Jeff Craven

People who eat red meat or processed meat should continue their current meat consumption, according to recent guidelines from an international panel that were recently published in the Annals of Internal Medicine.

Fuse/Thinkstock

This recommendation was based on the panel having found “low- to very-low-certainty evidence that diets lower in unprocessed red meat may have little or no effect on the risk for major cardiometabolic outcomes and cancer mortality and incidence.” Additionally, meta-analysis results from 23 cohort studies provided low- to very-low-certainty evidence that decreasing unprocessed red meat intake may result in a very small reduction in the risk for major cardiovascular outcomes and type 2 diabetes, with no statistically differences in all-cause mortality and cardiovascular mortality, the guidelines say.

“Our weak recommendation that people continue their current meat consumption highlights both the uncertainty associated with possible harmful effects and the very small magnitude of effect, even if the best estimates represent true causation, which we believe to be implausible,” Bradley C. Johnston, PhD, of the department of community health and epidemiology at Dalhousie University, Halifax, N.S., and colleagues wrote in their paper summarizing the panel’s guidelines.

The evidence Dr. Johnston and colleagues examined were from four systematic reviews analyzing the health effects of red meat and processed meat consumption in randomized trials and meta-analyses of cohort studies as well as one systematic review that identified how people viewed their consumption of meat and values surrounding meat consumption.

In one review of 12 randomized trials examining diets of high and low red meat consumption, a diet consisting of low red meat had little effect on cardiovascular mortality (hazard ratio, 0.98; 95% confidence interval, 0.91-1.06), cardiovascular disease (HR, 0.99; 95% CI, 0.94-1.05), all-cause mortality (0.99; 95% CI, 0.95-1.03) and total cancer mortality (HR, 0.95; 95% CI, 0.89-1.01), including on colorectal cancer or breast cancer (Zeraatkar D et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-0622). A different review of observational cohort studies with more than 1,000 participants found “very-small or possibly small decreases” in all-cause mortality, incidence, and all-cause mortality of cancer, cardiovascular mortality, nonfatal coronary heart disease and MI, and type 2 diabetes for patients who had a diet low in red meat or processed meat (Vernooij R et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1583); a second review by Zeraatkar and colleagues of 55 observational cohort studies with more than 4 million participants found three servings of unprocessed red meat and processed meat per week was associated with a “very small reduction” in risk for MI, stroke, type 2 diabetes, cardiovascular mortality, and all-cause mortality (Zeraatkar D et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1326). Another systematic review of 56 observational cohort studies found three servings of unprocessed red meat per week was associated with a slight reduction in overall cancer mortality (Han MA et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-0699).

The authors also performed a systematic review of participant preferences and values regarding meat consumption. The evidence from 54 qualitative studies showed omnivores preferred eating meat, considered it part of a healthy diet, “lack[ed] the skills needed” to prepare meals without meat, and were mostly unwilling to change their meat consumption (Valli C et al. Ann Intern Med. 2019. doi: 10.7326/M19-1326).

“There was a very small and often trivial absolute risk reduction based on a realistic decrease of three servings of red or processed meat per week,” Dr. Johnston and colleagues wrote in their guidelines. If the very-small exposure effect is true, given peoples’ attachment to their meat-based diet, the associated risk reduction is not likely to provide sufficient motivation to reduce consumption of red meat or processed meat in fully informed individuals, and the weak, rather than strong, recommendation is based on the large variability in peoples’ values and preferences related to meat.”

The authors noted they did not examine factors such as cost, acceptability, feasibility, equity, environmental impact, and views on animal welfare when creating the guidelines. In addition, the low level of evidence from the randomized trials and observational studies means that the potential benefits of reducing red meat or processed meat intake may not outweigh the cultural and personal preferences or quality of life issues that could arise from changing one’s diet.

“This assessment may be excessively pessimistic; indeed, we hope that is the case,” they said. “What is certain is that generating higher-quality evidence regarding the magnitude of any causal effect of meat consumption on health outcomes will test the ingenuity and imagination of health science investigators.”

Dr. El Dib reported receiving funding from the São Paulo Research Foundation, the National Council for Scientific and Technological Development, and the faculty of medicine at Dalhousie University. Dr. de Souza reports relationships with the Canadian Institutes of Health Research/Health Canada, the Canadian Foundation for Dietetic Research and the World Health Organization in the forms of personal fees, grants, and speakers bureau and board of directorship appointments. Dr. Patel reports receiving grants and person fees from the National Institutes of Health, Sanofi, the National Science Foundation, XY.health, doc.ai, Janssen, and the CDC.

SOURCE: Johnston B et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1621.

People who eat red meat or processed meat should continue their current meat consumption, according to recent guidelines from an international panel that were recently published in the Annals of Internal Medicine.

Fuse/Thinkstock

This recommendation was based on the panel having found “low- to very-low-certainty evidence that diets lower in unprocessed red meat may have little or no effect on the risk for major cardiometabolic outcomes and cancer mortality and incidence.” Additionally, meta-analysis results from 23 cohort studies provided low- to very-low-certainty evidence that decreasing unprocessed red meat intake may result in a very small reduction in the risk for major cardiovascular outcomes and type 2 diabetes, with no statistically differences in all-cause mortality and cardiovascular mortality, the guidelines say.

“Our weak recommendation that people continue their current meat consumption highlights both the uncertainty associated with possible harmful effects and the very small magnitude of effect, even if the best estimates represent true causation, which we believe to be implausible,” Bradley C. Johnston, PhD, of the department of community health and epidemiology at Dalhousie University, Halifax, N.S., and colleagues wrote in their paper summarizing the panel’s guidelines.

The evidence Dr. Johnston and colleagues examined were from four systematic reviews analyzing the health effects of red meat and processed meat consumption in randomized trials and meta-analyses of cohort studies as well as one systematic review that identified how people viewed their consumption of meat and values surrounding meat consumption.

In one review of 12 randomized trials examining diets of high and low red meat consumption, a diet consisting of low red meat had little effect on cardiovascular mortality (hazard ratio, 0.98; 95% confidence interval, 0.91-1.06), cardiovascular disease (HR, 0.99; 95% CI, 0.94-1.05), all-cause mortality (0.99; 95% CI, 0.95-1.03) and total cancer mortality (HR, 0.95; 95% CI, 0.89-1.01), including on colorectal cancer or breast cancer (Zeraatkar D et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-0622). A different review of observational cohort studies with more than 1,000 participants found “very-small or possibly small decreases” in all-cause mortality, incidence, and all-cause mortality of cancer, cardiovascular mortality, nonfatal coronary heart disease and MI, and type 2 diabetes for patients who had a diet low in red meat or processed meat (Vernooij R et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1583); a second review by Zeraatkar and colleagues of 55 observational cohort studies with more than 4 million participants found three servings of unprocessed red meat and processed meat per week was associated with a “very small reduction” in risk for MI, stroke, type 2 diabetes, cardiovascular mortality, and all-cause mortality (Zeraatkar D et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1326). Another systematic review of 56 observational cohort studies found three servings of unprocessed red meat per week was associated with a slight reduction in overall cancer mortality (Han MA et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-0699).

The authors also performed a systematic review of participant preferences and values regarding meat consumption. The evidence from 54 qualitative studies showed omnivores preferred eating meat, considered it part of a healthy diet, “lack[ed] the skills needed” to prepare meals without meat, and were mostly unwilling to change their meat consumption (Valli C et al. Ann Intern Med. 2019. doi: 10.7326/M19-1326).

“There was a very small and often trivial absolute risk reduction based on a realistic decrease of three servings of red or processed meat per week,” Dr. Johnston and colleagues wrote in their guidelines. If the very-small exposure effect is true, given peoples’ attachment to their meat-based diet, the associated risk reduction is not likely to provide sufficient motivation to reduce consumption of red meat or processed meat in fully informed individuals, and the weak, rather than strong, recommendation is based on the large variability in peoples’ values and preferences related to meat.”

The authors noted they did not examine factors such as cost, acceptability, feasibility, equity, environmental impact, and views on animal welfare when creating the guidelines. In addition, the low level of evidence from the randomized trials and observational studies means that the potential benefits of reducing red meat or processed meat intake may not outweigh the cultural and personal preferences or quality of life issues that could arise from changing one’s diet.

“This assessment may be excessively pessimistic; indeed, we hope that is the case,” they said. “What is certain is that generating higher-quality evidence regarding the magnitude of any causal effect of meat consumption on health outcomes will test the ingenuity and imagination of health science investigators.”

Dr. El Dib reported receiving funding from the São Paulo Research Foundation, the National Council for Scientific and Technological Development, and the faculty of medicine at Dalhousie University. Dr. de Souza reports relationships with the Canadian Institutes of Health Research/Health Canada, the Canadian Foundation for Dietetic Research and the World Health Organization in the forms of personal fees, grants, and speakers bureau and board of directorship appointments. Dr. Patel reports receiving grants and person fees from the National Institutes of Health, Sanofi, the National Science Foundation, XY.health, doc.ai, Janssen, and the CDC.

SOURCE: Johnston B et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1621.

People who eat red meat or processed meat should continue their current meat consumption, according to recent guidelines from an international panel that were recently published in the Annals of Internal Medicine.

Fuse/Thinkstock

This recommendation was based on the panel having found “low- to very-low-certainty evidence that diets lower in unprocessed red meat may have little or no effect on the risk for major cardiometabolic outcomes and cancer mortality and incidence.” Additionally, meta-analysis results from 23 cohort studies provided low- to very-low-certainty evidence that decreasing unprocessed red meat intake may result in a very small reduction in the risk for major cardiovascular outcomes and type 2 diabetes, with no statistically differences in all-cause mortality and cardiovascular mortality, the guidelines say.

“Our weak recommendation that people continue their current meat consumption highlights both the uncertainty associated with possible harmful effects and the very small magnitude of effect, even if the best estimates represent true causation, which we believe to be implausible,” Bradley C. Johnston, PhD, of the department of community health and epidemiology at Dalhousie University, Halifax, N.S., and colleagues wrote in their paper summarizing the panel’s guidelines.

The evidence Dr. Johnston and colleagues examined were from four systematic reviews analyzing the health effects of red meat and processed meat consumption in randomized trials and meta-analyses of cohort studies as well as one systematic review that identified how people viewed their consumption of meat and values surrounding meat consumption.

In one review of 12 randomized trials examining diets of high and low red meat consumption, a diet consisting of low red meat had little effect on cardiovascular mortality (hazard ratio, 0.98; 95% confidence interval, 0.91-1.06), cardiovascular disease (HR, 0.99; 95% CI, 0.94-1.05), all-cause mortality (0.99; 95% CI, 0.95-1.03) and total cancer mortality (HR, 0.95; 95% CI, 0.89-1.01), including on colorectal cancer or breast cancer (Zeraatkar D et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-0622). A different review of observational cohort studies with more than 1,000 participants found “very-small or possibly small decreases” in all-cause mortality, incidence, and all-cause mortality of cancer, cardiovascular mortality, nonfatal coronary heart disease and MI, and type 2 diabetes for patients who had a diet low in red meat or processed meat (Vernooij R et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1583); a second review by Zeraatkar and colleagues of 55 observational cohort studies with more than 4 million participants found three servings of unprocessed red meat and processed meat per week was associated with a “very small reduction” in risk for MI, stroke, type 2 diabetes, cardiovascular mortality, and all-cause mortality (Zeraatkar D et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1326). Another systematic review of 56 observational cohort studies found three servings of unprocessed red meat per week was associated with a slight reduction in overall cancer mortality (Han MA et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-0699).

The authors also performed a systematic review of participant preferences and values regarding meat consumption. The evidence from 54 qualitative studies showed omnivores preferred eating meat, considered it part of a healthy diet, “lack[ed] the skills needed” to prepare meals without meat, and were mostly unwilling to change their meat consumption (Valli C et al. Ann Intern Med. 2019. doi: 10.7326/M19-1326).

“There was a very small and often trivial absolute risk reduction based on a realistic decrease of three servings of red or processed meat per week,” Dr. Johnston and colleagues wrote in their guidelines. If the very-small exposure effect is true, given peoples’ attachment to their meat-based diet, the associated risk reduction is not likely to provide sufficient motivation to reduce consumption of red meat or processed meat in fully informed individuals, and the weak, rather than strong, recommendation is based on the large variability in peoples’ values and preferences related to meat.”

The authors noted they did not examine factors such as cost, acceptability, feasibility, equity, environmental impact, and views on animal welfare when creating the guidelines. In addition, the low level of evidence from the randomized trials and observational studies means that the potential benefits of reducing red meat or processed meat intake may not outweigh the cultural and personal preferences or quality of life issues that could arise from changing one’s diet.

“This assessment may be excessively pessimistic; indeed, we hope that is the case,” they said. “What is certain is that generating higher-quality evidence regarding the magnitude of any causal effect of meat consumption on health outcomes will test the ingenuity and imagination of health science investigators.”

Dr. El Dib reported receiving funding from the São Paulo Research Foundation, the National Council for Scientific and Technological Development, and the faculty of medicine at Dalhousie University. Dr. de Souza reports relationships with the Canadian Institutes of Health Research/Health Canada, the Canadian Foundation for Dietetic Research and the World Health Organization in the forms of personal fees, grants, and speakers bureau and board of directorship appointments. Dr. Patel reports receiving grants and person fees from the National Institutes of Health, Sanofi, the National Science Foundation, XY.health, doc.ai, Janssen, and the CDC.

SOURCE: Johnston B et al. Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1621.

ORLANDO – Older black women with postmenopausal osteoporosis had significantly higher mortality rates, were more likely to be placed in a long-term nursing facility, and were more likely to become newly eligible for Medicaid after a major fragility fracture event, compared with their white counterparts, according to a findings presented at the annual meeting of the American Society for Bone and Mineral Research.

Previous studies have examined racial differences in mortality and outcomes after fracture, but the data from those studies are older or limited to a certain region or health system, Nicole C. Wright, PhD, MPH, of the department of epidemiology at the University of Alabama at Birmingham, said in her presentation.

“To our knowledge, this is the first comprehensive evaluation of fractures and outcomes post fracture by race, particularly in black women,” she said.

Using Medicare data from between 2010 and 2016, Dr. Wright and colleagues performed a cohort-based, descriptive study of 400,479 white women and 11,563 black women with postmenopausal osteoporosis, who were covered by Medicare Parts A, B, C and D and had a hip, pelvis, femur, radius/ulna, humerus, or clinical vertebral fractures. Fractures were identified by way of a validated algorithm that used inpatient and outpatient claims, outpatient physical evaluations, and management claims, together with fracture repair codes (positive predictive value range, 90.9%-98.6%; from Wright N et al. J Bone Min Res. 2019 Jun 6. doi: 10.1002/jbmr.3807).

The groups had similar proportions of patients in each age group (65-75 years, 75-84 years, 85 years and older), with a slightly higher percentage of younger black patients than younger white patients (25.0% vs. 22.4%, respectively). Black patients were more likely than white patients to be from the South (58.6% vs. 39.7%) and have a Charlson Comorbidity Index score of 2 or higher (62.9% vs. 45.4%). White patients were more likely than black patients to have a Charlson score of 0 (42.0% vs. 24.1%).

The three identifying outcomes were: death/mortality, which was determined using the date in the Medicare vital status; debility, a term used for patients newly placed in a long-term nursing facility; and destitution, used to describe patients who became newly eligible for Medicaid after a major fragility fracture.

The results showed that the most common fracture types were hip and clinical vertebral fractures, with black women having a significantly lower rate of clinical vertebral fractures (29.0% vs. 34.1%, respectively) but a significantly higher rate of femur fractures (9.1% vs. 3.8%). Black women also had a significantly higher mortality rate after a fracture (19.6% vs. 15.4%), and a significantly higher composite outcome of all three identifying outcome measurements (24.6% vs. 20.2%). However, rates of debility and destitution were similar between the groups.

When measured by fracture type, black women had significantly different 1-year postfracture outcomes, compared with white women, with a 38.0% higher incidence of mortality, 40.2% higher rate of debility, 185.0% higher rate of destitution, and 35.4% higher composite outcome for hip fracture. For radius/ulna fractures, black women also had a 59.7% higher rate of death, 8.5% higher rate of debility, 164.7% higher rate of destitution, and 43.0% higher composite outcomes; and for clinical vertebral fractures, they had 11.4% higher rate of death, 10.8% higher rate of debility, 130.6% higher rate of destitution, and 13.6% higher composite outcome, compared with white women.

Overall, black women had higher incidence risk ratios for death (IRR, 1.24; 95% confidence interval, 1.15-1.33), debility (IRR, 1.19; 95% CI, 1.06-1.33), and destitution (IRR, 2.45; 95% CI, 2.20-2.73) for fractures of the hip; higher IRRs for death (IRR, 1.48; 95% CI, 1.33-1.66), debility (IRR, 1.02; 95% CI, 0.87-1.20), and destitution (IRR, 2.70; 95% CI, 2.33-3.13) for fractures of the radius or ulna; and higher IRRs for death (IRR, 1.07; 95% CI, 0.98-1.17) and destitution (IRR, 2.40; 95% CI, 2.15-2.67) for clinical vertebral fractures.

“These data show that we need to develop interventions and/or programs to mitigate and reduce disparities in fracture outcomes,” said Dr. Wright.

She noted that the study results were limited because of its observational nature, and results cannot be generalized beyond older women with postmenopausal osteoporosis with Medicare coverage. In addition, the algorithm used to determine fracture status also had a potentially low sensitivity, which may have affected the study results, she said.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Wright reported receiving grants from Amgen and serving as an expert witness for the law firm Norton Rose Fulbright and Pfizer. Dr. Chen reported receiving grants from Amgen. Dr. Curtis reported receiving grants from, and is a consultant for, Amgen, Eli Lilly, and Radius. Dr. Saag reported receiving grants from Amgen and is a consultant for Gilead and Radius.

SOURCE: Wright NC et al. ASBMR 2019, Abstract 1125.

ORLANDO – Older black women with postmenopausal osteoporosis had significantly higher mortality rates, were more likely to be placed in a long-term nursing facility, and were more likely to become newly eligible for Medicaid after a major fragility fracture event, compared with their white counterparts, according to a findings presented at the annual meeting of the American Society for Bone and Mineral Research.

Previous studies have examined racial differences in mortality and outcomes after fracture, but the data from those studies are older or limited to a certain region or health system, Nicole C. Wright, PhD, MPH, of the department of epidemiology at the University of Alabama at Birmingham, said in her presentation.

“To our knowledge, this is the first comprehensive evaluation of fractures and outcomes post fracture by race, particularly in black women,” she said.

Using Medicare data from between 2010 and 2016, Dr. Wright and colleagues performed a cohort-based, descriptive study of 400,479 white women and 11,563 black women with postmenopausal osteoporosis, who were covered by Medicare Parts A, B, C and D and had a hip, pelvis, femur, radius/ulna, humerus, or clinical vertebral fractures. Fractures were identified by way of a validated algorithm that used inpatient and outpatient claims, outpatient physical evaluations, and management claims, together with fracture repair codes (positive predictive value range, 90.9%-98.6%; from Wright N et al. J Bone Min Res. 2019 Jun 6. doi: 10.1002/jbmr.3807).

The groups had similar proportions of patients in each age group (65-75 years, 75-84 years, 85 years and older), with a slightly higher percentage of younger black patients than younger white patients (25.0% vs. 22.4%, respectively). Black patients were more likely than white patients to be from the South (58.6% vs. 39.7%) and have a Charlson Comorbidity Index score of 2 or higher (62.9% vs. 45.4%). White patients were more likely than black patients to have a Charlson score of 0 (42.0% vs. 24.1%).

The three identifying outcomes were: death/mortality, which was determined using the date in the Medicare vital status; debility, a term used for patients newly placed in a long-term nursing facility; and destitution, used to describe patients who became newly eligible for Medicaid after a major fragility fracture.

The results showed that the most common fracture types were hip and clinical vertebral fractures, with black women having a significantly lower rate of clinical vertebral fractures (29.0% vs. 34.1%, respectively) but a significantly higher rate of femur fractures (9.1% vs. 3.8%). Black women also had a significantly higher mortality rate after a fracture (19.6% vs. 15.4%), and a significantly higher composite outcome of all three identifying outcome measurements (24.6% vs. 20.2%). However, rates of debility and destitution were similar between the groups.

When measured by fracture type, black women had significantly different 1-year postfracture outcomes, compared with white women, with a 38.0% higher incidence of mortality, 40.2% higher rate of debility, 185.0% higher rate of destitution, and 35.4% higher composite outcome for hip fracture. For radius/ulna fractures, black women also had a 59.7% higher rate of death, 8.5% higher rate of debility, 164.7% higher rate of destitution, and 43.0% higher composite outcomes; and for clinical vertebral fractures, they had 11.4% higher rate of death, 10.8% higher rate of debility, 130.6% higher rate of destitution, and 13.6% higher composite outcome, compared with white women.

Overall, black women had higher incidence risk ratios for death (IRR, 1.24; 95% confidence interval, 1.15-1.33), debility (IRR, 1.19; 95% CI, 1.06-1.33), and destitution (IRR, 2.45; 95% CI, 2.20-2.73) for fractures of the hip; higher IRRs for death (IRR, 1.48; 95% CI, 1.33-1.66), debility (IRR, 1.02; 95% CI, 0.87-1.20), and destitution (IRR, 2.70; 95% CI, 2.33-3.13) for fractures of the radius or ulna; and higher IRRs for death (IRR, 1.07; 95% CI, 0.98-1.17) and destitution (IRR, 2.40; 95% CI, 2.15-2.67) for clinical vertebral fractures.

“These data show that we need to develop interventions and/or programs to mitigate and reduce disparities in fracture outcomes,” said Dr. Wright.

She noted that the study results were limited because of its observational nature, and results cannot be generalized beyond older women with postmenopausal osteoporosis with Medicare coverage. In addition, the algorithm used to determine fracture status also had a potentially low sensitivity, which may have affected the study results, she said.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Wright reported receiving grants from Amgen and serving as an expert witness for the law firm Norton Rose Fulbright and Pfizer. Dr. Chen reported receiving grants from Amgen. Dr. Curtis reported receiving grants from, and is a consultant for, Amgen, Eli Lilly, and Radius. Dr. Saag reported receiving grants from Amgen and is a consultant for Gilead and Radius.

SOURCE: Wright NC et al. ASBMR 2019, Abstract 1125.

ORLANDO – Older black women with postmenopausal osteoporosis had significantly higher mortality rates, were more likely to be placed in a long-term nursing facility, and were more likely to become newly eligible for Medicaid after a major fragility fracture event, compared with their white counterparts, according to a findings presented at the annual meeting of the American Society for Bone and Mineral Research.

Previous studies have examined racial differences in mortality and outcomes after fracture, but the data from those studies are older or limited to a certain region or health system, Nicole C. Wright, PhD, MPH, of the department of epidemiology at the University of Alabama at Birmingham, said in her presentation.

“To our knowledge, this is the first comprehensive evaluation of fractures and outcomes post fracture by race, particularly in black women,” she said.

Using Medicare data from between 2010 and 2016, Dr. Wright and colleagues performed a cohort-based, descriptive study of 400,479 white women and 11,563 black women with postmenopausal osteoporosis, who were covered by Medicare Parts A, B, C and D and had a hip, pelvis, femur, radius/ulna, humerus, or clinical vertebral fractures. Fractures were identified by way of a validated algorithm that used inpatient and outpatient claims, outpatient physical evaluations, and management claims, together with fracture repair codes (positive predictive value range, 90.9%-98.6%; from Wright N et al. J Bone Min Res. 2019 Jun 6. doi: 10.1002/jbmr.3807).

The groups had similar proportions of patients in each age group (65-75 years, 75-84 years, 85 years and older), with a slightly higher percentage of younger black patients than younger white patients (25.0% vs. 22.4%, respectively). Black patients were more likely than white patients to be from the South (58.6% vs. 39.7%) and have a Charlson Comorbidity Index score of 2 or higher (62.9% vs. 45.4%). White patients were more likely than black patients to have a Charlson score of 0 (42.0% vs. 24.1%).

The three identifying outcomes were: death/mortality, which was determined using the date in the Medicare vital status; debility, a term used for patients newly placed in a long-term nursing facility; and destitution, used to describe patients who became newly eligible for Medicaid after a major fragility fracture.

The results showed that the most common fracture types were hip and clinical vertebral fractures, with black women having a significantly lower rate of clinical vertebral fractures (29.0% vs. 34.1%, respectively) but a significantly higher rate of femur fractures (9.1% vs. 3.8%). Black women also had a significantly higher mortality rate after a fracture (19.6% vs. 15.4%), and a significantly higher composite outcome of all three identifying outcome measurements (24.6% vs. 20.2%). However, rates of debility and destitution were similar between the groups.

When measured by fracture type, black women had significantly different 1-year postfracture outcomes, compared with white women, with a 38.0% higher incidence of mortality, 40.2% higher rate of debility, 185.0% higher rate of destitution, and 35.4% higher composite outcome for hip fracture. For radius/ulna fractures, black women also had a 59.7% higher rate of death, 8.5% higher rate of debility, 164.7% higher rate of destitution, and 43.0% higher composite outcomes; and for clinical vertebral fractures, they had 11.4% higher rate of death, 10.8% higher rate of debility, 130.6% higher rate of destitution, and 13.6% higher composite outcome, compared with white women.

Overall, black women had higher incidence risk ratios for death (IRR, 1.24; 95% confidence interval, 1.15-1.33), debility (IRR, 1.19; 95% CI, 1.06-1.33), and destitution (IRR, 2.45; 95% CI, 2.20-2.73) for fractures of the hip; higher IRRs for death (IRR, 1.48; 95% CI, 1.33-1.66), debility (IRR, 1.02; 95% CI, 0.87-1.20), and destitution (IRR, 2.70; 95% CI, 2.33-3.13) for fractures of the radius or ulna; and higher IRRs for death (IRR, 1.07; 95% CI, 0.98-1.17) and destitution (IRR, 2.40; 95% CI, 2.15-2.67) for clinical vertebral fractures.

“These data show that we need to develop interventions and/or programs to mitigate and reduce disparities in fracture outcomes,” said Dr. Wright.

She noted that the study results were limited because of its observational nature, and results cannot be generalized beyond older women with postmenopausal osteoporosis with Medicare coverage. In addition, the algorithm used to determine fracture status also had a potentially low sensitivity, which may have affected the study results, she said.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Wright reported receiving grants from Amgen and serving as an expert witness for the law firm Norton Rose Fulbright and Pfizer. Dr. Chen reported receiving grants from Amgen. Dr. Curtis reported receiving grants from, and is a consultant for, Amgen, Eli Lilly, and Radius. Dr. Saag reported receiving grants from Amgen and is a consultant for Gilead and Radius.

SOURCE: Wright NC et al. ASBMR 2019, Abstract 1125.

ORLANDO – Patients who took romosozumab for 12 months and then switched to alendronate continued to see benefits in bone mineral density (BMD) of the lumbar spine after 12 months of therapy with alendronate, compared with patients who began taking, and continued to take, alendronate over the same time period, according to findings from a subgroup of the ARCH study presented at the annual meeting of the American Society for Bone and Mineral Research.

“These effects occurred rapidly, as early as month 6, were sustained beyond 12 months after transitioning to alendronate, and are consistent with greater fracture-risk reduction observed in ARCH with romosozumab to alendronate versus alendronate to alendronate,” Jacques P. Brown, MD, FRCPC, of Laval University, Quebec City, said in his presentation.

In the double-blinded ARCH study, 4,093 postmenopausal women with osteoporosis and a previous fracture history were randomized to receive subcutaneous monthly romosozumab 210 mg or oral weekly alendronate 70 mg for 12 months, followed by an open-label period during which romosozumab patients received oral weekly alendronate 70 mg and alendronate patients continued to receive the same dose on the same schedule for an additional 24 months (Saag KG et al. N Eng J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1708322).

Dr. Brown and colleagues performed an imaging substudy of ARCH, which included examining how the romosozumab-to-alendronate and alendronate-only groups improved lumbar spine BMD and lumbar spine bone strength. Lumbar spine BMD was assessed through quantitative CT, and lumbar spine bone strength was measured with finite element analysis. The researchers received quantitative CT images from baseline and at 6 months, 12 months, and 24 months, and determined the percentage change at each of those periods to calculate integral, trabecular, and cortical lumbar spine volumetric BMD (vBMD), and to bone mineral content (BMC). They also measured areal BMD (aBMD) at baseline, 6 months, 12 months, 18 months, and 24 months with dual-energy x-ray absorptiometry.

Overall, 49 romosozumab patients and 41 alendronate patients from the ARCH study were enrolled in the imaging substudy. Of those patients, 76 had vBMD and BMC information available at baseline and one or more time periods post baseline, and 86 patients had finite element analysis data at baseline and one or more postbaseline time periods. Patients in the romosozumab and alendronate groups had similar baseline characteristics with regard to age (73.1 years vs. 72.8 years, respectively), mean lumbar spine BMD T score (–2.82 vs. –3.38), mean total hip BMD T score (–2.65 vs. –2.75), mean femoral neck T score (–2.84 vs. –2.83), mean lumbar spine integral vBMD (130.3 mg/cm³ vs. 120.5 mg/cm³), trabecular vBMD (60.1 mg/cm³ vs. 53.7 mg/cm³) and cortical vBMD (284.6 mg/cm³ vs. 270.9 mg/cm³). Patients in both groups also had similar rates of previous osteoporotic fracture at or after aged 45 years, previous vertebral fracture, and history of hip fracture.

Beginning at 6 months, there were significant least squares mean BMD improvements in both groups, but the romosozumab group had significant improvements in aBMD percentage changes, compared with the alendronate group, which persisted until 24 months (P less than .001 at all time points). Integral, trabecular, and cortical vBMD in the romosozumab group also saw significantly greater increases from baseline, compared with the alendronate group, and those results persisted in the open-label portion of the study for patients in the romosozumab group who transitioned to alendronate and patients in the alendronate to alendronate group (P less than .001 at all time points).

“The rapid and large increases in BMD with romosozumab followed by BMD consolidation where [patients were] transitioning to alendronate, support the important role of romosozumab as a first-line therapy in treating patients who are at very high risk for fracture,” Dr. Brown said.

In regard to BMC, there were larger increases in least squares mean BMC changes from baseline in the cortical compartment than the trabecular compartment, and actual change in bone strength as measured by finite element analysis was highly correlated with integral BMC in the romosozumab group.

Dr. Brown said the study was limited to the small sample size from the imaging substudy of ARCH, and quantitative CT dictated the imaging sites for the substudy, which may have affected patient selection. However, he noted that the characteristics of the ARCH imaging substudy were similar to patients in the overall ARCH study.

Amgen, UCB Pharma, and Astellas Pharma funded the study in part. Amgen and UCB Pharma assisted in the preparation of Dr. Brown’s presentation at ASBMR 2019, including funding costs associated with its development. Dr. Brown and the other coauthors reported relationships with Amgen, UCB Pharma, and other companies in the form of consultancies, grants and research support, speaker’s bureau appointments, paid employment, and stock options.

SOURCE: Brown JP et al. ASBMR 2019, Abstract 1050.

ORLANDO – Patients who took romosozumab for 12 months and then switched to alendronate continued to see benefits in bone mineral density (BMD) of the lumbar spine after 12 months of therapy with alendronate, compared with patients who began taking, and continued to take, alendronate over the same time period, according to findings from a subgroup of the ARCH study presented at the annual meeting of the American Society for Bone and Mineral Research.

“These effects occurred rapidly, as early as month 6, were sustained beyond 12 months after transitioning to alendronate, and are consistent with greater fracture-risk reduction observed in ARCH with romosozumab to alendronate versus alendronate to alendronate,” Jacques P. Brown, MD, FRCPC, of Laval University, Quebec City, said in his presentation.

In the double-blinded ARCH study, 4,093 postmenopausal women with osteoporosis and a previous fracture history were randomized to receive subcutaneous monthly romosozumab 210 mg or oral weekly alendronate 70 mg for 12 months, followed by an open-label period during which romosozumab patients received oral weekly alendronate 70 mg and alendronate patients continued to receive the same dose on the same schedule for an additional 24 months (Saag KG et al. N Eng J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1708322).

Dr. Brown and colleagues performed an imaging substudy of ARCH, which included examining how the romosozumab-to-alendronate and alendronate-only groups improved lumbar spine BMD and lumbar spine bone strength. Lumbar spine BMD was assessed through quantitative CT, and lumbar spine bone strength was measured with finite element analysis. The researchers received quantitative CT images from baseline and at 6 months, 12 months, and 24 months, and determined the percentage change at each of those periods to calculate integral, trabecular, and cortical lumbar spine volumetric BMD (vBMD), and to bone mineral content (BMC). They also measured areal BMD (aBMD) at baseline, 6 months, 12 months, 18 months, and 24 months with dual-energy x-ray absorptiometry.

Overall, 49 romosozumab patients and 41 alendronate patients from the ARCH study were enrolled in the imaging substudy. Of those patients, 76 had vBMD and BMC information available at baseline and one or more time periods post baseline, and 86 patients had finite element analysis data at baseline and one or more postbaseline time periods. Patients in the romosozumab and alendronate groups had similar baseline characteristics with regard to age (73.1 years vs. 72.8 years, respectively), mean lumbar spine BMD T score (–2.82 vs. –3.38), mean total hip BMD T score (–2.65 vs. –2.75), mean femoral neck T score (–2.84 vs. –2.83), mean lumbar spine integral vBMD (130.3 mg/cm³ vs. 120.5 mg/cm³), trabecular vBMD (60.1 mg/cm³ vs. 53.7 mg/cm³) and cortical vBMD (284.6 mg/cm³ vs. 270.9 mg/cm³). Patients in both groups also had similar rates of previous osteoporotic fracture at or after aged 45 years, previous vertebral fracture, and history of hip fracture.

Beginning at 6 months, there were significant least squares mean BMD improvements in both groups, but the romosozumab group had significant improvements in aBMD percentage changes, compared with the alendronate group, which persisted until 24 months (P less than .001 at all time points). Integral, trabecular, and cortical vBMD in the romosozumab group also saw significantly greater increases from baseline, compared with the alendronate group, and those results persisted in the open-label portion of the study for patients in the romosozumab group who transitioned to alendronate and patients in the alendronate to alendronate group (P less than .001 at all time points).

“The rapid and large increases in BMD with romosozumab followed by BMD consolidation where [patients were] transitioning to alendronate, support the important role of romosozumab as a first-line therapy in treating patients who are at very high risk for fracture,” Dr. Brown said.

In regard to BMC, there were larger increases in least squares mean BMC changes from baseline in the cortical compartment than the trabecular compartment, and actual change in bone strength as measured by finite element analysis was highly correlated with integral BMC in the romosozumab group.

Dr. Brown said the study was limited to the small sample size from the imaging substudy of ARCH, and quantitative CT dictated the imaging sites for the substudy, which may have affected patient selection. However, he noted that the characteristics of the ARCH imaging substudy were similar to patients in the overall ARCH study.

Amgen, UCB Pharma, and Astellas Pharma funded the study in part. Amgen and UCB Pharma assisted in the preparation of Dr. Brown’s presentation at ASBMR 2019, including funding costs associated with its development. Dr. Brown and the other coauthors reported relationships with Amgen, UCB Pharma, and other companies in the form of consultancies, grants and research support, speaker’s bureau appointments, paid employment, and stock options.

SOURCE: Brown JP et al. ASBMR 2019, Abstract 1050.

ORLANDO – Patients who took romosozumab for 12 months and then switched to alendronate continued to see benefits in bone mineral density (BMD) of the lumbar spine after 12 months of therapy with alendronate, compared with patients who began taking, and continued to take, alendronate over the same time period, according to findings from a subgroup of the ARCH study presented at the annual meeting of the American Society for Bone and Mineral Research.

“These effects occurred rapidly, as early as month 6, were sustained beyond 12 months after transitioning to alendronate, and are consistent with greater fracture-risk reduction observed in ARCH with romosozumab to alendronate versus alendronate to alendronate,” Jacques P. Brown, MD, FRCPC, of Laval University, Quebec City, said in his presentation.

In the double-blinded ARCH study, 4,093 postmenopausal women with osteoporosis and a previous fracture history were randomized to receive subcutaneous monthly romosozumab 210 mg or oral weekly alendronate 70 mg for 12 months, followed by an open-label period during which romosozumab patients received oral weekly alendronate 70 mg and alendronate patients continued to receive the same dose on the same schedule for an additional 24 months (Saag KG et al. N Eng J Med. 2017 Oct 12. doi: 10.1056/NEJMoa1708322).

Dr. Brown and colleagues performed an imaging substudy of ARCH, which included examining how the romosozumab-to-alendronate and alendronate-only groups improved lumbar spine BMD and lumbar spine bone strength. Lumbar spine BMD was assessed through quantitative CT, and lumbar spine bone strength was measured with finite element analysis. The researchers received quantitative CT images from baseline and at 6 months, 12 months, and 24 months, and determined the percentage change at each of those periods to calculate integral, trabecular, and cortical lumbar spine volumetric BMD (vBMD), and to bone mineral content (BMC). They also measured areal BMD (aBMD) at baseline, 6 months, 12 months, 18 months, and 24 months with dual-energy x-ray absorptiometry.

Overall, 49 romosozumab patients and 41 alendronate patients from the ARCH study were enrolled in the imaging substudy. Of those patients, 76 had vBMD and BMC information available at baseline and one or more time periods post baseline, and 86 patients had finite element analysis data at baseline and one or more postbaseline time periods. Patients in the romosozumab and alendronate groups had similar baseline characteristics with regard to age (73.1 years vs. 72.8 years, respectively), mean lumbar spine BMD T score (–2.82 vs. –3.38), mean total hip BMD T score (–2.65 vs. –2.75), mean femoral neck T score (–2.84 vs. –2.83), mean lumbar spine integral vBMD (130.3 mg/cm³ vs. 120.5 mg/cm³), trabecular vBMD (60.1 mg/cm³ vs. 53.7 mg/cm³) and cortical vBMD (284.6 mg/cm³ vs. 270.9 mg/cm³). Patients in both groups also had similar rates of previous osteoporotic fracture at or after aged 45 years, previous vertebral fracture, and history of hip fracture.

Beginning at 6 months, there were significant least squares mean BMD improvements in both groups, but the romosozumab group had significant improvements in aBMD percentage changes, compared with the alendronate group, which persisted until 24 months (P less than .001 at all time points). Integral, trabecular, and cortical vBMD in the romosozumab group also saw significantly greater increases from baseline, compared with the alendronate group, and those results persisted in the open-label portion of the study for patients in the romosozumab group who transitioned to alendronate and patients in the alendronate to alendronate group (P less than .001 at all time points).

“The rapid and large increases in BMD with romosozumab followed by BMD consolidation where [patients were] transitioning to alendronate, support the important role of romosozumab as a first-line therapy in treating patients who are at very high risk for fracture,” Dr. Brown said.

In regard to BMC, there were larger increases in least squares mean BMC changes from baseline in the cortical compartment than the trabecular compartment, and actual change in bone strength as measured by finite element analysis was highly correlated with integral BMC in the romosozumab group.

Dr. Brown said the study was limited to the small sample size from the imaging substudy of ARCH, and quantitative CT dictated the imaging sites for the substudy, which may have affected patient selection. However, he noted that the characteristics of the ARCH imaging substudy were similar to patients in the overall ARCH study.

Amgen, UCB Pharma, and Astellas Pharma funded the study in part. Amgen and UCB Pharma assisted in the preparation of Dr. Brown’s presentation at ASBMR 2019, including funding costs associated with its development. Dr. Brown and the other coauthors reported relationships with Amgen, UCB Pharma, and other companies in the form of consultancies, grants and research support, speaker’s bureau appointments, paid employment, and stock options.

SOURCE: Brown JP et al. ASBMR 2019, Abstract 1050.

ORLANDO – Supplemental vitamin D₃ in healthy older men and women did not significantly affect areal bone mineral density in the whole body, femoral neck, total hip, or spine after 2 years of daily use, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Participants may have already reached the vitamin D level needed for bone health,” Meryl S. LeBoff, MD, of Brigham and Women’s Hospital in Boston, said in her presentation.

Dr. LeBoff presented results from 771 patients (mean age, 63.8 years) in the Bone Health Subcohort of VITAL (Vitamin D and OmegA-3 TriaL) who were not on any bone active medications and were randomized to receive daily vitamin D₃ at a dose of 2,000 IU or placebo. Patients received bone imaging at baseline and at 2 years; areal bone mineral density (aBMD) of the whole body, femoral neck, total hip, and spine was assessed via dual x-ray absorptiometry scan. Total 25-hydroxyvitamin D (25[OH]D) levels were measured via liquid chromatography tandem mass spectrometry, and free 25(OH)D levels were measured via the ELISA assay. The baseline characteristics of the vitamin D₃ supplementation and placebo groups were similar. Overall, 52% of patients had osteopenia and 10.4% had osteoporosis.

Between baseline and 2 years, the vitamin D group’s total 25(OH)D levels increased from a mean 27.0 ng/mL to 39.5 ng/mL (46%) and the free 25(OH)D levels increased from 5.8 pg/mL to 9.0 pg/mL (55%), whereas levels in the placebo stayed the same. The researchers found no significant absolute percentage changes over 2 years in aBMD of the whole body (P = .60), femoral neck (P = .16), total hip (P = .23) and spine (P = .55), compared with patients in the placebo group.

In a secondary analysis, Dr. LeBoff and colleagues found no benefit to volumetric BMD (vBMD) of the radius and the tibia at 2 years, and the results persisted after they performed a sensitivity analysis. Adverse events, such as hypercalciuria, kidney stones, and gastrointestinal symptoms, were not significantly different in the vitamin D group, compared with the placebo group.

Dr. LeBoff noted among the limitations of the study that it evaluated one dose level of vitamin D and was not designed to determine whether vitamin D supplementation was effective in people with vitamin D insufficiency, and the results are not generalizable to patients with osteoporosis or osteomalacia. Future studies should also examine whether free 25(OH)D levels can be used to detect which patients can benefit from vitamin D supplementation, she added.
 

Risk of falls

In a separate abstract, which Dr. LeBoff presented in a different session, 12,927 patients who received vitamin D supplementation for 5 years, were studied for risk of falls, compared with 12,994 individuals in a placebo group. At baseline, 33.3% of patients had fallen at least once in the previous year, and overall 6,605 patients reported 13,235 falls. At 5.3 years of follow-up, there were no significant differences in number of falls between groups, falls leading to injury, and falls leading to a doctor or a hospital visit.

There are ongoing parallel studies examining the incidence of fractures between groups in the total population of the VITAL study (25,871 participants); bone turnover markers; bone microarchitecture measurements through high-resolution peripheral quantitative computed tomography; and examining the connection between free 25(OH)D, parathyroid hormone, and vitamin D binding protein, said Dr. LeBoff.

The study was funded in part by grants from the National Cancer Institute, the National Heart, Lung and Blood Institute, the Office of Dietary Supplements, the National Institute of Neurological Disorders and Stroke, and the National Center for Complementary and Integrative Health. Dr. LeBoff reported receiving grants from the National Institute of Arthritis Musculoskeletal and Skin Diseases. Two authors reported nonfinancial support Pharmavite LLC of Northridge, Calif., Pronova BioPharma of Norway and BASF, and Quest Diagnostics. The remaining authors reported no conflicts of interest.

SOURCE: LeBoff M et al. ASBMR 2019, Abstracts 1046 and 1057.

ORLANDO – Supplemental vitamin D₃ in healthy older men and women did not significantly affect areal bone mineral density in the whole body, femoral neck, total hip, or spine after 2 years of daily use, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Participants may have already reached the vitamin D level needed for bone health,” Meryl S. LeBoff, MD, of Brigham and Women’s Hospital in Boston, said in her presentation.

Dr. LeBoff presented results from 771 patients (mean age, 63.8 years) in the Bone Health Subcohort of VITAL (Vitamin D and OmegA-3 TriaL) who were not on any bone active medications and were randomized to receive daily vitamin D₃ at a dose of 2,000 IU or placebo. Patients received bone imaging at baseline and at 2 years; areal bone mineral density (aBMD) of the whole body, femoral neck, total hip, and spine was assessed via dual x-ray absorptiometry scan. Total 25-hydroxyvitamin D (25[OH]D) levels were measured via liquid chromatography tandem mass spectrometry, and free 25(OH)D levels were measured via the ELISA assay. The baseline characteristics of the vitamin D₃ supplementation and placebo groups were similar. Overall, 52% of patients had osteopenia and 10.4% had osteoporosis.

Between baseline and 2 years, the vitamin D group’s total 25(OH)D levels increased from a mean 27.0 ng/mL to 39.5 ng/mL (46%) and the free 25(OH)D levels increased from 5.8 pg/mL to 9.0 pg/mL (55%), whereas levels in the placebo stayed the same. The researchers found no significant absolute percentage changes over 2 years in aBMD of the whole body (P = .60), femoral neck (P = .16), total hip (P = .23) and spine (P = .55), compared with patients in the placebo group.

In a secondary analysis, Dr. LeBoff and colleagues found no benefit to volumetric BMD (vBMD) of the radius and the tibia at 2 years, and the results persisted after they performed a sensitivity analysis. Adverse events, such as hypercalciuria, kidney stones, and gastrointestinal symptoms, were not significantly different in the vitamin D group, compared with the placebo group.

Dr. LeBoff noted among the limitations of the study that it evaluated one dose level of vitamin D and was not designed to determine whether vitamin D supplementation was effective in people with vitamin D insufficiency, and the results are not generalizable to patients with osteoporosis or osteomalacia. Future studies should also examine whether free 25(OH)D levels can be used to detect which patients can benefit from vitamin D supplementation, she added.
 

Risk of falls

In a separate abstract, which Dr. LeBoff presented in a different session, 12,927 patients who received vitamin D supplementation for 5 years, were studied for risk of falls, compared with 12,994 individuals in a placebo group. At baseline, 33.3% of patients had fallen at least once in the previous year, and overall 6,605 patients reported 13,235 falls. At 5.3 years of follow-up, there were no significant differences in number of falls between groups, falls leading to injury, and falls leading to a doctor or a hospital visit.

There are ongoing parallel studies examining the incidence of fractures between groups in the total population of the VITAL study (25,871 participants); bone turnover markers; bone microarchitecture measurements through high-resolution peripheral quantitative computed tomography; and examining the connection between free 25(OH)D, parathyroid hormone, and vitamin D binding protein, said Dr. LeBoff.

The study was funded in part by grants from the National Cancer Institute, the National Heart, Lung and Blood Institute, the Office of Dietary Supplements, the National Institute of Neurological Disorders and Stroke, and the National Center for Complementary and Integrative Health. Dr. LeBoff reported receiving grants from the National Institute of Arthritis Musculoskeletal and Skin Diseases. Two authors reported nonfinancial support Pharmavite LLC of Northridge, Calif., Pronova BioPharma of Norway and BASF, and Quest Diagnostics. The remaining authors reported no conflicts of interest.

SOURCE: LeBoff M et al. ASBMR 2019, Abstracts 1046 and 1057.

ORLANDO – Supplemental vitamin D₃ in healthy older men and women did not significantly affect areal bone mineral density in the whole body, femoral neck, total hip, or spine after 2 years of daily use, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Participants may have already reached the vitamin D level needed for bone health,” Meryl S. LeBoff, MD, of Brigham and Women’s Hospital in Boston, said in her presentation.

Dr. LeBoff presented results from 771 patients (mean age, 63.8 years) in the Bone Health Subcohort of VITAL (Vitamin D and OmegA-3 TriaL) who were not on any bone active medications and were randomized to receive daily vitamin D₃ at a dose of 2,000 IU or placebo. Patients received bone imaging at baseline and at 2 years; areal bone mineral density (aBMD) of the whole body, femoral neck, total hip, and spine was assessed via dual x-ray absorptiometry scan. Total 25-hydroxyvitamin D (25[OH]D) levels were measured via liquid chromatography tandem mass spectrometry, and free 25(OH)D levels were measured via the ELISA assay. The baseline characteristics of the vitamin D₃ supplementation and placebo groups were similar. Overall, 52% of patients had osteopenia and 10.4% had osteoporosis.

Between baseline and 2 years, the vitamin D group’s total 25(OH)D levels increased from a mean 27.0 ng/mL to 39.5 ng/mL (46%) and the free 25(OH)D levels increased from 5.8 pg/mL to 9.0 pg/mL (55%), whereas levels in the placebo stayed the same. The researchers found no significant absolute percentage changes over 2 years in aBMD of the whole body (P = .60), femoral neck (P = .16), total hip (P = .23) and spine (P = .55), compared with patients in the placebo group.

In a secondary analysis, Dr. LeBoff and colleagues found no benefit to volumetric BMD (vBMD) of the radius and the tibia at 2 years, and the results persisted after they performed a sensitivity analysis. Adverse events, such as hypercalciuria, kidney stones, and gastrointestinal symptoms, were not significantly different in the vitamin D group, compared with the placebo group.

Dr. LeBoff noted among the limitations of the study that it evaluated one dose level of vitamin D and was not designed to determine whether vitamin D supplementation was effective in people with vitamin D insufficiency, and the results are not generalizable to patients with osteoporosis or osteomalacia. Future studies should also examine whether free 25(OH)D levels can be used to detect which patients can benefit from vitamin D supplementation, she added.
 

Risk of falls

In a separate abstract, which Dr. LeBoff presented in a different session, 12,927 patients who received vitamin D supplementation for 5 years, were studied for risk of falls, compared with 12,994 individuals in a placebo group. At baseline, 33.3% of patients had fallen at least once in the previous year, and overall 6,605 patients reported 13,235 falls. At 5.3 years of follow-up, there were no significant differences in number of falls between groups, falls leading to injury, and falls leading to a doctor or a hospital visit.

There are ongoing parallel studies examining the incidence of fractures between groups in the total population of the VITAL study (25,871 participants); bone turnover markers; bone microarchitecture measurements through high-resolution peripheral quantitative computed tomography; and examining the connection between free 25(OH)D, parathyroid hormone, and vitamin D binding protein, said Dr. LeBoff.

The study was funded in part by grants from the National Cancer Institute, the National Heart, Lung and Blood Institute, the Office of Dietary Supplements, the National Institute of Neurological Disorders and Stroke, and the National Center for Complementary and Integrative Health. Dr. LeBoff reported receiving grants from the National Institute of Arthritis Musculoskeletal and Skin Diseases. Two authors reported nonfinancial support Pharmavite LLC of Northridge, Calif., Pronova BioPharma of Norway and BASF, and Quest Diagnostics. The remaining authors reported no conflicts of interest.

SOURCE: LeBoff M et al. ASBMR 2019, Abstracts 1046 and 1057.

ORLANDO – The use of a teleconferencing program to share knowledge about osteoporosis has helped health care professionals learn about the disease and may potentially reduce the osteoporosis treatment gap in underserved communities, according to a speaker at the annual meeting of the American Society for Bone and Mineral Research.

The concept, called “technology-enabled collaborative learning,” is intended to address the problem of there being not enough specialists to see patients who need treatment, and the ineffectiveness of educating primary care providers in how to treat complex medical conditions, E. Michael Lewiecki, MD, the director of the New Mexico Clinical Research & Osteoporosis Center said in his presentation.

“Primary care doctors are busy,” said Dr. Lewiecki. “They have limited time taking care of patients. They don’t have the time or often the skills to manage patients who have any questions or concerns about osteoporosis and treatments for osteoporosis.”

One solution, he said, is to find health care professionals in underserved communities who are already interested in and motivated to learn more about osteoporosis, turn them into near-experts on osteoporosis for their patients as well as in their own community.

Dr. Lewiecki proposed the Extension for Community Healthcare Outcomes (ECHO), or Project ECHO, an initiative out of the University of New Mexico School of Medicine, as a potential answer. Project ECHO uses videoconferencing to connect experts in a therapeutic area, with Bone Health TeleECHO focusing on raising knowledge of osteoporosis for its participants. “The idea of ECHO is to be a force multiplier to educate health care professionals, each of whom takes care of many patients, and to have many ECHO programs around the world in convenient time zones and convenient languages for people who are interested in participating,” said Dr. Lewiecki.

The idea began when a gastroenterologist at Dr. Lewiecki’s own center was frustrated that patients were not seeking treatment for hepatitis C because of time or travel issues. In response, a pilot program for Project ECHO was developed through a collaboration between the University of New Mexico Health Sciences Center and the Osteoporosis Foundation of New Mexico where gastroenterologists at University of New Mexico connected with primary care providers across the state, sharing information about hepatitis C and discussing case studies. The results of the pilot program were published in the New England Journal of Medicine and showed a similar rate of sustained viral response between patients treated at the University of New Mexico clinic (84 of 146 patients; 57.5%) and at 21 ECHO clinics (152 of 261 patients; 58.2%) (Arora S et al. N Eng J Med. 2011. doi: 10.1056/NEJMoa1009370).

“ECHO expands the capacity to deliver best practice medical care through collegial, interactive, case-based discussions with minimal disruption to the office routine,” said Dr. Lewiecki. “Patients benefit from better care, closer to home, with greater convenience and lower cost than referral to a medical center. And the potential is to reduce the osteoporosis treatment gap by having many ECHOs starting up in many places in the world.”

Today, the ECHO program is in 37 countries, with 322 ECHO hubs and 677 ECHO programs. The top three specialties are endocrinology, orthopedics, and rheumatology; 51% of ECHO participants are primary care providers, 24% are advanced care providers, and 19% are health care providers such as nutritionists, physical therapists, and other providers that have an interest in bone health.

In survey results adapted from a 2017 study from his own group, Dr. Lewiecki showed that 263 health care professionals who participated in Bone Health TeleECHO rated themselves as more confident in 20 different domains of osteoporosis treatment, such as secondary osteoporosis and anabolic therapy, after 21 months of using the ECHO program (Lewiecki EM et al. J Endocr Soc. 2017. doi: 10.1210/js.2017-00361). However, he admitted that showing fracture prevention outcomes at these ECHO centers has proven more difficult.

“Of course, we’re all interested in outcomes. The ultimate outcome here is preventing fractures, but it is extraordinarily difficult to design a study to actually show that we’re reducing fractures, but certainly self-confidence in managing osteoporosis has improved,” he said.

There have also been some misconceptions of the Project ECHO. The program is not only for beginners or primary care providers, said Dr. Lewiecki. It is also not limited to providers in rural areas, as the program has many participants at urban centers, he added.

“We are a virtual community of practice. It’s a collegial relationship,” he said. “It’s really recapitulating the way that we learned during our postgraduate training: When we see a patient, we present the case to our attending, the attending pontificates a little bit, we bounce things off of one another, and we go back and then we do some different things with our patients. And that’s exactly what we do with Echo. It makes learning fun again.”

Dr. Lewiecki challenged the attendees in the room who are already experts in osteoporosis to help share their knowledge of the disease to help other health care professionals learn more about how to better care for their patients. “If you have a passion for teaching, if you want to share knowledge and you’re willing to devote a little bit of your time to doing that and reaching out to more people, this is the way that you can do it.”

Dr. Lewiecki reports research grant support from Amgen, consulting fees from Alexion, Amgen, Radius, Shire, and Ultragenyx, speaking fees from Alexion, Radius, and Shire, and is an advisory board member with the National Osteoporosis Foundation, International Society for Clinical Densitometry, and the Osteoporosis Foundation of New Mexico.

SOURCE: Lewiecki ME. ASBMR 2019. Symposia: Cutting Edge Concepts: Novel Approaches to Reducing Fractures. Bone Health TeleECHO.

ORLANDO – The use of a teleconferencing program to share knowledge about osteoporosis has helped health care professionals learn about the disease and may potentially reduce the osteoporosis treatment gap in underserved communities, according to a speaker at the annual meeting of the American Society for Bone and Mineral Research.

The concept, called “technology-enabled collaborative learning,” is intended to address the problem of there being not enough specialists to see patients who need treatment, and the ineffectiveness of educating primary care providers in how to treat complex medical conditions, E. Michael Lewiecki, MD, the director of the New Mexico Clinical Research & Osteoporosis Center said in his presentation.

“Primary care doctors are busy,” said Dr. Lewiecki. “They have limited time taking care of patients. They don’t have the time or often the skills to manage patients who have any questions or concerns about osteoporosis and treatments for osteoporosis.”

One solution, he said, is to find health care professionals in underserved communities who are already interested in and motivated to learn more about osteoporosis, turn them into near-experts on osteoporosis for their patients as well as in their own community.

Dr. Lewiecki proposed the Extension for Community Healthcare Outcomes (ECHO), or Project ECHO, an initiative out of the University of New Mexico School of Medicine, as a potential answer. Project ECHO uses videoconferencing to connect experts in a therapeutic area, with Bone Health TeleECHO focusing on raising knowledge of osteoporosis for its participants. “The idea of ECHO is to be a force multiplier to educate health care professionals, each of whom takes care of many patients, and to have many ECHO programs around the world in convenient time zones and convenient languages for people who are interested in participating,” said Dr. Lewiecki.

The idea began when a gastroenterologist at Dr. Lewiecki’s own center was frustrated that patients were not seeking treatment for hepatitis C because of time or travel issues. In response, a pilot program for Project ECHO was developed through a collaboration between the University of New Mexico Health Sciences Center and the Osteoporosis Foundation of New Mexico where gastroenterologists at University of New Mexico connected with primary care providers across the state, sharing information about hepatitis C and discussing case studies. The results of the pilot program were published in the New England Journal of Medicine and showed a similar rate of sustained viral response between patients treated at the University of New Mexico clinic (84 of 146 patients; 57.5%) and at 21 ECHO clinics (152 of 261 patients; 58.2%) (Arora S et al. N Eng J Med. 2011. doi: 10.1056/NEJMoa1009370).

“ECHO expands the capacity to deliver best practice medical care through collegial, interactive, case-based discussions with minimal disruption to the office routine,” said Dr. Lewiecki. “Patients benefit from better care, closer to home, with greater convenience and lower cost than referral to a medical center. And the potential is to reduce the osteoporosis treatment gap by having many ECHOs starting up in many places in the world.”

Today, the ECHO program is in 37 countries, with 322 ECHO hubs and 677 ECHO programs. The top three specialties are endocrinology, orthopedics, and rheumatology; 51% of ECHO participants are primary care providers, 24% are advanced care providers, and 19% are health care providers such as nutritionists, physical therapists, and other providers that have an interest in bone health.

In survey results adapted from a 2017 study from his own group, Dr. Lewiecki showed that 263 health care professionals who participated in Bone Health TeleECHO rated themselves as more confident in 20 different domains of osteoporosis treatment, such as secondary osteoporosis and anabolic therapy, after 21 months of using the ECHO program (Lewiecki EM et al. J Endocr Soc. 2017. doi: 10.1210/js.2017-00361). However, he admitted that showing fracture prevention outcomes at these ECHO centers has proven more difficult.

“Of course, we’re all interested in outcomes. The ultimate outcome here is preventing fractures, but it is extraordinarily difficult to design a study to actually show that we’re reducing fractures, but certainly self-confidence in managing osteoporosis has improved,” he said.

There have also been some misconceptions of the Project ECHO. The program is not only for beginners or primary care providers, said Dr. Lewiecki. It is also not limited to providers in rural areas, as the program has many participants at urban centers, he added.

“We are a virtual community of practice. It’s a collegial relationship,” he said. “It’s really recapitulating the way that we learned during our postgraduate training: When we see a patient, we present the case to our attending, the attending pontificates a little bit, we bounce things off of one another, and we go back and then we do some different things with our patients. And that’s exactly what we do with Echo. It makes learning fun again.”

Dr. Lewiecki challenged the attendees in the room who are already experts in osteoporosis to help share their knowledge of the disease to help other health care professionals learn more about how to better care for their patients. “If you have a passion for teaching, if you want to share knowledge and you’re willing to devote a little bit of your time to doing that and reaching out to more people, this is the way that you can do it.”

Dr. Lewiecki reports research grant support from Amgen, consulting fees from Alexion, Amgen, Radius, Shire, and Ultragenyx, speaking fees from Alexion, Radius, and Shire, and is an advisory board member with the National Osteoporosis Foundation, International Society for Clinical Densitometry, and the Osteoporosis Foundation of New Mexico.

SOURCE: Lewiecki ME. ASBMR 2019. Symposia: Cutting Edge Concepts: Novel Approaches to Reducing Fractures. Bone Health TeleECHO.

ORLANDO – The use of a teleconferencing program to share knowledge about osteoporosis has helped health care professionals learn about the disease and may potentially reduce the osteoporosis treatment gap in underserved communities, according to a speaker at the annual meeting of the American Society for Bone and Mineral Research.

The concept, called “technology-enabled collaborative learning,” is intended to address the problem of there being not enough specialists to see patients who need treatment, and the ineffectiveness of educating primary care providers in how to treat complex medical conditions, E. Michael Lewiecki, MD, the director of the New Mexico Clinical Research & Osteoporosis Center said in his presentation.

“Primary care doctors are busy,” said Dr. Lewiecki. “They have limited time taking care of patients. They don’t have the time or often the skills to manage patients who have any questions or concerns about osteoporosis and treatments for osteoporosis.”

One solution, he said, is to find health care professionals in underserved communities who are already interested in and motivated to learn more about osteoporosis, turn them into near-experts on osteoporosis for their patients as well as in their own community.

Dr. Lewiecki proposed the Extension for Community Healthcare Outcomes (ECHO), or Project ECHO, an initiative out of the University of New Mexico School of Medicine, as a potential answer. Project ECHO uses videoconferencing to connect experts in a therapeutic area, with Bone Health TeleECHO focusing on raising knowledge of osteoporosis for its participants. “The idea of ECHO is to be a force multiplier to educate health care professionals, each of whom takes care of many patients, and to have many ECHO programs around the world in convenient time zones and convenient languages for people who are interested in participating,” said Dr. Lewiecki.

The idea began when a gastroenterologist at Dr. Lewiecki’s own center was frustrated that patients were not seeking treatment for hepatitis C because of time or travel issues. In response, a pilot program for Project ECHO was developed through a collaboration between the University of New Mexico Health Sciences Center and the Osteoporosis Foundation of New Mexico where gastroenterologists at University of New Mexico connected with primary care providers across the state, sharing information about hepatitis C and discussing case studies. The results of the pilot program were published in the New England Journal of Medicine and showed a similar rate of sustained viral response between patients treated at the University of New Mexico clinic (84 of 146 patients; 57.5%) and at 21 ECHO clinics (152 of 261 patients; 58.2%) (Arora S et al. N Eng J Med. 2011. doi: 10.1056/NEJMoa1009370).

“ECHO expands the capacity to deliver best practice medical care through collegial, interactive, case-based discussions with minimal disruption to the office routine,” said Dr. Lewiecki. “Patients benefit from better care, closer to home, with greater convenience and lower cost than referral to a medical center. And the potential is to reduce the osteoporosis treatment gap by having many ECHOs starting up in many places in the world.”

Today, the ECHO program is in 37 countries, with 322 ECHO hubs and 677 ECHO programs. The top three specialties are endocrinology, orthopedics, and rheumatology; 51% of ECHO participants are primary care providers, 24% are advanced care providers, and 19% are health care providers such as nutritionists, physical therapists, and other providers that have an interest in bone health.

In survey results adapted from a 2017 study from his own group, Dr. Lewiecki showed that 263 health care professionals who participated in Bone Health TeleECHO rated themselves as more confident in 20 different domains of osteoporosis treatment, such as secondary osteoporosis and anabolic therapy, after 21 months of using the ECHO program (Lewiecki EM et al. J Endocr Soc. 2017. doi: 10.1210/js.2017-00361). However, he admitted that showing fracture prevention outcomes at these ECHO centers has proven more difficult.

“Of course, we’re all interested in outcomes. The ultimate outcome here is preventing fractures, but it is extraordinarily difficult to design a study to actually show that we’re reducing fractures, but certainly self-confidence in managing osteoporosis has improved,” he said.

There have also been some misconceptions of the Project ECHO. The program is not only for beginners or primary care providers, said Dr. Lewiecki. It is also not limited to providers in rural areas, as the program has many participants at urban centers, he added.

“We are a virtual community of practice. It’s a collegial relationship,” he said. “It’s really recapitulating the way that we learned during our postgraduate training: When we see a patient, we present the case to our attending, the attending pontificates a little bit, we bounce things off of one another, and we go back and then we do some different things with our patients. And that’s exactly what we do with Echo. It makes learning fun again.”

Dr. Lewiecki challenged the attendees in the room who are already experts in osteoporosis to help share their knowledge of the disease to help other health care professionals learn more about how to better care for their patients. “If you have a passion for teaching, if you want to share knowledge and you’re willing to devote a little bit of your time to doing that and reaching out to more people, this is the way that you can do it.”

Dr. Lewiecki reports research grant support from Amgen, consulting fees from Alexion, Amgen, Radius, Shire, and Ultragenyx, speaking fees from Alexion, Radius, and Shire, and is an advisory board member with the National Osteoporosis Foundation, International Society for Clinical Densitometry, and the Osteoporosis Foundation of New Mexico.

SOURCE: Lewiecki ME. ASBMR 2019. Symposia: Cutting Edge Concepts: Novel Approaches to Reducing Fractures. Bone Health TeleECHO.

Pediatric cancer survivors have a higher likelihood of experiencing a cardiac event, developing diabetes, or having hypertension at a median 10-year follow-up, according to results from a recent research letter published in Circulation.

Ashna Khanna of the University of Toronto and colleagues identified 7,289 pediatric patients in the Pediatric Oncology Group of Ontario Networked Information System who were diagnosed with cancer at median age of 7 years old, who were treated between 1987 and 2010, and who were cancer survivors for 5 years. Each patient was matched to five cancer-free control subjects who were a median of 24 years old at the 10-year follow-up (36,205 cancer-free individuals). The researchers studied whether pediatric cancer survivors experienced cardiac events, such as heart failure, arrhythmia, pericardial disease, valvular disease, or coronary artery disease. They also evaluated the incidence of diabetes and hypertension in each group.

Of the children who survived cancer, 2.8% (n = 203) experienced at least one cardiac event versus 0.9% of controls (P less than .001). The cancer survivors experienced 3.2 cardiac events per 1,000 person-years (95% confidence interval, 2.8-3.6), compared with the control group in which there was a rate of 0.9 cardiac events per 1,000 person-years (95% CI, 0.9-1.9).

With regard to cardiovascular disease (CVD) risk, associated factors included cancer relapse or subsequent cancer (hazard ratio, 1.7; 95% CI, 1.1-2.7) and a 250-mg/m² or greater dose of doxorubicin-equivalent anthracycline chemotherapy, compared with a dose of less than 250 mg/m² or no anthracycline chemotherapy (HR, 2.0; 95% CI, 1.4-2.9). Patients who developed diabetes mellitus before a CVD diagnosis were also at higher risk of CVD (HR, 3.0; 95% CI, 1.6-5.8).

Heart failure risk was also statistically significant in patients with relapse and subsequent childhood cancer (HR, 2.0; 95% CI, 1.1-3.7), a 250-mg/m² or greater dose of doxorubicin-equivalent anthracycline chemotherapy (HR, 8.6; 95% CI, 4.5-16.6), diabetes (HR, 4.3; 95% CI, 1.8-10.7), and hypertension (HR, 3.1; 95% CI, 1.3-7.9).

“While anthracycline chemotherapy may induce heart disease, many patients require this cancer treatment to survive,” Paul Nathan, MD, of the Hospital for Sick Children in Canada and a study coauthor said in a statement. “Doctors should address heart disease risk factors – such as diabetes and hypertension – that can be modified.”

This study was funded in part from a grant by the Canadian Institutes for Health Research. Several authors reported support from noncommercial sources. The other authors reported having no relevant conflicts of interest.

SOURCE: Khanna A et al. Circulation. 2019 Aug 26. doi: 10.1161/CIRCULATIONAHA.119.041403.

Pediatric cancer survivors have a higher likelihood of experiencing a cardiac event, developing diabetes, or having hypertension at a median 10-year follow-up, according to results from a recent research letter published in Circulation.

Ashna Khanna of the University of Toronto and colleagues identified 7,289 pediatric patients in the Pediatric Oncology Group of Ontario Networked Information System who were diagnosed with cancer at median age of 7 years old, who were treated between 1987 and 2010, and who were cancer survivors for 5 years. Each patient was matched to five cancer-free control subjects who were a median of 24 years old at the 10-year follow-up (36,205 cancer-free individuals). The researchers studied whether pediatric cancer survivors experienced cardiac events, such as heart failure, arrhythmia, pericardial disease, valvular disease, or coronary artery disease. They also evaluated the incidence of diabetes and hypertension in each group.

Of the children who survived cancer, 2.8% (n = 203) experienced at least one cardiac event versus 0.9% of controls (P less than .001). The cancer survivors experienced 3.2 cardiac events per 1,000 person-years (95% confidence interval, 2.8-3.6), compared with the control group in which there was a rate of 0.9 cardiac events per 1,000 person-years (95% CI, 0.9-1.9).

With regard to cardiovascular disease (CVD) risk, associated factors included cancer relapse or subsequent cancer (hazard ratio, 1.7; 95% CI, 1.1-2.7) and a 250-mg/m² or greater dose of doxorubicin-equivalent anthracycline chemotherapy, compared with a dose of less than 250 mg/m² or no anthracycline chemotherapy (HR, 2.0; 95% CI, 1.4-2.9). Patients who developed diabetes mellitus before a CVD diagnosis were also at higher risk of CVD (HR, 3.0; 95% CI, 1.6-5.8).

Heart failure risk was also statistically significant in patients with relapse and subsequent childhood cancer (HR, 2.0; 95% CI, 1.1-3.7), a 250-mg/m² or greater dose of doxorubicin-equivalent anthracycline chemotherapy (HR, 8.6; 95% CI, 4.5-16.6), diabetes (HR, 4.3; 95% CI, 1.8-10.7), and hypertension (HR, 3.1; 95% CI, 1.3-7.9).

“While anthracycline chemotherapy may induce heart disease, many patients require this cancer treatment to survive,” Paul Nathan, MD, of the Hospital for Sick Children in Canada and a study coauthor said in a statement. “Doctors should address heart disease risk factors – such as diabetes and hypertension – that can be modified.”

This study was funded in part from a grant by the Canadian Institutes for Health Research. Several authors reported support from noncommercial sources. The other authors reported having no relevant conflicts of interest.

SOURCE: Khanna A et al. Circulation. 2019 Aug 26. doi: 10.1161/CIRCULATIONAHA.119.041403.

Pediatric cancer survivors have a higher likelihood of experiencing a cardiac event, developing diabetes, or having hypertension at a median 10-year follow-up, according to results from a recent research letter published in Circulation.

Ashna Khanna of the University of Toronto and colleagues identified 7,289 pediatric patients in the Pediatric Oncology Group of Ontario Networked Information System who were diagnosed with cancer at median age of 7 years old, who were treated between 1987 and 2010, and who were cancer survivors for 5 years. Each patient was matched to five cancer-free control subjects who were a median of 24 years old at the 10-year follow-up (36,205 cancer-free individuals). The researchers studied whether pediatric cancer survivors experienced cardiac events, such as heart failure, arrhythmia, pericardial disease, valvular disease, or coronary artery disease. They also evaluated the incidence of diabetes and hypertension in each group.

Of the children who survived cancer, 2.8% (n = 203) experienced at least one cardiac event versus 0.9% of controls (P less than .001). The cancer survivors experienced 3.2 cardiac events per 1,000 person-years (95% confidence interval, 2.8-3.6), compared with the control group in which there was a rate of 0.9 cardiac events per 1,000 person-years (95% CI, 0.9-1.9).

With regard to cardiovascular disease (CVD) risk, associated factors included cancer relapse or subsequent cancer (hazard ratio, 1.7; 95% CI, 1.1-2.7) and a 250-mg/m² or greater dose of doxorubicin-equivalent anthracycline chemotherapy, compared with a dose of less than 250 mg/m² or no anthracycline chemotherapy (HR, 2.0; 95% CI, 1.4-2.9). Patients who developed diabetes mellitus before a CVD diagnosis were also at higher risk of CVD (HR, 3.0; 95% CI, 1.6-5.8).

Heart failure risk was also statistically significant in patients with relapse and subsequent childhood cancer (HR, 2.0; 95% CI, 1.1-3.7), a 250-mg/m² or greater dose of doxorubicin-equivalent anthracycline chemotherapy (HR, 8.6; 95% CI, 4.5-16.6), diabetes (HR, 4.3; 95% CI, 1.8-10.7), and hypertension (HR, 3.1; 95% CI, 1.3-7.9).

“While anthracycline chemotherapy may induce heart disease, many patients require this cancer treatment to survive,” Paul Nathan, MD, of the Hospital for Sick Children in Canada and a study coauthor said in a statement. “Doctors should address heart disease risk factors – such as diabetes and hypertension – that can be modified.”

This study was funded in part from a grant by the Canadian Institutes for Health Research. Several authors reported support from noncommercial sources. The other authors reported having no relevant conflicts of interest.

SOURCE: Khanna A et al. Circulation. 2019 Aug 26. doi: 10.1161/CIRCULATIONAHA.119.041403.

The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

A predictive model estimates when a pregnant woman with obesity is at increased or decreased risk of failing induction of labor and requiring cesarean section, reported researchers from the University of Cincinnati and Cincinnati Children’s Hospital Medical Center.

abadonian/iStock/Getty Images Plus

The ten variables included in the model were prior vaginal delivery; prior cesarean delivery; maternal height, age, and weight at delivery; parity; gestational weight gain; Medicaid insurance; pregestational diabetes; and chronic hypertension, said Robert M. Rossi, MD, of the university and associates, who developed the model.

“Our hope is that this model may be useful as a tool to estimate an individualized risk based on commonly available prenatal factors that may assist in delivery planning and allocation of appropriate resources,” the investigators said in a study summarizing their findings, published in Obstetrics & Gynecology. 

The researchers conducted a population-based, retrospective cohort study of delivery records from 1,098,981 obese women in a National Center for Health Statistics birth-death cohort database who underwent induction of labor between 2012 and 2016. Of these women, 825,797 (75%) women succeeded in delivering after induction, while 273,184 (25%) women failed to deliver after induction of labor and instead underwent cesarean section. The women included in the study had a body mass index of 30 or higher and underwent induction between 37 weeks and 44 weeks of gestation.

The class of obesity prior to pregnancy impacted the rate of induction failure, as patients with class I obesity had a rate of cesarean section of 21.6% (95% confidence interval, 21.4%-21.7%), while women with class II obesity had a rate of 25% (95% CI, 24.8%-25.2%) and women with class III obesity had a rate of 31% (95% CI, 30.8%-31.3%). Women also were more likely to fail induction if they had received fertility treatment, if they were older than 35 years, if they were of non-Hispanic black race, if they had gestational weight gain or maternal weight gain, if they had pregestational diabetes or gestational diabetes, or if they had gestational hypertension or preeclampsia (all P less than .001). Factors that made a woman less likely to undergo cesarean delivery were Medicaid insurance status or receiving Special Supplemental Nutrition Program for Women, Infant and Children (SNAP WIC) support.

Under the predictive model, the receiver operator characteristic curve (ROC) had an area under the curve (AUC) of 0.79 (95% CI, 0.78-0.79), and subsequent validation of the model using a different external U.S. birth cohort dataset showed an AUC of 0.77 (95% CI, 0.76-0.77). In both datasets, the model was calibrated to predict failure of induction of labor up to 75%, at which point the model overestimated the risk in patients, Dr. Rossi and associates said.

“Although we do not stipulate that an elective cesarean delivery should be offered for ‘high risk’ obese women, this tool may allow the provider to have a heightened awareness and prepare accordingly with timing of delivery, increased staffing, and anesthesia presence, particularly given the higher rates of maternal and neonatal adverse outcomes after a failed induction of labor,” said Dr. Rossi and colleagues.

Martina Louise Badell, MD, commented in an interview, “This is well-designed, large, population-based cohort study of more than 1 million obese women with a singleton pregnancy who underwent induction of labor. To determine the chance of successful induction of labor, a 10-variable model was created. This model achieved an AUC of 0.79, which is fairly good accuracy.

“They created an easy-to-use risk calculator as a tool to help identify chance of successful induction of labor in obese women. Similar to the VBAC [vaginal birth after cesarean] calculator, this calculator may help clinicians with patient-specific counseling, risk stratifying, and delivery planning,” said Dr. Badell, a maternal-fetal medicine specialist who is director of the Emory Perinatal Center at Emory University, Atlanta. Dr. Badell, who was not a coauthor of this study, was asked to comment on the study’s merit.

The authors reported no relevant financial disclosures. Dr. Badell had no relevant financial disclosures. There was no external funding.

SOURCE: Rossi R et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003377.

A predictive model estimates when a pregnant woman with obesity is at increased or decreased risk of failing induction of labor and requiring cesarean section, reported researchers from the University of Cincinnati and Cincinnati Children’s Hospital Medical Center.

abadonian/iStock/Getty Images Plus

The ten variables included in the model were prior vaginal delivery; prior cesarean delivery; maternal height, age, and weight at delivery; parity; gestational weight gain; Medicaid insurance; pregestational diabetes; and chronic hypertension, said Robert M. Rossi, MD, of the university and associates, who developed the model.

“Our hope is that this model may be useful as a tool to estimate an individualized risk based on commonly available prenatal factors that may assist in delivery planning and allocation of appropriate resources,” the investigators said in a study summarizing their findings, published in Obstetrics & Gynecology. 

The researchers conducted a population-based, retrospective cohort study of delivery records from 1,098,981 obese women in a National Center for Health Statistics birth-death cohort database who underwent induction of labor between 2012 and 2016. Of these women, 825,797 (75%) women succeeded in delivering after induction, while 273,184 (25%) women failed to deliver after induction of labor and instead underwent cesarean section. The women included in the study had a body mass index of 30 or higher and underwent induction between 37 weeks and 44 weeks of gestation.

The class of obesity prior to pregnancy impacted the rate of induction failure, as patients with class I obesity had a rate of cesarean section of 21.6% (95% confidence interval, 21.4%-21.7%), while women with class II obesity had a rate of 25% (95% CI, 24.8%-25.2%) and women with class III obesity had a rate of 31% (95% CI, 30.8%-31.3%). Women also were more likely to fail induction if they had received fertility treatment, if they were older than 35 years, if they were of non-Hispanic black race, if they had gestational weight gain or maternal weight gain, if they had pregestational diabetes or gestational diabetes, or if they had gestational hypertension or preeclampsia (all P less than .001). Factors that made a woman less likely to undergo cesarean delivery were Medicaid insurance status or receiving Special Supplemental Nutrition Program for Women, Infant and Children (SNAP WIC) support.

Under the predictive model, the receiver operator characteristic curve (ROC) had an area under the curve (AUC) of 0.79 (95% CI, 0.78-0.79), and subsequent validation of the model using a different external U.S. birth cohort dataset showed an AUC of 0.77 (95% CI, 0.76-0.77). In both datasets, the model was calibrated to predict failure of induction of labor up to 75%, at which point the model overestimated the risk in patients, Dr. Rossi and associates said.

“Although we do not stipulate that an elective cesarean delivery should be offered for ‘high risk’ obese women, this tool may allow the provider to have a heightened awareness and prepare accordingly with timing of delivery, increased staffing, and anesthesia presence, particularly given the higher rates of maternal and neonatal adverse outcomes after a failed induction of labor,” said Dr. Rossi and colleagues.

Martina Louise Badell, MD, commented in an interview, “This is well-designed, large, population-based cohort study of more than 1 million obese women with a singleton pregnancy who underwent induction of labor. To determine the chance of successful induction of labor, a 10-variable model was created. This model achieved an AUC of 0.79, which is fairly good accuracy.

“They created an easy-to-use risk calculator as a tool to help identify chance of successful induction of labor in obese women. Similar to the VBAC [vaginal birth after cesarean] calculator, this calculator may help clinicians with patient-specific counseling, risk stratifying, and delivery planning,” said Dr. Badell, a maternal-fetal medicine specialist who is director of the Emory Perinatal Center at Emory University, Atlanta. Dr. Badell, who was not a coauthor of this study, was asked to comment on the study’s merit.

The authors reported no relevant financial disclosures. Dr. Badell had no relevant financial disclosures. There was no external funding.

SOURCE: Rossi R et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003377.

A predictive model estimates when a pregnant woman with obesity is at increased or decreased risk of failing induction of labor and requiring cesarean section, reported researchers from the University of Cincinnati and Cincinnati Children’s Hospital Medical Center.

abadonian/iStock/Getty Images Plus

The ten variables included in the model were prior vaginal delivery; prior cesarean delivery; maternal height, age, and weight at delivery; parity; gestational weight gain; Medicaid insurance; pregestational diabetes; and chronic hypertension, said Robert M. Rossi, MD, of the university and associates, who developed the model.

“Our hope is that this model may be useful as a tool to estimate an individualized risk based on commonly available prenatal factors that may assist in delivery planning and allocation of appropriate resources,” the investigators said in a study summarizing their findings, published in Obstetrics & Gynecology. 

The researchers conducted a population-based, retrospective cohort study of delivery records from 1,098,981 obese women in a National Center for Health Statistics birth-death cohort database who underwent induction of labor between 2012 and 2016. Of these women, 825,797 (75%) women succeeded in delivering after induction, while 273,184 (25%) women failed to deliver after induction of labor and instead underwent cesarean section. The women included in the study had a body mass index of 30 or higher and underwent induction between 37 weeks and 44 weeks of gestation.

The class of obesity prior to pregnancy impacted the rate of induction failure, as patients with class I obesity had a rate of cesarean section of 21.6% (95% confidence interval, 21.4%-21.7%), while women with class II obesity had a rate of 25% (95% CI, 24.8%-25.2%) and women with class III obesity had a rate of 31% (95% CI, 30.8%-31.3%). Women also were more likely to fail induction if they had received fertility treatment, if they were older than 35 years, if they were of non-Hispanic black race, if they had gestational weight gain or maternal weight gain, if they had pregestational diabetes or gestational diabetes, or if they had gestational hypertension or preeclampsia (all P less than .001). Factors that made a woman less likely to undergo cesarean delivery were Medicaid insurance status or receiving Special Supplemental Nutrition Program for Women, Infant and Children (SNAP WIC) support.

Under the predictive model, the receiver operator characteristic curve (ROC) had an area under the curve (AUC) of 0.79 (95% CI, 0.78-0.79), and subsequent validation of the model using a different external U.S. birth cohort dataset showed an AUC of 0.77 (95% CI, 0.76-0.77). In both datasets, the model was calibrated to predict failure of induction of labor up to 75%, at which point the model overestimated the risk in patients, Dr. Rossi and associates said.

“Although we do not stipulate that an elective cesarean delivery should be offered for ‘high risk’ obese women, this tool may allow the provider to have a heightened awareness and prepare accordingly with timing of delivery, increased staffing, and anesthesia presence, particularly given the higher rates of maternal and neonatal adverse outcomes after a failed induction of labor,” said Dr. Rossi and colleagues.

Martina Louise Badell, MD, commented in an interview, “This is well-designed, large, population-based cohort study of more than 1 million obese women with a singleton pregnancy who underwent induction of labor. To determine the chance of successful induction of labor, a 10-variable model was created. This model achieved an AUC of 0.79, which is fairly good accuracy.

“They created an easy-to-use risk calculator as a tool to help identify chance of successful induction of labor in obese women. Similar to the VBAC [vaginal birth after cesarean] calculator, this calculator may help clinicians with patient-specific counseling, risk stratifying, and delivery planning,” said Dr. Badell, a maternal-fetal medicine specialist who is director of the Emory Perinatal Center at Emory University, Atlanta. Dr. Badell, who was not a coauthor of this study, was asked to comment on the study’s merit.

The authors reported no relevant financial disclosures. Dr. Badell had no relevant financial disclosures. There was no external funding.

SOURCE: Rossi R et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003377.

Veterans with a clinically meaningful reduction in symptoms of PTSD are less likely to develop type 2 diabetes, research from a retrospective study shows.

“We cautiously speculate that normalization of hypothalamic-pituitary-adrenal axis and cortisol levels could be one mechanism behind our results,” wrote Jeffrey F. Scherrer, PhD, and colleagues. “PTSD is associated with inflammation, which may in turn be associated with increased risk for [type 2 diabetes].” The study was published in JAMA Psychiatry.

Using medical record data from the Veterans Health Administration, Dr. Scherrer and colleagues identified 5,916 patients with PTSD who visited a VHA medical center between 2008 and 2012, and scored at least 50 points or higher on the PTSD Checklist (PCL) followed by another PCL score at least 8 months after the previous score. The mean age of patients in the study was 42.1 years, the cohort consisted of 84.3% men, and 66.3% patients were white. PCL score reduction was deemed clinically meaningful if there was a decrease of 20 points or more in the score, reported Dr. Scherrer of the department of family and community medicine at Saint Louis University and colleagues.

Patients who were older (mean 43.6 years vs. mean 41.7 years; P = .02) and those who underwent minimally adequate duration of PTSD psychotherapy (P less than .001) were significantly more likely to have a clinically meaningful decrease in PCL scores. Patients who received antidepressants (P = .004) or antipsychotics (P less than .001) were significantly more likely to have less than clinically meaningful decreases in PCL scores. Factors that put patients at significantly higher risk of developing type 2 diabetes included older age (hazard ratio, 1.05; 95% confidence interval, 1.04-1.07; P less than .001), black race/ethnicity (HR, 1.86; 95% CI, 1.23-2.83; P = .004), hypertension (HR, 3.46; 95% CI, 2.33-5.16), hyperlipidemia (HR, 2.82; 95% CI, 1.91-4.16), and obesity (HR, 3.32; 95% CI, 2.12-5.21) (all P less than .001).

Minimally adequate duration of PTSD psychotherapy and high use of primary care health services also were associated with developing type 2 diabetes.

In a Cox proportional hazards regression model, patients with clinically meaningful decreases in PCL scores had significantly lower risk of developing type 2 diabetes, and those results remained consistent after adjusting for age, calculating the results using weighted data, and factoring in hypertension, obesity, and hyperlipidemia.

“This result was independent of numerous demographics and psychiatric and physical comorbidities,” said Dr. Scherrer and colleagues. “The association was also independent of the number of PTSD psychotherapy sessions used, suggesting that a healthy adherer effect, or a general orientation to improve health, is unlikely to explain our observations.”

Dr. Scherrer and colleagues cited several limitations, such as unmeasured confounding and the difficulty of generalizing the results beyond PTSD patients in a VHA setting. In addition, the researchers were unable to calculate the lifetime effect of reduced PTSD symptoms and incidence of type 2 diabetes.

This study was funded in part by a grant from the National Heart, Lung, and Blood Institute. Four authors reported receiving one or more grants from the National Heart, Lung, and Blood Institute during the study period. Some authors reported receiving other support from Noblis Therapeutics and Saint Louis University both during and outside the study period. The other authors reported no relevant conflicts of interest.

SOURCE: Scherrer JF et al. JAMA Psychiatry. 2019 Aug 21. doi: 10.1001/jamapsychiatry.2019.2096.

Veterans with a clinically meaningful reduction in symptoms of PTSD are less likely to develop type 2 diabetes, research from a retrospective study shows.

“We cautiously speculate that normalization of hypothalamic-pituitary-adrenal axis and cortisol levels could be one mechanism behind our results,” wrote Jeffrey F. Scherrer, PhD, and colleagues. “PTSD is associated with inflammation, which may in turn be associated with increased risk for [type 2 diabetes].” The study was published in JAMA Psychiatry.

Using medical record data from the Veterans Health Administration, Dr. Scherrer and colleagues identified 5,916 patients with PTSD who visited a VHA medical center between 2008 and 2012, and scored at least 50 points or higher on the PTSD Checklist (PCL) followed by another PCL score at least 8 months after the previous score. The mean age of patients in the study was 42.1 years, the cohort consisted of 84.3% men, and 66.3% patients were white. PCL score reduction was deemed clinically meaningful if there was a decrease of 20 points or more in the score, reported Dr. Scherrer of the department of family and community medicine at Saint Louis University and colleagues.

Patients who were older (mean 43.6 years vs. mean 41.7 years; P = .02) and those who underwent minimally adequate duration of PTSD psychotherapy (P less than .001) were significantly more likely to have a clinically meaningful decrease in PCL scores. Patients who received antidepressants (P = .004) or antipsychotics (P less than .001) were significantly more likely to have less than clinically meaningful decreases in PCL scores. Factors that put patients at significantly higher risk of developing type 2 diabetes included older age (hazard ratio, 1.05; 95% confidence interval, 1.04-1.07; P less than .001), black race/ethnicity (HR, 1.86; 95% CI, 1.23-2.83; P = .004), hypertension (HR, 3.46; 95% CI, 2.33-5.16), hyperlipidemia (HR, 2.82; 95% CI, 1.91-4.16), and obesity (HR, 3.32; 95% CI, 2.12-5.21) (all P less than .001).

Minimally adequate duration of PTSD psychotherapy and high use of primary care health services also were associated with developing type 2 diabetes.

In a Cox proportional hazards regression model, patients with clinically meaningful decreases in PCL scores had significantly lower risk of developing type 2 diabetes, and those results remained consistent after adjusting for age, calculating the results using weighted data, and factoring in hypertension, obesity, and hyperlipidemia.

“This result was independent of numerous demographics and psychiatric and physical comorbidities,” said Dr. Scherrer and colleagues. “The association was also independent of the number of PTSD psychotherapy sessions used, suggesting that a healthy adherer effect, or a general orientation to improve health, is unlikely to explain our observations.”

Dr. Scherrer and colleagues cited several limitations, such as unmeasured confounding and the difficulty of generalizing the results beyond PTSD patients in a VHA setting. In addition, the researchers were unable to calculate the lifetime effect of reduced PTSD symptoms and incidence of type 2 diabetes.

This study was funded in part by a grant from the National Heart, Lung, and Blood Institute. Four authors reported receiving one or more grants from the National Heart, Lung, and Blood Institute during the study period. Some authors reported receiving other support from Noblis Therapeutics and Saint Louis University both during and outside the study period. The other authors reported no relevant conflicts of interest.

SOURCE: Scherrer JF et al. JAMA Psychiatry. 2019 Aug 21. doi: 10.1001/jamapsychiatry.2019.2096.

Veterans with a clinically meaningful reduction in symptoms of PTSD are less likely to develop type 2 diabetes, research from a retrospective study shows.

“We cautiously speculate that normalization of hypothalamic-pituitary-adrenal axis and cortisol levels could be one mechanism behind our results,” wrote Jeffrey F. Scherrer, PhD, and colleagues. “PTSD is associated with inflammation, which may in turn be associated with increased risk for [type 2 diabetes].” The study was published in JAMA Psychiatry.

Using medical record data from the Veterans Health Administration, Dr. Scherrer and colleagues identified 5,916 patients with PTSD who visited a VHA medical center between 2008 and 2012, and scored at least 50 points or higher on the PTSD Checklist (PCL) followed by another PCL score at least 8 months after the previous score. The mean age of patients in the study was 42.1 years, the cohort consisted of 84.3% men, and 66.3% patients were white. PCL score reduction was deemed clinically meaningful if there was a decrease of 20 points or more in the score, reported Dr. Scherrer of the department of family and community medicine at Saint Louis University and colleagues.

Patients who were older (mean 43.6 years vs. mean 41.7 years; P = .02) and those who underwent minimally adequate duration of PTSD psychotherapy (P less than .001) were significantly more likely to have a clinically meaningful decrease in PCL scores. Patients who received antidepressants (P = .004) or antipsychotics (P less than .001) were significantly more likely to have less than clinically meaningful decreases in PCL scores. Factors that put patients at significantly higher risk of developing type 2 diabetes included older age (hazard ratio, 1.05; 95% confidence interval, 1.04-1.07; P less than .001), black race/ethnicity (HR, 1.86; 95% CI, 1.23-2.83; P = .004), hypertension (HR, 3.46; 95% CI, 2.33-5.16), hyperlipidemia (HR, 2.82; 95% CI, 1.91-4.16), and obesity (HR, 3.32; 95% CI, 2.12-5.21) (all P less than .001).

Minimally adequate duration of PTSD psychotherapy and high use of primary care health services also were associated with developing type 2 diabetes.

In a Cox proportional hazards regression model, patients with clinically meaningful decreases in PCL scores had significantly lower risk of developing type 2 diabetes, and those results remained consistent after adjusting for age, calculating the results using weighted data, and factoring in hypertension, obesity, and hyperlipidemia.

“This result was independent of numerous demographics and psychiatric and physical comorbidities,” said Dr. Scherrer and colleagues. “The association was also independent of the number of PTSD psychotherapy sessions used, suggesting that a healthy adherer effect, or a general orientation to improve health, is unlikely to explain our observations.”

Dr. Scherrer and colleagues cited several limitations, such as unmeasured confounding and the difficulty of generalizing the results beyond PTSD patients in a VHA setting. In addition, the researchers were unable to calculate the lifetime effect of reduced PTSD symptoms and incidence of type 2 diabetes.

This study was funded in part by a grant from the National Heart, Lung, and Blood Institute. Four authors reported receiving one or more grants from the National Heart, Lung, and Blood Institute during the study period. Some authors reported receiving other support from Noblis Therapeutics and Saint Louis University both during and outside the study period. The other authors reported no relevant conflicts of interest.

SOURCE: Scherrer JF et al. JAMA Psychiatry. 2019 Aug 21. doi: 10.1001/jamapsychiatry.2019.2096.

Maternal exposure to fluoride during pregnancy was associated with lower IQ scores in children at 3 years and 4 years, with boys having a lower mean score than girls, according to a recent prospective, multicenter birth cohort study.

LightFieldStudios/iStock/Getty Images Plus

“These findings were observed at fluoride levels typically found in white North American women,” wrote Rivka Green, York University, Toronto, and colleagues. “This indicates the possible need to reduce fluoride intake during pregnancy.”

This study confirms findings in a 2017 study suggesting a relationship between maternal fluoride levels and children’s later cognitive scores.

Ms. Green and colleagues evaluated 512 mother-child pairs in the Maternal-Infant Research on Environmental Chemicals (MIREC) cohort from six Canadian cities. The children were born between 2008 and 2012, underwent neurodevelopmental testing between 3 and 4 years, and were assessed using the Wechsler Preschool and Primary Scale of Intelligence, Third Edition. Full Scale IQ (FSIQ) test.

Of these, 400 mother-child pairs had data on fluoride intake, IQ, and complete covariate data; 141 of these mothers lived in areas with fluoridated tap water, while 228 mothers lived in areas without fluoridated tap water. Maternal urinary fluoride adjusted for specific gravity (MUF_SG) was averaged across three trimesters of data, and the estimated fluoride level was obtained through self-reported exposure by women included in the study.

The researchers found mothers living in areas with fluoridated water had significantly higher MUF_SG levels (0.69 mg/L), compared with women in areas without fluoridated water (0.40 mg/L; P equals .001). The median estimated fluoride intake was significantly higher among women living in areas with fluoridated water (0.93 mg per day) than in women who did not live in areas with fluoridated water (0.30 mg per day; P less than .001).

Overall, children scored a mean 107.16 (range, 52-143) on the IQ test, and girls had significantly higher mean IQ scores than did boys (109.56 vs. 104.61; P = .001). After adjusting for covariates of maternal age, race, parity, smoking, and alcohol status during pregnancy, child gender, gestational age, and birth weight, the researchers found a significant interaction between MUF_SG and the child’s gender (P = .02), and a 1-mg/L MUF_SG increase was associated with a decrease in 4.49 IQ points in boys (95% confidence interval, −8.38 to −0.60) but not girls. There also was an association between 1-mg higher daily intake of maternal fluoride intake and decreased IQ score in both boys and girls (−3.66; 95% CI, −7.16 to −0.15 ; P = .04).

Ms. Green and her colleagues acknowledged several limitations with the study, such as the short half-life of urinary fluoride and the potential inaccuracy of maternal urinary samples at predicting fetal exposure to fluoride, the self-reported nature of estimated fluoride consumption, lack of availability of maternal IQ data, and not including postnatal exposure and consumption of fluoride.

In a related editorial, David C. Bellinger, PhD, MSc, referred to a previous prospective study in Mexico City by Bashash et al. that found a maternal fluoride level of 0.9 mg/L was associated with a decrease in cognitive scores in children at 4 years and between 6 years and 12 years (Environ Health Perspect. 2017;125(9):097017. doi: 10.1289/EHP655), and noted the effect sizes seen in the Mexico City study were similar to those reported by Green et al. “If the effect sizes reported by Green et al. and others are valid, the total cognitive loss at the population level that might be associated with children’s prenatal exposure to fluoride could be substantial,” he said.

The study raises many questions, including whether there is a concentration where neurotoxicity risk is negligible, if gender plays a role (there was no gender risk difference in Bashash et al.), whether other developmental domains are affected apart from IQ, and if postnatal exposure carries a risk, Dr. Bellinger said. “The findings of Green et al. and others indicate that a dispassionate and tempered discussion of fluoride’s potential neurotoxicity is warranted, including consideration of what additional research is needed to reach more definitive conclusions about the implications, if any, for public health,” he said.

Dimitri A. Christakis, MD, MPH, editor of JAMA Pediatrics and director of the Center for Child Health, Behavior, and Development at Seattle Children’s Research Institute, said in an editor’s note that it was not an easy decision to publish the article because of the potential implications of the findings.

“The mission of the journal is to ensure that child health is optimized by bringing the best available evidence to the fore,” he said. “Publishing it serves as testament to the fact that JAMA Pediatrics is committed to disseminating the best science based entirely on the rigor of the methods and the soundness of the hypotheses tested, regardless of how contentious the results may be.”

However, “scientific inquiry is an iterative process,” Dr. Christakis said, and rarely does a single study provide “definitive evidence.

“We hope that purveyors and consumers of these findings are mindful of that as the implications of this study are debated in the public arena.”

This study was funded in a grant from the National Institute of Environmental Health Science, and the MIREC Study was funded by Chemicals Management Plan at Health Canada, the Ontario Ministry of the Environment, and the Canadian Institutes for Health Research. Dr. Bruce Lanphear reported being an unpaid expert witness for an upcoming case involving the U.S. Environmental Protection Agency and water fluoridation. Dr. Richard Hornung reported receiving personal fees from York University. Dr. E. Angeles Martinez-Mier reported receiving grants from the National Institutes of Health. The other authors report no relevant conflicts of interest. Dr. Bellinger reported no relevant conflicts of interest with regard to his editorial.

SOURCEs: Green R et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1729; Bellinger. JAMA Pediatr. 2019. doi: 10.1001/ jamapediatrics.2019.1728.

Maternal exposure to fluoride during pregnancy was associated with lower IQ scores in children at 3 years and 4 years, with boys having a lower mean score than girls, according to a recent prospective, multicenter birth cohort study.

LightFieldStudios/iStock/Getty Images Plus

“These findings were observed at fluoride levels typically found in white North American women,” wrote Rivka Green, York University, Toronto, and colleagues. “This indicates the possible need to reduce fluoride intake during pregnancy.”

This study confirms findings in a 2017 study suggesting a relationship between maternal fluoride levels and children’s later cognitive scores.

Ms. Green and colleagues evaluated 512 mother-child pairs in the Maternal-Infant Research on Environmental Chemicals (MIREC) cohort from six Canadian cities. The children were born between 2008 and 2012, underwent neurodevelopmental testing between 3 and 4 years, and were assessed using the Wechsler Preschool and Primary Scale of Intelligence, Third Edition. Full Scale IQ (FSIQ) test.

Of these, 400 mother-child pairs had data on fluoride intake, IQ, and complete covariate data; 141 of these mothers lived in areas with fluoridated tap water, while 228 mothers lived in areas without fluoridated tap water. Maternal urinary fluoride adjusted for specific gravity (MUF_SG) was averaged across three trimesters of data, and the estimated fluoride level was obtained through self-reported exposure by women included in the study.

The researchers found mothers living in areas with fluoridated water had significantly higher MUF_SG levels (0.69 mg/L), compared with women in areas without fluoridated water (0.40 mg/L; P equals .001). The median estimated fluoride intake was significantly higher among women living in areas with fluoridated water (0.93 mg per day) than in women who did not live in areas with fluoridated water (0.30 mg per day; P less than .001).

Overall, children scored a mean 107.16 (range, 52-143) on the IQ test, and girls had significantly higher mean IQ scores than did boys (109.56 vs. 104.61; P = .001). After adjusting for covariates of maternal age, race, parity, smoking, and alcohol status during pregnancy, child gender, gestational age, and birth weight, the researchers found a significant interaction between MUF_SG and the child’s gender (P = .02), and a 1-mg/L MUF_SG increase was associated with a decrease in 4.49 IQ points in boys (95% confidence interval, −8.38 to −0.60) but not girls. There also was an association between 1-mg higher daily intake of maternal fluoride intake and decreased IQ score in both boys and girls (−3.66; 95% CI, −7.16 to −0.15 ; P = .04).

Ms. Green and her colleagues acknowledged several limitations with the study, such as the short half-life of urinary fluoride and the potential inaccuracy of maternal urinary samples at predicting fetal exposure to fluoride, the self-reported nature of estimated fluoride consumption, lack of availability of maternal IQ data, and not including postnatal exposure and consumption of fluoride.

In a related editorial, David C. Bellinger, PhD, MSc, referred to a previous prospective study in Mexico City by Bashash et al. that found a maternal fluoride level of 0.9 mg/L was associated with a decrease in cognitive scores in children at 4 years and between 6 years and 12 years (Environ Health Perspect. 2017;125(9):097017. doi: 10.1289/EHP655), and noted the effect sizes seen in the Mexico City study were similar to those reported by Green et al. “If the effect sizes reported by Green et al. and others are valid, the total cognitive loss at the population level that might be associated with children’s prenatal exposure to fluoride could be substantial,” he said.

The study raises many questions, including whether there is a concentration where neurotoxicity risk is negligible, if gender plays a role (there was no gender risk difference in Bashash et al.), whether other developmental domains are affected apart from IQ, and if postnatal exposure carries a risk, Dr. Bellinger said. “The findings of Green et al. and others indicate that a dispassionate and tempered discussion of fluoride’s potential neurotoxicity is warranted, including consideration of what additional research is needed to reach more definitive conclusions about the implications, if any, for public health,” he said.

Dimitri A. Christakis, MD, MPH, editor of JAMA Pediatrics and director of the Center for Child Health, Behavior, and Development at Seattle Children’s Research Institute, said in an editor’s note that it was not an easy decision to publish the article because of the potential implications of the findings.

“The mission of the journal is to ensure that child health is optimized by bringing the best available evidence to the fore,” he said. “Publishing it serves as testament to the fact that JAMA Pediatrics is committed to disseminating the best science based entirely on the rigor of the methods and the soundness of the hypotheses tested, regardless of how contentious the results may be.”

However, “scientific inquiry is an iterative process,” Dr. Christakis said, and rarely does a single study provide “definitive evidence.

“We hope that purveyors and consumers of these findings are mindful of that as the implications of this study are debated in the public arena.”

This study was funded in a grant from the National Institute of Environmental Health Science, and the MIREC Study was funded by Chemicals Management Plan at Health Canada, the Ontario Ministry of the Environment, and the Canadian Institutes for Health Research. Dr. Bruce Lanphear reported being an unpaid expert witness for an upcoming case involving the U.S. Environmental Protection Agency and water fluoridation. Dr. Richard Hornung reported receiving personal fees from York University. Dr. E. Angeles Martinez-Mier reported receiving grants from the National Institutes of Health. The other authors report no relevant conflicts of interest. Dr. Bellinger reported no relevant conflicts of interest with regard to his editorial.

SOURCEs: Green R et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1729; Bellinger. JAMA Pediatr. 2019. doi: 10.1001/ jamapediatrics.2019.1728.

Maternal exposure to fluoride during pregnancy was associated with lower IQ scores in children at 3 years and 4 years, with boys having a lower mean score than girls, according to a recent prospective, multicenter birth cohort study.

LightFieldStudios/iStock/Getty Images Plus

“These findings were observed at fluoride levels typically found in white North American women,” wrote Rivka Green, York University, Toronto, and colleagues. “This indicates the possible need to reduce fluoride intake during pregnancy.”

This study confirms findings in a 2017 study suggesting a relationship between maternal fluoride levels and children’s later cognitive scores.

Ms. Green and colleagues evaluated 512 mother-child pairs in the Maternal-Infant Research on Environmental Chemicals (MIREC) cohort from six Canadian cities. The children were born between 2008 and 2012, underwent neurodevelopmental testing between 3 and 4 years, and were assessed using the Wechsler Preschool and Primary Scale of Intelligence, Third Edition. Full Scale IQ (FSIQ) test.

Of these, 400 mother-child pairs had data on fluoride intake, IQ, and complete covariate data; 141 of these mothers lived in areas with fluoridated tap water, while 228 mothers lived in areas without fluoridated tap water. Maternal urinary fluoride adjusted for specific gravity (MUF_SG) was averaged across three trimesters of data, and the estimated fluoride level was obtained through self-reported exposure by women included in the study.

The researchers found mothers living in areas with fluoridated water had significantly higher MUF_SG levels (0.69 mg/L), compared with women in areas without fluoridated water (0.40 mg/L; P equals .001). The median estimated fluoride intake was significantly higher among women living in areas with fluoridated water (0.93 mg per day) than in women who did not live in areas with fluoridated water (0.30 mg per day; P less than .001).

Overall, children scored a mean 107.16 (range, 52-143) on the IQ test, and girls had significantly higher mean IQ scores than did boys (109.56 vs. 104.61; P = .001). After adjusting for covariates of maternal age, race, parity, smoking, and alcohol status during pregnancy, child gender, gestational age, and birth weight, the researchers found a significant interaction between MUF_SG and the child’s gender (P = .02), and a 1-mg/L MUF_SG increase was associated with a decrease in 4.49 IQ points in boys (95% confidence interval, −8.38 to −0.60) but not girls. There also was an association between 1-mg higher daily intake of maternal fluoride intake and decreased IQ score in both boys and girls (−3.66; 95% CI, −7.16 to −0.15 ; P = .04).

Ms. Green and her colleagues acknowledged several limitations with the study, such as the short half-life of urinary fluoride and the potential inaccuracy of maternal urinary samples at predicting fetal exposure to fluoride, the self-reported nature of estimated fluoride consumption, lack of availability of maternal IQ data, and not including postnatal exposure and consumption of fluoride.

In a related editorial, David C. Bellinger, PhD, MSc, referred to a previous prospective study in Mexico City by Bashash et al. that found a maternal fluoride level of 0.9 mg/L was associated with a decrease in cognitive scores in children at 4 years and between 6 years and 12 years (Environ Health Perspect. 2017;125(9):097017. doi: 10.1289/EHP655), and noted the effect sizes seen in the Mexico City study were similar to those reported by Green et al. “If the effect sizes reported by Green et al. and others are valid, the total cognitive loss at the population level that might be associated with children’s prenatal exposure to fluoride could be substantial,” he said.

The study raises many questions, including whether there is a concentration where neurotoxicity risk is negligible, if gender plays a role (there was no gender risk difference in Bashash et al.), whether other developmental domains are affected apart from IQ, and if postnatal exposure carries a risk, Dr. Bellinger said. “The findings of Green et al. and others indicate that a dispassionate and tempered discussion of fluoride’s potential neurotoxicity is warranted, including consideration of what additional research is needed to reach more definitive conclusions about the implications, if any, for public health,” he said.

Dimitri A. Christakis, MD, MPH, editor of JAMA Pediatrics and director of the Center for Child Health, Behavior, and Development at Seattle Children’s Research Institute, said in an editor’s note that it was not an easy decision to publish the article because of the potential implications of the findings.

“The mission of the journal is to ensure that child health is optimized by bringing the best available evidence to the fore,” he said. “Publishing it serves as testament to the fact that JAMA Pediatrics is committed to disseminating the best science based entirely on the rigor of the methods and the soundness of the hypotheses tested, regardless of how contentious the results may be.”

However, “scientific inquiry is an iterative process,” Dr. Christakis said, and rarely does a single study provide “definitive evidence.

“We hope that purveyors and consumers of these findings are mindful of that as the implications of this study are debated in the public arena.”

This study was funded in a grant from the National Institute of Environmental Health Science, and the MIREC Study was funded by Chemicals Management Plan at Health Canada, the Ontario Ministry of the Environment, and the Canadian Institutes for Health Research. Dr. Bruce Lanphear reported being an unpaid expert witness for an upcoming case involving the U.S. Environmental Protection Agency and water fluoridation. Dr. Richard Hornung reported receiving personal fees from York University. Dr. E. Angeles Martinez-Mier reported receiving grants from the National Institutes of Health. The other authors report no relevant conflicts of interest. Dr. Bellinger reported no relevant conflicts of interest with regard to his editorial.

SOURCEs: Green R et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1729; Bellinger. JAMA Pediatr. 2019. doi: 10.1001/ jamapediatrics.2019.1728.