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Half of patients in hospital for COVID-19 get acute kidney injury
in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.
The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.
Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
COVID-19 giving nephrologists an opportunity to improve AKI care
“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.
“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.
He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:
- Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
- Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
- Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
- Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.
The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
In-hospital diuretic treatment links with AKI
One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m2.
During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.
Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).
The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.
For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
Second report links ventilation, vasopressors with worse AKI
A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.
Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.
In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.
Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.
Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.
The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.
Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
COVID-19 giving nephrologists an opportunity to improve AKI care
“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.
“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.
He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:
- Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
- Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
- Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
- Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.
The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
In-hospital diuretic treatment links with AKI
One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m2.
During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.
Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).
The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.
For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
Second report links ventilation, vasopressors with worse AKI
A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.
Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.
In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.
Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.
Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.
The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.
Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
COVID-19 giving nephrologists an opportunity to improve AKI care
“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.
“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.
He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:
- Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
- Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
- Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
- Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.
The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
In-hospital diuretic treatment links with AKI
One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m2.
During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.
Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).
The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.
For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
Second report links ventilation, vasopressors with worse AKI
A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.
Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.
In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.
Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.
Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Infective endocarditis from IV drug use tied to hemorrhagic stroke
One consequence of the ongoing opioid epidemic in the United States may be an increase in the number of hemorrhagic strokes caused by infective endocarditis, research suggests.
Intravenous drug use (IVDU) can cause this bacterial infection of the heart. In a single-center study, infective endocarditis was associated with an increase in the risk for hemorrhagic stroke as well as an increase in health care use and costs.
“Patients who are known IV drug users who have endocarditis should be more carefully screened for symptoms of cardiovascular disease,” Shahid M. Nimjee, MD, PhD, associate professor of neurosurgery and surgical director of the Comprehensive Stroke Center at the Ohio State University Wexner Medical Center, Columbus, said in a press release.
The findings were presented at the International Stroke Conference sponsored by the American Heart Association.
In the United States, 47,000 patients are treated in the hospital for endocarditis each year. Endocarditis increases the risk for stroke, which can entail significant morbidity and mortality, the authors noted.
IVDU is a risk factor for endocarditis. In the context of the opioid epidemic, Dr. Nimjee and colleagues sought to compare the risk for stroke among patients with endocarditis from IVDU with the risk among patients with endocarditis from other causes.
They retrospectively studied patients who had undergone treatment for infective endocarditis at Wexner Medical Center between Jan. 1, 2014, and July 1, 2018. They examined patients’ concomitant intravenous drug abuse and evaluated demographics, risk factors, and associated costs.
Dramatic increase
In all, 351 patients met the study’s inclusion criteria, and 170 (48%) had a history of IVDU-associated endocarditis. The incidence of patients with IVDU-associated endocarditis increased 630% from 2014 to 2018.
The prevalence of overall intracranial hemorrhage was increased among patients with IVDU, compared with those without (25.9% vs. 13.9%; P = .005).
This increase in prevalence included increases in intraparenchymal hemorrhage (12.4% vs. 5.1%; P = .012), subarachnoid hemorrhage (17.6% vs. 4.4%; P = .0001), and cerebral microbleeds (14.1% vs. 7.2%; P = .022).
IVDU also was associated with an increase in prevalence of infectious intracranial aneurysm (10.6% vs. 1.8%; P = .0001) and brain abscess (4.7% vs. 1.1%; P = .025).
Compared with patients with endocarditis from other causes, significantly higher numbers of patients with IVDU-associated endocarditis were homeless (5.9% vs. 1.1%; P = .014), uninsured (10.0% vs. 2.8%; P = .005), and unemployed (75.9% vs. 31.7%; P = .0001).
Medical costs were more than twice as high among patients with endocarditis from IVDU than among those with endocarditis from other causes. The difference in health care costs during admission per patient was more than $100,000.
“The wider societal impact of the opioid epidemic is not well understood,” Dr. Nimjee said in the press release. “Our research suggests that the impact of the opioid epidemic is far-reaching and contributes to increased costs in the criminal justice, health care systems, and the workplace. The increased costs can be particularly substantial for stroke care.”
Nationwide data desirable
“Past publications from the U.S. have shown an increase in incidence of IVDU-related endocarditis, and the current publication emphasizes this worrying trend,” Manuel Bolognese, MD, head of the stroke center at the Lucerne (Switzerland) Cantonal Hospital, said in an interview. “The higher degree of hemorrhagic strokes and brain abscesses as further complications is alarming as well and shows that IVDU-related endocarditis is becoming a more and more relevant medical problem in the U.S., with high morbidity and mortality.”
The study period is long enough to show a clear trend of increasing incidence of IVDU-related endocarditis, Dr. Bolognese said. The study’s biggest weaknesses are its retrospective design and restriction to a single center.
“Without knowing the prevalence of drug abuse and the socioeconomical situation in Columbus, it is difficult to generalize these findings to other regions in the U.S.A. or even abroad,” he said.
Also, the abstract does not provide some essential information, said Dr. Bolognese. It would be important to know which valve was affected in each patient, which bacteria were identified, whether patients also used nonopioid drugs, and what each patient’s immune status was.
A lack of sterile material such as syringes could explain the apparent association between IVDU-associated endocarditis and low socioeconomic status, said Dr. Bolognese. Delayed presentation to medical institutions because of a lack of insurance could have led to a more complicated course.
“It would be interesting to see numbers from a broader spectrum in a nationwide registry,” said Dr. Bolognese. “It might be worth studying interventions to improve the hygienic aspects (like supply of sterile material, especially in the most vulnerable groups, like homeless people) or to provide easier access to emergency health care despite lack of insurance, which could decrease the incidence of IVDU.”
Dr. Nimjee and Dr. Bolognese disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One consequence of the ongoing opioid epidemic in the United States may be an increase in the number of hemorrhagic strokes caused by infective endocarditis, research suggests.
Intravenous drug use (IVDU) can cause this bacterial infection of the heart. In a single-center study, infective endocarditis was associated with an increase in the risk for hemorrhagic stroke as well as an increase in health care use and costs.
“Patients who are known IV drug users who have endocarditis should be more carefully screened for symptoms of cardiovascular disease,” Shahid M. Nimjee, MD, PhD, associate professor of neurosurgery and surgical director of the Comprehensive Stroke Center at the Ohio State University Wexner Medical Center, Columbus, said in a press release.
The findings were presented at the International Stroke Conference sponsored by the American Heart Association.
In the United States, 47,000 patients are treated in the hospital for endocarditis each year. Endocarditis increases the risk for stroke, which can entail significant morbidity and mortality, the authors noted.
IVDU is a risk factor for endocarditis. In the context of the opioid epidemic, Dr. Nimjee and colleagues sought to compare the risk for stroke among patients with endocarditis from IVDU with the risk among patients with endocarditis from other causes.
They retrospectively studied patients who had undergone treatment for infective endocarditis at Wexner Medical Center between Jan. 1, 2014, and July 1, 2018. They examined patients’ concomitant intravenous drug abuse and evaluated demographics, risk factors, and associated costs.
Dramatic increase
In all, 351 patients met the study’s inclusion criteria, and 170 (48%) had a history of IVDU-associated endocarditis. The incidence of patients with IVDU-associated endocarditis increased 630% from 2014 to 2018.
The prevalence of overall intracranial hemorrhage was increased among patients with IVDU, compared with those without (25.9% vs. 13.9%; P = .005).
This increase in prevalence included increases in intraparenchymal hemorrhage (12.4% vs. 5.1%; P = .012), subarachnoid hemorrhage (17.6% vs. 4.4%; P = .0001), and cerebral microbleeds (14.1% vs. 7.2%; P = .022).
IVDU also was associated with an increase in prevalence of infectious intracranial aneurysm (10.6% vs. 1.8%; P = .0001) and brain abscess (4.7% vs. 1.1%; P = .025).
Compared with patients with endocarditis from other causes, significantly higher numbers of patients with IVDU-associated endocarditis were homeless (5.9% vs. 1.1%; P = .014), uninsured (10.0% vs. 2.8%; P = .005), and unemployed (75.9% vs. 31.7%; P = .0001).
Medical costs were more than twice as high among patients with endocarditis from IVDU than among those with endocarditis from other causes. The difference in health care costs during admission per patient was more than $100,000.
“The wider societal impact of the opioid epidemic is not well understood,” Dr. Nimjee said in the press release. “Our research suggests that the impact of the opioid epidemic is far-reaching and contributes to increased costs in the criminal justice, health care systems, and the workplace. The increased costs can be particularly substantial for stroke care.”
Nationwide data desirable
“Past publications from the U.S. have shown an increase in incidence of IVDU-related endocarditis, and the current publication emphasizes this worrying trend,” Manuel Bolognese, MD, head of the stroke center at the Lucerne (Switzerland) Cantonal Hospital, said in an interview. “The higher degree of hemorrhagic strokes and brain abscesses as further complications is alarming as well and shows that IVDU-related endocarditis is becoming a more and more relevant medical problem in the U.S., with high morbidity and mortality.”
The study period is long enough to show a clear trend of increasing incidence of IVDU-related endocarditis, Dr. Bolognese said. The study’s biggest weaknesses are its retrospective design and restriction to a single center.
“Without knowing the prevalence of drug abuse and the socioeconomical situation in Columbus, it is difficult to generalize these findings to other regions in the U.S.A. or even abroad,” he said.
Also, the abstract does not provide some essential information, said Dr. Bolognese. It would be important to know which valve was affected in each patient, which bacteria were identified, whether patients also used nonopioid drugs, and what each patient’s immune status was.
A lack of sterile material such as syringes could explain the apparent association between IVDU-associated endocarditis and low socioeconomic status, said Dr. Bolognese. Delayed presentation to medical institutions because of a lack of insurance could have led to a more complicated course.
“It would be interesting to see numbers from a broader spectrum in a nationwide registry,” said Dr. Bolognese. “It might be worth studying interventions to improve the hygienic aspects (like supply of sterile material, especially in the most vulnerable groups, like homeless people) or to provide easier access to emergency health care despite lack of insurance, which could decrease the incidence of IVDU.”
Dr. Nimjee and Dr. Bolognese disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One consequence of the ongoing opioid epidemic in the United States may be an increase in the number of hemorrhagic strokes caused by infective endocarditis, research suggests.
Intravenous drug use (IVDU) can cause this bacterial infection of the heart. In a single-center study, infective endocarditis was associated with an increase in the risk for hemorrhagic stroke as well as an increase in health care use and costs.
“Patients who are known IV drug users who have endocarditis should be more carefully screened for symptoms of cardiovascular disease,” Shahid M. Nimjee, MD, PhD, associate professor of neurosurgery and surgical director of the Comprehensive Stroke Center at the Ohio State University Wexner Medical Center, Columbus, said in a press release.
The findings were presented at the International Stroke Conference sponsored by the American Heart Association.
In the United States, 47,000 patients are treated in the hospital for endocarditis each year. Endocarditis increases the risk for stroke, which can entail significant morbidity and mortality, the authors noted.
IVDU is a risk factor for endocarditis. In the context of the opioid epidemic, Dr. Nimjee and colleagues sought to compare the risk for stroke among patients with endocarditis from IVDU with the risk among patients with endocarditis from other causes.
They retrospectively studied patients who had undergone treatment for infective endocarditis at Wexner Medical Center between Jan. 1, 2014, and July 1, 2018. They examined patients’ concomitant intravenous drug abuse and evaluated demographics, risk factors, and associated costs.
Dramatic increase
In all, 351 patients met the study’s inclusion criteria, and 170 (48%) had a history of IVDU-associated endocarditis. The incidence of patients with IVDU-associated endocarditis increased 630% from 2014 to 2018.
The prevalence of overall intracranial hemorrhage was increased among patients with IVDU, compared with those without (25.9% vs. 13.9%; P = .005).
This increase in prevalence included increases in intraparenchymal hemorrhage (12.4% vs. 5.1%; P = .012), subarachnoid hemorrhage (17.6% vs. 4.4%; P = .0001), and cerebral microbleeds (14.1% vs. 7.2%; P = .022).
IVDU also was associated with an increase in prevalence of infectious intracranial aneurysm (10.6% vs. 1.8%; P = .0001) and brain abscess (4.7% vs. 1.1%; P = .025).
Compared with patients with endocarditis from other causes, significantly higher numbers of patients with IVDU-associated endocarditis were homeless (5.9% vs. 1.1%; P = .014), uninsured (10.0% vs. 2.8%; P = .005), and unemployed (75.9% vs. 31.7%; P = .0001).
Medical costs were more than twice as high among patients with endocarditis from IVDU than among those with endocarditis from other causes. The difference in health care costs during admission per patient was more than $100,000.
“The wider societal impact of the opioid epidemic is not well understood,” Dr. Nimjee said in the press release. “Our research suggests that the impact of the opioid epidemic is far-reaching and contributes to increased costs in the criminal justice, health care systems, and the workplace. The increased costs can be particularly substantial for stroke care.”
Nationwide data desirable
“Past publications from the U.S. have shown an increase in incidence of IVDU-related endocarditis, and the current publication emphasizes this worrying trend,” Manuel Bolognese, MD, head of the stroke center at the Lucerne (Switzerland) Cantonal Hospital, said in an interview. “The higher degree of hemorrhagic strokes and brain abscesses as further complications is alarming as well and shows that IVDU-related endocarditis is becoming a more and more relevant medical problem in the U.S., with high morbidity and mortality.”
The study period is long enough to show a clear trend of increasing incidence of IVDU-related endocarditis, Dr. Bolognese said. The study’s biggest weaknesses are its retrospective design and restriction to a single center.
“Without knowing the prevalence of drug abuse and the socioeconomical situation in Columbus, it is difficult to generalize these findings to other regions in the U.S.A. or even abroad,” he said.
Also, the abstract does not provide some essential information, said Dr. Bolognese. It would be important to know which valve was affected in each patient, which bacteria were identified, whether patients also used nonopioid drugs, and what each patient’s immune status was.
A lack of sterile material such as syringes could explain the apparent association between IVDU-associated endocarditis and low socioeconomic status, said Dr. Bolognese. Delayed presentation to medical institutions because of a lack of insurance could have led to a more complicated course.
“It would be interesting to see numbers from a broader spectrum in a nationwide registry,” said Dr. Bolognese. “It might be worth studying interventions to improve the hygienic aspects (like supply of sterile material, especially in the most vulnerable groups, like homeless people) or to provide easier access to emergency health care despite lack of insurance, which could decrease the incidence of IVDU.”
Dr. Nimjee and Dr. Bolognese disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pediatric bronchiolitis: Less is more
A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.
Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.
Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.
“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.
These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.
Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.
Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.
Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.
According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.
For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.
Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.
The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.
“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”
Why the slow adoption of guidelines?
The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said.
Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”
Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.
Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”
At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.
Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”
But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.
Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”
To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”
The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.
A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.
Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.
Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.
“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.
These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.
Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.
Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.
Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.
According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.
For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.
Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.
The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.
“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”
Why the slow adoption of guidelines?
The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said.
Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”
Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.
Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”
At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.
Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”
But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.
Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”
To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”
The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.
A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.
Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.
Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.
“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.
These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.
Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.
Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.
Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.
According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.
For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.
Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.
The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.
“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”
Why the slow adoption of guidelines?
The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said.
Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”
Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.
Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”
At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.
Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”
But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.
Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”
To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”
The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.
Trend reversed: New cases of COVID-19 decline in children
New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.
The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.
Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.
Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.
New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.
The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.
Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.
Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.
New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.
The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.
Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.
Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.
Thyroid hormone analogues can reverse NASH
Background: Fat toxicity results in inflammation of the liver and eventual hepatic fibrosis and cirrhosis. Thyroid hormones can greatly reduce this hepatic steatosis by restoring metabolic pathways in damaged liver, prevent fibrosis progression, and have broad atherogenic lipid-lowering actions by activating hepatic thyroid beta-receptors.
However, hyperthyroidism also leads to osteoporosis, tachyarrhythmias, muscle wasting, and psychiatric side effects, mediated by the alpha-thyroid receptor. Resmetirom (MGL-3196) is a novel, highly selective thyroid beta-agonist, with a minimal side-effect profile, which avoids the alpha–side effects.
Study design: Randomized, double-blind, placebo-controlled study.
Setting: 25 centers in the United States.
Synopsis: Of 125 adults with NASH fibrosis 1-3 and greater than 10% hepatic fat, 84 received resmetirom and 41 received placebo. Resmetirom resulted in a nearly 30% decrease over placebo in hepatic fat, compared with baseline, significant improvement in lipid profile, improvement in liver enzymes, fibrosis markers, and histologic resolution of NASH in some patients.
While the study showed resolution of inflammation, the 36-week study was likely not long enough to show improvement of fibrosis. The relatively small sample size also limited results. Placebo patients who lost significant weight also showed improvement and were discarded from analysis, suggesting that weight loss itself is also an excellent alternative to reverse NASH. Resmetirom use in NASH is now moving into a large phase 3 trial.
Bottom line: Resmetirom results in major liver and cardiovascular benefits in patients with NASH.
Citation: Harrison SA et al. Resmetirom (MGL-3196) for the treatment of nonalcoholic steatohepatitis: A multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 11;394(10213):2012-24.
Dr. Raghavan is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: Fat toxicity results in inflammation of the liver and eventual hepatic fibrosis and cirrhosis. Thyroid hormones can greatly reduce this hepatic steatosis by restoring metabolic pathways in damaged liver, prevent fibrosis progression, and have broad atherogenic lipid-lowering actions by activating hepatic thyroid beta-receptors.
However, hyperthyroidism also leads to osteoporosis, tachyarrhythmias, muscle wasting, and psychiatric side effects, mediated by the alpha-thyroid receptor. Resmetirom (MGL-3196) is a novel, highly selective thyroid beta-agonist, with a minimal side-effect profile, which avoids the alpha–side effects.
Study design: Randomized, double-blind, placebo-controlled study.
Setting: 25 centers in the United States.
Synopsis: Of 125 adults with NASH fibrosis 1-3 and greater than 10% hepatic fat, 84 received resmetirom and 41 received placebo. Resmetirom resulted in a nearly 30% decrease over placebo in hepatic fat, compared with baseline, significant improvement in lipid profile, improvement in liver enzymes, fibrosis markers, and histologic resolution of NASH in some patients.
While the study showed resolution of inflammation, the 36-week study was likely not long enough to show improvement of fibrosis. The relatively small sample size also limited results. Placebo patients who lost significant weight also showed improvement and were discarded from analysis, suggesting that weight loss itself is also an excellent alternative to reverse NASH. Resmetirom use in NASH is now moving into a large phase 3 trial.
Bottom line: Resmetirom results in major liver and cardiovascular benefits in patients with NASH.
Citation: Harrison SA et al. Resmetirom (MGL-3196) for the treatment of nonalcoholic steatohepatitis: A multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 11;394(10213):2012-24.
Dr. Raghavan is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: Fat toxicity results in inflammation of the liver and eventual hepatic fibrosis and cirrhosis. Thyroid hormones can greatly reduce this hepatic steatosis by restoring metabolic pathways in damaged liver, prevent fibrosis progression, and have broad atherogenic lipid-lowering actions by activating hepatic thyroid beta-receptors.
However, hyperthyroidism also leads to osteoporosis, tachyarrhythmias, muscle wasting, and psychiatric side effects, mediated by the alpha-thyroid receptor. Resmetirom (MGL-3196) is a novel, highly selective thyroid beta-agonist, with a minimal side-effect profile, which avoids the alpha–side effects.
Study design: Randomized, double-blind, placebo-controlled study.
Setting: 25 centers in the United States.
Synopsis: Of 125 adults with NASH fibrosis 1-3 and greater than 10% hepatic fat, 84 received resmetirom and 41 received placebo. Resmetirom resulted in a nearly 30% decrease over placebo in hepatic fat, compared with baseline, significant improvement in lipid profile, improvement in liver enzymes, fibrosis markers, and histologic resolution of NASH in some patients.
While the study showed resolution of inflammation, the 36-week study was likely not long enough to show improvement of fibrosis. The relatively small sample size also limited results. Placebo patients who lost significant weight also showed improvement and were discarded from analysis, suggesting that weight loss itself is also an excellent alternative to reverse NASH. Resmetirom use in NASH is now moving into a large phase 3 trial.
Bottom line: Resmetirom results in major liver and cardiovascular benefits in patients with NASH.
Citation: Harrison SA et al. Resmetirom (MGL-3196) for the treatment of nonalcoholic steatohepatitis: A multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 11;394(10213):2012-24.
Dr. Raghavan is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Efficacy and safety of daily low-dose colchicine after recent MI
Background: Clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine (Colcrys) in an orally administered potent anti-inflammatory that is currently used to treat gout and pericarditis.
Study design: Randomized, double-blind, placebo-controlled, investigator-initiated trial.
Setting: Funded by Canadian Institute of Health and Research, 167 centers in 12 different countries. Centers were predominately located in Canada, South America, and Europe.
Synopsis: In this study, 4,745 patients with a MI within the last 30 days and treated according to national guidelines were enrolled. There were multiple exclusion criteria including severe heart, renal, and/or hepatic failure. The mean age of patients was 60.6 years. Patients were followed for a median of 22.6 months. The primary endpoint was a composite of death from cardiovascular causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization.
The primary endpoint occurred in 5.5% of patients in the colchicine group and 7.1% of those in the placebo group (hazard ratio, 0.77). This was largely because of a decreased incidence of stroke in the colchicine group compared to placebo (0.2% vs 0.8%) and decreased urgent hospitalizations for unstable angina leading to revascularization (1.1% vs 2.1%).
Nausea was more common in the colchicine group as well as pneumonia which was reported as a serious adverse event (0.9% compared to 0.4% in placebo).
Limitations included short follow-up and significant exclusion criteria.
Bottom line: In patients following a recent myocardial infraction, the use of low-dose colchicine at 0.5 mg daily led to a significantly lower percentage of ischemic cardiovascular events compared to placebo.
Citation: Tardif JC et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med. 2019 Dec 26;381:2497-505.
Dr. Qazi is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: Clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine (Colcrys) in an orally administered potent anti-inflammatory that is currently used to treat gout and pericarditis.
Study design: Randomized, double-blind, placebo-controlled, investigator-initiated trial.
Setting: Funded by Canadian Institute of Health and Research, 167 centers in 12 different countries. Centers were predominately located in Canada, South America, and Europe.
Synopsis: In this study, 4,745 patients with a MI within the last 30 days and treated according to national guidelines were enrolled. There were multiple exclusion criteria including severe heart, renal, and/or hepatic failure. The mean age of patients was 60.6 years. Patients were followed for a median of 22.6 months. The primary endpoint was a composite of death from cardiovascular causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization.
The primary endpoint occurred in 5.5% of patients in the colchicine group and 7.1% of those in the placebo group (hazard ratio, 0.77). This was largely because of a decreased incidence of stroke in the colchicine group compared to placebo (0.2% vs 0.8%) and decreased urgent hospitalizations for unstable angina leading to revascularization (1.1% vs 2.1%).
Nausea was more common in the colchicine group as well as pneumonia which was reported as a serious adverse event (0.9% compared to 0.4% in placebo).
Limitations included short follow-up and significant exclusion criteria.
Bottom line: In patients following a recent myocardial infraction, the use of low-dose colchicine at 0.5 mg daily led to a significantly lower percentage of ischemic cardiovascular events compared to placebo.
Citation: Tardif JC et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med. 2019 Dec 26;381:2497-505.
Dr. Qazi is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: Clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine (Colcrys) in an orally administered potent anti-inflammatory that is currently used to treat gout and pericarditis.
Study design: Randomized, double-blind, placebo-controlled, investigator-initiated trial.
Setting: Funded by Canadian Institute of Health and Research, 167 centers in 12 different countries. Centers were predominately located in Canada, South America, and Europe.
Synopsis: In this study, 4,745 patients with a MI within the last 30 days and treated according to national guidelines were enrolled. There were multiple exclusion criteria including severe heart, renal, and/or hepatic failure. The mean age of patients was 60.6 years. Patients were followed for a median of 22.6 months. The primary endpoint was a composite of death from cardiovascular causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization.
The primary endpoint occurred in 5.5% of patients in the colchicine group and 7.1% of those in the placebo group (hazard ratio, 0.77). This was largely because of a decreased incidence of stroke in the colchicine group compared to placebo (0.2% vs 0.8%) and decreased urgent hospitalizations for unstable angina leading to revascularization (1.1% vs 2.1%).
Nausea was more common in the colchicine group as well as pneumonia which was reported as a serious adverse event (0.9% compared to 0.4% in placebo).
Limitations included short follow-up and significant exclusion criteria.
Bottom line: In patients following a recent myocardial infraction, the use of low-dose colchicine at 0.5 mg daily led to a significantly lower percentage of ischemic cardiovascular events compared to placebo.
Citation: Tardif JC et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med. 2019 Dec 26;381:2497-505.
Dr. Qazi is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Feds lift pause of J&J COVID vaccine, add new warning
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
Study: COVID-19 can kill months after infection
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Can we get to ‘COVID zero’? Experts predict the next 8 months
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
Lower target LDL-C cuts risk of CV events in ischemic stroke patients
Background: The beneficial role of high-intensity statins in secondary prevention of recurrent atherosclerotic stroke is well established. It is uncertain whether the observed benefit was from a reduction in the cholesterol level or to other pleotropic effects of atorvastatin. The ideal target cholesterol level for secondary prevention is unclear. This trial was conducted to help determine an ideal target LDL-C level in the prevention of CV events following ischemic stroke.
Study design: Randomized, parallel-group, event-driven trial.
Setting: Conducted in France and South Korea.
Synopsis: In this study, patients with an ischemic stroke within the last 3 months or TIAs within 15 days were randomly assigned to receive statins with or without ezetimibe (Zetia) to achieve a higher-target LDL-C level (90-110 mg/dL) vs. lower-target LDL-C (less than 70 mg/dL). The composite primary endpoint was a major cardiovascular event, which included ischemic stroke, MI, new symptoms leading to urgent coronary or carotid revascularization, or death from CV causes.
There were 2,860 patients enrolled, 1,430 were assigned to each target group. At the end of 3.5 years, the primary endpoint occurred in 8.5% of patients in the lower target group, compared with 10.9% in the higher target group (hazard ratio, 0.78; 95% confidence interval, 0.61-0.98; P = .04). Unfortunately, the trial was stopped early because of a lack of funding.
Bottom line: Using medications including statins to lower the LDL-C to less than 70 mg/dL leads to better cardiovascular outcomes following ischemic stroke.
Citation: Amarenco P et al. A comparison of two LDL cholesterol targets after ischemic stroke. N Engl J Med. 2020 Jan 2;382:9-19.
Dr. Garg is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: The beneficial role of high-intensity statins in secondary prevention of recurrent atherosclerotic stroke is well established. It is uncertain whether the observed benefit was from a reduction in the cholesterol level or to other pleotropic effects of atorvastatin. The ideal target cholesterol level for secondary prevention is unclear. This trial was conducted to help determine an ideal target LDL-C level in the prevention of CV events following ischemic stroke.
Study design: Randomized, parallel-group, event-driven trial.
Setting: Conducted in France and South Korea.
Synopsis: In this study, patients with an ischemic stroke within the last 3 months or TIAs within 15 days were randomly assigned to receive statins with or without ezetimibe (Zetia) to achieve a higher-target LDL-C level (90-110 mg/dL) vs. lower-target LDL-C (less than 70 mg/dL). The composite primary endpoint was a major cardiovascular event, which included ischemic stroke, MI, new symptoms leading to urgent coronary or carotid revascularization, or death from CV causes.
There were 2,860 patients enrolled, 1,430 were assigned to each target group. At the end of 3.5 years, the primary endpoint occurred in 8.5% of patients in the lower target group, compared with 10.9% in the higher target group (hazard ratio, 0.78; 95% confidence interval, 0.61-0.98; P = .04). Unfortunately, the trial was stopped early because of a lack of funding.
Bottom line: Using medications including statins to lower the LDL-C to less than 70 mg/dL leads to better cardiovascular outcomes following ischemic stroke.
Citation: Amarenco P et al. A comparison of two LDL cholesterol targets after ischemic stroke. N Engl J Med. 2020 Jan 2;382:9-19.
Dr. Garg is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: The beneficial role of high-intensity statins in secondary prevention of recurrent atherosclerotic stroke is well established. It is uncertain whether the observed benefit was from a reduction in the cholesterol level or to other pleotropic effects of atorvastatin. The ideal target cholesterol level for secondary prevention is unclear. This trial was conducted to help determine an ideal target LDL-C level in the prevention of CV events following ischemic stroke.
Study design: Randomized, parallel-group, event-driven trial.
Setting: Conducted in France and South Korea.
Synopsis: In this study, patients with an ischemic stroke within the last 3 months or TIAs within 15 days were randomly assigned to receive statins with or without ezetimibe (Zetia) to achieve a higher-target LDL-C level (90-110 mg/dL) vs. lower-target LDL-C (less than 70 mg/dL). The composite primary endpoint was a major cardiovascular event, which included ischemic stroke, MI, new symptoms leading to urgent coronary or carotid revascularization, or death from CV causes.
There were 2,860 patients enrolled, 1,430 were assigned to each target group. At the end of 3.5 years, the primary endpoint occurred in 8.5% of patients in the lower target group, compared with 10.9% in the higher target group (hazard ratio, 0.78; 95% confidence interval, 0.61-0.98; P = .04). Unfortunately, the trial was stopped early because of a lack of funding.
Bottom line: Using medications including statins to lower the LDL-C to less than 70 mg/dL leads to better cardiovascular outcomes following ischemic stroke.
Citation: Amarenco P et al. A comparison of two LDL cholesterol targets after ischemic stroke. N Engl J Med. 2020 Jan 2;382:9-19.
Dr. Garg is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.