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Who can call themselves ‘doctor’? The debate heats up
Who Should Get to Be Called ‘Doctor’? shows. The topic has clearly struck a nerve, since a record number of respondents – over 12,000 – voted in the poll.
Most physicians think it’s appropriate for people with other doctorate degrees such as a PhD or EdD to call themselves ‘doctor,’ although slightly more than half said it depends on the context.
The controversy over who gets to be called a doctor was reignited when a Wall Street Journal opinion piece criticized First Lady Jill Biden, EdD, for wanting to be called “Dr Biden.” The piece also challenged the idea that having a PhD is worth the honorific of ‘doctor.’
Medical ethicist Arthur Caplan, PhD, disagreed with that viewpoint, saying the context matters. For example, he prefers to be called “professor” when he’s introduced to the public rather than “doctor” to avoid any confusion about his professional status.
More than 12,000 clinicians including physicians, medical students, nurses, pharmacists, and other health care professionals responded to the poll. The non-MD clinicians were the most likely to say it was always appropriate to be called “doctor” while physicians were the least likely.
Context matters
Large percentages of clinicians – 54% of doctors, 62% of medical students, and 41% of nurses – said that the context matters for being called “doctor.’’
“I earned my PhD in 1995 and my MD in 2000. I think it is contextual. In a research or University setting, “Dr.” seems appropriate for a PhD. That same person in public should probably not hold themselves out as “Dr.” So, maybe MDs and DOs can choose, while others maintain the title in their specific setting.”
Some readers proposed that people with MDs call themselves physicians rather than doctors. Said one: “Anyone with a terminal doctorate degree has the right to use the word doctor. As a physician when someone asks what I do, I say: ‘I am a physician.’ Problem solved. There can only be one physician but there are many types of doctors.”
Physicians and nurses differed most in their views. Just 24% of physicians said it was always appropriate for people with other doctorate degrees to call themselves doctor whereas about an equal number (22%) thought it was never appropriate.
In contrast, 43% of nurses (including advance practice nurses) said it was always appropriate for people with non-MD doctorates to be called doctor. Only 16% said it’s never appropriate.
This difference may reflect the growing number of nurses with doctorate degrees, either a DNP or PhD, who want to be called doctor in clinical settings.
Age made a difference too. Only 16% of physicians younger than age 45 said it was always appropriate for people with non-MD doctorate degrees to be called doctor, compared with 27% of physicians aged 45 and up.
Medical students (31%) were also more likely than physicians to say it was always appropriate for non-MD doctorates to use the title “doctor” and 64% said it depends on the context. This was noteworthy because twice as many medical students as physicians (16% vs. 8%) said they work in academia, research, or military government settings.
Too many ‘doctors’ confuse the public
Physicians (70%) were also more likely to say it was always or often confusing for the public to hear someone without a medical degree addressed as “doctor.” Only 6% of physicians thought it was never or rarely confusing.
Nurses disagreed. Just 45% said that it was always or often confusing while 16% said it was never or rarely confusing.
Medical students were more aligned with physicians on this issue – 60% said it was always or often confusing to the public and just 10% said it was never or rarely confusing.
One reader commented, “The problem is the confusion the ‘doctor’ title causes for patients, especially in a hospital setting. Is the ‘doctor’ a physician, a pharmacist, a psychologist, a nurse, etc., etc.? We need to think not of our own egos but if and how the confusion about this plethora of titles may be hindering good patient care.”
These concerns are not unfounded. The American Medical Association reported in its Truth in Advertising campaign that “patients mistake physicians with nonphysician providers” based on an online survey of 802 adults in 2018. The participants thought these specialists were MDs: dentists (61%), podiatrists (67%), optometrists (47%), psychologists (43%), doctors of nursing (39%), and chiropractors (27%).
The AMA has advocated that states pass the “Health Care Professional Transparency Act,” which New Jersey has enacted. The law requires all health care professionals dealing with patients to wear a name tag that clearly identifies their licensure. Health care professionals must also display their education, training, and licensure in their office.
A version of this article first appeared on Medscape.com.
Who Should Get to Be Called ‘Doctor’? shows. The topic has clearly struck a nerve, since a record number of respondents – over 12,000 – voted in the poll.
Most physicians think it’s appropriate for people with other doctorate degrees such as a PhD or EdD to call themselves ‘doctor,’ although slightly more than half said it depends on the context.
The controversy over who gets to be called a doctor was reignited when a Wall Street Journal opinion piece criticized First Lady Jill Biden, EdD, for wanting to be called “Dr Biden.” The piece also challenged the idea that having a PhD is worth the honorific of ‘doctor.’
Medical ethicist Arthur Caplan, PhD, disagreed with that viewpoint, saying the context matters. For example, he prefers to be called “professor” when he’s introduced to the public rather than “doctor” to avoid any confusion about his professional status.
More than 12,000 clinicians including physicians, medical students, nurses, pharmacists, and other health care professionals responded to the poll. The non-MD clinicians were the most likely to say it was always appropriate to be called “doctor” while physicians were the least likely.
Context matters
Large percentages of clinicians – 54% of doctors, 62% of medical students, and 41% of nurses – said that the context matters for being called “doctor.’’
“I earned my PhD in 1995 and my MD in 2000. I think it is contextual. In a research or University setting, “Dr.” seems appropriate for a PhD. That same person in public should probably not hold themselves out as “Dr.” So, maybe MDs and DOs can choose, while others maintain the title in their specific setting.”
Some readers proposed that people with MDs call themselves physicians rather than doctors. Said one: “Anyone with a terminal doctorate degree has the right to use the word doctor. As a physician when someone asks what I do, I say: ‘I am a physician.’ Problem solved. There can only be one physician but there are many types of doctors.”
Physicians and nurses differed most in their views. Just 24% of physicians said it was always appropriate for people with other doctorate degrees to call themselves doctor whereas about an equal number (22%) thought it was never appropriate.
In contrast, 43% of nurses (including advance practice nurses) said it was always appropriate for people with non-MD doctorates to be called doctor. Only 16% said it’s never appropriate.
This difference may reflect the growing number of nurses with doctorate degrees, either a DNP or PhD, who want to be called doctor in clinical settings.
Age made a difference too. Only 16% of physicians younger than age 45 said it was always appropriate for people with non-MD doctorate degrees to be called doctor, compared with 27% of physicians aged 45 and up.
Medical students (31%) were also more likely than physicians to say it was always appropriate for non-MD doctorates to use the title “doctor” and 64% said it depends on the context. This was noteworthy because twice as many medical students as physicians (16% vs. 8%) said they work in academia, research, or military government settings.
Too many ‘doctors’ confuse the public
Physicians (70%) were also more likely to say it was always or often confusing for the public to hear someone without a medical degree addressed as “doctor.” Only 6% of physicians thought it was never or rarely confusing.
Nurses disagreed. Just 45% said that it was always or often confusing while 16% said it was never or rarely confusing.
Medical students were more aligned with physicians on this issue – 60% said it was always or often confusing to the public and just 10% said it was never or rarely confusing.
One reader commented, “The problem is the confusion the ‘doctor’ title causes for patients, especially in a hospital setting. Is the ‘doctor’ a physician, a pharmacist, a psychologist, a nurse, etc., etc.? We need to think not of our own egos but if and how the confusion about this plethora of titles may be hindering good patient care.”
These concerns are not unfounded. The American Medical Association reported in its Truth in Advertising campaign that “patients mistake physicians with nonphysician providers” based on an online survey of 802 adults in 2018. The participants thought these specialists were MDs: dentists (61%), podiatrists (67%), optometrists (47%), psychologists (43%), doctors of nursing (39%), and chiropractors (27%).
The AMA has advocated that states pass the “Health Care Professional Transparency Act,” which New Jersey has enacted. The law requires all health care professionals dealing with patients to wear a name tag that clearly identifies their licensure. Health care professionals must also display their education, training, and licensure in their office.
A version of this article first appeared on Medscape.com.
Who Should Get to Be Called ‘Doctor’? shows. The topic has clearly struck a nerve, since a record number of respondents – over 12,000 – voted in the poll.
Most physicians think it’s appropriate for people with other doctorate degrees such as a PhD or EdD to call themselves ‘doctor,’ although slightly more than half said it depends on the context.
The controversy over who gets to be called a doctor was reignited when a Wall Street Journal opinion piece criticized First Lady Jill Biden, EdD, for wanting to be called “Dr Biden.” The piece also challenged the idea that having a PhD is worth the honorific of ‘doctor.’
Medical ethicist Arthur Caplan, PhD, disagreed with that viewpoint, saying the context matters. For example, he prefers to be called “professor” when he’s introduced to the public rather than “doctor” to avoid any confusion about his professional status.
More than 12,000 clinicians including physicians, medical students, nurses, pharmacists, and other health care professionals responded to the poll. The non-MD clinicians were the most likely to say it was always appropriate to be called “doctor” while physicians were the least likely.
Context matters
Large percentages of clinicians – 54% of doctors, 62% of medical students, and 41% of nurses – said that the context matters for being called “doctor.’’
“I earned my PhD in 1995 and my MD in 2000. I think it is contextual. In a research or University setting, “Dr.” seems appropriate for a PhD. That same person in public should probably not hold themselves out as “Dr.” So, maybe MDs and DOs can choose, while others maintain the title in their specific setting.”
Some readers proposed that people with MDs call themselves physicians rather than doctors. Said one: “Anyone with a terminal doctorate degree has the right to use the word doctor. As a physician when someone asks what I do, I say: ‘I am a physician.’ Problem solved. There can only be one physician but there are many types of doctors.”
Physicians and nurses differed most in their views. Just 24% of physicians said it was always appropriate for people with other doctorate degrees to call themselves doctor whereas about an equal number (22%) thought it was never appropriate.
In contrast, 43% of nurses (including advance practice nurses) said it was always appropriate for people with non-MD doctorates to be called doctor. Only 16% said it’s never appropriate.
This difference may reflect the growing number of nurses with doctorate degrees, either a DNP or PhD, who want to be called doctor in clinical settings.
Age made a difference too. Only 16% of physicians younger than age 45 said it was always appropriate for people with non-MD doctorate degrees to be called doctor, compared with 27% of physicians aged 45 and up.
Medical students (31%) were also more likely than physicians to say it was always appropriate for non-MD doctorates to use the title “doctor” and 64% said it depends on the context. This was noteworthy because twice as many medical students as physicians (16% vs. 8%) said they work in academia, research, or military government settings.
Too many ‘doctors’ confuse the public
Physicians (70%) were also more likely to say it was always or often confusing for the public to hear someone without a medical degree addressed as “doctor.” Only 6% of physicians thought it was never or rarely confusing.
Nurses disagreed. Just 45% said that it was always or often confusing while 16% said it was never or rarely confusing.
Medical students were more aligned with physicians on this issue – 60% said it was always or often confusing to the public and just 10% said it was never or rarely confusing.
One reader commented, “The problem is the confusion the ‘doctor’ title causes for patients, especially in a hospital setting. Is the ‘doctor’ a physician, a pharmacist, a psychologist, a nurse, etc., etc.? We need to think not of our own egos but if and how the confusion about this plethora of titles may be hindering good patient care.”
These concerns are not unfounded. The American Medical Association reported in its Truth in Advertising campaign that “patients mistake physicians with nonphysician providers” based on an online survey of 802 adults in 2018. The participants thought these specialists were MDs: dentists (61%), podiatrists (67%), optometrists (47%), psychologists (43%), doctors of nursing (39%), and chiropractors (27%).
The AMA has advocated that states pass the “Health Care Professional Transparency Act,” which New Jersey has enacted. The law requires all health care professionals dealing with patients to wear a name tag that clearly identifies their licensure. Health care professionals must also display their education, training, and licensure in their office.
A version of this article first appeared on Medscape.com.
Moderna announces first data showing efficacy of COVID-19 vaccine booster in development
among people already vaccinated for COVID-19, according to first results released May 5.
Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.
“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.
The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.
Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.
The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.
In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.
“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.
Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.
The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.
In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.
A version of this article first appeared on Medscape.com.
among people already vaccinated for COVID-19, according to first results released May 5.
Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.
“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.
The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.
Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.
The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.
In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.
“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.
Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.
The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.
In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.
A version of this article first appeared on Medscape.com.
among people already vaccinated for COVID-19, according to first results released May 5.
Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.
“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.
The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.
Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.
The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.
In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.
“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.
Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.
The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.
In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.
A version of this article first appeared on Medscape.com.
Hypertension worsened by commonly used prescription meds
Nearly half of these American adults had hypertension, and in this subgroup, 18.5% reported using a prescription drug known to increase blood pressure. The most widely used class of agents with this effect was antidepressants, used by 8.7%; followed by nonsteroidal anti-inflammatory drugs (NSAIDs), used by 6.5%; steroids, 1.9%; estrogens, 1.7%; and several other agents each used by fewer than 1% of the study cohort, John Vitarello, MD, said during a press briefing on reports from the upcoming annual scientific sessions of the American College of Cardiology.
He and his associates estimated that this use of prescription drugs known to raise blood pressure could be what stands in the way of some 560,000-2.2 million Americans from having their hypertension under control, depending on the exact blood pressure impact that various pressure-increasing drugs have and presuming that half of those on blood pressure increasing agents could stop them and switch to alternative agents, said Dr. Vitarello, a researcher at Beth Israel Deaconess Medical Center in Boston.
He also highlighted that the study assessed only prescription drugs and did not examine OTC drug use, which may be especially relevant for the many people who regularly take NSAIDs.
“Clinicians should review the prescription and OTC drug use of patients with hypertension and consider stopping drugs that increase blood pressure or switching the patient to alternatives” that are blood pressure neutral, Dr. Vitarello said during the briefing. He cautioned that maintaining hypertensive patients on agents that raise their blood pressure can result in “prescribing cascades” where taking drugs that boost blood pressure results in need for intensified antihypertensive treatment.
An opportunity for NSAID alternatives
“This study hopefully raises awareness that there is a very high use of medications that increase blood pressure, and use of OTC agents could increase the rate even higher” said Eugene Yang, MD, a cardiologist and codirector of the Cardiovascular Wellness and Prevention Program of the University of Washington, Seattle. Substituting for certain antidepressant agents may often not be realistic, but an opportunity exists for reducing NSAID use, a class also linked with an increased risk for bleeding and other adverse effects, Dr. Yang said during the briefing. Minimizing use of NSAIDs including ibuprofen and naproxen use “is something to think about,” he suggested.
“The effect of NSAIDs on blood pressure is not well studied and can vary from person to person” noted Dr. Vitarello, who added that higher NSAID dosages and more prolonged use likely increase the risk for an adverse effect on blood pressure. One reasonable option is to encourage patients to use an alternative class of pain reliever such as acetaminophen.
It remains “a challenge” to discern differences in adverse blood pressure effects, and in all adverse cardiovascular effects among different NSAIDs, said Dr. Yang. Results from “some studies show that certain NSAIDs may be safer, but other studies did not. We need to be very careful using NSAIDs because, on average, they increase blood pressure by about 3 mm Hg. We need to be mindful to try to prescribe alternative agents, like acetaminophen.”
A decade of data from NHANES
The analysis run by Dr. Vitarello and associates used data from 27,599 American adults included in the NHANES during 2009-2018, and focused on the 44% who either had an average blood pressure measurement of at least 130/80 mm Hg or reported having ever been told by a clinician that they had hypertension. The NHANES assessments included the prescription medications taken by each participant. The prevalence of using at least one prescription drug known to raise blood pressure was 24% among women and 14% among men, and 4% of those with hypertension were on two or more pressure-increasing agents.
The researchers based their identification of pressure-increasing prescription drugs on the list included in the 2017 guideline for managing high blood pressure from the American College of Cardiology and American Heart Association. This list specifies that the antidepressants that raise blood pressure are the monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitors, and tricyclic antidepressants.
Dr. Vitarello and Dr. Yang had no disclosures.
Nearly half of these American adults had hypertension, and in this subgroup, 18.5% reported using a prescription drug known to increase blood pressure. The most widely used class of agents with this effect was antidepressants, used by 8.7%; followed by nonsteroidal anti-inflammatory drugs (NSAIDs), used by 6.5%; steroids, 1.9%; estrogens, 1.7%; and several other agents each used by fewer than 1% of the study cohort, John Vitarello, MD, said during a press briefing on reports from the upcoming annual scientific sessions of the American College of Cardiology.
He and his associates estimated that this use of prescription drugs known to raise blood pressure could be what stands in the way of some 560,000-2.2 million Americans from having their hypertension under control, depending on the exact blood pressure impact that various pressure-increasing drugs have and presuming that half of those on blood pressure increasing agents could stop them and switch to alternative agents, said Dr. Vitarello, a researcher at Beth Israel Deaconess Medical Center in Boston.
He also highlighted that the study assessed only prescription drugs and did not examine OTC drug use, which may be especially relevant for the many people who regularly take NSAIDs.
“Clinicians should review the prescription and OTC drug use of patients with hypertension and consider stopping drugs that increase blood pressure or switching the patient to alternatives” that are blood pressure neutral, Dr. Vitarello said during the briefing. He cautioned that maintaining hypertensive patients on agents that raise their blood pressure can result in “prescribing cascades” where taking drugs that boost blood pressure results in need for intensified antihypertensive treatment.
An opportunity for NSAID alternatives
“This study hopefully raises awareness that there is a very high use of medications that increase blood pressure, and use of OTC agents could increase the rate even higher” said Eugene Yang, MD, a cardiologist and codirector of the Cardiovascular Wellness and Prevention Program of the University of Washington, Seattle. Substituting for certain antidepressant agents may often not be realistic, but an opportunity exists for reducing NSAID use, a class also linked with an increased risk for bleeding and other adverse effects, Dr. Yang said during the briefing. Minimizing use of NSAIDs including ibuprofen and naproxen use “is something to think about,” he suggested.
“The effect of NSAIDs on blood pressure is not well studied and can vary from person to person” noted Dr. Vitarello, who added that higher NSAID dosages and more prolonged use likely increase the risk for an adverse effect on blood pressure. One reasonable option is to encourage patients to use an alternative class of pain reliever such as acetaminophen.
It remains “a challenge” to discern differences in adverse blood pressure effects, and in all adverse cardiovascular effects among different NSAIDs, said Dr. Yang. Results from “some studies show that certain NSAIDs may be safer, but other studies did not. We need to be very careful using NSAIDs because, on average, they increase blood pressure by about 3 mm Hg. We need to be mindful to try to prescribe alternative agents, like acetaminophen.”
A decade of data from NHANES
The analysis run by Dr. Vitarello and associates used data from 27,599 American adults included in the NHANES during 2009-2018, and focused on the 44% who either had an average blood pressure measurement of at least 130/80 mm Hg or reported having ever been told by a clinician that they had hypertension. The NHANES assessments included the prescription medications taken by each participant. The prevalence of using at least one prescription drug known to raise blood pressure was 24% among women and 14% among men, and 4% of those with hypertension were on two or more pressure-increasing agents.
The researchers based their identification of pressure-increasing prescription drugs on the list included in the 2017 guideline for managing high blood pressure from the American College of Cardiology and American Heart Association. This list specifies that the antidepressants that raise blood pressure are the monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitors, and tricyclic antidepressants.
Dr. Vitarello and Dr. Yang had no disclosures.
Nearly half of these American adults had hypertension, and in this subgroup, 18.5% reported using a prescription drug known to increase blood pressure. The most widely used class of agents with this effect was antidepressants, used by 8.7%; followed by nonsteroidal anti-inflammatory drugs (NSAIDs), used by 6.5%; steroids, 1.9%; estrogens, 1.7%; and several other agents each used by fewer than 1% of the study cohort, John Vitarello, MD, said during a press briefing on reports from the upcoming annual scientific sessions of the American College of Cardiology.
He and his associates estimated that this use of prescription drugs known to raise blood pressure could be what stands in the way of some 560,000-2.2 million Americans from having their hypertension under control, depending on the exact blood pressure impact that various pressure-increasing drugs have and presuming that half of those on blood pressure increasing agents could stop them and switch to alternative agents, said Dr. Vitarello, a researcher at Beth Israel Deaconess Medical Center in Boston.
He also highlighted that the study assessed only prescription drugs and did not examine OTC drug use, which may be especially relevant for the many people who regularly take NSAIDs.
“Clinicians should review the prescription and OTC drug use of patients with hypertension and consider stopping drugs that increase blood pressure or switching the patient to alternatives” that are blood pressure neutral, Dr. Vitarello said during the briefing. He cautioned that maintaining hypertensive patients on agents that raise their blood pressure can result in “prescribing cascades” where taking drugs that boost blood pressure results in need for intensified antihypertensive treatment.
An opportunity for NSAID alternatives
“This study hopefully raises awareness that there is a very high use of medications that increase blood pressure, and use of OTC agents could increase the rate even higher” said Eugene Yang, MD, a cardiologist and codirector of the Cardiovascular Wellness and Prevention Program of the University of Washington, Seattle. Substituting for certain antidepressant agents may often not be realistic, but an opportunity exists for reducing NSAID use, a class also linked with an increased risk for bleeding and other adverse effects, Dr. Yang said during the briefing. Minimizing use of NSAIDs including ibuprofen and naproxen use “is something to think about,” he suggested.
“The effect of NSAIDs on blood pressure is not well studied and can vary from person to person” noted Dr. Vitarello, who added that higher NSAID dosages and more prolonged use likely increase the risk for an adverse effect on blood pressure. One reasonable option is to encourage patients to use an alternative class of pain reliever such as acetaminophen.
It remains “a challenge” to discern differences in adverse blood pressure effects, and in all adverse cardiovascular effects among different NSAIDs, said Dr. Yang. Results from “some studies show that certain NSAIDs may be safer, but other studies did not. We need to be very careful using NSAIDs because, on average, they increase blood pressure by about 3 mm Hg. We need to be mindful to try to prescribe alternative agents, like acetaminophen.”
A decade of data from NHANES
The analysis run by Dr. Vitarello and associates used data from 27,599 American adults included in the NHANES during 2009-2018, and focused on the 44% who either had an average blood pressure measurement of at least 130/80 mm Hg or reported having ever been told by a clinician that they had hypertension. The NHANES assessments included the prescription medications taken by each participant. The prevalence of using at least one prescription drug known to raise blood pressure was 24% among women and 14% among men, and 4% of those with hypertension were on two or more pressure-increasing agents.
The researchers based their identification of pressure-increasing prescription drugs on the list included in the 2017 guideline for managing high blood pressure from the American College of Cardiology and American Heart Association. This list specifies that the antidepressants that raise blood pressure are the monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitors, and tricyclic antidepressants.
Dr. Vitarello and Dr. Yang had no disclosures.
FROM ACC 2021
Exercise plus liraglutide better for maintaining weight loss than either strategy alone
For persons with obesity who lost a substantial amount of weight on a low-calorie diet, the combination of exercise and medication significantly improved weight-loss maintenance, and more so than either strategy alone, according to results of a randomized, head-to-head trial.
A year after starting moderate to vigorous exercise coupled with liraglutide treatment, study participants had a weight loss 9.5 kg more than those who received placebo and usual activity, study results show.
Reductions in both weight and fat loss seen with exercise and liraglutide was roughly twice as much as what was achieved at 1 year with the strategies of liraglutide or exercise alone, according to authors of the study, which appears in the New England Journal of Medicine .
Although the findings may not apply to those who can’t or won’t perform moderate to vigorous exercise, the intervention in this study was nevertheless feasible in this group of persons with obesity who had a very low level of fitness, according to the authors.
Hope for healthy weight loss maintenance
Investigator Signe S. Torekov, PhD, said in an interview that these results provide hope that more-intensive exercise regimens, with or without medication, can be useful and well accepted among individuals struggling with obesity.
“When we started our study, we were told, ‘you are never going to have people with obesity exercising that much, and for that long’ – but people were actually very happy about the exercise,” said Dr. Torekov, a professor in the department of biomedical sciences at the University of Copenhagen.
“If you actually set up a program where people are monitored and you have a feedback system, then exercise is an excellent component in obesity treatment that should be much more actively used – not only for its weight-lowering component, but also for improving health and quality of life,” she said in an interview.
Weight-management specialist John D. Clark, MD, PhD, said results of this study can be used to help inform patients about how successful different strategies incorporating exercise and medication may be following initial weight loss.
“When patients plateau on a consistent, calorie-restricted dietary plan, we can educate them and manage expectations about what options may be available to them after their initial weight loss,” said Dr. Clark, of the University of Texas, Dallas.
“If the patient’s goal specifically is weight loss at all costs, then I may suggest, ‘let’s consider liraglutide or liraglutide in combination with exercise,’ ” he said in an interview. “Exercise improves body composition, even if it may not on its own be as successful in the next phase of their weight-loss journey, as shown in this study.”
Obesity and weight-loss challenges
Although it’s not uncommon for obese patients to lose a large amount of weight, keeping the weight off is frequently a challenge unless the patient follows a structured weight maintenance program, according to Dr. Torekov and coauthors.
The rapid weight regain seen in many obese patients could be a result of reductions in total energy expenditure or increased appetite. Exercise is one strategy to sustain weight loss, though according to the authors, very few studies have looked at exercise in isolation to quantify its contribution to maintenance.
Accordingly, the present study sought to determine whether exercise, medication, or the combination thereof works best to keep weight off.
The study incorporated liraglutide, a GLP-1 receptor agonist indicated for chronic weight management, along with a reduced-calorie diet and increased physical activity, in adults with elevated body mass index and at least one weight-related comorbidity.
The investigator-initiated phase 3 trial included 215 adults with a body mass index of 32-43. Individuals with type 2 diabetes were excluded. All participants followed an 8-week, low-calorie diet comprising 800 calories per day.
Participants who lost 5% or more of their body weight were then randomized to 1 year of exercise plus liraglutide, exercise plus placebo, usual activity plus liraglutide, or usual activity plus placebo.
The exercise program – which was structured but flexible, according to investigators – included group exercise sessions that incorporated 30 minutes of indoor cycling and 15 minutes of circuit training 2 days each week. Participants wore heart rate monitors during exercise to make sure they reached targets for moderate to vigorous intensity.
Instructors trained in exercise physiology planned and monitored individualized exercise programs for each participant in the exercise-medication or exercise-only arms of the study.
Participants in all groups attended 12 one-on-one consultations where body weight was measured and dietetic support was provided.
Weight loss with exercise and medication
Out of 215 individuals enrolled in the study, 195 lost at least 5% of body weight and continued on to the randomized portion, the investigators reported. During the diet phase, they lost a mean of 13.1 kg, translating into a 12% mean reduction in body weight.
The mean frequency of exercise was 2.4 times per week in the exercise-plus-medication group and 2.5 times per week in the exercise-only group. About one-third of the exercise took place in the group sessions, and there was no difference in relative intensity between group and individual exercise regimens, the investigators said.
Individuals in the exercise plus medication group continued to lose more weight, such that, at the end of 1 year, the weight loss decreased even further, by a mean of –3.4 kg. By contrast, weight increased by a mean of 6.1 kg for the placebo group, adding up to a treatment difference of –9.5 kg (95% confidence interval, –13.1 to –5.9; P < .001), according to the report.
That treatment effect was also seen, but more muted, in the exercise- and liraglutide-only groups, at –4.1 kg and –6.8 kg, respectively.
A significant treatment effect was observed for exercise plus liraglutide, compared with exercise alone, at –5.4 kg (P = .004), while the treatment effect for the combination versus liraglutide alone was not significant at –2.7 kg (P = .13), the data show.
Body-fat reduction at 52 weeks was –3.9 percentage points for exercise plus liraglutide as compared with placebo, or roughly twice the reductions seen in the exercise- and liraglutide-alone groups, the investigators said, adding that the combination preserved lean mass.
Reductions in hemoglobin A1c, which are generally thought to reduce diabetes risk, were reduced in both the liraglutide and liraglutide-exercise combination group, according to their report.
The research was supported in part by grants from the Novo Nordisk Foundation.
For persons with obesity who lost a substantial amount of weight on a low-calorie diet, the combination of exercise and medication significantly improved weight-loss maintenance, and more so than either strategy alone, according to results of a randomized, head-to-head trial.
A year after starting moderate to vigorous exercise coupled with liraglutide treatment, study participants had a weight loss 9.5 kg more than those who received placebo and usual activity, study results show.
Reductions in both weight and fat loss seen with exercise and liraglutide was roughly twice as much as what was achieved at 1 year with the strategies of liraglutide or exercise alone, according to authors of the study, which appears in the New England Journal of Medicine .
Although the findings may not apply to those who can’t or won’t perform moderate to vigorous exercise, the intervention in this study was nevertheless feasible in this group of persons with obesity who had a very low level of fitness, according to the authors.
Hope for healthy weight loss maintenance
Investigator Signe S. Torekov, PhD, said in an interview that these results provide hope that more-intensive exercise regimens, with or without medication, can be useful and well accepted among individuals struggling with obesity.
“When we started our study, we were told, ‘you are never going to have people with obesity exercising that much, and for that long’ – but people were actually very happy about the exercise,” said Dr. Torekov, a professor in the department of biomedical sciences at the University of Copenhagen.
“If you actually set up a program where people are monitored and you have a feedback system, then exercise is an excellent component in obesity treatment that should be much more actively used – not only for its weight-lowering component, but also for improving health and quality of life,” she said in an interview.
Weight-management specialist John D. Clark, MD, PhD, said results of this study can be used to help inform patients about how successful different strategies incorporating exercise and medication may be following initial weight loss.
“When patients plateau on a consistent, calorie-restricted dietary plan, we can educate them and manage expectations about what options may be available to them after their initial weight loss,” said Dr. Clark, of the University of Texas, Dallas.
“If the patient’s goal specifically is weight loss at all costs, then I may suggest, ‘let’s consider liraglutide or liraglutide in combination with exercise,’ ” he said in an interview. “Exercise improves body composition, even if it may not on its own be as successful in the next phase of their weight-loss journey, as shown in this study.”
Obesity and weight-loss challenges
Although it’s not uncommon for obese patients to lose a large amount of weight, keeping the weight off is frequently a challenge unless the patient follows a structured weight maintenance program, according to Dr. Torekov and coauthors.
The rapid weight regain seen in many obese patients could be a result of reductions in total energy expenditure or increased appetite. Exercise is one strategy to sustain weight loss, though according to the authors, very few studies have looked at exercise in isolation to quantify its contribution to maintenance.
Accordingly, the present study sought to determine whether exercise, medication, or the combination thereof works best to keep weight off.
The study incorporated liraglutide, a GLP-1 receptor agonist indicated for chronic weight management, along with a reduced-calorie diet and increased physical activity, in adults with elevated body mass index and at least one weight-related comorbidity.
The investigator-initiated phase 3 trial included 215 adults with a body mass index of 32-43. Individuals with type 2 diabetes were excluded. All participants followed an 8-week, low-calorie diet comprising 800 calories per day.
Participants who lost 5% or more of their body weight were then randomized to 1 year of exercise plus liraglutide, exercise plus placebo, usual activity plus liraglutide, or usual activity plus placebo.
The exercise program – which was structured but flexible, according to investigators – included group exercise sessions that incorporated 30 minutes of indoor cycling and 15 minutes of circuit training 2 days each week. Participants wore heart rate monitors during exercise to make sure they reached targets for moderate to vigorous intensity.
Instructors trained in exercise physiology planned and monitored individualized exercise programs for each participant in the exercise-medication or exercise-only arms of the study.
Participants in all groups attended 12 one-on-one consultations where body weight was measured and dietetic support was provided.
Weight loss with exercise and medication
Out of 215 individuals enrolled in the study, 195 lost at least 5% of body weight and continued on to the randomized portion, the investigators reported. During the diet phase, they lost a mean of 13.1 kg, translating into a 12% mean reduction in body weight.
The mean frequency of exercise was 2.4 times per week in the exercise-plus-medication group and 2.5 times per week in the exercise-only group. About one-third of the exercise took place in the group sessions, and there was no difference in relative intensity between group and individual exercise regimens, the investigators said.
Individuals in the exercise plus medication group continued to lose more weight, such that, at the end of 1 year, the weight loss decreased even further, by a mean of –3.4 kg. By contrast, weight increased by a mean of 6.1 kg for the placebo group, adding up to a treatment difference of –9.5 kg (95% confidence interval, –13.1 to –5.9; P < .001), according to the report.
That treatment effect was also seen, but more muted, in the exercise- and liraglutide-only groups, at –4.1 kg and –6.8 kg, respectively.
A significant treatment effect was observed for exercise plus liraglutide, compared with exercise alone, at –5.4 kg (P = .004), while the treatment effect for the combination versus liraglutide alone was not significant at –2.7 kg (P = .13), the data show.
Body-fat reduction at 52 weeks was –3.9 percentage points for exercise plus liraglutide as compared with placebo, or roughly twice the reductions seen in the exercise- and liraglutide-alone groups, the investigators said, adding that the combination preserved lean mass.
Reductions in hemoglobin A1c, which are generally thought to reduce diabetes risk, were reduced in both the liraglutide and liraglutide-exercise combination group, according to their report.
The research was supported in part by grants from the Novo Nordisk Foundation.
For persons with obesity who lost a substantial amount of weight on a low-calorie diet, the combination of exercise and medication significantly improved weight-loss maintenance, and more so than either strategy alone, according to results of a randomized, head-to-head trial.
A year after starting moderate to vigorous exercise coupled with liraglutide treatment, study participants had a weight loss 9.5 kg more than those who received placebo and usual activity, study results show.
Reductions in both weight and fat loss seen with exercise and liraglutide was roughly twice as much as what was achieved at 1 year with the strategies of liraglutide or exercise alone, according to authors of the study, which appears in the New England Journal of Medicine .
Although the findings may not apply to those who can’t or won’t perform moderate to vigorous exercise, the intervention in this study was nevertheless feasible in this group of persons with obesity who had a very low level of fitness, according to the authors.
Hope for healthy weight loss maintenance
Investigator Signe S. Torekov, PhD, said in an interview that these results provide hope that more-intensive exercise regimens, with or without medication, can be useful and well accepted among individuals struggling with obesity.
“When we started our study, we were told, ‘you are never going to have people with obesity exercising that much, and for that long’ – but people were actually very happy about the exercise,” said Dr. Torekov, a professor in the department of biomedical sciences at the University of Copenhagen.
“If you actually set up a program where people are monitored and you have a feedback system, then exercise is an excellent component in obesity treatment that should be much more actively used – not only for its weight-lowering component, but also for improving health and quality of life,” she said in an interview.
Weight-management specialist John D. Clark, MD, PhD, said results of this study can be used to help inform patients about how successful different strategies incorporating exercise and medication may be following initial weight loss.
“When patients plateau on a consistent, calorie-restricted dietary plan, we can educate them and manage expectations about what options may be available to them after their initial weight loss,” said Dr. Clark, of the University of Texas, Dallas.
“If the patient’s goal specifically is weight loss at all costs, then I may suggest, ‘let’s consider liraglutide or liraglutide in combination with exercise,’ ” he said in an interview. “Exercise improves body composition, even if it may not on its own be as successful in the next phase of their weight-loss journey, as shown in this study.”
Obesity and weight-loss challenges
Although it’s not uncommon for obese patients to lose a large amount of weight, keeping the weight off is frequently a challenge unless the patient follows a structured weight maintenance program, according to Dr. Torekov and coauthors.
The rapid weight regain seen in many obese patients could be a result of reductions in total energy expenditure or increased appetite. Exercise is one strategy to sustain weight loss, though according to the authors, very few studies have looked at exercise in isolation to quantify its contribution to maintenance.
Accordingly, the present study sought to determine whether exercise, medication, or the combination thereof works best to keep weight off.
The study incorporated liraglutide, a GLP-1 receptor agonist indicated for chronic weight management, along with a reduced-calorie diet and increased physical activity, in adults with elevated body mass index and at least one weight-related comorbidity.
The investigator-initiated phase 3 trial included 215 adults with a body mass index of 32-43. Individuals with type 2 diabetes were excluded. All participants followed an 8-week, low-calorie diet comprising 800 calories per day.
Participants who lost 5% or more of their body weight were then randomized to 1 year of exercise plus liraglutide, exercise plus placebo, usual activity plus liraglutide, or usual activity plus placebo.
The exercise program – which was structured but flexible, according to investigators – included group exercise sessions that incorporated 30 minutes of indoor cycling and 15 minutes of circuit training 2 days each week. Participants wore heart rate monitors during exercise to make sure they reached targets for moderate to vigorous intensity.
Instructors trained in exercise physiology planned and monitored individualized exercise programs for each participant in the exercise-medication or exercise-only arms of the study.
Participants in all groups attended 12 one-on-one consultations where body weight was measured and dietetic support was provided.
Weight loss with exercise and medication
Out of 215 individuals enrolled in the study, 195 lost at least 5% of body weight and continued on to the randomized portion, the investigators reported. During the diet phase, they lost a mean of 13.1 kg, translating into a 12% mean reduction in body weight.
The mean frequency of exercise was 2.4 times per week in the exercise-plus-medication group and 2.5 times per week in the exercise-only group. About one-third of the exercise took place in the group sessions, and there was no difference in relative intensity between group and individual exercise regimens, the investigators said.
Individuals in the exercise plus medication group continued to lose more weight, such that, at the end of 1 year, the weight loss decreased even further, by a mean of –3.4 kg. By contrast, weight increased by a mean of 6.1 kg for the placebo group, adding up to a treatment difference of –9.5 kg (95% confidence interval, –13.1 to –5.9; P < .001), according to the report.
That treatment effect was also seen, but more muted, in the exercise- and liraglutide-only groups, at –4.1 kg and –6.8 kg, respectively.
A significant treatment effect was observed for exercise plus liraglutide, compared with exercise alone, at –5.4 kg (P = .004), while the treatment effect for the combination versus liraglutide alone was not significant at –2.7 kg (P = .13), the data show.
Body-fat reduction at 52 weeks was –3.9 percentage points for exercise plus liraglutide as compared with placebo, or roughly twice the reductions seen in the exercise- and liraglutide-alone groups, the investigators said, adding that the combination preserved lean mass.
Reductions in hemoglobin A1c, which are generally thought to reduce diabetes risk, were reduced in both the liraglutide and liraglutide-exercise combination group, according to their report.
The research was supported in part by grants from the Novo Nordisk Foundation.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Only a third of adults with diabetes receive ADA-recommended care
In 2017-2018, only one in three U.S. adults with diabetes received five basic elements of care recommended by the American Diabetes Association, new research indicates.
The proportions of patients who visited a physician for diabetes care and received hemoglobin A1c testing, foot and eye exams, and cholesterol testing increased from 2005 to 2018. However, this increase was primarily among those aged 65 years and older, and therefore eligible for Medicare.
“Our study suggests that providing affordable health care coverage can help ensure people with diabetes get recommended care. We also found that patients who were not receiving recommended care were more likely to be younger, newly diagnosed with diabetes, and not on diabetes medication. Clinicians can pay more attention to these patient populations to improve recommended care delivery and prevent diabetes-related complications,” lead author Jung-Im Shin, MD, said in an interview.
The data predate the COVID-19 pandemic, which has also had major effects on delivery of diabetes care, added Dr. Shin of Johns Hopkins University, Baltimore.
“Routine visits to the doctor and important screenings for retinopathy or foot examination have been postponed. People with diabetes have had to reschedule or cancel nonurgent visits, some have lost ... insurance following unemployment, and many have avoided health care facilities out of fear. We are only just beginning to understand the consequences of the pandemic on the health of people with diabetes,” Dr. Shin noted.
Overall improvements seen only in those aged 65 and older
The data, from 4,069 adults aged 20 years and older from the 2005-2018 National Health and Nutrition and Examination Survey (NHANES), were published online April 16, 2021, in Diabetes Care.
Dr. Shin and colleagues defined receipt of diabetes care as meeting all of the following five criteria in the past 12 months, based on the ADA Standards of Care and NHANES data availability: seeing a primary doctor for diabetes care, receiving A1c testing, receiving a foot examination, receiving an eye examination, and receiving cholesterol testing.
Over the entire 13-year period, 29.2% of respondents reported having received all five components.
That proportion increased significantly over time, from 25.0% in 2005-2006 to 34.1% in 2017-2018 (P = .004). However, among the individual components, only receiving A1c testing increased significantly over time, from 64.4% to 85.3%, in all age groups (P < .001).
Moreover, when stratified by age, receipt of all five components only increased significantly among participants aged 65 and older, from 29.3% in 2005-2006 to 44.2% in 2017-2018 (P = .001).
The proportion remained unchanged among those aged 40-64 (25.2% to 25.8%; P = .457) and showed a nonsignificant increase in those aged 20-39 (9.9% to 26.0%; P = .401).
In adjusted analyses, older age, higher income and education, health insurance, longer duration of diabetes, use of diabetes medications, and hypercholesterolemia were significantly associated with receipt of ADA guideline–recommended diabetes care.
Factors not found to be associated with care receipt included sex, race/ethnicity, body mass index, smoking status, A1c, hypertension, cardiovascular disease, chronic kidney disease, and depressive symptoms.
Participants who received ADA guideline–recommended care were significantly more likely to achieve A1c below 7.5% (adjusted odds ratio, 1.52), blood pressure less than 140/90 mm Hg (aOR, 1.47), and LDL cholesterol below 100 mg/dL (aOR, 1.47), and to receive cholesterol-lowering medication (aOR, 1.79).
Dr. Shin said that it will be “important to study the impact of COVID-19 on diabetes care when new data are available.”
The project was supported by a research grant from Merck to Johns Hopkins University. Shin has reported receiving a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Two coauthors are Merck employees.
A version of this article first appeared on Medscape.com.
In 2017-2018, only one in three U.S. adults with diabetes received five basic elements of care recommended by the American Diabetes Association, new research indicates.
The proportions of patients who visited a physician for diabetes care and received hemoglobin A1c testing, foot and eye exams, and cholesterol testing increased from 2005 to 2018. However, this increase was primarily among those aged 65 years and older, and therefore eligible for Medicare.
“Our study suggests that providing affordable health care coverage can help ensure people with diabetes get recommended care. We also found that patients who were not receiving recommended care were more likely to be younger, newly diagnosed with diabetes, and not on diabetes medication. Clinicians can pay more attention to these patient populations to improve recommended care delivery and prevent diabetes-related complications,” lead author Jung-Im Shin, MD, said in an interview.
The data predate the COVID-19 pandemic, which has also had major effects on delivery of diabetes care, added Dr. Shin of Johns Hopkins University, Baltimore.
“Routine visits to the doctor and important screenings for retinopathy or foot examination have been postponed. People with diabetes have had to reschedule or cancel nonurgent visits, some have lost ... insurance following unemployment, and many have avoided health care facilities out of fear. We are only just beginning to understand the consequences of the pandemic on the health of people with diabetes,” Dr. Shin noted.
Overall improvements seen only in those aged 65 and older
The data, from 4,069 adults aged 20 years and older from the 2005-2018 National Health and Nutrition and Examination Survey (NHANES), were published online April 16, 2021, in Diabetes Care.
Dr. Shin and colleagues defined receipt of diabetes care as meeting all of the following five criteria in the past 12 months, based on the ADA Standards of Care and NHANES data availability: seeing a primary doctor for diabetes care, receiving A1c testing, receiving a foot examination, receiving an eye examination, and receiving cholesterol testing.
Over the entire 13-year period, 29.2% of respondents reported having received all five components.
That proportion increased significantly over time, from 25.0% in 2005-2006 to 34.1% in 2017-2018 (P = .004). However, among the individual components, only receiving A1c testing increased significantly over time, from 64.4% to 85.3%, in all age groups (P < .001).
Moreover, when stratified by age, receipt of all five components only increased significantly among participants aged 65 and older, from 29.3% in 2005-2006 to 44.2% in 2017-2018 (P = .001).
The proportion remained unchanged among those aged 40-64 (25.2% to 25.8%; P = .457) and showed a nonsignificant increase in those aged 20-39 (9.9% to 26.0%; P = .401).
In adjusted analyses, older age, higher income and education, health insurance, longer duration of diabetes, use of diabetes medications, and hypercholesterolemia were significantly associated with receipt of ADA guideline–recommended diabetes care.
Factors not found to be associated with care receipt included sex, race/ethnicity, body mass index, smoking status, A1c, hypertension, cardiovascular disease, chronic kidney disease, and depressive symptoms.
Participants who received ADA guideline–recommended care were significantly more likely to achieve A1c below 7.5% (adjusted odds ratio, 1.52), blood pressure less than 140/90 mm Hg (aOR, 1.47), and LDL cholesterol below 100 mg/dL (aOR, 1.47), and to receive cholesterol-lowering medication (aOR, 1.79).
Dr. Shin said that it will be “important to study the impact of COVID-19 on diabetes care when new data are available.”
The project was supported by a research grant from Merck to Johns Hopkins University. Shin has reported receiving a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Two coauthors are Merck employees.
A version of this article first appeared on Medscape.com.
In 2017-2018, only one in three U.S. adults with diabetes received five basic elements of care recommended by the American Diabetes Association, new research indicates.
The proportions of patients who visited a physician for diabetes care and received hemoglobin A1c testing, foot and eye exams, and cholesterol testing increased from 2005 to 2018. However, this increase was primarily among those aged 65 years and older, and therefore eligible for Medicare.
“Our study suggests that providing affordable health care coverage can help ensure people with diabetes get recommended care. We also found that patients who were not receiving recommended care were more likely to be younger, newly diagnosed with diabetes, and not on diabetes medication. Clinicians can pay more attention to these patient populations to improve recommended care delivery and prevent diabetes-related complications,” lead author Jung-Im Shin, MD, said in an interview.
The data predate the COVID-19 pandemic, which has also had major effects on delivery of diabetes care, added Dr. Shin of Johns Hopkins University, Baltimore.
“Routine visits to the doctor and important screenings for retinopathy or foot examination have been postponed. People with diabetes have had to reschedule or cancel nonurgent visits, some have lost ... insurance following unemployment, and many have avoided health care facilities out of fear. We are only just beginning to understand the consequences of the pandemic on the health of people with diabetes,” Dr. Shin noted.
Overall improvements seen only in those aged 65 and older
The data, from 4,069 adults aged 20 years and older from the 2005-2018 National Health and Nutrition and Examination Survey (NHANES), were published online April 16, 2021, in Diabetes Care.
Dr. Shin and colleagues defined receipt of diabetes care as meeting all of the following five criteria in the past 12 months, based on the ADA Standards of Care and NHANES data availability: seeing a primary doctor for diabetes care, receiving A1c testing, receiving a foot examination, receiving an eye examination, and receiving cholesterol testing.
Over the entire 13-year period, 29.2% of respondents reported having received all five components.
That proportion increased significantly over time, from 25.0% in 2005-2006 to 34.1% in 2017-2018 (P = .004). However, among the individual components, only receiving A1c testing increased significantly over time, from 64.4% to 85.3%, in all age groups (P < .001).
Moreover, when stratified by age, receipt of all five components only increased significantly among participants aged 65 and older, from 29.3% in 2005-2006 to 44.2% in 2017-2018 (P = .001).
The proportion remained unchanged among those aged 40-64 (25.2% to 25.8%; P = .457) and showed a nonsignificant increase in those aged 20-39 (9.9% to 26.0%; P = .401).
In adjusted analyses, older age, higher income and education, health insurance, longer duration of diabetes, use of diabetes medications, and hypercholesterolemia were significantly associated with receipt of ADA guideline–recommended diabetes care.
Factors not found to be associated with care receipt included sex, race/ethnicity, body mass index, smoking status, A1c, hypertension, cardiovascular disease, chronic kidney disease, and depressive symptoms.
Participants who received ADA guideline–recommended care were significantly more likely to achieve A1c below 7.5% (adjusted odds ratio, 1.52), blood pressure less than 140/90 mm Hg (aOR, 1.47), and LDL cholesterol below 100 mg/dL (aOR, 1.47), and to receive cholesterol-lowering medication (aOR, 1.79).
Dr. Shin said that it will be “important to study the impact of COVID-19 on diabetes care when new data are available.”
The project was supported by a research grant from Merck to Johns Hopkins University. Shin has reported receiving a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Two coauthors are Merck employees.
A version of this article first appeared on Medscape.com.
Increasing salt intake proves beneficial in POTS
For patients with postural tachycardia syndrome (POTS), dietary sodium intake can be increased more confidently, suggests the first study to yield solid evidence to support this treatment strategy.
The results showed that high dietary sodium intake can lower plasma norepinephrine levels and ameliorate standing and orthostatic tachycardia for patients with POTS.
“These results suggest that increasing dietary salt is a good rationale for treatment of this condition, and this study gives reassurance we are doing the right thing for POTS patients by increasing their sodium intake,” senior author Satish R. Raj, MD, said in an interview.
The study, with lead author Emily M. Garland, PhD, was published online April 26, 2021, in the Journal of the American College of Cardiology.
Dr. Raj, who is professor of cardiac science at the University of Calgary (Alta.), explained that POTS includes a spectrum of disorders that affect the automatic nervous system, which regulates heart rate and blood pressure.
“It is a disorder of orthostatic intolerance – patients feel better when they lie down. It differs from orthostatic hypotension in that, when a POTS patient stands up, the blood pressure does not necessarily drop, but the heart rate increases excessively.”
Although it is normal for the heart rate to increase somewhat on standing, among patients with POTS, the heart rate increases excessively. The condition is defined as an orthostatic heart rate increase of at least 30 beats/min (or 40 beats/min among individuals aged 12-19 years ) in the absence of orthostatic hypotension.
The disorder is characterized by a range of symptoms, including lightheadedness, shortness of breath, palpitations, and exertional intolerance, that are worse when in an upright position. Patients also experience chronic fatigue and perceived cognitive impairment, Dr. Raj noted.
The typical demographic for POTS is young women; the condition often starts during the teenage years.
Patients often have low blood volume, so one approach to treatment is to increase the intake of salt and water so as to increase blood volume.
“This is one of the mainstays of treatment, but it has never really been properly studied,” Dr. Raj commented. Increasing salt intake “is an unusual message from a cardiologist, and there have been concerns that we are making recommendations against traditional advice, so we urgently need evidence to support this recommendation.”
The current crossover study enrolled 14 patients with POTS and 13 healthy control persons who, over a period of 6 days, underwent treatment with a low-sodium diet (10 mEq sodium per day) or a high-sodium diet (300 mEq sodium per day).
Supine and standing heart rate, blood pressure, serum aldosterone level, plasma renin activity, blood volume, and plasma norepinephrine and epinephrine levels were measured.
Results showed that, among the POTS patients, the high-sodium diet reduced upright heart rate and the change in heart rate on standing, compared with the low-sodium diet.
Heart rate increased by 46 beats/min with the high-sodium diet versus 60 beats/min with the low-sodium diet.
Total blood volume and plasma volume increased, and standing norepinephrine levels decreased with the high-sodium diet, compared with the low-sodium diet.
However, upright heart rate, change in heart rate, and upright norepinephrine levels remained higher among POTS patients than among control persons receiving the high-sodium diet.
There was a nonsignificant trend for a lower symptom burden score among the POTS patients who received the high-sodium diet in comparison with those taking the low-sodium diet. Scores for mental confusion, palpitations, lightheadedness, and headache trending downward on the high-sodium diet.
“We found that high levels of dietary salt did what we hoped, with increased blood volume and reduced norepinephrine levels on standing and reduced excessive increase in heart rate. While it didn’t completely normalize heart rate, this was reduced significantly,” Dr. Raj said.
Another observation from the study was that the increased salt intake seemed to be beneficial across the whole spectrum of patients.
“There are some patients who have very high levels of sympathetic activation, and there have been anecdotal reports that increasing salt may not work so well in this group,” he said. “In this study, we didn’t differentiate, but average norepinephrine levels were very high, and many patients would be considered to be hyperadrenergic. Our results suggest this treatment will help these patients too.”
He noted that sodium intake was increased in this study just through diet. “We had a special metabolic kitchen. In clinical practice, we advise patients to add regular table salt to their food, and we only use salt tablets when they cannot tolerate so much salt in their diet.”
Recognizing that there may be concerns about hypertension with long-term use of such a treatment, Dr. Raj said there were no signs of an increase in blood pressure in this study. “But this should be considered a short-term therapy for the time being, and patients need to be reassessed every few years as their physiology changes.”
The authors estimated that POTS affects up to 1% of the population. Because there is no diagnostic code for the condition at present, all incidence data are estimates.
Dr. Raj pointed out that potentially a lot of people are affected, but there is little recognition of the condition among patients and physicians.
“Many family doctors are unaware of POTS,” he noted. “Patients often have to research their symptoms themselves and inform their doctor of the condition. Many patients wait years and often see many different doctors before getting a correct diagnosis.”
He explained that patients with POTS are often diagnosed as having a psychiatric illness. “They are mainly young women with palpitations, heart pounding, shakiness, which is often labeled as anxiety.”
Dr. Raj urged clinicians to consider POTS if patients have symptoms that are worse when standing up. The diagnosis is confirmed if their blood pressure doesn’t fall when standing up but their heart rate increases by at least 30 beats/min.
He noted that not enough specialists treat this condition, so family doctors need to be able to diagnose and initiate treatment. If more aggressive treatment is required, patients can be referred to a specialist.
“One of the problems is that this condition pans across different medical specialties. No one field owns it, so it tends to get ignored. But there are clinicians who are interested in POTS, and the key is finding one of these,” he said.
“We have finally established that this high-sodium diet works as treatment for POTS,” he concluded. “We have been using it for some time, but now we have evidence for its use across the whole spectrum of patients.”
In an accompanying editorial (J Am Coll Cardiol. 2021 May 4;77[17]:2185-2186), Blair P. Grubb, MD, University of Toledo (Ohio) Medical Center, wrote that this “superb study by Garland et al. helps better establish our understanding of the pathophysiologic process taking place in POTS while at the same time providing good evidence for the augmentation of dietary sodium as one of the cornerstones of treatment.”
He added that the field needs more such studies “in our quest to better understand POTS and to elaborate therapeutic modalities to help those suffering from this debilitating illness.”
The study was supported in part by the National Heart, Lung, and Blood Institute; the National Center for Advancing Translational Sciences; and the Vanderbilt Hormone and Analytical Services Core. Dr. Raj has served as a consultant for Lundbeck NA and Theravance; has served as chair of the data safety and monitoring board for Arena Pharmaceuticals and as Cardiac Arrhythmia Network of Canada network investigator; and has served on the medical advisory board of Dysautonomia International and PoTS UK, both without financial compensation.
A version of this article first appeared on Medscape.com.
For patients with postural tachycardia syndrome (POTS), dietary sodium intake can be increased more confidently, suggests the first study to yield solid evidence to support this treatment strategy.
The results showed that high dietary sodium intake can lower plasma norepinephrine levels and ameliorate standing and orthostatic tachycardia for patients with POTS.
“These results suggest that increasing dietary salt is a good rationale for treatment of this condition, and this study gives reassurance we are doing the right thing for POTS patients by increasing their sodium intake,” senior author Satish R. Raj, MD, said in an interview.
The study, with lead author Emily M. Garland, PhD, was published online April 26, 2021, in the Journal of the American College of Cardiology.
Dr. Raj, who is professor of cardiac science at the University of Calgary (Alta.), explained that POTS includes a spectrum of disorders that affect the automatic nervous system, which regulates heart rate and blood pressure.
“It is a disorder of orthostatic intolerance – patients feel better when they lie down. It differs from orthostatic hypotension in that, when a POTS patient stands up, the blood pressure does not necessarily drop, but the heart rate increases excessively.”
Although it is normal for the heart rate to increase somewhat on standing, among patients with POTS, the heart rate increases excessively. The condition is defined as an orthostatic heart rate increase of at least 30 beats/min (or 40 beats/min among individuals aged 12-19 years ) in the absence of orthostatic hypotension.
The disorder is characterized by a range of symptoms, including lightheadedness, shortness of breath, palpitations, and exertional intolerance, that are worse when in an upright position. Patients also experience chronic fatigue and perceived cognitive impairment, Dr. Raj noted.
The typical demographic for POTS is young women; the condition often starts during the teenage years.
Patients often have low blood volume, so one approach to treatment is to increase the intake of salt and water so as to increase blood volume.
“This is one of the mainstays of treatment, but it has never really been properly studied,” Dr. Raj commented. Increasing salt intake “is an unusual message from a cardiologist, and there have been concerns that we are making recommendations against traditional advice, so we urgently need evidence to support this recommendation.”
The current crossover study enrolled 14 patients with POTS and 13 healthy control persons who, over a period of 6 days, underwent treatment with a low-sodium diet (10 mEq sodium per day) or a high-sodium diet (300 mEq sodium per day).
Supine and standing heart rate, blood pressure, serum aldosterone level, plasma renin activity, blood volume, and plasma norepinephrine and epinephrine levels were measured.
Results showed that, among the POTS patients, the high-sodium diet reduced upright heart rate and the change in heart rate on standing, compared with the low-sodium diet.
Heart rate increased by 46 beats/min with the high-sodium diet versus 60 beats/min with the low-sodium diet.
Total blood volume and plasma volume increased, and standing norepinephrine levels decreased with the high-sodium diet, compared with the low-sodium diet.
However, upright heart rate, change in heart rate, and upright norepinephrine levels remained higher among POTS patients than among control persons receiving the high-sodium diet.
There was a nonsignificant trend for a lower symptom burden score among the POTS patients who received the high-sodium diet in comparison with those taking the low-sodium diet. Scores for mental confusion, palpitations, lightheadedness, and headache trending downward on the high-sodium diet.
“We found that high levels of dietary salt did what we hoped, with increased blood volume and reduced norepinephrine levels on standing and reduced excessive increase in heart rate. While it didn’t completely normalize heart rate, this was reduced significantly,” Dr. Raj said.
Another observation from the study was that the increased salt intake seemed to be beneficial across the whole spectrum of patients.
“There are some patients who have very high levels of sympathetic activation, and there have been anecdotal reports that increasing salt may not work so well in this group,” he said. “In this study, we didn’t differentiate, but average norepinephrine levels were very high, and many patients would be considered to be hyperadrenergic. Our results suggest this treatment will help these patients too.”
He noted that sodium intake was increased in this study just through diet. “We had a special metabolic kitchen. In clinical practice, we advise patients to add regular table salt to their food, and we only use salt tablets when they cannot tolerate so much salt in their diet.”
Recognizing that there may be concerns about hypertension with long-term use of such a treatment, Dr. Raj said there were no signs of an increase in blood pressure in this study. “But this should be considered a short-term therapy for the time being, and patients need to be reassessed every few years as their physiology changes.”
The authors estimated that POTS affects up to 1% of the population. Because there is no diagnostic code for the condition at present, all incidence data are estimates.
Dr. Raj pointed out that potentially a lot of people are affected, but there is little recognition of the condition among patients and physicians.
“Many family doctors are unaware of POTS,” he noted. “Patients often have to research their symptoms themselves and inform their doctor of the condition. Many patients wait years and often see many different doctors before getting a correct diagnosis.”
He explained that patients with POTS are often diagnosed as having a psychiatric illness. “They are mainly young women with palpitations, heart pounding, shakiness, which is often labeled as anxiety.”
Dr. Raj urged clinicians to consider POTS if patients have symptoms that are worse when standing up. The diagnosis is confirmed if their blood pressure doesn’t fall when standing up but their heart rate increases by at least 30 beats/min.
He noted that not enough specialists treat this condition, so family doctors need to be able to diagnose and initiate treatment. If more aggressive treatment is required, patients can be referred to a specialist.
“One of the problems is that this condition pans across different medical specialties. No one field owns it, so it tends to get ignored. But there are clinicians who are interested in POTS, and the key is finding one of these,” he said.
“We have finally established that this high-sodium diet works as treatment for POTS,” he concluded. “We have been using it for some time, but now we have evidence for its use across the whole spectrum of patients.”
In an accompanying editorial (J Am Coll Cardiol. 2021 May 4;77[17]:2185-2186), Blair P. Grubb, MD, University of Toledo (Ohio) Medical Center, wrote that this “superb study by Garland et al. helps better establish our understanding of the pathophysiologic process taking place in POTS while at the same time providing good evidence for the augmentation of dietary sodium as one of the cornerstones of treatment.”
He added that the field needs more such studies “in our quest to better understand POTS and to elaborate therapeutic modalities to help those suffering from this debilitating illness.”
The study was supported in part by the National Heart, Lung, and Blood Institute; the National Center for Advancing Translational Sciences; and the Vanderbilt Hormone and Analytical Services Core. Dr. Raj has served as a consultant for Lundbeck NA and Theravance; has served as chair of the data safety and monitoring board for Arena Pharmaceuticals and as Cardiac Arrhythmia Network of Canada network investigator; and has served on the medical advisory board of Dysautonomia International and PoTS UK, both without financial compensation.
A version of this article first appeared on Medscape.com.
For patients with postural tachycardia syndrome (POTS), dietary sodium intake can be increased more confidently, suggests the first study to yield solid evidence to support this treatment strategy.
The results showed that high dietary sodium intake can lower plasma norepinephrine levels and ameliorate standing and orthostatic tachycardia for patients with POTS.
“These results suggest that increasing dietary salt is a good rationale for treatment of this condition, and this study gives reassurance we are doing the right thing for POTS patients by increasing their sodium intake,” senior author Satish R. Raj, MD, said in an interview.
The study, with lead author Emily M. Garland, PhD, was published online April 26, 2021, in the Journal of the American College of Cardiology.
Dr. Raj, who is professor of cardiac science at the University of Calgary (Alta.), explained that POTS includes a spectrum of disorders that affect the automatic nervous system, which regulates heart rate and blood pressure.
“It is a disorder of orthostatic intolerance – patients feel better when they lie down. It differs from orthostatic hypotension in that, when a POTS patient stands up, the blood pressure does not necessarily drop, but the heart rate increases excessively.”
Although it is normal for the heart rate to increase somewhat on standing, among patients with POTS, the heart rate increases excessively. The condition is defined as an orthostatic heart rate increase of at least 30 beats/min (or 40 beats/min among individuals aged 12-19 years ) in the absence of orthostatic hypotension.
The disorder is characterized by a range of symptoms, including lightheadedness, shortness of breath, palpitations, and exertional intolerance, that are worse when in an upright position. Patients also experience chronic fatigue and perceived cognitive impairment, Dr. Raj noted.
The typical demographic for POTS is young women; the condition often starts during the teenage years.
Patients often have low blood volume, so one approach to treatment is to increase the intake of salt and water so as to increase blood volume.
“This is one of the mainstays of treatment, but it has never really been properly studied,” Dr. Raj commented. Increasing salt intake “is an unusual message from a cardiologist, and there have been concerns that we are making recommendations against traditional advice, so we urgently need evidence to support this recommendation.”
The current crossover study enrolled 14 patients with POTS and 13 healthy control persons who, over a period of 6 days, underwent treatment with a low-sodium diet (10 mEq sodium per day) or a high-sodium diet (300 mEq sodium per day).
Supine and standing heart rate, blood pressure, serum aldosterone level, plasma renin activity, blood volume, and plasma norepinephrine and epinephrine levels were measured.
Results showed that, among the POTS patients, the high-sodium diet reduced upright heart rate and the change in heart rate on standing, compared with the low-sodium diet.
Heart rate increased by 46 beats/min with the high-sodium diet versus 60 beats/min with the low-sodium diet.
Total blood volume and plasma volume increased, and standing norepinephrine levels decreased with the high-sodium diet, compared with the low-sodium diet.
However, upright heart rate, change in heart rate, and upright norepinephrine levels remained higher among POTS patients than among control persons receiving the high-sodium diet.
There was a nonsignificant trend for a lower symptom burden score among the POTS patients who received the high-sodium diet in comparison with those taking the low-sodium diet. Scores for mental confusion, palpitations, lightheadedness, and headache trending downward on the high-sodium diet.
“We found that high levels of dietary salt did what we hoped, with increased blood volume and reduced norepinephrine levels on standing and reduced excessive increase in heart rate. While it didn’t completely normalize heart rate, this was reduced significantly,” Dr. Raj said.
Another observation from the study was that the increased salt intake seemed to be beneficial across the whole spectrum of patients.
“There are some patients who have very high levels of sympathetic activation, and there have been anecdotal reports that increasing salt may not work so well in this group,” he said. “In this study, we didn’t differentiate, but average norepinephrine levels were very high, and many patients would be considered to be hyperadrenergic. Our results suggest this treatment will help these patients too.”
He noted that sodium intake was increased in this study just through diet. “We had a special metabolic kitchen. In clinical practice, we advise patients to add regular table salt to their food, and we only use salt tablets when they cannot tolerate so much salt in their diet.”
Recognizing that there may be concerns about hypertension with long-term use of such a treatment, Dr. Raj said there were no signs of an increase in blood pressure in this study. “But this should be considered a short-term therapy for the time being, and patients need to be reassessed every few years as their physiology changes.”
The authors estimated that POTS affects up to 1% of the population. Because there is no diagnostic code for the condition at present, all incidence data are estimates.
Dr. Raj pointed out that potentially a lot of people are affected, but there is little recognition of the condition among patients and physicians.
“Many family doctors are unaware of POTS,” he noted. “Patients often have to research their symptoms themselves and inform their doctor of the condition. Many patients wait years and often see many different doctors before getting a correct diagnosis.”
He explained that patients with POTS are often diagnosed as having a psychiatric illness. “They are mainly young women with palpitations, heart pounding, shakiness, which is often labeled as anxiety.”
Dr. Raj urged clinicians to consider POTS if patients have symptoms that are worse when standing up. The diagnosis is confirmed if their blood pressure doesn’t fall when standing up but their heart rate increases by at least 30 beats/min.
He noted that not enough specialists treat this condition, so family doctors need to be able to diagnose and initiate treatment. If more aggressive treatment is required, patients can be referred to a specialist.
“One of the problems is that this condition pans across different medical specialties. No one field owns it, so it tends to get ignored. But there are clinicians who are interested in POTS, and the key is finding one of these,” he said.
“We have finally established that this high-sodium diet works as treatment for POTS,” he concluded. “We have been using it for some time, but now we have evidence for its use across the whole spectrum of patients.”
In an accompanying editorial (J Am Coll Cardiol. 2021 May 4;77[17]:2185-2186), Blair P. Grubb, MD, University of Toledo (Ohio) Medical Center, wrote that this “superb study by Garland et al. helps better establish our understanding of the pathophysiologic process taking place in POTS while at the same time providing good evidence for the augmentation of dietary sodium as one of the cornerstones of treatment.”
He added that the field needs more such studies “in our quest to better understand POTS and to elaborate therapeutic modalities to help those suffering from this debilitating illness.”
The study was supported in part by the National Heart, Lung, and Blood Institute; the National Center for Advancing Translational Sciences; and the Vanderbilt Hormone and Analytical Services Core. Dr. Raj has served as a consultant for Lundbeck NA and Theravance; has served as chair of the data safety and monitoring board for Arena Pharmaceuticals and as Cardiac Arrhythmia Network of Canada network investigator; and has served on the medical advisory board of Dysautonomia International and PoTS UK, both without financial compensation.
A version of this article first appeared on Medscape.com.
Prioritize goals of older patients with multimorbidities, gerontologist says
said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.
During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.
“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.
“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”
For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.
“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”
What is patient priorities care?
Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.
“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”
In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
How electronic health records can help
In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.
“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”
She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
Systemic obstacles and solutions
According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.
“Our health care system doesn’t always make it easy to do this,” Dr. Boyd said. “It’s important to acknowledge this because it can be hard to do. There’s no question,” Dr. Boyd said in an interview.
Among the headwinds that clinicians may face are clinical practice guidelines, the structure of electronic health records, and quality metrics focused on specific conditions, she explained.
“There’s a lot of things that push us – in primary care and other parts of medicine – away from the approach that’s best for people with multiple chronic conditions,” Dr. Boyd said.
Dr. Tinetti said a challenge to providing this care that she expects is for clinicians, regardless of specialty, “to feel uneasy” about transitioning away from a conventional approach.
Among Dr. Tinetti’s arguments in favor of providing patient priorities care is that “it’s going to bring more joy in practice because you’re really addressing what matters to that individual while also providing good care.”
To get the most out of patient priorities care, Dr. Boyd recommended that clinicians focus on ‘the 4 M’s’: what matters most, mentation, mobility, and medications.
In an effort to address the last of these on a broad scale, Dr. Boyd is co-leading the US Deprescribing Research Network(USDeN), which aims to “improve medication use among older adults and the outcomes that are important to them,” according to the USDeN website.
To encourage deprescribing on a day-to-day level, Dr. Boyd called for strong communication between co–managing providers.
In an ideal world, there would be a better way to communicate than largely via electronic health records, she said.
“We need more than the EHR to connect us. That’s why it’s really important for primary care providers and specialists to be able to have time to actually talk to each other. This gets into how we reimburse and organize the communication and cognitive aspects of care,” Dr. Boyd noted.
Dr. Tinetti disclosed support from the John A. Hartford Foundation, the Donaghue Foundation, the National Institute on Aging, and the Institute for Healthcare Improvement. Dr. Boyd disclosed a relationship with UpToDate, for which she coauthored a chapter on multimorbidity.
said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.
During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.
“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.
“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”
For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.
“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”
What is patient priorities care?
Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.
“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”
In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
How electronic health records can help
In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.
“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”
She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
Systemic obstacles and solutions
According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.
“Our health care system doesn’t always make it easy to do this,” Dr. Boyd said. “It’s important to acknowledge this because it can be hard to do. There’s no question,” Dr. Boyd said in an interview.
Among the headwinds that clinicians may face are clinical practice guidelines, the structure of electronic health records, and quality metrics focused on specific conditions, she explained.
“There’s a lot of things that push us – in primary care and other parts of medicine – away from the approach that’s best for people with multiple chronic conditions,” Dr. Boyd said.
Dr. Tinetti said a challenge to providing this care that she expects is for clinicians, regardless of specialty, “to feel uneasy” about transitioning away from a conventional approach.
Among Dr. Tinetti’s arguments in favor of providing patient priorities care is that “it’s going to bring more joy in practice because you’re really addressing what matters to that individual while also providing good care.”
To get the most out of patient priorities care, Dr. Boyd recommended that clinicians focus on ‘the 4 M’s’: what matters most, mentation, mobility, and medications.
In an effort to address the last of these on a broad scale, Dr. Boyd is co-leading the US Deprescribing Research Network(USDeN), which aims to “improve medication use among older adults and the outcomes that are important to them,” according to the USDeN website.
To encourage deprescribing on a day-to-day level, Dr. Boyd called for strong communication between co–managing providers.
In an ideal world, there would be a better way to communicate than largely via electronic health records, she said.
“We need more than the EHR to connect us. That’s why it’s really important for primary care providers and specialists to be able to have time to actually talk to each other. This gets into how we reimburse and organize the communication and cognitive aspects of care,” Dr. Boyd noted.
Dr. Tinetti disclosed support from the John A. Hartford Foundation, the Donaghue Foundation, the National Institute on Aging, and the Institute for Healthcare Improvement. Dr. Boyd disclosed a relationship with UpToDate, for which she coauthored a chapter on multimorbidity.
said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.
During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.
“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.
“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”
For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.
“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”
What is patient priorities care?
Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.
“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”
In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
How electronic health records can help
In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.
“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”
She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
Systemic obstacles and solutions
According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.
“Our health care system doesn’t always make it easy to do this,” Dr. Boyd said. “It’s important to acknowledge this because it can be hard to do. There’s no question,” Dr. Boyd said in an interview.
Among the headwinds that clinicians may face are clinical practice guidelines, the structure of electronic health records, and quality metrics focused on specific conditions, she explained.
“There’s a lot of things that push us – in primary care and other parts of medicine – away from the approach that’s best for people with multiple chronic conditions,” Dr. Boyd said.
Dr. Tinetti said a challenge to providing this care that she expects is for clinicians, regardless of specialty, “to feel uneasy” about transitioning away from a conventional approach.
Among Dr. Tinetti’s arguments in favor of providing patient priorities care is that “it’s going to bring more joy in practice because you’re really addressing what matters to that individual while also providing good care.”
To get the most out of patient priorities care, Dr. Boyd recommended that clinicians focus on ‘the 4 M’s’: what matters most, mentation, mobility, and medications.
In an effort to address the last of these on a broad scale, Dr. Boyd is co-leading the US Deprescribing Research Network(USDeN), which aims to “improve medication use among older adults and the outcomes that are important to them,” according to the USDeN website.
To encourage deprescribing on a day-to-day level, Dr. Boyd called for strong communication between co–managing providers.
In an ideal world, there would be a better way to communicate than largely via electronic health records, she said.
“We need more than the EHR to connect us. That’s why it’s really important for primary care providers and specialists to be able to have time to actually talk to each other. This gets into how we reimburse and organize the communication and cognitive aspects of care,” Dr. Boyd noted.
Dr. Tinetti disclosed support from the John A. Hartford Foundation, the Donaghue Foundation, the National Institute on Aging, and the Institute for Healthcare Improvement. Dr. Boyd disclosed a relationship with UpToDate, for which she coauthored a chapter on multimorbidity.
FROM INTERNAL MEDICINE 2021
Restrict J&J COVID vaccine in women under 50?
Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.
The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.
The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins
They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.
The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.
They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”
In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).
The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.
The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.
As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.
In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.
At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.
In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.
One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.
All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.
The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.
In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.
Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.
However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.
“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.
They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.
They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.
They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.
The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.
They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.
“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.
The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.
In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).
The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.
They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.
This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.
Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.
A version of this article first appeared on Medscape.com.
Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.
The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.
The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins
They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.
The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.
They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”
In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).
The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.
The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.
As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.
In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.
At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.
In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.
One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.
All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.
The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.
In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.
Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.
However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.
“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.
They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.
They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.
They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.
The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.
They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.
“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.
The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.
In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).
The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.
They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.
This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.
Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.
A version of this article first appeared on Medscape.com.
Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.
The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.
The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins
They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.
The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.
They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”
In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).
The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.
The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.
As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.
In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.
At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.
In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.
One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.
All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.
The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.
In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.
Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.
However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.
“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.
They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.
They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.
They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.
The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.
They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.
“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.
The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.
In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).
The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.
They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.
This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.
Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.
A version of this article first appeared on Medscape.com.
Torsemide over furosemide as first-line loop diuretic for HF
When starting a new loop diuretic for a patient with heart failure, strongly consider torsemide over furosemide, Anthony C. Breu, MD, advised at SHM Converge, the annual conference of the Society of Hospital Medicine.
“Whether or not you take a patient who’s already on furosemide and you make the switch to torsemide is a little bit tougher for me to advocate, though that has happened in clinical trials,” said Dr. Breu, assistant professor of medicine at Harvard Medical School, Boston, who spoke May 5 at the Converge session “Things We Do for No Reason.” He co-presented the session with Leonard Feldman, MD, SFHM, director of the Osler Medical Residency Urban Health Track and associate professor at Johns Hopkins Medicine, Baltimore.
“If you consider doing this it would make sense to do so concert with the outpatient primary doctor and the outpatient cardiologist,” Dr. Breu said. “But in my review of the literature, it’s at least worth having these discussions, particularly for a patient who has multiple readmissions for heart failure. That may be a time to pause and ask: ‘Could torsemide be of benefit here?’ ”
In Dr. Breu’s opinion, there are at least three reasons why consider torsemide should be considered a first-line treatment for heart failure. For one thing, the current evidence says so. In a trial published in 2001, researchers randomized 234 patients with heart failure to receive torsemide or furosemide for 1 year. The percentage of patients who had one or more hospital readmissions was lower among those who received torsemide, compared with those who received furosemide in the torsemide group for heart failure (17% vs. 32%, respectively; P < .01) and for other cardiovascular causes (44% vs. 59%; P = .03). In addition, the number of total admissions was numerically lower for patients in the torsemide group, compared with the furosemide group for heart failure (23 vs. 61; P < .01) and for cardiovascular causes (78 vs. 130; P = .02).
In a separate study, researchers conducted an open-label trial of 237 patients with New York Heart Association (NYHA) class II-IV heart failure who were randomized to torsemide or furosemide. They found that a significantly higher percentage of patients in the torsemide group improved by one or more NYHA heart failure class, compared with those in the furosemide group (40%; P = .001 vs. 31%; P = .3). Moreover, patients treated with furosemide had more restrictions of daily life at 9 months, compared with those treated with torsemide (P < .001).
A separate, open-label, nonrandomized, postmarketing surveillance trial also found benefits of torsemide over furosemide or other agents used for patients with NYHA class III and IV heart failure. Patients treated with torsemide had a lower total mortality, compared with those treated with furosemide or other agents (2.2% vs. 4.5%, respectively; P < .05) as well as a lower cardiac mortality (1.4% vs. 3.5%; P < .05). They were also more likely to improve by one or more heart failure class (46% vs. 37%; P < .01) and less likely to have potassium levels less than 3.5 mEq/L or greater than 5.0 mEq/L (13% vs. 18%; P = .01).
According to Dr. Breu, meta-analyses of this topic consistently show that the NYHA class improved more with torsemide than with furosemide. “Some meta-analyses find a mortality benefit, while others find a readmissions benefit,” he said. “None of them show a benefit of furosemide over torsemide.”
A second reason to use torsemide as a first-line treatment for heart failure is that it has superior pharmacokinetics/dynamics, compared with furosemide. “We’ve all heard that furosemide has variable bioavailability,” said Dr. Breu, who also deputy editor of the Journal of Hospital Medicine’s “Things We Do For No Reason” article series. “Torsemide and bumetanide are much more reliably absorbed, partially because they are not affected by food, whereas furosemide is. That could be potentially problematic for patients who take their diuretic with meals. The fact that torsemide has less renal clearance is a benefit, because patients with heart failure have changing renal function.” In addition, the half-life of torsemide is 3-4 hours and the duration of action is 12 hours, “which are both longer than those for furosemide or bumetanide,” he added.
He also pointed out that torsemide has been shown to block the aldosterone receptor in vitro and in rat models – an effect that has not been observed with other loop diuretics. A randomized trial of patients with chronic heart failure found that levels of renin and aldosterone increased more with torsemide, compared with furosemide, supporting the hypothesis of aldosterone receptor blockade.
A third main reason to use torsemide as your go-to for heart failure has to do with its purported antifibrotic effects, “so that it could be more than a diuretic,” Dr. Breu said. “In heart failure, myocardial fibrosis occurs from increased collagen synthesis and turnover. Aldosterone has been shown to play a role in this myocardial fibrosis. Spironolactone has been shown to mitigate this to some extent. If torsemide acts a little like spironolactone, maybe that could explain some of the long-term effects that we see in these studies.”
A study supporting this notion found that torsemide but not furosemide reduced levels of serum carboxyl-terminal peptide of procollagen type I, which is associated with exaggerated myocardial deposition of collagen type I fibers in cardiac diseases.
Going forward, a study known as TRANSFORM-HF, which is currently recruiting about 6,000 patients, should bring more clarity to the topic. The primary objective is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized. The estimated completion is mid-2022.
Dr. Breu and Dr. Feldman reported having no relevant financial disclosures.
When starting a new loop diuretic for a patient with heart failure, strongly consider torsemide over furosemide, Anthony C. Breu, MD, advised at SHM Converge, the annual conference of the Society of Hospital Medicine.
“Whether or not you take a patient who’s already on furosemide and you make the switch to torsemide is a little bit tougher for me to advocate, though that has happened in clinical trials,” said Dr. Breu, assistant professor of medicine at Harvard Medical School, Boston, who spoke May 5 at the Converge session “Things We Do for No Reason.” He co-presented the session with Leonard Feldman, MD, SFHM, director of the Osler Medical Residency Urban Health Track and associate professor at Johns Hopkins Medicine, Baltimore.
“If you consider doing this it would make sense to do so concert with the outpatient primary doctor and the outpatient cardiologist,” Dr. Breu said. “But in my review of the literature, it’s at least worth having these discussions, particularly for a patient who has multiple readmissions for heart failure. That may be a time to pause and ask: ‘Could torsemide be of benefit here?’ ”
In Dr. Breu’s opinion, there are at least three reasons why consider torsemide should be considered a first-line treatment for heart failure. For one thing, the current evidence says so. In a trial published in 2001, researchers randomized 234 patients with heart failure to receive torsemide or furosemide for 1 year. The percentage of patients who had one or more hospital readmissions was lower among those who received torsemide, compared with those who received furosemide in the torsemide group for heart failure (17% vs. 32%, respectively; P < .01) and for other cardiovascular causes (44% vs. 59%; P = .03). In addition, the number of total admissions was numerically lower for patients in the torsemide group, compared with the furosemide group for heart failure (23 vs. 61; P < .01) and for cardiovascular causes (78 vs. 130; P = .02).
In a separate study, researchers conducted an open-label trial of 237 patients with New York Heart Association (NYHA) class II-IV heart failure who were randomized to torsemide or furosemide. They found that a significantly higher percentage of patients in the torsemide group improved by one or more NYHA heart failure class, compared with those in the furosemide group (40%; P = .001 vs. 31%; P = .3). Moreover, patients treated with furosemide had more restrictions of daily life at 9 months, compared with those treated with torsemide (P < .001).
A separate, open-label, nonrandomized, postmarketing surveillance trial also found benefits of torsemide over furosemide or other agents used for patients with NYHA class III and IV heart failure. Patients treated with torsemide had a lower total mortality, compared with those treated with furosemide or other agents (2.2% vs. 4.5%, respectively; P < .05) as well as a lower cardiac mortality (1.4% vs. 3.5%; P < .05). They were also more likely to improve by one or more heart failure class (46% vs. 37%; P < .01) and less likely to have potassium levels less than 3.5 mEq/L or greater than 5.0 mEq/L (13% vs. 18%; P = .01).
According to Dr. Breu, meta-analyses of this topic consistently show that the NYHA class improved more with torsemide than with furosemide. “Some meta-analyses find a mortality benefit, while others find a readmissions benefit,” he said. “None of them show a benefit of furosemide over torsemide.”
A second reason to use torsemide as a first-line treatment for heart failure is that it has superior pharmacokinetics/dynamics, compared with furosemide. “We’ve all heard that furosemide has variable bioavailability,” said Dr. Breu, who also deputy editor of the Journal of Hospital Medicine’s “Things We Do For No Reason” article series. “Torsemide and bumetanide are much more reliably absorbed, partially because they are not affected by food, whereas furosemide is. That could be potentially problematic for patients who take their diuretic with meals. The fact that torsemide has less renal clearance is a benefit, because patients with heart failure have changing renal function.” In addition, the half-life of torsemide is 3-4 hours and the duration of action is 12 hours, “which are both longer than those for furosemide or bumetanide,” he added.
He also pointed out that torsemide has been shown to block the aldosterone receptor in vitro and in rat models – an effect that has not been observed with other loop diuretics. A randomized trial of patients with chronic heart failure found that levels of renin and aldosterone increased more with torsemide, compared with furosemide, supporting the hypothesis of aldosterone receptor blockade.
A third main reason to use torsemide as your go-to for heart failure has to do with its purported antifibrotic effects, “so that it could be more than a diuretic,” Dr. Breu said. “In heart failure, myocardial fibrosis occurs from increased collagen synthesis and turnover. Aldosterone has been shown to play a role in this myocardial fibrosis. Spironolactone has been shown to mitigate this to some extent. If torsemide acts a little like spironolactone, maybe that could explain some of the long-term effects that we see in these studies.”
A study supporting this notion found that torsemide but not furosemide reduced levels of serum carboxyl-terminal peptide of procollagen type I, which is associated with exaggerated myocardial deposition of collagen type I fibers in cardiac diseases.
Going forward, a study known as TRANSFORM-HF, which is currently recruiting about 6,000 patients, should bring more clarity to the topic. The primary objective is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized. The estimated completion is mid-2022.
Dr. Breu and Dr. Feldman reported having no relevant financial disclosures.
When starting a new loop diuretic for a patient with heart failure, strongly consider torsemide over furosemide, Anthony C. Breu, MD, advised at SHM Converge, the annual conference of the Society of Hospital Medicine.
“Whether or not you take a patient who’s already on furosemide and you make the switch to torsemide is a little bit tougher for me to advocate, though that has happened in clinical trials,” said Dr. Breu, assistant professor of medicine at Harvard Medical School, Boston, who spoke May 5 at the Converge session “Things We Do for No Reason.” He co-presented the session with Leonard Feldman, MD, SFHM, director of the Osler Medical Residency Urban Health Track and associate professor at Johns Hopkins Medicine, Baltimore.
“If you consider doing this it would make sense to do so concert with the outpatient primary doctor and the outpatient cardiologist,” Dr. Breu said. “But in my review of the literature, it’s at least worth having these discussions, particularly for a patient who has multiple readmissions for heart failure. That may be a time to pause and ask: ‘Could torsemide be of benefit here?’ ”
In Dr. Breu’s opinion, there are at least three reasons why consider torsemide should be considered a first-line treatment for heart failure. For one thing, the current evidence says so. In a trial published in 2001, researchers randomized 234 patients with heart failure to receive torsemide or furosemide for 1 year. The percentage of patients who had one or more hospital readmissions was lower among those who received torsemide, compared with those who received furosemide in the torsemide group for heart failure (17% vs. 32%, respectively; P < .01) and for other cardiovascular causes (44% vs. 59%; P = .03). In addition, the number of total admissions was numerically lower for patients in the torsemide group, compared with the furosemide group for heart failure (23 vs. 61; P < .01) and for cardiovascular causes (78 vs. 130; P = .02).
In a separate study, researchers conducted an open-label trial of 237 patients with New York Heart Association (NYHA) class II-IV heart failure who were randomized to torsemide or furosemide. They found that a significantly higher percentage of patients in the torsemide group improved by one or more NYHA heart failure class, compared with those in the furosemide group (40%; P = .001 vs. 31%; P = .3). Moreover, patients treated with furosemide had more restrictions of daily life at 9 months, compared with those treated with torsemide (P < .001).
A separate, open-label, nonrandomized, postmarketing surveillance trial also found benefits of torsemide over furosemide or other agents used for patients with NYHA class III and IV heart failure. Patients treated with torsemide had a lower total mortality, compared with those treated with furosemide or other agents (2.2% vs. 4.5%, respectively; P < .05) as well as a lower cardiac mortality (1.4% vs. 3.5%; P < .05). They were also more likely to improve by one or more heart failure class (46% vs. 37%; P < .01) and less likely to have potassium levels less than 3.5 mEq/L or greater than 5.0 mEq/L (13% vs. 18%; P = .01).
According to Dr. Breu, meta-analyses of this topic consistently show that the NYHA class improved more with torsemide than with furosemide. “Some meta-analyses find a mortality benefit, while others find a readmissions benefit,” he said. “None of them show a benefit of furosemide over torsemide.”
A second reason to use torsemide as a first-line treatment for heart failure is that it has superior pharmacokinetics/dynamics, compared with furosemide. “We’ve all heard that furosemide has variable bioavailability,” said Dr. Breu, who also deputy editor of the Journal of Hospital Medicine’s “Things We Do For No Reason” article series. “Torsemide and bumetanide are much more reliably absorbed, partially because they are not affected by food, whereas furosemide is. That could be potentially problematic for patients who take their diuretic with meals. The fact that torsemide has less renal clearance is a benefit, because patients with heart failure have changing renal function.” In addition, the half-life of torsemide is 3-4 hours and the duration of action is 12 hours, “which are both longer than those for furosemide or bumetanide,” he added.
He also pointed out that torsemide has been shown to block the aldosterone receptor in vitro and in rat models – an effect that has not been observed with other loop diuretics. A randomized trial of patients with chronic heart failure found that levels of renin and aldosterone increased more with torsemide, compared with furosemide, supporting the hypothesis of aldosterone receptor blockade.
A third main reason to use torsemide as your go-to for heart failure has to do with its purported antifibrotic effects, “so that it could be more than a diuretic,” Dr. Breu said. “In heart failure, myocardial fibrosis occurs from increased collagen synthesis and turnover. Aldosterone has been shown to play a role in this myocardial fibrosis. Spironolactone has been shown to mitigate this to some extent. If torsemide acts a little like spironolactone, maybe that could explain some of the long-term effects that we see in these studies.”
A study supporting this notion found that torsemide but not furosemide reduced levels of serum carboxyl-terminal peptide of procollagen type I, which is associated with exaggerated myocardial deposition of collagen type I fibers in cardiac diseases.
Going forward, a study known as TRANSFORM-HF, which is currently recruiting about 6,000 patients, should bring more clarity to the topic. The primary objective is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized. The estimated completion is mid-2022.
Dr. Breu and Dr. Feldman reported having no relevant financial disclosures.
FROM SHM CONVERGE 2021
COVID-19 outcomes similar with ECMO or mechanical ventilation
Severely ill COVID-19 patients treated with extracorporeal membrane oxygenation (ECMO) had similar survival to hospital discharge and long-term outcomes as survivors treated with mechanical ventilation alone, results of a new, multicenter study suggest.
Importantly, the study also showed that survivors, regardless of the treatment they received, experienced significant deficits following their stay in the ICU and were suffering problems with physical, psychological, and cognitive functioning for months afterward.
At 3 months after discharge, 50% of the survivors reported cognitive dysfunction, ICU-acquired weakness and depression, anxiety, or PTSD; over 25% still required supplemental oxygen; and only one in six survivors were back at work.
The findings were presented April 30 at the American Association for Thoracic Surgery annual meeting.
The study represents the efforts of a multidisciplinary team that included cardiothoracic surgeons, critical care doctors, medical staff at long-term care facilities, and physical therapists in addition to other specialists. The research followed patients at five academic centers: the University of Colorado, the University of Virginia, the University of Kentucky, Johns Hopkins University, and Vanderbilt University.
“We were a multidisciplinary team, a whole variety of people to really track the long-term outcomes for patients who have been critically ill from COVID-19 and survived to hospital discharge,” presenting author Lauren J. Taylor, MD, fellow at the University of Colorado at Denver, Aurora, said in an interview.
It’s unclear currently what happens to these patients once they leave the hospital, she noted. “This is information we have not had, but when we followed these patients in these multidisciplinary clinics, there was a high level of either physical, emotional, or cognitive dysfunction, even for patients who were well enough to be living at home at the time of follow-up.
“So, if you have somebody living at home and they come into the clinic, you assume they are functioning pretty well, but when you actually provide them with cognitive and psychological testing and check their physical capabilities, you find a high degree of deficits throughout the entire cohort of this study,” she said.
The study was prompted by discussion with patients’ family members about the rationale, risks, and benefits of ECMO cannulation in patients with COVID-19 failing mechanical ventilation, senior author Jessica V. Rove, MD, also from the University of Colorado, said in an interview.
“We wanted to find out what their hospital course would be like and what cognitive, physical, or emotional deficits might they experience if they survive,” Dr. Rove said.
The investigators compared 262 mechanically ventilated patients with 46 patients cannulated for ECMO who were hospitalized between March and May 2020.
ECMO patients were younger and traveled farther but there were no significant differences in gender, race, or body mass index.
ECMO patients were mechanically ventilated for longer durations (median, 26 days vs. 13 days) and were more likely to receive inhaled pulmonary vasodilators, neuromuscular blockade, investigational COVID-19 therapies, blood transfusions, and inotropes.
They also experienced greater bleeding and clotting events (P < .01).
Despite a more complex critical illness course, patients treated with ECMO had similar survival at discharge and long-term outcomes, compared with those who were treated with mechanical ventilation alone.
The survival rate for ECMO patients was 69.9%, and for mechanically ventilated patients it was 69.6%.
Of the 215 survivors, 66.5% had documented follow-up within 3 months of discharge from hospital. Most survivors (93.9%) were living at home; a small percentage (16.1%) had returned to work or their usual activities, and 26.2% were still using supplemental oxygen.
These rates did not differ significantly based on ECMO status and rates of physical, psychological, and cognitive deficits did not differ significantly.
“The cognitive, emotional, and physical deficits seen in survivors of critical illness from COVID-19 can only be treated if diagnosed,” Dr. Rove said.
“Detrimental effects can potentially be ameliorated with use of best practices in the ICU, maximizing acute rehabilitation services where indicated, and follow-up with providers in multidisciplinary post-ICU clinics who can assess and treat these patients to optimize survivorship,” she said.
A version of this article first appeared on Medscape.com.
Severely ill COVID-19 patients treated with extracorporeal membrane oxygenation (ECMO) had similar survival to hospital discharge and long-term outcomes as survivors treated with mechanical ventilation alone, results of a new, multicenter study suggest.
Importantly, the study also showed that survivors, regardless of the treatment they received, experienced significant deficits following their stay in the ICU and were suffering problems with physical, psychological, and cognitive functioning for months afterward.
At 3 months after discharge, 50% of the survivors reported cognitive dysfunction, ICU-acquired weakness and depression, anxiety, or PTSD; over 25% still required supplemental oxygen; and only one in six survivors were back at work.
The findings were presented April 30 at the American Association for Thoracic Surgery annual meeting.
The study represents the efforts of a multidisciplinary team that included cardiothoracic surgeons, critical care doctors, medical staff at long-term care facilities, and physical therapists in addition to other specialists. The research followed patients at five academic centers: the University of Colorado, the University of Virginia, the University of Kentucky, Johns Hopkins University, and Vanderbilt University.
“We were a multidisciplinary team, a whole variety of people to really track the long-term outcomes for patients who have been critically ill from COVID-19 and survived to hospital discharge,” presenting author Lauren J. Taylor, MD, fellow at the University of Colorado at Denver, Aurora, said in an interview.
It’s unclear currently what happens to these patients once they leave the hospital, she noted. “This is information we have not had, but when we followed these patients in these multidisciplinary clinics, there was a high level of either physical, emotional, or cognitive dysfunction, even for patients who were well enough to be living at home at the time of follow-up.
“So, if you have somebody living at home and they come into the clinic, you assume they are functioning pretty well, but when you actually provide them with cognitive and psychological testing and check their physical capabilities, you find a high degree of deficits throughout the entire cohort of this study,” she said.
The study was prompted by discussion with patients’ family members about the rationale, risks, and benefits of ECMO cannulation in patients with COVID-19 failing mechanical ventilation, senior author Jessica V. Rove, MD, also from the University of Colorado, said in an interview.
“We wanted to find out what their hospital course would be like and what cognitive, physical, or emotional deficits might they experience if they survive,” Dr. Rove said.
The investigators compared 262 mechanically ventilated patients with 46 patients cannulated for ECMO who were hospitalized between March and May 2020.
ECMO patients were younger and traveled farther but there were no significant differences in gender, race, or body mass index.
ECMO patients were mechanically ventilated for longer durations (median, 26 days vs. 13 days) and were more likely to receive inhaled pulmonary vasodilators, neuromuscular blockade, investigational COVID-19 therapies, blood transfusions, and inotropes.
They also experienced greater bleeding and clotting events (P < .01).
Despite a more complex critical illness course, patients treated with ECMO had similar survival at discharge and long-term outcomes, compared with those who were treated with mechanical ventilation alone.
The survival rate for ECMO patients was 69.9%, and for mechanically ventilated patients it was 69.6%.
Of the 215 survivors, 66.5% had documented follow-up within 3 months of discharge from hospital. Most survivors (93.9%) were living at home; a small percentage (16.1%) had returned to work or their usual activities, and 26.2% were still using supplemental oxygen.
These rates did not differ significantly based on ECMO status and rates of physical, psychological, and cognitive deficits did not differ significantly.
“The cognitive, emotional, and physical deficits seen in survivors of critical illness from COVID-19 can only be treated if diagnosed,” Dr. Rove said.
“Detrimental effects can potentially be ameliorated with use of best practices in the ICU, maximizing acute rehabilitation services where indicated, and follow-up with providers in multidisciplinary post-ICU clinics who can assess and treat these patients to optimize survivorship,” she said.
A version of this article first appeared on Medscape.com.
Severely ill COVID-19 patients treated with extracorporeal membrane oxygenation (ECMO) had similar survival to hospital discharge and long-term outcomes as survivors treated with mechanical ventilation alone, results of a new, multicenter study suggest.
Importantly, the study also showed that survivors, regardless of the treatment they received, experienced significant deficits following their stay in the ICU and were suffering problems with physical, psychological, and cognitive functioning for months afterward.
At 3 months after discharge, 50% of the survivors reported cognitive dysfunction, ICU-acquired weakness and depression, anxiety, or PTSD; over 25% still required supplemental oxygen; and only one in six survivors were back at work.
The findings were presented April 30 at the American Association for Thoracic Surgery annual meeting.
The study represents the efforts of a multidisciplinary team that included cardiothoracic surgeons, critical care doctors, medical staff at long-term care facilities, and physical therapists in addition to other specialists. The research followed patients at five academic centers: the University of Colorado, the University of Virginia, the University of Kentucky, Johns Hopkins University, and Vanderbilt University.
“We were a multidisciplinary team, a whole variety of people to really track the long-term outcomes for patients who have been critically ill from COVID-19 and survived to hospital discharge,” presenting author Lauren J. Taylor, MD, fellow at the University of Colorado at Denver, Aurora, said in an interview.
It’s unclear currently what happens to these patients once they leave the hospital, she noted. “This is information we have not had, but when we followed these patients in these multidisciplinary clinics, there was a high level of either physical, emotional, or cognitive dysfunction, even for patients who were well enough to be living at home at the time of follow-up.
“So, if you have somebody living at home and they come into the clinic, you assume they are functioning pretty well, but when you actually provide them with cognitive and psychological testing and check their physical capabilities, you find a high degree of deficits throughout the entire cohort of this study,” she said.
The study was prompted by discussion with patients’ family members about the rationale, risks, and benefits of ECMO cannulation in patients with COVID-19 failing mechanical ventilation, senior author Jessica V. Rove, MD, also from the University of Colorado, said in an interview.
“We wanted to find out what their hospital course would be like and what cognitive, physical, or emotional deficits might they experience if they survive,” Dr. Rove said.
The investigators compared 262 mechanically ventilated patients with 46 patients cannulated for ECMO who were hospitalized between March and May 2020.
ECMO patients were younger and traveled farther but there were no significant differences in gender, race, or body mass index.
ECMO patients were mechanically ventilated for longer durations (median, 26 days vs. 13 days) and were more likely to receive inhaled pulmonary vasodilators, neuromuscular blockade, investigational COVID-19 therapies, blood transfusions, and inotropes.
They also experienced greater bleeding and clotting events (P < .01).
Despite a more complex critical illness course, patients treated with ECMO had similar survival at discharge and long-term outcomes, compared with those who were treated with mechanical ventilation alone.
The survival rate for ECMO patients was 69.9%, and for mechanically ventilated patients it was 69.6%.
Of the 215 survivors, 66.5% had documented follow-up within 3 months of discharge from hospital. Most survivors (93.9%) were living at home; a small percentage (16.1%) had returned to work or their usual activities, and 26.2% were still using supplemental oxygen.
These rates did not differ significantly based on ECMO status and rates of physical, psychological, and cognitive deficits did not differ significantly.
“The cognitive, emotional, and physical deficits seen in survivors of critical illness from COVID-19 can only be treated if diagnosed,” Dr. Rove said.
“Detrimental effects can potentially be ameliorated with use of best practices in the ICU, maximizing acute rehabilitation services where indicated, and follow-up with providers in multidisciplinary post-ICU clinics who can assess and treat these patients to optimize survivorship,” she said.
A version of this article first appeared on Medscape.com.