Conference Coverage

SAN DIEGO — Compared with medical oncologists, dermatologists were more likely to correctly classify and grade dermatologic adverse events from cancer therapies, results from a multicenter survey showed.

“New cancer therapies have brought a diversity of treatment-related dermatologic adverse events (dAEs) beyond those experienced with conventional chemotherapy, which has demanded an evolving assessment of toxicities,” researchers led by Nicole R. LeBoeuf, MD, MPH, of the Department of Dermatology at Brigham and Women’s Hospital and the Center for Cutaneous Oncology at the Dana-Farber Brigham Cancer Center, Boston, wrote in a poster presented at the American Academy of Dermatology annual meeting.

The authors noted that “Version 5.0 of the Common Terminology Criteria for Adverse Events (CTCAE v5.0)” serves as the current, broadly accepted criteria for classification and grading during routine medical care and clinical trials. But despite extensive utilization of CTCAE, there is little data regarding its application.”

To evaluate how CTCAE is being used in clinical practice, they sent a four-case survey of dAEs to 81 dermatologists and 182 medical oncologists at six US-based academic institutions. For three of the cases, respondents were asked to classify and grade morbilliform, psoriasiform, and papulopustular rashes based on a review of photographs and text descriptions. For the fourth case, respondents were asked to grade a dAE using only a clinic note text description. The researchers used chi-square tests in R software to compare survey responses.

Compared with medical oncologists, dermatologists were significantly more likely to provide correct responses in characterizing morbilliform and psoriasiform eruptions. “As low as 12%” of medical oncologists were correct, and “as low as 87%” of dermatologists were correct (P < .001). Similarly, dermatologists were significantly more likely to grade the psoriasiform, papulopustular, and written cases correctly compared with medical oncologists (P < .001 for all associations).

“These cases demonstrated poor concordance of classification and grading between specialties and across medical oncology,” the authors concluded in their poster, noting that 87% of medical oncologists were interested in additional educational tools on dAEs. “With correct classification as low as 12%, medical oncologists may have more difficulty delivering appropriate, toxicity-specific therapy and may consider banal eruptions dangerous.”

Poor concordance of grading among the two groups of clinicians “raises the question of whether CTCAE v5.0 is an appropriate determinant for patient continuation on therapy or in trials,” they added. “As anticancer therapy becomes more complex — with new toxicities from novel agents and combinations — we must ensure we have a grading system that is valid across investigators and does not harm patients by instituting unnecessary treatment stops.”

Future studies, they said, “can explore what interventions beyond involvement of dermatologists improve classification and grading in practice.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, noted that with the continued expansion and introduction of new targeted and immunotherapies in the oncology space, “you can be sure we will continue to appreciate the importance and value of the field of supportive oncodermatology, as hair, skin, and nails are almost guaranteed collateral damage in this story.

“Ensuring early identification and consistent grading severity is not only important for the plethora of patients who are currently developing the litany of cutaneous adverse events but to evaluate potential mitigation strategies and even push along countermeasures down the FDA approval pathway,” Dr. Friedman said. In this study, the investigators demonstrated that work “is sorely needed, not just in dermatology but even more so for our colleagues across the aisle. A central tenet of supportive oncodermatology must also be education for all stakeholders, and the good news is our oncology partners will welcome it.”

Dr. LeBoeuf disclosed that she is a consultant to and has received honoraria from Bayer, Seattle Genetics, Sanofi, Silverback, Fortress Biotech, and Synox Therapeutics outside the submitted work. No other authors reported having financial disclosures. Dr. Friedman directs the supportive oncodermatology program at GW that received independent funding from La Roche-Posay.
 

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

SAN DIEGO — Compared with medical oncologists, dermatologists were more likely to correctly classify and grade dermatologic adverse events from cancer therapies, results from a multicenter survey showed.

“New cancer therapies have brought a diversity of treatment-related dermatologic adverse events (dAEs) beyond those experienced with conventional chemotherapy, which has demanded an evolving assessment of toxicities,” researchers led by Nicole R. LeBoeuf, MD, MPH, of the Department of Dermatology at Brigham and Women’s Hospital and the Center for Cutaneous Oncology at the Dana-Farber Brigham Cancer Center, Boston, wrote in a poster presented at the American Academy of Dermatology annual meeting.

The authors noted that “Version 5.0 of the Common Terminology Criteria for Adverse Events (CTCAE v5.0)” serves as the current, broadly accepted criteria for classification and grading during routine medical care and clinical trials. But despite extensive utilization of CTCAE, there is little data regarding its application.”

To evaluate how CTCAE is being used in clinical practice, they sent a four-case survey of dAEs to 81 dermatologists and 182 medical oncologists at six US-based academic institutions. For three of the cases, respondents were asked to classify and grade morbilliform, psoriasiform, and papulopustular rashes based on a review of photographs and text descriptions. For the fourth case, respondents were asked to grade a dAE using only a clinic note text description. The researchers used chi-square tests in R software to compare survey responses.

Compared with medical oncologists, dermatologists were significantly more likely to provide correct responses in characterizing morbilliform and psoriasiform eruptions. “As low as 12%” of medical oncologists were correct, and “as low as 87%” of dermatologists were correct (P < .001). Similarly, dermatologists were significantly more likely to grade the psoriasiform, papulopustular, and written cases correctly compared with medical oncologists (P < .001 for all associations).

“These cases demonstrated poor concordance of classification and grading between specialties and across medical oncology,” the authors concluded in their poster, noting that 87% of medical oncologists were interested in additional educational tools on dAEs. “With correct classification as low as 12%, medical oncologists may have more difficulty delivering appropriate, toxicity-specific therapy and may consider banal eruptions dangerous.”

Poor concordance of grading among the two groups of clinicians “raises the question of whether CTCAE v5.0 is an appropriate determinant for patient continuation on therapy or in trials,” they added. “As anticancer therapy becomes more complex — with new toxicities from novel agents and combinations — we must ensure we have a grading system that is valid across investigators and does not harm patients by instituting unnecessary treatment stops.”

Future studies, they said, “can explore what interventions beyond involvement of dermatologists improve classification and grading in practice.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, noted that with the continued expansion and introduction of new targeted and immunotherapies in the oncology space, “you can be sure we will continue to appreciate the importance and value of the field of supportive oncodermatology, as hair, skin, and nails are almost guaranteed collateral damage in this story.

“Ensuring early identification and consistent grading severity is not only important for the plethora of patients who are currently developing the litany of cutaneous adverse events but to evaluate potential mitigation strategies and even push along countermeasures down the FDA approval pathway,” Dr. Friedman said. In this study, the investigators demonstrated that work “is sorely needed, not just in dermatology but even more so for our colleagues across the aisle. A central tenet of supportive oncodermatology must also be education for all stakeholders, and the good news is our oncology partners will welcome it.”

Dr. LeBoeuf disclosed that she is a consultant to and has received honoraria from Bayer, Seattle Genetics, Sanofi, Silverback, Fortress Biotech, and Synox Therapeutics outside the submitted work. No other authors reported having financial disclosures. Dr. Friedman directs the supportive oncodermatology program at GW that received independent funding from La Roche-Posay.
 

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

SAN DIEGO — Compared with medical oncologists, dermatologists were more likely to correctly classify and grade dermatologic adverse events from cancer therapies, results from a multicenter survey showed.

“New cancer therapies have brought a diversity of treatment-related dermatologic adverse events (dAEs) beyond those experienced with conventional chemotherapy, which has demanded an evolving assessment of toxicities,” researchers led by Nicole R. LeBoeuf, MD, MPH, of the Department of Dermatology at Brigham and Women’s Hospital and the Center for Cutaneous Oncology at the Dana-Farber Brigham Cancer Center, Boston, wrote in a poster presented at the American Academy of Dermatology annual meeting.

The authors noted that “Version 5.0 of the Common Terminology Criteria for Adverse Events (CTCAE v5.0)” serves as the current, broadly accepted criteria for classification and grading during routine medical care and clinical trials. But despite extensive utilization of CTCAE, there is little data regarding its application.”

To evaluate how CTCAE is being used in clinical practice, they sent a four-case survey of dAEs to 81 dermatologists and 182 medical oncologists at six US-based academic institutions. For three of the cases, respondents were asked to classify and grade morbilliform, psoriasiform, and papulopustular rashes based on a review of photographs and text descriptions. For the fourth case, respondents were asked to grade a dAE using only a clinic note text description. The researchers used chi-square tests in R software to compare survey responses.

Compared with medical oncologists, dermatologists were significantly more likely to provide correct responses in characterizing morbilliform and psoriasiform eruptions. “As low as 12%” of medical oncologists were correct, and “as low as 87%” of dermatologists were correct (P < .001). Similarly, dermatologists were significantly more likely to grade the psoriasiform, papulopustular, and written cases correctly compared with medical oncologists (P < .001 for all associations).

“These cases demonstrated poor concordance of classification and grading between specialties and across medical oncology,” the authors concluded in their poster, noting that 87% of medical oncologists were interested in additional educational tools on dAEs. “With correct classification as low as 12%, medical oncologists may have more difficulty delivering appropriate, toxicity-specific therapy and may consider banal eruptions dangerous.”

Poor concordance of grading among the two groups of clinicians “raises the question of whether CTCAE v5.0 is an appropriate determinant for patient continuation on therapy or in trials,” they added. “As anticancer therapy becomes more complex — with new toxicities from novel agents and combinations — we must ensure we have a grading system that is valid across investigators and does not harm patients by instituting unnecessary treatment stops.”

Future studies, they said, “can explore what interventions beyond involvement of dermatologists improve classification and grading in practice.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, noted that with the continued expansion and introduction of new targeted and immunotherapies in the oncology space, “you can be sure we will continue to appreciate the importance and value of the field of supportive oncodermatology, as hair, skin, and nails are almost guaranteed collateral damage in this story.

“Ensuring early identification and consistent grading severity is not only important for the plethora of patients who are currently developing the litany of cutaneous adverse events but to evaluate potential mitigation strategies and even push along countermeasures down the FDA approval pathway,” Dr. Friedman said. In this study, the investigators demonstrated that work “is sorely needed, not just in dermatology but even more so for our colleagues across the aisle. A central tenet of supportive oncodermatology must also be education for all stakeholders, and the good news is our oncology partners will welcome it.”

Dr. LeBoeuf disclosed that she is a consultant to and has received honoraria from Bayer, Seattle Genetics, Sanofi, Silverback, Fortress Biotech, and Synox Therapeutics outside the submitted work. No other authors reported having financial disclosures. Dr. Friedman directs the supportive oncodermatology program at GW that received independent funding from La Roche-Posay.
 

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

The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.

“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”

Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.

However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.

“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”

Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”

Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.

The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).

In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.

“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.

Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).

Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.

The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.

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

The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.

“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”

Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.

However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.

“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”

Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”

Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.

The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).

In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.

“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.

Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).

Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.

The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.

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

The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.

“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”

Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.

However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.

“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”

Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”

Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.

The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).

In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.

“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.

Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).

Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.

The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.

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

DENVER — The ability to provide adolescents with highly effective anti-obesity medications that now carry approvals from the US Food and Drug Administration (FDA) and support in guidelines offers reassurance of their use; however, a reality check often awaits for clinicians in terms of challenges ranging from accessing and affording the medications to managing real and rumored side effects.

Weighing in on the issues, experts at Obesity Medicine (OMA) 2024 offered some key strategies and practice hacks for overcoming those hurdles.

The incentive to provide treatment with popular glucagon-like peptide 1 (GLP-1) drugs such as semaglutide or the dual glucose-dependent insulinotropic peptide (GIP) GLP-1 tirzepatide lies in the evidence that their high efficacy in promoting weight loss, and hence preventing metabolic syndrome, has benefits that far outweigh the potential side effects, said Alaina Vidmar, MD, in presenting at the meeting.

“We can look at all the evidence and without question acknowledge that the GLP-1s/GIP agonists are the most effective agents that we currently have, with the least heterogeneity in response, and the most high responders compared with other agents,” said Dr. Vidmar, an assistant professor of clinical pediatrics at the Keck School of Medicine of University of Southern California and director of obesity medicine and bariatric surgery at Children’s Hospital Los Angeles.

The strength of the evidence is reflected in the landmark American Academy of Pediatrics (AAP) Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity, which recommends that “pediatricians and other primary healthcare providers should offer adolescents 12 years and older with obesity weight loss pharmacotherapy, according to medication indications, risks and may offer adolescents 8 years old with obesity weight loss pharmacotherapy, according to medication indications, risks.”

The AAP guidance echoes the recommendations of the drug makers and FDA that “a combination of specific behavioral techniques within the context of family-based behavioral treatment and the use of pharmacotherapy may be necessary to prevent life-limiting complications over time.”

However, in real-world practice, with the various challenges in providing that intensive, comprehensive care, clinicians should be prepared to get creative: “We sometimes have to do the best we can with what we have because the watchful waiting approach is not effective and leads to more harm than good,” Dr. Vidmar said.
 

Facilitating Access

The ongoing reported shortages in the highly popular anti-obesity medications, as well as insurance denials and high costs, are among the leading obstacles, for adolescents and adults alike.

Dr. Vidmar noted that key strategies at her center, Children’s Hospital Los Angeles, have been essential, however, in helping at least facilitate the authorization process.

The center’s approach began with contacting all the payers the center has contracts with to determine which of their policies cover these medications for adults and pediatrics and which agents are covered.

“This took work on the front end, but it was worth it because it helped us understand the framework for what we were going to go up against every time that we prescribed these medications,” she said.

Furthermore, the center’s specialty pharmacy set up contracts to be able to provide the drugs within the institution.

While the strategy can’t entirely mitigate the ongoing distribution concerns, “our pharmacy is now able to share with our weight management program what GLP-1s are available so that we can be more efficient in our work,” Dr. Vidmar said.

The center also created a list of contacts to provide to patients and their families, detailing local pharmacies that were most likely to have the medications.

Another strategy Dr. Vidmar’s center has utilized to allow the timely implementation of a GLP-1 treatment plan while awaiting a drug to become available is to create an alternative protocol, for instance, using liraglutide when awaiting semaglutide.

“If we are unable to get the lower doses of a weekly agent for titration, we have a standard protocol to bridge instead with liraglutide, and our patients, pharmacies, and even our authorizations are aware of the protocol,” Dr. Vidmar said.

“We often do not have a lot of control or agency over the distribution concerns; however, we can be thoughtful within our programs about how we titrate patients up to their full doses,” Dr. Vidmar said.
 

Mitigating Side Effects

When the medications are available, the common gastrointestinal (GI) side effects of nausea, vomiting, and diarrhea of the once-weekly injections are well-known, and these side effects can affect quality of life and daily function, Dr. Vidmar noted.

“We have to acknowledge that the seminal trials of these agents showed that nausea and vomiting occur in more than half of young people who take these agents during the initial titration period, and while the side effects are tolerated by many, they can be disruptive to daily life,” she said.

Encouragingly, “we also do know that for the majority of patients, those effects improve over time, and for many, they can be mitigated with nutrition changes.”

Dr. Vidmar shared a handout her center issues with key recommendations for mitigating GI effects in youth. These include:

• Eat smaller meals and eat slower
• Eat about half of what you usually eat
• Take about 15-20 minutes to eat your meal
• Aim for 60 g of protein per day
• Add fruits, vegetables, whole grains, and lean proteins to meals
• Limit foods that are spicy, greasy, or fried
• Drink water instead of sweet drinks

Consider Zofran as needed during the titration period for GI symptoms. “We’ve started using this at our institution and are teaching patients how to use it; it can really help mitigate any ER visits when there is any vomiting by educating patients and families and providing appropriate expectations, and that has been very helpful,” Dr. Vidmar said.

Regarding the GI effects, Dr. Vidmar noted she has observed that tirzepatide use (though still off-label) in youths “tends to have milder GI side effects among younger people.”
 

Mood Concerns?

Another concern that has emerged in public discussion regarding side effects is that of possible mood and suicidal ideation, raising concerns for adults and adolescents alike.

Upon investigating the reports, the FDA, in a statement, offered cautious reassurance that their review, including reports and clinical trials, “did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.”

Noting that the agency is continuing to look into the issue, however, the FDA recommends that “healthcare professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.”
 

Concurrent Psychiatric Pharmacotherapy

Meanwhile, with weight gain a known and often challenging side effect of various psychiatric drugs, particularly in younger patients, obesity treatment of adolescents may commonly involve patients who are also being treated with those therapies.

Key culprits include certain antidepressants and antipsychotic medications, such as tricyclic antidepressants, and second-generation antipsychotics, such as olanzapine.

In terms of the use of GLP-1 medications for those patients, research includes a recent study of semaglutide in patients who were also being treated with antidepressants.

The study, a post hoc analysis of the STEP trials, showed “clinically meaningful weight loss regardless of baseline antidepressant use, with an adverse event profile consistent with previous studies.”

First author Robert F. Kushner, MD, said the study offers “reassurance that individuals who are taking antidepressant medications have a similar weight loss response and side-effect profile compared to individuals who are not taking these medications.”

Dr. Kushner, a professor of medicine and medicine education at Northwestern University in Chicago, and his team have not evaluated the safety profile for concomitant use with antipsychotic drugs. However, he noted that “there are studies showing that the daily GLP-1 drug liraglutide has been shown to be useful in combating antipsychotic-induced weight gain.”

“Similar studies will need to be conducted for the more effective agents, semaglutide and tirzepatide,” he said.

To counter the weight gain effects of antispychotics, metformin has long been a standard recommendation, and Dr. Vidmar noted that “I have historically always used metformin in this setting and found it very effective.”

However, the newer anti-obesity medications could prove to be important in those cases, Dr. Vidmar added.

“I do think and predict that GLP-1 agonists will be as effective, if not more, in combating the weight gain-promoting effects of these agents and act as a nice adjuvant to this treatment paradigm for psychiatrists.”

Dr. Vidmar has participated in an advisory board for Rhythm Pharmaceuticals. Dr. Kushner is on the advisory boards for Novo Nordisk, Weight Watchers, Lilly, Boehringer Ingelheim, and Altimmune.

A version of this article appeared on Medscape.com.

DENVER — The ability to provide adolescents with highly effective anti-obesity medications that now carry approvals from the US Food and Drug Administration (FDA) and support in guidelines offers reassurance of their use; however, a reality check often awaits for clinicians in terms of challenges ranging from accessing and affording the medications to managing real and rumored side effects.

Weighing in on the issues, experts at Obesity Medicine (OMA) 2024 offered some key strategies and practice hacks for overcoming those hurdles.

The incentive to provide treatment with popular glucagon-like peptide 1 (GLP-1) drugs such as semaglutide or the dual glucose-dependent insulinotropic peptide (GIP) GLP-1 tirzepatide lies in the evidence that their high efficacy in promoting weight loss, and hence preventing metabolic syndrome, has benefits that far outweigh the potential side effects, said Alaina Vidmar, MD, in presenting at the meeting.

“We can look at all the evidence and without question acknowledge that the GLP-1s/GIP agonists are the most effective agents that we currently have, with the least heterogeneity in response, and the most high responders compared with other agents,” said Dr. Vidmar, an assistant professor of clinical pediatrics at the Keck School of Medicine of University of Southern California and director of obesity medicine and bariatric surgery at Children’s Hospital Los Angeles.

The strength of the evidence is reflected in the landmark American Academy of Pediatrics (AAP) Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity, which recommends that “pediatricians and other primary healthcare providers should offer adolescents 12 years and older with obesity weight loss pharmacotherapy, according to medication indications, risks and may offer adolescents 8 years old with obesity weight loss pharmacotherapy, according to medication indications, risks.”

The AAP guidance echoes the recommendations of the drug makers and FDA that “a combination of specific behavioral techniques within the context of family-based behavioral treatment and the use of pharmacotherapy may be necessary to prevent life-limiting complications over time.”

However, in real-world practice, with the various challenges in providing that intensive, comprehensive care, clinicians should be prepared to get creative: “We sometimes have to do the best we can with what we have because the watchful waiting approach is not effective and leads to more harm than good,” Dr. Vidmar said.
 

Facilitating Access

The ongoing reported shortages in the highly popular anti-obesity medications, as well as insurance denials and high costs, are among the leading obstacles, for adolescents and adults alike.

Dr. Vidmar noted that key strategies at her center, Children’s Hospital Los Angeles, have been essential, however, in helping at least facilitate the authorization process.

The center’s approach began with contacting all the payers the center has contracts with to determine which of their policies cover these medications for adults and pediatrics and which agents are covered.

“This took work on the front end, but it was worth it because it helped us understand the framework for what we were going to go up against every time that we prescribed these medications,” she said.

Furthermore, the center’s specialty pharmacy set up contracts to be able to provide the drugs within the institution.

While the strategy can’t entirely mitigate the ongoing distribution concerns, “our pharmacy is now able to share with our weight management program what GLP-1s are available so that we can be more efficient in our work,” Dr. Vidmar said.

The center also created a list of contacts to provide to patients and their families, detailing local pharmacies that were most likely to have the medications.

Another strategy Dr. Vidmar’s center has utilized to allow the timely implementation of a GLP-1 treatment plan while awaiting a drug to become available is to create an alternative protocol, for instance, using liraglutide when awaiting semaglutide.

“If we are unable to get the lower doses of a weekly agent for titration, we have a standard protocol to bridge instead with liraglutide, and our patients, pharmacies, and even our authorizations are aware of the protocol,” Dr. Vidmar said.

“We often do not have a lot of control or agency over the distribution concerns; however, we can be thoughtful within our programs about how we titrate patients up to their full doses,” Dr. Vidmar said.
 

Mitigating Side Effects

When the medications are available, the common gastrointestinal (GI) side effects of nausea, vomiting, and diarrhea of the once-weekly injections are well-known, and these side effects can affect quality of life and daily function, Dr. Vidmar noted.

“We have to acknowledge that the seminal trials of these agents showed that nausea and vomiting occur in more than half of young people who take these agents during the initial titration period, and while the side effects are tolerated by many, they can be disruptive to daily life,” she said.

Encouragingly, “we also do know that for the majority of patients, those effects improve over time, and for many, they can be mitigated with nutrition changes.”

Dr. Vidmar shared a handout her center issues with key recommendations for mitigating GI effects in youth. These include:

• Eat smaller meals and eat slower
• Eat about half of what you usually eat
• Take about 15-20 minutes to eat your meal
• Aim for 60 g of protein per day
• Add fruits, vegetables, whole grains, and lean proteins to meals
• Limit foods that are spicy, greasy, or fried
• Drink water instead of sweet drinks

Consider Zofran as needed during the titration period for GI symptoms. “We’ve started using this at our institution and are teaching patients how to use it; it can really help mitigate any ER visits when there is any vomiting by educating patients and families and providing appropriate expectations, and that has been very helpful,” Dr. Vidmar said.

Regarding the GI effects, Dr. Vidmar noted she has observed that tirzepatide use (though still off-label) in youths “tends to have milder GI side effects among younger people.”
 

Mood Concerns?

Another concern that has emerged in public discussion regarding side effects is that of possible mood and suicidal ideation, raising concerns for adults and adolescents alike.

Upon investigating the reports, the FDA, in a statement, offered cautious reassurance that their review, including reports and clinical trials, “did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.”

Noting that the agency is continuing to look into the issue, however, the FDA recommends that “healthcare professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.”
 

Concurrent Psychiatric Pharmacotherapy

Meanwhile, with weight gain a known and often challenging side effect of various psychiatric drugs, particularly in younger patients, obesity treatment of adolescents may commonly involve patients who are also being treated with those therapies.

Key culprits include certain antidepressants and antipsychotic medications, such as tricyclic antidepressants, and second-generation antipsychotics, such as olanzapine.

In terms of the use of GLP-1 medications for those patients, research includes a recent study of semaglutide in patients who were also being treated with antidepressants.

The study, a post hoc analysis of the STEP trials, showed “clinically meaningful weight loss regardless of baseline antidepressant use, with an adverse event profile consistent with previous studies.”

First author Robert F. Kushner, MD, said the study offers “reassurance that individuals who are taking antidepressant medications have a similar weight loss response and side-effect profile compared to individuals who are not taking these medications.”

Dr. Kushner, a professor of medicine and medicine education at Northwestern University in Chicago, and his team have not evaluated the safety profile for concomitant use with antipsychotic drugs. However, he noted that “there are studies showing that the daily GLP-1 drug liraglutide has been shown to be useful in combating antipsychotic-induced weight gain.”

“Similar studies will need to be conducted for the more effective agents, semaglutide and tirzepatide,” he said.

To counter the weight gain effects of antispychotics, metformin has long been a standard recommendation, and Dr. Vidmar noted that “I have historically always used metformin in this setting and found it very effective.”

However, the newer anti-obesity medications could prove to be important in those cases, Dr. Vidmar added.

“I do think and predict that GLP-1 agonists will be as effective, if not more, in combating the weight gain-promoting effects of these agents and act as a nice adjuvant to this treatment paradigm for psychiatrists.”

Dr. Vidmar has participated in an advisory board for Rhythm Pharmaceuticals. Dr. Kushner is on the advisory boards for Novo Nordisk, Weight Watchers, Lilly, Boehringer Ingelheim, and Altimmune.

A version of this article appeared on Medscape.com.

DENVER — The ability to provide adolescents with highly effective anti-obesity medications that now carry approvals from the US Food and Drug Administration (FDA) and support in guidelines offers reassurance of their use; however, a reality check often awaits for clinicians in terms of challenges ranging from accessing and affording the medications to managing real and rumored side effects.

Weighing in on the issues, experts at Obesity Medicine (OMA) 2024 offered some key strategies and practice hacks for overcoming those hurdles.

The incentive to provide treatment with popular glucagon-like peptide 1 (GLP-1) drugs such as semaglutide or the dual glucose-dependent insulinotropic peptide (GIP) GLP-1 tirzepatide lies in the evidence that their high efficacy in promoting weight loss, and hence preventing metabolic syndrome, has benefits that far outweigh the potential side effects, said Alaina Vidmar, MD, in presenting at the meeting.

“We can look at all the evidence and without question acknowledge that the GLP-1s/GIP agonists are the most effective agents that we currently have, with the least heterogeneity in response, and the most high responders compared with other agents,” said Dr. Vidmar, an assistant professor of clinical pediatrics at the Keck School of Medicine of University of Southern California and director of obesity medicine and bariatric surgery at Children’s Hospital Los Angeles.

The strength of the evidence is reflected in the landmark American Academy of Pediatrics (AAP) Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity, which recommends that “pediatricians and other primary healthcare providers should offer adolescents 12 years and older with obesity weight loss pharmacotherapy, according to medication indications, risks and may offer adolescents 8 years old with obesity weight loss pharmacotherapy, according to medication indications, risks.”

The AAP guidance echoes the recommendations of the drug makers and FDA that “a combination of specific behavioral techniques within the context of family-based behavioral treatment and the use of pharmacotherapy may be necessary to prevent life-limiting complications over time.”

However, in real-world practice, with the various challenges in providing that intensive, comprehensive care, clinicians should be prepared to get creative: “We sometimes have to do the best we can with what we have because the watchful waiting approach is not effective and leads to more harm than good,” Dr. Vidmar said.
 

Facilitating Access

The ongoing reported shortages in the highly popular anti-obesity medications, as well as insurance denials and high costs, are among the leading obstacles, for adolescents and adults alike.

Dr. Vidmar noted that key strategies at her center, Children’s Hospital Los Angeles, have been essential, however, in helping at least facilitate the authorization process.

The center’s approach began with contacting all the payers the center has contracts with to determine which of their policies cover these medications for adults and pediatrics and which agents are covered.

“This took work on the front end, but it was worth it because it helped us understand the framework for what we were going to go up against every time that we prescribed these medications,” she said.

Furthermore, the center’s specialty pharmacy set up contracts to be able to provide the drugs within the institution.

While the strategy can’t entirely mitigate the ongoing distribution concerns, “our pharmacy is now able to share with our weight management program what GLP-1s are available so that we can be more efficient in our work,” Dr. Vidmar said.

The center also created a list of contacts to provide to patients and their families, detailing local pharmacies that were most likely to have the medications.

Another strategy Dr. Vidmar’s center has utilized to allow the timely implementation of a GLP-1 treatment plan while awaiting a drug to become available is to create an alternative protocol, for instance, using liraglutide when awaiting semaglutide.

“If we are unable to get the lower doses of a weekly agent for titration, we have a standard protocol to bridge instead with liraglutide, and our patients, pharmacies, and even our authorizations are aware of the protocol,” Dr. Vidmar said.

“We often do not have a lot of control or agency over the distribution concerns; however, we can be thoughtful within our programs about how we titrate patients up to their full doses,” Dr. Vidmar said.
 

Mitigating Side Effects

When the medications are available, the common gastrointestinal (GI) side effects of nausea, vomiting, and diarrhea of the once-weekly injections are well-known, and these side effects can affect quality of life and daily function, Dr. Vidmar noted.

“We have to acknowledge that the seminal trials of these agents showed that nausea and vomiting occur in more than half of young people who take these agents during the initial titration period, and while the side effects are tolerated by many, they can be disruptive to daily life,” she said.

Encouragingly, “we also do know that for the majority of patients, those effects improve over time, and for many, they can be mitigated with nutrition changes.”

Dr. Vidmar shared a handout her center issues with key recommendations for mitigating GI effects in youth. These include:

• Eat smaller meals and eat slower
• Eat about half of what you usually eat
• Take about 15-20 minutes to eat your meal
• Aim for 60 g of protein per day
• Add fruits, vegetables, whole grains, and lean proteins to meals
• Limit foods that are spicy, greasy, or fried
• Drink water instead of sweet drinks

Consider Zofran as needed during the titration period for GI symptoms. “We’ve started using this at our institution and are teaching patients how to use it; it can really help mitigate any ER visits when there is any vomiting by educating patients and families and providing appropriate expectations, and that has been very helpful,” Dr. Vidmar said.

Regarding the GI effects, Dr. Vidmar noted she has observed that tirzepatide use (though still off-label) in youths “tends to have milder GI side effects among younger people.”
 

Mood Concerns?

Another concern that has emerged in public discussion regarding side effects is that of possible mood and suicidal ideation, raising concerns for adults and adolescents alike.

Upon investigating the reports, the FDA, in a statement, offered cautious reassurance that their review, including reports and clinical trials, “did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.”

Noting that the agency is continuing to look into the issue, however, the FDA recommends that “healthcare professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.”
 

Concurrent Psychiatric Pharmacotherapy

Meanwhile, with weight gain a known and often challenging side effect of various psychiatric drugs, particularly in younger patients, obesity treatment of adolescents may commonly involve patients who are also being treated with those therapies.

Key culprits include certain antidepressants and antipsychotic medications, such as tricyclic antidepressants, and second-generation antipsychotics, such as olanzapine.

In terms of the use of GLP-1 medications for those patients, research includes a recent study of semaglutide in patients who were also being treated with antidepressants.

The study, a post hoc analysis of the STEP trials, showed “clinically meaningful weight loss regardless of baseline antidepressant use, with an adverse event profile consistent with previous studies.”

First author Robert F. Kushner, MD, said the study offers “reassurance that individuals who are taking antidepressant medications have a similar weight loss response and side-effect profile compared to individuals who are not taking these medications.”

Dr. Kushner, a professor of medicine and medicine education at Northwestern University in Chicago, and his team have not evaluated the safety profile for concomitant use with antipsychotic drugs. However, he noted that “there are studies showing that the daily GLP-1 drug liraglutide has been shown to be useful in combating antipsychotic-induced weight gain.”

“Similar studies will need to be conducted for the more effective agents, semaglutide and tirzepatide,” he said.

To counter the weight gain effects of antispychotics, metformin has long been a standard recommendation, and Dr. Vidmar noted that “I have historically always used metformin in this setting and found it very effective.”

However, the newer anti-obesity medications could prove to be important in those cases, Dr. Vidmar added.

“I do think and predict that GLP-1 agonists will be as effective, if not more, in combating the weight gain-promoting effects of these agents and act as a nice adjuvant to this treatment paradigm for psychiatrists.”

Dr. Vidmar has participated in an advisory board for Rhythm Pharmaceuticals. Dr. Kushner is on the advisory boards for Novo Nordisk, Weight Watchers, Lilly, Boehringer Ingelheim, and Altimmune.

A version of this article appeared on Medscape.com.

Targeted video games could help reduce symptoms of attention-deficit/hyperactivity disorder (ADHD) and depression in children and adolescents, results of a new review and meta-analysis suggested.

Although the video game–based or “gamified” digital mental health interventions (DMHIs) were associated with modest improvements in ADHD symptoms and depression, investigators found no significant benefit in the treatment of anxiety.

“The studies are showing these video games really do work, at least for ADHD and depression but maybe not for anxiety,” said Barry Bryant, MD, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore.

“The results may assist clinicians as they make recommendations to patients and parents regarding the efficacy of using these video games to treat mental health conditions.”

The findings were presented at the American Psychiatric Association (APA) 2024 Annual Meeting.
 

A Major Problem

Childhood mental illness is a “big problem,” with about 20% of children facing some mental health challenge such as ADHD, anxiety, or depression, said Dr. Bryant. Unfortunately, these youngsters typically have to wait a while to see a provider, he added.

DMHIs may be an option to consider in the meantime to help meet the increasing demand for treatment, he said.

Gamified DMHIs are like other video games, in that players advance in levels on digital platforms and are rewarded for progress. But they’re created specifically to target certain mental health conditions.

An ADHD game, for example, might involve users completing activities that require an increasing degree of attention. Games focused on depression might incorporate mindfulness and meditation practices or cognitive behavioral elements.

Experts in child psychiatry are involved in developing such games along with professionals in business and video game technology, said Dr. Bryant.

But the question is: Do these games really work?
 

Effective for ADHD, Depression

Investigators reviewed nearly 30 randomized controlled trials of gamified DMHIs as a treatment for anxiety, depression, and/or ADHD in people younger than 18 years that were published from January 1, 1990, to April 7, 2023.

The trials tested a wide variety of gamified DMHIs that fit the inclusion criteria: A control condition, a digital game intervention, sufficient data to calculate effect size, and available in English.

A meta-analysis was performed to examine the therapeutic effects of the gamified DMHIs for ADHD, depression, and anxiety. For all studies, the active treatment was compared with the control condition using Hedges’ g to measure effect size and 95% CIs.

Dr. Bryant noted there was significant heterogeneity of therapeutic effects between the studies and their corresponding gamified interventions.

The study found gamified DMHIs had a modest therapeutic effect for treating ADHD (pooled g = 0.280; P = .005) and depression (pooled g = 0.279; P = .005) in children and adolescents.

But games targeting anxiety didn’t seem to have the same positive impact (pooled g = 0.074; P = .197).

The results suggest the games “show potential and promise” for certain mental health conditions and could offer a “bridge” to accessing more traditional therapies, Dr. Bryant said.

“Maybe this is something that can help these children until they can get to see a psychiatrist, or it could be part of a comprehensive treatment plan,” he said.

The goal is to “make something that kids want to play and engage with” especially if they’re reluctant to sit in a therapist’s office.

The results provide clinicians with information they can actually use in their practices, said Dr. Bryant, adding that his team hopes to get their study published.
 

Gaining Traction

Commenting on the research, James Sherer, MD, medical director, Addiction Psychiatry, Overlook Medical Center, Atlantic Health System, said the study shows the literature supports video games, and these games “are gaining traction” in the field.

He noted the app for one such game, EndeavorRx, was one of the first to be approved by the US Food and Drug Administration (FDA) to treat ADHD in young people aged 8-17 years.

EndeavorRx challenges players to chase mystic creatures, race through different worlds, and use “boosts” to problem-solve while building their own universe, according to the company website.

By being incentivized to engage in certain activities, “there’s a level of executive functioning that’s being exercised and the idea is to do that repetitively,” said Dr. Sherer.

Users and their parents report improved ADHD symptoms after playing the game. One of the studies included in the review found 73% of children who played EndeavorRx reported improvement in their attention.

The company says there have been no serious adverse events seen in any clinical trial of EndeavorRx.

Dr. Sherer noted that many child psychiatrists play some sort of video game with their young patients who may be on the autism spectrum or have a learning disability.

“That may be one of the few ways to communicate with and effectively bond with the patient,” he said.

Despite their reputation of being violent and associated with “toxic subcultures,” video games can do a lot of good and be “restorative” for patients of all ages, Dr. Sherer added.

No relevant conflicts of interest were disclosed.

A version of this article appeared on Medscape.com.

Targeted video games could help reduce symptoms of attention-deficit/hyperactivity disorder (ADHD) and depression in children and adolescents, results of a new review and meta-analysis suggested.

Although the video game–based or “gamified” digital mental health interventions (DMHIs) were associated with modest improvements in ADHD symptoms and depression, investigators found no significant benefit in the treatment of anxiety.

“The studies are showing these video games really do work, at least for ADHD and depression but maybe not for anxiety,” said Barry Bryant, MD, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore.

“The results may assist clinicians as they make recommendations to patients and parents regarding the efficacy of using these video games to treat mental health conditions.”

The findings were presented at the American Psychiatric Association (APA) 2024 Annual Meeting.
 

A Major Problem

Childhood mental illness is a “big problem,” with about 20% of children facing some mental health challenge such as ADHD, anxiety, or depression, said Dr. Bryant. Unfortunately, these youngsters typically have to wait a while to see a provider, he added.

DMHIs may be an option to consider in the meantime to help meet the increasing demand for treatment, he said.

Gamified DMHIs are like other video games, in that players advance in levels on digital platforms and are rewarded for progress. But they’re created specifically to target certain mental health conditions.

An ADHD game, for example, might involve users completing activities that require an increasing degree of attention. Games focused on depression might incorporate mindfulness and meditation practices or cognitive behavioral elements.

Experts in child psychiatry are involved in developing such games along with professionals in business and video game technology, said Dr. Bryant.

But the question is: Do these games really work?
 

Effective for ADHD, Depression

Investigators reviewed nearly 30 randomized controlled trials of gamified DMHIs as a treatment for anxiety, depression, and/or ADHD in people younger than 18 years that were published from January 1, 1990, to April 7, 2023.

The trials tested a wide variety of gamified DMHIs that fit the inclusion criteria: A control condition, a digital game intervention, sufficient data to calculate effect size, and available in English.

A meta-analysis was performed to examine the therapeutic effects of the gamified DMHIs for ADHD, depression, and anxiety. For all studies, the active treatment was compared with the control condition using Hedges’ g to measure effect size and 95% CIs.

Dr. Bryant noted there was significant heterogeneity of therapeutic effects between the studies and their corresponding gamified interventions.

The study found gamified DMHIs had a modest therapeutic effect for treating ADHD (pooled g = 0.280; P = .005) and depression (pooled g = 0.279; P = .005) in children and adolescents.

But games targeting anxiety didn’t seem to have the same positive impact (pooled g = 0.074; P = .197).

The results suggest the games “show potential and promise” for certain mental health conditions and could offer a “bridge” to accessing more traditional therapies, Dr. Bryant said.

“Maybe this is something that can help these children until they can get to see a psychiatrist, or it could be part of a comprehensive treatment plan,” he said.

The goal is to “make something that kids want to play and engage with” especially if they’re reluctant to sit in a therapist’s office.

The results provide clinicians with information they can actually use in their practices, said Dr. Bryant, adding that his team hopes to get their study published.
 

Gaining Traction

Commenting on the research, James Sherer, MD, medical director, Addiction Psychiatry, Overlook Medical Center, Atlantic Health System, said the study shows the literature supports video games, and these games “are gaining traction” in the field.

He noted the app for one such game, EndeavorRx, was one of the first to be approved by the US Food and Drug Administration (FDA) to treat ADHD in young people aged 8-17 years.

EndeavorRx challenges players to chase mystic creatures, race through different worlds, and use “boosts” to problem-solve while building their own universe, according to the company website.

By being incentivized to engage in certain activities, “there’s a level of executive functioning that’s being exercised and the idea is to do that repetitively,” said Dr. Sherer.

Users and their parents report improved ADHD symptoms after playing the game. One of the studies included in the review found 73% of children who played EndeavorRx reported improvement in their attention.

The company says there have been no serious adverse events seen in any clinical trial of EndeavorRx.

Dr. Sherer noted that many child psychiatrists play some sort of video game with their young patients who may be on the autism spectrum or have a learning disability.

“That may be one of the few ways to communicate with and effectively bond with the patient,” he said.

Despite their reputation of being violent and associated with “toxic subcultures,” video games can do a lot of good and be “restorative” for patients of all ages, Dr. Sherer added.

No relevant conflicts of interest were disclosed.

A version of this article appeared on Medscape.com.

Targeted video games could help reduce symptoms of attention-deficit/hyperactivity disorder (ADHD) and depression in children and adolescents, results of a new review and meta-analysis suggested.

Although the video game–based or “gamified” digital mental health interventions (DMHIs) were associated with modest improvements in ADHD symptoms and depression, investigators found no significant benefit in the treatment of anxiety.

“The studies are showing these video games really do work, at least for ADHD and depression but maybe not for anxiety,” said Barry Bryant, MD, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore.

“The results may assist clinicians as they make recommendations to patients and parents regarding the efficacy of using these video games to treat mental health conditions.”

The findings were presented at the American Psychiatric Association (APA) 2024 Annual Meeting.
 

A Major Problem

Childhood mental illness is a “big problem,” with about 20% of children facing some mental health challenge such as ADHD, anxiety, or depression, said Dr. Bryant. Unfortunately, these youngsters typically have to wait a while to see a provider, he added.

DMHIs may be an option to consider in the meantime to help meet the increasing demand for treatment, he said.

Gamified DMHIs are like other video games, in that players advance in levels on digital platforms and are rewarded for progress. But they’re created specifically to target certain mental health conditions.

An ADHD game, for example, might involve users completing activities that require an increasing degree of attention. Games focused on depression might incorporate mindfulness and meditation practices or cognitive behavioral elements.

Experts in child psychiatry are involved in developing such games along with professionals in business and video game technology, said Dr. Bryant.

But the question is: Do these games really work?
 

Effective for ADHD, Depression

Investigators reviewed nearly 30 randomized controlled trials of gamified DMHIs as a treatment for anxiety, depression, and/or ADHD in people younger than 18 years that were published from January 1, 1990, to April 7, 2023.

The trials tested a wide variety of gamified DMHIs that fit the inclusion criteria: A control condition, a digital game intervention, sufficient data to calculate effect size, and available in English.

A meta-analysis was performed to examine the therapeutic effects of the gamified DMHIs for ADHD, depression, and anxiety. For all studies, the active treatment was compared with the control condition using Hedges’ g to measure effect size and 95% CIs.

Dr. Bryant noted there was significant heterogeneity of therapeutic effects between the studies and their corresponding gamified interventions.

The study found gamified DMHIs had a modest therapeutic effect for treating ADHD (pooled g = 0.280; P = .005) and depression (pooled g = 0.279; P = .005) in children and adolescents.

But games targeting anxiety didn’t seem to have the same positive impact (pooled g = 0.074; P = .197).

The results suggest the games “show potential and promise” for certain mental health conditions and could offer a “bridge” to accessing more traditional therapies, Dr. Bryant said.

“Maybe this is something that can help these children until they can get to see a psychiatrist, or it could be part of a comprehensive treatment plan,” he said.

The goal is to “make something that kids want to play and engage with” especially if they’re reluctant to sit in a therapist’s office.

The results provide clinicians with information they can actually use in their practices, said Dr. Bryant, adding that his team hopes to get their study published.
 

Gaining Traction

Commenting on the research, James Sherer, MD, medical director, Addiction Psychiatry, Overlook Medical Center, Atlantic Health System, said the study shows the literature supports video games, and these games “are gaining traction” in the field.

He noted the app for one such game, EndeavorRx, was one of the first to be approved by the US Food and Drug Administration (FDA) to treat ADHD in young people aged 8-17 years.

EndeavorRx challenges players to chase mystic creatures, race through different worlds, and use “boosts” to problem-solve while building their own universe, according to the company website.

By being incentivized to engage in certain activities, “there’s a level of executive functioning that’s being exercised and the idea is to do that repetitively,” said Dr. Sherer.

Users and their parents report improved ADHD symptoms after playing the game. One of the studies included in the review found 73% of children who played EndeavorRx reported improvement in their attention.

The company says there have been no serious adverse events seen in any clinical trial of EndeavorRx.

Dr. Sherer noted that many child psychiatrists play some sort of video game with their young patients who may be on the autism spectrum or have a learning disability.

“That may be one of the few ways to communicate with and effectively bond with the patient,” he said.

Despite their reputation of being violent and associated with “toxic subcultures,” video games can do a lot of good and be “restorative” for patients of all ages, Dr. Sherer added.

No relevant conflicts of interest were disclosed.

A version of this article appeared on Medscape.com.

BERLIN — To date, mRNA vaccines have had their largest global presence in combating the COVID-19 pandemic. Intensive research is underway on many other potential applications for this vaccine technology, which suggests a promising future. Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.

To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
 

Instability Challenge

Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.

With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
 

Improved Scalability

“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”

Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.

In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.

Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.

Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
 

Cancer Immunotherapy

Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.

Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.

The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
 

Genetic Engineering

Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.

Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.

In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.

Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
 

Research in Infections

Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.

“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”

“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”

Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.

An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
 

Elaborate Purification Process

Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.

These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”

Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
 

Prevention and Therapy

In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.

“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.

“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

BERLIN — To date, mRNA vaccines have had their largest global presence in combating the COVID-19 pandemic. Intensive research is underway on many other potential applications for this vaccine technology, which suggests a promising future. Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.

To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
 

Instability Challenge

Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.

With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
 

Improved Scalability

“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”

Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.

In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.

Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.

Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
 

Cancer Immunotherapy

Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.

Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.

The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
 

Genetic Engineering

Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.

Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.

In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.

Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
 

Research in Infections

Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.

“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”

“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”

Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.

An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
 

Elaborate Purification Process

Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.

These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”

Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
 

Prevention and Therapy

In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.

“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.

“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

BERLIN — To date, mRNA vaccines have had their largest global presence in combating the COVID-19 pandemic. Intensive research is underway on many other potential applications for this vaccine technology, which suggests a promising future. Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.

To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
 

Instability Challenge

Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.

With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
 

Improved Scalability

“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”

Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.

In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.

Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.

Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
 

Cancer Immunotherapy

Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.

Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.

The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
 

Genetic Engineering

Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.

Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.

In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.

Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
 

Research in Infections

Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.

“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”

“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”

Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.

An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
 

Elaborate Purification Process

Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.

These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”

Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
 

Prevention and Therapy

In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.

“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.

“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

By age 12 years, more than 14% of children have tried alcohol or tobacco, and religion, race, and income are the top predictors beginning to use these and other substances, new research suggests.

Aside from sociodemographic parameters, risk factors for substance use initiation include prenatal exposure to substances, peer use of alcohol and nicotine, and problematic school behavior, among other things, the study showed.

The results show certain modifiable risk factors may play a role in preventing youth from starting to use substances, said study author ReJoyce Green, PhD, research assistant professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.

“If we’re designing, say, a prevention program or an early intervention program, these are things that could make a difference, so let’s make sure we’re bringing them into the conversation.”

The findings were presented at the annual meeting of the American Psychiatric Association American Psychiatric Association (APA) and published online in The American Journal of Psychiatry.
 

Critical Risk Factors

Use of alcohol, tobacco, and cannabis often begins during adolescence. One recent survey showed that 23% of 13-year-olds reported using alcohol, 17% reported vaping nicotine, and 8% reported vaping cannabis. Other research links younger age at substance use initiation to a more rapid transition to substance use disorders and higher rates of psychiatric disorders.

Previous studies examining predictors of substance use initiation in the Adolescent Brain Cognitive Development (ABCD) Study dataset focused primarily on self-reported measures, but the current study also looked at models that include hormones and neurocognitive factors as well as neuroimaging.

This study included 6829, 9- and 10-year-olds from the ABCD Study who had never tried substances and were followed for 3 years.

A sophisticated statistical approach was used to examine 420 variables as predictors of substance use initiation. Initiation was defined as trying any nonprescribed substance by age 12 years. “That’s including a single sip of alcohol or puff of a cigarette,” said Dr. Green.

In addition to alcohol, nicotine, and cannabis, researchers looked at initiation of synthetic cannabinoids, cocaine, methamphetamine, and ketamine, among other substances.

Self-reported measures included demographic characteristics, self and peer involvement with substance use, parenting behaviors, mental and physical health, and culture and environmental factors.

The analytical approach used machine-learning algorithms to compare the ability of domains to identify the most critical risk factors. Magnitudes of coefficients were used to assess variable importance, with positive coefficients indicating greater likelihood of substance initiation and negative coefficients indicating lower likelihood of initiation.

By age 12 years, 14.4% of the children studied reported substance initiation. Alcohol was the substance most commonly initiated (365 individuals), followed by nicotine (94 individuals) and cannabis (40 individuals), with few or no children initiating other substances.

Both those who did and did not initiate substances were similarly aged, and most participants identified as White and non-Hispanic. But the substance-use group had a lower percentage of girls and higher percentage of White participants compared with the no-substance-use group.

The model with only self-reported data had similar accuracy in predicting substance use initiation (area under the curve [AUC], 0.67) as models that added resource-intensive measures such as neurocognitive tests and hormones (AUC, 0.67) and neuroimaging (AUC, 0.66).
 

Religious Predictors

The strongest predictors of substance use initiation were related to religion: Youths whose parents reported a religious preference for Mormonism were less likely to initiate substance use (coefficient, -0.87), whereas youths whose parents reported a religious preference for Judaism were more likely to initiate substance use (coefficient, 0.32).

The third top predictor was race: Black youths were less likely to initiate substance use (coefficient, -0.32). This was followed by youths whose parents reported a religious preference for Islam who were also less likely to initiate substance use (coefficient, -0.25).

The research examined over 15 different religious categories, “so we really tried to be expansive,” noted Dr. Green.

It’s unclear why some religions appeared to have a protective impact when it comes to substance use initiation whereas others have the opposite effect. Future research could perhaps identify which components of religiosity affect substance use initiation. If so, these aspects could be developed and incorporated into prevention and intervention programs, said Dr. Green.

Next on the list of most important predictors was being a part of a household with an income of $12,000-$15,999; these youths were less likely to initiate substance use (coefficient, 0.22).

Within the culture and environment domain, a history of detention or suspension was a top predictor of substance use initiation (coefficient, 0.20). Prenatal exposure to substance use was also a robust predictor in the physical health category (coefficient, 0.15).

Other predictors included: parents with less than a high school degree or GED (coefficient, -0.14), substance use availability (coefficient, 0.12), and age at baseline (coefficient, 0.12).

The study also showed that better cognitive functioning in selected domains (eg, cognitive control, attention, and language ability) is associated with a greater likelihood of substance use initiation.
 

Shaping Future Prevention

Applying these findings in clinical settings could help tailor prevention and early intervention efforts, said the authors. It might be prudent to allocate resources to collecting data related to self-, peer-, and familial-related factors, “which were more informative in predicting substance use initiation during late childhood and early adolescence in the present study,” they wrote.

Researchers will continue to track these children through to a 10-year follow-up, said Dr. Green. “I’m really curious to see if the factors we found when they were 12 and 13, such as those related to peers and family, still hold when they’re ages 17 and 18, because there’s going to be a huge amount of brain development that’s happening throughout this phase.”

The group that initiated substance use and the group that didn’t initiate substance use were not totally balanced, and sample sizes for some religious categories were small. Another study limitation was that the analytic approach didn’t account for multilevel data within the context of site and families.

Commenting on the findings, Kathleen Brady, MD, PhD, distinguished university professor and director, South Carolina Clinical and Translational Research Institute, Medical University of South Carolina, said that the study is “critical and complex.” This, she said, is especially true as cannabis has become more accessible and potent, and as the federal government reportedly considers reclassifying it from a Schedule I drug (which includes highly dangerous, addictive substances with no medical use) to a Schedule III drug (which can be prescribed as a medication).

“The part that is the most frightening to me is the long-lasting effects that can happen when young people start using high-potency marijuana at an early age,” said Dr. Brady. “So, any information that we can give to parents, to teachers, to the public, and to doctors is important.”

She’s looking forward to getting more “incredibly important” information on substance use initiation as the study progresses and the teens get older. 

The study received support from the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.

A version of this article appeared on Medscape.com.

By age 12 years, more than 14% of children have tried alcohol or tobacco, and religion, race, and income are the top predictors beginning to use these and other substances, new research suggests.

Aside from sociodemographic parameters, risk factors for substance use initiation include prenatal exposure to substances, peer use of alcohol and nicotine, and problematic school behavior, among other things, the study showed.

The results show certain modifiable risk factors may play a role in preventing youth from starting to use substances, said study author ReJoyce Green, PhD, research assistant professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.

“If we’re designing, say, a prevention program or an early intervention program, these are things that could make a difference, so let’s make sure we’re bringing them into the conversation.”

The findings were presented at the annual meeting of the American Psychiatric Association American Psychiatric Association (APA) and published online in The American Journal of Psychiatry.
 

Critical Risk Factors

Use of alcohol, tobacco, and cannabis often begins during adolescence. One recent survey showed that 23% of 13-year-olds reported using alcohol, 17% reported vaping nicotine, and 8% reported vaping cannabis. Other research links younger age at substance use initiation to a more rapid transition to substance use disorders and higher rates of psychiatric disorders.

Previous studies examining predictors of substance use initiation in the Adolescent Brain Cognitive Development (ABCD) Study dataset focused primarily on self-reported measures, but the current study also looked at models that include hormones and neurocognitive factors as well as neuroimaging.

This study included 6829, 9- and 10-year-olds from the ABCD Study who had never tried substances and were followed for 3 years.

A sophisticated statistical approach was used to examine 420 variables as predictors of substance use initiation. Initiation was defined as trying any nonprescribed substance by age 12 years. “That’s including a single sip of alcohol or puff of a cigarette,” said Dr. Green.

In addition to alcohol, nicotine, and cannabis, researchers looked at initiation of synthetic cannabinoids, cocaine, methamphetamine, and ketamine, among other substances.

Self-reported measures included demographic characteristics, self and peer involvement with substance use, parenting behaviors, mental and physical health, and culture and environmental factors.

The analytical approach used machine-learning algorithms to compare the ability of domains to identify the most critical risk factors. Magnitudes of coefficients were used to assess variable importance, with positive coefficients indicating greater likelihood of substance initiation and negative coefficients indicating lower likelihood of initiation.

By age 12 years, 14.4% of the children studied reported substance initiation. Alcohol was the substance most commonly initiated (365 individuals), followed by nicotine (94 individuals) and cannabis (40 individuals), with few or no children initiating other substances.

Both those who did and did not initiate substances were similarly aged, and most participants identified as White and non-Hispanic. But the substance-use group had a lower percentage of girls and higher percentage of White participants compared with the no-substance-use group.

The model with only self-reported data had similar accuracy in predicting substance use initiation (area under the curve [AUC], 0.67) as models that added resource-intensive measures such as neurocognitive tests and hormones (AUC, 0.67) and neuroimaging (AUC, 0.66).
 

Religious Predictors

The strongest predictors of substance use initiation were related to religion: Youths whose parents reported a religious preference for Mormonism were less likely to initiate substance use (coefficient, -0.87), whereas youths whose parents reported a religious preference for Judaism were more likely to initiate substance use (coefficient, 0.32).

The third top predictor was race: Black youths were less likely to initiate substance use (coefficient, -0.32). This was followed by youths whose parents reported a religious preference for Islam who were also less likely to initiate substance use (coefficient, -0.25).

The research examined over 15 different religious categories, “so we really tried to be expansive,” noted Dr. Green.

It’s unclear why some religions appeared to have a protective impact when it comes to substance use initiation whereas others have the opposite effect. Future research could perhaps identify which components of religiosity affect substance use initiation. If so, these aspects could be developed and incorporated into prevention and intervention programs, said Dr. Green.

Next on the list of most important predictors was being a part of a household with an income of $12,000-$15,999; these youths were less likely to initiate substance use (coefficient, 0.22).

Within the culture and environment domain, a history of detention or suspension was a top predictor of substance use initiation (coefficient, 0.20). Prenatal exposure to substance use was also a robust predictor in the physical health category (coefficient, 0.15).

Other predictors included: parents with less than a high school degree or GED (coefficient, -0.14), substance use availability (coefficient, 0.12), and age at baseline (coefficient, 0.12).

The study also showed that better cognitive functioning in selected domains (eg, cognitive control, attention, and language ability) is associated with a greater likelihood of substance use initiation.
 

Shaping Future Prevention

Applying these findings in clinical settings could help tailor prevention and early intervention efforts, said the authors. It might be prudent to allocate resources to collecting data related to self-, peer-, and familial-related factors, “which were more informative in predicting substance use initiation during late childhood and early adolescence in the present study,” they wrote.

Researchers will continue to track these children through to a 10-year follow-up, said Dr. Green. “I’m really curious to see if the factors we found when they were 12 and 13, such as those related to peers and family, still hold when they’re ages 17 and 18, because there’s going to be a huge amount of brain development that’s happening throughout this phase.”

The group that initiated substance use and the group that didn’t initiate substance use were not totally balanced, and sample sizes for some religious categories were small. Another study limitation was that the analytic approach didn’t account for multilevel data within the context of site and families.

Commenting on the findings, Kathleen Brady, MD, PhD, distinguished university professor and director, South Carolina Clinical and Translational Research Institute, Medical University of South Carolina, said that the study is “critical and complex.” This, she said, is especially true as cannabis has become more accessible and potent, and as the federal government reportedly considers reclassifying it from a Schedule I drug (which includes highly dangerous, addictive substances with no medical use) to a Schedule III drug (which can be prescribed as a medication).

“The part that is the most frightening to me is the long-lasting effects that can happen when young people start using high-potency marijuana at an early age,” said Dr. Brady. “So, any information that we can give to parents, to teachers, to the public, and to doctors is important.”

She’s looking forward to getting more “incredibly important” information on substance use initiation as the study progresses and the teens get older. 

The study received support from the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.

A version of this article appeared on Medscape.com.

By age 12 years, more than 14% of children have tried alcohol or tobacco, and religion, race, and income are the top predictors beginning to use these and other substances, new research suggests.

Aside from sociodemographic parameters, risk factors for substance use initiation include prenatal exposure to substances, peer use of alcohol and nicotine, and problematic school behavior, among other things, the study showed.

The results show certain modifiable risk factors may play a role in preventing youth from starting to use substances, said study author ReJoyce Green, PhD, research assistant professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.

“If we’re designing, say, a prevention program or an early intervention program, these are things that could make a difference, so let’s make sure we’re bringing them into the conversation.”

The findings were presented at the annual meeting of the American Psychiatric Association American Psychiatric Association (APA) and published online in The American Journal of Psychiatry.
 

Critical Risk Factors

Use of alcohol, tobacco, and cannabis often begins during adolescence. One recent survey showed that 23% of 13-year-olds reported using alcohol, 17% reported vaping nicotine, and 8% reported vaping cannabis. Other research links younger age at substance use initiation to a more rapid transition to substance use disorders and higher rates of psychiatric disorders.

Previous studies examining predictors of substance use initiation in the Adolescent Brain Cognitive Development (ABCD) Study dataset focused primarily on self-reported measures, but the current study also looked at models that include hormones and neurocognitive factors as well as neuroimaging.

This study included 6829, 9- and 10-year-olds from the ABCD Study who had never tried substances and were followed for 3 years.

A sophisticated statistical approach was used to examine 420 variables as predictors of substance use initiation. Initiation was defined as trying any nonprescribed substance by age 12 years. “That’s including a single sip of alcohol or puff of a cigarette,” said Dr. Green.

In addition to alcohol, nicotine, and cannabis, researchers looked at initiation of synthetic cannabinoids, cocaine, methamphetamine, and ketamine, among other substances.

Self-reported measures included demographic characteristics, self and peer involvement with substance use, parenting behaviors, mental and physical health, and culture and environmental factors.

The analytical approach used machine-learning algorithms to compare the ability of domains to identify the most critical risk factors. Magnitudes of coefficients were used to assess variable importance, with positive coefficients indicating greater likelihood of substance initiation and negative coefficients indicating lower likelihood of initiation.

By age 12 years, 14.4% of the children studied reported substance initiation. Alcohol was the substance most commonly initiated (365 individuals), followed by nicotine (94 individuals) and cannabis (40 individuals), with few or no children initiating other substances.

Both those who did and did not initiate substances were similarly aged, and most participants identified as White and non-Hispanic. But the substance-use group had a lower percentage of girls and higher percentage of White participants compared with the no-substance-use group.

The model with only self-reported data had similar accuracy in predicting substance use initiation (area under the curve [AUC], 0.67) as models that added resource-intensive measures such as neurocognitive tests and hormones (AUC, 0.67) and neuroimaging (AUC, 0.66).
 

Religious Predictors

The strongest predictors of substance use initiation were related to religion: Youths whose parents reported a religious preference for Mormonism were less likely to initiate substance use (coefficient, -0.87), whereas youths whose parents reported a religious preference for Judaism were more likely to initiate substance use (coefficient, 0.32).

The third top predictor was race: Black youths were less likely to initiate substance use (coefficient, -0.32). This was followed by youths whose parents reported a religious preference for Islam who were also less likely to initiate substance use (coefficient, -0.25).

The research examined over 15 different religious categories, “so we really tried to be expansive,” noted Dr. Green.

It’s unclear why some religions appeared to have a protective impact when it comes to substance use initiation whereas others have the opposite effect. Future research could perhaps identify which components of religiosity affect substance use initiation. If so, these aspects could be developed and incorporated into prevention and intervention programs, said Dr. Green.

Next on the list of most important predictors was being a part of a household with an income of $12,000-$15,999; these youths were less likely to initiate substance use (coefficient, 0.22).

Within the culture and environment domain, a history of detention or suspension was a top predictor of substance use initiation (coefficient, 0.20). Prenatal exposure to substance use was also a robust predictor in the physical health category (coefficient, 0.15).

Other predictors included: parents with less than a high school degree or GED (coefficient, -0.14), substance use availability (coefficient, 0.12), and age at baseline (coefficient, 0.12).

The study also showed that better cognitive functioning in selected domains (eg, cognitive control, attention, and language ability) is associated with a greater likelihood of substance use initiation.
 

Shaping Future Prevention

Applying these findings in clinical settings could help tailor prevention and early intervention efforts, said the authors. It might be prudent to allocate resources to collecting data related to self-, peer-, and familial-related factors, “which were more informative in predicting substance use initiation during late childhood and early adolescence in the present study,” they wrote.

Researchers will continue to track these children through to a 10-year follow-up, said Dr. Green. “I’m really curious to see if the factors we found when they were 12 and 13, such as those related to peers and family, still hold when they’re ages 17 and 18, because there’s going to be a huge amount of brain development that’s happening throughout this phase.”

The group that initiated substance use and the group that didn’t initiate substance use were not totally balanced, and sample sizes for some religious categories were small. Another study limitation was that the analytic approach didn’t account for multilevel data within the context of site and families.

Commenting on the findings, Kathleen Brady, MD, PhD, distinguished university professor and director, South Carolina Clinical and Translational Research Institute, Medical University of South Carolina, said that the study is “critical and complex.” This, she said, is especially true as cannabis has become more accessible and potent, and as the federal government reportedly considers reclassifying it from a Schedule I drug (which includes highly dangerous, addictive substances with no medical use) to a Schedule III drug (which can be prescribed as a medication).

“The part that is the most frightening to me is the long-lasting effects that can happen when young people start using high-potency marijuana at an early age,” said Dr. Brady. “So, any information that we can give to parents, to teachers, to the public, and to doctors is important.”

She’s looking forward to getting more “incredibly important” information on substance use initiation as the study progresses and the teens get older. 

The study received support from the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.

A version of this article appeared on Medscape.com.

CHICAGO — At the 2024 AGA Tech Summit, held April 11-12 at the Chicago headquarters of MATTER, a global healthcare startup incubator, five companies made their pitch to be the winner of the Shark Tank competition that recognizes an outstanding tech start up in the gastroenterology field.

After the companies’ rapid-fire pitches and Q&A sessions, four judges convened to determine a winner and returned to make an announcement.

The winner was Arithmedics, which uses AI technology to automate billing codes. Founder Venthan Elango, PhD, has worked as a software engineer at Google, Urban Engines, and Georgia Tech, and his wife of 17 years is Renumathy Dhanasekaran, MD, PhD, a gastroenterologist and assistant professor of medicine at Stanford (California) University.

Their marriage has brought a unique perspective, according to Dr. Elango. “There isn’t a single day that goes by when she talks to me about the inefficiencies in healthcare, and then I say, ‘this can be easily solved with a software solution,’ ” he said.

Arithmedics

Stanford University

• Aspero Medical: Balloon overtube that maximizes frictional properties to improve mucosal wall traction and anchoring consistency. (Voted ‘fan favorite’ by AGA Tech Summit attendees)
• Aurora Medical Technologies: Minimally invasive, guided, tissue-anchoring suturing system for complex endoscopic procedures.
• Ergami Endoscopy: Flexible overtube capable of automatic insertion and fixation in the colon, which could potentially eliminate sedation and prevent endoscopic injuries to the physician.
• Lazurite: Wireless surgical camera that eliminates the need for light or video cables, avoiding the associated fire, trip, and contamination hazards.

The judges were swayed by Arithmedics’ practical solution to a widespread problem. “There is for sure a need in terms of inaccurate billing and billing codes that are wrong. There’s lost revenue for physicians around that. So I think we were really focused from a judging standpoint on the fact that their solution was filling truly an unmet need,” said judge Andrea Vossler, a managing director of Varia Ventures, which has partnered with AGA to launch and manage the GI Opportunity Fund, an AGA-member venture fund.

“We were really focused on how to assist physicians in terms of supporting their practices, and really changing what you’re doing. I think AI has the ability to do that, so we liked that about the company,” she added.

The company is an example of how AI is poised to alter healthcare, according to Ms. Vossler. “I think it’s massive. I think we’re at the very beginning of its impact on healthcare,” she said.

Another judge had a similar view. “They won because there is a screaming need to fix billing. So, it’s well known that lots of money is indeed lost in billing practices, which are stressful for office personnel and stressful for physicians. They can fulfill a long-standing need, and we thought that that was the success story,” said Christopher Gostout, MD, emeritus professor of medicine at Mayo Clinic in Rochester, Minnesota.

Dr. Gostout offered advice for gastroenterologists and other physicians interested in starting tech companies. It’s imperative to be a realist, he said. “Is there a real market for it, or [is it just] a niche market? Does your device have legs — can it expand and can evolve into other [spin-off] products? These are things you need to think about because one-offs or single-trick ponies are pretty hard to move along now,” said Dr. Gostout.

He recommended that entrepreneurs apply for Small Business Innovation Research (SBIR) grants. “I think it’s a great opportunity to bring in money and get the ball rolling.”

Finally, he advised entrepreneurs to be thoughtful about their advisory groups. Founders may be tempted to find the highest profile names they can to give the business gravitas, but those big names may not have the best knowledge base to understand the problems that the technology is meant to address. “I’ve seen businesses fail because they went for marquee names that really were not helpful, and they didn’t do their due diligence in seeking out really useful value. You don’t need a lot of advisers, just a couple of really good ones,” said Dr. Gostout.

The summit was sponsored by the AGA Center for GI Innovation and Technology.

Dr. Gostout has founded and advises AdaptivEndo and Lean Medical. He is a consultant to Boston Scientific. Dr. Dhanasekaran has no financial disclosures. Ms. Vossler is an employee of Varia Ventures, which is an investment partner to AGA. Dr. Elango is an employee of Arithmedics.

CHICAGO — At the 2024 AGA Tech Summit, held April 11-12 at the Chicago headquarters of MATTER, a global healthcare startup incubator, five companies made their pitch to be the winner of the Shark Tank competition that recognizes an outstanding tech start up in the gastroenterology field.

After the companies’ rapid-fire pitches and Q&A sessions, four judges convened to determine a winner and returned to make an announcement.

The winner was Arithmedics, which uses AI technology to automate billing codes. Founder Venthan Elango, PhD, has worked as a software engineer at Google, Urban Engines, and Georgia Tech, and his wife of 17 years is Renumathy Dhanasekaran, MD, PhD, a gastroenterologist and assistant professor of medicine at Stanford (California) University.

Their marriage has brought a unique perspective, according to Dr. Elango. “There isn’t a single day that goes by when she talks to me about the inefficiencies in healthcare, and then I say, ‘this can be easily solved with a software solution,’ ” he said.

Arithmedics

Stanford University

• Aspero Medical: Balloon overtube that maximizes frictional properties to improve mucosal wall traction and anchoring consistency. (Voted ‘fan favorite’ by AGA Tech Summit attendees)
• Aurora Medical Technologies: Minimally invasive, guided, tissue-anchoring suturing system for complex endoscopic procedures.
• Ergami Endoscopy: Flexible overtube capable of automatic insertion and fixation in the colon, which could potentially eliminate sedation and prevent endoscopic injuries to the physician.
• Lazurite: Wireless surgical camera that eliminates the need for light or video cables, avoiding the associated fire, trip, and contamination hazards.

The judges were swayed by Arithmedics’ practical solution to a widespread problem. “There is for sure a need in terms of inaccurate billing and billing codes that are wrong. There’s lost revenue for physicians around that. So I think we were really focused from a judging standpoint on the fact that their solution was filling truly an unmet need,” said judge Andrea Vossler, a managing director of Varia Ventures, which has partnered with AGA to launch and manage the GI Opportunity Fund, an AGA-member venture fund.

“We were really focused on how to assist physicians in terms of supporting their practices, and really changing what you’re doing. I think AI has the ability to do that, so we liked that about the company,” she added.

The company is an example of how AI is poised to alter healthcare, according to Ms. Vossler. “I think it’s massive. I think we’re at the very beginning of its impact on healthcare,” she said.

Another judge had a similar view. “They won because there is a screaming need to fix billing. So, it’s well known that lots of money is indeed lost in billing practices, which are stressful for office personnel and stressful for physicians. They can fulfill a long-standing need, and we thought that that was the success story,” said Christopher Gostout, MD, emeritus professor of medicine at Mayo Clinic in Rochester, Minnesota.

Dr. Gostout offered advice for gastroenterologists and other physicians interested in starting tech companies. It’s imperative to be a realist, he said. “Is there a real market for it, or [is it just] a niche market? Does your device have legs — can it expand and can evolve into other [spin-off] products? These are things you need to think about because one-offs or single-trick ponies are pretty hard to move along now,” said Dr. Gostout.

He recommended that entrepreneurs apply for Small Business Innovation Research (SBIR) grants. “I think it’s a great opportunity to bring in money and get the ball rolling.”

Finally, he advised entrepreneurs to be thoughtful about their advisory groups. Founders may be tempted to find the highest profile names they can to give the business gravitas, but those big names may not have the best knowledge base to understand the problems that the technology is meant to address. “I’ve seen businesses fail because they went for marquee names that really were not helpful, and they didn’t do their due diligence in seeking out really useful value. You don’t need a lot of advisers, just a couple of really good ones,” said Dr. Gostout.

The summit was sponsored by the AGA Center for GI Innovation and Technology.

Dr. Gostout has founded and advises AdaptivEndo and Lean Medical. He is a consultant to Boston Scientific. Dr. Dhanasekaran has no financial disclosures. Ms. Vossler is an employee of Varia Ventures, which is an investment partner to AGA. Dr. Elango is an employee of Arithmedics.

CHICAGO — At the 2024 AGA Tech Summit, held April 11-12 at the Chicago headquarters of MATTER, a global healthcare startup incubator, five companies made their pitch to be the winner of the Shark Tank competition that recognizes an outstanding tech start up in the gastroenterology field.

After the companies’ rapid-fire pitches and Q&A sessions, four judges convened to determine a winner and returned to make an announcement.

The winner was Arithmedics, which uses AI technology to automate billing codes. Founder Venthan Elango, PhD, has worked as a software engineer at Google, Urban Engines, and Georgia Tech, and his wife of 17 years is Renumathy Dhanasekaran, MD, PhD, a gastroenterologist and assistant professor of medicine at Stanford (California) University.

Their marriage has brought a unique perspective, according to Dr. Elango. “There isn’t a single day that goes by when she talks to me about the inefficiencies in healthcare, and then I say, ‘this can be easily solved with a software solution,’ ” he said.

Arithmedics

Stanford University

• Aspero Medical: Balloon overtube that maximizes frictional properties to improve mucosal wall traction and anchoring consistency. (Voted ‘fan favorite’ by AGA Tech Summit attendees)
• Aurora Medical Technologies: Minimally invasive, guided, tissue-anchoring suturing system for complex endoscopic procedures.
• Ergami Endoscopy: Flexible overtube capable of automatic insertion and fixation in the colon, which could potentially eliminate sedation and prevent endoscopic injuries to the physician.
• Lazurite: Wireless surgical camera that eliminates the need for light or video cables, avoiding the associated fire, trip, and contamination hazards.

The judges were swayed by Arithmedics’ practical solution to a widespread problem. “There is for sure a need in terms of inaccurate billing and billing codes that are wrong. There’s lost revenue for physicians around that. So I think we were really focused from a judging standpoint on the fact that their solution was filling truly an unmet need,” said judge Andrea Vossler, a managing director of Varia Ventures, which has partnered with AGA to launch and manage the GI Opportunity Fund, an AGA-member venture fund.

“We were really focused on how to assist physicians in terms of supporting their practices, and really changing what you’re doing. I think AI has the ability to do that, so we liked that about the company,” she added.

The company is an example of how AI is poised to alter healthcare, according to Ms. Vossler. “I think it’s massive. I think we’re at the very beginning of its impact on healthcare,” she said.

Another judge had a similar view. “They won because there is a screaming need to fix billing. So, it’s well known that lots of money is indeed lost in billing practices, which are stressful for office personnel and stressful for physicians. They can fulfill a long-standing need, and we thought that that was the success story,” said Christopher Gostout, MD, emeritus professor of medicine at Mayo Clinic in Rochester, Minnesota.

Dr. Gostout offered advice for gastroenterologists and other physicians interested in starting tech companies. It’s imperative to be a realist, he said. “Is there a real market for it, or [is it just] a niche market? Does your device have legs — can it expand and can evolve into other [spin-off] products? These are things you need to think about because one-offs or single-trick ponies are pretty hard to move along now,” said Dr. Gostout.

He recommended that entrepreneurs apply for Small Business Innovation Research (SBIR) grants. “I think it’s a great opportunity to bring in money and get the ball rolling.”

Finally, he advised entrepreneurs to be thoughtful about their advisory groups. Founders may be tempted to find the highest profile names they can to give the business gravitas, but those big names may not have the best knowledge base to understand the problems that the technology is meant to address. “I’ve seen businesses fail because they went for marquee names that really were not helpful, and they didn’t do their due diligence in seeking out really useful value. You don’t need a lot of advisers, just a couple of really good ones,” said Dr. Gostout.

The summit was sponsored by the AGA Center for GI Innovation and Technology.

Dr. Gostout has founded and advises AdaptivEndo and Lean Medical. He is a consultant to Boston Scientific. Dr. Dhanasekaran has no financial disclosures. Ms. Vossler is an employee of Varia Ventures, which is an investment partner to AGA. Dr. Elango is an employee of Arithmedics.

In the first randomized controlled trial of prednisone for postvasectomy reversals, fertility researchers found that a high dose of the steroid reduced the rate of subsequent pregnancy.

“This is the first time it’s been shown that high doses [of prednisone] can make someone infertile,” said Landon Trost, MD, director of the Male Fertility and Peyronie’s Clinic in Orem, Utah, and a faculty member at Mayo Clinic, in Rochester, Minnesota, who presented the study (Abstract MP42-19) on May 4 at the 2024 annual meeting of the American Urological Association (AUA) in San Antonio, Texas. 

Dr. Trost called the findings “a real shock. I almost didn’t believe the data when I saw it. It opens up a whole new set of areas for research and exploration.”

Dr. Trost’s clinic performs 1200 reversals per year out of the estimated 20,000 performed annually in the United States, he said. He said his practice has stopped using high-dose prednisone as a result of the study, which he performed at his own expense to examine the varying protocols for vasectomy reversal.

William Berg, MD, director of the Stony Brook Urology Men’s Health Program, in Stony Brook, New York, said that the expected patency rate for modern postvasectomy reversals, if performed properly, can be as high as 98%. However, in some men, patency occurs initially, but the accumulation of scar tissue at the site of reversal causes sperm counts in ejaculate to drop to zero.

Since the 1970s, urologists — with limited research to back — the practice  prescribed prednisone to patients with the goal of preventing scarring and blockages associated with vasectomy reversals. Dr. Berg called this practice “unsubstantiated” and noted that Dr. Trost’s study is the first prospective randomized controlled trial of this approach.

The study enrolled 75 men, with a mean age of roughly 38 years. The mean time since vasectomy was 6.6 years.

The low-dose arm (25 patients) received 5 mg of prednisone per week alternating with no treatment per week over 6 months. The high-dose arm (n = 14) received 20 mg of prednisone, tapered to 10 mg, 5 mg, and then off over 1 month, followed by every other month for 6 months. A prednisone-as-needed group (n = 11) received a tapered course of prednisone on the basis of whether they had decreasing or zero sperm counts. They received 20 mg for 5 days, 10 mg for 5 days, and 5 mg for 20 days.

A control arm (n = 25) received no prednisone.

Urologists typically use patency rates to measure success of vasectomy reversals. The patency rates at 12 months in Dr. Trost’s study were 100% in the control participants, prednisone-as-needed, and low-dose groups and 92% (13/14) in the high-dose group. 

Dr. Trost said that the story was told in the pregnancy rates. At the 1-year mark, pregnancy rates were 67% in the low-risk group and 65% in the control group but 38% and 17% in the prednisone-as-needed and high-dose group, respectively (P = .02).

The mean maximum sperm concentration was 40 million per mL, ranging from 29.7 million per mL for men in the control group to 54.3 million per mL in the low-dose group.

Dr. Trost said that he immediately stopped using high doses of prednisone in his practice and predicted that other clinics would follow suit. 

Dr. Berg said the drop in pregnancies with higher doses of prednisone is a first-time finding and suggests that a high dose may “be detrimental to sperm function in some way. I don’t think this ever has been described before.”

Dr. Trost financed the study himself. Dr. Berg reported no conflicts.

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

In the first randomized controlled trial of prednisone for postvasectomy reversals, fertility researchers found that a high dose of the steroid reduced the rate of subsequent pregnancy.

“This is the first time it’s been shown that high doses [of prednisone] can make someone infertile,” said Landon Trost, MD, director of the Male Fertility and Peyronie’s Clinic in Orem, Utah, and a faculty member at Mayo Clinic, in Rochester, Minnesota, who presented the study (Abstract MP42-19) on May 4 at the 2024 annual meeting of the American Urological Association (AUA) in San Antonio, Texas. 

Dr. Trost called the findings “a real shock. I almost didn’t believe the data when I saw it. It opens up a whole new set of areas for research and exploration.”

Dr. Trost’s clinic performs 1200 reversals per year out of the estimated 20,000 performed annually in the United States, he said. He said his practice has stopped using high-dose prednisone as a result of the study, which he performed at his own expense to examine the varying protocols for vasectomy reversal.

William Berg, MD, director of the Stony Brook Urology Men’s Health Program, in Stony Brook, New York, said that the expected patency rate for modern postvasectomy reversals, if performed properly, can be as high as 98%. However, in some men, patency occurs initially, but the accumulation of scar tissue at the site of reversal causes sperm counts in ejaculate to drop to zero.

Since the 1970s, urologists — with limited research to back — the practice  prescribed prednisone to patients with the goal of preventing scarring and blockages associated with vasectomy reversals. Dr. Berg called this practice “unsubstantiated” and noted that Dr. Trost’s study is the first prospective randomized controlled trial of this approach.

The study enrolled 75 men, with a mean age of roughly 38 years. The mean time since vasectomy was 6.6 years.

The low-dose arm (25 patients) received 5 mg of prednisone per week alternating with no treatment per week over 6 months. The high-dose arm (n = 14) received 20 mg of prednisone, tapered to 10 mg, 5 mg, and then off over 1 month, followed by every other month for 6 months. A prednisone-as-needed group (n = 11) received a tapered course of prednisone on the basis of whether they had decreasing or zero sperm counts. They received 20 mg for 5 days, 10 mg for 5 days, and 5 mg for 20 days.

A control arm (n = 25) received no prednisone.

Urologists typically use patency rates to measure success of vasectomy reversals. The patency rates at 12 months in Dr. Trost’s study were 100% in the control participants, prednisone-as-needed, and low-dose groups and 92% (13/14) in the high-dose group. 

Dr. Trost said that the story was told in the pregnancy rates. At the 1-year mark, pregnancy rates were 67% in the low-risk group and 65% in the control group but 38% and 17% in the prednisone-as-needed and high-dose group, respectively (P = .02).

The mean maximum sperm concentration was 40 million per mL, ranging from 29.7 million per mL for men in the control group to 54.3 million per mL in the low-dose group.

Dr. Trost said that he immediately stopped using high doses of prednisone in his practice and predicted that other clinics would follow suit. 

Dr. Berg said the drop in pregnancies with higher doses of prednisone is a first-time finding and suggests that a high dose may “be detrimental to sperm function in some way. I don’t think this ever has been described before.”

Dr. Trost financed the study himself. Dr. Berg reported no conflicts.

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

In the first randomized controlled trial of prednisone for postvasectomy reversals, fertility researchers found that a high dose of the steroid reduced the rate of subsequent pregnancy.

“This is the first time it’s been shown that high doses [of prednisone] can make someone infertile,” said Landon Trost, MD, director of the Male Fertility and Peyronie’s Clinic in Orem, Utah, and a faculty member at Mayo Clinic, in Rochester, Minnesota, who presented the study (Abstract MP42-19) on May 4 at the 2024 annual meeting of the American Urological Association (AUA) in San Antonio, Texas. 

Dr. Trost called the findings “a real shock. I almost didn’t believe the data when I saw it. It opens up a whole new set of areas for research and exploration.”

Dr. Trost’s clinic performs 1200 reversals per year out of the estimated 20,000 performed annually in the United States, he said. He said his practice has stopped using high-dose prednisone as a result of the study, which he performed at his own expense to examine the varying protocols for vasectomy reversal.

William Berg, MD, director of the Stony Brook Urology Men’s Health Program, in Stony Brook, New York, said that the expected patency rate for modern postvasectomy reversals, if performed properly, can be as high as 98%. However, in some men, patency occurs initially, but the accumulation of scar tissue at the site of reversal causes sperm counts in ejaculate to drop to zero.

Since the 1970s, urologists — with limited research to back — the practice  prescribed prednisone to patients with the goal of preventing scarring and blockages associated with vasectomy reversals. Dr. Berg called this practice “unsubstantiated” and noted that Dr. Trost’s study is the first prospective randomized controlled trial of this approach.

The study enrolled 75 men, with a mean age of roughly 38 years. The mean time since vasectomy was 6.6 years.

The low-dose arm (25 patients) received 5 mg of prednisone per week alternating with no treatment per week over 6 months. The high-dose arm (n = 14) received 20 mg of prednisone, tapered to 10 mg, 5 mg, and then off over 1 month, followed by every other month for 6 months. A prednisone-as-needed group (n = 11) received a tapered course of prednisone on the basis of whether they had decreasing or zero sperm counts. They received 20 mg for 5 days, 10 mg for 5 days, and 5 mg for 20 days.

A control arm (n = 25) received no prednisone.

Urologists typically use patency rates to measure success of vasectomy reversals. The patency rates at 12 months in Dr. Trost’s study were 100% in the control participants, prednisone-as-needed, and low-dose groups and 92% (13/14) in the high-dose group. 

Dr. Trost said that the story was told in the pregnancy rates. At the 1-year mark, pregnancy rates were 67% in the low-risk group and 65% in the control group but 38% and 17% in the prednisone-as-needed and high-dose group, respectively (P = .02).

The mean maximum sperm concentration was 40 million per mL, ranging from 29.7 million per mL for men in the control group to 54.3 million per mL in the low-dose group.

Dr. Trost said that he immediately stopped using high doses of prednisone in his practice and predicted that other clinics would follow suit. 

Dr. Berg said the drop in pregnancies with higher doses of prednisone is a first-time finding and suggests that a high dose may “be detrimental to sperm function in some way. I don’t think this ever has been described before.”

Dr. Trost financed the study himself. Dr. Berg reported no conflicts.

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

An evolving legal landscape surrounding medication abortion has left physicians with as many questions as patients. A panel of clinicians at the annual meeting of the American College of Physicians offered guidance on how to help patients who choose medication abortion, which is available to women until 10 weeks of gestation.

Approved in 2000, abortion pills have become the most common method for terminating pregnancy in the United States, accounting for 63% of all abortions in 2023. The US Supreme Court is reviewing access to medication abortions, with a decision expected within months.

According to the Guttmacher Institute, 29 states as of February restrict access to medication abortion, either by limiting or banning the use of the drugs or by curtailing who can prescribe them and under what circumstances.
 

First, Determine Gestational Age

Cynthia Chuang, MD, MSc, an internist and professor of medicine at Penn State College of Medicine in Hershey, Pennsylvania, said in most cases, a woman can pinpoint the date of the first day of her last menstrual period, and the physician can confirm gestational age is 70 days or less. An ultrasound should be performed if the date of the last period is uncertain, she said, or if ectopic pregnancy is suspected, periods are irregular, or ultrasound is legally required in the state.

Women are not eligible for abortion pills if they have a bleeding or clotting disorder, have an intrauterine device, have adrenal insufficiency or chronic steroid use, or have porphyria or hemoglobin levels < 9 g/dL, she said.

“If the person has a known hemoglobin of less than 9, we would suggest that person have a procedural abortion,” Dr. Chuang said.
 

Components of Medication

Patients first receive 200 mg of oral mifepristone, which separates the pregnancy from the uterine wall. “Typically, people don’t experience side effects from the mifepristone alone,” Dr. Chaung said.

In the next 48 hours, the patient takes 800 mcg of misoprostol, either vaginally or buccally. “Patients can expect heavy cramping and bleeding 1-2 days after taking misoprostol,” she said. The bleeding should gradually subside over the following week or 2, she said. If the gestational age is 9 weeks or more, a second dose of misoprostol can be administered 3-6 hours after the first dose to improve efficacy.

If mifepristone is not available, misoprostol can be used alone in three doses spaced 3 hours apart, Dr. Chuang said.

The failure rate for mifepristone plus misoprostol has been calculated at 2% if the gestational age is less than 7 weeks. For misoprostol alone, the failure rate varies by the study, depending on gestational age and population analyzed, Dr. Chuang said. A 2023 meta-analysis in Contraception put the failure rate at 11%.
 

When to Call the Clinician

Dr. Chuang said clinicians should instruct women who have taken abortion pills to call the clinic if they are soaking through two sanitary pads an hour for more than 1 hour, if there is little to no bleeding, or if they think the medication isn’t working after taking the full regimen.

Mindy Sobota, MD, MS, an internist and associate professor of medicine at the Warren Alpert Medical School of Brown University in Providence, Rhode Island, recommended a continuing medical education site for evidence-based guidance on how best to talk with women about medication abortions.

She also recommended physicians and patients consult the Plan C website for guidance on telehealth services and price information on receiving abortion pills by mail in every state. “It’s a very reliable and safe clearing house,” Dr. Sobota said.

Internists should let patients know that whatever their choices are around pregnancy, they are open to discussing those choices and helping them through the process, Dr. Sobota said, adding that she makes those statements in annual visits.

Alexandra Bachorik, MD, EdM, director of education in the Women’s Health Unit and assistant professor of medicine at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, said patients in restrictive states who need financial help related to obtaining abortion services in a less restricted state can visit the National Network of Abortion Funds, which can help people with travel or housing expenses.

Facilitating access to a clinic in a less restrictive state may be helpful to people approaching a gestational age limit, she said.

Adelaide McClintock, MD, an internist and assistant professor of general internal medicine at the University of Washington School of Medicine in Seattle, Washington, noted that even clinicians who cannot legally prescribe abortion pills can support their patients by providing resources and counseling on options before, during, and after pregnancy. Those who live in restrictive states also can provide support to women who have traveled to less restrictive states for an abortion if they have postabortion complications, she said.

She recommended the Reproductive Health Access Project website for a comprehensive guide for evidence-based care and counseling patients about all choices in reproductive healthcare.

Panelists urged clinicians to get familiar with abortion-access resources and keep them at their fingertips in practice. Patient requests for the services are common, she noted, as “one in four women will have an abortion by the age of 45.”

Dr. Chuang, Dr. McClintock, Dr. Sobota, and Dr. Bachorik reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

An evolving legal landscape surrounding medication abortion has left physicians with as many questions as patients. A panel of clinicians at the annual meeting of the American College of Physicians offered guidance on how to help patients who choose medication abortion, which is available to women until 10 weeks of gestation.

Approved in 2000, abortion pills have become the most common method for terminating pregnancy in the United States, accounting for 63% of all abortions in 2023. The US Supreme Court is reviewing access to medication abortions, with a decision expected within months.

According to the Guttmacher Institute, 29 states as of February restrict access to medication abortion, either by limiting or banning the use of the drugs or by curtailing who can prescribe them and under what circumstances.
 

First, Determine Gestational Age

Cynthia Chuang, MD, MSc, an internist and professor of medicine at Penn State College of Medicine in Hershey, Pennsylvania, said in most cases, a woman can pinpoint the date of the first day of her last menstrual period, and the physician can confirm gestational age is 70 days or less. An ultrasound should be performed if the date of the last period is uncertain, she said, or if ectopic pregnancy is suspected, periods are irregular, or ultrasound is legally required in the state.

Women are not eligible for abortion pills if they have a bleeding or clotting disorder, have an intrauterine device, have adrenal insufficiency or chronic steroid use, or have porphyria or hemoglobin levels < 9 g/dL, she said.

“If the person has a known hemoglobin of less than 9, we would suggest that person have a procedural abortion,” Dr. Chuang said.
 

Components of Medication

Patients first receive 200 mg of oral mifepristone, which separates the pregnancy from the uterine wall. “Typically, people don’t experience side effects from the mifepristone alone,” Dr. Chaung said.

In the next 48 hours, the patient takes 800 mcg of misoprostol, either vaginally or buccally. “Patients can expect heavy cramping and bleeding 1-2 days after taking misoprostol,” she said. The bleeding should gradually subside over the following week or 2, she said. If the gestational age is 9 weeks or more, a second dose of misoprostol can be administered 3-6 hours after the first dose to improve efficacy.

If mifepristone is not available, misoprostol can be used alone in three doses spaced 3 hours apart, Dr. Chuang said.

The failure rate for mifepristone plus misoprostol has been calculated at 2% if the gestational age is less than 7 weeks. For misoprostol alone, the failure rate varies by the study, depending on gestational age and population analyzed, Dr. Chuang said. A 2023 meta-analysis in Contraception put the failure rate at 11%.
 

When to Call the Clinician

Dr. Chuang said clinicians should instruct women who have taken abortion pills to call the clinic if they are soaking through two sanitary pads an hour for more than 1 hour, if there is little to no bleeding, or if they think the medication isn’t working after taking the full regimen.

Mindy Sobota, MD, MS, an internist and associate professor of medicine at the Warren Alpert Medical School of Brown University in Providence, Rhode Island, recommended a continuing medical education site for evidence-based guidance on how best to talk with women about medication abortions.

She also recommended physicians and patients consult the Plan C website for guidance on telehealth services and price information on receiving abortion pills by mail in every state. “It’s a very reliable and safe clearing house,” Dr. Sobota said.

Internists should let patients know that whatever their choices are around pregnancy, they are open to discussing those choices and helping them through the process, Dr. Sobota said, adding that she makes those statements in annual visits.

Alexandra Bachorik, MD, EdM, director of education in the Women’s Health Unit and assistant professor of medicine at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, said patients in restrictive states who need financial help related to obtaining abortion services in a less restricted state can visit the National Network of Abortion Funds, which can help people with travel or housing expenses.

Facilitating access to a clinic in a less restrictive state may be helpful to people approaching a gestational age limit, she said.

Adelaide McClintock, MD, an internist and assistant professor of general internal medicine at the University of Washington School of Medicine in Seattle, Washington, noted that even clinicians who cannot legally prescribe abortion pills can support their patients by providing resources and counseling on options before, during, and after pregnancy. Those who live in restrictive states also can provide support to women who have traveled to less restrictive states for an abortion if they have postabortion complications, she said.

She recommended the Reproductive Health Access Project website for a comprehensive guide for evidence-based care and counseling patients about all choices in reproductive healthcare.

Panelists urged clinicians to get familiar with abortion-access resources and keep them at their fingertips in practice. Patient requests for the services are common, she noted, as “one in four women will have an abortion by the age of 45.”

Dr. Chuang, Dr. McClintock, Dr. Sobota, and Dr. Bachorik reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

An evolving legal landscape surrounding medication abortion has left physicians with as many questions as patients. A panel of clinicians at the annual meeting of the American College of Physicians offered guidance on how to help patients who choose medication abortion, which is available to women until 10 weeks of gestation.

Approved in 2000, abortion pills have become the most common method for terminating pregnancy in the United States, accounting for 63% of all abortions in 2023. The US Supreme Court is reviewing access to medication abortions, with a decision expected within months.

According to the Guttmacher Institute, 29 states as of February restrict access to medication abortion, either by limiting or banning the use of the drugs or by curtailing who can prescribe them and under what circumstances.
 

First, Determine Gestational Age

Cynthia Chuang, MD, MSc, an internist and professor of medicine at Penn State College of Medicine in Hershey, Pennsylvania, said in most cases, a woman can pinpoint the date of the first day of her last menstrual period, and the physician can confirm gestational age is 70 days or less. An ultrasound should be performed if the date of the last period is uncertain, she said, or if ectopic pregnancy is suspected, periods are irregular, or ultrasound is legally required in the state.

Women are not eligible for abortion pills if they have a bleeding or clotting disorder, have an intrauterine device, have adrenal insufficiency or chronic steroid use, or have porphyria or hemoglobin levels < 9 g/dL, she said.

“If the person has a known hemoglobin of less than 9, we would suggest that person have a procedural abortion,” Dr. Chuang said.
 

Components of Medication

Patients first receive 200 mg of oral mifepristone, which separates the pregnancy from the uterine wall. “Typically, people don’t experience side effects from the mifepristone alone,” Dr. Chaung said.

In the next 48 hours, the patient takes 800 mcg of misoprostol, either vaginally or buccally. “Patients can expect heavy cramping and bleeding 1-2 days after taking misoprostol,” she said. The bleeding should gradually subside over the following week or 2, she said. If the gestational age is 9 weeks or more, a second dose of misoprostol can be administered 3-6 hours after the first dose to improve efficacy.

If mifepristone is not available, misoprostol can be used alone in three doses spaced 3 hours apart, Dr. Chuang said.

The failure rate for mifepristone plus misoprostol has been calculated at 2% if the gestational age is less than 7 weeks. For misoprostol alone, the failure rate varies by the study, depending on gestational age and population analyzed, Dr. Chuang said. A 2023 meta-analysis in Contraception put the failure rate at 11%.
 

When to Call the Clinician

Dr. Chuang said clinicians should instruct women who have taken abortion pills to call the clinic if they are soaking through two sanitary pads an hour for more than 1 hour, if there is little to no bleeding, or if they think the medication isn’t working after taking the full regimen.

Mindy Sobota, MD, MS, an internist and associate professor of medicine at the Warren Alpert Medical School of Brown University in Providence, Rhode Island, recommended a continuing medical education site for evidence-based guidance on how best to talk with women about medication abortions.

She also recommended physicians and patients consult the Plan C website for guidance on telehealth services and price information on receiving abortion pills by mail in every state. “It’s a very reliable and safe clearing house,” Dr. Sobota said.

Internists should let patients know that whatever their choices are around pregnancy, they are open to discussing those choices and helping them through the process, Dr. Sobota said, adding that she makes those statements in annual visits.

Alexandra Bachorik, MD, EdM, director of education in the Women’s Health Unit and assistant professor of medicine at Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, said patients in restrictive states who need financial help related to obtaining abortion services in a less restricted state can visit the National Network of Abortion Funds, which can help people with travel or housing expenses.

Facilitating access to a clinic in a less restrictive state may be helpful to people approaching a gestational age limit, she said.

Adelaide McClintock, MD, an internist and assistant professor of general internal medicine at the University of Washington School of Medicine in Seattle, Washington, noted that even clinicians who cannot legally prescribe abortion pills can support their patients by providing resources and counseling on options before, during, and after pregnancy. Those who live in restrictive states also can provide support to women who have traveled to less restrictive states for an abortion if they have postabortion complications, she said.

She recommended the Reproductive Health Access Project website for a comprehensive guide for evidence-based care and counseling patients about all choices in reproductive healthcare.

Panelists urged clinicians to get familiar with abortion-access resources and keep them at their fingertips in practice. Patient requests for the services are common, she noted, as “one in four women will have an abortion by the age of 45.”

Dr. Chuang, Dr. McClintock, Dr. Sobota, and Dr. Bachorik reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

An experimental handheld ultrasonic device used in an office setting was shown to guide residual kidney stone fragments out of the body and markedly reduce the risk for relapse, researchers reported (Abstract MP29-10) at the 2024 annual meeting of the American Urological Association AUA in San Antonio, Texas.

Mathew Sorensen, MD, MS, an associate professor of urology at the University of Washington, Seattle, and director of the Comprehensive Metabolic Stone Clinic at the Puget Sound VA, said that the risk for relapse of kidney stones was 70% lower in the treatment group than in the control group.

“This is an ultrasound-based propulsion procedure that is not like anything else that has ever existed. There’s nothing else that’s like it,” Dr. Sorensen said. “Essentially, in a session in the office with no anesthesia, we can use ultrasound energy to focus on those fragments and try to push them out of the unfavorable areas of the kidney.”

Roughly 20%-30% of patients who undergo surgery to remove kidney stones have residual fragments that can ultimately cause pain and send them to the emergency department or into hospital admission for treatment.

In the new study, 82 patients with stone fragments ≤ 5 mm were randomly assigned to receive the ultrasound treatment — which Dr. Sorensen and his colleagues developed over the past decade — or no procedure.

During a median follow-up of 2.6 years, 20% of patients in the treatment group experienced relapse of stones compared with 50% of patients in the control group. 

Relapse was measured as the future occurrence of urgent medical visits for stone-related symptoms, surgeries, or growth of the residual fragments as measured on annual CT.

Dr. Sorensen and his colleagues found asymptomatic passage of fragments was twelvefold higher in the treatment group in the first 3 weeks (60% vs 5%). Asymptomatic passage was similar in both groups after 3 weeks.

Dr. Sorensen said that mild discomfort after the procedure was common, occurring in 38% of patients who underwent the treatment, but that it was short-lived and resolved without intervention; 8% of the treatment group and 7% of the control group had blood in the urine.

The propulsion device is available at two test sites in the University of Washington system; the manufacturer, SonoMotion Inc, a spinoff from the institution, is seeking US Food and Drug Administration approval for the technology, Dr. Sorensen said. 

David Schulsinger, MD, an associate professor in the Department of Urology at Stony Brook University Hospital, Stony Brook, New York, said that patients with stone fragments currently have two options: follow-up surgery or active surveillance.

“With this new device, we actually have the potential for doing one other thing, and that is treating these patients noninvasively and without anesthesia,” Dr. Schulsinger said. “Once it’s ready for prime time, I think [ultrasonic propulsion] will be very well accepted among urologists to manage patients with asymptomatic residual stones.”

Dr. Sorensen is an advisor and equity holder in SonoMotion Inc. Dr. Schulsinger reported no relevant financial conflicts of interest.

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

An experimental handheld ultrasonic device used in an office setting was shown to guide residual kidney stone fragments out of the body and markedly reduce the risk for relapse, researchers reported (Abstract MP29-10) at the 2024 annual meeting of the American Urological Association AUA in San Antonio, Texas.

Mathew Sorensen, MD, MS, an associate professor of urology at the University of Washington, Seattle, and director of the Comprehensive Metabolic Stone Clinic at the Puget Sound VA, said that the risk for relapse of kidney stones was 70% lower in the treatment group than in the control group.

“This is an ultrasound-based propulsion procedure that is not like anything else that has ever existed. There’s nothing else that’s like it,” Dr. Sorensen said. “Essentially, in a session in the office with no anesthesia, we can use ultrasound energy to focus on those fragments and try to push them out of the unfavorable areas of the kidney.”

Roughly 20%-30% of patients who undergo surgery to remove kidney stones have residual fragments that can ultimately cause pain and send them to the emergency department or into hospital admission for treatment.

In the new study, 82 patients with stone fragments ≤ 5 mm were randomly assigned to receive the ultrasound treatment — which Dr. Sorensen and his colleagues developed over the past decade — or no procedure.

During a median follow-up of 2.6 years, 20% of patients in the treatment group experienced relapse of stones compared with 50% of patients in the control group. 

Relapse was measured as the future occurrence of urgent medical visits for stone-related symptoms, surgeries, or growth of the residual fragments as measured on annual CT.

Dr. Sorensen and his colleagues found asymptomatic passage of fragments was twelvefold higher in the treatment group in the first 3 weeks (60% vs 5%). Asymptomatic passage was similar in both groups after 3 weeks.

Dr. Sorensen said that mild discomfort after the procedure was common, occurring in 38% of patients who underwent the treatment, but that it was short-lived and resolved without intervention; 8% of the treatment group and 7% of the control group had blood in the urine.

The propulsion device is available at two test sites in the University of Washington system; the manufacturer, SonoMotion Inc, a spinoff from the institution, is seeking US Food and Drug Administration approval for the technology, Dr. Sorensen said. 

David Schulsinger, MD, an associate professor in the Department of Urology at Stony Brook University Hospital, Stony Brook, New York, said that patients with stone fragments currently have two options: follow-up surgery or active surveillance.

“With this new device, we actually have the potential for doing one other thing, and that is treating these patients noninvasively and without anesthesia,” Dr. Schulsinger said. “Once it’s ready for prime time, I think [ultrasonic propulsion] will be very well accepted among urologists to manage patients with asymptomatic residual stones.”

Dr. Sorensen is an advisor and equity holder in SonoMotion Inc. Dr. Schulsinger reported no relevant financial conflicts of interest.

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

An experimental handheld ultrasonic device used in an office setting was shown to guide residual kidney stone fragments out of the body and markedly reduce the risk for relapse, researchers reported (Abstract MP29-10) at the 2024 annual meeting of the American Urological Association AUA in San Antonio, Texas.

Mathew Sorensen, MD, MS, an associate professor of urology at the University of Washington, Seattle, and director of the Comprehensive Metabolic Stone Clinic at the Puget Sound VA, said that the risk for relapse of kidney stones was 70% lower in the treatment group than in the control group.

“This is an ultrasound-based propulsion procedure that is not like anything else that has ever existed. There’s nothing else that’s like it,” Dr. Sorensen said. “Essentially, in a session in the office with no anesthesia, we can use ultrasound energy to focus on those fragments and try to push them out of the unfavorable areas of the kidney.”

Roughly 20%-30% of patients who undergo surgery to remove kidney stones have residual fragments that can ultimately cause pain and send them to the emergency department or into hospital admission for treatment.

In the new study, 82 patients with stone fragments ≤ 5 mm were randomly assigned to receive the ultrasound treatment — which Dr. Sorensen and his colleagues developed over the past decade — or no procedure.

During a median follow-up of 2.6 years, 20% of patients in the treatment group experienced relapse of stones compared with 50% of patients in the control group. 

Relapse was measured as the future occurrence of urgent medical visits for stone-related symptoms, surgeries, or growth of the residual fragments as measured on annual CT.

Dr. Sorensen and his colleagues found asymptomatic passage of fragments was twelvefold higher in the treatment group in the first 3 weeks (60% vs 5%). Asymptomatic passage was similar in both groups after 3 weeks.

Dr. Sorensen said that mild discomfort after the procedure was common, occurring in 38% of patients who underwent the treatment, but that it was short-lived and resolved without intervention; 8% of the treatment group and 7% of the control group had blood in the urine.

The propulsion device is available at two test sites in the University of Washington system; the manufacturer, SonoMotion Inc, a spinoff from the institution, is seeking US Food and Drug Administration approval for the technology, Dr. Sorensen said. 

David Schulsinger, MD, an associate professor in the Department of Urology at Stony Brook University Hospital, Stony Brook, New York, said that patients with stone fragments currently have two options: follow-up surgery or active surveillance.

“With this new device, we actually have the potential for doing one other thing, and that is treating these patients noninvasively and without anesthesia,” Dr. Schulsinger said. “Once it’s ready for prime time, I think [ultrasonic propulsion] will be very well accepted among urologists to manage patients with asymptomatic residual stones.”

Dr. Sorensen is an advisor and equity holder in SonoMotion Inc. Dr. Schulsinger reported no relevant financial conflicts of interest.

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