User login
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.
Reassuring data on impact of mild COVID-19 on the heart
Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.
“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.
“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).
Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
‘Alarming’ early data
Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.
As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).
To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.
A total of 157 (21.5%) participants seroconverted during the study period.
Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.
The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).
Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.
Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
Limitations and caveats
They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.
The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.
“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.
They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.
The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”
Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .
“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.
Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.
Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.
COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.
“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.
“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).
Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
‘Alarming’ early data
Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.
As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).
To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.
A total of 157 (21.5%) participants seroconverted during the study period.
Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.
The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).
Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.
Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
Limitations and caveats
They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.
The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.
“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.
They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.
The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”
Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .
“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.
Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.
Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.
COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.
“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.
“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).
Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
‘Alarming’ early data
Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.
As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).
To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.
A total of 157 (21.5%) participants seroconverted during the study period.
Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.
The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).
Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.
Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
Limitations and caveats
They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.
The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.
“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.
They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.
The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”
Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .
“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.
Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.
Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.
COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Attending a patient’s funeral: How psychiatrists decide
Psychiatrists often develop long-term relationships with their patients, but what happens when a patient dies? Should the psychiatrist attend the patient’s funeral?
It’s a question Ashley Pettaway, MD, faced as a medical resident at the University of Alabama School of Medicine.
For 2 months, Dr. Pettaway was involved in the day-to-day care of a woman in her 40s who ultimately died. As part of that care, Dr. Pettaway had regular meetings with the patient’s husband and family members.
“The patient was about my mother’s age, so I naturally was kind of attached to her,” Dr. Pettaway told this news organization. After she died, her family invited Dr. Pettaway to the funeral.
“While I couldn’t make it to the funeral, it got me thinking. Should I go? If I go, what do I say? Who do I sit with? How do I introduce myself?” wondered Dr. Pettaway, now a resident in the department of psychiatry and neurobehavioral sciences, University of Virginia, Charlottesville.
She turned to the literature but found very little regarding psychiatrists attending their patients’ funerals. “This was surprising to me because in psychiatry, you can get so engrossed in patients’ lives,” Dr. Pettaway said.
Given the lack of rules or formal guidance on psychiatrists attending patients’ funerals, Dr. Pettaway and her mentor, Gabrielle Marzani, MD, conducted an informal survey of 12 supervising psychiatrists at the University of Virginia.
The survey results were presented at the virtual American Psychiatric Association 2021 Annual Meeting.
Ten of the 12 psychiatrists who were surveyed were caring for a patient who died while under their care. Five of those psychiatrists reported going to at least one patient’s funeral over the course of their career.
Among the psychiatrists who attended a patient’s funeral, their attendance was often based on their clinical intuition, their relationship with the family, or whether the patient was an established presence in the community. In the latter case, the psychiatrist attended as a community member.
The number of years in practice also mattered. Fewer senior faculty reported that they would be hesitant to attend and that they would not attend without a formal invitation from the family. Senior career psychiatrists were more likely to attend and felt that an invitation was not required.
None of the psychiatrists surveyed had received training or guidance on attending patients’ funerals at any point in their career.
Given the absence of formal recommendations, Dr. Pettaway believes increased conversation on this topic as part of residency training programs would help psychiatrists navigate these complex situations.
A complex issue
Commenting on the topic for an interview, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, said this is an “interesting and important topic that is underdiscussed.”
“I don’t think there’s a right answer that applies to every situation,” said Dr. Appelbaum, a past president of the APA.
There will be times, he said, when psychiatrists or other mental health professionals have worked closely with a patient for many years and may have interacted with the family over that period.
“When that patient passes away, they may feel, and the family may feel, that it would be comforting and appropriate for them to be at the funeral,” said Dr. Appelbaum.
However, he added,
“There are obviously a number of complexities involved. One is how the family feels about the relationship with the psychiatrist – whether they were accepting of the reality that the patient had a mental disorder and was in treatment,” he said.
There is also the question of confidentiality, said Dr. Appelbaum.
“If it’s a large funeral and the psychiatrist is just one face in the crowd, that’s not likely to be an issue. But if it’s a relatively small group of mourners, all of whom know each other, and an unknown figure pops up, that could raise questions and perhaps inadvertently reveal to family members or friends that the deceased had a psychiatric condition and was in treatment. That needs to be taken into account as well,” he added.
In cases in which the family invites the psychiatrist, confidentiality is not a concern, and attendance by the psychiatrist is something the patient would have wanted, said Dr. Appelbaum.
How the patient died may also be factor. When a patient dies by suicide, it’s an “emotionally charged situation for both sides,” said Dr. Appelbaum.
In the case of a suicide, he noted, the deceased was often an active patient, and both the psychiatrist and the family are dealing with strong emotions – the psychiatrist with regret over loss of the patient and perhaps with questions as to what could have been done differently, and the family with sorrow but “also sometimes with suspicion or anger in that the psychiatrist somehow failed to keep the patient alive,” Dr. Appelbaum noted.
“In this situation, it’s even more crucial for the psychiatrist or other mental health professionals to take the lead from the family – perhaps to initiate contact to express condolences and inquire delicately about the funeral arrangements and whether their presence would be welcomed,” he said.
The research had no specific funding. Dr. Pettaway and Dr. Appelbaum have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Psychiatrists often develop long-term relationships with their patients, but what happens when a patient dies? Should the psychiatrist attend the patient’s funeral?
It’s a question Ashley Pettaway, MD, faced as a medical resident at the University of Alabama School of Medicine.
For 2 months, Dr. Pettaway was involved in the day-to-day care of a woman in her 40s who ultimately died. As part of that care, Dr. Pettaway had regular meetings with the patient’s husband and family members.
“The patient was about my mother’s age, so I naturally was kind of attached to her,” Dr. Pettaway told this news organization. After she died, her family invited Dr. Pettaway to the funeral.
“While I couldn’t make it to the funeral, it got me thinking. Should I go? If I go, what do I say? Who do I sit with? How do I introduce myself?” wondered Dr. Pettaway, now a resident in the department of psychiatry and neurobehavioral sciences, University of Virginia, Charlottesville.
She turned to the literature but found very little regarding psychiatrists attending their patients’ funerals. “This was surprising to me because in psychiatry, you can get so engrossed in patients’ lives,” Dr. Pettaway said.
Given the lack of rules or formal guidance on psychiatrists attending patients’ funerals, Dr. Pettaway and her mentor, Gabrielle Marzani, MD, conducted an informal survey of 12 supervising psychiatrists at the University of Virginia.
The survey results were presented at the virtual American Psychiatric Association 2021 Annual Meeting.
Ten of the 12 psychiatrists who were surveyed were caring for a patient who died while under their care. Five of those psychiatrists reported going to at least one patient’s funeral over the course of their career.
Among the psychiatrists who attended a patient’s funeral, their attendance was often based on their clinical intuition, their relationship with the family, or whether the patient was an established presence in the community. In the latter case, the psychiatrist attended as a community member.
The number of years in practice also mattered. Fewer senior faculty reported that they would be hesitant to attend and that they would not attend without a formal invitation from the family. Senior career psychiatrists were more likely to attend and felt that an invitation was not required.
None of the psychiatrists surveyed had received training or guidance on attending patients’ funerals at any point in their career.
Given the absence of formal recommendations, Dr. Pettaway believes increased conversation on this topic as part of residency training programs would help psychiatrists navigate these complex situations.
A complex issue
Commenting on the topic for an interview, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, said this is an “interesting and important topic that is underdiscussed.”
“I don’t think there’s a right answer that applies to every situation,” said Dr. Appelbaum, a past president of the APA.
There will be times, he said, when psychiatrists or other mental health professionals have worked closely with a patient for many years and may have interacted with the family over that period.
“When that patient passes away, they may feel, and the family may feel, that it would be comforting and appropriate for them to be at the funeral,” said Dr. Appelbaum.
However, he added,
“There are obviously a number of complexities involved. One is how the family feels about the relationship with the psychiatrist – whether they were accepting of the reality that the patient had a mental disorder and was in treatment,” he said.
There is also the question of confidentiality, said Dr. Appelbaum.
“If it’s a large funeral and the psychiatrist is just one face in the crowd, that’s not likely to be an issue. But if it’s a relatively small group of mourners, all of whom know each other, and an unknown figure pops up, that could raise questions and perhaps inadvertently reveal to family members or friends that the deceased had a psychiatric condition and was in treatment. That needs to be taken into account as well,” he added.
In cases in which the family invites the psychiatrist, confidentiality is not a concern, and attendance by the psychiatrist is something the patient would have wanted, said Dr. Appelbaum.
How the patient died may also be factor. When a patient dies by suicide, it’s an “emotionally charged situation for both sides,” said Dr. Appelbaum.
In the case of a suicide, he noted, the deceased was often an active patient, and both the psychiatrist and the family are dealing with strong emotions – the psychiatrist with regret over loss of the patient and perhaps with questions as to what could have been done differently, and the family with sorrow but “also sometimes with suspicion or anger in that the psychiatrist somehow failed to keep the patient alive,” Dr. Appelbaum noted.
“In this situation, it’s even more crucial for the psychiatrist or other mental health professionals to take the lead from the family – perhaps to initiate contact to express condolences and inquire delicately about the funeral arrangements and whether their presence would be welcomed,” he said.
The research had no specific funding. Dr. Pettaway and Dr. Appelbaum have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Psychiatrists often develop long-term relationships with their patients, but what happens when a patient dies? Should the psychiatrist attend the patient’s funeral?
It’s a question Ashley Pettaway, MD, faced as a medical resident at the University of Alabama School of Medicine.
For 2 months, Dr. Pettaway was involved in the day-to-day care of a woman in her 40s who ultimately died. As part of that care, Dr. Pettaway had regular meetings with the patient’s husband and family members.
“The patient was about my mother’s age, so I naturally was kind of attached to her,” Dr. Pettaway told this news organization. After she died, her family invited Dr. Pettaway to the funeral.
“While I couldn’t make it to the funeral, it got me thinking. Should I go? If I go, what do I say? Who do I sit with? How do I introduce myself?” wondered Dr. Pettaway, now a resident in the department of psychiatry and neurobehavioral sciences, University of Virginia, Charlottesville.
She turned to the literature but found very little regarding psychiatrists attending their patients’ funerals. “This was surprising to me because in psychiatry, you can get so engrossed in patients’ lives,” Dr. Pettaway said.
Given the lack of rules or formal guidance on psychiatrists attending patients’ funerals, Dr. Pettaway and her mentor, Gabrielle Marzani, MD, conducted an informal survey of 12 supervising psychiatrists at the University of Virginia.
The survey results were presented at the virtual American Psychiatric Association 2021 Annual Meeting.
Ten of the 12 psychiatrists who were surveyed were caring for a patient who died while under their care. Five of those psychiatrists reported going to at least one patient’s funeral over the course of their career.
Among the psychiatrists who attended a patient’s funeral, their attendance was often based on their clinical intuition, their relationship with the family, or whether the patient was an established presence in the community. In the latter case, the psychiatrist attended as a community member.
The number of years in practice also mattered. Fewer senior faculty reported that they would be hesitant to attend and that they would not attend without a formal invitation from the family. Senior career psychiatrists were more likely to attend and felt that an invitation was not required.
None of the psychiatrists surveyed had received training or guidance on attending patients’ funerals at any point in their career.
Given the absence of formal recommendations, Dr. Pettaway believes increased conversation on this topic as part of residency training programs would help psychiatrists navigate these complex situations.
A complex issue
Commenting on the topic for an interview, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, said this is an “interesting and important topic that is underdiscussed.”
“I don’t think there’s a right answer that applies to every situation,” said Dr. Appelbaum, a past president of the APA.
There will be times, he said, when psychiatrists or other mental health professionals have worked closely with a patient for many years and may have interacted with the family over that period.
“When that patient passes away, they may feel, and the family may feel, that it would be comforting and appropriate for them to be at the funeral,” said Dr. Appelbaum.
However, he added,
“There are obviously a number of complexities involved. One is how the family feels about the relationship with the psychiatrist – whether they were accepting of the reality that the patient had a mental disorder and was in treatment,” he said.
There is also the question of confidentiality, said Dr. Appelbaum.
“If it’s a large funeral and the psychiatrist is just one face in the crowd, that’s not likely to be an issue. But if it’s a relatively small group of mourners, all of whom know each other, and an unknown figure pops up, that could raise questions and perhaps inadvertently reveal to family members or friends that the deceased had a psychiatric condition and was in treatment. That needs to be taken into account as well,” he added.
In cases in which the family invites the psychiatrist, confidentiality is not a concern, and attendance by the psychiatrist is something the patient would have wanted, said Dr. Appelbaum.
How the patient died may also be factor. When a patient dies by suicide, it’s an “emotionally charged situation for both sides,” said Dr. Appelbaum.
In the case of a suicide, he noted, the deceased was often an active patient, and both the psychiatrist and the family are dealing with strong emotions – the psychiatrist with regret over loss of the patient and perhaps with questions as to what could have been done differently, and the family with sorrow but “also sometimes with suspicion or anger in that the psychiatrist somehow failed to keep the patient alive,” Dr. Appelbaum noted.
“In this situation, it’s even more crucial for the psychiatrist or other mental health professionals to take the lead from the family – perhaps to initiate contact to express condolences and inquire delicately about the funeral arrangements and whether their presence would be welcomed,” he said.
The research had no specific funding. Dr. Pettaway and Dr. Appelbaum have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Support group for Asian Americans uses theater to cope with COVID
An online, culturally based peer support group that uses theater and other creative outlets is helping Asian Americans cope with the COVID-19 pandemic, new research shows.
The findings of the qualitative study suggest that the program could be a model to support the mental health of other minority community groups during the COVID pandemic and beyond, say investigators from the Yale University Child Study Center, New Haven, Conn.
The Yale Compassionate Home, Action Together (CHATogether) group was created to promote emotional wellness among Asian American youth, young adults, and their families.
Early in the pandemic, it expanded its purpose to serve as a COVID-19 support group. Through social media outreach, CHATogether encourages members to cope with COVID-19 by using productive and creative outlets.
“We are a community education program serving Asian American families,” said Eunice Yuen, MD, PhD, the program’s founder and director, who is with the Yale University Child Study Center.
“ such as family conflict and xenophobic attacks,” said Dr. Yuen.
She discussed the program at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Skits, role playing
CHATogether groups consist of people with similar experiences and challenges who support each other through weekly online group meetings, she explained.
Group members work together to create family conflict scenarios and role-play dialogues on topics amplified during the COVID-19 pandemic, such as cross-cultural challenges among Asian Americans, academic expectations in home schooling, and Black Lives Matter and LGBTQ conflicts within Asian families.
Group members create skits that are based on their personal experiences and that allow them to work through their own internal conflicts and gain a sense of agency, said Dr. Yuen.
“CHATogether is really the interface of mental health, art, and theater, and we’re trying to create a vehicle that can be a lighthearted way for people to talk about mental health, especially for Asian American families,” said Dr. Yuen.
Preliminary results from a focus group with 10 CHATogether members who joined the program since the pandemic started identified four major ways in which the program has had a positive impact on the mental health and well-being of participants:
- It provides a safe and supportive environment, strengthens bonds between members, and increases the sense of belonging, thus encouraging engagement.
- It provides structural consistency/stability through regular meetings and consistent group functions. Weekly meetings provide a sense of control and hope in the midst of uncertainty during periods of sheltering in place.
- Through adapting the group to virtual platforms, group members experience the inherent strengths of a growth mindset and cognitive flexibility when facing challenges.
- It supports healthy coping skills through sublimation and altruism.
Looking ahead, Dr. Yuen said, the team plans to investigate the validity and effectiveness of this model and to expand the group to include other minorities, school educators, and medical education for trainees and medical students.
Commenting on the program, briefing moderator Jeffrey Borenstein, MD, president and CEO of the Brain and Behavior Research Foundation and editor-in-chief of Psychiatric News, described the initiative as a “great project that serves as a model that can be used not only for Asian Americans but for other groups.
“I think the key to it is that cultural sensitivity that we need to really take into account and cultural differences among people in order to best engage them and help support them. I think this program does that beautifully,” said Dr. Borenstein.
The work was supported by the APA’s Substance Abuse and Mental Health Services Administration Minority Fellowship, which provides a 1-year fellowship to psychiatry residents committed to addressing minority psychiatric mental health issues. Dr. Yuen and Dr. Borenstein disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An online, culturally based peer support group that uses theater and other creative outlets is helping Asian Americans cope with the COVID-19 pandemic, new research shows.
The findings of the qualitative study suggest that the program could be a model to support the mental health of other minority community groups during the COVID pandemic and beyond, say investigators from the Yale University Child Study Center, New Haven, Conn.
The Yale Compassionate Home, Action Together (CHATogether) group was created to promote emotional wellness among Asian American youth, young adults, and their families.
Early in the pandemic, it expanded its purpose to serve as a COVID-19 support group. Through social media outreach, CHATogether encourages members to cope with COVID-19 by using productive and creative outlets.
“We are a community education program serving Asian American families,” said Eunice Yuen, MD, PhD, the program’s founder and director, who is with the Yale University Child Study Center.
“ such as family conflict and xenophobic attacks,” said Dr. Yuen.
She discussed the program at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Skits, role playing
CHATogether groups consist of people with similar experiences and challenges who support each other through weekly online group meetings, she explained.
Group members work together to create family conflict scenarios and role-play dialogues on topics amplified during the COVID-19 pandemic, such as cross-cultural challenges among Asian Americans, academic expectations in home schooling, and Black Lives Matter and LGBTQ conflicts within Asian families.
Group members create skits that are based on their personal experiences and that allow them to work through their own internal conflicts and gain a sense of agency, said Dr. Yuen.
“CHATogether is really the interface of mental health, art, and theater, and we’re trying to create a vehicle that can be a lighthearted way for people to talk about mental health, especially for Asian American families,” said Dr. Yuen.
Preliminary results from a focus group with 10 CHATogether members who joined the program since the pandemic started identified four major ways in which the program has had a positive impact on the mental health and well-being of participants:
- It provides a safe and supportive environment, strengthens bonds between members, and increases the sense of belonging, thus encouraging engagement.
- It provides structural consistency/stability through regular meetings and consistent group functions. Weekly meetings provide a sense of control and hope in the midst of uncertainty during periods of sheltering in place.
- Through adapting the group to virtual platforms, group members experience the inherent strengths of a growth mindset and cognitive flexibility when facing challenges.
- It supports healthy coping skills through sublimation and altruism.
Looking ahead, Dr. Yuen said, the team plans to investigate the validity and effectiveness of this model and to expand the group to include other minorities, school educators, and medical education for trainees and medical students.
Commenting on the program, briefing moderator Jeffrey Borenstein, MD, president and CEO of the Brain and Behavior Research Foundation and editor-in-chief of Psychiatric News, described the initiative as a “great project that serves as a model that can be used not only for Asian Americans but for other groups.
“I think the key to it is that cultural sensitivity that we need to really take into account and cultural differences among people in order to best engage them and help support them. I think this program does that beautifully,” said Dr. Borenstein.
The work was supported by the APA’s Substance Abuse and Mental Health Services Administration Minority Fellowship, which provides a 1-year fellowship to psychiatry residents committed to addressing minority psychiatric mental health issues. Dr. Yuen and Dr. Borenstein disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An online, culturally based peer support group that uses theater and other creative outlets is helping Asian Americans cope with the COVID-19 pandemic, new research shows.
The findings of the qualitative study suggest that the program could be a model to support the mental health of other minority community groups during the COVID pandemic and beyond, say investigators from the Yale University Child Study Center, New Haven, Conn.
The Yale Compassionate Home, Action Together (CHATogether) group was created to promote emotional wellness among Asian American youth, young adults, and their families.
Early in the pandemic, it expanded its purpose to serve as a COVID-19 support group. Through social media outreach, CHATogether encourages members to cope with COVID-19 by using productive and creative outlets.
“We are a community education program serving Asian American families,” said Eunice Yuen, MD, PhD, the program’s founder and director, who is with the Yale University Child Study Center.
“ such as family conflict and xenophobic attacks,” said Dr. Yuen.
She discussed the program at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Skits, role playing
CHATogether groups consist of people with similar experiences and challenges who support each other through weekly online group meetings, she explained.
Group members work together to create family conflict scenarios and role-play dialogues on topics amplified during the COVID-19 pandemic, such as cross-cultural challenges among Asian Americans, academic expectations in home schooling, and Black Lives Matter and LGBTQ conflicts within Asian families.
Group members create skits that are based on their personal experiences and that allow them to work through their own internal conflicts and gain a sense of agency, said Dr. Yuen.
“CHATogether is really the interface of mental health, art, and theater, and we’re trying to create a vehicle that can be a lighthearted way for people to talk about mental health, especially for Asian American families,” said Dr. Yuen.
Preliminary results from a focus group with 10 CHATogether members who joined the program since the pandemic started identified four major ways in which the program has had a positive impact on the mental health and well-being of participants:
- It provides a safe and supportive environment, strengthens bonds between members, and increases the sense of belonging, thus encouraging engagement.
- It provides structural consistency/stability through regular meetings and consistent group functions. Weekly meetings provide a sense of control and hope in the midst of uncertainty during periods of sheltering in place.
- Through adapting the group to virtual platforms, group members experience the inherent strengths of a growth mindset and cognitive flexibility when facing challenges.
- It supports healthy coping skills through sublimation and altruism.
Looking ahead, Dr. Yuen said, the team plans to investigate the validity and effectiveness of this model and to expand the group to include other minorities, school educators, and medical education for trainees and medical students.
Commenting on the program, briefing moderator Jeffrey Borenstein, MD, president and CEO of the Brain and Behavior Research Foundation and editor-in-chief of Psychiatric News, described the initiative as a “great project that serves as a model that can be used not only for Asian Americans but for other groups.
“I think the key to it is that cultural sensitivity that we need to really take into account and cultural differences among people in order to best engage them and help support them. I think this program does that beautifully,” said Dr. Borenstein.
The work was supported by the APA’s Substance Abuse and Mental Health Services Administration Minority Fellowship, which provides a 1-year fellowship to psychiatry residents committed to addressing minority psychiatric mental health issues. Dr. Yuen and Dr. Borenstein disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Novel drug offers rapid relief from agitation in serious mental illness
An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.
The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Noninvasive option
Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.
“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.
The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).
Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.
Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).
PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).
Compared with placebo, and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.
The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.
All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
Nipping it in the bud
SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.
Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).
Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.
BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.
“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.
“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.
Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
Negotiation first, medication second
Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.
“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.
“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.
He also noted that patients in the SERENITY trials had moderate to severe acute agitation.
“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.
“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.
He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.
A version of this article first appeared on Medscape.com.
An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.
The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Noninvasive option
Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.
“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.
The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).
Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.
Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).
PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).
Compared with placebo, and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.
The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.
All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
Nipping it in the bud
SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.
Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).
Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.
BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.
“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.
“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.
Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
Negotiation first, medication second
Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.
“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.
“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.
He also noted that patients in the SERENITY trials had moderate to severe acute agitation.
“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.
“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.
He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.
A version of this article first appeared on Medscape.com.
An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show.
For both disorders, BXCL501 showed “superiority over placebo” by meeting the primary endpoint of reduction of agitation as measured by the excited component of the Positive and Negative Syndrome Scale (PANSS), study investigator Leslie Citrome, MD, MPH, department of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in an interview.
The findings were presented at the annual meeting of the American Psychiatric Association, which was held as a virtual live event.
Noninvasive option
Acute agitation in patients with schizophrenia or BD is often encountered in emergency departments (EDs) and inpatient units. When nondrug tactics fail to calm the patient, drug options include injectable antipsychotics or benzodiazepines. BXCL501 is a thin, orally dissolving film for sublingual or buccal use.
“Dexmedetomidine is a highly-selective alpha-2a receptor agonist and we haven’t really had one of those before in psychiatry for this purpose. And we haven’t had much in the way of orally dissolving thin films that are absorbed in the oral mucosa so this represents an opportunity to provide a potential intervention that does not require an injection and yet could possibly be of use in people who are agitated,” Dr. Citrome said.
The study, known as SERENITY I, included 380 adults (mean age 45.6 years, 63% male) with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and acute agitation in the ED (total score ≥ 14 on the PANSS-Excited Component (PEC) scale at baseline and a score ≥ 4 on at least one of the five PEC items).
Patients were randomly allocated to a single oral dose of BXCL501: 120 mcg, 180 mcg, or placebo. A total of 372 patients (97.9%) completed the study.
Mean PEC total score was 17.6 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs. placebo).
PEC response rates (≥ 40% reduction from baseline) were 80.6% and 89.6% with BXCL501 120 mcg and 180 mcg versus 47.6% with placebo (P < .0001 vs. placebo).
Compared with placebo, and in the Agitation and Calmness Evaluation Scale (ACES) at 2 hours post dosing.
The incidence of adverse events (AE) was 39.5%, 37.3%, and 15.1% with BXCL501 120 mg, 180 mg, and placebo groups.
All AEs were mild or moderate. The most common AEs with BXCL501 were somnolence, dizziness, dry mouth, hypotension, orthostatic hypotension, hypoesthesia, and paresthesia. No drug-related severe or serious AEs occurred.
Nipping it in the bud
SERENITY II had a similar design. This study included 380 adults (mean age 48, 55% female) with bipolar I or II disorder and acute agitation in the ED (total score ≥14 on the PEC scale at baseline and a score ≥4 on at least one PEC item). A total of 362 (95.3%) of patients completed the study.
Mean PEC total score was 18 at baseline. The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -9.0 and -10.4 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.9 for placebo (P < .0001 vs. placebo).
Bipolar patients also saw significant improvement on the secondary outcomes of CGI-I and ACES, with an adverse event profile similar to that seen in patients with schizophrenia.
BXCL501 demonstrated “rapid, robust and clinically meaningful efficacy” in both patient populations and represents a “novel, noninvasive and well tolerated treatment of agitation,” the investigators concluded in their APA abstracts.
“Patients who are agitated are in psychic pain and they want relief from this psychic pain. We’re also worried that they might get worse and that agitation escalates to aggression potentially requiring restraints. We want to avoid that,” Dr. Citrome said.
“By nipping it in the bud with a pharmacological intervention, we can ease their psychic pain and we can manage a potentially dangerous situation. Offering an oral medicine that would work quickly would be ideal in my mind and patients might potentially be more accepting of that than an injection,” Dr. Citrome said.
Based on the SERENITY I and II data, BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration.
Negotiation first, medication second
Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York (N.Y.) University, cautioned that, “when we talk about treating an agitated patient, medication is only part of the picture.
“There is a negotiating process with the patient. Number one, you offer them an environment that is conducive to making them feel calm, safe, and secure and that they are being listened to. Providing all of those things sometimes can be very helpful,” said Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York City.
“If someone starts throwing chairs at you or assaulting you, that is not really the time to negotiate a medicine; you basically have to restrain the patient, and many times give them intramuscular medicine,” Dr. Ahmad said.
He also noted that patients in the SERENITY trials had moderate to severe acute agitation.
“These are people you can potentially negotiate with. But again, when a patient crosses a certain line, you have to immediately do something and that could be intramuscular injection or something oral, which they may spit right in your face, which has happened numerous times,” Dr. Ahmad said.
“I don’t think intramuscular options will ever go away but an oral agent could be a useful tool as well,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York City.
He cautioned that clinicians are not going to be using this medicine in their offices. “If a patient walks in and is floridly psychotic, you will need to call 911. We’re really talking about its use either in the ED or acute inpatient setting,” Dr. Ahmad said.
A version of this article first appeared on Medscape.com.
Nutritional support may be lifesaving in heart failure
Personalized nutritional support for adults hospitalized with chronic heart failure and deemed to be at high nutritional risk reduced the risk of death or adverse cardiovascular events, compared with standard hospital food, new research indicates.
The Swiss EFFORT trial focused on patients with chronic heart failure and high risk of malnutrition defined by low body mass index, weight loss, and low food intake upon hospital admission.
“This high-risk group of chronic heart failure patients showed a significant improvement in mortality over 30 and 180 days, as well as other clinical outcomes, when individualized nutritional support interventions were offered to patients,” Philipp Schuetz, MD, MPH, Kantonsspital Aarau, Switzerland, said in an interview.
“While monitoring the nutritional status should be done also in outpatient settings by [general practitioners], malnutrition screening upon hospital admission may help to identify high-risk patients with high risk for nutritional status deterioration during the hospital stay who will benefit from nutritional assessment and treatment,” said Dr. Schuetz.
The study was published online May 3 in the Journal of the American College of Cardiology.
It’s not all about salt
The findings are based on a prespecified secondary analysis of outcomes in 645 patients (median age, 78.8 years, 52% men) hospitalized with chronic heart failure who participated in the open-label EFFORT study.
One-third of patients were hospitalized for acute decompensated heart failure and two-thirds had chronic heart failure and other acute medical illnesses requiring hospitalization.
All patients were at risk of malnutrition based on a Nutritional Risk Screening (NRS) score of 3 points or higher. They were randomly allocated 1:1 to individualized nutritional support to reach energy, protein, and micronutrient goals or usual hospital food (control group).
By 30 days, 27 of 321 patients (8.4%) receiving nutritional support had died compared with 48 of 324 patients (14.8%) in the control group (adjusted odds ratio [OR]: 0.44; 95% confidence interval, 0.26-0.75; P = .002)
Patients with high nutritional risk (NRS >4 points) showed the most benefit from nutritional support.
Compared with patients with moderate nutritional risk scores (NRS score 3-4), those with high nutritional risk (NRS >4) had a highly significant 65% increased mortality risk over 180 days.
The individual component of the NRS with the strongest association with mortality was low food intake in the week before hospitalization.
Patients who received nutritional support in the hospital also had a lower risk for major cardiovascular events at 30 days (17.4% vs. 26.9%; OR, 0.50; 95% CI, 0.34-0.75; P = .001).
“Historically, cardiologists and internists caring for patients with heart failure have mainly focused on salt-restrictive diets to reduce blood volume and thus optimize heart function. Yet, reduction of salt intake has not been shown to effectively improve clinical outcome but may, on the contrary, increase the risk of malnutrition as low-salt diets are often not tasty,” Dr. Schuetz said.
“Our data suggest that we should move our focus away from salt-restrictive diets to high-protein diets to cover individual nutritional goals in this high-risk group of patients, which includes screening, assessment, and nutritional support by dietitians,” Dr. Schuetz said.
In a linked editorial, Sheldon Gottlieb, MD, Johns Hopkins University, Baltimore, said there has been “relatively little attention” paid to the role of diet in heart failure other than recommending reduced salt intake.
In fact, in the 2021 American College of Cardiology expert consensus recommendations for optimizing heart failure treatment, roughly five words are devoted to diet and exercise and there is no mention of nutrition assessment by a dietitian, he points out.
“This study adds another tile to the still-fragmentary mosaic picture of the patient with heart failure at nutritional risk who might benefit from nutritional support,” Dr. Dr. Gottlieb wrote.
“ ‘Good medical care’ dictates that all hospitalized patients deserve to have a standardized nutritional assessment; the challenge remains: how to determine which patient with heart failure at nutritional risk will benefit by medical nutrition therapy,” Dr. Gottlieb said.
The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau provided funding for the trial. Dr. Schuetz’s institution has previously received unrestricted grant money unrelated to this project from Nestle Health Science and Abbott Nutrition. Dr. Gottlieb owns a federal trademark for the “Greens, Beans, and Leans” diet, and has a pending federal trademark for “FLOATS”: flax + oats cereal.
A version of this article first appeared on Medscape.com.
Personalized nutritional support for adults hospitalized with chronic heart failure and deemed to be at high nutritional risk reduced the risk of death or adverse cardiovascular events, compared with standard hospital food, new research indicates.
The Swiss EFFORT trial focused on patients with chronic heart failure and high risk of malnutrition defined by low body mass index, weight loss, and low food intake upon hospital admission.
“This high-risk group of chronic heart failure patients showed a significant improvement in mortality over 30 and 180 days, as well as other clinical outcomes, when individualized nutritional support interventions were offered to patients,” Philipp Schuetz, MD, MPH, Kantonsspital Aarau, Switzerland, said in an interview.
“While monitoring the nutritional status should be done also in outpatient settings by [general practitioners], malnutrition screening upon hospital admission may help to identify high-risk patients with high risk for nutritional status deterioration during the hospital stay who will benefit from nutritional assessment and treatment,” said Dr. Schuetz.
The study was published online May 3 in the Journal of the American College of Cardiology.
It’s not all about salt
The findings are based on a prespecified secondary analysis of outcomes in 645 patients (median age, 78.8 years, 52% men) hospitalized with chronic heart failure who participated in the open-label EFFORT study.
One-third of patients were hospitalized for acute decompensated heart failure and two-thirds had chronic heart failure and other acute medical illnesses requiring hospitalization.
All patients were at risk of malnutrition based on a Nutritional Risk Screening (NRS) score of 3 points or higher. They were randomly allocated 1:1 to individualized nutritional support to reach energy, protein, and micronutrient goals or usual hospital food (control group).
By 30 days, 27 of 321 patients (8.4%) receiving nutritional support had died compared with 48 of 324 patients (14.8%) in the control group (adjusted odds ratio [OR]: 0.44; 95% confidence interval, 0.26-0.75; P = .002)
Patients with high nutritional risk (NRS >4 points) showed the most benefit from nutritional support.
Compared with patients with moderate nutritional risk scores (NRS score 3-4), those with high nutritional risk (NRS >4) had a highly significant 65% increased mortality risk over 180 days.
The individual component of the NRS with the strongest association with mortality was low food intake in the week before hospitalization.
Patients who received nutritional support in the hospital also had a lower risk for major cardiovascular events at 30 days (17.4% vs. 26.9%; OR, 0.50; 95% CI, 0.34-0.75; P = .001).
“Historically, cardiologists and internists caring for patients with heart failure have mainly focused on salt-restrictive diets to reduce blood volume and thus optimize heart function. Yet, reduction of salt intake has not been shown to effectively improve clinical outcome but may, on the contrary, increase the risk of malnutrition as low-salt diets are often not tasty,” Dr. Schuetz said.
“Our data suggest that we should move our focus away from salt-restrictive diets to high-protein diets to cover individual nutritional goals in this high-risk group of patients, which includes screening, assessment, and nutritional support by dietitians,” Dr. Schuetz said.
In a linked editorial, Sheldon Gottlieb, MD, Johns Hopkins University, Baltimore, said there has been “relatively little attention” paid to the role of diet in heart failure other than recommending reduced salt intake.
In fact, in the 2021 American College of Cardiology expert consensus recommendations for optimizing heart failure treatment, roughly five words are devoted to diet and exercise and there is no mention of nutrition assessment by a dietitian, he points out.
“This study adds another tile to the still-fragmentary mosaic picture of the patient with heart failure at nutritional risk who might benefit from nutritional support,” Dr. Dr. Gottlieb wrote.
“ ‘Good medical care’ dictates that all hospitalized patients deserve to have a standardized nutritional assessment; the challenge remains: how to determine which patient with heart failure at nutritional risk will benefit by medical nutrition therapy,” Dr. Gottlieb said.
The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau provided funding for the trial. Dr. Schuetz’s institution has previously received unrestricted grant money unrelated to this project from Nestle Health Science and Abbott Nutrition. Dr. Gottlieb owns a federal trademark for the “Greens, Beans, and Leans” diet, and has a pending federal trademark for “FLOATS”: flax + oats cereal.
A version of this article first appeared on Medscape.com.
Personalized nutritional support for adults hospitalized with chronic heart failure and deemed to be at high nutritional risk reduced the risk of death or adverse cardiovascular events, compared with standard hospital food, new research indicates.
The Swiss EFFORT trial focused on patients with chronic heart failure and high risk of malnutrition defined by low body mass index, weight loss, and low food intake upon hospital admission.
“This high-risk group of chronic heart failure patients showed a significant improvement in mortality over 30 and 180 days, as well as other clinical outcomes, when individualized nutritional support interventions were offered to patients,” Philipp Schuetz, MD, MPH, Kantonsspital Aarau, Switzerland, said in an interview.
“While monitoring the nutritional status should be done also in outpatient settings by [general practitioners], malnutrition screening upon hospital admission may help to identify high-risk patients with high risk for nutritional status deterioration during the hospital stay who will benefit from nutritional assessment and treatment,” said Dr. Schuetz.
The study was published online May 3 in the Journal of the American College of Cardiology.
It’s not all about salt
The findings are based on a prespecified secondary analysis of outcomes in 645 patients (median age, 78.8 years, 52% men) hospitalized with chronic heart failure who participated in the open-label EFFORT study.
One-third of patients were hospitalized for acute decompensated heart failure and two-thirds had chronic heart failure and other acute medical illnesses requiring hospitalization.
All patients were at risk of malnutrition based on a Nutritional Risk Screening (NRS) score of 3 points or higher. They were randomly allocated 1:1 to individualized nutritional support to reach energy, protein, and micronutrient goals or usual hospital food (control group).
By 30 days, 27 of 321 patients (8.4%) receiving nutritional support had died compared with 48 of 324 patients (14.8%) in the control group (adjusted odds ratio [OR]: 0.44; 95% confidence interval, 0.26-0.75; P = .002)
Patients with high nutritional risk (NRS >4 points) showed the most benefit from nutritional support.
Compared with patients with moderate nutritional risk scores (NRS score 3-4), those with high nutritional risk (NRS >4) had a highly significant 65% increased mortality risk over 180 days.
The individual component of the NRS with the strongest association with mortality was low food intake in the week before hospitalization.
Patients who received nutritional support in the hospital also had a lower risk for major cardiovascular events at 30 days (17.4% vs. 26.9%; OR, 0.50; 95% CI, 0.34-0.75; P = .001).
“Historically, cardiologists and internists caring for patients with heart failure have mainly focused on salt-restrictive diets to reduce blood volume and thus optimize heart function. Yet, reduction of salt intake has not been shown to effectively improve clinical outcome but may, on the contrary, increase the risk of malnutrition as low-salt diets are often not tasty,” Dr. Schuetz said.
“Our data suggest that we should move our focus away from salt-restrictive diets to high-protein diets to cover individual nutritional goals in this high-risk group of patients, which includes screening, assessment, and nutritional support by dietitians,” Dr. Schuetz said.
In a linked editorial, Sheldon Gottlieb, MD, Johns Hopkins University, Baltimore, said there has been “relatively little attention” paid to the role of diet in heart failure other than recommending reduced salt intake.
In fact, in the 2021 American College of Cardiology expert consensus recommendations for optimizing heart failure treatment, roughly five words are devoted to diet and exercise and there is no mention of nutrition assessment by a dietitian, he points out.
“This study adds another tile to the still-fragmentary mosaic picture of the patient with heart failure at nutritional risk who might benefit from nutritional support,” Dr. Dr. Gottlieb wrote.
“ ‘Good medical care’ dictates that all hospitalized patients deserve to have a standardized nutritional assessment; the challenge remains: how to determine which patient with heart failure at nutritional risk will benefit by medical nutrition therapy,” Dr. Gottlieb said.
The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau provided funding for the trial. Dr. Schuetz’s institution has previously received unrestricted grant money unrelated to this project from Nestle Health Science and Abbott Nutrition. Dr. Gottlieb owns a federal trademark for the “Greens, Beans, and Leans” diet, and has a pending federal trademark for “FLOATS”: flax + oats cereal.
A version of this article first appeared on Medscape.com.