Myocardial inflammation is present in a small proportion of patients who have recovered from relatively mild cases of COVID-19 infection, a new study shows.

“Our findings suggest that even in patients who have had relatively mild cases of COVID-19, some will have inflammatory changes to the heart, and these changes can be present without any cardiac symptoms,” senior author, Paaladinesh Thavendiranathan, MD, University of Toronto, told this news organization.

Floaria Bicher/iStock/Getty Images Plus

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

Myocardial inflammation is present in a small proportion of patients who have recovered from relatively mild cases of COVID-19 infection, a new study shows.

“Our findings suggest that even in patients who have had relatively mild cases of COVID-19, some will have inflammatory changes to the heart, and these changes can be present without any cardiac symptoms,” senior author, Paaladinesh Thavendiranathan, MD, University of Toronto, told this news organization.

Floaria Bicher/iStock/Getty Images Plus

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

Myocardial inflammation is present in a small proportion of patients who have recovered from relatively mild cases of COVID-19 infection, a new study shows.

“Our findings suggest that even in patients who have had relatively mild cases of COVID-19, some will have inflammatory changes to the heart, and these changes can be present without any cardiac symptoms,” senior author, Paaladinesh Thavendiranathan, MD, University of Toronto, told this news organization.

Floaria Bicher/iStock/Getty Images Plus

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

Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.

“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.

The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.

In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.

In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.

Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.

The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.

Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.

Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.

Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.

The full Jan. 10 FAQ is available here.

This article was updated Jan. 14, 2022.

Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.

“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.

The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.

In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.

In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.

Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.

The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.

Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.

Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.

Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.

The full Jan. 10 FAQ is available here.

This article was updated Jan. 14, 2022.

Private insurers are now required to cover the cost of follow-up colonoscopies after a positive stool-based test, according to updated guidance from the Biden administration cited in a press release from the American Gastroenterological Association.

“Now patients can choose the best colorectal cancer screening test for them without fear of a surprise bill. Patients have full coverage of the full screening continuum – from an initial stool or endoscopic test to a follow-up colonoscopy. Now that the financial barriers have been eliminated, we can focus on increasing screening so we can prevent cancer deaths,” John Inadomi, MD, president of the AGA, said in the press release.

The updated guidance, issued on Jan. 10, 2022, “will prevent patients from receiving surprise bills for a colonoscopy when they receive a positive result from a stool-based test,” according to the AGA press release.

In 2016, the U.S. Preventive Services Task Force recommended colorectal cancer screening for all adults starting at age 50 years and continuing to age 75 years, with an “A” rating. Because the Affordable Care Act (ACA) mandated coverage for preventive screenings without cost-sharing that receive an “A” or “B” grade from the USPSTF, previous statements have confirmed that cost sharing may not be imposed on patients for screening in accordance with the USPSTF recommendation, which included specialist consultation prior to the procedure, bowel prep medications, anesthesia services in conjunction with a preventive colonoscopy, polyp removal performed during the screening procedure, and any pathology exam on a polyp biopsy performed as part of the screening. By adding colonoscopies following positive stool tests to that list, the updated guidance means that all aspects of the screening procedure are now covered without cost sharing.

In May 2021, an update to the USPSTF recommendations called for a follow-up colonoscopy in the wake of a positive test: “Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The 2021 update also extended the screening recommendation to adults aged 45-49 years with a “B” rating.

Private insurers must now pay for follow-up colonoscopy as needed in addition to the initial noninvasive screening, according to the guidance.

The updated guidance is presented as part of a series of frequently asked questions regarding implementation of the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Affordable Care Act. The colonoscopy guidance falls under the heading of “Coverage of Preventive Services,” which includes evidence-based recommendations given an A or B rating by the USPSTF.

Coverage without cost sharing must begin on or after May 31, 2022, which is 1 year after the date of the latest recommendations, according to the FAQ.

Representatives of multiple organizations, including the AGA, American Cancer Society, American Cancer Society Cancer Action Network, and Fight CRC collaborated to promote the additional coverage. “We applaud the administration for supporting coverage of the full colorectal cancer screening continuum, which will improve access to lifesaving screening,” the collaborators said in the press release.

Colorectal cancer remains the second leading cancer killer in the United States, but only two-thirds of eligible individuals were screened in 2018, according to the AGA, and screening challenges were exacerbated by the arrival of the COVID-19 pandemic. The AGA estimates that colorectal cancer screening declined by 86% during the first few months of the COVID-19 pandemic in 2020.

The full Jan. 10 FAQ is available here.

This article was updated Jan. 14, 2022.

Virtual reality (VR) has been taking positive steps in a variety of treatment areas for some time. Now a Japanese company is asking the question: Can people with depression benefit from watching VR scenarios in which actors portray characters coping with the condition?

That’s the assertion of the Tokyo-based company Jolly Good, a VR start-up that introduced the U.S. version of its VRDTx program at the annual meeting of the Consumer Electronics Show.

“Using this as an adjunct for psychotherapy to help someone see an example of someone who’s struggling with depression can be a helpful tool,” said Katharine Larsson, PhD, RN, clinical director of Boston Behavioral Medicine in Brookline. Larsson and her BBM colleague, Amaro J. Laria, PhD, are helping Jolly Good to adapt the program for use in the United States.

VRDTx uses techniques from cognitive-behavioral therapy (CBT). Donning goggles, viewers watch people acting out situations common to depression.

One technique frequently used in CBT is to make a detailed plan, Dr. Laria said. For example, VRDTx users might watch a character with depression struggling to get out of bed but resolving to get up for at least 10 minutes one day, to go for a walk the next day, etc. “The virtual reality allows you to watch a person actually going through the process of applying the intervention,” he said.

In this way, the program could work like hypnotherapy or imaginal therapy where patients picture themselves in a situation that might trigger their depression and then picture themselves coping with that situation.

Dr. Larsson advised using the program primarily as a sort of homework. “Using this to enhance a therapeutic relationship is a very appropriate use,” she said. “Using it to substitute or replace the time with a therapist, I don’t think it could begin to have any kind of real efficacy.”

Deploying virtual reality to treat mood disorders is not new, said Preethi Premkumar, PhD, a senior lecturer in psychology at London South Bank University, who has no relationship to Jolly Good.

Dr. Premkumar is first author of a study of a VR program used to treat people who have anxiety about speaking in public. The program depicts the user speaking before an audience and allows the user to vary the number of people in the audience and the audience’s reactions. The users gave it high marks, Dr. Premkumar said. “They felt that it encouraged them to take on public speaking more in reality.”

VR could work in a similar way for depressed people because they tend to catastrophize about specific situations. “Virtual reality can recreate those scenes and then make people confront it without overexposing them,” Dr. Premkumar said.

One recent review article found several studies on VR as a treatment for anxiety. While only a handful focused on depression, they had mostly favorable results.

Jolly Good sponsored one such study, presented Sept. 17, 2021, at the European Association for Behavioural and Cognitive Therapies. “Results indicate improvement in the scores of the targeted patients with depression,” according to an abstract the company published online. “Use of VR caused no adverse events, demonstrating that VR can be used safely in the CBT for of depression.” The company did not respond to a request for more details.

After viewing scenarios created for Japanese patients, Dr. Larsson and Dr. Laria offered Jolly Good several tips about making the transition to the United States. The actors should be more emotionally expressive. They should portray a more diverse cast of characters, including some female bosses. And not all scenes should be set in the workplace.

“In the U.S., at least in our experience, a lot of what depressed patients talk about is just their personal lives, their intimate relationship with a significant other, family relations, friends,” Dr. Laria said. “We gave them a whole list of topics that we felt would be more relevant for a U.S. audience.”

Dr. Larsson and Dr. Laria are consultants to Jolly Good. Dr. Premkumar reported no relevant financial interests.

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

Virtual reality (VR) has been taking positive steps in a variety of treatment areas for some time. Now a Japanese company is asking the question: Can people with depression benefit from watching VR scenarios in which actors portray characters coping with the condition?

That’s the assertion of the Tokyo-based company Jolly Good, a VR start-up that introduced the U.S. version of its VRDTx program at the annual meeting of the Consumer Electronics Show.

“Using this as an adjunct for psychotherapy to help someone see an example of someone who’s struggling with depression can be a helpful tool,” said Katharine Larsson, PhD, RN, clinical director of Boston Behavioral Medicine in Brookline. Larsson and her BBM colleague, Amaro J. Laria, PhD, are helping Jolly Good to adapt the program for use in the United States.

VRDTx uses techniques from cognitive-behavioral therapy (CBT). Donning goggles, viewers watch people acting out situations common to depression.

One technique frequently used in CBT is to make a detailed plan, Dr. Laria said. For example, VRDTx users might watch a character with depression struggling to get out of bed but resolving to get up for at least 10 minutes one day, to go for a walk the next day, etc. “The virtual reality allows you to watch a person actually going through the process of applying the intervention,” he said.

In this way, the program could work like hypnotherapy or imaginal therapy where patients picture themselves in a situation that might trigger their depression and then picture themselves coping with that situation.

Dr. Larsson advised using the program primarily as a sort of homework. “Using this to enhance a therapeutic relationship is a very appropriate use,” she said. “Using it to substitute or replace the time with a therapist, I don’t think it could begin to have any kind of real efficacy.”

Deploying virtual reality to treat mood disorders is not new, said Preethi Premkumar, PhD, a senior lecturer in psychology at London South Bank University, who has no relationship to Jolly Good.

Dr. Premkumar is first author of a study of a VR program used to treat people who have anxiety about speaking in public. The program depicts the user speaking before an audience and allows the user to vary the number of people in the audience and the audience’s reactions. The users gave it high marks, Dr. Premkumar said. “They felt that it encouraged them to take on public speaking more in reality.”

VR could work in a similar way for depressed people because they tend to catastrophize about specific situations. “Virtual reality can recreate those scenes and then make people confront it without overexposing them,” Dr. Premkumar said.

One recent review article found several studies on VR as a treatment for anxiety. While only a handful focused on depression, they had mostly favorable results.

Jolly Good sponsored one such study, presented Sept. 17, 2021, at the European Association for Behavioural and Cognitive Therapies. “Results indicate improvement in the scores of the targeted patients with depression,” according to an abstract the company published online. “Use of VR caused no adverse events, demonstrating that VR can be used safely in the CBT for of depression.” The company did not respond to a request for more details.

After viewing scenarios created for Japanese patients, Dr. Larsson and Dr. Laria offered Jolly Good several tips about making the transition to the United States. The actors should be more emotionally expressive. They should portray a more diverse cast of characters, including some female bosses. And not all scenes should be set in the workplace.

“In the U.S., at least in our experience, a lot of what depressed patients talk about is just their personal lives, their intimate relationship with a significant other, family relations, friends,” Dr. Laria said. “We gave them a whole list of topics that we felt would be more relevant for a U.S. audience.”

Dr. Larsson and Dr. Laria are consultants to Jolly Good. Dr. Premkumar reported no relevant financial interests.

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

Virtual reality (VR) has been taking positive steps in a variety of treatment areas for some time. Now a Japanese company is asking the question: Can people with depression benefit from watching VR scenarios in which actors portray characters coping with the condition?

That’s the assertion of the Tokyo-based company Jolly Good, a VR start-up that introduced the U.S. version of its VRDTx program at the annual meeting of the Consumer Electronics Show.

“Using this as an adjunct for psychotherapy to help someone see an example of someone who’s struggling with depression can be a helpful tool,” said Katharine Larsson, PhD, RN, clinical director of Boston Behavioral Medicine in Brookline. Larsson and her BBM colleague, Amaro J. Laria, PhD, are helping Jolly Good to adapt the program for use in the United States.

VRDTx uses techniques from cognitive-behavioral therapy (CBT). Donning goggles, viewers watch people acting out situations common to depression.

One technique frequently used in CBT is to make a detailed plan, Dr. Laria said. For example, VRDTx users might watch a character with depression struggling to get out of bed but resolving to get up for at least 10 minutes one day, to go for a walk the next day, etc. “The virtual reality allows you to watch a person actually going through the process of applying the intervention,” he said.

In this way, the program could work like hypnotherapy or imaginal therapy where patients picture themselves in a situation that might trigger their depression and then picture themselves coping with that situation.

Dr. Larsson advised using the program primarily as a sort of homework. “Using this to enhance a therapeutic relationship is a very appropriate use,” she said. “Using it to substitute or replace the time with a therapist, I don’t think it could begin to have any kind of real efficacy.”

Deploying virtual reality to treat mood disorders is not new, said Preethi Premkumar, PhD, a senior lecturer in psychology at London South Bank University, who has no relationship to Jolly Good.

Dr. Premkumar is first author of a study of a VR program used to treat people who have anxiety about speaking in public. The program depicts the user speaking before an audience and allows the user to vary the number of people in the audience and the audience’s reactions. The users gave it high marks, Dr. Premkumar said. “They felt that it encouraged them to take on public speaking more in reality.”

VR could work in a similar way for depressed people because they tend to catastrophize about specific situations. “Virtual reality can recreate those scenes and then make people confront it without overexposing them,” Dr. Premkumar said.

One recent review article found several studies on VR as a treatment for anxiety. While only a handful focused on depression, they had mostly favorable results.

Jolly Good sponsored one such study, presented Sept. 17, 2021, at the European Association for Behavioural and Cognitive Therapies. “Results indicate improvement in the scores of the targeted patients with depression,” according to an abstract the company published online. “Use of VR caused no adverse events, demonstrating that VR can be used safely in the CBT for of depression.” The company did not respond to a request for more details.

After viewing scenarios created for Japanese patients, Dr. Larsson and Dr. Laria offered Jolly Good several tips about making the transition to the United States. The actors should be more emotionally expressive. They should portray a more diverse cast of characters, including some female bosses. And not all scenes should be set in the workplace.

“In the U.S., at least in our experience, a lot of what depressed patients talk about is just their personal lives, their intimate relationship with a significant other, family relations, friends,” Dr. Laria said. “We gave them a whole list of topics that we felt would be more relevant for a U.S. audience.”

Dr. Larsson and Dr. Laria are consultants to Jolly Good. Dr. Premkumar reported no relevant financial interests.

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

The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.

Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”

The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.

The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”

In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.

One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.

The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.

Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”

Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.

Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.

The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.

Dr. Ho and Dr. Donta reported no relevant financial relationships.

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

The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.

Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”

The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.

The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”

In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.

One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.

The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.

Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”

Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.

Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.

The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.

Dr. Ho and Dr. Donta reported no relevant financial relationships.

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

The recently published “Clinical Practice Guidelines for the Prevention and Management of Tick-Borne Illness,” from the Wilderness Medical Society, are a good compilation of treatment suggestions but are not, in fact, new recommendations, lead author Benjamin Ho, MD, of Southern Wisconsin Emergency Associates in Janesville, acknowledged in an interview.

Dr. Ho emphasized that the focus of the report was on “practitioners who practice in resource-limited settings” and are “the group’s way of solidifying a ... standard of practice” for such physicians. Dr. Ho also said that, while “a lot of the recommendations aren’t well supported, the risk-benefit ratio, we believe, supports the recommendations.”

The article first reviewed the different types of ticks and their distribution in the United States, the specific pathogen associated with each, the disease it causes, and comments about seasonal variations in biting behavior. Another table outlines the most common clinical syndromes, typical lab findings, recommended diagnostic testing, and antibiotic treatments. A third section contains images of different types of ticks and photos of ticks in various life-cycle stages and different levels of engorgement.

The authors were careful to note: “Several tick species are able to carry multiple pathogens. In one study, nearly 25% of Ixodes were coinfected with some combination of the bacteria or parasites causing Lyme disease, anaplasmosis, or babesiosis. Although TBI [tick-borne illness] diagnosis is not the focus of this [clinical practice guideline], providers should be aware of high rates of coinfection; the presence of one TBI should in many instances prompt testing for others.”

In terms of recommendations for preventing TBIs, the authors challenge the suggestion of wearing light-colored clothing. For repellents, they recommend DEET, picaridin, and permethrin. And they also give instructions for laundering clothing and removing ticks.

One recommendation is controversial: that of providing single-dose doxycycline as prophylaxis against Lyme disease. Dr. Ho stresses that this was only for “high-risk” tick bites, defined as a tick bite from an identified Ixodes vector species in which the tick was attached for at least 36 hours and that occurred in an endemic area.

The recommendation for prophylactic doxycycline originated with an article by Robert Nadelman and colleagues in the New England Journal of Medicine and has been strongly challenged by ILADS (International Lyme and Associated Diseases Society) physicians, including Daniel Cameron, MD, and others.

Sam Donta, MD, a recent member of the Department of Health & Human Services Tick-borne Working Group and a member of the Infectious Disease Society of America, said in an interview: “The problem with the one-dose doxycycline is you may not begin to develop symptoms until 2 months later.” It might mask the early symptoms of Lyme. “My impression is that the doxycycline – even the single dose – might have abrogated the ability to see an immune response. The idea, though, if you’ve had a tick bite, is to do nothing and to wait for symptoms to develop. That becomes a little bit more complex. But even then, you could choose to follow the patient and see the patient in 2 weeks and then get blood testing.”

Dr. Donta added: “I think the screening test is inadequate. So you have to go directly to the Western blot. And you have to do both the IgM and IgG” and look for specific bands.

Dr. Donta emphasized that patients should be encouraged to save any ticks that were attached and that, if at all possible, ticks should be sent to a reference lab for testing before committing a patient to a course of antibiotics. There is no harm in that brief delay, he said, and most labs can identify an array of pathogens.

The Wilderness Society guidelines on TBIs provide a good overview for clinicians practicing in limited resource settings and mirror those from the IDSA.

Dr. Ho and Dr. Donta reported no relevant financial relationships.

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

A study showing that once-weekly subcutaneous semaglutide 2.4 mg (Wegovy, Novo Nordisk) produces greater long-term weight loss than once-daily injected liraglutide 3.0 mg (Saxenda, Novo Nordisk) among adults with overweight or obesity without diabetes has now been published.

The data, previously reported at Obesity Week 2021, were published online Jan. 11 in JAMA.

The findings are from the phase 3 Semaglutide Treatment Effect in People with Obesity (STEP) 8 trial by Domenica M. Rubino, MD, of the Washington Center for Weight Management and Research, Arlington, Virginia, and colleagues.

Semaglutide and liraglutide, subcutaneously injectable glucagon-like peptide-1 (GLP-1) agonists, were both first approved for the treatment of type 2 diabetes in the United States and elsewhere, but are now also approved, in different doses, for chronic weight management and in people with obesity or overweight and comorbidities. A phase 2 trial demonstrated that once-daily semaglutide 0.4 mg produced significantly more weight loss than liraglutide 3.0 mg.

“Semaglutide and liraglutide induce weight loss by lowering energy intake. However, the reduction in caloric intake versus placebo appears to be larger with semaglutide (35%) than liraglutide (approximately 16%),” say Dr. Rubino and colleagues.

“Semaglutide has also been associated with reductions in food cravings, which is less evident with liraglutide, suggesting different mechanisms of energy intake regulation,” they add.   

Novo Nordisk has recently reported that there may be supply problems with Wegovy, as a contract manufacturer that fills syringes for pens to inject the drug temporarily halted deliveries and manufacturing after issues related to good manufacturing practice.

The company is also developing an oral form of semaglutide for weight loss. The oral form has already been approved in doses of 7 or 14 mg/day for the treatment of type 2 diabetes in the United States as Rybelsus.

Individualize treatment for those with obesity

STEP 8 was a randomized, open-label, 68-week phase 3b trial of 338 adults randomized to once-weekly semaglutide 2.4 mg (n = 126), once-daily liraglutide 3.0 mg (n = 127), or matched injected placebo (n = 85) for 68 weeks, all provided with counseling on diet and physical activity.  

The primary outcome – estimated mean change in body weight at week 68 – was –15.8% with semaglutide versus –6.4% with liraglutide, a significant difference (P < .001). The proportions of patients achieving loss of body weight of 10%, 15%, or 20% were 70.9%, 55.6%, and 38.5% with semaglutide versus 25.6%, 12.0%, and 6.0% with liraglutide, respectively.

Significantly greater reductions were also seen at 68 weeks for weekly semaglutide versus daily liraglutide in absolute body weight, waist circumference, diastolic blood pressure, total cholesterol, very low-density cholesterol, triglycerides, A1c, fasting plasma glucose, and C-reactive protein. Differences in systolic blood pressure, LDL and HDL cholesterol, free fatty acids, and fasting serum insulin did not achieve significance.

Overall, 19.8% of patients permanently discontinued treatment, with the most discontinuations in the liraglutide group (27.6%), followed by placebo (17.6%) and semaglutide (3.5%). Time to first and permanent discontinuation were shorter with liraglutide than with semaglutide or placebo.

Adverse events were reported by 95.2% of patients with semaglutide, 96.1% with liraglutide, and 95.3% with placebo. Gastrointestinal disorders were the most common with the two active drugs, reported by 84.1% with semaglutide and 82.7% with liraglutide versus 55.3% with placebo.

Most side effects were mild to moderate and resolved without treatment discontinuation. Severe gastrointestinal adverse events were reported by only 3.2%, 2.4%, and 3.5% of patients with semaglutide, liraglutide, and placebo, respectively.

“This trial found weight loss with semaglutide was significantly greater than with liraglutide. However, the variability in treatment response means an individual’s tolerance and sensitivity to a specific treatment is important for obesity management,” the researchers observe.

“Therefore, having multiple antiobesity medications proven to lower body weight through different mechanisms, with different adverse effect profiles and dosing regimens, can only benefit clinicians and patients,” they conclude.

The trial was funded by Novo Nordisk. Dr. Rubino has reported being a clinical investigator for Boehringer Ingelheim, AstraZeneca, and Novo Nordisk; receiving honoraria from WebMD; receiving speaker fees, consulting fees, scientific advisory fees, and honoraria from Novo Nordisk; receiving grants from SARL and personal fees from Medscape, PeerView, and the Endocrine Society; and being a shareholder in Novo Nordisk.

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

A study showing that once-weekly subcutaneous semaglutide 2.4 mg (Wegovy, Novo Nordisk) produces greater long-term weight loss than once-daily injected liraglutide 3.0 mg (Saxenda, Novo Nordisk) among adults with overweight or obesity without diabetes has now been published.

The data, previously reported at Obesity Week 2021, were published online Jan. 11 in JAMA.

The findings are from the phase 3 Semaglutide Treatment Effect in People with Obesity (STEP) 8 trial by Domenica M. Rubino, MD, of the Washington Center for Weight Management and Research, Arlington, Virginia, and colleagues.

Semaglutide and liraglutide, subcutaneously injectable glucagon-like peptide-1 (GLP-1) agonists, were both first approved for the treatment of type 2 diabetes in the United States and elsewhere, but are now also approved, in different doses, for chronic weight management and in people with obesity or overweight and comorbidities. A phase 2 trial demonstrated that once-daily semaglutide 0.4 mg produced significantly more weight loss than liraglutide 3.0 mg.

“Semaglutide and liraglutide induce weight loss by lowering energy intake. However, the reduction in caloric intake versus placebo appears to be larger with semaglutide (35%) than liraglutide (approximately 16%),” say Dr. Rubino and colleagues.

“Semaglutide has also been associated with reductions in food cravings, which is less evident with liraglutide, suggesting different mechanisms of energy intake regulation,” they add.   

Novo Nordisk has recently reported that there may be supply problems with Wegovy, as a contract manufacturer that fills syringes for pens to inject the drug temporarily halted deliveries and manufacturing after issues related to good manufacturing practice.

The company is also developing an oral form of semaglutide for weight loss. The oral form has already been approved in doses of 7 or 14 mg/day for the treatment of type 2 diabetes in the United States as Rybelsus.

Individualize treatment for those with obesity

STEP 8 was a randomized, open-label, 68-week phase 3b trial of 338 adults randomized to once-weekly semaglutide 2.4 mg (n = 126), once-daily liraglutide 3.0 mg (n = 127), or matched injected placebo (n = 85) for 68 weeks, all provided with counseling on diet and physical activity.  

The primary outcome – estimated mean change in body weight at week 68 – was –15.8% with semaglutide versus –6.4% with liraglutide, a significant difference (P < .001). The proportions of patients achieving loss of body weight of 10%, 15%, or 20% were 70.9%, 55.6%, and 38.5% with semaglutide versus 25.6%, 12.0%, and 6.0% with liraglutide, respectively.

Significantly greater reductions were also seen at 68 weeks for weekly semaglutide versus daily liraglutide in absolute body weight, waist circumference, diastolic blood pressure, total cholesterol, very low-density cholesterol, triglycerides, A1c, fasting plasma glucose, and C-reactive protein. Differences in systolic blood pressure, LDL and HDL cholesterol, free fatty acids, and fasting serum insulin did not achieve significance.

Overall, 19.8% of patients permanently discontinued treatment, with the most discontinuations in the liraglutide group (27.6%), followed by placebo (17.6%) and semaglutide (3.5%). Time to first and permanent discontinuation were shorter with liraglutide than with semaglutide or placebo.

Adverse events were reported by 95.2% of patients with semaglutide, 96.1% with liraglutide, and 95.3% with placebo. Gastrointestinal disorders were the most common with the two active drugs, reported by 84.1% with semaglutide and 82.7% with liraglutide versus 55.3% with placebo.

Most side effects were mild to moderate and resolved without treatment discontinuation. Severe gastrointestinal adverse events were reported by only 3.2%, 2.4%, and 3.5% of patients with semaglutide, liraglutide, and placebo, respectively.

“This trial found weight loss with semaglutide was significantly greater than with liraglutide. However, the variability in treatment response means an individual’s tolerance and sensitivity to a specific treatment is important for obesity management,” the researchers observe.

“Therefore, having multiple antiobesity medications proven to lower body weight through different mechanisms, with different adverse effect profiles and dosing regimens, can only benefit clinicians and patients,” they conclude.

The trial was funded by Novo Nordisk. Dr. Rubino has reported being a clinical investigator for Boehringer Ingelheim, AstraZeneca, and Novo Nordisk; receiving honoraria from WebMD; receiving speaker fees, consulting fees, scientific advisory fees, and honoraria from Novo Nordisk; receiving grants from SARL and personal fees from Medscape, PeerView, and the Endocrine Society; and being a shareholder in Novo Nordisk.

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

A study showing that once-weekly subcutaneous semaglutide 2.4 mg (Wegovy, Novo Nordisk) produces greater long-term weight loss than once-daily injected liraglutide 3.0 mg (Saxenda, Novo Nordisk) among adults with overweight or obesity without diabetes has now been published.

The data, previously reported at Obesity Week 2021, were published online Jan. 11 in JAMA.

The findings are from the phase 3 Semaglutide Treatment Effect in People with Obesity (STEP) 8 trial by Domenica M. Rubino, MD, of the Washington Center for Weight Management and Research, Arlington, Virginia, and colleagues.

Semaglutide and liraglutide, subcutaneously injectable glucagon-like peptide-1 (GLP-1) agonists, were both first approved for the treatment of type 2 diabetes in the United States and elsewhere, but are now also approved, in different doses, for chronic weight management and in people with obesity or overweight and comorbidities. A phase 2 trial demonstrated that once-daily semaglutide 0.4 mg produced significantly more weight loss than liraglutide 3.0 mg.

“Semaglutide and liraglutide induce weight loss by lowering energy intake. However, the reduction in caloric intake versus placebo appears to be larger with semaglutide (35%) than liraglutide (approximately 16%),” say Dr. Rubino and colleagues.

“Semaglutide has also been associated with reductions in food cravings, which is less evident with liraglutide, suggesting different mechanisms of energy intake regulation,” they add.   

Novo Nordisk has recently reported that there may be supply problems with Wegovy, as a contract manufacturer that fills syringes for pens to inject the drug temporarily halted deliveries and manufacturing after issues related to good manufacturing practice.

The company is also developing an oral form of semaglutide for weight loss. The oral form has already been approved in doses of 7 or 14 mg/day for the treatment of type 2 diabetes in the United States as Rybelsus.

Individualize treatment for those with obesity

STEP 8 was a randomized, open-label, 68-week phase 3b trial of 338 adults randomized to once-weekly semaglutide 2.4 mg (n = 126), once-daily liraglutide 3.0 mg (n = 127), or matched injected placebo (n = 85) for 68 weeks, all provided with counseling on diet and physical activity.  

The primary outcome – estimated mean change in body weight at week 68 – was –15.8% with semaglutide versus –6.4% with liraglutide, a significant difference (P < .001). The proportions of patients achieving loss of body weight of 10%, 15%, or 20% were 70.9%, 55.6%, and 38.5% with semaglutide versus 25.6%, 12.0%, and 6.0% with liraglutide, respectively.

Significantly greater reductions were also seen at 68 weeks for weekly semaglutide versus daily liraglutide in absolute body weight, waist circumference, diastolic blood pressure, total cholesterol, very low-density cholesterol, triglycerides, A1c, fasting plasma glucose, and C-reactive protein. Differences in systolic blood pressure, LDL and HDL cholesterol, free fatty acids, and fasting serum insulin did not achieve significance.

Overall, 19.8% of patients permanently discontinued treatment, with the most discontinuations in the liraglutide group (27.6%), followed by placebo (17.6%) and semaglutide (3.5%). Time to first and permanent discontinuation were shorter with liraglutide than with semaglutide or placebo.

Adverse events were reported by 95.2% of patients with semaglutide, 96.1% with liraglutide, and 95.3% with placebo. Gastrointestinal disorders were the most common with the two active drugs, reported by 84.1% with semaglutide and 82.7% with liraglutide versus 55.3% with placebo.

Most side effects were mild to moderate and resolved without treatment discontinuation. Severe gastrointestinal adverse events were reported by only 3.2%, 2.4%, and 3.5% of patients with semaglutide, liraglutide, and placebo, respectively.

“This trial found weight loss with semaglutide was significantly greater than with liraglutide. However, the variability in treatment response means an individual’s tolerance and sensitivity to a specific treatment is important for obesity management,” the researchers observe.

“Therefore, having multiple antiobesity medications proven to lower body weight through different mechanisms, with different adverse effect profiles and dosing regimens, can only benefit clinicians and patients,” they conclude.

The trial was funded by Novo Nordisk. Dr. Rubino has reported being a clinical investigator for Boehringer Ingelheim, AstraZeneca, and Novo Nordisk; receiving honoraria from WebMD; receiving speaker fees, consulting fees, scientific advisory fees, and honoraria from Novo Nordisk; receiving grants from SARL and personal fees from Medscape, PeerView, and the Endocrine Society; and being a shareholder in Novo Nordisk.

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

Orally dissolving medications containing buprenorphine are linked to severe dental problems, including total tooth loss, the U.S. Food and Drug Administration warns in a safety communication.

The oral side effects of these medications, which are used to treat opioid use disorder (OUD) and pain, include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.

More than 300 reported cases

Buprenorphine was approved in 2002 as a sublingual tablet, and in 2015 as a film to be placed inside the cheek to treat pain. Both delivery methods have been associated with dental problems.

Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious.

There may be other cases, the FDA says, as this represents only cases reported to the FDA or published in the medical literature.

The average age of the patients who developed dental problems while taking buprenorphine is 42 years, but those as young as 18 years old were also affected.

Most cases occurred in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.

In 26 cases, patients had no prior history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

Among all 305 cases reported, 113 involved two or more teeth.

The most common treatment for the dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases required root canals, dental surgery, and other procedures such as crowns and implants.
 

Recommendations

The FDA says health care providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their health care provider, as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.

Patients are also being advised to take extra steps to help lessen the risk of serious dental problems.

Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines.

Counsel them that after the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth, as the FDA advises. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

The FDA also advises that patients tell their provider about any history of tooth problems, including cavities, and schedule a dentist visit soon after starting the medicine.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

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

Orally dissolving medications containing buprenorphine are linked to severe dental problems, including total tooth loss, the U.S. Food and Drug Administration warns in a safety communication.

The oral side effects of these medications, which are used to treat opioid use disorder (OUD) and pain, include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.

More than 300 reported cases

Buprenorphine was approved in 2002 as a sublingual tablet, and in 2015 as a film to be placed inside the cheek to treat pain. Both delivery methods have been associated with dental problems.

Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious.

There may be other cases, the FDA says, as this represents only cases reported to the FDA or published in the medical literature.

The average age of the patients who developed dental problems while taking buprenorphine is 42 years, but those as young as 18 years old were also affected.

Most cases occurred in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.

In 26 cases, patients had no prior history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

Among all 305 cases reported, 113 involved two or more teeth.

The most common treatment for the dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases required root canals, dental surgery, and other procedures such as crowns and implants.
 

Recommendations

The FDA says health care providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their health care provider, as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.

Patients are also being advised to take extra steps to help lessen the risk of serious dental problems.

Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines.

Counsel them that after the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth, as the FDA advises. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

The FDA also advises that patients tell their provider about any history of tooth problems, including cavities, and schedule a dentist visit soon after starting the medicine.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

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

Orally dissolving medications containing buprenorphine are linked to severe dental problems, including total tooth loss, the U.S. Food and Drug Administration warns in a safety communication.

The oral side effects of these medications, which are used to treat opioid use disorder (OUD) and pain, include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.

More than 300 reported cases

Buprenorphine was approved in 2002 as a sublingual tablet, and in 2015 as a film to be placed inside the cheek to treat pain. Both delivery methods have been associated with dental problems.

Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious.

There may be other cases, the FDA says, as this represents only cases reported to the FDA or published in the medical literature.

The average age of the patients who developed dental problems while taking buprenorphine is 42 years, but those as young as 18 years old were also affected.

Most cases occurred in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.

In 26 cases, patients had no prior history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

Among all 305 cases reported, 113 involved two or more teeth.

The most common treatment for the dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases required root canals, dental surgery, and other procedures such as crowns and implants.
 

Recommendations

The FDA says health care providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their health care provider, as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.

Patients are also being advised to take extra steps to help lessen the risk of serious dental problems.

Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines.

Counsel them that after the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth, as the FDA advises. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

The FDA also advises that patients tell their provider about any history of tooth problems, including cavities, and schedule a dentist visit soon after starting the medicine.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

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

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices has now recommended using Sanofi’s dengue vaccine, Dengvaxia, in the United States, with specific restrictions. The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.

Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.

The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.

The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.

Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.

In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.

Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
 

Antibody tests prevaccination

The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.

Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.

If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.

There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”

One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”

Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”

Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”

Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.

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

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices has now recommended using Sanofi’s dengue vaccine, Dengvaxia, in the United States, with specific restrictions. The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.

Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.

The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.

The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.

Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.

In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.

Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
 

Antibody tests prevaccination

The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.

Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.

If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.

There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”

One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”

Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”

Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”

Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.

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

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices has now recommended using Sanofi’s dengue vaccine, Dengvaxia, in the United States, with specific restrictions. The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.

Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.

The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.

The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.

Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.

In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.

Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
 

Antibody tests prevaccination

The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.

Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.

If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.

There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”

One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”

Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”

Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”

Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.

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

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.