has been seen for other major causes of pediatric death in the U.S.”
SOURCE: Cunningham R et al. Health Affairs. 2019. doi: 10.1377/hlthaff.2019.00476.
FROM HEALTH AFFAIRS
Guidelines updated for treating community-acquired pneumonia
An update to the 2007 guidelines on the treatment of community-acquired pneumonia (CAP) was published by two medical societies, based upon the work of a multidisciplinary panel that “conducted pragmatic systematic reviews of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations.”
The panel addressed 16 questions in the areas including diagnostic testing, determination of site of care, selection of initial empiric antibiotic therapy, and subsequent management decisions. Some of their recommendations remained unchanged from the 2007 guideline, but others were updated based upon more-recent clinical trials and epidemiological studies, according to Joshua P. Metlay, MD, of Massachusetts General Hospital, Boston, and colleagues on behalf of the Infectious Diseases Society of America and the American Thoracic Society.
Among the key recommendations differing from the previous guidelines, the 2019 guidelines include the following:
- Sputum and blood culture samples are recommended in patients with severe disease, as well as in all inpatients empirically treated for methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa.
- Macrolide monotherapy is only conditionally recommended for outpatients based on resistance levels.
- Procalcitonin assessment, not covered in the 2007 guidelines, is not recommended in order to determine initial antibiotic therapy.
- Corticosteroid use, not covered in the 2007 guidelines, is not recommended, though it may be considered in patients with refractory septic shock.
- The use of health care–associated pneumonia (HCAP) as a category should be dropped, with a switch to an emphasis on local epidemiology and validated risk factors to determine the need for MRSA or P. aeruginosa treatment.
- Standard empiric therapy for severe CAP should be beta-lactam/macrolide and beta-lactam/fluoroquinolone combinations, but with stronger evidence in favor of the beta-lactam/macrolide combination.
The updated guidelines also include a number of other recommendations, such as those dealing with the management of patients with comorbidities, and were published in the American Journal of Respiratory and Critical Care Medicine.
“A difference between this guideline and previous ones is that we have significantly increased the proportion of patients in whom we recommend routinely obtaining respiratory tract samples for microbiologic studies. This decision is largely based on a desire to correct the overuse of anti-MRSA and antipseudomonal therapy that has occurred since the introduction of the HCAP classification (which we recommend abandoning) rather than high-quality evidence,” the authors stated in their conclusions. They added that they “expect our move against endorsing monotherapy with macrolides, which is based on population resistance data rather than high-quality clinical studies, will generate future outcomes studies comparing different treatment strategies.”
Many of the authors reported relationships with a variety of pharmaceutical companies; full disclosures are detailed at the end of the guideline publication.
SOURCE: Metlay JP et al. Am J Respir Crit Med. 2019;200(7):e45-67.
“Ever since we wrote the first CAP [community-acquired pneumonia] guidelines in 1993, we’ve heard good and bad things, and I agree with both,” Michael S. Niederman, MD, FCCP, said in a presentation at IDWeek 2019. “For good or for bad, [guidelines] are a standard against which care can be evaluated.” He discussed how, as guidelines have become more evidence based, they have often become “more wishy washy,” that when the evidence is weak, the recommendation is weak, and the guidelines merely advise doctors: “You figure it out.”
However, he pointed out that, since CAP guidelines were developed, there have been overall improvements in patient care and antibiotic stewardship. But he saw several weaknesses in the new guidelines, including the fact that they did not update minor criteria for determining severe CAP from the 2007 guidelines, despite several studies indicating that there were other criteria to consider. In addition, the updated guidelines held a negative view of the use of serum procalcitonin to guide site-of-care decisions, which Dr. Niederman argued went against an analysis of the Etiology of Pneumonia in the Community (EPIC) study (CHEST. 2016; 150[4]:819-28) and other studies that showed its utility. He referred to his own editorial, in which he discussed the subject extensively (Lancet Resp Med. 2016;4[12]:956).
“Similarly, to me, the macrolide issue is not resolved,” he added, citing several studies that, in contrast to the guideline recommendations, used outpatient macrolide monotherapy to good results, and one study showed that “there was a much better patient outcome for patients who got macrolide monotherapy than for those who got quinolones” (Resp Med. 2012;106[3]:451-8).
Dr. Niederman is clinical director of the division of pulmonary and critical care medicine at New York Presbyterian Hospital/Weill Cornell Medical Center, and professor of clinical medicine at Weill Cornell Medical College, New York. He disclosed that he is a consultant for and has received grants from a variety of pharmaceutical companies, including Bayer and Merck.
“Ever since we wrote the first CAP [community-acquired pneumonia] guidelines in 1993, we’ve heard good and bad things, and I agree with both,” Michael S. Niederman, MD, FCCP, said in a presentation at IDWeek 2019. “For good or for bad, [guidelines] are a standard against which care can be evaluated.” He discussed how, as guidelines have become more evidence based, they have often become “more wishy washy,” that when the evidence is weak, the recommendation is weak, and the guidelines merely advise doctors: “You figure it out.”
However, he pointed out that, since CAP guidelines were developed, there have been overall improvements in patient care and antibiotic stewardship. But he saw several weaknesses in the new guidelines, including the fact that they did not update minor criteria for determining severe CAP from the 2007 guidelines, despite several studies indicating that there were other criteria to consider. In addition, the updated guidelines held a negative view of the use of serum procalcitonin to guide site-of-care decisions, which Dr. Niederman argued went against an analysis of the Etiology of Pneumonia in the Community (EPIC) study (CHEST. 2016; 150[4]:819-28) and other studies that showed its utility. He referred to his own editorial, in which he discussed the subject extensively (Lancet Resp Med. 2016;4[12]:956).
“Similarly, to me, the macrolide issue is not resolved,” he added, citing several studies that, in contrast to the guideline recommendations, used outpatient macrolide monotherapy to good results, and one study showed that “there was a much better patient outcome for patients who got macrolide monotherapy than for those who got quinolones” (Resp Med. 2012;106[3]:451-8).
Dr. Niederman is clinical director of the division of pulmonary and critical care medicine at New York Presbyterian Hospital/Weill Cornell Medical Center, and professor of clinical medicine at Weill Cornell Medical College, New York. He disclosed that he is a consultant for and has received grants from a variety of pharmaceutical companies, including Bayer and Merck.
“Ever since we wrote the first CAP [community-acquired pneumonia] guidelines in 1993, we’ve heard good and bad things, and I agree with both,” Michael S. Niederman, MD, FCCP, said in a presentation at IDWeek 2019. “For good or for bad, [guidelines] are a standard against which care can be evaluated.” He discussed how, as guidelines have become more evidence based, they have often become “more wishy washy,” that when the evidence is weak, the recommendation is weak, and the guidelines merely advise doctors: “You figure it out.”
However, he pointed out that, since CAP guidelines were developed, there have been overall improvements in patient care and antibiotic stewardship. But he saw several weaknesses in the new guidelines, including the fact that they did not update minor criteria for determining severe CAP from the 2007 guidelines, despite several studies indicating that there were other criteria to consider. In addition, the updated guidelines held a negative view of the use of serum procalcitonin to guide site-of-care decisions, which Dr. Niederman argued went against an analysis of the Etiology of Pneumonia in the Community (EPIC) study (CHEST. 2016; 150[4]:819-28) and other studies that showed its utility. He referred to his own editorial, in which he discussed the subject extensively (Lancet Resp Med. 2016;4[12]:956).
“Similarly, to me, the macrolide issue is not resolved,” he added, citing several studies that, in contrast to the guideline recommendations, used outpatient macrolide monotherapy to good results, and one study showed that “there was a much better patient outcome for patients who got macrolide monotherapy than for those who got quinolones” (Resp Med. 2012;106[3]:451-8).
Dr. Niederman is clinical director of the division of pulmonary and critical care medicine at New York Presbyterian Hospital/Weill Cornell Medical Center, and professor of clinical medicine at Weill Cornell Medical College, New York. He disclosed that he is a consultant for and has received grants from a variety of pharmaceutical companies, including Bayer and Merck.
An update to the 2007 guidelines on the treatment of community-acquired pneumonia (CAP) was published by two medical societies, based upon the work of a multidisciplinary panel that “conducted pragmatic systematic reviews of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations.”
The panel addressed 16 questions in the areas including diagnostic testing, determination of site of care, selection of initial empiric antibiotic therapy, and subsequent management decisions. Some of their recommendations remained unchanged from the 2007 guideline, but others were updated based upon more-recent clinical trials and epidemiological studies, according to Joshua P. Metlay, MD, of Massachusetts General Hospital, Boston, and colleagues on behalf of the Infectious Diseases Society of America and the American Thoracic Society.
Among the key recommendations differing from the previous guidelines, the 2019 guidelines include the following:
- Sputum and blood culture samples are recommended in patients with severe disease, as well as in all inpatients empirically treated for methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa.
- Macrolide monotherapy is only conditionally recommended for outpatients based on resistance levels.
- Procalcitonin assessment, not covered in the 2007 guidelines, is not recommended in order to determine initial antibiotic therapy.
- Corticosteroid use, not covered in the 2007 guidelines, is not recommended, though it may be considered in patients with refractory septic shock.
- The use of health care–associated pneumonia (HCAP) as a category should be dropped, with a switch to an emphasis on local epidemiology and validated risk factors to determine the need for MRSA or P. aeruginosa treatment.
- Standard empiric therapy for severe CAP should be beta-lactam/macrolide and beta-lactam/fluoroquinolone combinations, but with stronger evidence in favor of the beta-lactam/macrolide combination.
The updated guidelines also include a number of other recommendations, such as those dealing with the management of patients with comorbidities, and were published in the American Journal of Respiratory and Critical Care Medicine.
“A difference between this guideline and previous ones is that we have significantly increased the proportion of patients in whom we recommend routinely obtaining respiratory tract samples for microbiologic studies. This decision is largely based on a desire to correct the overuse of anti-MRSA and antipseudomonal therapy that has occurred since the introduction of the HCAP classification (which we recommend abandoning) rather than high-quality evidence,” the authors stated in their conclusions. They added that they “expect our move against endorsing monotherapy with macrolides, which is based on population resistance data rather than high-quality clinical studies, will generate future outcomes studies comparing different treatment strategies.”
Many of the authors reported relationships with a variety of pharmaceutical companies; full disclosures are detailed at the end of the guideline publication.
SOURCE: Metlay JP et al. Am J Respir Crit Med. 2019;200(7):e45-67.
An update to the 2007 guidelines on the treatment of community-acquired pneumonia (CAP) was published by two medical societies, based upon the work of a multidisciplinary panel that “conducted pragmatic systematic reviews of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations.”
The panel addressed 16 questions in the areas including diagnostic testing, determination of site of care, selection of initial empiric antibiotic therapy, and subsequent management decisions. Some of their recommendations remained unchanged from the 2007 guideline, but others were updated based upon more-recent clinical trials and epidemiological studies, according to Joshua P. Metlay, MD, of Massachusetts General Hospital, Boston, and colleagues on behalf of the Infectious Diseases Society of America and the American Thoracic Society.
Among the key recommendations differing from the previous guidelines, the 2019 guidelines include the following:
- Sputum and blood culture samples are recommended in patients with severe disease, as well as in all inpatients empirically treated for methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa.
- Macrolide monotherapy is only conditionally recommended for outpatients based on resistance levels.
- Procalcitonin assessment, not covered in the 2007 guidelines, is not recommended in order to determine initial antibiotic therapy.
- Corticosteroid use, not covered in the 2007 guidelines, is not recommended, though it may be considered in patients with refractory septic shock.
- The use of health care–associated pneumonia (HCAP) as a category should be dropped, with a switch to an emphasis on local epidemiology and validated risk factors to determine the need for MRSA or P. aeruginosa treatment.
- Standard empiric therapy for severe CAP should be beta-lactam/macrolide and beta-lactam/fluoroquinolone combinations, but with stronger evidence in favor of the beta-lactam/macrolide combination.
The updated guidelines also include a number of other recommendations, such as those dealing with the management of patients with comorbidities, and were published in the American Journal of Respiratory and Critical Care Medicine.
“A difference between this guideline and previous ones is that we have significantly increased the proportion of patients in whom we recommend routinely obtaining respiratory tract samples for microbiologic studies. This decision is largely based on a desire to correct the overuse of anti-MRSA and antipseudomonal therapy that has occurred since the introduction of the HCAP classification (which we recommend abandoning) rather than high-quality evidence,” the authors stated in their conclusions. They added that they “expect our move against endorsing monotherapy with macrolides, which is based on population resistance data rather than high-quality clinical studies, will generate future outcomes studies comparing different treatment strategies.”
Many of the authors reported relationships with a variety of pharmaceutical companies; full disclosures are detailed at the end of the guideline publication.
SOURCE: Metlay JP et al. Am J Respir Crit Med. 2019;200(7):e45-67.
FROM THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Vaping-linked lung injuries near 1,500
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
Policymakers must invest in health care innovation
Affordable pharma tops consumer list
In 2017, the United States spent $3.5 trillion on health care, and that number is projected to be close 20% of our GDP over the next 10 years. For consumers, prescription drugs feel like the biggest contributor.
“Although pharmaceutical spending accounts for less than 10% of health care spending, consumers bear much more of the out-of-pocket cost of the prescription drugs through copays or coinsurance at the pharmacy counter than they pay for hospital or physician costs,” said Tanisha Carino, PhD, author of a Health Affairs blog post about directions for innovation in health care. “This experience has led to rising concerns among Americans about the cost of prescription drugs.”
In fact, a December 2018 Politico-Harvard poll showed Americans from both political parties overwhelmingly agreed that taking action to lower drug prices should have been the top priority of the new Congress that took office in January of this year.
“Addressing the affordability of prescription drugs will require investing in medical research and policies that speed new products to the market that will promote competition and, hopefully, will hold down prices and offer greater choice to patients,” said Dr. Carino, who is executive director of FasterCures, a center of the Milken Institute devoted to improving the biomedical innovation ecosystem. “Policymakers have an opportunity to address the immediate concerns patients have in affording their medication.”
According to Dr. Carino, policymakers can also continue to encourage health-improving medical innovation through the following:
- Boosting investment in research and development.
- Increasing safety and coordination of health data for biomedical research.
- Incentivizing innovation in underinvested areas.
- Building the capacity of patient organizations.
Hospitalists, she added, will play a critical role in participating in the clinical research that will lead to the next generation of treatments.
Reference
1. Carino T. “To get more bang for your health-care buck, invest in innovation.” Health Affairs Blog. 2019 Jan 24. doi: 10.1377/hblog20190123.483080. Accessed Feb. 6, 2019.
Affordable pharma tops consumer list
Affordable pharma tops consumer list
In 2017, the United States spent $3.5 trillion on health care, and that number is projected to be close 20% of our GDP over the next 10 years. For consumers, prescription drugs feel like the biggest contributor.
“Although pharmaceutical spending accounts for less than 10% of health care spending, consumers bear much more of the out-of-pocket cost of the prescription drugs through copays or coinsurance at the pharmacy counter than they pay for hospital or physician costs,” said Tanisha Carino, PhD, author of a Health Affairs blog post about directions for innovation in health care. “This experience has led to rising concerns among Americans about the cost of prescription drugs.”
In fact, a December 2018 Politico-Harvard poll showed Americans from both political parties overwhelmingly agreed that taking action to lower drug prices should have been the top priority of the new Congress that took office in January of this year.
“Addressing the affordability of prescription drugs will require investing in medical research and policies that speed new products to the market that will promote competition and, hopefully, will hold down prices and offer greater choice to patients,” said Dr. Carino, who is executive director of FasterCures, a center of the Milken Institute devoted to improving the biomedical innovation ecosystem. “Policymakers have an opportunity to address the immediate concerns patients have in affording their medication.”
According to Dr. Carino, policymakers can also continue to encourage health-improving medical innovation through the following:
- Boosting investment in research and development.
- Increasing safety and coordination of health data for biomedical research.
- Incentivizing innovation in underinvested areas.
- Building the capacity of patient organizations.
Hospitalists, she added, will play a critical role in participating in the clinical research that will lead to the next generation of treatments.
Reference
1. Carino T. “To get more bang for your health-care buck, invest in innovation.” Health Affairs Blog. 2019 Jan 24. doi: 10.1377/hblog20190123.483080. Accessed Feb. 6, 2019.
In 2017, the United States spent $3.5 trillion on health care, and that number is projected to be close 20% of our GDP over the next 10 years. For consumers, prescription drugs feel like the biggest contributor.
“Although pharmaceutical spending accounts for less than 10% of health care spending, consumers bear much more of the out-of-pocket cost of the prescription drugs through copays or coinsurance at the pharmacy counter than they pay for hospital or physician costs,” said Tanisha Carino, PhD, author of a Health Affairs blog post about directions for innovation in health care. “This experience has led to rising concerns among Americans about the cost of prescription drugs.”
In fact, a December 2018 Politico-Harvard poll showed Americans from both political parties overwhelmingly agreed that taking action to lower drug prices should have been the top priority of the new Congress that took office in January of this year.
“Addressing the affordability of prescription drugs will require investing in medical research and policies that speed new products to the market that will promote competition and, hopefully, will hold down prices and offer greater choice to patients,” said Dr. Carino, who is executive director of FasterCures, a center of the Milken Institute devoted to improving the biomedical innovation ecosystem. “Policymakers have an opportunity to address the immediate concerns patients have in affording their medication.”
According to Dr. Carino, policymakers can also continue to encourage health-improving medical innovation through the following:
- Boosting investment in research and development.
- Increasing safety and coordination of health data for biomedical research.
- Incentivizing innovation in underinvested areas.
- Building the capacity of patient organizations.
Hospitalists, she added, will play a critical role in participating in the clinical research that will lead to the next generation of treatments.
Reference
1. Carino T. “To get more bang for your health-care buck, invest in innovation.” Health Affairs Blog. 2019 Jan 24. doi: 10.1377/hblog20190123.483080. Accessed Feb. 6, 2019.
Minimize blood pressure peaks, variability after stroke reperfusion
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
ST. LOUIS – Albuquerque. Investigators found that every 10–mm Hg increase in peak systolic pressure boosted the risk of in-hospital death 24% (P = .01) and reduced the chance of being discharged home or to a inpatient rehabilitation facility 13% (P = .03). Results were even stronger for peak mean arterial pressure, at 76% (P = .01) and 29% (P = .04), respectively; trends in the same direction for peak diastolic pressure were not statistically significant.
Also, every 10–mm Hg increase in blood pressure variability again increased the risk of dying in the hospital, whether it was systolic (33%; P = .002), diastolic (33%; P = .03), or mean arterial pressure variability (58%; P = .02). Higher variability also reduced the chance of being discharged home or to a rehab 10%-20%, but the findings, although close, were not statistically significant.
Neurologists generally do what they can to control blood pressure after stroke, and the study confirms the need to do that. What’s new is that the work was limited to reperfusion patients – intravenous thrombolysis with alteplase in 83.5%, mechanical thrombectomy in 60%, with some having both – which has not been the specific focus of much research.
“Be much more aggressive in terms of making sure the variability is limited and limiting the peaks,” especially within 24 hours of reperfusion, said lead investigator and stroke neurologist Dinesh Jillella, MD, of Emory University, Atlanta, at the annual meeting of the American Neurological Association. “We want to be much more aggressive [with these patients]; it might limit our worse outcomes,” Dr. Jillella said. He conducted the review while in training at the University of New Mexico.
What led to the study is that Dr. Jillella and colleagues noticed that similar reperfusion patients can have very different outcomes, and he wanted to find modifiable risk factors that could account for the differences. The study did not address why high peaks and variability lead to worse outcomes, but he said hemorrhagic conversion might play a role.
It is also possible that higher pressures could be a marker of bad outcomes, as opposed to a direct cause, but the findings were adjusted for two significant confounders: age and the National Institutes of Health Stroke Scale score, which were both significantly higher in patients who did not do well. But after adjustment, “we [still] found an independent association with blood pressures and worse outcomes,” he said.
Higher peak systolic pressures and variability were also associated with about a 15% lower odds of leaving the hospital with a modified Rankin Scale score of 3 or less, which means the patient has some moderate disability but is still able to walk without assistance.
Patients were 69 years old on average, and about 60% were men. The majority were white. About a third had a modified Rankin Scale score at or below 3 at discharge, and about two-thirds were discharged home or to a rehabilitation facility; 17% of patients died in the hospital.
Differences in antihypertensive regimens were not associated with outcomes on univariate analysis. Dr. Jillella said that, ideally, he would like to run a multicenter, prospective trial of blood pressure reduction targets after reperfusion.
There was no external funding, and Dr. Jillella didn’t have any relevant disclosures.
REPORTING FROM ANA 2019
FDA approves rivaroxaban for VTE prevention in hospitalized, acutely ill patients
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
No clear benefit from conservative oxygen in mechanical ventilation
More conservative oxygen therapy during mechanical ventilation in intensive care does not appear to increase the number of ventilator-free days or reduce mortality, according to a study published online in the New England Journal of Medicine.
Diane Mackle of the Medical Research Institute of New Zealand and her co-authors wrote that hyperoxemia in adults undergoing mechanical ventilation has been associated with increased mortality, as well as fewer days free of ventilation, but there was a lack of data to guide oxygen administration.
In a parallel-group trial, 1,000 adults who were expected to require mechanical ventilation – with an intention-to-treat population of 965 – were randomized either to conservative oxygen therapy or usual therapy. For the conservative therapy, the upper limit of the pulse oximetry alarm would sound when levels reached 97% and the F102 was decreased to 0.21 if the pulse oximetry was above the acceptable lower limit, while usual therapy involved no specific limiting measures. In both groups, the default lower limit for oxygen saturation was 90%.
At day 28 after ventilation, there was no significant difference between the conservative and usual care groups in the number of ventilator-free days (21.3 days vs. 22.1 days). The patients in the conservative oxygen group spent a median of 29 hours receiving an F102 level of 0.21, compared with 1 hour in the usual care group.
The mortality rate at day 180 was 35.7% in the conservative oxygen group, and 34.5% in the usual-oxygen group (HR 1.05, 95% CI 0.85 – 1.30). Researchers also saw no differences between the two groups in paid employment and cognitive function.
In patients with suspected hypoxic-ischemic encephalopathy between-group differences were apparent; At day 28, those in the conservative-oxygen group had a median of 21.1 ventilator-free days, compared with none in the usual-oxygen group. The usual-oxygen group also had a higher 180-day mortality rate than those in the conservative-oxygen group (43% vs. 59%).
“Our data are suggestive of a possible benefit of conservative oxygen therapy in patients with suspected hypoxic-ischemic encephalopathy,” the authors wrote. “It is biologically plausible that conservative oxygen therapy reduces the incidence of secondary brain damage after resuscitation from cardiac arrest, and observational data suggest that exposure to hyperoxemia in such patients may be harmful.”
The authors noted that their trial did not rule out the possibility of benefit or harm had they used a more liberal oxygen regimen in their usual-care group, and that different conservative regimens might also have achieved different outcomes.
The study was funded by the New Zealand Health Research Council. Six authors declared research support for the trial from the study funder, and two declared unrelated research grants from private industry. No other conflicts of interest were declared.
SOURCE: Mackle D et al. NJEM 2019, October 14. DOI:10.1056/NEJMoa1903297.
More conservative oxygen therapy during mechanical ventilation in intensive care does not appear to increase the number of ventilator-free days or reduce mortality, according to a study published online in the New England Journal of Medicine.
Diane Mackle of the Medical Research Institute of New Zealand and her co-authors wrote that hyperoxemia in adults undergoing mechanical ventilation has been associated with increased mortality, as well as fewer days free of ventilation, but there was a lack of data to guide oxygen administration.
In a parallel-group trial, 1,000 adults who were expected to require mechanical ventilation – with an intention-to-treat population of 965 – were randomized either to conservative oxygen therapy or usual therapy. For the conservative therapy, the upper limit of the pulse oximetry alarm would sound when levels reached 97% and the F102 was decreased to 0.21 if the pulse oximetry was above the acceptable lower limit, while usual therapy involved no specific limiting measures. In both groups, the default lower limit for oxygen saturation was 90%.
At day 28 after ventilation, there was no significant difference between the conservative and usual care groups in the number of ventilator-free days (21.3 days vs. 22.1 days). The patients in the conservative oxygen group spent a median of 29 hours receiving an F102 level of 0.21, compared with 1 hour in the usual care group.
The mortality rate at day 180 was 35.7% in the conservative oxygen group, and 34.5% in the usual-oxygen group (HR 1.05, 95% CI 0.85 – 1.30). Researchers also saw no differences between the two groups in paid employment and cognitive function.
In patients with suspected hypoxic-ischemic encephalopathy between-group differences were apparent; At day 28, those in the conservative-oxygen group had a median of 21.1 ventilator-free days, compared with none in the usual-oxygen group. The usual-oxygen group also had a higher 180-day mortality rate than those in the conservative-oxygen group (43% vs. 59%).
“Our data are suggestive of a possible benefit of conservative oxygen therapy in patients with suspected hypoxic-ischemic encephalopathy,” the authors wrote. “It is biologically plausible that conservative oxygen therapy reduces the incidence of secondary brain damage after resuscitation from cardiac arrest, and observational data suggest that exposure to hyperoxemia in such patients may be harmful.”
The authors noted that their trial did not rule out the possibility of benefit or harm had they used a more liberal oxygen regimen in their usual-care group, and that different conservative regimens might also have achieved different outcomes.
The study was funded by the New Zealand Health Research Council. Six authors declared research support for the trial from the study funder, and two declared unrelated research grants from private industry. No other conflicts of interest were declared.
SOURCE: Mackle D et al. NJEM 2019, October 14. DOI:10.1056/NEJMoa1903297.
More conservative oxygen therapy during mechanical ventilation in intensive care does not appear to increase the number of ventilator-free days or reduce mortality, according to a study published online in the New England Journal of Medicine.
Diane Mackle of the Medical Research Institute of New Zealand and her co-authors wrote that hyperoxemia in adults undergoing mechanical ventilation has been associated with increased mortality, as well as fewer days free of ventilation, but there was a lack of data to guide oxygen administration.
In a parallel-group trial, 1,000 adults who were expected to require mechanical ventilation – with an intention-to-treat population of 965 – were randomized either to conservative oxygen therapy or usual therapy. For the conservative therapy, the upper limit of the pulse oximetry alarm would sound when levels reached 97% and the F102 was decreased to 0.21 if the pulse oximetry was above the acceptable lower limit, while usual therapy involved no specific limiting measures. In both groups, the default lower limit for oxygen saturation was 90%.
At day 28 after ventilation, there was no significant difference between the conservative and usual care groups in the number of ventilator-free days (21.3 days vs. 22.1 days). The patients in the conservative oxygen group spent a median of 29 hours receiving an F102 level of 0.21, compared with 1 hour in the usual care group.
The mortality rate at day 180 was 35.7% in the conservative oxygen group, and 34.5% in the usual-oxygen group (HR 1.05, 95% CI 0.85 – 1.30). Researchers also saw no differences between the two groups in paid employment and cognitive function.
In patients with suspected hypoxic-ischemic encephalopathy between-group differences were apparent; At day 28, those in the conservative-oxygen group had a median of 21.1 ventilator-free days, compared with none in the usual-oxygen group. The usual-oxygen group also had a higher 180-day mortality rate than those in the conservative-oxygen group (43% vs. 59%).
“Our data are suggestive of a possible benefit of conservative oxygen therapy in patients with suspected hypoxic-ischemic encephalopathy,” the authors wrote. “It is biologically plausible that conservative oxygen therapy reduces the incidence of secondary brain damage after resuscitation from cardiac arrest, and observational data suggest that exposure to hyperoxemia in such patients may be harmful.”
The authors noted that their trial did not rule out the possibility of benefit or harm had they used a more liberal oxygen regimen in their usual-care group, and that different conservative regimens might also have achieved different outcomes.
The study was funded by the New Zealand Health Research Council. Six authors declared research support for the trial from the study funder, and two declared unrelated research grants from private industry. No other conflicts of interest were declared.
SOURCE: Mackle D et al. NJEM 2019, October 14. DOI:10.1056/NEJMoa1903297.
FROM NEJM
Key clinical point: Conservative oxygen therapy during mechanical ventilation does not increase ventilation-free days.
Major finding: The number of ventilation-free days was similar in adults on conservative oxygen therapy and those on usual care.
Study details: Parallel-group randomized controlled trial in 965 adults undergoing mechanical ventilation.
Disclosures: The study was funded by the New Zealand Health Research Council. Six authors declared research support for the trial from the study funder, and two declared unrelated research grants from private industry. No other conflicts of interest were declared.
Source: Mackle D et al. NJEM 2019, October 14. DOI: 10.1056/NEJMoa1903297.
MRI saves money, better than CT in acute stroke
ST. LOUIS – , according to a review from Johns Hopkins University, Baltimore.
MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”
Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.
The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.
Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.
A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.
The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.
Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.
Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.
The average age for stroke admissions at Hopkins is 55 years, with as many men as women.
There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.
ST. LOUIS – , according to a review from Johns Hopkins University, Baltimore.
MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”
Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.
The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.
Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.
A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.
The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.
Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.
Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.
The average age for stroke admissions at Hopkins is 55 years, with as many men as women.
There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.
ST. LOUIS – , according to a review from Johns Hopkins University, Baltimore.
MRI as the first scan leads to “a definitive diagnoses sooner and helps you manage the person more rapidly and appropriately, without negatively affecting outcomes even in stroke patients who receive endovascular therapy,” said neurologist and senior investigator Argye Hillis, MD, director of the Center of Excellence in Stroke Detection and Diagnosis at Hopkins. “Consider skipping the CT and getting an MRI, and get the MRI while they are still in the emergency room.”
Almost all emergency departments in the United States are set up to get a CT first, but MRI is known to be the better study, according to the researchers. MRI is much more sensitive to stroke, especially in the first 24 hours, and pinpoints the location and extent of the damage. It can detect causes of stroke invisible to CT, with no radiation, and rule out stroke entirely, whereas CT can rule out only intracranial bleeding. Increasingly in Europe, MRI is the first study in suspected stroke, and new EDs in the United States are being designed with an in-house MRI, or one nearby.
The ED at Hopkins’ main campus in downtown Baltimore already has an MRI, and uses it first whenever possible. The problem has been that MRI techs are available only during weekdays, so physicians have to default back to CT at night and on weekends. The impetus for the review, presented at the annual meeting of the American Neurological Association, was to see if savings from unnecessary admissions prevented by MRI would be enough to offset the cost of around-the-clock staffing for the MRI scanner.
Dr. Hillis and her team reviewed 320 patients with suspected ischemic stroke who were seen at the main campus in 2018 and had CT in the ED, and then definitive diagnosis by MRI, which is the usual approach in most U.S. hospitals.
A total of 134 patients had a final diagnosis on MRI that did not justify admission; techs were available to give 75 of them MRIs in the ED after the CT, and those patients were sent home. Techs were not available, however, for 59 patients and since the CT was not able to rule out stroke, those patients were admitted. The cost of those 59 admissions was $814,016.
The cost of the noncontrast CTs for the 75 patients who were sent home after definitive MRI imaging was $28,050, plus an additional $46,072 for those who had CT neck/head angiograms. Altogether, skipping the CT and going straight to the MRI would have saved Hopkins $888,138 in 2018, enough to cover round-the-clock MRI staffing in the ED, which is now the plan at the main campus.
Once the facility moves to 24-and-7 MRI coverage, the next step in the project is to compare stroke outcomes with Johns Hopkins Bayview Medical Center, also in Baltimore, which will continue to do CT first. “We know MRI first is cheaper. We want to see if we have better outcomes. If we find they’re much better, I think many hospitals will say it’s worth the 5 minutes longer it takes to get to the MRI scanner,” Dr. Hillis said.
Stroke mimics among the 134 patients included peripheral nerve palsy and migraine, but also people simply faking it for a hot meal and a warm bed. “Its pretty common, unfortunately,” she said.
The average age for stroke admissions at Hopkins is 55 years, with as many men as women.
There was no industry funding, and Dr. Hillis didn’t have any relevant disclosures.
REPORTING FROM ANA 2019
Key clinical point: Getting an MRI first for suspected stroke, instead of a CT, saves money by avoiding unnecessary admissions and might lead to better outcomes.
Major finding: An MRI-first approach at a busy ED in downtown Baltimore would have saved $888,138 in 1 year.
Study details: Review of 320 patients with suspected ischemic strokes.
Disclosures: There was no industry funding, and the senior investigator did not have any relevant disclosures.
Source: Sherry E et al. ANA 2019. Abstract M123.