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Transgender Women and Prostate Cancer: It’s Complicated

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Tue, 09/24/2024 - 15:58

The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.

Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”

Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.

Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.

In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.

The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”

In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”

She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”

In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said. 

A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.

“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”

The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”

Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”

 

Farnoosh Nik-Ahd discloses consulting for Janssen.

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The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.

Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”

Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.

Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.

In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.

The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”

In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”

She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”

In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said. 

A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.

“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”

The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”

Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”

 

Farnoosh Nik-Ahd discloses consulting for Janssen.

The Veterans Health Administration (VHA) provides care for about 10,000 transgender women, and clinicians must understand their distinctive needs for prostate cancer screening, a urologist told cancer specialists during a presentation at the 2024 annual meeting of the Association of VA Hematology/Oncology in Atlanta.

Even if they’ve undergone gender reassignment surgery, “all transgender women still have a prostate, so therefore they remain at risk of prostate cancer and could still be considered for prostate cancer screening,” said Farnoosh Nik-Ahd, MD, a resident physician at the University of California San Francisco. However, “clinicians and patients may not be aware of prostate cancer risk, so that they may not think [of screening] transgender women.”

Nik-Ahd also noted another complication: The results of prostate screening tests may be misleading in this population.

Transgender women were born biologically male but now identify as female. These individuals may have undergone gender reassignment surgery to remove male genitalia, but the procedures do not remove the prostate. They also might be taking estrogen therapy. “Prostate cancer is a hormonally driven cancer, and the exact impact of gender-affirming hormones on prostate cancer risk and development is unknown,” Nik-Ahd said.

In a 2023 study in JAMA, Nik-Ahd and colleagues identified 155 cases of prostate cancer in transgender women within the VHA (about 14 cases per year) from 2000 to 2022. Of these patients, 116 had never used estrogen, while 17 had used it previously and 22 used it at diagnosis.

The median age of patients was 61 years, 88% identified as White, and the median prostate-specific antigen (PSA) was 6.8 ng/mL. “Given estimates of 10,000 transgender women in the US Department of Veterans Affairs, 33 cases per year would be expected. Instead, only about 14 per year were observed,” the researchers wrote. “Lower rates may stem from less PSA screening owing to barriers including lack of prostate cancer risk awareness or stigma, the suppressive effects of estrogen on prostate cancer development, or prostate cancers being missed in transgender women because of misinterpretation of ‘normal’ PSA levels among those receiving gender-affirming hormone therapies.”

In the presentation, Nik-Ahd said, “PSA density, which is a marker of prostate cancer aggressiveness, was highest in transgender women who were actively on estrogen.”

She noted, “the existing thyrotropin reference ranges, which is what we use to interpret PSA values, are all based on data from cisgender men.” The ranges would be expected to be far lower in transgender women who are taking estrogen, potentially throwing off screening tests, she said, and “ultimately missing clinically significant prostate cancer.”

In the larger picture, there are no specific guidelines about PSA screening in transgender women, she said. 

A recent study published in JAMA by Nik-Ahd and colleagues examined PSA levels in 210 transgender women (mean age 60 years) treated within the VHA from 2000 to 2023. All were aged 40 to 80 years, had received estrogen for at least 6 months (mean duration 4.7 years), and didn’t have prostate cancer diagnoses.

“Median (IQR) PSA was 0.02 (0-0.2) ng/mL and the 95th percentile value was 0.6 ng/mL,” the report found. “PSAs were undetectable in 36% of patients (23% and 49% of PSAs in patients without and with orchiectomy, respectively).”

The researchers write that “the historic cut point of 4 ng/mL, often used as a threshold for further evaluation, is likely far too high a threshold for this population.”

Nik-Ahd noted, “clinicians should interpret PSA values in transgender women on estrogen with extreme caution. In this population, normal might actually not be normal, and a value that is considered normal might be very abnormal for somebody who is on estrogen. If you're unsure of whether a PSA value is appropriate for a transgender woman on estrogen, refer that patient to a urologist so they can undergo further evaluation.”

 

Farnoosh Nik-Ahd discloses consulting for Janssen.

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Follow our continuing CROI coverage

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Keep up to date with the Conference on Retroviruses and Opportunistic Infections home page for the latest in ID Practitioner's continuing reporting from the CROI meeting and our follow-ups afterward. You can also check out our archival coverage from last year's meeting.

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Keep up to date with the Conference on Retroviruses and Opportunistic Infections home page for the latest in ID Practitioner's continuing reporting from the CROI meeting and our follow-ups afterward. You can also check out our archival coverage from last year's meeting.

Keep up to date with the Conference on Retroviruses and Opportunistic Infections home page for the latest in ID Practitioner's continuing reporting from the CROI meeting and our follow-ups afterward. You can also check out our archival coverage from last year's meeting.

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Digital Twin Model Predicts Sepsis Mortality

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Mon, 11/04/2024 - 12:33

A “digital twin” model successfully predicted adverse outcomes in intensive care unit (ICU) patients treated for sepsis. The research used an adaptive approach, updating time-sensitive values such as blood pressure and vitals every 15 minutes. The approach also took into account treatment decisions and has potential as a decision-making and educational tool.

The digital twin could reduce the risk for some interventions, according to Amos Lal, MD, who presented the study at the CHEST Annual Meeting. That’s because the model can predict the outcome. “You don’t actually have to make an intervention to the patient, which might be risky. By doing that, you can actually prevent a lot of harm,” said Dr. Lal, assistant professor of medicine at Mayo Clinic in Rochester, Minnesota.

The researchers used a one-dimensional convolutional neural network (CNN), similar to two-dimensional CNNs that are used to classify images, substituting the color channels used in imaging with 38 time-dependent variables. They applied it to predicting outcomes in the ICU, focusing on data generated within the first 24 hours of admission. The team made the model dynamic by adding time-sensitive data like vitals, laboratory values, and interventions every 15 minutes. That contrasts with existing models that are usually static, relying on values at admission or at 24 hours, for example. It also takes into account time-insensitive data like age, gender, and comorbidities. “Combining these two and coming up with the prediction model in real time can give you a more informed decision about how these patients are going to perform over a period of 2 weeks or 4 weeks of their stay within the ICU. And of course, as we get more and more data within the first 24 hours, the performance of the model improves as well,” said Dr. Lal.

The researchers tested the model by creating a virtual model of the patient and then performing an intervention on the patient and a simulated intervention on the virtual patient. “Then we advance the clock and the patient either improved or deteriorated, and we compared how the digital twin performed, whether the changes were concordant or discordant [between the virtual and real-world patients],” said Dr. Lal.

The model was designed to predict which patients with sepsis would be at greater risk for death or ICU stays longer than 14 days. It was created using data from 28,617 patients with critical care sepsis at a single hospital who were treated between 2011 and 2018, with 70% used as a training set, 20% as a test set, and 10% as a validation set. The researchers conducted an external validation using MIMIC-IV data on 30,903 patients from the Beth Israel Deaconess Medical Center in Boston. The model included 31 time-independent variables and 38 time-dependent variables that were collected every 15 minutes at the Mayo Clinic and every 60 minutes at Beth Israel Deaconess. Surgical patients represented 24% of the Mayo dataset and 58% of the MIMIC-IV dataset, but otherwise the two groups were demographically similar.

At 24 hours, the area under the receiver operating characteristic curve for predicting 14-day mortality was −0.82 in the Mayo validation cohort and −0.78 in the MIMIC validation cohort. The model improved in accuracy over time as more data were accumulated.

The session’s co-moderators, Sandeep Jain, MD, and Casey Cable, MD, praised the work. Dr. Cable, associate professor of pulmonary care medicine at VCU Health, Richmond, Virginia, noted that the model used both surgical patients and medical patients with sepsis, and the two groups can present quite differently. Another variable was the COVID pandemic, where some patients presented at the hospital when they were quite sick. “I’m curious how different starting points would play into it,” she said.

She called for institutions to develop such models on their own rather than relying on companies that might develop software solutions. “I think that this needs to be clinician-led, from the ground up,” said Dr. Cable.

Dr. Jain, an associate professor of pulmonary care medicine at Broward Health, suggested that such models might need to be individualized for each institution, but “my fear is it could become too expensive, so I think a group like CHEST could come together and [create] an open source system to have their researchers jumpstart the research on this,” he said.

Dr. Lal, Dr. Jain, and Dr. Cable reported no relevant financial relationships.


A version of this article appeared on Medscape.com.

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A “digital twin” model successfully predicted adverse outcomes in intensive care unit (ICU) patients treated for sepsis. The research used an adaptive approach, updating time-sensitive values such as blood pressure and vitals every 15 minutes. The approach also took into account treatment decisions and has potential as a decision-making and educational tool.

The digital twin could reduce the risk for some interventions, according to Amos Lal, MD, who presented the study at the CHEST Annual Meeting. That’s because the model can predict the outcome. “You don’t actually have to make an intervention to the patient, which might be risky. By doing that, you can actually prevent a lot of harm,” said Dr. Lal, assistant professor of medicine at Mayo Clinic in Rochester, Minnesota.

The researchers used a one-dimensional convolutional neural network (CNN), similar to two-dimensional CNNs that are used to classify images, substituting the color channels used in imaging with 38 time-dependent variables. They applied it to predicting outcomes in the ICU, focusing on data generated within the first 24 hours of admission. The team made the model dynamic by adding time-sensitive data like vitals, laboratory values, and interventions every 15 minutes. That contrasts with existing models that are usually static, relying on values at admission or at 24 hours, for example. It also takes into account time-insensitive data like age, gender, and comorbidities. “Combining these two and coming up with the prediction model in real time can give you a more informed decision about how these patients are going to perform over a period of 2 weeks or 4 weeks of their stay within the ICU. And of course, as we get more and more data within the first 24 hours, the performance of the model improves as well,” said Dr. Lal.

The researchers tested the model by creating a virtual model of the patient and then performing an intervention on the patient and a simulated intervention on the virtual patient. “Then we advance the clock and the patient either improved or deteriorated, and we compared how the digital twin performed, whether the changes were concordant or discordant [between the virtual and real-world patients],” said Dr. Lal.

The model was designed to predict which patients with sepsis would be at greater risk for death or ICU stays longer than 14 days. It was created using data from 28,617 patients with critical care sepsis at a single hospital who were treated between 2011 and 2018, with 70% used as a training set, 20% as a test set, and 10% as a validation set. The researchers conducted an external validation using MIMIC-IV data on 30,903 patients from the Beth Israel Deaconess Medical Center in Boston. The model included 31 time-independent variables and 38 time-dependent variables that were collected every 15 minutes at the Mayo Clinic and every 60 minutes at Beth Israel Deaconess. Surgical patients represented 24% of the Mayo dataset and 58% of the MIMIC-IV dataset, but otherwise the two groups were demographically similar.

At 24 hours, the area under the receiver operating characteristic curve for predicting 14-day mortality was −0.82 in the Mayo validation cohort and −0.78 in the MIMIC validation cohort. The model improved in accuracy over time as more data were accumulated.

The session’s co-moderators, Sandeep Jain, MD, and Casey Cable, MD, praised the work. Dr. Cable, associate professor of pulmonary care medicine at VCU Health, Richmond, Virginia, noted that the model used both surgical patients and medical patients with sepsis, and the two groups can present quite differently. Another variable was the COVID pandemic, where some patients presented at the hospital when they were quite sick. “I’m curious how different starting points would play into it,” she said.

She called for institutions to develop such models on their own rather than relying on companies that might develop software solutions. “I think that this needs to be clinician-led, from the ground up,” said Dr. Cable.

Dr. Jain, an associate professor of pulmonary care medicine at Broward Health, suggested that such models might need to be individualized for each institution, but “my fear is it could become too expensive, so I think a group like CHEST could come together and [create] an open source system to have their researchers jumpstart the research on this,” he said.

Dr. Lal, Dr. Jain, and Dr. Cable reported no relevant financial relationships.


A version of this article appeared on Medscape.com.

A “digital twin” model successfully predicted adverse outcomes in intensive care unit (ICU) patients treated for sepsis. The research used an adaptive approach, updating time-sensitive values such as blood pressure and vitals every 15 minutes. The approach also took into account treatment decisions and has potential as a decision-making and educational tool.

The digital twin could reduce the risk for some interventions, according to Amos Lal, MD, who presented the study at the CHEST Annual Meeting. That’s because the model can predict the outcome. “You don’t actually have to make an intervention to the patient, which might be risky. By doing that, you can actually prevent a lot of harm,” said Dr. Lal, assistant professor of medicine at Mayo Clinic in Rochester, Minnesota.

The researchers used a one-dimensional convolutional neural network (CNN), similar to two-dimensional CNNs that are used to classify images, substituting the color channels used in imaging with 38 time-dependent variables. They applied it to predicting outcomes in the ICU, focusing on data generated within the first 24 hours of admission. The team made the model dynamic by adding time-sensitive data like vitals, laboratory values, and interventions every 15 minutes. That contrasts with existing models that are usually static, relying on values at admission or at 24 hours, for example. It also takes into account time-insensitive data like age, gender, and comorbidities. “Combining these two and coming up with the prediction model in real time can give you a more informed decision about how these patients are going to perform over a period of 2 weeks or 4 weeks of their stay within the ICU. And of course, as we get more and more data within the first 24 hours, the performance of the model improves as well,” said Dr. Lal.

The researchers tested the model by creating a virtual model of the patient and then performing an intervention on the patient and a simulated intervention on the virtual patient. “Then we advance the clock and the patient either improved or deteriorated, and we compared how the digital twin performed, whether the changes were concordant or discordant [between the virtual and real-world patients],” said Dr. Lal.

The model was designed to predict which patients with sepsis would be at greater risk for death or ICU stays longer than 14 days. It was created using data from 28,617 patients with critical care sepsis at a single hospital who were treated between 2011 and 2018, with 70% used as a training set, 20% as a test set, and 10% as a validation set. The researchers conducted an external validation using MIMIC-IV data on 30,903 patients from the Beth Israel Deaconess Medical Center in Boston. The model included 31 time-independent variables and 38 time-dependent variables that were collected every 15 minutes at the Mayo Clinic and every 60 minutes at Beth Israel Deaconess. Surgical patients represented 24% of the Mayo dataset and 58% of the MIMIC-IV dataset, but otherwise the two groups were demographically similar.

At 24 hours, the area under the receiver operating characteristic curve for predicting 14-day mortality was −0.82 in the Mayo validation cohort and −0.78 in the MIMIC validation cohort. The model improved in accuracy over time as more data were accumulated.

The session’s co-moderators, Sandeep Jain, MD, and Casey Cable, MD, praised the work. Dr. Cable, associate professor of pulmonary care medicine at VCU Health, Richmond, Virginia, noted that the model used both surgical patients and medical patients with sepsis, and the two groups can present quite differently. Another variable was the COVID pandemic, where some patients presented at the hospital when they were quite sick. “I’m curious how different starting points would play into it,” she said.

She called for institutions to develop such models on their own rather than relying on companies that might develop software solutions. “I think that this needs to be clinician-led, from the ground up,” said Dr. Cable.

Dr. Jain, an associate professor of pulmonary care medicine at Broward Health, suggested that such models might need to be individualized for each institution, but “my fear is it could become too expensive, so I think a group like CHEST could come together and [create] an open source system to have their researchers jumpstart the research on this,” he said.

Dr. Lal, Dr. Jain, and Dr. Cable reported no relevant financial relationships.


A version of this article appeared on Medscape.com.

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Older Patients With COPD at Increased Risk for PE-Associated Death

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— Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

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

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— Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

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

— Patients with COPD are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years.

The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania, Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the CHEST Annual Meeting.
 

Known Risk Factor

COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 to 2020 from the Centers for Disease Control and Prevention’s WONDER database.

They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths.

A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years.

The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001).

The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” said Oudah, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443.

In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said.

Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories.

The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”
 

Confounding Comorbidities

In an interview, a pulmonary specialist who was not involved in the study commented that older persons with COPD tend to have multiple comorbidities that may contribute to the risk for PE.

“Older patients have so many comorbidities, and their risk for pulmonary embolism and thromboembolic disease is pretty high, so I’m not surprised that 75 to 79 years olds are having a higher mortality from PE, but it’s a little difficult to say whether that’s due to COPD,” said Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, who moderated the session.

The authors did not report a study funding source. Oudah and Sundar reported no relevant financial relationships.

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

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AF Burden Increases Around Time of COPD Hospitalizations

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Mon, 11/04/2024 - 12:11

— Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

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— Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

— Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

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A Finger-Prick Test for Alzheimer’s Disease?

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Mon, 11/04/2024 - 12:03

A finger-prick blood test can accurately identify p-tau217 — a key biomarker of Alzheimer’s disease — without the need for temperature or storage control measures.

In a pilot study, researchers found a good correlation of p-tau217 levels from blood obtained via standard venous sampling and from a single finger prick.

“We see the potential that capillary p-tau217 from dried blood spots could overcome the limitations of standard venous collection of being invasive, dependent on centrifuges and ultra-low temperature freezers, and also requiring less volume than standard plasma analysis,” said lead investigator Hanna Huber, PhD, Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, University of Gothenburg, Sweden. 

The findings were presented at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
 

Strong Link Between Venous and Capillary Samples 

p-tau217 has emerged as the most effective blood test to identify Alzheimer’s disease. However, traditional venous blood sampling requires certain infrastructure and immediate processing. Increased and simplified access to this blood biomarker could be crucial for early diagnosis, proper patient management, and prompt initiation of disease-modifying treatments. 

The DROP-AD project is investigating the diagnostic performance of finger-prick collection to accurately measure p-tau217. In the current study, the research team obtained paired venous blood and capillary blood samples from 206 adults (mean age, 71.8 years; 59% women), with or without cognitive impairment, from five European centers. A subset of participants provided a second finger-prick sample collected without any supervision. 

The capillary blood samples were obtained via a single finger prick, and then single blood drops were applied to a dried plasma spot (DPS) card, which was then shipped to a lab (without temperature control or cooling) for p-tau217 measurement. Cerebrospinal fluid biomarkers were available for a subset of individuals.

Throughout the entire study population, there was a “very convincing correlation” between p-tau217 levels from capillary DPS and venous plasma, Huber told conference attendees. 

Additionally, capillary DPS p-tau217 levels were able to discriminate amyloid-positive from amyloid-negative individuals, with levels of this biomarker increasing in a stepwise fashion, “from cognitively unimpaired individuals to individuals with mild cognitive impairment and, finally, to dementia patients,” Huber said.

Of note, capillary p-tau217 levels from DPS samples that were collected by research staff did not differ from unsupervised self-collected samples. 

What about the stability of the samples? Capillary DPS p-tau-217 is “stable over 2 weeks at room temperature,” Huber said. 
 

Ready for Prime Time?

Preliminary data from the DROP-AD project highlight the potential of using finger-prick blood collection to identify neurofilament light (NfL) and glial fibrillary acidic protein (GFAP), two other Alzheimer’s disease biomarkers.

“We think that capillary p-tau217, but also other biomarkers, could be a widely accessible and cheap alternative for clinical practice and clinical trials in individuals with cognitive decline if the results are confirmed in longitudinal and home-sampling cohorts,” Huber concluded. 

“Measuring biomarkers by a simple finger prick could facilitate regular and autonomous sampling at home, which would be particularly useful in remote and rural settings,” she noted. 

The findings in this study confirm and extend earlier findings that the study team reported last year at the Alzheimer’s Association International Conference (AAIC). 

“The data shared at CTAD 2024, along with the related material previously presented at AAIC 2023, reporting on a ‘finger prick’ blood test approach is interesting and emerging work but not yet ready for clinical use,” said Rebecca M. Edelmayer, PhD, Alzheimer’s Association vice president of scientific engagement.

“That said, the idea of a highly accessible and scalable tool that can aid in easier and more equitable diagnosis would be welcomed by researchers, clinicians, and individuals and families affected by Alzheimer’s disease and all other dementias,” Edelmayer said.

“This finger-prick blood testing technology for Alzheimer’s biomarkers still has to be validated more broadly, but it is very promising. Advancements in technology and practice demonstrate the simplicity, transportability, and diagnostic value of blood-based biomarkers for Alzheimer’s,” she added. 

The Alzheimer’s Association is currently conducting a systematic review of the evidence and preparing clinical practice guidelines on blood-based biomarker tests for specialized healthcare settings, with publications, clinical resources, and tools anticipated in 2025, Edelmayer noted. 

The study had no commercial funding. Huber and Edelmayer report no relevant conflicts of interest. 
 

A version of this article appeared on Medscape.com.

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A finger-prick blood test can accurately identify p-tau217 — a key biomarker of Alzheimer’s disease — without the need for temperature or storage control measures.

In a pilot study, researchers found a good correlation of p-tau217 levels from blood obtained via standard venous sampling and from a single finger prick.

“We see the potential that capillary p-tau217 from dried blood spots could overcome the limitations of standard venous collection of being invasive, dependent on centrifuges and ultra-low temperature freezers, and also requiring less volume than standard plasma analysis,” said lead investigator Hanna Huber, PhD, Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, University of Gothenburg, Sweden. 

The findings were presented at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
 

Strong Link Between Venous and Capillary Samples 

p-tau217 has emerged as the most effective blood test to identify Alzheimer’s disease. However, traditional venous blood sampling requires certain infrastructure and immediate processing. Increased and simplified access to this blood biomarker could be crucial for early diagnosis, proper patient management, and prompt initiation of disease-modifying treatments. 

The DROP-AD project is investigating the diagnostic performance of finger-prick collection to accurately measure p-tau217. In the current study, the research team obtained paired venous blood and capillary blood samples from 206 adults (mean age, 71.8 years; 59% women), with or without cognitive impairment, from five European centers. A subset of participants provided a second finger-prick sample collected without any supervision. 

The capillary blood samples were obtained via a single finger prick, and then single blood drops were applied to a dried plasma spot (DPS) card, which was then shipped to a lab (without temperature control or cooling) for p-tau217 measurement. Cerebrospinal fluid biomarkers were available for a subset of individuals.

Throughout the entire study population, there was a “very convincing correlation” between p-tau217 levels from capillary DPS and venous plasma, Huber told conference attendees. 

Additionally, capillary DPS p-tau217 levels were able to discriminate amyloid-positive from amyloid-negative individuals, with levels of this biomarker increasing in a stepwise fashion, “from cognitively unimpaired individuals to individuals with mild cognitive impairment and, finally, to dementia patients,” Huber said.

Of note, capillary p-tau217 levels from DPS samples that were collected by research staff did not differ from unsupervised self-collected samples. 

What about the stability of the samples? Capillary DPS p-tau-217 is “stable over 2 weeks at room temperature,” Huber said. 
 

Ready for Prime Time?

Preliminary data from the DROP-AD project highlight the potential of using finger-prick blood collection to identify neurofilament light (NfL) and glial fibrillary acidic protein (GFAP), two other Alzheimer’s disease biomarkers.

“We think that capillary p-tau217, but also other biomarkers, could be a widely accessible and cheap alternative for clinical practice and clinical trials in individuals with cognitive decline if the results are confirmed in longitudinal and home-sampling cohorts,” Huber concluded. 

“Measuring biomarkers by a simple finger prick could facilitate regular and autonomous sampling at home, which would be particularly useful in remote and rural settings,” she noted. 

The findings in this study confirm and extend earlier findings that the study team reported last year at the Alzheimer’s Association International Conference (AAIC). 

“The data shared at CTAD 2024, along with the related material previously presented at AAIC 2023, reporting on a ‘finger prick’ blood test approach is interesting and emerging work but not yet ready for clinical use,” said Rebecca M. Edelmayer, PhD, Alzheimer’s Association vice president of scientific engagement.

“That said, the idea of a highly accessible and scalable tool that can aid in easier and more equitable diagnosis would be welcomed by researchers, clinicians, and individuals and families affected by Alzheimer’s disease and all other dementias,” Edelmayer said.

“This finger-prick blood testing technology for Alzheimer’s biomarkers still has to be validated more broadly, but it is very promising. Advancements in technology and practice demonstrate the simplicity, transportability, and diagnostic value of blood-based biomarkers for Alzheimer’s,” she added. 

The Alzheimer’s Association is currently conducting a systematic review of the evidence and preparing clinical practice guidelines on blood-based biomarker tests for specialized healthcare settings, with publications, clinical resources, and tools anticipated in 2025, Edelmayer noted. 

The study had no commercial funding. Huber and Edelmayer report no relevant conflicts of interest. 
 

A version of this article appeared on Medscape.com.

A finger-prick blood test can accurately identify p-tau217 — a key biomarker of Alzheimer’s disease — without the need for temperature or storage control measures.

In a pilot study, researchers found a good correlation of p-tau217 levels from blood obtained via standard venous sampling and from a single finger prick.

“We see the potential that capillary p-tau217 from dried blood spots could overcome the limitations of standard venous collection of being invasive, dependent on centrifuges and ultra-low temperature freezers, and also requiring less volume than standard plasma analysis,” said lead investigator Hanna Huber, PhD, Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, University of Gothenburg, Sweden. 

The findings were presented at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
 

Strong Link Between Venous and Capillary Samples 

p-tau217 has emerged as the most effective blood test to identify Alzheimer’s disease. However, traditional venous blood sampling requires certain infrastructure and immediate processing. Increased and simplified access to this blood biomarker could be crucial for early diagnosis, proper patient management, and prompt initiation of disease-modifying treatments. 

The DROP-AD project is investigating the diagnostic performance of finger-prick collection to accurately measure p-tau217. In the current study, the research team obtained paired venous blood and capillary blood samples from 206 adults (mean age, 71.8 years; 59% women), with or without cognitive impairment, from five European centers. A subset of participants provided a second finger-prick sample collected without any supervision. 

The capillary blood samples were obtained via a single finger prick, and then single blood drops were applied to a dried plasma spot (DPS) card, which was then shipped to a lab (without temperature control or cooling) for p-tau217 measurement. Cerebrospinal fluid biomarkers were available for a subset of individuals.

Throughout the entire study population, there was a “very convincing correlation” between p-tau217 levels from capillary DPS and venous plasma, Huber told conference attendees. 

Additionally, capillary DPS p-tau217 levels were able to discriminate amyloid-positive from amyloid-negative individuals, with levels of this biomarker increasing in a stepwise fashion, “from cognitively unimpaired individuals to individuals with mild cognitive impairment and, finally, to dementia patients,” Huber said.

Of note, capillary p-tau217 levels from DPS samples that were collected by research staff did not differ from unsupervised self-collected samples. 

What about the stability of the samples? Capillary DPS p-tau-217 is “stable over 2 weeks at room temperature,” Huber said. 
 

Ready for Prime Time?

Preliminary data from the DROP-AD project highlight the potential of using finger-prick blood collection to identify neurofilament light (NfL) and glial fibrillary acidic protein (GFAP), two other Alzheimer’s disease biomarkers.

“We think that capillary p-tau217, but also other biomarkers, could be a widely accessible and cheap alternative for clinical practice and clinical trials in individuals with cognitive decline if the results are confirmed in longitudinal and home-sampling cohorts,” Huber concluded. 

“Measuring biomarkers by a simple finger prick could facilitate regular and autonomous sampling at home, which would be particularly useful in remote and rural settings,” she noted. 

The findings in this study confirm and extend earlier findings that the study team reported last year at the Alzheimer’s Association International Conference (AAIC). 

“The data shared at CTAD 2024, along with the related material previously presented at AAIC 2023, reporting on a ‘finger prick’ blood test approach is interesting and emerging work but not yet ready for clinical use,” said Rebecca M. Edelmayer, PhD, Alzheimer’s Association vice president of scientific engagement.

“That said, the idea of a highly accessible and scalable tool that can aid in easier and more equitable diagnosis would be welcomed by researchers, clinicians, and individuals and families affected by Alzheimer’s disease and all other dementias,” Edelmayer said.

“This finger-prick blood testing technology for Alzheimer’s biomarkers still has to be validated more broadly, but it is very promising. Advancements in technology and practice demonstrate the simplicity, transportability, and diagnostic value of blood-based biomarkers for Alzheimer’s,” she added. 

The Alzheimer’s Association is currently conducting a systematic review of the evidence and preparing clinical practice guidelines on blood-based biomarker tests for specialized healthcare settings, with publications, clinical resources, and tools anticipated in 2025, Edelmayer noted. 

The study had no commercial funding. Huber and Edelmayer report no relevant conflicts of interest. 
 

A version of this article appeared on Medscape.com.

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Weight Loss Surgery, Obesity Drugs Achieve Similar Results but Have Different Safety Profiles

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Fri, 11/01/2024 - 15:56

Roux-en-Y gastric bypass (RYGB) produces maximal weight loss in patients with obesity, compared with other surgical procedures and with weight loss drugs, according to a meta-analysis comparing the efficacy and safety of the different treatment options. 

However, tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 receptor agonist (GLP-1 RA), produces comparable weight loss and has a favorable safety profile, reported principal investigator Jena Velji-Ibrahim, MD, MSc, from Prisma Health–Upstate/University of South Carolina School of Medicine in Greenville. 

In addition, there was “no significant difference in percentage total body weight loss between tirzepatide when comparing it to one-anastomosis gastric bypass (OAGB), as well as laparoscopic sleeve gastrectomy,” she said. 

All 11 interventions studied exerted weight loss effects, and side-effect profiles were also deemed largely favorable, particularly for endoscopic interventions, she added. 

“When we compare bariatric surgery to bariatric endoscopy, endoscopic sleeve gastroplasty and transpyloric shuttle offer a minimally invasive alternative with good weight loss outcomes and fewer adverse events,” she said.

Velji-Ibrahim presented the findings at the annual meeting of the American College of Gastroenterology (ACG)
 

Comparing Weight Loss Interventions

Many of the studies comparing weight loss interventions to date have been limited by relatively small sample sizes, observational designs, and inconsistent results. This prompted Velji-Ibrahim and her colleagues to conduct what they believe to be the first-of-its-kind meta-analysis on this topic. 

They began by conducting a systematic search of the literature to identify randomized controlled trials (RCTs) that compared the efficacy of Food and Drug Administration–approved bariatric surgeries, bariatric endoscopies, and medications — against each other or with placebo — in adults with a body mass index of 25-45, with or without concurrent type 2 diabetes. 

A network meta-analysis was then performed to assess the various interventions’ impact on percentage total weight loss and side-effect profiles. P-scores were calculated to rank the treatments and identify the preferred interventions. The duration of therapy was 52 weeks. 

In total, 34 eligible RCTs with 15,660 patients were included. Overall, the RCTs analyzed 11 weight loss treatments, including bariatric surgeries (four studies), bariatric endoscopies (three studies), and medications (four studies). 

Specifically, the bariatric surgeries included RYGB, laparoscopic sleeve gastrectomy, OAGB, and laparoscopic adjustable gastric banding; bariatric endoscopies included endoscopic sleeve gastroplasty, transpyloric shuttle, and intragastric balloon; and medications included tirzepatide, semaglutide, and liraglutide.

Although all interventions were associated with reductions in percentage total weight loss compared with placebo, RYGB led to the greatest reductions (19.29%) and was ranked as the first preferred treatment (97% probability). It was followed in the rankings by OAGB, tirzepatide 15 mg, laparoscopic sleeve gastrectomy, and semaglutide 2.4 mg. 

Tirzepatide 15 mg had a slightly lower percentage total weight loss (15.18%) but a favorable safety profile. There was no significant difference in percentage total weight loss between tirzepatide 15 mg and OAGB (mean difference, 2.97%) or laparoscopic sleeve gastrectomy (mean difference, 0.43%). 

There was also no significant difference in percentage total weight loss between semaglutide 2.4 mg, compared with endoscopic sleeve gastroplasty and transpyloric shuttle. 

Endoscopic sleeve, transpyloric shuttle, and intragastric balloon all resulted in weight loss > 5%. 

When compared with bariatric surgery, “endoscopic interventions had a better side-effect profile, with no increased odds of mortality and intensive care needs,” Velji-Ibrahim said. 

When it came to the medications, “the most common side effects were gastrointestinal in nature, which included nausea, vomiting, diarrhea, and constipation,” she said.
 

 

 

Combining, Rather Than Comparing, Therapies

Following the presentation, session co-moderator Shivangi T. Kothari, MD, assistant professor of medicine and associate director of endoscopy at the University of Rochester Medical Center in New York, shared her thoughts of what the future of obesity management research might look like. 

It’s not just going to be about percentage total weight loss, she said, but about how well the effect is sustained following the intervention. 

And we might move “away from comparing one modality to another” and instead study combination therapies, “which would be ideal,” said Kothari.

This was the focus of another meta-analysis presented at ACG 2024, in which Nihal Ijaz I. Khan, MD, and colleagues compared the efficacy of endoscopic bariatric treatment alone vs its combined use with GLP-1 RAs.

The researchers identified three retrospective studies with 266 patients, of whom 143 underwent endoscopic bariatric treatment alone (either endoscopic sleeve gastroplasty or intragastric balloon) and 123 had it combined with GLP-1 RAs, specifically liraglutide. 

They reported that superior absolute weight loss was achieved in the group of patients receiving GLP-1 RAs in combination with endoscopic bariatric treatment. The standardized mean difference in body weight loss at treatment follow-up was 0.61 (P <.01). 

“Further studies are required to evaluate the safety and adverse events comparing these two treatment modalities and to discover differences between comparing the two endoscopic options to various GLP-1 receptor agonists,” Khan noted. 

Neither study had specific funding. Velji-Ibrahim and Khan reported no relevant financial relationships. Kothari reported serving as a consultant for Boston Scientific and Olympus, as well as serving as an advisory committee/board member for Castle Biosciences.

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

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Roux-en-Y gastric bypass (RYGB) produces maximal weight loss in patients with obesity, compared with other surgical procedures and with weight loss drugs, according to a meta-analysis comparing the efficacy and safety of the different treatment options. 

However, tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 receptor agonist (GLP-1 RA), produces comparable weight loss and has a favorable safety profile, reported principal investigator Jena Velji-Ibrahim, MD, MSc, from Prisma Health–Upstate/University of South Carolina School of Medicine in Greenville. 

In addition, there was “no significant difference in percentage total body weight loss between tirzepatide when comparing it to one-anastomosis gastric bypass (OAGB), as well as laparoscopic sleeve gastrectomy,” she said. 

All 11 interventions studied exerted weight loss effects, and side-effect profiles were also deemed largely favorable, particularly for endoscopic interventions, she added. 

“When we compare bariatric surgery to bariatric endoscopy, endoscopic sleeve gastroplasty and transpyloric shuttle offer a minimally invasive alternative with good weight loss outcomes and fewer adverse events,” she said.

Velji-Ibrahim presented the findings at the annual meeting of the American College of Gastroenterology (ACG)
 

Comparing Weight Loss Interventions

Many of the studies comparing weight loss interventions to date have been limited by relatively small sample sizes, observational designs, and inconsistent results. This prompted Velji-Ibrahim and her colleagues to conduct what they believe to be the first-of-its-kind meta-analysis on this topic. 

They began by conducting a systematic search of the literature to identify randomized controlled trials (RCTs) that compared the efficacy of Food and Drug Administration–approved bariatric surgeries, bariatric endoscopies, and medications — against each other or with placebo — in adults with a body mass index of 25-45, with or without concurrent type 2 diabetes. 

A network meta-analysis was then performed to assess the various interventions’ impact on percentage total weight loss and side-effect profiles. P-scores were calculated to rank the treatments and identify the preferred interventions. The duration of therapy was 52 weeks. 

In total, 34 eligible RCTs with 15,660 patients were included. Overall, the RCTs analyzed 11 weight loss treatments, including bariatric surgeries (four studies), bariatric endoscopies (three studies), and medications (four studies). 

Specifically, the bariatric surgeries included RYGB, laparoscopic sleeve gastrectomy, OAGB, and laparoscopic adjustable gastric banding; bariatric endoscopies included endoscopic sleeve gastroplasty, transpyloric shuttle, and intragastric balloon; and medications included tirzepatide, semaglutide, and liraglutide.

Although all interventions were associated with reductions in percentage total weight loss compared with placebo, RYGB led to the greatest reductions (19.29%) and was ranked as the first preferred treatment (97% probability). It was followed in the rankings by OAGB, tirzepatide 15 mg, laparoscopic sleeve gastrectomy, and semaglutide 2.4 mg. 

Tirzepatide 15 mg had a slightly lower percentage total weight loss (15.18%) but a favorable safety profile. There was no significant difference in percentage total weight loss between tirzepatide 15 mg and OAGB (mean difference, 2.97%) or laparoscopic sleeve gastrectomy (mean difference, 0.43%). 

There was also no significant difference in percentage total weight loss between semaglutide 2.4 mg, compared with endoscopic sleeve gastroplasty and transpyloric shuttle. 

Endoscopic sleeve, transpyloric shuttle, and intragastric balloon all resulted in weight loss > 5%. 

When compared with bariatric surgery, “endoscopic interventions had a better side-effect profile, with no increased odds of mortality and intensive care needs,” Velji-Ibrahim said. 

When it came to the medications, “the most common side effects were gastrointestinal in nature, which included nausea, vomiting, diarrhea, and constipation,” she said.
 

 

 

Combining, Rather Than Comparing, Therapies

Following the presentation, session co-moderator Shivangi T. Kothari, MD, assistant professor of medicine and associate director of endoscopy at the University of Rochester Medical Center in New York, shared her thoughts of what the future of obesity management research might look like. 

It’s not just going to be about percentage total weight loss, she said, but about how well the effect is sustained following the intervention. 

And we might move “away from comparing one modality to another” and instead study combination therapies, “which would be ideal,” said Kothari.

This was the focus of another meta-analysis presented at ACG 2024, in which Nihal Ijaz I. Khan, MD, and colleagues compared the efficacy of endoscopic bariatric treatment alone vs its combined use with GLP-1 RAs.

The researchers identified three retrospective studies with 266 patients, of whom 143 underwent endoscopic bariatric treatment alone (either endoscopic sleeve gastroplasty or intragastric balloon) and 123 had it combined with GLP-1 RAs, specifically liraglutide. 

They reported that superior absolute weight loss was achieved in the group of patients receiving GLP-1 RAs in combination with endoscopic bariatric treatment. The standardized mean difference in body weight loss at treatment follow-up was 0.61 (P <.01). 

“Further studies are required to evaluate the safety and adverse events comparing these two treatment modalities and to discover differences between comparing the two endoscopic options to various GLP-1 receptor agonists,” Khan noted. 

Neither study had specific funding. Velji-Ibrahim and Khan reported no relevant financial relationships. Kothari reported serving as a consultant for Boston Scientific and Olympus, as well as serving as an advisory committee/board member for Castle Biosciences.

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

Roux-en-Y gastric bypass (RYGB) produces maximal weight loss in patients with obesity, compared with other surgical procedures and with weight loss drugs, according to a meta-analysis comparing the efficacy and safety of the different treatment options. 

However, tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 receptor agonist (GLP-1 RA), produces comparable weight loss and has a favorable safety profile, reported principal investigator Jena Velji-Ibrahim, MD, MSc, from Prisma Health–Upstate/University of South Carolina School of Medicine in Greenville. 

In addition, there was “no significant difference in percentage total body weight loss between tirzepatide when comparing it to one-anastomosis gastric bypass (OAGB), as well as laparoscopic sleeve gastrectomy,” she said. 

All 11 interventions studied exerted weight loss effects, and side-effect profiles were also deemed largely favorable, particularly for endoscopic interventions, she added. 

“When we compare bariatric surgery to bariatric endoscopy, endoscopic sleeve gastroplasty and transpyloric shuttle offer a minimally invasive alternative with good weight loss outcomes and fewer adverse events,” she said.

Velji-Ibrahim presented the findings at the annual meeting of the American College of Gastroenterology (ACG)
 

Comparing Weight Loss Interventions

Many of the studies comparing weight loss interventions to date have been limited by relatively small sample sizes, observational designs, and inconsistent results. This prompted Velji-Ibrahim and her colleagues to conduct what they believe to be the first-of-its-kind meta-analysis on this topic. 

They began by conducting a systematic search of the literature to identify randomized controlled trials (RCTs) that compared the efficacy of Food and Drug Administration–approved bariatric surgeries, bariatric endoscopies, and medications — against each other or with placebo — in adults with a body mass index of 25-45, with or without concurrent type 2 diabetes. 

A network meta-analysis was then performed to assess the various interventions’ impact on percentage total weight loss and side-effect profiles. P-scores were calculated to rank the treatments and identify the preferred interventions. The duration of therapy was 52 weeks. 

In total, 34 eligible RCTs with 15,660 patients were included. Overall, the RCTs analyzed 11 weight loss treatments, including bariatric surgeries (four studies), bariatric endoscopies (three studies), and medications (four studies). 

Specifically, the bariatric surgeries included RYGB, laparoscopic sleeve gastrectomy, OAGB, and laparoscopic adjustable gastric banding; bariatric endoscopies included endoscopic sleeve gastroplasty, transpyloric shuttle, and intragastric balloon; and medications included tirzepatide, semaglutide, and liraglutide.

Although all interventions were associated with reductions in percentage total weight loss compared with placebo, RYGB led to the greatest reductions (19.29%) and was ranked as the first preferred treatment (97% probability). It was followed in the rankings by OAGB, tirzepatide 15 mg, laparoscopic sleeve gastrectomy, and semaglutide 2.4 mg. 

Tirzepatide 15 mg had a slightly lower percentage total weight loss (15.18%) but a favorable safety profile. There was no significant difference in percentage total weight loss between tirzepatide 15 mg and OAGB (mean difference, 2.97%) or laparoscopic sleeve gastrectomy (mean difference, 0.43%). 

There was also no significant difference in percentage total weight loss between semaglutide 2.4 mg, compared with endoscopic sleeve gastroplasty and transpyloric shuttle. 

Endoscopic sleeve, transpyloric shuttle, and intragastric balloon all resulted in weight loss > 5%. 

When compared with bariatric surgery, “endoscopic interventions had a better side-effect profile, with no increased odds of mortality and intensive care needs,” Velji-Ibrahim said. 

When it came to the medications, “the most common side effects were gastrointestinal in nature, which included nausea, vomiting, diarrhea, and constipation,” she said.
 

 

 

Combining, Rather Than Comparing, Therapies

Following the presentation, session co-moderator Shivangi T. Kothari, MD, assistant professor of medicine and associate director of endoscopy at the University of Rochester Medical Center in New York, shared her thoughts of what the future of obesity management research might look like. 

It’s not just going to be about percentage total weight loss, she said, but about how well the effect is sustained following the intervention. 

And we might move “away from comparing one modality to another” and instead study combination therapies, “which would be ideal,” said Kothari.

This was the focus of another meta-analysis presented at ACG 2024, in which Nihal Ijaz I. Khan, MD, and colleagues compared the efficacy of endoscopic bariatric treatment alone vs its combined use with GLP-1 RAs.

The researchers identified three retrospective studies with 266 patients, of whom 143 underwent endoscopic bariatric treatment alone (either endoscopic sleeve gastroplasty or intragastric balloon) and 123 had it combined with GLP-1 RAs, specifically liraglutide. 

They reported that superior absolute weight loss was achieved in the group of patients receiving GLP-1 RAs in combination with endoscopic bariatric treatment. The standardized mean difference in body weight loss at treatment follow-up was 0.61 (P <.01). 

“Further studies are required to evaluate the safety and adverse events comparing these two treatment modalities and to discover differences between comparing the two endoscopic options to various GLP-1 receptor agonists,” Khan noted. 

Neither study had specific funding. Velji-Ibrahim and Khan reported no relevant financial relationships. Kothari reported serving as a consultant for Boston Scientific and Olympus, as well as serving as an advisory committee/board member for Castle Biosciences.

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

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Weight Loss Drugs Don’t Reduce Oocyte Retrieval

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Changed
Fri, 11/01/2024 - 13:44

The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

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

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The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

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

The use of glucagon-like peptide 1 (GLP-1) agonists within a year had no apparent effect on the number of oocytes retrieved in controlled ovarian hyperstimulation (COH), based on data from 73 patients in a multicenter study.

Obesity rates continue to rise in women of reproductive age and many women are using GLP-1 agonists for weight loss, but data on the effect of these drugs on fertility treatments are lacking, said Victoria K. Lazarov, MD, of Icahn School of Medicine at Mount Sinai, New York City, in an abstract presented at the American Society for Reproductive Medicine (ASRM) 2024 scientific congress.

Clinical opinions regarding the use, duration, and discontinuation of GLP-1 agonists during fertility treatments are variable given the limited research, Lazarov noted in her abstract. More data are needed to standardize patient counseling.

Lazarov and colleagues reviewed data from patients who sought treatment at clinics affiliated with a national fertility network from 2005 to 2023 who also utilized a GLP-1 agonist within 1 year of COH.

The study population included 73 adult women; participants were divided into six groups based on the number of days without GLP-1 agonist use prior to retrieval (0-14, 15-30, 31-60, 61-90, 91-180, and 181-365 days). The primary outcome was oocyte yield following COH.

Overall, the mean oocyte yields were not significantly different across the six timing groups (14.4, 16.2, 16.8, 7.7, 13.8, and 15, respectively; = .40).

In a secondary subgroup analysis, the researchers found an inverse relationship between oocyte yield and timing of GLP-1 agonist discontinuation in patients with body mass index (BMI) > 35. However, no changes in oocyte yield were observed in patients with BMIs in the normal or overweight range. Neither duration of GLP-1 agonist use or indication for use had a significant effect on oocyte yield across exposure group.

The findings were limited by several factors, including the relatively small study population, especially the small number of patients with obesity. “Additional investigation is needed to clarify potential effects of GLP-1 agonist use on aspiration risk during oocyte retrieval and embryo creation outcomes,” the researchers wrote in their abstract.

However, the results suggest that most women who use GLP-1 agonists experience no significant effects on oocyte retrieval and embryo creation, and that GLP-1 agonists may have a role in improving oocyte yield for obese patients, the researchers concluded.
 

Larger Studies Needed for Real Reassurance

“Infertility patients who are overweight have lower chances for conception and higher risks of pregnancy complications,” Mark Trolice, MD, professor at the University of Central Florida College of Medicine, Orlando, and founder/director of The IVF Center, Winter Park, Florida, said in an interview.

The use of GLP-1 agonists has dramatically increased given the medication’s effectiveness for weight loss, as well as its use to manage diabetes, but the use of GLP-1 agonists in pregnancy is not well known and current recommendations advise discontinuation of the medication for 6-8 weeks prior to conception, said Trolice, who was not involved in the study.

GLP-1 agonist use is associated with lowered blood glucose levels, Trolice said. “Additionally, the medication can delay gastric emptying and suppress appetite, both of which assist in weight management.”

The current study examined whether there was a difference in oocyte retrieval number in women based on days of discontinuation of GLP-1 agonists prior to the procedure, Trolice told this news organization. “Given the drug’s mechanism of action, there is no apparent biological influence that would impact oocyte yield. Consequently, the study outcome is not unexpected.”

The study purports potential reassurance that GLP-1 exposure, regardless of the duration of discontinuation, has no impact on egg retrieval number, said Trolice. However, “Based on the size of the study, to accept the findings as definitive would risk a type II statistical error.”

Two key areas for additional research are urgently needed, Trolice said, namely, the duration of time to discontinue GLP-1 agonists, if at all, prior to conception, and the discontinuation interval, if at all, prior to anesthesia to avoid airway complications.

The American Society of Anesthesiologists advises patients on daily dosing to consider holding GLP-1 agonists on the day of a procedure or surgery, and those on weekly dosing should consider discontinuing the medication 1 week before the procedure or surgery, Trolice noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Trolice had no financial conflicts to disclose and serves on the editorial advisory board of OB/GYN News.

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

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Primary Care Physicians Underutilize Nonantibiotic Prophylaxis for Recurrent UTIs

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Changed
Fri, 11/01/2024 - 13:39

While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

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

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While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

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

While primary care physicians are generally comfortable prescribing vaginal estrogen therapy for recurrent urinary tract infections (UTIs), other nonantibiotic prophylactic options remain significantly underutilized, according to new research that highlights a crucial gap in antibiotic stewardship practices among primary care physicians.

UTIs are the most common bacterial infection in women of all ages, and an estimated 30%-40% of women will experience reinfection within 6 months. Recurrent UTI is typically defined as two or more infections within 6 months or a greater number of infections within a year, according to the American Academy of Family Physicians.

Antibiotics are the first line of defense in preventing and treating recurrent UTIs, but repeated and prolonged use could lead to antibiotic resistance.

Researchers at the University of North Carolina surveyed 40 primary care physicians at one academic medical center and found that 96% of primary care physicians prescribe vaginal estrogen therapy for recurrent UTI prevention, with 58% doing so “often.” Estrogen deficiency and urinary retention are strong contributors to infection.

However, 78% of physicians surveyed said they had never prescribed methenamine hippurate, and 85% said they had never prescribed D-mannose.

Physicians with specialized training in menopausal care felt more at ease prescribing vaginal estrogen therapy to patients with complex medical histories, such as those with a family history of breast cancer or endometrial cancer. This suggests that enhanced education could play a vital role in increasing comfort levels among general practitioners, said Lauren Tholemeier, MD, a urogynecology fellow at the University of North Carolina at Chapel Hill.

“Primary care physicians are the front line of managing patients with recurrent UTI,” said Tholemeier.

“There’s an opportunity for further education on, and even awareness of, methenamine hippurate and D-mannose as an option that has data behind it and can be included as a tool” for patient care, she said.

Indeed, physicians who saw six or more recurrent patients with UTI each month were more likely to prescribe methenamine hippurate, the study found, suggesting that familiarity with recurrent UTI cases can lead to greater confidence in employing alternative prophylactic strategies.

Tholemeier presented her research at the American Urogynecologic Society’s PFD Week in Washington, DC.

Expanding physician knowledge and utilization of all available nonantibiotic therapies can help them better care for patients who don’t necessarily have access to a subspecialist, Tholemeier said.

According to the American Urogynecologic Society’s best practice guidelines, there is limited evidence supporting routine use of D-mannose to prevent recurrent UTI. Methenamine hippurate, however, may be effective for short-term UTI prevention, according to the group.

By broadening the use of vaginal estrogen therapy, methenamine hippurate, and D-mannose, primary care physicians can help reduce reliance on antibiotics for recurrent UTI prevention — a practice that may contribute to growing antibiotic resistance, said Tholemeier.

“The end goal isn’t going to be to say that we should never prescribe antibiotics for UTI infection,” said Tholemeier, adding that, in some cases, physicians can consider using these other medications in conjunction with antibiotics.

“But it’s knowing they [clinicians] have some other options in their toolbox,” she said.

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

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Over-the-Counter UTI Products: What Primary Care Clinicians Need to Know

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Fri, 11/01/2024 - 11:51

When it comes to managing urinary tract infections (UTIs), patients often turn to over-the-counter (OTC) products in search of quick relief. However, recent research suggests some products promise more than they can deliver and can vary widely in price and ingredients. For primary care clinicians, understanding these differences could make all the difference in offering effective, cost-conscious advice to patients.

Researchers from the University of Wisconsin analyzed OTC products marketed for urinary tract health in three major US drugstores and found significant price variations and a wide array of active ingredients.

Their study, presented at the American Urogynecologic Society’s PFD Week conference, found that the price of OTC products fluctuates dramatically. Phenazopyridine hydrochloride, commonly used for UTI symptom relief, ranged from $0.17 to $0.83 per tablet, the study found. Methenamine/sodium salicylate combinations, which are marketed for UTI prevention, varied from $0.13 to $0.33 per tablet. Cranberry supplements — often touted for their preventive benefits — showed the most extreme price range, from as low as $0.07 to as high as $1.00 per serving.

The study also looked into the ingredients, which were categorized into five main groups: Phenazopyridine hydrochloride, methenamine/sodium salicylate, cranberry supplements, D-mannose, and cranberry/D-mannose combinations.

These ingredients vary not only in price but also in the strength of scientific evidence supporting their use.

The researchers concluded:

  • Phenazopyridine hydrochloride offers effective symptom relief but is not a UTI treatment.
  • Methenamine/sodium salicylate shows potential for preventing recurrent UTIs in certain patients.
  • Cranberry supplements have limited evidence for preventing UTIs, with no proof they treat infections.
  • D-mannose has shown promise for short-term use in preventing recurrent UTIs, though more research is needed to weigh its effectiveness in the long run.

“No OTC product within its respective category is superior to another,” said Ushma J. Patel, MD, a fellow in Urogynecology and Reconstructive Pelvic Surgery at the University of Wisconsin School of Medicine and Public Health, Madison, and lead author of the study.

Patel and her coresearcher also found that many products are falsely marketed as treatments for UTI.

“The products in each type of category are for symptom relief or UTI prevention — not treatment,” said Patel. “These products within the categories described are interchangeable, and consumers should make cost-effective choices as no product is superior to another within its respective category.”

This presents the opportunity for clinicians to guide individuals to pick the right products while explaining that symptom relief doesn’t necessarily mean an infection is being treated, Patel said.

Indeed, Patel proposed that clinicians utilize a summary table created from their findings to offer patients vetted information about OTC UTI products.

And, while OTC products can provide benefits, they should not replace proper medical evaluation and treatment of UTIs.

“If patients are experiencing ongoing symptoms or develop new-onset symptoms despite trialing an over-the-counter product, they should contact a healthcare provider,” said Patel. “OTC products can provide symptom relief until patients are able to see a healthcare provider.”

The researchers reported no relevant disclosures.

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

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When it comes to managing urinary tract infections (UTIs), patients often turn to over-the-counter (OTC) products in search of quick relief. However, recent research suggests some products promise more than they can deliver and can vary widely in price and ingredients. For primary care clinicians, understanding these differences could make all the difference in offering effective, cost-conscious advice to patients.

Researchers from the University of Wisconsin analyzed OTC products marketed for urinary tract health in three major US drugstores and found significant price variations and a wide array of active ingredients.

Their study, presented at the American Urogynecologic Society’s PFD Week conference, found that the price of OTC products fluctuates dramatically. Phenazopyridine hydrochloride, commonly used for UTI symptom relief, ranged from $0.17 to $0.83 per tablet, the study found. Methenamine/sodium salicylate combinations, which are marketed for UTI prevention, varied from $0.13 to $0.33 per tablet. Cranberry supplements — often touted for their preventive benefits — showed the most extreme price range, from as low as $0.07 to as high as $1.00 per serving.

The study also looked into the ingredients, which were categorized into five main groups: Phenazopyridine hydrochloride, methenamine/sodium salicylate, cranberry supplements, D-mannose, and cranberry/D-mannose combinations.

These ingredients vary not only in price but also in the strength of scientific evidence supporting their use.

The researchers concluded:

  • Phenazopyridine hydrochloride offers effective symptom relief but is not a UTI treatment.
  • Methenamine/sodium salicylate shows potential for preventing recurrent UTIs in certain patients.
  • Cranberry supplements have limited evidence for preventing UTIs, with no proof they treat infections.
  • D-mannose has shown promise for short-term use in preventing recurrent UTIs, though more research is needed to weigh its effectiveness in the long run.

“No OTC product within its respective category is superior to another,” said Ushma J. Patel, MD, a fellow in Urogynecology and Reconstructive Pelvic Surgery at the University of Wisconsin School of Medicine and Public Health, Madison, and lead author of the study.

Patel and her coresearcher also found that many products are falsely marketed as treatments for UTI.

“The products in each type of category are for symptom relief or UTI prevention — not treatment,” said Patel. “These products within the categories described are interchangeable, and consumers should make cost-effective choices as no product is superior to another within its respective category.”

This presents the opportunity for clinicians to guide individuals to pick the right products while explaining that symptom relief doesn’t necessarily mean an infection is being treated, Patel said.

Indeed, Patel proposed that clinicians utilize a summary table created from their findings to offer patients vetted information about OTC UTI products.

And, while OTC products can provide benefits, they should not replace proper medical evaluation and treatment of UTIs.

“If patients are experiencing ongoing symptoms or develop new-onset symptoms despite trialing an over-the-counter product, they should contact a healthcare provider,” said Patel. “OTC products can provide symptom relief until patients are able to see a healthcare provider.”

The researchers reported no relevant disclosures.

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

When it comes to managing urinary tract infections (UTIs), patients often turn to over-the-counter (OTC) products in search of quick relief. However, recent research suggests some products promise more than they can deliver and can vary widely in price and ingredients. For primary care clinicians, understanding these differences could make all the difference in offering effective, cost-conscious advice to patients.

Researchers from the University of Wisconsin analyzed OTC products marketed for urinary tract health in three major US drugstores and found significant price variations and a wide array of active ingredients.

Their study, presented at the American Urogynecologic Society’s PFD Week conference, found that the price of OTC products fluctuates dramatically. Phenazopyridine hydrochloride, commonly used for UTI symptom relief, ranged from $0.17 to $0.83 per tablet, the study found. Methenamine/sodium salicylate combinations, which are marketed for UTI prevention, varied from $0.13 to $0.33 per tablet. Cranberry supplements — often touted for their preventive benefits — showed the most extreme price range, from as low as $0.07 to as high as $1.00 per serving.

The study also looked into the ingredients, which were categorized into five main groups: Phenazopyridine hydrochloride, methenamine/sodium salicylate, cranberry supplements, D-mannose, and cranberry/D-mannose combinations.

These ingredients vary not only in price but also in the strength of scientific evidence supporting their use.

The researchers concluded:

  • Phenazopyridine hydrochloride offers effective symptom relief but is not a UTI treatment.
  • Methenamine/sodium salicylate shows potential for preventing recurrent UTIs in certain patients.
  • Cranberry supplements have limited evidence for preventing UTIs, with no proof they treat infections.
  • D-mannose has shown promise for short-term use in preventing recurrent UTIs, though more research is needed to weigh its effectiveness in the long run.

“No OTC product within its respective category is superior to another,” said Ushma J. Patel, MD, a fellow in Urogynecology and Reconstructive Pelvic Surgery at the University of Wisconsin School of Medicine and Public Health, Madison, and lead author of the study.

Patel and her coresearcher also found that many products are falsely marketed as treatments for UTI.

“The products in each type of category are for symptom relief or UTI prevention — not treatment,” said Patel. “These products within the categories described are interchangeable, and consumers should make cost-effective choices as no product is superior to another within its respective category.”

This presents the opportunity for clinicians to guide individuals to pick the right products while explaining that symptom relief doesn’t necessarily mean an infection is being treated, Patel said.

Indeed, Patel proposed that clinicians utilize a summary table created from their findings to offer patients vetted information about OTC UTI products.

And, while OTC products can provide benefits, they should not replace proper medical evaluation and treatment of UTIs.

“If patients are experiencing ongoing symptoms or develop new-onset symptoms despite trialing an over-the-counter product, they should contact a healthcare provider,” said Patel. “OTC products can provide symptom relief until patients are able to see a healthcare provider.”

The researchers reported no relevant disclosures.

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

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