Brittany Vargas

An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

TOPLINE:

A natural sugar used to treat recurring urinary tract infections (rUTIs) did not reduce future episodes, outpatient visits, the use of antibiotics, or symptoms compared with a placebo, according to a new study.

METHODOLOGY:

• D-Mannose is recommended as a natural alternative to antibiotics and sold as a dietary supplement; research showing the efficacy of D-mannose in treating UTIs is mixed.
• The double-blind, randomized controlled trial followed 598 women older than 18 years (median age, 61.3; range 18.2-93.5 years) with a history of rUTIs over 6 months from nearly 100 primary care clinics in the United Kingdom.
• Patients took 2 g of D-mannose or placebo powder daily and recorded their symptoms using a daily diary or through responses to health surveys, weekly questionnaires, and phone calls.
• Researchers checked medical records for urine culture results, antibiotic prescriptions, hospitalizations, and outpatient visits for UTIs.

TAKEAWAY:

• Approximately 51% of participants who took D-mannose and 55.7% of those who took a placebo contacted a healthcare professional reporting a UTI (relative risk, 0.92; 95% CI, 0.80-1.05; P = .22).
• Women in both groups reported similar durations of “moderately bad” or “worse” symptoms, and the number of antibiotic courses, instances of clinically suspected UTIs, and hospital admissions were similar between the two groups.
• Some studies have reported that synthetic mannosides are promising alternatives to D-mannose.

IN PRACTICE:

“D-Mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care,” the study authors wrote.

SOURCE:

The study was led by Gail Hayward, DPhil, associate professor at the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England, and was published online in JAMA Internal Medicine.

LIMITATIONS:

Some participants may have taken less than 2 mg/d or skipped days. Because researchers used powder rather than capsules, dosing could have been inconsistent. Researchers did not obtain a microbiologic confirmation for each rUTI. A small percentage of women were taking antibiotics.

DISCLOSURES:

The study was funded by the National Institute for Health and Care Research (NIHR) School for Primary Care Research and the NIHR Oxford Biomedical Research Centre. Various authors reported receiving support from the NIHR Health Protection Research Unit on Healthcare-Associated Infections and Antimicrobial Resistance and were NIHR investigators.

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

The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.

Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.

“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.

But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.

“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
 

The Promise and Risks of OTT

OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.

Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.

The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.

OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.

Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.

The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.

The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.

While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.

“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.

Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.

A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
 

Why Delay Menopause?

While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.

Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.

Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.

But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.

“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”

The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.

A version of this article appeared on Medscape.com.

The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.

Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.

“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.

But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.

“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
 

The Promise and Risks of OTT

OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.

Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.

The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.

OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.

Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.

The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.

The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.

While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.

“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.

Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.

A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
 

Why Delay Menopause?

While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.

Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.

Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.

But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.

“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”

The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.

A version of this article appeared on Medscape.com.

The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.

Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.

“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.

But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.

“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
 

The Promise and Risks of OTT

OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.

Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.

The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.

OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.

Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.

The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.

The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.

While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.

“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.

Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.

A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
 

Why Delay Menopause?

While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.

Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.

Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.

But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.

“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”

The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics

METHODOLOGY:

• School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
• Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
• The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
• Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
• Researchers compared the rates of new cavities and fillings between the two groups over time.

TAKEAWAY:

• Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
• The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
• The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
• Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).

IN PRACTICE:

“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”

SOURCE:

The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.

LIMITATIONS:

The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition. 

DISCLOSURES:

Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics

METHODOLOGY:

• School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
• Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
• The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
• Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
• Researchers compared the rates of new cavities and fillings between the two groups over time.

TAKEAWAY:

• Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
• The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
• The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
• Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).

IN PRACTICE:

“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”

SOURCE:

The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.

LIMITATIONS:

The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition. 

DISCLOSURES:

Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics

METHODOLOGY:

• School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
• Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
• The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
• Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
• Researchers compared the rates of new cavities and fillings between the two groups over time.

TAKEAWAY:

• Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
• The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
• The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
• Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).

IN PRACTICE:

“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”

SOURCE:

The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.

LIMITATIONS:

The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition. 

DISCLOSURES:

Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

Watchful waiting is as medically appropriate as physical therapy (PT) for patients with shoulder adhesive capsulitis but carries substantial cost savings, according to a study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons. 

The lack of active treatment for the condition, commonly known as frozen shoulder, may be a win for some patients and their clinicians, said Scott D. Martin, MD, orthopedic surgeon and associate professor of orthopedic surgery at Harvard Medical School in Boston, Massachusetts, and lead author of the study. 

“When you tell them [patients], ‘you’re going to have to go to therapy two times a week, and it’s going to be for a very extended period of time,’ they just look at you and you know that they don’t have money for the copay, that they’re not going to go,” Dr. Martin said. 

The 31 patients who were randomly assigned to watchful waiting and the 30 who received PT in the prospective controlled trial reported similar reductions in symptoms over a year-long period. But those who received PT spent 10 times more on healthcare costs than did those in the other group. 

“The findings are compelling,” said Jonathan L. Tueting, MD, an orthopedic surgeon at Rush University in Chicago. “Anytime we can save on healthcare costs for patients, it’s an advantage, as long as the outcomes are the same or better.”

Dr. Tueting typically advises both watchful waiting and PT for his patients for a 6-month period before recommending surgery unless a patient has a severely stuck shoulder. 

The study took place between 2014 and 2022 at the Massachusetts General Hospital Sports Medicine Clinic. Researchers assessed the effectiveness of the two approaches using patient questionnaires, including one that asked about shoulder mobility and levels of pain. 

Assessments were collected at 6 weeks, and at the 3- , 6- , and 12-month marks. 

Patients in the PT group received treatment twice a week and were also given a home exercise program. Meanwhile, those in the watchful waiting group were told to use their affected shoulder as tolerated for daily activities. 

Patients in both groups received a corticosteroid injection at the start of the study plus another in 6 months if they still had extremely limited shoulder movement and were encouraged to take nonsteroidal anti-inflammatory drugs for pain control. 

By the end of the year, patients in both groups recovered their shoulder function almost completely and with limited pain. 

Measures of pain and mobility as reported by patients improved incrementally throughout the year, with no significant differences between the two groups at any point (P > .05). No significant difference in satisfaction with their treatment regimen and outcomes was observed between the groups (P = .51), according to the researchers. 

To calculate treatment value, researchers considered a wide range of costs associated with treatment, including parking fees, gas, copays, childcare, lost work time, and insurance. Watchful waiting proved to be a much better value proposition than did PT. 

“Patients with frozen shoulder need to go to physical therapy a lot, if that’s what they choose, because there’s not much progress,” Dr. Martin said. “So the economic burden is huge, and that cost gets passed on to the insured. 

Dr. Martin and his team are continuing to follow study participants for another year and will publish outcomes at the 2-year mark. Dr. Tueting said he looks forward to seeing those data because sometimes, the condition can take over a year to resolve. 

The study was funded by the Conine Family Fund for Joint Preservation. The authors report no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

METHODOLOGY:

• Cefepime-taniborbactam is an antibiotic currently being explored as a treatment for antibiotic-resistant bacteria.
• The phase 3, double-blind, randomized trial included participants from 15 countries, including a safety group of 657 patients who were studied for adverse events and 436 in the micro intention-to-treat group who were studied for drug effectiveness.
• Each drug’s efficacy was measured as a combination of reduced bacteria levels and a resolution of symptoms and signs of infection.
• Patients in the study were over age 18; had a diagnosis of either complicated UTI or acute pyelonephritis; and had pyuria, at least one systemic sign, and at least one local sign or symptom. People were excluded if they had already received antibacterial drug therapy for more than 24 hours before randomization or had an infection with a meropenem-resistant pathogen.

TAKEAWAY:

• At days 19-23, 70.6% of patients in the cefepime-taniborbactam group showed a successful reduction in bacteria and symptoms compared with 58.0% in the meropenem group.
• Cefepime-taniborbactam was more effective than meropenem during follow-up, with 89.1% efficacy less than 24 hours after the last dose, compared to meropenem’s 86%. Cefepime-taniborbactam continued to have 63.8% efficacy up to 35 days after starting treatment, while meropenem was 51.7% during that timeframe.
• In the cefepime-taniborbactam group, 35.5% of patients experienced adverse effects that were mild to moderate, including headache, diarrhea, constipation, hypertension, and nausea, compared to 29% in the meropenem group.
• Overall, 3% of participants discontinued cefepime-taniborbactam and 1.8% discontinued meropenem, but reasons were heterogeneous.

IN PRACTICE:

“Cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a safety profile similar to that of meropenem,” the study authors wrote.

SOURCE:

Paul McGovern, MD, infectious disease specialist and senior vice president of Venatorx Pharmaceuticals, was the corresponding author of the study.

LIMITATIONS:

The authors reported no limitations.

DISCLOSURES:

The study was funded by Venatorx Pharmaceuticals, which received funding from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Global Antibiotic Research and Development Partnership, and Everest Medicines.

A version of this article appeared on Medscape.com.

TOPLINE:

Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

METHODOLOGY:

• Cefepime-taniborbactam is an antibiotic currently being explored as a treatment for antibiotic-resistant bacteria.
• The phase 3, double-blind, randomized trial included participants from 15 countries, including a safety group of 657 patients who were studied for adverse events and 436 in the micro intention-to-treat group who were studied for drug effectiveness.
• Each drug’s efficacy was measured as a combination of reduced bacteria levels and a resolution of symptoms and signs of infection.
• Patients in the study were over age 18; had a diagnosis of either complicated UTI or acute pyelonephritis; and had pyuria, at least one systemic sign, and at least one local sign or symptom. People were excluded if they had already received antibacterial drug therapy for more than 24 hours before randomization or had an infection with a meropenem-resistant pathogen.

TAKEAWAY:

• At days 19-23, 70.6% of patients in the cefepime-taniborbactam group showed a successful reduction in bacteria and symptoms compared with 58.0% in the meropenem group.
• Cefepime-taniborbactam was more effective than meropenem during follow-up, with 89.1% efficacy less than 24 hours after the last dose, compared to meropenem’s 86%. Cefepime-taniborbactam continued to have 63.8% efficacy up to 35 days after starting treatment, while meropenem was 51.7% during that timeframe.
• In the cefepime-taniborbactam group, 35.5% of patients experienced adverse effects that were mild to moderate, including headache, diarrhea, constipation, hypertension, and nausea, compared to 29% in the meropenem group.
• Overall, 3% of participants discontinued cefepime-taniborbactam and 1.8% discontinued meropenem, but reasons were heterogeneous.

IN PRACTICE:

“Cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a safety profile similar to that of meropenem,” the study authors wrote.

SOURCE:

Paul McGovern, MD, infectious disease specialist and senior vice president of Venatorx Pharmaceuticals, was the corresponding author of the study.

LIMITATIONS:

The authors reported no limitations.

DISCLOSURES:

The study was funded by Venatorx Pharmaceuticals, which received funding from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Global Antibiotic Research and Development Partnership, and Everest Medicines.

A version of this article appeared on Medscape.com.

TOPLINE:

Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

METHODOLOGY:

• Cefepime-taniborbactam is an antibiotic currently being explored as a treatment for antibiotic-resistant bacteria.
• The phase 3, double-blind, randomized trial included participants from 15 countries, including a safety group of 657 patients who were studied for adverse events and 436 in the micro intention-to-treat group who were studied for drug effectiveness.
• Each drug’s efficacy was measured as a combination of reduced bacteria levels and a resolution of symptoms and signs of infection.
• Patients in the study were over age 18; had a diagnosis of either complicated UTI or acute pyelonephritis; and had pyuria, at least one systemic sign, and at least one local sign or symptom. People were excluded if they had already received antibacterial drug therapy for more than 24 hours before randomization or had an infection with a meropenem-resistant pathogen.

TAKEAWAY:

• At days 19-23, 70.6% of patients in the cefepime-taniborbactam group showed a successful reduction in bacteria and symptoms compared with 58.0% in the meropenem group.
• Cefepime-taniborbactam was more effective than meropenem during follow-up, with 89.1% efficacy less than 24 hours after the last dose, compared to meropenem’s 86%. Cefepime-taniborbactam continued to have 63.8% efficacy up to 35 days after starting treatment, while meropenem was 51.7% during that timeframe.
• In the cefepime-taniborbactam group, 35.5% of patients experienced adverse effects that were mild to moderate, including headache, diarrhea, constipation, hypertension, and nausea, compared to 29% in the meropenem group.
• Overall, 3% of participants discontinued cefepime-taniborbactam and 1.8% discontinued meropenem, but reasons were heterogeneous.

IN PRACTICE:

“Cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a safety profile similar to that of meropenem,” the study authors wrote.

SOURCE:

Paul McGovern, MD, infectious disease specialist and senior vice president of Venatorx Pharmaceuticals, was the corresponding author of the study.

LIMITATIONS:

The authors reported no limitations.

DISCLOSURES:

The study was funded by Venatorx Pharmaceuticals, which received funding from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Global Antibiotic Research and Development Partnership, and Everest Medicines.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral antibiotics may be a safe alternative to receiving prolonged intravenous (IV) antibiotics, according to a recent observational study published in JAMA Network Open.

METHODOLOGY:

• Patients receiving antibiotics through an IV line risk developing a secondary infection; antibiotics received orally are considered safer.
• Researchers analyzed observational data from 914 adults with uncomplicated gram-negative bacteremia who received care in four hospitals in Denmark between 2018 and 2021.
• The outcomes of patients who were switched to oral antibiotics within 4 days after a positive blood culture were compared with those who continued to receive IV antibiotics for at least 5 days after the blood culture; participants in both groups received antibiotics for 7-14 days.
• Researchers assessed mortality rates over a 90-day window and used a target trial emulation method to conduct the study.

TAKEAWAY:

• Overall, 14.3% of patients who received prolonged IV treatment died, compared with 6.9% in the oral antibiotics group.
• In an intention-to-treat analysis, patients who were switched to oral antibiotics had a 22% lower risk for death within 90 days of initiation of treatment (relative risk [RR], 0.78; 95% CI, 0.60-1.10).
• In a per-protocol analysis, patients who switched to the oral route had a 1% lower odds of dying within 90 days (RR, 0.99; 95% CI, 0.70-1.40).
• Individuals who were switched to oral antibiotic treatment were younger than those who continued to receive antibiotics via the IV route (median age, 73 vs 76 years, respectively), had fewer comorbidities (four vs five), and were more likely to have community-acquired gram-negative bacteremia (89.4% vs 80.9%).

IN PRACTICE:

“These findings suggest that the mortality associated with early antibiotic stepdown treatment is comparable to that associated with receiving prolonged IV antibiotic treatment for individuals with uncomplicated gram-negative bacteremia,” the authors of the study wrote.

SOURCE:

The study was led by Sandra Tingsgård, MD, of the Center of Research & Department of Infectious Diseases at Copenhagen University Hospital–Amager and Hvidovre in Denmark.

LIMITATIONS:

The study was based on data from electronic health records, so some factors may not have been recorded or considered. The researchers identified few cases of multidrug-resistant infections, and the findings may not apply to those cases. Complicated cases and people who were not stabilized by day 4 were excluded from the analysis.

DISCLOSURES:

The authors report no disclosures or sources of funding.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral antibiotics may be a safe alternative to receiving prolonged intravenous (IV) antibiotics, according to a recent observational study published in JAMA Network Open.

METHODOLOGY:

• Patients receiving antibiotics through an IV line risk developing a secondary infection; antibiotics received orally are considered safer.
• Researchers analyzed observational data from 914 adults with uncomplicated gram-negative bacteremia who received care in four hospitals in Denmark between 2018 and 2021.
• The outcomes of patients who were switched to oral antibiotics within 4 days after a positive blood culture were compared with those who continued to receive IV antibiotics for at least 5 days after the blood culture; participants in both groups received antibiotics for 7-14 days.
• Researchers assessed mortality rates over a 90-day window and used a target trial emulation method to conduct the study.

TAKEAWAY:

• Overall, 14.3% of patients who received prolonged IV treatment died, compared with 6.9% in the oral antibiotics group.
• In an intention-to-treat analysis, patients who were switched to oral antibiotics had a 22% lower risk for death within 90 days of initiation of treatment (relative risk [RR], 0.78; 95% CI, 0.60-1.10).
• In a per-protocol analysis, patients who switched to the oral route had a 1% lower odds of dying within 90 days (RR, 0.99; 95% CI, 0.70-1.40).
• Individuals who were switched to oral antibiotic treatment were younger than those who continued to receive antibiotics via the IV route (median age, 73 vs 76 years, respectively), had fewer comorbidities (four vs five), and were more likely to have community-acquired gram-negative bacteremia (89.4% vs 80.9%).

IN PRACTICE:

“These findings suggest that the mortality associated with early antibiotic stepdown treatment is comparable to that associated with receiving prolonged IV antibiotic treatment for individuals with uncomplicated gram-negative bacteremia,” the authors of the study wrote.

SOURCE:

The study was led by Sandra Tingsgård, MD, of the Center of Research & Department of Infectious Diseases at Copenhagen University Hospital–Amager and Hvidovre in Denmark.

LIMITATIONS:

The study was based on data from electronic health records, so some factors may not have been recorded or considered. The researchers identified few cases of multidrug-resistant infections, and the findings may not apply to those cases. Complicated cases and people who were not stabilized by day 4 were excluded from the analysis.

DISCLOSURES:

The authors report no disclosures or sources of funding.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral antibiotics may be a safe alternative to receiving prolonged intravenous (IV) antibiotics, according to a recent observational study published in JAMA Network Open.

METHODOLOGY:

• Patients receiving antibiotics through an IV line risk developing a secondary infection; antibiotics received orally are considered safer.
• Researchers analyzed observational data from 914 adults with uncomplicated gram-negative bacteremia who received care in four hospitals in Denmark between 2018 and 2021.
• The outcomes of patients who were switched to oral antibiotics within 4 days after a positive blood culture were compared with those who continued to receive IV antibiotics for at least 5 days after the blood culture; participants in both groups received antibiotics for 7-14 days.
• Researchers assessed mortality rates over a 90-day window and used a target trial emulation method to conduct the study.

TAKEAWAY:

• Overall, 14.3% of patients who received prolonged IV treatment died, compared with 6.9% in the oral antibiotics group.
• In an intention-to-treat analysis, patients who were switched to oral antibiotics had a 22% lower risk for death within 90 days of initiation of treatment (relative risk [RR], 0.78; 95% CI, 0.60-1.10).
• In a per-protocol analysis, patients who switched to the oral route had a 1% lower odds of dying within 90 days (RR, 0.99; 95% CI, 0.70-1.40).
• Individuals who were switched to oral antibiotic treatment were younger than those who continued to receive antibiotics via the IV route (median age, 73 vs 76 years, respectively), had fewer comorbidities (four vs five), and were more likely to have community-acquired gram-negative bacteremia (89.4% vs 80.9%).

IN PRACTICE:

“These findings suggest that the mortality associated with early antibiotic stepdown treatment is comparable to that associated with receiving prolonged IV antibiotic treatment for individuals with uncomplicated gram-negative bacteremia,” the authors of the study wrote.

SOURCE:

The study was led by Sandra Tingsgård, MD, of the Center of Research & Department of Infectious Diseases at Copenhagen University Hospital–Amager and Hvidovre in Denmark.

LIMITATIONS:

The study was based on data from electronic health records, so some factors may not have been recorded or considered. The researchers identified few cases of multidrug-resistant infections, and the findings may not apply to those cases. Complicated cases and people who were not stabilized by day 4 were excluded from the analysis.

DISCLOSURES:

The authors report no disclosures or sources of funding.

A version of this article appeared on Medscape.com.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

Two doses of the recombinant zoster vaccine (RZV) are effective against herpes zoster (HZ) for 4 years after vaccination, according to a new study published in Annals of Internal Medicine.

Findings from the prospective cohort study showed that people who received two doses of the vaccine, regardless of when they received their second dose, experienced 79% vaccine effectiveness (VE) during the first year, with effectiveness decreasing to 73% by year 4. By contrast, the rate of effectiveness during the first year was 70% for people who received a single dose, falling to 52% effectiveness by year 4.

The findings also showed that the rate of effectiveness was 65% for those taking corticosteroids.

The study was conducted between 2018 and 2022 using data from the Vaccine Safety Datalink, a collaboration between the US Centers for Disease Control and Prevention (CDC) and nine healthcare systems across the country.

Researchers evaluated the incidence of HZ, as determined by a diagnosis and prescription for antiviral medication within 7 days of diagnosis, and monitored RZV status over time.

The findings may quell fears that waiting too long for the second dose reduces the effectiveness of the herpes vaccine, according to Nicola Klein, MD, PhD, director of the Vaccine Study Center at Kaiser Permanente in Oakland, California, who led the study.

The long-term efficacy of the vaccine is especially important because older adults are now living much longer than in previous years, according to Alexandra Tien, MD, a family physician at Medical Associates of Rhode Island in Providence.

“People live these days into their 80s and even 90s,” Dr. Tien said. “That’s a large number of years to need protection for, so it’s really important to have a long-lasting vaccine.”

The CDC currently recommends two doses of RZV separated by 2-6 months for patients aged 50 years and older. Adults older than 19 years who are immunocompromised should receive two doses of RZV separated by 1-2 months, the agency said.

According to Dr. Klein, research does not show whether VE for RZV wanes after 4 years. But interim findings from another study following people in clinical trials found VE levels remained high after 7 years.

The risk for HZ increases with age, reaching a lifetime risk of 50% among adults aged 85 years. Complications like postherpetic neuralgia (PHN) — characterized by long-term tingling, numbness, and disabling pain at the site of the rash — can interfere with the quality of life and ability to function in older adults. The CDC estimates that up to 18% of people with shingles experience PHN, and the risk increases with age.

Just like with any other vaccine, patients sometimes have concerns about the potential side effects of RZV, said Dr. Tien. But those effects, such as muscle pain, nausea, and fever, are mild compared to shingles.

“I always tell patients, with any vaccine, immunization is one of the biggest bangs for your buck in healthcare because you’re preventing a problem,” Dr. Tien said.

This study was funded by the CDC through contracts with participating sites. Study authors reported no disclosures. Dr. Tien reported no disclosures.

A version of this article appeared on Medscape.com.

Two doses of the recombinant zoster vaccine (RZV) are effective against herpes zoster (HZ) for 4 years after vaccination, according to a new study published in Annals of Internal Medicine.

Findings from the prospective cohort study showed that people who received two doses of the vaccine, regardless of when they received their second dose, experienced 79% vaccine effectiveness (VE) during the first year, with effectiveness decreasing to 73% by year 4. By contrast, the rate of effectiveness during the first year was 70% for people who received a single dose, falling to 52% effectiveness by year 4.

The findings also showed that the rate of effectiveness was 65% for those taking corticosteroids.

The study was conducted between 2018 and 2022 using data from the Vaccine Safety Datalink, a collaboration between the US Centers for Disease Control and Prevention (CDC) and nine healthcare systems across the country.

Researchers evaluated the incidence of HZ, as determined by a diagnosis and prescription for antiviral medication within 7 days of diagnosis, and monitored RZV status over time.

The findings may quell fears that waiting too long for the second dose reduces the effectiveness of the herpes vaccine, according to Nicola Klein, MD, PhD, director of the Vaccine Study Center at Kaiser Permanente in Oakland, California, who led the study.

The long-term efficacy of the vaccine is especially important because older adults are now living much longer than in previous years, according to Alexandra Tien, MD, a family physician at Medical Associates of Rhode Island in Providence.

“People live these days into their 80s and even 90s,” Dr. Tien said. “That’s a large number of years to need protection for, so it’s really important to have a long-lasting vaccine.”

The CDC currently recommends two doses of RZV separated by 2-6 months for patients aged 50 years and older. Adults older than 19 years who are immunocompromised should receive two doses of RZV separated by 1-2 months, the agency said.

According to Dr. Klein, research does not show whether VE for RZV wanes after 4 years. But interim findings from another study following people in clinical trials found VE levels remained high after 7 years.

The risk for HZ increases with age, reaching a lifetime risk of 50% among adults aged 85 years. Complications like postherpetic neuralgia (PHN) — characterized by long-term tingling, numbness, and disabling pain at the site of the rash — can interfere with the quality of life and ability to function in older adults. The CDC estimates that up to 18% of people with shingles experience PHN, and the risk increases with age.

Just like with any other vaccine, patients sometimes have concerns about the potential side effects of RZV, said Dr. Tien. But those effects, such as muscle pain, nausea, and fever, are mild compared to shingles.

“I always tell patients, with any vaccine, immunization is one of the biggest bangs for your buck in healthcare because you’re preventing a problem,” Dr. Tien said.

This study was funded by the CDC through contracts with participating sites. Study authors reported no disclosures. Dr. Tien reported no disclosures.

A version of this article appeared on Medscape.com.

Two doses of the recombinant zoster vaccine (RZV) are effective against herpes zoster (HZ) for 4 years after vaccination, according to a new study published in Annals of Internal Medicine.

Findings from the prospective cohort study showed that people who received two doses of the vaccine, regardless of when they received their second dose, experienced 79% vaccine effectiveness (VE) during the first year, with effectiveness decreasing to 73% by year 4. By contrast, the rate of effectiveness during the first year was 70% for people who received a single dose, falling to 52% effectiveness by year 4.

The findings also showed that the rate of effectiveness was 65% for those taking corticosteroids.

The study was conducted between 2018 and 2022 using data from the Vaccine Safety Datalink, a collaboration between the US Centers for Disease Control and Prevention (CDC) and nine healthcare systems across the country.

Researchers evaluated the incidence of HZ, as determined by a diagnosis and prescription for antiviral medication within 7 days of diagnosis, and monitored RZV status over time.

The findings may quell fears that waiting too long for the second dose reduces the effectiveness of the herpes vaccine, according to Nicola Klein, MD, PhD, director of the Vaccine Study Center at Kaiser Permanente in Oakland, California, who led the study.

The long-term efficacy of the vaccine is especially important because older adults are now living much longer than in previous years, according to Alexandra Tien, MD, a family physician at Medical Associates of Rhode Island in Providence.

“People live these days into their 80s and even 90s,” Dr. Tien said. “That’s a large number of years to need protection for, so it’s really important to have a long-lasting vaccine.”

The CDC currently recommends two doses of RZV separated by 2-6 months for patients aged 50 years and older. Adults older than 19 years who are immunocompromised should receive two doses of RZV separated by 1-2 months, the agency said.

According to Dr. Klein, research does not show whether VE for RZV wanes after 4 years. But interim findings from another study following people in clinical trials found VE levels remained high after 7 years.

The risk for HZ increases with age, reaching a lifetime risk of 50% among adults aged 85 years. Complications like postherpetic neuralgia (PHN) — characterized by long-term tingling, numbness, and disabling pain at the site of the rash — can interfere with the quality of life and ability to function in older adults. The CDC estimates that up to 18% of people with shingles experience PHN, and the risk increases with age.

Just like with any other vaccine, patients sometimes have concerns about the potential side effects of RZV, said Dr. Tien. But those effects, such as muscle pain, nausea, and fever, are mild compared to shingles.

“I always tell patients, with any vaccine, immunization is one of the biggest bangs for your buck in healthcare because you’re preventing a problem,” Dr. Tien said.

This study was funded by the CDC through contracts with participating sites. Study authors reported no disclosures. Dr. Tien reported no disclosures.

A version of this article appeared on Medscape.com.