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Cell phone, smart watch magnets can affect medical devices, FDA says

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The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

  • Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
  • Do not carry consumer electronics in a pocket over the medical device.
  • Check your device using your home monitoring system, if you have one.
  • Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

A version of this article first appeared on Medscape.com.

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The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

  • Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
  • Do not carry consumer electronics in a pocket over the medical device.
  • Check your device using your home monitoring system, if you have one.
  • Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration is recommending patients and caregivers keep cell phones and smart watches at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators.

Terry Rudd/MDedge News

The warning, published on May 13, comes on the heels of recent research reporting that high–field strength magnets in newer smartphones may cause some implanted medical devices to switch to “magnet mode” and suspend normal lifesaving operations until the magnet is moved away.

This, for example, may cause a cardiac defibrillator to be unable to detect tachycardia events, the agency noted. The magnets may also change the operational mode such as turning on asynchronous mode in a pacemaker.

“The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact,” it said. “The FDA also conducted its own testing on some products that use the high–field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”

The FDA said it believes the risk to patients is low and is not aware of any adverse events associated with this issue at this time.

The American Heart Association has also cautioned that magnetic fields can inhibit the pulse generators for implantable cardioverter defibrillators and pacemakers.

The FDA offered the following simple precautions for individuals with implanted medical devices:

  • Keep the consumer electronics, such as certain cell phones and smart watches, 6 inches away from implanted medical devices.
  • Do not carry consumer electronics in a pocket over the medical device.
  • Check your device using your home monitoring system, if you have one.
  • Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

A version of this article first appeared on Medscape.com.

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Doctors prescribe fewer statins in the afternoon

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Primary care physicians are more likely to write a prescription for statins for their patients at risk for cardiovascular adverse events in the morning than in the afternoon, new research suggests.

RogerAshford/Thinkstock

In an observational cohort study, researchers from the nudge unit, University of Pennsylvania, Philadelphia, found that patients who had the first appointments of the day were most likely to have statins prescribed for them, and that this likelihood decreased as the day went on.

The study was published online May 11, 2021, in JAMA Network Open.

“Physicians are faced with decision fatigue, where they are seeing 20 patients in a day and may not have the mental bandwidth or cognitive bandwidth to fully think through every decision for every patient and to make all the appropriate decisions all of the time,” lead author Allison J. Hare, medical student and clinical informatics fellow in the nudge unit, said in an interview.

The Penn Medicine nudge unit attempts to better align clinician decision-making with current standards in best practices for the provision of various therapies, Ms. Hare explained.

“As we see more and more best-practice guidelines come out, we also see that there is a gap in the intention to treat and actual provision of these therapies,” she said. “There are also increasing expectations for clinicians to provide all of these different evidence-backed therapies. It can be hard to keep up with all these guidelines, especially when you are expected to take care of more and more patients, more and more efficiently.”

Guideline-directed statin therapy has been demonstrated to reduce the risk for major adverse cardiovascular events, yet 50% of statin-eligible patients have not been prescribed one.

“In our prior work at the nudge unit, we observed that rates of preventive care, including flu vaccination and cancer screening, declined as the clinic day progressed. We wanted to see if this occurred with statin scripts,” Ms. Hare said.

The researchers obtained data from 28 Penn Medicine primary care practices that included 10,757 patients at risk for heart disease for the period from March 2019 to February 2020.

Their mean age was 66.0 years (standard deviation, 10.5 years), 5,072 (47.2%) were female, and 7,071 (65.7%) were White. Patient characteristics were similar between morning and afternoon appointments.

All patients had clinical atherosclerotic cardiovascular disease, familial hypercholesterolemia, or LDL cholesterol of at least 190 mg/dL, conditions which qualified them for statins based on the U.S. Preventive Services Task Force guidelines.

The appointment times for each patient were broken down into hour blocks, ranging from the 8:00 a.m. hour to the 4:00 p.m. hour, which bookend open times in most practices.

Overall, statins were prescribed in 36% (n = 3,864) of visits.

The data showed a clear decline in statin prescribing as the day went on. For example, compared with patients who came in at 8:00 a.m. (the reference group), patients who came in at 9:00 a.m. were 12% less likely to get a prescription.

Patients coming in for noon appointments were 37% less likely to get a statin prescription, which made them the least likely to get a script. After the noon visits, there was a slight increase, but the likelihood of a statin prescription remained 27% less likely or worse for the rest of the day.

“In the context of the myriad tasks that clinicians are faced with doing for a single patient, and then also within the context of seeing 20 patients in 15-minute increments, it is easy to see how certain things fall through the cracks,” Ms. Hare said. “It’s impossible for any clinician to remember every single little thing for their patient every single time, so if we can augment the clinician’s ability to make those appropriate decisions with electronic tools, we can narrow that gap a little bit.”
 

 

 

Why the variability?

“The nudge unit uses prompts to ask the physician about prescribing statins. The question is, what is causing the variability in statin prescriptions?” Nieca Goldberg, MD, medical director of the New York University women’s heart program, said in an interview.

Dr. Nieca Goldberg

“Is it fatigue, lack of familiarity of guidelines, or is this due to the volume of patients and lack of time to discuss the therapy and make a shared decision with their patient? The answer to these questions was not part of the study,” said Dr. Goldberg, who is also an American Heart Association volunteer expert. “It would be interesting to know the thoughts of the physicians who were studied after they were informed of the results. Also, having a nudge to write the prescription will increase the prescriptions of statins, but will patients take the medication?”

The study was funded in part by a grant from the National Institute on Aging. Ms. Hare and Dr. Goldberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Primary care physicians are more likely to write a prescription for statins for their patients at risk for cardiovascular adverse events in the morning than in the afternoon, new research suggests.

RogerAshford/Thinkstock

In an observational cohort study, researchers from the nudge unit, University of Pennsylvania, Philadelphia, found that patients who had the first appointments of the day were most likely to have statins prescribed for them, and that this likelihood decreased as the day went on.

The study was published online May 11, 2021, in JAMA Network Open.

“Physicians are faced with decision fatigue, where they are seeing 20 patients in a day and may not have the mental bandwidth or cognitive bandwidth to fully think through every decision for every patient and to make all the appropriate decisions all of the time,” lead author Allison J. Hare, medical student and clinical informatics fellow in the nudge unit, said in an interview.

The Penn Medicine nudge unit attempts to better align clinician decision-making with current standards in best practices for the provision of various therapies, Ms. Hare explained.

“As we see more and more best-practice guidelines come out, we also see that there is a gap in the intention to treat and actual provision of these therapies,” she said. “There are also increasing expectations for clinicians to provide all of these different evidence-backed therapies. It can be hard to keep up with all these guidelines, especially when you are expected to take care of more and more patients, more and more efficiently.”

Guideline-directed statin therapy has been demonstrated to reduce the risk for major adverse cardiovascular events, yet 50% of statin-eligible patients have not been prescribed one.

“In our prior work at the nudge unit, we observed that rates of preventive care, including flu vaccination and cancer screening, declined as the clinic day progressed. We wanted to see if this occurred with statin scripts,” Ms. Hare said.

The researchers obtained data from 28 Penn Medicine primary care practices that included 10,757 patients at risk for heart disease for the period from March 2019 to February 2020.

Their mean age was 66.0 years (standard deviation, 10.5 years), 5,072 (47.2%) were female, and 7,071 (65.7%) were White. Patient characteristics were similar between morning and afternoon appointments.

All patients had clinical atherosclerotic cardiovascular disease, familial hypercholesterolemia, or LDL cholesterol of at least 190 mg/dL, conditions which qualified them for statins based on the U.S. Preventive Services Task Force guidelines.

The appointment times for each patient were broken down into hour blocks, ranging from the 8:00 a.m. hour to the 4:00 p.m. hour, which bookend open times in most practices.

Overall, statins were prescribed in 36% (n = 3,864) of visits.

The data showed a clear decline in statin prescribing as the day went on. For example, compared with patients who came in at 8:00 a.m. (the reference group), patients who came in at 9:00 a.m. were 12% less likely to get a prescription.

Patients coming in for noon appointments were 37% less likely to get a statin prescription, which made them the least likely to get a script. After the noon visits, there was a slight increase, but the likelihood of a statin prescription remained 27% less likely or worse for the rest of the day.

“In the context of the myriad tasks that clinicians are faced with doing for a single patient, and then also within the context of seeing 20 patients in 15-minute increments, it is easy to see how certain things fall through the cracks,” Ms. Hare said. “It’s impossible for any clinician to remember every single little thing for their patient every single time, so if we can augment the clinician’s ability to make those appropriate decisions with electronic tools, we can narrow that gap a little bit.”
 

 

 

Why the variability?

“The nudge unit uses prompts to ask the physician about prescribing statins. The question is, what is causing the variability in statin prescriptions?” Nieca Goldberg, MD, medical director of the New York University women’s heart program, said in an interview.

Dr. Nieca Goldberg

“Is it fatigue, lack of familiarity of guidelines, or is this due to the volume of patients and lack of time to discuss the therapy and make a shared decision with their patient? The answer to these questions was not part of the study,” said Dr. Goldberg, who is also an American Heart Association volunteer expert. “It would be interesting to know the thoughts of the physicians who were studied after they were informed of the results. Also, having a nudge to write the prescription will increase the prescriptions of statins, but will patients take the medication?”

The study was funded in part by a grant from the National Institute on Aging. Ms. Hare and Dr. Goldberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Primary care physicians are more likely to write a prescription for statins for their patients at risk for cardiovascular adverse events in the morning than in the afternoon, new research suggests.

RogerAshford/Thinkstock

In an observational cohort study, researchers from the nudge unit, University of Pennsylvania, Philadelphia, found that patients who had the first appointments of the day were most likely to have statins prescribed for them, and that this likelihood decreased as the day went on.

The study was published online May 11, 2021, in JAMA Network Open.

“Physicians are faced with decision fatigue, where they are seeing 20 patients in a day and may not have the mental bandwidth or cognitive bandwidth to fully think through every decision for every patient and to make all the appropriate decisions all of the time,” lead author Allison J. Hare, medical student and clinical informatics fellow in the nudge unit, said in an interview.

The Penn Medicine nudge unit attempts to better align clinician decision-making with current standards in best practices for the provision of various therapies, Ms. Hare explained.

“As we see more and more best-practice guidelines come out, we also see that there is a gap in the intention to treat and actual provision of these therapies,” she said. “There are also increasing expectations for clinicians to provide all of these different evidence-backed therapies. It can be hard to keep up with all these guidelines, especially when you are expected to take care of more and more patients, more and more efficiently.”

Guideline-directed statin therapy has been demonstrated to reduce the risk for major adverse cardiovascular events, yet 50% of statin-eligible patients have not been prescribed one.

“In our prior work at the nudge unit, we observed that rates of preventive care, including flu vaccination and cancer screening, declined as the clinic day progressed. We wanted to see if this occurred with statin scripts,” Ms. Hare said.

The researchers obtained data from 28 Penn Medicine primary care practices that included 10,757 patients at risk for heart disease for the period from March 2019 to February 2020.

Their mean age was 66.0 years (standard deviation, 10.5 years), 5,072 (47.2%) were female, and 7,071 (65.7%) were White. Patient characteristics were similar between morning and afternoon appointments.

All patients had clinical atherosclerotic cardiovascular disease, familial hypercholesterolemia, or LDL cholesterol of at least 190 mg/dL, conditions which qualified them for statins based on the U.S. Preventive Services Task Force guidelines.

The appointment times for each patient were broken down into hour blocks, ranging from the 8:00 a.m. hour to the 4:00 p.m. hour, which bookend open times in most practices.

Overall, statins were prescribed in 36% (n = 3,864) of visits.

The data showed a clear decline in statin prescribing as the day went on. For example, compared with patients who came in at 8:00 a.m. (the reference group), patients who came in at 9:00 a.m. were 12% less likely to get a prescription.

Patients coming in for noon appointments were 37% less likely to get a statin prescription, which made them the least likely to get a script. After the noon visits, there was a slight increase, but the likelihood of a statin prescription remained 27% less likely or worse for the rest of the day.

“In the context of the myriad tasks that clinicians are faced with doing for a single patient, and then also within the context of seeing 20 patients in 15-minute increments, it is easy to see how certain things fall through the cracks,” Ms. Hare said. “It’s impossible for any clinician to remember every single little thing for their patient every single time, so if we can augment the clinician’s ability to make those appropriate decisions with electronic tools, we can narrow that gap a little bit.”
 

 

 

Why the variability?

“The nudge unit uses prompts to ask the physician about prescribing statins. The question is, what is causing the variability in statin prescriptions?” Nieca Goldberg, MD, medical director of the New York University women’s heart program, said in an interview.

Dr. Nieca Goldberg

“Is it fatigue, lack of familiarity of guidelines, or is this due to the volume of patients and lack of time to discuss the therapy and make a shared decision with their patient? The answer to these questions was not part of the study,” said Dr. Goldberg, who is also an American Heart Association volunteer expert. “It would be interesting to know the thoughts of the physicians who were studied after they were informed of the results. Also, having a nudge to write the prescription will increase the prescriptions of statins, but will patients take the medication?”

The study was funded in part by a grant from the National Institute on Aging. Ms. Hare and Dr. Goldberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Among asymptomatic, 2% may harbor 90% of community’s viral load: Study

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About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

 

 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

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About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

 

 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

 

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

 

 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

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Online patient reviews and HIPAA

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In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Dr. Joseph S. Eastern

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

  • Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
  • Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
  • Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
  • Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Dr. Joseph S. Eastern

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

  • Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
  • Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
  • Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
  • Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Dr. Joseph S. Eastern

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

  • Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
  • Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
  • Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
  • Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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CDC: Vaccinated? You don’t need a mask indoors

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People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

A version of this article first appeared on Medscape.com.

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People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

A version of this article first appeared on Medscape.com.

 

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

A version of this article first appeared on Medscape.com.

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Vegetarians have better cholesterol levels, and more, than meat eaters

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Vegetarians have more favorable levels of a number of biomarkers including cardiovascular-linked ones – total cholesterol, low-density lipoprotein cholesterol, and apolipoprotein A and B – than meat eaters, according to results of the largest study of its kind to date.

Results of the cross-sectional, observational study of 178,000 participants were presented as an electronic poster at this year’s online European Congress on Obesity by Jirapitcha Boonpor of the Institute of Cardiovascular & Medical Sciences, University of Glasgow (Scotland).

“We found that the health benefits of becoming a vegetarian were independent of adiposity and other sociodemographic and lifestyle-related confounding factors,” senior author Carlos Celis-Morales, PhD, also from the University of Glasgow, said in an interview.

Total cholesterol and LDL cholesterol concentrations for vegetarians were 21% and 16.4% lower than in meat eaters. But some biomarkers considered beneficial – including vitamin D concentrations – were lower in vegetarians, while some considered unhealthy – including triglycerides and cystatin-C levels – were higher.  

Vegetarian diets have recently become much more popular, but there is insufficient information about the health benefits. Prior reports of associations between biomarkers and a vegetarian diet were unclear, including evidence of any metabolic benefits, noted Dr. Celis-Morales.

Importantly, participants in the study had followed a vegetarian or meat-eater diet for at least 5 years before their biomarkers in blood and urine were assessed.

“If you modify your diet, then, 2 weeks later, you can see changes in some metabolic markers, but changes in markers of cardiovascular disease will take 5-10 years,” he explained.
 

No single biomarker can assess health

Asked to comment on the findings, John C. Mathers, PhD, noted that they clearly confirm the importance of not reading any biomarker result in isolation.

Health is complex and individual markers tell you just part of the story,” said Dr. Mathers of the Human Nutrition Research Centre, Newcastle (England) University.

He says a vegetarian diet can be nourishing but cautioned that “just because someone excludes meat from their diet does not mean necessarily that they will be eating a healthy diet.”

“Some of the biomarker differences seen in this work – such as the lower concentrations of total cholesterol and LDL cholesterol, GGT [gamma-glutamyl transferase], and ALT [alanine transaminase] – are indicators that the vegetarians were healthier than the meat eaters. However, other differences were less encouraging, including the lower concentrations of vitamin D and higher concentrations of triglycerides and cystatin-C.”

Also reflecting on the results, Jose Lara Gallegos, PhD, senior lecturer in human nutrition at Northumbria University, Newcastle upon Tyne, England, said they support previous evidence from large studies such as the European Prospective Investigation into Cancer and Nutrition (EPIC), which showed that a vegetarian diet is associated with a lower risk of heart disease.

“A vegetarian diet might also be associated with lower risk for liver diseases such as nonalcoholic fatty liver disease,” Dr. Gallegos said, but added that some levels of biomarkers considered to be “healthy” were lower in the vegetarians, and it is important to remember that strictly restricted diets might be associated with potential risks of nutritional inadequacies.

“Other, less restrictive dietary patterns, such as a Mediterranean diet, are also associated with ... health benefits,” he observed.
 

 

 

Large data sample from the UK Biobank study

“Specifically, we wanted to know if vegetarians were healthier because they are generally leaner and lead healthier lives, or whether their diet specifically was responsible for their improved metabolic and cardiovascular health,” Dr. Celis-Morales explained.

Data were included from 177,723 healthy participants from the UK Biobank study who were aged 37-73 years and had reported no major dietary changes over the last 5 years. In total, 4,111 participants were self-reported vegetarians who followed a diet without red meat, poultry, or fish, and 166,516 participants were meat eaters.

Nineteen biomarkers related to diabetes, hypertension, cardiovascular diseases, cancer, and liver and renal function were included, and the associations between vegetarian diet and biomarkers, compared with meat eaters, were examined.

To minimize confounding, the findings were adjusted for age, sex, deprivation, education, ethnicity, smoking, total sedentary time, type of physical activity, alcohol intake, body mass index, and waist circumference.

Compared with meat eaters, vegetarians had significantly lower concentrations of 14 biomarkers, including total cholesterol (21% lower); LDL (16% lower); lipoprotein A (1% lower), lipoprotein B (4% lower), and liver function markers (GGT: 354% lower, and ALT: 153% lower), IGF-1 (134% lower), urate (122% lower), total protein (29% lower), creatinine (607% lower), and C-reactive protein (10% lower).

However, the researchers found that, compared with meat eaters, vegetarians had significantly higher concentrations of some unhealthy biomarkers, including triglycerides (15% higher) and cystatin-C (4% higher), and lower levels of some beneficial biomarkers including high-density lipoprotein (HDL) cholesterol (5% lower), vitamin D (635% lower), and calcium (0.7% lower).

No associations were found for hemoglobin A1c, systolic blood pressure, and aminotransferase.

“Some biomarkers, for example urate, were very low in vegetarians, and this served to verify our results because we expected meat eaters to have higher levels of urate,” remarked Dr. Celis-Morales.
 

Diet commitment and cardiovascular outcomes

Many people, whether vegetarians or meat-eaters, follow short-term diets, for example, the Atkins or the 5:2 diet, and often lack continuity switching from one diet to the next, or back to regular eating.  

“They are healthy, but they do not commit for long enough to make a difference to metabolic markers or potentially long-term health. In contrast, vegetarians are usually fully committed but the reasons behind this commitment might be a concern for the environment or animal welfare, for example,” Dr. Celis-Morales pointed out.

However, he added that many vegetarians replace the meat in their diet with unhealthy alternatives. “They often eat too much pasta or potatoes, or other high-energy food with low nutritional value.”

Having identified metabolic markers specific to long-term vegetarian diets, Dr. Celis-Morales wanted to know what happens to vegetarians’ long-term cardiovascular health. He analyzed and published these outcomes in a separate study published in December 2020.

“Over 9 years of follow-up, we have found that vegetarians have a lower risk in terms of myocardial infarction in the long-term, as well as other cardiovascular disease,” he reported.

Asked whether there was an optimum age or time in life to become a vegetarian to improve health, Dr. Celis-Morales explained that the healthier you are, the less likely you will reap the health benefits of dietary changes – for example to being a vegetarian.

“It is more likely that those people who have unhealthy lifestyle risk factors, such as smoking, and high consumption of high-energy foods or processed meat are more likely to see positive health effects,” he said.  

Lifestyle changes to improve cardiovascular outcomes are usually more likely to be required at 40 or 50 years old than at younger ages. He also noted that metabolic markers tend to show clear improvement at around 3 months after adopting a particular diet but improvements in disease outcomes take a lot longer to become evident.

Dr. Celis-Morales and his team are currently conducting a further analysis to understand if the vegetarian diet is also associated with a lower risk of cancer, depression, and dementia, compared with meat-eaters.

Dr. Celis-Morales, Dr. Mathers, and Dr. Gallegos have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Vegetarians have more favorable levels of a number of biomarkers including cardiovascular-linked ones – total cholesterol, low-density lipoprotein cholesterol, and apolipoprotein A and B – than meat eaters, according to results of the largest study of its kind to date.

Results of the cross-sectional, observational study of 178,000 participants were presented as an electronic poster at this year’s online European Congress on Obesity by Jirapitcha Boonpor of the Institute of Cardiovascular & Medical Sciences, University of Glasgow (Scotland).

“We found that the health benefits of becoming a vegetarian were independent of adiposity and other sociodemographic and lifestyle-related confounding factors,” senior author Carlos Celis-Morales, PhD, also from the University of Glasgow, said in an interview.

Total cholesterol and LDL cholesterol concentrations for vegetarians were 21% and 16.4% lower than in meat eaters. But some biomarkers considered beneficial – including vitamin D concentrations – were lower in vegetarians, while some considered unhealthy – including triglycerides and cystatin-C levels – were higher.  

Vegetarian diets have recently become much more popular, but there is insufficient information about the health benefits. Prior reports of associations between biomarkers and a vegetarian diet were unclear, including evidence of any metabolic benefits, noted Dr. Celis-Morales.

Importantly, participants in the study had followed a vegetarian or meat-eater diet for at least 5 years before their biomarkers in blood and urine were assessed.

“If you modify your diet, then, 2 weeks later, you can see changes in some metabolic markers, but changes in markers of cardiovascular disease will take 5-10 years,” he explained.
 

No single biomarker can assess health

Asked to comment on the findings, John C. Mathers, PhD, noted that they clearly confirm the importance of not reading any biomarker result in isolation.

Health is complex and individual markers tell you just part of the story,” said Dr. Mathers of the Human Nutrition Research Centre, Newcastle (England) University.

He says a vegetarian diet can be nourishing but cautioned that “just because someone excludes meat from their diet does not mean necessarily that they will be eating a healthy diet.”

“Some of the biomarker differences seen in this work – such as the lower concentrations of total cholesterol and LDL cholesterol, GGT [gamma-glutamyl transferase], and ALT [alanine transaminase] – are indicators that the vegetarians were healthier than the meat eaters. However, other differences were less encouraging, including the lower concentrations of vitamin D and higher concentrations of triglycerides and cystatin-C.”

Also reflecting on the results, Jose Lara Gallegos, PhD, senior lecturer in human nutrition at Northumbria University, Newcastle upon Tyne, England, said they support previous evidence from large studies such as the European Prospective Investigation into Cancer and Nutrition (EPIC), which showed that a vegetarian diet is associated with a lower risk of heart disease.

“A vegetarian diet might also be associated with lower risk for liver diseases such as nonalcoholic fatty liver disease,” Dr. Gallegos said, but added that some levels of biomarkers considered to be “healthy” were lower in the vegetarians, and it is important to remember that strictly restricted diets might be associated with potential risks of nutritional inadequacies.

“Other, less restrictive dietary patterns, such as a Mediterranean diet, are also associated with ... health benefits,” he observed.
 

 

 

Large data sample from the UK Biobank study

“Specifically, we wanted to know if vegetarians were healthier because they are generally leaner and lead healthier lives, or whether their diet specifically was responsible for their improved metabolic and cardiovascular health,” Dr. Celis-Morales explained.

Data were included from 177,723 healthy participants from the UK Biobank study who were aged 37-73 years and had reported no major dietary changes over the last 5 years. In total, 4,111 participants were self-reported vegetarians who followed a diet without red meat, poultry, or fish, and 166,516 participants were meat eaters.

Nineteen biomarkers related to diabetes, hypertension, cardiovascular diseases, cancer, and liver and renal function were included, and the associations between vegetarian diet and biomarkers, compared with meat eaters, were examined.

To minimize confounding, the findings were adjusted for age, sex, deprivation, education, ethnicity, smoking, total sedentary time, type of physical activity, alcohol intake, body mass index, and waist circumference.

Compared with meat eaters, vegetarians had significantly lower concentrations of 14 biomarkers, including total cholesterol (21% lower); LDL (16% lower); lipoprotein A (1% lower), lipoprotein B (4% lower), and liver function markers (GGT: 354% lower, and ALT: 153% lower), IGF-1 (134% lower), urate (122% lower), total protein (29% lower), creatinine (607% lower), and C-reactive protein (10% lower).

However, the researchers found that, compared with meat eaters, vegetarians had significantly higher concentrations of some unhealthy biomarkers, including triglycerides (15% higher) and cystatin-C (4% higher), and lower levels of some beneficial biomarkers including high-density lipoprotein (HDL) cholesterol (5% lower), vitamin D (635% lower), and calcium (0.7% lower).

No associations were found for hemoglobin A1c, systolic blood pressure, and aminotransferase.

“Some biomarkers, for example urate, were very low in vegetarians, and this served to verify our results because we expected meat eaters to have higher levels of urate,” remarked Dr. Celis-Morales.
 

Diet commitment and cardiovascular outcomes

Many people, whether vegetarians or meat-eaters, follow short-term diets, for example, the Atkins or the 5:2 diet, and often lack continuity switching from one diet to the next, or back to regular eating.  

“They are healthy, but they do not commit for long enough to make a difference to metabolic markers or potentially long-term health. In contrast, vegetarians are usually fully committed but the reasons behind this commitment might be a concern for the environment or animal welfare, for example,” Dr. Celis-Morales pointed out.

However, he added that many vegetarians replace the meat in their diet with unhealthy alternatives. “They often eat too much pasta or potatoes, or other high-energy food with low nutritional value.”

Having identified metabolic markers specific to long-term vegetarian diets, Dr. Celis-Morales wanted to know what happens to vegetarians’ long-term cardiovascular health. He analyzed and published these outcomes in a separate study published in December 2020.

“Over 9 years of follow-up, we have found that vegetarians have a lower risk in terms of myocardial infarction in the long-term, as well as other cardiovascular disease,” he reported.

Asked whether there was an optimum age or time in life to become a vegetarian to improve health, Dr. Celis-Morales explained that the healthier you are, the less likely you will reap the health benefits of dietary changes – for example to being a vegetarian.

“It is more likely that those people who have unhealthy lifestyle risk factors, such as smoking, and high consumption of high-energy foods or processed meat are more likely to see positive health effects,” he said.  

Lifestyle changes to improve cardiovascular outcomes are usually more likely to be required at 40 or 50 years old than at younger ages. He also noted that metabolic markers tend to show clear improvement at around 3 months after adopting a particular diet but improvements in disease outcomes take a lot longer to become evident.

Dr. Celis-Morales and his team are currently conducting a further analysis to understand if the vegetarian diet is also associated with a lower risk of cancer, depression, and dementia, compared with meat-eaters.

Dr. Celis-Morales, Dr. Mathers, and Dr. Gallegos have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

Vegetarians have more favorable levels of a number of biomarkers including cardiovascular-linked ones – total cholesterol, low-density lipoprotein cholesterol, and apolipoprotein A and B – than meat eaters, according to results of the largest study of its kind to date.

Results of the cross-sectional, observational study of 178,000 participants were presented as an electronic poster at this year’s online European Congress on Obesity by Jirapitcha Boonpor of the Institute of Cardiovascular & Medical Sciences, University of Glasgow (Scotland).

“We found that the health benefits of becoming a vegetarian were independent of adiposity and other sociodemographic and lifestyle-related confounding factors,” senior author Carlos Celis-Morales, PhD, also from the University of Glasgow, said in an interview.

Total cholesterol and LDL cholesterol concentrations for vegetarians were 21% and 16.4% lower than in meat eaters. But some biomarkers considered beneficial – including vitamin D concentrations – were lower in vegetarians, while some considered unhealthy – including triglycerides and cystatin-C levels – were higher.  

Vegetarian diets have recently become much more popular, but there is insufficient information about the health benefits. Prior reports of associations between biomarkers and a vegetarian diet were unclear, including evidence of any metabolic benefits, noted Dr. Celis-Morales.

Importantly, participants in the study had followed a vegetarian or meat-eater diet for at least 5 years before their biomarkers in blood and urine were assessed.

“If you modify your diet, then, 2 weeks later, you can see changes in some metabolic markers, but changes in markers of cardiovascular disease will take 5-10 years,” he explained.
 

No single biomarker can assess health

Asked to comment on the findings, John C. Mathers, PhD, noted that they clearly confirm the importance of not reading any biomarker result in isolation.

Health is complex and individual markers tell you just part of the story,” said Dr. Mathers of the Human Nutrition Research Centre, Newcastle (England) University.

He says a vegetarian diet can be nourishing but cautioned that “just because someone excludes meat from their diet does not mean necessarily that they will be eating a healthy diet.”

“Some of the biomarker differences seen in this work – such as the lower concentrations of total cholesterol and LDL cholesterol, GGT [gamma-glutamyl transferase], and ALT [alanine transaminase] – are indicators that the vegetarians were healthier than the meat eaters. However, other differences were less encouraging, including the lower concentrations of vitamin D and higher concentrations of triglycerides and cystatin-C.”

Also reflecting on the results, Jose Lara Gallegos, PhD, senior lecturer in human nutrition at Northumbria University, Newcastle upon Tyne, England, said they support previous evidence from large studies such as the European Prospective Investigation into Cancer and Nutrition (EPIC), which showed that a vegetarian diet is associated with a lower risk of heart disease.

“A vegetarian diet might also be associated with lower risk for liver diseases such as nonalcoholic fatty liver disease,” Dr. Gallegos said, but added that some levels of biomarkers considered to be “healthy” were lower in the vegetarians, and it is important to remember that strictly restricted diets might be associated with potential risks of nutritional inadequacies.

“Other, less restrictive dietary patterns, such as a Mediterranean diet, are also associated with ... health benefits,” he observed.
 

 

 

Large data sample from the UK Biobank study

“Specifically, we wanted to know if vegetarians were healthier because they are generally leaner and lead healthier lives, or whether their diet specifically was responsible for their improved metabolic and cardiovascular health,” Dr. Celis-Morales explained.

Data were included from 177,723 healthy participants from the UK Biobank study who were aged 37-73 years and had reported no major dietary changes over the last 5 years. In total, 4,111 participants were self-reported vegetarians who followed a diet without red meat, poultry, or fish, and 166,516 participants were meat eaters.

Nineteen biomarkers related to diabetes, hypertension, cardiovascular diseases, cancer, and liver and renal function were included, and the associations between vegetarian diet and biomarkers, compared with meat eaters, were examined.

To minimize confounding, the findings were adjusted for age, sex, deprivation, education, ethnicity, smoking, total sedentary time, type of physical activity, alcohol intake, body mass index, and waist circumference.

Compared with meat eaters, vegetarians had significantly lower concentrations of 14 biomarkers, including total cholesterol (21% lower); LDL (16% lower); lipoprotein A (1% lower), lipoprotein B (4% lower), and liver function markers (GGT: 354% lower, and ALT: 153% lower), IGF-1 (134% lower), urate (122% lower), total protein (29% lower), creatinine (607% lower), and C-reactive protein (10% lower).

However, the researchers found that, compared with meat eaters, vegetarians had significantly higher concentrations of some unhealthy biomarkers, including triglycerides (15% higher) and cystatin-C (4% higher), and lower levels of some beneficial biomarkers including high-density lipoprotein (HDL) cholesterol (5% lower), vitamin D (635% lower), and calcium (0.7% lower).

No associations were found for hemoglobin A1c, systolic blood pressure, and aminotransferase.

“Some biomarkers, for example urate, were very low in vegetarians, and this served to verify our results because we expected meat eaters to have higher levels of urate,” remarked Dr. Celis-Morales.
 

Diet commitment and cardiovascular outcomes

Many people, whether vegetarians or meat-eaters, follow short-term diets, for example, the Atkins or the 5:2 diet, and often lack continuity switching from one diet to the next, or back to regular eating.  

“They are healthy, but they do not commit for long enough to make a difference to metabolic markers or potentially long-term health. In contrast, vegetarians are usually fully committed but the reasons behind this commitment might be a concern for the environment or animal welfare, for example,” Dr. Celis-Morales pointed out.

However, he added that many vegetarians replace the meat in their diet with unhealthy alternatives. “They often eat too much pasta or potatoes, or other high-energy food with low nutritional value.”

Having identified metabolic markers specific to long-term vegetarian diets, Dr. Celis-Morales wanted to know what happens to vegetarians’ long-term cardiovascular health. He analyzed and published these outcomes in a separate study published in December 2020.

“Over 9 years of follow-up, we have found that vegetarians have a lower risk in terms of myocardial infarction in the long-term, as well as other cardiovascular disease,” he reported.

Asked whether there was an optimum age or time in life to become a vegetarian to improve health, Dr. Celis-Morales explained that the healthier you are, the less likely you will reap the health benefits of dietary changes – for example to being a vegetarian.

“It is more likely that those people who have unhealthy lifestyle risk factors, such as smoking, and high consumption of high-energy foods or processed meat are more likely to see positive health effects,” he said.  

Lifestyle changes to improve cardiovascular outcomes are usually more likely to be required at 40 or 50 years old than at younger ages. He also noted that metabolic markers tend to show clear improvement at around 3 months after adopting a particular diet but improvements in disease outcomes take a lot longer to become evident.

Dr. Celis-Morales and his team are currently conducting a further analysis to understand if the vegetarian diet is also associated with a lower risk of cancer, depression, and dementia, compared with meat-eaters.

Dr. Celis-Morales, Dr. Mathers, and Dr. Gallegos have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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AMA announces major commitment to health equity

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The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

  • Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
  • Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
  • Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
  • Ensure equitable opportunities in innovation.
  • Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

  • End segregated health care.
  • Establish national health care equity and racial justice standards.
  • End the use of race-based clinical decision models.
  • Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
  • Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
  • Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
  • Solidify connections and coordination between health care and public health.
  • Acknowledge and repair past harms committed by institutions.
  •  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

A version of this article first appeared on WebMD.com.

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The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

  • Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
  • Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
  • Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
  • Ensure equitable opportunities in innovation.
  • Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

  • End segregated health care.
  • Establish national health care equity and racial justice standards.
  • End the use of race-based clinical decision models.
  • Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
  • Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
  • Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
  • Solidify connections and coordination between health care and public health.
  • Acknowledge and repair past harms committed by institutions.
  •  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

A version of this article first appeared on WebMD.com.

 

The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

  • Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
  • Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
  • Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
  • Ensure equitable opportunities in innovation.
  • Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

  • End segregated health care.
  • Establish national health care equity and racial justice standards.
  • End the use of race-based clinical decision models.
  • Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
  • Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
  • Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
  • Solidify connections and coordination between health care and public health.
  • Acknowledge and repair past harms committed by institutions.
  •  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

A version of this article first appeared on WebMD.com.

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ACC 21 looks to repeat success despite pandemic headwinds

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The American College of Cardiology pulled off an impressive all-virtual meeting in March 2020, less than 3 weeks after canceling its in-person event and just 2 weeks after COVID-19 was declared a national emergency.

Optimistic plans for the annual scientific sessions of the American College of Cardiology (ACC 2021) to be a March hybrid affair in Atlanta pivoted not once, but twice, as the pandemic evolved, with the date pushed back 2 full months, to May 15-17, and the format revised to fully virtual.

“While this meeting is being delivered virtually, I think you’ll see there have been benefits in the time to plan and also the lessons that ACC has learned in virtual education over the past year. This has come together to really create a robust educational and scientific agenda,” ACC 2021 chair Pamela B. Morris, MD, said in a press conference focused on the upcoming meeting.

Over the 3 days, there will be more than 200 education sessions, 10 guideline-specific sessions, and 11 learning pathways that include core areas, but also special topics, such as COVID-19 and the emerging cardio-obstetrics subspecialty.

The meeting will be delivered through a new virtual education program built to optimize real-time interaction between faculty members and attendees, she said. A dedicated portal on the platform will allow attendees to interact virtually, for example, with presenters of the nearly 3,000 ePosters and 420 moderated posters.

For those suffering from Zoom fatigue, the increasingly popular Heart2Heart stage talks have also been converted to podcasts, which cover topics like gender equity in cardiology, the evolving role of advanced practice professionals, and “one of my favorites: art as a tool for healing,” said Dr. Morris, from the Medical University of South Carolina, Charleston. “Those sessions are really not to be missed.”

Reconnecting is an underlying theme of the meeting but the great divider will not be ignored. COVID-19 will be the focus of two 90-minute Intensive Sessions on Saturday, May 15, the first kicking off at 10:30 a.m. ET, with the Bishop Keynote lecture on bringing health equity to the frontline of cardiovascular care, followed by lessons learned during the pandemic, how to conduct clinical trials, and vaccine development.

The second session, set for 12:15 p.m., continues the “silver linings” theme, with case presentations on advances in telehealth, myocardial involvement, and thrombosis in COVID. For those wanting more, 18 abstracts are on tap in a 2-hour Spotlight on Special Topics session beginning at 2:30 p.m.

Asked about the pandemic’s effect on bringing science to fruition this past year, Dr. Morris said there’s no question it’s slowed some of the progress the cardiology community had made but, like clinical practice, “we’ve also surmounted many of those obstacles.”

“I think research has rebounded,” she said. “Just in terms of the number of abstracts and the quality of abstracts that were submitted this year, I don’t think there’s any question that we are right on par with previous years.”

Indeed, 5,258 abstracts from 76 countries were submitted, with more than 3,400 chosen for oral and poster presentation, including 25 late-breaking clinical trials to be presented in five sessions.

The late-breaking presentations and discussions will be prerecorded but speakers and panelists have been invited to be present during the streaming to answer live any questions that may arise in the chat box, ACC 2021 vice chair Douglas Drachman, MD, Massachusetts General Hospital, Boston, said in an interview.
 

 

 

Late-breaking clinical trials

The Joint ACC/JACC Late-Breaking Clinical Trials I (Saturday, May 15, 9:00 a.m.–-10:00 a.m.) kicks off with PARADISE-MI, the first head-to-head comparison of an angiotensin receptor neprilysin inhibitor (ARNI) and an ACE inhibitor in patients with reduced ejection fractions (EFs) after MI but no history of heart failure (HF), studying 200 mg sacubitril/valsartan (Entresto) versus 5 mg of ramipril, both twice daily, in 5,669 patients.

Sacubitril/valsartan was initially approved for HF with reduced EF and added a new indication to treat some HF patients with preserved EF. Novartis, however, recently told investors that although numerical trends consistently favored the ARNI over the ACE inhibitor ramipril, the phase 3 study failed to meet the primary endpoint for efficacy superiority of reducing the risk for cardiovascular (CV) death and HF events after an acute MI.

Second up is ADAPTABLE, which looks to close a surprising evidence gap over whether 81 mg or 325 mg daily is the optimal dose of the ubiquitously prescribed aspirin for secondary prevention in high-risk patients with established atherosclerotic CV disease.

The open-label, randomized study will look at efficacy and major bleeding over roughly 4 years in 15,000 patients within PCORnet, the National Patient-centered Clinical Research Network, a partnership of clinical research, health plan research, and patient-powered networks created to streamline patient-reported outcomes research.

“This study will not only give important clinical information for us, practically speaking, whether we should prescribe lower- or higher-dose aspirin, but it may also serve as a template for future pragmatic clinical trial design in the real world,” Dr. Drachman said during the press conference.

Up next is the 4,812-patient Canadian LAAOS III, the largest trial to examine the efficacy of left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation (AFib) already undergoing cardiac surgery. The primary outcome is the first occurrence of stroke or systemic arterial embolism over an average follow-up of 4 years.

Percutaneous closure of the left atrial appendage (LAA) has been shown to reduce stroke in AFib patients at high-risk of bleeding on systemic anticoagulation. But these devices can be expensive and studies haven’t included patients who also have valvular heart disease, a group that actually comprises more than half of patients undergoing cardiac surgery who also have AFib, he noted.

At the same time, surgical LAA closure studies have been small and have had very mixed results. “There isn’t a large-scale rigorous assessment out there for these patients undergoing surgery, so I think this is going to be fascinating to see,” Dr. Drachman said.

The session closes with ATLANTIS, which looks to shed some light on the role of anticoagulation therapy in patients after transcatheter aortic valve replacement (TAVR or TAVI). POPular TAVI, presented at ACC 2020, showed aspirin alone was the preferred antithrombotic therapy over aspirin plus clopidogrel (Plavix) in patients not on oral anticoagulants, but the optimal anticoagulation regimen remains unsettled.

The French open-label, 1,510-patient ATLANTIS trial examined whether the novel oral anticoagulant apixaban (Eliquis) is superior in preventing CV events after TAVR, compared with antiplatelet therapy in patients without an indication for anticoagulation and compared with vitamin K antagonists in those receiving anticoagulants.

An ATLANTIS 4D CT substudy of valve thrombosis is also slated for Saturday’s Featured Clinical Research 1 session at 12:15 p.m. to 1:45 p.m..
 

 

 

Sunday LBCTs

Dr. Drachman highlighted a series of other late-breaking studies, including the global DARE-19 trial testing the diabetes and HF drug dapagliflozin (Farxiga) given with local standard-of-care therapy for 30 days in hospitalized COVID-19 patients with CV, metabolic, or renal risk factors.

Although sodium-glucose cotransporter-2 inhibitors have been white-hot of late, top-line results reported last month show dapagliflozin failed to achieve statistical significance for the primary endpoints of reducing organ dysfunction and all-cause mortality and for improving recovery. Details will be presented in the Joint ACC/JAMA Late-Breaking Clinical Trials II (Sunday, May 16, 8:00 a.m.-9:30 a.m.).

Two trials, FLOWER-MI and RADIANCE-HTN TRIO, were singled out in the Joint ACC/New England Journal of Medicine Late-Breaking Clinical Trials III (Sunday, May 16, 10:45 a.m.-12:00 p.m.). FLOWER-MI examines whether fractional flow reserve (FFR) is better than angiography to guide complete multivessel revascularization in ST-elevation MI patients with at least 50% stenosis in at least one nonculprit lesion requiring percutaneous coronary intervention (PCI). Recent studies have shown the superiority of FFR-guided PCI for nonculprit lesions, compared with culprit lesion treatment-only, but this is the first time FFR- and angiography-guided PCI have been compared in STEMI patients.

RADIANCE-HTN TRIO already tipped its hand, with top-line results reported in late 2020 showing that the trial met its primary efficacy endpoint of greater reduction in daytime blood pressure over 2 months with the Paradise endovascular ultrasound renal denervation system, compared with a sham procedure, in 136 patients with resistant hypertension, importantly, after being given a single pill containing a calcium channel blocker, angiotensin II receptor blocker, and diuretic.

Renal denervation for hypertension has been making something of a comeback, with the 2018 RADIANCE-HTN SOLO reporting better ambulatory blood pressure control with the Paradise system than with a sham procedure in the absence of antihypertensive agents. The device has been granted breakthrough device designation from the Food and Drug Administration for the treatment of hypertensive patients who are unable to sufficiently respond to or are intolerant of antihypertensive therapy.
 

Monday LBCTs

In the Late-Breaking Clinical Trials IV session (Monday, May 17, 8 a.m.–9:30 a.m.), Drachman called out a secondary analysis from GALATIC-HF looking at the impact of EF on the therapeutic effect of omecamtiv mecarbil. In last year’s primary analysis, the selective cardiac myosin activator produced a modest but significant reduction in HF events or CV death in 8,232 patients with HF and an EF of 35% or less.

Rounding out the list is the Canadian CAPITAL CHILL study of moderate versus mild therapeutic hypothermia in out-of-hospital cardiac arrest, to be presented in the final Late-Breaking Clinical Trials V session (Monday, May 17, 10:45 a.m.–12:00 p.m.).

The double-blind trial sought to determine whether neurologic outcomes at 6 months are improved by targeting a core temperature of 31 ˚C versus 34 ˚C after the return of spontaneous circulation in comatose survivors of out-of-hospital cardiac arrest.

“For me, I think this could really change practice and has personal relevance from experience with cardiac arrest survivors that I’ve known and care for very deeply,” Dr. Drachman said in an interview. “I think that there’s a lot of opportunity here as well.”

Asked what other trials have the potential to change practice, Dr. Drachman said FLOWER-MI holds particular interest because it looks at how to manage patients with STEMI with multiple lesions at the point of care.

“We’ve gained a lot of clarity from several other prior clinical trials, but this will help to answer the question in a slightly different way of saying: can you eyeball it, can you look at the angiogram and say whether or not that other, nonculprit lesion ought to be treated in the same hospitalization or should you really be using a pressure wire,” he said. “For me as an interventionalist, this is really important because when you finish up doing an intervention on a patient it might be the middle of the night and the patient may be more or less stable, but you’ve already exposed them to the risk of a procedure, should you then move on and do another aspect of the procedure to interrogate with a pressure wire a remaining narrowing? I think that’s very important; that’ll help me make decisions on a day-to-day basis.”

Dr. Drachman also cited RADIANCE-HTN TRIO because it employs an endovascular technique to control blood pressure in patients with hypertension, specifically those resistant to multiple drugs.

During the press conference, Dr. Morris, a preventive cardiologist, put her money on the ADAPTABLE study of aspirin dosing, reiterating that the unique trial design could inform future research, and on Sunday’s 8:45 a.m. late-breaking post hoc analysis from the STRENGTH trial that looks to pick up where the controversy over omega-3 fatty acid preparations left off at last year’s American Heart Association meeting.

A lack of benefit on CV event rates reported with Epanova, a high-dose combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid, led to a contentious debate over how to reconcile STRENGTH with the findings from REDUCE-IT, which showed a 25% relative risk reduction in major CV events with the EPA product icosapent ethyl (Vascepa).

STRENGTH investigator Steven Nissen, MD, Cleveland Clinic, and REDUCE-IT investigator and session panelist Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, will share the virtual stage at ACC 2021, but Dr. Morris said the “good news” is both researchers know one another very well and “will really be focusing on no political issues, just the omega-3 fatty levels in the bloodstream and what does that mean in either trial.

“This is not designed to be a debate, point counterpoint,” she added.

For that, as all cardiologists and journalists know, there will be the wild and woolly #CardioTwitter sphere.

A version of this article first appeared on Medscape.com.

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The American College of Cardiology pulled off an impressive all-virtual meeting in March 2020, less than 3 weeks after canceling its in-person event and just 2 weeks after COVID-19 was declared a national emergency.

Optimistic plans for the annual scientific sessions of the American College of Cardiology (ACC 2021) to be a March hybrid affair in Atlanta pivoted not once, but twice, as the pandemic evolved, with the date pushed back 2 full months, to May 15-17, and the format revised to fully virtual.

“While this meeting is being delivered virtually, I think you’ll see there have been benefits in the time to plan and also the lessons that ACC has learned in virtual education over the past year. This has come together to really create a robust educational and scientific agenda,” ACC 2021 chair Pamela B. Morris, MD, said in a press conference focused on the upcoming meeting.

Over the 3 days, there will be more than 200 education sessions, 10 guideline-specific sessions, and 11 learning pathways that include core areas, but also special topics, such as COVID-19 and the emerging cardio-obstetrics subspecialty.

The meeting will be delivered through a new virtual education program built to optimize real-time interaction between faculty members and attendees, she said. A dedicated portal on the platform will allow attendees to interact virtually, for example, with presenters of the nearly 3,000 ePosters and 420 moderated posters.

For those suffering from Zoom fatigue, the increasingly popular Heart2Heart stage talks have also been converted to podcasts, which cover topics like gender equity in cardiology, the evolving role of advanced practice professionals, and “one of my favorites: art as a tool for healing,” said Dr. Morris, from the Medical University of South Carolina, Charleston. “Those sessions are really not to be missed.”

Reconnecting is an underlying theme of the meeting but the great divider will not be ignored. COVID-19 will be the focus of two 90-minute Intensive Sessions on Saturday, May 15, the first kicking off at 10:30 a.m. ET, with the Bishop Keynote lecture on bringing health equity to the frontline of cardiovascular care, followed by lessons learned during the pandemic, how to conduct clinical trials, and vaccine development.

The second session, set for 12:15 p.m., continues the “silver linings” theme, with case presentations on advances in telehealth, myocardial involvement, and thrombosis in COVID. For those wanting more, 18 abstracts are on tap in a 2-hour Spotlight on Special Topics session beginning at 2:30 p.m.

Asked about the pandemic’s effect on bringing science to fruition this past year, Dr. Morris said there’s no question it’s slowed some of the progress the cardiology community had made but, like clinical practice, “we’ve also surmounted many of those obstacles.”

“I think research has rebounded,” she said. “Just in terms of the number of abstracts and the quality of abstracts that were submitted this year, I don’t think there’s any question that we are right on par with previous years.”

Indeed, 5,258 abstracts from 76 countries were submitted, with more than 3,400 chosen for oral and poster presentation, including 25 late-breaking clinical trials to be presented in five sessions.

The late-breaking presentations and discussions will be prerecorded but speakers and panelists have been invited to be present during the streaming to answer live any questions that may arise in the chat box, ACC 2021 vice chair Douglas Drachman, MD, Massachusetts General Hospital, Boston, said in an interview.
 

 

 

Late-breaking clinical trials

The Joint ACC/JACC Late-Breaking Clinical Trials I (Saturday, May 15, 9:00 a.m.–-10:00 a.m.) kicks off with PARADISE-MI, the first head-to-head comparison of an angiotensin receptor neprilysin inhibitor (ARNI) and an ACE inhibitor in patients with reduced ejection fractions (EFs) after MI but no history of heart failure (HF), studying 200 mg sacubitril/valsartan (Entresto) versus 5 mg of ramipril, both twice daily, in 5,669 patients.

Sacubitril/valsartan was initially approved for HF with reduced EF and added a new indication to treat some HF patients with preserved EF. Novartis, however, recently told investors that although numerical trends consistently favored the ARNI over the ACE inhibitor ramipril, the phase 3 study failed to meet the primary endpoint for efficacy superiority of reducing the risk for cardiovascular (CV) death and HF events after an acute MI.

Second up is ADAPTABLE, which looks to close a surprising evidence gap over whether 81 mg or 325 mg daily is the optimal dose of the ubiquitously prescribed aspirin for secondary prevention in high-risk patients with established atherosclerotic CV disease.

The open-label, randomized study will look at efficacy and major bleeding over roughly 4 years in 15,000 patients within PCORnet, the National Patient-centered Clinical Research Network, a partnership of clinical research, health plan research, and patient-powered networks created to streamline patient-reported outcomes research.

“This study will not only give important clinical information for us, practically speaking, whether we should prescribe lower- or higher-dose aspirin, but it may also serve as a template for future pragmatic clinical trial design in the real world,” Dr. Drachman said during the press conference.

Up next is the 4,812-patient Canadian LAAOS III, the largest trial to examine the efficacy of left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation (AFib) already undergoing cardiac surgery. The primary outcome is the first occurrence of stroke or systemic arterial embolism over an average follow-up of 4 years.

Percutaneous closure of the left atrial appendage (LAA) has been shown to reduce stroke in AFib patients at high-risk of bleeding on systemic anticoagulation. But these devices can be expensive and studies haven’t included patients who also have valvular heart disease, a group that actually comprises more than half of patients undergoing cardiac surgery who also have AFib, he noted.

At the same time, surgical LAA closure studies have been small and have had very mixed results. “There isn’t a large-scale rigorous assessment out there for these patients undergoing surgery, so I think this is going to be fascinating to see,” Dr. Drachman said.

The session closes with ATLANTIS, which looks to shed some light on the role of anticoagulation therapy in patients after transcatheter aortic valve replacement (TAVR or TAVI). POPular TAVI, presented at ACC 2020, showed aspirin alone was the preferred antithrombotic therapy over aspirin plus clopidogrel (Plavix) in patients not on oral anticoagulants, but the optimal anticoagulation regimen remains unsettled.

The French open-label, 1,510-patient ATLANTIS trial examined whether the novel oral anticoagulant apixaban (Eliquis) is superior in preventing CV events after TAVR, compared with antiplatelet therapy in patients without an indication for anticoagulation and compared with vitamin K antagonists in those receiving anticoagulants.

An ATLANTIS 4D CT substudy of valve thrombosis is also slated for Saturday’s Featured Clinical Research 1 session at 12:15 p.m. to 1:45 p.m..
 

 

 

Sunday LBCTs

Dr. Drachman highlighted a series of other late-breaking studies, including the global DARE-19 trial testing the diabetes and HF drug dapagliflozin (Farxiga) given with local standard-of-care therapy for 30 days in hospitalized COVID-19 patients with CV, metabolic, or renal risk factors.

Although sodium-glucose cotransporter-2 inhibitors have been white-hot of late, top-line results reported last month show dapagliflozin failed to achieve statistical significance for the primary endpoints of reducing organ dysfunction and all-cause mortality and for improving recovery. Details will be presented in the Joint ACC/JAMA Late-Breaking Clinical Trials II (Sunday, May 16, 8:00 a.m.-9:30 a.m.).

Two trials, FLOWER-MI and RADIANCE-HTN TRIO, were singled out in the Joint ACC/New England Journal of Medicine Late-Breaking Clinical Trials III (Sunday, May 16, 10:45 a.m.-12:00 p.m.). FLOWER-MI examines whether fractional flow reserve (FFR) is better than angiography to guide complete multivessel revascularization in ST-elevation MI patients with at least 50% stenosis in at least one nonculprit lesion requiring percutaneous coronary intervention (PCI). Recent studies have shown the superiority of FFR-guided PCI for nonculprit lesions, compared with culprit lesion treatment-only, but this is the first time FFR- and angiography-guided PCI have been compared in STEMI patients.

RADIANCE-HTN TRIO already tipped its hand, with top-line results reported in late 2020 showing that the trial met its primary efficacy endpoint of greater reduction in daytime blood pressure over 2 months with the Paradise endovascular ultrasound renal denervation system, compared with a sham procedure, in 136 patients with resistant hypertension, importantly, after being given a single pill containing a calcium channel blocker, angiotensin II receptor blocker, and diuretic.

Renal denervation for hypertension has been making something of a comeback, with the 2018 RADIANCE-HTN SOLO reporting better ambulatory blood pressure control with the Paradise system than with a sham procedure in the absence of antihypertensive agents. The device has been granted breakthrough device designation from the Food and Drug Administration for the treatment of hypertensive patients who are unable to sufficiently respond to or are intolerant of antihypertensive therapy.
 

Monday LBCTs

In the Late-Breaking Clinical Trials IV session (Monday, May 17, 8 a.m.–9:30 a.m.), Drachman called out a secondary analysis from GALATIC-HF looking at the impact of EF on the therapeutic effect of omecamtiv mecarbil. In last year’s primary analysis, the selective cardiac myosin activator produced a modest but significant reduction in HF events or CV death in 8,232 patients with HF and an EF of 35% or less.

Rounding out the list is the Canadian CAPITAL CHILL study of moderate versus mild therapeutic hypothermia in out-of-hospital cardiac arrest, to be presented in the final Late-Breaking Clinical Trials V session (Monday, May 17, 10:45 a.m.–12:00 p.m.).

The double-blind trial sought to determine whether neurologic outcomes at 6 months are improved by targeting a core temperature of 31 ˚C versus 34 ˚C after the return of spontaneous circulation in comatose survivors of out-of-hospital cardiac arrest.

“For me, I think this could really change practice and has personal relevance from experience with cardiac arrest survivors that I’ve known and care for very deeply,” Dr. Drachman said in an interview. “I think that there’s a lot of opportunity here as well.”

Asked what other trials have the potential to change practice, Dr. Drachman said FLOWER-MI holds particular interest because it looks at how to manage patients with STEMI with multiple lesions at the point of care.

“We’ve gained a lot of clarity from several other prior clinical trials, but this will help to answer the question in a slightly different way of saying: can you eyeball it, can you look at the angiogram and say whether or not that other, nonculprit lesion ought to be treated in the same hospitalization or should you really be using a pressure wire,” he said. “For me as an interventionalist, this is really important because when you finish up doing an intervention on a patient it might be the middle of the night and the patient may be more or less stable, but you’ve already exposed them to the risk of a procedure, should you then move on and do another aspect of the procedure to interrogate with a pressure wire a remaining narrowing? I think that’s very important; that’ll help me make decisions on a day-to-day basis.”

Dr. Drachman also cited RADIANCE-HTN TRIO because it employs an endovascular technique to control blood pressure in patients with hypertension, specifically those resistant to multiple drugs.

During the press conference, Dr. Morris, a preventive cardiologist, put her money on the ADAPTABLE study of aspirin dosing, reiterating that the unique trial design could inform future research, and on Sunday’s 8:45 a.m. late-breaking post hoc analysis from the STRENGTH trial that looks to pick up where the controversy over omega-3 fatty acid preparations left off at last year’s American Heart Association meeting.

A lack of benefit on CV event rates reported with Epanova, a high-dose combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid, led to a contentious debate over how to reconcile STRENGTH with the findings from REDUCE-IT, which showed a 25% relative risk reduction in major CV events with the EPA product icosapent ethyl (Vascepa).

STRENGTH investigator Steven Nissen, MD, Cleveland Clinic, and REDUCE-IT investigator and session panelist Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, will share the virtual stage at ACC 2021, but Dr. Morris said the “good news” is both researchers know one another very well and “will really be focusing on no political issues, just the omega-3 fatty levels in the bloodstream and what does that mean in either trial.

“This is not designed to be a debate, point counterpoint,” she added.

For that, as all cardiologists and journalists know, there will be the wild and woolly #CardioTwitter sphere.

A version of this article first appeared on Medscape.com.

 

The American College of Cardiology pulled off an impressive all-virtual meeting in March 2020, less than 3 weeks after canceling its in-person event and just 2 weeks after COVID-19 was declared a national emergency.

Optimistic plans for the annual scientific sessions of the American College of Cardiology (ACC 2021) to be a March hybrid affair in Atlanta pivoted not once, but twice, as the pandemic evolved, with the date pushed back 2 full months, to May 15-17, and the format revised to fully virtual.

“While this meeting is being delivered virtually, I think you’ll see there have been benefits in the time to plan and also the lessons that ACC has learned in virtual education over the past year. This has come together to really create a robust educational and scientific agenda,” ACC 2021 chair Pamela B. Morris, MD, said in a press conference focused on the upcoming meeting.

Over the 3 days, there will be more than 200 education sessions, 10 guideline-specific sessions, and 11 learning pathways that include core areas, but also special topics, such as COVID-19 and the emerging cardio-obstetrics subspecialty.

The meeting will be delivered through a new virtual education program built to optimize real-time interaction between faculty members and attendees, she said. A dedicated portal on the platform will allow attendees to interact virtually, for example, with presenters of the nearly 3,000 ePosters and 420 moderated posters.

For those suffering from Zoom fatigue, the increasingly popular Heart2Heart stage talks have also been converted to podcasts, which cover topics like gender equity in cardiology, the evolving role of advanced practice professionals, and “one of my favorites: art as a tool for healing,” said Dr. Morris, from the Medical University of South Carolina, Charleston. “Those sessions are really not to be missed.”

Reconnecting is an underlying theme of the meeting but the great divider will not be ignored. COVID-19 will be the focus of two 90-minute Intensive Sessions on Saturday, May 15, the first kicking off at 10:30 a.m. ET, with the Bishop Keynote lecture on bringing health equity to the frontline of cardiovascular care, followed by lessons learned during the pandemic, how to conduct clinical trials, and vaccine development.

The second session, set for 12:15 p.m., continues the “silver linings” theme, with case presentations on advances in telehealth, myocardial involvement, and thrombosis in COVID. For those wanting more, 18 abstracts are on tap in a 2-hour Spotlight on Special Topics session beginning at 2:30 p.m.

Asked about the pandemic’s effect on bringing science to fruition this past year, Dr. Morris said there’s no question it’s slowed some of the progress the cardiology community had made but, like clinical practice, “we’ve also surmounted many of those obstacles.”

“I think research has rebounded,” she said. “Just in terms of the number of abstracts and the quality of abstracts that were submitted this year, I don’t think there’s any question that we are right on par with previous years.”

Indeed, 5,258 abstracts from 76 countries were submitted, with more than 3,400 chosen for oral and poster presentation, including 25 late-breaking clinical trials to be presented in five sessions.

The late-breaking presentations and discussions will be prerecorded but speakers and panelists have been invited to be present during the streaming to answer live any questions that may arise in the chat box, ACC 2021 vice chair Douglas Drachman, MD, Massachusetts General Hospital, Boston, said in an interview.
 

 

 

Late-breaking clinical trials

The Joint ACC/JACC Late-Breaking Clinical Trials I (Saturday, May 15, 9:00 a.m.–-10:00 a.m.) kicks off with PARADISE-MI, the first head-to-head comparison of an angiotensin receptor neprilysin inhibitor (ARNI) and an ACE inhibitor in patients with reduced ejection fractions (EFs) after MI but no history of heart failure (HF), studying 200 mg sacubitril/valsartan (Entresto) versus 5 mg of ramipril, both twice daily, in 5,669 patients.

Sacubitril/valsartan was initially approved for HF with reduced EF and added a new indication to treat some HF patients with preserved EF. Novartis, however, recently told investors that although numerical trends consistently favored the ARNI over the ACE inhibitor ramipril, the phase 3 study failed to meet the primary endpoint for efficacy superiority of reducing the risk for cardiovascular (CV) death and HF events after an acute MI.

Second up is ADAPTABLE, which looks to close a surprising evidence gap over whether 81 mg or 325 mg daily is the optimal dose of the ubiquitously prescribed aspirin for secondary prevention in high-risk patients with established atherosclerotic CV disease.

The open-label, randomized study will look at efficacy and major bleeding over roughly 4 years in 15,000 patients within PCORnet, the National Patient-centered Clinical Research Network, a partnership of clinical research, health plan research, and patient-powered networks created to streamline patient-reported outcomes research.

“This study will not only give important clinical information for us, practically speaking, whether we should prescribe lower- or higher-dose aspirin, but it may also serve as a template for future pragmatic clinical trial design in the real world,” Dr. Drachman said during the press conference.

Up next is the 4,812-patient Canadian LAAOS III, the largest trial to examine the efficacy of left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation (AFib) already undergoing cardiac surgery. The primary outcome is the first occurrence of stroke or systemic arterial embolism over an average follow-up of 4 years.

Percutaneous closure of the left atrial appendage (LAA) has been shown to reduce stroke in AFib patients at high-risk of bleeding on systemic anticoagulation. But these devices can be expensive and studies haven’t included patients who also have valvular heart disease, a group that actually comprises more than half of patients undergoing cardiac surgery who also have AFib, he noted.

At the same time, surgical LAA closure studies have been small and have had very mixed results. “There isn’t a large-scale rigorous assessment out there for these patients undergoing surgery, so I think this is going to be fascinating to see,” Dr. Drachman said.

The session closes with ATLANTIS, which looks to shed some light on the role of anticoagulation therapy in patients after transcatheter aortic valve replacement (TAVR or TAVI). POPular TAVI, presented at ACC 2020, showed aspirin alone was the preferred antithrombotic therapy over aspirin plus clopidogrel (Plavix) in patients not on oral anticoagulants, but the optimal anticoagulation regimen remains unsettled.

The French open-label, 1,510-patient ATLANTIS trial examined whether the novel oral anticoagulant apixaban (Eliquis) is superior in preventing CV events after TAVR, compared with antiplatelet therapy in patients without an indication for anticoagulation and compared with vitamin K antagonists in those receiving anticoagulants.

An ATLANTIS 4D CT substudy of valve thrombosis is also slated for Saturday’s Featured Clinical Research 1 session at 12:15 p.m. to 1:45 p.m..
 

 

 

Sunday LBCTs

Dr. Drachman highlighted a series of other late-breaking studies, including the global DARE-19 trial testing the diabetes and HF drug dapagliflozin (Farxiga) given with local standard-of-care therapy for 30 days in hospitalized COVID-19 patients with CV, metabolic, or renal risk factors.

Although sodium-glucose cotransporter-2 inhibitors have been white-hot of late, top-line results reported last month show dapagliflozin failed to achieve statistical significance for the primary endpoints of reducing organ dysfunction and all-cause mortality and for improving recovery. Details will be presented in the Joint ACC/JAMA Late-Breaking Clinical Trials II (Sunday, May 16, 8:00 a.m.-9:30 a.m.).

Two trials, FLOWER-MI and RADIANCE-HTN TRIO, were singled out in the Joint ACC/New England Journal of Medicine Late-Breaking Clinical Trials III (Sunday, May 16, 10:45 a.m.-12:00 p.m.). FLOWER-MI examines whether fractional flow reserve (FFR) is better than angiography to guide complete multivessel revascularization in ST-elevation MI patients with at least 50% stenosis in at least one nonculprit lesion requiring percutaneous coronary intervention (PCI). Recent studies have shown the superiority of FFR-guided PCI for nonculprit lesions, compared with culprit lesion treatment-only, but this is the first time FFR- and angiography-guided PCI have been compared in STEMI patients.

RADIANCE-HTN TRIO already tipped its hand, with top-line results reported in late 2020 showing that the trial met its primary efficacy endpoint of greater reduction in daytime blood pressure over 2 months with the Paradise endovascular ultrasound renal denervation system, compared with a sham procedure, in 136 patients with resistant hypertension, importantly, after being given a single pill containing a calcium channel blocker, angiotensin II receptor blocker, and diuretic.

Renal denervation for hypertension has been making something of a comeback, with the 2018 RADIANCE-HTN SOLO reporting better ambulatory blood pressure control with the Paradise system than with a sham procedure in the absence of antihypertensive agents. The device has been granted breakthrough device designation from the Food and Drug Administration for the treatment of hypertensive patients who are unable to sufficiently respond to or are intolerant of antihypertensive therapy.
 

Monday LBCTs

In the Late-Breaking Clinical Trials IV session (Monday, May 17, 8 a.m.–9:30 a.m.), Drachman called out a secondary analysis from GALATIC-HF looking at the impact of EF on the therapeutic effect of omecamtiv mecarbil. In last year’s primary analysis, the selective cardiac myosin activator produced a modest but significant reduction in HF events or CV death in 8,232 patients with HF and an EF of 35% or less.

Rounding out the list is the Canadian CAPITAL CHILL study of moderate versus mild therapeutic hypothermia in out-of-hospital cardiac arrest, to be presented in the final Late-Breaking Clinical Trials V session (Monday, May 17, 10:45 a.m.–12:00 p.m.).

The double-blind trial sought to determine whether neurologic outcomes at 6 months are improved by targeting a core temperature of 31 ˚C versus 34 ˚C after the return of spontaneous circulation in comatose survivors of out-of-hospital cardiac arrest.

“For me, I think this could really change practice and has personal relevance from experience with cardiac arrest survivors that I’ve known and care for very deeply,” Dr. Drachman said in an interview. “I think that there’s a lot of opportunity here as well.”

Asked what other trials have the potential to change practice, Dr. Drachman said FLOWER-MI holds particular interest because it looks at how to manage patients with STEMI with multiple lesions at the point of care.

“We’ve gained a lot of clarity from several other prior clinical trials, but this will help to answer the question in a slightly different way of saying: can you eyeball it, can you look at the angiogram and say whether or not that other, nonculprit lesion ought to be treated in the same hospitalization or should you really be using a pressure wire,” he said. “For me as an interventionalist, this is really important because when you finish up doing an intervention on a patient it might be the middle of the night and the patient may be more or less stable, but you’ve already exposed them to the risk of a procedure, should you then move on and do another aspect of the procedure to interrogate with a pressure wire a remaining narrowing? I think that’s very important; that’ll help me make decisions on a day-to-day basis.”

Dr. Drachman also cited RADIANCE-HTN TRIO because it employs an endovascular technique to control blood pressure in patients with hypertension, specifically those resistant to multiple drugs.

During the press conference, Dr. Morris, a preventive cardiologist, put her money on the ADAPTABLE study of aspirin dosing, reiterating that the unique trial design could inform future research, and on Sunday’s 8:45 a.m. late-breaking post hoc analysis from the STRENGTH trial that looks to pick up where the controversy over omega-3 fatty acid preparations left off at last year’s American Heart Association meeting.

A lack of benefit on CV event rates reported with Epanova, a high-dose combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid, led to a contentious debate over how to reconcile STRENGTH with the findings from REDUCE-IT, which showed a 25% relative risk reduction in major CV events with the EPA product icosapent ethyl (Vascepa).

STRENGTH investigator Steven Nissen, MD, Cleveland Clinic, and REDUCE-IT investigator and session panelist Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, will share the virtual stage at ACC 2021, but Dr. Morris said the “good news” is both researchers know one another very well and “will really be focusing on no political issues, just the omega-3 fatty levels in the bloodstream and what does that mean in either trial.

“This is not designed to be a debate, point counterpoint,” she added.

For that, as all cardiologists and journalists know, there will be the wild and woolly #CardioTwitter sphere.

A version of this article first appeared on Medscape.com.

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Lower blood sugar with sardines

Brand X Pictures/thinkstock.com

If you’ve ever turned your nose up at someone eating sardines straight from the can, you could be the one missing out on a good way to boost your own health.

New research from Open University of Catalonia (Spain) has found that eating two cans of whole sardines a week can help prevent people from developing type 2 diabetes (T2D). Now you might be thinking: That’s a lot of fish, can’t I just take a supplement pill? Actually, no.

“Nutrients can play an essential role in the prevention and treatment of many different pathologies, but their effect is usually caused by the synergy that exists between them and the food that they are contained in,” study coauthor Diana Rizzolo, PhD, said in a written statement. See, we told you.

In a study of 152 patients with prediabetes, each participant was put on a specific diet to reduce their chances of developing T2D. Among the patients who were not given sardines each week, the proportion considered to be at the highest risk fell from 27% to 22% after 1 year, but for those who did get the sardines, the size of the high-risk group shrank from 37% to just 8%.

Suggesting sardines during checkups could make eating them more widely accepted, Dr. Rizzolo and associates said. Sardines are cheap, easy to find, and also have the benefits of other oily fish, like boosting insulin resistance and increasing good cholesterol.

So why not have a can with a couple of saltine crackers for lunch? Your blood sugar will thank you. Just please avoid indulging on a plane or in your office, where workers are slowly returning – no need to give them another excuse to avoid their cubicle.
 

Come for the torture, stay for the vaccine

MMZ84 from Pixabay

Bran Castle. Home of Dracula and Vlad the Impaler (at least in pop culture’s eyes). A moody Gothic structure atop a hill. You can practically hear the ancient screams of thousands of tortured souls as you wander the grounds and its cursed halls. Naturally, it’s a major tourist destination.

Unfortunately for Romania, the pandemic has rather put a damper on tourism. The restrictions have done their damage, but here’s a quick LOTME theory: Perhaps people don’t want to be reminded of medieval tortures when we’ve got plenty of modern-day ones right now.

The management of Bran Castle has developed a new gimmick to drum up attendance – come to Bran Castle and get your COVID vaccine. Anyone can come and get jabbed with the Pfizer vaccine on all weekends in May, and when they do, they gain free admittance to the castle and the exhibit within, home to 52 medieval torture instruments. “The idea … was to show how people got jabbed 500-600 years ago in Europe,” the castle’s marketing director said.

While it may not be kind of the jabbing ole Vladdy got his name for – fully impaling people on hundreds of wooden stakes while you eat a nice dinner isn’t exactly smiled upon in today’s world – we’re sure he’d approve of this more limited but ultimately beneficial version. Jabbing people while helping them really is the dream.
 

 

 

Fuzzy little COVID detectors

temmuzcan/Getty Images

Before we get started, we need a moment to get our deep, movie trailer announcer-type voice ready. Okay, here goes.

“In a world where an organism too tiny to see brings entire economies to a standstill and pits scientists against doofuses, who can humanity turn to for help?”

How about bees? That’s right, we said bees. But not just any bees. Specially trained bees. Specially trained Dutch bees. Bees trained to sniff out our greatest nemesis. No, we’re not talking about Ted Cruz anymore. Let it go, that was just a joke. We’re talking COVID.

We’ll let Wim van der Poel, professor of virology at Wageningen (the Netherlands) University, explain the process: “We collect normal honeybees from a beekeeper, and we put the bees in harnesses.” And you thought their tulips were pretty great – the Dutch are putting harnesses on bees! (Which is much better than our previous story of bees involving a Taiwanese patient.)

The researchers presented the bees with two types of samples: COVID infected and non–COVID infected. The infected samples came with a sugary water reward and the noninfected samples did not, so the bees quickly learned to tell the difference.

The bees, then, could cut the waiting time for test results down to seconds, and at a fraction of the cost, making them an option in countries without a lot of testing infrastructure, the research team suggested.

The plan is not without its flaws, of course, but we’re convinced. More than that, we are true bee-lievers.
 

A little slice of … well, not heaven

risalbudiman006/Pixaby

If you’ve been around for the last 2 decades, you’ve seen your share of Internet trends: Remember the ice bucket challenge? Tide pod eating? We know what you’re thinking: Sigh, what could they be doing now?

Well, people are eating old meat, and before you think about the expired ground beef you got on special from the grocery store yesterday, that’s not quite what we mean. We all know expiration dates are “suggestions,” like yield signs and yellow lights. People are eating rotten, decomposing, borderline moldy meat.

They claim that the meat tastes better. We’re not so sure, but don’t worry, because it gets weirder. Some folks, apparently, are getting high from eating this meat, experiencing a feeling of euphoria. Personally, we think that rotten fumes probably knocked these people out and made them hallucinate.

Singaporean dietitian Naras Lapsys says that eating rotten meat can possibly cause a person to go into another state of consciousness, but it’s not a good thing. We don’t think you have to be a dietitian to know that.

It has not been definitively proven that eating rotting meat makes you high, but it’s definitely proven that this is disgusting … and very dangerous.
 

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Lower blood sugar with sardines

Brand X Pictures/thinkstock.com

If you’ve ever turned your nose up at someone eating sardines straight from the can, you could be the one missing out on a good way to boost your own health.

New research from Open University of Catalonia (Spain) has found that eating two cans of whole sardines a week can help prevent people from developing type 2 diabetes (T2D). Now you might be thinking: That’s a lot of fish, can’t I just take a supplement pill? Actually, no.

“Nutrients can play an essential role in the prevention and treatment of many different pathologies, but their effect is usually caused by the synergy that exists between them and the food that they are contained in,” study coauthor Diana Rizzolo, PhD, said in a written statement. See, we told you.

In a study of 152 patients with prediabetes, each participant was put on a specific diet to reduce their chances of developing T2D. Among the patients who were not given sardines each week, the proportion considered to be at the highest risk fell from 27% to 22% after 1 year, but for those who did get the sardines, the size of the high-risk group shrank from 37% to just 8%.

Suggesting sardines during checkups could make eating them more widely accepted, Dr. Rizzolo and associates said. Sardines are cheap, easy to find, and also have the benefits of other oily fish, like boosting insulin resistance and increasing good cholesterol.

So why not have a can with a couple of saltine crackers for lunch? Your blood sugar will thank you. Just please avoid indulging on a plane or in your office, where workers are slowly returning – no need to give them another excuse to avoid their cubicle.
 

Come for the torture, stay for the vaccine

MMZ84 from Pixabay

Bran Castle. Home of Dracula and Vlad the Impaler (at least in pop culture’s eyes). A moody Gothic structure atop a hill. You can practically hear the ancient screams of thousands of tortured souls as you wander the grounds and its cursed halls. Naturally, it’s a major tourist destination.

Unfortunately for Romania, the pandemic has rather put a damper on tourism. The restrictions have done their damage, but here’s a quick LOTME theory: Perhaps people don’t want to be reminded of medieval tortures when we’ve got plenty of modern-day ones right now.

The management of Bran Castle has developed a new gimmick to drum up attendance – come to Bran Castle and get your COVID vaccine. Anyone can come and get jabbed with the Pfizer vaccine on all weekends in May, and when they do, they gain free admittance to the castle and the exhibit within, home to 52 medieval torture instruments. “The idea … was to show how people got jabbed 500-600 years ago in Europe,” the castle’s marketing director said.

While it may not be kind of the jabbing ole Vladdy got his name for – fully impaling people on hundreds of wooden stakes while you eat a nice dinner isn’t exactly smiled upon in today’s world – we’re sure he’d approve of this more limited but ultimately beneficial version. Jabbing people while helping them really is the dream.
 

 

 

Fuzzy little COVID detectors

temmuzcan/Getty Images

Before we get started, we need a moment to get our deep, movie trailer announcer-type voice ready. Okay, here goes.

“In a world where an organism too tiny to see brings entire economies to a standstill and pits scientists against doofuses, who can humanity turn to for help?”

How about bees? That’s right, we said bees. But not just any bees. Specially trained bees. Specially trained Dutch bees. Bees trained to sniff out our greatest nemesis. No, we’re not talking about Ted Cruz anymore. Let it go, that was just a joke. We’re talking COVID.

We’ll let Wim van der Poel, professor of virology at Wageningen (the Netherlands) University, explain the process: “We collect normal honeybees from a beekeeper, and we put the bees in harnesses.” And you thought their tulips were pretty great – the Dutch are putting harnesses on bees! (Which is much better than our previous story of bees involving a Taiwanese patient.)

The researchers presented the bees with two types of samples: COVID infected and non–COVID infected. The infected samples came with a sugary water reward and the noninfected samples did not, so the bees quickly learned to tell the difference.

The bees, then, could cut the waiting time for test results down to seconds, and at a fraction of the cost, making them an option in countries without a lot of testing infrastructure, the research team suggested.

The plan is not without its flaws, of course, but we’re convinced. More than that, we are true bee-lievers.
 

A little slice of … well, not heaven

risalbudiman006/Pixaby

If you’ve been around for the last 2 decades, you’ve seen your share of Internet trends: Remember the ice bucket challenge? Tide pod eating? We know what you’re thinking: Sigh, what could they be doing now?

Well, people are eating old meat, and before you think about the expired ground beef you got on special from the grocery store yesterday, that’s not quite what we mean. We all know expiration dates are “suggestions,” like yield signs and yellow lights. People are eating rotten, decomposing, borderline moldy meat.

They claim that the meat tastes better. We’re not so sure, but don’t worry, because it gets weirder. Some folks, apparently, are getting high from eating this meat, experiencing a feeling of euphoria. Personally, we think that rotten fumes probably knocked these people out and made them hallucinate.

Singaporean dietitian Naras Lapsys says that eating rotten meat can possibly cause a person to go into another state of consciousness, but it’s not a good thing. We don’t think you have to be a dietitian to know that.

It has not been definitively proven that eating rotting meat makes you high, but it’s definitely proven that this is disgusting … and very dangerous.
 

 

Lower blood sugar with sardines

Brand X Pictures/thinkstock.com

If you’ve ever turned your nose up at someone eating sardines straight from the can, you could be the one missing out on a good way to boost your own health.

New research from Open University of Catalonia (Spain) has found that eating two cans of whole sardines a week can help prevent people from developing type 2 diabetes (T2D). Now you might be thinking: That’s a lot of fish, can’t I just take a supplement pill? Actually, no.

“Nutrients can play an essential role in the prevention and treatment of many different pathologies, but their effect is usually caused by the synergy that exists between them and the food that they are contained in,” study coauthor Diana Rizzolo, PhD, said in a written statement. See, we told you.

In a study of 152 patients with prediabetes, each participant was put on a specific diet to reduce their chances of developing T2D. Among the patients who were not given sardines each week, the proportion considered to be at the highest risk fell from 27% to 22% after 1 year, but for those who did get the sardines, the size of the high-risk group shrank from 37% to just 8%.

Suggesting sardines during checkups could make eating them more widely accepted, Dr. Rizzolo and associates said. Sardines are cheap, easy to find, and also have the benefits of other oily fish, like boosting insulin resistance and increasing good cholesterol.

So why not have a can with a couple of saltine crackers for lunch? Your blood sugar will thank you. Just please avoid indulging on a plane or in your office, where workers are slowly returning – no need to give them another excuse to avoid their cubicle.
 

Come for the torture, stay for the vaccine

MMZ84 from Pixabay

Bran Castle. Home of Dracula and Vlad the Impaler (at least in pop culture’s eyes). A moody Gothic structure atop a hill. You can practically hear the ancient screams of thousands of tortured souls as you wander the grounds and its cursed halls. Naturally, it’s a major tourist destination.

Unfortunately for Romania, the pandemic has rather put a damper on tourism. The restrictions have done their damage, but here’s a quick LOTME theory: Perhaps people don’t want to be reminded of medieval tortures when we’ve got plenty of modern-day ones right now.

The management of Bran Castle has developed a new gimmick to drum up attendance – come to Bran Castle and get your COVID vaccine. Anyone can come and get jabbed with the Pfizer vaccine on all weekends in May, and when they do, they gain free admittance to the castle and the exhibit within, home to 52 medieval torture instruments. “The idea … was to show how people got jabbed 500-600 years ago in Europe,” the castle’s marketing director said.

While it may not be kind of the jabbing ole Vladdy got his name for – fully impaling people on hundreds of wooden stakes while you eat a nice dinner isn’t exactly smiled upon in today’s world – we’re sure he’d approve of this more limited but ultimately beneficial version. Jabbing people while helping them really is the dream.
 

 

 

Fuzzy little COVID detectors

temmuzcan/Getty Images

Before we get started, we need a moment to get our deep, movie trailer announcer-type voice ready. Okay, here goes.

“In a world where an organism too tiny to see brings entire economies to a standstill and pits scientists against doofuses, who can humanity turn to for help?”

How about bees? That’s right, we said bees. But not just any bees. Specially trained bees. Specially trained Dutch bees. Bees trained to sniff out our greatest nemesis. No, we’re not talking about Ted Cruz anymore. Let it go, that was just a joke. We’re talking COVID.

We’ll let Wim van der Poel, professor of virology at Wageningen (the Netherlands) University, explain the process: “We collect normal honeybees from a beekeeper, and we put the bees in harnesses.” And you thought their tulips were pretty great – the Dutch are putting harnesses on bees! (Which is much better than our previous story of bees involving a Taiwanese patient.)

The researchers presented the bees with two types of samples: COVID infected and non–COVID infected. The infected samples came with a sugary water reward and the noninfected samples did not, so the bees quickly learned to tell the difference.

The bees, then, could cut the waiting time for test results down to seconds, and at a fraction of the cost, making them an option in countries without a lot of testing infrastructure, the research team suggested.

The plan is not without its flaws, of course, but we’re convinced. More than that, we are true bee-lievers.
 

A little slice of … well, not heaven

risalbudiman006/Pixaby

If you’ve been around for the last 2 decades, you’ve seen your share of Internet trends: Remember the ice bucket challenge? Tide pod eating? We know what you’re thinking: Sigh, what could they be doing now?

Well, people are eating old meat, and before you think about the expired ground beef you got on special from the grocery store yesterday, that’s not quite what we mean. We all know expiration dates are “suggestions,” like yield signs and yellow lights. People are eating rotten, decomposing, borderline moldy meat.

They claim that the meat tastes better. We’re not so sure, but don’t worry, because it gets weirder. Some folks, apparently, are getting high from eating this meat, experiencing a feeling of euphoria. Personally, we think that rotten fumes probably knocked these people out and made them hallucinate.

Singaporean dietitian Naras Lapsys says that eating rotten meat can possibly cause a person to go into another state of consciousness, but it’s not a good thing. We don’t think you have to be a dietitian to know that.

It has not been definitively proven that eating rotting meat makes you high, but it’s definitely proven that this is disgusting … and very dangerous.
 

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Any bone break increases risk for subsequent fracture in older women

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No matter where an initial fracture occurs in a postmenopausal woman, there is a subsequent increased risk of another fracture, with the risk surprisingly highest in the youngest postmenopausal group and among certain minorities, new data indicate.

Dr. Carolyn J. Crandall

“To our knowledge, no previous prospective study has reported detailed patterns of subsequent fracture locations after initial fracture according to age strata among women in the U.S.,” the authors noted in their article, published online May 5, 2021, in EClinicalMedicine.

The results show that a first fracture of the lower arm or wrist; upper arm; or shoulder, upper leg, knee, lower leg, or ankle – as well as those of the hip or pelvis – were associated with an approximately three- to sixfold increased risk for subsequent fractures. The findings have important implications for clinicians, said lead author Carolyn J. Crandall, MD, professor of medicine at the University of California, Los Angeles.

“By not paying attention to which types of fractures increase the risk of future fractures, we are missing the opportunity to identify people at increased risk of future fracture and counsel them regarding risk reduction,” she said in a press statement.

Commenting on the research, Michael R. McClung, MD, stressed this message to clinicians needs to be underscored.

“This paper is one of a series of papers highlighting the fact that having a previous fracture is a risk factor for subsequent fractures,” he said in an interview.

Dr. Michael R. McClung

“This has been known for a very long time, but it is a point still not appreciated by patients and primary care doctors, so having another study pointing this out is important,” emphasized Dr. McClung, of the Oregon Osteoporosis Center in Portland.
 

30% of women’s health initiative participants had a fracture

For the study, Dr. Crandall and colleagues evaluated data on 157,282 women between the ages of 50 and 79 who were enrolled in the Women’s Health Initiative between 1993 and 2018.

The women were a mean age of 63.1 years and 47,126 (30%) experienced an incident fracture during the study period.

With a mean follow-up of 15.4 years, each type of fracture was associated with an increased risk of a subsequent fracture after adjusting for age, race/ethnicity, body mass index, hormone therapy use, and other factors.

A wide range of initial risk fractures – including an initial lower arm or wrist fracture (adjusted hazard ratio, 4.80), upper arm or shoulder fracture (aHR, 5.06), upper leg fracture (aHR, 5.11), knee fracture (aHR, 5.03), lower leg/ankle fracture (aHR, 4.10), and spinal fracture (aHR, 6.69) – increased the risk of sustaining a subsequent hip fracture

For initial fractures of the lower arm or wrist, there was an increased risk of a subsequent fracture of the upper arm/shoulder, upper leg, knee, lower leg/ankle, hip/pelvis, and spine (aHRs ranged from 2.63 to 5.68). 

“The finding that knee fracture has the same prognostic value for subsequent fracture as hip or wrist fracture is a novel key finding, as knee fracture is generally not considered ‘osteoporotic’,” the authors noted.

The risk of fracture after sustaining an initial hip or pelvis fracture was exceptionally high – with as much as a 27-fold higher risk of a subsequent upper leg (nonhip) fracture (aHR, 27.18).

“Thirty-four percent of women who experienced initial hip or pelvis fracture experienced a subsequent nonhip fracture,” the authors noted.

However, the risks associated with an initial hip fracture are already well established, and the study’s more notable findings are the risks of other bone breaks, Dr. Crandall told this news organization.

“The (increased risk with hip fracture) is a rather substantial result,” she said. “However, the more major point of this study is that no matter where the initial fracture happened, the risk of the future fracture was elevated.”
 

 

 

Don’t disregard risks in younger women, racial/ethnic groups

The findings regarding age are also important. The highest risk was observed in the youngest postmenopausal age group of 50-59 years (aHR, 6.45), which decreased slightly in the 60- to 69-year age group (aHR, 6.04) and further decreased in the 70- to 79-year age group (aHR, 4.99).

“This was a surprise, and it highlights that clinicians should not disregard initial fractures among young postmenopausal women,” Dr. Crandall told this news organization.

Even greater increased risks for a subsequent fracture following an initial lower extremity fracture were observed in non-Hispanic Black women, Hispanic or Latina women, and women of Asian Pacific Islander ethnicity, ranging from ninefold to 14-fold, versus a sevenfold risk among non-Hispanic White women.

“This has public health implications because it means that we may have been missing the opportunity to prevent fractures among younger postmenopausal women and underrepresented racial/ethnic groups,” Dr. Crandall noted.

Is risk greatest 1-2 years after the initial fracture?

The findings suggest that current treatment guidelines may need to be revisited in light of inconsistencies regarding when, and for which fracture types, to initiate treatment.

“It will be important to determine whether existing risk calculators can be adapted (or new calculators developed) to help refine decision-making to determine which of the women with fractures other than hip or vertebral fractures should be treated,” the authors wrote.

Dr. McClung said a randomized, controlled trial of osteoporosis treatment in people who present with all types of fractures would help determine whether having a knee or a wrist fracture does indeed warrant such therapy.

He further commented that future studies should evaluate the shorter- versus longer-term risks.

“The most recent research suggests that the risk of having a second fracture is much higher in the first year or 2 after the first or incident fracture,” he observed. “So, the next stage in research with this dataset would be to ask not what happens over a 10-year time frame but what happens over the first year or 2 after the fracture.”

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Crandall reported no relevant financial relationships. Dr. McClung reported being a consultant and on the speakers bureau for Amgen and being a speaker for Alexion.

A version of this article first appeared on Medscape.com.

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No matter where an initial fracture occurs in a postmenopausal woman, there is a subsequent increased risk of another fracture, with the risk surprisingly highest in the youngest postmenopausal group and among certain minorities, new data indicate.

Dr. Carolyn J. Crandall

“To our knowledge, no previous prospective study has reported detailed patterns of subsequent fracture locations after initial fracture according to age strata among women in the U.S.,” the authors noted in their article, published online May 5, 2021, in EClinicalMedicine.

The results show that a first fracture of the lower arm or wrist; upper arm; or shoulder, upper leg, knee, lower leg, or ankle – as well as those of the hip or pelvis – were associated with an approximately three- to sixfold increased risk for subsequent fractures. The findings have important implications for clinicians, said lead author Carolyn J. Crandall, MD, professor of medicine at the University of California, Los Angeles.

“By not paying attention to which types of fractures increase the risk of future fractures, we are missing the opportunity to identify people at increased risk of future fracture and counsel them regarding risk reduction,” she said in a press statement.

Commenting on the research, Michael R. McClung, MD, stressed this message to clinicians needs to be underscored.

“This paper is one of a series of papers highlighting the fact that having a previous fracture is a risk factor for subsequent fractures,” he said in an interview.

Dr. Michael R. McClung

“This has been known for a very long time, but it is a point still not appreciated by patients and primary care doctors, so having another study pointing this out is important,” emphasized Dr. McClung, of the Oregon Osteoporosis Center in Portland.
 

30% of women’s health initiative participants had a fracture

For the study, Dr. Crandall and colleagues evaluated data on 157,282 women between the ages of 50 and 79 who were enrolled in the Women’s Health Initiative between 1993 and 2018.

The women were a mean age of 63.1 years and 47,126 (30%) experienced an incident fracture during the study period.

With a mean follow-up of 15.4 years, each type of fracture was associated with an increased risk of a subsequent fracture after adjusting for age, race/ethnicity, body mass index, hormone therapy use, and other factors.

A wide range of initial risk fractures – including an initial lower arm or wrist fracture (adjusted hazard ratio, 4.80), upper arm or shoulder fracture (aHR, 5.06), upper leg fracture (aHR, 5.11), knee fracture (aHR, 5.03), lower leg/ankle fracture (aHR, 4.10), and spinal fracture (aHR, 6.69) – increased the risk of sustaining a subsequent hip fracture

For initial fractures of the lower arm or wrist, there was an increased risk of a subsequent fracture of the upper arm/shoulder, upper leg, knee, lower leg/ankle, hip/pelvis, and spine (aHRs ranged from 2.63 to 5.68). 

“The finding that knee fracture has the same prognostic value for subsequent fracture as hip or wrist fracture is a novel key finding, as knee fracture is generally not considered ‘osteoporotic’,” the authors noted.

The risk of fracture after sustaining an initial hip or pelvis fracture was exceptionally high – with as much as a 27-fold higher risk of a subsequent upper leg (nonhip) fracture (aHR, 27.18).

“Thirty-four percent of women who experienced initial hip or pelvis fracture experienced a subsequent nonhip fracture,” the authors noted.

However, the risks associated with an initial hip fracture are already well established, and the study’s more notable findings are the risks of other bone breaks, Dr. Crandall told this news organization.

“The (increased risk with hip fracture) is a rather substantial result,” she said. “However, the more major point of this study is that no matter where the initial fracture happened, the risk of the future fracture was elevated.”
 

 

 

Don’t disregard risks in younger women, racial/ethnic groups

The findings regarding age are also important. The highest risk was observed in the youngest postmenopausal age group of 50-59 years (aHR, 6.45), which decreased slightly in the 60- to 69-year age group (aHR, 6.04) and further decreased in the 70- to 79-year age group (aHR, 4.99).

“This was a surprise, and it highlights that clinicians should not disregard initial fractures among young postmenopausal women,” Dr. Crandall told this news organization.

Even greater increased risks for a subsequent fracture following an initial lower extremity fracture were observed in non-Hispanic Black women, Hispanic or Latina women, and women of Asian Pacific Islander ethnicity, ranging from ninefold to 14-fold, versus a sevenfold risk among non-Hispanic White women.

“This has public health implications because it means that we may have been missing the opportunity to prevent fractures among younger postmenopausal women and underrepresented racial/ethnic groups,” Dr. Crandall noted.

Is risk greatest 1-2 years after the initial fracture?

The findings suggest that current treatment guidelines may need to be revisited in light of inconsistencies regarding when, and for which fracture types, to initiate treatment.

“It will be important to determine whether existing risk calculators can be adapted (or new calculators developed) to help refine decision-making to determine which of the women with fractures other than hip or vertebral fractures should be treated,” the authors wrote.

Dr. McClung said a randomized, controlled trial of osteoporosis treatment in people who present with all types of fractures would help determine whether having a knee or a wrist fracture does indeed warrant such therapy.

He further commented that future studies should evaluate the shorter- versus longer-term risks.

“The most recent research suggests that the risk of having a second fracture is much higher in the first year or 2 after the first or incident fracture,” he observed. “So, the next stage in research with this dataset would be to ask not what happens over a 10-year time frame but what happens over the first year or 2 after the fracture.”

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Crandall reported no relevant financial relationships. Dr. McClung reported being a consultant and on the speakers bureau for Amgen and being a speaker for Alexion.

A version of this article first appeared on Medscape.com.

No matter where an initial fracture occurs in a postmenopausal woman, there is a subsequent increased risk of another fracture, with the risk surprisingly highest in the youngest postmenopausal group and among certain minorities, new data indicate.

Dr. Carolyn J. Crandall

“To our knowledge, no previous prospective study has reported detailed patterns of subsequent fracture locations after initial fracture according to age strata among women in the U.S.,” the authors noted in their article, published online May 5, 2021, in EClinicalMedicine.

The results show that a first fracture of the lower arm or wrist; upper arm; or shoulder, upper leg, knee, lower leg, or ankle – as well as those of the hip or pelvis – were associated with an approximately three- to sixfold increased risk for subsequent fractures. The findings have important implications for clinicians, said lead author Carolyn J. Crandall, MD, professor of medicine at the University of California, Los Angeles.

“By not paying attention to which types of fractures increase the risk of future fractures, we are missing the opportunity to identify people at increased risk of future fracture and counsel them regarding risk reduction,” she said in a press statement.

Commenting on the research, Michael R. McClung, MD, stressed this message to clinicians needs to be underscored.

“This paper is one of a series of papers highlighting the fact that having a previous fracture is a risk factor for subsequent fractures,” he said in an interview.

Dr. Michael R. McClung

“This has been known for a very long time, but it is a point still not appreciated by patients and primary care doctors, so having another study pointing this out is important,” emphasized Dr. McClung, of the Oregon Osteoporosis Center in Portland.
 

30% of women’s health initiative participants had a fracture

For the study, Dr. Crandall and colleagues evaluated data on 157,282 women between the ages of 50 and 79 who were enrolled in the Women’s Health Initiative between 1993 and 2018.

The women were a mean age of 63.1 years and 47,126 (30%) experienced an incident fracture during the study period.

With a mean follow-up of 15.4 years, each type of fracture was associated with an increased risk of a subsequent fracture after adjusting for age, race/ethnicity, body mass index, hormone therapy use, and other factors.

A wide range of initial risk fractures – including an initial lower arm or wrist fracture (adjusted hazard ratio, 4.80), upper arm or shoulder fracture (aHR, 5.06), upper leg fracture (aHR, 5.11), knee fracture (aHR, 5.03), lower leg/ankle fracture (aHR, 4.10), and spinal fracture (aHR, 6.69) – increased the risk of sustaining a subsequent hip fracture

For initial fractures of the lower arm or wrist, there was an increased risk of a subsequent fracture of the upper arm/shoulder, upper leg, knee, lower leg/ankle, hip/pelvis, and spine (aHRs ranged from 2.63 to 5.68). 

“The finding that knee fracture has the same prognostic value for subsequent fracture as hip or wrist fracture is a novel key finding, as knee fracture is generally not considered ‘osteoporotic’,” the authors noted.

The risk of fracture after sustaining an initial hip or pelvis fracture was exceptionally high – with as much as a 27-fold higher risk of a subsequent upper leg (nonhip) fracture (aHR, 27.18).

“Thirty-four percent of women who experienced initial hip or pelvis fracture experienced a subsequent nonhip fracture,” the authors noted.

However, the risks associated with an initial hip fracture are already well established, and the study’s more notable findings are the risks of other bone breaks, Dr. Crandall told this news organization.

“The (increased risk with hip fracture) is a rather substantial result,” she said. “However, the more major point of this study is that no matter where the initial fracture happened, the risk of the future fracture was elevated.”
 

 

 

Don’t disregard risks in younger women, racial/ethnic groups

The findings regarding age are also important. The highest risk was observed in the youngest postmenopausal age group of 50-59 years (aHR, 6.45), which decreased slightly in the 60- to 69-year age group (aHR, 6.04) and further decreased in the 70- to 79-year age group (aHR, 4.99).

“This was a surprise, and it highlights that clinicians should not disregard initial fractures among young postmenopausal women,” Dr. Crandall told this news organization.

Even greater increased risks for a subsequent fracture following an initial lower extremity fracture were observed in non-Hispanic Black women, Hispanic or Latina women, and women of Asian Pacific Islander ethnicity, ranging from ninefold to 14-fold, versus a sevenfold risk among non-Hispanic White women.

“This has public health implications because it means that we may have been missing the opportunity to prevent fractures among younger postmenopausal women and underrepresented racial/ethnic groups,” Dr. Crandall noted.

Is risk greatest 1-2 years after the initial fracture?

The findings suggest that current treatment guidelines may need to be revisited in light of inconsistencies regarding when, and for which fracture types, to initiate treatment.

“It will be important to determine whether existing risk calculators can be adapted (or new calculators developed) to help refine decision-making to determine which of the women with fractures other than hip or vertebral fractures should be treated,” the authors wrote.

Dr. McClung said a randomized, controlled trial of osteoporosis treatment in people who present with all types of fractures would help determine whether having a knee or a wrist fracture does indeed warrant such therapy.

He further commented that future studies should evaluate the shorter- versus longer-term risks.

“The most recent research suggests that the risk of having a second fracture is much higher in the first year or 2 after the first or incident fracture,” he observed. “So, the next stage in research with this dataset would be to ask not what happens over a 10-year time frame but what happens over the first year or 2 after the fracture.”

The study was funded by the National Heart, Lung, and Blood Institute. Dr. Crandall reported no relevant financial relationships. Dr. McClung reported being a consultant and on the speakers bureau for Amgen and being a speaker for Alexion.

A version of this article first appeared on Medscape.com.

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