COVID vaccination rates vary by zodiac sign

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COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.

The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.

“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.

“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”

According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.

Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.

“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.

The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.

“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.

The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”

Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.

If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.

“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.

Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.

“We do have message fatigue around vaccines,” Mr. Rupp said.

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

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COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.

The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.

“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.

“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”

According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.

Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.

“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.

The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.

“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.

The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”

Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.

If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.

“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.

Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.

“We do have message fatigue around vaccines,” Mr. Rupp said.

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

COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.

The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.

“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.

“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”

According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.

Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.

“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.

The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.

“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.

The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”

Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.

If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.

“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.

Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.

“We do have message fatigue around vaccines,” Mr. Rupp said.

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

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FDA approves first nasal spray for dry eye

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The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

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

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The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

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

 

The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.

Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.

“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.

The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.

The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.

Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.

“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”

The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.

The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.

In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.

The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.

Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.

A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.

“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.

Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.

A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.

ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.

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

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ACIP recommends Shingrix for younger immunocompromised adults; updates pneumococcal vaccine guidance

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The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.

Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.

The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.

According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”

For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.

During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.

These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.

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

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The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.

Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.

The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.

According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”

For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.

During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.

These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.

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

The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.

Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.

The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.

According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”

For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.

During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.

These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.

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

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Laser-based alcohol-level tester fine-tuned to detect diseases

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Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

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Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

Most people think of alcohol-level testers, commonly called Breathalyzers, as tools for measuring alcohol when someone exhales. But scientists have taken the technology well beyond DUI checkpoints, aiming it instead at detecting diseases.

The breath of someone who is sick often has a chemical profile that is specific to their health condition. Methane in a person’s exhalations, for example, could signal an intestinal issue. If these chemical profiles can be matched to specific illnesses, then these testing devices could become handy screening tools for some conditions.

But existing devices typically detect only a single compound, with results taking 10 minutes or more, leading to a quest for faster devices that can identify more chemicals at the same time. Researchers have turned to a tool called a frequency comb to solve this problem.

This tool, first developed in 2008, pings breath samples with laser pulses in distinct frequency ranges of the light spectrum, separated like the teeth of a comb. Every mini-cloud of droplets we exhale contains over 1,000 compounds. When researchers send the pulses through these exhaled droplets, each chemical absorbs the light in its own specific pattern, creating a light “signature.”

In a study published in the Proceedings of the National Academy of Sciences investigators report that an updated version of the frequency comb can detect at least four and possibly up to 10 compounds linked to a health condition. In addition to accurately sorting out methane, methanol, and two chemical forms of water in breath, the combs also might be able to identify formaldehyde and ammonia, among others.

Before frequency combs become common in the clinic, though, a few steps remain. Scientists must link chemical profiles to specific diseases and find a way to make a compact version of the combs. If all goes well, the result could be a device capable of rapid, inexpensive screening for some diseases, with no need for lab testing, which would be especially welcome where testing facilities are scarce.

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

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How can doctors help kids recover from COVID-19 school disruptions?

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Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

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Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.

The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.

“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”

In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.

Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.

Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.

Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.

Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.

A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.

“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.

Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.

What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
 

Education

Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.

Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.

Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.

Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”

Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
 

Emotional health

Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.

Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.

Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.

And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.

Dr. Tridas and Mr. Chow had no relevant financial disclosures.

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New prescription for loop diuretic improves 30-day heart failure outcomes

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Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Dr. Peter Wallenhorst


Study design: Retrospective matched cohort study.

Setting: OPTIMIZE-HF registry.

Synopsis: Using the data from the OPTIMIZE-HF registry to develop a matched cohort of 2,191 pairs of patients, researchers showed that patients hospitalized for heart failure who were not previously taking any diuretic had significantly better 30-day clinical outcomes if they were discharged on a loop diuretic. Specifically, a loop diuretic on discharge resulted in a lower 30-day all-cause mortality (hazard ratio, 0.73; 95% CI, 0.57-0.94; P = .016) and a lower risk of 30-day heart failure readmission (HR, 0.79; 95% CI, 0.63-0.99; P = .037), compared with patients not discharged on a loop diuretic.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

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Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Dr. Peter Wallenhorst


Study design: Retrospective matched cohort study.

Setting: OPTIMIZE-HF registry.

Synopsis: Using the data from the OPTIMIZE-HF registry to develop a matched cohort of 2,191 pairs of patients, researchers showed that patients hospitalized for heart failure who were not previously taking any diuretic had significantly better 30-day clinical outcomes if they were discharged on a loop diuretic. Specifically, a loop diuretic on discharge resulted in a lower 30-day all-cause mortality (hazard ratio, 0.73; 95% CI, 0.57-0.94; P = .016) and a lower risk of 30-day heart failure readmission (HR, 0.79; 95% CI, 0.63-0.99; P = .037), compared with patients not discharged on a loop diuretic.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Dr. Peter Wallenhorst


Study design: Retrospective matched cohort study.

Setting: OPTIMIZE-HF registry.

Synopsis: Using the data from the OPTIMIZE-HF registry to develop a matched cohort of 2,191 pairs of patients, researchers showed that patients hospitalized for heart failure who were not previously taking any diuretic had significantly better 30-day clinical outcomes if they were discharged on a loop diuretic. Specifically, a loop diuretic on discharge resulted in a lower 30-day all-cause mortality (hazard ratio, 0.73; 95% CI, 0.57-0.94; P = .016) and a lower risk of 30-day heart failure readmission (HR, 0.79; 95% CI, 0.63-0.99; P = .037), compared with patients not discharged on a loop diuretic.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

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To tackle obesity, up fitness and activity or lose weight?

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Obesity interventions would be more effective at preventing premature mortality if they focused less on weight loss and more on increased physical activity and improved cardiorespiratory fitness, a pair of researchers concluded in a recent review.

The authors promote a “weight-neutral approach to treating obesity-related health conditions,” which they say is “as or more effective than a weight-loss centric approach.”

One expert agrees. “The obsession with the bathroom scale as the primary determinant of treatment efficacy when managing obesity is just not right,” Robert Ross, PhD, said in an interview.

“It masks the tremendous health benefits of improved fitness regardless of obesity. If you increase fitness, you improve outcomes even when people don’t lose weight,” noted Dr. Ross, a researcher in the School of Kinesiology and Health Studies at Queen’s University in Kingston, Ontario, Canada.

However, this proposition reprises a long-standing gulf between two schools of thought on obesity intervention.

One indication of the divided sentiment came in another expert review, published just days later, that strongly calls for weight loss of at least 15% of starting body weight as the primary intervention goal for most patients with obesity and type 2 diabetes. (According to 2020 statistics from the U.S. Centers for Disease Control and Prevention, more than 60% of U.S. adults with diabetes are obese.)

However, some question whether it must be all one, or the other, when obesity management could instead combine these approaches and simultaneously promote weight loss, increased activity, and improved fitness.

“It only muddies the water to dichotomize this as either weight management or activity and physical fitness,” observed Scott Kahan, MD, an obesity specialist and director of the National Center for Weight and Wellness in Washington, D.C.
 

Weight-neutral ‘is the way to go’

“The most significant new information [in the review] is the direct comparison of the magnitude of mortality risk reduction associated with weight loss compared with increasing fitness, physical activity, or both,” said Glenn A. Gaesser, PhD, the first author of the new review and professor of exercise physiology at Arizona State University, Phoenix.

“The results are quite clear: Increasing fitness, physical activity, or both are associated with greater mortality reductions than intentional weight loss. We argue that a weight-neutral approach to treating obesity is the way to go.”

The data call “into question the widely perceived notion of ‘lose weight, live longer,’” resulting in a “paradigm shift,” Dr. Gaesser said in an interview.

“There are no downsides to exercise, but there are significant downsides to weight loss, especially when it is inevitably followed by weight regain, which gives rise to the undesirable ‘weight-loss futile cycle’,” he added.
 

No simple, single solutions

Dr. Kahan said, however, that comparison of the effects of weight loss with the effects of increased activity and fitness on mortality is inherently problematic.

“It’s hard to make definitive conclusions from observational studies,” he cautioned, noting that the data cited in the review of activity and fitness compared with weight loss are generally “estimations” that carry a “lot of cloudiness.”

Dr. Kahan also takes issue with the premise detailed in the review that targeting reduced weight and implementing healthful and evidence-based approaches to try to achieve it are bound to fail and have frequent adverse consequences.

“Managing weight in a reasonable, patient-centered, thoughtful way is a standard and central part of long-term health,” he said in an interview.

He did concede, however, that the U.S. weight-loss landscape is awash with hucksterism that takes advantage of many patients, and he cautioned against approaches that focus on weight loss at all costs and as a pathway to selling products.

“But staying focused on activity and not paying attention to healthy eating is extreme,” he said, reemphasizing that obesity management is not a simple intervention with a single solution.
 

 

 

Not the first time

This is not the first time that Dr. Gaesser, and others, have published articles promoting a pivot away from weight loss as the primary goal of obesity interventions. In 2015, Dr. Gaesser and colleagues published an evidence review that gave this recommendation for managing people with obesity: “We propose that the proxy for health improvements should not be weight loss but instead improvements in cardiometabolic parameters, functional status, and fitness.”

Dr. Gaesser’s latest review also acknowledges similar recommendations from others, including Dr. Ross, who said it’s nothing new to conclude that increased fitness and activity in the absence of weight loss is not failure.

“It’s something we’ve promoted for decades,” but “it’s not understood and acted on in clinical settings, and that’s unfortunate,” he said.

More than a decade ago, Dr. Ross and his coauthor wrote in a published review that “a monolithic focus on weight loss as the only determinant of success for strategies that aim to reduce obesity is not justified and, more importantly, eliminates opportunities to focus on lifestyle behaviors that are associated with benefit across a wide range of health outcomes.”

And an effective intervention that focuses on activity and fitness means that, at the least, patients should not gain weight, and they may lose weight as a side benefit, he stressed.

“We always advocate a balanced diet, so that people do not gain more weight.”

Dr. Ross also highlighted the usefulness of measuring fitness as an alternative to recording weight to track the response by patients with obesity to various interventions. Dr. Ross recommends nonexercise prediction equations for routine practice to easily estimate cardiorespiratory fitness, an approach detailed in a 2016 statement from the American Heart Association by a writing panel chaired by Dr. Ross.

The AHA statement notes that “not including cardiorespiratory fitness measurement in routine clinical practice fails to provide an optimal approach for stratifying patients according to risk.”

The AHA also advises that “routine estimation of cardiorespiratory fitness in clinical practice is no more difficult than measuring blood pressure,” and details ways of incorporating this into routine clinical assessment.

Dr. Gaesser and Dr. Kahan have reported no relevant financial relationships. Dr. Ross has been an advisor to the Canadian Sugar Institute.

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

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Obesity interventions would be more effective at preventing premature mortality if they focused less on weight loss and more on increased physical activity and improved cardiorespiratory fitness, a pair of researchers concluded in a recent review.

The authors promote a “weight-neutral approach to treating obesity-related health conditions,” which they say is “as or more effective than a weight-loss centric approach.”

One expert agrees. “The obsession with the bathroom scale as the primary determinant of treatment efficacy when managing obesity is just not right,” Robert Ross, PhD, said in an interview.

“It masks the tremendous health benefits of improved fitness regardless of obesity. If you increase fitness, you improve outcomes even when people don’t lose weight,” noted Dr. Ross, a researcher in the School of Kinesiology and Health Studies at Queen’s University in Kingston, Ontario, Canada.

However, this proposition reprises a long-standing gulf between two schools of thought on obesity intervention.

One indication of the divided sentiment came in another expert review, published just days later, that strongly calls for weight loss of at least 15% of starting body weight as the primary intervention goal for most patients with obesity and type 2 diabetes. (According to 2020 statistics from the U.S. Centers for Disease Control and Prevention, more than 60% of U.S. adults with diabetes are obese.)

However, some question whether it must be all one, or the other, when obesity management could instead combine these approaches and simultaneously promote weight loss, increased activity, and improved fitness.

“It only muddies the water to dichotomize this as either weight management or activity and physical fitness,” observed Scott Kahan, MD, an obesity specialist and director of the National Center for Weight and Wellness in Washington, D.C.
 

Weight-neutral ‘is the way to go’

“The most significant new information [in the review] is the direct comparison of the magnitude of mortality risk reduction associated with weight loss compared with increasing fitness, physical activity, or both,” said Glenn A. Gaesser, PhD, the first author of the new review and professor of exercise physiology at Arizona State University, Phoenix.

“The results are quite clear: Increasing fitness, physical activity, or both are associated with greater mortality reductions than intentional weight loss. We argue that a weight-neutral approach to treating obesity is the way to go.”

The data call “into question the widely perceived notion of ‘lose weight, live longer,’” resulting in a “paradigm shift,” Dr. Gaesser said in an interview.

“There are no downsides to exercise, but there are significant downsides to weight loss, especially when it is inevitably followed by weight regain, which gives rise to the undesirable ‘weight-loss futile cycle’,” he added.
 

No simple, single solutions

Dr. Kahan said, however, that comparison of the effects of weight loss with the effects of increased activity and fitness on mortality is inherently problematic.

“It’s hard to make definitive conclusions from observational studies,” he cautioned, noting that the data cited in the review of activity and fitness compared with weight loss are generally “estimations” that carry a “lot of cloudiness.”

Dr. Kahan also takes issue with the premise detailed in the review that targeting reduced weight and implementing healthful and evidence-based approaches to try to achieve it are bound to fail and have frequent adverse consequences.

“Managing weight in a reasonable, patient-centered, thoughtful way is a standard and central part of long-term health,” he said in an interview.

He did concede, however, that the U.S. weight-loss landscape is awash with hucksterism that takes advantage of many patients, and he cautioned against approaches that focus on weight loss at all costs and as a pathway to selling products.

“But staying focused on activity and not paying attention to healthy eating is extreme,” he said, reemphasizing that obesity management is not a simple intervention with a single solution.
 

 

 

Not the first time

This is not the first time that Dr. Gaesser, and others, have published articles promoting a pivot away from weight loss as the primary goal of obesity interventions. In 2015, Dr. Gaesser and colleagues published an evidence review that gave this recommendation for managing people with obesity: “We propose that the proxy for health improvements should not be weight loss but instead improvements in cardiometabolic parameters, functional status, and fitness.”

Dr. Gaesser’s latest review also acknowledges similar recommendations from others, including Dr. Ross, who said it’s nothing new to conclude that increased fitness and activity in the absence of weight loss is not failure.

“It’s something we’ve promoted for decades,” but “it’s not understood and acted on in clinical settings, and that’s unfortunate,” he said.

More than a decade ago, Dr. Ross and his coauthor wrote in a published review that “a monolithic focus on weight loss as the only determinant of success for strategies that aim to reduce obesity is not justified and, more importantly, eliminates opportunities to focus on lifestyle behaviors that are associated with benefit across a wide range of health outcomes.”

And an effective intervention that focuses on activity and fitness means that, at the least, patients should not gain weight, and they may lose weight as a side benefit, he stressed.

“We always advocate a balanced diet, so that people do not gain more weight.”

Dr. Ross also highlighted the usefulness of measuring fitness as an alternative to recording weight to track the response by patients with obesity to various interventions. Dr. Ross recommends nonexercise prediction equations for routine practice to easily estimate cardiorespiratory fitness, an approach detailed in a 2016 statement from the American Heart Association by a writing panel chaired by Dr. Ross.

The AHA statement notes that “not including cardiorespiratory fitness measurement in routine clinical practice fails to provide an optimal approach for stratifying patients according to risk.”

The AHA also advises that “routine estimation of cardiorespiratory fitness in clinical practice is no more difficult than measuring blood pressure,” and details ways of incorporating this into routine clinical assessment.

Dr. Gaesser and Dr. Kahan have reported no relevant financial relationships. Dr. Ross has been an advisor to the Canadian Sugar Institute.

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

Obesity interventions would be more effective at preventing premature mortality if they focused less on weight loss and more on increased physical activity and improved cardiorespiratory fitness, a pair of researchers concluded in a recent review.

The authors promote a “weight-neutral approach to treating obesity-related health conditions,” which they say is “as or more effective than a weight-loss centric approach.”

One expert agrees. “The obsession with the bathroom scale as the primary determinant of treatment efficacy when managing obesity is just not right,” Robert Ross, PhD, said in an interview.

“It masks the tremendous health benefits of improved fitness regardless of obesity. If you increase fitness, you improve outcomes even when people don’t lose weight,” noted Dr. Ross, a researcher in the School of Kinesiology and Health Studies at Queen’s University in Kingston, Ontario, Canada.

However, this proposition reprises a long-standing gulf between two schools of thought on obesity intervention.

One indication of the divided sentiment came in another expert review, published just days later, that strongly calls for weight loss of at least 15% of starting body weight as the primary intervention goal for most patients with obesity and type 2 diabetes. (According to 2020 statistics from the U.S. Centers for Disease Control and Prevention, more than 60% of U.S. adults with diabetes are obese.)

However, some question whether it must be all one, or the other, when obesity management could instead combine these approaches and simultaneously promote weight loss, increased activity, and improved fitness.

“It only muddies the water to dichotomize this as either weight management or activity and physical fitness,” observed Scott Kahan, MD, an obesity specialist and director of the National Center for Weight and Wellness in Washington, D.C.
 

Weight-neutral ‘is the way to go’

“The most significant new information [in the review] is the direct comparison of the magnitude of mortality risk reduction associated with weight loss compared with increasing fitness, physical activity, or both,” said Glenn A. Gaesser, PhD, the first author of the new review and professor of exercise physiology at Arizona State University, Phoenix.

“The results are quite clear: Increasing fitness, physical activity, or both are associated with greater mortality reductions than intentional weight loss. We argue that a weight-neutral approach to treating obesity is the way to go.”

The data call “into question the widely perceived notion of ‘lose weight, live longer,’” resulting in a “paradigm shift,” Dr. Gaesser said in an interview.

“There are no downsides to exercise, but there are significant downsides to weight loss, especially when it is inevitably followed by weight regain, which gives rise to the undesirable ‘weight-loss futile cycle’,” he added.
 

No simple, single solutions

Dr. Kahan said, however, that comparison of the effects of weight loss with the effects of increased activity and fitness on mortality is inherently problematic.

“It’s hard to make definitive conclusions from observational studies,” he cautioned, noting that the data cited in the review of activity and fitness compared with weight loss are generally “estimations” that carry a “lot of cloudiness.”

Dr. Kahan also takes issue with the premise detailed in the review that targeting reduced weight and implementing healthful and evidence-based approaches to try to achieve it are bound to fail and have frequent adverse consequences.

“Managing weight in a reasonable, patient-centered, thoughtful way is a standard and central part of long-term health,” he said in an interview.

He did concede, however, that the U.S. weight-loss landscape is awash with hucksterism that takes advantage of many patients, and he cautioned against approaches that focus on weight loss at all costs and as a pathway to selling products.

“But staying focused on activity and not paying attention to healthy eating is extreme,” he said, reemphasizing that obesity management is not a simple intervention with a single solution.
 

 

 

Not the first time

This is not the first time that Dr. Gaesser, and others, have published articles promoting a pivot away from weight loss as the primary goal of obesity interventions. In 2015, Dr. Gaesser and colleagues published an evidence review that gave this recommendation for managing people with obesity: “We propose that the proxy for health improvements should not be weight loss but instead improvements in cardiometabolic parameters, functional status, and fitness.”

Dr. Gaesser’s latest review also acknowledges similar recommendations from others, including Dr. Ross, who said it’s nothing new to conclude that increased fitness and activity in the absence of weight loss is not failure.

“It’s something we’ve promoted for decades,” but “it’s not understood and acted on in clinical settings, and that’s unfortunate,” he said.

More than a decade ago, Dr. Ross and his coauthor wrote in a published review that “a monolithic focus on weight loss as the only determinant of success for strategies that aim to reduce obesity is not justified and, more importantly, eliminates opportunities to focus on lifestyle behaviors that are associated with benefit across a wide range of health outcomes.”

And an effective intervention that focuses on activity and fitness means that, at the least, patients should not gain weight, and they may lose weight as a side benefit, he stressed.

“We always advocate a balanced diet, so that people do not gain more weight.”

Dr. Ross also highlighted the usefulness of measuring fitness as an alternative to recording weight to track the response by patients with obesity to various interventions. Dr. Ross recommends nonexercise prediction equations for routine practice to easily estimate cardiorespiratory fitness, an approach detailed in a 2016 statement from the American Heart Association by a writing panel chaired by Dr. Ross.

The AHA statement notes that “not including cardiorespiratory fitness measurement in routine clinical practice fails to provide an optimal approach for stratifying patients according to risk.”

The AHA also advises that “routine estimation of cardiorespiratory fitness in clinical practice is no more difficult than measuring blood pressure,” and details ways of incorporating this into routine clinical assessment.

Dr. Gaesser and Dr. Kahan have reported no relevant financial relationships. Dr. Ross has been an advisor to the Canadian Sugar Institute.

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

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Better COVID-19 outcomes confirmed in TNF inhibitor users

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Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

Dr. Joel M. Gelfand

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.



All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

 

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University
Dr. Stephen B. Hanauer

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

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Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

Dr. Joel M. Gelfand

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.



All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

 

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University
Dr. Stephen B. Hanauer

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

Dr. Joel M. Gelfand

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.



All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

 

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University
Dr. Stephen B. Hanauer

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

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Pandemic drives uptick in need for mental health services

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In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.

Emily Terlizzi

Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.

The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.

Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).

This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.

Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.

The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
 

Social and emotional support

Despite rising mental health care needs, more than 3 in 4 U.S. adults (77.5%) indicated that they always or usually received the social and emotional support they needed during the pandemic period of July to Dec. 2020, also based on NHIS data.

Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.

However, social and emotional support varies by age and race/ethnicity.

Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.

“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.

As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.

The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.

One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.

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

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In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.

Emily Terlizzi

Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.

The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.

Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).

This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.

Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.

The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
 

Social and emotional support

Despite rising mental health care needs, more than 3 in 4 U.S. adults (77.5%) indicated that they always or usually received the social and emotional support they needed during the pandemic period of July to Dec. 2020, also based on NHIS data.

Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.

However, social and emotional support varies by age and race/ethnicity.

Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.

“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.

As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.

The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.

One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.

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

In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.

Emily Terlizzi

Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.

The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.

Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).

This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.

Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.

The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
 

Social and emotional support

Despite rising mental health care needs, more than 3 in 4 U.S. adults (77.5%) indicated that they always or usually received the social and emotional support they needed during the pandemic period of July to Dec. 2020, also based on NHIS data.

Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.

However, social and emotional support varies by age and race/ethnicity.

Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.

“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.

As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.

The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.

One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.

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

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Drink up: Large study confirms coffee beneficial to liver health

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Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

Dr. Elliot Tapper

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

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Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

Dr. Elliot Tapper

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

Dr. Elliot Tapper

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

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