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New AHA/ASA guideline on secondary stroke prevention
When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.
“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.
“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.
The updated guideline was published online May 24, 2021, in Stroke.
“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.
The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
Let pathogenic subtype guide prevention
For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.
Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.
“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.
For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.
Among the recommendations:
- Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
- Screen for and initiate anticoagulant drug therapy to reduce recurrent events.
- Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
- Consider or carotid artery stenting for select patients with narrowing of carotid arteries.
- Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
- In some patients, it’s reasonable to consider percutaneous closure of .
The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.
“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.
The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.
“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.
“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.
The updated guideline was published online May 24, 2021, in Stroke.
“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.
The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
Let pathogenic subtype guide prevention
For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.
Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.
“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.
For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.
Among the recommendations:
- Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
- Screen for and initiate anticoagulant drug therapy to reduce recurrent events.
- Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
- Consider or carotid artery stenting for select patients with narrowing of carotid arteries.
- Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
- In some patients, it’s reasonable to consider percutaneous closure of .
The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.
“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.
The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.
“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.
“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.
The updated guideline was published online May 24, 2021, in Stroke.
“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.
The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
Let pathogenic subtype guide prevention
For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.
Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.
“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.
For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.
Among the recommendations:
- Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
- Screen for and initiate anticoagulant drug therapy to reduce recurrent events.
- Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
- Consider or carotid artery stenting for select patients with narrowing of carotid arteries.
- Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
- In some patients, it’s reasonable to consider percutaneous closure of .
The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.
“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.
The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
FDA restricts obeticholic acid (Ocaliva) over serious liver injury risk
The risk for serious liver injury with obeticholic acid (Ocaliva, Intercept Pharmaceuticals) has prompted the U.S. Food and Drug Administration to restrict its use in patients with primary biliary cholangitis (PBC) and advanced cirrhosis.
The agency has added a new contraindication to the obeticholic acid prescribing information and patient medication guide stating that the drug should not be used in patients with PBC and advanced cirrhosis.
The boxed warning on the label has also been revised to include this information.
For patients with PBC who do not have advanced cirrhosis, the FDA believes the benefits of Ocaliva outweigh the risks, based on the original clinical trials.
Five years ago, the FDA granted accelerated approval to obeticholic acid in combination with ursodeoxycholic acid (UDCA) in adults who fail to respond adequately to UDCA, or as a monotherapy in adults who cannot tolerate UDCA.
Since then, the FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure in patients with PBC and cirrhosis who were taking obeticholic acid at recommended doses.
According to the FDA, 18 of the cases happened in patients with PBC and compensated cirrhosis who experienced liver injury that led to decompensation. Ten of these patients had evidence or suspicion of portal hypertension at baseline; in the other eight patients, it was unclear whether portal hypertension was present.
PBC was not expected to progress rapidly in these patients, yet they experienced accelerated clinical deterioration within months of starting obeticholic acid, the FDA said.
The median time to liver decompensation after initiating treatment was 4 months (range, 2 weeks to 10 months). Four patients with PBC and compensated cirrhosis needed a liver transplant within 1.3 years after starting obeticholic acid, and one patient died from liver failure.
The other seven cases of serious liver injury occurred in patients with PBC and decompensated cirrhosis, two of whom died.
Although there was a temporal relationship between starting obeticholic acid and liver injury, it is difficult to distinguish a drug-induced effect from disease progression in the patients with advanced baseline liver disease, the FDA cautioned.
The median time to a new decompensation event after starting the drug was 2.5 months (range, 10 days to 8 months).
Before starting obeticholic acid, clinicians should determine whether a patient with PBC has advanced cirrhosis as the drug is now contraindicated in these patients, the FDA said.
During obeticholic acid treatment, patients should be routinely monitored for progression of PBC with laboratory and clinical assessments to determine whether the drug needs to be discontinued.
The medication should be permanently discontinued in patients with cirrhosis who progress to advanced cirrhosis.
Patients should also be monitored for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine.
Obeticholic acid should be stopped permanently in any patient who develops these symptoms, the FDA advised.
Health care professionals are encouraged to report adverse events or side effects related to the use of obeticholic acid to MedWatch, FDA’s adverse event reporting site.
A version of this article first appeared on Medscape.com.
The risk for serious liver injury with obeticholic acid (Ocaliva, Intercept Pharmaceuticals) has prompted the U.S. Food and Drug Administration to restrict its use in patients with primary biliary cholangitis (PBC) and advanced cirrhosis.
The agency has added a new contraindication to the obeticholic acid prescribing information and patient medication guide stating that the drug should not be used in patients with PBC and advanced cirrhosis.
The boxed warning on the label has also been revised to include this information.
For patients with PBC who do not have advanced cirrhosis, the FDA believes the benefits of Ocaliva outweigh the risks, based on the original clinical trials.
Five years ago, the FDA granted accelerated approval to obeticholic acid in combination with ursodeoxycholic acid (UDCA) in adults who fail to respond adequately to UDCA, or as a monotherapy in adults who cannot tolerate UDCA.
Since then, the FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure in patients with PBC and cirrhosis who were taking obeticholic acid at recommended doses.
According to the FDA, 18 of the cases happened in patients with PBC and compensated cirrhosis who experienced liver injury that led to decompensation. Ten of these patients had evidence or suspicion of portal hypertension at baseline; in the other eight patients, it was unclear whether portal hypertension was present.
PBC was not expected to progress rapidly in these patients, yet they experienced accelerated clinical deterioration within months of starting obeticholic acid, the FDA said.
The median time to liver decompensation after initiating treatment was 4 months (range, 2 weeks to 10 months). Four patients with PBC and compensated cirrhosis needed a liver transplant within 1.3 years after starting obeticholic acid, and one patient died from liver failure.
The other seven cases of serious liver injury occurred in patients with PBC and decompensated cirrhosis, two of whom died.
Although there was a temporal relationship between starting obeticholic acid and liver injury, it is difficult to distinguish a drug-induced effect from disease progression in the patients with advanced baseline liver disease, the FDA cautioned.
The median time to a new decompensation event after starting the drug was 2.5 months (range, 10 days to 8 months).
Before starting obeticholic acid, clinicians should determine whether a patient with PBC has advanced cirrhosis as the drug is now contraindicated in these patients, the FDA said.
During obeticholic acid treatment, patients should be routinely monitored for progression of PBC with laboratory and clinical assessments to determine whether the drug needs to be discontinued.
The medication should be permanently discontinued in patients with cirrhosis who progress to advanced cirrhosis.
Patients should also be monitored for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine.
Obeticholic acid should be stopped permanently in any patient who develops these symptoms, the FDA advised.
Health care professionals are encouraged to report adverse events or side effects related to the use of obeticholic acid to MedWatch, FDA’s adverse event reporting site.
A version of this article first appeared on Medscape.com.
The risk for serious liver injury with obeticholic acid (Ocaliva, Intercept Pharmaceuticals) has prompted the U.S. Food and Drug Administration to restrict its use in patients with primary biliary cholangitis (PBC) and advanced cirrhosis.
The agency has added a new contraindication to the obeticholic acid prescribing information and patient medication guide stating that the drug should not be used in patients with PBC and advanced cirrhosis.
The boxed warning on the label has also been revised to include this information.
For patients with PBC who do not have advanced cirrhosis, the FDA believes the benefits of Ocaliva outweigh the risks, based on the original clinical trials.
Five years ago, the FDA granted accelerated approval to obeticholic acid in combination with ursodeoxycholic acid (UDCA) in adults who fail to respond adequately to UDCA, or as a monotherapy in adults who cannot tolerate UDCA.
Since then, the FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure in patients with PBC and cirrhosis who were taking obeticholic acid at recommended doses.
According to the FDA, 18 of the cases happened in patients with PBC and compensated cirrhosis who experienced liver injury that led to decompensation. Ten of these patients had evidence or suspicion of portal hypertension at baseline; in the other eight patients, it was unclear whether portal hypertension was present.
PBC was not expected to progress rapidly in these patients, yet they experienced accelerated clinical deterioration within months of starting obeticholic acid, the FDA said.
The median time to liver decompensation after initiating treatment was 4 months (range, 2 weeks to 10 months). Four patients with PBC and compensated cirrhosis needed a liver transplant within 1.3 years after starting obeticholic acid, and one patient died from liver failure.
The other seven cases of serious liver injury occurred in patients with PBC and decompensated cirrhosis, two of whom died.
Although there was a temporal relationship between starting obeticholic acid and liver injury, it is difficult to distinguish a drug-induced effect from disease progression in the patients with advanced baseline liver disease, the FDA cautioned.
The median time to a new decompensation event after starting the drug was 2.5 months (range, 10 days to 8 months).
Before starting obeticholic acid, clinicians should determine whether a patient with PBC has advanced cirrhosis as the drug is now contraindicated in these patients, the FDA said.
During obeticholic acid treatment, patients should be routinely monitored for progression of PBC with laboratory and clinical assessments to determine whether the drug needs to be discontinued.
The medication should be permanently discontinued in patients with cirrhosis who progress to advanced cirrhosis.
Patients should also be monitored for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine.
Obeticholic acid should be stopped permanently in any patient who develops these symptoms, the FDA advised.
Health care professionals are encouraged to report adverse events or side effects related to the use of obeticholic acid to MedWatch, FDA’s adverse event reporting site.
A version of this article first appeared on Medscape.com.
Sustained long-term benefit of gene therapy for SMA
, new long-term follow-up data show. At a median of 5.2 years since receiving the approved therapeutic dose, onasemnogene abeparvovec provided “sustained, durable efficacy, with all patients alive and without the need for permanent ventilation,” reported Jerry Mendell, MD, with the Center for Gene Therapy, Nationwide Children’s Hospital, Columbus, Ohio, and colleagues.
The study was published online May 17 in JAMA Neurology.
Single infusion
SMA is a rare genetic disease that can lead to paralysis, breathing difficulty, and death. The disorder is caused by a mutation in the survival motor neuron 1 (SMN1) gene, which encodes the SMN protein critical for maintenance and function of motor neurons.
In 2019, Zolgensma was approved in the United States for children with SMA and younger than 2 years of age.
Zolgensma is an adeno-associated virus vector-based gene therapy that addresses the genetic root cause of SMA by replacing the defective or missing SMN1 gene to halt disease progression. A single, one-time intravenous infusion results in expression of the SMN protein motor neurons, which improves chances of survival, as well as muscle movement and function.
In the phase 1 START study, 15 infants with SMA type 1 were treated with either a low or therapeutic dose of Zolgensma at Nationwide Children’s Hospital between 2014 and 2017.
The START long-term follow-up study (START LTFU) is an ongoing, observational study assessing safety and durability of response over 15 years in 13 of the infants; three infants received the low dose and 10 received the approved high dose.
Prior to baseline, four patients (40%) in the therapeutic dose cohort required noninvasive ventilatory support, and six (60%) did not require regular ventilatory support, which did not change in long-term follow-up.
All 10 patients who received the therapeutic dose remained alive and without the need for permanent ventilation up to 6.2 years after dosing, Dr. Mendell and colleagues report.
These patients also maintained previously acquired motor milestones. Two patients attained the new milestone of “standing with assistance” without the use of nusinersen (Spinraza, Biogen).
Serious adverse events occurred in eight patients (62%), none of which resulted in study discontinuation or death. The most common serious adverse events were related to the underlying SMA disease process and included acute respiratory failure (31%), pneumonia (31%), dehydration (23%), respiratory distress (15%), and bronchiolitis (15%).
Importantly, the investigators noted, no new safety signals or “adverse events of special interest” emerged during follow-up, including liver function enzyme elevations, new incidences of malignancy or hematologic disorders, and new incidences or exacerbations of existing neurologic or autoimmune disorders.
The investigators acknowledged that this follow-up study is limited by the small sample size of the patient population and confounded by treatment with nusinersen in several patients. “However, given that the two patients who acquired the new motor milestone of standing with assistance did not receive nusinersen at any time, this benefit can be attributed solely to onasemnogene abeparvovec,” Dr. Mendell and colleagues said.
The study was supported by Novartis Gene Therapies. Dr. Mendell and several co-investigators have disclosed financial relationships with the company.
A version of this article first appeared on Medscape.com.
, new long-term follow-up data show. At a median of 5.2 years since receiving the approved therapeutic dose, onasemnogene abeparvovec provided “sustained, durable efficacy, with all patients alive and without the need for permanent ventilation,” reported Jerry Mendell, MD, with the Center for Gene Therapy, Nationwide Children’s Hospital, Columbus, Ohio, and colleagues.
The study was published online May 17 in JAMA Neurology.
Single infusion
SMA is a rare genetic disease that can lead to paralysis, breathing difficulty, and death. The disorder is caused by a mutation in the survival motor neuron 1 (SMN1) gene, which encodes the SMN protein critical for maintenance and function of motor neurons.
In 2019, Zolgensma was approved in the United States for children with SMA and younger than 2 years of age.
Zolgensma is an adeno-associated virus vector-based gene therapy that addresses the genetic root cause of SMA by replacing the defective or missing SMN1 gene to halt disease progression. A single, one-time intravenous infusion results in expression of the SMN protein motor neurons, which improves chances of survival, as well as muscle movement and function.
In the phase 1 START study, 15 infants with SMA type 1 were treated with either a low or therapeutic dose of Zolgensma at Nationwide Children’s Hospital between 2014 and 2017.
The START long-term follow-up study (START LTFU) is an ongoing, observational study assessing safety and durability of response over 15 years in 13 of the infants; three infants received the low dose and 10 received the approved high dose.
Prior to baseline, four patients (40%) in the therapeutic dose cohort required noninvasive ventilatory support, and six (60%) did not require regular ventilatory support, which did not change in long-term follow-up.
All 10 patients who received the therapeutic dose remained alive and without the need for permanent ventilation up to 6.2 years after dosing, Dr. Mendell and colleagues report.
These patients also maintained previously acquired motor milestones. Two patients attained the new milestone of “standing with assistance” without the use of nusinersen (Spinraza, Biogen).
Serious adverse events occurred in eight patients (62%), none of which resulted in study discontinuation or death. The most common serious adverse events were related to the underlying SMA disease process and included acute respiratory failure (31%), pneumonia (31%), dehydration (23%), respiratory distress (15%), and bronchiolitis (15%).
Importantly, the investigators noted, no new safety signals or “adverse events of special interest” emerged during follow-up, including liver function enzyme elevations, new incidences of malignancy or hematologic disorders, and new incidences or exacerbations of existing neurologic or autoimmune disorders.
The investigators acknowledged that this follow-up study is limited by the small sample size of the patient population and confounded by treatment with nusinersen in several patients. “However, given that the two patients who acquired the new motor milestone of standing with assistance did not receive nusinersen at any time, this benefit can be attributed solely to onasemnogene abeparvovec,” Dr. Mendell and colleagues said.
The study was supported by Novartis Gene Therapies. Dr. Mendell and several co-investigators have disclosed financial relationships with the company.
A version of this article first appeared on Medscape.com.
, new long-term follow-up data show. At a median of 5.2 years since receiving the approved therapeutic dose, onasemnogene abeparvovec provided “sustained, durable efficacy, with all patients alive and without the need for permanent ventilation,” reported Jerry Mendell, MD, with the Center for Gene Therapy, Nationwide Children’s Hospital, Columbus, Ohio, and colleagues.
The study was published online May 17 in JAMA Neurology.
Single infusion
SMA is a rare genetic disease that can lead to paralysis, breathing difficulty, and death. The disorder is caused by a mutation in the survival motor neuron 1 (SMN1) gene, which encodes the SMN protein critical for maintenance and function of motor neurons.
In 2019, Zolgensma was approved in the United States for children with SMA and younger than 2 years of age.
Zolgensma is an adeno-associated virus vector-based gene therapy that addresses the genetic root cause of SMA by replacing the defective or missing SMN1 gene to halt disease progression. A single, one-time intravenous infusion results in expression of the SMN protein motor neurons, which improves chances of survival, as well as muscle movement and function.
In the phase 1 START study, 15 infants with SMA type 1 were treated with either a low or therapeutic dose of Zolgensma at Nationwide Children’s Hospital between 2014 and 2017.
The START long-term follow-up study (START LTFU) is an ongoing, observational study assessing safety and durability of response over 15 years in 13 of the infants; three infants received the low dose and 10 received the approved high dose.
Prior to baseline, four patients (40%) in the therapeutic dose cohort required noninvasive ventilatory support, and six (60%) did not require regular ventilatory support, which did not change in long-term follow-up.
All 10 patients who received the therapeutic dose remained alive and without the need for permanent ventilation up to 6.2 years after dosing, Dr. Mendell and colleagues report.
These patients also maintained previously acquired motor milestones. Two patients attained the new milestone of “standing with assistance” without the use of nusinersen (Spinraza, Biogen).
Serious adverse events occurred in eight patients (62%), none of which resulted in study discontinuation or death. The most common serious adverse events were related to the underlying SMA disease process and included acute respiratory failure (31%), pneumonia (31%), dehydration (23%), respiratory distress (15%), and bronchiolitis (15%).
Importantly, the investigators noted, no new safety signals or “adverse events of special interest” emerged during follow-up, including liver function enzyme elevations, new incidences of malignancy or hematologic disorders, and new incidences or exacerbations of existing neurologic or autoimmune disorders.
The investigators acknowledged that this follow-up study is limited by the small sample size of the patient population and confounded by treatment with nusinersen in several patients. “However, given that the two patients who acquired the new motor milestone of standing with assistance did not receive nusinersen at any time, this benefit can be attributed solely to onasemnogene abeparvovec,” Dr. Mendell and colleagues said.
The study was supported by Novartis Gene Therapies. Dr. Mendell and several co-investigators have disclosed financial relationships with the company.
A version of this article first appeared on Medscape.com.
Cardiologists’ pay increases, despite COVID-19 impacts
Despite the huge challenges of COVID-19, including a drop in patient visits, cardiologists reported an average increase in income in 2020 and remain among the top earners in medicine, according to the 2021 Medscape Cardiologist Compensation Report.
Although 46% of cardiologists reported some decline in compensation, average cardiologist income was $459,000 in 2020 – up from $438,000 in 2019.
Cardiologist pay is the third highest of all specialties in the overall 2021 Medscape Physician Compensation Report, which covers U.S. physicians as a whole and almost 18,000 physicians in 29 specialties.
Only plastic surgeons ($526,000) and orthopedists ($511,000) earned more than cardiologists in 2020.
On average among cardiologists, self-employment yields a somewhat higher paycheck than does being employed ($477,000 vs. $450,000).
Just like in last year’s report, nearly two-thirds (61%) of cardiologists overall say they feel fairly compensated.
The average incentive bonus payment for cardiologists in 2020 was 14% of total salary, about the same as last year. Two-thirds of cardiologists who earn an incentive bonus achieve more than three-quarters of their potential annual payment, up from 55% the prior year.
COVID challenges and the road back
The vast majority (92%) of cardiologists who saw a drop in income last year cited COVID-related issues such as job loss, working fewer hours, and seeing fewer patients.
Close to half (48%) of cardiologists who suffered financial or practice-related ill effects as a result of the pandemic expect their income to return to normal this year; 38% believe it will take 2 to 3 years. Notably, 45% of physicians overall said the pandemic did not cause them financial or practice-related harm.
Physician work hours generally declined for at least some time during the pandemic – and some physicians were furloughed – but most are now working about the same number of hours they did prior to COVID-19.
Cardiologists are back working an average of 57 hours per week. Perhaps not surprising, intensivists, infectious disease physicians, and public health/preventive medicine physicians are pulling longer hours now, about 6 or 7 more per week than before.
Although working about the same number of hours per week now as they did before the pandemic, physicians overall are typically seeing fewer patients because of time spent on medical office safety protocols, answering COVID-19–related questions and other factors.
Cardiologists are seeing an average decline in weekly patient visits of about 6% – from 77 to 72 patients. Pediatricians are experiencing the largest average declines – from 78 patients per week prior to 64 now, an 18% drop.
Among self-employed cardiologists, 43% believe that a drop in patient volume of up to one-quarter is permanent.
Most cardiologists remain happy at work
Despite COVID-19 and other professional challenges, most cardiologists (and physicians overall) continue to find their work rewarding.
Cardiologists say the most rewarding aspect of their profession is “being good at what I do/finding answers and diagnoses” (27%), followed by relationships with and gratitude from patients (26%), making the world a better place (23%) and making good money at a job they like (12%). A few cited pride in their profession (6%) and teaching (2%). These figures are in line with last year’s responses.
The most challenging part of practicing cardiology is having so many rules and regulations (22%), followed by having to work long hours (16%), working with electronic health records (13%), trouble getting fair reimbursement (11%), danger/risk associated with treating COVID-19 patients (11%), dealing with difficult patients (8%) and worry about being sued (7%).
Bureaucratic tasks continue to be a burden for physicians in all specialties. On average, cardiologists spend 17.4 hours per week on paperwork and administration, similar to last year (16.9 hours per week) and to physicians overall (16.3 hours).
Despite the challenges, 86% of cardiologists said they would choose medicine again, and 92% would choose cardiology again, about the same as last year.
Most cardiologists (83%) plan to keep Medicare and/or Medicaid patients; only 1% say they won’t take new Medicare or Medicaid patients; and 16% are undecided.
Thirty-nine percent of cardiologists plan to participate in the Merit-based Incentive Payment System (MIPS) in 2021.
“The stakes of the Quality Payment Program – the program that incorporates MIPS – are high, with a 9% penalty applied to all Medicare reimbursement for failure to participate,” said Elizabeth Woodcock, MBA, CPC, president of physician practice consulting firm Woodcock & Associates, Atlanta.
“With margins already slim, most physicians can’t afford this massive penalty. It makes sense to protect your revenue by complying with at least the bare minimum,” she noted.
A version of this article first appeared on Medscape.com.
Despite the huge challenges of COVID-19, including a drop in patient visits, cardiologists reported an average increase in income in 2020 and remain among the top earners in medicine, according to the 2021 Medscape Cardiologist Compensation Report.
Although 46% of cardiologists reported some decline in compensation, average cardiologist income was $459,000 in 2020 – up from $438,000 in 2019.
Cardiologist pay is the third highest of all specialties in the overall 2021 Medscape Physician Compensation Report, which covers U.S. physicians as a whole and almost 18,000 physicians in 29 specialties.
Only plastic surgeons ($526,000) and orthopedists ($511,000) earned more than cardiologists in 2020.
On average among cardiologists, self-employment yields a somewhat higher paycheck than does being employed ($477,000 vs. $450,000).
Just like in last year’s report, nearly two-thirds (61%) of cardiologists overall say they feel fairly compensated.
The average incentive bonus payment for cardiologists in 2020 was 14% of total salary, about the same as last year. Two-thirds of cardiologists who earn an incentive bonus achieve more than three-quarters of their potential annual payment, up from 55% the prior year.
COVID challenges and the road back
The vast majority (92%) of cardiologists who saw a drop in income last year cited COVID-related issues such as job loss, working fewer hours, and seeing fewer patients.
Close to half (48%) of cardiologists who suffered financial or practice-related ill effects as a result of the pandemic expect their income to return to normal this year; 38% believe it will take 2 to 3 years. Notably, 45% of physicians overall said the pandemic did not cause them financial or practice-related harm.
Physician work hours generally declined for at least some time during the pandemic – and some physicians were furloughed – but most are now working about the same number of hours they did prior to COVID-19.
Cardiologists are back working an average of 57 hours per week. Perhaps not surprising, intensivists, infectious disease physicians, and public health/preventive medicine physicians are pulling longer hours now, about 6 or 7 more per week than before.
Although working about the same number of hours per week now as they did before the pandemic, physicians overall are typically seeing fewer patients because of time spent on medical office safety protocols, answering COVID-19–related questions and other factors.
Cardiologists are seeing an average decline in weekly patient visits of about 6% – from 77 to 72 patients. Pediatricians are experiencing the largest average declines – from 78 patients per week prior to 64 now, an 18% drop.
Among self-employed cardiologists, 43% believe that a drop in patient volume of up to one-quarter is permanent.
Most cardiologists remain happy at work
Despite COVID-19 and other professional challenges, most cardiologists (and physicians overall) continue to find their work rewarding.
Cardiologists say the most rewarding aspect of their profession is “being good at what I do/finding answers and diagnoses” (27%), followed by relationships with and gratitude from patients (26%), making the world a better place (23%) and making good money at a job they like (12%). A few cited pride in their profession (6%) and teaching (2%). These figures are in line with last year’s responses.
The most challenging part of practicing cardiology is having so many rules and regulations (22%), followed by having to work long hours (16%), working with electronic health records (13%), trouble getting fair reimbursement (11%), danger/risk associated with treating COVID-19 patients (11%), dealing with difficult patients (8%) and worry about being sued (7%).
Bureaucratic tasks continue to be a burden for physicians in all specialties. On average, cardiologists spend 17.4 hours per week on paperwork and administration, similar to last year (16.9 hours per week) and to physicians overall (16.3 hours).
Despite the challenges, 86% of cardiologists said they would choose medicine again, and 92% would choose cardiology again, about the same as last year.
Most cardiologists (83%) plan to keep Medicare and/or Medicaid patients; only 1% say they won’t take new Medicare or Medicaid patients; and 16% are undecided.
Thirty-nine percent of cardiologists plan to participate in the Merit-based Incentive Payment System (MIPS) in 2021.
“The stakes of the Quality Payment Program – the program that incorporates MIPS – are high, with a 9% penalty applied to all Medicare reimbursement for failure to participate,” said Elizabeth Woodcock, MBA, CPC, president of physician practice consulting firm Woodcock & Associates, Atlanta.
“With margins already slim, most physicians can’t afford this massive penalty. It makes sense to protect your revenue by complying with at least the bare minimum,” she noted.
A version of this article first appeared on Medscape.com.
Despite the huge challenges of COVID-19, including a drop in patient visits, cardiologists reported an average increase in income in 2020 and remain among the top earners in medicine, according to the 2021 Medscape Cardiologist Compensation Report.
Although 46% of cardiologists reported some decline in compensation, average cardiologist income was $459,000 in 2020 – up from $438,000 in 2019.
Cardiologist pay is the third highest of all specialties in the overall 2021 Medscape Physician Compensation Report, which covers U.S. physicians as a whole and almost 18,000 physicians in 29 specialties.
Only plastic surgeons ($526,000) and orthopedists ($511,000) earned more than cardiologists in 2020.
On average among cardiologists, self-employment yields a somewhat higher paycheck than does being employed ($477,000 vs. $450,000).
Just like in last year’s report, nearly two-thirds (61%) of cardiologists overall say they feel fairly compensated.
The average incentive bonus payment for cardiologists in 2020 was 14% of total salary, about the same as last year. Two-thirds of cardiologists who earn an incentive bonus achieve more than three-quarters of their potential annual payment, up from 55% the prior year.
COVID challenges and the road back
The vast majority (92%) of cardiologists who saw a drop in income last year cited COVID-related issues such as job loss, working fewer hours, and seeing fewer patients.
Close to half (48%) of cardiologists who suffered financial or practice-related ill effects as a result of the pandemic expect their income to return to normal this year; 38% believe it will take 2 to 3 years. Notably, 45% of physicians overall said the pandemic did not cause them financial or practice-related harm.
Physician work hours generally declined for at least some time during the pandemic – and some physicians were furloughed – but most are now working about the same number of hours they did prior to COVID-19.
Cardiologists are back working an average of 57 hours per week. Perhaps not surprising, intensivists, infectious disease physicians, and public health/preventive medicine physicians are pulling longer hours now, about 6 or 7 more per week than before.
Although working about the same number of hours per week now as they did before the pandemic, physicians overall are typically seeing fewer patients because of time spent on medical office safety protocols, answering COVID-19–related questions and other factors.
Cardiologists are seeing an average decline in weekly patient visits of about 6% – from 77 to 72 patients. Pediatricians are experiencing the largest average declines – from 78 patients per week prior to 64 now, an 18% drop.
Among self-employed cardiologists, 43% believe that a drop in patient volume of up to one-quarter is permanent.
Most cardiologists remain happy at work
Despite COVID-19 and other professional challenges, most cardiologists (and physicians overall) continue to find their work rewarding.
Cardiologists say the most rewarding aspect of their profession is “being good at what I do/finding answers and diagnoses” (27%), followed by relationships with and gratitude from patients (26%), making the world a better place (23%) and making good money at a job they like (12%). A few cited pride in their profession (6%) and teaching (2%). These figures are in line with last year’s responses.
The most challenging part of practicing cardiology is having so many rules and regulations (22%), followed by having to work long hours (16%), working with electronic health records (13%), trouble getting fair reimbursement (11%), danger/risk associated with treating COVID-19 patients (11%), dealing with difficult patients (8%) and worry about being sued (7%).
Bureaucratic tasks continue to be a burden for physicians in all specialties. On average, cardiologists spend 17.4 hours per week on paperwork and administration, similar to last year (16.9 hours per week) and to physicians overall (16.3 hours).
Despite the challenges, 86% of cardiologists said they would choose medicine again, and 92% would choose cardiology again, about the same as last year.
Most cardiologists (83%) plan to keep Medicare and/or Medicaid patients; only 1% say they won’t take new Medicare or Medicaid patients; and 16% are undecided.
Thirty-nine percent of cardiologists plan to participate in the Merit-based Incentive Payment System (MIPS) in 2021.
“The stakes of the Quality Payment Program – the program that incorporates MIPS – are high, with a 9% penalty applied to all Medicare reimbursement for failure to participate,” said Elizabeth Woodcock, MBA, CPC, president of physician practice consulting firm Woodcock & Associates, Atlanta.
“With margins already slim, most physicians can’t afford this massive penalty. It makes sense to protect your revenue by complying with at least the bare minimum,” she noted.
A version of this article first appeared on Medscape.com.
The end of happy hour? No safe level of alcohol for the brain
There is no safe amount of alcohol consumption for the brain; even moderate drinking adversely affects brain structure and function, according a British study of more 25,000 adults.
“This is one of the largest studies of alcohol and brain health to date,” Anya Topiwala, DPhil, University of Oxford (England), told this news organization.
“There have been previous claims the relationship between alcohol and brain health are J-shaped (ie., small amounts are protective), but we formally tested this and did not find it to be the case. In fact, we found that any level of alcohol was associated with poorer brain health, compared to no alcohol,” Dr. Topiwala added.
The study, which has not yet been peer reviewed, was published online May 12 in MedRxiv.
Global impact on the brain
Participants provided detailed information on their alcohol intake. The cohort included 691 never-drinkers, 617 former drinkers, and 24,069 current drinkers.
Median alcohol intake was 13.5 units (102 g) weekly. Almost half of the sample (48.2%) were drinking above current UK low-risk guidelines (14 units, 112 g weekly), but few were heavy drinkers (>50 units, 400 g weekly).
After adjusting for all known potential confounders and multiple comparisons, a higher volume of alcohol consumed per week was associated with lower gray matter in “almost all areas of the brain,” Dr. Topiwala said in an interview.
Alcohol consumption accounted for up to 0.8% of gray matter volume variance. “The size of the effect is small, albeit greater than any other modifiable risk factor. These brain changes have been previously linked to aging, poorer performance on memory changes, and dementia,” Dr. Topiwala said.
Widespread negative associations were also found between drinking alcohol and all the measures of white matter integrity that were assessed. There was a significant positive association between alcohol consumption and resting-state functional connectivity.
Higher blood pressure and body mass index “steepened” the negative associations between alcohol and brain health, and binge drinking had additive negative effects on brain structure beyond the absolute volume consumed.
There was no evidence that the risk for alcohol-related brain harm differs according to the type of alcohol consumed (wine, beer, or spirits).
A key limitation of the study is that the study population from the UK Biobank represents a sample that is healthier, better educated, and less deprived and is characterized by less ethnic diversity than the general population. “As with any observational study, we cannot infer causality from association,” the authors note.
What remains unclear, they say, is the duration of drinking needed to cause an effect on the brain. It may be that vulnerability is increased during periods of life in which dynamic brain changes occur, such as adolescence and older age.
They also note that some studies of alcohol-dependent individuals have suggested that at least some brain damage is reversible upon abstinence. Whether that is true for moderate drinkers is unknown.
On the basis of their findings, there is “no safe dose of alcohol for the brain,” Dr. Topiwala and colleagues conclude. They suggest that current low-risk drinking guidelines be revisited to take account of brain effects.
Experts weigh in
Several experts weighed in on the study in a statement from the nonprofit UK Science Media Center.
Paul Matthews, MD, head of the department of brain sciences, Imperial College London, noted that this “carefully performed preliminary report extends our earlier UK Dementia Research Institute study of a smaller group from same UK Biobank population also showing that even moderate drinking is associated with greater atrophy of the brain, as well as injury to the heart and liver.”
Dr. Matthews said the investigators’ conclusion that there is no safe threshold below which alcohol consumption has no toxic effects “echoes our own. We join with them in suggesting that current public health guidelines concerning alcohol consumption may need to be revisited.”
Rebecca Dewey, PhD, research fellow in neuroimaging, University of Nottingham (England), cautioned that “the degree to which very small changes in brain volume are harmful” is unknown.
“While there was no threshold under which alcohol consumption did not cause changes in the brain, there may a degree of brain volume difference that is irrelevant to brain health. We don’t know what these people’s brains looked like before they drank alcohol, so the brain may have learned to cope/compensate,” Dewey said.
Sadie Boniface, PhD, head of research at the Institute of Alcohol Studies and visiting researcher at King’s College London, said, “While we can’t yet say for sure whether there is ‘no safe level’ of alcohol regarding brain health at the moment, it has been known for decades that heavy drinking is bad for brain health.
“We also shouldn’t forget alcohol affects all parts of the body and there are multiple health risks. For example, it is already known there is ‘no safe level’ of alcohol consumption for the seven types of cancer caused by alcohol, as identified by the UK chief medical officers,” Dr. Boniface said.
The study was supported in part by the Wellcome Trust, Li Ka Shing Center for Health Information and Discovery, the National Institutes of Health, and the UK Medical Research Council. Dr. Topiwala, Dr. Boniface, Dr. Dewey, and Dr. Matthews have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There is no safe amount of alcohol consumption for the brain; even moderate drinking adversely affects brain structure and function, according a British study of more 25,000 adults.
“This is one of the largest studies of alcohol and brain health to date,” Anya Topiwala, DPhil, University of Oxford (England), told this news organization.
“There have been previous claims the relationship between alcohol and brain health are J-shaped (ie., small amounts are protective), but we formally tested this and did not find it to be the case. In fact, we found that any level of alcohol was associated with poorer brain health, compared to no alcohol,” Dr. Topiwala added.
The study, which has not yet been peer reviewed, was published online May 12 in MedRxiv.
Global impact on the brain
Participants provided detailed information on their alcohol intake. The cohort included 691 never-drinkers, 617 former drinkers, and 24,069 current drinkers.
Median alcohol intake was 13.5 units (102 g) weekly. Almost half of the sample (48.2%) were drinking above current UK low-risk guidelines (14 units, 112 g weekly), but few were heavy drinkers (>50 units, 400 g weekly).
After adjusting for all known potential confounders and multiple comparisons, a higher volume of alcohol consumed per week was associated with lower gray matter in “almost all areas of the brain,” Dr. Topiwala said in an interview.
Alcohol consumption accounted for up to 0.8% of gray matter volume variance. “The size of the effect is small, albeit greater than any other modifiable risk factor. These brain changes have been previously linked to aging, poorer performance on memory changes, and dementia,” Dr. Topiwala said.
Widespread negative associations were also found between drinking alcohol and all the measures of white matter integrity that were assessed. There was a significant positive association between alcohol consumption and resting-state functional connectivity.
Higher blood pressure and body mass index “steepened” the negative associations between alcohol and brain health, and binge drinking had additive negative effects on brain structure beyond the absolute volume consumed.
There was no evidence that the risk for alcohol-related brain harm differs according to the type of alcohol consumed (wine, beer, or spirits).
A key limitation of the study is that the study population from the UK Biobank represents a sample that is healthier, better educated, and less deprived and is characterized by less ethnic diversity than the general population. “As with any observational study, we cannot infer causality from association,” the authors note.
What remains unclear, they say, is the duration of drinking needed to cause an effect on the brain. It may be that vulnerability is increased during periods of life in which dynamic brain changes occur, such as adolescence and older age.
They also note that some studies of alcohol-dependent individuals have suggested that at least some brain damage is reversible upon abstinence. Whether that is true for moderate drinkers is unknown.
On the basis of their findings, there is “no safe dose of alcohol for the brain,” Dr. Topiwala and colleagues conclude. They suggest that current low-risk drinking guidelines be revisited to take account of brain effects.
Experts weigh in
Several experts weighed in on the study in a statement from the nonprofit UK Science Media Center.
Paul Matthews, MD, head of the department of brain sciences, Imperial College London, noted that this “carefully performed preliminary report extends our earlier UK Dementia Research Institute study of a smaller group from same UK Biobank population also showing that even moderate drinking is associated with greater atrophy of the brain, as well as injury to the heart and liver.”
Dr. Matthews said the investigators’ conclusion that there is no safe threshold below which alcohol consumption has no toxic effects “echoes our own. We join with them in suggesting that current public health guidelines concerning alcohol consumption may need to be revisited.”
Rebecca Dewey, PhD, research fellow in neuroimaging, University of Nottingham (England), cautioned that “the degree to which very small changes in brain volume are harmful” is unknown.
“While there was no threshold under which alcohol consumption did not cause changes in the brain, there may a degree of brain volume difference that is irrelevant to brain health. We don’t know what these people’s brains looked like before they drank alcohol, so the brain may have learned to cope/compensate,” Dewey said.
Sadie Boniface, PhD, head of research at the Institute of Alcohol Studies and visiting researcher at King’s College London, said, “While we can’t yet say for sure whether there is ‘no safe level’ of alcohol regarding brain health at the moment, it has been known for decades that heavy drinking is bad for brain health.
“We also shouldn’t forget alcohol affects all parts of the body and there are multiple health risks. For example, it is already known there is ‘no safe level’ of alcohol consumption for the seven types of cancer caused by alcohol, as identified by the UK chief medical officers,” Dr. Boniface said.
The study was supported in part by the Wellcome Trust, Li Ka Shing Center for Health Information and Discovery, the National Institutes of Health, and the UK Medical Research Council. Dr. Topiwala, Dr. Boniface, Dr. Dewey, and Dr. Matthews have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There is no safe amount of alcohol consumption for the brain; even moderate drinking adversely affects brain structure and function, according a British study of more 25,000 adults.
“This is one of the largest studies of alcohol and brain health to date,” Anya Topiwala, DPhil, University of Oxford (England), told this news organization.
“There have been previous claims the relationship between alcohol and brain health are J-shaped (ie., small amounts are protective), but we formally tested this and did not find it to be the case. In fact, we found that any level of alcohol was associated with poorer brain health, compared to no alcohol,” Dr. Topiwala added.
The study, which has not yet been peer reviewed, was published online May 12 in MedRxiv.
Global impact on the brain
Participants provided detailed information on their alcohol intake. The cohort included 691 never-drinkers, 617 former drinkers, and 24,069 current drinkers.
Median alcohol intake was 13.5 units (102 g) weekly. Almost half of the sample (48.2%) were drinking above current UK low-risk guidelines (14 units, 112 g weekly), but few were heavy drinkers (>50 units, 400 g weekly).
After adjusting for all known potential confounders and multiple comparisons, a higher volume of alcohol consumed per week was associated with lower gray matter in “almost all areas of the brain,” Dr. Topiwala said in an interview.
Alcohol consumption accounted for up to 0.8% of gray matter volume variance. “The size of the effect is small, albeit greater than any other modifiable risk factor. These brain changes have been previously linked to aging, poorer performance on memory changes, and dementia,” Dr. Topiwala said.
Widespread negative associations were also found between drinking alcohol and all the measures of white matter integrity that were assessed. There was a significant positive association between alcohol consumption and resting-state functional connectivity.
Higher blood pressure and body mass index “steepened” the negative associations between alcohol and brain health, and binge drinking had additive negative effects on brain structure beyond the absolute volume consumed.
There was no evidence that the risk for alcohol-related brain harm differs according to the type of alcohol consumed (wine, beer, or spirits).
A key limitation of the study is that the study population from the UK Biobank represents a sample that is healthier, better educated, and less deprived and is characterized by less ethnic diversity than the general population. “As with any observational study, we cannot infer causality from association,” the authors note.
What remains unclear, they say, is the duration of drinking needed to cause an effect on the brain. It may be that vulnerability is increased during periods of life in which dynamic brain changes occur, such as adolescence and older age.
They also note that some studies of alcohol-dependent individuals have suggested that at least some brain damage is reversible upon abstinence. Whether that is true for moderate drinkers is unknown.
On the basis of their findings, there is “no safe dose of alcohol for the brain,” Dr. Topiwala and colleagues conclude. They suggest that current low-risk drinking guidelines be revisited to take account of brain effects.
Experts weigh in
Several experts weighed in on the study in a statement from the nonprofit UK Science Media Center.
Paul Matthews, MD, head of the department of brain sciences, Imperial College London, noted that this “carefully performed preliminary report extends our earlier UK Dementia Research Institute study of a smaller group from same UK Biobank population also showing that even moderate drinking is associated with greater atrophy of the brain, as well as injury to the heart and liver.”
Dr. Matthews said the investigators’ conclusion that there is no safe threshold below which alcohol consumption has no toxic effects “echoes our own. We join with them in suggesting that current public health guidelines concerning alcohol consumption may need to be revisited.”
Rebecca Dewey, PhD, research fellow in neuroimaging, University of Nottingham (England), cautioned that “the degree to which very small changes in brain volume are harmful” is unknown.
“While there was no threshold under which alcohol consumption did not cause changes in the brain, there may a degree of brain volume difference that is irrelevant to brain health. We don’t know what these people’s brains looked like before they drank alcohol, so the brain may have learned to cope/compensate,” Dewey said.
Sadie Boniface, PhD, head of research at the Institute of Alcohol Studies and visiting researcher at King’s College London, said, “While we can’t yet say for sure whether there is ‘no safe level’ of alcohol regarding brain health at the moment, it has been known for decades that heavy drinking is bad for brain health.
“We also shouldn’t forget alcohol affects all parts of the body and there are multiple health risks. For example, it is already known there is ‘no safe level’ of alcohol consumption for the seven types of cancer caused by alcohol, as identified by the UK chief medical officers,” Dr. Boniface said.
The study was supported in part by the Wellcome Trust, Li Ka Shing Center for Health Information and Discovery, the National Institutes of Health, and the UK Medical Research Council. Dr. Topiwala, Dr. Boniface, Dr. Dewey, and Dr. Matthews have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AHA reassures myocarditis rare after COVID vaccination, benefits overwhelm risks
The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.
The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.
The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.
“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”
In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.
“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.
Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”
“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.
Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.
The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”
All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.
“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.
A version of this article first appeared on Medscape.com.
The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.
The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.
The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.
“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”
In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.
“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.
Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”
“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.
Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.
The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”
All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.
“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.
A version of this article first appeared on Medscape.com.
The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.
The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.
The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.
“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”
In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.
“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.
Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”
“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.
Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.
The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”
All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.
“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.
A version of this article first appeared on Medscape.com.
Final SPRINT data confirm lower BP is better
The results include data on some outcome events from the trial that had yet to be adjudicated when the primary analysis was released in 2015, as well as posttrial observational follow-up data collected through July 2016.
The data confirm and enhance the earlier findings and show that “lower is better” when it comes to blood pressure, primary investigator Cora E. Lewis, MD, professor and chair, department of epidemiology, University of Alabama at Birmingham, said in an interview.
Final results of the Systolic Blood Pressure Intervention Trial (SPRINT) were published in the May 20 issue of the New England Journal of Medicine.
For the trial, researchers enrolled 9,361 adults 50 years and older with a SBP between 130 and 180 mm Hg who were at increased risk for cardiovascular disease (CVD) but did not have a history of diabetes or stroke. Patients were randomly assigned to an intensive treatment target (SBP < 120 mm Hg) or a standard treatment target (SBP < 140 mm Hg).
In the final analysis, the rate of the primary outcome was 1.77% per year in the intensive-treatment group and 2.40% per year in the standard-treatment group (hazard ratio [HR], 0.73; 95% confidence interval [CR], 0.63-0.86; P < .001), similar to the earlier SPRINT findings.
All-cause mortality was 1.06% per year in the intensive-treatment group and 1.41% per year in the standard-treatment group (HR, 0.75; 95% CI, 0.61-0.92; P = .006), again similar to the previous findings.
“These results were highly statistically significant. It is remarkable in a trial powered for a composite CVD outcome to obtain a significant benefit for total mortality,” Dr. Lewis said.
She noted that one criticism of the initial SPRINT results was that, for the components of the primary outcome, only heart failure and death due to CVD were significantly lower in the intensively treated group.
“Heart failure can be difficult to diagnose from records in a clinical trial, and the critiques were that this was shaky evidence, given that more participants treated to less than 120 were on diuretics, which could decrease swelling, a key symptom of heart failure,” she explained.
“In these final results, SPRINT found that risk of myocardial infarction, heart failure, and death from CVD were significantly lower in the group treated to less than 120, and risk of the primary outcome, excluding heart failure, was still significantly lower in the more intensively treated group,” she noted.
After the trial phase ended, blood pressure treatment was returned to the participants’ usual source of medical care and the trial treatment goals were no longer pursued. SPRINT continued to collect data on the outcomes through July 2016. During this time, SBP rose 6.9 mm Hg in the intensive-treatment group and 2.6 mm Hg in the standard-treatment group.
“Putting all the data together from the trial phase and the phase after randomized interventions had been stopped, there was still a significant benefit for the more intensive treatment on the primary outcome and on death from all causes,” Dr. Lewis said.
In addition, a separate new analysis based on all the data showed significantly fewer first and recurrent primary outcome events with intensive treatment than with standard treatment (435 vs. 552; HR, 0.78; 95% CI, 0.69-0.89; P < .001).
Manageable risk
The pattern of safety events in the final analysis was similar to the 2015 report. In the intervention period, rates of serious adverse events overall did not differ significantly between the groups. However, rates of hypotension, electrolyte abnormalities, syncope (none leading to injurious falls), and acute kidney injury were higher in the intensive-treatment group.
As in other SPRINT reports, “acute kidney injury safety events were generally mild and there was nearly complete recovery of kidney function within 1 year,” Dr. Lewis said. “This and other analyses we have published indicate this is probably a hemodynamic effect.”
“Intensive treatment can be well tolerated and is generally safe with proper patient selection and monitoring. There are advantages to intensive therapy, and some risks, but I don’t think the risks are such that we should just throw the idea of more intensive treatment out the window,” Dr. Lewis said.
Reached for comment, Carlos G. Santos-Gallego, MD, from the Icahn School of Medicine at Mount Sinai in New York, said there has been “controversy” over whether intensive blood pressure control targeting systolic to below 120 mm Hg is beneficial.
“The original SPRINT trial is incredibly important, in that it conclusively demonstrated that among patients with hypertension and increased cardiovascular risk, targeting systolic blood pressure to below 120 mm Hg resulted in lower rates of adverse cardiovascular events and, importantly, all-cause mortality," compared with the conventional target of 140 mm Hg, he said in an interview.
“This final report of the SPRINT trial basically consolidates, confirms, and corroborates the original SPRINT data,” he noted. However, the final data are “more robust, with additional primary outcome events and all events having been adjudicated by a central committee, and there is an additional observation period of 1 extra year in which the treatment has been discontinued,” he said.
“Over time, we are becoming more and more certain that lower is better with blood pressure. We still have a long way to go, but the cardiology community is slowly becoming more intense in our treatment of blood pressure for our patients,” Dr. Santos-Gallego said.
The potential adverse effects of intensive blood pressure control are “very manageable,” he added.
Support for SPRINT was provided by the National Institutes of Health. Full disclosures for authors are available in the original article. Dr. Santos-Gallego has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The results include data on some outcome events from the trial that had yet to be adjudicated when the primary analysis was released in 2015, as well as posttrial observational follow-up data collected through July 2016.
The data confirm and enhance the earlier findings and show that “lower is better” when it comes to blood pressure, primary investigator Cora E. Lewis, MD, professor and chair, department of epidemiology, University of Alabama at Birmingham, said in an interview.
Final results of the Systolic Blood Pressure Intervention Trial (SPRINT) were published in the May 20 issue of the New England Journal of Medicine.
For the trial, researchers enrolled 9,361 adults 50 years and older with a SBP between 130 and 180 mm Hg who were at increased risk for cardiovascular disease (CVD) but did not have a history of diabetes or stroke. Patients were randomly assigned to an intensive treatment target (SBP < 120 mm Hg) or a standard treatment target (SBP < 140 mm Hg).
In the final analysis, the rate of the primary outcome was 1.77% per year in the intensive-treatment group and 2.40% per year in the standard-treatment group (hazard ratio [HR], 0.73; 95% confidence interval [CR], 0.63-0.86; P < .001), similar to the earlier SPRINT findings.
All-cause mortality was 1.06% per year in the intensive-treatment group and 1.41% per year in the standard-treatment group (HR, 0.75; 95% CI, 0.61-0.92; P = .006), again similar to the previous findings.
“These results were highly statistically significant. It is remarkable in a trial powered for a composite CVD outcome to obtain a significant benefit for total mortality,” Dr. Lewis said.
She noted that one criticism of the initial SPRINT results was that, for the components of the primary outcome, only heart failure and death due to CVD were significantly lower in the intensively treated group.
“Heart failure can be difficult to diagnose from records in a clinical trial, and the critiques were that this was shaky evidence, given that more participants treated to less than 120 were on diuretics, which could decrease swelling, a key symptom of heart failure,” she explained.
“In these final results, SPRINT found that risk of myocardial infarction, heart failure, and death from CVD were significantly lower in the group treated to less than 120, and risk of the primary outcome, excluding heart failure, was still significantly lower in the more intensively treated group,” she noted.
After the trial phase ended, blood pressure treatment was returned to the participants’ usual source of medical care and the trial treatment goals were no longer pursued. SPRINT continued to collect data on the outcomes through July 2016. During this time, SBP rose 6.9 mm Hg in the intensive-treatment group and 2.6 mm Hg in the standard-treatment group.
“Putting all the data together from the trial phase and the phase after randomized interventions had been stopped, there was still a significant benefit for the more intensive treatment on the primary outcome and on death from all causes,” Dr. Lewis said.
In addition, a separate new analysis based on all the data showed significantly fewer first and recurrent primary outcome events with intensive treatment than with standard treatment (435 vs. 552; HR, 0.78; 95% CI, 0.69-0.89; P < .001).
Manageable risk
The pattern of safety events in the final analysis was similar to the 2015 report. In the intervention period, rates of serious adverse events overall did not differ significantly between the groups. However, rates of hypotension, electrolyte abnormalities, syncope (none leading to injurious falls), and acute kidney injury were higher in the intensive-treatment group.
As in other SPRINT reports, “acute kidney injury safety events were generally mild and there was nearly complete recovery of kidney function within 1 year,” Dr. Lewis said. “This and other analyses we have published indicate this is probably a hemodynamic effect.”
“Intensive treatment can be well tolerated and is generally safe with proper patient selection and monitoring. There are advantages to intensive therapy, and some risks, but I don’t think the risks are such that we should just throw the idea of more intensive treatment out the window,” Dr. Lewis said.
Reached for comment, Carlos G. Santos-Gallego, MD, from the Icahn School of Medicine at Mount Sinai in New York, said there has been “controversy” over whether intensive blood pressure control targeting systolic to below 120 mm Hg is beneficial.
“The original SPRINT trial is incredibly important, in that it conclusively demonstrated that among patients with hypertension and increased cardiovascular risk, targeting systolic blood pressure to below 120 mm Hg resulted in lower rates of adverse cardiovascular events and, importantly, all-cause mortality," compared with the conventional target of 140 mm Hg, he said in an interview.
“This final report of the SPRINT trial basically consolidates, confirms, and corroborates the original SPRINT data,” he noted. However, the final data are “more robust, with additional primary outcome events and all events having been adjudicated by a central committee, and there is an additional observation period of 1 extra year in which the treatment has been discontinued,” he said.
“Over time, we are becoming more and more certain that lower is better with blood pressure. We still have a long way to go, but the cardiology community is slowly becoming more intense in our treatment of blood pressure for our patients,” Dr. Santos-Gallego said.
The potential adverse effects of intensive blood pressure control are “very manageable,” he added.
Support for SPRINT was provided by the National Institutes of Health. Full disclosures for authors are available in the original article. Dr. Santos-Gallego has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The results include data on some outcome events from the trial that had yet to be adjudicated when the primary analysis was released in 2015, as well as posttrial observational follow-up data collected through July 2016.
The data confirm and enhance the earlier findings and show that “lower is better” when it comes to blood pressure, primary investigator Cora E. Lewis, MD, professor and chair, department of epidemiology, University of Alabama at Birmingham, said in an interview.
Final results of the Systolic Blood Pressure Intervention Trial (SPRINT) were published in the May 20 issue of the New England Journal of Medicine.
For the trial, researchers enrolled 9,361 adults 50 years and older with a SBP between 130 and 180 mm Hg who were at increased risk for cardiovascular disease (CVD) but did not have a history of diabetes or stroke. Patients were randomly assigned to an intensive treatment target (SBP < 120 mm Hg) or a standard treatment target (SBP < 140 mm Hg).
In the final analysis, the rate of the primary outcome was 1.77% per year in the intensive-treatment group and 2.40% per year in the standard-treatment group (hazard ratio [HR], 0.73; 95% confidence interval [CR], 0.63-0.86; P < .001), similar to the earlier SPRINT findings.
All-cause mortality was 1.06% per year in the intensive-treatment group and 1.41% per year in the standard-treatment group (HR, 0.75; 95% CI, 0.61-0.92; P = .006), again similar to the previous findings.
“These results were highly statistically significant. It is remarkable in a trial powered for a composite CVD outcome to obtain a significant benefit for total mortality,” Dr. Lewis said.
She noted that one criticism of the initial SPRINT results was that, for the components of the primary outcome, only heart failure and death due to CVD were significantly lower in the intensively treated group.
“Heart failure can be difficult to diagnose from records in a clinical trial, and the critiques were that this was shaky evidence, given that more participants treated to less than 120 were on diuretics, which could decrease swelling, a key symptom of heart failure,” she explained.
“In these final results, SPRINT found that risk of myocardial infarction, heart failure, and death from CVD were significantly lower in the group treated to less than 120, and risk of the primary outcome, excluding heart failure, was still significantly lower in the more intensively treated group,” she noted.
After the trial phase ended, blood pressure treatment was returned to the participants’ usual source of medical care and the trial treatment goals were no longer pursued. SPRINT continued to collect data on the outcomes through July 2016. During this time, SBP rose 6.9 mm Hg in the intensive-treatment group and 2.6 mm Hg in the standard-treatment group.
“Putting all the data together from the trial phase and the phase after randomized interventions had been stopped, there was still a significant benefit for the more intensive treatment on the primary outcome and on death from all causes,” Dr. Lewis said.
In addition, a separate new analysis based on all the data showed significantly fewer first and recurrent primary outcome events with intensive treatment than with standard treatment (435 vs. 552; HR, 0.78; 95% CI, 0.69-0.89; P < .001).
Manageable risk
The pattern of safety events in the final analysis was similar to the 2015 report. In the intervention period, rates of serious adverse events overall did not differ significantly between the groups. However, rates of hypotension, electrolyte abnormalities, syncope (none leading to injurious falls), and acute kidney injury were higher in the intensive-treatment group.
As in other SPRINT reports, “acute kidney injury safety events were generally mild and there was nearly complete recovery of kidney function within 1 year,” Dr. Lewis said. “This and other analyses we have published indicate this is probably a hemodynamic effect.”
“Intensive treatment can be well tolerated and is generally safe with proper patient selection and monitoring. There are advantages to intensive therapy, and some risks, but I don’t think the risks are such that we should just throw the idea of more intensive treatment out the window,” Dr. Lewis said.
Reached for comment, Carlos G. Santos-Gallego, MD, from the Icahn School of Medicine at Mount Sinai in New York, said there has been “controversy” over whether intensive blood pressure control targeting systolic to below 120 mm Hg is beneficial.
“The original SPRINT trial is incredibly important, in that it conclusively demonstrated that among patients with hypertension and increased cardiovascular risk, targeting systolic blood pressure to below 120 mm Hg resulted in lower rates of adverse cardiovascular events and, importantly, all-cause mortality," compared with the conventional target of 140 mm Hg, he said in an interview.
“This final report of the SPRINT trial basically consolidates, confirms, and corroborates the original SPRINT data,” he noted. However, the final data are “more robust, with additional primary outcome events and all events having been adjudicated by a central committee, and there is an additional observation period of 1 extra year in which the treatment has been discontinued,” he said.
“Over time, we are becoming more and more certain that lower is better with blood pressure. We still have a long way to go, but the cardiology community is slowly becoming more intense in our treatment of blood pressure for our patients,” Dr. Santos-Gallego said.
The potential adverse effects of intensive blood pressure control are “very manageable,” he added.
Support for SPRINT was provided by the National Institutes of Health. Full disclosures for authors are available in the original article. Dr. Santos-Gallego has no relevant disclosures.
A version of this article first appeared on Medscape.com.
Depot buprenorphine a shot in the arm for opioid addiction?
Adults in treatment for opioid dependence report high satisfaction with buprenorphine injections, in new findings that researchers say could help improve treatment and management of patients with opioid dependence.
In the DEBUT trial, patients who received weekly or monthly depot buprenorphine had significantly higher overall treatment satisfaction, reduced treatment burden, and higher quality-of-life ratings than peers who received daily treatment with sublingual buprenorphine.
“The study’s focus on patient-reported outcomes (PROs) can help to better inform patients and clinicians when selecting treatment options than the clinical traditional outcomes of opioid dependence treatment studies,” lead investigator Fredrik Tiberg, PhD, president and CEO of Camurus, a pharmaceutical company in Lund, Sweden, said in an interview.
“The positive patient experiences with the depot buprenorphine injection reported in the DEBUT study indicate that long-acting treatments could contribute to advancing the quality of care and access to treatment for patients with opioid dependence/use disorder,” said Dr. Tiberg.
The study was published online May 10 in JAMA Network Open.
Novel study
The study was an open-label, parallel-group randomized controlled trial that included 119 patients from six outpatient clinics in Australia; 60 received weekly or monthly depot buprenorphine and 59 received sublingual buprenorphine for 24 weeks.
The primary outcome was global treatment satisfaction, as measured by the 14-question Treatment Satisfaction Questionnaire for Medication (TSQM) at the end of the study at week 24.
The study met its primary endpoint with a significantly higher TSQM global satisfaction score among adults who received depot injections, compared with those who received sublingual buprenorphine (mean score 82.5 vs. 74.3; difference, 8.2; 95% confidence interval, 1.7-14.6; P = .01).
Improvement was also observed for several secondary outcomes, including decreased treatment burden and higher quality of life.
The safety profile was consistent with the known safety profile of buprenorphine, aside from transient, mild-to-moderate injection site reactions.
“To our knowledge, this is the first randomized study that has used a range of PROs to compare outcomes between a long-acting injection and daily dosing of buprenorphine in the treatment of opioid dependence,” the investigators note.
“The study highlights the application of PROs as alternate endpoints to traditional markers of substance use in addiction treatment outcome studies,” they conclude.
Giving patients a voice
In an invited commentary, from most of the work in medication development, including for opioid use disorder.
The current study addresses this very issue in a “well designed and executed” fashion and the results “consistently demonstrated” the superiority of injectable buprenorphine across many outcomes.
The study highlights the importance of considering PRO measures in clinical trials, Dr. Volkow and Dr. Compton say.
“Even if efficacy is no different for various formulations, PROs may provide an important reason to select a new formulation. Patient preferences and apparently improved function may prove to be useful secondary outcomes in medication trials, and the measures used in this new study deserve consideration,” they write.
In addition, the greater treatment satisfaction by patients receiving extended-release buprenorphine suggests that these formulations “might help to improve long-term retention and, as such, be a valuable tool to help combat the current opioid epidemic and reduce its associated mortality,” they conclude.
This study was supported by Camurus AB. Dr. Tiberg is president and CEO of Camurus AB. A complete list of author disclosures is with the original article. Dr. Volkow and Dr. Compton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adults in treatment for opioid dependence report high satisfaction with buprenorphine injections, in new findings that researchers say could help improve treatment and management of patients with opioid dependence.
In the DEBUT trial, patients who received weekly or monthly depot buprenorphine had significantly higher overall treatment satisfaction, reduced treatment burden, and higher quality-of-life ratings than peers who received daily treatment with sublingual buprenorphine.
“The study’s focus on patient-reported outcomes (PROs) can help to better inform patients and clinicians when selecting treatment options than the clinical traditional outcomes of opioid dependence treatment studies,” lead investigator Fredrik Tiberg, PhD, president and CEO of Camurus, a pharmaceutical company in Lund, Sweden, said in an interview.
“The positive patient experiences with the depot buprenorphine injection reported in the DEBUT study indicate that long-acting treatments could contribute to advancing the quality of care and access to treatment for patients with opioid dependence/use disorder,” said Dr. Tiberg.
The study was published online May 10 in JAMA Network Open.
Novel study
The study was an open-label, parallel-group randomized controlled trial that included 119 patients from six outpatient clinics in Australia; 60 received weekly or monthly depot buprenorphine and 59 received sublingual buprenorphine for 24 weeks.
The primary outcome was global treatment satisfaction, as measured by the 14-question Treatment Satisfaction Questionnaire for Medication (TSQM) at the end of the study at week 24.
The study met its primary endpoint with a significantly higher TSQM global satisfaction score among adults who received depot injections, compared with those who received sublingual buprenorphine (mean score 82.5 vs. 74.3; difference, 8.2; 95% confidence interval, 1.7-14.6; P = .01).
Improvement was also observed for several secondary outcomes, including decreased treatment burden and higher quality of life.
The safety profile was consistent with the known safety profile of buprenorphine, aside from transient, mild-to-moderate injection site reactions.
“To our knowledge, this is the first randomized study that has used a range of PROs to compare outcomes between a long-acting injection and daily dosing of buprenorphine in the treatment of opioid dependence,” the investigators note.
“The study highlights the application of PROs as alternate endpoints to traditional markers of substance use in addiction treatment outcome studies,” they conclude.
Giving patients a voice
In an invited commentary, from most of the work in medication development, including for opioid use disorder.
The current study addresses this very issue in a “well designed and executed” fashion and the results “consistently demonstrated” the superiority of injectable buprenorphine across many outcomes.
The study highlights the importance of considering PRO measures in clinical trials, Dr. Volkow and Dr. Compton say.
“Even if efficacy is no different for various formulations, PROs may provide an important reason to select a new formulation. Patient preferences and apparently improved function may prove to be useful secondary outcomes in medication trials, and the measures used in this new study deserve consideration,” they write.
In addition, the greater treatment satisfaction by patients receiving extended-release buprenorphine suggests that these formulations “might help to improve long-term retention and, as such, be a valuable tool to help combat the current opioid epidemic and reduce its associated mortality,” they conclude.
This study was supported by Camurus AB. Dr. Tiberg is president and CEO of Camurus AB. A complete list of author disclosures is with the original article. Dr. Volkow and Dr. Compton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adults in treatment for opioid dependence report high satisfaction with buprenorphine injections, in new findings that researchers say could help improve treatment and management of patients with opioid dependence.
In the DEBUT trial, patients who received weekly or monthly depot buprenorphine had significantly higher overall treatment satisfaction, reduced treatment burden, and higher quality-of-life ratings than peers who received daily treatment with sublingual buprenorphine.
“The study’s focus on patient-reported outcomes (PROs) can help to better inform patients and clinicians when selecting treatment options than the clinical traditional outcomes of opioid dependence treatment studies,” lead investigator Fredrik Tiberg, PhD, president and CEO of Camurus, a pharmaceutical company in Lund, Sweden, said in an interview.
“The positive patient experiences with the depot buprenorphine injection reported in the DEBUT study indicate that long-acting treatments could contribute to advancing the quality of care and access to treatment for patients with opioid dependence/use disorder,” said Dr. Tiberg.
The study was published online May 10 in JAMA Network Open.
Novel study
The study was an open-label, parallel-group randomized controlled trial that included 119 patients from six outpatient clinics in Australia; 60 received weekly or monthly depot buprenorphine and 59 received sublingual buprenorphine for 24 weeks.
The primary outcome was global treatment satisfaction, as measured by the 14-question Treatment Satisfaction Questionnaire for Medication (TSQM) at the end of the study at week 24.
The study met its primary endpoint with a significantly higher TSQM global satisfaction score among adults who received depot injections, compared with those who received sublingual buprenorphine (mean score 82.5 vs. 74.3; difference, 8.2; 95% confidence interval, 1.7-14.6; P = .01).
Improvement was also observed for several secondary outcomes, including decreased treatment burden and higher quality of life.
The safety profile was consistent with the known safety profile of buprenorphine, aside from transient, mild-to-moderate injection site reactions.
“To our knowledge, this is the first randomized study that has used a range of PROs to compare outcomes between a long-acting injection and daily dosing of buprenorphine in the treatment of opioid dependence,” the investigators note.
“The study highlights the application of PROs as alternate endpoints to traditional markers of substance use in addiction treatment outcome studies,” they conclude.
Giving patients a voice
In an invited commentary, from most of the work in medication development, including for opioid use disorder.
The current study addresses this very issue in a “well designed and executed” fashion and the results “consistently demonstrated” the superiority of injectable buprenorphine across many outcomes.
The study highlights the importance of considering PRO measures in clinical trials, Dr. Volkow and Dr. Compton say.
“Even if efficacy is no different for various formulations, PROs may provide an important reason to select a new formulation. Patient preferences and apparently improved function may prove to be useful secondary outcomes in medication trials, and the measures used in this new study deserve consideration,” they write.
In addition, the greater treatment satisfaction by patients receiving extended-release buprenorphine suggests that these formulations “might help to improve long-term retention and, as such, be a valuable tool to help combat the current opioid epidemic and reduce its associated mortality,” they conclude.
This study was supported by Camurus AB. Dr. Tiberg is president and CEO of Camurus AB. A complete list of author disclosures is with the original article. Dr. Volkow and Dr. Compton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Long-acting injectable antipsychotics cut suicide death risk in half
Results from a large study make a strong case for offering long-acting injectable antipsychotics (LAIs) to patients newly diagnosed with schizophrenia.
Investigators found that among patients who switched to LAIs, mortality was lower and there were fewer suicide attempts in comparison with patients who continued taking the corresponding oral antipsychotic (OAP).
In addition, switching to an LAI antipsychotic within the first 2 years of OAP cut the risk for suicide death by 47%.
“With newly diagnosed schizophrenia, more active consideration of LAIs in this stage for better long-term outcomes (i.e., mortality and suicide risk) should be encouraged, particularly for those who have already exhibited poor adherence attitudes,” Cheng-yi Huang, MD, Bali Psychiatric Center, Ministry of Health and Welfare, New Taipei City, Taiwan, said in an interview.
The study was published online May 11 in JAMA Network Open.
Powerful incentive to switch
Using data from the Taiwan National Health Insurance Research Database, the investigators identified patients newly diagnosed with schizophrenia who received OAPs from 2002 to 2017.
Within this cohort, they defined the LAI group as patients who switched to LAIs and were prescribed LAIs at least four times within 1 year. The LAI group was propensity matched to patients who continued receiving OAPs of the same compounds. There were 2,614 patients in each group (median age, 30 years).
During the 16-year follow-up period, compared with patients who continued taking the OAP, those who switched to the LAI had a 34% lower risk for all-cause mortality (adjusted hazard ratio [aHR], 0.66; 95% confidence interval, 0.54-0.81), a 37% lower risk for natural-cause mortality (aHR, 0.63; 95% CI, 0.52-0.76), and a 28% lower risk for suicide attempts (incidence rate ratio, 0.72; 95% CI, 0.55-0.93).
The risk for suicide mortality was 47% lower for patients who switched to LAIs within the first 2 years of having begun taking the OAP (aHR, 0.53; 95% CI, 0.30-0.92).
A recent study from Canada found that the suicide rate among patients with schizophrenia spectrum disorders was more than 20 times higher than that of the general population.
“Clinically, most psychiatrists use LAIs with a conservative attitude, and the reasons for this attitude are generally not well supported by current scientific evidence,” Dr. Huang and colleagues note in their article.
Dr. Huang said the study provides a powerful incentive to begin treatment with LAIs for patients newly diagnosed with schizophrenia.
“Because this study compared depot versus the same oral compound, as soon as patients show response and tolerability to the OAP, they will benefit much more when switching to LAI of the same compound,” Dr. Huang told this news organization.
‘Remarkably underutilized’
Commenting on the study for an interview, William Carpenter Jr., MD, Maryland Psychiatric Research Center, University of Maryland, Baltimore, said this report is “very important and in a high-quality journal.”
“LAIs have been remarkably underutilized in the U.S. and not considered as main line and initial treatment. All of this is unfortunate attitude, not science,” Dr. Carpenter said.
There is now evidence that the field is shifting toward LAIs as frontline treatment, “at least conceptually and by research leaders,” he noted.
“In this report, the health and suicide information is new, extremely important, and robust. This report should alert clinicians to possible advantage of LAI in suicide prevention,” Dr. Carpenter added.
Also commenting for this news organization, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences, Staten Island University Hospital, New York, said the findings provide “another very robust argument for LAIs.”
“The decrease in all-cause mortality is really interesting,” said Dr. Sullivan, “and it would be interesting to find out whether some of this reflects improved metabolic states” with LAIs versus OAPs.
The finding that people who switched to LAIs within 2 years were at much lower risk for suicide and other mortality represents a “powerful argument for switching within 2 years,” Dr. Sullivan said.
However, in current clinical practice, clinicians often don’t suggest LAIs until patients have suffered repeated acute episodes of illness after not taking their oral antipsychotics. Such episodes have an impact on the individual and on their nervous system, Dr. Sullivan explained.
“That’s really undesirable. We know from other data that the more episodes someone has, the harder it is to get the illness symptoms under control,” he noted.
“We really ought to be thinking preventively about approaches that will decrease the risk of recurrence, and Thinking about LAIs as a preventive measure is a message that hasn’t gotten out to the practice community yet,” Dr. Sullivan added.
The study was supported by the Bali Psychiatric Center, Taiwan, through a grant from the Ministry of Health and Welfare. Dr. Huang, Dr. Carpenter, and Dr. Sullivan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from a large study make a strong case for offering long-acting injectable antipsychotics (LAIs) to patients newly diagnosed with schizophrenia.
Investigators found that among patients who switched to LAIs, mortality was lower and there were fewer suicide attempts in comparison with patients who continued taking the corresponding oral antipsychotic (OAP).
In addition, switching to an LAI antipsychotic within the first 2 years of OAP cut the risk for suicide death by 47%.
“With newly diagnosed schizophrenia, more active consideration of LAIs in this stage for better long-term outcomes (i.e., mortality and suicide risk) should be encouraged, particularly for those who have already exhibited poor adherence attitudes,” Cheng-yi Huang, MD, Bali Psychiatric Center, Ministry of Health and Welfare, New Taipei City, Taiwan, said in an interview.
The study was published online May 11 in JAMA Network Open.
Powerful incentive to switch
Using data from the Taiwan National Health Insurance Research Database, the investigators identified patients newly diagnosed with schizophrenia who received OAPs from 2002 to 2017.
Within this cohort, they defined the LAI group as patients who switched to LAIs and were prescribed LAIs at least four times within 1 year. The LAI group was propensity matched to patients who continued receiving OAPs of the same compounds. There were 2,614 patients in each group (median age, 30 years).
During the 16-year follow-up period, compared with patients who continued taking the OAP, those who switched to the LAI had a 34% lower risk for all-cause mortality (adjusted hazard ratio [aHR], 0.66; 95% confidence interval, 0.54-0.81), a 37% lower risk for natural-cause mortality (aHR, 0.63; 95% CI, 0.52-0.76), and a 28% lower risk for suicide attempts (incidence rate ratio, 0.72; 95% CI, 0.55-0.93).
The risk for suicide mortality was 47% lower for patients who switched to LAIs within the first 2 years of having begun taking the OAP (aHR, 0.53; 95% CI, 0.30-0.92).
A recent study from Canada found that the suicide rate among patients with schizophrenia spectrum disorders was more than 20 times higher than that of the general population.
“Clinically, most psychiatrists use LAIs with a conservative attitude, and the reasons for this attitude are generally not well supported by current scientific evidence,” Dr. Huang and colleagues note in their article.
Dr. Huang said the study provides a powerful incentive to begin treatment with LAIs for patients newly diagnosed with schizophrenia.
“Because this study compared depot versus the same oral compound, as soon as patients show response and tolerability to the OAP, they will benefit much more when switching to LAI of the same compound,” Dr. Huang told this news organization.
‘Remarkably underutilized’
Commenting on the study for an interview, William Carpenter Jr., MD, Maryland Psychiatric Research Center, University of Maryland, Baltimore, said this report is “very important and in a high-quality journal.”
“LAIs have been remarkably underutilized in the U.S. and not considered as main line and initial treatment. All of this is unfortunate attitude, not science,” Dr. Carpenter said.
There is now evidence that the field is shifting toward LAIs as frontline treatment, “at least conceptually and by research leaders,” he noted.
“In this report, the health and suicide information is new, extremely important, and robust. This report should alert clinicians to possible advantage of LAI in suicide prevention,” Dr. Carpenter added.
Also commenting for this news organization, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences, Staten Island University Hospital, New York, said the findings provide “another very robust argument for LAIs.”
“The decrease in all-cause mortality is really interesting,” said Dr. Sullivan, “and it would be interesting to find out whether some of this reflects improved metabolic states” with LAIs versus OAPs.
The finding that people who switched to LAIs within 2 years were at much lower risk for suicide and other mortality represents a “powerful argument for switching within 2 years,” Dr. Sullivan said.
However, in current clinical practice, clinicians often don’t suggest LAIs until patients have suffered repeated acute episodes of illness after not taking their oral antipsychotics. Such episodes have an impact on the individual and on their nervous system, Dr. Sullivan explained.
“That’s really undesirable. We know from other data that the more episodes someone has, the harder it is to get the illness symptoms under control,” he noted.
“We really ought to be thinking preventively about approaches that will decrease the risk of recurrence, and Thinking about LAIs as a preventive measure is a message that hasn’t gotten out to the practice community yet,” Dr. Sullivan added.
The study was supported by the Bali Psychiatric Center, Taiwan, through a grant from the Ministry of Health and Welfare. Dr. Huang, Dr. Carpenter, and Dr. Sullivan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from a large study make a strong case for offering long-acting injectable antipsychotics (LAIs) to patients newly diagnosed with schizophrenia.
Investigators found that among patients who switched to LAIs, mortality was lower and there were fewer suicide attempts in comparison with patients who continued taking the corresponding oral antipsychotic (OAP).
In addition, switching to an LAI antipsychotic within the first 2 years of OAP cut the risk for suicide death by 47%.
“With newly diagnosed schizophrenia, more active consideration of LAIs in this stage for better long-term outcomes (i.e., mortality and suicide risk) should be encouraged, particularly for those who have already exhibited poor adherence attitudes,” Cheng-yi Huang, MD, Bali Psychiatric Center, Ministry of Health and Welfare, New Taipei City, Taiwan, said in an interview.
The study was published online May 11 in JAMA Network Open.
Powerful incentive to switch
Using data from the Taiwan National Health Insurance Research Database, the investigators identified patients newly diagnosed with schizophrenia who received OAPs from 2002 to 2017.
Within this cohort, they defined the LAI group as patients who switched to LAIs and were prescribed LAIs at least four times within 1 year. The LAI group was propensity matched to patients who continued receiving OAPs of the same compounds. There were 2,614 patients in each group (median age, 30 years).
During the 16-year follow-up period, compared with patients who continued taking the OAP, those who switched to the LAI had a 34% lower risk for all-cause mortality (adjusted hazard ratio [aHR], 0.66; 95% confidence interval, 0.54-0.81), a 37% lower risk for natural-cause mortality (aHR, 0.63; 95% CI, 0.52-0.76), and a 28% lower risk for suicide attempts (incidence rate ratio, 0.72; 95% CI, 0.55-0.93).
The risk for suicide mortality was 47% lower for patients who switched to LAIs within the first 2 years of having begun taking the OAP (aHR, 0.53; 95% CI, 0.30-0.92).
A recent study from Canada found that the suicide rate among patients with schizophrenia spectrum disorders was more than 20 times higher than that of the general population.
“Clinically, most psychiatrists use LAIs with a conservative attitude, and the reasons for this attitude are generally not well supported by current scientific evidence,” Dr. Huang and colleagues note in their article.
Dr. Huang said the study provides a powerful incentive to begin treatment with LAIs for patients newly diagnosed with schizophrenia.
“Because this study compared depot versus the same oral compound, as soon as patients show response and tolerability to the OAP, they will benefit much more when switching to LAI of the same compound,” Dr. Huang told this news organization.
‘Remarkably underutilized’
Commenting on the study for an interview, William Carpenter Jr., MD, Maryland Psychiatric Research Center, University of Maryland, Baltimore, said this report is “very important and in a high-quality journal.”
“LAIs have been remarkably underutilized in the U.S. and not considered as main line and initial treatment. All of this is unfortunate attitude, not science,” Dr. Carpenter said.
There is now evidence that the field is shifting toward LAIs as frontline treatment, “at least conceptually and by research leaders,” he noted.
“In this report, the health and suicide information is new, extremely important, and robust. This report should alert clinicians to possible advantage of LAI in suicide prevention,” Dr. Carpenter added.
Also commenting for this news organization, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences, Staten Island University Hospital, New York, said the findings provide “another very robust argument for LAIs.”
“The decrease in all-cause mortality is really interesting,” said Dr. Sullivan, “and it would be interesting to find out whether some of this reflects improved metabolic states” with LAIs versus OAPs.
The finding that people who switched to LAIs within 2 years were at much lower risk for suicide and other mortality represents a “powerful argument for switching within 2 years,” Dr. Sullivan said.
However, in current clinical practice, clinicians often don’t suggest LAIs until patients have suffered repeated acute episodes of illness after not taking their oral antipsychotics. Such episodes have an impact on the individual and on their nervous system, Dr. Sullivan explained.
“That’s really undesirable. We know from other data that the more episodes someone has, the harder it is to get the illness symptoms under control,” he noted.
“We really ought to be thinking preventively about approaches that will decrease the risk of recurrence, and Thinking about LAIs as a preventive measure is a message that hasn’t gotten out to the practice community yet,” Dr. Sullivan added.
The study was supported by the Bali Psychiatric Center, Taiwan, through a grant from the Ministry of Health and Welfare. Dr. Huang, Dr. Carpenter, and Dr. Sullivan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AHA/ACC guidance on ethics, professionalism in cardiovascular care
The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.
The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.
The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .
The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.
“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.
“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.
“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
Road map to improve diversity, achieve allyship
The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.
The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.
The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.
It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.
The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.
“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.
“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.
The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.
It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.
The report also highlights additional opportunities to:
- improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
- identify and assist clinicians who experience mental health conditions, , or
- emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
- increase privacy protections for patient data used in research
- maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
- perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
- expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry
The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.
The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.
This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.
A version of this article first appeared on Medscape.com.
The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.
The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.
The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .
The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.
“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.
“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.
“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
Road map to improve diversity, achieve allyship
The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.
The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.
The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.
It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.
The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.
“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.
“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.
The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.
It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.
The report also highlights additional opportunities to:
- improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
- identify and assist clinicians who experience mental health conditions, , or
- emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
- increase privacy protections for patient data used in research
- maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
- perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
- expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry
The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.
The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.
This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.
A version of this article first appeared on Medscape.com.
The American Heart Association and the American College of Cardiology have issued a new report on medical ethics and professionalism in cardiovascular medicine.
The report addresses a variety of topics including diversity, equity, inclusion, and belonging; racial, ethnic and gender inequities; conflicts of interest; clinician well-being; data privacy; social justice; and modern health care delivery systems.
The 54-page report is based on the proceedings of the joint 2020 Consensus Conference on Professionalism and Ethics, held Oct. 19 and 20, 2020. It was published online May 11 in Circulation and the Journal of the American College of Cardiology .
The 2020 consensus conference on professionalism and ethics came at a time even more fraught than the eras of the three previous meetings on the same topics, held in 1989, 1997, and 2004, the writing group notes.
“We have seen the COVID-19 pandemic challenge the physical and economic health of the entire country, coupled with a series of national tragedies that have awakened the call for social justice,” conference cochair C. Michael Valentine, MD, said in a news release.
“There is no better time than now to review, evaluate, and take a fresh perspective on medical ethics and professionalism,” said Dr. Valentine, professor of medicine at the Heart and Vascular Center, University of Virginia, Charlottesville.
“We hope this report will provide cardiovascular professionals and health systems with the recommendations and tools they need to address conflicts of interest; racial, ethnic, and gender inequities; and improve diversity, inclusion, and wellness among our workforce,” Dr. Valentine added. “The majority of our members are now employed and must be engaged as the leaders for change in cardiovascular care.”
Road map to improve diversity, achieve allyship
The writing committee was made up of a diverse group of cardiologists, internists, and associated health care professionals and laypeople and was organized into five task forces, each addressing a specific topic: conflicts of interest; diversity, equity, inclusion, and belonging; clinician well-being; patient autonomy, privacy, and social justice in health care; and modern health care delivery.
The report serves as a road map to achieve equity, inclusion, and belonging among cardiovascular professionals and calls for ongoing assessment of the professional culture and climate, focused on improving diversity and achieving effective allyship, the writing group says.
The report proposes continuous training to address individual, structural, and systemic racism, sexism, homophobia, classism, and ableism.
It offers recommendations for championing equity in patient care that include an annual review of practice records to look for differences in patient treatment by race, ethnicity, zip code, and primary language.
The report calls for a foundation of training in allyship and antiracism as part of medical school course requirements and experiences: A required course on social justice, race, and racism as part of the first-year curriculum; school programs and professional organizations supporting students, trainees, and members in allyship and antiracism action; and facilitating immersion and partnership with surrounding communities.
“As much as 80% of a person’s health is determined by the social and economic conditions of their environment,” consensus cochair Ivor Benjamin, MD, said in the release.
“To achieve social justice and mitigate health disparities, we must go to the margins and shift our discussions to be inclusive of populations such as rural and marginalized groups from the perspective of health equity lens for all,” said Dr. Benjamin, professor of medicine, Medical College of Wisconsin, Milwaukee.
The report also highlights the need for psychosocial support of the cardiovascular community and recommends that health care organizations prioritize regular assessment of clinicians’ well-being and engagement.
It also recommends addressing the well-being of trainees in postgraduate training programs and calls for an ombudsman program that allows for confidential reporting of mistreatment and access to support.
The report also highlights additional opportunities to:
- improve the efficiency of health information technology, such as electronic health records, and reduce the administrative burden
- identify and assist clinicians who experience mental health conditions, , or
- emphasize patient autonomy using shared decision-making and patient-centered care that is supportive of the individual patient’s values
- increase privacy protections for patient data used in research
- maintain integrity as new ways of delivering care, such as telemedicine, team-based care approaches, and physician-owned specialty centers emerge
- perform routine audits of electronic health records to promote optimal patient care, as well as ethical medical practice
- expand and make mandatory the reporting of intellectual or associational interests in addition to relationships with industry
The report’s details and recommendations will be presented and discussed Saturday, May 15, at 8:00 AM ET, during ACC.21. The session is titled Diversity and Equity: The Means to Expand Inclusion and Belonging.
The AHA will present a live webinar and six-episode podcast series (available on demand) to highlight the report’s details, dialogue, and actionable steps for cardiovascular and health care professionals, researchers, and educators.
This research had no commercial funding. The list of 40 volunteer committee members and coauthors, including their disclosures, are listed in the original report.
A version of this article first appeared on Medscape.com.