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Teens streaming on Twitch vulnerable to predators

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Changed
Tue, 10/31/2023 - 13:09

– Half of youth broadcasting live streams on the online platform Twitch revealed their real-world location, and nearly half provided their name to viewers, according to research presented at the annual meeting of the American Academy of Pediatrics. It took researchers less than 5 minutes – and sometimes as little as 12 seconds – to find minors in different video game categories, suggesting the environment offers opportunities to predators to gain sensitive information about minors, reported Fiona Dubrosa, BS, BA, a visiting scholar at Cohen Children’s Medical Center, New York, and colleagues.

A ‘clandestine, threatening digital environment’

“Twitch represents a clandestine, threatening digital environment where minors are interacting with adult strangers without parental supervision,” the authors concluded. “The nature of live streaming makes it particularly dangerous, as there is no way to take back information that has been revealed or regulate content or viewers. Parents and pediatricians should be aware of the dangers presented by Twitch and other live-streaming platforms and counsel children on best practices for Internet safety.”

Twitch is an online streaming platform where people can watch creator’s live content, such as music performances or narrating real-time video game playing. The platform requires live streamers to be 13 years old with a valid email address or phone number to create an account, but no age restrictions or identification requirements exist for viewers, “potentially putting minors in danger of being watched, followed, and groomed by predators,” the researchers noted. They added that people following different streamers receive notifications when those streamers are live. Further, “viewers can donate money to streamers, which can make it easier for predators to manipulate, track, and encourage risky behaviors from minors.”

To better understand the risks the platform might pose to minors, the researchers searched for and analyzed popular video game live streams that appeared to be streamed by minors who had their cameras on and their faces visible. Then the researchers noted the name of the video game, the topics discussed by the streamers, the time it took to find minors under each game, and each streamer’s age, name, follower count, location, streaming schedule, and social media links for money donations.

The researchers analyzed 100 Twitch streamers who were minors, who had a combined 1,755,452 million followers. Nearly half the streamers (47%) provided their presumably real names, and half (50%) gave out their location. Nearly two-thirds (64%) linked other social media accounts they had and encouraged viewers to follow them. Detailed schedules of when they would be live were available for 38% of the streamers, and 37% of the minor streamers were accepting money donations.

Only 11% of the discussion on the streams revealed personal details, most often related to trying on different outfits for viewers and talking about real-world locations they liked to visit. The researchers needed anywhere from 12 seconds to 5 minutes to find a minor in each game category.

”Young users clearly feel a false sense of safety on the platform; a significant proportion were willing to reveal personal information despite having no knowledge of who might be listening,” the researchers said. “The donation system provides a menacing avenue for manipulation and continued exploitation of minors. Our findings reveal the need for stricter age limitations for streamers and more stringent identity verification of audience members on Twitch.”
 

 

 

Open-minded parental guidance is warranted

Jenny Radesky, MD, a developmental behavioral pediatrician and media researcher at University of Michigan Medicine, Ann Arbor, was not surprised that many teens live stream on Twitch since it’s a popular platform for video gaming, but she was surprised at how many revealed their locations and other personal details.

courtesy University of Michigan Medicine
Dr. Jenny Radesky

“I suspect that they do this to build closeness with their viewers, by seeming more authentic,” said Dr. Radesky, who was not involved in the study. “It is this type of parasocial relationship with influencers and gamers that keeps an audience engaged, and encourages future viewing and purchases.”

Their willingness to share personal details suggests it’s important to conduct qualitative research to find out how teen live streamers think about privacy risks, what privacy settings they can use and choose to use, and how they handle inappropriate contact from adults, Dr. Radesky said.

Meanwhile, parents should talk with their kids in an open-minded way about what platforms they use and what they like and dislike about them. She recommended parents read the Common Sense Media guide about different social platforms ”to understand what attracts kids to content on specific sites, what their pitfalls are, and what types of privacy and safety settings are available.”

“A child or teen is much more likely to be honest about negative experiences online if they think their parent will hear them out – not judge them or take away their tech. No teen wants to talk with a panicky parent,” Dr. Radesky said.

David Hill, MD, a hospitalist pediatrician for Goldsboro Pediatrics in Wayne County, North Carolina, who also specializes in media communication, said that Twitch is just one example of a social media platform where children can encounter a variety of dangers, including sometimes adult predators.

courtesy Goldsboro Pediatrics
Dr. David Hill

“This just highlights the importance of parents having an ongoing conversation with their children about how they use their social media platforms and ensuring, just as we do with learning to ride a bicycle or learning to drive a car, that they apply some basic rules of safety,” Dr. Hill said. Then it’s important to keep coming back to that conversation “again and again as they grow and change and as those platforms change to ensure that those kids are continuing to apply those rules consistently.

“The best way for parents to keep up is ask your kids,” he said. “They love to share. They love to teach. They love to be in a position to show you something, especially if it’s something that interests them.”

An example of a rule would be setting personal accounts to private, not public, by default, Dr. Radesky said. “When interviewed, teens often say that they feel intruded upon by older people ‘stalking’ them or trying to connect with them on social platforms,” so making an account private can reduce those opportunities.

For teens who specifically want to create content on social platforms, parent oversight is needed, she said, but she acknowledged it can be a lot of work. “This might take the form of talking about what a teen plans to post before they do, expectations for positive behaviors or language, plans for privacy settings (such as public vs. private accounts), and what to do with trolls or hateful comment,” she said. “Parents may want to follow their child’s account to check in on it.”
 

 

 

Useful advice

Dr. Radesky also provided a handful of talking points that pediatricians can use in talking with patients who use these platforms:

  • Keep your account private to just your friends and people you want to interact with. There are a lot of people on the Internet that you don’t want intruding upon your social life.
  • Maintain your feed and the accounts you follow to keep it positive, entertaining, and not a source of stress or self-doubt. Content creators are always trying to grab your attention in new ways, some of which are rude or dehumanizing, so don’t waste your time on things that bring you down.
  • Talk about why you want to post or live stream. Is it to get reactions or feel validated? If so, can you find other ways to feel validated that don’t require performing for other people? Is it to share a special skill? If so, how do you keep your posts creative and community building rather than attention grabbing? And how can you keep your parents involved so that they can help you navigate challenges?”

Ms. Dubrosa and Dr. Hill had no disclosures. Dr. Radesky is a consultant for Melissa & Doug. No information on external funding was provided.

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– Half of youth broadcasting live streams on the online platform Twitch revealed their real-world location, and nearly half provided their name to viewers, according to research presented at the annual meeting of the American Academy of Pediatrics. It took researchers less than 5 minutes – and sometimes as little as 12 seconds – to find minors in different video game categories, suggesting the environment offers opportunities to predators to gain sensitive information about minors, reported Fiona Dubrosa, BS, BA, a visiting scholar at Cohen Children’s Medical Center, New York, and colleagues.

A ‘clandestine, threatening digital environment’

“Twitch represents a clandestine, threatening digital environment where minors are interacting with adult strangers without parental supervision,” the authors concluded. “The nature of live streaming makes it particularly dangerous, as there is no way to take back information that has been revealed or regulate content or viewers. Parents and pediatricians should be aware of the dangers presented by Twitch and other live-streaming platforms and counsel children on best practices for Internet safety.”

Twitch is an online streaming platform where people can watch creator’s live content, such as music performances or narrating real-time video game playing. The platform requires live streamers to be 13 years old with a valid email address or phone number to create an account, but no age restrictions or identification requirements exist for viewers, “potentially putting minors in danger of being watched, followed, and groomed by predators,” the researchers noted. They added that people following different streamers receive notifications when those streamers are live. Further, “viewers can donate money to streamers, which can make it easier for predators to manipulate, track, and encourage risky behaviors from minors.”

To better understand the risks the platform might pose to minors, the researchers searched for and analyzed popular video game live streams that appeared to be streamed by minors who had their cameras on and their faces visible. Then the researchers noted the name of the video game, the topics discussed by the streamers, the time it took to find minors under each game, and each streamer’s age, name, follower count, location, streaming schedule, and social media links for money donations.

The researchers analyzed 100 Twitch streamers who were minors, who had a combined 1,755,452 million followers. Nearly half the streamers (47%) provided their presumably real names, and half (50%) gave out their location. Nearly two-thirds (64%) linked other social media accounts they had and encouraged viewers to follow them. Detailed schedules of when they would be live were available for 38% of the streamers, and 37% of the minor streamers were accepting money donations.

Only 11% of the discussion on the streams revealed personal details, most often related to trying on different outfits for viewers and talking about real-world locations they liked to visit. The researchers needed anywhere from 12 seconds to 5 minutes to find a minor in each game category.

”Young users clearly feel a false sense of safety on the platform; a significant proportion were willing to reveal personal information despite having no knowledge of who might be listening,” the researchers said. “The donation system provides a menacing avenue for manipulation and continued exploitation of minors. Our findings reveal the need for stricter age limitations for streamers and more stringent identity verification of audience members on Twitch.”
 

 

 

Open-minded parental guidance is warranted

Jenny Radesky, MD, a developmental behavioral pediatrician and media researcher at University of Michigan Medicine, Ann Arbor, was not surprised that many teens live stream on Twitch since it’s a popular platform for video gaming, but she was surprised at how many revealed their locations and other personal details.

courtesy University of Michigan Medicine
Dr. Jenny Radesky

“I suspect that they do this to build closeness with their viewers, by seeming more authentic,” said Dr. Radesky, who was not involved in the study. “It is this type of parasocial relationship with influencers and gamers that keeps an audience engaged, and encourages future viewing and purchases.”

Their willingness to share personal details suggests it’s important to conduct qualitative research to find out how teen live streamers think about privacy risks, what privacy settings they can use and choose to use, and how they handle inappropriate contact from adults, Dr. Radesky said.

Meanwhile, parents should talk with their kids in an open-minded way about what platforms they use and what they like and dislike about them. She recommended parents read the Common Sense Media guide about different social platforms ”to understand what attracts kids to content on specific sites, what their pitfalls are, and what types of privacy and safety settings are available.”

“A child or teen is much more likely to be honest about negative experiences online if they think their parent will hear them out – not judge them or take away their tech. No teen wants to talk with a panicky parent,” Dr. Radesky said.

David Hill, MD, a hospitalist pediatrician for Goldsboro Pediatrics in Wayne County, North Carolina, who also specializes in media communication, said that Twitch is just one example of a social media platform where children can encounter a variety of dangers, including sometimes adult predators.

courtesy Goldsboro Pediatrics
Dr. David Hill

“This just highlights the importance of parents having an ongoing conversation with their children about how they use their social media platforms and ensuring, just as we do with learning to ride a bicycle or learning to drive a car, that they apply some basic rules of safety,” Dr. Hill said. Then it’s important to keep coming back to that conversation “again and again as they grow and change and as those platforms change to ensure that those kids are continuing to apply those rules consistently.

“The best way for parents to keep up is ask your kids,” he said. “They love to share. They love to teach. They love to be in a position to show you something, especially if it’s something that interests them.”

An example of a rule would be setting personal accounts to private, not public, by default, Dr. Radesky said. “When interviewed, teens often say that they feel intruded upon by older people ‘stalking’ them or trying to connect with them on social platforms,” so making an account private can reduce those opportunities.

For teens who specifically want to create content on social platforms, parent oversight is needed, she said, but she acknowledged it can be a lot of work. “This might take the form of talking about what a teen plans to post before they do, expectations for positive behaviors or language, plans for privacy settings (such as public vs. private accounts), and what to do with trolls or hateful comment,” she said. “Parents may want to follow their child’s account to check in on it.”
 

 

 

Useful advice

Dr. Radesky also provided a handful of talking points that pediatricians can use in talking with patients who use these platforms:

  • Keep your account private to just your friends and people you want to interact with. There are a lot of people on the Internet that you don’t want intruding upon your social life.
  • Maintain your feed and the accounts you follow to keep it positive, entertaining, and not a source of stress or self-doubt. Content creators are always trying to grab your attention in new ways, some of which are rude or dehumanizing, so don’t waste your time on things that bring you down.
  • Talk about why you want to post or live stream. Is it to get reactions or feel validated? If so, can you find other ways to feel validated that don’t require performing for other people? Is it to share a special skill? If so, how do you keep your posts creative and community building rather than attention grabbing? And how can you keep your parents involved so that they can help you navigate challenges?”

Ms. Dubrosa and Dr. Hill had no disclosures. Dr. Radesky is a consultant for Melissa & Doug. No information on external funding was provided.

– Half of youth broadcasting live streams on the online platform Twitch revealed their real-world location, and nearly half provided their name to viewers, according to research presented at the annual meeting of the American Academy of Pediatrics. It took researchers less than 5 minutes – and sometimes as little as 12 seconds – to find minors in different video game categories, suggesting the environment offers opportunities to predators to gain sensitive information about minors, reported Fiona Dubrosa, BS, BA, a visiting scholar at Cohen Children’s Medical Center, New York, and colleagues.

A ‘clandestine, threatening digital environment’

“Twitch represents a clandestine, threatening digital environment where minors are interacting with adult strangers without parental supervision,” the authors concluded. “The nature of live streaming makes it particularly dangerous, as there is no way to take back information that has been revealed or regulate content or viewers. Parents and pediatricians should be aware of the dangers presented by Twitch and other live-streaming platforms and counsel children on best practices for Internet safety.”

Twitch is an online streaming platform where people can watch creator’s live content, such as music performances or narrating real-time video game playing. The platform requires live streamers to be 13 years old with a valid email address or phone number to create an account, but no age restrictions or identification requirements exist for viewers, “potentially putting minors in danger of being watched, followed, and groomed by predators,” the researchers noted. They added that people following different streamers receive notifications when those streamers are live. Further, “viewers can donate money to streamers, which can make it easier for predators to manipulate, track, and encourage risky behaviors from minors.”

To better understand the risks the platform might pose to minors, the researchers searched for and analyzed popular video game live streams that appeared to be streamed by minors who had their cameras on and their faces visible. Then the researchers noted the name of the video game, the topics discussed by the streamers, the time it took to find minors under each game, and each streamer’s age, name, follower count, location, streaming schedule, and social media links for money donations.

The researchers analyzed 100 Twitch streamers who were minors, who had a combined 1,755,452 million followers. Nearly half the streamers (47%) provided their presumably real names, and half (50%) gave out their location. Nearly two-thirds (64%) linked other social media accounts they had and encouraged viewers to follow them. Detailed schedules of when they would be live were available for 38% of the streamers, and 37% of the minor streamers were accepting money donations.

Only 11% of the discussion on the streams revealed personal details, most often related to trying on different outfits for viewers and talking about real-world locations they liked to visit. The researchers needed anywhere from 12 seconds to 5 minutes to find a minor in each game category.

”Young users clearly feel a false sense of safety on the platform; a significant proportion were willing to reveal personal information despite having no knowledge of who might be listening,” the researchers said. “The donation system provides a menacing avenue for manipulation and continued exploitation of minors. Our findings reveal the need for stricter age limitations for streamers and more stringent identity verification of audience members on Twitch.”
 

 

 

Open-minded parental guidance is warranted

Jenny Radesky, MD, a developmental behavioral pediatrician and media researcher at University of Michigan Medicine, Ann Arbor, was not surprised that many teens live stream on Twitch since it’s a popular platform for video gaming, but she was surprised at how many revealed their locations and other personal details.

courtesy University of Michigan Medicine
Dr. Jenny Radesky

“I suspect that they do this to build closeness with their viewers, by seeming more authentic,” said Dr. Radesky, who was not involved in the study. “It is this type of parasocial relationship with influencers and gamers that keeps an audience engaged, and encourages future viewing and purchases.”

Their willingness to share personal details suggests it’s important to conduct qualitative research to find out how teen live streamers think about privacy risks, what privacy settings they can use and choose to use, and how they handle inappropriate contact from adults, Dr. Radesky said.

Meanwhile, parents should talk with their kids in an open-minded way about what platforms they use and what they like and dislike about them. She recommended parents read the Common Sense Media guide about different social platforms ”to understand what attracts kids to content on specific sites, what their pitfalls are, and what types of privacy and safety settings are available.”

“A child or teen is much more likely to be honest about negative experiences online if they think their parent will hear them out – not judge them or take away their tech. No teen wants to talk with a panicky parent,” Dr. Radesky said.

David Hill, MD, a hospitalist pediatrician for Goldsboro Pediatrics in Wayne County, North Carolina, who also specializes in media communication, said that Twitch is just one example of a social media platform where children can encounter a variety of dangers, including sometimes adult predators.

courtesy Goldsboro Pediatrics
Dr. David Hill

“This just highlights the importance of parents having an ongoing conversation with their children about how they use their social media platforms and ensuring, just as we do with learning to ride a bicycle or learning to drive a car, that they apply some basic rules of safety,” Dr. Hill said. Then it’s important to keep coming back to that conversation “again and again as they grow and change and as those platforms change to ensure that those kids are continuing to apply those rules consistently.

“The best way for parents to keep up is ask your kids,” he said. “They love to share. They love to teach. They love to be in a position to show you something, especially if it’s something that interests them.”

An example of a rule would be setting personal accounts to private, not public, by default, Dr. Radesky said. “When interviewed, teens often say that they feel intruded upon by older people ‘stalking’ them or trying to connect with them on social platforms,” so making an account private can reduce those opportunities.

For teens who specifically want to create content on social platforms, parent oversight is needed, she said, but she acknowledged it can be a lot of work. “This might take the form of talking about what a teen plans to post before they do, expectations for positive behaviors or language, plans for privacy settings (such as public vs. private accounts), and what to do with trolls or hateful comment,” she said. “Parents may want to follow their child’s account to check in on it.”
 

 

 

Useful advice

Dr. Radesky also provided a handful of talking points that pediatricians can use in talking with patients who use these platforms:

  • Keep your account private to just your friends and people you want to interact with. There are a lot of people on the Internet that you don’t want intruding upon your social life.
  • Maintain your feed and the accounts you follow to keep it positive, entertaining, and not a source of stress or self-doubt. Content creators are always trying to grab your attention in new ways, some of which are rude or dehumanizing, so don’t waste your time on things that bring you down.
  • Talk about why you want to post or live stream. Is it to get reactions or feel validated? If so, can you find other ways to feel validated that don’t require performing for other people? Is it to share a special skill? If so, how do you keep your posts creative and community building rather than attention grabbing? And how can you keep your parents involved so that they can help you navigate challenges?”

Ms. Dubrosa and Dr. Hill had no disclosures. Dr. Radesky is a consultant for Melissa & Doug. No information on external funding was provided.

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Teens have easy online access to Delta-8 cannabinoid products

Article Type
Changed
Fri, 11/03/2023 - 15:38

Teens can access products containing Delta 8, a psychoactive cannabinoid, fairly easily and cheaply through online sites that don’t require age verification for purchases, researchers reported at the 2023 annual meeting of the American Academy of Pediatrics. Most of the products identified came in bright, colorful, kid-friendly packaging and cost less than $10, the researchers found, and only 2 out of 45 sites had a third-party age verification requirement for purchases.

AAP
Kid-friendly packaging of Delta 8. Each package in this figure came from a separate website that was examined during the study. These are some examples of the many kid-friendly packages that are available for purchase.

Delta-8 THC, also called D8, is a synthetically produced cannabinoid whose chemical structure and effects are nearly identical to traditional THC, the authors explained, and past research has found that D8 products, such as e-cigarettes, can contain toxic byproducts and contaminants.

”Since D8 is not traditional THC, minors may underestimate its strength and potential danger,” wrote lead author Abhijeet Grewal, BS, a research assistant at Cohen Children’s Medical Center, New York, and senior author Ruth Milanaik, DO, director of the Neonatal Neurodevelopmental Program at Cohen Children’s and a developmental/behavioral pediatrician at Northwell Health, also in New York. “Although traditional THC is a federally banned substance, D8 is legal on a federal level and less restricted on a state by state basis, making it easier for individuals to acquire D8.”
 

Easily accessible

During the first seven moments of 2021, 77% of reports of accidental exposure occurred in people under age 18, including some children who required ICU admission. The U.S. Food and Drug Administration also received 104 reports of adverse events from products containing D8 between December 2020-February 2022, and more than half of those required medical intervention.

To better understand how easy it is to access D8, the authors collected data on 45 websites they identified that sold D8. The researchers looked for age verification questions for accessing the site, third-party age certification, what kinds of products (edibles, smoke products, or tinctures) were sold, the price and dosage of the cheapest product, and examples of packaging, flavors, marketing claims, and warning statements at each site.

More than a third of the sites (36%) did not ask for customers’ age and almost none of the sites asked for proof: 96% of the sites lacked formal third-party age verification procedures. All but one of the sites sold D8 edibles, and most (82%) sold D8 vaping or smoking products. Only 42% sold tinctures, a mix of concentrated D8 with oil that’s orally consumed.

The cheapest product was priced under $5 on one-third of the sites and under $10 on another third of the sites. The cheapest product was between $10-20 on 16% of the sites while the remaining nine sites’ cheapest product was more than $20. In assessing only the cheapest D8 products on each site, nearly half (47%) contained 51 mg or more of D8, and 20% of the products didn’t report the dosage. Another 22% contained 41-50 mg of D8, and the remaining five products contained 20-40 mg.
 

 

 

Kid-friendly D8

More than half of the D8 products were sold in kid-friendly packaging – packages with bright, colorful designs and fonts that resemble candy or snack food, sometimes cartoon characters or fun items like dice on the packaging. Further, 24% of the websites did not include any warnings or other health information about D8.

“The low prices, high dosages available, and eye-popping packaging make these products extremely attractive to teens who are looking for a high,” the researchers concluded. They advised clinicians to talk with teen patients about the dangers of D8 and advocated for policymakers to more strictly regulate online distributors of D8 products, particularly in requiring age verification procedures and prohibiting kid-friendly packaging.

Megan Moreno, MD, MSEd, MPH, an adolescent medicine physician and researcher at the University of Wisconsin, Madison, School of Medicine and Public Health and UWHealthKids, was particularly struck by how eye-catching the packaging was. “The bright colors and font choices are really designed to attract adolescents,” commented Dr. Moreno, who was not involved in the study. But she was not surprised overall by the findings.

“Other studies have found that the cannabis industry leverages online tools and social media, alongside youth-friendly packaging, to attract youth to their products,” she said. “What is disappointing is that these companies do not use industry standard approaches, such as the alcohol industry, to age-gate their websites.”

It’s important for providers who care for adolescents to ask about substance use but to especially include questions about substances that teens might not think of as “drugs,” such as Delta 8, Dr. Moreno said.

“Prior research on other types of substance such as these has found that teens can think these are less dangerous versions of cannabis, so providing accurate information and asking about these products can prevent harm to kids,” Dr. Moreno said. Although this study focused on websites that sell D8 products, she said that “another important area of influence to consider is social media messaging around these products, which may drive traffic to the purchasing site.” It’s clear this industry is not going to self-regulate without policy changes, Dr. Moreno added, so she noted the importance of advocating for policy that regulates these sites.

Mr. Grewal, Dr. Milanaik and Dr. Moreno had no disclosures. No external funding sources were noted.

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Teens can access products containing Delta 8, a psychoactive cannabinoid, fairly easily and cheaply through online sites that don’t require age verification for purchases, researchers reported at the 2023 annual meeting of the American Academy of Pediatrics. Most of the products identified came in bright, colorful, kid-friendly packaging and cost less than $10, the researchers found, and only 2 out of 45 sites had a third-party age verification requirement for purchases.

AAP
Kid-friendly packaging of Delta 8. Each package in this figure came from a separate website that was examined during the study. These are some examples of the many kid-friendly packages that are available for purchase.

Delta-8 THC, also called D8, is a synthetically produced cannabinoid whose chemical structure and effects are nearly identical to traditional THC, the authors explained, and past research has found that D8 products, such as e-cigarettes, can contain toxic byproducts and contaminants.

”Since D8 is not traditional THC, minors may underestimate its strength and potential danger,” wrote lead author Abhijeet Grewal, BS, a research assistant at Cohen Children’s Medical Center, New York, and senior author Ruth Milanaik, DO, director of the Neonatal Neurodevelopmental Program at Cohen Children’s and a developmental/behavioral pediatrician at Northwell Health, also in New York. “Although traditional THC is a federally banned substance, D8 is legal on a federal level and less restricted on a state by state basis, making it easier for individuals to acquire D8.”
 

Easily accessible

During the first seven moments of 2021, 77% of reports of accidental exposure occurred in people under age 18, including some children who required ICU admission. The U.S. Food and Drug Administration also received 104 reports of adverse events from products containing D8 between December 2020-February 2022, and more than half of those required medical intervention.

To better understand how easy it is to access D8, the authors collected data on 45 websites they identified that sold D8. The researchers looked for age verification questions for accessing the site, third-party age certification, what kinds of products (edibles, smoke products, or tinctures) were sold, the price and dosage of the cheapest product, and examples of packaging, flavors, marketing claims, and warning statements at each site.

More than a third of the sites (36%) did not ask for customers’ age and almost none of the sites asked for proof: 96% of the sites lacked formal third-party age verification procedures. All but one of the sites sold D8 edibles, and most (82%) sold D8 vaping or smoking products. Only 42% sold tinctures, a mix of concentrated D8 with oil that’s orally consumed.

The cheapest product was priced under $5 on one-third of the sites and under $10 on another third of the sites. The cheapest product was between $10-20 on 16% of the sites while the remaining nine sites’ cheapest product was more than $20. In assessing only the cheapest D8 products on each site, nearly half (47%) contained 51 mg or more of D8, and 20% of the products didn’t report the dosage. Another 22% contained 41-50 mg of D8, and the remaining five products contained 20-40 mg.
 

 

 

Kid-friendly D8

More than half of the D8 products were sold in kid-friendly packaging – packages with bright, colorful designs and fonts that resemble candy or snack food, sometimes cartoon characters or fun items like dice on the packaging. Further, 24% of the websites did not include any warnings or other health information about D8.

“The low prices, high dosages available, and eye-popping packaging make these products extremely attractive to teens who are looking for a high,” the researchers concluded. They advised clinicians to talk with teen patients about the dangers of D8 and advocated for policymakers to more strictly regulate online distributors of D8 products, particularly in requiring age verification procedures and prohibiting kid-friendly packaging.

Megan Moreno, MD, MSEd, MPH, an adolescent medicine physician and researcher at the University of Wisconsin, Madison, School of Medicine and Public Health and UWHealthKids, was particularly struck by how eye-catching the packaging was. “The bright colors and font choices are really designed to attract adolescents,” commented Dr. Moreno, who was not involved in the study. But she was not surprised overall by the findings.

“Other studies have found that the cannabis industry leverages online tools and social media, alongside youth-friendly packaging, to attract youth to their products,” she said. “What is disappointing is that these companies do not use industry standard approaches, such as the alcohol industry, to age-gate their websites.”

It’s important for providers who care for adolescents to ask about substance use but to especially include questions about substances that teens might not think of as “drugs,” such as Delta 8, Dr. Moreno said.

“Prior research on other types of substance such as these has found that teens can think these are less dangerous versions of cannabis, so providing accurate information and asking about these products can prevent harm to kids,” Dr. Moreno said. Although this study focused on websites that sell D8 products, she said that “another important area of influence to consider is social media messaging around these products, which may drive traffic to the purchasing site.” It’s clear this industry is not going to self-regulate without policy changes, Dr. Moreno added, so she noted the importance of advocating for policy that regulates these sites.

Mr. Grewal, Dr. Milanaik and Dr. Moreno had no disclosures. No external funding sources were noted.

Teens can access products containing Delta 8, a psychoactive cannabinoid, fairly easily and cheaply through online sites that don’t require age verification for purchases, researchers reported at the 2023 annual meeting of the American Academy of Pediatrics. Most of the products identified came in bright, colorful, kid-friendly packaging and cost less than $10, the researchers found, and only 2 out of 45 sites had a third-party age verification requirement for purchases.

AAP
Kid-friendly packaging of Delta 8. Each package in this figure came from a separate website that was examined during the study. These are some examples of the many kid-friendly packages that are available for purchase.

Delta-8 THC, also called D8, is a synthetically produced cannabinoid whose chemical structure and effects are nearly identical to traditional THC, the authors explained, and past research has found that D8 products, such as e-cigarettes, can contain toxic byproducts and contaminants.

”Since D8 is not traditional THC, minors may underestimate its strength and potential danger,” wrote lead author Abhijeet Grewal, BS, a research assistant at Cohen Children’s Medical Center, New York, and senior author Ruth Milanaik, DO, director of the Neonatal Neurodevelopmental Program at Cohen Children’s and a developmental/behavioral pediatrician at Northwell Health, also in New York. “Although traditional THC is a federally banned substance, D8 is legal on a federal level and less restricted on a state by state basis, making it easier for individuals to acquire D8.”
 

Easily accessible

During the first seven moments of 2021, 77% of reports of accidental exposure occurred in people under age 18, including some children who required ICU admission. The U.S. Food and Drug Administration also received 104 reports of adverse events from products containing D8 between December 2020-February 2022, and more than half of those required medical intervention.

To better understand how easy it is to access D8, the authors collected data on 45 websites they identified that sold D8. The researchers looked for age verification questions for accessing the site, third-party age certification, what kinds of products (edibles, smoke products, or tinctures) were sold, the price and dosage of the cheapest product, and examples of packaging, flavors, marketing claims, and warning statements at each site.

More than a third of the sites (36%) did not ask for customers’ age and almost none of the sites asked for proof: 96% of the sites lacked formal third-party age verification procedures. All but one of the sites sold D8 edibles, and most (82%) sold D8 vaping or smoking products. Only 42% sold tinctures, a mix of concentrated D8 with oil that’s orally consumed.

The cheapest product was priced under $5 on one-third of the sites and under $10 on another third of the sites. The cheapest product was between $10-20 on 16% of the sites while the remaining nine sites’ cheapest product was more than $20. In assessing only the cheapest D8 products on each site, nearly half (47%) contained 51 mg or more of D8, and 20% of the products didn’t report the dosage. Another 22% contained 41-50 mg of D8, and the remaining five products contained 20-40 mg.
 

 

 

Kid-friendly D8

More than half of the D8 products were sold in kid-friendly packaging – packages with bright, colorful designs and fonts that resemble candy or snack food, sometimes cartoon characters or fun items like dice on the packaging. Further, 24% of the websites did not include any warnings or other health information about D8.

“The low prices, high dosages available, and eye-popping packaging make these products extremely attractive to teens who are looking for a high,” the researchers concluded. They advised clinicians to talk with teen patients about the dangers of D8 and advocated for policymakers to more strictly regulate online distributors of D8 products, particularly in requiring age verification procedures and prohibiting kid-friendly packaging.

Megan Moreno, MD, MSEd, MPH, an adolescent medicine physician and researcher at the University of Wisconsin, Madison, School of Medicine and Public Health and UWHealthKids, was particularly struck by how eye-catching the packaging was. “The bright colors and font choices are really designed to attract adolescents,” commented Dr. Moreno, who was not involved in the study. But she was not surprised overall by the findings.

“Other studies have found that the cannabis industry leverages online tools and social media, alongside youth-friendly packaging, to attract youth to their products,” she said. “What is disappointing is that these companies do not use industry standard approaches, such as the alcohol industry, to age-gate their websites.”

It’s important for providers who care for adolescents to ask about substance use but to especially include questions about substances that teens might not think of as “drugs,” such as Delta 8, Dr. Moreno said.

“Prior research on other types of substance such as these has found that teens can think these are less dangerous versions of cannabis, so providing accurate information and asking about these products can prevent harm to kids,” Dr. Moreno said. Although this study focused on websites that sell D8 products, she said that “another important area of influence to consider is social media messaging around these products, which may drive traffic to the purchasing site.” It’s clear this industry is not going to self-regulate without policy changes, Dr. Moreno added, so she noted the importance of advocating for policy that regulates these sites.

Mr. Grewal, Dr. Milanaik and Dr. Moreno had no disclosures. No external funding sources were noted.

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Systematic review spotlights the use of nutraceuticals for acne

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Fri, 10/27/2023 - 15:13

Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

Dr. John S. Barbieri

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.



The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri
Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

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Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

Dr. John S. Barbieri

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.



The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri
Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

Dr. John S. Barbieri

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.



The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri
Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

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FDA approves fixed dose combination topical treatment for acne

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Wed, 10/25/2023 - 10:23

The Food and Drug Administration has approved a topical combination of 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide for the treatment of acne vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.

The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.



The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.

Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.

The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.

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The Food and Drug Administration has approved a topical combination of 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide for the treatment of acne vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.

The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.



The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.

Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.

The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.

The Food and Drug Administration has approved a topical combination of 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide for the treatment of acne vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.

The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.



The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.

Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.

The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.

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New meningococcal vaccine wins FDA approval

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Tue, 10/24/2023 - 16:21

The U.S. Food and Drug Administration has approved a meningococcal vaccine against the five most common serogroups causing disease in children and young adults.

The new formulation called Penbraya is manufactured by Pfizer and combines the components from two existing meningococcal vaccines, Trumenba the group B vaccine and Nimenrix groups A, C, W-135, and Y conjugate vaccine.

This is the first pentavalent vaccine for meningococcal disease and is approved for use in people aged 10-25.

“Today marks an important step forward in the prevention of meningococcal disease in the U.S.,” Annaliesa Anderson, PhD, head of vaccine research and development at Pfizer, said in a news release. “In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”
 

One shot, five common types

“Incomplete protection against invasive meningococcal disease,” is common, added Jana Shaw, MD, MPH, a pediatric infectious diseases specialist from Upstate Golisano Children’s Hospital in Syracuse, N.Y. Reducing the number of shots is important because streamlining the vaccination process should help increase the number of young people who get fully vaccinated against meningococcal disease.

Rates are low in the United States, according to the Centers for Disease Control and Prevention, and in 2021 there were around 210 cases reported. But a statewide outbreak has been going on in Virginia since June 2022, with 29 confirmed cases and 6 deaths.

The FDA’s decision is based on the positive results from phase 2 and phase 3 trials, including a randomized, active-controlled and observer-blinded phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate, compared with currently licensed meningococcal vaccines. The phase 3 trial evaluated more than 2,400 patients from the United States and Europe.

The CDC Advisory Committee on Immunization Practices is meeting on Oct. 25 to discuss recommendations for the appropriate use of Penbraya in young people.

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

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The U.S. Food and Drug Administration has approved a meningococcal vaccine against the five most common serogroups causing disease in children and young adults.

The new formulation called Penbraya is manufactured by Pfizer and combines the components from two existing meningococcal vaccines, Trumenba the group B vaccine and Nimenrix groups A, C, W-135, and Y conjugate vaccine.

This is the first pentavalent vaccine for meningococcal disease and is approved for use in people aged 10-25.

“Today marks an important step forward in the prevention of meningococcal disease in the U.S.,” Annaliesa Anderson, PhD, head of vaccine research and development at Pfizer, said in a news release. “In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”
 

One shot, five common types

“Incomplete protection against invasive meningococcal disease,” is common, added Jana Shaw, MD, MPH, a pediatric infectious diseases specialist from Upstate Golisano Children’s Hospital in Syracuse, N.Y. Reducing the number of shots is important because streamlining the vaccination process should help increase the number of young people who get fully vaccinated against meningococcal disease.

Rates are low in the United States, according to the Centers for Disease Control and Prevention, and in 2021 there were around 210 cases reported. But a statewide outbreak has been going on in Virginia since June 2022, with 29 confirmed cases and 6 deaths.

The FDA’s decision is based on the positive results from phase 2 and phase 3 trials, including a randomized, active-controlled and observer-blinded phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate, compared with currently licensed meningococcal vaccines. The phase 3 trial evaluated more than 2,400 patients from the United States and Europe.

The CDC Advisory Committee on Immunization Practices is meeting on Oct. 25 to discuss recommendations for the appropriate use of Penbraya in young people.

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

The U.S. Food and Drug Administration has approved a meningococcal vaccine against the five most common serogroups causing disease in children and young adults.

The new formulation called Penbraya is manufactured by Pfizer and combines the components from two existing meningococcal vaccines, Trumenba the group B vaccine and Nimenrix groups A, C, W-135, and Y conjugate vaccine.

This is the first pentavalent vaccine for meningococcal disease and is approved for use in people aged 10-25.

“Today marks an important step forward in the prevention of meningococcal disease in the U.S.,” Annaliesa Anderson, PhD, head of vaccine research and development at Pfizer, said in a news release. “In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”
 

One shot, five common types

“Incomplete protection against invasive meningococcal disease,” is common, added Jana Shaw, MD, MPH, a pediatric infectious diseases specialist from Upstate Golisano Children’s Hospital in Syracuse, N.Y. Reducing the number of shots is important because streamlining the vaccination process should help increase the number of young people who get fully vaccinated against meningococcal disease.

Rates are low in the United States, according to the Centers for Disease Control and Prevention, and in 2021 there were around 210 cases reported. But a statewide outbreak has been going on in Virginia since June 2022, with 29 confirmed cases and 6 deaths.

The FDA’s decision is based on the positive results from phase 2 and phase 3 trials, including a randomized, active-controlled and observer-blinded phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate, compared with currently licensed meningococcal vaccines. The phase 3 trial evaluated more than 2,400 patients from the United States and Europe.

The CDC Advisory Committee on Immunization Practices is meeting on Oct. 25 to discuss recommendations for the appropriate use of Penbraya in young people.

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

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Why legal pot makes this physician sick

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Thu, 10/19/2023 - 12:07

Last year, my husband and I took a 16-day road trip from Kentucky through Massachusetts to Maine. On our first morning in Boston, we exited the Park Street Station en route to Boston Common, but instead of being greeted by the aroma of molasses, we were hit full-on with a pungent, repulsive odor. “That’s skunk weed,” my husband chuckled as we stepped right into the middle of the Boston Freedom Rally, a celebration of all things cannabis.

As we boarded a hop-on-hop-off bus, we learned that this was the one week of the year that the city skips testing tour bus drivers for tetrahydrocannabinol (THC), “because we all test positive,” the driver quipped. As our open-air bus circled the Common, a crowd of pot enthusiasts displayed signs in support of relaxed regulation for public consumption.

The 34-year-old Boston Freedom Rally is a sign that U.S. culture has transformed forever. Mary Jane is no friend of emergency physicians nor of staff on hospital wards and offices. Health care workers should brace for the true impact of THC as its adoption by all ages rises.
 

Toking boomers and millennials

Researchers at the University of California, San Diego, looked at cannabis-related emergency department visits from all acute-care hospitals in the state from 2005 to 2019 and found an 1,808% increase in patients aged 65 or older (that is not a typo) who were there for complications from cannabis use.

The lead author said in an interview that, “older patients taking marijuana or related products may have dizziness and falls, heart palpitations, panic attacks, confusion, anxiety or worsening of underlying lung diseases, such as asthma or [chronic obstructive pulmonary disease].”

A recent study from Canada suggests that commercialization has been associated with an increase in related hospitalizations, including cannabis-induced psychosis.

According to a National Study of Drug Use and Health, marijuana use in young adults reached an all-time high (pun intended) in 2021. Nearly 10% of eighth graders and 20% of 10th graders reported using marijuana this past year.

The full downside of any drug, legal or illegal, is largely unknown until it infiltrates the mainstream market, but these are the typical cases we see:

Let’s start with the demotivated high school honors student who dropped out of college to work at the local cinema. He stumbled and broke his clavicle outside a bar at 2 AM, but he wasn’t sure if he passed out, so a cardiology consult was requested to “rule out” arrhythmia associated with syncope. He related that his plan to become a railway conductor had been upended because he knew he would be drug tested and just couldn’t give up pot. After a normal cardiac exam, ECG, labs, a Holter, and an echocardiogram were also requested and normal at a significant cost.
 

Cannabinoid hyperemesis syndrome

One of my Midwest colleagues related her encounter with two middle-aged pot users with ventricular tachycardia (VT). These episodes coincided with potassium levels less than 3.0 mEq/L in the setting of repetitive vomiting. The QTc interval didn’t normalize despite a corrected potassium level in one patient. They were both informed that they should never smoke pot because vomiting would predictably drop their K+ levels again and prolong their QTc intervals. Then began “the circular argument,” as my friend described it. The patient claims, “I smoke pot to relieve my nausea,” to which she explains that “in many folks, pot use induces nausea.” Of course, the classic reply is, “Not me.” Predictably one of these stoners soon returned with more VT, more puking, and more hypokalemia. “Consider yourself ‘allergic’ to pot smoke,” my friend advised, but “was met with no meaningful hint of understanding or hope for transformative change,” she told me.

I’ve seen cannabinoid hyperemesis syndrome several times in the past few years. It occurs in daily to weekly pot users. Very rarely, it can cause cerebral edema, but it is also associated with seizures and dehydration that can lead to hypovolemic shock and kidney failure.
 

Heart and brain harm

Then there are the young patients who for various reasons have developed heart failure. Unfortunately, some are repetitively tox screen positive with varying trifectas of methamphetamine (meth), cocaine, and THC; opiates, meth, and THC; alcohol, meth, and THC; or heroin, meth, and THC. THC, the ever present and essential third leg of the stool of stupor. These unfortunate patients often need heart failure medications that they can’t afford or won’t take because illicit drug use is expensive and dulls their ability to prioritize their health. Some desperately need a heart transplant, but the necessary negative drug screen is a pipe dream.

And it’s not just the heart that is affected. There are data linking cannabis use to a higher risk for both ischemic and hemorrhagic stroke. A retrospective study published in Stroke, of more than 1,000 people diagnosed with an aneurysmal subarachnoid hemorrhage, found that more than half of the 46 who tested positive for THC at admission developed delayed cerebral ischemia (DCI), which increases the risk for disability or early death. This was after adjusting for several patient characteristics as well as recent exposure to other illicit substances; cocaine, meth, and tobacco use were not associated with DCI.
 

Natural my ...

I’m certain my anti-cannabis stance will strike a nerve with those who love their recreational THC and push for its legal sale; after all, “It’s perfectly natural.” But I counter with the fact that tornadoes, earthquakes, cyanide, and appendicitis are all natural but certainly not optimal. And what we are seeing in the vascular specialties is completely unnatural. We are treating a different mix of complications than before pot was readily accessible across several states.

Our most effective action is to educate our patients. We should encourage those who don’t currently smoke cannabis to never start and those who do to quit. People who require marijuana for improved quality of life for terminal care or true (not supposed) disorders that mainstream medicine fails should be approached with empathy and caution.

A good rule of thumb is to never breathe anything you can see. Never put anything in your body that comes off the street: Drug dealers who sell cannabis cut with fentanyl will be ecstatic to take someone’s money then merely keep scrolling when their obituary comes up.

Let’s try to reverse the rise of vascular complications, orthopedic injuries, and vomiting across America. We can start by encouraging our patients to avoid “skunk weed” and get back to the sweet smells of nature in our cities and parks.

Some details have been changed to protect the patients’ identities, but the essence of their diagnoses has been preserved.

Dr. Walton-Shirley is a retired clinical cardiologist from Nashville, Tenn. She disclosed no relevant conflicts of interest.

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

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Last year, my husband and I took a 16-day road trip from Kentucky through Massachusetts to Maine. On our first morning in Boston, we exited the Park Street Station en route to Boston Common, but instead of being greeted by the aroma of molasses, we were hit full-on with a pungent, repulsive odor. “That’s skunk weed,” my husband chuckled as we stepped right into the middle of the Boston Freedom Rally, a celebration of all things cannabis.

As we boarded a hop-on-hop-off bus, we learned that this was the one week of the year that the city skips testing tour bus drivers for tetrahydrocannabinol (THC), “because we all test positive,” the driver quipped. As our open-air bus circled the Common, a crowd of pot enthusiasts displayed signs in support of relaxed regulation for public consumption.

The 34-year-old Boston Freedom Rally is a sign that U.S. culture has transformed forever. Mary Jane is no friend of emergency physicians nor of staff on hospital wards and offices. Health care workers should brace for the true impact of THC as its adoption by all ages rises.
 

Toking boomers and millennials

Researchers at the University of California, San Diego, looked at cannabis-related emergency department visits from all acute-care hospitals in the state from 2005 to 2019 and found an 1,808% increase in patients aged 65 or older (that is not a typo) who were there for complications from cannabis use.

The lead author said in an interview that, “older patients taking marijuana or related products may have dizziness and falls, heart palpitations, panic attacks, confusion, anxiety or worsening of underlying lung diseases, such as asthma or [chronic obstructive pulmonary disease].”

A recent study from Canada suggests that commercialization has been associated with an increase in related hospitalizations, including cannabis-induced psychosis.

According to a National Study of Drug Use and Health, marijuana use in young adults reached an all-time high (pun intended) in 2021. Nearly 10% of eighth graders and 20% of 10th graders reported using marijuana this past year.

The full downside of any drug, legal or illegal, is largely unknown until it infiltrates the mainstream market, but these are the typical cases we see:

Let’s start with the demotivated high school honors student who dropped out of college to work at the local cinema. He stumbled and broke his clavicle outside a bar at 2 AM, but he wasn’t sure if he passed out, so a cardiology consult was requested to “rule out” arrhythmia associated with syncope. He related that his plan to become a railway conductor had been upended because he knew he would be drug tested and just couldn’t give up pot. After a normal cardiac exam, ECG, labs, a Holter, and an echocardiogram were also requested and normal at a significant cost.
 

Cannabinoid hyperemesis syndrome

One of my Midwest colleagues related her encounter with two middle-aged pot users with ventricular tachycardia (VT). These episodes coincided with potassium levels less than 3.0 mEq/L in the setting of repetitive vomiting. The QTc interval didn’t normalize despite a corrected potassium level in one patient. They were both informed that they should never smoke pot because vomiting would predictably drop their K+ levels again and prolong their QTc intervals. Then began “the circular argument,” as my friend described it. The patient claims, “I smoke pot to relieve my nausea,” to which she explains that “in many folks, pot use induces nausea.” Of course, the classic reply is, “Not me.” Predictably one of these stoners soon returned with more VT, more puking, and more hypokalemia. “Consider yourself ‘allergic’ to pot smoke,” my friend advised, but “was met with no meaningful hint of understanding or hope for transformative change,” she told me.

I’ve seen cannabinoid hyperemesis syndrome several times in the past few years. It occurs in daily to weekly pot users. Very rarely, it can cause cerebral edema, but it is also associated with seizures and dehydration that can lead to hypovolemic shock and kidney failure.
 

Heart and brain harm

Then there are the young patients who for various reasons have developed heart failure. Unfortunately, some are repetitively tox screen positive with varying trifectas of methamphetamine (meth), cocaine, and THC; opiates, meth, and THC; alcohol, meth, and THC; or heroin, meth, and THC. THC, the ever present and essential third leg of the stool of stupor. These unfortunate patients often need heart failure medications that they can’t afford or won’t take because illicit drug use is expensive and dulls their ability to prioritize their health. Some desperately need a heart transplant, but the necessary negative drug screen is a pipe dream.

And it’s not just the heart that is affected. There are data linking cannabis use to a higher risk for both ischemic and hemorrhagic stroke. A retrospective study published in Stroke, of more than 1,000 people diagnosed with an aneurysmal subarachnoid hemorrhage, found that more than half of the 46 who tested positive for THC at admission developed delayed cerebral ischemia (DCI), which increases the risk for disability or early death. This was after adjusting for several patient characteristics as well as recent exposure to other illicit substances; cocaine, meth, and tobacco use were not associated with DCI.
 

Natural my ...

I’m certain my anti-cannabis stance will strike a nerve with those who love their recreational THC and push for its legal sale; after all, “It’s perfectly natural.” But I counter with the fact that tornadoes, earthquakes, cyanide, and appendicitis are all natural but certainly not optimal. And what we are seeing in the vascular specialties is completely unnatural. We are treating a different mix of complications than before pot was readily accessible across several states.

Our most effective action is to educate our patients. We should encourage those who don’t currently smoke cannabis to never start and those who do to quit. People who require marijuana for improved quality of life for terminal care or true (not supposed) disorders that mainstream medicine fails should be approached with empathy and caution.

A good rule of thumb is to never breathe anything you can see. Never put anything in your body that comes off the street: Drug dealers who sell cannabis cut with fentanyl will be ecstatic to take someone’s money then merely keep scrolling when their obituary comes up.

Let’s try to reverse the rise of vascular complications, orthopedic injuries, and vomiting across America. We can start by encouraging our patients to avoid “skunk weed” and get back to the sweet smells of nature in our cities and parks.

Some details have been changed to protect the patients’ identities, but the essence of their diagnoses has been preserved.

Dr. Walton-Shirley is a retired clinical cardiologist from Nashville, Tenn. She disclosed no relevant conflicts of interest.

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

Last year, my husband and I took a 16-day road trip from Kentucky through Massachusetts to Maine. On our first morning in Boston, we exited the Park Street Station en route to Boston Common, but instead of being greeted by the aroma of molasses, we were hit full-on with a pungent, repulsive odor. “That’s skunk weed,” my husband chuckled as we stepped right into the middle of the Boston Freedom Rally, a celebration of all things cannabis.

As we boarded a hop-on-hop-off bus, we learned that this was the one week of the year that the city skips testing tour bus drivers for tetrahydrocannabinol (THC), “because we all test positive,” the driver quipped. As our open-air bus circled the Common, a crowd of pot enthusiasts displayed signs in support of relaxed regulation for public consumption.

The 34-year-old Boston Freedom Rally is a sign that U.S. culture has transformed forever. Mary Jane is no friend of emergency physicians nor of staff on hospital wards and offices. Health care workers should brace for the true impact of THC as its adoption by all ages rises.
 

Toking boomers and millennials

Researchers at the University of California, San Diego, looked at cannabis-related emergency department visits from all acute-care hospitals in the state from 2005 to 2019 and found an 1,808% increase in patients aged 65 or older (that is not a typo) who were there for complications from cannabis use.

The lead author said in an interview that, “older patients taking marijuana or related products may have dizziness and falls, heart palpitations, panic attacks, confusion, anxiety or worsening of underlying lung diseases, such as asthma or [chronic obstructive pulmonary disease].”

A recent study from Canada suggests that commercialization has been associated with an increase in related hospitalizations, including cannabis-induced psychosis.

According to a National Study of Drug Use and Health, marijuana use in young adults reached an all-time high (pun intended) in 2021. Nearly 10% of eighth graders and 20% of 10th graders reported using marijuana this past year.

The full downside of any drug, legal or illegal, is largely unknown until it infiltrates the mainstream market, but these are the typical cases we see:

Let’s start with the demotivated high school honors student who dropped out of college to work at the local cinema. He stumbled and broke his clavicle outside a bar at 2 AM, but he wasn’t sure if he passed out, so a cardiology consult was requested to “rule out” arrhythmia associated with syncope. He related that his plan to become a railway conductor had been upended because he knew he would be drug tested and just couldn’t give up pot. After a normal cardiac exam, ECG, labs, a Holter, and an echocardiogram were also requested and normal at a significant cost.
 

Cannabinoid hyperemesis syndrome

One of my Midwest colleagues related her encounter with two middle-aged pot users with ventricular tachycardia (VT). These episodes coincided with potassium levels less than 3.0 mEq/L in the setting of repetitive vomiting. The QTc interval didn’t normalize despite a corrected potassium level in one patient. They were both informed that they should never smoke pot because vomiting would predictably drop their K+ levels again and prolong their QTc intervals. Then began “the circular argument,” as my friend described it. The patient claims, “I smoke pot to relieve my nausea,” to which she explains that “in many folks, pot use induces nausea.” Of course, the classic reply is, “Not me.” Predictably one of these stoners soon returned with more VT, more puking, and more hypokalemia. “Consider yourself ‘allergic’ to pot smoke,” my friend advised, but “was met with no meaningful hint of understanding or hope for transformative change,” she told me.

I’ve seen cannabinoid hyperemesis syndrome several times in the past few years. It occurs in daily to weekly pot users. Very rarely, it can cause cerebral edema, but it is also associated with seizures and dehydration that can lead to hypovolemic shock and kidney failure.
 

Heart and brain harm

Then there are the young patients who for various reasons have developed heart failure. Unfortunately, some are repetitively tox screen positive with varying trifectas of methamphetamine (meth), cocaine, and THC; opiates, meth, and THC; alcohol, meth, and THC; or heroin, meth, and THC. THC, the ever present and essential third leg of the stool of stupor. These unfortunate patients often need heart failure medications that they can’t afford or won’t take because illicit drug use is expensive and dulls their ability to prioritize their health. Some desperately need a heart transplant, but the necessary negative drug screen is a pipe dream.

And it’s not just the heart that is affected. There are data linking cannabis use to a higher risk for both ischemic and hemorrhagic stroke. A retrospective study published in Stroke, of more than 1,000 people diagnosed with an aneurysmal subarachnoid hemorrhage, found that more than half of the 46 who tested positive for THC at admission developed delayed cerebral ischemia (DCI), which increases the risk for disability or early death. This was after adjusting for several patient characteristics as well as recent exposure to other illicit substances; cocaine, meth, and tobacco use were not associated with DCI.
 

Natural my ...

I’m certain my anti-cannabis stance will strike a nerve with those who love their recreational THC and push for its legal sale; after all, “It’s perfectly natural.” But I counter with the fact that tornadoes, earthquakes, cyanide, and appendicitis are all natural but certainly not optimal. And what we are seeing in the vascular specialties is completely unnatural. We are treating a different mix of complications than before pot was readily accessible across several states.

Our most effective action is to educate our patients. We should encourage those who don’t currently smoke cannabis to never start and those who do to quit. People who require marijuana for improved quality of life for terminal care or true (not supposed) disorders that mainstream medicine fails should be approached with empathy and caution.

A good rule of thumb is to never breathe anything you can see. Never put anything in your body that comes off the street: Drug dealers who sell cannabis cut with fentanyl will be ecstatic to take someone’s money then merely keep scrolling when their obituary comes up.

Let’s try to reverse the rise of vascular complications, orthopedic injuries, and vomiting across America. We can start by encouraging our patients to avoid “skunk weed” and get back to the sweet smells of nature in our cities and parks.

Some details have been changed to protect the patients’ identities, but the essence of their diagnoses has been preserved.

Dr. Walton-Shirley is a retired clinical cardiologist from Nashville, Tenn. She disclosed no relevant conflicts of interest.

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

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Once-weekly topical therapy shows promise for moderate to severe acne

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Changed
Fri, 10/20/2023 - 15:27

 

TOPLINE:

DMT310, a novel topical treatment applied once per week, appears to be safe and effective for moderate to severe acne.

METHODOLOGY:

  • Poor patient compliance with topical acne therapies is a common clinical challenge.
  • In a 12-week, randomized, controlled, phase 2b trial of 181 patients 12 years of age and older, researchers investigated the safety, tolerability, and efficacy of DMT310, a powdered mixture of Spongilla lacustris for treating moderate to severe acne. (In vitro studies have found that components of S. lacustris, a freshwater sponge, have effects that include antimicrobial activity against Cutibacterium acnes and anti-inflammatory activity in human keratinocytes).
  • The study’s primary efficacy endpoint was the absolute change in inflammatory lesion count from baseline to week 12.
  • Endpoint success was defined as an Investigator Global Assessment (IGA) score of 0 or 1 and at least a two-grade improvement from baseline at week 12.
  •  

TAKEAWAY:

  • Of the 181 patients, 91 received DMT310 (applied once a week to the face and washed off after 10-15 minutes), and 90 received placebo.
  • Patients in the DMT310 arm showed a significantly greater mean reduction in the number of inflammatory lesions at week 12, compared with those in the placebo arm (–15.64 vs. –10.84, respectively; P < .001).
  • Similarly, patients in the DMT310 arm showed a significantly greater mean reduction in the number of noninflammatory lesions at week 12, compared with those in the placebo arm (–18.26 vs. –12.41, respectively; P < .001).
  • At week 12, endpoint success based on IGA scores also significantly favored patients in the DMT310 arm, compared with those in the placebo arm (44.40% vs. 17.78%; P < .001).

IN PRACTICE:

This study is too preliminary to have practice application. The researchers concluded that the findings “support further study of DMT310 in larger, confirmatory phase 3 trials.”

SOURCE:

Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, led the research. The study was published online June 7 in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The analysis did not include an active comparator group and it enrolled a limited number of Asian patients.

DISCLOSURES:

Dr. Eichenfield disclosed that he is a consultant to Dermata, which is developing DMT310, as were three other authors of the study. One author is a company employee. The remaining authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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TOPLINE:

DMT310, a novel topical treatment applied once per week, appears to be safe and effective for moderate to severe acne.

METHODOLOGY:

  • Poor patient compliance with topical acne therapies is a common clinical challenge.
  • In a 12-week, randomized, controlled, phase 2b trial of 181 patients 12 years of age and older, researchers investigated the safety, tolerability, and efficacy of DMT310, a powdered mixture of Spongilla lacustris for treating moderate to severe acne. (In vitro studies have found that components of S. lacustris, a freshwater sponge, have effects that include antimicrobial activity against Cutibacterium acnes and anti-inflammatory activity in human keratinocytes).
  • The study’s primary efficacy endpoint was the absolute change in inflammatory lesion count from baseline to week 12.
  • Endpoint success was defined as an Investigator Global Assessment (IGA) score of 0 or 1 and at least a two-grade improvement from baseline at week 12.
  •  

TAKEAWAY:

  • Of the 181 patients, 91 received DMT310 (applied once a week to the face and washed off after 10-15 minutes), and 90 received placebo.
  • Patients in the DMT310 arm showed a significantly greater mean reduction in the number of inflammatory lesions at week 12, compared with those in the placebo arm (–15.64 vs. –10.84, respectively; P < .001).
  • Similarly, patients in the DMT310 arm showed a significantly greater mean reduction in the number of noninflammatory lesions at week 12, compared with those in the placebo arm (–18.26 vs. –12.41, respectively; P < .001).
  • At week 12, endpoint success based on IGA scores also significantly favored patients in the DMT310 arm, compared with those in the placebo arm (44.40% vs. 17.78%; P < .001).

IN PRACTICE:

This study is too preliminary to have practice application. The researchers concluded that the findings “support further study of DMT310 in larger, confirmatory phase 3 trials.”

SOURCE:

Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, led the research. The study was published online June 7 in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The analysis did not include an active comparator group and it enrolled a limited number of Asian patients.

DISCLOSURES:

Dr. Eichenfield disclosed that he is a consultant to Dermata, which is developing DMT310, as were three other authors of the study. One author is a company employee. The remaining authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

 

TOPLINE:

DMT310, a novel topical treatment applied once per week, appears to be safe and effective for moderate to severe acne.

METHODOLOGY:

  • Poor patient compliance with topical acne therapies is a common clinical challenge.
  • In a 12-week, randomized, controlled, phase 2b trial of 181 patients 12 years of age and older, researchers investigated the safety, tolerability, and efficacy of DMT310, a powdered mixture of Spongilla lacustris for treating moderate to severe acne. (In vitro studies have found that components of S. lacustris, a freshwater sponge, have effects that include antimicrobial activity against Cutibacterium acnes and anti-inflammatory activity in human keratinocytes).
  • The study’s primary efficacy endpoint was the absolute change in inflammatory lesion count from baseline to week 12.
  • Endpoint success was defined as an Investigator Global Assessment (IGA) score of 0 or 1 and at least a two-grade improvement from baseline at week 12.
  •  

TAKEAWAY:

  • Of the 181 patients, 91 received DMT310 (applied once a week to the face and washed off after 10-15 minutes), and 90 received placebo.
  • Patients in the DMT310 arm showed a significantly greater mean reduction in the number of inflammatory lesions at week 12, compared with those in the placebo arm (–15.64 vs. –10.84, respectively; P < .001).
  • Similarly, patients in the DMT310 arm showed a significantly greater mean reduction in the number of noninflammatory lesions at week 12, compared with those in the placebo arm (–18.26 vs. –12.41, respectively; P < .001).
  • At week 12, endpoint success based on IGA scores also significantly favored patients in the DMT310 arm, compared with those in the placebo arm (44.40% vs. 17.78%; P < .001).

IN PRACTICE:

This study is too preliminary to have practice application. The researchers concluded that the findings “support further study of DMT310 in larger, confirmatory phase 3 trials.”

SOURCE:

Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, led the research. The study was published online June 7 in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The analysis did not include an active comparator group and it enrolled a limited number of Asian patients.

DISCLOSURES:

Dr. Eichenfield disclosed that he is a consultant to Dermata, which is developing DMT310, as were three other authors of the study. One author is a company employee. The remaining authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Asthma severity higher among LGBTQ+ population

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Changed
Wed, 10/18/2023 - 12:01

HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

 

 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

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

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HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

 

 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

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

HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

 

 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

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

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Are migraine preventives underused in young adults?

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Prescribing patterns of preventive migraine medications for young adults do not appear to vary based on whether the provider is a pediatric or adult neurologist, but researchers say preventive medications may be underused for this group, according to recent research published in the journal Headache.

“Approximately two-fifths of young adults with migraine were prescribed preventive medications, and this did not differ between pediatric and adult neurologists,” Hannah F. J. Shapiro MD, of the department of neurology at the University of California, San Francisco, and the UCSF Benioff Children’s Hospitals, and colleagues wrote in their study. “This finding suggests that pediatric neurologists are providing comparable care to adult neurologists for young adults with migraine; however, this may represent the underuse of preventive medications in this patient population.”

Dr. Hannah F. J. Shapiro

Dr. Shapiro and colleagues conducted a retrospective study of 767 patients (mean age 20.3 years) at Mass General Brigham Hospital in Boston between 2017 and 2021 who received care from a pediatric or adult neurologist for episodic migraine. The majority of patients in the study were white (72.2%), non-Hispanic (82.1%) women (80.3%) with episodic migraine (72.8%), some of whom experienced a psychiatric comorbidity (12.7%), and had a 3.88 mean clinic visits for migraine. Researchers assessed prescription of migraine preventive medication as a primary outcome, with a secondary outcome of comparing the rate of migraine preventive prescriptions written by pediatric and adult neurologists.

Overall, 290 patients (37.8%) received care from a pediatric neurologist, and 131 of those 290 patients (45.2%) received preventive medications (95% confidence interval, 39.5%-51.0%). The remaining 477 patients received care from an adult neurologist; of these, 206 patients (43.2%) received preventive medications (95% CI, 39.0%-47.7%; P = .591). The most common preventive medication prescribed was topiramate, which was prescribed in 19.1% of cases by adult neurologists and 15.2% of cases by pediatric neurologists. Other preventive medications included tricyclic antidepressants such as amitriptyline and nortriptyline; pediatric neurologists prescribed amitriptyline more often than adult neurologists (14.5% vs. 5.5%; P <  .001), and adult neurologists prescribed nortriptyline more often than pediatric neurologists (12.8% vs. 2.4%; P < .001).

Dr. Shapiro and colleagues performed a mixed effects logistic regression analysis of potential confounders, and found no significant association between clinician specialty and use of preventive medication (adjusted odds ratio, 1.20; 95% CI, 0.62­-2.31), while factors such as female sex (aOR, 1.69; 95% CI, 1.07-2.66) and number of visits (aOR, 1.64; 95% CI, 1.49-1.80) carried associations with preventive medication use.

The finding that pediatric and adult neurologists use similar preventive medications is a positive one because “patients who continue care into adulthood with a pediatric neurologist should receive comparable care to the care they would receive with an adult neurologist,” Dr. Shapiro and colleagues said. “It is even more pertinent now for pediatric neurologists to have comfort prescribing preventive medication to young adults, as the newer calcitonin gene-related peptide (CGRP) pathway antagonists are currently only FDA approved for use in patients aged 18 years or older.”
 

 

 

Roadblocks may prevent adoption

M. Cristina Victorio, MD, a pediatric neurologist and director of the headache program at Akron (Ohio) Children’s, said in an interview that the study is well-designed, but the results cannot be generalized as the study is retrospective, was conducted at a single institution, and data about nutraceuticals and drug-free neuromodulation devices were excluded from the analysis.

Dr. M. Cristina Victorio

Another aspect of the study to consider is that episodic migraine, defined as between 0 and 14 migraine days per month, comprised most of the diagnoses in this study, while preventive medication is usually considered in patients with migraines occurring at least 6 days per month. “[I]f migraine is only once every other month or once a month, preventive treatment may not be recommended,” she said.

There is also the element of patient preference, which is “difficult to obtain” in a retrospective study, she noted.

Citing the authors’ comments about pediatric neurologists’ comfortability prescribing preventive medications, including CGRP antagonists, Dr. Victorio said she offers CGRP antagonists to “young adult patients who have failed at least two of the guideline-recommended preventive medications.”

However, pediatric neurologists may encounter roadblocks to prescribing these medications. “A big challenge is access, as it requires prior authorization as well as writing a letter of appeal or medical necessity, which can be a nuisance for clinicians who are already inundated with clinical responsibilities,” she said.
 

More education is needed

“As a pediatric headache specialist and knowing the results of this study, my colleagues and I have a role in educating all clinicians as well as trainees on headache management to improve and provide optimal care for young adult patients with migraine,” Dr. Victorio said.

In her experience, more clinic visits usually mean a need for preventative medication, and psychiatric morbidities are common. “I differ in the sense that as a headache specialist I am comfortable offering various preventive treatment options when indicated, so I do not believe I am underutilizing,” she said.

Dr. Victorio said she prescribes topiramate, amitriptyline, and propranolol as migraine preventatives for adolescents and young adults, but recommends cyproheptadine for younger children “due to lesser side effects, tolerability, and convenience of formulation (both liquid and tablet forms are available), which can be challenging for younger children who are unable to swallow pills.”

“Cognizant that there are patients who are reluctant to take daily prescription medication and that consideration for preventive treatment includes patient’s preference, I include the use of nutraceuticals and drug-free neuromodulation devices when discussing preventive treatment options,” she added, noting that children and adolescents “[m]ore often than not” prefer nutraceuticals like magnesium and vitamin B2.

“I think the bottom line is that all clinicians managing young adults with migraine should know when to consider starting preventive migraine medication,” Dr. Victorio said. “Not offering preventive treatment to young adults specifically for those who have frequent migraine attacks, or those who have severe migraine despite adequate acute treatment, or those with significant adverse reactions to acute medications will only put these patients at risk to progression to chronic migraine (meaning having migraine more often than not – at least 15 days per month), and increases headache-related disability and reduces quality of life.”

The authors report no relevant financial disclosures. This study was supported by Harvard University and an award from the National Institutes of Health. Dr. Victorio reports being on the advisory board for Theranica Bio-electronics, has received honorarium serving as an author of the Merck Manual, and is involved in industry-sponsored clinical trials through Akron Children’s Hospital.

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Prescribing patterns of preventive migraine medications for young adults do not appear to vary based on whether the provider is a pediatric or adult neurologist, but researchers say preventive medications may be underused for this group, according to recent research published in the journal Headache.

“Approximately two-fifths of young adults with migraine were prescribed preventive medications, and this did not differ between pediatric and adult neurologists,” Hannah F. J. Shapiro MD, of the department of neurology at the University of California, San Francisco, and the UCSF Benioff Children’s Hospitals, and colleagues wrote in their study. “This finding suggests that pediatric neurologists are providing comparable care to adult neurologists for young adults with migraine; however, this may represent the underuse of preventive medications in this patient population.”

Dr. Hannah F. J. Shapiro

Dr. Shapiro and colleagues conducted a retrospective study of 767 patients (mean age 20.3 years) at Mass General Brigham Hospital in Boston between 2017 and 2021 who received care from a pediatric or adult neurologist for episodic migraine. The majority of patients in the study were white (72.2%), non-Hispanic (82.1%) women (80.3%) with episodic migraine (72.8%), some of whom experienced a psychiatric comorbidity (12.7%), and had a 3.88 mean clinic visits for migraine. Researchers assessed prescription of migraine preventive medication as a primary outcome, with a secondary outcome of comparing the rate of migraine preventive prescriptions written by pediatric and adult neurologists.

Overall, 290 patients (37.8%) received care from a pediatric neurologist, and 131 of those 290 patients (45.2%) received preventive medications (95% confidence interval, 39.5%-51.0%). The remaining 477 patients received care from an adult neurologist; of these, 206 patients (43.2%) received preventive medications (95% CI, 39.0%-47.7%; P = .591). The most common preventive medication prescribed was topiramate, which was prescribed in 19.1% of cases by adult neurologists and 15.2% of cases by pediatric neurologists. Other preventive medications included tricyclic antidepressants such as amitriptyline and nortriptyline; pediatric neurologists prescribed amitriptyline more often than adult neurologists (14.5% vs. 5.5%; P <  .001), and adult neurologists prescribed nortriptyline more often than pediatric neurologists (12.8% vs. 2.4%; P < .001).

Dr. Shapiro and colleagues performed a mixed effects logistic regression analysis of potential confounders, and found no significant association between clinician specialty and use of preventive medication (adjusted odds ratio, 1.20; 95% CI, 0.62­-2.31), while factors such as female sex (aOR, 1.69; 95% CI, 1.07-2.66) and number of visits (aOR, 1.64; 95% CI, 1.49-1.80) carried associations with preventive medication use.

The finding that pediatric and adult neurologists use similar preventive medications is a positive one because “patients who continue care into adulthood with a pediatric neurologist should receive comparable care to the care they would receive with an adult neurologist,” Dr. Shapiro and colleagues said. “It is even more pertinent now for pediatric neurologists to have comfort prescribing preventive medication to young adults, as the newer calcitonin gene-related peptide (CGRP) pathway antagonists are currently only FDA approved for use in patients aged 18 years or older.”
 

 

 

Roadblocks may prevent adoption

M. Cristina Victorio, MD, a pediatric neurologist and director of the headache program at Akron (Ohio) Children’s, said in an interview that the study is well-designed, but the results cannot be generalized as the study is retrospective, was conducted at a single institution, and data about nutraceuticals and drug-free neuromodulation devices were excluded from the analysis.

Dr. M. Cristina Victorio

Another aspect of the study to consider is that episodic migraine, defined as between 0 and 14 migraine days per month, comprised most of the diagnoses in this study, while preventive medication is usually considered in patients with migraines occurring at least 6 days per month. “[I]f migraine is only once every other month or once a month, preventive treatment may not be recommended,” she said.

There is also the element of patient preference, which is “difficult to obtain” in a retrospective study, she noted.

Citing the authors’ comments about pediatric neurologists’ comfortability prescribing preventive medications, including CGRP antagonists, Dr. Victorio said she offers CGRP antagonists to “young adult patients who have failed at least two of the guideline-recommended preventive medications.”

However, pediatric neurologists may encounter roadblocks to prescribing these medications. “A big challenge is access, as it requires prior authorization as well as writing a letter of appeal or medical necessity, which can be a nuisance for clinicians who are already inundated with clinical responsibilities,” she said.
 

More education is needed

“As a pediatric headache specialist and knowing the results of this study, my colleagues and I have a role in educating all clinicians as well as trainees on headache management to improve and provide optimal care for young adult patients with migraine,” Dr. Victorio said.

In her experience, more clinic visits usually mean a need for preventative medication, and psychiatric morbidities are common. “I differ in the sense that as a headache specialist I am comfortable offering various preventive treatment options when indicated, so I do not believe I am underutilizing,” she said.

Dr. Victorio said she prescribes topiramate, amitriptyline, and propranolol as migraine preventatives for adolescents and young adults, but recommends cyproheptadine for younger children “due to lesser side effects, tolerability, and convenience of formulation (both liquid and tablet forms are available), which can be challenging for younger children who are unable to swallow pills.”

“Cognizant that there are patients who are reluctant to take daily prescription medication and that consideration for preventive treatment includes patient’s preference, I include the use of nutraceuticals and drug-free neuromodulation devices when discussing preventive treatment options,” she added, noting that children and adolescents “[m]ore often than not” prefer nutraceuticals like magnesium and vitamin B2.

“I think the bottom line is that all clinicians managing young adults with migraine should know when to consider starting preventive migraine medication,” Dr. Victorio said. “Not offering preventive treatment to young adults specifically for those who have frequent migraine attacks, or those who have severe migraine despite adequate acute treatment, or those with significant adverse reactions to acute medications will only put these patients at risk to progression to chronic migraine (meaning having migraine more often than not – at least 15 days per month), and increases headache-related disability and reduces quality of life.”

The authors report no relevant financial disclosures. This study was supported by Harvard University and an award from the National Institutes of Health. Dr. Victorio reports being on the advisory board for Theranica Bio-electronics, has received honorarium serving as an author of the Merck Manual, and is involved in industry-sponsored clinical trials through Akron Children’s Hospital.

Prescribing patterns of preventive migraine medications for young adults do not appear to vary based on whether the provider is a pediatric or adult neurologist, but researchers say preventive medications may be underused for this group, according to recent research published in the journal Headache.

“Approximately two-fifths of young adults with migraine were prescribed preventive medications, and this did not differ between pediatric and adult neurologists,” Hannah F. J. Shapiro MD, of the department of neurology at the University of California, San Francisco, and the UCSF Benioff Children’s Hospitals, and colleagues wrote in their study. “This finding suggests that pediatric neurologists are providing comparable care to adult neurologists for young adults with migraine; however, this may represent the underuse of preventive medications in this patient population.”

Dr. Hannah F. J. Shapiro

Dr. Shapiro and colleagues conducted a retrospective study of 767 patients (mean age 20.3 years) at Mass General Brigham Hospital in Boston between 2017 and 2021 who received care from a pediatric or adult neurologist for episodic migraine. The majority of patients in the study were white (72.2%), non-Hispanic (82.1%) women (80.3%) with episodic migraine (72.8%), some of whom experienced a psychiatric comorbidity (12.7%), and had a 3.88 mean clinic visits for migraine. Researchers assessed prescription of migraine preventive medication as a primary outcome, with a secondary outcome of comparing the rate of migraine preventive prescriptions written by pediatric and adult neurologists.

Overall, 290 patients (37.8%) received care from a pediatric neurologist, and 131 of those 290 patients (45.2%) received preventive medications (95% confidence interval, 39.5%-51.0%). The remaining 477 patients received care from an adult neurologist; of these, 206 patients (43.2%) received preventive medications (95% CI, 39.0%-47.7%; P = .591). The most common preventive medication prescribed was topiramate, which was prescribed in 19.1% of cases by adult neurologists and 15.2% of cases by pediatric neurologists. Other preventive medications included tricyclic antidepressants such as amitriptyline and nortriptyline; pediatric neurologists prescribed amitriptyline more often than adult neurologists (14.5% vs. 5.5%; P <  .001), and adult neurologists prescribed nortriptyline more often than pediatric neurologists (12.8% vs. 2.4%; P < .001).

Dr. Shapiro and colleagues performed a mixed effects logistic regression analysis of potential confounders, and found no significant association between clinician specialty and use of preventive medication (adjusted odds ratio, 1.20; 95% CI, 0.62­-2.31), while factors such as female sex (aOR, 1.69; 95% CI, 1.07-2.66) and number of visits (aOR, 1.64; 95% CI, 1.49-1.80) carried associations with preventive medication use.

The finding that pediatric and adult neurologists use similar preventive medications is a positive one because “patients who continue care into adulthood with a pediatric neurologist should receive comparable care to the care they would receive with an adult neurologist,” Dr. Shapiro and colleagues said. “It is even more pertinent now for pediatric neurologists to have comfort prescribing preventive medication to young adults, as the newer calcitonin gene-related peptide (CGRP) pathway antagonists are currently only FDA approved for use in patients aged 18 years or older.”
 

 

 

Roadblocks may prevent adoption

M. Cristina Victorio, MD, a pediatric neurologist and director of the headache program at Akron (Ohio) Children’s, said in an interview that the study is well-designed, but the results cannot be generalized as the study is retrospective, was conducted at a single institution, and data about nutraceuticals and drug-free neuromodulation devices were excluded from the analysis.

Dr. M. Cristina Victorio

Another aspect of the study to consider is that episodic migraine, defined as between 0 and 14 migraine days per month, comprised most of the diagnoses in this study, while preventive medication is usually considered in patients with migraines occurring at least 6 days per month. “[I]f migraine is only once every other month or once a month, preventive treatment may not be recommended,” she said.

There is also the element of patient preference, which is “difficult to obtain” in a retrospective study, she noted.

Citing the authors’ comments about pediatric neurologists’ comfortability prescribing preventive medications, including CGRP antagonists, Dr. Victorio said she offers CGRP antagonists to “young adult patients who have failed at least two of the guideline-recommended preventive medications.”

However, pediatric neurologists may encounter roadblocks to prescribing these medications. “A big challenge is access, as it requires prior authorization as well as writing a letter of appeal or medical necessity, which can be a nuisance for clinicians who are already inundated with clinical responsibilities,” she said.
 

More education is needed

“As a pediatric headache specialist and knowing the results of this study, my colleagues and I have a role in educating all clinicians as well as trainees on headache management to improve and provide optimal care for young adult patients with migraine,” Dr. Victorio said.

In her experience, more clinic visits usually mean a need for preventative medication, and psychiatric morbidities are common. “I differ in the sense that as a headache specialist I am comfortable offering various preventive treatment options when indicated, so I do not believe I am underutilizing,” she said.

Dr. Victorio said she prescribes topiramate, amitriptyline, and propranolol as migraine preventatives for adolescents and young adults, but recommends cyproheptadine for younger children “due to lesser side effects, tolerability, and convenience of formulation (both liquid and tablet forms are available), which can be challenging for younger children who are unable to swallow pills.”

“Cognizant that there are patients who are reluctant to take daily prescription medication and that consideration for preventive treatment includes patient’s preference, I include the use of nutraceuticals and drug-free neuromodulation devices when discussing preventive treatment options,” she added, noting that children and adolescents “[m]ore often than not” prefer nutraceuticals like magnesium and vitamin B2.

“I think the bottom line is that all clinicians managing young adults with migraine should know when to consider starting preventive migraine medication,” Dr. Victorio said. “Not offering preventive treatment to young adults specifically for those who have frequent migraine attacks, or those who have severe migraine despite adequate acute treatment, or those with significant adverse reactions to acute medications will only put these patients at risk to progression to chronic migraine (meaning having migraine more often than not – at least 15 days per month), and increases headache-related disability and reduces quality of life.”

The authors report no relevant financial disclosures. This study was supported by Harvard University and an award from the National Institutes of Health. Dr. Victorio reports being on the advisory board for Theranica Bio-electronics, has received honorarium serving as an author of the Merck Manual, and is involved in industry-sponsored clinical trials through Akron Children’s Hospital.

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ADHD rates holding steady in U.S. children

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Wed, 10/11/2023 - 12:05

 

TOPLINE:

While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016, more recent data show rates remained steady at around 10% from 2017 to 2022.

METHODOLOGY:

  • Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
  • The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
  • Information on health care provider–diagnosed ADHD was reported by a parent or guardian.

TAKEAWAY:

  • A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
  • The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
  • There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
  • The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.

IN PRACTICE:

The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.

SOURCE:

The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.

LIMITATIONS:

Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.

DISCLOSURES:

The study had no specific funding. The authors reported no relevant financial relationships.

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

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TOPLINE:

While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016, more recent data show rates remained steady at around 10% from 2017 to 2022.

METHODOLOGY:

  • Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
  • The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
  • Information on health care provider–diagnosed ADHD was reported by a parent or guardian.

TAKEAWAY:

  • A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
  • The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
  • There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
  • The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.

IN PRACTICE:

The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.

SOURCE:

The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.

LIMITATIONS:

Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.

DISCLOSURES:

The study had no specific funding. The authors reported no relevant financial relationships.

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

 

TOPLINE:

While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016, more recent data show rates remained steady at around 10% from 2017 to 2022.

METHODOLOGY:

  • Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
  • The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
  • Information on health care provider–diagnosed ADHD was reported by a parent or guardian.

TAKEAWAY:

  • A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
  • The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
  • There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
  • The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.

IN PRACTICE:

The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.

SOURCE:

The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.

LIMITATIONS:

Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.

DISCLOSURES:

The study had no specific funding. The authors reported no relevant financial relationships.

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

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