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Children with increased suicide risk are falling through the cracks
Children in the welfare system who died by suicide were twice as likely to receive mental health services within the 6 months before their death, according to a recent study published in Pediatrics.
“Health care settings that provide more robust mental health screening and suicide risk assessment are needed for youth with child welfare system involvement,” study author Donna Ruch, PhD, a research scientist at the Nationwide Children’s Hospital, said in an interview.
Researchers noted that integrating suicide prevention strategies in primary care and providing access to effective health services for this vulnerable group could be beneficial.
At-risk kids are falling through the cracks
Suicide is the second leading cause of death in children, adolescents, and young adults between the ages of 15 and 24 years old. Children in the welfare system are four times more likely to have attempted suicide; however, research on suicide rates in this population is minimal.
“Kids in the child welfare system are so understudied and yet at such a high risk for suicide,” said Lisa Horowitz, PhD, clinical psychologist at the National Institutes of Health, who was not involved in the study. “A lot of kids pass through the health care system undetected.”
In an attempt to understand and prevent suicide in this group, Dr. Ruch and her team examined health service utilization patterns of children in the welfare system who committed suicide, compared with those in the system who did not die by suicide.
Researchers collected data on 120 deceased youth between the ages of 5 and 21 years old who had an open case in Ohio’s Statewide Automated Child Welfare Information System between 2010 and 2017. For the purpose of the study, open cases were defined as investigated child maltreatment where the family received services or the child was removed from the home.
Researchers matched each child who died by suicide with 10 controls – children in the welfare system who did not commit suicide – based on sex, race, and ethnicity.
The findings revealed that 59.2% of suicide decedents had a diagnosed mental health condition, compared with 31.3% of the control group. Researchers also found that the suicide decedent group was more likely to have multiple mental health diagnoses, with a quarter of them having at least three diagnosed conditions.
Children who died by suicide were also more likely to have a history of self-harm and to have been placed in foster or kinship care.
“Existing research also suggests that known risk factors for youth suicide are more common in youth involved with the child welfare system. This includes mental health conditions, developmental delays, problematic family-related issues, and trauma,” said Dr. Ruch. “All of these factors may be compounded for youth who are removed from their homes.”
Dr. Ruch said it is likely that children who are removed from their homes and placed in foster care may not have consistent access to necessary health services, such as therapy, which may place them at an increased risk for suicidal behavior.
Robust prevention strategies needed
Researchers also found that 90% of children who died by suicide had a health care visit within 6 months of their deaths, compared with 69.4% of controls; 48% of those visits occurred 1 month before they died.
The frequency of health care services used by suicide decedents suggests that prevention strategies for children in the welfare system should be embedded in routine medical and mental health care.
“If we as mental health counselors allow these kids to pass through the health care system, it’s really further neglect,” said Dr. Horowitz, who wrote an accompanying commentary. “And these children already deal with abuse and neglect – we don’t need to further neglect them.”
Dr. Horowitz said health care providers could go over coping strategies and discuss how children deal with hard times and make sure they have access to suicide prevention resources, such as the suicide hotline.
Additionally, better coordination with health care systems and the child welfare system is necessary to make sure there are follow-ups and screenings for suicide and other mental health conditions.
It’s not one size fits all: There may be tailored suicide prevention strategies that work better,” Dr. Horowitz explained.
Dr. Ruch and her team also believe suicide prevention strategies such as the Zero Suicide approach – an initiative that aims to embed suicide prevention health and behavioral health care systems – as well as interventions focused on family preservation to reduce the chance of a child being removed from their home could also benefit children in the welfare system.
Dr. Ruch, the other authors of the study, and Dr. Horowitz disclosed no relevant financial conflicts,
Children in the welfare system who died by suicide were twice as likely to receive mental health services within the 6 months before their death, according to a recent study published in Pediatrics.
“Health care settings that provide more robust mental health screening and suicide risk assessment are needed for youth with child welfare system involvement,” study author Donna Ruch, PhD, a research scientist at the Nationwide Children’s Hospital, said in an interview.
Researchers noted that integrating suicide prevention strategies in primary care and providing access to effective health services for this vulnerable group could be beneficial.
At-risk kids are falling through the cracks
Suicide is the second leading cause of death in children, adolescents, and young adults between the ages of 15 and 24 years old. Children in the welfare system are four times more likely to have attempted suicide; however, research on suicide rates in this population is minimal.
“Kids in the child welfare system are so understudied and yet at such a high risk for suicide,” said Lisa Horowitz, PhD, clinical psychologist at the National Institutes of Health, who was not involved in the study. “A lot of kids pass through the health care system undetected.”
In an attempt to understand and prevent suicide in this group, Dr. Ruch and her team examined health service utilization patterns of children in the welfare system who committed suicide, compared with those in the system who did not die by suicide.
Researchers collected data on 120 deceased youth between the ages of 5 and 21 years old who had an open case in Ohio’s Statewide Automated Child Welfare Information System between 2010 and 2017. For the purpose of the study, open cases were defined as investigated child maltreatment where the family received services or the child was removed from the home.
Researchers matched each child who died by suicide with 10 controls – children in the welfare system who did not commit suicide – based on sex, race, and ethnicity.
The findings revealed that 59.2% of suicide decedents had a diagnosed mental health condition, compared with 31.3% of the control group. Researchers also found that the suicide decedent group was more likely to have multiple mental health diagnoses, with a quarter of them having at least three diagnosed conditions.
Children who died by suicide were also more likely to have a history of self-harm and to have been placed in foster or kinship care.
“Existing research also suggests that known risk factors for youth suicide are more common in youth involved with the child welfare system. This includes mental health conditions, developmental delays, problematic family-related issues, and trauma,” said Dr. Ruch. “All of these factors may be compounded for youth who are removed from their homes.”
Dr. Ruch said it is likely that children who are removed from their homes and placed in foster care may not have consistent access to necessary health services, such as therapy, which may place them at an increased risk for suicidal behavior.
Robust prevention strategies needed
Researchers also found that 90% of children who died by suicide had a health care visit within 6 months of their deaths, compared with 69.4% of controls; 48% of those visits occurred 1 month before they died.
The frequency of health care services used by suicide decedents suggests that prevention strategies for children in the welfare system should be embedded in routine medical and mental health care.
“If we as mental health counselors allow these kids to pass through the health care system, it’s really further neglect,” said Dr. Horowitz, who wrote an accompanying commentary. “And these children already deal with abuse and neglect – we don’t need to further neglect them.”
Dr. Horowitz said health care providers could go over coping strategies and discuss how children deal with hard times and make sure they have access to suicide prevention resources, such as the suicide hotline.
Additionally, better coordination with health care systems and the child welfare system is necessary to make sure there are follow-ups and screenings for suicide and other mental health conditions.
It’s not one size fits all: There may be tailored suicide prevention strategies that work better,” Dr. Horowitz explained.
Dr. Ruch and her team also believe suicide prevention strategies such as the Zero Suicide approach – an initiative that aims to embed suicide prevention health and behavioral health care systems – as well as interventions focused on family preservation to reduce the chance of a child being removed from their home could also benefit children in the welfare system.
Dr. Ruch, the other authors of the study, and Dr. Horowitz disclosed no relevant financial conflicts,
Children in the welfare system who died by suicide were twice as likely to receive mental health services within the 6 months before their death, according to a recent study published in Pediatrics.
“Health care settings that provide more robust mental health screening and suicide risk assessment are needed for youth with child welfare system involvement,” study author Donna Ruch, PhD, a research scientist at the Nationwide Children’s Hospital, said in an interview.
Researchers noted that integrating suicide prevention strategies in primary care and providing access to effective health services for this vulnerable group could be beneficial.
At-risk kids are falling through the cracks
Suicide is the second leading cause of death in children, adolescents, and young adults between the ages of 15 and 24 years old. Children in the welfare system are four times more likely to have attempted suicide; however, research on suicide rates in this population is minimal.
“Kids in the child welfare system are so understudied and yet at such a high risk for suicide,” said Lisa Horowitz, PhD, clinical psychologist at the National Institutes of Health, who was not involved in the study. “A lot of kids pass through the health care system undetected.”
In an attempt to understand and prevent suicide in this group, Dr. Ruch and her team examined health service utilization patterns of children in the welfare system who committed suicide, compared with those in the system who did not die by suicide.
Researchers collected data on 120 deceased youth between the ages of 5 and 21 years old who had an open case in Ohio’s Statewide Automated Child Welfare Information System between 2010 and 2017. For the purpose of the study, open cases were defined as investigated child maltreatment where the family received services or the child was removed from the home.
Researchers matched each child who died by suicide with 10 controls – children in the welfare system who did not commit suicide – based on sex, race, and ethnicity.
The findings revealed that 59.2% of suicide decedents had a diagnosed mental health condition, compared with 31.3% of the control group. Researchers also found that the suicide decedent group was more likely to have multiple mental health diagnoses, with a quarter of them having at least three diagnosed conditions.
Children who died by suicide were also more likely to have a history of self-harm and to have been placed in foster or kinship care.
“Existing research also suggests that known risk factors for youth suicide are more common in youth involved with the child welfare system. This includes mental health conditions, developmental delays, problematic family-related issues, and trauma,” said Dr. Ruch. “All of these factors may be compounded for youth who are removed from their homes.”
Dr. Ruch said it is likely that children who are removed from their homes and placed in foster care may not have consistent access to necessary health services, such as therapy, which may place them at an increased risk for suicidal behavior.
Robust prevention strategies needed
Researchers also found that 90% of children who died by suicide had a health care visit within 6 months of their deaths, compared with 69.4% of controls; 48% of those visits occurred 1 month before they died.
The frequency of health care services used by suicide decedents suggests that prevention strategies for children in the welfare system should be embedded in routine medical and mental health care.
“If we as mental health counselors allow these kids to pass through the health care system, it’s really further neglect,” said Dr. Horowitz, who wrote an accompanying commentary. “And these children already deal with abuse and neglect – we don’t need to further neglect them.”
Dr. Horowitz said health care providers could go over coping strategies and discuss how children deal with hard times and make sure they have access to suicide prevention resources, such as the suicide hotline.
Additionally, better coordination with health care systems and the child welfare system is necessary to make sure there are follow-ups and screenings for suicide and other mental health conditions.
It’s not one size fits all: There may be tailored suicide prevention strategies that work better,” Dr. Horowitz explained.
Dr. Ruch and her team also believe suicide prevention strategies such as the Zero Suicide approach – an initiative that aims to embed suicide prevention health and behavioral health care systems – as well as interventions focused on family preservation to reduce the chance of a child being removed from their home could also benefit children in the welfare system.
Dr. Ruch, the other authors of the study, and Dr. Horowitz disclosed no relevant financial conflicts,
2021 match sets records: Who matched and who didn’t?
A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.
“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.
The report comes amid a year of Zoom interview fatigue, canceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.
Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.
Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
Primary care results strong
Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.
Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
Some specialties filled all positions
PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*
PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*
PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).
The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.
Full data are available on the NRMP’s website.
Correction, 3/22/21: An earlier version of this article misstated the affected specialties.
A version of this article first appeared on Medscape.com.
A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.
“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.
The report comes amid a year of Zoom interview fatigue, canceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.
Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.
Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
Primary care results strong
Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.
Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
Some specialties filled all positions
PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*
PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*
PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).
The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.
Full data are available on the NRMP’s website.
Correction, 3/22/21: An earlier version of this article misstated the affected specialties.
A version of this article first appeared on Medscape.com.
A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.
“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.
The report comes amid a year of Zoom interview fatigue, canceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.
Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.
Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
Primary care results strong
Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.
Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
Some specialties filled all positions
PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*
PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*
PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).
The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.
Full data are available on the NRMP’s website.
Correction, 3/22/21: An earlier version of this article misstated the affected specialties.
A version of this article first appeared on Medscape.com.
Dose-related AFib risk with omega-3 fatty acids?
There may be a dose-related risk for atrial fibrillation (AFib) with omega-3 fatty acid intake, data from four randomized clinical trials suggest.
The latest trial to evaluate the association, the VITAL-RHYTHM study, showed that using a low dose of omega-3 fatty acids or a vitamin D supplement had no significant effect on the risks of developing incident AFib.
The trial, first reported at last year’s American Heart Association meeting, was published online March 16 in the Journal of the American Medical Association.
Together with three other randomized clinical trials, however, these results suggest a possible dose-related effect of omega-3 fatty acids on the risk for AFib, an accompanying “Editor’s Note” suggests.
The note, by JAMA deputy editor Gregory Curfman, MD, points out that in the past 2 years, four randomized clinical trials have provided data on the risk of AFib with omega-3 fatty acid intake.
In the STRENGTH and REDUCE-IT trials, both of which evaluated high doses (4 g/day) of omega-3 fatty acids in patients with heart disease (or at high risk for it), there was a highly statistically significant increase in risk for AFib in the omega-3 groups vs. controls in both trials.
In the OMEMI trial in elderly patients with a recent myocardial infarction, an intermediate dose (1.8 g/day) of omega-3 fatty acids also showed an increase in AFib risk (hazard ratio, 1.84) but this was not significant. And now, the VITAL-RHYTHM trial shows no significant effect of a low dose (840 mg/day) of omega-3 fatty acids on the risk of developing AFib in a primary prevention population.
“Patients who choose to take omega-3 fatty acids, especially in high doses, should be informed of the risk of AF [AFib] and followed up for the possible development of this common and potentially hazardous arrhythmia,” Dr. Curfman concludes.
The authors of the VITAL-RHYTHM trial, led by Christine M. Albert, MD, MPH, Cedars-Sinai Medical Center, Los Angeles, Calif., explain that the trial was conducted after observational studies had shown that individuals with low blood levels of omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and vitamin D3 have higher risks of incident AFib, but data on dietary or supplemental intake of these nutrients on AFib risk were mixed.
“To our knowledge, this study is the first randomized, placebo-controlled trial to prospectively test the effect of any intervention on incident AF and is the only trial to test alternative upstream preventive agents for AF in a large enough population over a long enough time period to provide an assessment of the plausible benefits and risks,” they write.
The VITAL-RHYTHM study was an ancillary trial embedded within the Vitamin D and Omega-3 (VITAL) trial, which used a 2 x 2 factorial design to evaluate daily supplementation with 2,000 IU of vitamin D3 and/or 840 mg of marine omega-3 fatty acids (460 mg EPA and 380 mg DHA), in the primary prevention of cardiovascular disease and cancer in 25,871 men and women age 50 and older in the United States.
Results showed that over a median 5.3 years of treatment and follow-up, the primary endpoint of incident AFib occurred in 3.6% of the study population. For the omega-3 part of the trial, incident AFib events occurred in 3.7% of patients taking EPA/DHA vs. 3.4% of the placebo group, giving a hazard ratio of 1.09, which was not significant (P = .19).
For the vitamin D3 vs. placebo comparison, results were very similar, with incident AFib events occurring in 3.7% vs. 3.4% of participants, respectively, giving a hazard ratio of 1.09, which was again not significant (P = .19). There was no evidence for interaction between the two study agents.
“Overall, these findings do not support the use of supplemental EPA-DHA or vitamin D3 for the primary prevention of AFib and provide reassurance regarding lack of a major risk of AFib incidence associated with these commonly used supplements at these doses,” the authors conclude.
Noting that significant increases in AFib have been seen with much higher doses of omega-3 fatty acids in the REDUCE-IT and STRENGTH trials, they add: “Potentially, the adverse effect on AF risk may be dose related, and the higher dosages of EPA used in these other studies might account for the significant adverse effect on AF.”
The researchers say that, to their knowledge, this is the only randomized trial to assess the effect of vitamin D3 supplementation on AFib risk and results suggest a null effect. They add that subgroup analyses in patients with vitamin D levels considered deficient (<20 ng/mL) did not suggest a benefit; however, the power to detect a benefit in this much smaller subset of the population was limited.
They point out that, while there were no significant differences in incident AFib for either omega-3 fatty acid or vitamin D in the overall study population, an increased risk for incident AFib associated with randomized treatment was observed in selected subgroups.
For omega-3 fatty acids, AFib risk was modestly increased in taller individuals, and for vitamin D3, elevations in AFib risk were observed in younger individuals and participants who drank less alcohol.
“Although the hazard ratios and tests for interaction were significant, the P values associated with these subgroup analyses have not been adjusted for multiple comparisons. Thus, these findings should be interpreted with caution and considered hypothesis generating,” they warn.
The VITAL Rhythm Study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Albert reported receipt of grants from St Jude Medical, Abbott, and Roche Diagnostics. Dr. Curfman reports no relevant disclosures.
A version of this article first appeared on Medscape.com.
There may be a dose-related risk for atrial fibrillation (AFib) with omega-3 fatty acid intake, data from four randomized clinical trials suggest.
The latest trial to evaluate the association, the VITAL-RHYTHM study, showed that using a low dose of omega-3 fatty acids or a vitamin D supplement had no significant effect on the risks of developing incident AFib.
The trial, first reported at last year’s American Heart Association meeting, was published online March 16 in the Journal of the American Medical Association.
Together with three other randomized clinical trials, however, these results suggest a possible dose-related effect of omega-3 fatty acids on the risk for AFib, an accompanying “Editor’s Note” suggests.
The note, by JAMA deputy editor Gregory Curfman, MD, points out that in the past 2 years, four randomized clinical trials have provided data on the risk of AFib with omega-3 fatty acid intake.
In the STRENGTH and REDUCE-IT trials, both of which evaluated high doses (4 g/day) of omega-3 fatty acids in patients with heart disease (or at high risk for it), there was a highly statistically significant increase in risk for AFib in the omega-3 groups vs. controls in both trials.
In the OMEMI trial in elderly patients with a recent myocardial infarction, an intermediate dose (1.8 g/day) of omega-3 fatty acids also showed an increase in AFib risk (hazard ratio, 1.84) but this was not significant. And now, the VITAL-RHYTHM trial shows no significant effect of a low dose (840 mg/day) of omega-3 fatty acids on the risk of developing AFib in a primary prevention population.
“Patients who choose to take omega-3 fatty acids, especially in high doses, should be informed of the risk of AF [AFib] and followed up for the possible development of this common and potentially hazardous arrhythmia,” Dr. Curfman concludes.
The authors of the VITAL-RHYTHM trial, led by Christine M. Albert, MD, MPH, Cedars-Sinai Medical Center, Los Angeles, Calif., explain that the trial was conducted after observational studies had shown that individuals with low blood levels of omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and vitamin D3 have higher risks of incident AFib, but data on dietary or supplemental intake of these nutrients on AFib risk were mixed.
“To our knowledge, this study is the first randomized, placebo-controlled trial to prospectively test the effect of any intervention on incident AF and is the only trial to test alternative upstream preventive agents for AF in a large enough population over a long enough time period to provide an assessment of the plausible benefits and risks,” they write.
The VITAL-RHYTHM study was an ancillary trial embedded within the Vitamin D and Omega-3 (VITAL) trial, which used a 2 x 2 factorial design to evaluate daily supplementation with 2,000 IU of vitamin D3 and/or 840 mg of marine omega-3 fatty acids (460 mg EPA and 380 mg DHA), in the primary prevention of cardiovascular disease and cancer in 25,871 men and women age 50 and older in the United States.
Results showed that over a median 5.3 years of treatment and follow-up, the primary endpoint of incident AFib occurred in 3.6% of the study population. For the omega-3 part of the trial, incident AFib events occurred in 3.7% of patients taking EPA/DHA vs. 3.4% of the placebo group, giving a hazard ratio of 1.09, which was not significant (P = .19).
For the vitamin D3 vs. placebo comparison, results were very similar, with incident AFib events occurring in 3.7% vs. 3.4% of participants, respectively, giving a hazard ratio of 1.09, which was again not significant (P = .19). There was no evidence for interaction between the two study agents.
“Overall, these findings do not support the use of supplemental EPA-DHA or vitamin D3 for the primary prevention of AFib and provide reassurance regarding lack of a major risk of AFib incidence associated with these commonly used supplements at these doses,” the authors conclude.
Noting that significant increases in AFib have been seen with much higher doses of omega-3 fatty acids in the REDUCE-IT and STRENGTH trials, they add: “Potentially, the adverse effect on AF risk may be dose related, and the higher dosages of EPA used in these other studies might account for the significant adverse effect on AF.”
The researchers say that, to their knowledge, this is the only randomized trial to assess the effect of vitamin D3 supplementation on AFib risk and results suggest a null effect. They add that subgroup analyses in patients with vitamin D levels considered deficient (<20 ng/mL) did not suggest a benefit; however, the power to detect a benefit in this much smaller subset of the population was limited.
They point out that, while there were no significant differences in incident AFib for either omega-3 fatty acid or vitamin D in the overall study population, an increased risk for incident AFib associated with randomized treatment was observed in selected subgroups.
For omega-3 fatty acids, AFib risk was modestly increased in taller individuals, and for vitamin D3, elevations in AFib risk were observed in younger individuals and participants who drank less alcohol.
“Although the hazard ratios and tests for interaction were significant, the P values associated with these subgroup analyses have not been adjusted for multiple comparisons. Thus, these findings should be interpreted with caution and considered hypothesis generating,” they warn.
The VITAL Rhythm Study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Albert reported receipt of grants from St Jude Medical, Abbott, and Roche Diagnostics. Dr. Curfman reports no relevant disclosures.
A version of this article first appeared on Medscape.com.
There may be a dose-related risk for atrial fibrillation (AFib) with omega-3 fatty acid intake, data from four randomized clinical trials suggest.
The latest trial to evaluate the association, the VITAL-RHYTHM study, showed that using a low dose of omega-3 fatty acids or a vitamin D supplement had no significant effect on the risks of developing incident AFib.
The trial, first reported at last year’s American Heart Association meeting, was published online March 16 in the Journal of the American Medical Association.
Together with three other randomized clinical trials, however, these results suggest a possible dose-related effect of omega-3 fatty acids on the risk for AFib, an accompanying “Editor’s Note” suggests.
The note, by JAMA deputy editor Gregory Curfman, MD, points out that in the past 2 years, four randomized clinical trials have provided data on the risk of AFib with omega-3 fatty acid intake.
In the STRENGTH and REDUCE-IT trials, both of which evaluated high doses (4 g/day) of omega-3 fatty acids in patients with heart disease (or at high risk for it), there was a highly statistically significant increase in risk for AFib in the omega-3 groups vs. controls in both trials.
In the OMEMI trial in elderly patients with a recent myocardial infarction, an intermediate dose (1.8 g/day) of omega-3 fatty acids also showed an increase in AFib risk (hazard ratio, 1.84) but this was not significant. And now, the VITAL-RHYTHM trial shows no significant effect of a low dose (840 mg/day) of omega-3 fatty acids on the risk of developing AFib in a primary prevention population.
“Patients who choose to take omega-3 fatty acids, especially in high doses, should be informed of the risk of AF [AFib] and followed up for the possible development of this common and potentially hazardous arrhythmia,” Dr. Curfman concludes.
The authors of the VITAL-RHYTHM trial, led by Christine M. Albert, MD, MPH, Cedars-Sinai Medical Center, Los Angeles, Calif., explain that the trial was conducted after observational studies had shown that individuals with low blood levels of omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and vitamin D3 have higher risks of incident AFib, but data on dietary or supplemental intake of these nutrients on AFib risk were mixed.
“To our knowledge, this study is the first randomized, placebo-controlled trial to prospectively test the effect of any intervention on incident AF and is the only trial to test alternative upstream preventive agents for AF in a large enough population over a long enough time period to provide an assessment of the plausible benefits and risks,” they write.
The VITAL-RHYTHM study was an ancillary trial embedded within the Vitamin D and Omega-3 (VITAL) trial, which used a 2 x 2 factorial design to evaluate daily supplementation with 2,000 IU of vitamin D3 and/or 840 mg of marine omega-3 fatty acids (460 mg EPA and 380 mg DHA), in the primary prevention of cardiovascular disease and cancer in 25,871 men and women age 50 and older in the United States.
Results showed that over a median 5.3 years of treatment and follow-up, the primary endpoint of incident AFib occurred in 3.6% of the study population. For the omega-3 part of the trial, incident AFib events occurred in 3.7% of patients taking EPA/DHA vs. 3.4% of the placebo group, giving a hazard ratio of 1.09, which was not significant (P = .19).
For the vitamin D3 vs. placebo comparison, results were very similar, with incident AFib events occurring in 3.7% vs. 3.4% of participants, respectively, giving a hazard ratio of 1.09, which was again not significant (P = .19). There was no evidence for interaction between the two study agents.
“Overall, these findings do not support the use of supplemental EPA-DHA or vitamin D3 for the primary prevention of AFib and provide reassurance regarding lack of a major risk of AFib incidence associated with these commonly used supplements at these doses,” the authors conclude.
Noting that significant increases in AFib have been seen with much higher doses of omega-3 fatty acids in the REDUCE-IT and STRENGTH trials, they add: “Potentially, the adverse effect on AF risk may be dose related, and the higher dosages of EPA used in these other studies might account for the significant adverse effect on AF.”
The researchers say that, to their knowledge, this is the only randomized trial to assess the effect of vitamin D3 supplementation on AFib risk and results suggest a null effect. They add that subgroup analyses in patients with vitamin D levels considered deficient (<20 ng/mL) did not suggest a benefit; however, the power to detect a benefit in this much smaller subset of the population was limited.
They point out that, while there were no significant differences in incident AFib for either omega-3 fatty acid or vitamin D in the overall study population, an increased risk for incident AFib associated with randomized treatment was observed in selected subgroups.
For omega-3 fatty acids, AFib risk was modestly increased in taller individuals, and for vitamin D3, elevations in AFib risk were observed in younger individuals and participants who drank less alcohol.
“Although the hazard ratios and tests for interaction were significant, the P values associated with these subgroup analyses have not been adjusted for multiple comparisons. Thus, these findings should be interpreted with caution and considered hypothesis generating,” they warn.
The VITAL Rhythm Study was supported by a grant from the National Heart, Lung, and Blood Institute. Dr. Albert reported receipt of grants from St Jude Medical, Abbott, and Roche Diagnostics. Dr. Curfman reports no relevant disclosures.
A version of this article first appeared on Medscape.com.
Type of bariatric surgery influences likelihood of migraine remission
Key clinical point: Over half of the patients with migraine who underwent bariatric surgery experienced migraine remission following surgery, with likelihood of remission being higher after Roux-en-Y gastric bypass (RYGB) than after vertical sleeve gastrectomy (VSG).
Major finding: Remission of migraine was observed in 55.4% of patients who underwent surgery. Likelihood of migraine remission was higher with RYGB vs. VSG (adjusted relative rate, 1.11; 95% confidence interval, 1.05-1.17).
Study details: The data come from a retrospective analysis of 1,680 patients with chronic migraine who underwent bariatric surgery (RYGB, n=742; VSG, n=938) between 2010 and 2017.
Disclosures: No source of funding was declared. The authors declared no conflicts of interest.
Source: Nudotor R et al. Obes Surg. 2021 Feb 11. doi: 10.1007/s11695-020-05204-w.
Key clinical point: Over half of the patients with migraine who underwent bariatric surgery experienced migraine remission following surgery, with likelihood of remission being higher after Roux-en-Y gastric bypass (RYGB) than after vertical sleeve gastrectomy (VSG).
Major finding: Remission of migraine was observed in 55.4% of patients who underwent surgery. Likelihood of migraine remission was higher with RYGB vs. VSG (adjusted relative rate, 1.11; 95% confidence interval, 1.05-1.17).
Study details: The data come from a retrospective analysis of 1,680 patients with chronic migraine who underwent bariatric surgery (RYGB, n=742; VSG, n=938) between 2010 and 2017.
Disclosures: No source of funding was declared. The authors declared no conflicts of interest.
Source: Nudotor R et al. Obes Surg. 2021 Feb 11. doi: 10.1007/s11695-020-05204-w.
Key clinical point: Over half of the patients with migraine who underwent bariatric surgery experienced migraine remission following surgery, with likelihood of remission being higher after Roux-en-Y gastric bypass (RYGB) than after vertical sleeve gastrectomy (VSG).
Major finding: Remission of migraine was observed in 55.4% of patients who underwent surgery. Likelihood of migraine remission was higher with RYGB vs. VSG (adjusted relative rate, 1.11; 95% confidence interval, 1.05-1.17).
Study details: The data come from a retrospective analysis of 1,680 patients with chronic migraine who underwent bariatric surgery (RYGB, n=742; VSG, n=938) between 2010 and 2017.
Disclosures: No source of funding was declared. The authors declared no conflicts of interest.
Source: Nudotor R et al. Obes Surg. 2021 Feb 11. doi: 10.1007/s11695-020-05204-w.
Real-world efficacy of candesartan as a preventive migraine treatment
Key clinical point: In real-world settings, candesartan showed benefit as a preventive treatment for migraine with a 50% responder rate, similar to that observed in previous trials.
Major finding: Candesartan significantly reduced the number of headache days per month compared with baseline at weeks 8-12 (−4.3 days) and 20-24 (−4.7 days; both P less than .001). By weeks 8-12 and 20-24, 50% response was observed in 32.5% and 31.7% of patients, respectively. Common adverse events were light-headedness (5.0%), hypotension (4.2%), sleepiness (0.8%), and asthenia (0.8%).
Study details: The data come from a retrospective cohort study of 120 patients with chronic or episodic migraine who received candesartan between April 2008 and February 2019.
Disclosures: The study was a dissertation project supported by Junta de Castilla y León (Spain) and the European Social Fund. The authors declared no conflicts of interest.
Source: Sánchez-Rodríguez C et al. Sci Rep. 2021 Feb 15. doi: 10.1038/s41598-021-83508-2.
Key clinical point: In real-world settings, candesartan showed benefit as a preventive treatment for migraine with a 50% responder rate, similar to that observed in previous trials.
Major finding: Candesartan significantly reduced the number of headache days per month compared with baseline at weeks 8-12 (−4.3 days) and 20-24 (−4.7 days; both P less than .001). By weeks 8-12 and 20-24, 50% response was observed in 32.5% and 31.7% of patients, respectively. Common adverse events were light-headedness (5.0%), hypotension (4.2%), sleepiness (0.8%), and asthenia (0.8%).
Study details: The data come from a retrospective cohort study of 120 patients with chronic or episodic migraine who received candesartan between April 2008 and February 2019.
Disclosures: The study was a dissertation project supported by Junta de Castilla y León (Spain) and the European Social Fund. The authors declared no conflicts of interest.
Source: Sánchez-Rodríguez C et al. Sci Rep. 2021 Feb 15. doi: 10.1038/s41598-021-83508-2.
Key clinical point: In real-world settings, candesartan showed benefit as a preventive treatment for migraine with a 50% responder rate, similar to that observed in previous trials.
Major finding: Candesartan significantly reduced the number of headache days per month compared with baseline at weeks 8-12 (−4.3 days) and 20-24 (−4.7 days; both P less than .001). By weeks 8-12 and 20-24, 50% response was observed in 32.5% and 31.7% of patients, respectively. Common adverse events were light-headedness (5.0%), hypotension (4.2%), sleepiness (0.8%), and asthenia (0.8%).
Study details: The data come from a retrospective cohort study of 120 patients with chronic or episodic migraine who received candesartan between April 2008 and February 2019.
Disclosures: The study was a dissertation project supported by Junta de Castilla y León (Spain) and the European Social Fund. The authors declared no conflicts of interest.
Source: Sánchez-Rodríguez C et al. Sci Rep. 2021 Feb 15. doi: 10.1038/s41598-021-83508-2.
GVHD prophylaxis: Similar outcomes with PTCy and ATG
A newer regimen was no more effective than an older regimen when both were compared for graft versus host disease (GVHD) prophylaxis in patients who underwent reduced-intensity conditioning followed by a hematopoietic stem cell transplant (HSCT) from a 10/10 HLA-matched related or unrelated donor.
These results come from a multicenter randomized trial that compared posttransplant cyclophosphamide (PTCy) to antithymocyte globulin (ATG), which has been used for decades.
There were no significant differences between the two in either disease-free or overall survival, GVHD-free relapse-free survival (GRFS), or nonrelapse mortality, reported lead investigator Eolia Brissot, MD, of Hôpital Saint-Antoine, Sorbonne University, Paris.
Her presentation was judged ‘top abstract’ at the annual meeting of the European Society for Blood and Marrow Transplantation (EBMT), held virtually because of the pandemic.
ATG has been used for more than 30 years for GVHD prophylaxis in allogeneic HSCT. In contrast, PTCy is the new kid on the block, developed to facilitate haploidentical transplants using unmanipulated bone marrow cells to act as a method for selective allodepletion in vivo.
“PTCy [has proved] to be effective in preventing both acute and chronic GVHD,” Dr. Brissot said. “However, controversial outcome data remain when comparing PTCy and ATG according to the type of donors.”
Until now, she noted, there have been no prospective randomized data available for patients with donors (related or unrelated) that have 10 of 10 matched human leukocyte antigen (HLA) alleles. Hence, these were the patients studied in this latest trial, and in this population both regimens showed similar outcomes.
A bone marrow transplant specialist who was not involved in the study said that it’s a good first step.
“This is an important study to gain preliminary data to design a larger, subsequent phase 3 study,” said Zachariah DeFilipp, MD, of Mass General Cancer Center in Boston.
“The use of ATG as part of GVHD prophylaxis is common at many centers, especially in Europe, “ he explained. “The use of posttransplant cyclophosphamide is being expanded to more settings with transplant, beyond haploidentical transplant.
“Further investigations comparing the use of PTCy to ATG will help determine whether PTCy should be more broadly adopted as a standard-of-care GVHD prophylaxis approach, given currently available regimens,” he said in an interview.
Study details
The randomized phase 2b study (NCT02876679), conducted in centers in 11 cities in France, compared PTCy with ATG in patients with hematologic malignancies for whom a reduced-intensity allogeneic HSCT was indicated. This included patients aged 50 and older, and/or heavily pretreated patients who received an autologous HSCT or more than two prior lines of chemotherapy before allogeneic HSCT, as well as patients with poor performance status due to significant medical comorbidities.
Excluded from the trial were patients with creatinine clearance less than 30 mL/min; bilirubin or liver amino transferases more than three times the upper limit of normal; cardiac ejection fraction less than 40%; or pulmonary impairment with less than 50% lung carbon monoxide diffusing capacity.
Of 90 patients enrolled, 1 experienced a relapse before randomization, and the remaining 89 patients were assigned to either PTCy (experimental arm, 45 patients) or to ATG (control group, 44 patients).
Most patients had good performance status (Eastern Cooperative Oncology Group performance status 0 or 1). Diagnoses included acute myeloid and lymphoblastic leukemia, multiple myeloma, lymphomas, and myelodysplastic syndrome. The median age was 64 years, and the male to female ratio was about 2:1 in both groups.
All patients received “FB2” reduced-intensity conditioning with fludarabine30 mg/m2 per day for 4 days, and intravenous busulfan 130 mg/m2 per day for 2 days.
Patients in the experimental arm received cyclophosphamide 50 mg/kg per day on days 3 and 4 after transplant. Patients in the control group received ATG 2.5 mg/kg per day on days 3 and 2 prior to transplant.
All patients also received cyclosporine A, and those who had unrelated donors also received mycophenolate mofetil. In all, 39% of patients received cells from matched sibling donors, and 61% received cells from matched unrelated donors.
No significant differences seen
At 12 months of follow-up, there was no significant difference between the trial arms in the primary endpoint of GRFS, a composite of grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. The rates of GRFS were 52.2% with PTCy vs. 45% with ATG.
Rates of disease-free survival were 68.5% with PTCy and 67.1% with ATG. The respective 12-month overall survival rates were 78.9% and 80.4%, respectively. The differences were not statistically significant.
The incidence of relapse at 1 year was 22.1% in the ATG group vs. 17.6% in the PTCy group. Respective nonrelapse mortality rates were 10.8% for the ATG group and 14% for the PTCy group. Neither difference was statistically significant.
There were also no significant between-group differences in the incidence at 12-month follow-up of either acute GVHD (34.9% PTCy arm vs. 24.3% ATG arm for grades II-IV combined, and 9.3% PTCy vs. 2.7% ATG for grades III or IV) or chronic GVHD (30.2% ATG vs. 26% PTCy).
The safety analysis showed no significant between-group differences in selected adverse events, including Epstein-Barr viral reactivation, cytomegalovirus reactivation, cardiac adverse events, or hemorrhagic cystitis.
The study was supported by Hospitals of Paris. Dr. Brissot and Dr. DeFilipp have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A newer regimen was no more effective than an older regimen when both were compared for graft versus host disease (GVHD) prophylaxis in patients who underwent reduced-intensity conditioning followed by a hematopoietic stem cell transplant (HSCT) from a 10/10 HLA-matched related or unrelated donor.
These results come from a multicenter randomized trial that compared posttransplant cyclophosphamide (PTCy) to antithymocyte globulin (ATG), which has been used for decades.
There were no significant differences between the two in either disease-free or overall survival, GVHD-free relapse-free survival (GRFS), or nonrelapse mortality, reported lead investigator Eolia Brissot, MD, of Hôpital Saint-Antoine, Sorbonne University, Paris.
Her presentation was judged ‘top abstract’ at the annual meeting of the European Society for Blood and Marrow Transplantation (EBMT), held virtually because of the pandemic.
ATG has been used for more than 30 years for GVHD prophylaxis in allogeneic HSCT. In contrast, PTCy is the new kid on the block, developed to facilitate haploidentical transplants using unmanipulated bone marrow cells to act as a method for selective allodepletion in vivo.
“PTCy [has proved] to be effective in preventing both acute and chronic GVHD,” Dr. Brissot said. “However, controversial outcome data remain when comparing PTCy and ATG according to the type of donors.”
Until now, she noted, there have been no prospective randomized data available for patients with donors (related or unrelated) that have 10 of 10 matched human leukocyte antigen (HLA) alleles. Hence, these were the patients studied in this latest trial, and in this population both regimens showed similar outcomes.
A bone marrow transplant specialist who was not involved in the study said that it’s a good first step.
“This is an important study to gain preliminary data to design a larger, subsequent phase 3 study,” said Zachariah DeFilipp, MD, of Mass General Cancer Center in Boston.
“The use of ATG as part of GVHD prophylaxis is common at many centers, especially in Europe, “ he explained. “The use of posttransplant cyclophosphamide is being expanded to more settings with transplant, beyond haploidentical transplant.
“Further investigations comparing the use of PTCy to ATG will help determine whether PTCy should be more broadly adopted as a standard-of-care GVHD prophylaxis approach, given currently available regimens,” he said in an interview.
Study details
The randomized phase 2b study (NCT02876679), conducted in centers in 11 cities in France, compared PTCy with ATG in patients with hematologic malignancies for whom a reduced-intensity allogeneic HSCT was indicated. This included patients aged 50 and older, and/or heavily pretreated patients who received an autologous HSCT or more than two prior lines of chemotherapy before allogeneic HSCT, as well as patients with poor performance status due to significant medical comorbidities.
Excluded from the trial were patients with creatinine clearance less than 30 mL/min; bilirubin or liver amino transferases more than three times the upper limit of normal; cardiac ejection fraction less than 40%; or pulmonary impairment with less than 50% lung carbon monoxide diffusing capacity.
Of 90 patients enrolled, 1 experienced a relapse before randomization, and the remaining 89 patients were assigned to either PTCy (experimental arm, 45 patients) or to ATG (control group, 44 patients).
Most patients had good performance status (Eastern Cooperative Oncology Group performance status 0 or 1). Diagnoses included acute myeloid and lymphoblastic leukemia, multiple myeloma, lymphomas, and myelodysplastic syndrome. The median age was 64 years, and the male to female ratio was about 2:1 in both groups.
All patients received “FB2” reduced-intensity conditioning with fludarabine30 mg/m2 per day for 4 days, and intravenous busulfan 130 mg/m2 per day for 2 days.
Patients in the experimental arm received cyclophosphamide 50 mg/kg per day on days 3 and 4 after transplant. Patients in the control group received ATG 2.5 mg/kg per day on days 3 and 2 prior to transplant.
All patients also received cyclosporine A, and those who had unrelated donors also received mycophenolate mofetil. In all, 39% of patients received cells from matched sibling donors, and 61% received cells from matched unrelated donors.
No significant differences seen
At 12 months of follow-up, there was no significant difference between the trial arms in the primary endpoint of GRFS, a composite of grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. The rates of GRFS were 52.2% with PTCy vs. 45% with ATG.
Rates of disease-free survival were 68.5% with PTCy and 67.1% with ATG. The respective 12-month overall survival rates were 78.9% and 80.4%, respectively. The differences were not statistically significant.
The incidence of relapse at 1 year was 22.1% in the ATG group vs. 17.6% in the PTCy group. Respective nonrelapse mortality rates were 10.8% for the ATG group and 14% for the PTCy group. Neither difference was statistically significant.
There were also no significant between-group differences in the incidence at 12-month follow-up of either acute GVHD (34.9% PTCy arm vs. 24.3% ATG arm for grades II-IV combined, and 9.3% PTCy vs. 2.7% ATG for grades III or IV) or chronic GVHD (30.2% ATG vs. 26% PTCy).
The safety analysis showed no significant between-group differences in selected adverse events, including Epstein-Barr viral reactivation, cytomegalovirus reactivation, cardiac adverse events, or hemorrhagic cystitis.
The study was supported by Hospitals of Paris. Dr. Brissot and Dr. DeFilipp have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A newer regimen was no more effective than an older regimen when both were compared for graft versus host disease (GVHD) prophylaxis in patients who underwent reduced-intensity conditioning followed by a hematopoietic stem cell transplant (HSCT) from a 10/10 HLA-matched related or unrelated donor.
These results come from a multicenter randomized trial that compared posttransplant cyclophosphamide (PTCy) to antithymocyte globulin (ATG), which has been used for decades.
There were no significant differences between the two in either disease-free or overall survival, GVHD-free relapse-free survival (GRFS), or nonrelapse mortality, reported lead investigator Eolia Brissot, MD, of Hôpital Saint-Antoine, Sorbonne University, Paris.
Her presentation was judged ‘top abstract’ at the annual meeting of the European Society for Blood and Marrow Transplantation (EBMT), held virtually because of the pandemic.
ATG has been used for more than 30 years for GVHD prophylaxis in allogeneic HSCT. In contrast, PTCy is the new kid on the block, developed to facilitate haploidentical transplants using unmanipulated bone marrow cells to act as a method for selective allodepletion in vivo.
“PTCy [has proved] to be effective in preventing both acute and chronic GVHD,” Dr. Brissot said. “However, controversial outcome data remain when comparing PTCy and ATG according to the type of donors.”
Until now, she noted, there have been no prospective randomized data available for patients with donors (related or unrelated) that have 10 of 10 matched human leukocyte antigen (HLA) alleles. Hence, these were the patients studied in this latest trial, and in this population both regimens showed similar outcomes.
A bone marrow transplant specialist who was not involved in the study said that it’s a good first step.
“This is an important study to gain preliminary data to design a larger, subsequent phase 3 study,” said Zachariah DeFilipp, MD, of Mass General Cancer Center in Boston.
“The use of ATG as part of GVHD prophylaxis is common at many centers, especially in Europe, “ he explained. “The use of posttransplant cyclophosphamide is being expanded to more settings with transplant, beyond haploidentical transplant.
“Further investigations comparing the use of PTCy to ATG will help determine whether PTCy should be more broadly adopted as a standard-of-care GVHD prophylaxis approach, given currently available regimens,” he said in an interview.
Study details
The randomized phase 2b study (NCT02876679), conducted in centers in 11 cities in France, compared PTCy with ATG in patients with hematologic malignancies for whom a reduced-intensity allogeneic HSCT was indicated. This included patients aged 50 and older, and/or heavily pretreated patients who received an autologous HSCT or more than two prior lines of chemotherapy before allogeneic HSCT, as well as patients with poor performance status due to significant medical comorbidities.
Excluded from the trial were patients with creatinine clearance less than 30 mL/min; bilirubin or liver amino transferases more than three times the upper limit of normal; cardiac ejection fraction less than 40%; or pulmonary impairment with less than 50% lung carbon monoxide diffusing capacity.
Of 90 patients enrolled, 1 experienced a relapse before randomization, and the remaining 89 patients were assigned to either PTCy (experimental arm, 45 patients) or to ATG (control group, 44 patients).
Most patients had good performance status (Eastern Cooperative Oncology Group performance status 0 or 1). Diagnoses included acute myeloid and lymphoblastic leukemia, multiple myeloma, lymphomas, and myelodysplastic syndrome. The median age was 64 years, and the male to female ratio was about 2:1 in both groups.
All patients received “FB2” reduced-intensity conditioning with fludarabine30 mg/m2 per day for 4 days, and intravenous busulfan 130 mg/m2 per day for 2 days.
Patients in the experimental arm received cyclophosphamide 50 mg/kg per day on days 3 and 4 after transplant. Patients in the control group received ATG 2.5 mg/kg per day on days 3 and 2 prior to transplant.
All patients also received cyclosporine A, and those who had unrelated donors also received mycophenolate mofetil. In all, 39% of patients received cells from matched sibling donors, and 61% received cells from matched unrelated donors.
No significant differences seen
At 12 months of follow-up, there was no significant difference between the trial arms in the primary endpoint of GRFS, a composite of grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. The rates of GRFS were 52.2% with PTCy vs. 45% with ATG.
Rates of disease-free survival were 68.5% with PTCy and 67.1% with ATG. The respective 12-month overall survival rates were 78.9% and 80.4%, respectively. The differences were not statistically significant.
The incidence of relapse at 1 year was 22.1% in the ATG group vs. 17.6% in the PTCy group. Respective nonrelapse mortality rates were 10.8% for the ATG group and 14% for the PTCy group. Neither difference was statistically significant.
There were also no significant between-group differences in the incidence at 12-month follow-up of either acute GVHD (34.9% PTCy arm vs. 24.3% ATG arm for grades II-IV combined, and 9.3% PTCy vs. 2.7% ATG for grades III or IV) or chronic GVHD (30.2% ATG vs. 26% PTCy).
The safety analysis showed no significant between-group differences in selected adverse events, including Epstein-Barr viral reactivation, cytomegalovirus reactivation, cardiac adverse events, or hemorrhagic cystitis.
The study was supported by Hospitals of Paris. Dr. Brissot and Dr. DeFilipp have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Highlights in Atopic Dermatitis From AAAAI 2021
Dr Elaine Siegfried, an expert in pediatric dermatology in St. Louis, Missouri, examines some of the key data and research highlights in atopic dermatitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.
Dr Siegfried starts with two studies on the selective JAK1 inhibitor abrocitinib, in which results in both adults and adolescents confirm the efficacy of the 200 mg dose. However, she cautions that the jury is still out on the long-term safety for this class of drugs.
She then reviews two studies looking at whether individuals with atopic dermatitis who are hospitalized with COVID-19 suffer more severe outcomes than the general population.
Dr Siegfried's final selections focus on food allergy, an important aspect of management in patients with atopic dermatitis.
The first two look at the outcomes of food challenges in shrimp-sensitized children and those with a history suggestive of milk allergy.
The last three studies examine the latest data on an oral immunotherapy peanut allergen powder (Palforzia) approved by the FDA and some of the nonclinical factors that could hamper its uptake.
--
Director, Division of Pediatric Dermatology, Cardinal Glennon Children's Hospital, Saint Louis University Health Sciences Center; Owner, Director, Kids Dermatology, St. Louis, Missouri
Elaine C. Siegfried, MD, has disclosed the following relevant financial relationships:
Contracted research from: AI Therapeutics.
Received consulting fees from: Boehringer Ingelheim; Incyte; Regeneron; Sanofi Genzyme; UCB; AbbVie; Verrica; Leo; Novan; Novartis; Pfizer; Pierre Fabre
Received honoraria from: Regeneron; Sanofi Genzyme; Verrica.
Received fees to SSM/SLU related to sponsoring clinical trials from: Regeneron; Verrica; Pierre Fabre; Janssen; Eli Lilly and Company.
Served on the Data Safety Monitoring Board for: UCB; Leo; Pfizer; Novan.
Received grant funding to support 2020-2022 Peds Derm Fellow from: Pfizer.
Dr Elaine Siegfried, an expert in pediatric dermatology in St. Louis, Missouri, examines some of the key data and research highlights in atopic dermatitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.
Dr Siegfried starts with two studies on the selective JAK1 inhibitor abrocitinib, in which results in both adults and adolescents confirm the efficacy of the 200 mg dose. However, she cautions that the jury is still out on the long-term safety for this class of drugs.
She then reviews two studies looking at whether individuals with atopic dermatitis who are hospitalized with COVID-19 suffer more severe outcomes than the general population.
Dr Siegfried's final selections focus on food allergy, an important aspect of management in patients with atopic dermatitis.
The first two look at the outcomes of food challenges in shrimp-sensitized children and those with a history suggestive of milk allergy.
The last three studies examine the latest data on an oral immunotherapy peanut allergen powder (Palforzia) approved by the FDA and some of the nonclinical factors that could hamper its uptake.
--
Director, Division of Pediatric Dermatology, Cardinal Glennon Children's Hospital, Saint Louis University Health Sciences Center; Owner, Director, Kids Dermatology, St. Louis, Missouri
Elaine C. Siegfried, MD, has disclosed the following relevant financial relationships:
Contracted research from: AI Therapeutics.
Received consulting fees from: Boehringer Ingelheim; Incyte; Regeneron; Sanofi Genzyme; UCB; AbbVie; Verrica; Leo; Novan; Novartis; Pfizer; Pierre Fabre
Received honoraria from: Regeneron; Sanofi Genzyme; Verrica.
Received fees to SSM/SLU related to sponsoring clinical trials from: Regeneron; Verrica; Pierre Fabre; Janssen; Eli Lilly and Company.
Served on the Data Safety Monitoring Board for: UCB; Leo; Pfizer; Novan.
Received grant funding to support 2020-2022 Peds Derm Fellow from: Pfizer.
Dr Elaine Siegfried, an expert in pediatric dermatology in St. Louis, Missouri, examines some of the key data and research highlights in atopic dermatitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.
Dr Siegfried starts with two studies on the selective JAK1 inhibitor abrocitinib, in which results in both adults and adolescents confirm the efficacy of the 200 mg dose. However, she cautions that the jury is still out on the long-term safety for this class of drugs.
She then reviews two studies looking at whether individuals with atopic dermatitis who are hospitalized with COVID-19 suffer more severe outcomes than the general population.
Dr Siegfried's final selections focus on food allergy, an important aspect of management in patients with atopic dermatitis.
The first two look at the outcomes of food challenges in shrimp-sensitized children and those with a history suggestive of milk allergy.
The last three studies examine the latest data on an oral immunotherapy peanut allergen powder (Palforzia) approved by the FDA and some of the nonclinical factors that could hamper its uptake.
--
Director, Division of Pediatric Dermatology, Cardinal Glennon Children's Hospital, Saint Louis University Health Sciences Center; Owner, Director, Kids Dermatology, St. Louis, Missouri
Elaine C. Siegfried, MD, has disclosed the following relevant financial relationships:
Contracted research from: AI Therapeutics.
Received consulting fees from: Boehringer Ingelheim; Incyte; Regeneron; Sanofi Genzyme; UCB; AbbVie; Verrica; Leo; Novan; Novartis; Pfizer; Pierre Fabre
Received honoraria from: Regeneron; Sanofi Genzyme; Verrica.
Received fees to SSM/SLU related to sponsoring clinical trials from: Regeneron; Verrica; Pierre Fabre; Janssen; Eli Lilly and Company.
Served on the Data Safety Monitoring Board for: UCB; Leo; Pfizer; Novan.
Received grant funding to support 2020-2022 Peds Derm Fellow from: Pfizer.
Cardiac rehab after cardiac valve surgery associated with reduced mortality
Background: National guidelines recommend CR after CVS. However, neither enrollment in CR nor its benefits have been well described in this population.
Study design: Observational cohort study.
Setting: Enrolled Medicare beneficiaries residing in the United States in 2014.
Synopsis: There were 41,369 Medicare patients who underwent CVS and met the study requirements; of these, 43.2% enrolled in CR programs. Those who had concomitant coronary artery bypass grafting (CABG) surgery or who resided in the Midwest region of the United States were more likely to enroll in CR. Asian, black, and Hispanic patients were less likely to enroll in CR. Enrollment in CR after CVS was associated with a decreased risk of 1-year hospitalization (hazard ratio, 0.66; 95% confidence interval, 0.63-0.69). CR utilization was also associated with a decrease in 1-year mortality after CVS (HR, 0.39; 95% CI, 0.35-0.44).
Enrollment rates in CR after CVS were lower than that of heart transplant patients, but higher than that for patients with systolic heart failure or after CABG. Major study limitations were the lack of generalizability to younger patients because all patients examined were older than 64 years.
Bottom line: Racial and geographic factors influence the rate of enrollment in CR for patients undergoing CVS. All patients should be encouraged to participate in CR after CVS because it is associated with reduced 1-year mortality and risk of hospitalization.
Citation: Patel DK et. al. Association of cardiac rehabilitation with decreased hospitalization and mortality risk after cardiac valve surgery. JAMA Cardiol. 2019 Oct 23. doi: 10.1001/jamacardio.2019.4032.
Dr. Babbel is a hospitalist and assistant professor of medicine at the University of Utah, Salt Lake City.
Background: National guidelines recommend CR after CVS. However, neither enrollment in CR nor its benefits have been well described in this population.
Study design: Observational cohort study.
Setting: Enrolled Medicare beneficiaries residing in the United States in 2014.
Synopsis: There were 41,369 Medicare patients who underwent CVS and met the study requirements; of these, 43.2% enrolled in CR programs. Those who had concomitant coronary artery bypass grafting (CABG) surgery or who resided in the Midwest region of the United States were more likely to enroll in CR. Asian, black, and Hispanic patients were less likely to enroll in CR. Enrollment in CR after CVS was associated with a decreased risk of 1-year hospitalization (hazard ratio, 0.66; 95% confidence interval, 0.63-0.69). CR utilization was also associated with a decrease in 1-year mortality after CVS (HR, 0.39; 95% CI, 0.35-0.44).
Enrollment rates in CR after CVS were lower than that of heart transplant patients, but higher than that for patients with systolic heart failure or after CABG. Major study limitations were the lack of generalizability to younger patients because all patients examined were older than 64 years.
Bottom line: Racial and geographic factors influence the rate of enrollment in CR for patients undergoing CVS. All patients should be encouraged to participate in CR after CVS because it is associated with reduced 1-year mortality and risk of hospitalization.
Citation: Patel DK et. al. Association of cardiac rehabilitation with decreased hospitalization and mortality risk after cardiac valve surgery. JAMA Cardiol. 2019 Oct 23. doi: 10.1001/jamacardio.2019.4032.
Dr. Babbel is a hospitalist and assistant professor of medicine at the University of Utah, Salt Lake City.
Background: National guidelines recommend CR after CVS. However, neither enrollment in CR nor its benefits have been well described in this population.
Study design: Observational cohort study.
Setting: Enrolled Medicare beneficiaries residing in the United States in 2014.
Synopsis: There were 41,369 Medicare patients who underwent CVS and met the study requirements; of these, 43.2% enrolled in CR programs. Those who had concomitant coronary artery bypass grafting (CABG) surgery or who resided in the Midwest region of the United States were more likely to enroll in CR. Asian, black, and Hispanic patients were less likely to enroll in CR. Enrollment in CR after CVS was associated with a decreased risk of 1-year hospitalization (hazard ratio, 0.66; 95% confidence interval, 0.63-0.69). CR utilization was also associated with a decrease in 1-year mortality after CVS (HR, 0.39; 95% CI, 0.35-0.44).
Enrollment rates in CR after CVS were lower than that of heart transplant patients, but higher than that for patients with systolic heart failure or after CABG. Major study limitations were the lack of generalizability to younger patients because all patients examined were older than 64 years.
Bottom line: Racial and geographic factors influence the rate of enrollment in CR for patients undergoing CVS. All patients should be encouraged to participate in CR after CVS because it is associated with reduced 1-year mortality and risk of hospitalization.
Citation: Patel DK et. al. Association of cardiac rehabilitation with decreased hospitalization and mortality risk after cardiac valve surgery. JAMA Cardiol. 2019 Oct 23. doi: 10.1001/jamacardio.2019.4032.
Dr. Babbel is a hospitalist and assistant professor of medicine at the University of Utah, Salt Lake City.
Adherence to antireflux lifestyle factors shows benefit in women
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.
Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.
“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.
To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.
The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.
For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.
Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).
Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).
Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).
One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.
“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.
Lifestyle matters
According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”
Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.
“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”
Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”
The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.
FROM JAMA INTERNAL MEDICINE
High obesity rates in Southern states magnify COVID threats
In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.
Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.
As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.
At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.
“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”
The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.
In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.
The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.
Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.
“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.
And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”
Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.
Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.
“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.
Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.
In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.
Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.
The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.
Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.
Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.
They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.
Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.
There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.
Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.
“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.
Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.
“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.
Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.
As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.
At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.
“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”
The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.
In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.
The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.
Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.
“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.
And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”
Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.
Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.
“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.
Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.
In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.
Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.
The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.
Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.
Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.
They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.
Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.
There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.
Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.
“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.
Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.
“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.
Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.
As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.
At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.
“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”
The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.
In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.
The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.
Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.
“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.
And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”
Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.
Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.
“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.
Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.
In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.
Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.
The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.
Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.
Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.
They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.
Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.
There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.
Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.
“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.
Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.
“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.