Federal Practitioner

Public spending on colchicine has grown exponentially over the past decade despite generics suggesting an uphill slog for patients seeking access to long-term therapy for gout or cardiac conditions.

Medicaid spending on single-ingredient colchicine jumped 2,833%, from $1.1 million in 2008 to $32.2 million in 2017, new findings show. Medicaid expansion likely played a role in the increase, but 58% was due to price hikes alone.

The centuries-old drug sold for pennies in the United States before increasing 50-fold to about $5 per pill in 2009 after the first FDA-approved colchicine product, Colcrys, was granted 3 years’ market exclusivity for the treatment of acute gout based on a 1-week trial.

If prices had remained at pre-Colcrys levels, Medicaid spending in 2017 would have totaled just $2.1 million rather than $32.2 million according to the analysis, published online Nov. 30 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2020.5017).

The study was motivated by difficulties gout patients have in accessing colchicine, but also last year’s COLCOT trial, which reported fewer ischemic cardiovascular events in patients receiving colchicine after MI, observed Natalie McCormick, PhD, of Massachusetts General Hospital and Harvard Medical School, both in Boston.

“They were suggesting it could be a cost-effective way for secondary prevention and it is fairly inexpensive in most countries, but not the U.S.,” she said in an interview. “So there’s really a potential to increase public spending if more and more patients are then taking colchicine for prevention of cardiovascular events and the prices don’t change.”

The current pandemic could potentially further increase demand. Results initially slated for September are expected this month from the COLCORONA trial, which is testing whether the anti-inflammatory agent can prevent hospitalizations, lung complications, and death when given early in the course of COVID-19.

University of Oxford (England) researchers also announced last week that colchicine is being added to the massive RECOVERY trial, which is studying treatments for hospitalized COVID-19 patients.

Notably, the Canadian-based COLCOT trial did not use Colcrys, but rather a colchicine product that costs just $0.26 a pill in Canada, roughly the price of most generics available worldwide.

Authorized generics typically drive down drug prices when competing with independent generics, but this competition is missing in the United States, where Colcrys holds patents until 2029, Dr. McCormick and colleagues noted. More than a half-dozen independent generics have FDA approval to date, but only authorized generics with price points set by the brand-name companies are available to treat acute gout, pericarditis, and potentially millions with MI.

“One of the key takeaways is this difference between the brand names and the authorized generics and the independents,” she said. “The authorized [generics] have really not saved money. The list prices were just slightly lower and patients can also have more difficulty in getting those covered.”

For this analysis, the investigators used Medicaid and Medicare data to examine prices for all available forms of colchicine from 2008 to 2017, including unregulated/unapproved colchicine (2008-2010), generic combination probenecid-colchicine (2008-2017), Colcrys (2009-2017), brand-name single-ingredient colchicine Mitigare (approved in late 2014 but not marketed until 2015), and their authorized generics (2015-2017). Medicare trends from 2012 to 2017 were analyzed separately because pre-Colcrys Medicare data were not available.

Based on the results, combined spending on Medicare and Medicaid claims for single-ingredient colchicine exceeded $340 million in 2017.

Inflation- and rebate-adjusted Medicaid unit prices rose from $0.24 a pill in 2008, when unapproved formulations were still available, to $4.20 a pill in 2011 (Colcrys only), and peaked at $4.66 a pill in 2015 (Colcrys plus authorized generics).

Prescribing of lower-priced probenecid-colchicine ($0.66/pill in 2017) remained stable throughout. Medicaid rebate-adjusted prices in 2017 were $3.99/pill for all single-ingredient colchicine products, $5.13/pill for Colcrys, $4.49/pill for Mitigare, and $3.88/pill for authorized generics.

Medicare rebate-adjusted 2017 per-pill prices were $5.81 for all single-ingredient colchicine products, $6.78 for Colcrys, $5.68 for Mitigare, $5.16 for authorized generics, and $0.70 for probenecid-colchicine.

“Authorized generics have still driven high spending,” Dr. McCormick said. “We really need to encourage more competition in order to improve access.”

In an accompanying commentary, B. Joseph Guglielmo, PharmD, University of California, San Francisco, pointed out that the estimated median research and development cost to bring a drug to market is between $985 million and $1,335 million, which inevitably translates into a high selling price for the drug. Such investment and its resultant cost, however, should be associated with potential worth to society.

“Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system,” he wrote. “The current study findings illustrate that we can never allow such an egregious case to take place again.”

Dr. McCormick reported grants from Canadian Institutes of Health Research during the conduct of the study. Dr. Guglielmo reported having no relevant conflicts of interest.

This article first appeared on Medscape.com.

Public spending on colchicine has grown exponentially over the past decade despite generics suggesting an uphill slog for patients seeking access to long-term therapy for gout or cardiac conditions.

Medicaid spending on single-ingredient colchicine jumped 2,833%, from $1.1 million in 2008 to $32.2 million in 2017, new findings show. Medicaid expansion likely played a role in the increase, but 58% was due to price hikes alone.

The centuries-old drug sold for pennies in the United States before increasing 50-fold to about $5 per pill in 2009 after the first FDA-approved colchicine product, Colcrys, was granted 3 years’ market exclusivity for the treatment of acute gout based on a 1-week trial.

If prices had remained at pre-Colcrys levels, Medicaid spending in 2017 would have totaled just $2.1 million rather than $32.2 million according to the analysis, published online Nov. 30 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2020.5017).

The study was motivated by difficulties gout patients have in accessing colchicine, but also last year’s COLCOT trial, which reported fewer ischemic cardiovascular events in patients receiving colchicine after MI, observed Natalie McCormick, PhD, of Massachusetts General Hospital and Harvard Medical School, both in Boston.

“They were suggesting it could be a cost-effective way for secondary prevention and it is fairly inexpensive in most countries, but not the U.S.,” she said in an interview. “So there’s really a potential to increase public spending if more and more patients are then taking colchicine for prevention of cardiovascular events and the prices don’t change.”

The current pandemic could potentially further increase demand. Results initially slated for September are expected this month from the COLCORONA trial, which is testing whether the anti-inflammatory agent can prevent hospitalizations, lung complications, and death when given early in the course of COVID-19.

University of Oxford (England) researchers also announced last week that colchicine is being added to the massive RECOVERY trial, which is studying treatments for hospitalized COVID-19 patients.

Notably, the Canadian-based COLCOT trial did not use Colcrys, but rather a colchicine product that costs just $0.26 a pill in Canada, roughly the price of most generics available worldwide.

Authorized generics typically drive down drug prices when competing with independent generics, but this competition is missing in the United States, where Colcrys holds patents until 2029, Dr. McCormick and colleagues noted. More than a half-dozen independent generics have FDA approval to date, but only authorized generics with price points set by the brand-name companies are available to treat acute gout, pericarditis, and potentially millions with MI.

“One of the key takeaways is this difference between the brand names and the authorized generics and the independents,” she said. “The authorized [generics] have really not saved money. The list prices were just slightly lower and patients can also have more difficulty in getting those covered.”

For this analysis, the investigators used Medicaid and Medicare data to examine prices for all available forms of colchicine from 2008 to 2017, including unregulated/unapproved colchicine (2008-2010), generic combination probenecid-colchicine (2008-2017), Colcrys (2009-2017), brand-name single-ingredient colchicine Mitigare (approved in late 2014 but not marketed until 2015), and their authorized generics (2015-2017). Medicare trends from 2012 to 2017 were analyzed separately because pre-Colcrys Medicare data were not available.

Based on the results, combined spending on Medicare and Medicaid claims for single-ingredient colchicine exceeded $340 million in 2017.

Inflation- and rebate-adjusted Medicaid unit prices rose from $0.24 a pill in 2008, when unapproved formulations were still available, to $4.20 a pill in 2011 (Colcrys only), and peaked at $4.66 a pill in 2015 (Colcrys plus authorized generics).

Prescribing of lower-priced probenecid-colchicine ($0.66/pill in 2017) remained stable throughout. Medicaid rebate-adjusted prices in 2017 were $3.99/pill for all single-ingredient colchicine products, $5.13/pill for Colcrys, $4.49/pill for Mitigare, and $3.88/pill for authorized generics.

Medicare rebate-adjusted 2017 per-pill prices were $5.81 for all single-ingredient colchicine products, $6.78 for Colcrys, $5.68 for Mitigare, $5.16 for authorized generics, and $0.70 for probenecid-colchicine.

“Authorized generics have still driven high spending,” Dr. McCormick said. “We really need to encourage more competition in order to improve access.”

In an accompanying commentary, B. Joseph Guglielmo, PharmD, University of California, San Francisco, pointed out that the estimated median research and development cost to bring a drug to market is between $985 million and $1,335 million, which inevitably translates into a high selling price for the drug. Such investment and its resultant cost, however, should be associated with potential worth to society.

“Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system,” he wrote. “The current study findings illustrate that we can never allow such an egregious case to take place again.”

Dr. McCormick reported grants from Canadian Institutes of Health Research during the conduct of the study. Dr. Guglielmo reported having no relevant conflicts of interest.

This article first appeared on Medscape.com.

Public spending on colchicine has grown exponentially over the past decade despite generics suggesting an uphill slog for patients seeking access to long-term therapy for gout or cardiac conditions.

Medicaid spending on single-ingredient colchicine jumped 2,833%, from $1.1 million in 2008 to $32.2 million in 2017, new findings show. Medicaid expansion likely played a role in the increase, but 58% was due to price hikes alone.

The centuries-old drug sold for pennies in the United States before increasing 50-fold to about $5 per pill in 2009 after the first FDA-approved colchicine product, Colcrys, was granted 3 years’ market exclusivity for the treatment of acute gout based on a 1-week trial.

If prices had remained at pre-Colcrys levels, Medicaid spending in 2017 would have totaled just $2.1 million rather than $32.2 million according to the analysis, published online Nov. 30 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2020.5017).

The study was motivated by difficulties gout patients have in accessing colchicine, but also last year’s COLCOT trial, which reported fewer ischemic cardiovascular events in patients receiving colchicine after MI, observed Natalie McCormick, PhD, of Massachusetts General Hospital and Harvard Medical School, both in Boston.

“They were suggesting it could be a cost-effective way for secondary prevention and it is fairly inexpensive in most countries, but not the U.S.,” she said in an interview. “So there’s really a potential to increase public spending if more and more patients are then taking colchicine for prevention of cardiovascular events and the prices don’t change.”

The current pandemic could potentially further increase demand. Results initially slated for September are expected this month from the COLCORONA trial, which is testing whether the anti-inflammatory agent can prevent hospitalizations, lung complications, and death when given early in the course of COVID-19.

University of Oxford (England) researchers also announced last week that colchicine is being added to the massive RECOVERY trial, which is studying treatments for hospitalized COVID-19 patients.

Notably, the Canadian-based COLCOT trial did not use Colcrys, but rather a colchicine product that costs just $0.26 a pill in Canada, roughly the price of most generics available worldwide.

Authorized generics typically drive down drug prices when competing with independent generics, but this competition is missing in the United States, where Colcrys holds patents until 2029, Dr. McCormick and colleagues noted. More than a half-dozen independent generics have FDA approval to date, but only authorized generics with price points set by the brand-name companies are available to treat acute gout, pericarditis, and potentially millions with MI.

“One of the key takeaways is this difference between the brand names and the authorized generics and the independents,” she said. “The authorized [generics] have really not saved money. The list prices were just slightly lower and patients can also have more difficulty in getting those covered.”

For this analysis, the investigators used Medicaid and Medicare data to examine prices for all available forms of colchicine from 2008 to 2017, including unregulated/unapproved colchicine (2008-2010), generic combination probenecid-colchicine (2008-2017), Colcrys (2009-2017), brand-name single-ingredient colchicine Mitigare (approved in late 2014 but not marketed until 2015), and their authorized generics (2015-2017). Medicare trends from 2012 to 2017 were analyzed separately because pre-Colcrys Medicare data were not available.

Based on the results, combined spending on Medicare and Medicaid claims for single-ingredient colchicine exceeded $340 million in 2017.

Inflation- and rebate-adjusted Medicaid unit prices rose from $0.24 a pill in 2008, when unapproved formulations were still available, to $4.20 a pill in 2011 (Colcrys only), and peaked at $4.66 a pill in 2015 (Colcrys plus authorized generics).

Prescribing of lower-priced probenecid-colchicine ($0.66/pill in 2017) remained stable throughout. Medicaid rebate-adjusted prices in 2017 were $3.99/pill for all single-ingredient colchicine products, $5.13/pill for Colcrys, $4.49/pill for Mitigare, and $3.88/pill for authorized generics.

Medicare rebate-adjusted 2017 per-pill prices were $5.81 for all single-ingredient colchicine products, $6.78 for Colcrys, $5.68 for Mitigare, $5.16 for authorized generics, and $0.70 for probenecid-colchicine.

“Authorized generics have still driven high spending,” Dr. McCormick said. “We really need to encourage more competition in order to improve access.”

In an accompanying commentary, B. Joseph Guglielmo, PharmD, University of California, San Francisco, pointed out that the estimated median research and development cost to bring a drug to market is between $985 million and $1,335 million, which inevitably translates into a high selling price for the drug. Such investment and its resultant cost, however, should be associated with potential worth to society.

“Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system,” he wrote. “The current study findings illustrate that we can never allow such an egregious case to take place again.”

Dr. McCormick reported grants from Canadian Institutes of Health Research during the conduct of the study. Dr. Guglielmo reported having no relevant conflicts of interest.

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.

The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.

In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.

The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.

Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.

Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.

Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.

The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.

However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”

Optimal dosing questions remain

Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.

The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.

“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”

The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.

SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.

Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.

The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.

In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.

The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.

Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.

Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.

Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.

The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.

However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”

Optimal dosing questions remain

Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.

The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.

“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”

The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.

SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.

Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.

The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.

In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.

The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.

Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.

Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.

Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.

The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.

However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”

Optimal dosing questions remain

Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.

The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.

“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”

The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.

SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.

A novel lower-cost noninvasive continuous glucose monitor (CGM) combined with a digital education/guidance program is set to launch in the United States and Europe this month for use in type 2 diabetes.

With the goal of improving management, or even reversing the condition, Neumara’s SugarBEAT device is thought to be the world’s first noninvasive CGM.

Its cost is anticipated to be far lower than traditional CGM, and it’s aimed at a different patient population: those with type 2 diabetes or prediabetes who may or may not be performing fingerstick glucose monitoring, but if they are, they still aren’t using the information to guide management.

“This isn’t about handing out devices and letting patients get on about it on their own accord. This is really about supporting those individuals,” Faz Chowdhury, MD, Nemaura’s chief executive officer, said in an interview.

He pointed to studies showing improvements in glycemic control in patients with type 2 diabetes who were instructed to perform fingerstick blood glucose testing seven times a day for 3-4 days a month and given advice about how to respond to the data.

“This is well established. We’re saying we can make that process a lot more scalable and affordable and convenient for the patient. ... The behavior change side is digitized,” Dr. Chowdhury said. “We want to provide a program to help people reverse their diabetes or at least stabilize it as much as possible.”

Nicholas Argento, MD, diabetes technology director at Maryland Endocrine and Diabetes, Columbia, said in an interview: “It’s interesting. They’re taking a very different approach. I think there’s a lot of validity to what they’re looking at because we have great CGMs right now, but because of the price point it’s not accessible to a lot of people.

“I think they’re onto something that could prove to be useful to a larger group of patients,” he added.
 

Worn a few days per month and accurate despite being noninvasive

Instead of inserting a catheter under the skin with a needle, as do current CGMs, the device comprises a small rechargeable transmitter and adhesive patch with a sensor that sits on the top of the skin, typically the upper arm. Glucose molecules are drawn out of the interstitial fluid just below the skin and into a chamber where the transmitter measures the glucose level and transmits the data every 5 minutes via Bluetooth to a smartphone app.

Despite this noninvasive approach, the device appears to be about as accurate as traditional CGMs, with comparable mean absolute relative difference (MARD) from a gold standard glucose measure of about 11%-12% with once-daily calibration versus 10%-11% for the Abbott FreeStyle Libre.

Unlike traditional CGMs, SugarBEAT is meant to be worn for only 14 hours at a time during the day and for 2-4 days per month rather than every day.

It’s not aimed at patients with type 1 diabetes or those with type 2 diabetes who are at high risk for hypoglycemia. It requires once-daily fingerstick calibration and is not indicated to replace fingersticks for treatment decisions.

SugarBEAT received a CE Mark in Europe as a Class IIb medical device in May 2019. That version provides real-time glucose values visible to the wearer. In the United States the company submitted a premarketing approval application for the device to the Food and Drug Administration in July 2020, which awaits a decision.

However, FDA is allowing it to enter the U.S. market as a “wellness” device that won’t deliver real-time values for now but instead will generate retroactive reports available to the physician and the patient.   

And last month, U.K.-based Neumara launched the BEATdiabetes site, which allows users to sign in and link to the device once it becomes available.

The site provides “scientifically validated, personalized coaching” based on a program developed at the Joslin Diabetes Clinic in Syracuse, N.Y., and will ultimately include monitoring of other cardiovascular risk factors with digital connectivity to a variety of wearables.
 

Fingerstick monitoring in type 2 diabetes is only so useful

“Fingerstick monitoring for type 2 diabetes is only so useful,” Dr. Argento said in an interview.

“It’s difficult to get people to monitor in a meaningful way.” If patients perform them only in the morning or at other sporadic times of the day, he said, “Then you get a one-dimensional picture ... and they don’t know what to do with the information anyway, so they stop doing it.”

In contrast, with SugarBEAT and BEATDiabetes, “I think it does address a need that fingerstick monitoring doesn’t.”

Dr. Argento did express a few caveats about the device, however. For one, it still requires one fingerstick a day for calibration. “If people don’t like needles, that might be a disincentive.”

Also, despite the apparently comparable mean absolute relative difference with that of conventional CGMs, that measure can still “hide” values that may be consistently either above or below target range.

“MARD is like A1c in that it’s useful but limited. ... It doesn’t tell you about variability or systemic bias,” he said.

Dr. Argento also said that he’d like to see data on the lag time between the interstitial fluid and blood glucose measures with this noninvasive method as compared with that of a subcutaneous catheter.

However, he acknowledged that these potentials for error would be less important for patients with type 2 diabetes who aren’t generally taking medications that increase their risk for hypoglycemia.

In all, he said, “stay tuned. I think this is part of a movement going away from point-in-time to looking at trends and wearables and data to enrich decision-making…There are still some unanswered questions I have but I think they’re onto a concept that’s useful for a broader population.”  

Dr. Chowdhury is an employee of Neumara. Dr. Argento consults for Senseonics and Dexcom, and is also a speaker for Dexcom.

This article first appeared on Medscape.com.

A novel lower-cost noninvasive continuous glucose monitor (CGM) combined with a digital education/guidance program is set to launch in the United States and Europe this month for use in type 2 diabetes.

With the goal of improving management, or even reversing the condition, Neumara’s SugarBEAT device is thought to be the world’s first noninvasive CGM.

Its cost is anticipated to be far lower than traditional CGM, and it’s aimed at a different patient population: those with type 2 diabetes or prediabetes who may or may not be performing fingerstick glucose monitoring, but if they are, they still aren’t using the information to guide management.

“This isn’t about handing out devices and letting patients get on about it on their own accord. This is really about supporting those individuals,” Faz Chowdhury, MD, Nemaura’s chief executive officer, said in an interview.

He pointed to studies showing improvements in glycemic control in patients with type 2 diabetes who were instructed to perform fingerstick blood glucose testing seven times a day for 3-4 days a month and given advice about how to respond to the data.

“This is well established. We’re saying we can make that process a lot more scalable and affordable and convenient for the patient. ... The behavior change side is digitized,” Dr. Chowdhury said. “We want to provide a program to help people reverse their diabetes or at least stabilize it as much as possible.”

Nicholas Argento, MD, diabetes technology director at Maryland Endocrine and Diabetes, Columbia, said in an interview: “It’s interesting. They’re taking a very different approach. I think there’s a lot of validity to what they’re looking at because we have great CGMs right now, but because of the price point it’s not accessible to a lot of people.

“I think they’re onto something that could prove to be useful to a larger group of patients,” he added.
 

Worn a few days per month and accurate despite being noninvasive

Instead of inserting a catheter under the skin with a needle, as do current CGMs, the device comprises a small rechargeable transmitter and adhesive patch with a sensor that sits on the top of the skin, typically the upper arm. Glucose molecules are drawn out of the interstitial fluid just below the skin and into a chamber where the transmitter measures the glucose level and transmits the data every 5 minutes via Bluetooth to a smartphone app.

Despite this noninvasive approach, the device appears to be about as accurate as traditional CGMs, with comparable mean absolute relative difference (MARD) from a gold standard glucose measure of about 11%-12% with once-daily calibration versus 10%-11% for the Abbott FreeStyle Libre.

Unlike traditional CGMs, SugarBEAT is meant to be worn for only 14 hours at a time during the day and for 2-4 days per month rather than every day.

It’s not aimed at patients with type 1 diabetes or those with type 2 diabetes who are at high risk for hypoglycemia. It requires once-daily fingerstick calibration and is not indicated to replace fingersticks for treatment decisions.

SugarBEAT received a CE Mark in Europe as a Class IIb medical device in May 2019. That version provides real-time glucose values visible to the wearer. In the United States the company submitted a premarketing approval application for the device to the Food and Drug Administration in July 2020, which awaits a decision.

However, FDA is allowing it to enter the U.S. market as a “wellness” device that won’t deliver real-time values for now but instead will generate retroactive reports available to the physician and the patient.   

And last month, U.K.-based Neumara launched the BEATdiabetes site, which allows users to sign in and link to the device once it becomes available.

The site provides “scientifically validated, personalized coaching” based on a program developed at the Joslin Diabetes Clinic in Syracuse, N.Y., and will ultimately include monitoring of other cardiovascular risk factors with digital connectivity to a variety of wearables.
 

Fingerstick monitoring in type 2 diabetes is only so useful

“Fingerstick monitoring for type 2 diabetes is only so useful,” Dr. Argento said in an interview.

“It’s difficult to get people to monitor in a meaningful way.” If patients perform them only in the morning or at other sporadic times of the day, he said, “Then you get a one-dimensional picture ... and they don’t know what to do with the information anyway, so they stop doing it.”

In contrast, with SugarBEAT and BEATDiabetes, “I think it does address a need that fingerstick monitoring doesn’t.”

Dr. Argento did express a few caveats about the device, however. For one, it still requires one fingerstick a day for calibration. “If people don’t like needles, that might be a disincentive.”

Also, despite the apparently comparable mean absolute relative difference with that of conventional CGMs, that measure can still “hide” values that may be consistently either above or below target range.

“MARD is like A1c in that it’s useful but limited. ... It doesn’t tell you about variability or systemic bias,” he said.

Dr. Argento also said that he’d like to see data on the lag time between the interstitial fluid and blood glucose measures with this noninvasive method as compared with that of a subcutaneous catheter.

However, he acknowledged that these potentials for error would be less important for patients with type 2 diabetes who aren’t generally taking medications that increase their risk for hypoglycemia.

In all, he said, “stay tuned. I think this is part of a movement going away from point-in-time to looking at trends and wearables and data to enrich decision-making…There are still some unanswered questions I have but I think they’re onto a concept that’s useful for a broader population.”  

Dr. Chowdhury is an employee of Neumara. Dr. Argento consults for Senseonics and Dexcom, and is also a speaker for Dexcom.

This article first appeared on Medscape.com.

A novel lower-cost noninvasive continuous glucose monitor (CGM) combined with a digital education/guidance program is set to launch in the United States and Europe this month for use in type 2 diabetes.

With the goal of improving management, or even reversing the condition, Neumara’s SugarBEAT device is thought to be the world’s first noninvasive CGM.

Its cost is anticipated to be far lower than traditional CGM, and it’s aimed at a different patient population: those with type 2 diabetes or prediabetes who may or may not be performing fingerstick glucose monitoring, but if they are, they still aren’t using the information to guide management.

“This isn’t about handing out devices and letting patients get on about it on their own accord. This is really about supporting those individuals,” Faz Chowdhury, MD, Nemaura’s chief executive officer, said in an interview.

He pointed to studies showing improvements in glycemic control in patients with type 2 diabetes who were instructed to perform fingerstick blood glucose testing seven times a day for 3-4 days a month and given advice about how to respond to the data.

“This is well established. We’re saying we can make that process a lot more scalable and affordable and convenient for the patient. ... The behavior change side is digitized,” Dr. Chowdhury said. “We want to provide a program to help people reverse their diabetes or at least stabilize it as much as possible.”

Nicholas Argento, MD, diabetes technology director at Maryland Endocrine and Diabetes, Columbia, said in an interview: “It’s interesting. They’re taking a very different approach. I think there’s a lot of validity to what they’re looking at because we have great CGMs right now, but because of the price point it’s not accessible to a lot of people.

“I think they’re onto something that could prove to be useful to a larger group of patients,” he added.
 

Worn a few days per month and accurate despite being noninvasive

Instead of inserting a catheter under the skin with a needle, as do current CGMs, the device comprises a small rechargeable transmitter and adhesive patch with a sensor that sits on the top of the skin, typically the upper arm. Glucose molecules are drawn out of the interstitial fluid just below the skin and into a chamber where the transmitter measures the glucose level and transmits the data every 5 minutes via Bluetooth to a smartphone app.

Despite this noninvasive approach, the device appears to be about as accurate as traditional CGMs, with comparable mean absolute relative difference (MARD) from a gold standard glucose measure of about 11%-12% with once-daily calibration versus 10%-11% for the Abbott FreeStyle Libre.

Unlike traditional CGMs, SugarBEAT is meant to be worn for only 14 hours at a time during the day and for 2-4 days per month rather than every day.

It’s not aimed at patients with type 1 diabetes or those with type 2 diabetes who are at high risk for hypoglycemia. It requires once-daily fingerstick calibration and is not indicated to replace fingersticks for treatment decisions.

SugarBEAT received a CE Mark in Europe as a Class IIb medical device in May 2019. That version provides real-time glucose values visible to the wearer. In the United States the company submitted a premarketing approval application for the device to the Food and Drug Administration in July 2020, which awaits a decision.

However, FDA is allowing it to enter the U.S. market as a “wellness” device that won’t deliver real-time values for now but instead will generate retroactive reports available to the physician and the patient.   

And last month, U.K.-based Neumara launched the BEATdiabetes site, which allows users to sign in and link to the device once it becomes available.

The site provides “scientifically validated, personalized coaching” based on a program developed at the Joslin Diabetes Clinic in Syracuse, N.Y., and will ultimately include monitoring of other cardiovascular risk factors with digital connectivity to a variety of wearables.
 

Fingerstick monitoring in type 2 diabetes is only so useful

“Fingerstick monitoring for type 2 diabetes is only so useful,” Dr. Argento said in an interview.

“It’s difficult to get people to monitor in a meaningful way.” If patients perform them only in the morning or at other sporadic times of the day, he said, “Then you get a one-dimensional picture ... and they don’t know what to do with the information anyway, so they stop doing it.”

In contrast, with SugarBEAT and BEATDiabetes, “I think it does address a need that fingerstick monitoring doesn’t.”

Dr. Argento did express a few caveats about the device, however. For one, it still requires one fingerstick a day for calibration. “If people don’t like needles, that might be a disincentive.”

Also, despite the apparently comparable mean absolute relative difference with that of conventional CGMs, that measure can still “hide” values that may be consistently either above or below target range.

“MARD is like A1c in that it’s useful but limited. ... It doesn’t tell you about variability or systemic bias,” he said.

Dr. Argento also said that he’d like to see data on the lag time between the interstitial fluid and blood glucose measures with this noninvasive method as compared with that of a subcutaneous catheter.

However, he acknowledged that these potentials for error would be less important for patients with type 2 diabetes who aren’t generally taking medications that increase their risk for hypoglycemia.

In all, he said, “stay tuned. I think this is part of a movement going away from point-in-time to looking at trends and wearables and data to enrich decision-making…There are still some unanswered questions I have but I think they’re onto a concept that’s useful for a broader population.”  

Dr. Chowdhury is an employee of Neumara. Dr. Argento consults for Senseonics and Dexcom, and is also a speaker for Dexcom.

This article first appeared on Medscape.com.

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Low-dose chest CT for lung cancer screening provides the opportunity to simultaneously screen patients for osteoporosis, detecting notably higher rates of osteoporosis in men than the traditional tool of DXA, research published in the Journal of Bone and Mineral Research shows.

“Our large-scale, multicenter study of bone density measured from routine low-dose CT scans demonstrated the great potential of using low-dose CT for the opportunistic screening of osteoporosis as an alternative to standard DXA scans,” said senior author Wei Tian, MD, of the Chinese Academy of Engineering and Peking University, in a press statement from the journal.

“Our study revealed the unexpectedly high prevalence of osteoporosis in men, which may impact on the management strategy of men in the future,” Dr. Tian added.

Josephine Therkildsen, MD, of Herning Hospital, Denmark, who has conducted similar research using cardiac CT scans, said the findings add important new insights into the issue of opportunistic screening.

“The results are highly interesting, as they show that low-dose CT-based opportunistic screening could identify a substantial number of patients with low lumbar bone mineral density (BMD) with the future potential to diagnose osteoporosis and initiate relevant treatment before a fracture occurs,” she told this news organization.

Perry J. Pickhardt, MD, chief of gastrointestinal imaging at the University of Wisconsin School of Medicine and Public Health in Madison, agrees. He said in an interview that CT scans of the chest and abdomen, commonly performed for a variety of clinical indications and widespread in most developed countries, can in fact be essential for the detection of a multitude of other concerns – yet are underused for those other purposes.

Use of CT in this way “would likely be very cost effective and clinically efficacious,” he said, adding: “We are seeing greatly increased interest in leveraging this extra information that is contained within every CT scan.” And, “Importantly, artificial intelligence advances now allow for automated approaches, which should allow for expanded use.”
 

Lung cancer CT scans shed light on osteoporosis prevalence

In the study, led by Xiaoguang Cheng, MD, PhD, of the department of radiology, Beijing Jishuitan Hospital, China, researchers examined lung cancer CT screening data from the prospective China Biobank Project to determine the prevalence of osteoporosis in China.

This included the thoracic low-dose CT scans of 69,095 adults, including 40,733 men and 28,362 women, taken between 2018 and 2019.

To screen for osteoporosis, they used quantitative CT software to evaluate lumbar spine (L1-L2) trabecular volume BMD (vBMD) and diagnostic criteria from the American College of Radiology. Using the vBMD measures from the CT imaging, they found the prevalence of osteoporosis among those over 50 years of age in the Chinese population to be 29% for women (49 million) and 13.5% for men (22.8 million).

Interestingly, the osteoporosis prevalence rate among women was comparable to estimates in the population derived from DXA (29.1%); however, the rate in men was twice that estimated from DXA scans (6.5%).

Decreases in trabecular vBMD with age were observed in both genders. However, declines were steeper among women, who had higher peak trabecular vBMD (185.4 mg/cm³), compared with men (176.6 mg/cm³) at age 30-34 years, but significantly lower measures (62.4 mg/cm³) than men (92.1 mg/cm³) at age 80 years.

The prevalence of osteoporosis in women increased from 2.8% at age 50-54 years to 79.8% at age 85 or older, while in men, the prevalence was 3.2% at age 50-54 years and 44.1% at age 85 or older.

“This is the first study to establish Chinese reference data for vBMD using opportunistic screening from low-dose chest CT in a large population cohort,” the authors write.

“The opportunistic screening of osteoporosis using low-dose CT is clinically feasible and requires no additional exposure to ionizing radiation.”

In addition, no additional equipment or patient time was required, suggesting that “this approach has potential for opportunistic screening for osteoporosis.”

They note, however, that further cohort studies are needed to assess clinical utility of this method.
 

CT ‘likely a more accurate measure’ of volumetric BMD

Dr. Pickhardt said the differences in osteoporosis prevalence observed between DXA and CT-derived measures in men likely reflect the greater accuracy of CT.

“DXA is a planar technique with a number of drawbacks,” he said in an interview. “CT provides a more direct volumetric measure and is likely a more accurate method for BMD assessment.”

He speculated that the greater differences between DXA versus CT seen in men than women “may relate to sex differences in cortical bone of vertebral bodies, which cannot be separated from the underlying trabecular bone with DXA (whereas CT directly measures the inner trabecular bone).” 

The authors note that, although areal BMD (aBMD) derived from DXA is required for osteoporosis diagnosis according to World Health Organization criteria, “trabecular vBMD derived from CT can be also used for diagnosis based on thresholds published by the American College of Radiology of 120 mg/cm³ and 80 mg/cm³ to define osteopenia and osteoporosis, respectively, thresholds that were subsequently confirmed for the Chinese population.”

Furthermore, vBMD has been shown in some studies to be more strongly related to fracture risk, compared with DXA aBMD measures.

Importantly, in another recent study involving 9,223 adults, Dr. Pickhardt and colleagues reported that bone and muscle biomarkers derived from CT were comparable to the Fracture Risk Assessment Tool score for the presymptomatic prediction of future osteoporotic fractures.

Dr. Pickhardt is an advisor to Bracco Imaging and Zebra Medical Vision. Dr. Therkildsen has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Low-dose chest CT for lung cancer screening provides the opportunity to simultaneously screen patients for osteoporosis, detecting notably higher rates of osteoporosis in men than the traditional tool of DXA, research published in the Journal of Bone and Mineral Research shows.

“Our large-scale, multicenter study of bone density measured from routine low-dose CT scans demonstrated the great potential of using low-dose CT for the opportunistic screening of osteoporosis as an alternative to standard DXA scans,” said senior author Wei Tian, MD, of the Chinese Academy of Engineering and Peking University, in a press statement from the journal.

“Our study revealed the unexpectedly high prevalence of osteoporosis in men, which may impact on the management strategy of men in the future,” Dr. Tian added.

Josephine Therkildsen, MD, of Herning Hospital, Denmark, who has conducted similar research using cardiac CT scans, said the findings add important new insights into the issue of opportunistic screening.

“The results are highly interesting, as they show that low-dose CT-based opportunistic screening could identify a substantial number of patients with low lumbar bone mineral density (BMD) with the future potential to diagnose osteoporosis and initiate relevant treatment before a fracture occurs,” she told this news organization.

Perry J. Pickhardt, MD, chief of gastrointestinal imaging at the University of Wisconsin School of Medicine and Public Health in Madison, agrees. He said in an interview that CT scans of the chest and abdomen, commonly performed for a variety of clinical indications and widespread in most developed countries, can in fact be essential for the detection of a multitude of other concerns – yet are underused for those other purposes.

Use of CT in this way “would likely be very cost effective and clinically efficacious,” he said, adding: “We are seeing greatly increased interest in leveraging this extra information that is contained within every CT scan.” And, “Importantly, artificial intelligence advances now allow for automated approaches, which should allow for expanded use.”
 

Lung cancer CT scans shed light on osteoporosis prevalence

In the study, led by Xiaoguang Cheng, MD, PhD, of the department of radiology, Beijing Jishuitan Hospital, China, researchers examined lung cancer CT screening data from the prospective China Biobank Project to determine the prevalence of osteoporosis in China.

This included the thoracic low-dose CT scans of 69,095 adults, including 40,733 men and 28,362 women, taken between 2018 and 2019.

To screen for osteoporosis, they used quantitative CT software to evaluate lumbar spine (L1-L2) trabecular volume BMD (vBMD) and diagnostic criteria from the American College of Radiology. Using the vBMD measures from the CT imaging, they found the prevalence of osteoporosis among those over 50 years of age in the Chinese population to be 29% for women (49 million) and 13.5% for men (22.8 million).

Interestingly, the osteoporosis prevalence rate among women was comparable to estimates in the population derived from DXA (29.1%); however, the rate in men was twice that estimated from DXA scans (6.5%).

Decreases in trabecular vBMD with age were observed in both genders. However, declines were steeper among women, who had higher peak trabecular vBMD (185.4 mg/cm³), compared with men (176.6 mg/cm³) at age 30-34 years, but significantly lower measures (62.4 mg/cm³) than men (92.1 mg/cm³) at age 80 years.

The prevalence of osteoporosis in women increased from 2.8% at age 50-54 years to 79.8% at age 85 or older, while in men, the prevalence was 3.2% at age 50-54 years and 44.1% at age 85 or older.

“This is the first study to establish Chinese reference data for vBMD using opportunistic screening from low-dose chest CT in a large population cohort,” the authors write.

“The opportunistic screening of osteoporosis using low-dose CT is clinically feasible and requires no additional exposure to ionizing radiation.”

In addition, no additional equipment or patient time was required, suggesting that “this approach has potential for opportunistic screening for osteoporosis.”

They note, however, that further cohort studies are needed to assess clinical utility of this method.
 

CT ‘likely a more accurate measure’ of volumetric BMD

Dr. Pickhardt said the differences in osteoporosis prevalence observed between DXA and CT-derived measures in men likely reflect the greater accuracy of CT.

“DXA is a planar technique with a number of drawbacks,” he said in an interview. “CT provides a more direct volumetric measure and is likely a more accurate method for BMD assessment.”

He speculated that the greater differences between DXA versus CT seen in men than women “may relate to sex differences in cortical bone of vertebral bodies, which cannot be separated from the underlying trabecular bone with DXA (whereas CT directly measures the inner trabecular bone).” 

The authors note that, although areal BMD (aBMD) derived from DXA is required for osteoporosis diagnosis according to World Health Organization criteria, “trabecular vBMD derived from CT can be also used for diagnosis based on thresholds published by the American College of Radiology of 120 mg/cm³ and 80 mg/cm³ to define osteopenia and osteoporosis, respectively, thresholds that were subsequently confirmed for the Chinese population.”

Furthermore, vBMD has been shown in some studies to be more strongly related to fracture risk, compared with DXA aBMD measures.

Importantly, in another recent study involving 9,223 adults, Dr. Pickhardt and colleagues reported that bone and muscle biomarkers derived from CT were comparable to the Fracture Risk Assessment Tool score for the presymptomatic prediction of future osteoporotic fractures.

Dr. Pickhardt is an advisor to Bracco Imaging and Zebra Medical Vision. Dr. Therkildsen has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Low-dose chest CT for lung cancer screening provides the opportunity to simultaneously screen patients for osteoporosis, detecting notably higher rates of osteoporosis in men than the traditional tool of DXA, research published in the Journal of Bone and Mineral Research shows.

“Our large-scale, multicenter study of bone density measured from routine low-dose CT scans demonstrated the great potential of using low-dose CT for the opportunistic screening of osteoporosis as an alternative to standard DXA scans,” said senior author Wei Tian, MD, of the Chinese Academy of Engineering and Peking University, in a press statement from the journal.

“Our study revealed the unexpectedly high prevalence of osteoporosis in men, which may impact on the management strategy of men in the future,” Dr. Tian added.

Josephine Therkildsen, MD, of Herning Hospital, Denmark, who has conducted similar research using cardiac CT scans, said the findings add important new insights into the issue of opportunistic screening.

“The results are highly interesting, as they show that low-dose CT-based opportunistic screening could identify a substantial number of patients with low lumbar bone mineral density (BMD) with the future potential to diagnose osteoporosis and initiate relevant treatment before a fracture occurs,” she told this news organization.

Perry J. Pickhardt, MD, chief of gastrointestinal imaging at the University of Wisconsin School of Medicine and Public Health in Madison, agrees. He said in an interview that CT scans of the chest and abdomen, commonly performed for a variety of clinical indications and widespread in most developed countries, can in fact be essential for the detection of a multitude of other concerns – yet are underused for those other purposes.

Use of CT in this way “would likely be very cost effective and clinically efficacious,” he said, adding: “We are seeing greatly increased interest in leveraging this extra information that is contained within every CT scan.” And, “Importantly, artificial intelligence advances now allow for automated approaches, which should allow for expanded use.”
 

Lung cancer CT scans shed light on osteoporosis prevalence

In the study, led by Xiaoguang Cheng, MD, PhD, of the department of radiology, Beijing Jishuitan Hospital, China, researchers examined lung cancer CT screening data from the prospective China Biobank Project to determine the prevalence of osteoporosis in China.

This included the thoracic low-dose CT scans of 69,095 adults, including 40,733 men and 28,362 women, taken between 2018 and 2019.

To screen for osteoporosis, they used quantitative CT software to evaluate lumbar spine (L1-L2) trabecular volume BMD (vBMD) and diagnostic criteria from the American College of Radiology. Using the vBMD measures from the CT imaging, they found the prevalence of osteoporosis among those over 50 years of age in the Chinese population to be 29% for women (49 million) and 13.5% for men (22.8 million).

Interestingly, the osteoporosis prevalence rate among women was comparable to estimates in the population derived from DXA (29.1%); however, the rate in men was twice that estimated from DXA scans (6.5%).

Decreases in trabecular vBMD with age were observed in both genders. However, declines were steeper among women, who had higher peak trabecular vBMD (185.4 mg/cm³), compared with men (176.6 mg/cm³) at age 30-34 years, but significantly lower measures (62.4 mg/cm³) than men (92.1 mg/cm³) at age 80 years.

The prevalence of osteoporosis in women increased from 2.8% at age 50-54 years to 79.8% at age 85 or older, while in men, the prevalence was 3.2% at age 50-54 years and 44.1% at age 85 or older.

“This is the first study to establish Chinese reference data for vBMD using opportunistic screening from low-dose chest CT in a large population cohort,” the authors write.

“The opportunistic screening of osteoporosis using low-dose CT is clinically feasible and requires no additional exposure to ionizing radiation.”

In addition, no additional equipment or patient time was required, suggesting that “this approach has potential for opportunistic screening for osteoporosis.”

They note, however, that further cohort studies are needed to assess clinical utility of this method.
 

CT ‘likely a more accurate measure’ of volumetric BMD

Dr. Pickhardt said the differences in osteoporosis prevalence observed between DXA and CT-derived measures in men likely reflect the greater accuracy of CT.

“DXA is a planar technique with a number of drawbacks,” he said in an interview. “CT provides a more direct volumetric measure and is likely a more accurate method for BMD assessment.”

He speculated that the greater differences between DXA versus CT seen in men than women “may relate to sex differences in cortical bone of vertebral bodies, which cannot be separated from the underlying trabecular bone with DXA (whereas CT directly measures the inner trabecular bone).” 

The authors note that, although areal BMD (aBMD) derived from DXA is required for osteoporosis diagnosis according to World Health Organization criteria, “trabecular vBMD derived from CT can be also used for diagnosis based on thresholds published by the American College of Radiology of 120 mg/cm³ and 80 mg/cm³ to define osteopenia and osteoporosis, respectively, thresholds that were subsequently confirmed for the Chinese population.”

Furthermore, vBMD has been shown in some studies to be more strongly related to fracture risk, compared with DXA aBMD measures.

Importantly, in another recent study involving 9,223 adults, Dr. Pickhardt and colleagues reported that bone and muscle biomarkers derived from CT were comparable to the Fracture Risk Assessment Tool score for the presymptomatic prediction of future osteoporotic fractures.

Dr. Pickhardt is an advisor to Bracco Imaging and Zebra Medical Vision. Dr. Therkildsen has reported no relevant financial relationships.

This article first appeared on Medscape.com.

A radioactive diagnostic agent has been approved by the U.S. Food and Drug Administration for use in patients with prostate cancer, but only for those treated at two institutions in California.

The product, Gallium 68 PSMA-11 (Ga 68 PSMA-11), is the first agent approved specifically for use in positron-emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer, the FDA noted.

This imaging approach can “detect whether or not the cancer has spread to other parts of the body,” commented Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research.

Ga 68 PSMA-11 is indicated for use in patients with suspected prostate cancer metastasis whose conditions are potentially curable by surgery or radiotherapy and in patients with suspected prostate cancer recurrence, as determined on the basis of elevated serum prostate-specific antigen (PSA) levels.
 

Institutional use only

Ga 68 PSMA-11 has been approved for institutional use at the University of California, Los Angeles and the University of California, San Francisco under an academic new drug application (NDA).

The FDA approval was based partly on a clinical trial conducted by the UCSF and UCLA research teams on the effectiveness of PSMA-PET.

“It is rare for academic institutions to obtain FDA approval of a drug, and this unique collaboration has led to what is one of the first coapprovals of a drug at two institutions,” said Thomas Hope, MD, an associate professor at UCSF. “We hope that this first step will lead to a more widespread availability of this imaging test to men with prostate cancer throughout the country.”

Ga 68 PSMA-11 was developed outside the United States at the University of Heidelberg (Germany).

A commercial NDA from Telix Pharmaceuticals for TL591-CDx, a radiopharmaceutical cold kit for the preparation of Ga 68 PSMA-11 injection, is under consideration by the FDA.

The agency noted that two other PET diagnostic agents – fluciclovine F18 and choline C11 – are approved for prostate cancer imaging. However, they are only approved for use in patients with suspected cancer recurrence.
 

Trial results with PSMA-PET/CT

“PSMA-PET/CT is a novel molecular and functional imaging modality specific for prostate cancer cells that has good sensitivity and outstanding specificity in detecting metastasis,” commented T. Martin Ma, MD, PhD, of UCLA.

Dr. Ma presented a U.S. study on the technique at the recent annual meeting of the American Society for Radiation Oncology. That study showed that PSMA-PET/CT led to nodal upstaging in 19.7% of patients and metastasis upstaging in 9.4%.

He said these results were similar to those from the Australian proPSMA trial, which was published in The Lancet earlier this year. That trial found PSMA-PET/CT to be superior to conventional imaging with CT and bone scanning for primary staging of high-risk prostate cancer.

“These findings carry significant clinical implications and can affect treatment decision-making,” Dr. Ma commented.

“PSMA-PET has been a real game changer in high-risk prostate cancer and has implications in the various stages of prostate cancer management from diagnosis and staging to theranostics,” said Renu Eapen, MBBS, of Peter MacCallum Cancer Center, Melbourne, who was not involved in either study.

“PSMA-PET/CT has challenged conventional imaging in staging before curative-intent surgery or radiotherapy,” Dr. Eapen added.

The accuracy of PSMA-PET/CT was 27% higher than that of conventional imaging in the proPSMA trial, she noted in an interview last month. This superior accuracy can ultimately affect management. The imaging has additional benefits of lower radiation dose as well as reproducibility with high reporter agreement, potentially making it a “one-stop-shop” scan.
 

Trial results with Ga 68 PSMA-11

The safety and efficacy of Ga 68 PSMA-11 were evaluated in two prospective clinical trials with a total of 960 men with prostate cancer, each of whom received one injection of the product.

The first trial involved 325 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans performed with Ga 68 PSMA-11.

“These patients were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis. Among the patients who proceeded to surgery, those with positive readings in the pelvic lymph nodes on Ga 68 PSMA-11 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology,” the FDA noted.

“The availability of this information prior to treatment is expected to have important implications for patient care,” the FDA commented. “For example, it may spare certain patients from undergoing unnecessary surgery.”

The second trial enrolled 635 patients with rising serum PSA levels after initial prostate surgery or radiotherapy. All patients received a single Ga 68 PSMA-11 PET/CT scan or PET/MRI scan.

About three-quarters of patients (74%) had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one region – bone, prostate bed, pelvic lymph node, or extra-pelvic soft tissue.

“In patients with positive Ga 68 PSMA-11 PET readings who had correlative tissue pathology from biopsies, results from baseline or follow-up imaging by conventional methods, and serial PSA levels available for comparison, local recurrence or metastasis of prostate cancer was confirmed in an estimated 91% of cases,” the FDA noted.

“Thus, the second trial demonstrated that Ga 68 PSMA-11 PET can detect sites of disease in patients with biochemical evidence of recurrent prostate cancer, thereby providing important information that may impact the approach to therapy,” the agency added.

The FDA also noted that no serious adverse reactions were attributed to Ga 68 PSMA-11. The most common adverse reactions were nausea, diarrhea, and dizziness.

The FDA said there is a risk for misdiagnosis because Ga 68 PSMA-11 binding may occur in other types of cancer, and certain nonmalignant processes may lead to errors in interpreting images. In addition, there are radiation risks because Ga 68 PSMA-11 contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer.

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

A radioactive diagnostic agent has been approved by the U.S. Food and Drug Administration for use in patients with prostate cancer, but only for those treated at two institutions in California.

The product, Gallium 68 PSMA-11 (Ga 68 PSMA-11), is the first agent approved specifically for use in positron-emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer, the FDA noted.

This imaging approach can “detect whether or not the cancer has spread to other parts of the body,” commented Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research.

Ga 68 PSMA-11 is indicated for use in patients with suspected prostate cancer metastasis whose conditions are potentially curable by surgery or radiotherapy and in patients with suspected prostate cancer recurrence, as determined on the basis of elevated serum prostate-specific antigen (PSA) levels.
 

Institutional use only

Ga 68 PSMA-11 has been approved for institutional use at the University of California, Los Angeles and the University of California, San Francisco under an academic new drug application (NDA).

The FDA approval was based partly on a clinical trial conducted by the UCSF and UCLA research teams on the effectiveness of PSMA-PET.

“It is rare for academic institutions to obtain FDA approval of a drug, and this unique collaboration has led to what is one of the first coapprovals of a drug at two institutions,” said Thomas Hope, MD, an associate professor at UCSF. “We hope that this first step will lead to a more widespread availability of this imaging test to men with prostate cancer throughout the country.”

Ga 68 PSMA-11 was developed outside the United States at the University of Heidelberg (Germany).

A commercial NDA from Telix Pharmaceuticals for TL591-CDx, a radiopharmaceutical cold kit for the preparation of Ga 68 PSMA-11 injection, is under consideration by the FDA.

The agency noted that two other PET diagnostic agents – fluciclovine F18 and choline C11 – are approved for prostate cancer imaging. However, they are only approved for use in patients with suspected cancer recurrence.
 

Trial results with PSMA-PET/CT

“PSMA-PET/CT is a novel molecular and functional imaging modality specific for prostate cancer cells that has good sensitivity and outstanding specificity in detecting metastasis,” commented T. Martin Ma, MD, PhD, of UCLA.

Dr. Ma presented a U.S. study on the technique at the recent annual meeting of the American Society for Radiation Oncology. That study showed that PSMA-PET/CT led to nodal upstaging in 19.7% of patients and metastasis upstaging in 9.4%.

He said these results were similar to those from the Australian proPSMA trial, which was published in The Lancet earlier this year. That trial found PSMA-PET/CT to be superior to conventional imaging with CT and bone scanning for primary staging of high-risk prostate cancer.

“These findings carry significant clinical implications and can affect treatment decision-making,” Dr. Ma commented.

“PSMA-PET has been a real game changer in high-risk prostate cancer and has implications in the various stages of prostate cancer management from diagnosis and staging to theranostics,” said Renu Eapen, MBBS, of Peter MacCallum Cancer Center, Melbourne, who was not involved in either study.

“PSMA-PET/CT has challenged conventional imaging in staging before curative-intent surgery or radiotherapy,” Dr. Eapen added.

The accuracy of PSMA-PET/CT was 27% higher than that of conventional imaging in the proPSMA trial, she noted in an interview last month. This superior accuracy can ultimately affect management. The imaging has additional benefits of lower radiation dose as well as reproducibility with high reporter agreement, potentially making it a “one-stop-shop” scan.
 

Trial results with Ga 68 PSMA-11

The safety and efficacy of Ga 68 PSMA-11 were evaluated in two prospective clinical trials with a total of 960 men with prostate cancer, each of whom received one injection of the product.

The first trial involved 325 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans performed with Ga 68 PSMA-11.

“These patients were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis. Among the patients who proceeded to surgery, those with positive readings in the pelvic lymph nodes on Ga 68 PSMA-11 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology,” the FDA noted.

“The availability of this information prior to treatment is expected to have important implications for patient care,” the FDA commented. “For example, it may spare certain patients from undergoing unnecessary surgery.”

The second trial enrolled 635 patients with rising serum PSA levels after initial prostate surgery or radiotherapy. All patients received a single Ga 68 PSMA-11 PET/CT scan or PET/MRI scan.

About three-quarters of patients (74%) had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one region – bone, prostate bed, pelvic lymph node, or extra-pelvic soft tissue.

“In patients with positive Ga 68 PSMA-11 PET readings who had correlative tissue pathology from biopsies, results from baseline or follow-up imaging by conventional methods, and serial PSA levels available for comparison, local recurrence or metastasis of prostate cancer was confirmed in an estimated 91% of cases,” the FDA noted.

“Thus, the second trial demonstrated that Ga 68 PSMA-11 PET can detect sites of disease in patients with biochemical evidence of recurrent prostate cancer, thereby providing important information that may impact the approach to therapy,” the agency added.

The FDA also noted that no serious adverse reactions were attributed to Ga 68 PSMA-11. The most common adverse reactions were nausea, diarrhea, and dizziness.

The FDA said there is a risk for misdiagnosis because Ga 68 PSMA-11 binding may occur in other types of cancer, and certain nonmalignant processes may lead to errors in interpreting images. In addition, there are radiation risks because Ga 68 PSMA-11 contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer.

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

A radioactive diagnostic agent has been approved by the U.S. Food and Drug Administration for use in patients with prostate cancer, but only for those treated at two institutions in California.

The product, Gallium 68 PSMA-11 (Ga 68 PSMA-11), is the first agent approved specifically for use in positron-emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer, the FDA noted.

This imaging approach can “detect whether or not the cancer has spread to other parts of the body,” commented Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research.

Ga 68 PSMA-11 is indicated for use in patients with suspected prostate cancer metastasis whose conditions are potentially curable by surgery or radiotherapy and in patients with suspected prostate cancer recurrence, as determined on the basis of elevated serum prostate-specific antigen (PSA) levels.
 

Institutional use only

Ga 68 PSMA-11 has been approved for institutional use at the University of California, Los Angeles and the University of California, San Francisco under an academic new drug application (NDA).

The FDA approval was based partly on a clinical trial conducted by the UCSF and UCLA research teams on the effectiveness of PSMA-PET.

“It is rare for academic institutions to obtain FDA approval of a drug, and this unique collaboration has led to what is one of the first coapprovals of a drug at two institutions,” said Thomas Hope, MD, an associate professor at UCSF. “We hope that this first step will lead to a more widespread availability of this imaging test to men with prostate cancer throughout the country.”

Ga 68 PSMA-11 was developed outside the United States at the University of Heidelberg (Germany).

A commercial NDA from Telix Pharmaceuticals for TL591-CDx, a radiopharmaceutical cold kit for the preparation of Ga 68 PSMA-11 injection, is under consideration by the FDA.

The agency noted that two other PET diagnostic agents – fluciclovine F18 and choline C11 – are approved for prostate cancer imaging. However, they are only approved for use in patients with suspected cancer recurrence.
 

Trial results with PSMA-PET/CT

“PSMA-PET/CT is a novel molecular and functional imaging modality specific for prostate cancer cells that has good sensitivity and outstanding specificity in detecting metastasis,” commented T. Martin Ma, MD, PhD, of UCLA.

Dr. Ma presented a U.S. study on the technique at the recent annual meeting of the American Society for Radiation Oncology. That study showed that PSMA-PET/CT led to nodal upstaging in 19.7% of patients and metastasis upstaging in 9.4%.

He said these results were similar to those from the Australian proPSMA trial, which was published in The Lancet earlier this year. That trial found PSMA-PET/CT to be superior to conventional imaging with CT and bone scanning for primary staging of high-risk prostate cancer.

“These findings carry significant clinical implications and can affect treatment decision-making,” Dr. Ma commented.

“PSMA-PET has been a real game changer in high-risk prostate cancer and has implications in the various stages of prostate cancer management from diagnosis and staging to theranostics,” said Renu Eapen, MBBS, of Peter MacCallum Cancer Center, Melbourne, who was not involved in either study.

“PSMA-PET/CT has challenged conventional imaging in staging before curative-intent surgery or radiotherapy,” Dr. Eapen added.

The accuracy of PSMA-PET/CT was 27% higher than that of conventional imaging in the proPSMA trial, she noted in an interview last month. This superior accuracy can ultimately affect management. The imaging has additional benefits of lower radiation dose as well as reproducibility with high reporter agreement, potentially making it a “one-stop-shop” scan.
 

Trial results with Ga 68 PSMA-11

The safety and efficacy of Ga 68 PSMA-11 were evaluated in two prospective clinical trials with a total of 960 men with prostate cancer, each of whom received one injection of the product.

The first trial involved 325 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans performed with Ga 68 PSMA-11.

“These patients were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis. Among the patients who proceeded to surgery, those with positive readings in the pelvic lymph nodes on Ga 68 PSMA-11 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology,” the FDA noted.

“The availability of this information prior to treatment is expected to have important implications for patient care,” the FDA commented. “For example, it may spare certain patients from undergoing unnecessary surgery.”

The second trial enrolled 635 patients with rising serum PSA levels after initial prostate surgery or radiotherapy. All patients received a single Ga 68 PSMA-11 PET/CT scan or PET/MRI scan.

About three-quarters of patients (74%) had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one region – bone, prostate bed, pelvic lymph node, or extra-pelvic soft tissue.

“In patients with positive Ga 68 PSMA-11 PET readings who had correlative tissue pathology from biopsies, results from baseline or follow-up imaging by conventional methods, and serial PSA levels available for comparison, local recurrence or metastasis of prostate cancer was confirmed in an estimated 91% of cases,” the FDA noted.

“Thus, the second trial demonstrated that Ga 68 PSMA-11 PET can detect sites of disease in patients with biochemical evidence of recurrent prostate cancer, thereby providing important information that may impact the approach to therapy,” the agency added.

The FDA also noted that no serious adverse reactions were attributed to Ga 68 PSMA-11. The most common adverse reactions were nausea, diarrhea, and dizziness.

The FDA said there is a risk for misdiagnosis because Ga 68 PSMA-11 binding may occur in other types of cancer, and certain nonmalignant processes may lead to errors in interpreting images. In addition, there are radiation risks because Ga 68 PSMA-11 contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer.

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

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

An international panel of experts has published the first set of recommendations based on current clinical practices and scientific evidence for using ketogenic diet therapies in adults with drug-resistant epilepsy.

Just as in children with epilepsy, ketogenic diet therapies can be safe and effective in adults with epilepsy but should only be undertaken with the support of medical professionals trained in their use, the group said.

Novel in adult neurology

Ketogenic diet therapies are high-fat, low-carbohydrate, and adequate-protein diets that induce fat metabolism and ketone production. Despite its use as an effective antiseizure therapy since the 1920s, ketogenic diet therapies remain novel in adult neurology.

Furthermore, while there are established guidelines for ketogenic diet therapies to reduce seizures in children, there were no formal recommendations for adults, until now.

Drawing on the experience of experts at 20 centers using ketogenic diet therapies in more than 2,100 adults with epilepsy in 10 countries, Dr. Cervenka and an international team developed recommendations on use of ketogenic diet therapies in adults.

The panel noted, “with a relatively mild side effect profile and the potential to reduce seizures in nearly 60% of adults with drug-resistant epilepsy, ketogenic diet therapies should be part of the repertoire of available options.”

Ketogenic diet therapies are appropriate to offer to adults with seizure types and epilepsy syndromes for which these treatments are known to be effective in children, they said. These include tuberous sclerosis complex, Rett syndrome, Lennox-Gastaut syndrome, glucose transporter type 1 deficiency syndrome, genetic generalized epilepsies, and focal epilepsies caused by underlying migrational disorders and resistant to antiseizure medication.

However, adults with drug-resistant focal epilepsy should be offered surgical evaluation first, given the higher anticipated rate of seizure freedom via this route, the panel said.
 

A focus on compliance

Experts at nearly all of the centers report using two or more ketogenic diet therapies. Ninety percent use the modified Atkins diet, 84% use the classic ketogenic diet, and 63% use the modified ketogenic diet and/or low glycemic index treatment. More than half of the centers (58%) use medium-chain triglyceride oil in combination with another ketogenic diet therapy to boost ketone body production.

The most important factors influencing the choice of ketogenic diet therapy are ease of diet application for the patient (100%) and patient and/or caregiver preference, home setting, and mode of feeding (90% each).

The panel recommended that ketogenic diet therapies be tailored to fit the needs of the individual, taking into account his or her physical and mental characteristics, underlying medical conditions, food preferences, type and amount of support from family and others, level of self-sufficiency, feeding habits, and ease of following the diet.

“Most of the differences between the child and adult recommendations have to do with compliance. Often, it’s more of a challenge for adults than for children,” said Dr. Cervenka.

The panel recommended providing adult patients with recipe ideas, individualized training on the ketogenic diet lifestyle from a dietitian or nutritionist, and guidance for meal planning and preparation before starting the diet. This will provide the greatest likelihood of success, as patients often report difficulties coping with carbohydrate restriction.

“In pediatric practice, positive responders typically remain on a ketogenic diet therapy for 2 years before considering weaning. Ketogenic diet therapy in adults is not time-limited. However, a minimum of 3 months of ketogenic diet therapy is recommended before any judgment of response is made,” the panel advised.

The panel pointed out the absolute metabolic contraindications and cautions related to feeding difficulties, gastrointestinal dysfunction, and digestion remain the same for both children and adults. However, they added that a range of common adult conditions such as hyperlipidemia, heart disease, diabetes, low bone density, and pregnancy “bring additional consideration, caution, and monitoring to ketogenic diet therapy use.”
 

Beyond epilepsy

The guidelines also call for pre–ketogenic diet therapy biochemical studies to screen adults for preexisting abnormalities and establish a reference for comparing follow-up results after 3, 6, and 12 months, and then annually or as needed.

They also noted that metabolic studies such as urine organic acid and serum amino acid levels are generally not needed in adults unless there is a strong clinical suspicion for an underlying metabolic disorder.

Updated genetic evaluation may also be considered in adults with intellectual disability and epilepsy of unknown etiology. Serial bone mineral density scans may be obtained every 5 years.

The guidelines also call for ketone monitoring (blood beta-hydroxybutyrate or urine amino acids) during the early months of ketogenic diet therapy as an objective indication of compliance and biochemical response.

Dietary adjustments should focus on optimizing the treatment response, minimizing side effects, and maximizing sustainability.

Adults on a ketogenic diet therapy should also be advised to take multivitamin and mineral supplements and drink plenty of fluids.

The panel said emerging evidence also supports the use of ketogenic diet therapies in other adult neurologic disorders such as migraine, Parkinson’s disease, dementia, and multiple sclerosis.

However, the panel said further evidence is needed to guide recommendations on use of ketogenic diet therapies in other neurologic conditions.

The research had no targeted funding. Dr. Cervenka has reported receiving grants from Nutricia, Vitaflo, BrightFocus Foundation, and Army Research Laboratory; honoraria from the American Epilepsy Society, the Neurology Center, Epigenix, LivaNova, and Nutricia; royalties from Demos; and consulting for Nutricia, Glut1 Deficiency Foundation, and Sage Therapeutics. Disclosures for the other authors are listed in the article.