CHEST Physician

CHICAGO — Osimertinib (Tagrisso) may soon have approvals across all stages of epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC).

The third-generation EGFR tyrosine kinase inhibitor (TKI) already carries indications for metastatic disease and for adjuvant use in earlier-stage EGFR-mutated NSCLC.

Results from the phase 3 LAURA trial, presented at the American Society of Clinical Oncology (ASCO) annual meeting and funded by AstraZeneca, will likely lead to an approval for the remaining indication: Unresectable stage III disease.

Among patients randomized to either osimertinib or placebo following definitive chemoradiation, osimertinib extended median progression-free survival by 33.5 months compared with placebo — 39.1 vs 5.6 months, respectively (hazard ratio, 0.16; P = .001).

The news was greeted with a standing ovation at the meeting where it was presented by lead investigator and medical oncologist Suresh S. Ramalingam, MD, a lung cancer specialist at Emory University, Atlanta.

David R. Spigel, MD, a discussant on the trial, called the results “outstanding.”

“To have an 84% reduction in the risk of cancer progression or death is meaningful,” said Dr. Spigel, a medical oncologist at the Sarah Cannon Research Institute, Nashville, Tennessee, who reported ties to AstraZeneca. “This will be practice changing as soon as the label gets expanded.”

In the trial, investigators randomized 216 patients with unresectable stage III EGFR-mutated NSCLC who had not progressed after definitive platinum-based chemoradiation to receive either 80 mg osimertinib (n = 143) or placebo (n = 73). Baseline characteristics were generally balanced between the study arms, with a mostly even split between stage III subtypes.

Patients were staged by biopsy or CT at baseline plus MRI to confirm the absence of brain lesions. Subsequent imaging was repeated at regular intervals.

Twelve-month progression-free survival, assessed by blinded independent central review, was 74% with osimertinib vs 22% with placebo. At 24 months, the rates were 65% and 13%, respectively.

The progression-free survival benefit held across numerous subgroups but was statistically significant only among Asian individuals, who made up over 80% of both study arms.

Although the data are immature, osimertinib is also showing a trend toward improved overall survival, despite 81% of placebo patients crossing over to osimertinib after progression, Dr. Ramalingam reported. Mature overall survival results are expected within 2 years.

Based on these results, “osimertinib will become the new standard of care” after definitive chemoradiation in this patient population, Dr. Ramalingam said.

EGFR mutation testing “is now critical for stage III patients to ensure optimal” treatment, he added. Nearly a third of patients with NSCLC present with stage III disease, and the majority are unresectable. Of those, about a third are EGFR mutated.

Placebo was a fair comparator in the trial, Dr. Ramalingam stressed. While the current standard of care for unresectable stage III disease is 1 year of durvalumab after chemoradiation, durvalumab has proven ineffective in EGFR-mutated disease and often isn›t used in the setting.

If the control arm had been on durvalumab, patients would have needed to wait until it was safe to give them an EGFR TKI after progression, which didn’t seem to be in their best interest, he told this news organization.

A total of 68% of patients receiving placebo developed new lesions during the study, including brain metastases in 29%. New lesions developed in 22% of those on osimertinib, with new brain lesions in 8%.

The incidence of radiation pneumonitis, the most common adverse event, was 48% with osimertinib and 38% with placebo. Skin rash, diarrhea, and other known TKI side effects were also more common with osimertinib.

Treatment-related grade 3 or worse adverse events occurred in 13% of osimertinib patients vs 3% of placebo patients. Overall, 8% of osimertinib patients developed interstitial lung disease; most cases were low grade, but one person died.

About half of patients interrupted osimertinib dosing due to side effects, with a minority discontinuing.

Another study discussant, medical oncologist Lecia Sequist, MD, called the results “practice-changing” and said the findings support immediate consolidation with osimertinib instead of waiting for patients to progress.

Dr. Sequist, who reported ties to AstraZeneca, noted that patients were treated with osimertinib until progression, not for a limited duration as in past EGFR TKI trials, raising the possibility of indefinite, life-long treatment.

Treating until progression acknowledges the fact that for most patients, unresectable stage III NSCLC can’t be cured. However, she said a minority of patients might not need indefinite treatment — an important cohort to identify, given the drug costs more than $18,000 a month.

The study was funded by osimertinib maker AstraZeneca. Investigators included employees. Dr. Ramalingam, Dr. Spigel, and Dr. Sequist are advisers for and disclosed research funding from AstraZeneca. Dr. Spigel also disclosed travel funding.

A version of this article appeared on Medscape.com.

CHICAGO — Osimertinib (Tagrisso) may soon have approvals across all stages of epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC).

The third-generation EGFR tyrosine kinase inhibitor (TKI) already carries indications for metastatic disease and for adjuvant use in earlier-stage EGFR-mutated NSCLC.

Results from the phase 3 LAURA trial, presented at the American Society of Clinical Oncology (ASCO) annual meeting and funded by AstraZeneca, will likely lead to an approval for the remaining indication: Unresectable stage III disease.

Among patients randomized to either osimertinib or placebo following definitive chemoradiation, osimertinib extended median progression-free survival by 33.5 months compared with placebo — 39.1 vs 5.6 months, respectively (hazard ratio, 0.16; P = .001).

The news was greeted with a standing ovation at the meeting where it was presented by lead investigator and medical oncologist Suresh S. Ramalingam, MD, a lung cancer specialist at Emory University, Atlanta.

David R. Spigel, MD, a discussant on the trial, called the results “outstanding.”

“To have an 84% reduction in the risk of cancer progression or death is meaningful,” said Dr. Spigel, a medical oncologist at the Sarah Cannon Research Institute, Nashville, Tennessee, who reported ties to AstraZeneca. “This will be practice changing as soon as the label gets expanded.”

In the trial, investigators randomized 216 patients with unresectable stage III EGFR-mutated NSCLC who had not progressed after definitive platinum-based chemoradiation to receive either 80 mg osimertinib (n = 143) or placebo (n = 73). Baseline characteristics were generally balanced between the study arms, with a mostly even split between stage III subtypes.

Patients were staged by biopsy or CT at baseline plus MRI to confirm the absence of brain lesions. Subsequent imaging was repeated at regular intervals.

Twelve-month progression-free survival, assessed by blinded independent central review, was 74% with osimertinib vs 22% with placebo. At 24 months, the rates were 65% and 13%, respectively.

The progression-free survival benefit held across numerous subgroups but was statistically significant only among Asian individuals, who made up over 80% of both study arms.

Although the data are immature, osimertinib is also showing a trend toward improved overall survival, despite 81% of placebo patients crossing over to osimertinib after progression, Dr. Ramalingam reported. Mature overall survival results are expected within 2 years.

Based on these results, “osimertinib will become the new standard of care” after definitive chemoradiation in this patient population, Dr. Ramalingam said.

EGFR mutation testing “is now critical for stage III patients to ensure optimal” treatment, he added. Nearly a third of patients with NSCLC present with stage III disease, and the majority are unresectable. Of those, about a third are EGFR mutated.

Placebo was a fair comparator in the trial, Dr. Ramalingam stressed. While the current standard of care for unresectable stage III disease is 1 year of durvalumab after chemoradiation, durvalumab has proven ineffective in EGFR-mutated disease and often isn›t used in the setting.

If the control arm had been on durvalumab, patients would have needed to wait until it was safe to give them an EGFR TKI after progression, which didn’t seem to be in their best interest, he told this news organization.

A total of 68% of patients receiving placebo developed new lesions during the study, including brain metastases in 29%. New lesions developed in 22% of those on osimertinib, with new brain lesions in 8%.

The incidence of radiation pneumonitis, the most common adverse event, was 48% with osimertinib and 38% with placebo. Skin rash, diarrhea, and other known TKI side effects were also more common with osimertinib.

Treatment-related grade 3 or worse adverse events occurred in 13% of osimertinib patients vs 3% of placebo patients. Overall, 8% of osimertinib patients developed interstitial lung disease; most cases were low grade, but one person died.

About half of patients interrupted osimertinib dosing due to side effects, with a minority discontinuing.

Another study discussant, medical oncologist Lecia Sequist, MD, called the results “practice-changing” and said the findings support immediate consolidation with osimertinib instead of waiting for patients to progress.

Dr. Sequist, who reported ties to AstraZeneca, noted that patients were treated with osimertinib until progression, not for a limited duration as in past EGFR TKI trials, raising the possibility of indefinite, life-long treatment.

Treating until progression acknowledges the fact that for most patients, unresectable stage III NSCLC can’t be cured. However, she said a minority of patients might not need indefinite treatment — an important cohort to identify, given the drug costs more than $18,000 a month.

The study was funded by osimertinib maker AstraZeneca. Investigators included employees. Dr. Ramalingam, Dr. Spigel, and Dr. Sequist are advisers for and disclosed research funding from AstraZeneca. Dr. Spigel also disclosed travel funding.

A version of this article appeared on Medscape.com.

CHICAGO — Osimertinib (Tagrisso) may soon have approvals across all stages of epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC).

The third-generation EGFR tyrosine kinase inhibitor (TKI) already carries indications for metastatic disease and for adjuvant use in earlier-stage EGFR-mutated NSCLC.

Results from the phase 3 LAURA trial, presented at the American Society of Clinical Oncology (ASCO) annual meeting and funded by AstraZeneca, will likely lead to an approval for the remaining indication: Unresectable stage III disease.

Among patients randomized to either osimertinib or placebo following definitive chemoradiation, osimertinib extended median progression-free survival by 33.5 months compared with placebo — 39.1 vs 5.6 months, respectively (hazard ratio, 0.16; P = .001).

The news was greeted with a standing ovation at the meeting where it was presented by lead investigator and medical oncologist Suresh S. Ramalingam, MD, a lung cancer specialist at Emory University, Atlanta.

David R. Spigel, MD, a discussant on the trial, called the results “outstanding.”

“To have an 84% reduction in the risk of cancer progression or death is meaningful,” said Dr. Spigel, a medical oncologist at the Sarah Cannon Research Institute, Nashville, Tennessee, who reported ties to AstraZeneca. “This will be practice changing as soon as the label gets expanded.”

In the trial, investigators randomized 216 patients with unresectable stage III EGFR-mutated NSCLC who had not progressed after definitive platinum-based chemoradiation to receive either 80 mg osimertinib (n = 143) or placebo (n = 73). Baseline characteristics were generally balanced between the study arms, with a mostly even split between stage III subtypes.

Patients were staged by biopsy or CT at baseline plus MRI to confirm the absence of brain lesions. Subsequent imaging was repeated at regular intervals.

Twelve-month progression-free survival, assessed by blinded independent central review, was 74% with osimertinib vs 22% with placebo. At 24 months, the rates were 65% and 13%, respectively.

The progression-free survival benefit held across numerous subgroups but was statistically significant only among Asian individuals, who made up over 80% of both study arms.

Although the data are immature, osimertinib is also showing a trend toward improved overall survival, despite 81% of placebo patients crossing over to osimertinib after progression, Dr. Ramalingam reported. Mature overall survival results are expected within 2 years.

Based on these results, “osimertinib will become the new standard of care” after definitive chemoradiation in this patient population, Dr. Ramalingam said.

EGFR mutation testing “is now critical for stage III patients to ensure optimal” treatment, he added. Nearly a third of patients with NSCLC present with stage III disease, and the majority are unresectable. Of those, about a third are EGFR mutated.

Placebo was a fair comparator in the trial, Dr. Ramalingam stressed. While the current standard of care for unresectable stage III disease is 1 year of durvalumab after chemoradiation, durvalumab has proven ineffective in EGFR-mutated disease and often isn›t used in the setting.

If the control arm had been on durvalumab, patients would have needed to wait until it was safe to give them an EGFR TKI after progression, which didn’t seem to be in their best interest, he told this news organization.

A total of 68% of patients receiving placebo developed new lesions during the study, including brain metastases in 29%. New lesions developed in 22% of those on osimertinib, with new brain lesions in 8%.

The incidence of radiation pneumonitis, the most common adverse event, was 48% with osimertinib and 38% with placebo. Skin rash, diarrhea, and other known TKI side effects were also more common with osimertinib.

Treatment-related grade 3 or worse adverse events occurred in 13% of osimertinib patients vs 3% of placebo patients. Overall, 8% of osimertinib patients developed interstitial lung disease; most cases were low grade, but one person died.

About half of patients interrupted osimertinib dosing due to side effects, with a minority discontinuing.

Another study discussant, medical oncologist Lecia Sequist, MD, called the results “practice-changing” and said the findings support immediate consolidation with osimertinib instead of waiting for patients to progress.

Dr. Sequist, who reported ties to AstraZeneca, noted that patients were treated with osimertinib until progression, not for a limited duration as in past EGFR TKI trials, raising the possibility of indefinite, life-long treatment.

Treating until progression acknowledges the fact that for most patients, unresectable stage III NSCLC can’t be cured. However, she said a minority of patients might not need indefinite treatment — an important cohort to identify, given the drug costs more than $18,000 a month.

The study was funded by osimertinib maker AstraZeneca. Investigators included employees. Dr. Ramalingam, Dr. Spigel, and Dr. Sequist are advisers for and disclosed research funding from AstraZeneca. Dr. Spigel also disclosed travel funding.

A version of this article appeared on Medscape.com.

Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.

HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues. 

“Lack of knowledge about HP and its therapeutics contributes to significant uncertainty and impacts quality of life,” the researchers wrote in their abstract. 

Surveys Conducted to Understand Patient Concerns

To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.

The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.

The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).

The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.

Findings Will Fuel Needed Education

Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted. 

“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.

The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.

In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.

“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.

The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.

HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues. 

“Lack of knowledge about HP and its therapeutics contributes to significant uncertainty and impacts quality of life,” the researchers wrote in their abstract. 

Surveys Conducted to Understand Patient Concerns

To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.

The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.

The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).

The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.

Findings Will Fuel Needed Education

Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted. 

“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.

The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.

In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.

“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.

The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.

HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues. 

“Lack of knowledge about HP and its therapeutics contributes to significant uncertainty and impacts quality of life,” the researchers wrote in their abstract. 

Surveys Conducted to Understand Patient Concerns

To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.

The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.

The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).

The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.

Findings Will Fuel Needed Education

Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted. 

“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.

The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.

In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.

“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.

The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

LONG BEACH, CALIFORNIA — A small fraction of patients with pulmonary embolism (PE) who are eligible for advanced therapies are actually getting them, reported investigators who conducted a big data analysis.

“Advanced PE therapy seems to be vulnerable to disparate use, and perhaps underuse,” Sahil Parikh, MD, a cardiovascular interventionalist at the Columbia University Medical Center in New York, said when he presented results from the REAL-PE study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2024 Scientific Sessions.

The underuse of advanced PE therapies is “the controversy,” Dr. Parikh said after his presentation. “It remains unclear what the role of invasive therapy is in the management of so-called high-intermediate–risk people. There isn’t a Class 1 guideline recommendation, and there is a very rapidly evolving trend that we’re increasingly treating these patients invasively,” he said.

“However, if you come to these meetings [such as SCAI], you might think everyone is getting one of these devices, but these data show that’s not the case,” Dr. Parikh said.

The analysis mined deidentified data from Truveta, a collective of health systems that provides regulatory-grade electronic health record data for research. The database included 105 million diagnoses made from January 1, 2018, to May 5, 2023; according to the diagnosis codes, 435,296 of these were for pulmonary embolism, and according to the procedure codes, 2072 patients — 0.48% of all patients with a PE diagnosis — received advanced therapy.

The researchers accessed data on patients treated with ultrasound-assisted catheter-directed thrombolysis or mechanical thrombectomy, identified from claims codes. Patient characteristics — age, race, ethnicity, sex, comorbidities, and diagnoses — were also accessed for the analysis. Earlier results were published in the January issue of the Journal of the Society for Cardiovascular Angioplasty Interventions. 
 

Less Intervention for Black Patients and Women

White patients were more likely to receive advanced therapy than were Black patients (0.5% vs 0.37%; P = .000), Dr. Parikh reported, and women were less likely to receive advanced therapy than were men (0.41% vs 0.55%; P = .000).

The only discernable differences in outcomes were in major bleeding events in the 7 days after the procedure, which affected more White patients than it did Black patients (13.9% vs 9.3%) and affected more women than it did men (16.6% vs 11.1%).

What’s noteworthy about this study is that it demonstrates the potential of advanced data analytics to identify disparities in care and outcomes, Dr. Parikh said during his presentation. “These analyses provide a means of evaluating disparities in real clinical practice, both in the area of PE and otherwise, and may also be used for real-time monitoring of clinical decision-making and decisional support,” he said. “We do think that both novel and established therapies can benefit equally from similar types of analyses.”
 

Big Data Signaling Disparities

“That’s where these data are helpful,” Dr. Parikh explained. They provide “a real snapshot of how many procedures are being performed and in what kinds of patients. The low number of patients getting the procedure would suggest that there are probably more patients who would be eligible for treatment based on some of the emerging consensus documents, and they’re not receiving them.”

The data are “hypotheses generating,” Dr. Parikh said in an interview. “These hypotheses have to be evaluated further in more granular databases.”

REAL-PE is also a “clarion call” for clinical trials of investigative devices going forward, he said. “In those trials, we need to endeavor to enroll enough women and men, minority and nonminority patients so that we can make meaningful assessments of differences in efficacy and safety.”

This study is “real proof that big data can be used to provide information on outcomes for patients in a very rapid manner; that’s really exciting,” said Ethan Korngold, MD, chair of structural and interventional cardiology at the Providence Health Institute in Portland, Oregon. “This is an area of great research with great innovation, and it’s proof that, with these type of techniques using artificial intelligence and big data, we can generate data quickly on how we’re doing and what kind of patients we’re reaching.”

Findings like these may also help identify sources of the disparities, Dr. Korngold added. 

“This shows we need to be reaching every patient with advanced therapies,” he said. “Different hospitals have different capabilities and different expertise in this area and they reach different patient populations. A lot of the difference in utilization stems from this fact,” he said.

“It just underscores the fact that we need to standardize our treatment approaches, and then we need to reach every person who’s suffering from this disease,” Dr. Korngold said.

A version of this article appeared on Medscape.com.

LONG BEACH, CALIFORNIA — A small fraction of patients with pulmonary embolism (PE) who are eligible for advanced therapies are actually getting them, reported investigators who conducted a big data analysis.

“Advanced PE therapy seems to be vulnerable to disparate use, and perhaps underuse,” Sahil Parikh, MD, a cardiovascular interventionalist at the Columbia University Medical Center in New York, said when he presented results from the REAL-PE study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2024 Scientific Sessions.

The underuse of advanced PE therapies is “the controversy,” Dr. Parikh said after his presentation. “It remains unclear what the role of invasive therapy is in the management of so-called high-intermediate–risk people. There isn’t a Class 1 guideline recommendation, and there is a very rapidly evolving trend that we’re increasingly treating these patients invasively,” he said.

“However, if you come to these meetings [such as SCAI], you might think everyone is getting one of these devices, but these data show that’s not the case,” Dr. Parikh said.

The analysis mined deidentified data from Truveta, a collective of health systems that provides regulatory-grade electronic health record data for research. The database included 105 million diagnoses made from January 1, 2018, to May 5, 2023; according to the diagnosis codes, 435,296 of these were for pulmonary embolism, and according to the procedure codes, 2072 patients — 0.48% of all patients with a PE diagnosis — received advanced therapy.

The researchers accessed data on patients treated with ultrasound-assisted catheter-directed thrombolysis or mechanical thrombectomy, identified from claims codes. Patient characteristics — age, race, ethnicity, sex, comorbidities, and diagnoses — were also accessed for the analysis. Earlier results were published in the January issue of the Journal of the Society for Cardiovascular Angioplasty Interventions. 
 

Less Intervention for Black Patients and Women

White patients were more likely to receive advanced therapy than were Black patients (0.5% vs 0.37%; P = .000), Dr. Parikh reported, and women were less likely to receive advanced therapy than were men (0.41% vs 0.55%; P = .000).

The only discernable differences in outcomes were in major bleeding events in the 7 days after the procedure, which affected more White patients than it did Black patients (13.9% vs 9.3%) and affected more women than it did men (16.6% vs 11.1%).

What’s noteworthy about this study is that it demonstrates the potential of advanced data analytics to identify disparities in care and outcomes, Dr. Parikh said during his presentation. “These analyses provide a means of evaluating disparities in real clinical practice, both in the area of PE and otherwise, and may also be used for real-time monitoring of clinical decision-making and decisional support,” he said. “We do think that both novel and established therapies can benefit equally from similar types of analyses.”
 

Big Data Signaling Disparities

“That’s where these data are helpful,” Dr. Parikh explained. They provide “a real snapshot of how many procedures are being performed and in what kinds of patients. The low number of patients getting the procedure would suggest that there are probably more patients who would be eligible for treatment based on some of the emerging consensus documents, and they’re not receiving them.”

The data are “hypotheses generating,” Dr. Parikh said in an interview. “These hypotheses have to be evaluated further in more granular databases.”

REAL-PE is also a “clarion call” for clinical trials of investigative devices going forward, he said. “In those trials, we need to endeavor to enroll enough women and men, minority and nonminority patients so that we can make meaningful assessments of differences in efficacy and safety.”

This study is “real proof that big data can be used to provide information on outcomes for patients in a very rapid manner; that’s really exciting,” said Ethan Korngold, MD, chair of structural and interventional cardiology at the Providence Health Institute in Portland, Oregon. “This is an area of great research with great innovation, and it’s proof that, with these type of techniques using artificial intelligence and big data, we can generate data quickly on how we’re doing and what kind of patients we’re reaching.”

Findings like these may also help identify sources of the disparities, Dr. Korngold added. 

“This shows we need to be reaching every patient with advanced therapies,” he said. “Different hospitals have different capabilities and different expertise in this area and they reach different patient populations. A lot of the difference in utilization stems from this fact,” he said.

“It just underscores the fact that we need to standardize our treatment approaches, and then we need to reach every person who’s suffering from this disease,” Dr. Korngold said.

A version of this article appeared on Medscape.com.

LONG BEACH, CALIFORNIA — A small fraction of patients with pulmonary embolism (PE) who are eligible for advanced therapies are actually getting them, reported investigators who conducted a big data analysis.

“Advanced PE therapy seems to be vulnerable to disparate use, and perhaps underuse,” Sahil Parikh, MD, a cardiovascular interventionalist at the Columbia University Medical Center in New York, said when he presented results from the REAL-PE study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2024 Scientific Sessions.

The underuse of advanced PE therapies is “the controversy,” Dr. Parikh said after his presentation. “It remains unclear what the role of invasive therapy is in the management of so-called high-intermediate–risk people. There isn’t a Class 1 guideline recommendation, and there is a very rapidly evolving trend that we’re increasingly treating these patients invasively,” he said.

“However, if you come to these meetings [such as SCAI], you might think everyone is getting one of these devices, but these data show that’s not the case,” Dr. Parikh said.

The analysis mined deidentified data from Truveta, a collective of health systems that provides regulatory-grade electronic health record data for research. The database included 105 million diagnoses made from January 1, 2018, to May 5, 2023; according to the diagnosis codes, 435,296 of these were for pulmonary embolism, and according to the procedure codes, 2072 patients — 0.48% of all patients with a PE diagnosis — received advanced therapy.

The researchers accessed data on patients treated with ultrasound-assisted catheter-directed thrombolysis or mechanical thrombectomy, identified from claims codes. Patient characteristics — age, race, ethnicity, sex, comorbidities, and diagnoses — were also accessed for the analysis. Earlier results were published in the January issue of the Journal of the Society for Cardiovascular Angioplasty Interventions. 
 

Less Intervention for Black Patients and Women

White patients were more likely to receive advanced therapy than were Black patients (0.5% vs 0.37%; P = .000), Dr. Parikh reported, and women were less likely to receive advanced therapy than were men (0.41% vs 0.55%; P = .000).

The only discernable differences in outcomes were in major bleeding events in the 7 days after the procedure, which affected more White patients than it did Black patients (13.9% vs 9.3%) and affected more women than it did men (16.6% vs 11.1%).

What’s noteworthy about this study is that it demonstrates the potential of advanced data analytics to identify disparities in care and outcomes, Dr. Parikh said during his presentation. “These analyses provide a means of evaluating disparities in real clinical practice, both in the area of PE and otherwise, and may also be used for real-time monitoring of clinical decision-making and decisional support,” he said. “We do think that both novel and established therapies can benefit equally from similar types of analyses.”
 

Big Data Signaling Disparities

“That’s where these data are helpful,” Dr. Parikh explained. They provide “a real snapshot of how many procedures are being performed and in what kinds of patients. The low number of patients getting the procedure would suggest that there are probably more patients who would be eligible for treatment based on some of the emerging consensus documents, and they’re not receiving them.”

The data are “hypotheses generating,” Dr. Parikh said in an interview. “These hypotheses have to be evaluated further in more granular databases.”

REAL-PE is also a “clarion call” for clinical trials of investigative devices going forward, he said. “In those trials, we need to endeavor to enroll enough women and men, minority and nonminority patients so that we can make meaningful assessments of differences in efficacy and safety.”

This study is “real proof that big data can be used to provide information on outcomes for patients in a very rapid manner; that’s really exciting,” said Ethan Korngold, MD, chair of structural and interventional cardiology at the Providence Health Institute in Portland, Oregon. “This is an area of great research with great innovation, and it’s proof that, with these type of techniques using artificial intelligence and big data, we can generate data quickly on how we’re doing and what kind of patients we’re reaching.”

Findings like these may also help identify sources of the disparities, Dr. Korngold added. 

“This shows we need to be reaching every patient with advanced therapies,” he said. “Different hospitals have different capabilities and different expertise in this area and they reach different patient populations. A lot of the difference in utilization stems from this fact,” he said.

“It just underscores the fact that we need to standardize our treatment approaches, and then we need to reach every person who’s suffering from this disease,” Dr. Korngold said.

A version of this article appeared on Medscape.com.

Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

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

A version of this article appeared on Medscape.com.

Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

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

A version of this article appeared on Medscape.com.

Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

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

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345, Moderna), a vaccine for respiratory syncytial virus (RSV).

The mRNA vaccine is approved for adults aged 60 years or older to prevent lower respiratory tract disease caused by RSV. It is the third vaccine to be approved for RSV in the past year after Arexvy from GSK and Abrysvo by Pfizer.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

mRESVIA is a single-dose vaccine available in prefilled syringes, which the company says are designed to maximize ease of administration, saving vaccinators’ time, and reducing the risk for administrative errors.

The approval is based on the positive results from the phase 3 ConquerRSV clinical trial, published in The New England Journal of Medicine in December 2023. The study, conducted in approximately 37,000 adults aged 60 years or older in 22 countries, found a vaccine efficacy against RSV lower respiratory tract disease of 83.7% after a median 3.7 months of follow-up.

An additional longer-term analysis showed continued protection over 8.6 months median follow-up. No serious safety concerns were identified. The most reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna has also filed for approval in multiple markets around the world, and says it expects mRESVIA to be available in the United States in time for the 2024-2025 respiratory virus season.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345, Moderna), a vaccine for respiratory syncytial virus (RSV).

The mRNA vaccine is approved for adults aged 60 years or older to prevent lower respiratory tract disease caused by RSV. It is the third vaccine to be approved for RSV in the past year after Arexvy from GSK and Abrysvo by Pfizer.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

mRESVIA is a single-dose vaccine available in prefilled syringes, which the company says are designed to maximize ease of administration, saving vaccinators’ time, and reducing the risk for administrative errors.

The approval is based on the positive results from the phase 3 ConquerRSV clinical trial, published in The New England Journal of Medicine in December 2023. The study, conducted in approximately 37,000 adults aged 60 years or older in 22 countries, found a vaccine efficacy against RSV lower respiratory tract disease of 83.7% after a median 3.7 months of follow-up.

An additional longer-term analysis showed continued protection over 8.6 months median follow-up. No serious safety concerns were identified. The most reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna has also filed for approval in multiple markets around the world, and says it expects mRESVIA to be available in the United States in time for the 2024-2025 respiratory virus season.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345, Moderna), a vaccine for respiratory syncytial virus (RSV).

The mRNA vaccine is approved for adults aged 60 years or older to prevent lower respiratory tract disease caused by RSV. It is the third vaccine to be approved for RSV in the past year after Arexvy from GSK and Abrysvo by Pfizer.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

mRESVIA is a single-dose vaccine available in prefilled syringes, which the company says are designed to maximize ease of administration, saving vaccinators’ time, and reducing the risk for administrative errors.

The approval is based on the positive results from the phase 3 ConquerRSV clinical trial, published in The New England Journal of Medicine in December 2023. The study, conducted in approximately 37,000 adults aged 60 years or older in 22 countries, found a vaccine efficacy against RSV lower respiratory tract disease of 83.7% after a median 3.7 months of follow-up.

An additional longer-term analysis showed continued protection over 8.6 months median follow-up. No serious safety concerns were identified. The most reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna has also filed for approval in multiple markets around the world, and says it expects mRESVIA to be available in the United States in time for the 2024-2025 respiratory virus season.

A version of this article appeared on Medscape.com.

Adding durvalumab as consolidation treatment following concurrent chemoradiation (cCRT) adds 2 years of life and increases progression-free survival by 24%, compared with placebo, in patients with limited stage small cell lung cancer (LS-SCLC).

These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.

Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.

“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.

“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
 

ADRIATIC Methods and Results

The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.

The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.

After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
 

New Standard of Care for Patients with LS-SCLC

“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.

“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.

Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”

Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.

“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.

“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.

“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”

The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.

Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.

Dr. Campbell has served as an advisor for Novocure and Genentech.

Adding durvalumab as consolidation treatment following concurrent chemoradiation (cCRT) adds 2 years of life and increases progression-free survival by 24%, compared with placebo, in patients with limited stage small cell lung cancer (LS-SCLC).

These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.

Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.

“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.

“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
 

ADRIATIC Methods and Results

The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.

The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.

After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
 

New Standard of Care for Patients with LS-SCLC

“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.

“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.

Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”

Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.

“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.

“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.

“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”

The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.

Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.

Dr. Campbell has served as an advisor for Novocure and Genentech.

Adding durvalumab as consolidation treatment following concurrent chemoradiation (cCRT) adds 2 years of life and increases progression-free survival by 24%, compared with placebo, in patients with limited stage small cell lung cancer (LS-SCLC).

These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.

Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.

“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.

“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
 

ADRIATIC Methods and Results

The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.

The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.

After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
 

New Standard of Care for Patients with LS-SCLC

“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.

“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.

Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”

Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.

“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.

“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.

“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”

The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.

Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.

Dr. Campbell has served as an advisor for Novocure and Genentech.

BOSTON — New Endocrine Society guidelines call for limiting vitamin D supplementation beyond the daily recommended intake to specific risk groups and advises against routine 25-hydroxyvitamin D [25(OH)D] testing in healthy individuals. 

The evidence-based document was presented on June 3, 2024, at the Endocrine Society annual meeting, and simultaneously published in The Journal of Clinical Endocrinology and Metabolism. It advises that people who may benefit from vitamin D supplementation include: 

• Children aged 1-18 years to prevent rickets and to potentially lower the risk for respiratory tract infections
• Pregnant people to lower the risk for maternal and fetal or neonatal complications
• Adults older than 75 years to lower the risk for mortality
• Adults with prediabetes to lower the risk for type 2 diabetes

In those groups, the recommendation is for daily (rather than intermittent) empiric vitamin D supplementation of more than what was recommended in 2011 by the National Academy of Medicine (NAM), which was then called the Institute of Medicine (IOM): 600 IU/d for those aged 1-70 years and 800 IU/d for those older than 70 years. The document acknowledges that the optimal dose for these populations isn’t known, but it provides the dose ranges that were used in the trials cited as evidence for the recommendations. 

In contrast, the document advises against more vitamin D than the recommended daily intake for most healthier adults younger than 75 years and recommends against testing for blood vitamin D levels in the general population, including those with obesity or darker complexions. 

Guideline author Anastassios G. Pittas, MD, professor of medicine at Tufts University School of Medicine, Boston, told this news organization, “this guideline refers to people who are otherwise healthy, and there’s no clear indication for vitamin D, such as people with already established osteoporosis. This guideline is not relevant to them.”

Dr. Pittas also noted, “there’s no single question and single answer about the role of vitamin D in health and disease, which is what people often want to know. There are many questions, and we cannot answer all of them.”

Panel Chair Marie B. Demay, MD, professor of medicine at Harvard Medical School, Boston, told this news organization that indeed the panel was limited by lack of randomized clinical trial evidence to answer many important questions. “There is a paucity of data regarding definition of optimal levels and optimal intake of vitamin D for preventing specific diseases ... What we really need are large scale clinical trials and biomarkers so we can predict disease outcome before it happens.”

Overall, Dr. Demay said, “The recommendations are that populations adhere to the [NAM/IOM] dietary recommended intakes, and there are certain populations that will likely benefit from levels of intake above [those].” 

Asked to comment, session moderator Clifford J. Rosen, MD, director of Clinical and Translational Research and senior scientist at Maine Medical Center Research Institute, Scarborough, Maine, noted that screening for vitamin D is quite common in clinical practice, but the recommendation against doing so makes sense. 

“When clinicians measure vitamin D, then they’re forced to make a decision what to do about it. That’s where questions about the levels come in. And that’s a big problem. So what the panel’s saying is, don’t screen ... This really gets to the heart of the issue, because we have no data that there’s anything about screening that allows us to improve quality of life ... Screening is probably not worthwhile in any age group.”

Dr. Rosen, who was an author on the 2011 NAM/IOM dietary reference intakes, said that since then, new data have come out regarding the role of vitamin D in mortality in people older than 75 years, benefit in children with regard to respiratory illness, and the potential benefit of vitamin D in pregnancy. “Otherwise, I think we’re going over a lot of the same stuff that we’ve talked about since I was on the IOM panel 15 years ago ... But I think the level of evidence and rigor with which they did it is really impressive.”

However, Simeon I. Taylor, MD, professor of medicine at the University of Maryland, Baltimore, expressed disappointment that the document was limited to healthy people. “Although acknowledging challenges in managing vitamin D status in patients with several diseases, [such as] chronic kidney disease or inflammatory bowel disease, the new guidelines do not provide sufficient guidance for practicing physicians about how to manage these complex patients.”

In addition, Dr. Taylor said that the guidelines “do not explicitly consider the literature suggesting that alternative testing strategies may provide more relevant insights into vitamin D status. Just as variation in levels of thyroid-binding globulin have convinced endocrinologists not to rely on measurement of total thyroxine; interindividual variation in levels of vitamin D binding protein must be accounted for to interpret measurements of total levels of 25(OH)D. It would have been useful to explicitly consider the possible value of measuring vitamin D binding protein-independent indices of vitamin D status.”

Dr. Taylor also raised the same point as an audience member did during the Q&A period regarding patients with osteoporosis or osteopenia. “The value and utility of the new guidelines would be greatly strengthened by providing guidance for how to approach this important and very large group of individuals.”

Dr. Taylor did say that the document has “several strengths, including the fact that they acknowledge the major limitations of the quality of relevant evidence derived from clinical trials.” 

In an accompanying commentary, the guideline authors delve into the issues of skin pigmentation and race as they pertain to vitamin D metabolism, writing: 

The panel discovered that no randomized clinical trials have directly assessed vitamin D related patient-important outcomes based on participants’ skin pigmentation, although race and ethnicity often served as presumed proxies for skin pigmentation in the literature. In their deliberations, guideline panel members and selected Endocrine Society leaders underscored the critical need to distinguish between skin pigmentation as a biological variable and race and ethnicity as socially determined constructs. This differentiation is vital to maximize scientific rigor and, thus, the validity of resulting recommendations.

Dr. Pittas and Dr. Demay have no disclosures relevant to this clinical practice guideline. Dr. Rosen has no disclosures. Dr. Taylor serves as a consultant for Ionis Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

BOSTON — New Endocrine Society guidelines call for limiting vitamin D supplementation beyond the daily recommended intake to specific risk groups and advises against routine 25-hydroxyvitamin D [25(OH)D] testing in healthy individuals. 

The evidence-based document was presented on June 3, 2024, at the Endocrine Society annual meeting, and simultaneously published in The Journal of Clinical Endocrinology and Metabolism. It advises that people who may benefit from vitamin D supplementation include: 

• Children aged 1-18 years to prevent rickets and to potentially lower the risk for respiratory tract infections
• Pregnant people to lower the risk for maternal and fetal or neonatal complications
• Adults older than 75 years to lower the risk for mortality
• Adults with prediabetes to lower the risk for type 2 diabetes

In those groups, the recommendation is for daily (rather than intermittent) empiric vitamin D supplementation of more than what was recommended in 2011 by the National Academy of Medicine (NAM), which was then called the Institute of Medicine (IOM): 600 IU/d for those aged 1-70 years and 800 IU/d for those older than 70 years. The document acknowledges that the optimal dose for these populations isn’t known, but it provides the dose ranges that were used in the trials cited as evidence for the recommendations. 

In contrast, the document advises against more vitamin D than the recommended daily intake for most healthier adults younger than 75 years and recommends against testing for blood vitamin D levels in the general population, including those with obesity or darker complexions. 

Guideline author Anastassios G. Pittas, MD, professor of medicine at Tufts University School of Medicine, Boston, told this news organization, “this guideline refers to people who are otherwise healthy, and there’s no clear indication for vitamin D, such as people with already established osteoporosis. This guideline is not relevant to them.”

Dr. Pittas also noted, “there’s no single question and single answer about the role of vitamin D in health and disease, which is what people often want to know. There are many questions, and we cannot answer all of them.”

Panel Chair Marie B. Demay, MD, professor of medicine at Harvard Medical School, Boston, told this news organization that indeed the panel was limited by lack of randomized clinical trial evidence to answer many important questions. “There is a paucity of data regarding definition of optimal levels and optimal intake of vitamin D for preventing specific diseases ... What we really need are large scale clinical trials and biomarkers so we can predict disease outcome before it happens.”

Overall, Dr. Demay said, “The recommendations are that populations adhere to the [NAM/IOM] dietary recommended intakes, and there are certain populations that will likely benefit from levels of intake above [those].” 

Asked to comment, session moderator Clifford J. Rosen, MD, director of Clinical and Translational Research and senior scientist at Maine Medical Center Research Institute, Scarborough, Maine, noted that screening for vitamin D is quite common in clinical practice, but the recommendation against doing so makes sense. 

“When clinicians measure vitamin D, then they’re forced to make a decision what to do about it. That’s where questions about the levels come in. And that’s a big problem. So what the panel’s saying is, don’t screen ... This really gets to the heart of the issue, because we have no data that there’s anything about screening that allows us to improve quality of life ... Screening is probably not worthwhile in any age group.”

Dr. Rosen, who was an author on the 2011 NAM/IOM dietary reference intakes, said that since then, new data have come out regarding the role of vitamin D in mortality in people older than 75 years, benefit in children with regard to respiratory illness, and the potential benefit of vitamin D in pregnancy. “Otherwise, I think we’re going over a lot of the same stuff that we’ve talked about since I was on the IOM panel 15 years ago ... But I think the level of evidence and rigor with which they did it is really impressive.”

However, Simeon I. Taylor, MD, professor of medicine at the University of Maryland, Baltimore, expressed disappointment that the document was limited to healthy people. “Although acknowledging challenges in managing vitamin D status in patients with several diseases, [such as] chronic kidney disease or inflammatory bowel disease, the new guidelines do not provide sufficient guidance for practicing physicians about how to manage these complex patients.”

In addition, Dr. Taylor said that the guidelines “do not explicitly consider the literature suggesting that alternative testing strategies may provide more relevant insights into vitamin D status. Just as variation in levels of thyroid-binding globulin have convinced endocrinologists not to rely on measurement of total thyroxine; interindividual variation in levels of vitamin D binding protein must be accounted for to interpret measurements of total levels of 25(OH)D. It would have been useful to explicitly consider the possible value of measuring vitamin D binding protein-independent indices of vitamin D status.”

Dr. Taylor also raised the same point as an audience member did during the Q&A period regarding patients with osteoporosis or osteopenia. “The value and utility of the new guidelines would be greatly strengthened by providing guidance for how to approach this important and very large group of individuals.”

Dr. Taylor did say that the document has “several strengths, including the fact that they acknowledge the major limitations of the quality of relevant evidence derived from clinical trials.” 

In an accompanying commentary, the guideline authors delve into the issues of skin pigmentation and race as they pertain to vitamin D metabolism, writing: 

The panel discovered that no randomized clinical trials have directly assessed vitamin D related patient-important outcomes based on participants’ skin pigmentation, although race and ethnicity often served as presumed proxies for skin pigmentation in the literature. In their deliberations, guideline panel members and selected Endocrine Society leaders underscored the critical need to distinguish between skin pigmentation as a biological variable and race and ethnicity as socially determined constructs. This differentiation is vital to maximize scientific rigor and, thus, the validity of resulting recommendations.

Dr. Pittas and Dr. Demay have no disclosures relevant to this clinical practice guideline. Dr. Rosen has no disclosures. Dr. Taylor serves as a consultant for Ionis Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

BOSTON — New Endocrine Society guidelines call for limiting vitamin D supplementation beyond the daily recommended intake to specific risk groups and advises against routine 25-hydroxyvitamin D [25(OH)D] testing in healthy individuals. 

The evidence-based document was presented on June 3, 2024, at the Endocrine Society annual meeting, and simultaneously published in The Journal of Clinical Endocrinology and Metabolism. It advises that people who may benefit from vitamin D supplementation include: 

• Children aged 1-18 years to prevent rickets and to potentially lower the risk for respiratory tract infections
• Pregnant people to lower the risk for maternal and fetal or neonatal complications
• Adults older than 75 years to lower the risk for mortality
• Adults with prediabetes to lower the risk for type 2 diabetes

In those groups, the recommendation is for daily (rather than intermittent) empiric vitamin D supplementation of more than what was recommended in 2011 by the National Academy of Medicine (NAM), which was then called the Institute of Medicine (IOM): 600 IU/d for those aged 1-70 years and 800 IU/d for those older than 70 years. The document acknowledges that the optimal dose for these populations isn’t known, but it provides the dose ranges that were used in the trials cited as evidence for the recommendations. 

In contrast, the document advises against more vitamin D than the recommended daily intake for most healthier adults younger than 75 years and recommends against testing for blood vitamin D levels in the general population, including those with obesity or darker complexions. 

Guideline author Anastassios G. Pittas, MD, professor of medicine at Tufts University School of Medicine, Boston, told this news organization, “this guideline refers to people who are otherwise healthy, and there’s no clear indication for vitamin D, such as people with already established osteoporosis. This guideline is not relevant to them.”

Dr. Pittas also noted, “there’s no single question and single answer about the role of vitamin D in health and disease, which is what people often want to know. There are many questions, and we cannot answer all of them.”

Panel Chair Marie B. Demay, MD, professor of medicine at Harvard Medical School, Boston, told this news organization that indeed the panel was limited by lack of randomized clinical trial evidence to answer many important questions. “There is a paucity of data regarding definition of optimal levels and optimal intake of vitamin D for preventing specific diseases ... What we really need are large scale clinical trials and biomarkers so we can predict disease outcome before it happens.”

Overall, Dr. Demay said, “The recommendations are that populations adhere to the [NAM/IOM] dietary recommended intakes, and there are certain populations that will likely benefit from levels of intake above [those].” 

Asked to comment, session moderator Clifford J. Rosen, MD, director of Clinical and Translational Research and senior scientist at Maine Medical Center Research Institute, Scarborough, Maine, noted that screening for vitamin D is quite common in clinical practice, but the recommendation against doing so makes sense. 

“When clinicians measure vitamin D, then they’re forced to make a decision what to do about it. That’s where questions about the levels come in. And that’s a big problem. So what the panel’s saying is, don’t screen ... This really gets to the heart of the issue, because we have no data that there’s anything about screening that allows us to improve quality of life ... Screening is probably not worthwhile in any age group.”

Dr. Rosen, who was an author on the 2011 NAM/IOM dietary reference intakes, said that since then, new data have come out regarding the role of vitamin D in mortality in people older than 75 years, benefit in children with regard to respiratory illness, and the potential benefit of vitamin D in pregnancy. “Otherwise, I think we’re going over a lot of the same stuff that we’ve talked about since I was on the IOM panel 15 years ago ... But I think the level of evidence and rigor with which they did it is really impressive.”

However, Simeon I. Taylor, MD, professor of medicine at the University of Maryland, Baltimore, expressed disappointment that the document was limited to healthy people. “Although acknowledging challenges in managing vitamin D status in patients with several diseases, [such as] chronic kidney disease or inflammatory bowel disease, the new guidelines do not provide sufficient guidance for practicing physicians about how to manage these complex patients.”

In addition, Dr. Taylor said that the guidelines “do not explicitly consider the literature suggesting that alternative testing strategies may provide more relevant insights into vitamin D status. Just as variation in levels of thyroid-binding globulin have convinced endocrinologists not to rely on measurement of total thyroxine; interindividual variation in levels of vitamin D binding protein must be accounted for to interpret measurements of total levels of 25(OH)D. It would have been useful to explicitly consider the possible value of measuring vitamin D binding protein-independent indices of vitamin D status.”

Dr. Taylor also raised the same point as an audience member did during the Q&A period regarding patients with osteoporosis or osteopenia. “The value and utility of the new guidelines would be greatly strengthened by providing guidance for how to approach this important and very large group of individuals.”

Dr. Taylor did say that the document has “several strengths, including the fact that they acknowledge the major limitations of the quality of relevant evidence derived from clinical trials.” 

In an accompanying commentary, the guideline authors delve into the issues of skin pigmentation and race as they pertain to vitamin D metabolism, writing: 

The panel discovered that no randomized clinical trials have directly assessed vitamin D related patient-important outcomes based on participants’ skin pigmentation, although race and ethnicity often served as presumed proxies for skin pigmentation in the literature. In their deliberations, guideline panel members and selected Endocrine Society leaders underscored the critical need to distinguish between skin pigmentation as a biological variable and race and ethnicity as socially determined constructs. This differentiation is vital to maximize scientific rigor and, thus, the validity of resulting recommendations.

Dr. Pittas and Dr. Demay have no disclosures relevant to this clinical practice guideline. Dr. Rosen has no disclosures. Dr. Taylor serves as a consultant for Ionis Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Arterial stiffness increases the risk for developing glaucoma, a new study found.

METHODOLOGY:

• To study the link between arterial stiffness and glaucoma, the researchers evaluated 4713 individuals (mean age, 66 years; 58% men) without the eye condition at baseline between April 2011 and November 2012.
• They assessed arterial stiffness by measuring aortic pulse wave velocity, estimated carotid-femoral pulse wave velocity, and aortic pulse pressure.
• The primary outcome was incident glaucoma, identified from prescriptions for eye drops or hospital records.

TAKEAWAY:

• Overall, 301 people in the study developed glaucoma over a mean follow-up period of 10.5 years.
• For every standard deviation increase in aortic pulse wave velocity, participants had a 32% higher risk for developing glaucoma (standardized hazard ratio [sHR], 1.32; 95% CI, 1.10-1.60), while estimated carotid-femoral pulse wave velocity was associated with a 37% higher risk (sHR, 1.37; 95% CI, 1.11-1.70).
• Incident glaucoma increased across all quartiles of arterial stiffness, with the highest risk observed in the fourth quartile for aortic pulse wave velocity (HR, 2.41; 95% CI, 1.36-4.26), estimated carotid-femoral pulse wave velocity (HR, 2.29; 95% CI, 1.27-4.13), and aortic pulse pressure (HR, 1.76; 95% CI, 1.10-2.82).
• The cumulative incidence of glaucoma rose with increases in arterial stiffness. This trend was statistically significant for both aortic and estimated pulse wave velocity (P < .0001) and aortic pulse pressure (P = .02).

IN PRACTICE:

“Arterial stiffness…which can be easily and accurately measured, could be used as a tool in clinical practice [as part of routine blood pressure measurement] to help identify people at risk of glaucoma and as a therapeutic target to prevent glaucoma progression,” the authors wrote.

SOURCE:

This study was led by Angela L. Beros, MPH, of the School of Population Health at the University of Auckland, Auckland, New Zealand, and published online in the American Journal of Ophthalmology.

LIMITATIONS:

The cohort study did not clinically assess for glaucoma, potentially leading to the inclusion of individuals with the condition. Not all participants with incident glaucoma, particularly those unaware of their diagnosis, may have been identified. Intraocular pressure and central corneal thickness, which are common risk factors for glaucoma, were not included in the multivariate analysis.

DISCLOSURES:

The study did not receive any funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Arterial stiffness increases the risk for developing glaucoma, a new study found.

METHODOLOGY:

• To study the link between arterial stiffness and glaucoma, the researchers evaluated 4713 individuals (mean age, 66 years; 58% men) without the eye condition at baseline between April 2011 and November 2012.
• They assessed arterial stiffness by measuring aortic pulse wave velocity, estimated carotid-femoral pulse wave velocity, and aortic pulse pressure.
• The primary outcome was incident glaucoma, identified from prescriptions for eye drops or hospital records.

TAKEAWAY:

• Overall, 301 people in the study developed glaucoma over a mean follow-up period of 10.5 years.
• For every standard deviation increase in aortic pulse wave velocity, participants had a 32% higher risk for developing glaucoma (standardized hazard ratio [sHR], 1.32; 95% CI, 1.10-1.60), while estimated carotid-femoral pulse wave velocity was associated with a 37% higher risk (sHR, 1.37; 95% CI, 1.11-1.70).
• Incident glaucoma increased across all quartiles of arterial stiffness, with the highest risk observed in the fourth quartile for aortic pulse wave velocity (HR, 2.41; 95% CI, 1.36-4.26), estimated carotid-femoral pulse wave velocity (HR, 2.29; 95% CI, 1.27-4.13), and aortic pulse pressure (HR, 1.76; 95% CI, 1.10-2.82).
• The cumulative incidence of glaucoma rose with increases in arterial stiffness. This trend was statistically significant for both aortic and estimated pulse wave velocity (P < .0001) and aortic pulse pressure (P = .02).

IN PRACTICE:

“Arterial stiffness…which can be easily and accurately measured, could be used as a tool in clinical practice [as part of routine blood pressure measurement] to help identify people at risk of glaucoma and as a therapeutic target to prevent glaucoma progression,” the authors wrote.

SOURCE:

This study was led by Angela L. Beros, MPH, of the School of Population Health at the University of Auckland, Auckland, New Zealand, and published online in the American Journal of Ophthalmology.

LIMITATIONS:

The cohort study did not clinically assess for glaucoma, potentially leading to the inclusion of individuals with the condition. Not all participants with incident glaucoma, particularly those unaware of their diagnosis, may have been identified. Intraocular pressure and central corneal thickness, which are common risk factors for glaucoma, were not included in the multivariate analysis.

DISCLOSURES:

The study did not receive any funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Arterial stiffness increases the risk for developing glaucoma, a new study found.

METHODOLOGY:

• To study the link between arterial stiffness and glaucoma, the researchers evaluated 4713 individuals (mean age, 66 years; 58% men) without the eye condition at baseline between April 2011 and November 2012.
• They assessed arterial stiffness by measuring aortic pulse wave velocity, estimated carotid-femoral pulse wave velocity, and aortic pulse pressure.
• The primary outcome was incident glaucoma, identified from prescriptions for eye drops or hospital records.

TAKEAWAY:

• Overall, 301 people in the study developed glaucoma over a mean follow-up period of 10.5 years.
• For every standard deviation increase in aortic pulse wave velocity, participants had a 32% higher risk for developing glaucoma (standardized hazard ratio [sHR], 1.32; 95% CI, 1.10-1.60), while estimated carotid-femoral pulse wave velocity was associated with a 37% higher risk (sHR, 1.37; 95% CI, 1.11-1.70).
• Incident glaucoma increased across all quartiles of arterial stiffness, with the highest risk observed in the fourth quartile for aortic pulse wave velocity (HR, 2.41; 95% CI, 1.36-4.26), estimated carotid-femoral pulse wave velocity (HR, 2.29; 95% CI, 1.27-4.13), and aortic pulse pressure (HR, 1.76; 95% CI, 1.10-2.82).
• The cumulative incidence of glaucoma rose with increases in arterial stiffness. This trend was statistically significant for both aortic and estimated pulse wave velocity (P < .0001) and aortic pulse pressure (P = .02).

IN PRACTICE:

“Arterial stiffness…which can be easily and accurately measured, could be used as a tool in clinical practice [as part of routine blood pressure measurement] to help identify people at risk of glaucoma and as a therapeutic target to prevent glaucoma progression,” the authors wrote.

SOURCE:

This study was led by Angela L. Beros, MPH, of the School of Population Health at the University of Auckland, Auckland, New Zealand, and published online in the American Journal of Ophthalmology.

LIMITATIONS:

The cohort study did not clinically assess for glaucoma, potentially leading to the inclusion of individuals with the condition. Not all participants with incident glaucoma, particularly those unaware of their diagnosis, may have been identified. Intraocular pressure and central corneal thickness, which are common risk factors for glaucoma, were not included in the multivariate analysis.

DISCLOSURES:

The study did not receive any funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

Tricia Ward: Hi. I’m Tricia Ward, from theheart.org/Medscape Cardiology. I’m joined today by Dr Matthew Budoff. He is professor of medicine at UCLA and the endowed chair of preventive cardiology at the Lundquist Institute. Welcome, Dr Budoff. 

Matthew J. Budoff, MD: Thank you. 

Dietary Calcium vs Coronary Calcium

Ms. Ward: The reason I wanted to talk to you today is because there have been some recent studies linking calcium supplements to an increased risk for cardiovascular disease. I’m old enough to remember when we used to tell people that dietary calcium and coronary calcium weren’t connected and weren’t the same. Were we wrong?

Dr. Budoff: I think there’s a large amount of mixed data out there still. The US Preventive Services Task Force looked into this a number of years ago and said there’s no association between calcium supplementation and increased risk for cardiovascular disease. 

As you mentioned, there are a couple of newer studies that point us toward a relationship. I think that we still have a little bit of a mixed bag, but we need to dive a little deeper into that to figure out what’s going on. 

Ms. Ward: Does it appear to be connected to calcium in the form of supplements vs calcium from foods? 

Dr. Budoff: We looked very carefully at dietary calcium in the MESA study, the multiethnic study of atherosclerosis. There is no relationship between dietary calcium intake and coronary calcium or cardiovascular events. We’re talking mostly about supplements now when we talk about this increased risk that we’re seeing.
 

Does Vitamin D Exacerbate Risk? 

Ms. Ward: Because it’s seen with supplements, is that likely because that’s a much higher concentration of calcium coming in or do you think it’s something inherent in its being in the form of a supplement?

Dr. Budoff: I think there are two things. One, it’s definitely a higher concentration all at once. You get many more milligrams at a time when you take a supplement than if you had a high-calcium food or drink.

Also, most supplements have vitamin D as well. I think vitamin D and calcium work synergistically. When you give them both together simultaneously, I think that may have more of a potentiating effect that might exacerbate any potential risk. 

Ms. Ward: Is there any reason to think there might be a difference in type of calcium supplement? I always think of the chalky tablet form vs calcium chews. 

Dr. Budoff: I’m not aware of a difference in the supplement type. I think the vitamin D issue is a big problem because we all have patients who take thousands of units of vitamin D — just crazy numbers. People advocate really high numbers and that stays in the system. 

Personally, I think part of the explanation is that with very high levels of vitamin D on top of calcium supplementation, you now absorb it better. You now get it into the bone, but maybe also into the coronary arteries. If you’re very high in vitamin D and then are taking a large calcium supplement, it might be the calcium/vitamin D combination that’s giving us some trouble. I think people on vitamin D supplements really need to watch their levels and not get supratherapeutic. 

Ms. Ward: With the vitamin D? 

Dr. Budoff: With the vitamin D.
 

Diabetes and Renal Function

Ms. Ward: In some of the studies, there seems to be a higher risk in patients with diabetes. Is there any reason why that would be?

Dr. Budoff: I can’t think of a reason exactly why with diabetes per se, except for renal disease. Patients with diabetes have more intrinsic renal disease, proteinuria, and even a reduced eGFR. We’ve seen that the kidney is very strongly tied to this. We have a very strong relationship, in work I’ve done a decade ago now, showing that calcium supplementation (in the form of phosphate binders) in patients on dialysis or with advanced renal disease is linked to much higher coronary calcium progression. 

We did prospective, randomized trials showing that calcium intake as binders to reduce phosphorus led to more coronary calcium. We always thought that was just relegated to the renal population, and there might be an overlap here with the diabetes and more renal disease. I have a feeling that it has to do with more of that. It might be regulation of parathyroid hormone as well, which might be more abnormal in patients with diabetes. 
 

Avoid Supratherapeutic Vitamin D Levels

Ms. Ward:: What are you telling your patients? 

Dr. Budoff: I tell patients with normal kidney function that the bone will modulate 99.9% of the calcium uptake. If they have osteopenia or osteoporosis, regardless of their calcium score, I’m very comfortable putting them on supplements. 

I’m a little more cautious with the vitamin D levels, and I keep an eye on that and regulate how much vitamin D they get based on their levels. I get them into the normal range, but I don’t want them supratherapeutic. You can even follow their calcium score. Again, we’ve shown that if you’re taking too much calcium, your calcium score will go up. I can just check it again in a couple of years to make sure that it’s safe. 

Ms. Ward:: In terms of vitamin D levels, when you’re saying “supratherapeutic,” what levels do you consider a safe amount to take?

Dr. Budoff: I’d like them under 100 ng/mL as far as their upper level. Normal is around 70 ng/mL at most labs. I try to keep them in the normal range. I don’t even want them to be high-normal if I’m going to be concomitantly giving them calcium supplements. Of course, if they have renal insufficiency, then I’m much more cautious. We’ve even seen calcium supplements raise the serum calcium, which you never see with dietary calcium. That’s another potential proof that it might be too much too fast. 

For renal patients, even in mild renal insufficiency, maybe even in diabetes where we’ve seen a signal, maybe aim lower in the amount of calcium supplementation if diet is insufficient, and aim a little lower in vitamin D targets, and I think you’ll be in a safer place. 

Ms. Ward: Is there anything else you want to add? 

Dr. Budoff: The evidence is still evolving. I’d say that it’s interesting and maybe a little frustrating that we don’t have a final answer on all of this. I would stay tuned for more data because we’re looking at many of the epidemiologic studies to try to see what happens in the real world, with both dietary intake of calcium and calcium supplementation. 

Ms. Ward: Thank you very much for joining me today. 

Dr. Budoff: It’s a pleasure. Thanks for having me. 

Dr. Budoff disclosed being a speaker for Amarin Pharma.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

Tricia Ward: Hi. I’m Tricia Ward, from theheart.org/Medscape Cardiology. I’m joined today by Dr Matthew Budoff. He is professor of medicine at UCLA and the endowed chair of preventive cardiology at the Lundquist Institute. Welcome, Dr Budoff. 

Matthew J. Budoff, MD: Thank you. 

Dietary Calcium vs Coronary Calcium

Ms. Ward: The reason I wanted to talk to you today is because there have been some recent studies linking calcium supplements to an increased risk for cardiovascular disease. I’m old enough to remember when we used to tell people that dietary calcium and coronary calcium weren’t connected and weren’t the same. Were we wrong?

Dr. Budoff: I think there’s a large amount of mixed data out there still. The US Preventive Services Task Force looked into this a number of years ago and said there’s no association between calcium supplementation and increased risk for cardiovascular disease. 

As you mentioned, there are a couple of newer studies that point us toward a relationship. I think that we still have a little bit of a mixed bag, but we need to dive a little deeper into that to figure out what’s going on. 

Ms. Ward: Does it appear to be connected to calcium in the form of supplements vs calcium from foods? 

Dr. Budoff: We looked very carefully at dietary calcium in the MESA study, the multiethnic study of atherosclerosis. There is no relationship between dietary calcium intake and coronary calcium or cardiovascular events. We’re talking mostly about supplements now when we talk about this increased risk that we’re seeing.
 

Does Vitamin D Exacerbate Risk? 

Ms. Ward: Because it’s seen with supplements, is that likely because that’s a much higher concentration of calcium coming in or do you think it’s something inherent in its being in the form of a supplement?

Dr. Budoff: I think there are two things. One, it’s definitely a higher concentration all at once. You get many more milligrams at a time when you take a supplement than if you had a high-calcium food or drink.

Also, most supplements have vitamin D as well. I think vitamin D and calcium work synergistically. When you give them both together simultaneously, I think that may have more of a potentiating effect that might exacerbate any potential risk. 

Ms. Ward: Is there any reason to think there might be a difference in type of calcium supplement? I always think of the chalky tablet form vs calcium chews. 

Dr. Budoff: I’m not aware of a difference in the supplement type. I think the vitamin D issue is a big problem because we all have patients who take thousands of units of vitamin D — just crazy numbers. People advocate really high numbers and that stays in the system. 

Personally, I think part of the explanation is that with very high levels of vitamin D on top of calcium supplementation, you now absorb it better. You now get it into the bone, but maybe also into the coronary arteries. If you’re very high in vitamin D and then are taking a large calcium supplement, it might be the calcium/vitamin D combination that’s giving us some trouble. I think people on vitamin D supplements really need to watch their levels and not get supratherapeutic. 

Ms. Ward: With the vitamin D? 

Dr. Budoff: With the vitamin D.
 

Diabetes and Renal Function

Ms. Ward: In some of the studies, there seems to be a higher risk in patients with diabetes. Is there any reason why that would be?

Dr. Budoff: I can’t think of a reason exactly why with diabetes per se, except for renal disease. Patients with diabetes have more intrinsic renal disease, proteinuria, and even a reduced eGFR. We’ve seen that the kidney is very strongly tied to this. We have a very strong relationship, in work I’ve done a decade ago now, showing that calcium supplementation (in the form of phosphate binders) in patients on dialysis or with advanced renal disease is linked to much higher coronary calcium progression. 

We did prospective, randomized trials showing that calcium intake as binders to reduce phosphorus led to more coronary calcium. We always thought that was just relegated to the renal population, and there might be an overlap here with the diabetes and more renal disease. I have a feeling that it has to do with more of that. It might be regulation of parathyroid hormone as well, which might be more abnormal in patients with diabetes. 
 

Avoid Supratherapeutic Vitamin D Levels

Ms. Ward:: What are you telling your patients? 

Dr. Budoff: I tell patients with normal kidney function that the bone will modulate 99.9% of the calcium uptake. If they have osteopenia or osteoporosis, regardless of their calcium score, I’m very comfortable putting them on supplements. 

I’m a little more cautious with the vitamin D levels, and I keep an eye on that and regulate how much vitamin D they get based on their levels. I get them into the normal range, but I don’t want them supratherapeutic. You can even follow their calcium score. Again, we’ve shown that if you’re taking too much calcium, your calcium score will go up. I can just check it again in a couple of years to make sure that it’s safe. 

Ms. Ward:: In terms of vitamin D levels, when you’re saying “supratherapeutic,” what levels do you consider a safe amount to take?

Dr. Budoff: I’d like them under 100 ng/mL as far as their upper level. Normal is around 70 ng/mL at most labs. I try to keep them in the normal range. I don’t even want them to be high-normal if I’m going to be concomitantly giving them calcium supplements. Of course, if they have renal insufficiency, then I’m much more cautious. We’ve even seen calcium supplements raise the serum calcium, which you never see with dietary calcium. That’s another potential proof that it might be too much too fast. 

For renal patients, even in mild renal insufficiency, maybe even in diabetes where we’ve seen a signal, maybe aim lower in the amount of calcium supplementation if diet is insufficient, and aim a little lower in vitamin D targets, and I think you’ll be in a safer place. 

Ms. Ward: Is there anything else you want to add? 

Dr. Budoff: The evidence is still evolving. I’d say that it’s interesting and maybe a little frustrating that we don’t have a final answer on all of this. I would stay tuned for more data because we’re looking at many of the epidemiologic studies to try to see what happens in the real world, with both dietary intake of calcium and calcium supplementation. 

Ms. Ward: Thank you very much for joining me today. 

Dr. Budoff: It’s a pleasure. Thanks for having me. 

Dr. Budoff disclosed being a speaker for Amarin Pharma.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

Tricia Ward: Hi. I’m Tricia Ward, from theheart.org/Medscape Cardiology. I’m joined today by Dr Matthew Budoff. He is professor of medicine at UCLA and the endowed chair of preventive cardiology at the Lundquist Institute. Welcome, Dr Budoff. 

Matthew J. Budoff, MD: Thank you. 

Dietary Calcium vs Coronary Calcium

Ms. Ward: The reason I wanted to talk to you today is because there have been some recent studies linking calcium supplements to an increased risk for cardiovascular disease. I’m old enough to remember when we used to tell people that dietary calcium and coronary calcium weren’t connected and weren’t the same. Were we wrong?

Dr. Budoff: I think there’s a large amount of mixed data out there still. The US Preventive Services Task Force looked into this a number of years ago and said there’s no association between calcium supplementation and increased risk for cardiovascular disease. 

As you mentioned, there are a couple of newer studies that point us toward a relationship. I think that we still have a little bit of a mixed bag, but we need to dive a little deeper into that to figure out what’s going on. 

Ms. Ward: Does it appear to be connected to calcium in the form of supplements vs calcium from foods? 

Dr. Budoff: We looked very carefully at dietary calcium in the MESA study, the multiethnic study of atherosclerosis. There is no relationship between dietary calcium intake and coronary calcium or cardiovascular events. We’re talking mostly about supplements now when we talk about this increased risk that we’re seeing.
 

Does Vitamin D Exacerbate Risk? 

Ms. Ward: Because it’s seen with supplements, is that likely because that’s a much higher concentration of calcium coming in or do you think it’s something inherent in its being in the form of a supplement?

Dr. Budoff: I think there are two things. One, it’s definitely a higher concentration all at once. You get many more milligrams at a time when you take a supplement than if you had a high-calcium food or drink.

Also, most supplements have vitamin D as well. I think vitamin D and calcium work synergistically. When you give them both together simultaneously, I think that may have more of a potentiating effect that might exacerbate any potential risk. 

Ms. Ward: Is there any reason to think there might be a difference in type of calcium supplement? I always think of the chalky tablet form vs calcium chews. 

Dr. Budoff: I’m not aware of a difference in the supplement type. I think the vitamin D issue is a big problem because we all have patients who take thousands of units of vitamin D — just crazy numbers. People advocate really high numbers and that stays in the system. 

Personally, I think part of the explanation is that with very high levels of vitamin D on top of calcium supplementation, you now absorb it better. You now get it into the bone, but maybe also into the coronary arteries. If you’re very high in vitamin D and then are taking a large calcium supplement, it might be the calcium/vitamin D combination that’s giving us some trouble. I think people on vitamin D supplements really need to watch their levels and not get supratherapeutic. 

Ms. Ward: With the vitamin D? 

Dr. Budoff: With the vitamin D.
 

Diabetes and Renal Function

Ms. Ward: In some of the studies, there seems to be a higher risk in patients with diabetes. Is there any reason why that would be?

Dr. Budoff: I can’t think of a reason exactly why with diabetes per se, except for renal disease. Patients with diabetes have more intrinsic renal disease, proteinuria, and even a reduced eGFR. We’ve seen that the kidney is very strongly tied to this. We have a very strong relationship, in work I’ve done a decade ago now, showing that calcium supplementation (in the form of phosphate binders) in patients on dialysis or with advanced renal disease is linked to much higher coronary calcium progression. 

We did prospective, randomized trials showing that calcium intake as binders to reduce phosphorus led to more coronary calcium. We always thought that was just relegated to the renal population, and there might be an overlap here with the diabetes and more renal disease. I have a feeling that it has to do with more of that. It might be regulation of parathyroid hormone as well, which might be more abnormal in patients with diabetes. 
 

Avoid Supratherapeutic Vitamin D Levels

Ms. Ward:: What are you telling your patients? 

Dr. Budoff: I tell patients with normal kidney function that the bone will modulate 99.9% of the calcium uptake. If they have osteopenia or osteoporosis, regardless of their calcium score, I’m very comfortable putting them on supplements. 

I’m a little more cautious with the vitamin D levels, and I keep an eye on that and regulate how much vitamin D they get based on their levels. I get them into the normal range, but I don’t want them supratherapeutic. You can even follow their calcium score. Again, we’ve shown that if you’re taking too much calcium, your calcium score will go up. I can just check it again in a couple of years to make sure that it’s safe. 

Ms. Ward:: In terms of vitamin D levels, when you’re saying “supratherapeutic,” what levels do you consider a safe amount to take?

Dr. Budoff: I’d like them under 100 ng/mL as far as their upper level. Normal is around 70 ng/mL at most labs. I try to keep them in the normal range. I don’t even want them to be high-normal if I’m going to be concomitantly giving them calcium supplements. Of course, if they have renal insufficiency, then I’m much more cautious. We’ve even seen calcium supplements raise the serum calcium, which you never see with dietary calcium. That’s another potential proof that it might be too much too fast. 

For renal patients, even in mild renal insufficiency, maybe even in diabetes where we’ve seen a signal, maybe aim lower in the amount of calcium supplementation if diet is insufficient, and aim a little lower in vitamin D targets, and I think you’ll be in a safer place. 

Ms. Ward: Is there anything else you want to add? 

Dr. Budoff: The evidence is still evolving. I’d say that it’s interesting and maybe a little frustrating that we don’t have a final answer on all of this. I would stay tuned for more data because we’re looking at many of the epidemiologic studies to try to see what happens in the real world, with both dietary intake of calcium and calcium supplementation. 

Ms. Ward: Thank you very much for joining me today. 

Dr. Budoff: It’s a pleasure. Thanks for having me. 

Dr. Budoff disclosed being a speaker for Amarin Pharma.

A version of this article appeared on Medscape.com.

Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

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

A version of this article appeared on Medscape.com.

Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

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

A version of this article appeared on Medscape.com.

Use of biologics significantly reduced exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD) and overlapping type 2 asthma inflammation, based on data from a new study presented at the American Thoracic Society’s international conference.

Patients diagnosed with COPD on maximum medical therapy may continue to have disease exacerbations that are highly morbid and are associated with worsening lung function, increased hospitalizations, and worsened mortality, said lead author Stephen Dachert, MD, Temple University Hospital, Philadelphia, in an interview.

“Biologic therapy has been shown to reduce exacerbations in type 2 airway inflammation in patients with asthma and may be a potential target in patients with COPD and type 2 inflammation,” he said. In type 2 inflammation, a systematic allergic response activates immune cells, including eosinophils, mast cells, and T cells.

Previous research has examined the association between use of individual biologics and reduction in acute exacerbations of COPD, but real-world data on the use of biologics for COPD and asthma-COPD overlap syndrome (ACOS) are lacking, Dr. Dachert and colleagues wrote in their abstract.

In the current study, the researchers reviewed data from 53 adults with COPD who were seen at a single center; 30 had ACOS, and 23 had COPD only. The mean age of the participants was 68.2 years, approximately half were White/Caucasian individuals, 26% were Black/African American individuals, 17% were Hispanic individuals, 4% were Asian individuals/Pacific Islanders, and 2% were from other races/ethnicities; 62% were women. The study population included patients with prior diagnosis codes for COPD and dupilumab, mepolizumab, benralizumab, or tezepelumab; the mean eosinophil count before biologics initiation was 471.
 

Reduction in Exacerbations and Hospitalizations

The researchers assessed change in exacerbations, hospitalizations, and spirometry from 1 year before to 1 year after initiation of treatment with biologics. Overall, after the use of biologics, patients experienced a significant mean reduction in exacerbations and hospitalizations of 1.780 and 0.944, respectively (both P < .001, using a paired T-test). 

In addition, the researchers found a mean reduction of forced expiratory volume per second percent predicted of 0.57% and a mean increase in forced vital capacity percent predicted of 1.3% after the initiation of biologics.

Increases also occurred in total lung capacity percent predicted, residual volume percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted (3.37%, 9.90%, and 4.58%, respectively). Of these, only DLCO percent predicted approached statistical significance, the researchers wrote.

The study findings make sense physiologically, Dr. Dachert said in an interview. “If large, randomized trials have shown a reduction in exacerbations in patients with type 2 inflammation asthma, it makes sense that we would see similar results in patients with COPD and type 2 inflammation,” he said. However, as yet only one of several large randomized trials has shown reductions in exacerbations and COPD with type 2 inflammation, he added.

“In our real-world cohort, we saw both a reduction in exacerbations and hospitalizations in the year following initiation of biologic therapy,” Dr. Dachert said. A reduction in hospitalizations, in particular, had not previously been shown in this population, he noted.

The findings were limited by the retrospective design and use of data from a single center; moreover, larger real-world studies are needed to confirm the results, said Dr. Dachert. “As we add patients to our cohort, we may be able to identify which clinical characteristics/risk factors may be associated with an even more robust reduction in exacerbations or hospitalizations,” he said.

“Our cohort of patients was more diverse than those included in prior randomized clinical trials and also has high rates of emphysema and airflow obstruction, populations typically excluded in large randomized trials,” he said.
 

Data Support the Potential of Biologics for COPD

Biologic agents have been effective in reducing asthma exacerbations, and understanding their effectiveness in reducing COPD exacerbations in a real-world setting is important, said Arianne K. Baldomero, MD, assistant professor of medicine at Minneapolis VA Health Care System, Minneapolis, in an interview.

Dr, Baldomero said she was not surprised by the current study results “as clinical trials are showing similar findings among this group of patients with elevated eosinophil counts.”

The current study adds to the growing evidence supporting the use of biologics to reduce COPD exacerbations, Dr. Baldomero told this news organization. “I anticipate that we will soon begin using biologics to manage frequent exacerbations in patients with COPD,” she said.

“For both asthma and COPD, more research is needed to guide clinicians in tapering or weaning down biologic treatment and determining whether patients still need to use inhalers,” Dr. Baldomero added.

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

A version of this article appeared on Medscape.com.