Conference Coverage

SAN DIEGO — A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

SAN DIEGO — A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

SAN DIEGO — A lifestyle intervention focused on diet and exercise can improve cardiac function and the quality of life for patients with pulmonary arterial hypertension (PAH), results of a randomized clinical trial show.

At 12 weeks of follow-up, patients with PAH who were randomized to undergo a diet and cardiovascular exercise program had improved right ventricular function, better exercise capacity, and improved quality of life compared with patients randomized to the standard of care.

In addition, for those participants in the diet and exercise group who lost weight, right ventricular glucose uptake improved, reported Gustavo A. Heresi, MD, MS of the division of pulmonary medicine at the Cleveland Clinic.

Neil Osterweil/MDedge News

The intervention did not, however, have an effect on insulin sensitivity, suggesting that insulin resistance is not a significant pathological mechanism in PAH, he said in an oral abstract session at the American Thoracic Society’s international conference.

“With these data, in the context of prior studies showing the benefits of exercise interventions, we believe that diet and exercise should be incorporated and thought of as part of the treatment armamentarium for pulmonary arterial hypertension,” he said.

Despite the availability of 14 FDA-approved medications for PAH, the disease is incurable. It is marked by progressive pulmonary vasoconstriction, pulmonary vascular remodeling, fibrosis and inflammation, in situ thrombosis, and right ventricular failure.

Because abnormalities in both glucose and insulin metabolism are prevalent and associated with decreased survival in patients with PAH, Dr. Heresi and colleagues designed a randomized trial to test the hypothesis that a diet and exercise intervention could improve insulin sensitivity and right ventricular function.
 

PHINE details

In the study, dubbed Pulmonary Arterial Hypertension Improvement with Nutrition and Exercise (PHINE), the investigators enrolled adults with group 1 PAH who were stable on PAH medications for at least 2 months. Patients with portopulmonary hypertension, New York Heart Association (NYHA) class IV heart failure, syncope, or on supplemental oxygen greater than 4 liters per minute were excluded.

The patients were screened with a graded exercise test, intravenous glucose tolerance test, and other measures at baseline, and after stratification by NYHA class and tricuspid annular plane systolic excursion (TAPSE) score were randomized to the intervention arm (16 patients) or standard of care control arm (14 patients).

The intervention consisted of supervised exercise training for 50-60 minutes on a treadmill at 80%-85% of the patient’s maximum heart rate 5 days per week, plus weekly counseling on a combination low glycemic index/Mediterranean dietary pattern. The diet portion included olive oil as the primary fat source, three 1-ounce servings of nuts and peanuts weekly, fish and legumes at a minimum of 3 servings weekly, and no sugar-sweetened beverage, commercial bakery products, pastries, white breads, white rice, or white potatoes.
 

Results

At the conclusion of the study at 12 weeks there were no statistically significant differences between the groups in either insulin sensitivity or right ventricular strain.

However, patients in the intervention arm had significant improvements compared with controls in mean RV function as measured by TAPSE, improved exercise capacity as measured by peak oxygen uptake and 6-minute walking distance, quality of life as measured by EmPHasis-10 health-related quality of life score, and NYHA functional class.

As noted, right ventricular glucose uptake was improved among those patients in the intervention group who lost weight over the study period.
 

Worth trying

Ravi Kalhan, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago, who co-moderated the session but was not involved in the study, said in an interview that the study results show promise.

“We’re so centered on what’s the next big pharmacotherapy you can give to fix the disease, but sometimes maybe we should be pushing lifestyle interventions that are impactful, and they have biologic mechanisms — it’s not just that you got in better shape, but right ventricular function also improves. I’m pretty drawn to that sort of thing,” he said.

“That’s a pretty major effect over a 3-month intervention,” agreed co-moderator Nuala J. Meyer, MD, MS, ATSF, of the Hospital of the University of Pennsylvania.

The PHINE trial was supported by National Institute of Health grants. Dr. Heresi, Dr. Kalhan, and Dr. Meyer reported no conflicts of interest.

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

SAN FRANCISCO — More than a quarter of pregnant or postpartum patients who screened positive for cardiovascular disease ended up with a cardiovascular disease diagnosis when providers used a risk screening tool built into the electronic medical records system for all patients, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Timely diagnosis of cardiovascular disease is critical, though challenging, since pregnancy is a state of hemodynamic stress with symptoms that are like those of cardiovascular disease, and healthcare providers may not suspect cardiovascular disease in pregnant patients with symptoms of it,” Kevin Flatley, MD, a resident ob.gyn. at Montefiore Health System and the Albert Einstein College of Medicine in New York City, told attendees at the conference. “The cardiovascular risk assessment tool proved valuable for identifying and providing individualized care for cardio-obstetric patients.”

The study senior author, Diana S. Wolfe, MD, MPH, associate division director of Maternal Fetal Medicine at Montefiore Health System and associate professor of medicine in cardiology at Albert Einstein College of Medicine, said in an interview that cardiovascular risk in Montefiore’s urban population is significant.

“Cardiovascular disease risk screening identifies true cardiac disease in this population and can change the medical management and outcome of pregnant and postpartum patients,” Dr. Wolfe said. Screening has the potential to decrease maternal morbidity and mortality in our country, she said.

Dawnette Lewis, MD, MPH, director of the Center for Maternal Health at Northwell Health and an ob.gyn. and maternal fetal medicine specialist who was not involved in the study, was impressed with the research.

“We know that cardiovascular disease is one of the leading causes of maternal mortality,” Dr. Lewis said in an interview. “It is important to have an accurate risk assessment score, so I think what is being presented in this abstract is great.” She said she’s aware that other cardio-obstetric programs across the country are also implementing cardiovascular risk assessment tools during pregnancy.

The researchers built into their electronic health records a screening algorithm developed by the California Maternal Quality Care Initiative that had been based on a retrospective review of cardiovascular maternal deaths in California from 2002 to 2006. Their study aimed to identify the true positives — those who actually had cardiovascular disease — of those determined to be at risk by the screening toolkit.

The institution’s goal was for all patients to undergo a screening risk assessment at least once during prenatal and/or postpartum visits. Patients were considered to screen positive if they had at least one symptom, at least one vital sign abnormality, and at least one risk factor, or any combination of these that added up to 4.

Symptoms in the screening tool included shortness of breath, shortness of breath while lying flat, a rapid heart rate, asthma that was unresponsive to therapy, palpitations, fainting or other loss of consciousness, and chest pain. Abnormal vital signs included a resting heart rate of 110 bpm or greater, systolic blood pressure of 140 mm Hg or higher, a respiratory rate of 24 or higher, and an oxygen saturation of 96% or lower.

Risk factors included being 40 or older, being Black, having a pre-pregnancy BMI of 35 or greater, preexisting diabetes, hypertension, substance use, and a history of cancer, chemotherapy, or chest radiation. “Current practice acknowledges that the risk factor currently included in the algorithm of self-identified as Black actually represents racism, bias, and social determinants of health, known risk factors for CVD,” Wolfe said.

Patients who screened positive underwent an echocardiogram, a cardio-obstetric consultation, and an additional work-up.

During the June 2022–September 2023 study period, 148 out of 1877 screened patients (7.9%) had a positive screen. Of these, 108 were false positives and 40 (27%) were true positives. The number of true false positives is not known because many women did not come for their workups.* The true positives mostly included patients with mild valvular disease, but about a quarter had mild, moderate, or severe ventricular dilation or hypertrophy and a little less than a quarter were positive for systolic or diastolic dysfunction.

Most (72.5%) of the 40 true-positive cases needed a multidisciplinary cardio-obstetrics team plan, and 11 patients (27.5%) needed follow-up and had multiple visits with the cardio-obstetrics team. Six of the true-positive cases (15%) “were deemed to be of higher risk for decompensation during labor and required detailed plans for intrapartum and postpartum management,” the researchers reported. Nine patients (22.5%) began new cardiovascular medications.

This research is a validation study of the current algorithm, Wolfe said, and the algorithm will be revised based on the results of the completed validation study.

“The objective is universal cardiovascular risk screening for all pregnant and postpartum persons in the US,” Wolfe said. “Once the data collection from this validation study is concluded, our goal is to disseminate a revised CVD risk screening tool that can be implemented into the electronic medical records of all institutions in our country.”

*The study partially funded by the National Institute of Child Health and Human Development award #5R21HD101783. All the authors and Dr. Lewis had no disclosures. Dr. Afshan B. Hameed of the University of California at Irvine was a partner in the study.

*This study was updated on May 30, 2024.

BOSTON — Primary care clinicians face challenges in knowledge and care coordination as they care for a rising number of cancer survivors in the United States, according to panelists who spoke during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

By the year 2040, an estimated 26 million people will have lived ≥ 5 years after their initial cancer diagnosis, an increase of eight million from 2022, according to the National Cancer Institute. Primary care clinicians must help patients with new health problems that emerge as the result of previous cancer treatments and with side effects that can last for decades.

“It’s a good thing that more people are living longer and living better after cancer, but now that means we have to train an army of primary care doctors to feel empowered to take care of these patients in a general setting,” said Ilana Yurkiewicz, MD, an oncologist, internal medicine physician, and clinical assistant professor at Stanford University, Stanford, California, who co-moderated the workshop.

Dr. Yurkiewicz and her fellow panelists emphasized the high likelihood that every primary care clinician is currently caring for a survivor of cancer.

One of the greatest barriers these clinicians face in caring for survivors is the difficulty in getting screening tests paid for by insurers, according to Regina Jacob, MD, associate professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, who co-moderated the session.

“We have a tough time getting surveillance tests [for cancer] covered through insurance” because in some cases physician groups do not provide consensus on which surveillance tools to use or how often people should be screened, Dr. Jacob said.

For instance, the American Gastroenterological Association and the US Preventive Services Task Force — which many insurers use as basis for coverage determinations — offer differing recommendations.

Primary care physicians also face challenges in understanding the complexity of conditions patients may face during and after cancer treatment since conditions that emerge from cancer or treatment may vary among patients.

“Cancer survivorship starts the day of the diagnosis,” said Dr. Yurkiewicz. “It doesn’t necessarily mean someone who has completed cancer treatment.”

During the workshop, participants offered their own recommendations for care based on case studies, which included issues such as long-term effects of cancer and its therapies, which may arise immediately after or even years or decades after treatment.

A common situation for cancer survivors involves new health issues that occur after treatment has ended.

“Who do they turn to in cases where they don’t know if it’s related to the cancer or the cancer treatment or are separate issues? Do they turn to their oncologist? Do they turn to their primary care doctor?” Dr. Yurkiewicz said. “How should I, the primary care doctor, be thinking about the issue?”

She proposed that primary care clinicians give patients a 2-week waiting period at the onset of a symptom before intervening.

Participants also suggested establishing rapport with the treating oncologist and other specialists so that if a question arises, the primary care clinician can ask for advice.

The method physicians choose to communicate and coordinate care should be tailored to the health system in which they work, participants suggested.

“Some people have the luxury of having a unified electronic health record; some people don’t have that luxury,” said Dr. Jacob. “Recognize the institution in which you work, recognize the context in which you work, and develop a communication strategy that closes the gap.”

The moderators reported no relevant disclosures.

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

BOSTON — Primary care clinicians face challenges in knowledge and care coordination as they care for a rising number of cancer survivors in the United States, according to panelists who spoke during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

By the year 2040, an estimated 26 million people will have lived ≥ 5 years after their initial cancer diagnosis, an increase of eight million from 2022, according to the National Cancer Institute. Primary care clinicians must help patients with new health problems that emerge as the result of previous cancer treatments and with side effects that can last for decades.

“It’s a good thing that more people are living longer and living better after cancer, but now that means we have to train an army of primary care doctors to feel empowered to take care of these patients in a general setting,” said Ilana Yurkiewicz, MD, an oncologist, internal medicine physician, and clinical assistant professor at Stanford University, Stanford, California, who co-moderated the workshop.

Dr. Yurkiewicz and her fellow panelists emphasized the high likelihood that every primary care clinician is currently caring for a survivor of cancer.

One of the greatest barriers these clinicians face in caring for survivors is the difficulty in getting screening tests paid for by insurers, according to Regina Jacob, MD, associate professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, who co-moderated the session.

“We have a tough time getting surveillance tests [for cancer] covered through insurance” because in some cases physician groups do not provide consensus on which surveillance tools to use or how often people should be screened, Dr. Jacob said.

For instance, the American Gastroenterological Association and the US Preventive Services Task Force — which many insurers use as basis for coverage determinations — offer differing recommendations.

Primary care physicians also face challenges in understanding the complexity of conditions patients may face during and after cancer treatment since conditions that emerge from cancer or treatment may vary among patients.

“Cancer survivorship starts the day of the diagnosis,” said Dr. Yurkiewicz. “It doesn’t necessarily mean someone who has completed cancer treatment.”

During the workshop, participants offered their own recommendations for care based on case studies, which included issues such as long-term effects of cancer and its therapies, which may arise immediately after or even years or decades after treatment.

A common situation for cancer survivors involves new health issues that occur after treatment has ended.

“Who do they turn to in cases where they don’t know if it’s related to the cancer or the cancer treatment or are separate issues? Do they turn to their oncologist? Do they turn to their primary care doctor?” Dr. Yurkiewicz said. “How should I, the primary care doctor, be thinking about the issue?”

She proposed that primary care clinicians give patients a 2-week waiting period at the onset of a symptom before intervening.

Participants also suggested establishing rapport with the treating oncologist and other specialists so that if a question arises, the primary care clinician can ask for advice.

The method physicians choose to communicate and coordinate care should be tailored to the health system in which they work, participants suggested.

“Some people have the luxury of having a unified electronic health record; some people don’t have that luxury,” said Dr. Jacob. “Recognize the institution in which you work, recognize the context in which you work, and develop a communication strategy that closes the gap.”

The moderators reported no relevant disclosures.

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

BOSTON — Primary care clinicians face challenges in knowledge and care coordination as they care for a rising number of cancer survivors in the United States, according to panelists who spoke during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

By the year 2040, an estimated 26 million people will have lived ≥ 5 years after their initial cancer diagnosis, an increase of eight million from 2022, according to the National Cancer Institute. Primary care clinicians must help patients with new health problems that emerge as the result of previous cancer treatments and with side effects that can last for decades.

“It’s a good thing that more people are living longer and living better after cancer, but now that means we have to train an army of primary care doctors to feel empowered to take care of these patients in a general setting,” said Ilana Yurkiewicz, MD, an oncologist, internal medicine physician, and clinical assistant professor at Stanford University, Stanford, California, who co-moderated the workshop.

Dr. Yurkiewicz and her fellow panelists emphasized the high likelihood that every primary care clinician is currently caring for a survivor of cancer.

One of the greatest barriers these clinicians face in caring for survivors is the difficulty in getting screening tests paid for by insurers, according to Regina Jacob, MD, associate professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, who co-moderated the session.

“We have a tough time getting surveillance tests [for cancer] covered through insurance” because in some cases physician groups do not provide consensus on which surveillance tools to use or how often people should be screened, Dr. Jacob said.

For instance, the American Gastroenterological Association and the US Preventive Services Task Force — which many insurers use as basis for coverage determinations — offer differing recommendations.

Primary care physicians also face challenges in understanding the complexity of conditions patients may face during and after cancer treatment since conditions that emerge from cancer or treatment may vary among patients.

“Cancer survivorship starts the day of the diagnosis,” said Dr. Yurkiewicz. “It doesn’t necessarily mean someone who has completed cancer treatment.”

During the workshop, participants offered their own recommendations for care based on case studies, which included issues such as long-term effects of cancer and its therapies, which may arise immediately after or even years or decades after treatment.

A common situation for cancer survivors involves new health issues that occur after treatment has ended.

“Who do they turn to in cases where they don’t know if it’s related to the cancer or the cancer treatment or are separate issues? Do they turn to their oncologist? Do they turn to their primary care doctor?” Dr. Yurkiewicz said. “How should I, the primary care doctor, be thinking about the issue?”

She proposed that primary care clinicians give patients a 2-week waiting period at the onset of a symptom before intervening.

Participants also suggested establishing rapport with the treating oncologist and other specialists so that if a question arises, the primary care clinician can ask for advice.

The method physicians choose to communicate and coordinate care should be tailored to the health system in which they work, participants suggested.

“Some people have the luxury of having a unified electronic health record; some people don’t have that luxury,” said Dr. Jacob. “Recognize the institution in which you work, recognize the context in which you work, and develop a communication strategy that closes the gap.”

The moderators reported no relevant disclosures.

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

WASHINGTON — Eating within 3 hours of bedtime at least 4 days a week could increase chances for developing colorectal cancer, according to the results of research presented at the annual Digestive Disease Week^® (DDW).

Investigators in a new study questioned 664 people getting a colonoscopy to screen for cancer, and 42% said they were late eaters. This group was 46% more likely than non–late eaters to have an adenoma found during colonoscopy. An estimated 5% to 10% of them become cancerous over time.

“A lot of other studies are about what we eat but not when we eat,” said Edena Khoshaba, lead investigator and a medical student at Rush University Medical College in Chicago. “The common advice includes not eating red meat, eating more fruits and vegetables — which is great, of course — but we wanted to see if the timing affects us at all.”

Ms. Khoshaba and colleagues found it did. Late eaters were 5.5 times more likely to have three or more tubular adenomas compared to non–late eaters, even after adjusting for what people were eating. Tubular adenomas are the most common type of polyp found in the colon.

So, what’s the possible connection between late eating and the risk for colorectal cancer?
 

Resetting Your Internal Clock

Eating close to bedtime could be throwing off the body’s circadian rhythm. But in this case, it’s not the central circadian center located in the brain — the one that releases melatonin. Instead, late eating could disrupt the peripheral circadian rhythm, part of which is found in the GI tract. For example, if a person is eating late at night, the brain thinks it is nighttime while the gut thinks it is daytime, Ms. Khoshaba said in an interview.

This is an interesting study, said Amy Bragagnini, MS, RD, spokesperson for the Academy of Nutrition and Dietetics, when asked to comment on the research. “It is true that eating later at night can disrupt your circadian rhythm.”

“In addition, many of my patients have told me that when they do eat later at night, they don’t always make the healthiest food choices,” Ms. Bragagnini said. “Their late-night food choices are generally higher in added sugar and fat. This may cause them to consume far more calories than their body needs.” So, eating late at night can also lead to unwanted weight gain.

An unanswered question is if late eating is connected in any way at all to increasing rates of colorectal cancer seen in younger patients.

This was an observational study, and another possible limitation, Ms. Khoshaba said, is that people were asked to recall their diets over 24 hours, which may not always be accurate.

Some of the organisms in the gut have their own internal clocks that follow a daily rhythm, and what someone eat determines how many different kinds of these organisms are active, Ms. Bragagnini said.

“So, if your late-night eating consists of foods high in sugar and fat, you may be negatively impacting your microbiome.” she said.

The next step for Ms. Khoshaba and colleagues is a study examining the peripheral circadian rhythm, changes in the gut microbiome, and the risk for developing metabolic syndrome. Ms. Khoshaba and Ms. Bragagnini had no relevant disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Eating within 3 hours of bedtime at least 4 days a week could increase chances for developing colorectal cancer, according to the results of research presented at the annual Digestive Disease Week^® (DDW).

Investigators in a new study questioned 664 people getting a colonoscopy to screen for cancer, and 42% said they were late eaters. This group was 46% more likely than non–late eaters to have an adenoma found during colonoscopy. An estimated 5% to 10% of them become cancerous over time.

“A lot of other studies are about what we eat but not when we eat,” said Edena Khoshaba, lead investigator and a medical student at Rush University Medical College in Chicago. “The common advice includes not eating red meat, eating more fruits and vegetables — which is great, of course — but we wanted to see if the timing affects us at all.”

Ms. Khoshaba and colleagues found it did. Late eaters were 5.5 times more likely to have three or more tubular adenomas compared to non–late eaters, even after adjusting for what people were eating. Tubular adenomas are the most common type of polyp found in the colon.

So, what’s the possible connection between late eating and the risk for colorectal cancer?
 

Resetting Your Internal Clock

Eating close to bedtime could be throwing off the body’s circadian rhythm. But in this case, it’s not the central circadian center located in the brain — the one that releases melatonin. Instead, late eating could disrupt the peripheral circadian rhythm, part of which is found in the GI tract. For example, if a person is eating late at night, the brain thinks it is nighttime while the gut thinks it is daytime, Ms. Khoshaba said in an interview.

This is an interesting study, said Amy Bragagnini, MS, RD, spokesperson for the Academy of Nutrition and Dietetics, when asked to comment on the research. “It is true that eating later at night can disrupt your circadian rhythm.”

“In addition, many of my patients have told me that when they do eat later at night, they don’t always make the healthiest food choices,” Ms. Bragagnini said. “Their late-night food choices are generally higher in added sugar and fat. This may cause them to consume far more calories than their body needs.” So, eating late at night can also lead to unwanted weight gain.

An unanswered question is if late eating is connected in any way at all to increasing rates of colorectal cancer seen in younger patients.

This was an observational study, and another possible limitation, Ms. Khoshaba said, is that people were asked to recall their diets over 24 hours, which may not always be accurate.

Some of the organisms in the gut have their own internal clocks that follow a daily rhythm, and what someone eat determines how many different kinds of these organisms are active, Ms. Bragagnini said.

“So, if your late-night eating consists of foods high in sugar and fat, you may be negatively impacting your microbiome.” she said.

The next step for Ms. Khoshaba and colleagues is a study examining the peripheral circadian rhythm, changes in the gut microbiome, and the risk for developing metabolic syndrome. Ms. Khoshaba and Ms. Bragagnini had no relevant disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Eating within 3 hours of bedtime at least 4 days a week could increase chances for developing colorectal cancer, according to the results of research presented at the annual Digestive Disease Week^® (DDW).

Investigators in a new study questioned 664 people getting a colonoscopy to screen for cancer, and 42% said they were late eaters. This group was 46% more likely than non–late eaters to have an adenoma found during colonoscopy. An estimated 5% to 10% of them become cancerous over time.

“A lot of other studies are about what we eat but not when we eat,” said Edena Khoshaba, lead investigator and a medical student at Rush University Medical College in Chicago. “The common advice includes not eating red meat, eating more fruits and vegetables — which is great, of course — but we wanted to see if the timing affects us at all.”

Ms. Khoshaba and colleagues found it did. Late eaters were 5.5 times more likely to have three or more tubular adenomas compared to non–late eaters, even after adjusting for what people were eating. Tubular adenomas are the most common type of polyp found in the colon.

So, what’s the possible connection between late eating and the risk for colorectal cancer?
 

Resetting Your Internal Clock

Eating close to bedtime could be throwing off the body’s circadian rhythm. But in this case, it’s not the central circadian center located in the brain — the one that releases melatonin. Instead, late eating could disrupt the peripheral circadian rhythm, part of which is found in the GI tract. For example, if a person is eating late at night, the brain thinks it is nighttime while the gut thinks it is daytime, Ms. Khoshaba said in an interview.

This is an interesting study, said Amy Bragagnini, MS, RD, spokesperson for the Academy of Nutrition and Dietetics, when asked to comment on the research. “It is true that eating later at night can disrupt your circadian rhythm.”

“In addition, many of my patients have told me that when they do eat later at night, they don’t always make the healthiest food choices,” Ms. Bragagnini said. “Their late-night food choices are generally higher in added sugar and fat. This may cause them to consume far more calories than their body needs.” So, eating late at night can also lead to unwanted weight gain.

An unanswered question is if late eating is connected in any way at all to increasing rates of colorectal cancer seen in younger patients.

This was an observational study, and another possible limitation, Ms. Khoshaba said, is that people were asked to recall their diets over 24 hours, which may not always be accurate.

Some of the organisms in the gut have their own internal clocks that follow a daily rhythm, and what someone eat determines how many different kinds of these organisms are active, Ms. Bragagnini said.

“So, if your late-night eating consists of foods high in sugar and fat, you may be negatively impacting your microbiome.” she said.

The next step for Ms. Khoshaba and colleagues is a study examining the peripheral circadian rhythm, changes in the gut microbiome, and the risk for developing metabolic syndrome. Ms. Khoshaba and Ms. Bragagnini had no relevant disclosures.

A version of this article appeared on Medscape.com.

Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.

Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.

The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.

A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.

Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).

Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).

As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.

The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
 

Data Add to Awareness of Risk Factors

The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.  

The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.

The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.

Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.

The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.

Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.

Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.

The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.

A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.

Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).

Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).

As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.

The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
 

Data Add to Awareness of Risk Factors

The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.  

The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.

The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.

Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.

The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.

Approximately one-quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2,000 individuals.

Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care,” the researchers wrote in their abstract.

The researchers reviewed data from 2,172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance.

A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery.

Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008), and placental abnormalities (P = .027).

Neonatal factors of weight, large for gestational age, head circumference, and height were not significantly associated with failed IOL (P > .05 for all).

As for neonatal outcomes, failed IOL was significantly associated with admission to neonatal intensive care unit, hyperbilirubinemia, and longer hospital stay (P = .001 for all). Failed IOL was significantly associated with lower 1-minute APGAR scores, but not with lower 5-minute APGAR scores, the researchers noted (P = .033 for 1-minute score). No association was noted between failed IOL and neonatal readmission, lower umbilical cord pH value, or maternal ethnicity.

The findings were limited by the retrospective design, but data analysis is ongoing, Dr. Alhousseini said. The researchers are continuing to assess the roles not only of optimal glucose control, but other maternal factors in improving maternal and neonatal outcomes, he said.
 

Data Add to Awareness of Risk Factors

The current study is important because of the increasing incidence of diabetes and the need to examine associated risk factors in pregnancy, Michael Richley, MD, a maternal fetal medicine physician at the University of Washington, Seattle, said in an interview. “The average age of onset of diabetes is becoming younger and type 2 diabetes in pregnancy is an increasingly common diagnosis,” said Dr. Richley, who was not involved in the study.  

The increase in both maternal and neonatal adverse outcomes is expected given the risk factors identified in the study, said Dr. Richley. “The patients with diabetes also were sicker at baseline, with hypertensive disorders, growth restriction, and pregestational diabetes,” he noted.

The study findings support data from previous research, Dr. Richley said. The message to clinicians is that patients with diabetes not only have an increased risk of needing a cesarean delivery but also have an increased risk of poor outcomes if a cesarean delivery is needed, he said.

Although a prospective study would be useful to show causality as opposed to just an association, such a study is challenging in this patient population given the limitations of conducting research on labor and delivery, he said.

The study received no outside funding. The researchers and Dr. Richley had no financial conflicts to disclose.

Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.

The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.

Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.

“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.

The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.

“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.

The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.

The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.

Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.

The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.

The study was limited primarily by the retrospective design, Dr. Olsen said.

Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.

“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.

The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.

Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.

“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.

The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.

“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.

The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.

The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.

Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.

The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.

The study was limited primarily by the retrospective design, Dr. Olsen said.

Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.

“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals.

The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City.

Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr. Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview.

“Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight;” however, data on the fetal effects of buprenorphine are limited, said Dr. Olsen.

The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr. Olsen said.

“This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients,” said Dr. Olsen.

The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020.

The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine.

Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269.

The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr. Olsen. “Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies,” he said.

The study was limited primarily by the retrospective design, Dr. Olsen said.

Although current treatment guidelines do not emphasize the effects of maternal buprenorphine use on fetal development, these findings support previous research showing effects of buprenorphine on fetal brain structure, the researchers wrote in their abstract. Looking ahead, “We recommend additional study on the maternal buprenorphine medication–assisted treatment dose effects for fetal and neonatal development with attention to such factors as head circumference, birth weight, achievement of developmental milestones, and school performance,” Dr. Olsen said.

“We and others have shown that the lowest effective dose of buprenorphine can lower neonatal abstinence syndrome/neonatal opioid withdrawal syndrome rates,” but data showing an impact of lowest effective dose management on long-term complications of fetal buprenorphine exposure are lacking, he noted.

The study received no outside funding. The researchers had no financial conflicts to disclose.

TOPLINE:

Healthier sleep is associated with lower odds of developing a wide range of gastrointestinal conditions, regardless of genetic susceptibility, new research revealed.

METHODOLOGY:

• Due to the widespread prevalence of sleep issues and a growing burden of digestive diseases globally, researchers investigated the association between sleep quality and digestive disorders in a prospective cohort study of 410,586 people in the UK Biobank.
• Five individual sleep behaviors were assessed: sleep duration, insomnia, snoring, daytime sleepiness, and chronotype.
• A healthy sleep was defined as a morning chronotype, 7-8 hours of sleep duration, no self-reported snoring, never or rare insomnia, and a low frequency of daytime sleepiness, for a score of 5/5.
• The study investigators tracked the development of 16 digestive diseases over a mean period of 13.2 years.
• As well as looking at healthy sleep scores, researchers considered genetic susceptibility to gastrointestinal conditions.

TAKEAWAY:

• Participants with a healthy sleep score had 28% lower odds of developing any digestive disease (hazard ratio [HR], 0.72; 95% CI, 0.69-0.75) than those with a sleep score of 0/1.
• Of the 16 digestive diseases looked at, the reduction of risk was highest for irritable bowel syndrome at 50% (HR, 0.50; 95% CI, 0.45-0.57).
• A healthy sleep score was also associated with 37% reduced odds for metabolic dysfunction–associated steatotic liver disease (formerly known as nonalcoholic fatty liver disease; HR, 0.63; 95% CI, 0.55-0.71), 35% lower chance for peptic ulcer (HR, 0.65; 95% CI, 0.058-0.74), 34% reduced chance for dyspepsia (HR, 0.66; 95% CI, 0.58-0.75), and a 25% lower risk for diverticulosis (HR, 0.75; 95% CI, 0.71-0.80).
• High genetic risk and poor sleep scores were also associated with increased odds (53% to > 200%) of developing digestive diseases.
• However, healthy sleep reduced the risk for digestive diseases regardless of genetic susceptibility.

IN PRACTICE:

“Our findings underscore the potential holistic impact of different sleep behaviors in mitigating the risk of digestive diseases in clinical practice,” wrote Shiyi Yu, MD, of Guangdong Provincial People’s Hospital, Guangzhou, Guangdong, China, and colleagues.

Poor sleep can also change our gut microbiome, Dr. Yu told this news organization. If you don’t sleep well, the repair of the gut lining cannot be finished during the night.

SOURCE:

The study was presented at the Digestive Disease Week® (DDW), 2024, annual meeting.

DISCLOSURES:

Dr. Yu had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Healthier sleep is associated with lower odds of developing a wide range of gastrointestinal conditions, regardless of genetic susceptibility, new research revealed.

METHODOLOGY:

• Due to the widespread prevalence of sleep issues and a growing burden of digestive diseases globally, researchers investigated the association between sleep quality and digestive disorders in a prospective cohort study of 410,586 people in the UK Biobank.
• Five individual sleep behaviors were assessed: sleep duration, insomnia, snoring, daytime sleepiness, and chronotype.
• A healthy sleep was defined as a morning chronotype, 7-8 hours of sleep duration, no self-reported snoring, never or rare insomnia, and a low frequency of daytime sleepiness, for a score of 5/5.
• The study investigators tracked the development of 16 digestive diseases over a mean period of 13.2 years.
• As well as looking at healthy sleep scores, researchers considered genetic susceptibility to gastrointestinal conditions.

TAKEAWAY:

• Participants with a healthy sleep score had 28% lower odds of developing any digestive disease (hazard ratio [HR], 0.72; 95% CI, 0.69-0.75) than those with a sleep score of 0/1.
• Of the 16 digestive diseases looked at, the reduction of risk was highest for irritable bowel syndrome at 50% (HR, 0.50; 95% CI, 0.45-0.57).
• A healthy sleep score was also associated with 37% reduced odds for metabolic dysfunction–associated steatotic liver disease (formerly known as nonalcoholic fatty liver disease; HR, 0.63; 95% CI, 0.55-0.71), 35% lower chance for peptic ulcer (HR, 0.65; 95% CI, 0.058-0.74), 34% reduced chance for dyspepsia (HR, 0.66; 95% CI, 0.58-0.75), and a 25% lower risk for diverticulosis (HR, 0.75; 95% CI, 0.71-0.80).
• High genetic risk and poor sleep scores were also associated with increased odds (53% to > 200%) of developing digestive diseases.
• However, healthy sleep reduced the risk for digestive diseases regardless of genetic susceptibility.

IN PRACTICE:

“Our findings underscore the potential holistic impact of different sleep behaviors in mitigating the risk of digestive diseases in clinical practice,” wrote Shiyi Yu, MD, of Guangdong Provincial People’s Hospital, Guangzhou, Guangdong, China, and colleagues.

Poor sleep can also change our gut microbiome, Dr. Yu told this news organization. If you don’t sleep well, the repair of the gut lining cannot be finished during the night.

SOURCE:

The study was presented at the Digestive Disease Week® (DDW), 2024, annual meeting.

DISCLOSURES:

Dr. Yu had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Healthier sleep is associated with lower odds of developing a wide range of gastrointestinal conditions, regardless of genetic susceptibility, new research revealed.

METHODOLOGY:

• Due to the widespread prevalence of sleep issues and a growing burden of digestive diseases globally, researchers investigated the association between sleep quality and digestive disorders in a prospective cohort study of 410,586 people in the UK Biobank.
• Five individual sleep behaviors were assessed: sleep duration, insomnia, snoring, daytime sleepiness, and chronotype.
• A healthy sleep was defined as a morning chronotype, 7-8 hours of sleep duration, no self-reported snoring, never or rare insomnia, and a low frequency of daytime sleepiness, for a score of 5/5.
• The study investigators tracked the development of 16 digestive diseases over a mean period of 13.2 years.
• As well as looking at healthy sleep scores, researchers considered genetic susceptibility to gastrointestinal conditions.

TAKEAWAY:

• Participants with a healthy sleep score had 28% lower odds of developing any digestive disease (hazard ratio [HR], 0.72; 95% CI, 0.69-0.75) than those with a sleep score of 0/1.
• Of the 16 digestive diseases looked at, the reduction of risk was highest for irritable bowel syndrome at 50% (HR, 0.50; 95% CI, 0.45-0.57).
• A healthy sleep score was also associated with 37% reduced odds for metabolic dysfunction–associated steatotic liver disease (formerly known as nonalcoholic fatty liver disease; HR, 0.63; 95% CI, 0.55-0.71), 35% lower chance for peptic ulcer (HR, 0.65; 95% CI, 0.058-0.74), 34% reduced chance for dyspepsia (HR, 0.66; 95% CI, 0.58-0.75), and a 25% lower risk for diverticulosis (HR, 0.75; 95% CI, 0.71-0.80).
• High genetic risk and poor sleep scores were also associated with increased odds (53% to > 200%) of developing digestive diseases.
• However, healthy sleep reduced the risk for digestive diseases regardless of genetic susceptibility.

IN PRACTICE:

“Our findings underscore the potential holistic impact of different sleep behaviors in mitigating the risk of digestive diseases in clinical practice,” wrote Shiyi Yu, MD, of Guangdong Provincial People’s Hospital, Guangzhou, Guangdong, China, and colleagues.

Poor sleep can also change our gut microbiome, Dr. Yu told this news organization. If you don’t sleep well, the repair of the gut lining cannot be finished during the night.

SOURCE:

The study was presented at the Digestive Disease Week® (DDW), 2024, annual meeting.

DISCLOSURES:

Dr. Yu had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Guselkumab (Tremfya, Janssen/Johnson & Johnson) was superior to placebo for maintenance therapy in people with moderately to severely active ulcerative colitis (UC), according to the results of the phase 3 Quasar Maintenance Study.

The primary outcome of clinical remission at 44 weeks was greater with either of two dose regimens of guselkumab than with placebo, David Rubin, MD, AGAF, reported as part of his presentation (Abstract 759) at the annual Digestive Disease Week® (DDW).

Guselkumab is not the only biologic approved or in development for UC, but it is unique because of its dual action. It is an interleukin (IL)-23p19 subunit inhibitor that blocks IL-23 and also binds to the CD64 receptor on cells that produce IL-23.

Dr. Rubin, who is chief of the Section of Gastroenterology, Hepatology and Nutrition at University of Chicago Medicine, Chicago, said he was unsure at the beginning of the trial if this dual activity “might have any value.”

Targeting both the IL-23 circulating in the tissue and the receptor remains to be proven, “but nonetheless seems reasonable,” he said.

The study included 568 people, about 42% of whom had an inadequate response or were intolerant to prior advanced therapy, and 42.5% of whom had failed two or more advanced therapy classes.

Clinical responders from two prior guselkumab induction studies were enrolled in this randomized withdrawal, double-blind maintenance trial. At either 12 weeks or 24 weeks of induction, patients were randomly assigned to subcutaneous 200-mg guselkumab every 4 weeks (n = 190), 100-mg guselkumab every 8 weeks (n = 188), or placebo (n = 190). The placebo group served as a guselkumab withdrawal group.

Participants had a mean age of 41 years and a mean disease duration of 7.8 years. The 40% using oral corticosteroids were tapered off during the study.

A total of 45.2% of the 100-mg guselkumab group and 50.0% of the 200-mg guselkumab group met the primary outcome of clinical remission at week 44 compared with 18.9% with placebo.

“It was interesting to note that the 200 mg every 4 weeks was similar in efficacy at week 44 to the 100 mg every 8 weeks. It’s much less medicine, but you get similar results,” Dr. Rubin said.
 

Secondary Outcomes Also Superior

“The bottom line is not only did it work, but it worked when you look at some secondary endpoints, including endoscopic remission, where the bowel is completely healed,” Dr. Rubin said in an interview.

Overall, 34% of all participants who received guselkumab achieved this outcome, “which is a very high rate,” he said. “We haven’t seen a Mayo score of zero — meaning endoscopic remission — at that rate with any of our other therapies currently.”

Among the participants who achieved clinical remission, 69% of them also showed complete remission on endoscopy.

Other secondary outcomes significantly better at week 44 vs placebo included corticosteroid-free clinical remission, maintenance of clinical remission, clinical response, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, endoscopic normalization, Inflammatory Bowel Disease Questionnaire remission, and fatigue response.

“It was a great study. I think it’s very promising data,” said session co-moderator Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston.

“As we get more data from these more selective interleukins, we’ll get a better sense of how that plays out” vs other similar agents in development, he added.
 

IL-23 Target Seems Safe

One or more adverse events were reported by 70% of the higher-dose guselkumab group, 65% of the lower-dose guselkumab group, and 68% of the placebo group.

The most common adverse events in a combined 200-mg and 100-mg guselkumab group were lower than in the placebo group: 11.2% vs 14.1% reported COVID-19, 11.2% vs 29.7% reported exacerbation of UC, and 6.1% vs 6.8% experienced arthralgia, respectively.

No cases of active tuberculosis, opportunistic infection, anaphylaxis, serum sickness, Hy’s law, or serious hepatic issues were reported. One patient had clear cell renal carcinoma, another had rectal adenocarcinoma, and one hemorrhagic stroke was reported in the treatment groups. No patients died during the trial.

A higher proportion of people in the placebo group (13.7%) discontinued the study than those in the 100-mg guselkumab group (10.6%) and the 200-mg guselkumab group (11.6%).

“In general, we have accepted that the IL-23 target seems to be a very safe one,” Dr. Rubin said.

A leading theory is that unlike some interleukins, IL-23 is only expressed where the body has inflammation; therefore, targeting IL-23 does not affect other areas, he explained.

If approved by the Food and Drug Administration, it would expand the official indications for guselkumab, which was approved in 2020 for psoriatic arthritis and in 2017 for plaque psoriasis.

The study was supported by Janssen Research & Development, LLC. Dr. Rubin is a consultant for Janssen. Dr. Ananthakrishnan had no relevant disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Guselkumab (Tremfya, Janssen/Johnson & Johnson) was superior to placebo for maintenance therapy in people with moderately to severely active ulcerative colitis (UC), according to the results of the phase 3 Quasar Maintenance Study.

The primary outcome of clinical remission at 44 weeks was greater with either of two dose regimens of guselkumab than with placebo, David Rubin, MD, AGAF, reported as part of his presentation (Abstract 759) at the annual Digestive Disease Week® (DDW).

Guselkumab is not the only biologic approved or in development for UC, but it is unique because of its dual action. It is an interleukin (IL)-23p19 subunit inhibitor that blocks IL-23 and also binds to the CD64 receptor on cells that produce IL-23.

Dr. Rubin, who is chief of the Section of Gastroenterology, Hepatology and Nutrition at University of Chicago Medicine, Chicago, said he was unsure at the beginning of the trial if this dual activity “might have any value.”

Targeting both the IL-23 circulating in the tissue and the receptor remains to be proven, “but nonetheless seems reasonable,” he said.

The study included 568 people, about 42% of whom had an inadequate response or were intolerant to prior advanced therapy, and 42.5% of whom had failed two or more advanced therapy classes.

Clinical responders from two prior guselkumab induction studies were enrolled in this randomized withdrawal, double-blind maintenance trial. At either 12 weeks or 24 weeks of induction, patients were randomly assigned to subcutaneous 200-mg guselkumab every 4 weeks (n = 190), 100-mg guselkumab every 8 weeks (n = 188), or placebo (n = 190). The placebo group served as a guselkumab withdrawal group.

Participants had a mean age of 41 years and a mean disease duration of 7.8 years. The 40% using oral corticosteroids were tapered off during the study.

A total of 45.2% of the 100-mg guselkumab group and 50.0% of the 200-mg guselkumab group met the primary outcome of clinical remission at week 44 compared with 18.9% with placebo.

“It was interesting to note that the 200 mg every 4 weeks was similar in efficacy at week 44 to the 100 mg every 8 weeks. It’s much less medicine, but you get similar results,” Dr. Rubin said.
 

Secondary Outcomes Also Superior

“The bottom line is not only did it work, but it worked when you look at some secondary endpoints, including endoscopic remission, where the bowel is completely healed,” Dr. Rubin said in an interview.

Overall, 34% of all participants who received guselkumab achieved this outcome, “which is a very high rate,” he said. “We haven’t seen a Mayo score of zero — meaning endoscopic remission — at that rate with any of our other therapies currently.”

Among the participants who achieved clinical remission, 69% of them also showed complete remission on endoscopy.

Other secondary outcomes significantly better at week 44 vs placebo included corticosteroid-free clinical remission, maintenance of clinical remission, clinical response, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, endoscopic normalization, Inflammatory Bowel Disease Questionnaire remission, and fatigue response.

“It was a great study. I think it’s very promising data,” said session co-moderator Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston.

“As we get more data from these more selective interleukins, we’ll get a better sense of how that plays out” vs other similar agents in development, he added.
 

IL-23 Target Seems Safe

One or more adverse events were reported by 70% of the higher-dose guselkumab group, 65% of the lower-dose guselkumab group, and 68% of the placebo group.

The most common adverse events in a combined 200-mg and 100-mg guselkumab group were lower than in the placebo group: 11.2% vs 14.1% reported COVID-19, 11.2% vs 29.7% reported exacerbation of UC, and 6.1% vs 6.8% experienced arthralgia, respectively.

No cases of active tuberculosis, opportunistic infection, anaphylaxis, serum sickness, Hy’s law, or serious hepatic issues were reported. One patient had clear cell renal carcinoma, another had rectal adenocarcinoma, and one hemorrhagic stroke was reported in the treatment groups. No patients died during the trial.

A higher proportion of people in the placebo group (13.7%) discontinued the study than those in the 100-mg guselkumab group (10.6%) and the 200-mg guselkumab group (11.6%).

“In general, we have accepted that the IL-23 target seems to be a very safe one,” Dr. Rubin said.

A leading theory is that unlike some interleukins, IL-23 is only expressed where the body has inflammation; therefore, targeting IL-23 does not affect other areas, he explained.

If approved by the Food and Drug Administration, it would expand the official indications for guselkumab, which was approved in 2020 for psoriatic arthritis and in 2017 for plaque psoriasis.

The study was supported by Janssen Research & Development, LLC. Dr. Rubin is a consultant for Janssen. Dr. Ananthakrishnan had no relevant disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Guselkumab (Tremfya, Janssen/Johnson & Johnson) was superior to placebo for maintenance therapy in people with moderately to severely active ulcerative colitis (UC), according to the results of the phase 3 Quasar Maintenance Study.

The primary outcome of clinical remission at 44 weeks was greater with either of two dose regimens of guselkumab than with placebo, David Rubin, MD, AGAF, reported as part of his presentation (Abstract 759) at the annual Digestive Disease Week® (DDW).

Guselkumab is not the only biologic approved or in development for UC, but it is unique because of its dual action. It is an interleukin (IL)-23p19 subunit inhibitor that blocks IL-23 and also binds to the CD64 receptor on cells that produce IL-23.

Dr. Rubin, who is chief of the Section of Gastroenterology, Hepatology and Nutrition at University of Chicago Medicine, Chicago, said he was unsure at the beginning of the trial if this dual activity “might have any value.”

Targeting both the IL-23 circulating in the tissue and the receptor remains to be proven, “but nonetheless seems reasonable,” he said.

The study included 568 people, about 42% of whom had an inadequate response or were intolerant to prior advanced therapy, and 42.5% of whom had failed two or more advanced therapy classes.

Clinical responders from two prior guselkumab induction studies were enrolled in this randomized withdrawal, double-blind maintenance trial. At either 12 weeks or 24 weeks of induction, patients were randomly assigned to subcutaneous 200-mg guselkumab every 4 weeks (n = 190), 100-mg guselkumab every 8 weeks (n = 188), or placebo (n = 190). The placebo group served as a guselkumab withdrawal group.

Participants had a mean age of 41 years and a mean disease duration of 7.8 years. The 40% using oral corticosteroids were tapered off during the study.

A total of 45.2% of the 100-mg guselkumab group and 50.0% of the 200-mg guselkumab group met the primary outcome of clinical remission at week 44 compared with 18.9% with placebo.

“It was interesting to note that the 200 mg every 4 weeks was similar in efficacy at week 44 to the 100 mg every 8 weeks. It’s much less medicine, but you get similar results,” Dr. Rubin said.
 

Secondary Outcomes Also Superior

“The bottom line is not only did it work, but it worked when you look at some secondary endpoints, including endoscopic remission, where the bowel is completely healed,” Dr. Rubin said in an interview.

Overall, 34% of all participants who received guselkumab achieved this outcome, “which is a very high rate,” he said. “We haven’t seen a Mayo score of zero — meaning endoscopic remission — at that rate with any of our other therapies currently.”

Among the participants who achieved clinical remission, 69% of them also showed complete remission on endoscopy.

Other secondary outcomes significantly better at week 44 vs placebo included corticosteroid-free clinical remission, maintenance of clinical remission, clinical response, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, endoscopic normalization, Inflammatory Bowel Disease Questionnaire remission, and fatigue response.

“It was a great study. I think it’s very promising data,” said session co-moderator Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston.

“As we get more data from these more selective interleukins, we’ll get a better sense of how that plays out” vs other similar agents in development, he added.
 

IL-23 Target Seems Safe

One or more adverse events were reported by 70% of the higher-dose guselkumab group, 65% of the lower-dose guselkumab group, and 68% of the placebo group.

The most common adverse events in a combined 200-mg and 100-mg guselkumab group were lower than in the placebo group: 11.2% vs 14.1% reported COVID-19, 11.2% vs 29.7% reported exacerbation of UC, and 6.1% vs 6.8% experienced arthralgia, respectively.

No cases of active tuberculosis, opportunistic infection, anaphylaxis, serum sickness, Hy’s law, or serious hepatic issues were reported. One patient had clear cell renal carcinoma, another had rectal adenocarcinoma, and one hemorrhagic stroke was reported in the treatment groups. No patients died during the trial.

A higher proportion of people in the placebo group (13.7%) discontinued the study than those in the 100-mg guselkumab group (10.6%) and the 200-mg guselkumab group (11.6%).

“In general, we have accepted that the IL-23 target seems to be a very safe one,” Dr. Rubin said.

A leading theory is that unlike some interleukins, IL-23 is only expressed where the body has inflammation; therefore, targeting IL-23 does not affect other areas, he explained.

If approved by the Food and Drug Administration, it would expand the official indications for guselkumab, which was approved in 2020 for psoriatic arthritis and in 2017 for plaque psoriasis.

The study was supported by Janssen Research & Development, LLC. Dr. Rubin is a consultant for Janssen. Dr. Ananthakrishnan had no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Avoiding the use of antianaerobic antibiotics for empiric treatment of patients with sepsis can prevent depletion of beneficial bacteria in the gut microbiome and reduce both organ dysfunction and in-hospital mortality, a critical care specialists contends.

“You may not be personally moved by a 2- to 5-percent absolute difference in mortality, but sepsis is so common and so lethal that even small differences in outcomes can actually translate into enormous public health implications,” said Robert P. Dickson, MD a pulmonary and critical care specialist at the University of Michigan in Ann Arbor.

Neil Osterweil/MDedge News

If instead of prescribing piperacillin-tazobactam (Zosyn; pip-tazo) for sepsis critical care specialists were to switch to cefepime “even if you make very conservative assumptions like a modest effect size, you’re still talking about [saving] thousands of lives a year,” he said in a scientific symposium at the American Thoracic Society’s international conference.

“This is why I say this isn’t really over the horizon; this is microbiome modulation that’s happening all the time,” he said.

Most patients with sepsis in a medical ICU with respiratory, urinary or bloodstream sources of infection do not have indications for antianaerobic antibiotics, and there are no head-to-head clinical trials demonstrating a benefit for one anti-sepsis antibiotic strategy over another he said.

“In contrast, every observational study between antianaerobic and non-antianaerobic shows benefits to the anaerobe-sparing [drugs], and it’s been shown with animal models too. So to my mind, it’s already practice changing. I need to be talked into giving antianaerobic antibiotics for septic patients” he said.
 

Targeting gut microbiota

There are three basic approaches to focusing on the gut microbiome as a therapeutic target. The hardest is attempting to engineer an ecosystem — a fiendishly complex task with unpredictable results that has never been shown to work in either the gut or in the ICU, Dr. Dickson said.

A second approach, the use of probiotics to repopulate the gut with beneficial bacteria, is largely futile in the ICU, as the large majority of patients are on antibiotics and can’t be safely weaned off of them while in critical care. In this situation, giving probiotics would be akin to try to repopulate a forest while a forest fire is raging, he said.

The third and easiest approach is to minimize dysbiosis — imbalance of organisms in the gut — in the first place.

Anaerobic bacteria in the gut have been shown in several different disease states and animals models to be protective against pneumonia, organ failure, and death.

To see whether antianaerobic antibiotics could increase risk for adverse outcomes in the ICU, Dr. Dickson and colleagues previously conducted a retrospective study of 3032 mechanically ventilated patients in their center who received antibiotics either with or without anaerobic coverage in the first 72 hours.

They found that patients treated with early antianaerobic antibiotics had decreased ventilator-associated pneumonia-free survival (hazard ratio [HR] 1.24), infection-free survival (HR 1.22), and overall survival (HR 1.14) compared with patients who received antibiotics without anaerobic cover (all comparisons statistically significant by confidence intervals).

In a subcohort of 116 patients for whom gut microbiota data compositions were available, those who received antianaerobic antibiotics had decreased initial gut bacterial density (P = .00038), increased microbiome expansion during hospitalization (P = .011), and domination of the microbiome by Enterobacteriaceae species (P = .045). They also found that Enterobacteriaceae were enriched among respiratory pathogens in antianaerobic treated patients, and that in murine models, treatment with antianaerobic antibiotics increased susceptibility to Enterobacteriaceae pneumonia and increased the risk of death from non-infectious injuries.
 

Pip-tazo vs. cefepime

In the ACORN (Antibiotic Choice on Renal Outcomes) trial, results of which were reported by this news organization in November 2023, there were no differences in the highest stage of acute kidney injury or death in the first 14 days between piperacillin-tazobactam and cefepime. Remarking on the results, lead investigator Edward T. Qian, MD, MSc from Vanderbilt University in Nashville, Tennessee, said “I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection.”

But as Dr. Dickson’s group reported more recently in JAMA Internal Medicine, a 15-month pip-tazo shortage allowed the investigators to conduct a natural experiment comparing 90-day outcomes among 7569 patients with sepsis who received vancomycin plus either pip-tazo or cefepime.

They found in an instrumental variable analysis that piperacillin-tazobactam was associated with an absolute increase in mortality at 90 days of 5.0%, and that patients who received this antianaerobic antibiotic had 2.1 fewer organ failure–free days, 1.1 fewer ventilator-free days, and 1.5 fewer vasopressor-free days.

“Our study reveals the potential risks associated with empirical piperacillin-tazobactam in patients with sepsis without a specific indication for antianaerobic therapy. These findings should prompt reconsideration and further study of the widespread use of empirical antianaerobic antibiotics in sepsis,” the investigators concluded.
 

Who gets what?

In the question-and-answer at the end of the session, comoderator Christina Sarah Thornton, MD, PhD, FRCPC from the University of Calgary, Alberta, asked Dr. Dickson whether the question of antianaerobic overuse in the ICU “is a function that we aren’t able yet from a diagnostic perspective to identify the group that may need antianaerobes? Because we often don’t get culture data back in time for a critically ill patient. Do you think there could maybe be a more rapid diagnostic for these patients?”

He replied that “a lot of our problems would be solved if we had really good, reliable rapid diagnostics for infection,” but noted that most of the patients in the study mentioned above did not have indications for antianaerobics.

Asked by this reporter whether Dr. Dickson’s presentation changed her mind about the use of piperacillin-tazobactam in her patients, Dr. Thornton replied “Yes! It did for me.”

She noted that although in Canada respirologists don’t work in intensive care units, “it makes me wonder about just giving pip-tazo to patients that are really sick. It definitely changed my mind.”

The work of Dr. Dickson and colleagues is supported by National Institute of Health and Agency for Healthcare Research and Quality grants. He reported no other relevant disclosures. Dr. Thornton had no relevant disclosures.

SAN DIEGO — Avoiding the use of antianaerobic antibiotics for empiric treatment of patients with sepsis can prevent depletion of beneficial bacteria in the gut microbiome and reduce both organ dysfunction and in-hospital mortality, a critical care specialists contends.

“You may not be personally moved by a 2- to 5-percent absolute difference in mortality, but sepsis is so common and so lethal that even small differences in outcomes can actually translate into enormous public health implications,” said Robert P. Dickson, MD a pulmonary and critical care specialist at the University of Michigan in Ann Arbor.

Neil Osterweil/MDedge News

If instead of prescribing piperacillin-tazobactam (Zosyn; pip-tazo) for sepsis critical care specialists were to switch to cefepime “even if you make very conservative assumptions like a modest effect size, you’re still talking about [saving] thousands of lives a year,” he said in a scientific symposium at the American Thoracic Society’s international conference.

“This is why I say this isn’t really over the horizon; this is microbiome modulation that’s happening all the time,” he said.

Most patients with sepsis in a medical ICU with respiratory, urinary or bloodstream sources of infection do not have indications for antianaerobic antibiotics, and there are no head-to-head clinical trials demonstrating a benefit for one anti-sepsis antibiotic strategy over another he said.

“In contrast, every observational study between antianaerobic and non-antianaerobic shows benefits to the anaerobe-sparing [drugs], and it’s been shown with animal models too. So to my mind, it’s already practice changing. I need to be talked into giving antianaerobic antibiotics for septic patients” he said.
 

Targeting gut microbiota

There are three basic approaches to focusing on the gut microbiome as a therapeutic target. The hardest is attempting to engineer an ecosystem — a fiendishly complex task with unpredictable results that has never been shown to work in either the gut or in the ICU, Dr. Dickson said.

A second approach, the use of probiotics to repopulate the gut with beneficial bacteria, is largely futile in the ICU, as the large majority of patients are on antibiotics and can’t be safely weaned off of them while in critical care. In this situation, giving probiotics would be akin to try to repopulate a forest while a forest fire is raging, he said.

The third and easiest approach is to minimize dysbiosis — imbalance of organisms in the gut — in the first place.

Anaerobic bacteria in the gut have been shown in several different disease states and animals models to be protective against pneumonia, organ failure, and death.

To see whether antianaerobic antibiotics could increase risk for adverse outcomes in the ICU, Dr. Dickson and colleagues previously conducted a retrospective study of 3032 mechanically ventilated patients in their center who received antibiotics either with or without anaerobic coverage in the first 72 hours.

They found that patients treated with early antianaerobic antibiotics had decreased ventilator-associated pneumonia-free survival (hazard ratio [HR] 1.24), infection-free survival (HR 1.22), and overall survival (HR 1.14) compared with patients who received antibiotics without anaerobic cover (all comparisons statistically significant by confidence intervals).

In a subcohort of 116 patients for whom gut microbiota data compositions were available, those who received antianaerobic antibiotics had decreased initial gut bacterial density (P = .00038), increased microbiome expansion during hospitalization (P = .011), and domination of the microbiome by Enterobacteriaceae species (P = .045). They also found that Enterobacteriaceae were enriched among respiratory pathogens in antianaerobic treated patients, and that in murine models, treatment with antianaerobic antibiotics increased susceptibility to Enterobacteriaceae pneumonia and increased the risk of death from non-infectious injuries.
 

Pip-tazo vs. cefepime

In the ACORN (Antibiotic Choice on Renal Outcomes) trial, results of which were reported by this news organization in November 2023, there were no differences in the highest stage of acute kidney injury or death in the first 14 days between piperacillin-tazobactam and cefepime. Remarking on the results, lead investigator Edward T. Qian, MD, MSc from Vanderbilt University in Nashville, Tennessee, said “I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection.”

But as Dr. Dickson’s group reported more recently in JAMA Internal Medicine, a 15-month pip-tazo shortage allowed the investigators to conduct a natural experiment comparing 90-day outcomes among 7569 patients with sepsis who received vancomycin plus either pip-tazo or cefepime.

They found in an instrumental variable analysis that piperacillin-tazobactam was associated with an absolute increase in mortality at 90 days of 5.0%, and that patients who received this antianaerobic antibiotic had 2.1 fewer organ failure–free days, 1.1 fewer ventilator-free days, and 1.5 fewer vasopressor-free days.

“Our study reveals the potential risks associated with empirical piperacillin-tazobactam in patients with sepsis without a specific indication for antianaerobic therapy. These findings should prompt reconsideration and further study of the widespread use of empirical antianaerobic antibiotics in sepsis,” the investigators concluded.
 

Who gets what?

In the question-and-answer at the end of the session, comoderator Christina Sarah Thornton, MD, PhD, FRCPC from the University of Calgary, Alberta, asked Dr. Dickson whether the question of antianaerobic overuse in the ICU “is a function that we aren’t able yet from a diagnostic perspective to identify the group that may need antianaerobes? Because we often don’t get culture data back in time for a critically ill patient. Do you think there could maybe be a more rapid diagnostic for these patients?”

He replied that “a lot of our problems would be solved if we had really good, reliable rapid diagnostics for infection,” but noted that most of the patients in the study mentioned above did not have indications for antianaerobics.

Asked by this reporter whether Dr. Dickson’s presentation changed her mind about the use of piperacillin-tazobactam in her patients, Dr. Thornton replied “Yes! It did for me.”

She noted that although in Canada respirologists don’t work in intensive care units, “it makes me wonder about just giving pip-tazo to patients that are really sick. It definitely changed my mind.”

The work of Dr. Dickson and colleagues is supported by National Institute of Health and Agency for Healthcare Research and Quality grants. He reported no other relevant disclosures. Dr. Thornton had no relevant disclosures.

SAN DIEGO — Avoiding the use of antianaerobic antibiotics for empiric treatment of patients with sepsis can prevent depletion of beneficial bacteria in the gut microbiome and reduce both organ dysfunction and in-hospital mortality, a critical care specialists contends.

“You may not be personally moved by a 2- to 5-percent absolute difference in mortality, but sepsis is so common and so lethal that even small differences in outcomes can actually translate into enormous public health implications,” said Robert P. Dickson, MD a pulmonary and critical care specialist at the University of Michigan in Ann Arbor.

Neil Osterweil/MDedge News

If instead of prescribing piperacillin-tazobactam (Zosyn; pip-tazo) for sepsis critical care specialists were to switch to cefepime “even if you make very conservative assumptions like a modest effect size, you’re still talking about [saving] thousands of lives a year,” he said in a scientific symposium at the American Thoracic Society’s international conference.

“This is why I say this isn’t really over the horizon; this is microbiome modulation that’s happening all the time,” he said.

Most patients with sepsis in a medical ICU with respiratory, urinary or bloodstream sources of infection do not have indications for antianaerobic antibiotics, and there are no head-to-head clinical trials demonstrating a benefit for one anti-sepsis antibiotic strategy over another he said.

“In contrast, every observational study between antianaerobic and non-antianaerobic shows benefits to the anaerobe-sparing [drugs], and it’s been shown with animal models too. So to my mind, it’s already practice changing. I need to be talked into giving antianaerobic antibiotics for septic patients” he said.
 

Targeting gut microbiota

There are three basic approaches to focusing on the gut microbiome as a therapeutic target. The hardest is attempting to engineer an ecosystem — a fiendishly complex task with unpredictable results that has never been shown to work in either the gut or in the ICU, Dr. Dickson said.

A second approach, the use of probiotics to repopulate the gut with beneficial bacteria, is largely futile in the ICU, as the large majority of patients are on antibiotics and can’t be safely weaned off of them while in critical care. In this situation, giving probiotics would be akin to try to repopulate a forest while a forest fire is raging, he said.

The third and easiest approach is to minimize dysbiosis — imbalance of organisms in the gut — in the first place.

Anaerobic bacteria in the gut have been shown in several different disease states and animals models to be protective against pneumonia, organ failure, and death.

To see whether antianaerobic antibiotics could increase risk for adverse outcomes in the ICU, Dr. Dickson and colleagues previously conducted a retrospective study of 3032 mechanically ventilated patients in their center who received antibiotics either with or without anaerobic coverage in the first 72 hours.

They found that patients treated with early antianaerobic antibiotics had decreased ventilator-associated pneumonia-free survival (hazard ratio [HR] 1.24), infection-free survival (HR 1.22), and overall survival (HR 1.14) compared with patients who received antibiotics without anaerobic cover (all comparisons statistically significant by confidence intervals).

In a subcohort of 116 patients for whom gut microbiota data compositions were available, those who received antianaerobic antibiotics had decreased initial gut bacterial density (P = .00038), increased microbiome expansion during hospitalization (P = .011), and domination of the microbiome by Enterobacteriaceae species (P = .045). They also found that Enterobacteriaceae were enriched among respiratory pathogens in antianaerobic treated patients, and that in murine models, treatment with antianaerobic antibiotics increased susceptibility to Enterobacteriaceae pneumonia and increased the risk of death from non-infectious injuries.
 

Pip-tazo vs. cefepime

In the ACORN (Antibiotic Choice on Renal Outcomes) trial, results of which were reported by this news organization in November 2023, there were no differences in the highest stage of acute kidney injury or death in the first 14 days between piperacillin-tazobactam and cefepime. Remarking on the results, lead investigator Edward T. Qian, MD, MSc from Vanderbilt University in Nashville, Tennessee, said “I think the big takeaway is that you should feel comfortable starting or using pip-tazo for your patients who are coming into the hospital and receiving empiric antibiotics for acute infection.”

But as Dr. Dickson’s group reported more recently in JAMA Internal Medicine, a 15-month pip-tazo shortage allowed the investigators to conduct a natural experiment comparing 90-day outcomes among 7569 patients with sepsis who received vancomycin plus either pip-tazo or cefepime.

They found in an instrumental variable analysis that piperacillin-tazobactam was associated with an absolute increase in mortality at 90 days of 5.0%, and that patients who received this antianaerobic antibiotic had 2.1 fewer organ failure–free days, 1.1 fewer ventilator-free days, and 1.5 fewer vasopressor-free days.

“Our study reveals the potential risks associated with empirical piperacillin-tazobactam in patients with sepsis without a specific indication for antianaerobic therapy. These findings should prompt reconsideration and further study of the widespread use of empirical antianaerobic antibiotics in sepsis,” the investigators concluded.
 

Who gets what?

In the question-and-answer at the end of the session, comoderator Christina Sarah Thornton, MD, PhD, FRCPC from the University of Calgary, Alberta, asked Dr. Dickson whether the question of antianaerobic overuse in the ICU “is a function that we aren’t able yet from a diagnostic perspective to identify the group that may need antianaerobes? Because we often don’t get culture data back in time for a critically ill patient. Do you think there could maybe be a more rapid diagnostic for these patients?”

He replied that “a lot of our problems would be solved if we had really good, reliable rapid diagnostics for infection,” but noted that most of the patients in the study mentioned above did not have indications for antianaerobics.

Asked by this reporter whether Dr. Dickson’s presentation changed her mind about the use of piperacillin-tazobactam in her patients, Dr. Thornton replied “Yes! It did for me.”

She noted that although in Canada respirologists don’t work in intensive care units, “it makes me wonder about just giving pip-tazo to patients that are really sick. It definitely changed my mind.”

The work of Dr. Dickson and colleagues is supported by National Institute of Health and Agency for Healthcare Research and Quality grants. He reported no other relevant disclosures. Dr. Thornton had no relevant disclosures.

Lung cancer screening with low-dose CT (LDCT) can effectively evaluate a high-risk population for undiagnosed chronic obstructive pulmonary disease (COPD) and airflow obstruction, based on data from a new study of approximately 2000 individuals.

Previous research suggests that approximately 70%-90% of individuals with COPD are undiagnosed, especially low-income and minority populations who may be less likely to undergo screening, said Michaela A. Seigo, DO, of Temple University Hospital, Philadelphia, in a study presented at the American Thoracic Society (ATS) 2024 International Conference.

Although the current guidance from the United States Preventive Services Task Force (USPSTF) recommends against universal COPD screening in asymptomatic adults, the use of LDCT may be an option for evaluating a high-risk population, the researchers noted.

The researchers reviewed data from 2083 adults enrolled in the Temple Healthy Chest Initiative, an urban health system-wide lung cancer screening program, combined with the detection of symptoms and comorbidities.
 

Baseline LDCT for Identification of Comorbidities

Study participants underwent baseline LDCT between October 2021 and October 2022. The images were reviewed by radiologists for pulmonary comorbidities including emphysema, airway disease, bronchiectasis, and interstitial lung disease. In addition, 604 participants (29%) completed a symptom survey, and 624 (30%) underwent spirometry. The mean age of the participants was 65.8 years and 63.9 years for those with and without a history of COPD, respectively.

Approximately half of the participants in both groups were female.

Overall, 66 of 181 (36.5%) individuals previously undiagnosed with COPD had spirometry consistent with airflow obstruction (forced expiratory volume in 1 second/forced vital capacity, < 70%). Individuals with previously undiagnosed COPD were more likely to be younger, male, current smokers, and identified as Hispanic or other race (not Black, White, Hispanic, or Asian/Native American/Pacific Islander).

Individuals without a reported history of COPD had fewer pulmonary comorbidities on LDCT and lower rates of respiratory symptoms than those with COPD. However, nearly 25% of individuals with no reported history of COPD said that breathing issues affected their “ability to do things,” Ms. Seigo said, and a majority of those with no COPD diagnosis exhibited airway disease (76.2% compared with 84% of diagnosed patients with COPD). In addition, 88.1% reported ever experiencing dyspnea and 72.6% reported experiencing cough; both symptoms are compatible with a clinical diagnosis of COPD, the researchers noted.

“We detected pulmonary comorbidities at higher rates than previously published,” Ms. Seigo said in an interview. The increase likely reflects the patient population at Temple, which includes a relatively high percentage of city-dwelling, lower-income individuals, as well as more racial-ethnic minorities and persons of color, she said.

However, “these findings will help clinicians target the most at-risk populations for previously undiagnosed COPD,” Ms. Seigo said.

Looking ahead, Ms. Seigo said she sees a dominant role for artificial intelligence (AI) in COPD screening. “At-risk populations will get LDCT scans, and AI will identify pulmonary and extra-pulmonary comorbidities that may need to be addressed,” she said.

A combination of symptom detection plus strategic and more widely available access to screening offers “a huge opportunity to intervene earlier and potentially save lives,” she told this news organization.
 

Lung Cancer Screening May Promote Earlier COPD Intervention

The current study examines the prevalence of undiagnosed COPD, especially among low-income and minority populations, in an asymptomatic high-risk group. “By integrating lung cancer CT screening with the detection of pulmonary comorbidities on LDCT and respiratory symptoms, the current study aimed to identify individuals with undiagnosed COPD,” said Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, in an interview.

“The study highlighted the feasibility and potential benefits of coupling lung cancer screening tests with COPD detection, which is noteworthy, and hits two targets with one arrow — early detection of lung cancer and COPD — in high-risk groups, Dr. Narendra said.

“Although the USPSTF recommends against screening for COPD in asymptomatic patients, abnormal pulmonary comorbidities observed on CT chest scans could serve as a gateway for clinicians to screen for COPD,” said Dr. Narendra. “This approach allows for early diagnosis, education on smoking cessation, and timely treatment of COPD, potentially preventing lung function deterioration and reducing the risk of exacerbations,” she noted.

The finding that one third of previously undiagnosed and asymptomatic patients with COPD showed significant rates of airflow obstruction on spirometry is consistent with previous research, Dr. Narendra told this news organization.

“Interestingly, in questions about specific symptoms, undiagnosed COPD patients reported higher rates of dyspnea, more cough, and breathing difficulties affecting their daily activities, at 16.1%, 27.4%, and 24.5%, respectively, highlighting a lower perception of symptoms,” she said.

“Barriers to lung cancer screening in urban, high-risk communities include limited healthcare facility access, insufficient awareness of screening programs, financial constraints, and cultural or language barriers,” said Dr. Narendra.

Potential strategies to overcome these barriers include improving access through additional screening centers and providing transportation, implementing community-based education and outreach programs to increase awareness about the benefits of lung cancer screening and early COPD detection, and providing financial assistance in the form of free screening options and collaboration with insurers to cover screening expenses, she said.

“Healthcare providers must recognize the dual benefits of lung cancer screening programs, including the opportunity to screen for undiagnosed COPD,” Dr. Narendra emphasized. “This integrated approach is crucial in identifying high-risk individuals who could benefit from early intervention and effective management of COPD. Clinicians should actively support implementing comprehensive screening programs incorporating assessments for pulmonary comorbidities through LDCT and screening questionnaires for COPD symptoms,” she said.

“Further research is needed to evaluate long-term mortality outcomes and identify best practices to determine the most effective methods and cost-effectiveness for implementing and sustaining combined screening programs in various urban settings,” Dr. Narendra told this news organization.

Other areas to address in future studies include investigating specific barriers to screening among different high-risk groups and tailoring interventions to improve screening uptake and adherence, Narendra said. “By addressing these research gaps, health care providers can optimize screening programs and enhance the overall health of urban, high-risk populations,” she added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Narendra serves on the editorial board of CHEST Physician.

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

Lung cancer screening with low-dose CT (LDCT) can effectively evaluate a high-risk population for undiagnosed chronic obstructive pulmonary disease (COPD) and airflow obstruction, based on data from a new study of approximately 2000 individuals.

Previous research suggests that approximately 70%-90% of individuals with COPD are undiagnosed, especially low-income and minority populations who may be less likely to undergo screening, said Michaela A. Seigo, DO, of Temple University Hospital, Philadelphia, in a study presented at the American Thoracic Society (ATS) 2024 International Conference.

Although the current guidance from the United States Preventive Services Task Force (USPSTF) recommends against universal COPD screening in asymptomatic adults, the use of LDCT may be an option for evaluating a high-risk population, the researchers noted.

The researchers reviewed data from 2083 adults enrolled in the Temple Healthy Chest Initiative, an urban health system-wide lung cancer screening program, combined with the detection of symptoms and comorbidities.
 

Baseline LDCT for Identification of Comorbidities

Study participants underwent baseline LDCT between October 2021 and October 2022. The images were reviewed by radiologists for pulmonary comorbidities including emphysema, airway disease, bronchiectasis, and interstitial lung disease. In addition, 604 participants (29%) completed a symptom survey, and 624 (30%) underwent spirometry. The mean age of the participants was 65.8 years and 63.9 years for those with and without a history of COPD, respectively.

Approximately half of the participants in both groups were female.

Overall, 66 of 181 (36.5%) individuals previously undiagnosed with COPD had spirometry consistent with airflow obstruction (forced expiratory volume in 1 second/forced vital capacity, < 70%). Individuals with previously undiagnosed COPD were more likely to be younger, male, current smokers, and identified as Hispanic or other race (not Black, White, Hispanic, or Asian/Native American/Pacific Islander).

Individuals without a reported history of COPD had fewer pulmonary comorbidities on LDCT and lower rates of respiratory symptoms than those with COPD. However, nearly 25% of individuals with no reported history of COPD said that breathing issues affected their “ability to do things,” Ms. Seigo said, and a majority of those with no COPD diagnosis exhibited airway disease (76.2% compared with 84% of diagnosed patients with COPD). In addition, 88.1% reported ever experiencing dyspnea and 72.6% reported experiencing cough; both symptoms are compatible with a clinical diagnosis of COPD, the researchers noted.

“We detected pulmonary comorbidities at higher rates than previously published,” Ms. Seigo said in an interview. The increase likely reflects the patient population at Temple, which includes a relatively high percentage of city-dwelling, lower-income individuals, as well as more racial-ethnic minorities and persons of color, she said.

However, “these findings will help clinicians target the most at-risk populations for previously undiagnosed COPD,” Ms. Seigo said.

Looking ahead, Ms. Seigo said she sees a dominant role for artificial intelligence (AI) in COPD screening. “At-risk populations will get LDCT scans, and AI will identify pulmonary and extra-pulmonary comorbidities that may need to be addressed,” she said.

A combination of symptom detection plus strategic and more widely available access to screening offers “a huge opportunity to intervene earlier and potentially save lives,” she told this news organization.
 

Lung Cancer Screening May Promote Earlier COPD Intervention

The current study examines the prevalence of undiagnosed COPD, especially among low-income and minority populations, in an asymptomatic high-risk group. “By integrating lung cancer CT screening with the detection of pulmonary comorbidities on LDCT and respiratory symptoms, the current study aimed to identify individuals with undiagnosed COPD,” said Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, in an interview.

“The study highlighted the feasibility and potential benefits of coupling lung cancer screening tests with COPD detection, which is noteworthy, and hits two targets with one arrow — early detection of lung cancer and COPD — in high-risk groups, Dr. Narendra said.

“Although the USPSTF recommends against screening for COPD in asymptomatic patients, abnormal pulmonary comorbidities observed on CT chest scans could serve as a gateway for clinicians to screen for COPD,” said Dr. Narendra. “This approach allows for early diagnosis, education on smoking cessation, and timely treatment of COPD, potentially preventing lung function deterioration and reducing the risk of exacerbations,” she noted.

The finding that one third of previously undiagnosed and asymptomatic patients with COPD showed significant rates of airflow obstruction on spirometry is consistent with previous research, Dr. Narendra told this news organization.

“Interestingly, in questions about specific symptoms, undiagnosed COPD patients reported higher rates of dyspnea, more cough, and breathing difficulties affecting their daily activities, at 16.1%, 27.4%, and 24.5%, respectively, highlighting a lower perception of symptoms,” she said.

“Barriers to lung cancer screening in urban, high-risk communities include limited healthcare facility access, insufficient awareness of screening programs, financial constraints, and cultural or language barriers,” said Dr. Narendra.

Potential strategies to overcome these barriers include improving access through additional screening centers and providing transportation, implementing community-based education and outreach programs to increase awareness about the benefits of lung cancer screening and early COPD detection, and providing financial assistance in the form of free screening options and collaboration with insurers to cover screening expenses, she said.

“Healthcare providers must recognize the dual benefits of lung cancer screening programs, including the opportunity to screen for undiagnosed COPD,” Dr. Narendra emphasized. “This integrated approach is crucial in identifying high-risk individuals who could benefit from early intervention and effective management of COPD. Clinicians should actively support implementing comprehensive screening programs incorporating assessments for pulmonary comorbidities through LDCT and screening questionnaires for COPD symptoms,” she said.

“Further research is needed to evaluate long-term mortality outcomes and identify best practices to determine the most effective methods and cost-effectiveness for implementing and sustaining combined screening programs in various urban settings,” Dr. Narendra told this news organization.

Other areas to address in future studies include investigating specific barriers to screening among different high-risk groups and tailoring interventions to improve screening uptake and adherence, Narendra said. “By addressing these research gaps, health care providers can optimize screening programs and enhance the overall health of urban, high-risk populations,” she added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Narendra serves on the editorial board of CHEST Physician.

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

Lung cancer screening with low-dose CT (LDCT) can effectively evaluate a high-risk population for undiagnosed chronic obstructive pulmonary disease (COPD) and airflow obstruction, based on data from a new study of approximately 2000 individuals.

Previous research suggests that approximately 70%-90% of individuals with COPD are undiagnosed, especially low-income and minority populations who may be less likely to undergo screening, said Michaela A. Seigo, DO, of Temple University Hospital, Philadelphia, in a study presented at the American Thoracic Society (ATS) 2024 International Conference.

Although the current guidance from the United States Preventive Services Task Force (USPSTF) recommends against universal COPD screening in asymptomatic adults, the use of LDCT may be an option for evaluating a high-risk population, the researchers noted.

The researchers reviewed data from 2083 adults enrolled in the Temple Healthy Chest Initiative, an urban health system-wide lung cancer screening program, combined with the detection of symptoms and comorbidities.
 

Baseline LDCT for Identification of Comorbidities

Study participants underwent baseline LDCT between October 2021 and October 2022. The images were reviewed by radiologists for pulmonary comorbidities including emphysema, airway disease, bronchiectasis, and interstitial lung disease. In addition, 604 participants (29%) completed a symptom survey, and 624 (30%) underwent spirometry. The mean age of the participants was 65.8 years and 63.9 years for those with and without a history of COPD, respectively.

Approximately half of the participants in both groups were female.

Overall, 66 of 181 (36.5%) individuals previously undiagnosed with COPD had spirometry consistent with airflow obstruction (forced expiratory volume in 1 second/forced vital capacity, < 70%). Individuals with previously undiagnosed COPD were more likely to be younger, male, current smokers, and identified as Hispanic or other race (not Black, White, Hispanic, or Asian/Native American/Pacific Islander).

Individuals without a reported history of COPD had fewer pulmonary comorbidities on LDCT and lower rates of respiratory symptoms than those with COPD. However, nearly 25% of individuals with no reported history of COPD said that breathing issues affected their “ability to do things,” Ms. Seigo said, and a majority of those with no COPD diagnosis exhibited airway disease (76.2% compared with 84% of diagnosed patients with COPD). In addition, 88.1% reported ever experiencing dyspnea and 72.6% reported experiencing cough; both symptoms are compatible with a clinical diagnosis of COPD, the researchers noted.

“We detected pulmonary comorbidities at higher rates than previously published,” Ms. Seigo said in an interview. The increase likely reflects the patient population at Temple, which includes a relatively high percentage of city-dwelling, lower-income individuals, as well as more racial-ethnic minorities and persons of color, she said.

However, “these findings will help clinicians target the most at-risk populations for previously undiagnosed COPD,” Ms. Seigo said.

Looking ahead, Ms. Seigo said she sees a dominant role for artificial intelligence (AI) in COPD screening. “At-risk populations will get LDCT scans, and AI will identify pulmonary and extra-pulmonary comorbidities that may need to be addressed,” she said.

A combination of symptom detection plus strategic and more widely available access to screening offers “a huge opportunity to intervene earlier and potentially save lives,” she told this news organization.
 

Lung Cancer Screening May Promote Earlier COPD Intervention

The current study examines the prevalence of undiagnosed COPD, especially among low-income and minority populations, in an asymptomatic high-risk group. “By integrating lung cancer CT screening with the detection of pulmonary comorbidities on LDCT and respiratory symptoms, the current study aimed to identify individuals with undiagnosed COPD,” said Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, in an interview.

“The study highlighted the feasibility and potential benefits of coupling lung cancer screening tests with COPD detection, which is noteworthy, and hits two targets with one arrow — early detection of lung cancer and COPD — in high-risk groups, Dr. Narendra said.

“Although the USPSTF recommends against screening for COPD in asymptomatic patients, abnormal pulmonary comorbidities observed on CT chest scans could serve as a gateway for clinicians to screen for COPD,” said Dr. Narendra. “This approach allows for early diagnosis, education on smoking cessation, and timely treatment of COPD, potentially preventing lung function deterioration and reducing the risk of exacerbations,” she noted.

The finding that one third of previously undiagnosed and asymptomatic patients with COPD showed significant rates of airflow obstruction on spirometry is consistent with previous research, Dr. Narendra told this news organization.

“Interestingly, in questions about specific symptoms, undiagnosed COPD patients reported higher rates of dyspnea, more cough, and breathing difficulties affecting their daily activities, at 16.1%, 27.4%, and 24.5%, respectively, highlighting a lower perception of symptoms,” she said.

“Barriers to lung cancer screening in urban, high-risk communities include limited healthcare facility access, insufficient awareness of screening programs, financial constraints, and cultural or language barriers,” said Dr. Narendra.

Potential strategies to overcome these barriers include improving access through additional screening centers and providing transportation, implementing community-based education and outreach programs to increase awareness about the benefits of lung cancer screening and early COPD detection, and providing financial assistance in the form of free screening options and collaboration with insurers to cover screening expenses, she said.

“Healthcare providers must recognize the dual benefits of lung cancer screening programs, including the opportunity to screen for undiagnosed COPD,” Dr. Narendra emphasized. “This integrated approach is crucial in identifying high-risk individuals who could benefit from early intervention and effective management of COPD. Clinicians should actively support implementing comprehensive screening programs incorporating assessments for pulmonary comorbidities through LDCT and screening questionnaires for COPD symptoms,” she said.

“Further research is needed to evaluate long-term mortality outcomes and identify best practices to determine the most effective methods and cost-effectiveness for implementing and sustaining combined screening programs in various urban settings,” Dr. Narendra told this news organization.

Other areas to address in future studies include investigating specific barriers to screening among different high-risk groups and tailoring interventions to improve screening uptake and adherence, Narendra said. “By addressing these research gaps, health care providers can optimize screening programs and enhance the overall health of urban, high-risk populations,” she added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Narendra serves on the editorial board of CHEST Physician.

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