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Myeloma: Isa-KRd Induction Shows High MRD Responses
“We found that this induction induced exceptionally high response and minimal residual disease (MRD) negativity rates,” said first author Aurore Perrot, MD, PhD, an associate professor of hematology at the University of Toulouse in France, in presenting the findings at the annual meeting of the International Myeloma Society (IMS).
“These rates are the highest reported to date regarding MRD negativity,” she said.
The results from a first interim analysis offer encouraging groundwork in the trial that is investigating the tailoring of subsequent therapeutic choices in patients with newly diagnosed MM based on MRD status after six cycles of induction therapy.
In the standard treatment regimen of induction therapy followed by up-front autologous stem cell transplant (ASCT), the use of ever-improving quadruplet regimens is bolstering prognoses, while the role of up-front ASCT continues to be debated, Perrot explained. She noted that no prospective trials have compared up-front transplant vs no transplant following a quadruplet regimen.
In reporting on the initial findings from the induction phase of the phase 3 IFM 2020-02 MIDAS study, Perrot described results among 791 transplant-eligible patients with newly diagnosed MM and a median age of 59 who were enrolled at 72 centers between December 2021 and July 2023.
The patients were treated with six cycles of 28 days of the Isa-KRd regimen, consisting of isatuximab 10 mg/kg (weekly for 4 weeks then biweekly), carfilzomib 20 mg/m2 on day 1 cycle 1, then 56 mg/m2 (days 1, 8, and 15), lenalidomide 25 mg/d (from day 1 to day 21), and dexamethasone at 40 mg/wk.
Overall, MM was classified as International Staging System (ISS) III in 120 patients (15%) and revised-ISS III in 76 (10%) patients.
Of 757 patients undergoing cytogenetics, 8% were considered high risk on the basis of a linear predictor score > 1, while the t(11;14) translocation, a chromosomal abnormality, was present in 26% of patients.
Extramedullary disease was present in five patients, while 53 (7%) had circulating plasma cells.
All 791 patients initiated Isa-KRd induction, and most (766, 97%) had at least one peripheral stem cell mobilization course, with 761 having at least one apheresis. The median number of CD34+ cells collected was 7.106/kg.
The peripheral stem cells collected allowed for potential tandem transplants in 719 patients. In total, 757 patients completed six cycles of Isa-KRd, with an overall response rate of 95%.
In the intent-to-treat (ITT) population, a very good partial response or better was achieved in 92% of patients following induction, with a rate of 99% in the per-protocol [PP] population.
Of 751 patients in the post-induction ITT population, the MRD negativity rates were 63% at the threshold of 10−5 and 47% at the threshold of 10−6, with corresponding rates of 66% and 50%, respectively, in the PP population.
The rates of near-complete response and complete response were 64% and 66% in the ITT population, and 69% and 71% in the PP population.
Of note, no significant differences were observed in prognostic subgroups, with a trend for a higher MRD negative rate among poorer prognostic groups, Perrot said.
However, notable variability was observed in terms of MRD negativity at 10−5 after induction among some cytogenic groups, with an MRD negativity rate as high as 81% among patients with the t(4;14) translocation vs 62% among those without the abnormality (P = .002), while it was only 40% among patients with the t(11;14) translocation vs 64% without (P < .0001).
“This is the first time we have observed this correlation between the MRD negativity and these cytogenetic subgroups,” Perrot noted.
“For the moment, we are not saying that patients with the t(11;14) translocation have a poor prognosis,” she added. “But just that the early assessment of MRD shows the lower negativity rates.”
Safety
Seven patients experienced disease progression and five died during induction, with one dying from disease progression, two deaths related to cardiac adverse events (AEs), and two related to other AEs.
In terms of safety, the most common grade 3-4 AEs were neutropenia (25%), thrombocytopenia (5%), and infections (7%).
Peripheral neuropathy was reported among 13% of patients at any grade, and less than 1% grade 3-4.
“Our findings confirm that six cycles of Isa-KRd induce exceptionally high response and MRD negativity rates, not only at a sensitivity of 10−5 but also at 10−6,” Perrot said.
She noted that, in comparison, the MRD negativity rate at 10−5 in the related CASSIOPEIA, GRIFFIN, and IsKia trials were 35%, 22%, and 45%, respectively.
“A longer follow-up is needed to better interpret the significance of achieving MRD negativity in patients with different cytogenetic abnormalities,” Perrot added.
“Importantly, the Isa-KRd induction ensures successful stem cell collection, with no new safety signals,” she said.
The Isa-KRd regimen is not yet approved, hence only used in clinical trials, but Perrot told this publication the current evidence should help change that.
“The IsKia trial is comparing KRd and Isa-KRd, and Sanofi should try to approve the combo,” she said. “We hope the Midas data will support this approval.”
Questions Aplenty Moving Ahead
While the results are just the first from the ongoing trial, interest in the study and its design is high, Joseph Mikhael, MD, chief medical officer of the International Myeloma Foundation, told this publication.
“To have a large trial algorithm that is based on response and in particular MRD is novel and reflects the power of MRD in myeloma,” said Mikhael, a professor of applied cancer research and drug discovery at the Translational Genomics Research Institute, City of Hope Cancer Center, Phoenix, Arizona.
“Although the results are preliminary, these kinds of trials can inform our approach to MRD testing and may result in more personalized and effective treatments for patients,” he said. “This may include the potential to de-escalate or even stop therapies that have historically been given for longer or provide more intense therapies for patients with inadequate response.”
“We know the biology of myeloma is ‘one size fits all’, so the design of our trials should reflect that heterogeneity.”
Further commenting on the research, the meeting discussant Sagar Lonial, MD, professor and chair of the Department of Hematology and Medical Oncology and the Anne and Bernard Gray Professor in Cancer at the Winship Cancer Institute of Emory University, Atlanta, Georgia, offered cautious optimism.
Referencing the tale of Midas in Greek mythology as having a “be careful what you wish for” lesson, Lonial pondered that, likewise, a question that may be considered regarding MRD is “whether this is in fact a gift — or could this be a curse that’s going to get us into trouble at some point down the road. I don’t know the answer.”
Some cautionary lessons include prior research indicating that patients with high-risk disease may achieve a complete remission early — but they lose remission earlier down the road, he noted.
Other considerations as the research moves forward: “Recognizing that MRD may in fact be more important than genetics — which is a premise of the current trial,” Lonial pondered. “Does MRD override genetics, or do they travel together?”
The study is ongoing, with future results expected in terms of ASCT vs no ASCT for patients with high and low risk, as well as single vs tandem ASCT.
The trial received financial support from Amgen, Bristol-Myers Squibb, and Sanofi. Perrot reported ties with Amgen, Bristol Myers Squibb, and Sanofi. Mikhael disclosed ties with Amgen, Bristol Myers Squibb, and Sanofi. Lonial reported relationships with Celgene, Bristol-Myers Squibb, Amgen, and Sanofi.
A version of this article first appeared on Medscape.com.
“We found that this induction induced exceptionally high response and minimal residual disease (MRD) negativity rates,” said first author Aurore Perrot, MD, PhD, an associate professor of hematology at the University of Toulouse in France, in presenting the findings at the annual meeting of the International Myeloma Society (IMS).
“These rates are the highest reported to date regarding MRD negativity,” she said.
The results from a first interim analysis offer encouraging groundwork in the trial that is investigating the tailoring of subsequent therapeutic choices in patients with newly diagnosed MM based on MRD status after six cycles of induction therapy.
In the standard treatment regimen of induction therapy followed by up-front autologous stem cell transplant (ASCT), the use of ever-improving quadruplet regimens is bolstering prognoses, while the role of up-front ASCT continues to be debated, Perrot explained. She noted that no prospective trials have compared up-front transplant vs no transplant following a quadruplet regimen.
In reporting on the initial findings from the induction phase of the phase 3 IFM 2020-02 MIDAS study, Perrot described results among 791 transplant-eligible patients with newly diagnosed MM and a median age of 59 who were enrolled at 72 centers between December 2021 and July 2023.
The patients were treated with six cycles of 28 days of the Isa-KRd regimen, consisting of isatuximab 10 mg/kg (weekly for 4 weeks then biweekly), carfilzomib 20 mg/m2 on day 1 cycle 1, then 56 mg/m2 (days 1, 8, and 15), lenalidomide 25 mg/d (from day 1 to day 21), and dexamethasone at 40 mg/wk.
Overall, MM was classified as International Staging System (ISS) III in 120 patients (15%) and revised-ISS III in 76 (10%) patients.
Of 757 patients undergoing cytogenetics, 8% were considered high risk on the basis of a linear predictor score > 1, while the t(11;14) translocation, a chromosomal abnormality, was present in 26% of patients.
Extramedullary disease was present in five patients, while 53 (7%) had circulating plasma cells.
All 791 patients initiated Isa-KRd induction, and most (766, 97%) had at least one peripheral stem cell mobilization course, with 761 having at least one apheresis. The median number of CD34+ cells collected was 7.106/kg.
The peripheral stem cells collected allowed for potential tandem transplants in 719 patients. In total, 757 patients completed six cycles of Isa-KRd, with an overall response rate of 95%.
In the intent-to-treat (ITT) population, a very good partial response or better was achieved in 92% of patients following induction, with a rate of 99% in the per-protocol [PP] population.
Of 751 patients in the post-induction ITT population, the MRD negativity rates were 63% at the threshold of 10−5 and 47% at the threshold of 10−6, with corresponding rates of 66% and 50%, respectively, in the PP population.
The rates of near-complete response and complete response were 64% and 66% in the ITT population, and 69% and 71% in the PP population.
Of note, no significant differences were observed in prognostic subgroups, with a trend for a higher MRD negative rate among poorer prognostic groups, Perrot said.
However, notable variability was observed in terms of MRD negativity at 10−5 after induction among some cytogenic groups, with an MRD negativity rate as high as 81% among patients with the t(4;14) translocation vs 62% among those without the abnormality (P = .002), while it was only 40% among patients with the t(11;14) translocation vs 64% without (P < .0001).
“This is the first time we have observed this correlation between the MRD negativity and these cytogenetic subgroups,” Perrot noted.
“For the moment, we are not saying that patients with the t(11;14) translocation have a poor prognosis,” she added. “But just that the early assessment of MRD shows the lower negativity rates.”
Safety
Seven patients experienced disease progression and five died during induction, with one dying from disease progression, two deaths related to cardiac adverse events (AEs), and two related to other AEs.
In terms of safety, the most common grade 3-4 AEs were neutropenia (25%), thrombocytopenia (5%), and infections (7%).
Peripheral neuropathy was reported among 13% of patients at any grade, and less than 1% grade 3-4.
“Our findings confirm that six cycles of Isa-KRd induce exceptionally high response and MRD negativity rates, not only at a sensitivity of 10−5 but also at 10−6,” Perrot said.
She noted that, in comparison, the MRD negativity rate at 10−5 in the related CASSIOPEIA, GRIFFIN, and IsKia trials were 35%, 22%, and 45%, respectively.
“A longer follow-up is needed to better interpret the significance of achieving MRD negativity in patients with different cytogenetic abnormalities,” Perrot added.
“Importantly, the Isa-KRd induction ensures successful stem cell collection, with no new safety signals,” she said.
The Isa-KRd regimen is not yet approved, hence only used in clinical trials, but Perrot told this publication the current evidence should help change that.
“The IsKia trial is comparing KRd and Isa-KRd, and Sanofi should try to approve the combo,” she said. “We hope the Midas data will support this approval.”
Questions Aplenty Moving Ahead
While the results are just the first from the ongoing trial, interest in the study and its design is high, Joseph Mikhael, MD, chief medical officer of the International Myeloma Foundation, told this publication.
“To have a large trial algorithm that is based on response and in particular MRD is novel and reflects the power of MRD in myeloma,” said Mikhael, a professor of applied cancer research and drug discovery at the Translational Genomics Research Institute, City of Hope Cancer Center, Phoenix, Arizona.
“Although the results are preliminary, these kinds of trials can inform our approach to MRD testing and may result in more personalized and effective treatments for patients,” he said. “This may include the potential to de-escalate or even stop therapies that have historically been given for longer or provide more intense therapies for patients with inadequate response.”
“We know the biology of myeloma is ‘one size fits all’, so the design of our trials should reflect that heterogeneity.”
Further commenting on the research, the meeting discussant Sagar Lonial, MD, professor and chair of the Department of Hematology and Medical Oncology and the Anne and Bernard Gray Professor in Cancer at the Winship Cancer Institute of Emory University, Atlanta, Georgia, offered cautious optimism.
Referencing the tale of Midas in Greek mythology as having a “be careful what you wish for” lesson, Lonial pondered that, likewise, a question that may be considered regarding MRD is “whether this is in fact a gift — or could this be a curse that’s going to get us into trouble at some point down the road. I don’t know the answer.”
Some cautionary lessons include prior research indicating that patients with high-risk disease may achieve a complete remission early — but they lose remission earlier down the road, he noted.
Other considerations as the research moves forward: “Recognizing that MRD may in fact be more important than genetics — which is a premise of the current trial,” Lonial pondered. “Does MRD override genetics, or do they travel together?”
The study is ongoing, with future results expected in terms of ASCT vs no ASCT for patients with high and low risk, as well as single vs tandem ASCT.
The trial received financial support from Amgen, Bristol-Myers Squibb, and Sanofi. Perrot reported ties with Amgen, Bristol Myers Squibb, and Sanofi. Mikhael disclosed ties with Amgen, Bristol Myers Squibb, and Sanofi. Lonial reported relationships with Celgene, Bristol-Myers Squibb, Amgen, and Sanofi.
A version of this article first appeared on Medscape.com.
“We found that this induction induced exceptionally high response and minimal residual disease (MRD) negativity rates,” said first author Aurore Perrot, MD, PhD, an associate professor of hematology at the University of Toulouse in France, in presenting the findings at the annual meeting of the International Myeloma Society (IMS).
“These rates are the highest reported to date regarding MRD negativity,” she said.
The results from a first interim analysis offer encouraging groundwork in the trial that is investigating the tailoring of subsequent therapeutic choices in patients with newly diagnosed MM based on MRD status after six cycles of induction therapy.
In the standard treatment regimen of induction therapy followed by up-front autologous stem cell transplant (ASCT), the use of ever-improving quadruplet regimens is bolstering prognoses, while the role of up-front ASCT continues to be debated, Perrot explained. She noted that no prospective trials have compared up-front transplant vs no transplant following a quadruplet regimen.
In reporting on the initial findings from the induction phase of the phase 3 IFM 2020-02 MIDAS study, Perrot described results among 791 transplant-eligible patients with newly diagnosed MM and a median age of 59 who were enrolled at 72 centers between December 2021 and July 2023.
The patients were treated with six cycles of 28 days of the Isa-KRd regimen, consisting of isatuximab 10 mg/kg (weekly for 4 weeks then biweekly), carfilzomib 20 mg/m2 on day 1 cycle 1, then 56 mg/m2 (days 1, 8, and 15), lenalidomide 25 mg/d (from day 1 to day 21), and dexamethasone at 40 mg/wk.
Overall, MM was classified as International Staging System (ISS) III in 120 patients (15%) and revised-ISS III in 76 (10%) patients.
Of 757 patients undergoing cytogenetics, 8% were considered high risk on the basis of a linear predictor score > 1, while the t(11;14) translocation, a chromosomal abnormality, was present in 26% of patients.
Extramedullary disease was present in five patients, while 53 (7%) had circulating plasma cells.
All 791 patients initiated Isa-KRd induction, and most (766, 97%) had at least one peripheral stem cell mobilization course, with 761 having at least one apheresis. The median number of CD34+ cells collected was 7.106/kg.
The peripheral stem cells collected allowed for potential tandem transplants in 719 patients. In total, 757 patients completed six cycles of Isa-KRd, with an overall response rate of 95%.
In the intent-to-treat (ITT) population, a very good partial response or better was achieved in 92% of patients following induction, with a rate of 99% in the per-protocol [PP] population.
Of 751 patients in the post-induction ITT population, the MRD negativity rates were 63% at the threshold of 10−5 and 47% at the threshold of 10−6, with corresponding rates of 66% and 50%, respectively, in the PP population.
The rates of near-complete response and complete response were 64% and 66% in the ITT population, and 69% and 71% in the PP population.
Of note, no significant differences were observed in prognostic subgroups, with a trend for a higher MRD negative rate among poorer prognostic groups, Perrot said.
However, notable variability was observed in terms of MRD negativity at 10−5 after induction among some cytogenic groups, with an MRD negativity rate as high as 81% among patients with the t(4;14) translocation vs 62% among those without the abnormality (P = .002), while it was only 40% among patients with the t(11;14) translocation vs 64% without (P < .0001).
“This is the first time we have observed this correlation between the MRD negativity and these cytogenetic subgroups,” Perrot noted.
“For the moment, we are not saying that patients with the t(11;14) translocation have a poor prognosis,” she added. “But just that the early assessment of MRD shows the lower negativity rates.”
Safety
Seven patients experienced disease progression and five died during induction, with one dying from disease progression, two deaths related to cardiac adverse events (AEs), and two related to other AEs.
In terms of safety, the most common grade 3-4 AEs were neutropenia (25%), thrombocytopenia (5%), and infections (7%).
Peripheral neuropathy was reported among 13% of patients at any grade, and less than 1% grade 3-4.
“Our findings confirm that six cycles of Isa-KRd induce exceptionally high response and MRD negativity rates, not only at a sensitivity of 10−5 but also at 10−6,” Perrot said.
She noted that, in comparison, the MRD negativity rate at 10−5 in the related CASSIOPEIA, GRIFFIN, and IsKia trials were 35%, 22%, and 45%, respectively.
“A longer follow-up is needed to better interpret the significance of achieving MRD negativity in patients with different cytogenetic abnormalities,” Perrot added.
“Importantly, the Isa-KRd induction ensures successful stem cell collection, with no new safety signals,” she said.
The Isa-KRd regimen is not yet approved, hence only used in clinical trials, but Perrot told this publication the current evidence should help change that.
“The IsKia trial is comparing KRd and Isa-KRd, and Sanofi should try to approve the combo,” she said. “We hope the Midas data will support this approval.”
Questions Aplenty Moving Ahead
While the results are just the first from the ongoing trial, interest in the study and its design is high, Joseph Mikhael, MD, chief medical officer of the International Myeloma Foundation, told this publication.
“To have a large trial algorithm that is based on response and in particular MRD is novel and reflects the power of MRD in myeloma,” said Mikhael, a professor of applied cancer research and drug discovery at the Translational Genomics Research Institute, City of Hope Cancer Center, Phoenix, Arizona.
“Although the results are preliminary, these kinds of trials can inform our approach to MRD testing and may result in more personalized and effective treatments for patients,” he said. “This may include the potential to de-escalate or even stop therapies that have historically been given for longer or provide more intense therapies for patients with inadequate response.”
“We know the biology of myeloma is ‘one size fits all’, so the design of our trials should reflect that heterogeneity.”
Further commenting on the research, the meeting discussant Sagar Lonial, MD, professor and chair of the Department of Hematology and Medical Oncology and the Anne and Bernard Gray Professor in Cancer at the Winship Cancer Institute of Emory University, Atlanta, Georgia, offered cautious optimism.
Referencing the tale of Midas in Greek mythology as having a “be careful what you wish for” lesson, Lonial pondered that, likewise, a question that may be considered regarding MRD is “whether this is in fact a gift — or could this be a curse that’s going to get us into trouble at some point down the road. I don’t know the answer.”
Some cautionary lessons include prior research indicating that patients with high-risk disease may achieve a complete remission early — but they lose remission earlier down the road, he noted.
Other considerations as the research moves forward: “Recognizing that MRD may in fact be more important than genetics — which is a premise of the current trial,” Lonial pondered. “Does MRD override genetics, or do they travel together?”
The study is ongoing, with future results expected in terms of ASCT vs no ASCT for patients with high and low risk, as well as single vs tandem ASCT.
The trial received financial support from Amgen, Bristol-Myers Squibb, and Sanofi. Perrot reported ties with Amgen, Bristol Myers Squibb, and Sanofi. Mikhael disclosed ties with Amgen, Bristol Myers Squibb, and Sanofi. Lonial reported relationships with Celgene, Bristol-Myers Squibb, Amgen, and Sanofi.
A version of this article first appeared on Medscape.com.
FROM IMS 2024
ILD Linked to Poorer Outcomes in Pulmonary Embolism
BOSTON — Patients with pulmonary embolism (PE) who also present with interstitial lung disease (ILD) have worse outcomes with respect to in-hospital mortality, length of hospital stay, hospital cost, and all-cause readmission, according to results from a new retrospective analysis.
Unfortunately, there’s not a whole lot of evidence out there to really demonstrate it,” Leah Yuan, MD, said during a presentation of the results at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.
The question is complicated by the nebulous nature of ILD, which includes a diverse set of diseases and etiologies, and different levels of inflammation and fibrosis. It has been employed in the Pulmonary Embolism Severity Index but counts for only 10 points out of 210. “If you look at ILD and PE outcomes, there’s nothing really out there [in the literature],” Yuan said in an interview. She is a resident physician at Cook County Health and Hospitals System.
The new study suggested that ILD could have an important influence and perhaps should have greater weight in risk stratification of patients with PE, she said. “We looked at all-cause readmissions and we looked at in-hospital mortality, [both] of which are significant for increased odds ratio. One thing that I’m very curious to see is whether there is increased PE readmissions [associated with ILD], which is something that we couldn’t find to be significant in our study,” said Yuan.
The researchers used data from hospitalizations for PE drawn from the Nationwide Readmissions Database in 2019, using International Classification of Diseases, Tenth Revision, codes to identify admissions. Among a total of 105,133 patients admitted for PE, 158 patients also had ILD. The mean age was 63.6 years for those without ILD (SD, 0.1) and 66.5 years for those with ILD (SD, 1.3).
Admission with ILD was associated with all-cause readmission (odds ratio [OR], 4.12; P < .01), in-hospital mortality (OR, 2.17; P = .01), a longer length of stay (+2.07 days; P < .01), and higher hospitalization charges (+$22,627; P < .01).
In the Q&A period after the presentation, Parth Rali, MD, professor of thoracic medicine and surgery at Temple University, Philadelphia, suggested phenotyping patients to better understand the location of the PE in relation to the ILD. “It may not fall into your classic PE classification. It may just depend on where the clot is in relationship to the interstitial lung disease. I think that’s where the field is going to evolve,” he later said in an interview.
“What is interesting is that patients with interstitial lung disease have a lot of fibrotic disease, and they do not need to have a large clot burden to make them sick. An example [is someone] who has undergone a lung transplant evaluation, and if their right lung is completely diseased from interstitial lung disease and if they get a big blood clot on the right side, it doesn’t affect them because the lung is already fibrotic, so the clot doesn’t matter. If they get a small clot [in the left lung], even though if you look at the standard PE classification they may qualify as a low-risk PE or even as an intermediate-low-risk PE, they are much sicker because that’s the functioning part of the lung,” said Rali.
He advised physicians to pay close attention to the location of PEs in relation to fibrotic tissue in patients with ILD. A PE in healthy lung tissue could have an outsized effect on hemodynamics, whereas a PE in fibrotic tissue may be clinically insignificant and not require treatment. “So it goes both ways: You don’t overtreat and you don’t undertreat,” Rali said.
Yuan and Rali disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
BOSTON — Patients with pulmonary embolism (PE) who also present with interstitial lung disease (ILD) have worse outcomes with respect to in-hospital mortality, length of hospital stay, hospital cost, and all-cause readmission, according to results from a new retrospective analysis.
Unfortunately, there’s not a whole lot of evidence out there to really demonstrate it,” Leah Yuan, MD, said during a presentation of the results at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.
The question is complicated by the nebulous nature of ILD, which includes a diverse set of diseases and etiologies, and different levels of inflammation and fibrosis. It has been employed in the Pulmonary Embolism Severity Index but counts for only 10 points out of 210. “If you look at ILD and PE outcomes, there’s nothing really out there [in the literature],” Yuan said in an interview. She is a resident physician at Cook County Health and Hospitals System.
The new study suggested that ILD could have an important influence and perhaps should have greater weight in risk stratification of patients with PE, she said. “We looked at all-cause readmissions and we looked at in-hospital mortality, [both] of which are significant for increased odds ratio. One thing that I’m very curious to see is whether there is increased PE readmissions [associated with ILD], which is something that we couldn’t find to be significant in our study,” said Yuan.
The researchers used data from hospitalizations for PE drawn from the Nationwide Readmissions Database in 2019, using International Classification of Diseases, Tenth Revision, codes to identify admissions. Among a total of 105,133 patients admitted for PE, 158 patients also had ILD. The mean age was 63.6 years for those without ILD (SD, 0.1) and 66.5 years for those with ILD (SD, 1.3).
Admission with ILD was associated with all-cause readmission (odds ratio [OR], 4.12; P < .01), in-hospital mortality (OR, 2.17; P = .01), a longer length of stay (+2.07 days; P < .01), and higher hospitalization charges (+$22,627; P < .01).
In the Q&A period after the presentation, Parth Rali, MD, professor of thoracic medicine and surgery at Temple University, Philadelphia, suggested phenotyping patients to better understand the location of the PE in relation to the ILD. “It may not fall into your classic PE classification. It may just depend on where the clot is in relationship to the interstitial lung disease. I think that’s where the field is going to evolve,” he later said in an interview.
“What is interesting is that patients with interstitial lung disease have a lot of fibrotic disease, and they do not need to have a large clot burden to make them sick. An example [is someone] who has undergone a lung transplant evaluation, and if their right lung is completely diseased from interstitial lung disease and if they get a big blood clot on the right side, it doesn’t affect them because the lung is already fibrotic, so the clot doesn’t matter. If they get a small clot [in the left lung], even though if you look at the standard PE classification they may qualify as a low-risk PE or even as an intermediate-low-risk PE, they are much sicker because that’s the functioning part of the lung,” said Rali.
He advised physicians to pay close attention to the location of PEs in relation to fibrotic tissue in patients with ILD. A PE in healthy lung tissue could have an outsized effect on hemodynamics, whereas a PE in fibrotic tissue may be clinically insignificant and not require treatment. “So it goes both ways: You don’t overtreat and you don’t undertreat,” Rali said.
Yuan and Rali disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
BOSTON — Patients with pulmonary embolism (PE) who also present with interstitial lung disease (ILD) have worse outcomes with respect to in-hospital mortality, length of hospital stay, hospital cost, and all-cause readmission, according to results from a new retrospective analysis.
Unfortunately, there’s not a whole lot of evidence out there to really demonstrate it,” Leah Yuan, MD, said during a presentation of the results at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.
The question is complicated by the nebulous nature of ILD, which includes a diverse set of diseases and etiologies, and different levels of inflammation and fibrosis. It has been employed in the Pulmonary Embolism Severity Index but counts for only 10 points out of 210. “If you look at ILD and PE outcomes, there’s nothing really out there [in the literature],” Yuan said in an interview. She is a resident physician at Cook County Health and Hospitals System.
The new study suggested that ILD could have an important influence and perhaps should have greater weight in risk stratification of patients with PE, she said. “We looked at all-cause readmissions and we looked at in-hospital mortality, [both] of which are significant for increased odds ratio. One thing that I’m very curious to see is whether there is increased PE readmissions [associated with ILD], which is something that we couldn’t find to be significant in our study,” said Yuan.
The researchers used data from hospitalizations for PE drawn from the Nationwide Readmissions Database in 2019, using International Classification of Diseases, Tenth Revision, codes to identify admissions. Among a total of 105,133 patients admitted for PE, 158 patients also had ILD. The mean age was 63.6 years for those without ILD (SD, 0.1) and 66.5 years for those with ILD (SD, 1.3).
Admission with ILD was associated with all-cause readmission (odds ratio [OR], 4.12; P < .01), in-hospital mortality (OR, 2.17; P = .01), a longer length of stay (+2.07 days; P < .01), and higher hospitalization charges (+$22,627; P < .01).
In the Q&A period after the presentation, Parth Rali, MD, professor of thoracic medicine and surgery at Temple University, Philadelphia, suggested phenotyping patients to better understand the location of the PE in relation to the ILD. “It may not fall into your classic PE classification. It may just depend on where the clot is in relationship to the interstitial lung disease. I think that’s where the field is going to evolve,” he later said in an interview.
“What is interesting is that patients with interstitial lung disease have a lot of fibrotic disease, and they do not need to have a large clot burden to make them sick. An example [is someone] who has undergone a lung transplant evaluation, and if their right lung is completely diseased from interstitial lung disease and if they get a big blood clot on the right side, it doesn’t affect them because the lung is already fibrotic, so the clot doesn’t matter. If they get a small clot [in the left lung], even though if you look at the standard PE classification they may qualify as a low-risk PE or even as an intermediate-low-risk PE, they are much sicker because that’s the functioning part of the lung,” said Rali.
He advised physicians to pay close attention to the location of PEs in relation to fibrotic tissue in patients with ILD. A PE in healthy lung tissue could have an outsized effect on hemodynamics, whereas a PE in fibrotic tissue may be clinically insignificant and not require treatment. “So it goes both ways: You don’t overtreat and you don’t undertreat,” Rali said.
Yuan and Rali disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
CHEST 2024
Use of SGLT2 Inhibitors Associated With Better Survival in PAH
BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.
“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.
The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).
At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).
The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.
Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.
Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.
Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.
The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.
“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.
The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).
At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).
The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.
Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.
Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.
Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.
The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.
“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.
The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).
At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).
The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.
Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.
Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.
Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.
The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM CHEST 2024
How to Treat Cancer While Preserving Fertility
Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.
Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
Therapy Selection
The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. “Preserving fertility is also an aim of cancer therapy,” he said.
Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.
Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”
Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
Chemotherapies and Immunotherapies
Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.
Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.
These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.
Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.
In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.
Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”
In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.
In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
Adjusting the Regimen
In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.
By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.
During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.
Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.
FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.
Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
More Data Needed
The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.
For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.
The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.
Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
Therapy Selection
The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. “Preserving fertility is also an aim of cancer therapy,” he said.
Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.
Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”
Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
Chemotherapies and Immunotherapies
Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.
Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.
These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.
Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.
In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.
Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”
In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.
In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
Adjusting the Regimen
In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.
By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.
During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.
Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.
FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.
Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
More Data Needed
The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.
For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.
The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.
Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
Therapy Selection
The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. “Preserving fertility is also an aim of cancer therapy,” he said.
Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.
Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”
Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
Chemotherapies and Immunotherapies
Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.
Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.
These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.
Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.
In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.
Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”
In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.
In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
Adjusting the Regimen
In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.
By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.
During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.
Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.
FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.
Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
More Data Needed
The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.
For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.
The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Lawsuit Targets Publishers: Is Peer Review Flawed?
The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.
The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.
The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
Flawed Reviews
A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.
As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”
Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.
Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
Lack of Awareness
A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.
While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”
Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.
A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.
The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
Fanelli’s Perspective
Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.
“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.
The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.
The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
Flawed Reviews
A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.
As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”
Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.
Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
Lack of Awareness
A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.
While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”
Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.
A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.
The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
Fanelli’s Perspective
Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.
“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.
The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.
The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
Flawed Reviews
A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.
As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”
Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.
Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
Lack of Awareness
A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.
While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”
Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.
A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.
The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
Fanelli’s Perspective
Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.
“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Is Metformin An Unexpected Ally Against Long COVID?
TOPLINE:
METHODOLOGY:
- Previous studies have shown that metformin use before and during SARS-CoV-2 infection reduces severe COVID-19 and postacute sequelae of SARS-CoV-2 (PASC), also referred to as long COVID, in adults.
- A retrospective cohort analysis was conducted to evaluate the association between metformin use before and during SARS-CoV-2 infection and the subsequent incidence of PASC.
- Researchers used data from the National COVID Cohort Collaborative (N3C) and National Patient-Centered Clinical Research Network (PCORnet) electronic health record (EHR) databases to identify adults (age, ≥ 21 years) with T2D prescribed a diabetes medication within the past 12 months.
- Participants were categorized into those using metformin (metformin group) and those using other noninsulin diabetes medications such as sulfonylureas, dipeptidyl peptidase-4 inhibitors, or thiazolidinediones (the comparator group); those who used glucagon-like peptide 1 receptor agonists or sodium-glucose cotransporter-2 inhibitors were excluded.
- The primary outcome was the incidence of PASC or death within 180 days after SARS-CoV-2 infection, defined using International Classification of Diseases U09.9 diagnosis code and/or computable phenotype defined by a predicted probability of > 75% for PASC using a machine learning model trained on patients diagnosed using U09.9 (PASC computable phenotype).
TAKEAWAY:
- Researchers identified 51,385 and 37,947 participants from the N3C and PCORnet datasets, respectively.
- Metformin use was associated with a 21% lower risk for death or PASC using the U09.9 diagnosis code (P < .001) and a 15% lower risk using the PASC computable phenotype (P < .001) in the N3C dataset than non-metformin use.
- In the PCORnet dataset, the risk for death or PASC was 13% lower using the U09.9 diagnosis code (P = .08) with metformin use vs non-metformin use, whereas the risk did not differ significantly between the groups when using the PASC computable phenotype (P = .58).
- The incidence of PASC using the U09.9 diagnosis code for the metformin and comparator groups was similar between the two datasets (1.6% and 2.0% in N3C and 2.2 and 2.6% in PCORnet, respectively).
- However, when using the computable phenotype, the incidence rates of PASC for the metformin and comparator groups were 4.8% and 5.2% in N3C and 25.2% and 24.2% in PCORnet, respectively.
IN PRACTICE:
“The incidence of PASC was lower when defined by [International Classification of Diseases] code, compared with a computable phenotype in both databases,” the authors wrote. “This may reflect the challenges of clinical care for adults needing chronic medication management and the likelihood of those adults receiving a formal PASC diagnosis.”
SOURCE:
The study was led by Steven G. Johnson, PhD, Institute for Health Informatics, University of Minnesota, Minneapolis. It was published online in Diabetes Care.
LIMITATIONS:
The use of EHR data had several limitations, including the inability to examine a dose-dependent relationship and the lack of information on whether medications were taken before, during, or after the acute infection. The outcome definition involved the need for a medical encounter and, thus, may not capture data on all patients experiencing symptoms of PASC. The analysis focused on the prevalent use of chronic medications, limiting the assessment of initiating metformin in those diagnosed with COVID-19.
DISCLOSURES:
The study was supported by the National Institutes of Health Agreement as part of the RECOVER research program. One author reported receiving salary support from the Center for Pharmacoepidemiology and owning stock options in various pharmaceutical and biopharmaceutical companies. Another author reported receiving grant support and consulting contracts, being involved in expert witness engagement, and owning stock options in various pharmaceutical, biopharmaceutical, diabetes management, and medical device companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Previous studies have shown that metformin use before and during SARS-CoV-2 infection reduces severe COVID-19 and postacute sequelae of SARS-CoV-2 (PASC), also referred to as long COVID, in adults.
- A retrospective cohort analysis was conducted to evaluate the association between metformin use before and during SARS-CoV-2 infection and the subsequent incidence of PASC.
- Researchers used data from the National COVID Cohort Collaborative (N3C) and National Patient-Centered Clinical Research Network (PCORnet) electronic health record (EHR) databases to identify adults (age, ≥ 21 years) with T2D prescribed a diabetes medication within the past 12 months.
- Participants were categorized into those using metformin (metformin group) and those using other noninsulin diabetes medications such as sulfonylureas, dipeptidyl peptidase-4 inhibitors, or thiazolidinediones (the comparator group); those who used glucagon-like peptide 1 receptor agonists or sodium-glucose cotransporter-2 inhibitors were excluded.
- The primary outcome was the incidence of PASC or death within 180 days after SARS-CoV-2 infection, defined using International Classification of Diseases U09.9 diagnosis code and/or computable phenotype defined by a predicted probability of > 75% for PASC using a machine learning model trained on patients diagnosed using U09.9 (PASC computable phenotype).
TAKEAWAY:
- Researchers identified 51,385 and 37,947 participants from the N3C and PCORnet datasets, respectively.
- Metformin use was associated with a 21% lower risk for death or PASC using the U09.9 diagnosis code (P < .001) and a 15% lower risk using the PASC computable phenotype (P < .001) in the N3C dataset than non-metformin use.
- In the PCORnet dataset, the risk for death or PASC was 13% lower using the U09.9 diagnosis code (P = .08) with metformin use vs non-metformin use, whereas the risk did not differ significantly between the groups when using the PASC computable phenotype (P = .58).
- The incidence of PASC using the U09.9 diagnosis code for the metformin and comparator groups was similar between the two datasets (1.6% and 2.0% in N3C and 2.2 and 2.6% in PCORnet, respectively).
- However, when using the computable phenotype, the incidence rates of PASC for the metformin and comparator groups were 4.8% and 5.2% in N3C and 25.2% and 24.2% in PCORnet, respectively.
IN PRACTICE:
“The incidence of PASC was lower when defined by [International Classification of Diseases] code, compared with a computable phenotype in both databases,” the authors wrote. “This may reflect the challenges of clinical care for adults needing chronic medication management and the likelihood of those adults receiving a formal PASC diagnosis.”
SOURCE:
The study was led by Steven G. Johnson, PhD, Institute for Health Informatics, University of Minnesota, Minneapolis. It was published online in Diabetes Care.
LIMITATIONS:
The use of EHR data had several limitations, including the inability to examine a dose-dependent relationship and the lack of information on whether medications were taken before, during, or after the acute infection. The outcome definition involved the need for a medical encounter and, thus, may not capture data on all patients experiencing symptoms of PASC. The analysis focused on the prevalent use of chronic medications, limiting the assessment of initiating metformin in those diagnosed with COVID-19.
DISCLOSURES:
The study was supported by the National Institutes of Health Agreement as part of the RECOVER research program. One author reported receiving salary support from the Center for Pharmacoepidemiology and owning stock options in various pharmaceutical and biopharmaceutical companies. Another author reported receiving grant support and consulting contracts, being involved in expert witness engagement, and owning stock options in various pharmaceutical, biopharmaceutical, diabetes management, and medical device companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Previous studies have shown that metformin use before and during SARS-CoV-2 infection reduces severe COVID-19 and postacute sequelae of SARS-CoV-2 (PASC), also referred to as long COVID, in adults.
- A retrospective cohort analysis was conducted to evaluate the association between metformin use before and during SARS-CoV-2 infection and the subsequent incidence of PASC.
- Researchers used data from the National COVID Cohort Collaborative (N3C) and National Patient-Centered Clinical Research Network (PCORnet) electronic health record (EHR) databases to identify adults (age, ≥ 21 years) with T2D prescribed a diabetes medication within the past 12 months.
- Participants were categorized into those using metformin (metformin group) and those using other noninsulin diabetes medications such as sulfonylureas, dipeptidyl peptidase-4 inhibitors, or thiazolidinediones (the comparator group); those who used glucagon-like peptide 1 receptor agonists or sodium-glucose cotransporter-2 inhibitors were excluded.
- The primary outcome was the incidence of PASC or death within 180 days after SARS-CoV-2 infection, defined using International Classification of Diseases U09.9 diagnosis code and/or computable phenotype defined by a predicted probability of > 75% for PASC using a machine learning model trained on patients diagnosed using U09.9 (PASC computable phenotype).
TAKEAWAY:
- Researchers identified 51,385 and 37,947 participants from the N3C and PCORnet datasets, respectively.
- Metformin use was associated with a 21% lower risk for death or PASC using the U09.9 diagnosis code (P < .001) and a 15% lower risk using the PASC computable phenotype (P < .001) in the N3C dataset than non-metformin use.
- In the PCORnet dataset, the risk for death or PASC was 13% lower using the U09.9 diagnosis code (P = .08) with metformin use vs non-metformin use, whereas the risk did not differ significantly between the groups when using the PASC computable phenotype (P = .58).
- The incidence of PASC using the U09.9 diagnosis code for the metformin and comparator groups was similar between the two datasets (1.6% and 2.0% in N3C and 2.2 and 2.6% in PCORnet, respectively).
- However, when using the computable phenotype, the incidence rates of PASC for the metformin and comparator groups were 4.8% and 5.2% in N3C and 25.2% and 24.2% in PCORnet, respectively.
IN PRACTICE:
“The incidence of PASC was lower when defined by [International Classification of Diseases] code, compared with a computable phenotype in both databases,” the authors wrote. “This may reflect the challenges of clinical care for adults needing chronic medication management and the likelihood of those adults receiving a formal PASC diagnosis.”
SOURCE:
The study was led by Steven G. Johnson, PhD, Institute for Health Informatics, University of Minnesota, Minneapolis. It was published online in Diabetes Care.
LIMITATIONS:
The use of EHR data had several limitations, including the inability to examine a dose-dependent relationship and the lack of information on whether medications were taken before, during, or after the acute infection. The outcome definition involved the need for a medical encounter and, thus, may not capture data on all patients experiencing symptoms of PASC. The analysis focused on the prevalent use of chronic medications, limiting the assessment of initiating metformin in those diagnosed with COVID-19.
DISCLOSURES:
The study was supported by the National Institutes of Health Agreement as part of the RECOVER research program. One author reported receiving salary support from the Center for Pharmacoepidemiology and owning stock options in various pharmaceutical and biopharmaceutical companies. Another author reported receiving grant support and consulting contracts, being involved in expert witness engagement, and owning stock options in various pharmaceutical, biopharmaceutical, diabetes management, and medical device companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Hospitalized Patients With COPD and GERD Have Better Short-Term Outcomes
BOSTON — Gastroesophageal reflux disease (GERD) is associated with better in-hospital outcomes for patients hospitalized with chronic obstructive pulmonary disease (COPD).
“It was a very surprising result. We double-checked the analysis once we got it the first time because the whole expectation was that the outcomes will be worse. But because it’s a retrospective study and it’s based on a national database, there are some limitations,” said ABM Nasibul Alam, MD, who presented the study at the annual meeting of the American College of Chest Physicians (CHEST) . Alam is an internal medicine resident at Northwestern Medicine McHenry Hospital, McHenry, Illinois.
One possible conclusion is that acid reflux therapies received in hospital may be benefitting COPD. The retrospective nature of the study precludes establishing a causal relationship, but there are possible mechanisms that could account for a benefit, according to Alam.
“They might prevent micro-aspirations or silent aspirations in COPD patients. Sometimes you may not have a clinical diagnosis of GERD, but the patient might have silent micro-aspirations, so it might contribute to decreasing that,” said Alam.
The study was conducted to fill a gap in the literature. “Some studies have shown that the lung function in COPD patients gets moderately decreased if they have coexisting GERD, but there aren’t any studies that have looked into how it impacts COPD patients when they’re hospitalized, and especially acute complications,” said Alam.
The researchers retrospectively analyzed data from the Nationwide Readmissions Database from 2017 to 2020, utilizing ICD-10 codes to identify 3,798,952 hospitalized adults with a primary diagnosis of COPD, of which 26.97% also had GERD. Individuals without GERD were more likely to be male (47.72% vs 39.88%).
After multivariate adjustment, the presence of GERD was associated with a lower mortality rate (adjusted odds ratio [aOR], 0.717; P < .001) and reduced risks for acute respiratory failure (aOR, 0.915; P < .001), need for noninvasive mechanical ventilation (aOR, 0.907; P < .001), need for invasive ventilation for 24 hours or more (aOR, 0.727; P < .001), acute kidney injury (aOR, 0.877; P < .001), septic shock (aOR, 0.731; P < .001), and acute heart failure (aOR, 0.762; P < .001).
Despite these improved in-hospital outcomes, the researchers found that patients with GERD were at a higher risk for 30-day readmission (aOR, 1.08; P < .001). They also had slightly longer lengths of stay (+0.09 day; P < .001) and lower total charges (−$2824.5996; P < .001).
There have also been studies suggesting that GERD can directly lead to worse lung function among patients with COPD. “So it will be interesting to see if these medications have some kind of impact on the lung function as well. We need more robust studies [to determine that],” said Alam.
It is also important to keep in mind the long-term risk of proton pump inhibitors, especially in older patients. “We have to have good data before we start recommending this,” said Alam.
He suggested that physicians should begin to think more holistically about COPD management and consider the comorbidities. Alam has studied vitamin B12 deficiency in patients with COPD and found an association with cardiovascular comorbidities. “There are so many comorbidities with COPD. COPD itself puts patients at risk of cardiovascular comorbidity, for example. So when we have patients with COPD, we have to think about all those comorbidities and have to manage the patients comprehensively rather than just focusing on the specific targeted interventions,” said Alam.
The study should encourage further research, according to Kunal Deokar, MD, who moderated the session where the study was presented. “It does give us a signal that probably we should have more studies to look into whether patients hospitalized for COPD with GERD really have lower mortality rates, and what will be the effect of treatment on these patients,” said Deokar, who is an assistant professor of pulmonary medicine at the All India Institute of Medical Sciences, Delhi, India.
Alam and Deokar disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON — Gastroesophageal reflux disease (GERD) is associated with better in-hospital outcomes for patients hospitalized with chronic obstructive pulmonary disease (COPD).
“It was a very surprising result. We double-checked the analysis once we got it the first time because the whole expectation was that the outcomes will be worse. But because it’s a retrospective study and it’s based on a national database, there are some limitations,” said ABM Nasibul Alam, MD, who presented the study at the annual meeting of the American College of Chest Physicians (CHEST) . Alam is an internal medicine resident at Northwestern Medicine McHenry Hospital, McHenry, Illinois.
One possible conclusion is that acid reflux therapies received in hospital may be benefitting COPD. The retrospective nature of the study precludes establishing a causal relationship, but there are possible mechanisms that could account for a benefit, according to Alam.
“They might prevent micro-aspirations or silent aspirations in COPD patients. Sometimes you may not have a clinical diagnosis of GERD, but the patient might have silent micro-aspirations, so it might contribute to decreasing that,” said Alam.
The study was conducted to fill a gap in the literature. “Some studies have shown that the lung function in COPD patients gets moderately decreased if they have coexisting GERD, but there aren’t any studies that have looked into how it impacts COPD patients when they’re hospitalized, and especially acute complications,” said Alam.
The researchers retrospectively analyzed data from the Nationwide Readmissions Database from 2017 to 2020, utilizing ICD-10 codes to identify 3,798,952 hospitalized adults with a primary diagnosis of COPD, of which 26.97% also had GERD. Individuals without GERD were more likely to be male (47.72% vs 39.88%).
After multivariate adjustment, the presence of GERD was associated with a lower mortality rate (adjusted odds ratio [aOR], 0.717; P < .001) and reduced risks for acute respiratory failure (aOR, 0.915; P < .001), need for noninvasive mechanical ventilation (aOR, 0.907; P < .001), need for invasive ventilation for 24 hours or more (aOR, 0.727; P < .001), acute kidney injury (aOR, 0.877; P < .001), septic shock (aOR, 0.731; P < .001), and acute heart failure (aOR, 0.762; P < .001).
Despite these improved in-hospital outcomes, the researchers found that patients with GERD were at a higher risk for 30-day readmission (aOR, 1.08; P < .001). They also had slightly longer lengths of stay (+0.09 day; P < .001) and lower total charges (−$2824.5996; P < .001).
There have also been studies suggesting that GERD can directly lead to worse lung function among patients with COPD. “So it will be interesting to see if these medications have some kind of impact on the lung function as well. We need more robust studies [to determine that],” said Alam.
It is also important to keep in mind the long-term risk of proton pump inhibitors, especially in older patients. “We have to have good data before we start recommending this,” said Alam.
He suggested that physicians should begin to think more holistically about COPD management and consider the comorbidities. Alam has studied vitamin B12 deficiency in patients with COPD and found an association with cardiovascular comorbidities. “There are so many comorbidities with COPD. COPD itself puts patients at risk of cardiovascular comorbidity, for example. So when we have patients with COPD, we have to think about all those comorbidities and have to manage the patients comprehensively rather than just focusing on the specific targeted interventions,” said Alam.
The study should encourage further research, according to Kunal Deokar, MD, who moderated the session where the study was presented. “It does give us a signal that probably we should have more studies to look into whether patients hospitalized for COPD with GERD really have lower mortality rates, and what will be the effect of treatment on these patients,” said Deokar, who is an assistant professor of pulmonary medicine at the All India Institute of Medical Sciences, Delhi, India.
Alam and Deokar disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON — Gastroesophageal reflux disease (GERD) is associated with better in-hospital outcomes for patients hospitalized with chronic obstructive pulmonary disease (COPD).
“It was a very surprising result. We double-checked the analysis once we got it the first time because the whole expectation was that the outcomes will be worse. But because it’s a retrospective study and it’s based on a national database, there are some limitations,” said ABM Nasibul Alam, MD, who presented the study at the annual meeting of the American College of Chest Physicians (CHEST) . Alam is an internal medicine resident at Northwestern Medicine McHenry Hospital, McHenry, Illinois.
One possible conclusion is that acid reflux therapies received in hospital may be benefitting COPD. The retrospective nature of the study precludes establishing a causal relationship, but there are possible mechanisms that could account for a benefit, according to Alam.
“They might prevent micro-aspirations or silent aspirations in COPD patients. Sometimes you may not have a clinical diagnosis of GERD, but the patient might have silent micro-aspirations, so it might contribute to decreasing that,” said Alam.
The study was conducted to fill a gap in the literature. “Some studies have shown that the lung function in COPD patients gets moderately decreased if they have coexisting GERD, but there aren’t any studies that have looked into how it impacts COPD patients when they’re hospitalized, and especially acute complications,” said Alam.
The researchers retrospectively analyzed data from the Nationwide Readmissions Database from 2017 to 2020, utilizing ICD-10 codes to identify 3,798,952 hospitalized adults with a primary diagnosis of COPD, of which 26.97% also had GERD. Individuals without GERD were more likely to be male (47.72% vs 39.88%).
After multivariate adjustment, the presence of GERD was associated with a lower mortality rate (adjusted odds ratio [aOR], 0.717; P < .001) and reduced risks for acute respiratory failure (aOR, 0.915; P < .001), need for noninvasive mechanical ventilation (aOR, 0.907; P < .001), need for invasive ventilation for 24 hours or more (aOR, 0.727; P < .001), acute kidney injury (aOR, 0.877; P < .001), septic shock (aOR, 0.731; P < .001), and acute heart failure (aOR, 0.762; P < .001).
Despite these improved in-hospital outcomes, the researchers found that patients with GERD were at a higher risk for 30-day readmission (aOR, 1.08; P < .001). They also had slightly longer lengths of stay (+0.09 day; P < .001) and lower total charges (−$2824.5996; P < .001).
There have also been studies suggesting that GERD can directly lead to worse lung function among patients with COPD. “So it will be interesting to see if these medications have some kind of impact on the lung function as well. We need more robust studies [to determine that],” said Alam.
It is also important to keep in mind the long-term risk of proton pump inhibitors, especially in older patients. “We have to have good data before we start recommending this,” said Alam.
He suggested that physicians should begin to think more holistically about COPD management and consider the comorbidities. Alam has studied vitamin B12 deficiency in patients with COPD and found an association with cardiovascular comorbidities. “There are so many comorbidities with COPD. COPD itself puts patients at risk of cardiovascular comorbidity, for example. So when we have patients with COPD, we have to think about all those comorbidities and have to manage the patients comprehensively rather than just focusing on the specific targeted interventions,” said Alam.
The study should encourage further research, according to Kunal Deokar, MD, who moderated the session where the study was presented. “It does give us a signal that probably we should have more studies to look into whether patients hospitalized for COPD with GERD really have lower mortality rates, and what will be the effect of treatment on these patients,” said Deokar, who is an assistant professor of pulmonary medicine at the All India Institute of Medical Sciences, Delhi, India.
Alam and Deokar disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CHEST 2024
Vitamin D in Pregnancy Results in Stronger Bones for Kids
TOPLINE:
Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.
METHODOLOGY:
- The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
- In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
- Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
- In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
- Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.
TAKEAWAY:
- The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
- At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
- The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
- The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.
IN PRACTICE:
“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.
SOURCE:
This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.
LIMITATIONS:
Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.
DISCLOSURES:
The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.
METHODOLOGY:
- The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
- In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
- Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
- In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
- Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.
TAKEAWAY:
- The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
- At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
- The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
- The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.
IN PRACTICE:
“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.
SOURCE:
This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.
LIMITATIONS:
Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.
DISCLOSURES:
The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.
METHODOLOGY:
- The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
- In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
- Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
- In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
- Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.
TAKEAWAY:
- The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
- At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
- The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
- The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.
IN PRACTICE:
“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.
SOURCE:
This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.
LIMITATIONS:
Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.
DISCLOSURES:
The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
ACS: Breast Cancer Incidence Rising, Mortality Disparities Persist
Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).
The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.
Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.
“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”
The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
Incidence and Mortality
Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.
Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.
Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.
Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.
However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.
Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.
In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.
Additional key findings from the report:
- In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
- On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
- As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
- The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
- The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
- American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.
Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.
The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.
Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.
Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.
Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.
For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.
Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.
A version of this article first appeared on Medscape.com.
Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).
The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.
Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.
“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”
The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
Incidence and Mortality
Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.
Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.
Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.
Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.
However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.
Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.
In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.
Additional key findings from the report:
- In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
- On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
- As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
- The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
- The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
- American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.
Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.
The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.
Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.
Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.
Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.
For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.
Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.
A version of this article first appeared on Medscape.com.
Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).
The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.
Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.
“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”
The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
Incidence and Mortality
Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.
Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.
Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.
Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.
However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.
Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.
In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.
Additional key findings from the report:
- In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
- On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
- As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
- The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
- The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
- American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.
Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.
The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.
Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.
Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.
Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.
For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.
Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.
A version of this article first appeared on Medscape.com.
Poor Arm Position May Significantly Skew BP Readings
Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.
Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million adults in the United States and more than 1 billion people globally.
This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
Substantial Overestimation
In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.
Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk.
Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.
Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
Study’s Design Sets It Apart
The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”
Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.
Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.
“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
Incorrect Readings for Many Reasons
Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.
“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”
He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension.
“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said.
Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.
This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.
Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.
A version of this article first appeared on Medscape.com.
Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.
Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million adults in the United States and more than 1 billion people globally.
This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
Substantial Overestimation
In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.
Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk.
Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.
Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
Study’s Design Sets It Apart
The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”
Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.
Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.
“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
Incorrect Readings for Many Reasons
Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.
“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”
He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension.
“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said.
Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.
This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.
Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.
A version of this article first appeared on Medscape.com.
Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.
Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million adults in the United States and more than 1 billion people globally.
This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
Substantial Overestimation
In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.
Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk.
Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.
Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
Study’s Design Sets It Apart
The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”
Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.
Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.
“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
Incorrect Readings for Many Reasons
Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.
“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”
He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension.
“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said.
Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.
This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.
Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.
A version of this article first appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE