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FDA authorizes COVID boosters for all U.S. adults
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.
“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.
Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.
FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.
A version of this article first appeared on WebMD.com.
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.
“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.
Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.
FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.
A version of this article first appeared on WebMD.com.
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.
“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.
Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.
FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.
A version of this article first appeared on WebMD.com.
Mask-wearing cuts new COVID-19 cases by 53%, study says
Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.
“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.
The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.
Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.
In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.
But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.
Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.
Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.
Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.
The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.
That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.
“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.
“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.
A version of this article first appeared on WebMD.com.
Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.
“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.
The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.
Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.
In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.
But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.
Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.
Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.
Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.
The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.
That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.
“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.
“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.
A version of this article first appeared on WebMD.com.
Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.
“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.
The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.
Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.
In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.
But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.
Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.
Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.
Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.
The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.
That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.
“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.
“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.
A version of this article first appeared on WebMD.com.
FROM THE BMJ
Advanced CKD doesn’t derail empagliflozin in EMPEROR-preserved
More than half of the nearly 6,000 patients with heart failure and HFpEF enrolled in EMPEROR-Preserved had CKD (although renal function was not an enrollment criterion), including 10% with an estimated glomerular filtration rate (eGFR) that fell in the range of 20-29 mL/min/1.73 m2, which categorized them as having stage 4 CKD.
The results showed, in a prespecified analysis, that treatment with empagliflozin led to a consistent, significant relative risk reduction compared with placebo in the primary endpoint of cardiovascular death or hospitalization for heart failure “across the full spectrum of kidney function, down to an eGFR of 20 mL/min/1.73m2,” said Faiez Zannad, MD, PhD, who presented the findings at the annual meeting of the American Society of Nephrology.
Among the 46.5% of enrolled patients without CKD, empagliflozin produced a significant 20% drop in the primary outcome relative to those who received placebo. Among the 53.5% of patients with CKD at time of randomization (defined as an eGFR <60 mL/min/1/73 m2 or a urinary albumin to creatinine ratio >300 mg/g), treatment with empagliflozin was associated with a significant 25% cut in the primary endpoint compared with placebo.
Empagliflozin was also “well tolerated” by patients with HFpEF, whether or not they also had CKD, “including patients with severely impaired kidney function,” said Dr. Zannad, a professor of cardiology therapeutics at the University of Lorraine in Nancy, France, at the virtual meeting.
An end to ‘renalism’
“This is a nail in the coffin for the concept of ‘renalism,’” the erroneous notion held by many clinicians and researchers that various treatments are not as effective and potentially more likely to cause adverse effects in patients with CKD compared with those with better renal function, commented Janani Rangaswami, MD, a nephrologist who is a professor and director of the cardiorenal program at George Washington University, Washington, D.C.
In addition to EMPEROR-Preserved, other large trials of agents from the SGLT2 inhibitor class bucked the premise of renalism and took the “groundbreaking step” of enrolling patients with moderate-severe CKD, noted Dr. Rangaswami in an interview. In particular, two trials took this approach when enrolling patients with heart failure with reduced ejection fraction (HFrEF), EMPEROR-Reduced (which also tested empagliflozin and matched the design of EMPEROR-Preserved) and DAPA-HF (which tested the SGLT2 inhibitor dapagliflozin [Farxiga, AstraZeneca]).
“It was a huge, bold step, especially in EMPEROR-Preserved and in EMPEROR-Reduced, which both enrolled patients with eGFRs as low as 20 mL/min/1.73m2,” Dr. Rangaswami said. DAPA-HF included patients with eGFRs as low as 30 mL/min/1.73m2.
EMPEROR-Reduced and DAPA-HF – published earlier this year – both had similar findings as EMPEROR-Preserved as reported by Dr. Zannad: consistent benefit from empagliflozin or dapagliflozin regardless of eGFR level and no signal of increased adverse events from treatment.
In fact, all three analyses show that patients with worse renal function had the highest risk for cardiovascular death and hospitalization for heart failure; hence, the beneficial impact from SGLT2 inhibitors is greatest in these patients.
These observations “make it easier to focus on the group with moderate-to-severe CKD,” both in the routine care setting as well as in future trials, said Dr. Rangaswami.
“This is a welcome trend that paves the way to test more treatments in patients with stage 4 and even stage 5 CKD, patients ... excluded from trials in the past,” she said.
In addition, the consistent benefit from SGLT2 inhibitors in these three heart failure trials regardless of CKD “means there is simply no room for renalism. There is no room for clinicians to say that because a patient’s eGFR is 30 mL/min/1.73m2 they are worried about starting an SGLT2 inhibitor,” she stressed.
More CKD-independent effects of empagliflozin
Results of other new analyses from EMPEROR-Preserved, also reported by Dr. Zannad, included the finding that empagliflozin was associated with a similar slowing of loss of renal function over time compared with placebo, regardless of CKD status.
In patients with CKD, empagliflozin slowed eGFR loss by 1.4 mL/min/1.73 m2/year, and in those without CKD, by 1.3 mL/min/1.73 m2/year, relative to placebo.
“Even in patients without CKD, there was a relevant eGFR decline in the placebo group that was attenuated by empagliflozin,” Dr. Zannad said.
At the end of the study, when empagliflozin was stopped, patients with or without CKD had their eGFR bounce back by an identical 2.4 mL/min/1.73 m2 relative to placebo.
Empagliflozin slowed progression to macroalbuminuria and significantly reduced the incidence of acute kidney injury by a similar amount regardless of CKD status compared with placebo.
EMPEROR-Preserved enrolled patients with function-limiting HFpEF, a left ventricular ejection fraction >40%, and a minimum level of a reliable serum marker of heart failure, N-terminal pro-B-type natriuretic peptide (NT-proBNP). Compared with placebo, empagliflozin reduced the trial’s primary outcome by an absolute 3.3 percentage points and by a significant relative risk reduction of 21% after a median 26 months of follow-up, according to a report published in October 2021.
EMPEROR-Preserved is the first prospective, randomized trial to unequivocally show the efficacy and safety of a drug for improving outcomes in patients with HFpEF.
EMPEROR-Preserved was sponsored by Boehringer-Ingelheim and Lilly, which market empagliflozin (Jardiance). Dr. Zannad has reported financial relationships with Boehringer Ingelheim as well as other companies. Dr. Rangaswami has reported being a consultant for Boehringer Ingelheim, Lilly, and AstraZeneca.
A version of this article first appeared on Medscape.com.
More than half of the nearly 6,000 patients with heart failure and HFpEF enrolled in EMPEROR-Preserved had CKD (although renal function was not an enrollment criterion), including 10% with an estimated glomerular filtration rate (eGFR) that fell in the range of 20-29 mL/min/1.73 m2, which categorized them as having stage 4 CKD.
The results showed, in a prespecified analysis, that treatment with empagliflozin led to a consistent, significant relative risk reduction compared with placebo in the primary endpoint of cardiovascular death or hospitalization for heart failure “across the full spectrum of kidney function, down to an eGFR of 20 mL/min/1.73m2,” said Faiez Zannad, MD, PhD, who presented the findings at the annual meeting of the American Society of Nephrology.
Among the 46.5% of enrolled patients without CKD, empagliflozin produced a significant 20% drop in the primary outcome relative to those who received placebo. Among the 53.5% of patients with CKD at time of randomization (defined as an eGFR <60 mL/min/1/73 m2 or a urinary albumin to creatinine ratio >300 mg/g), treatment with empagliflozin was associated with a significant 25% cut in the primary endpoint compared with placebo.
Empagliflozin was also “well tolerated” by patients with HFpEF, whether or not they also had CKD, “including patients with severely impaired kidney function,” said Dr. Zannad, a professor of cardiology therapeutics at the University of Lorraine in Nancy, France, at the virtual meeting.
An end to ‘renalism’
“This is a nail in the coffin for the concept of ‘renalism,’” the erroneous notion held by many clinicians and researchers that various treatments are not as effective and potentially more likely to cause adverse effects in patients with CKD compared with those with better renal function, commented Janani Rangaswami, MD, a nephrologist who is a professor and director of the cardiorenal program at George Washington University, Washington, D.C.
In addition to EMPEROR-Preserved, other large trials of agents from the SGLT2 inhibitor class bucked the premise of renalism and took the “groundbreaking step” of enrolling patients with moderate-severe CKD, noted Dr. Rangaswami in an interview. In particular, two trials took this approach when enrolling patients with heart failure with reduced ejection fraction (HFrEF), EMPEROR-Reduced (which also tested empagliflozin and matched the design of EMPEROR-Preserved) and DAPA-HF (which tested the SGLT2 inhibitor dapagliflozin [Farxiga, AstraZeneca]).
“It was a huge, bold step, especially in EMPEROR-Preserved and in EMPEROR-Reduced, which both enrolled patients with eGFRs as low as 20 mL/min/1.73m2,” Dr. Rangaswami said. DAPA-HF included patients with eGFRs as low as 30 mL/min/1.73m2.
EMPEROR-Reduced and DAPA-HF – published earlier this year – both had similar findings as EMPEROR-Preserved as reported by Dr. Zannad: consistent benefit from empagliflozin or dapagliflozin regardless of eGFR level and no signal of increased adverse events from treatment.
In fact, all three analyses show that patients with worse renal function had the highest risk for cardiovascular death and hospitalization for heart failure; hence, the beneficial impact from SGLT2 inhibitors is greatest in these patients.
These observations “make it easier to focus on the group with moderate-to-severe CKD,” both in the routine care setting as well as in future trials, said Dr. Rangaswami.
“This is a welcome trend that paves the way to test more treatments in patients with stage 4 and even stage 5 CKD, patients ... excluded from trials in the past,” she said.
In addition, the consistent benefit from SGLT2 inhibitors in these three heart failure trials regardless of CKD “means there is simply no room for renalism. There is no room for clinicians to say that because a patient’s eGFR is 30 mL/min/1.73m2 they are worried about starting an SGLT2 inhibitor,” she stressed.
More CKD-independent effects of empagliflozin
Results of other new analyses from EMPEROR-Preserved, also reported by Dr. Zannad, included the finding that empagliflozin was associated with a similar slowing of loss of renal function over time compared with placebo, regardless of CKD status.
In patients with CKD, empagliflozin slowed eGFR loss by 1.4 mL/min/1.73 m2/year, and in those without CKD, by 1.3 mL/min/1.73 m2/year, relative to placebo.
“Even in patients without CKD, there was a relevant eGFR decline in the placebo group that was attenuated by empagliflozin,” Dr. Zannad said.
At the end of the study, when empagliflozin was stopped, patients with or without CKD had their eGFR bounce back by an identical 2.4 mL/min/1.73 m2 relative to placebo.
Empagliflozin slowed progression to macroalbuminuria and significantly reduced the incidence of acute kidney injury by a similar amount regardless of CKD status compared with placebo.
EMPEROR-Preserved enrolled patients with function-limiting HFpEF, a left ventricular ejection fraction >40%, and a minimum level of a reliable serum marker of heart failure, N-terminal pro-B-type natriuretic peptide (NT-proBNP). Compared with placebo, empagliflozin reduced the trial’s primary outcome by an absolute 3.3 percentage points and by a significant relative risk reduction of 21% after a median 26 months of follow-up, according to a report published in October 2021.
EMPEROR-Preserved is the first prospective, randomized trial to unequivocally show the efficacy and safety of a drug for improving outcomes in patients with HFpEF.
EMPEROR-Preserved was sponsored by Boehringer-Ingelheim and Lilly, which market empagliflozin (Jardiance). Dr. Zannad has reported financial relationships with Boehringer Ingelheim as well as other companies. Dr. Rangaswami has reported being a consultant for Boehringer Ingelheim, Lilly, and AstraZeneca.
A version of this article first appeared on Medscape.com.
More than half of the nearly 6,000 patients with heart failure and HFpEF enrolled in EMPEROR-Preserved had CKD (although renal function was not an enrollment criterion), including 10% with an estimated glomerular filtration rate (eGFR) that fell in the range of 20-29 mL/min/1.73 m2, which categorized them as having stage 4 CKD.
The results showed, in a prespecified analysis, that treatment with empagliflozin led to a consistent, significant relative risk reduction compared with placebo in the primary endpoint of cardiovascular death or hospitalization for heart failure “across the full spectrum of kidney function, down to an eGFR of 20 mL/min/1.73m2,” said Faiez Zannad, MD, PhD, who presented the findings at the annual meeting of the American Society of Nephrology.
Among the 46.5% of enrolled patients without CKD, empagliflozin produced a significant 20% drop in the primary outcome relative to those who received placebo. Among the 53.5% of patients with CKD at time of randomization (defined as an eGFR <60 mL/min/1/73 m2 or a urinary albumin to creatinine ratio >300 mg/g), treatment with empagliflozin was associated with a significant 25% cut in the primary endpoint compared with placebo.
Empagliflozin was also “well tolerated” by patients with HFpEF, whether or not they also had CKD, “including patients with severely impaired kidney function,” said Dr. Zannad, a professor of cardiology therapeutics at the University of Lorraine in Nancy, France, at the virtual meeting.
An end to ‘renalism’
“This is a nail in the coffin for the concept of ‘renalism,’” the erroneous notion held by many clinicians and researchers that various treatments are not as effective and potentially more likely to cause adverse effects in patients with CKD compared with those with better renal function, commented Janani Rangaswami, MD, a nephrologist who is a professor and director of the cardiorenal program at George Washington University, Washington, D.C.
In addition to EMPEROR-Preserved, other large trials of agents from the SGLT2 inhibitor class bucked the premise of renalism and took the “groundbreaking step” of enrolling patients with moderate-severe CKD, noted Dr. Rangaswami in an interview. In particular, two trials took this approach when enrolling patients with heart failure with reduced ejection fraction (HFrEF), EMPEROR-Reduced (which also tested empagliflozin and matched the design of EMPEROR-Preserved) and DAPA-HF (which tested the SGLT2 inhibitor dapagliflozin [Farxiga, AstraZeneca]).
“It was a huge, bold step, especially in EMPEROR-Preserved and in EMPEROR-Reduced, which both enrolled patients with eGFRs as low as 20 mL/min/1.73m2,” Dr. Rangaswami said. DAPA-HF included patients with eGFRs as low as 30 mL/min/1.73m2.
EMPEROR-Reduced and DAPA-HF – published earlier this year – both had similar findings as EMPEROR-Preserved as reported by Dr. Zannad: consistent benefit from empagliflozin or dapagliflozin regardless of eGFR level and no signal of increased adverse events from treatment.
In fact, all three analyses show that patients with worse renal function had the highest risk for cardiovascular death and hospitalization for heart failure; hence, the beneficial impact from SGLT2 inhibitors is greatest in these patients.
These observations “make it easier to focus on the group with moderate-to-severe CKD,” both in the routine care setting as well as in future trials, said Dr. Rangaswami.
“This is a welcome trend that paves the way to test more treatments in patients with stage 4 and even stage 5 CKD, patients ... excluded from trials in the past,” she said.
In addition, the consistent benefit from SGLT2 inhibitors in these three heart failure trials regardless of CKD “means there is simply no room for renalism. There is no room for clinicians to say that because a patient’s eGFR is 30 mL/min/1.73m2 they are worried about starting an SGLT2 inhibitor,” she stressed.
More CKD-independent effects of empagliflozin
Results of other new analyses from EMPEROR-Preserved, also reported by Dr. Zannad, included the finding that empagliflozin was associated with a similar slowing of loss of renal function over time compared with placebo, regardless of CKD status.
In patients with CKD, empagliflozin slowed eGFR loss by 1.4 mL/min/1.73 m2/year, and in those without CKD, by 1.3 mL/min/1.73 m2/year, relative to placebo.
“Even in patients without CKD, there was a relevant eGFR decline in the placebo group that was attenuated by empagliflozin,” Dr. Zannad said.
At the end of the study, when empagliflozin was stopped, patients with or without CKD had their eGFR bounce back by an identical 2.4 mL/min/1.73 m2 relative to placebo.
Empagliflozin slowed progression to macroalbuminuria and significantly reduced the incidence of acute kidney injury by a similar amount regardless of CKD status compared with placebo.
EMPEROR-Preserved enrolled patients with function-limiting HFpEF, a left ventricular ejection fraction >40%, and a minimum level of a reliable serum marker of heart failure, N-terminal pro-B-type natriuretic peptide (NT-proBNP). Compared with placebo, empagliflozin reduced the trial’s primary outcome by an absolute 3.3 percentage points and by a significant relative risk reduction of 21% after a median 26 months of follow-up, according to a report published in October 2021.
EMPEROR-Preserved is the first prospective, randomized trial to unequivocally show the efficacy and safety of a drug for improving outcomes in patients with HFpEF.
EMPEROR-Preserved was sponsored by Boehringer-Ingelheim and Lilly, which market empagliflozin (Jardiance). Dr. Zannad has reported financial relationships with Boehringer Ingelheim as well as other companies. Dr. Rangaswami has reported being a consultant for Boehringer Ingelheim, Lilly, and AstraZeneca.
A version of this article first appeared on Medscape.com.
FROM KIDNEY WEEK 2021
Empagliflozin a winner in challenging arena of stabilized acute HF
The sodium-glucose transporter 2 inhibitors, relative newcomers among first-line agents for chronic heart failure (HF), could well attain the same go-to status in patients hospitalized with acute HF if the EMPULSE trial has anything to say about it.
Of the study’s 530 such patients, those started on daily empagliflozin (Jardiance) soon after they were stabilized, compared with a control group, were less likely to die or be rehospitalized for HF over the next 3 months.
Also, “we saw an improvement in quality of life, we saw a greater reduction in body weight, and we didn’t see any safety concerns in this very vulnerable and sick patient population,” Adriaan A. Voors, MD, University Medical Center Groningen (the Netherlands), said when presenting the trial at the American Heart Association scientific sessions.
Patients assigned to empagliflozin had a 36% greater likelihood of showing a benefit as reflected in the treatment’s win ratio when opposed by placebo, an emerging way to express outcomes in cardiovascular clinical trials. The SGLT2 inhibitor’s win ratio for the primary endpoint was 1.36 (95% confidence interval, 1.09-1.68, P = .0054), Dr. Voors reported. The outcome consisted of death, number of HF events, time to first HF event, and 90-day change in quality of life scores.
There is reluctance in practice to start patients that early after decompensation on drugs used in chronic HF, Dr. Voors said in an interview. Empagliflozin in the trial was initiated in the stabilized setting an average of 3 days after hospital admission, he said. The trial should reassure physicians that the drug “is not only safe to start early in hospital, but it’s also beneficial to start early in hospital.”
EMPULSE, combined with support from other recent trials, “should be clinical practice changing, with early in-hospital initiation of SGLT2 inhibitors in patients hospitalized with HF being the expectation, along with clear recognition that delaying SGLT2 inhibitor initiation may expose patients to unnecessary harms and delays in improved health status,” Gregg C. Fonarow, MD, University of California Los Angeles Medical Center, told this news organization.
“For patients with HF, irrespective of ejection fraction, early in-hospital initiation of SGLT2 inhibitors – once stabilized and in the absence of contraindications – should be considered a new standard of care,” said Fonarow, who was not part of EMPULSE.
The trial also lends new weight to the strategy of “simultaneous or rapid-sequence initiation” of the so-called four pillars of guideline-directed medical therapy of HF with reduced ejection fraction in patients hospitalized with HFrEF, once they are stabilized, Dr. Fonarow said. The four-pronged approach, he noted, consists of sacubitril/valsartan (Entresto), a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor.
Indeed, the new findings “fill an important gap and are clearly practice changing,” agreed Nancy K. Sweitzer, MD, PhD, University of Arizona Sarver Heart Center, Tucson, as an invited discussant following Dr. Voors’ presentation. “Few therapies have been shown to impact the course of those hospitalized with acute decompensated heart failure.”
Of note in the trial, Dr. Sweitzer continued, patients were started on empagliflozin regardless of any drug therapy they might already be on for chronic HF. “Because patients in the EMPULSE trial could be enrolled with a new diagnosis of heart failure, they were, by definition, not all on chronic guideline-directed heart failure therapy. Nevertheless, such patients benefited equally from the study intervention,” she said.
“This is crucial, as it tells us these drugs have immediate and important effects and should not be withheld while other drug classes are initiated and optimized.”
EMPULSE entered patients hospitalized for acute HF, which could be de novo or a decompensation of chronic HF, without regard to ejection fraction or whether they had diabetes, and who were clinically stable after at least one dose of loop diuretics. Their ejection fractions averaged 35% and exceeded 40% in about one-third of the total cohort.
At 90 days in the win ratio analysis, the 265 patients assigned to empagliflozin 10 mg once daily were the “winners”; that is, they were more likely to show a clinical benefit about 54% of the time in paired match-ups of patient outcomes, compared with about 40% for the 265 in the control group. The match-ups were a tie 6.4% of the time.
The empagliflozin group also benefited significantly for the endpoint of death from any cause or first HF event, with a hazard ratio of 0.65 (95% CI, 0.43-0.99; P = .042). They also were less likely to experience acute renal failure (7.7% vs. 12.1% for the control group) or serious adverse events (32.3% vs. 43.6%), Dr. Voors reported.
Tempting as it might be, the findings can’t necessarily be generalized to other SGLT2 inhibitors without an evidence base. But as Dr. Voors observed, several ongoing trials are exploring dapagliflozin (Farxiga) in a similar clinical setting.
They include DICTATE-AHF in patients with diabetes admitted with acute HF, and DAPA ACT HF-TIMI 68, which is entering patients stabilized during hospitalization with acute decompensated HFrEF. The trials are scheduled for completion in 2022 and 2023, respectively.
EMPULSE was supported by the Boehringer Ingelheim–Eli Lilly Diabetes Alliance. Dr. Voors disclosed research support and consulting for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Merck, Myokardia, Novo Nordisk, Novartis, and Roche Diagnostics. Dr. Sweitzer disclosed honoraria from Acorda and Myokardia, and reported receiving research support from Novartis and Merck. Dr. Fonarow cited honoraria from Abbott, Amgen, Janssen, Medtronic, Bayer, Merck, AstraZeneca, Cytokinetics, and Novartis.
A version of this article first appeared on Medscape.com.
The sodium-glucose transporter 2 inhibitors, relative newcomers among first-line agents for chronic heart failure (HF), could well attain the same go-to status in patients hospitalized with acute HF if the EMPULSE trial has anything to say about it.
Of the study’s 530 such patients, those started on daily empagliflozin (Jardiance) soon after they were stabilized, compared with a control group, were less likely to die or be rehospitalized for HF over the next 3 months.
Also, “we saw an improvement in quality of life, we saw a greater reduction in body weight, and we didn’t see any safety concerns in this very vulnerable and sick patient population,” Adriaan A. Voors, MD, University Medical Center Groningen (the Netherlands), said when presenting the trial at the American Heart Association scientific sessions.
Patients assigned to empagliflozin had a 36% greater likelihood of showing a benefit as reflected in the treatment’s win ratio when opposed by placebo, an emerging way to express outcomes in cardiovascular clinical trials. The SGLT2 inhibitor’s win ratio for the primary endpoint was 1.36 (95% confidence interval, 1.09-1.68, P = .0054), Dr. Voors reported. The outcome consisted of death, number of HF events, time to first HF event, and 90-day change in quality of life scores.
There is reluctance in practice to start patients that early after decompensation on drugs used in chronic HF, Dr. Voors said in an interview. Empagliflozin in the trial was initiated in the stabilized setting an average of 3 days after hospital admission, he said. The trial should reassure physicians that the drug “is not only safe to start early in hospital, but it’s also beneficial to start early in hospital.”
EMPULSE, combined with support from other recent trials, “should be clinical practice changing, with early in-hospital initiation of SGLT2 inhibitors in patients hospitalized with HF being the expectation, along with clear recognition that delaying SGLT2 inhibitor initiation may expose patients to unnecessary harms and delays in improved health status,” Gregg C. Fonarow, MD, University of California Los Angeles Medical Center, told this news organization.
“For patients with HF, irrespective of ejection fraction, early in-hospital initiation of SGLT2 inhibitors – once stabilized and in the absence of contraindications – should be considered a new standard of care,” said Fonarow, who was not part of EMPULSE.
The trial also lends new weight to the strategy of “simultaneous or rapid-sequence initiation” of the so-called four pillars of guideline-directed medical therapy of HF with reduced ejection fraction in patients hospitalized with HFrEF, once they are stabilized, Dr. Fonarow said. The four-pronged approach, he noted, consists of sacubitril/valsartan (Entresto), a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor.
Indeed, the new findings “fill an important gap and are clearly practice changing,” agreed Nancy K. Sweitzer, MD, PhD, University of Arizona Sarver Heart Center, Tucson, as an invited discussant following Dr. Voors’ presentation. “Few therapies have been shown to impact the course of those hospitalized with acute decompensated heart failure.”
Of note in the trial, Dr. Sweitzer continued, patients were started on empagliflozin regardless of any drug therapy they might already be on for chronic HF. “Because patients in the EMPULSE trial could be enrolled with a new diagnosis of heart failure, they were, by definition, not all on chronic guideline-directed heart failure therapy. Nevertheless, such patients benefited equally from the study intervention,” she said.
“This is crucial, as it tells us these drugs have immediate and important effects and should not be withheld while other drug classes are initiated and optimized.”
EMPULSE entered patients hospitalized for acute HF, which could be de novo or a decompensation of chronic HF, without regard to ejection fraction or whether they had diabetes, and who were clinically stable after at least one dose of loop diuretics. Their ejection fractions averaged 35% and exceeded 40% in about one-third of the total cohort.
At 90 days in the win ratio analysis, the 265 patients assigned to empagliflozin 10 mg once daily were the “winners”; that is, they were more likely to show a clinical benefit about 54% of the time in paired match-ups of patient outcomes, compared with about 40% for the 265 in the control group. The match-ups were a tie 6.4% of the time.
The empagliflozin group also benefited significantly for the endpoint of death from any cause or first HF event, with a hazard ratio of 0.65 (95% CI, 0.43-0.99; P = .042). They also were less likely to experience acute renal failure (7.7% vs. 12.1% for the control group) or serious adverse events (32.3% vs. 43.6%), Dr. Voors reported.
Tempting as it might be, the findings can’t necessarily be generalized to other SGLT2 inhibitors without an evidence base. But as Dr. Voors observed, several ongoing trials are exploring dapagliflozin (Farxiga) in a similar clinical setting.
They include DICTATE-AHF in patients with diabetes admitted with acute HF, and DAPA ACT HF-TIMI 68, which is entering patients stabilized during hospitalization with acute decompensated HFrEF. The trials are scheduled for completion in 2022 and 2023, respectively.
EMPULSE was supported by the Boehringer Ingelheim–Eli Lilly Diabetes Alliance. Dr. Voors disclosed research support and consulting for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Merck, Myokardia, Novo Nordisk, Novartis, and Roche Diagnostics. Dr. Sweitzer disclosed honoraria from Acorda and Myokardia, and reported receiving research support from Novartis and Merck. Dr. Fonarow cited honoraria from Abbott, Amgen, Janssen, Medtronic, Bayer, Merck, AstraZeneca, Cytokinetics, and Novartis.
A version of this article first appeared on Medscape.com.
The sodium-glucose transporter 2 inhibitors, relative newcomers among first-line agents for chronic heart failure (HF), could well attain the same go-to status in patients hospitalized with acute HF if the EMPULSE trial has anything to say about it.
Of the study’s 530 such patients, those started on daily empagliflozin (Jardiance) soon after they were stabilized, compared with a control group, were less likely to die or be rehospitalized for HF over the next 3 months.
Also, “we saw an improvement in quality of life, we saw a greater reduction in body weight, and we didn’t see any safety concerns in this very vulnerable and sick patient population,” Adriaan A. Voors, MD, University Medical Center Groningen (the Netherlands), said when presenting the trial at the American Heart Association scientific sessions.
Patients assigned to empagliflozin had a 36% greater likelihood of showing a benefit as reflected in the treatment’s win ratio when opposed by placebo, an emerging way to express outcomes in cardiovascular clinical trials. The SGLT2 inhibitor’s win ratio for the primary endpoint was 1.36 (95% confidence interval, 1.09-1.68, P = .0054), Dr. Voors reported. The outcome consisted of death, number of HF events, time to first HF event, and 90-day change in quality of life scores.
There is reluctance in practice to start patients that early after decompensation on drugs used in chronic HF, Dr. Voors said in an interview. Empagliflozin in the trial was initiated in the stabilized setting an average of 3 days after hospital admission, he said. The trial should reassure physicians that the drug “is not only safe to start early in hospital, but it’s also beneficial to start early in hospital.”
EMPULSE, combined with support from other recent trials, “should be clinical practice changing, with early in-hospital initiation of SGLT2 inhibitors in patients hospitalized with HF being the expectation, along with clear recognition that delaying SGLT2 inhibitor initiation may expose patients to unnecessary harms and delays in improved health status,” Gregg C. Fonarow, MD, University of California Los Angeles Medical Center, told this news organization.
“For patients with HF, irrespective of ejection fraction, early in-hospital initiation of SGLT2 inhibitors – once stabilized and in the absence of contraindications – should be considered a new standard of care,” said Fonarow, who was not part of EMPULSE.
The trial also lends new weight to the strategy of “simultaneous or rapid-sequence initiation” of the so-called four pillars of guideline-directed medical therapy of HF with reduced ejection fraction in patients hospitalized with HFrEF, once they are stabilized, Dr. Fonarow said. The four-pronged approach, he noted, consists of sacubitril/valsartan (Entresto), a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor.
Indeed, the new findings “fill an important gap and are clearly practice changing,” agreed Nancy K. Sweitzer, MD, PhD, University of Arizona Sarver Heart Center, Tucson, as an invited discussant following Dr. Voors’ presentation. “Few therapies have been shown to impact the course of those hospitalized with acute decompensated heart failure.”
Of note in the trial, Dr. Sweitzer continued, patients were started on empagliflozin regardless of any drug therapy they might already be on for chronic HF. “Because patients in the EMPULSE trial could be enrolled with a new diagnosis of heart failure, they were, by definition, not all on chronic guideline-directed heart failure therapy. Nevertheless, such patients benefited equally from the study intervention,” she said.
“This is crucial, as it tells us these drugs have immediate and important effects and should not be withheld while other drug classes are initiated and optimized.”
EMPULSE entered patients hospitalized for acute HF, which could be de novo or a decompensation of chronic HF, without regard to ejection fraction or whether they had diabetes, and who were clinically stable after at least one dose of loop diuretics. Their ejection fractions averaged 35% and exceeded 40% in about one-third of the total cohort.
At 90 days in the win ratio analysis, the 265 patients assigned to empagliflozin 10 mg once daily were the “winners”; that is, they were more likely to show a clinical benefit about 54% of the time in paired match-ups of patient outcomes, compared with about 40% for the 265 in the control group. The match-ups were a tie 6.4% of the time.
The empagliflozin group also benefited significantly for the endpoint of death from any cause or first HF event, with a hazard ratio of 0.65 (95% CI, 0.43-0.99; P = .042). They also were less likely to experience acute renal failure (7.7% vs. 12.1% for the control group) or serious adverse events (32.3% vs. 43.6%), Dr. Voors reported.
Tempting as it might be, the findings can’t necessarily be generalized to other SGLT2 inhibitors without an evidence base. But as Dr. Voors observed, several ongoing trials are exploring dapagliflozin (Farxiga) in a similar clinical setting.
They include DICTATE-AHF in patients with diabetes admitted with acute HF, and DAPA ACT HF-TIMI 68, which is entering patients stabilized during hospitalization with acute decompensated HFrEF. The trials are scheduled for completion in 2022 and 2023, respectively.
EMPULSE was supported by the Boehringer Ingelheim–Eli Lilly Diabetes Alliance. Dr. Voors disclosed research support and consulting for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Merck, Myokardia, Novo Nordisk, Novartis, and Roche Diagnostics. Dr. Sweitzer disclosed honoraria from Acorda and Myokardia, and reported receiving research support from Novartis and Merck. Dr. Fonarow cited honoraria from Abbott, Amgen, Janssen, Medtronic, Bayer, Merck, AstraZeneca, Cytokinetics, and Novartis.
A version of this article first appeared on Medscape.com.
FROM AHA 2021
Medical technology should keep patient in mind
Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.
Threats to the physician-patient relationship
Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.
In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.1
Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.
After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.
Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”2
We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.
Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.
In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.
‘From the Beating End of the Stethoscope’
John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:
I speak, as I say, the patient’s point of view.
But, given time, doctors are patients, too.
And there’s our bond: beyond anatomy,
Or in it, through it, to the mystery
Medicine takes the pulse of and lets go
Forever unexplained. It’s art, we know,
Not science at the heart. Doctor be whole,
I won’t insist the patient is a soul,
But he’s a something, possibly laughable,
Or possibly sublime, but not quite graphable.
Not quite containable on a bed chart.
Where science touches man it turns to art.3
This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.
Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.4 As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.
References
1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1
2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.
3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.
4. Albert Einstein, Out of My Later Years, 1950.
Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.
Threats to the physician-patient relationship
Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.
In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.1
Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.
After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.
Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”2
We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.
Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.
In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.
‘From the Beating End of the Stethoscope’
John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:
I speak, as I say, the patient’s point of view.
But, given time, doctors are patients, too.
And there’s our bond: beyond anatomy,
Or in it, through it, to the mystery
Medicine takes the pulse of and lets go
Forever unexplained. It’s art, we know,
Not science at the heart. Doctor be whole,
I won’t insist the patient is a soul,
But he’s a something, possibly laughable,
Or possibly sublime, but not quite graphable.
Not quite containable on a bed chart.
Where science touches man it turns to art.3
This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.
Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.4 As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.
References
1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1
2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.
3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.
4. Albert Einstein, Out of My Later Years, 1950.
Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.
Threats to the physician-patient relationship
Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.
In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.1
Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.
After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.
Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”2
We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.
Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.
In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.
‘From the Beating End of the Stethoscope’
John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:
I speak, as I say, the patient’s point of view.
But, given time, doctors are patients, too.
And there’s our bond: beyond anatomy,
Or in it, through it, to the mystery
Medicine takes the pulse of and lets go
Forever unexplained. It’s art, we know,
Not science at the heart. Doctor be whole,
I won’t insist the patient is a soul,
But he’s a something, possibly laughable,
Or possibly sublime, but not quite graphable.
Not quite containable on a bed chart.
Where science touches man it turns to art.3
This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.
Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.4 As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.
References
1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1
2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.
3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.
4. Albert Einstein, Out of My Later Years, 1950.
Case: Older patient with T2D has recurrent flushing
He has had no other symptoms. His only abnormalities on physical exam are a blood pressure of 160/100 and mild peripheral edema.
His current medications include: Famotidine 20 mg b.i.d., Pseudoephedrine/guaifenesin SR b.i.d., Metformin 1,000 mg twice a day, Nifedipine 60 mg XL once a day, and Atorvastatin 20 mg once a day.
His laboratory work up includes: blood urea nitrogen: 20, creatinine: 1.3, sodium: 140, Chloride: 104, potassium: 3.9, glucose: 205, white blood cell count: 6,000, hematocrit: 41, 24-hour urine 5-hydroxyindoleacetic acid (5HIAA) test: 12 mg/day (normal 2-8 mg/day), free catecholamines: 80 mg/24 hours (normal less than 100 mg/24 hours).
What is the most likely diagnosis?
A. Drug effect
B. Pheochromocytoma
C. Carcinoid syndrome
D. Mastocytosis
E. Medullary thyroid cancer
The most likely diagnosis is a drug effect. His flushing is likely caused by nifedipine.
Flushing is one of the most common side effects of this drug.1 This patient had lab testing done for carcinoid (urine 5HIAA), presumably because he had flushing. This lab test result was a false positive, likely because of guaifenesin ingestion, which can cause false-positive 5HIAA results.2
Carcinoid syndrome is very rare (estimates from less than 1 patient/100,000), and the vast majority of patients who have it present with metastatic disease at presentation. Drug side effects are common, and usually are much more likely than rare diseases.
Four principles for assisting with making a diagnosis
This case points out the following four principles that I will touch on to help us make diagnoses in challenging cases.
1. Trigger symptoms: These are symptoms that make us think of a rare disease. In this case, the symptom is flushing, which may make you think of carcinoid syndrome.
Another good example of a trigger symptom is night sweats, where you may think of tuberculosis or lymphoma. These symptoms almost always have a much more common and likely cause, which in this case is a common drug side effect.
Trigger symptoms are great to pay attention to, but do not jump to working up the rare diagnosis without more evidence that it is a plausible diagnosis. Working up rare diseases without a reasonable pretest probability will lead to significant false-positive results.
2. Distinguishing features: These are findings, or combinations of findings, that make rarer diseases more likely. For example, flushing, although seen in many patients with carcinoid syndrome, is much more commonly caused by rosacea, medications, or estrogen/testosterone deficiency.
If a patient presents with flushing plus diarrhea, carcinoid syndrome becomes more likely in differentials. An example of a specific distinguishing feature is transient visual obstructions in patients with idiopathic intracranial hypertension (IIH or pseudotumor cerebri).
Sudden transient visual loss is not a symptom we see often, but headaches and obesity are problems we see every day. A patient with headaches and obesity is very likely to have IIH if they have transient visual obstructions along with headaches and obesity.
3. Intentional physical exams: Do the physical exam focusing on what findings will change your diagnostic probabilities. For example, in this case, if you are considering carcinoid, do a careful abdominal exam, with close attention to the liver, as 75% of patients with carcinoid syndrome have liver metastases.
If you are thinking about IIH, a fundoscopic exam is mandatory, as papilledema is a key feature of this diagnosis.
Read about the rare diagnosis you are considering, this will help with targeting your exam.
4. Remember the unusual presentation of a common disease is more common than the common presentation of a rare disease: Good examples of this are sleep apnea and gastroesophageal reflux disease causing night sweats more commonly than finding lymphomas or active tuberculosis (in the United States) as the cause.3
Pearl: Trigger symptoms help us think of rare diseases, but distinguishing features are most helpful in including or excluding the diagnosis.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Gueret P et al. Drugs. 1990;39 Suppl 2:67-72.
2. Corcuff J et al. Endocr Connect. 2017;6:R87.
3. Smith CS and Paauw DS. J Am Board Fam Pract. 2000;13:424-9.
He has had no other symptoms. His only abnormalities on physical exam are a blood pressure of 160/100 and mild peripheral edema.
His current medications include: Famotidine 20 mg b.i.d., Pseudoephedrine/guaifenesin SR b.i.d., Metformin 1,000 mg twice a day, Nifedipine 60 mg XL once a day, and Atorvastatin 20 mg once a day.
His laboratory work up includes: blood urea nitrogen: 20, creatinine: 1.3, sodium: 140, Chloride: 104, potassium: 3.9, glucose: 205, white blood cell count: 6,000, hematocrit: 41, 24-hour urine 5-hydroxyindoleacetic acid (5HIAA) test: 12 mg/day (normal 2-8 mg/day), free catecholamines: 80 mg/24 hours (normal less than 100 mg/24 hours).
What is the most likely diagnosis?
A. Drug effect
B. Pheochromocytoma
C. Carcinoid syndrome
D. Mastocytosis
E. Medullary thyroid cancer
The most likely diagnosis is a drug effect. His flushing is likely caused by nifedipine.
Flushing is one of the most common side effects of this drug.1 This patient had lab testing done for carcinoid (urine 5HIAA), presumably because he had flushing. This lab test result was a false positive, likely because of guaifenesin ingestion, which can cause false-positive 5HIAA results.2
Carcinoid syndrome is very rare (estimates from less than 1 patient/100,000), and the vast majority of patients who have it present with metastatic disease at presentation. Drug side effects are common, and usually are much more likely than rare diseases.
Four principles for assisting with making a diagnosis
This case points out the following four principles that I will touch on to help us make diagnoses in challenging cases.
1. Trigger symptoms: These are symptoms that make us think of a rare disease. In this case, the symptom is flushing, which may make you think of carcinoid syndrome.
Another good example of a trigger symptom is night sweats, where you may think of tuberculosis or lymphoma. These symptoms almost always have a much more common and likely cause, which in this case is a common drug side effect.
Trigger symptoms are great to pay attention to, but do not jump to working up the rare diagnosis without more evidence that it is a plausible diagnosis. Working up rare diseases without a reasonable pretest probability will lead to significant false-positive results.
2. Distinguishing features: These are findings, or combinations of findings, that make rarer diseases more likely. For example, flushing, although seen in many patients with carcinoid syndrome, is much more commonly caused by rosacea, medications, or estrogen/testosterone deficiency.
If a patient presents with flushing plus diarrhea, carcinoid syndrome becomes more likely in differentials. An example of a specific distinguishing feature is transient visual obstructions in patients with idiopathic intracranial hypertension (IIH or pseudotumor cerebri).
Sudden transient visual loss is not a symptom we see often, but headaches and obesity are problems we see every day. A patient with headaches and obesity is very likely to have IIH if they have transient visual obstructions along with headaches and obesity.
3. Intentional physical exams: Do the physical exam focusing on what findings will change your diagnostic probabilities. For example, in this case, if you are considering carcinoid, do a careful abdominal exam, with close attention to the liver, as 75% of patients with carcinoid syndrome have liver metastases.
If you are thinking about IIH, a fundoscopic exam is mandatory, as papilledema is a key feature of this diagnosis.
Read about the rare diagnosis you are considering, this will help with targeting your exam.
4. Remember the unusual presentation of a common disease is more common than the common presentation of a rare disease: Good examples of this are sleep apnea and gastroesophageal reflux disease causing night sweats more commonly than finding lymphomas or active tuberculosis (in the United States) as the cause.3
Pearl: Trigger symptoms help us think of rare diseases, but distinguishing features are most helpful in including or excluding the diagnosis.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Gueret P et al. Drugs. 1990;39 Suppl 2:67-72.
2. Corcuff J et al. Endocr Connect. 2017;6:R87.
3. Smith CS and Paauw DS. J Am Board Fam Pract. 2000;13:424-9.
He has had no other symptoms. His only abnormalities on physical exam are a blood pressure of 160/100 and mild peripheral edema.
His current medications include: Famotidine 20 mg b.i.d., Pseudoephedrine/guaifenesin SR b.i.d., Metformin 1,000 mg twice a day, Nifedipine 60 mg XL once a day, and Atorvastatin 20 mg once a day.
His laboratory work up includes: blood urea nitrogen: 20, creatinine: 1.3, sodium: 140, Chloride: 104, potassium: 3.9, glucose: 205, white blood cell count: 6,000, hematocrit: 41, 24-hour urine 5-hydroxyindoleacetic acid (5HIAA) test: 12 mg/day (normal 2-8 mg/day), free catecholamines: 80 mg/24 hours (normal less than 100 mg/24 hours).
What is the most likely diagnosis?
A. Drug effect
B. Pheochromocytoma
C. Carcinoid syndrome
D. Mastocytosis
E. Medullary thyroid cancer
The most likely diagnosis is a drug effect. His flushing is likely caused by nifedipine.
Flushing is one of the most common side effects of this drug.1 This patient had lab testing done for carcinoid (urine 5HIAA), presumably because he had flushing. This lab test result was a false positive, likely because of guaifenesin ingestion, which can cause false-positive 5HIAA results.2
Carcinoid syndrome is very rare (estimates from less than 1 patient/100,000), and the vast majority of patients who have it present with metastatic disease at presentation. Drug side effects are common, and usually are much more likely than rare diseases.
Four principles for assisting with making a diagnosis
This case points out the following four principles that I will touch on to help us make diagnoses in challenging cases.
1. Trigger symptoms: These are symptoms that make us think of a rare disease. In this case, the symptom is flushing, which may make you think of carcinoid syndrome.
Another good example of a trigger symptom is night sweats, where you may think of tuberculosis or lymphoma. These symptoms almost always have a much more common and likely cause, which in this case is a common drug side effect.
Trigger symptoms are great to pay attention to, but do not jump to working up the rare diagnosis without more evidence that it is a plausible diagnosis. Working up rare diseases without a reasonable pretest probability will lead to significant false-positive results.
2. Distinguishing features: These are findings, or combinations of findings, that make rarer diseases more likely. For example, flushing, although seen in many patients with carcinoid syndrome, is much more commonly caused by rosacea, medications, or estrogen/testosterone deficiency.
If a patient presents with flushing plus diarrhea, carcinoid syndrome becomes more likely in differentials. An example of a specific distinguishing feature is transient visual obstructions in patients with idiopathic intracranial hypertension (IIH or pseudotumor cerebri).
Sudden transient visual loss is not a symptom we see often, but headaches and obesity are problems we see every day. A patient with headaches and obesity is very likely to have IIH if they have transient visual obstructions along with headaches and obesity.
3. Intentional physical exams: Do the physical exam focusing on what findings will change your diagnostic probabilities. For example, in this case, if you are considering carcinoid, do a careful abdominal exam, with close attention to the liver, as 75% of patients with carcinoid syndrome have liver metastases.
If you are thinking about IIH, a fundoscopic exam is mandatory, as papilledema is a key feature of this diagnosis.
Read about the rare diagnosis you are considering, this will help with targeting your exam.
4. Remember the unusual presentation of a common disease is more common than the common presentation of a rare disease: Good examples of this are sleep apnea and gastroesophageal reflux disease causing night sweats more commonly than finding lymphomas or active tuberculosis (in the United States) as the cause.3
Pearl: Trigger symptoms help us think of rare diseases, but distinguishing features are most helpful in including or excluding the diagnosis.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Gueret P et al. Drugs. 1990;39 Suppl 2:67-72.
2. Corcuff J et al. Endocr Connect. 2017;6:R87.
3. Smith CS and Paauw DS. J Am Board Fam Pract. 2000;13:424-9.
FDA flags cardiac perforation risks during leadless pacemaker implantation
The Food and Drug Administration is reminding health care providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation.
Cardiac perforation is a rare complication and the overall risk associated with leadless pacemaker implantation appears similar to that with traditional transvenous pacemakers, the agency says. However, premarket clinical studies of the Micra leadless pacemaker (Medtronic) suggested major complications related to cardiac perforation appear to be more severe for those receiving a leadless pacemaker.
“Information from real-world use suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers,” the FDA said Nov. 17 in a letter to health care professionals.
“The FDA is bringing this information to your attention as a reminder and to encourage you to report leadless pacemaker cardiac perforations and complications related to perforation to the manufacturer and the FDA,” it notes.
The Micra Transcatheter Pacing System in 2015 was the first leadless pacemaker approved in Europe, and was approved in the United States the following year with a mandated postapproval study to help assess continued safety and efficacy. The Micra device is currently the only approved leadless pacemaker in the United States.
The FDA continues to evaluate outcomes in patients who receive leadless pacing systems and recommends that health care providers discuss the risks and benefits of available pacing system options with patients as part of shared clinical decision-making.
Providers are advised to read and carefully follow the instructions for use and training for Medtronic’s Micra pacemaker.
Any adverse events or suspected adverse events related to the Micra Transcatheter Pacing System or any other pacemaker systems should be reported to the FDA through MedWatch, its adverse-event reporting program.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration is reminding health care providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation.
Cardiac perforation is a rare complication and the overall risk associated with leadless pacemaker implantation appears similar to that with traditional transvenous pacemakers, the agency says. However, premarket clinical studies of the Micra leadless pacemaker (Medtronic) suggested major complications related to cardiac perforation appear to be more severe for those receiving a leadless pacemaker.
“Information from real-world use suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers,” the FDA said Nov. 17 in a letter to health care professionals.
“The FDA is bringing this information to your attention as a reminder and to encourage you to report leadless pacemaker cardiac perforations and complications related to perforation to the manufacturer and the FDA,” it notes.
The Micra Transcatheter Pacing System in 2015 was the first leadless pacemaker approved in Europe, and was approved in the United States the following year with a mandated postapproval study to help assess continued safety and efficacy. The Micra device is currently the only approved leadless pacemaker in the United States.
The FDA continues to evaluate outcomes in patients who receive leadless pacing systems and recommends that health care providers discuss the risks and benefits of available pacing system options with patients as part of shared clinical decision-making.
Providers are advised to read and carefully follow the instructions for use and training for Medtronic’s Micra pacemaker.
Any adverse events or suspected adverse events related to the Micra Transcatheter Pacing System or any other pacemaker systems should be reported to the FDA through MedWatch, its adverse-event reporting program.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration is reminding health care providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation.
Cardiac perforation is a rare complication and the overall risk associated with leadless pacemaker implantation appears similar to that with traditional transvenous pacemakers, the agency says. However, premarket clinical studies of the Micra leadless pacemaker (Medtronic) suggested major complications related to cardiac perforation appear to be more severe for those receiving a leadless pacemaker.
“Information from real-world use suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers,” the FDA said Nov. 17 in a letter to health care professionals.
“The FDA is bringing this information to your attention as a reminder and to encourage you to report leadless pacemaker cardiac perforations and complications related to perforation to the manufacturer and the FDA,” it notes.
The Micra Transcatheter Pacing System in 2015 was the first leadless pacemaker approved in Europe, and was approved in the United States the following year with a mandated postapproval study to help assess continued safety and efficacy. The Micra device is currently the only approved leadless pacemaker in the United States.
The FDA continues to evaluate outcomes in patients who receive leadless pacing systems and recommends that health care providers discuss the risks and benefits of available pacing system options with patients as part of shared clinical decision-making.
Providers are advised to read and carefully follow the instructions for use and training for Medtronic’s Micra pacemaker.
Any adverse events or suspected adverse events related to the Micra Transcatheter Pacing System or any other pacemaker systems should be reported to the FDA through MedWatch, its adverse-event reporting program.
A version of this article first appeared on Medscape.com.
The neurological super powers of grandma are real
Deer, COVID, how?
Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.
Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.
A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.
If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.
The more you know!
The neurological super powers of grandma are real
What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.
So what makes these super matriarchs? The answer is in the brain.
Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”
And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.
So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.
Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.
Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.
A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
Brain cleanup on aisle 5
You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.
There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.
For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.
In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.
The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
The real endgame: Friction is the winner
Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.
For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.
Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.
Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.
With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.
Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.
Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.
That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”
Deer, COVID, how?
Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.
Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.
A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.
If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.
The more you know!
The neurological super powers of grandma are real
What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.
So what makes these super matriarchs? The answer is in the brain.
Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”
And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.
So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.
Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.
Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.
A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
Brain cleanup on aisle 5
You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.
There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.
For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.
In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.
The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
The real endgame: Friction is the winner
Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.
For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.
Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.
Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.
With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.
Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.
Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.
That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”
Deer, COVID, how?
Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.
Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.
A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.
If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.
The more you know!
The neurological super powers of grandma are real
What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.
So what makes these super matriarchs? The answer is in the brain.
Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”
And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.
So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.
Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.
Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.
A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
Brain cleanup on aisle 5
You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.
There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.
For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.
In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.
The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
The real endgame: Friction is the winner
Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.
For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.
Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.
Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.
With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.
Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.
Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.
That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”
Coffee or tea? Drinking both tied to lower stroke, dementia risk
Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.
Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.
“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.
The study was published online Nov. 16 in PLOS Medicine.
Synergistic effect?
Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.
Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.
During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.
After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).
Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).
Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).
Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).
There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.
The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.
Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.
“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.
The study was published online Nov. 16 in PLOS Medicine.
Synergistic effect?
Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.
Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.
During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.
After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).
Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).
Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).
Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).
There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.
The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.
Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.
“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.
The study was published online Nov. 16 in PLOS Medicine.
Synergistic effect?
Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.
Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.
During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.
After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).
Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).
Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).
Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).
There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.
The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
High triglycerides in normal-weight men with obstructive sleep apnea
, according to results of a study published in Nature and Science of Sleep (2021:13 1771-82).
Layla B. Guscoth, MD, of the South Australian Health and Medical Research Institute and Faculty of Health and Medical Sciences, University of Adelaide, Australia, and colleagues assessed unselected male community-dwelling participants in the Men Androgen Inflammation Lifestyle Environment and Stress (MAILES) and the Florey Adelaide Male Aging Study (FAMAS) studies.
They examined the association of OSA and nocturnal hypoxemia with serum lipid profiles, and suggested that the cardiometabolic risk profiles of healthy weight individuals with OSA require clinical attention, according to the researchers.
The partial or complete obstruction of upper airways found in the OSA syndrome results in intermittent hypoxia, accompanied variably by sleep fragmentation and daytime sleepiness. While the prevalence of moderate to severe OSA was 49.7% in the Swiss HypnoLaus cohort, it was 74.7% in men aged 40 or older (or having OSA syndrome according to ICD-3 criteria). Dr. Guscoth and colleagues point out, however, that OSA is frequently underdiagnosed or unrecognized in clinical settings, and that OSA has been implicated in development of cardiovascular conditions. Furthermore, the nocturnal hypoxemia resulting from OSA during rapid eye movement (REM) sleep is longitudinally associated with cardiovascular disease and its risk factors (hypertension, insulin resistance, metabolic syndrome and carotid atherosclerosis).
Study details
Prior research suggests that intermittent hypoxemia activates the sympathetic nervous system, increases oxidative stress and systemic inflammation, and that when chronic, reduces clearance of triglyceride-rich lipoproteins and inhibits adipose tissue lipoprotein lipase activity. To clarify inconsistent results in studies investigating potential OSA-dyslipidemia associations, and to confirm research suggesting an independent association with severe OSA (apnea-hypopnea index [AHI] ≥ 30/h), the authors conducted analyses stratified by waist circumference to observe an obesity-independent association between OSA metrics and dyslipidemia.
The investigators assessed 753 MAILES participants (mean age 60.8 years) who underwent full in-home polysomnography (Embletta X100). They looked at triglycerides, high- (HDL) and low-density lipoprotein (LDL), total cholesterol, associations between lipids and continuous measures of nocturnal hypoxemia (oxygen desaturation index [ODI], AHI, and REM-AHI), and adjusted for chronic conditions, risk behavior, and sociodemographic factors.
Mean waist circumference was 99.3 cm and OSA (AHI ≥ 10) prevalence was 52.6%. No significant associations were found between OSA metrics and lipid measures in an overall analysis, nor in a sensitivity analysis excluding lipid-lowering therapies.
In a covariate adjusted analysis stratified according to waist circumference (< 95 cm, 95-100 cm, > 100 cm) to minimize the contribution of obesity to hypertriglyceridemia, triglyceride levels were positively associated with AHI, ODI and REM-AHI in the participants with a waist circumference < 95 cm (P < .05), but not in participants with waist circumferences of 95-100 cm or > 100 cm.
Worse during REM
The authors observed also that OSA during REM sleep is marked by longer obstructive events with greater oxygen desaturations. Obstructive events during REM sleep, research has shown, may be more harmful than obstructive events during non-REM sleep with respect to hypertension, cardiovascular disease, and glycemic control in type 2 diabetes.
Looking at clinical categories of OSA, Dr. Guscoth and colleagues found that severe OSA was significantly associated with higher likelihood of triglyceride levels ≥ 1.7 mmol/L (odds ratio, 4.1, 95% confidence interval, 1.1-15.5, P = .039). Analysis according to waist circumference confirmed the relationship only among men with waist circumference < 95 cm.
Clinical concern
“We therefore suggest that with our data unstratified by weight circumference, metabolic derangements associated with insulin resistance induced by intermittent hypoxia due to OSA cannot be separated from the predominant effect of visceral obesity. When stratified by weight circumference, our data show that these derangements in triglycerides are observed only in lean participants where obesity does not have a dominant effect,” the researchers concluded.
“These findings of high prevalence of metabolic risk in lean patients with OSA, I find very worrying,” coauthor Sarah Appleton, PhD, Flinders Medical Center, Adelaide, Australia, said in an interview. She cited a study showing a 61% risk of dyslipidemia in lean patients with OSA (AHI > 5/hr, body mass index < 25 kg/m2, and waist < 80 cm in women, < 90 cm in men), and two of three metabolic syndrome components in 64%. “Annual fasting blood tests would identify metabolic problems such as elevated fasting glucose and triglyceride levels,” she noted.
This work was supported by a National Health and Medical Research Council of Australia Project Grant (627227), the Hospital Research Foundation and ResMed Foundation. There were no relevant conflicts reported.
, according to results of a study published in Nature and Science of Sleep (2021:13 1771-82).
Layla B. Guscoth, MD, of the South Australian Health and Medical Research Institute and Faculty of Health and Medical Sciences, University of Adelaide, Australia, and colleagues assessed unselected male community-dwelling participants in the Men Androgen Inflammation Lifestyle Environment and Stress (MAILES) and the Florey Adelaide Male Aging Study (FAMAS) studies.
They examined the association of OSA and nocturnal hypoxemia with serum lipid profiles, and suggested that the cardiometabolic risk profiles of healthy weight individuals with OSA require clinical attention, according to the researchers.
The partial or complete obstruction of upper airways found in the OSA syndrome results in intermittent hypoxia, accompanied variably by sleep fragmentation and daytime sleepiness. While the prevalence of moderate to severe OSA was 49.7% in the Swiss HypnoLaus cohort, it was 74.7% in men aged 40 or older (or having OSA syndrome according to ICD-3 criteria). Dr. Guscoth and colleagues point out, however, that OSA is frequently underdiagnosed or unrecognized in clinical settings, and that OSA has been implicated in development of cardiovascular conditions. Furthermore, the nocturnal hypoxemia resulting from OSA during rapid eye movement (REM) sleep is longitudinally associated with cardiovascular disease and its risk factors (hypertension, insulin resistance, metabolic syndrome and carotid atherosclerosis).
Study details
Prior research suggests that intermittent hypoxemia activates the sympathetic nervous system, increases oxidative stress and systemic inflammation, and that when chronic, reduces clearance of triglyceride-rich lipoproteins and inhibits adipose tissue lipoprotein lipase activity. To clarify inconsistent results in studies investigating potential OSA-dyslipidemia associations, and to confirm research suggesting an independent association with severe OSA (apnea-hypopnea index [AHI] ≥ 30/h), the authors conducted analyses stratified by waist circumference to observe an obesity-independent association between OSA metrics and dyslipidemia.
The investigators assessed 753 MAILES participants (mean age 60.8 years) who underwent full in-home polysomnography (Embletta X100). They looked at triglycerides, high- (HDL) and low-density lipoprotein (LDL), total cholesterol, associations between lipids and continuous measures of nocturnal hypoxemia (oxygen desaturation index [ODI], AHI, and REM-AHI), and adjusted for chronic conditions, risk behavior, and sociodemographic factors.
Mean waist circumference was 99.3 cm and OSA (AHI ≥ 10) prevalence was 52.6%. No significant associations were found between OSA metrics and lipid measures in an overall analysis, nor in a sensitivity analysis excluding lipid-lowering therapies.
In a covariate adjusted analysis stratified according to waist circumference (< 95 cm, 95-100 cm, > 100 cm) to minimize the contribution of obesity to hypertriglyceridemia, triglyceride levels were positively associated with AHI, ODI and REM-AHI in the participants with a waist circumference < 95 cm (P < .05), but not in participants with waist circumferences of 95-100 cm or > 100 cm.
Worse during REM
The authors observed also that OSA during REM sleep is marked by longer obstructive events with greater oxygen desaturations. Obstructive events during REM sleep, research has shown, may be more harmful than obstructive events during non-REM sleep with respect to hypertension, cardiovascular disease, and glycemic control in type 2 diabetes.
Looking at clinical categories of OSA, Dr. Guscoth and colleagues found that severe OSA was significantly associated with higher likelihood of triglyceride levels ≥ 1.7 mmol/L (odds ratio, 4.1, 95% confidence interval, 1.1-15.5, P = .039). Analysis according to waist circumference confirmed the relationship only among men with waist circumference < 95 cm.
Clinical concern
“We therefore suggest that with our data unstratified by weight circumference, metabolic derangements associated with insulin resistance induced by intermittent hypoxia due to OSA cannot be separated from the predominant effect of visceral obesity. When stratified by weight circumference, our data show that these derangements in triglycerides are observed only in lean participants where obesity does not have a dominant effect,” the researchers concluded.
“These findings of high prevalence of metabolic risk in lean patients with OSA, I find very worrying,” coauthor Sarah Appleton, PhD, Flinders Medical Center, Adelaide, Australia, said in an interview. She cited a study showing a 61% risk of dyslipidemia in lean patients with OSA (AHI > 5/hr, body mass index < 25 kg/m2, and waist < 80 cm in women, < 90 cm in men), and two of three metabolic syndrome components in 64%. “Annual fasting blood tests would identify metabolic problems such as elevated fasting glucose and triglyceride levels,” she noted.
This work was supported by a National Health and Medical Research Council of Australia Project Grant (627227), the Hospital Research Foundation and ResMed Foundation. There were no relevant conflicts reported.
, according to results of a study published in Nature and Science of Sleep (2021:13 1771-82).
Layla B. Guscoth, MD, of the South Australian Health and Medical Research Institute and Faculty of Health and Medical Sciences, University of Adelaide, Australia, and colleagues assessed unselected male community-dwelling participants in the Men Androgen Inflammation Lifestyle Environment and Stress (MAILES) and the Florey Adelaide Male Aging Study (FAMAS) studies.
They examined the association of OSA and nocturnal hypoxemia with serum lipid profiles, and suggested that the cardiometabolic risk profiles of healthy weight individuals with OSA require clinical attention, according to the researchers.
The partial or complete obstruction of upper airways found in the OSA syndrome results in intermittent hypoxia, accompanied variably by sleep fragmentation and daytime sleepiness. While the prevalence of moderate to severe OSA was 49.7% in the Swiss HypnoLaus cohort, it was 74.7% in men aged 40 or older (or having OSA syndrome according to ICD-3 criteria). Dr. Guscoth and colleagues point out, however, that OSA is frequently underdiagnosed or unrecognized in clinical settings, and that OSA has been implicated in development of cardiovascular conditions. Furthermore, the nocturnal hypoxemia resulting from OSA during rapid eye movement (REM) sleep is longitudinally associated with cardiovascular disease and its risk factors (hypertension, insulin resistance, metabolic syndrome and carotid atherosclerosis).
Study details
Prior research suggests that intermittent hypoxemia activates the sympathetic nervous system, increases oxidative stress and systemic inflammation, and that when chronic, reduces clearance of triglyceride-rich lipoproteins and inhibits adipose tissue lipoprotein lipase activity. To clarify inconsistent results in studies investigating potential OSA-dyslipidemia associations, and to confirm research suggesting an independent association with severe OSA (apnea-hypopnea index [AHI] ≥ 30/h), the authors conducted analyses stratified by waist circumference to observe an obesity-independent association between OSA metrics and dyslipidemia.
The investigators assessed 753 MAILES participants (mean age 60.8 years) who underwent full in-home polysomnography (Embletta X100). They looked at triglycerides, high- (HDL) and low-density lipoprotein (LDL), total cholesterol, associations between lipids and continuous measures of nocturnal hypoxemia (oxygen desaturation index [ODI], AHI, and REM-AHI), and adjusted for chronic conditions, risk behavior, and sociodemographic factors.
Mean waist circumference was 99.3 cm and OSA (AHI ≥ 10) prevalence was 52.6%. No significant associations were found between OSA metrics and lipid measures in an overall analysis, nor in a sensitivity analysis excluding lipid-lowering therapies.
In a covariate adjusted analysis stratified according to waist circumference (< 95 cm, 95-100 cm, > 100 cm) to minimize the contribution of obesity to hypertriglyceridemia, triglyceride levels were positively associated with AHI, ODI and REM-AHI in the participants with a waist circumference < 95 cm (P < .05), but not in participants with waist circumferences of 95-100 cm or > 100 cm.
Worse during REM
The authors observed also that OSA during REM sleep is marked by longer obstructive events with greater oxygen desaturations. Obstructive events during REM sleep, research has shown, may be more harmful than obstructive events during non-REM sleep with respect to hypertension, cardiovascular disease, and glycemic control in type 2 diabetes.
Looking at clinical categories of OSA, Dr. Guscoth and colleagues found that severe OSA was significantly associated with higher likelihood of triglyceride levels ≥ 1.7 mmol/L (odds ratio, 4.1, 95% confidence interval, 1.1-15.5, P = .039). Analysis according to waist circumference confirmed the relationship only among men with waist circumference < 95 cm.
Clinical concern
“We therefore suggest that with our data unstratified by weight circumference, metabolic derangements associated with insulin resistance induced by intermittent hypoxia due to OSA cannot be separated from the predominant effect of visceral obesity. When stratified by weight circumference, our data show that these derangements in triglycerides are observed only in lean participants where obesity does not have a dominant effect,” the researchers concluded.
“These findings of high prevalence of metabolic risk in lean patients with OSA, I find very worrying,” coauthor Sarah Appleton, PhD, Flinders Medical Center, Adelaide, Australia, said in an interview. She cited a study showing a 61% risk of dyslipidemia in lean patients with OSA (AHI > 5/hr, body mass index < 25 kg/m2, and waist < 80 cm in women, < 90 cm in men), and two of three metabolic syndrome components in 64%. “Annual fasting blood tests would identify metabolic problems such as elevated fasting glucose and triglyceride levels,” she noted.
This work was supported by a National Health and Medical Research Council of Australia Project Grant (627227), the Hospital Research Foundation and ResMed Foundation. There were no relevant conflicts reported.
FROM NATURE AND SCIENCE OF SLEEP