MDedge Family Medicine

TOPLINE:

Rituximab and cyclophosphamide are equally effective in achieving remission or low disease activity rates in childhood-onset antineutrophil cytoplasmic antibody–associated vasculitis (AAV), and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.

METHODOLOGY:

• Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
• A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
• The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
• The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.

TAKEAWAY:

• At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
• Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
• Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
• The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).

IN PRACTICE:

“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.

SOURCE:

This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.

LIMITATIONS:

Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.

DISCLOSURES:

This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.

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

TOPLINE:

Rituximab and cyclophosphamide are equally effective in achieving remission or low disease activity rates in childhood-onset antineutrophil cytoplasmic antibody–associated vasculitis (AAV), and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.

METHODOLOGY:

• Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
• A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
• The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
• The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.

TAKEAWAY:

• At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
• Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
• Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
• The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).

IN PRACTICE:

“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.

SOURCE:

This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.

LIMITATIONS:

Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.

DISCLOSURES:

This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.

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

TOPLINE:

Rituximab and cyclophosphamide are equally effective in achieving remission or low disease activity rates in childhood-onset antineutrophil cytoplasmic antibody–associated vasculitis (AAV), and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.

METHODOLOGY:

• Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
• A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
• The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
• The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.

TAKEAWAY:

• At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
• Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
• Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
• The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).

IN PRACTICE:

“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.

SOURCE:

This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.

LIMITATIONS:

Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.

DISCLOSURES:

This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.

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

This transcript has been edited for clarity. 

This episode of Medicine Matters reviews highlights from the Advisory Committee on Immunization Practices’ (ACIP’s) October 2024 meeting, with new recommendations for pneumococcal, COVID, and meningococcal B (Men B) vaccines, as well as a safety update for maternal RSV vaccination.

Pneumococcal Vaccination and New Lower Age-Based Recommendations 

New age-based recommendation. ACIP has lowered the age for routine vaccination with the pneumococcal conjugate vaccine (PCV) from age 65 down to age 50, but only with PCV. Review of data revealed that more than half of those in the 50- to 64-year-old age group already had a risk indication to receive a PCV dose. In addition, rates of invasive pneumococcal disease peak at younger ages in Black patients compared with White patients. The rate of invasive pneumococcal disease (IPD) among Black adults aged 50 or older exceeds the average rate of IPD for all adults aged 65 or older. The goal of this age-based change is to reduce disease in demographic groups with the highest burden of disease. 

The new expanded age-based recommendation applies only to vaccination with PCV. Conjugate vaccines trigger memory B-cell production and therefore induce greater long-term immunity. New research is now focusing on higher-valent PCV vaccines. Two 24-valent pneumococcal conjugate vaccines and one 31-valent pneumococcal conjugate vaccine are now in advanced stages of development.

Risk-based recommendation. A risk-based recommendation for ages 19 through 49 years still applies to those with certain medical conditions, including diabetes; chronic heart, lung, liver, or kidney disease; and also for those with immunocompromising conditions. Risk-based recommendations are harder to implement particularly because many vaccines are now administered in pharmacies and pharmacists don’t know the patients as well as their physicians do, so it’s harder for them to know who should get the vaccine if the recommendation is based on risk.

COVID-19 Vaccines With Additional Dose Recommendations 

Everyone 6 months or older is recommended to receive a dose of the updated 2024-2025 COVID vaccine. An additional updated COVID vaccine dose is now recommended for everyone aged 65 or older, and for those aged 6 months or older with immunocompromising (moderate or severe) conditions. Review of data revealed that 1 in 6 patients hospitalized with COVID have an immunocompromising condition, and 70% of COVID hospitalizations are in those aged 65 or older. This older age group also has the highest death rates due to COVID-19. We know that vaccination protection wanes with time. Data from previous studies show that additional vaccine doses provide additional protection. Additional doses are now being recommended for those at highest risk.

Timing of additional doses. This second dose is recommended at 6 months after the last updated COVID-19 vaccine dose. However, the additional dose can be given as early as 2 months after the last dose. Those who recently had COVID-19 can wait 3 months before getting an additional vaccine dose. This flexibility allows patients to maximize additional protection by timing additional doses around travel and life events, such as weddings, family get-togethers, or chemotherapy.

Those with immunocompromising conditions may receive more doses. Patients with immunocompromising conditions can receive even more additional doses, if recommended by their physician, under shared clinical decision-making. 

Meningococcal Vaccines

Meningococcal disease is rare but deadly. The disease can progress rapidly. As many as 10%-15% of people with meningococcal infection die, even with appropriate antibiotic therapy. And for those who survive, about 20% suffer long-term sequalae (cognitive deficits, hearing loss, limb amputations).

Aligning Men B vaccine dosing intervals. The new ACIP vote applies only to Men B vaccines, of which there are two: one by GSK (brand name Bexsero), and the other by Wyeth, a Pfizer subsidiary (brand name Trumenba). The two MenB vaccine products are not interchangeable. The same type of MenB vaccine has to be used to complete the series.

The MenB vaccines initially had different dosing schedules and now they don’t. ACIP voted to harmonize and align the dosing schedule for the two different MenB products to mirror recent FDA (Food and Drug Administration) labeling updates. So now the dosing recommendations for both MenB vaccines are the same: either two doses given 6 months apart to healthy adolescents and young adults, or a three-dose series given at zero, 1-2 months, and 6 months for those at high risk or for those who want to optimize rapid protection (for example, if they are starting the series within 6 months of going off to college). But understand that the current recommendation for MenB vaccination for healthy adolescents and young adults is based on shared clinical decision-making, preferably for those aged 16-18.

MenACWY. Two doses of MenACWY are routinely recommended, with the first dose at age 11-12 and a second dose at age 16. The MenACWY vaccines are interchangeable.

Implementation challenges and new pentavalent vaccines. Having to use the same MenB vaccine product for all doses in a patient’s series is difficult. It’s even more difficult when the patient needs both MenACWY and MenB vaccinations. 

Adding to the complexity is a new pentavalent vaccine from Pfizer (brand name Penbraya) that combines MenACWY with the MenB vaccine. And another pentavalent vaccine version by GSK is up for regulatory decision in February 2025.

The work group did say that they plan to take a fresh look at the meningococcal vaccination schedule. Let’s hope it gets simpler, so more to come on that.
 

Respiratory Syncytial Virus (RSV) Vaccines 

Current RSV vaccine recommendations for older adults. RSV vaccine has both age- and risk-based recommendations. Now, everyone aged 75 or older needs a dose of RSV vaccine. Adults aged 60-75 with risk factors for severe RSV are also recommended to receive a dose of RSV vaccine, but not adults without these risk factors. The conditions associated with increased risk for severe RSV disease include lung disease, heart disease, immune compromise, diabetes, obesity with BMI (body mass index) of 40 or higher, neurologic or neuromuscular conditions, chronic kidney disease, liver disorders, and hematologic disorders. Frailty, as well as living in a nursing home or other long-term care facility, are other risk factors for severe RSV disease. Those aged 60-75 without these risk factors are no longer recommended to receive it. 

Three RSV vaccines. We now have three RSV vaccine to choose from. Two are protein subunit vaccines. One is by Pfizer (brand name Abrysvo) that does not contain an adjuvant. The other protein-based RSV vaccine by GSK (brand name Arexvy) does contain an adjuvant. The third RSV vaccine by Moderna (brand name mRESVIA) uses an mRNA platform, and durability of protection is still unclear. However, recent studies now suggest that the RSV protein subunit vaccines confer 36 months of protection rather than only 24 months. 

All three RSV vaccines are licensed for those aged 60 or older. The age indication for GSK’s RSV vaccine, Arexvy, has already been lowered by the FDA to age 50. FDA recently lowered the age approval for Abrysvo to age 18 for those at high risk. However, ACIP has not yet expanded its age recommendations for getting these vaccines. One of the main hesitations is vaccine safety concerns. FDA›s safety update presented to ACIP still suggests an increased risk for Guillain-Barré syndrome with both protein-based RSV vaccines among those aged 65 or older. Fortunately, the risk is rare: less than 10 cases per million vaccinations. 

RSV immunization for infant protection. RSV season starts in October and goes through March. We now have two new ways to protect babies. One is a maternal RSV vaccine, given at 32-36 weeks of pregnancy to moms who will deliver their babies during RSV season. But only Pfizer’s RSV vaccine (brand name Abrysvo, without an adjuvant) can be given during pregnancy. 

A maternal RSV vaccine safety update, presented at ACIP, was reassuring. Abrysvo was not associated with increased risk for preterm birth or small gestational age at birth. 

Nirsevimab, a long-acting monoclonal antibody, can be given to infants. Nirsevimab is indicated for all babies under 8 months of age entering their first RSV season. 

People who received a maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during subsequent pregnancies. However, infants born to women who were vaccinated during a prior pregnancy should receive nirsevimab.

Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed conflicts of interest with the American Medical Association, the Medical Association of Atlanta, ACIP, and Medscape.

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

This transcript has been edited for clarity. 

This episode of Medicine Matters reviews highlights from the Advisory Committee on Immunization Practices’ (ACIP’s) October 2024 meeting, with new recommendations for pneumococcal, COVID, and meningococcal B (Men B) vaccines, as well as a safety update for maternal RSV vaccination.

Pneumococcal Vaccination and New Lower Age-Based Recommendations 

New age-based recommendation. ACIP has lowered the age for routine vaccination with the pneumococcal conjugate vaccine (PCV) from age 65 down to age 50, but only with PCV. Review of data revealed that more than half of those in the 50- to 64-year-old age group already had a risk indication to receive a PCV dose. In addition, rates of invasive pneumococcal disease peak at younger ages in Black patients compared with White patients. The rate of invasive pneumococcal disease (IPD) among Black adults aged 50 or older exceeds the average rate of IPD for all adults aged 65 or older. The goal of this age-based change is to reduce disease in demographic groups with the highest burden of disease. 

The new expanded age-based recommendation applies only to vaccination with PCV. Conjugate vaccines trigger memory B-cell production and therefore induce greater long-term immunity. New research is now focusing on higher-valent PCV vaccines. Two 24-valent pneumococcal conjugate vaccines and one 31-valent pneumococcal conjugate vaccine are now in advanced stages of development.

Risk-based recommendation. A risk-based recommendation for ages 19 through 49 years still applies to those with certain medical conditions, including diabetes; chronic heart, lung, liver, or kidney disease; and also for those with immunocompromising conditions. Risk-based recommendations are harder to implement particularly because many vaccines are now administered in pharmacies and pharmacists don’t know the patients as well as their physicians do, so it’s harder for them to know who should get the vaccine if the recommendation is based on risk.

COVID-19 Vaccines With Additional Dose Recommendations 

Everyone 6 months or older is recommended to receive a dose of the updated 2024-2025 COVID vaccine. An additional updated COVID vaccine dose is now recommended for everyone aged 65 or older, and for those aged 6 months or older with immunocompromising (moderate or severe) conditions. Review of data revealed that 1 in 6 patients hospitalized with COVID have an immunocompromising condition, and 70% of COVID hospitalizations are in those aged 65 or older. This older age group also has the highest death rates due to COVID-19. We know that vaccination protection wanes with time. Data from previous studies show that additional vaccine doses provide additional protection. Additional doses are now being recommended for those at highest risk.

Timing of additional doses. This second dose is recommended at 6 months after the last updated COVID-19 vaccine dose. However, the additional dose can be given as early as 2 months after the last dose. Those who recently had COVID-19 can wait 3 months before getting an additional vaccine dose. This flexibility allows patients to maximize additional protection by timing additional doses around travel and life events, such as weddings, family get-togethers, or chemotherapy.

Those with immunocompromising conditions may receive more doses. Patients with immunocompromising conditions can receive even more additional doses, if recommended by their physician, under shared clinical decision-making. 

Meningococcal Vaccines

Meningococcal disease is rare but deadly. The disease can progress rapidly. As many as 10%-15% of people with meningococcal infection die, even with appropriate antibiotic therapy. And for those who survive, about 20% suffer long-term sequalae (cognitive deficits, hearing loss, limb amputations).

Aligning Men B vaccine dosing intervals. The new ACIP vote applies only to Men B vaccines, of which there are two: one by GSK (brand name Bexsero), and the other by Wyeth, a Pfizer subsidiary (brand name Trumenba). The two MenB vaccine products are not interchangeable. The same type of MenB vaccine has to be used to complete the series.

The MenB vaccines initially had different dosing schedules and now they don’t. ACIP voted to harmonize and align the dosing schedule for the two different MenB products to mirror recent FDA (Food and Drug Administration) labeling updates. So now the dosing recommendations for both MenB vaccines are the same: either two doses given 6 months apart to healthy adolescents and young adults, or a three-dose series given at zero, 1-2 months, and 6 months for those at high risk or for those who want to optimize rapid protection (for example, if they are starting the series within 6 months of going off to college). But understand that the current recommendation for MenB vaccination for healthy adolescents and young adults is based on shared clinical decision-making, preferably for those aged 16-18.

MenACWY. Two doses of MenACWY are routinely recommended, with the first dose at age 11-12 and a second dose at age 16. The MenACWY vaccines are interchangeable.

Implementation challenges and new pentavalent vaccines. Having to use the same MenB vaccine product for all doses in a patient’s series is difficult. It’s even more difficult when the patient needs both MenACWY and MenB vaccinations. 

Adding to the complexity is a new pentavalent vaccine from Pfizer (brand name Penbraya) that combines MenACWY with the MenB vaccine. And another pentavalent vaccine version by GSK is up for regulatory decision in February 2025.

The work group did say that they plan to take a fresh look at the meningococcal vaccination schedule. Let’s hope it gets simpler, so more to come on that.
 

Respiratory Syncytial Virus (RSV) Vaccines 

Current RSV vaccine recommendations for older adults. RSV vaccine has both age- and risk-based recommendations. Now, everyone aged 75 or older needs a dose of RSV vaccine. Adults aged 60-75 with risk factors for severe RSV are also recommended to receive a dose of RSV vaccine, but not adults without these risk factors. The conditions associated with increased risk for severe RSV disease include lung disease, heart disease, immune compromise, diabetes, obesity with BMI (body mass index) of 40 or higher, neurologic or neuromuscular conditions, chronic kidney disease, liver disorders, and hematologic disorders. Frailty, as well as living in a nursing home or other long-term care facility, are other risk factors for severe RSV disease. Those aged 60-75 without these risk factors are no longer recommended to receive it. 

Three RSV vaccines. We now have three RSV vaccine to choose from. Two are protein subunit vaccines. One is by Pfizer (brand name Abrysvo) that does not contain an adjuvant. The other protein-based RSV vaccine by GSK (brand name Arexvy) does contain an adjuvant. The third RSV vaccine by Moderna (brand name mRESVIA) uses an mRNA platform, and durability of protection is still unclear. However, recent studies now suggest that the RSV protein subunit vaccines confer 36 months of protection rather than only 24 months. 

All three RSV vaccines are licensed for those aged 60 or older. The age indication for GSK’s RSV vaccine, Arexvy, has already been lowered by the FDA to age 50. FDA recently lowered the age approval for Abrysvo to age 18 for those at high risk. However, ACIP has not yet expanded its age recommendations for getting these vaccines. One of the main hesitations is vaccine safety concerns. FDA›s safety update presented to ACIP still suggests an increased risk for Guillain-Barré syndrome with both protein-based RSV vaccines among those aged 65 or older. Fortunately, the risk is rare: less than 10 cases per million vaccinations. 

RSV immunization for infant protection. RSV season starts in October and goes through March. We now have two new ways to protect babies. One is a maternal RSV vaccine, given at 32-36 weeks of pregnancy to moms who will deliver their babies during RSV season. But only Pfizer’s RSV vaccine (brand name Abrysvo, without an adjuvant) can be given during pregnancy. 

A maternal RSV vaccine safety update, presented at ACIP, was reassuring. Abrysvo was not associated with increased risk for preterm birth or small gestational age at birth. 

Nirsevimab, a long-acting monoclonal antibody, can be given to infants. Nirsevimab is indicated for all babies under 8 months of age entering their first RSV season. 

People who received a maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during subsequent pregnancies. However, infants born to women who were vaccinated during a prior pregnancy should receive nirsevimab.

Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed conflicts of interest with the American Medical Association, the Medical Association of Atlanta, ACIP, and Medscape.

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

This transcript has been edited for clarity. 

This episode of Medicine Matters reviews highlights from the Advisory Committee on Immunization Practices’ (ACIP’s) October 2024 meeting, with new recommendations for pneumococcal, COVID, and meningococcal B (Men B) vaccines, as well as a safety update for maternal RSV vaccination.

Pneumococcal Vaccination and New Lower Age-Based Recommendations 

New age-based recommendation. ACIP has lowered the age for routine vaccination with the pneumococcal conjugate vaccine (PCV) from age 65 down to age 50, but only with PCV. Review of data revealed that more than half of those in the 50- to 64-year-old age group already had a risk indication to receive a PCV dose. In addition, rates of invasive pneumococcal disease peak at younger ages in Black patients compared with White patients. The rate of invasive pneumococcal disease (IPD) among Black adults aged 50 or older exceeds the average rate of IPD for all adults aged 65 or older. The goal of this age-based change is to reduce disease in demographic groups with the highest burden of disease. 

The new expanded age-based recommendation applies only to vaccination with PCV. Conjugate vaccines trigger memory B-cell production and therefore induce greater long-term immunity. New research is now focusing on higher-valent PCV vaccines. Two 24-valent pneumococcal conjugate vaccines and one 31-valent pneumococcal conjugate vaccine are now in advanced stages of development.

Risk-based recommendation. A risk-based recommendation for ages 19 through 49 years still applies to those with certain medical conditions, including diabetes; chronic heart, lung, liver, or kidney disease; and also for those with immunocompromising conditions. Risk-based recommendations are harder to implement particularly because many vaccines are now administered in pharmacies and pharmacists don’t know the patients as well as their physicians do, so it’s harder for them to know who should get the vaccine if the recommendation is based on risk.

COVID-19 Vaccines With Additional Dose Recommendations 

Everyone 6 months or older is recommended to receive a dose of the updated 2024-2025 COVID vaccine. An additional updated COVID vaccine dose is now recommended for everyone aged 65 or older, and for those aged 6 months or older with immunocompromising (moderate or severe) conditions. Review of data revealed that 1 in 6 patients hospitalized with COVID have an immunocompromising condition, and 70% of COVID hospitalizations are in those aged 65 or older. This older age group also has the highest death rates due to COVID-19. We know that vaccination protection wanes with time. Data from previous studies show that additional vaccine doses provide additional protection. Additional doses are now being recommended for those at highest risk.

Timing of additional doses. This second dose is recommended at 6 months after the last updated COVID-19 vaccine dose. However, the additional dose can be given as early as 2 months after the last dose. Those who recently had COVID-19 can wait 3 months before getting an additional vaccine dose. This flexibility allows patients to maximize additional protection by timing additional doses around travel and life events, such as weddings, family get-togethers, or chemotherapy.

Those with immunocompromising conditions may receive more doses. Patients with immunocompromising conditions can receive even more additional doses, if recommended by their physician, under shared clinical decision-making. 

Meningococcal Vaccines

Meningococcal disease is rare but deadly. The disease can progress rapidly. As many as 10%-15% of people with meningococcal infection die, even with appropriate antibiotic therapy. And for those who survive, about 20% suffer long-term sequalae (cognitive deficits, hearing loss, limb amputations).

Aligning Men B vaccine dosing intervals. The new ACIP vote applies only to Men B vaccines, of which there are two: one by GSK (brand name Bexsero), and the other by Wyeth, a Pfizer subsidiary (brand name Trumenba). The two MenB vaccine products are not interchangeable. The same type of MenB vaccine has to be used to complete the series.

The MenB vaccines initially had different dosing schedules and now they don’t. ACIP voted to harmonize and align the dosing schedule for the two different MenB products to mirror recent FDA (Food and Drug Administration) labeling updates. So now the dosing recommendations for both MenB vaccines are the same: either two doses given 6 months apart to healthy adolescents and young adults, or a three-dose series given at zero, 1-2 months, and 6 months for those at high risk or for those who want to optimize rapid protection (for example, if they are starting the series within 6 months of going off to college). But understand that the current recommendation for MenB vaccination for healthy adolescents and young adults is based on shared clinical decision-making, preferably for those aged 16-18.

MenACWY. Two doses of MenACWY are routinely recommended, with the first dose at age 11-12 and a second dose at age 16. The MenACWY vaccines are interchangeable.

Implementation challenges and new pentavalent vaccines. Having to use the same MenB vaccine product for all doses in a patient’s series is difficult. It’s even more difficult when the patient needs both MenACWY and MenB vaccinations. 

Adding to the complexity is a new pentavalent vaccine from Pfizer (brand name Penbraya) that combines MenACWY with the MenB vaccine. And another pentavalent vaccine version by GSK is up for regulatory decision in February 2025.

The work group did say that they plan to take a fresh look at the meningococcal vaccination schedule. Let’s hope it gets simpler, so more to come on that.
 

Respiratory Syncytial Virus (RSV) Vaccines 

Current RSV vaccine recommendations for older adults. RSV vaccine has both age- and risk-based recommendations. Now, everyone aged 75 or older needs a dose of RSV vaccine. Adults aged 60-75 with risk factors for severe RSV are also recommended to receive a dose of RSV vaccine, but not adults without these risk factors. The conditions associated with increased risk for severe RSV disease include lung disease, heart disease, immune compromise, diabetes, obesity with BMI (body mass index) of 40 or higher, neurologic or neuromuscular conditions, chronic kidney disease, liver disorders, and hematologic disorders. Frailty, as well as living in a nursing home or other long-term care facility, are other risk factors for severe RSV disease. Those aged 60-75 without these risk factors are no longer recommended to receive it. 

Three RSV vaccines. We now have three RSV vaccine to choose from. Two are protein subunit vaccines. One is by Pfizer (brand name Abrysvo) that does not contain an adjuvant. The other protein-based RSV vaccine by GSK (brand name Arexvy) does contain an adjuvant. The third RSV vaccine by Moderna (brand name mRESVIA) uses an mRNA platform, and durability of protection is still unclear. However, recent studies now suggest that the RSV protein subunit vaccines confer 36 months of protection rather than only 24 months. 

All three RSV vaccines are licensed for those aged 60 or older. The age indication for GSK’s RSV vaccine, Arexvy, has already been lowered by the FDA to age 50. FDA recently lowered the age approval for Abrysvo to age 18 for those at high risk. However, ACIP has not yet expanded its age recommendations for getting these vaccines. One of the main hesitations is vaccine safety concerns. FDA›s safety update presented to ACIP still suggests an increased risk for Guillain-Barré syndrome with both protein-based RSV vaccines among those aged 65 or older. Fortunately, the risk is rare: less than 10 cases per million vaccinations. 

RSV immunization for infant protection. RSV season starts in October and goes through March. We now have two new ways to protect babies. One is a maternal RSV vaccine, given at 32-36 weeks of pregnancy to moms who will deliver their babies during RSV season. But only Pfizer’s RSV vaccine (brand name Abrysvo, without an adjuvant) can be given during pregnancy. 

A maternal RSV vaccine safety update, presented at ACIP, was reassuring. Abrysvo was not associated with increased risk for preterm birth or small gestational age at birth. 

Nirsevimab, a long-acting monoclonal antibody, can be given to infants. Nirsevimab is indicated for all babies under 8 months of age entering their first RSV season. 

People who received a maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during subsequent pregnancies. However, infants born to women who were vaccinated during a prior pregnancy should receive nirsevimab.

Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed conflicts of interest with the American Medical Association, the Medical Association of Atlanta, ACIP, and Medscape.

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

First, there were “Ozempic babies.” Now, there is also Ozempic-before-baby.

Unplanned pregnancies are still regularly being reported among people using glucagon-like peptide 1 receptor agonist (GLP-1 RA) drugs, and now fertility specialists are increasingly incorporating the medicines into preconception care plans.

The specialists say their colleagues in other areas of medicine may have an opportunity, too, to talk about weight loss using these new drugs in terms of reproductive health. Motivation and compliance can transform when the goal isn’t simply weight loss but having children.

“We have this really special moment to help patients be healthier, in order to be healthier for their kids,” said Christina Boots, MD, MSci, an associate professor of reproductive endocrinology and infertility at Northwestern University’s Feinberg School of Medicine, Chicago. “And I think that’s also a very motivating moment. It may be hard to get up and go for a run to make my jeans fit better, but when I think about it in terms of, ‘this might someday help my future daughter,’ that is a whole different level of motivation.”

Discussing obesity treatment can be a delicate conversation, but one that would be beneficial to have with any patient of reproductive age. Here’s why, what to know about the current lengthy list of unknowns and risks, and some options for approaching the topic with patients.
 

What Fertility Docs Are Doing

While overweight and obesity are consistently linked to fertility and pregnancy outcomes, Boots predicts the biggest impact of GLP-1 weight loss for fertility among women will be a specific subset: Those who are not cycling regularly, such as those with polycystic ovary syndrome (PCOS).

“The women who are cycling regularly who have very unexplained infertility and no other comorbidities like high blood pressure or something else going on, I don’t think it’s going to help their fertility very much at all,” she said “It might, but I think there’s probably something else going on in her tubes or with her eggs or his sperm, but it has nothing to do with her metabolic health.

Women who aren’t cycling regularly will benefit, but those with truly unexplained fertility probably won’t, she said.

In their recent narrative review on treating obesity and fertility with GLP-1 RAs that appeared in Fertility and Sterility, Boots and co-author Alyse S. Goldberg, MD, an endocrinologist with the University of Toronto, Ontario, Canada, advocate for the use of GLP-1s as a go-to treatment for obesity as part of preconception care by reproductive endocrinologists, calling the drugs “the most effective, least invasive means of weight loss.”

The paper is timely and necessary because use of GLP-1s is only going to increase, Patricia Jimenez, MD, an associate professor of obstetrics and gynecology at Washington University School of Medicine in St. Louis, Missouri, said in an email to this news organization.

“GLP-1 RAs are becoming a larger part of my practice. More patients are either using them already or interested in using them,” said Jimenez, who is board certified in reproductive endocrinology, obstetrics and gynecology, and obesity medicine. “I specifically see patients to discuss this and do prescribe antiobesity medications, not only GLP-1 RAs. Often this is with people with PCOS who are not planning to conceive soon or patients willing to delay fertility treatment [by] 3-6 months.”

Treating obesity is also important for women who are seeking in vitro fertilization, Boots said, because many IVF clinics have a body mass index cutoff of 40 kg/m².

Like Jimenez’s approach, Boots and Goldberg call for comprehensive obesity care beyond the use of medication, including nutritional counseling and mental health support. Those supports are important during the transition off of GLP-1 medications, which poses a risk for rapid weight regain. That’s even with the potential support of taking metformin, which Boots often prescribes as a bridge.

Semaglutide should be stopped at least 2 months prior to conception, and tirzepatide should be stopped 1 month prior to conception, according to the manufacturers. (Boots and Goldberg listed the Canadian label recommendation for stopping tirzepatide, noting there is no suggested timeline for stopping prior to conception on the US label.)

Numerous studies have shown rapid weight regain is common when stopping GLP-1s, which presents a unique set of risks for pregnant women including early pregnancy loss, gestational diabetes, preeclampsia, and nonelective cesarean delivery.
 

Weighing Risks, Benefits, and Unknowns

Early looks at small human data sets, mostly involving semaglutide and earlier short-acting GLP-1s, and their impact on the risk for birth defects are “reassuring,” Boots said.

“But birth defects are just one small aspect. There’s also metabolic health and things like that long-term. Understanding what it does to the growing baby and the proximity of that medication to that growing baby is really important to see, and can’t be answered with animal studies, not perfectly anyway,” Boots said.

There are no published reports, from clinical trials nor case collections, examining the use of tirzepatide among pregnant people.

“One of the most important questions we need to answer is the preconception safety of these medications, and that includes safety for men,” Joshua Halpern, MD, MS, an adjunct assistant professor of urology at Northwestern University’s Feinberg School of Medicine, and chief scientific officer for Posterity Health, said in an email to this news organization.

“For example, a recent study found that men who were taking metformin, another popular medication for diabetes, were more likely to have children with birth defects, compared with those who were not taking the medication,” Halpern said. “Further studies are needed to determine whether a similar effect might hold true for the GLP-1 agonists.”

Small early studies on sperm are encouraging, Halpern said, suggesting that GLP-1 use may be beneficial, but a better understanding of direct effects is needed.

Among women, there may be cases where continuing use of a GLP-1 during pregnancy may offer benefits that outweigh risks, Boots suggested. Manufacturers have also created pregnancy exposure registries to measure the safety of their therapies during pregnancy.

“I have a group of patients whose sugars are so well controlled on these medications, but as soon as they come off, they get weight regain and their glucose is just so poorly controlled,” she said. “There may be a group of women where the benefits of glucose control outweigh the risks of being on the medication the whole pregnancy.”

The list of important unknowns also includes a need to examine how rapid weight loss may impact ovulation rates and spontaneous conception, as well as miscarriage rates, birth weight, and metabolic health of the child.

More detailed rebound weight gain data is coming next year, with additional analysis expected as well on birth weight and pregnancy outcomes, said Jacqueline Maya, MD, first author of the research abstract presented at this year’s American Diabetes Association conference that examined gestational weight gain among people with preexisting type 2 diabetes who were exposed to GLP-1s during pregnancy. The study included 47 exposed pregnancies (based on prescription records and electronic chart information) and compared gestational weight gain to 141 unexposed matched pregnancies. Among the exposed group, 62% exceeded recommended weight gain, compared with 41% in the unexposed group. On average, gestational weight gain in exposed pregnancies exceeded that among matched unexposed pregnancies by about 6 pounds.

The team is now working with an additional data set to examine exposed pregnancies among people with obesity, said Maya, an instructor of pediatrics at Mass General Hospital and Harvard School of Medicine. She is particularly interested in examining weight trajectories during pregnancy to see how they may affect fetal outcomes. Her team’s current project also will likely include analysis to examine other variables like postpartum weight gain and adiposity characteristics of the baby.

Maya said the team hopes to have more to report at the American Diabetes Association conference in June next year.
 

Offer the Conversation

Using a GLP-1 for weight loss takes time, usually around 1 year to reach a plateau. Boots encouraged nonfertility providers to ask patients of reproductive age about their family plans as an opening.

“I hope for all primary care doctors and gynecologists, that with any patient of reproductive age, you should be bringing this up, asking, ‘Have you thought about having kids? Are you thinking about it soon?’ And if they say they are sometime in the near future, then you can say, ‘Is it OK if I bring up your weight?’ And you should ask permission.”

If the patient declines, it’s OK to bring it up again at a future visit.

“People with obesity have often experienced negative weight bias that impacts their care,” Jimenez said. “Treat obesity as a disease, not a personal failing. Ask permission to discuss weight with the patient beforehand. If they say no, respect that answer. This goes a long way in developing a positive relationship, so they return for care and may be willing to discuss later.” 

When patients are open to the conversation, Boots suggests not focusing on the potential for poor outcomes, and instead perhaps saying, “If you’re thinking about having a baby in 5 years, optimizing your health now will not only make your pregnancy healthier, but your child healthier long-term.”

Discussing contraception plans remains important. People starting semaglutide or tirzepatide should use contraception other than oral birth control for 4 weeks while starting the medicine and for 4 weeks after each dose increase.

Boots said that the contraception conversation is particularly important because many people have come to deeply believe that they are infertile and, thus, may perhaps think contraception advice doesn’t apply to them. Maya hypothesized that behavioral changes following weight loss may also be a pathway toward pregnancy.

“Pregnancy while on GLP-1 RAs does happen. I always have a discussion about this possibility and contraception. This can sometimes be challenging for people with infertility to consider,” Jimenez said. “Explaining the risks, benefits, and unknowns can help. As the [Fertility and Sterility] paper describes, the limited data available has not shown increased fetal or maternal complications. We need more high quality data to better understand the impact of exposure or use around the time of conception and during pregnancy.”

It’s also important to introduce the idea to patients that they may someday need to come off the medications, such as when they are ready to have children, and how important lifestyle and behavioral changes will be at that time, Maya said.

“We do know what the alternative is, and we do know what the risks of obesity are,” she said. “So, it’s a tug and pull. We’re not starting off with healthy. We’re starting off with a disease that is physically and emotionally very difficult for the patient, especially when it starts in childhood.”
 

A version of this article appeared on Medscape.com.

First, there were “Ozempic babies.” Now, there is also Ozempic-before-baby.

Unplanned pregnancies are still regularly being reported among people using glucagon-like peptide 1 receptor agonist (GLP-1 RA) drugs, and now fertility specialists are increasingly incorporating the medicines into preconception care plans.

The specialists say their colleagues in other areas of medicine may have an opportunity, too, to talk about weight loss using these new drugs in terms of reproductive health. Motivation and compliance can transform when the goal isn’t simply weight loss but having children.

“We have this really special moment to help patients be healthier, in order to be healthier for their kids,” said Christina Boots, MD, MSci, an associate professor of reproductive endocrinology and infertility at Northwestern University’s Feinberg School of Medicine, Chicago. “And I think that’s also a very motivating moment. It may be hard to get up and go for a run to make my jeans fit better, but when I think about it in terms of, ‘this might someday help my future daughter,’ that is a whole different level of motivation.”

Discussing obesity treatment can be a delicate conversation, but one that would be beneficial to have with any patient of reproductive age. Here’s why, what to know about the current lengthy list of unknowns and risks, and some options for approaching the topic with patients.
 

What Fertility Docs Are Doing

While overweight and obesity are consistently linked to fertility and pregnancy outcomes, Boots predicts the biggest impact of GLP-1 weight loss for fertility among women will be a specific subset: Those who are not cycling regularly, such as those with polycystic ovary syndrome (PCOS).

“The women who are cycling regularly who have very unexplained infertility and no other comorbidities like high blood pressure or something else going on, I don’t think it’s going to help their fertility very much at all,” she said “It might, but I think there’s probably something else going on in her tubes or with her eggs or his sperm, but it has nothing to do with her metabolic health.

Women who aren’t cycling regularly will benefit, but those with truly unexplained fertility probably won’t, she said.

In their recent narrative review on treating obesity and fertility with GLP-1 RAs that appeared in Fertility and Sterility, Boots and co-author Alyse S. Goldberg, MD, an endocrinologist with the University of Toronto, Ontario, Canada, advocate for the use of GLP-1s as a go-to treatment for obesity as part of preconception care by reproductive endocrinologists, calling the drugs “the most effective, least invasive means of weight loss.”

The paper is timely and necessary because use of GLP-1s is only going to increase, Patricia Jimenez, MD, an associate professor of obstetrics and gynecology at Washington University School of Medicine in St. Louis, Missouri, said in an email to this news organization.

“GLP-1 RAs are becoming a larger part of my practice. More patients are either using them already or interested in using them,” said Jimenez, who is board certified in reproductive endocrinology, obstetrics and gynecology, and obesity medicine. “I specifically see patients to discuss this and do prescribe antiobesity medications, not only GLP-1 RAs. Often this is with people with PCOS who are not planning to conceive soon or patients willing to delay fertility treatment [by] 3-6 months.”

Treating obesity is also important for women who are seeking in vitro fertilization, Boots said, because many IVF clinics have a body mass index cutoff of 40 kg/m².

Like Jimenez’s approach, Boots and Goldberg call for comprehensive obesity care beyond the use of medication, including nutritional counseling and mental health support. Those supports are important during the transition off of GLP-1 medications, which poses a risk for rapid weight regain. That’s even with the potential support of taking metformin, which Boots often prescribes as a bridge.

Semaglutide should be stopped at least 2 months prior to conception, and tirzepatide should be stopped 1 month prior to conception, according to the manufacturers. (Boots and Goldberg listed the Canadian label recommendation for stopping tirzepatide, noting there is no suggested timeline for stopping prior to conception on the US label.)

Numerous studies have shown rapid weight regain is common when stopping GLP-1s, which presents a unique set of risks for pregnant women including early pregnancy loss, gestational diabetes, preeclampsia, and nonelective cesarean delivery.
 

Weighing Risks, Benefits, and Unknowns

Early looks at small human data sets, mostly involving semaglutide and earlier short-acting GLP-1s, and their impact on the risk for birth defects are “reassuring,” Boots said.

“But birth defects are just one small aspect. There’s also metabolic health and things like that long-term. Understanding what it does to the growing baby and the proximity of that medication to that growing baby is really important to see, and can’t be answered with animal studies, not perfectly anyway,” Boots said.

There are no published reports, from clinical trials nor case collections, examining the use of tirzepatide among pregnant people.

“One of the most important questions we need to answer is the preconception safety of these medications, and that includes safety for men,” Joshua Halpern, MD, MS, an adjunct assistant professor of urology at Northwestern University’s Feinberg School of Medicine, and chief scientific officer for Posterity Health, said in an email to this news organization.

“For example, a recent study found that men who were taking metformin, another popular medication for diabetes, were more likely to have children with birth defects, compared with those who were not taking the medication,” Halpern said. “Further studies are needed to determine whether a similar effect might hold true for the GLP-1 agonists.”

Small early studies on sperm are encouraging, Halpern said, suggesting that GLP-1 use may be beneficial, but a better understanding of direct effects is needed.

Among women, there may be cases where continuing use of a GLP-1 during pregnancy may offer benefits that outweigh risks, Boots suggested. Manufacturers have also created pregnancy exposure registries to measure the safety of their therapies during pregnancy.

“I have a group of patients whose sugars are so well controlled on these medications, but as soon as they come off, they get weight regain and their glucose is just so poorly controlled,” she said. “There may be a group of women where the benefits of glucose control outweigh the risks of being on the medication the whole pregnancy.”

The list of important unknowns also includes a need to examine how rapid weight loss may impact ovulation rates and spontaneous conception, as well as miscarriage rates, birth weight, and metabolic health of the child.

More detailed rebound weight gain data is coming next year, with additional analysis expected as well on birth weight and pregnancy outcomes, said Jacqueline Maya, MD, first author of the research abstract presented at this year’s American Diabetes Association conference that examined gestational weight gain among people with preexisting type 2 diabetes who were exposed to GLP-1s during pregnancy. The study included 47 exposed pregnancies (based on prescription records and electronic chart information) and compared gestational weight gain to 141 unexposed matched pregnancies. Among the exposed group, 62% exceeded recommended weight gain, compared with 41% in the unexposed group. On average, gestational weight gain in exposed pregnancies exceeded that among matched unexposed pregnancies by about 6 pounds.

The team is now working with an additional data set to examine exposed pregnancies among people with obesity, said Maya, an instructor of pediatrics at Mass General Hospital and Harvard School of Medicine. She is particularly interested in examining weight trajectories during pregnancy to see how they may affect fetal outcomes. Her team’s current project also will likely include analysis to examine other variables like postpartum weight gain and adiposity characteristics of the baby.

Maya said the team hopes to have more to report at the American Diabetes Association conference in June next year.
 

Offer the Conversation

Using a GLP-1 for weight loss takes time, usually around 1 year to reach a plateau. Boots encouraged nonfertility providers to ask patients of reproductive age about their family plans as an opening.

“I hope for all primary care doctors and gynecologists, that with any patient of reproductive age, you should be bringing this up, asking, ‘Have you thought about having kids? Are you thinking about it soon?’ And if they say they are sometime in the near future, then you can say, ‘Is it OK if I bring up your weight?’ And you should ask permission.”

If the patient declines, it’s OK to bring it up again at a future visit.

“People with obesity have often experienced negative weight bias that impacts their care,” Jimenez said. “Treat obesity as a disease, not a personal failing. Ask permission to discuss weight with the patient beforehand. If they say no, respect that answer. This goes a long way in developing a positive relationship, so they return for care and may be willing to discuss later.” 

When patients are open to the conversation, Boots suggests not focusing on the potential for poor outcomes, and instead perhaps saying, “If you’re thinking about having a baby in 5 years, optimizing your health now will not only make your pregnancy healthier, but your child healthier long-term.”

Discussing contraception plans remains important. People starting semaglutide or tirzepatide should use contraception other than oral birth control for 4 weeks while starting the medicine and for 4 weeks after each dose increase.

Boots said that the contraception conversation is particularly important because many people have come to deeply believe that they are infertile and, thus, may perhaps think contraception advice doesn’t apply to them. Maya hypothesized that behavioral changes following weight loss may also be a pathway toward pregnancy.

“Pregnancy while on GLP-1 RAs does happen. I always have a discussion about this possibility and contraception. This can sometimes be challenging for people with infertility to consider,” Jimenez said. “Explaining the risks, benefits, and unknowns can help. As the [Fertility and Sterility] paper describes, the limited data available has not shown increased fetal or maternal complications. We need more high quality data to better understand the impact of exposure or use around the time of conception and during pregnancy.”

It’s also important to introduce the idea to patients that they may someday need to come off the medications, such as when they are ready to have children, and how important lifestyle and behavioral changes will be at that time, Maya said.

“We do know what the alternative is, and we do know what the risks of obesity are,” she said. “So, it’s a tug and pull. We’re not starting off with healthy. We’re starting off with a disease that is physically and emotionally very difficult for the patient, especially when it starts in childhood.”
 

A version of this article appeared on Medscape.com.

First, there were “Ozempic babies.” Now, there is also Ozempic-before-baby.

Unplanned pregnancies are still regularly being reported among people using glucagon-like peptide 1 receptor agonist (GLP-1 RA) drugs, and now fertility specialists are increasingly incorporating the medicines into preconception care plans.

The specialists say their colleagues in other areas of medicine may have an opportunity, too, to talk about weight loss using these new drugs in terms of reproductive health. Motivation and compliance can transform when the goal isn’t simply weight loss but having children.

“We have this really special moment to help patients be healthier, in order to be healthier for their kids,” said Christina Boots, MD, MSci, an associate professor of reproductive endocrinology and infertility at Northwestern University’s Feinberg School of Medicine, Chicago. “And I think that’s also a very motivating moment. It may be hard to get up and go for a run to make my jeans fit better, but when I think about it in terms of, ‘this might someday help my future daughter,’ that is a whole different level of motivation.”

Discussing obesity treatment can be a delicate conversation, but one that would be beneficial to have with any patient of reproductive age. Here’s why, what to know about the current lengthy list of unknowns and risks, and some options for approaching the topic with patients.
 

What Fertility Docs Are Doing

While overweight and obesity are consistently linked to fertility and pregnancy outcomes, Boots predicts the biggest impact of GLP-1 weight loss for fertility among women will be a specific subset: Those who are not cycling regularly, such as those with polycystic ovary syndrome (PCOS).

“The women who are cycling regularly who have very unexplained infertility and no other comorbidities like high blood pressure or something else going on, I don’t think it’s going to help their fertility very much at all,” she said “It might, but I think there’s probably something else going on in her tubes or with her eggs or his sperm, but it has nothing to do with her metabolic health.

Women who aren’t cycling regularly will benefit, but those with truly unexplained fertility probably won’t, she said.

In their recent narrative review on treating obesity and fertility with GLP-1 RAs that appeared in Fertility and Sterility, Boots and co-author Alyse S. Goldberg, MD, an endocrinologist with the University of Toronto, Ontario, Canada, advocate for the use of GLP-1s as a go-to treatment for obesity as part of preconception care by reproductive endocrinologists, calling the drugs “the most effective, least invasive means of weight loss.”

The paper is timely and necessary because use of GLP-1s is only going to increase, Patricia Jimenez, MD, an associate professor of obstetrics and gynecology at Washington University School of Medicine in St. Louis, Missouri, said in an email to this news organization.

“GLP-1 RAs are becoming a larger part of my practice. More patients are either using them already or interested in using them,” said Jimenez, who is board certified in reproductive endocrinology, obstetrics and gynecology, and obesity medicine. “I specifically see patients to discuss this and do prescribe antiobesity medications, not only GLP-1 RAs. Often this is with people with PCOS who are not planning to conceive soon or patients willing to delay fertility treatment [by] 3-6 months.”

Treating obesity is also important for women who are seeking in vitro fertilization, Boots said, because many IVF clinics have a body mass index cutoff of 40 kg/m².

Like Jimenez’s approach, Boots and Goldberg call for comprehensive obesity care beyond the use of medication, including nutritional counseling and mental health support. Those supports are important during the transition off of GLP-1 medications, which poses a risk for rapid weight regain. That’s even with the potential support of taking metformin, which Boots often prescribes as a bridge.

Semaglutide should be stopped at least 2 months prior to conception, and tirzepatide should be stopped 1 month prior to conception, according to the manufacturers. (Boots and Goldberg listed the Canadian label recommendation for stopping tirzepatide, noting there is no suggested timeline for stopping prior to conception on the US label.)

Numerous studies have shown rapid weight regain is common when stopping GLP-1s, which presents a unique set of risks for pregnant women including early pregnancy loss, gestational diabetes, preeclampsia, and nonelective cesarean delivery.
 

Weighing Risks, Benefits, and Unknowns

Early looks at small human data sets, mostly involving semaglutide and earlier short-acting GLP-1s, and their impact on the risk for birth defects are “reassuring,” Boots said.

“But birth defects are just one small aspect. There’s also metabolic health and things like that long-term. Understanding what it does to the growing baby and the proximity of that medication to that growing baby is really important to see, and can’t be answered with animal studies, not perfectly anyway,” Boots said.

There are no published reports, from clinical trials nor case collections, examining the use of tirzepatide among pregnant people.

“One of the most important questions we need to answer is the preconception safety of these medications, and that includes safety for men,” Joshua Halpern, MD, MS, an adjunct assistant professor of urology at Northwestern University’s Feinberg School of Medicine, and chief scientific officer for Posterity Health, said in an email to this news organization.

“For example, a recent study found that men who were taking metformin, another popular medication for diabetes, were more likely to have children with birth defects, compared with those who were not taking the medication,” Halpern said. “Further studies are needed to determine whether a similar effect might hold true for the GLP-1 agonists.”

Small early studies on sperm are encouraging, Halpern said, suggesting that GLP-1 use may be beneficial, but a better understanding of direct effects is needed.

Among women, there may be cases where continuing use of a GLP-1 during pregnancy may offer benefits that outweigh risks, Boots suggested. Manufacturers have also created pregnancy exposure registries to measure the safety of their therapies during pregnancy.

“I have a group of patients whose sugars are so well controlled on these medications, but as soon as they come off, they get weight regain and their glucose is just so poorly controlled,” she said. “There may be a group of women where the benefits of glucose control outweigh the risks of being on the medication the whole pregnancy.”

The list of important unknowns also includes a need to examine how rapid weight loss may impact ovulation rates and spontaneous conception, as well as miscarriage rates, birth weight, and metabolic health of the child.

More detailed rebound weight gain data is coming next year, with additional analysis expected as well on birth weight and pregnancy outcomes, said Jacqueline Maya, MD, first author of the research abstract presented at this year’s American Diabetes Association conference that examined gestational weight gain among people with preexisting type 2 diabetes who were exposed to GLP-1s during pregnancy. The study included 47 exposed pregnancies (based on prescription records and electronic chart information) and compared gestational weight gain to 141 unexposed matched pregnancies. Among the exposed group, 62% exceeded recommended weight gain, compared with 41% in the unexposed group. On average, gestational weight gain in exposed pregnancies exceeded that among matched unexposed pregnancies by about 6 pounds.

The team is now working with an additional data set to examine exposed pregnancies among people with obesity, said Maya, an instructor of pediatrics at Mass General Hospital and Harvard School of Medicine. She is particularly interested in examining weight trajectories during pregnancy to see how they may affect fetal outcomes. Her team’s current project also will likely include analysis to examine other variables like postpartum weight gain and adiposity characteristics of the baby.

Maya said the team hopes to have more to report at the American Diabetes Association conference in June next year.
 

Offer the Conversation

Using a GLP-1 for weight loss takes time, usually around 1 year to reach a plateau. Boots encouraged nonfertility providers to ask patients of reproductive age about their family plans as an opening.

“I hope for all primary care doctors and gynecologists, that with any patient of reproductive age, you should be bringing this up, asking, ‘Have you thought about having kids? Are you thinking about it soon?’ And if they say they are sometime in the near future, then you can say, ‘Is it OK if I bring up your weight?’ And you should ask permission.”

If the patient declines, it’s OK to bring it up again at a future visit.

“People with obesity have often experienced negative weight bias that impacts their care,” Jimenez said. “Treat obesity as a disease, not a personal failing. Ask permission to discuss weight with the patient beforehand. If they say no, respect that answer. This goes a long way in developing a positive relationship, so they return for care and may be willing to discuss later.” 

When patients are open to the conversation, Boots suggests not focusing on the potential for poor outcomes, and instead perhaps saying, “If you’re thinking about having a baby in 5 years, optimizing your health now will not only make your pregnancy healthier, but your child healthier long-term.”

Discussing contraception plans remains important. People starting semaglutide or tirzepatide should use contraception other than oral birth control for 4 weeks while starting the medicine and for 4 weeks after each dose increase.

Boots said that the contraception conversation is particularly important because many people have come to deeply believe that they are infertile and, thus, may perhaps think contraception advice doesn’t apply to them. Maya hypothesized that behavioral changes following weight loss may also be a pathway toward pregnancy.

“Pregnancy while on GLP-1 RAs does happen. I always have a discussion about this possibility and contraception. This can sometimes be challenging for people with infertility to consider,” Jimenez said. “Explaining the risks, benefits, and unknowns can help. As the [Fertility and Sterility] paper describes, the limited data available has not shown increased fetal or maternal complications. We need more high quality data to better understand the impact of exposure or use around the time of conception and during pregnancy.”

It’s also important to introduce the idea to patients that they may someday need to come off the medications, such as when they are ready to have children, and how important lifestyle and behavioral changes will be at that time, Maya said.

“We do know what the alternative is, and we do know what the risks of obesity are,” she said. “So, it’s a tug and pull. We’re not starting off with healthy. We’re starting off with a disease that is physically and emotionally very difficult for the patient, especially when it starts in childhood.”
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Several types of anti-obesity medications (AOMs), including glucagon-like peptide 1s (GLP-1s), are associated with decreased alcohol use, new research suggests.

The findings, from surveys of more than 14,000 participants in WeightWatchers’ telehealth weight management program, were presented on November 6 at the Obesity Society’s Obesity Week 2024 meeting by the company’s Chief Nutrition Officer, Michelle I. Cardel, PhD, RD, based in Gainesville, Florida.

Similar reductions in alcohol consumption were seen in people taking different classes of AOMs, suggesting “an additional mechanism by which AOMs reduce energy intake, and also signal a potential role for these medications to reduce alcohol use,” Cardel said, adding “Clinicians treating individuals for obesity may consider anti-obesity medications particularly among those who report higher alcohol intake.”

Asked to comment, session moderator and obesity researcher Joseph A. Skelton, MD, professor of pediatrics at Wake Forest University School of Medicine, Winston-Salem, North Carolina, said, “I think there are some overlapping pathways there, possibly a reward system or something like that in the brain. I don’t think we know exactly what the end result will be as a potential use of the medications. But there’s a signal that needs to be investigated more.”

Cardel noted that there was one previous large cohort study finding that semaglutide was associated with a lower risk for alcohol use disorder, and another study that analyzed social media threads of people saying they’d quit drinking after starting a GLP-1 drug. But this new study is the first to examine the relationship with different classes of AOMs and to quantify the amount of alcohol consumed.
 

About Half Reported Reduced Alcohol Consumption, Regardless the AOM Class

The study included 14,053 WeightWatchers’ telehealth program participants who initiated an AOM between January 2022 and August 2023 and refilled the same AOM between October and November 2023. Those who had previously used AOMs before coming to the program or who had undergone bariatric surgery were excluded.

Participants had a mean age of 43 years, were 86% women, were 60% White, and had a mean body mass index of 36. They were surveyed about their weekly alcohol use prior to AOM initiation and again at the time of AOM refill.

At baseline, they were divided into categories of 0 (no alcohol use; n = 6562), category 1 (one to three drinks for women and one to six for men; n = 5948), category 2 (4-6 for women and 7-14 for men; n = 1216), and category 3 (≥ 7 for women and ≥ 15 for men; n = 327).

At the second survey, 24% reported decreased drinking after starting an AOM, 71% reported no change, and 4% reported increased drinking (P < .0001). But when just the 7491 individuals who reported any alcohol use at baseline were included, 45% reported decreased drinking after starting an AOM, 52% reported no change, and only 2% reported increased drinking.

The decrease in drinking with AOM use rose with greater alcohol use at baseline, from 37% for category 1, 76% for category 2, and 91% for category 3. The proportions reporting increased drinking were just 3%, 1%, and 0%, respectively. The adjusted odds ratios (ORs) for decreasing drinking were 5.97 for category 2 (P < .0001) and 19.18 for category 3 (P < .0001) vs category 1.

The proportions reporting reduced drinking were similar across AOM classes: 51% for metformin, 46% for bupropion/naltrexone, 46% for first-generation GLP-1s (Saxenda, Trulicity, and Victoza), and 45% for the second-generation GLP-1 drugs (Mounjaro, Ozempic, Rybelsus, Wegovy, and Zepbound). All were statistically significant at P < .0001.

The highest proportion reporting increased drinking was 4% for bupropion/naltrexone. Compared with women, men were significantly more likely to report decreased drinking with AOM use (adjusted OR, 0.74; P < .001), but there were no differences by race/ethnicity or age.

Compared with those who had overweight, those in obesity classes I, II, and III were all more likely to decrease drinking with AOM use, with adjusted ORs of 1.26 (P = .0045), 1.49 (P < .001), and 1.63 (P < .001), respectively.
 

Mechanisms Appear Both Biological and Behavioral

During the discussion, Cardel said that qualitative assessments with participants suggest that there are at least two mechanisms behind this phenomenon: One biological and the other intentional.

“What we hear from them is twofold, one, particularly amongst those folks on GLP-1 medications, we’re hearing that physiologically, they feel different with the medications, that their cravings for alcohol are decreased, and that when they do choose to drink that there’s often a very much a negative reinforcement ... I’ve had a patient tell me, ‘I used to be able to have two or three margaritas, and maybe I didn’t feel like the best I’d ever felt in the morning, but I was okay. And now if I have two or three drinks, I will be throwing up for 5 hours, and it’s the worst hangover I’ve ever had in my life.’ And so it very much creates that negative reinforcement loop.”

But at the same time, “folks who are coming to us and seeking these medications are very much on a on a health-based journey. That’s what they tell us. The majority of our patients are there to improve their health. We rarely hear about the vanity or aesthetic part of it. So perhaps it’s that, in terms of trying to improve their health, they’re also trying to reduce their alcohol consumption, either just for their overall health or also as a means of trying to decrease their overall calorie consumption.”

In future research, Cardel said, “we want to examine whether the anti-obesity medications are more successful at reducing alcohol use compared to non-pharmacological weight management interventions, as we know that people often reduce their alcohol consumption on a weight management journey as a means of prioritizing their calories for food and decreasing the calories from alcohol.”

Cardel and all the study coauthors were employees and shareholders at WeightWatchers at the time the research was conducted. Skelton is editor in chief of the journal Childhood Obesity.
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Several types of anti-obesity medications (AOMs), including glucagon-like peptide 1s (GLP-1s), are associated with decreased alcohol use, new research suggests.

The findings, from surveys of more than 14,000 participants in WeightWatchers’ telehealth weight management program, were presented on November 6 at the Obesity Society’s Obesity Week 2024 meeting by the company’s Chief Nutrition Officer, Michelle I. Cardel, PhD, RD, based in Gainesville, Florida.

Similar reductions in alcohol consumption were seen in people taking different classes of AOMs, suggesting “an additional mechanism by which AOMs reduce energy intake, and also signal a potential role for these medications to reduce alcohol use,” Cardel said, adding “Clinicians treating individuals for obesity may consider anti-obesity medications particularly among those who report higher alcohol intake.”

Asked to comment, session moderator and obesity researcher Joseph A. Skelton, MD, professor of pediatrics at Wake Forest University School of Medicine, Winston-Salem, North Carolina, said, “I think there are some overlapping pathways there, possibly a reward system or something like that in the brain. I don’t think we know exactly what the end result will be as a potential use of the medications. But there’s a signal that needs to be investigated more.”

Cardel noted that there was one previous large cohort study finding that semaglutide was associated with a lower risk for alcohol use disorder, and another study that analyzed social media threads of people saying they’d quit drinking after starting a GLP-1 drug. But this new study is the first to examine the relationship with different classes of AOMs and to quantify the amount of alcohol consumed.
 

About Half Reported Reduced Alcohol Consumption, Regardless the AOM Class

The study included 14,053 WeightWatchers’ telehealth program participants who initiated an AOM between January 2022 and August 2023 and refilled the same AOM between October and November 2023. Those who had previously used AOMs before coming to the program or who had undergone bariatric surgery were excluded.

Participants had a mean age of 43 years, were 86% women, were 60% White, and had a mean body mass index of 36. They were surveyed about their weekly alcohol use prior to AOM initiation and again at the time of AOM refill.

At baseline, they were divided into categories of 0 (no alcohol use; n = 6562), category 1 (one to three drinks for women and one to six for men; n = 5948), category 2 (4-6 for women and 7-14 for men; n = 1216), and category 3 (≥ 7 for women and ≥ 15 for men; n = 327).

At the second survey, 24% reported decreased drinking after starting an AOM, 71% reported no change, and 4% reported increased drinking (P < .0001). But when just the 7491 individuals who reported any alcohol use at baseline were included, 45% reported decreased drinking after starting an AOM, 52% reported no change, and only 2% reported increased drinking.

The decrease in drinking with AOM use rose with greater alcohol use at baseline, from 37% for category 1, 76% for category 2, and 91% for category 3. The proportions reporting increased drinking were just 3%, 1%, and 0%, respectively. The adjusted odds ratios (ORs) for decreasing drinking were 5.97 for category 2 (P < .0001) and 19.18 for category 3 (P < .0001) vs category 1.

The proportions reporting reduced drinking were similar across AOM classes: 51% for metformin, 46% for bupropion/naltrexone, 46% for first-generation GLP-1s (Saxenda, Trulicity, and Victoza), and 45% for the second-generation GLP-1 drugs (Mounjaro, Ozempic, Rybelsus, Wegovy, and Zepbound). All were statistically significant at P < .0001.

The highest proportion reporting increased drinking was 4% for bupropion/naltrexone. Compared with women, men were significantly more likely to report decreased drinking with AOM use (adjusted OR, 0.74; P < .001), but there were no differences by race/ethnicity or age.

Compared with those who had overweight, those in obesity classes I, II, and III were all more likely to decrease drinking with AOM use, with adjusted ORs of 1.26 (P = .0045), 1.49 (P < .001), and 1.63 (P < .001), respectively.
 

Mechanisms Appear Both Biological and Behavioral

During the discussion, Cardel said that qualitative assessments with participants suggest that there are at least two mechanisms behind this phenomenon: One biological and the other intentional.

“What we hear from them is twofold, one, particularly amongst those folks on GLP-1 medications, we’re hearing that physiologically, they feel different with the medications, that their cravings for alcohol are decreased, and that when they do choose to drink that there’s often a very much a negative reinforcement ... I’ve had a patient tell me, ‘I used to be able to have two or three margaritas, and maybe I didn’t feel like the best I’d ever felt in the morning, but I was okay. And now if I have two or three drinks, I will be throwing up for 5 hours, and it’s the worst hangover I’ve ever had in my life.’ And so it very much creates that negative reinforcement loop.”

But at the same time, “folks who are coming to us and seeking these medications are very much on a on a health-based journey. That’s what they tell us. The majority of our patients are there to improve their health. We rarely hear about the vanity or aesthetic part of it. So perhaps it’s that, in terms of trying to improve their health, they’re also trying to reduce their alcohol consumption, either just for their overall health or also as a means of trying to decrease their overall calorie consumption.”

In future research, Cardel said, “we want to examine whether the anti-obesity medications are more successful at reducing alcohol use compared to non-pharmacological weight management interventions, as we know that people often reduce their alcohol consumption on a weight management journey as a means of prioritizing their calories for food and decreasing the calories from alcohol.”

Cardel and all the study coauthors were employees and shareholders at WeightWatchers at the time the research was conducted. Skelton is editor in chief of the journal Childhood Obesity.
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Several types of anti-obesity medications (AOMs), including glucagon-like peptide 1s (GLP-1s), are associated with decreased alcohol use, new research suggests.

The findings, from surveys of more than 14,000 participants in WeightWatchers’ telehealth weight management program, were presented on November 6 at the Obesity Society’s Obesity Week 2024 meeting by the company’s Chief Nutrition Officer, Michelle I. Cardel, PhD, RD, based in Gainesville, Florida.

Similar reductions in alcohol consumption were seen in people taking different classes of AOMs, suggesting “an additional mechanism by which AOMs reduce energy intake, and also signal a potential role for these medications to reduce alcohol use,” Cardel said, adding “Clinicians treating individuals for obesity may consider anti-obesity medications particularly among those who report higher alcohol intake.”

Asked to comment, session moderator and obesity researcher Joseph A. Skelton, MD, professor of pediatrics at Wake Forest University School of Medicine, Winston-Salem, North Carolina, said, “I think there are some overlapping pathways there, possibly a reward system or something like that in the brain. I don’t think we know exactly what the end result will be as a potential use of the medications. But there’s a signal that needs to be investigated more.”

Cardel noted that there was one previous large cohort study finding that semaglutide was associated with a lower risk for alcohol use disorder, and another study that analyzed social media threads of people saying they’d quit drinking after starting a GLP-1 drug. But this new study is the first to examine the relationship with different classes of AOMs and to quantify the amount of alcohol consumed.
 

About Half Reported Reduced Alcohol Consumption, Regardless the AOM Class

The study included 14,053 WeightWatchers’ telehealth program participants who initiated an AOM between January 2022 and August 2023 and refilled the same AOM between October and November 2023. Those who had previously used AOMs before coming to the program or who had undergone bariatric surgery were excluded.

Participants had a mean age of 43 years, were 86% women, were 60% White, and had a mean body mass index of 36. They were surveyed about their weekly alcohol use prior to AOM initiation and again at the time of AOM refill.

At baseline, they were divided into categories of 0 (no alcohol use; n = 6562), category 1 (one to three drinks for women and one to six for men; n = 5948), category 2 (4-6 for women and 7-14 for men; n = 1216), and category 3 (≥ 7 for women and ≥ 15 for men; n = 327).

At the second survey, 24% reported decreased drinking after starting an AOM, 71% reported no change, and 4% reported increased drinking (P < .0001). But when just the 7491 individuals who reported any alcohol use at baseline were included, 45% reported decreased drinking after starting an AOM, 52% reported no change, and only 2% reported increased drinking.

The decrease in drinking with AOM use rose with greater alcohol use at baseline, from 37% for category 1, 76% for category 2, and 91% for category 3. The proportions reporting increased drinking were just 3%, 1%, and 0%, respectively. The adjusted odds ratios (ORs) for decreasing drinking were 5.97 for category 2 (P < .0001) and 19.18 for category 3 (P < .0001) vs category 1.

The proportions reporting reduced drinking were similar across AOM classes: 51% for metformin, 46% for bupropion/naltrexone, 46% for first-generation GLP-1s (Saxenda, Trulicity, and Victoza), and 45% for the second-generation GLP-1 drugs (Mounjaro, Ozempic, Rybelsus, Wegovy, and Zepbound). All were statistically significant at P < .0001.

The highest proportion reporting increased drinking was 4% for bupropion/naltrexone. Compared with women, men were significantly more likely to report decreased drinking with AOM use (adjusted OR, 0.74; P < .001), but there were no differences by race/ethnicity or age.

Compared with those who had overweight, those in obesity classes I, II, and III were all more likely to decrease drinking with AOM use, with adjusted ORs of 1.26 (P = .0045), 1.49 (P < .001), and 1.63 (P < .001), respectively.
 

Mechanisms Appear Both Biological and Behavioral

During the discussion, Cardel said that qualitative assessments with participants suggest that there are at least two mechanisms behind this phenomenon: One biological and the other intentional.

“What we hear from them is twofold, one, particularly amongst those folks on GLP-1 medications, we’re hearing that physiologically, they feel different with the medications, that their cravings for alcohol are decreased, and that when they do choose to drink that there’s often a very much a negative reinforcement ... I’ve had a patient tell me, ‘I used to be able to have two or three margaritas, and maybe I didn’t feel like the best I’d ever felt in the morning, but I was okay. And now if I have two or three drinks, I will be throwing up for 5 hours, and it’s the worst hangover I’ve ever had in my life.’ And so it very much creates that negative reinforcement loop.”

But at the same time, “folks who are coming to us and seeking these medications are very much on a on a health-based journey. That’s what they tell us. The majority of our patients are there to improve their health. We rarely hear about the vanity or aesthetic part of it. So perhaps it’s that, in terms of trying to improve their health, they’re also trying to reduce their alcohol consumption, either just for their overall health or also as a means of trying to decrease their overall calorie consumption.”

In future research, Cardel said, “we want to examine whether the anti-obesity medications are more successful at reducing alcohol use compared to non-pharmacological weight management interventions, as we know that people often reduce their alcohol consumption on a weight management journey as a means of prioritizing their calories for food and decreasing the calories from alcohol.”

Cardel and all the study coauthors were employees and shareholders at WeightWatchers at the time the research was conducted. Skelton is editor in chief of the journal Childhood Obesity.
 

A version of this article appeared on Medscape.com.

“Petechial rash often prompts further investigation into hematological, dermatological, or vasculitis causes. However, if the above investigations are negative and skin biopsy has not revealed a cause, there is a Renaissance-era diagnosis that is often overlooked but is easily investigated and treated,” wrote Andrew Dermawan, MD, and colleagues from Sir Charles Gairdner Hospital in Nedlands, Australia, in BMJ Case Reports. The diagnosis they highlight is scurvy, a disease that has faded from common medical concern but is reemerging, partly because of the rise in bariatric surgery.

Diagnosing Scurvy in the 2020s

In their article, Dermawan and colleagues present the case of a 50-year-old man with a bilateral petechial rash on his lower limbs, without any history of trauma. The patient, who exhibited no infectious symptoms, also had gross hematuria, microcytic anemia, mild neutropenia, and lymphopenia. Tests for autoimmune and hematological diseases were negative, as were abdominal and leg CT scans, ruling out abdominal hemorrhage and vasculitis. Additionally, a skin biopsy showed no causative findings.

The doctors noted that the patient had undergone sleeve gastrectomy, prompting them to inquire about his diet. They discovered that, because of financial difficulties, his diet primarily consisted of processed foods with little to no fruits or vegetables, and he had stopped taking supplements recommended by his gastroenterologist. Further tests revealed a vitamin D deficiency and a severe deficiency in vitamin C. With the diagnosis of scurvy confirmed, the doctors treated the patient with 1000 mg of ascorbic acid daily, along with cholecalciferol, folic acid, and a multivitamin complex, leading to a complete resolution of his symptoms.
 

Risk Factors Then and Now

Scurvy can present with a range of symptoms, including petechiae, perifollicular hemorrhage, ecchymosis, gingivitis, edema, anemia, delayed wound healing, malaise, weakness, joint swelling, arthralgia, anorexia, neuropathy, and vasomotor instability. It can cause mucosal and gastric hemorrhages, and if left untreated, it can lead to fatal bleeding.

Historically known as “sailors’ disease,” scurvy plagued men on long voyages who lacked access to fresh fruits or vegetables and thus did not get enough vitamin C. In 1747, James Lind, a British physician in the Royal Navy, demonstrated that the consumption of oranges and lemons could combat scurvy.

Today’s risk factors for scurvy include malnutrition, gastrointestinal disorders (eg, chronic inflammatory bowel diseases), alcohol and tobacco use, eating disorders, psychiatric illnesses, dialysis, and the use of medications that reduce the absorption of ascorbic acid (such as corticosteroids and proton pump inhibitors).

Scurvy remains more common among individuals with unfavorable socioeconomic conditions. The authors of the study emphasize how the rising cost of living — specifically in Australia but applicable elsewhere — is changing eating habits, leading to a high consumption of low-cost, nutritionally poor foods.

Poverty has always been a risk factor for scurvy, but today there may be an additional cause: bariatric surgery. Patients undergoing these procedures are at a risk for deficiencies in fat-soluble vitamins A, D, E, and K, and if their diet is inadequate, they may also experience a vitamin C deficiency. Awareness of this can facilitate the timely diagnosis of scurvy in these patients.

This story was translated from Univadis Italy 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.

“Petechial rash often prompts further investigation into hematological, dermatological, or vasculitis causes. However, if the above investigations are negative and skin biopsy has not revealed a cause, there is a Renaissance-era diagnosis that is often overlooked but is easily investigated and treated,” wrote Andrew Dermawan, MD, and colleagues from Sir Charles Gairdner Hospital in Nedlands, Australia, in BMJ Case Reports. The diagnosis they highlight is scurvy, a disease that has faded from common medical concern but is reemerging, partly because of the rise in bariatric surgery.

Diagnosing Scurvy in the 2020s

In their article, Dermawan and colleagues present the case of a 50-year-old man with a bilateral petechial rash on his lower limbs, without any history of trauma. The patient, who exhibited no infectious symptoms, also had gross hematuria, microcytic anemia, mild neutropenia, and lymphopenia. Tests for autoimmune and hematological diseases were negative, as were abdominal and leg CT scans, ruling out abdominal hemorrhage and vasculitis. Additionally, a skin biopsy showed no causative findings.

The doctors noted that the patient had undergone sleeve gastrectomy, prompting them to inquire about his diet. They discovered that, because of financial difficulties, his diet primarily consisted of processed foods with little to no fruits or vegetables, and he had stopped taking supplements recommended by his gastroenterologist. Further tests revealed a vitamin D deficiency and a severe deficiency in vitamin C. With the diagnosis of scurvy confirmed, the doctors treated the patient with 1000 mg of ascorbic acid daily, along with cholecalciferol, folic acid, and a multivitamin complex, leading to a complete resolution of his symptoms.
 

Risk Factors Then and Now

Scurvy can present with a range of symptoms, including petechiae, perifollicular hemorrhage, ecchymosis, gingivitis, edema, anemia, delayed wound healing, malaise, weakness, joint swelling, arthralgia, anorexia, neuropathy, and vasomotor instability. It can cause mucosal and gastric hemorrhages, and if left untreated, it can lead to fatal bleeding.

Historically known as “sailors’ disease,” scurvy plagued men on long voyages who lacked access to fresh fruits or vegetables and thus did not get enough vitamin C. In 1747, James Lind, a British physician in the Royal Navy, demonstrated that the consumption of oranges and lemons could combat scurvy.

Today’s risk factors for scurvy include malnutrition, gastrointestinal disorders (eg, chronic inflammatory bowel diseases), alcohol and tobacco use, eating disorders, psychiatric illnesses, dialysis, and the use of medications that reduce the absorption of ascorbic acid (such as corticosteroids and proton pump inhibitors).

Scurvy remains more common among individuals with unfavorable socioeconomic conditions. The authors of the study emphasize how the rising cost of living — specifically in Australia but applicable elsewhere — is changing eating habits, leading to a high consumption of low-cost, nutritionally poor foods.

Poverty has always been a risk factor for scurvy, but today there may be an additional cause: bariatric surgery. Patients undergoing these procedures are at a risk for deficiencies in fat-soluble vitamins A, D, E, and K, and if their diet is inadequate, they may also experience a vitamin C deficiency. Awareness of this can facilitate the timely diagnosis of scurvy in these patients.

This story was translated from Univadis Italy 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.

“Petechial rash often prompts further investigation into hematological, dermatological, or vasculitis causes. However, if the above investigations are negative and skin biopsy has not revealed a cause, there is a Renaissance-era diagnosis that is often overlooked but is easily investigated and treated,” wrote Andrew Dermawan, MD, and colleagues from Sir Charles Gairdner Hospital in Nedlands, Australia, in BMJ Case Reports. The diagnosis they highlight is scurvy, a disease that has faded from common medical concern but is reemerging, partly because of the rise in bariatric surgery.

Diagnosing Scurvy in the 2020s

In their article, Dermawan and colleagues present the case of a 50-year-old man with a bilateral petechial rash on his lower limbs, without any history of trauma. The patient, who exhibited no infectious symptoms, also had gross hematuria, microcytic anemia, mild neutropenia, and lymphopenia. Tests for autoimmune and hematological diseases were negative, as were abdominal and leg CT scans, ruling out abdominal hemorrhage and vasculitis. Additionally, a skin biopsy showed no causative findings.

The doctors noted that the patient had undergone sleeve gastrectomy, prompting them to inquire about his diet. They discovered that, because of financial difficulties, his diet primarily consisted of processed foods with little to no fruits or vegetables, and he had stopped taking supplements recommended by his gastroenterologist. Further tests revealed a vitamin D deficiency and a severe deficiency in vitamin C. With the diagnosis of scurvy confirmed, the doctors treated the patient with 1000 mg of ascorbic acid daily, along with cholecalciferol, folic acid, and a multivitamin complex, leading to a complete resolution of his symptoms.
 

Risk Factors Then and Now

Scurvy can present with a range of symptoms, including petechiae, perifollicular hemorrhage, ecchymosis, gingivitis, edema, anemia, delayed wound healing, malaise, weakness, joint swelling, arthralgia, anorexia, neuropathy, and vasomotor instability. It can cause mucosal and gastric hemorrhages, and if left untreated, it can lead to fatal bleeding.

Historically known as “sailors’ disease,” scurvy plagued men on long voyages who lacked access to fresh fruits or vegetables and thus did not get enough vitamin C. In 1747, James Lind, a British physician in the Royal Navy, demonstrated that the consumption of oranges and lemons could combat scurvy.

Today’s risk factors for scurvy include malnutrition, gastrointestinal disorders (eg, chronic inflammatory bowel diseases), alcohol and tobacco use, eating disorders, psychiatric illnesses, dialysis, and the use of medications that reduce the absorption of ascorbic acid (such as corticosteroids and proton pump inhibitors).

Scurvy remains more common among individuals with unfavorable socioeconomic conditions. The authors of the study emphasize how the rising cost of living — specifically in Australia but applicable elsewhere — is changing eating habits, leading to a high consumption of low-cost, nutritionally poor foods.

Poverty has always been a risk factor for scurvy, but today there may be an additional cause: bariatric surgery. Patients undergoing these procedures are at a risk for deficiencies in fat-soluble vitamins A, D, E, and K, and if their diet is inadequate, they may also experience a vitamin C deficiency. Awareness of this can facilitate the timely diagnosis of scurvy in these patients.

This story was translated from Univadis Italy 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.

PHILADELPHIA — Patients with celiac disease who take an angiotensin receptor blocker (ARB) may experience worse outcomes, such as increased risk of iron deficiency, diarrhea, and abdominal pain, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

The association may be related to the similar pathophysiology between ARB-associated enteropathy and celiac disease, though additional research is needed.

“Based on our findings, people should take caution when prescribing angiotensin receptor blockers to people with celiac disease,” said lead author Isabel Hujoel, MD, clinical assistant professor of gastroenterology and clinic director of the Celiac Disease Center at the University of Washington, Seattle.

University of Washington, Seattle

“When we see someone with nonresponsive celiac disease, meaning persistent symptoms despite a gluten-free diet, I do think we should review their medication list, and if they’re on an ARB, we should consider a trial off those medications to see if they respond,” she said. “A primary care provider may choose other hypertensives as well.”

Hujoel and co-author Margaux Hujoel, PhD, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston; Broad Institute, Cambridge; and Harvard Medical School, Boston, analyzed data from the National Institutes of Health’s All of Us, a large publicly available US longitudinal dataset.

The researchers conducted a survival analysis of time-to-first event after celiac disease diagnosis, allowing patients to have a time-dependent covariate of ARB use. They looked at outcomes such as iron deficiency, diarrhea, abdominal pain, vitamin deficiency, vitamin D deficiency, malabsorption, low hemoglobin, and weight loss.

The analysis included 1849 patients with celiac disease, including 1460 women and 389 men, with a median age of nearly 50 years at diagnosis. While the vast majority of patients (nearly 1600) didn’t take an ARB, 120 started one before celiac disease diagnosis and 142 started one after diagnosis.

Overall, taking an ARB was associated with increased hazard ratios [HRs] for low hemoglobin, iron deficiency, diarrhea, and abdominal pain. There weren’t increased risks for weight loss, malabsorption, or vitamin deficiencies.

When excluding those who had an ARB prescription before diagnosis, the HRs remained significantly higher for low hemoglobin (HR, 1.98) and iron deficiency (HR, 1.72) for those who started an ARB after diagnosis.

“The use of angiotensin receptor blockers may be associated with worse outcomes in the setting of celiac disease, specifically persistent symptoms and possibly poor small bowel healing as evidenced by malabsorption,” Hujoel said.

Future studies could look specifically at losartan, which was the most common ARB prescribed in this analysis, she said. Other studies could also analyze different patient outcomes, whether patients were on a gluten-free diet, medication adherence, and recurrence or persistence of symptoms rather than initial occurrence. The associations between ARB use and celiac disease could shift among patients who are in remission, for instance.

“ARBs are some of the most widely used medications, so studies like these can help people to understand that they may have symptoms but not know it’s related to their medication. Public awareness of this fact is key,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, Miami. Jones co-moderated the plenary session on small intestine, functional, and liver research.

University of Miami

“There are many types of antihypertensives, so while ARBs are used often, other options are available if people have symptoms, especially if they have worsening symptoms with celiac disease,” she said. “It’s important to make changes in your practice.”

The study was named an ACG Newsworthy Abstract. Isabel Hujoel and Patricia Jones reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Patients with celiac disease who take an angiotensin receptor blocker (ARB) may experience worse outcomes, such as increased risk of iron deficiency, diarrhea, and abdominal pain, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

The association may be related to the similar pathophysiology between ARB-associated enteropathy and celiac disease, though additional research is needed.

“Based on our findings, people should take caution when prescribing angiotensin receptor blockers to people with celiac disease,” said lead author Isabel Hujoel, MD, clinical assistant professor of gastroenterology and clinic director of the Celiac Disease Center at the University of Washington, Seattle.

University of Washington, Seattle

“When we see someone with nonresponsive celiac disease, meaning persistent symptoms despite a gluten-free diet, I do think we should review their medication list, and if they’re on an ARB, we should consider a trial off those medications to see if they respond,” she said. “A primary care provider may choose other hypertensives as well.”

Hujoel and co-author Margaux Hujoel, PhD, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston; Broad Institute, Cambridge; and Harvard Medical School, Boston, analyzed data from the National Institutes of Health’s All of Us, a large publicly available US longitudinal dataset.

The researchers conducted a survival analysis of time-to-first event after celiac disease diagnosis, allowing patients to have a time-dependent covariate of ARB use. They looked at outcomes such as iron deficiency, diarrhea, abdominal pain, vitamin deficiency, vitamin D deficiency, malabsorption, low hemoglobin, and weight loss.

The analysis included 1849 patients with celiac disease, including 1460 women and 389 men, with a median age of nearly 50 years at diagnosis. While the vast majority of patients (nearly 1600) didn’t take an ARB, 120 started one before celiac disease diagnosis and 142 started one after diagnosis.

Overall, taking an ARB was associated with increased hazard ratios [HRs] for low hemoglobin, iron deficiency, diarrhea, and abdominal pain. There weren’t increased risks for weight loss, malabsorption, or vitamin deficiencies.

When excluding those who had an ARB prescription before diagnosis, the HRs remained significantly higher for low hemoglobin (HR, 1.98) and iron deficiency (HR, 1.72) for those who started an ARB after diagnosis.

“The use of angiotensin receptor blockers may be associated with worse outcomes in the setting of celiac disease, specifically persistent symptoms and possibly poor small bowel healing as evidenced by malabsorption,” Hujoel said.

Future studies could look specifically at losartan, which was the most common ARB prescribed in this analysis, she said. Other studies could also analyze different patient outcomes, whether patients were on a gluten-free diet, medication adherence, and recurrence or persistence of symptoms rather than initial occurrence. The associations between ARB use and celiac disease could shift among patients who are in remission, for instance.

“ARBs are some of the most widely used medications, so studies like these can help people to understand that they may have symptoms but not know it’s related to their medication. Public awareness of this fact is key,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, Miami. Jones co-moderated the plenary session on small intestine, functional, and liver research.

University of Miami

“There are many types of antihypertensives, so while ARBs are used often, other options are available if people have symptoms, especially if they have worsening symptoms with celiac disease,” she said. “It’s important to make changes in your practice.”

The study was named an ACG Newsworthy Abstract. Isabel Hujoel and Patricia Jones reported no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — Patients with celiac disease who take an angiotensin receptor blocker (ARB) may experience worse outcomes, such as increased risk of iron deficiency, diarrhea, and abdominal pain, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

The association may be related to the similar pathophysiology between ARB-associated enteropathy and celiac disease, though additional research is needed.

“Based on our findings, people should take caution when prescribing angiotensin receptor blockers to people with celiac disease,” said lead author Isabel Hujoel, MD, clinical assistant professor of gastroenterology and clinic director of the Celiac Disease Center at the University of Washington, Seattle.

University of Washington, Seattle

“When we see someone with nonresponsive celiac disease, meaning persistent symptoms despite a gluten-free diet, I do think we should review their medication list, and if they’re on an ARB, we should consider a trial off those medications to see if they respond,” she said. “A primary care provider may choose other hypertensives as well.”

Hujoel and co-author Margaux Hujoel, PhD, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston; Broad Institute, Cambridge; and Harvard Medical School, Boston, analyzed data from the National Institutes of Health’s All of Us, a large publicly available US longitudinal dataset.

The researchers conducted a survival analysis of time-to-first event after celiac disease diagnosis, allowing patients to have a time-dependent covariate of ARB use. They looked at outcomes such as iron deficiency, diarrhea, abdominal pain, vitamin deficiency, vitamin D deficiency, malabsorption, low hemoglobin, and weight loss.

The analysis included 1849 patients with celiac disease, including 1460 women and 389 men, with a median age of nearly 50 years at diagnosis. While the vast majority of patients (nearly 1600) didn’t take an ARB, 120 started one before celiac disease diagnosis and 142 started one after diagnosis.

Overall, taking an ARB was associated with increased hazard ratios [HRs] for low hemoglobin, iron deficiency, diarrhea, and abdominal pain. There weren’t increased risks for weight loss, malabsorption, or vitamin deficiencies.

When excluding those who had an ARB prescription before diagnosis, the HRs remained significantly higher for low hemoglobin (HR, 1.98) and iron deficiency (HR, 1.72) for those who started an ARB after diagnosis.

“The use of angiotensin receptor blockers may be associated with worse outcomes in the setting of celiac disease, specifically persistent symptoms and possibly poor small bowel healing as evidenced by malabsorption,” Hujoel said.

Future studies could look specifically at losartan, which was the most common ARB prescribed in this analysis, she said. Other studies could also analyze different patient outcomes, whether patients were on a gluten-free diet, medication adherence, and recurrence or persistence of symptoms rather than initial occurrence. The associations between ARB use and celiac disease could shift among patients who are in remission, for instance.

“ARBs are some of the most widely used medications, so studies like these can help people to understand that they may have symptoms but not know it’s related to their medication. Public awareness of this fact is key,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, Miami. Jones co-moderated the plenary session on small intestine, functional, and liver research.

University of Miami

“There are many types of antihypertensives, so while ARBs are used often, other options are available if people have symptoms, especially if they have worsening symptoms with celiac disease,” she said. “It’s important to make changes in your practice.”

The study was named an ACG Newsworthy Abstract. Isabel Hujoel and Patricia Jones reported no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

This article was created 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.

TOPLINE:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

This article was created 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.

TOPLINE:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

This article was created 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.

TOPLINE:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

• Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
• They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
• Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
• The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinence, erectile dysfunction, and secondary cancers. 
• Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

• At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
• Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
• The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
• The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. Additional disclosures are noted in the original article.

This article was created 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.

TOPLINE:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

• Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
• They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
• Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
• The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinence, erectile dysfunction, and secondary cancers. 
• Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

• At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
• Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
• The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
• The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. Additional disclosures are noted in the original article.

This article was created 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.

TOPLINE:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

• Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
• They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
• Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
• The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinence, erectile dysfunction, and secondary cancers. 
• Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

• At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
• Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
• The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
• The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. Additional disclosures are noted in the original article.

This article was created 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.

On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.

In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.

In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
 

Healthcare Systems = ‘Soft Targets’

Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”

Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”

Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.

The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
 

Vulnerable Users

Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.

“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”

Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.

High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
 

The Impact of Cyberattacks on Patients 

Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.

According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:

• 56% of respondents saw a delay in patient tests/procedures
• 53% experienced increased patient complications from medical procedures
• 52% noted a longer patient length of stay
• 44% saw an increase in patient transfers to other facilities
• 28% had an increase in mortality rate

What Hospitals and Physicians Can Do

Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.

Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”

Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
 

A Continuing Threat

Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”

That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.

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

On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.

In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.

In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
 

Healthcare Systems = ‘Soft Targets’

Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”

Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”

Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.

The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
 

Vulnerable Users

Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.

“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”

Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.

High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
 

The Impact of Cyberattacks on Patients 

Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.

According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:

• 56% of respondents saw a delay in patient tests/procedures
• 53% experienced increased patient complications from medical procedures
• 52% noted a longer patient length of stay
• 44% saw an increase in patient transfers to other facilities
• 28% had an increase in mortality rate

What Hospitals and Physicians Can Do

Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.

Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”

Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
 

A Continuing Threat

Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”

That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.

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

On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.

In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.

In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
 

Healthcare Systems = ‘Soft Targets’

Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”

Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”

Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.

The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
 

Vulnerable Users

Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.

“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”

Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.

High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
 

The Impact of Cyberattacks on Patients 

Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.

According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:

• 56% of respondents saw a delay in patient tests/procedures
• 53% experienced increased patient complications from medical procedures
• 52% noted a longer patient length of stay
• 44% saw an increase in patient transfers to other facilities
• 28% had an increase in mortality rate

What Hospitals and Physicians Can Do

Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.

Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”

Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
 

A Continuing Threat

Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”

That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.

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

Although a 2019 World Health Organization (WHO) report concluded that microplastics in drinking water posed no risk to human health, accumulating evidence is beginning to challenge these findings.

Since plastics became widely used in the mid-20th century, they have evolved from a novel substance to an essential component in countless applications, with global production reaching 368 million tons in 2019 and expected to double by 2039. The production and degradation of plastics involve physical, chemical, and biological processes, leading to the formation of tiny fragments known as microplastics (MPs) and nanoplastics (NPs), which accumulate in the environment. Beyond the well-documented environmental harms of MPs and NPs, growing evidence of their presence within the human body raises concerns about their potential to trigger various harmful biological processes. Their detection in the urinary tract and their potential links to kidney and bladder diseases, as shown in animal studies, are particularly alarming.
 

Impacts Becoming Apparent

As the impact of plastic pollution becomes increasingly apparent, the need for standardized international definitions of MPs and NPs is pressing. Government publications reveal notable discrepancies between organizations in defining these fragmented plastics. The lack of consensus among regulatory bodies highlights the challenges in mitigating the environmental and health impacts of MPs and NPs. The International Organization for Standardization offers the most precise classification, defining MPs as solid, insoluble plastic particles ranging from 1 µm to 1 mm and NPs as particles smaller than 1 µm.

The intrusion of MPs and NPs into the human body, whether through inhalation, ingestion, or skin exposure (via wounds, hair follicles, or sweat glands), has been linked to harmful biological effects, including inflammation, alterations in cellular metabolism, physical cellular damage, and reduced cell viability.
 

Urinary Tract Plastics

The detection of MPs and NPs in the human urinary tract, combined with limited understanding of their effects, is a growing concern. An exploratory study published earlier this year aimed to systematically summarize the existing literature regarding the presence of MPs and NPs in the urinary tract and their potential consequences, guided by these research questions:

• What are the characteristics of the plastics detected in the human urinary tract?
• How are MPs and NPs defined in the current literature?
• What methodologies are used to explore the presence and effects of MPs and NPs?
• What are the pathophysiologic consequences of the presence of MPs and NPs in the human urinary tract?

For this study, the “urinary tract” included the kidneys, bladder, ureter, urethra, and urine. By focusing on the urinary tract, the study aimed to consolidate current understanding of MPs and NPs, raise awareness of this emerging issue, and lay the groundwork for further research that could contribute to public health policies and clinical practice guidelines.

The researchers conducted a scoping literature review following the recommendations of the JBI [formerly known as the Joanna Briggs Institute). They systematically searched five databases — PubMed, Scopus, CINAHL, Web of Science, and Embase — as well as gray literature sources.
 

Concerning Study Results

Eighteen articles were identified. The authors represent seven countries: Pakistan (n = 1), the Netherlands (n = 1), the US (n = 1), Taiwan (n = 1), Germany (n = 3), China (n = 5), and Italy (n = 6). Among these studies, six investigated and characterized the presence of MPs and NPs in the human urinary tract. MPs and NPs were detected in urine samples (n = 5), kidney cancer samples (n = 2), and bladder cancer samples (n = 1).

Additionally, 12 studies examined the effects of MPs and NPs on human urinary tract cell lines. Their findings suggest that MPs and NPs have cytotoxic effects, increase inflammation, reduce cell viability, and alter mitogen-activated protein kinase signaling pathways.

Raman spectroscopy was the primary method used to detect and characterize MPs and NPs in human samples (five out of six studies; 83%). Alternatively, pyrolysis-gas chromatography-mass spectrometry combined with direct laser infrared spectroscopy was used in one study.
 

Further Research Needed

This exploratory study underscores the urgent need for further research and policy development to address the challenges posed by microplastic contamination. It highlights the rapidly emerging threat of human urinary tract contamination by microplastics, questioning the WHO’s claim that microplastics pose no public health risk. The documented cytotoxic effects of microplastics, and their ability to induce inflammation, reduce cell viability, and disrupt signaling pathways, raise significant public health concerns related to bladder cancer, chronic kidney disease, chronic urinary infections, and incontinence.

Bernard-Alex Gauzere, retired physician formerly with the national health system in France (intensive care unit, tropical medicine), has disclosed no relevant financial relationships.
 

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

Although a 2019 World Health Organization (WHO) report concluded that microplastics in drinking water posed no risk to human health, accumulating evidence is beginning to challenge these findings.

Since plastics became widely used in the mid-20th century, they have evolved from a novel substance to an essential component in countless applications, with global production reaching 368 million tons in 2019 and expected to double by 2039. The production and degradation of plastics involve physical, chemical, and biological processes, leading to the formation of tiny fragments known as microplastics (MPs) and nanoplastics (NPs), which accumulate in the environment. Beyond the well-documented environmental harms of MPs and NPs, growing evidence of their presence within the human body raises concerns about their potential to trigger various harmful biological processes. Their detection in the urinary tract and their potential links to kidney and bladder diseases, as shown in animal studies, are particularly alarming.
 

Impacts Becoming Apparent

As the impact of plastic pollution becomes increasingly apparent, the need for standardized international definitions of MPs and NPs is pressing. Government publications reveal notable discrepancies between organizations in defining these fragmented plastics. The lack of consensus among regulatory bodies highlights the challenges in mitigating the environmental and health impacts of MPs and NPs. The International Organization for Standardization offers the most precise classification, defining MPs as solid, insoluble plastic particles ranging from 1 µm to 1 mm and NPs as particles smaller than 1 µm.

The intrusion of MPs and NPs into the human body, whether through inhalation, ingestion, or skin exposure (via wounds, hair follicles, or sweat glands), has been linked to harmful biological effects, including inflammation, alterations in cellular metabolism, physical cellular damage, and reduced cell viability.
 

Urinary Tract Plastics

The detection of MPs and NPs in the human urinary tract, combined with limited understanding of their effects, is a growing concern. An exploratory study published earlier this year aimed to systematically summarize the existing literature regarding the presence of MPs and NPs in the urinary tract and their potential consequences, guided by these research questions:

• What are the characteristics of the plastics detected in the human urinary tract?
• How are MPs and NPs defined in the current literature?
• What methodologies are used to explore the presence and effects of MPs and NPs?
• What are the pathophysiologic consequences of the presence of MPs and NPs in the human urinary tract?

For this study, the “urinary tract” included the kidneys, bladder, ureter, urethra, and urine. By focusing on the urinary tract, the study aimed to consolidate current understanding of MPs and NPs, raise awareness of this emerging issue, and lay the groundwork for further research that could contribute to public health policies and clinical practice guidelines.

The researchers conducted a scoping literature review following the recommendations of the JBI [formerly known as the Joanna Briggs Institute). They systematically searched five databases — PubMed, Scopus, CINAHL, Web of Science, and Embase — as well as gray literature sources.
 

Concerning Study Results

Eighteen articles were identified. The authors represent seven countries: Pakistan (n = 1), the Netherlands (n = 1), the US (n = 1), Taiwan (n = 1), Germany (n = 3), China (n = 5), and Italy (n = 6). Among these studies, six investigated and characterized the presence of MPs and NPs in the human urinary tract. MPs and NPs were detected in urine samples (n = 5), kidney cancer samples (n = 2), and bladder cancer samples (n = 1).

Additionally, 12 studies examined the effects of MPs and NPs on human urinary tract cell lines. Their findings suggest that MPs and NPs have cytotoxic effects, increase inflammation, reduce cell viability, and alter mitogen-activated protein kinase signaling pathways.

Raman spectroscopy was the primary method used to detect and characterize MPs and NPs in human samples (five out of six studies; 83%). Alternatively, pyrolysis-gas chromatography-mass spectrometry combined with direct laser infrared spectroscopy was used in one study.
 

Further Research Needed

This exploratory study underscores the urgent need for further research and policy development to address the challenges posed by microplastic contamination. It highlights the rapidly emerging threat of human urinary tract contamination by microplastics, questioning the WHO’s claim that microplastics pose no public health risk. The documented cytotoxic effects of microplastics, and their ability to induce inflammation, reduce cell viability, and disrupt signaling pathways, raise significant public health concerns related to bladder cancer, chronic kidney disease, chronic urinary infections, and incontinence.

Bernard-Alex Gauzere, retired physician formerly with the national health system in France (intensive care unit, tropical medicine), has disclosed no relevant financial relationships.
 

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

Although a 2019 World Health Organization (WHO) report concluded that microplastics in drinking water posed no risk to human health, accumulating evidence is beginning to challenge these findings.

Since plastics became widely used in the mid-20th century, they have evolved from a novel substance to an essential component in countless applications, with global production reaching 368 million tons in 2019 and expected to double by 2039. The production and degradation of plastics involve physical, chemical, and biological processes, leading to the formation of tiny fragments known as microplastics (MPs) and nanoplastics (NPs), which accumulate in the environment. Beyond the well-documented environmental harms of MPs and NPs, growing evidence of their presence within the human body raises concerns about their potential to trigger various harmful biological processes. Their detection in the urinary tract and their potential links to kidney and bladder diseases, as shown in animal studies, are particularly alarming.
 

Impacts Becoming Apparent

As the impact of plastic pollution becomes increasingly apparent, the need for standardized international definitions of MPs and NPs is pressing. Government publications reveal notable discrepancies between organizations in defining these fragmented plastics. The lack of consensus among regulatory bodies highlights the challenges in mitigating the environmental and health impacts of MPs and NPs. The International Organization for Standardization offers the most precise classification, defining MPs as solid, insoluble plastic particles ranging from 1 µm to 1 mm and NPs as particles smaller than 1 µm.

The intrusion of MPs and NPs into the human body, whether through inhalation, ingestion, or skin exposure (via wounds, hair follicles, or sweat glands), has been linked to harmful biological effects, including inflammation, alterations in cellular metabolism, physical cellular damage, and reduced cell viability.
 

Urinary Tract Plastics

The detection of MPs and NPs in the human urinary tract, combined with limited understanding of their effects, is a growing concern. An exploratory study published earlier this year aimed to systematically summarize the existing literature regarding the presence of MPs and NPs in the urinary tract and their potential consequences, guided by these research questions:

• What are the characteristics of the plastics detected in the human urinary tract?
• How are MPs and NPs defined in the current literature?
• What methodologies are used to explore the presence and effects of MPs and NPs?
• What are the pathophysiologic consequences of the presence of MPs and NPs in the human urinary tract?

For this study, the “urinary tract” included the kidneys, bladder, ureter, urethra, and urine. By focusing on the urinary tract, the study aimed to consolidate current understanding of MPs and NPs, raise awareness of this emerging issue, and lay the groundwork for further research that could contribute to public health policies and clinical practice guidelines.

The researchers conducted a scoping literature review following the recommendations of the JBI [formerly known as the Joanna Briggs Institute). They systematically searched five databases — PubMed, Scopus, CINAHL, Web of Science, and Embase — as well as gray literature sources.
 

Concerning Study Results

Eighteen articles were identified. The authors represent seven countries: Pakistan (n = 1), the Netherlands (n = 1), the US (n = 1), Taiwan (n = 1), Germany (n = 3), China (n = 5), and Italy (n = 6). Among these studies, six investigated and characterized the presence of MPs and NPs in the human urinary tract. MPs and NPs were detected in urine samples (n = 5), kidney cancer samples (n = 2), and bladder cancer samples (n = 1).

Additionally, 12 studies examined the effects of MPs and NPs on human urinary tract cell lines. Their findings suggest that MPs and NPs have cytotoxic effects, increase inflammation, reduce cell viability, and alter mitogen-activated protein kinase signaling pathways.

Raman spectroscopy was the primary method used to detect and characterize MPs and NPs in human samples (five out of six studies; 83%). Alternatively, pyrolysis-gas chromatography-mass spectrometry combined with direct laser infrared spectroscopy was used in one study.
 

Further Research Needed

This exploratory study underscores the urgent need for further research and policy development to address the challenges posed by microplastic contamination. It highlights the rapidly emerging threat of human urinary tract contamination by microplastics, questioning the WHO’s claim that microplastics pose no public health risk. The documented cytotoxic effects of microplastics, and their ability to induce inflammation, reduce cell viability, and disrupt signaling pathways, raise significant public health concerns related to bladder cancer, chronic kidney disease, chronic urinary infections, and incontinence.

Bernard-Alex Gauzere, retired physician formerly with the national health system in France (intensive care unit, tropical medicine), has disclosed no relevant financial relationships.
 

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