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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Cardiovascular risk varies between black ethnic subgroups
PHOENIX, ARIZ. – Cardiovascular disease risk factors differ significantly between three black ethnic subgroups in the United States, compared with whites, results from a large, long-term cross-sectional study show.
“Race alone does not account for health disparities in CVD risk factors,” lead author Diana Baptiste, DNP, RN, CNE, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “We must consider the environmental, psychosocial, and social factors that may play a larger role in CVD risk among these populations.”
Dr. Baptiste, of the Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care in Baltimore, noted that blacks bear a disproportionately greater burden of CVD than that of any other racial group. “Blacks living in the U.S. are not monolithic and include different ethnic subgroups: African Americans, Afro-Caribbeans, defined as black persons who are born in the Caribbean islands, and African immigrants, defined as black persons who are born in Africa,” she said. “It is unclear how Afro-Caribbeans and African immigrants compare to African Americans and whites with regard to CVD risk factors.”
To examine trends in CVD risk factors among the three black ethnic subgroups compared with whites, she and her colleagues performed a cross-sectional analysis of 452,997 adults who participated in the 2010-2018 National Health Interview Survey (NHIS). Of these, 82% were white and 18% were black. Among blacks, 89% were African Americans, 6% were Afro-Caribbeans, and 5% were African immigrants. Outcomes of interest were four self-reported CVD risk factors: hypertension, diabetes, overweight/obesity, and smoking. The researchers used generalized linear models with Poisson distribution to calculate predictive probabilities of CVD risk factors, adjusted for age and sex.
Dr. Baptiste reported that African immigrants represented the youngest subgroup, with an average age of 41 years, compared with an average age of 50 among whites. They were also less likely to have health insurance (76%), compared with Afro-Caribbeans (81%), African Americans (83%), and whites (91%; P < .001). Disparities were observed in the proportion of individuals living below the poverty level. This was led by African Americans (24%), followed by African immigrants (22%), Afro-Caribbeans (18%), and whites (9%).
African immigrants were most likely to be college educated (36%), compared with whites (32%), Afro-Caribbeans (23%), and African Americans (17%; P =.001). In addition, only 33% of African Americans were married, compared with more than 50% of participants in the other ethnic groups.
African Americans had the highest prevalence of hypertension over the time period (from 44% in 2010 to 42% in 2018), while African immigrants had the lowest (from 19% to 17%). African Americans also had the highest prevalence of diabetes over the time period (from 14% to 15%), while African immigrants had the lowest (from 9% to 7%). The prevalence of overweight and obesity was highest among African Americans (from 74% to 76%), while African immigrants had the lowest (63% to 60%). Finally, smoking prevalence was highest in whites and African Americans compared with African immigrants and Afro-Caribbeans, but the prevalence decreased significantly between 2010 and 2018 (P for trend < .001).
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, said that the study’s findings underscore the importance of heterogeneity when counseling patients about CVD risk factors. “Everybody comes from a different cultural background,” said Dr. Brown, a cardiologist and physician scientist at Mayo Clinic, Rochester, Minn. “Cultural backgrounds have an impact on when people eat, how they eat, who they eat with, when they exercise, and whether obesity is valued or not. It’s important to recognize that those cultural underpinnings can contribute to heterogeneity. Other factors – whether they are psychosocial or socioeconomic or environmental – also contribute.”
Strengths of the study, Dr. Baptiste said, included the use of a large, nationally representative dataset. Limitations included its cross-sectional design and the National Health Interview Survey’s reliance on self-reported data. “There were also small sample sizes for African immigrants and Afro-Caribbeans,” she said.
The study was supported by Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care. Dr. Baptiste reported having no financial disclosures.
The meeting was sponsored by the American Heart Association.
SOURCE: Baptiste D et al. EPI/Lifestyle 2020, Session 4, Abstract 8.
PHOENIX, ARIZ. – Cardiovascular disease risk factors differ significantly between three black ethnic subgroups in the United States, compared with whites, results from a large, long-term cross-sectional study show.
“Race alone does not account for health disparities in CVD risk factors,” lead author Diana Baptiste, DNP, RN, CNE, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “We must consider the environmental, psychosocial, and social factors that may play a larger role in CVD risk among these populations.”
Dr. Baptiste, of the Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care in Baltimore, noted that blacks bear a disproportionately greater burden of CVD than that of any other racial group. “Blacks living in the U.S. are not monolithic and include different ethnic subgroups: African Americans, Afro-Caribbeans, defined as black persons who are born in the Caribbean islands, and African immigrants, defined as black persons who are born in Africa,” she said. “It is unclear how Afro-Caribbeans and African immigrants compare to African Americans and whites with regard to CVD risk factors.”
To examine trends in CVD risk factors among the three black ethnic subgroups compared with whites, she and her colleagues performed a cross-sectional analysis of 452,997 adults who participated in the 2010-2018 National Health Interview Survey (NHIS). Of these, 82% were white and 18% were black. Among blacks, 89% were African Americans, 6% were Afro-Caribbeans, and 5% were African immigrants. Outcomes of interest were four self-reported CVD risk factors: hypertension, diabetes, overweight/obesity, and smoking. The researchers used generalized linear models with Poisson distribution to calculate predictive probabilities of CVD risk factors, adjusted for age and sex.
Dr. Baptiste reported that African immigrants represented the youngest subgroup, with an average age of 41 years, compared with an average age of 50 among whites. They were also less likely to have health insurance (76%), compared with Afro-Caribbeans (81%), African Americans (83%), and whites (91%; P < .001). Disparities were observed in the proportion of individuals living below the poverty level. This was led by African Americans (24%), followed by African immigrants (22%), Afro-Caribbeans (18%), and whites (9%).
African immigrants were most likely to be college educated (36%), compared with whites (32%), Afro-Caribbeans (23%), and African Americans (17%; P =.001). In addition, only 33% of African Americans were married, compared with more than 50% of participants in the other ethnic groups.
African Americans had the highest prevalence of hypertension over the time period (from 44% in 2010 to 42% in 2018), while African immigrants had the lowest (from 19% to 17%). African Americans also had the highest prevalence of diabetes over the time period (from 14% to 15%), while African immigrants had the lowest (from 9% to 7%). The prevalence of overweight and obesity was highest among African Americans (from 74% to 76%), while African immigrants had the lowest (63% to 60%). Finally, smoking prevalence was highest in whites and African Americans compared with African immigrants and Afro-Caribbeans, but the prevalence decreased significantly between 2010 and 2018 (P for trend < .001).
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, said that the study’s findings underscore the importance of heterogeneity when counseling patients about CVD risk factors. “Everybody comes from a different cultural background,” said Dr. Brown, a cardiologist and physician scientist at Mayo Clinic, Rochester, Minn. “Cultural backgrounds have an impact on when people eat, how they eat, who they eat with, when they exercise, and whether obesity is valued or not. It’s important to recognize that those cultural underpinnings can contribute to heterogeneity. Other factors – whether they are psychosocial or socioeconomic or environmental – also contribute.”
Strengths of the study, Dr. Baptiste said, included the use of a large, nationally representative dataset. Limitations included its cross-sectional design and the National Health Interview Survey’s reliance on self-reported data. “There were also small sample sizes for African immigrants and Afro-Caribbeans,” she said.
The study was supported by Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care. Dr. Baptiste reported having no financial disclosures.
The meeting was sponsored by the American Heart Association.
SOURCE: Baptiste D et al. EPI/Lifestyle 2020, Session 4, Abstract 8.
PHOENIX, ARIZ. – Cardiovascular disease risk factors differ significantly between three black ethnic subgroups in the United States, compared with whites, results from a large, long-term cross-sectional study show.
“Race alone does not account for health disparities in CVD risk factors,” lead author Diana Baptiste, DNP, RN, CNE, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “We must consider the environmental, psychosocial, and social factors that may play a larger role in CVD risk among these populations.”
Dr. Baptiste, of the Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care in Baltimore, noted that blacks bear a disproportionately greater burden of CVD than that of any other racial group. “Blacks living in the U.S. are not monolithic and include different ethnic subgroups: African Americans, Afro-Caribbeans, defined as black persons who are born in the Caribbean islands, and African immigrants, defined as black persons who are born in Africa,” she said. “It is unclear how Afro-Caribbeans and African immigrants compare to African Americans and whites with regard to CVD risk factors.”
To examine trends in CVD risk factors among the three black ethnic subgroups compared with whites, she and her colleagues performed a cross-sectional analysis of 452,997 adults who participated in the 2010-2018 National Health Interview Survey (NHIS). Of these, 82% were white and 18% were black. Among blacks, 89% were African Americans, 6% were Afro-Caribbeans, and 5% were African immigrants. Outcomes of interest were four self-reported CVD risk factors: hypertension, diabetes, overweight/obesity, and smoking. The researchers used generalized linear models with Poisson distribution to calculate predictive probabilities of CVD risk factors, adjusted for age and sex.
Dr. Baptiste reported that African immigrants represented the youngest subgroup, with an average age of 41 years, compared with an average age of 50 among whites. They were also less likely to have health insurance (76%), compared with Afro-Caribbeans (81%), African Americans (83%), and whites (91%; P < .001). Disparities were observed in the proportion of individuals living below the poverty level. This was led by African Americans (24%), followed by African immigrants (22%), Afro-Caribbeans (18%), and whites (9%).
African immigrants were most likely to be college educated (36%), compared with whites (32%), Afro-Caribbeans (23%), and African Americans (17%; P =.001). In addition, only 33% of African Americans were married, compared with more than 50% of participants in the other ethnic groups.
African Americans had the highest prevalence of hypertension over the time period (from 44% in 2010 to 42% in 2018), while African immigrants had the lowest (from 19% to 17%). African Americans also had the highest prevalence of diabetes over the time period (from 14% to 15%), while African immigrants had the lowest (from 9% to 7%). The prevalence of overweight and obesity was highest among African Americans (from 74% to 76%), while African immigrants had the lowest (63% to 60%). Finally, smoking prevalence was highest in whites and African Americans compared with African immigrants and Afro-Caribbeans, but the prevalence decreased significantly between 2010 and 2018 (P for trend < .001).
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, said that the study’s findings underscore the importance of heterogeneity when counseling patients about CVD risk factors. “Everybody comes from a different cultural background,” said Dr. Brown, a cardiologist and physician scientist at Mayo Clinic, Rochester, Minn. “Cultural backgrounds have an impact on when people eat, how they eat, who they eat with, when they exercise, and whether obesity is valued or not. It’s important to recognize that those cultural underpinnings can contribute to heterogeneity. Other factors – whether they are psychosocial or socioeconomic or environmental – also contribute.”
Strengths of the study, Dr. Baptiste said, included the use of a large, nationally representative dataset. Limitations included its cross-sectional design and the National Health Interview Survey’s reliance on self-reported data. “There were also small sample sizes for African immigrants and Afro-Caribbeans,” she said.
The study was supported by Johns Hopkins University School of Nursing Center for Cardiovascular and Chronic Care. Dr. Baptiste reported having no financial disclosures.
The meeting was sponsored by the American Heart Association.
SOURCE: Baptiste D et al. EPI/Lifestyle 2020, Session 4, Abstract 8.
REPORTING FROM EPI/LIFESTYLE 2020
African Americans with SLE face increased risk of CVD hospitalizations
PHOENIX – African Americans with systemic lupus erythematosus are more likely to experience recurrent hospitalizations for cardiovascular disease, compared with other racial/ethnic groups, results from a single-state registry study found.
“SLE is an autoimmune disease that causes inflammation affecting multiple organ systems including the cardiovascular system,” Meghan Angley, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “Therefore, individuals with SLE are at risk for early CVD. African Americans represent the racial group at greatest risk for SLE.”
According to Ms. Angley, with the department of epidemiology at Emory University, Atlanta, white women with SLE have CVD associated mortality 12 years earlier than their non-SLE counterparts, while African American women with SLE have CVD-associated mortality 19 years earlier than their non-SLE counterparts. “We know that recurrent hospitalizations for CVD are associated with mortality,” she said. “These represent potential points of identification of high-risk individuals and also points of interventions.”
In order to study racial disparities across recurrent hospitalizations for cardiovascular disease in an SLE population, Ms. Angley and her colleagues drew from the Georgia Lupus Registry, which is a population-based registry of patients with validated SLE in two Georgia counties. They included all cases diagnosed between 2000 and 2004. The registry was linked to records of all inpatient hospitalizations in Georgia between 2000 and 2013. The researchers used ICD-9 codes to identify hospitalizations for coronary heart disease, peripheral artery disease, cerebrovascular disease, and heart failure and used the Prentice-Williams-Peterson model for recurrent time-to-event analysis. Specifically, they looked at the total time scale from the point of diagnosis to each of the subsequent CVD hospitalizations and truncated the number of hospitalizations at three to maintain stable modeling estimates. The analysis was censored at the time of patient death or at the end of 2013 and adjusted for sex and age at diagnosis.
The sample included 417 African Americans with SLE and 149 non–African Americans with the disease. Most (86%) were female, and the non–African American group was slightly more likely to have been diagnosed with SLE after the age of 45 years, compared with the African American group (36% vs. 30%, respectively).
Ms. Angley and her colleagues found that 24% of African Americans had at least one CVD hospitalization, and 14% had at least two, while 13% of non–African Americans had at least one CVD hospitalization, and 5% had at least two. Among those in the African American group, reasons for hospitalizations were congestive heart failure, (58%), cerebrovascular disease (27%), coronary heart disease (18%), and peripheral artery disease (2%). Among those in the non–African American group, reasons for hospitalizations were congestive heart failure (38%), coronary heart disease (38%), cerebrovascular disease (25%), and peripheral artery disease (6%).
Overall, African American race was associated with recurrent hospitalizations (adjusted hazard ratio, 1.9). In an event-specific stratified analysis, the association between African American race and the hazard of recurrence became even more pronounced with each event (hospitalization 1 aHR, 1.2; hospitalization 2 aHR, 1.5; hospitalization 3 aHR, 1.9). The researchers also observed that African Americans were hospitalized sooner, compared with non–African Americans: a median of 3.68 versus 4.61 years for hospitalization 1, 3.73 years versus 5.98 years for hospitalization 2, and 4.84 years versus 8.14 years for hospitalization 3.
“African Americans with SLE are more likely to experience recurrent hospitalizations for CVD,” Ms. Angley concluded at the meeting, which was sponsored by the American Heart Association. “The events occur sooner after diagnosis than in non–African Americans, suggesting that African Americans may be more vulnerable to the cardiovascular complications of SLE. Our next steps include examining potential reasons for these disparities, such as looking at primary care patterns over time, SLE severity over time, and treatment at CVD hospitalizations.”
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, called for additional research to determine the reasons for disparities that were observed between African Americans with SLE and their non–African American counterparts. “We need to figure out why and address it,” said Dr. Brown, who is a cardiologist and physician-scientist at Mayo Clinic, Rochester, Minn. “We recognize that social determinants of health, such as insurance, socioeconomic factors, and psychosocial factors, can contribute. We need to figure out the additional steps we need to take in order to close that gap.”
Ms. Angley reported having no disclosures. The study was funded by grants from the Centers for Disease Control and Prevention and by the National Institutes of Health.
SOURCE: Angley M et al. Epi/Lifestyle 2020, Abstract 5.
PHOENIX – African Americans with systemic lupus erythematosus are more likely to experience recurrent hospitalizations for cardiovascular disease, compared with other racial/ethnic groups, results from a single-state registry study found.
“SLE is an autoimmune disease that causes inflammation affecting multiple organ systems including the cardiovascular system,” Meghan Angley, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “Therefore, individuals with SLE are at risk for early CVD. African Americans represent the racial group at greatest risk for SLE.”
According to Ms. Angley, with the department of epidemiology at Emory University, Atlanta, white women with SLE have CVD associated mortality 12 years earlier than their non-SLE counterparts, while African American women with SLE have CVD-associated mortality 19 years earlier than their non-SLE counterparts. “We know that recurrent hospitalizations for CVD are associated with mortality,” she said. “These represent potential points of identification of high-risk individuals and also points of interventions.”
In order to study racial disparities across recurrent hospitalizations for cardiovascular disease in an SLE population, Ms. Angley and her colleagues drew from the Georgia Lupus Registry, which is a population-based registry of patients with validated SLE in two Georgia counties. They included all cases diagnosed between 2000 and 2004. The registry was linked to records of all inpatient hospitalizations in Georgia between 2000 and 2013. The researchers used ICD-9 codes to identify hospitalizations for coronary heart disease, peripheral artery disease, cerebrovascular disease, and heart failure and used the Prentice-Williams-Peterson model for recurrent time-to-event analysis. Specifically, they looked at the total time scale from the point of diagnosis to each of the subsequent CVD hospitalizations and truncated the number of hospitalizations at three to maintain stable modeling estimates. The analysis was censored at the time of patient death or at the end of 2013 and adjusted for sex and age at diagnosis.
The sample included 417 African Americans with SLE and 149 non–African Americans with the disease. Most (86%) were female, and the non–African American group was slightly more likely to have been diagnosed with SLE after the age of 45 years, compared with the African American group (36% vs. 30%, respectively).
Ms. Angley and her colleagues found that 24% of African Americans had at least one CVD hospitalization, and 14% had at least two, while 13% of non–African Americans had at least one CVD hospitalization, and 5% had at least two. Among those in the African American group, reasons for hospitalizations were congestive heart failure, (58%), cerebrovascular disease (27%), coronary heart disease (18%), and peripheral artery disease (2%). Among those in the non–African American group, reasons for hospitalizations were congestive heart failure (38%), coronary heart disease (38%), cerebrovascular disease (25%), and peripheral artery disease (6%).
Overall, African American race was associated with recurrent hospitalizations (adjusted hazard ratio, 1.9). In an event-specific stratified analysis, the association between African American race and the hazard of recurrence became even more pronounced with each event (hospitalization 1 aHR, 1.2; hospitalization 2 aHR, 1.5; hospitalization 3 aHR, 1.9). The researchers also observed that African Americans were hospitalized sooner, compared with non–African Americans: a median of 3.68 versus 4.61 years for hospitalization 1, 3.73 years versus 5.98 years for hospitalization 2, and 4.84 years versus 8.14 years for hospitalization 3.
“African Americans with SLE are more likely to experience recurrent hospitalizations for CVD,” Ms. Angley concluded at the meeting, which was sponsored by the American Heart Association. “The events occur sooner after diagnosis than in non–African Americans, suggesting that African Americans may be more vulnerable to the cardiovascular complications of SLE. Our next steps include examining potential reasons for these disparities, such as looking at primary care patterns over time, SLE severity over time, and treatment at CVD hospitalizations.”
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, called for additional research to determine the reasons for disparities that were observed between African Americans with SLE and their non–African American counterparts. “We need to figure out why and address it,” said Dr. Brown, who is a cardiologist and physician-scientist at Mayo Clinic, Rochester, Minn. “We recognize that social determinants of health, such as insurance, socioeconomic factors, and psychosocial factors, can contribute. We need to figure out the additional steps we need to take in order to close that gap.”
Ms. Angley reported having no disclosures. The study was funded by grants from the Centers for Disease Control and Prevention and by the National Institutes of Health.
SOURCE: Angley M et al. Epi/Lifestyle 2020, Abstract 5.
PHOENIX – African Americans with systemic lupus erythematosus are more likely to experience recurrent hospitalizations for cardiovascular disease, compared with other racial/ethnic groups, results from a single-state registry study found.
“SLE is an autoimmune disease that causes inflammation affecting multiple organ systems including the cardiovascular system,” Meghan Angley, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “Therefore, individuals with SLE are at risk for early CVD. African Americans represent the racial group at greatest risk for SLE.”
According to Ms. Angley, with the department of epidemiology at Emory University, Atlanta, white women with SLE have CVD associated mortality 12 years earlier than their non-SLE counterparts, while African American women with SLE have CVD-associated mortality 19 years earlier than their non-SLE counterparts. “We know that recurrent hospitalizations for CVD are associated with mortality,” she said. “These represent potential points of identification of high-risk individuals and also points of interventions.”
In order to study racial disparities across recurrent hospitalizations for cardiovascular disease in an SLE population, Ms. Angley and her colleagues drew from the Georgia Lupus Registry, which is a population-based registry of patients with validated SLE in two Georgia counties. They included all cases diagnosed between 2000 and 2004. The registry was linked to records of all inpatient hospitalizations in Georgia between 2000 and 2013. The researchers used ICD-9 codes to identify hospitalizations for coronary heart disease, peripheral artery disease, cerebrovascular disease, and heart failure and used the Prentice-Williams-Peterson model for recurrent time-to-event analysis. Specifically, they looked at the total time scale from the point of diagnosis to each of the subsequent CVD hospitalizations and truncated the number of hospitalizations at three to maintain stable modeling estimates. The analysis was censored at the time of patient death or at the end of 2013 and adjusted for sex and age at diagnosis.
The sample included 417 African Americans with SLE and 149 non–African Americans with the disease. Most (86%) were female, and the non–African American group was slightly more likely to have been diagnosed with SLE after the age of 45 years, compared with the African American group (36% vs. 30%, respectively).
Ms. Angley and her colleagues found that 24% of African Americans had at least one CVD hospitalization, and 14% had at least two, while 13% of non–African Americans had at least one CVD hospitalization, and 5% had at least two. Among those in the African American group, reasons for hospitalizations were congestive heart failure, (58%), cerebrovascular disease (27%), coronary heart disease (18%), and peripheral artery disease (2%). Among those in the non–African American group, reasons for hospitalizations were congestive heart failure (38%), coronary heart disease (38%), cerebrovascular disease (25%), and peripheral artery disease (6%).
Overall, African American race was associated with recurrent hospitalizations (adjusted hazard ratio, 1.9). In an event-specific stratified analysis, the association between African American race and the hazard of recurrence became even more pronounced with each event (hospitalization 1 aHR, 1.2; hospitalization 2 aHR, 1.5; hospitalization 3 aHR, 1.9). The researchers also observed that African Americans were hospitalized sooner, compared with non–African Americans: a median of 3.68 versus 4.61 years for hospitalization 1, 3.73 years versus 5.98 years for hospitalization 2, and 4.84 years versus 8.14 years for hospitalization 3.
“African Americans with SLE are more likely to experience recurrent hospitalizations for CVD,” Ms. Angley concluded at the meeting, which was sponsored by the American Heart Association. “The events occur sooner after diagnosis than in non–African Americans, suggesting that African Americans may be more vulnerable to the cardiovascular complications of SLE. Our next steps include examining potential reasons for these disparities, such as looking at primary care patterns over time, SLE severity over time, and treatment at CVD hospitalizations.”
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, called for additional research to determine the reasons for disparities that were observed between African Americans with SLE and their non–African American counterparts. “We need to figure out why and address it,” said Dr. Brown, who is a cardiologist and physician-scientist at Mayo Clinic, Rochester, Minn. “We recognize that social determinants of health, such as insurance, socioeconomic factors, and psychosocial factors, can contribute. We need to figure out the additional steps we need to take in order to close that gap.”
Ms. Angley reported having no disclosures. The study was funded by grants from the Centers for Disease Control and Prevention and by the National Institutes of Health.
SOURCE: Angley M et al. Epi/Lifestyle 2020, Abstract 5.
REPORTING FROM EPI/LIFESTYLE 2020
Fracture liaison services confer benefit on recurrent fracture risk
Implementation of fracture liaison services (FLS) at two Swedish hospitals was associated with an 18% reduction of recurrent fracture over a median follow-up of 2.2 years, results from an observational cohort study found.
“Patients receiving fracture care within an FLS have higher rates of [bone mineral density] testing, treatment initiation and better adherence,” first author Kristian F. Axelsson, MD, and colleagues wrote in a study published in the Journal of Bone and Mineral Research. “However, the evidence regarding FLS and association to reduced risk of recurrent fracture is insufficient, consisting of smaller studies, studies with short follow-up time, and studies with high risk of various biases.”
Dr. Axelsson, of the department of orthopedic surgery at Skaraborg Hospital, Skövde, Sweden, and colleagues used electronic patient records from four hospitals in Western Sweden to identify all patients aged 50 years or older with a major osteoporotic fracture – defined as a fracture of the wrist, upper arm, hip, vertebra, or pelvis – between 2012 and 2017. The study population consisted of 15,449 patients from two hospitals with FLS and 5,634 patients from two hospitals with no FLS. The researchers used multivariable Cox models to compare all patients with a major osteoporotic fracture during the FLS period with all patients with a major osteoporotic fracture prior to the FLS implementation. The FLS hospitals and non-FLS hospitals were analyzed separately using the same methodology.
The mean age of patients was 74 years, 76% were female, and the most common index fracture site was the wrist (42%). In the hospitals with FLS, the researchers observed 1,247 recurrent fractures during a median follow-up time of 2.2 years. In an unadjusted Cox model, the risk of recurrent fracture was 18% lower in the FLS period, compared with the control period (hazard ratio, 0.82; P = .001). This corresponded to a 3-year number needed to screen of 61, and did not change after adjustment for clinical risk factors. In the non-FLS hospitals, no change in recurrent fracture rate was observed.
Osteoporosis medication treatment rates after fracture did not differ between the FLS and non-FLS hospitals, prior to FLS implementation (14.7% vs. 13.3%, respectively; P = .10). However, following FLS implementation, a larger proportion of fracture patients were treated at the FLS hospitals, compared with those at the non-FLS hospitals (28% vs. 12.9%; P less than .001).
“Our study is the largest yet, including both historic controls and controls at nearby hospitals without implementations of fracture liaison services,” one of the study authors, Mattias Lorentzon, MD, said in an interview. “We were able to rule out temporal trends in refracture risk and show that, [in] patients who had an index fracture at a hospital with an FLS, the refracture rate was lower than for patients who had an index fracture before the FLS was started, indicating that FLS reduce the risk of recurrent fracture. No such trends were observed in hospitals without FLS during the same time period.”
Dr. Lorentzon, head of geriatric medicine at Sahlgrenska University Hospital, Mölndal, Sweden, said that FLS implementation “led to a large increase in the use of osteoporosis medication, which we believe is the reason for the reduction in recurrent fracture risk observed. We believe that our results provide solid evidence that FLS implementation can reduce the rate of recurrent fractures, suggesting that all hospitals treating fracture patients should have fracture liaison services.”
In an interview, Stuart L. Silverman, MD, said that the study adds to compelling data on the efficacy and need for patients with clinical fracture to have case management by a FLS. “We recognize that near term risk is substantial in the year following a fracture,” said Dr. Silverman, who is clinical professor of medicine at Cedars-Sinai Medical Center and the University of California, Los Angeles, and is not affiliated with the Swedish study. “For example, the risk of a subsequent fracture after hip fracture is 8.3%, which is similar to the risk of subsequent acute myocardial infarction after an initial acute MI. However, only 23% of patients receive osteoporosis medication after a hip fracture. Yet a fracture is to osteoporosis what an acute MI is to cardiovascular disease. We recognize that men and women age 65 years and older who have suffered a hip or vertebral fracture should be evaluated for treatment, as this subpopulation is at high risk for a second fracture and evidence supporting treatment efficacy is robust. We need a multidisciplinary clinical system which includes case management such as a fracture liaison service. We know FLS can reduce hip fracture rate in a closed system such as Kaiser by over 40%. This manuscript addresses the utility of a FLS in terms of reducing risk of future fracture.”
The researchers acknowledged certain limitations of the study, including its observational design and the fact that patients prior to the FLS period were fewer and had longer follow-up time, compared with patients during the FLS period.
The study was funded by the Swedish Research Council and by grants from the Sahlgrenska University Hospital. Dr. Axelsson reported that he has received lecture fees from Lilly, Meda/Mylan, and Amgen. Dr. Lorentzon has received lecture fees from Amgen, Lilly, UCB, Radius Health, Meda, GE-Lunar, and Santax Medico/Hologic. The other coauthors reported having no financial disclosures. Dr. Silverman reported that he is a member of the speakers’ bureaus for Amgen and Radius. He is also a consultant for Lilly, Pfizer, and Amgen and has received research grants from Radius and Amgen.
SOURCE: Axelsson K et al. J Bone Min Res. 2020 Feb 25. doi: 10.1002/jbmr.3990.
Implementation of fracture liaison services (FLS) at two Swedish hospitals was associated with an 18% reduction of recurrent fracture over a median follow-up of 2.2 years, results from an observational cohort study found.
“Patients receiving fracture care within an FLS have higher rates of [bone mineral density] testing, treatment initiation and better adherence,” first author Kristian F. Axelsson, MD, and colleagues wrote in a study published in the Journal of Bone and Mineral Research. “However, the evidence regarding FLS and association to reduced risk of recurrent fracture is insufficient, consisting of smaller studies, studies with short follow-up time, and studies with high risk of various biases.”
Dr. Axelsson, of the department of orthopedic surgery at Skaraborg Hospital, Skövde, Sweden, and colleagues used electronic patient records from four hospitals in Western Sweden to identify all patients aged 50 years or older with a major osteoporotic fracture – defined as a fracture of the wrist, upper arm, hip, vertebra, or pelvis – between 2012 and 2017. The study population consisted of 15,449 patients from two hospitals with FLS and 5,634 patients from two hospitals with no FLS. The researchers used multivariable Cox models to compare all patients with a major osteoporotic fracture during the FLS period with all patients with a major osteoporotic fracture prior to the FLS implementation. The FLS hospitals and non-FLS hospitals were analyzed separately using the same methodology.
The mean age of patients was 74 years, 76% were female, and the most common index fracture site was the wrist (42%). In the hospitals with FLS, the researchers observed 1,247 recurrent fractures during a median follow-up time of 2.2 years. In an unadjusted Cox model, the risk of recurrent fracture was 18% lower in the FLS period, compared with the control period (hazard ratio, 0.82; P = .001). This corresponded to a 3-year number needed to screen of 61, and did not change after adjustment for clinical risk factors. In the non-FLS hospitals, no change in recurrent fracture rate was observed.
Osteoporosis medication treatment rates after fracture did not differ between the FLS and non-FLS hospitals, prior to FLS implementation (14.7% vs. 13.3%, respectively; P = .10). However, following FLS implementation, a larger proportion of fracture patients were treated at the FLS hospitals, compared with those at the non-FLS hospitals (28% vs. 12.9%; P less than .001).
“Our study is the largest yet, including both historic controls and controls at nearby hospitals without implementations of fracture liaison services,” one of the study authors, Mattias Lorentzon, MD, said in an interview. “We were able to rule out temporal trends in refracture risk and show that, [in] patients who had an index fracture at a hospital with an FLS, the refracture rate was lower than for patients who had an index fracture before the FLS was started, indicating that FLS reduce the risk of recurrent fracture. No such trends were observed in hospitals without FLS during the same time period.”
Dr. Lorentzon, head of geriatric medicine at Sahlgrenska University Hospital, Mölndal, Sweden, said that FLS implementation “led to a large increase in the use of osteoporosis medication, which we believe is the reason for the reduction in recurrent fracture risk observed. We believe that our results provide solid evidence that FLS implementation can reduce the rate of recurrent fractures, suggesting that all hospitals treating fracture patients should have fracture liaison services.”
In an interview, Stuart L. Silverman, MD, said that the study adds to compelling data on the efficacy and need for patients with clinical fracture to have case management by a FLS. “We recognize that near term risk is substantial in the year following a fracture,” said Dr. Silverman, who is clinical professor of medicine at Cedars-Sinai Medical Center and the University of California, Los Angeles, and is not affiliated with the Swedish study. “For example, the risk of a subsequent fracture after hip fracture is 8.3%, which is similar to the risk of subsequent acute myocardial infarction after an initial acute MI. However, only 23% of patients receive osteoporosis medication after a hip fracture. Yet a fracture is to osteoporosis what an acute MI is to cardiovascular disease. We recognize that men and women age 65 years and older who have suffered a hip or vertebral fracture should be evaluated for treatment, as this subpopulation is at high risk for a second fracture and evidence supporting treatment efficacy is robust. We need a multidisciplinary clinical system which includes case management such as a fracture liaison service. We know FLS can reduce hip fracture rate in a closed system such as Kaiser by over 40%. This manuscript addresses the utility of a FLS in terms of reducing risk of future fracture.”
The researchers acknowledged certain limitations of the study, including its observational design and the fact that patients prior to the FLS period were fewer and had longer follow-up time, compared with patients during the FLS period.
The study was funded by the Swedish Research Council and by grants from the Sahlgrenska University Hospital. Dr. Axelsson reported that he has received lecture fees from Lilly, Meda/Mylan, and Amgen. Dr. Lorentzon has received lecture fees from Amgen, Lilly, UCB, Radius Health, Meda, GE-Lunar, and Santax Medico/Hologic. The other coauthors reported having no financial disclosures. Dr. Silverman reported that he is a member of the speakers’ bureaus for Amgen and Radius. He is also a consultant for Lilly, Pfizer, and Amgen and has received research grants from Radius and Amgen.
SOURCE: Axelsson K et al. J Bone Min Res. 2020 Feb 25. doi: 10.1002/jbmr.3990.
Implementation of fracture liaison services (FLS) at two Swedish hospitals was associated with an 18% reduction of recurrent fracture over a median follow-up of 2.2 years, results from an observational cohort study found.
“Patients receiving fracture care within an FLS have higher rates of [bone mineral density] testing, treatment initiation and better adherence,” first author Kristian F. Axelsson, MD, and colleagues wrote in a study published in the Journal of Bone and Mineral Research. “However, the evidence regarding FLS and association to reduced risk of recurrent fracture is insufficient, consisting of smaller studies, studies with short follow-up time, and studies with high risk of various biases.”
Dr. Axelsson, of the department of orthopedic surgery at Skaraborg Hospital, Skövde, Sweden, and colleagues used electronic patient records from four hospitals in Western Sweden to identify all patients aged 50 years or older with a major osteoporotic fracture – defined as a fracture of the wrist, upper arm, hip, vertebra, or pelvis – between 2012 and 2017. The study population consisted of 15,449 patients from two hospitals with FLS and 5,634 patients from two hospitals with no FLS. The researchers used multivariable Cox models to compare all patients with a major osteoporotic fracture during the FLS period with all patients with a major osteoporotic fracture prior to the FLS implementation. The FLS hospitals and non-FLS hospitals were analyzed separately using the same methodology.
The mean age of patients was 74 years, 76% were female, and the most common index fracture site was the wrist (42%). In the hospitals with FLS, the researchers observed 1,247 recurrent fractures during a median follow-up time of 2.2 years. In an unadjusted Cox model, the risk of recurrent fracture was 18% lower in the FLS period, compared with the control period (hazard ratio, 0.82; P = .001). This corresponded to a 3-year number needed to screen of 61, and did not change after adjustment for clinical risk factors. In the non-FLS hospitals, no change in recurrent fracture rate was observed.
Osteoporosis medication treatment rates after fracture did not differ between the FLS and non-FLS hospitals, prior to FLS implementation (14.7% vs. 13.3%, respectively; P = .10). However, following FLS implementation, a larger proportion of fracture patients were treated at the FLS hospitals, compared with those at the non-FLS hospitals (28% vs. 12.9%; P less than .001).
“Our study is the largest yet, including both historic controls and controls at nearby hospitals without implementations of fracture liaison services,” one of the study authors, Mattias Lorentzon, MD, said in an interview. “We were able to rule out temporal trends in refracture risk and show that, [in] patients who had an index fracture at a hospital with an FLS, the refracture rate was lower than for patients who had an index fracture before the FLS was started, indicating that FLS reduce the risk of recurrent fracture. No such trends were observed in hospitals without FLS during the same time period.”
Dr. Lorentzon, head of geriatric medicine at Sahlgrenska University Hospital, Mölndal, Sweden, said that FLS implementation “led to a large increase in the use of osteoporosis medication, which we believe is the reason for the reduction in recurrent fracture risk observed. We believe that our results provide solid evidence that FLS implementation can reduce the rate of recurrent fractures, suggesting that all hospitals treating fracture patients should have fracture liaison services.”
In an interview, Stuart L. Silverman, MD, said that the study adds to compelling data on the efficacy and need for patients with clinical fracture to have case management by a FLS. “We recognize that near term risk is substantial in the year following a fracture,” said Dr. Silverman, who is clinical professor of medicine at Cedars-Sinai Medical Center and the University of California, Los Angeles, and is not affiliated with the Swedish study. “For example, the risk of a subsequent fracture after hip fracture is 8.3%, which is similar to the risk of subsequent acute myocardial infarction after an initial acute MI. However, only 23% of patients receive osteoporosis medication after a hip fracture. Yet a fracture is to osteoporosis what an acute MI is to cardiovascular disease. We recognize that men and women age 65 years and older who have suffered a hip or vertebral fracture should be evaluated for treatment, as this subpopulation is at high risk for a second fracture and evidence supporting treatment efficacy is robust. We need a multidisciplinary clinical system which includes case management such as a fracture liaison service. We know FLS can reduce hip fracture rate in a closed system such as Kaiser by over 40%. This manuscript addresses the utility of a FLS in terms of reducing risk of future fracture.”
The researchers acknowledged certain limitations of the study, including its observational design and the fact that patients prior to the FLS period were fewer and had longer follow-up time, compared with patients during the FLS period.
The study was funded by the Swedish Research Council and by grants from the Sahlgrenska University Hospital. Dr. Axelsson reported that he has received lecture fees from Lilly, Meda/Mylan, and Amgen. Dr. Lorentzon has received lecture fees from Amgen, Lilly, UCB, Radius Health, Meda, GE-Lunar, and Santax Medico/Hologic. The other coauthors reported having no financial disclosures. Dr. Silverman reported that he is a member of the speakers’ bureaus for Amgen and Radius. He is also a consultant for Lilly, Pfizer, and Amgen and has received research grants from Radius and Amgen.
SOURCE: Axelsson K et al. J Bone Min Res. 2020 Feb 25. doi: 10.1002/jbmr.3990.
FROM THE JOURNAL OF BONE AND MINERAL RESEARCH
CV health in pregnancy improves outcomes for mother and infant
PHOENIX – according to results from a multinational cohort study.
“Over the past 10 years, cardiovascular health [CVH] has been characterized across most of the life course and is associated with a variety of health outcomes, but CVH as a whole has not been well studied during pregnancy,” Amanda M. Perak, MD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
In an effort to examine the associations of maternal gestational CVH with adverse maternal and newborn outcomes, Dr. Perak of the departments of pediatrics and preventive medicine at Northwestern University and Lurie Children’s Hospital, both in Chicago, and colleagues drew from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study, which examined pregnant women at a target of 28 weeks’ gestation and assessed the associations of glycemia with pregnancy outcomes. The researchers analyzed data from an ancillary study of 2,230 mother-child dyads to characterize clinical gestational CVH with use of five metrics: body mass index, blood pressure, cholesterol, glucose, and smoking. The study excluded women with prepregnancy diabetes, preterm births, and cases of fetal death/major malformations.
Each maternal CVH metric was classified as ideal, intermediate, or poor according to modified definitions based on pregnancy guidelines. “For lipids, it’s known that levels change substantially during pregnancy, but there are no pregnancy guidelines,” Dr. Perak said. “We and others have also shown that higher triglycerides in pregnancy are associated with adverse pregnancy outcomes. We selected thresholds of less than 250 mg/dL for ideal and at least 500 mg/dL for poor, based on triglyceride distribution and clinical relevance.”
Total CVH was scored by assigning 2 points for ideal, 1 for intermediate, and 0 for each poor metric, for a total possible 10 points, with 10 being most favorable. They also created four CVH categories, ranging from all ideal to two or more poor metrics. Maternal adverse pregnancy outcomes included preeclampsia and unplanned primary cesarean section. Newborn adverse pregnancy outcomes included birth weight above the 90th percentile and a cord blood insulin sensitivity index lower than the 10th percentile.
The researchers used logistic and multinomial logistic regression of pregnancy outcomes on maternal gestational CVH in two adjusted models. Secondarily, they examined associations of individual CVH metrics with outcomes, with adjustment for the other metrics.
The cohort comprised mother-child dyads from nine field centers in six countries: the United States (25%), Barbados (23%), United Kingdom (21%), China (18%), Thailand (7%), and Canada (7%). The mothers’ mean age was 30 years, and the mean gestational age was 28 weeks. The mean gestational CVH score was 8.8 out of 10. Nearly half of mothers (42%) had ideal metrics, while 4% had two or more poor metrics. Delivery occurred at a mean of 39.8 weeks, and adverse pregnancy outcomes occurred in 4.7%-17.9% of pregnancies.
In the fully adjusted model, which accounted for maternal age, height, alcohol use, gestational age at pregnancy exam, maternal parity, and newborn sex and race/ethnicity, odds ratios per 1-point higher (better) CVH score were 0.61 (95% confidence interval, 0.53-0.70) for preeclampsia, 0.85 (95% CI, 0.76-0.95) for unplanned primary cesarean section (among primiparous mothers), 0.83 (95% CI, 0.77-0.91) for large for gestational age infant, and 0.79 (95% CI, 0.72-0.87) for infant insulin sensitivity index below the 10th percentile. CVH categories were also associated with outcomes. For example, odds ratios for preeclampsia were 4.61 (95% CI, 2.13-11.14) for mothers with one or more intermediate metrics, 7.62 (95% CI, 3.60-18.13) for mothers with one poor metric, and 12.02 (95% CI, 4.70-32.50) for mothers with two or more poor metrics, compared with mothers with all metrics ideal.
“Except for smoking, each CVH metric was independently associated with adverse outcomes,” Dr. Perak said. “However, total CVH was associated with a wider range of outcomes than any single metric. This suggests that CVH provides health insights beyond single risk factors.”
Strengths of the study, she continued, included geographic and racial diversity of participants and high-quality research measurements of CVH. Limitations were that the cohort excluded prepregnancy diabetes and preterm births. “Diet and exercise data were not available, and CVH was measured once at 28 weeks,” she said. “Further study is needed across pregnancy and in other settings, but this study provides the first data on the relevance of gestational CVH for pregnancy outcomes.”
In an interview, Stephen S. Rich, PhD, who directs the Center for Public Health Genomics at the University of Virginia, said that the data “provide strong epidemiologic support to focus on the full range of cardiovascular health. In my view, the primary limitation of the study is that there may be significant differences in how one achieves ideal CHV across a single country, not to mention across the world, particularly in absence of a highly controlled, research environment. It is not clear that the approach used in this study at nine selected sites in six relatively highly developed countries could be translated into primary care – particularly in the U.S. with different regulatory and reimbursement plans and payers. Nonetheless, the evidence suggests a way to reduce adverse outcomes in pregnancy and the area deserves greater research.”
According to Dr. Perak, gestational diabetes is associated with a twofold higher maternal risk for cardiovascular disease (Diabetologia. 2019;62:905-14), while diabetes is also associated with higher offspring risk for CVD (BMJ. 2019;367:16398). However, a paucity of data exists on gestational CVH. In one report, better gestational CVH was associated with less subclinical CVD for the mother 10 years later (J Am Heart Assoc. 2019 Jul 23. doi:10.1161/JAHA.118.011394). In a separate analysis, Dr. Perak and her colleagues found that better gestational CVH was associated with better offspring CVH in childhood. “Unfortunately, we also reported that, among pregnant women in the United States, fewer than 1 in 10 had high CVH,” she said (J Am Heart Assoc. 2020 Feb 17. doi:10.1161/JAHA.119.015123). “However, the relevance of gestational CVH for pregnancy outcomes is unknown, but a it’s key question when considering CVH monitoring in prenatal care.”
Dr. Perak reported having received grant support from the National Heart, Lung, and Blood Institute, the American Heart Association, and Northwestern University. The HAPO Study was supported by NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases.
The meeting was sponsored by the American Heart Association.
SOURCE: Perak A et al. Epi/Lifestyle 2020, Abstract 33.
PHOENIX – according to results from a multinational cohort study.
“Over the past 10 years, cardiovascular health [CVH] has been characterized across most of the life course and is associated with a variety of health outcomes, but CVH as a whole has not been well studied during pregnancy,” Amanda M. Perak, MD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
In an effort to examine the associations of maternal gestational CVH with adverse maternal and newborn outcomes, Dr. Perak of the departments of pediatrics and preventive medicine at Northwestern University and Lurie Children’s Hospital, both in Chicago, and colleagues drew from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study, which examined pregnant women at a target of 28 weeks’ gestation and assessed the associations of glycemia with pregnancy outcomes. The researchers analyzed data from an ancillary study of 2,230 mother-child dyads to characterize clinical gestational CVH with use of five metrics: body mass index, blood pressure, cholesterol, glucose, and smoking. The study excluded women with prepregnancy diabetes, preterm births, and cases of fetal death/major malformations.
Each maternal CVH metric was classified as ideal, intermediate, or poor according to modified definitions based on pregnancy guidelines. “For lipids, it’s known that levels change substantially during pregnancy, but there are no pregnancy guidelines,” Dr. Perak said. “We and others have also shown that higher triglycerides in pregnancy are associated with adverse pregnancy outcomes. We selected thresholds of less than 250 mg/dL for ideal and at least 500 mg/dL for poor, based on triglyceride distribution and clinical relevance.”
Total CVH was scored by assigning 2 points for ideal, 1 for intermediate, and 0 for each poor metric, for a total possible 10 points, with 10 being most favorable. They also created four CVH categories, ranging from all ideal to two or more poor metrics. Maternal adverse pregnancy outcomes included preeclampsia and unplanned primary cesarean section. Newborn adverse pregnancy outcomes included birth weight above the 90th percentile and a cord blood insulin sensitivity index lower than the 10th percentile.
The researchers used logistic and multinomial logistic regression of pregnancy outcomes on maternal gestational CVH in two adjusted models. Secondarily, they examined associations of individual CVH metrics with outcomes, with adjustment for the other metrics.
The cohort comprised mother-child dyads from nine field centers in six countries: the United States (25%), Barbados (23%), United Kingdom (21%), China (18%), Thailand (7%), and Canada (7%). The mothers’ mean age was 30 years, and the mean gestational age was 28 weeks. The mean gestational CVH score was 8.8 out of 10. Nearly half of mothers (42%) had ideal metrics, while 4% had two or more poor metrics. Delivery occurred at a mean of 39.8 weeks, and adverse pregnancy outcomes occurred in 4.7%-17.9% of pregnancies.
In the fully adjusted model, which accounted for maternal age, height, alcohol use, gestational age at pregnancy exam, maternal parity, and newborn sex and race/ethnicity, odds ratios per 1-point higher (better) CVH score were 0.61 (95% confidence interval, 0.53-0.70) for preeclampsia, 0.85 (95% CI, 0.76-0.95) for unplanned primary cesarean section (among primiparous mothers), 0.83 (95% CI, 0.77-0.91) for large for gestational age infant, and 0.79 (95% CI, 0.72-0.87) for infant insulin sensitivity index below the 10th percentile. CVH categories were also associated with outcomes. For example, odds ratios for preeclampsia were 4.61 (95% CI, 2.13-11.14) for mothers with one or more intermediate metrics, 7.62 (95% CI, 3.60-18.13) for mothers with one poor metric, and 12.02 (95% CI, 4.70-32.50) for mothers with two or more poor metrics, compared with mothers with all metrics ideal.
“Except for smoking, each CVH metric was independently associated with adverse outcomes,” Dr. Perak said. “However, total CVH was associated with a wider range of outcomes than any single metric. This suggests that CVH provides health insights beyond single risk factors.”
Strengths of the study, she continued, included geographic and racial diversity of participants and high-quality research measurements of CVH. Limitations were that the cohort excluded prepregnancy diabetes and preterm births. “Diet and exercise data were not available, and CVH was measured once at 28 weeks,” she said. “Further study is needed across pregnancy and in other settings, but this study provides the first data on the relevance of gestational CVH for pregnancy outcomes.”
In an interview, Stephen S. Rich, PhD, who directs the Center for Public Health Genomics at the University of Virginia, said that the data “provide strong epidemiologic support to focus on the full range of cardiovascular health. In my view, the primary limitation of the study is that there may be significant differences in how one achieves ideal CHV across a single country, not to mention across the world, particularly in absence of a highly controlled, research environment. It is not clear that the approach used in this study at nine selected sites in six relatively highly developed countries could be translated into primary care – particularly in the U.S. with different regulatory and reimbursement plans and payers. Nonetheless, the evidence suggests a way to reduce adverse outcomes in pregnancy and the area deserves greater research.”
According to Dr. Perak, gestational diabetes is associated with a twofold higher maternal risk for cardiovascular disease (Diabetologia. 2019;62:905-14), while diabetes is also associated with higher offspring risk for CVD (BMJ. 2019;367:16398). However, a paucity of data exists on gestational CVH. In one report, better gestational CVH was associated with less subclinical CVD for the mother 10 years later (J Am Heart Assoc. 2019 Jul 23. doi:10.1161/JAHA.118.011394). In a separate analysis, Dr. Perak and her colleagues found that better gestational CVH was associated with better offspring CVH in childhood. “Unfortunately, we also reported that, among pregnant women in the United States, fewer than 1 in 10 had high CVH,” she said (J Am Heart Assoc. 2020 Feb 17. doi:10.1161/JAHA.119.015123). “However, the relevance of gestational CVH for pregnancy outcomes is unknown, but a it’s key question when considering CVH monitoring in prenatal care.”
Dr. Perak reported having received grant support from the National Heart, Lung, and Blood Institute, the American Heart Association, and Northwestern University. The HAPO Study was supported by NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases.
The meeting was sponsored by the American Heart Association.
SOURCE: Perak A et al. Epi/Lifestyle 2020, Abstract 33.
PHOENIX – according to results from a multinational cohort study.
“Over the past 10 years, cardiovascular health [CVH] has been characterized across most of the life course and is associated with a variety of health outcomes, but CVH as a whole has not been well studied during pregnancy,” Amanda M. Perak, MD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
In an effort to examine the associations of maternal gestational CVH with adverse maternal and newborn outcomes, Dr. Perak of the departments of pediatrics and preventive medicine at Northwestern University and Lurie Children’s Hospital, both in Chicago, and colleagues drew from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study, which examined pregnant women at a target of 28 weeks’ gestation and assessed the associations of glycemia with pregnancy outcomes. The researchers analyzed data from an ancillary study of 2,230 mother-child dyads to characterize clinical gestational CVH with use of five metrics: body mass index, blood pressure, cholesterol, glucose, and smoking. The study excluded women with prepregnancy diabetes, preterm births, and cases of fetal death/major malformations.
Each maternal CVH metric was classified as ideal, intermediate, or poor according to modified definitions based on pregnancy guidelines. “For lipids, it’s known that levels change substantially during pregnancy, but there are no pregnancy guidelines,” Dr. Perak said. “We and others have also shown that higher triglycerides in pregnancy are associated with adverse pregnancy outcomes. We selected thresholds of less than 250 mg/dL for ideal and at least 500 mg/dL for poor, based on triglyceride distribution and clinical relevance.”
Total CVH was scored by assigning 2 points for ideal, 1 for intermediate, and 0 for each poor metric, for a total possible 10 points, with 10 being most favorable. They also created four CVH categories, ranging from all ideal to two or more poor metrics. Maternal adverse pregnancy outcomes included preeclampsia and unplanned primary cesarean section. Newborn adverse pregnancy outcomes included birth weight above the 90th percentile and a cord blood insulin sensitivity index lower than the 10th percentile.
The researchers used logistic and multinomial logistic regression of pregnancy outcomes on maternal gestational CVH in two adjusted models. Secondarily, they examined associations of individual CVH metrics with outcomes, with adjustment for the other metrics.
The cohort comprised mother-child dyads from nine field centers in six countries: the United States (25%), Barbados (23%), United Kingdom (21%), China (18%), Thailand (7%), and Canada (7%). The mothers’ mean age was 30 years, and the mean gestational age was 28 weeks. The mean gestational CVH score was 8.8 out of 10. Nearly half of mothers (42%) had ideal metrics, while 4% had two or more poor metrics. Delivery occurred at a mean of 39.8 weeks, and adverse pregnancy outcomes occurred in 4.7%-17.9% of pregnancies.
In the fully adjusted model, which accounted for maternal age, height, alcohol use, gestational age at pregnancy exam, maternal parity, and newborn sex and race/ethnicity, odds ratios per 1-point higher (better) CVH score were 0.61 (95% confidence interval, 0.53-0.70) for preeclampsia, 0.85 (95% CI, 0.76-0.95) for unplanned primary cesarean section (among primiparous mothers), 0.83 (95% CI, 0.77-0.91) for large for gestational age infant, and 0.79 (95% CI, 0.72-0.87) for infant insulin sensitivity index below the 10th percentile. CVH categories were also associated with outcomes. For example, odds ratios for preeclampsia were 4.61 (95% CI, 2.13-11.14) for mothers with one or more intermediate metrics, 7.62 (95% CI, 3.60-18.13) for mothers with one poor metric, and 12.02 (95% CI, 4.70-32.50) for mothers with two or more poor metrics, compared with mothers with all metrics ideal.
“Except for smoking, each CVH metric was independently associated with adverse outcomes,” Dr. Perak said. “However, total CVH was associated with a wider range of outcomes than any single metric. This suggests that CVH provides health insights beyond single risk factors.”
Strengths of the study, she continued, included geographic and racial diversity of participants and high-quality research measurements of CVH. Limitations were that the cohort excluded prepregnancy diabetes and preterm births. “Diet and exercise data were not available, and CVH was measured once at 28 weeks,” she said. “Further study is needed across pregnancy and in other settings, but this study provides the first data on the relevance of gestational CVH for pregnancy outcomes.”
In an interview, Stephen S. Rich, PhD, who directs the Center for Public Health Genomics at the University of Virginia, said that the data “provide strong epidemiologic support to focus on the full range of cardiovascular health. In my view, the primary limitation of the study is that there may be significant differences in how one achieves ideal CHV across a single country, not to mention across the world, particularly in absence of a highly controlled, research environment. It is not clear that the approach used in this study at nine selected sites in six relatively highly developed countries could be translated into primary care – particularly in the U.S. with different regulatory and reimbursement plans and payers. Nonetheless, the evidence suggests a way to reduce adverse outcomes in pregnancy and the area deserves greater research.”
According to Dr. Perak, gestational diabetes is associated with a twofold higher maternal risk for cardiovascular disease (Diabetologia. 2019;62:905-14), while diabetes is also associated with higher offspring risk for CVD (BMJ. 2019;367:16398). However, a paucity of data exists on gestational CVH. In one report, better gestational CVH was associated with less subclinical CVD for the mother 10 years later (J Am Heart Assoc. 2019 Jul 23. doi:10.1161/JAHA.118.011394). In a separate analysis, Dr. Perak and her colleagues found that better gestational CVH was associated with better offspring CVH in childhood. “Unfortunately, we also reported that, among pregnant women in the United States, fewer than 1 in 10 had high CVH,” she said (J Am Heart Assoc. 2020 Feb 17. doi:10.1161/JAHA.119.015123). “However, the relevance of gestational CVH for pregnancy outcomes is unknown, but a it’s key question when considering CVH monitoring in prenatal care.”
Dr. Perak reported having received grant support from the National Heart, Lung, and Blood Institute, the American Heart Association, and Northwestern University. The HAPO Study was supported by NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases.
The meeting was sponsored by the American Heart Association.
SOURCE: Perak A et al. Epi/Lifestyle 2020, Abstract 33.
REPORTING FROM EPI/LIFESTYLE 2020
Red meat intake linked to increased risk of fatal CHD in men
PHOENIX – Consumption of red meat, particularly the processed form, is linked to a higher risk of developing coronary heart disease in men, results from a large prospective analysis demonstrated.
“The findings of this study are in line with randomized trials showing that the consumption of red meat, as compared with plant-based protein sources, increases LDL cholesterol levels, and with previous studies on red meat and risk of coronary heart disease,” lead study author Laila Al-Shaar, MPH, PhD, said in an interview in advance of the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
According to Dr. Al-Shaar, a postdoctoral research fellow in the department of nutrition at the T.H. Chan School of Public Health at Harvard University, Boston, most of the existing studies on red meat and heart disease have examined the impact of increasing consumption of red meat while decreasing consumption of all other foods. For the current study, she and her colleagues used a substitution analysis approach to understand how replacing red meat (total, processed, or unprocessed) with another protein-rich food was associated with the risk of heart disease. “This would potentially provide more specific guidance for healthier alternatives for those planning to cut down their red meat intake,” she said.
She and her colleagues prospectively followed 43,259 men in the Health Professionals Follow-up Study (1986-2012) who had no known history of cancer or cardiovascular disease. Diet was assessed by a standardized and validated food frequency questionnaire that was updated every 4 years. Dr. Al-Shaar and her colleagues used multivariate Cox models to estimate hazard ratios and 95% confidence intervals of CHD risk across categories of red meat consumption. They performed substitution analyses by comparing coefficients in models including alternative foods as continuous variables.
Over roughly 933,000 person-years of follow-up, the researchers documented 4,148 incident CHD cases. Of these, 1,680 were fatal. After multivariate adjustment for dietary and nondietary risk factors, both total and processed red meat intake were associated with a modestly higher risk of CHD (hazard ratio for a one serving/day increment, 1.08; 95% confidence interval, 1.01-1.14 for total red meat; and HR, 1.13; 95% CI, 1.03-1.22 for processed red meat). Substitutions of one serving per day of other foods (including nuts, legumes, soy, whole grains, and low- and high-fat dairy) for one serving per day of total red meat were associated with a 10%-47% lower CHD risk.
Stronger inverse associations were observed between some of these substitutions for red meat and risk of fatal CHD. Substituting nuts lowered the risk of fatal heart disease by 17%, while replacing red meat with whole grains was linked to a 48% reduction in that outcome. Those associations were more pronounced when replacing processed red meat.
“Processed meats and meats in general have been thought to be potentially not favorable in terms of cardiovascular disease and cardiovascular disease risk,” Robert H. Eckel, MD, professor emeritus of medicine at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Now we have increasing data that not only is there a negative cardiovascular disease impact of animal protein, but we see this on all-cause mortality, including cancer.”
Dr. Al-Shaar said that the findings “support current recommendations to limit consumption of red meat and suggest that high-quality plant-based proteins such as nuts, legumes, and soy are good alternatives for individuals planning to have better food choices and healthier eating patterns.”
She acknowledged certain limitations of the study, including its observational design and the fact that it was limited to non-Hispanic white health professionals, “thus limiting the generalizability of its findings to the whole population.”
Dr. Eckel, who is a past president of the American Heart Association, underscored the importance of one’s overall diet in mitigating the risk of developing coronary heart disease. “It’s not simply substituting animal protein with plant protein,” he said. “Fruits and vegetables and whole grains, lean protein from fish – a Mediterranean-style diet – is what the AHA recommends.”
Dr. Al-Shaar reported having no financial disclosures. The study was supported by a T32 training grant from the National Institutes of Health and by other grants from the NIH. The meeting was sponsored by the AHA.
SOURCE: Al-Shaar L et al. Epi/Lifestyle 2020, Abstract P512.
PHOENIX – Consumption of red meat, particularly the processed form, is linked to a higher risk of developing coronary heart disease in men, results from a large prospective analysis demonstrated.
“The findings of this study are in line with randomized trials showing that the consumption of red meat, as compared with plant-based protein sources, increases LDL cholesterol levels, and with previous studies on red meat and risk of coronary heart disease,” lead study author Laila Al-Shaar, MPH, PhD, said in an interview in advance of the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
According to Dr. Al-Shaar, a postdoctoral research fellow in the department of nutrition at the T.H. Chan School of Public Health at Harvard University, Boston, most of the existing studies on red meat and heart disease have examined the impact of increasing consumption of red meat while decreasing consumption of all other foods. For the current study, she and her colleagues used a substitution analysis approach to understand how replacing red meat (total, processed, or unprocessed) with another protein-rich food was associated with the risk of heart disease. “This would potentially provide more specific guidance for healthier alternatives for those planning to cut down their red meat intake,” she said.
She and her colleagues prospectively followed 43,259 men in the Health Professionals Follow-up Study (1986-2012) who had no known history of cancer or cardiovascular disease. Diet was assessed by a standardized and validated food frequency questionnaire that was updated every 4 years. Dr. Al-Shaar and her colleagues used multivariate Cox models to estimate hazard ratios and 95% confidence intervals of CHD risk across categories of red meat consumption. They performed substitution analyses by comparing coefficients in models including alternative foods as continuous variables.
Over roughly 933,000 person-years of follow-up, the researchers documented 4,148 incident CHD cases. Of these, 1,680 were fatal. After multivariate adjustment for dietary and nondietary risk factors, both total and processed red meat intake were associated with a modestly higher risk of CHD (hazard ratio for a one serving/day increment, 1.08; 95% confidence interval, 1.01-1.14 for total red meat; and HR, 1.13; 95% CI, 1.03-1.22 for processed red meat). Substitutions of one serving per day of other foods (including nuts, legumes, soy, whole grains, and low- and high-fat dairy) for one serving per day of total red meat were associated with a 10%-47% lower CHD risk.
Stronger inverse associations were observed between some of these substitutions for red meat and risk of fatal CHD. Substituting nuts lowered the risk of fatal heart disease by 17%, while replacing red meat with whole grains was linked to a 48% reduction in that outcome. Those associations were more pronounced when replacing processed red meat.
“Processed meats and meats in general have been thought to be potentially not favorable in terms of cardiovascular disease and cardiovascular disease risk,” Robert H. Eckel, MD, professor emeritus of medicine at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Now we have increasing data that not only is there a negative cardiovascular disease impact of animal protein, but we see this on all-cause mortality, including cancer.”
Dr. Al-Shaar said that the findings “support current recommendations to limit consumption of red meat and suggest that high-quality plant-based proteins such as nuts, legumes, and soy are good alternatives for individuals planning to have better food choices and healthier eating patterns.”
She acknowledged certain limitations of the study, including its observational design and the fact that it was limited to non-Hispanic white health professionals, “thus limiting the generalizability of its findings to the whole population.”
Dr. Eckel, who is a past president of the American Heart Association, underscored the importance of one’s overall diet in mitigating the risk of developing coronary heart disease. “It’s not simply substituting animal protein with plant protein,” he said. “Fruits and vegetables and whole grains, lean protein from fish – a Mediterranean-style diet – is what the AHA recommends.”
Dr. Al-Shaar reported having no financial disclosures. The study was supported by a T32 training grant from the National Institutes of Health and by other grants from the NIH. The meeting was sponsored by the AHA.
SOURCE: Al-Shaar L et al. Epi/Lifestyle 2020, Abstract P512.
PHOENIX – Consumption of red meat, particularly the processed form, is linked to a higher risk of developing coronary heart disease in men, results from a large prospective analysis demonstrated.
“The findings of this study are in line with randomized trials showing that the consumption of red meat, as compared with plant-based protein sources, increases LDL cholesterol levels, and with previous studies on red meat and risk of coronary heart disease,” lead study author Laila Al-Shaar, MPH, PhD, said in an interview in advance of the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
According to Dr. Al-Shaar, a postdoctoral research fellow in the department of nutrition at the T.H. Chan School of Public Health at Harvard University, Boston, most of the existing studies on red meat and heart disease have examined the impact of increasing consumption of red meat while decreasing consumption of all other foods. For the current study, she and her colleagues used a substitution analysis approach to understand how replacing red meat (total, processed, or unprocessed) with another protein-rich food was associated with the risk of heart disease. “This would potentially provide more specific guidance for healthier alternatives for those planning to cut down their red meat intake,” she said.
She and her colleagues prospectively followed 43,259 men in the Health Professionals Follow-up Study (1986-2012) who had no known history of cancer or cardiovascular disease. Diet was assessed by a standardized and validated food frequency questionnaire that was updated every 4 years. Dr. Al-Shaar and her colleagues used multivariate Cox models to estimate hazard ratios and 95% confidence intervals of CHD risk across categories of red meat consumption. They performed substitution analyses by comparing coefficients in models including alternative foods as continuous variables.
Over roughly 933,000 person-years of follow-up, the researchers documented 4,148 incident CHD cases. Of these, 1,680 were fatal. After multivariate adjustment for dietary and nondietary risk factors, both total and processed red meat intake were associated with a modestly higher risk of CHD (hazard ratio for a one serving/day increment, 1.08; 95% confidence interval, 1.01-1.14 for total red meat; and HR, 1.13; 95% CI, 1.03-1.22 for processed red meat). Substitutions of one serving per day of other foods (including nuts, legumes, soy, whole grains, and low- and high-fat dairy) for one serving per day of total red meat were associated with a 10%-47% lower CHD risk.
Stronger inverse associations were observed between some of these substitutions for red meat and risk of fatal CHD. Substituting nuts lowered the risk of fatal heart disease by 17%, while replacing red meat with whole grains was linked to a 48% reduction in that outcome. Those associations were more pronounced when replacing processed red meat.
“Processed meats and meats in general have been thought to be potentially not favorable in terms of cardiovascular disease and cardiovascular disease risk,” Robert H. Eckel, MD, professor emeritus of medicine at the University of Colorado Anschutz Medical Campus, Aurora, said in an interview. “Now we have increasing data that not only is there a negative cardiovascular disease impact of animal protein, but we see this on all-cause mortality, including cancer.”
Dr. Al-Shaar said that the findings “support current recommendations to limit consumption of red meat and suggest that high-quality plant-based proteins such as nuts, legumes, and soy are good alternatives for individuals planning to have better food choices and healthier eating patterns.”
She acknowledged certain limitations of the study, including its observational design and the fact that it was limited to non-Hispanic white health professionals, “thus limiting the generalizability of its findings to the whole population.”
Dr. Eckel, who is a past president of the American Heart Association, underscored the importance of one’s overall diet in mitigating the risk of developing coronary heart disease. “It’s not simply substituting animal protein with plant protein,” he said. “Fruits and vegetables and whole grains, lean protein from fish – a Mediterranean-style diet – is what the AHA recommends.”
Dr. Al-Shaar reported having no financial disclosures. The study was supported by a T32 training grant from the National Institutes of Health and by other grants from the NIH. The meeting was sponsored by the AHA.
SOURCE: Al-Shaar L et al. Epi/Lifestyle 2020, Abstract P512.
REPORTING FROM EPI/LIFESTYLE 2020
Gender, racial disparities persist in statin use by ASCVD patients
PHOENIX – Statin use for the secondary prevention of cardiovascular disease increased modestly between 2008 and 2017 in the United States, but more than 40% of patients with established atherosclerotic cardiovascular disease are still not on a statin.
In addition, even after release of the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014;129:S1-45) that markedly increased the pool of eligible patients, disparities exist in the proportion of women versus men, and blacks and Hispanics versus whites with atherosclerotic cardiovascular disease (ASCVD) who are currently receiving a statin.
“Despite repeated calls for the use of statins for secondary prevention of CVD in multiple guidelines, gender and racial inequalities in the use of statins persist,” Joseph A. Salami, MD, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the American Heart Association. “Cardiovascular disease remains the leading cause of death in the U.S. In 2017, it was responsible for 647,457 deaths. We have an opportunity to improve CVD-related outcomes and cost by intensifying efforts to use statins for the secondary prevention of CVD and closing gender and racial gaps. Action is needed.”
Dr. Salami, a biostatistician with the Baptist Health South Florida Center for Advanced Analytics in Coral Gables, based his remarks on an analysis of data contained in the 2008-2017 Medical Expenditure Panel Survey (MEPS), a national representative survey sponsored by the Agency for Healthcare Research and Quality. “Between 2013 and 2018 there were six different guidelines released encouraging statin use among ASCVD patients,” he said. “Besides the good number needed to treat, statin use on secondary prevention of CVD is cost effective.”
Given the proven efficacy of statin use in the prevention of CVD, he and his associates set out to examine trends in the proportion of adults with ASCVD using statins and to assess for gender and racial differences in their use. The researchers used ICD-9 and ICD-10 codes to define ASCVD among the MEPS study population, as well as self-reported history of coronary artery disease, peripheral artery disease, and stroke. After excluding adults aged younger than 40 years and those without ASCVD, this left a population of 15,911 patients. Of these, 44% were female, their mean age was 62 years, and 72% were Caucasian.
Overall, statin use increased from 50% in 2008 to 58.7% in 2017, with an average annual percentage change of 0.95% between 2010 and 2017 (P = .01). However, the annual percentage change in statin use was 0.25% among men versus 0.14% among women (P = .022). “Each year during the study period, more than 3 million women with ASCVD were not prescribed a statin, which translated into about 36 million adult-years,” Dr. Salami said. “In 2017, 16% of these women were African Americans and 15% were Hispanic.”
Logistic regression analysis revealed that in 2017, females with ASCVD were less likely to be prescribed a statin, compared with males (odds ratio, 0.52; P less than .001). In addition, compared with whites, blacks were less likely to be prescribed a statin (OR, 0.69; P = .012), as were Hispanics (OR, 0.62; P = .003). “In a multivariate logistic regression controlling for age, health insurance status, and comorbidities, the gender disparity remained statistically significant, but the racial disparity did not,” Dr. Salami said.
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, characterized the study’s findings as sobering. “This should be an eye-opener for all of us in medicine, whether we are physicians, pharmacists, nurses, or researchers,” said Dr. Brown, who is a cardiologist and physician scientist at the Mayo Clinic in Rochester, Minn. “We’re all in this together, and we all have a role to play in addressing social determinants of health. I think we need to recognize the fact that we’re not treating blacks, Hispanics, and women to the degree that we should be, compared to whites and men. I think we need to do better, and we need to figure out how to reach that population, and how to improve.”
Dr. Salami acknowledged certain limitations of the study, including the fact that MEPS was carried out in a noninstitutionalized adult population and that the definition of ASCVD was based partly on self-report. “Therefore, an underestimation of number adults with ASCVD is likely,” he said. “We also couldn’t determine adherence to medication nor long-term use of statins among adults with ASCVD.”
He concluded his presentation by noting that, over the 10-year study period, there were about 71.2 million ASCVD adult-years without a statin prescription. “That is a staggering number,” Dr. Salami said.
He reported having no financial disclosures.
SOURCE: Salami A et al. Epi/Lifestyle 2020, Abstract 4.
PHOENIX – Statin use for the secondary prevention of cardiovascular disease increased modestly between 2008 and 2017 in the United States, but more than 40% of patients with established atherosclerotic cardiovascular disease are still not on a statin.
In addition, even after release of the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014;129:S1-45) that markedly increased the pool of eligible patients, disparities exist in the proportion of women versus men, and blacks and Hispanics versus whites with atherosclerotic cardiovascular disease (ASCVD) who are currently receiving a statin.
“Despite repeated calls for the use of statins for secondary prevention of CVD in multiple guidelines, gender and racial inequalities in the use of statins persist,” Joseph A. Salami, MD, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the American Heart Association. “Cardiovascular disease remains the leading cause of death in the U.S. In 2017, it was responsible for 647,457 deaths. We have an opportunity to improve CVD-related outcomes and cost by intensifying efforts to use statins for the secondary prevention of CVD and closing gender and racial gaps. Action is needed.”
Dr. Salami, a biostatistician with the Baptist Health South Florida Center for Advanced Analytics in Coral Gables, based his remarks on an analysis of data contained in the 2008-2017 Medical Expenditure Panel Survey (MEPS), a national representative survey sponsored by the Agency for Healthcare Research and Quality. “Between 2013 and 2018 there were six different guidelines released encouraging statin use among ASCVD patients,” he said. “Besides the good number needed to treat, statin use on secondary prevention of CVD is cost effective.”
Given the proven efficacy of statin use in the prevention of CVD, he and his associates set out to examine trends in the proportion of adults with ASCVD using statins and to assess for gender and racial differences in their use. The researchers used ICD-9 and ICD-10 codes to define ASCVD among the MEPS study population, as well as self-reported history of coronary artery disease, peripheral artery disease, and stroke. After excluding adults aged younger than 40 years and those without ASCVD, this left a population of 15,911 patients. Of these, 44% were female, their mean age was 62 years, and 72% were Caucasian.
Overall, statin use increased from 50% in 2008 to 58.7% in 2017, with an average annual percentage change of 0.95% between 2010 and 2017 (P = .01). However, the annual percentage change in statin use was 0.25% among men versus 0.14% among women (P = .022). “Each year during the study period, more than 3 million women with ASCVD were not prescribed a statin, which translated into about 36 million adult-years,” Dr. Salami said. “In 2017, 16% of these women were African Americans and 15% were Hispanic.”
Logistic regression analysis revealed that in 2017, females with ASCVD were less likely to be prescribed a statin, compared with males (odds ratio, 0.52; P less than .001). In addition, compared with whites, blacks were less likely to be prescribed a statin (OR, 0.69; P = .012), as were Hispanics (OR, 0.62; P = .003). “In a multivariate logistic regression controlling for age, health insurance status, and comorbidities, the gender disparity remained statistically significant, but the racial disparity did not,” Dr. Salami said.
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, characterized the study’s findings as sobering. “This should be an eye-opener for all of us in medicine, whether we are physicians, pharmacists, nurses, or researchers,” said Dr. Brown, who is a cardiologist and physician scientist at the Mayo Clinic in Rochester, Minn. “We’re all in this together, and we all have a role to play in addressing social determinants of health. I think we need to recognize the fact that we’re not treating blacks, Hispanics, and women to the degree that we should be, compared to whites and men. I think we need to do better, and we need to figure out how to reach that population, and how to improve.”
Dr. Salami acknowledged certain limitations of the study, including the fact that MEPS was carried out in a noninstitutionalized adult population and that the definition of ASCVD was based partly on self-report. “Therefore, an underestimation of number adults with ASCVD is likely,” he said. “We also couldn’t determine adherence to medication nor long-term use of statins among adults with ASCVD.”
He concluded his presentation by noting that, over the 10-year study period, there were about 71.2 million ASCVD adult-years without a statin prescription. “That is a staggering number,” Dr. Salami said.
He reported having no financial disclosures.
SOURCE: Salami A et al. Epi/Lifestyle 2020, Abstract 4.
PHOENIX – Statin use for the secondary prevention of cardiovascular disease increased modestly between 2008 and 2017 in the United States, but more than 40% of patients with established atherosclerotic cardiovascular disease are still not on a statin.
In addition, even after release of the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (Circulation. 2014;129:S1-45) that markedly increased the pool of eligible patients, disparities exist in the proportion of women versus men, and blacks and Hispanics versus whites with atherosclerotic cardiovascular disease (ASCVD) who are currently receiving a statin.
“Despite repeated calls for the use of statins for secondary prevention of CVD in multiple guidelines, gender and racial inequalities in the use of statins persist,” Joseph A. Salami, MD, MPH, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the American Heart Association. “Cardiovascular disease remains the leading cause of death in the U.S. In 2017, it was responsible for 647,457 deaths. We have an opportunity to improve CVD-related outcomes and cost by intensifying efforts to use statins for the secondary prevention of CVD and closing gender and racial gaps. Action is needed.”
Dr. Salami, a biostatistician with the Baptist Health South Florida Center for Advanced Analytics in Coral Gables, based his remarks on an analysis of data contained in the 2008-2017 Medical Expenditure Panel Survey (MEPS), a national representative survey sponsored by the Agency for Healthcare Research and Quality. “Between 2013 and 2018 there were six different guidelines released encouraging statin use among ASCVD patients,” he said. “Besides the good number needed to treat, statin use on secondary prevention of CVD is cost effective.”
Given the proven efficacy of statin use in the prevention of CVD, he and his associates set out to examine trends in the proportion of adults with ASCVD using statins and to assess for gender and racial differences in their use. The researchers used ICD-9 and ICD-10 codes to define ASCVD among the MEPS study population, as well as self-reported history of coronary artery disease, peripheral artery disease, and stroke. After excluding adults aged younger than 40 years and those without ASCVD, this left a population of 15,911 patients. Of these, 44% were female, their mean age was 62 years, and 72% were Caucasian.
Overall, statin use increased from 50% in 2008 to 58.7% in 2017, with an average annual percentage change of 0.95% between 2010 and 2017 (P = .01). However, the annual percentage change in statin use was 0.25% among men versus 0.14% among women (P = .022). “Each year during the study period, more than 3 million women with ASCVD were not prescribed a statin, which translated into about 36 million adult-years,” Dr. Salami said. “In 2017, 16% of these women were African Americans and 15% were Hispanic.”
Logistic regression analysis revealed that in 2017, females with ASCVD were less likely to be prescribed a statin, compared with males (odds ratio, 0.52; P less than .001). In addition, compared with whites, blacks were less likely to be prescribed a statin (OR, 0.69; P = .012), as were Hispanics (OR, 0.62; P = .003). “In a multivariate logistic regression controlling for age, health insurance status, and comorbidities, the gender disparity remained statistically significant, but the racial disparity did not,” Dr. Salami said.
In an interview, one of the meeting session’s moderators, Sherry-Ann Brown, MD, PhD, characterized the study’s findings as sobering. “This should be an eye-opener for all of us in medicine, whether we are physicians, pharmacists, nurses, or researchers,” said Dr. Brown, who is a cardiologist and physician scientist at the Mayo Clinic in Rochester, Minn. “We’re all in this together, and we all have a role to play in addressing social determinants of health. I think we need to recognize the fact that we’re not treating blacks, Hispanics, and women to the degree that we should be, compared to whites and men. I think we need to do better, and we need to figure out how to reach that population, and how to improve.”
Dr. Salami acknowledged certain limitations of the study, including the fact that MEPS was carried out in a noninstitutionalized adult population and that the definition of ASCVD was based partly on self-report. “Therefore, an underestimation of number adults with ASCVD is likely,” he said. “We also couldn’t determine adherence to medication nor long-term use of statins among adults with ASCVD.”
He concluded his presentation by noting that, over the 10-year study period, there were about 71.2 million ASCVD adult-years without a statin prescription. “That is a staggering number,” Dr. Salami said.
He reported having no financial disclosures.
SOURCE: Salami A et al. Epi/Lifestyle 2020, Abstract 4.
REPORTING FROM EPI/LIFESTYLE 2020
Exercise needn’t be strenuous to reduce heart risk
PHOENIX – results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.
In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.
The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.
“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”
For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.
Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.
She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”
Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”
Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”
In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.
Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.
“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.
According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”
The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.
During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.
“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.
He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”
“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”
Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.
SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.
PHOENIX – results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.
In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.
The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.
“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”
For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.
Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.
She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”
Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”
Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”
In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.
Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.
“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.
According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”
The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.
During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.
“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.
He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”
“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”
Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.
SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.
PHOENIX – results from two studies presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting showed.
In one study, women who walked 2,100-4,500 steps each day reduced their risk of dying from cardiovascular disease by up to 38%, compared with those who walked fewer than 2,100 steps each day. In addition, women who walked more than 4,500 steps each day reduced their risk of cardiovascular disease (CVD) mortality risk by 48%.
The findings come from an ancillary analysis of the Women’s Health Study known as the Objective Physical Activity and Cardiovascular Health (OPACH) Study.
“Our work shows that both light-intensity and moderate-/vigorous-intensity steps are associated with reduced risk of cardiovascular disease death,” lead author Andrea Z. LaCroix, PhD, said in an interview. “And our previous studies show that all movement while standing, stepping, or just moving about at whatever intensity you choose, appears to have cardiovascular benefits, whereas long hours spent sedentary, especially prolonged sitting bouts are associated with increased risk of cardiovascular disease. These new findings on steps are best interpreted as showing that moving instead of sitting is good for your heart and blood vessels as we get older. Find the things you love to do and get moving.”
For OPACH, 6,379 women with an average age of 79 years wore ActiGraph GT3X+ triaxial accelerometers on their wrist for 7 days during 2012-2014, as a way to ascertain the number of steps they took. The researchers followed the study participants to March 1, 2019, and used Cox proportional hazard models to estimate CVD mortality across four quartiles of steps per day, adjusted for age, race/ethnicity, education, smoking, alcohol consumption, self-reported health, comorbidities, and physical function. The lowest quartile reference category was less than 2,108 steps per day. The second, third and fourth quartiles were: 2,108 to fewer than 3,136 steps, 3,136 to fewer than 4,499, and 4,500 and above.
Dr. LaCroix, distinguished professor and chief of epidemiology at the University of California, San Diego, reported that women who walked 2,100-4,500 steps daily reduced their risk of dying from CVD by up to up to 38%, compared with women who walked fewer than 2,100 daily steps. The women who walked more than 4,500 steps per day reduced their risk by 48%.
She noted that, for many years, common wisdom was that 10,000 steps per day should be used as a general fitness target, [but] that goal “was never evidence based, and so far, emerging evidence using accelerometers to measure steps shows benefit way below the level of 10,000 steps.” Dr. LaCroix added that, in this study, “we were able separate steps taken at a light intensity of energy expenditure versus a moderate or vigorous level of energy expenditure. This is like comparing slower versus faster steps. Both influenced the risk of CVD death and we found no evidence that faster steps were more beneficial for reducing risk of CVD death than slower steps. So, the main message I want my demographic [women aged over 60] to understand is that all movement appears to be good for your heart.”
Barry A. Franklin, PhD, director of preventive cardiology and cardiac rehabilitation at Beaumont Health in Royal Oak, Mich., characterized the study findings as “good news” but not entirely surprising. “It goes along with other research showing that the biggest bang from the buck is going from the least fit, least active cohort, which we call the bottom 20%, to the next lowest level,” he said in an interview. “So, by simply doing some steps, certainly less than 10,000, there were significant benefits for this older age group.”
Dr. LaCroix acknowledged certain limitations of the OPACH study, including the fact that it did not include men or women aged younger than 60 years. In addition, the accelerometer used in this and other studies may measure fewer steps than women are actually taking. “Devices vary in their accuracy,” she said. “If you are tracking steps, try to aim for 4,500 or a little more, but know that every step counts.”
In a separate study, researchers found that an increase of 30 minutes per day of low-intensity physical activity (LIPA) may lower the risk of death among older adults, regardless of the amount of moderate to vigorous physical activity (MVPA) participants are involved in or whether they have impaired physical function. In addition, an increase of 30 minutes of sedentary time per day may increase the risk of death regardless of the amount of MVPA or whether participants have impaired physical function.
Those are key findings from an analysis of 1,262 participants in the Framingham Offspring Study.
“Given that MVPA tends to decline with age, particularly during the mid- to late-life transition, promoting LIPA and reducing sedentary time may be a more practical alternative among older adults for reducing the risk of mortality,” lead author Joowon Lee, PhD, said in an interview at the meeting sponsored by the American Heart Association.
According to Dr. Lee, a postdoctoral fellow at Boston University, prior studies found that the inverse association between MVPA and cardiovascular and all-cause mortality among older adults. “However, we focused on sedentary and light-intensity physical activity, which is prevalent in older adult population,” he said. “Additionally, we looked at the association between physical activity and mortality after excluding participants with frailty as a sensitivity analysis.”
The researchers drew from accelerometry-derived physical activity data from 1,262 Framingham Offspring Study participants at their ninth examination (2011-2014). The mean age of the subjects was 69 years, 54% were women, and they had worn the accelerometers at least 10 hours per day for at least 4 days prior to the exam visit. The researchers used multivariable Cox proportional hazards regression models to relate physician activity and sedentary time with all-cause mortality adjusting for potential confounders.
During a median follow-up of 4.8 years, 67 study participants died. Dr. Lee and colleagues observed that higher total physical activity, LIPA, adherence to physical activity guidelines (at least 150 minutes of activity each week), and lower sedentary time were associated with a lower risk of all-cause mortality. Specifically, they were 67% less likely to die of any cause if they spent at least 150 minutes per week in moderate to vigorous physical activity, compared with those who did not. In addition, the researchers found that each 30-minute interval of LIPA, such as doing household chores or casual walking, was associated with a 20% lower risk of dying from any cause. On the other hand, every additional 30 minutes of being sedentary was related to a 32% higher risk of dying from any cause. The results remained statistically significant even after excluding those with frailty.
“In the present analysis, an increase of 10 minutes in MVPA was not associated with the risk of all-cause mortality although meeting physical activity guidelines [MVPA of at least 150 minutes per week] was the strongest factor associated with the risk of all-cause mortality,” Dr. Lee said.
He acknowledged certain limitations of the analysis, including the fact that the study participants were white individuals with European ancestry. “Additionally, a small number of mortality events were observed in the current investigation,” he said. “So, an additional study of larger multiethnic samples of older adults is warranted to confirm our findings.”
“We tell people: ‘You need 30 minutes of moderate intensity exercise most days of the week,’ ” Dr. Franklin said. “That’s true, but a classic study in Lancet showed that if you do 12 or 15 minutes of moderate exercise, not 30 minutes, you also get a 14% reduction in mortality. Some exercise is better than none, and for older adults, they don’t even have to do moderate intensity exercise to get benefits.”
Dr. LaCroix’s study was funded by the National Heart, Lung, and Blood Institute; Dr. LaCroix reported having no financial disclosures. Dr. Lee’s study was supported by the National Heart, Lung, and Blood Institute; Dr. Lee reported having no disclosures.
SOURCES: LaCroix A et al. Epi/Lifestyle 2020, Abstract 30; Lee J et al. Epi/Lifestyle 2020, Abstract 31.
REPORTING FROM EPI/LIFESTYLE 2020
Complexity of suicidal ideation, behavior points to need for new treatments
LAS VEGAS – More than 10 years ago, Gerard Sanacora, PhD, MD, came across a study in the medical literature that stopped him in his tracks.
For the study, Austrian neurologist Eberhard A. Deisenhammer, MD, and colleagues sought to determine the length of the period between consideration and accomplishment of a suicide attempt (J Clin Psychiatry. 2009;70[1]:19-24). To do so, they interviewed 82 patients who were referred to a psychiatric university hospital after a suicide attempt. Nearly half of the patients (48%) reported that the period between the first current thought of suicide and the actual attempt had lasted 10 minutes or less.
“When you’re talking about treating suicide behavior, there are so many components: the impulsivity component, the resilience component – all these things that can’t be measured with a simple outcome measure,” Dr. Sanacora said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “That’s one of the real challenges. It requires us to take a good look at how we’re treating these patients in general.”
It also underscores the need for new treatments that target suicidal ideation and behavior.
“There is increasing evidence that ketamine and esketamine can produce effects that could be used in the treatment of mood disorder patients with suicidal ideation or behavior,” said Dr. Sanacora, professor of psychiatry at Yale University, New Haven, Conn. “However, there are many challenges to performing the studies that are required to more definitively demonstrate rapid and sustained improvement in suicide risks.”
The global 12-month prevalence of nonfatal suicide attempts is about 0.3% to 0.4%, and the lifetime prevalence is 3%, “which is pretty shocking,” he said. In the United States, there are more than 30 suicide attempts for each suicide death. At the same time, a World Health Organization community survey conducted in 21 countries found that the 12-month prevalence of suicidal ideation was about 2%, and that the lifetime prevalence was 9%. “These are large numbers that we’re talking about internationally,” said Dr. Sanacora, who also directs the Yale Depression Research Program. In 2013, suicidal ideation constituted nearly 1% of all adult ED visits in the United States, with conservative costs of $2.2 billion. “Every step along the process takes a large toll on the health care system and society, from the top level of completed suicide to suicidal ideation,” he said.
According to 2016 data from the Centers for Disease Control and Prevention, nearly 10 million people in the United States have seriously considered suicide, about 2.5 million made a plan, about 1 million attempted suicide, and about 40,000 completed suicide. “We have to think about what we’re treating,” Dr. Sanacora said. “Are we treating the suicidal ideation, or are we trying to prevent completed suicides?”
A prior history of attempted suicide is the strongest single predictive factor of a completed suicide. “In fact, the risk of dying by suicide is approximately 100 times than that of the general population within 1 year of an index attempt,” he said. Another major risk factor is having a previous psychiatric hospitalization. In fact, up to 41% of those who completed suicide had been psychiatric inpatients within the previous year, and as many as 9% of suicides occurred within 1 day of discharge from psychiatric inpatient care. Other identified risk factors include marital status, belonging to a sexual minority, occupation, military service, general medical comorbidities, diagnosis of personality disorder, chronic pain, traumatic brain injury, childhood abuse, location of residence, access to firearms, and family history of suicide. Protective factors include having a strong social support network, being a parent, and religiosity. “These are things that typically aren’t part of a treatment, but they can be woven into a treatment plan in some way,” he said.
Other identified risk symptoms include feelings of worthlessness and hopelessness, the combination of depression and anxiety, and psychosis, regardless of the specific diagnosis.
Medical stabilization constitutes the first step in the standard treatment approach to suicidal ideation and behavior. “You want to make sure the person is hospitalized and take care of any injuries that may have been sustained in the suicide attempt,” Dr. Sanacora said. The next step is reducing the immediate risks. “For the most part, that’s making sure the individual is in a safe setting commensurate with the level of risk,” he said. “You want to remove any other risks that could be around them. Then, you want to assure that an appropriate level of follow-up is provided on stepdown to lower levels of care. That year after hospitalization puts you at incredible risk, so we want to make sure we’re not just treating something in the acute phase and then not having longer-term follow-up for it.”
Existing treatments that have some evidence to help with the treatment of suicidal ideation and behavior include the use of antidepressants, lithium, and clozapine, but these agents are far from fast-acting for a patient in crisis. “In addition, a lot of docs are hesitant to give lithium because it has the potential of overdose itself,” Dr. Sanacora said. With clozapine, he continued, “there is some level of confounding by indication because, when you’re giving clozapine, it’s usually a more reliable patient, one who is not at risk of self-harm.”
The STAR*D (Sequenced Treatment Alternatives to Relieve Depression) trial demonstrated that, for the patients who do not respond to the first two levels of treatment with citalopram, their chances of having a remission by getting a third or fourth level of treatment is reduced to below 15% (Am J Psychiatry. 2006;163[1]:28-40).
“This suggests that, with our current armamentarium, we are limited,” said Dr. Sanacora, who is also codirector of the Yale New Haven Hospital Interventional Psychiatry Service. In the STAR*D trial, the time to response to citalopram was 6 weeks in 50% of patients. “So, when somebody is going through a crisis and is at imminent risk for suicide, and you tell them, ‘You’ll be 50% better in 6 weeks,’ that’s hard to swallow,” he said.
Recent studies of ketamine and esketamine have demonstrated a rapid onset of effect in patients with major depressive disorder, but whether they alter suicidal ideation and behavior remains unclear. “If you are wanting to improve suicidal ideation and behavior, what outcome measure are you using to do this?” Dr. Sanacora asked. “It may seem simple, but it’s not. To do a clinical trial, you would need large sample sizes to look at behavior as an outcome. In fact, even retrospective studies on this topic don’t have enough events to give you statistical meaning.” This leaves clinicians to consider scales that have been used for examining suicidal ideation and behavior over the years, including the MINI suicidality module, the SAD PERSONS scale, and the Suicide Intent Scale. “However, while they could have some value to be used clinically, these scales really don’t have great value as outcome measures,” Dr. Sanacora said.
There also have been attempts to develop scales that capture changes in suicidal ideation and behavior over time, including the C-SSRS (Columbia-Suicide Severity Rating Scale) and the Sheehan Suicidality Tracking Scale. “The sad thing is, none of these measures have been proven to be very useful clinically,” he said. “They may have some level of sensitivity and specificity, but their actual predictive value is not great. So using these clinically is somewhat difficult.”
In 2018, Dr. Sanacora and his colleagues published results from a systematic review and individual participant data meta-analysis examining the effects of a single dose of ketamine on suicidal ideation (Am J Psychiatry. 2018;175[2]:150-8). The analysis included 167 participants with suicidal ideation at baseline. “Within 24 hours there was a very clear decrease in suicidal ideation in terms of clinician-reported scale,” he said. “Over 50% of patients reported having minimal or no ideation after treatment. That was maintained for 7 days.” Effect sizes were moderate to large at all time points post dose.
In the largest meta-analysis of its kind to date, researchers reviewed 15 independent trials of ketamine for suicide ideation in 572 adults with psychiatric disorders, all with a single dose of drug with varying routes and dosages (Aust N Z J Psychiatry. 2020;54[1]:29-45). The researchers in that study concluded that ketamine “may have a role in acute treatment for suicidality. However, there is clearly a need for clinical measures to ensure persistence of any benefits.”
Esketamine, which was approved in March 2019 for major depressive disorder, also shows promise in patients with suicidal ideation and behavior. In a double-blind, multicenter, proof-of-concept study, researchers randomized 68 participants to receive esketamine (84 mg) or placebo twice weekly for 4 weeks, in addition to comprehensive standard-of-care treatment (Am J Psychiatry. 2018;175[7]:620-30). The primary efficacy endpoint was change in score from baseline to 4 hours after initial dose on the MADRS (Montgomery-Asberg Depression Rating Scale). “There was a nice effect in the antidepressant response, compared with placebo. It hit the primary endpoint at 4 hours. The patients got treated twice a week for 4 weeks. People got better quickly and stayed well moving on.” The researchers also found that the rate of remission at day 25 was 60% in the esketamine group, compared with 42% in the placebo group. “The take-home message is that, even without the esketamine, the remission rate was 42% at day 25. That means if you’re giving people really good care, meaning that you’re seeing them twice a week and they’re inpatient until they’re able to go outpatient, people can do pretty well with that level of care.”
Meanwhile, In a proof-of-concept trial, 18 depressed subjects with acute suicidal ideation who presented to the emergency department and required hospitalization were randomized to either IV ketamine 0.2 mg/kg or to saline placebo (Depress Anxiety. 2019 Nov 16. doi: 10.1002/da.22975). Ninety minutes after infusion, 88% of patients in the ketamine group had achieved remission of suicidal ideation, compared with 33% in the placebo group (P less than .05). No serious adverse events were noted.
“There is a clear need for new treatments targeting suicidal ideation and behavior,” Dr. Sanacora concluded. “Any plan to institute a rapid-acting treatment for individuals with imminent risk of suicidal behavior must be placed in the context of a larger comprehensive treatment plan. Getting somebody to feel better in the short run is great, but you really have to think about the whole treatment plan.”
Dr. Sanacora reported having received grants and research support from numerous pharmaceutical companies. He also holds an ownership interest in Biohaven Pharmaceuticals.
LAS VEGAS – More than 10 years ago, Gerard Sanacora, PhD, MD, came across a study in the medical literature that stopped him in his tracks.
For the study, Austrian neurologist Eberhard A. Deisenhammer, MD, and colleagues sought to determine the length of the period between consideration and accomplishment of a suicide attempt (J Clin Psychiatry. 2009;70[1]:19-24). To do so, they interviewed 82 patients who were referred to a psychiatric university hospital after a suicide attempt. Nearly half of the patients (48%) reported that the period between the first current thought of suicide and the actual attempt had lasted 10 minutes or less.
“When you’re talking about treating suicide behavior, there are so many components: the impulsivity component, the resilience component – all these things that can’t be measured with a simple outcome measure,” Dr. Sanacora said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “That’s one of the real challenges. It requires us to take a good look at how we’re treating these patients in general.”
It also underscores the need for new treatments that target suicidal ideation and behavior.
“There is increasing evidence that ketamine and esketamine can produce effects that could be used in the treatment of mood disorder patients with suicidal ideation or behavior,” said Dr. Sanacora, professor of psychiatry at Yale University, New Haven, Conn. “However, there are many challenges to performing the studies that are required to more definitively demonstrate rapid and sustained improvement in suicide risks.”
The global 12-month prevalence of nonfatal suicide attempts is about 0.3% to 0.4%, and the lifetime prevalence is 3%, “which is pretty shocking,” he said. In the United States, there are more than 30 suicide attempts for each suicide death. At the same time, a World Health Organization community survey conducted in 21 countries found that the 12-month prevalence of suicidal ideation was about 2%, and that the lifetime prevalence was 9%. “These are large numbers that we’re talking about internationally,” said Dr. Sanacora, who also directs the Yale Depression Research Program. In 2013, suicidal ideation constituted nearly 1% of all adult ED visits in the United States, with conservative costs of $2.2 billion. “Every step along the process takes a large toll on the health care system and society, from the top level of completed suicide to suicidal ideation,” he said.
According to 2016 data from the Centers for Disease Control and Prevention, nearly 10 million people in the United States have seriously considered suicide, about 2.5 million made a plan, about 1 million attempted suicide, and about 40,000 completed suicide. “We have to think about what we’re treating,” Dr. Sanacora said. “Are we treating the suicidal ideation, or are we trying to prevent completed suicides?”
A prior history of attempted suicide is the strongest single predictive factor of a completed suicide. “In fact, the risk of dying by suicide is approximately 100 times than that of the general population within 1 year of an index attempt,” he said. Another major risk factor is having a previous psychiatric hospitalization. In fact, up to 41% of those who completed suicide had been psychiatric inpatients within the previous year, and as many as 9% of suicides occurred within 1 day of discharge from psychiatric inpatient care. Other identified risk factors include marital status, belonging to a sexual minority, occupation, military service, general medical comorbidities, diagnosis of personality disorder, chronic pain, traumatic brain injury, childhood abuse, location of residence, access to firearms, and family history of suicide. Protective factors include having a strong social support network, being a parent, and religiosity. “These are things that typically aren’t part of a treatment, but they can be woven into a treatment plan in some way,” he said.
Other identified risk symptoms include feelings of worthlessness and hopelessness, the combination of depression and anxiety, and psychosis, regardless of the specific diagnosis.
Medical stabilization constitutes the first step in the standard treatment approach to suicidal ideation and behavior. “You want to make sure the person is hospitalized and take care of any injuries that may have been sustained in the suicide attempt,” Dr. Sanacora said. The next step is reducing the immediate risks. “For the most part, that’s making sure the individual is in a safe setting commensurate with the level of risk,” he said. “You want to remove any other risks that could be around them. Then, you want to assure that an appropriate level of follow-up is provided on stepdown to lower levels of care. That year after hospitalization puts you at incredible risk, so we want to make sure we’re not just treating something in the acute phase and then not having longer-term follow-up for it.”
Existing treatments that have some evidence to help with the treatment of suicidal ideation and behavior include the use of antidepressants, lithium, and clozapine, but these agents are far from fast-acting for a patient in crisis. “In addition, a lot of docs are hesitant to give lithium because it has the potential of overdose itself,” Dr. Sanacora said. With clozapine, he continued, “there is some level of confounding by indication because, when you’re giving clozapine, it’s usually a more reliable patient, one who is not at risk of self-harm.”
The STAR*D (Sequenced Treatment Alternatives to Relieve Depression) trial demonstrated that, for the patients who do not respond to the first two levels of treatment with citalopram, their chances of having a remission by getting a third or fourth level of treatment is reduced to below 15% (Am J Psychiatry. 2006;163[1]:28-40).
“This suggests that, with our current armamentarium, we are limited,” said Dr. Sanacora, who is also codirector of the Yale New Haven Hospital Interventional Psychiatry Service. In the STAR*D trial, the time to response to citalopram was 6 weeks in 50% of patients. “So, when somebody is going through a crisis and is at imminent risk for suicide, and you tell them, ‘You’ll be 50% better in 6 weeks,’ that’s hard to swallow,” he said.
Recent studies of ketamine and esketamine have demonstrated a rapid onset of effect in patients with major depressive disorder, but whether they alter suicidal ideation and behavior remains unclear. “If you are wanting to improve suicidal ideation and behavior, what outcome measure are you using to do this?” Dr. Sanacora asked. “It may seem simple, but it’s not. To do a clinical trial, you would need large sample sizes to look at behavior as an outcome. In fact, even retrospective studies on this topic don’t have enough events to give you statistical meaning.” This leaves clinicians to consider scales that have been used for examining suicidal ideation and behavior over the years, including the MINI suicidality module, the SAD PERSONS scale, and the Suicide Intent Scale. “However, while they could have some value to be used clinically, these scales really don’t have great value as outcome measures,” Dr. Sanacora said.
There also have been attempts to develop scales that capture changes in suicidal ideation and behavior over time, including the C-SSRS (Columbia-Suicide Severity Rating Scale) and the Sheehan Suicidality Tracking Scale. “The sad thing is, none of these measures have been proven to be very useful clinically,” he said. “They may have some level of sensitivity and specificity, but their actual predictive value is not great. So using these clinically is somewhat difficult.”
In 2018, Dr. Sanacora and his colleagues published results from a systematic review and individual participant data meta-analysis examining the effects of a single dose of ketamine on suicidal ideation (Am J Psychiatry. 2018;175[2]:150-8). The analysis included 167 participants with suicidal ideation at baseline. “Within 24 hours there was a very clear decrease in suicidal ideation in terms of clinician-reported scale,” he said. “Over 50% of patients reported having minimal or no ideation after treatment. That was maintained for 7 days.” Effect sizes were moderate to large at all time points post dose.
In the largest meta-analysis of its kind to date, researchers reviewed 15 independent trials of ketamine for suicide ideation in 572 adults with psychiatric disorders, all with a single dose of drug with varying routes and dosages (Aust N Z J Psychiatry. 2020;54[1]:29-45). The researchers in that study concluded that ketamine “may have a role in acute treatment for suicidality. However, there is clearly a need for clinical measures to ensure persistence of any benefits.”
Esketamine, which was approved in March 2019 for major depressive disorder, also shows promise in patients with suicidal ideation and behavior. In a double-blind, multicenter, proof-of-concept study, researchers randomized 68 participants to receive esketamine (84 mg) or placebo twice weekly for 4 weeks, in addition to comprehensive standard-of-care treatment (Am J Psychiatry. 2018;175[7]:620-30). The primary efficacy endpoint was change in score from baseline to 4 hours after initial dose on the MADRS (Montgomery-Asberg Depression Rating Scale). “There was a nice effect in the antidepressant response, compared with placebo. It hit the primary endpoint at 4 hours. The patients got treated twice a week for 4 weeks. People got better quickly and stayed well moving on.” The researchers also found that the rate of remission at day 25 was 60% in the esketamine group, compared with 42% in the placebo group. “The take-home message is that, even without the esketamine, the remission rate was 42% at day 25. That means if you’re giving people really good care, meaning that you’re seeing them twice a week and they’re inpatient until they’re able to go outpatient, people can do pretty well with that level of care.”
Meanwhile, In a proof-of-concept trial, 18 depressed subjects with acute suicidal ideation who presented to the emergency department and required hospitalization were randomized to either IV ketamine 0.2 mg/kg or to saline placebo (Depress Anxiety. 2019 Nov 16. doi: 10.1002/da.22975). Ninety minutes after infusion, 88% of patients in the ketamine group had achieved remission of suicidal ideation, compared with 33% in the placebo group (P less than .05). No serious adverse events were noted.
“There is a clear need for new treatments targeting suicidal ideation and behavior,” Dr. Sanacora concluded. “Any plan to institute a rapid-acting treatment for individuals with imminent risk of suicidal behavior must be placed in the context of a larger comprehensive treatment plan. Getting somebody to feel better in the short run is great, but you really have to think about the whole treatment plan.”
Dr. Sanacora reported having received grants and research support from numerous pharmaceutical companies. He also holds an ownership interest in Biohaven Pharmaceuticals.
LAS VEGAS – More than 10 years ago, Gerard Sanacora, PhD, MD, came across a study in the medical literature that stopped him in his tracks.
For the study, Austrian neurologist Eberhard A. Deisenhammer, MD, and colleagues sought to determine the length of the period between consideration and accomplishment of a suicide attempt (J Clin Psychiatry. 2009;70[1]:19-24). To do so, they interviewed 82 patients who were referred to a psychiatric university hospital after a suicide attempt. Nearly half of the patients (48%) reported that the period between the first current thought of suicide and the actual attempt had lasted 10 minutes or less.
“When you’re talking about treating suicide behavior, there are so many components: the impulsivity component, the resilience component – all these things that can’t be measured with a simple outcome measure,” Dr. Sanacora said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “That’s one of the real challenges. It requires us to take a good look at how we’re treating these patients in general.”
It also underscores the need for new treatments that target suicidal ideation and behavior.
“There is increasing evidence that ketamine and esketamine can produce effects that could be used in the treatment of mood disorder patients with suicidal ideation or behavior,” said Dr. Sanacora, professor of psychiatry at Yale University, New Haven, Conn. “However, there are many challenges to performing the studies that are required to more definitively demonstrate rapid and sustained improvement in suicide risks.”
The global 12-month prevalence of nonfatal suicide attempts is about 0.3% to 0.4%, and the lifetime prevalence is 3%, “which is pretty shocking,” he said. In the United States, there are more than 30 suicide attempts for each suicide death. At the same time, a World Health Organization community survey conducted in 21 countries found that the 12-month prevalence of suicidal ideation was about 2%, and that the lifetime prevalence was 9%. “These are large numbers that we’re talking about internationally,” said Dr. Sanacora, who also directs the Yale Depression Research Program. In 2013, suicidal ideation constituted nearly 1% of all adult ED visits in the United States, with conservative costs of $2.2 billion. “Every step along the process takes a large toll on the health care system and society, from the top level of completed suicide to suicidal ideation,” he said.
According to 2016 data from the Centers for Disease Control and Prevention, nearly 10 million people in the United States have seriously considered suicide, about 2.5 million made a plan, about 1 million attempted suicide, and about 40,000 completed suicide. “We have to think about what we’re treating,” Dr. Sanacora said. “Are we treating the suicidal ideation, or are we trying to prevent completed suicides?”
A prior history of attempted suicide is the strongest single predictive factor of a completed suicide. “In fact, the risk of dying by suicide is approximately 100 times than that of the general population within 1 year of an index attempt,” he said. Another major risk factor is having a previous psychiatric hospitalization. In fact, up to 41% of those who completed suicide had been psychiatric inpatients within the previous year, and as many as 9% of suicides occurred within 1 day of discharge from psychiatric inpatient care. Other identified risk factors include marital status, belonging to a sexual minority, occupation, military service, general medical comorbidities, diagnosis of personality disorder, chronic pain, traumatic brain injury, childhood abuse, location of residence, access to firearms, and family history of suicide. Protective factors include having a strong social support network, being a parent, and religiosity. “These are things that typically aren’t part of a treatment, but they can be woven into a treatment plan in some way,” he said.
Other identified risk symptoms include feelings of worthlessness and hopelessness, the combination of depression and anxiety, and psychosis, regardless of the specific diagnosis.
Medical stabilization constitutes the first step in the standard treatment approach to suicidal ideation and behavior. “You want to make sure the person is hospitalized and take care of any injuries that may have been sustained in the suicide attempt,” Dr. Sanacora said. The next step is reducing the immediate risks. “For the most part, that’s making sure the individual is in a safe setting commensurate with the level of risk,” he said. “You want to remove any other risks that could be around them. Then, you want to assure that an appropriate level of follow-up is provided on stepdown to lower levels of care. That year after hospitalization puts you at incredible risk, so we want to make sure we’re not just treating something in the acute phase and then not having longer-term follow-up for it.”
Existing treatments that have some evidence to help with the treatment of suicidal ideation and behavior include the use of antidepressants, lithium, and clozapine, but these agents are far from fast-acting for a patient in crisis. “In addition, a lot of docs are hesitant to give lithium because it has the potential of overdose itself,” Dr. Sanacora said. With clozapine, he continued, “there is some level of confounding by indication because, when you’re giving clozapine, it’s usually a more reliable patient, one who is not at risk of self-harm.”
The STAR*D (Sequenced Treatment Alternatives to Relieve Depression) trial demonstrated that, for the patients who do not respond to the first two levels of treatment with citalopram, their chances of having a remission by getting a third or fourth level of treatment is reduced to below 15% (Am J Psychiatry. 2006;163[1]:28-40).
“This suggests that, with our current armamentarium, we are limited,” said Dr. Sanacora, who is also codirector of the Yale New Haven Hospital Interventional Psychiatry Service. In the STAR*D trial, the time to response to citalopram was 6 weeks in 50% of patients. “So, when somebody is going through a crisis and is at imminent risk for suicide, and you tell them, ‘You’ll be 50% better in 6 weeks,’ that’s hard to swallow,” he said.
Recent studies of ketamine and esketamine have demonstrated a rapid onset of effect in patients with major depressive disorder, but whether they alter suicidal ideation and behavior remains unclear. “If you are wanting to improve suicidal ideation and behavior, what outcome measure are you using to do this?” Dr. Sanacora asked. “It may seem simple, but it’s not. To do a clinical trial, you would need large sample sizes to look at behavior as an outcome. In fact, even retrospective studies on this topic don’t have enough events to give you statistical meaning.” This leaves clinicians to consider scales that have been used for examining suicidal ideation and behavior over the years, including the MINI suicidality module, the SAD PERSONS scale, and the Suicide Intent Scale. “However, while they could have some value to be used clinically, these scales really don’t have great value as outcome measures,” Dr. Sanacora said.
There also have been attempts to develop scales that capture changes in suicidal ideation and behavior over time, including the C-SSRS (Columbia-Suicide Severity Rating Scale) and the Sheehan Suicidality Tracking Scale. “The sad thing is, none of these measures have been proven to be very useful clinically,” he said. “They may have some level of sensitivity and specificity, but their actual predictive value is not great. So using these clinically is somewhat difficult.”
In 2018, Dr. Sanacora and his colleagues published results from a systematic review and individual participant data meta-analysis examining the effects of a single dose of ketamine on suicidal ideation (Am J Psychiatry. 2018;175[2]:150-8). The analysis included 167 participants with suicidal ideation at baseline. “Within 24 hours there was a very clear decrease in suicidal ideation in terms of clinician-reported scale,” he said. “Over 50% of patients reported having minimal or no ideation after treatment. That was maintained for 7 days.” Effect sizes were moderate to large at all time points post dose.
In the largest meta-analysis of its kind to date, researchers reviewed 15 independent trials of ketamine for suicide ideation in 572 adults with psychiatric disorders, all with a single dose of drug with varying routes and dosages (Aust N Z J Psychiatry. 2020;54[1]:29-45). The researchers in that study concluded that ketamine “may have a role in acute treatment for suicidality. However, there is clearly a need for clinical measures to ensure persistence of any benefits.”
Esketamine, which was approved in March 2019 for major depressive disorder, also shows promise in patients with suicidal ideation and behavior. In a double-blind, multicenter, proof-of-concept study, researchers randomized 68 participants to receive esketamine (84 mg) or placebo twice weekly for 4 weeks, in addition to comprehensive standard-of-care treatment (Am J Psychiatry. 2018;175[7]:620-30). The primary efficacy endpoint was change in score from baseline to 4 hours after initial dose on the MADRS (Montgomery-Asberg Depression Rating Scale). “There was a nice effect in the antidepressant response, compared with placebo. It hit the primary endpoint at 4 hours. The patients got treated twice a week for 4 weeks. People got better quickly and stayed well moving on.” The researchers also found that the rate of remission at day 25 was 60% in the esketamine group, compared with 42% in the placebo group. “The take-home message is that, even without the esketamine, the remission rate was 42% at day 25. That means if you’re giving people really good care, meaning that you’re seeing them twice a week and they’re inpatient until they’re able to go outpatient, people can do pretty well with that level of care.”
Meanwhile, In a proof-of-concept trial, 18 depressed subjects with acute suicidal ideation who presented to the emergency department and required hospitalization were randomized to either IV ketamine 0.2 mg/kg or to saline placebo (Depress Anxiety. 2019 Nov 16. doi: 10.1002/da.22975). Ninety minutes after infusion, 88% of patients in the ketamine group had achieved remission of suicidal ideation, compared with 33% in the placebo group (P less than .05). No serious adverse events were noted.
“There is a clear need for new treatments targeting suicidal ideation and behavior,” Dr. Sanacora concluded. “Any plan to institute a rapid-acting treatment for individuals with imminent risk of suicidal behavior must be placed in the context of a larger comprehensive treatment plan. Getting somebody to feel better in the short run is great, but you really have to think about the whole treatment plan.”
Dr. Sanacora reported having received grants and research support from numerous pharmaceutical companies. He also holds an ownership interest in Biohaven Pharmaceuticals.
EXPERT ANALYSIS FROM NPA 2020
Beginning estrogen soon after menopause slows atherosclerosis progression
PHOENIX – Oral estrogen therapy taken within 6 years after the onset of menopause significantly reduced progression of lipid deposition in the carotid arterial wall, compared with placebo. However, starting oral estrogen 10 years after menopause did not confer a similar benefit.
“The clinical practice of estradiol therapy has been nothing short of a roller coaster ride,” lead study author Roksana Karim, PhD, MBBS, said in an interview at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting sponsored by the American Heart Association. “Clinicians have been sort of conservative in terms of prescribing estradiol therapy. But over the last 2 decades things have changed, and eventually the timing hypothesis evolved based on the final analysis of the Women’s Health Initiative results as well.”
The findings come from a secondary analysis of the Early Versus Late Intervention Trial With Estradiol (ELITE), which examined the effects of oral 17-beta-estradiol (estrogen) on the progression of early atherosclerosis and cognitive decline in healthy postmenopausal women.
In the original trial, 643 healthy postmenopausal women were randomized to receive 1 mg/day of estradiol or a placebo pill either within 6 years after the onset of menopause or more than a decade after menopause (N Engl J Med 2016;374[13]:1221-31). All study participants took estradiol or placebo daily for an average of 5 years. The study’s initial findings showed that the mean carotid intima-media thickness progression rate was decreased by 0.0034 mm per year with estradiol, compared with placebo, but only in women who initiated hormone therapy within 6 years of menopause onset.
For the current analysis, researchers led by Dr. Karim looked further into estradiol’s impact on heart health by using echogenicity to analyze lipids in the arterial wall among the ELITE participants. The main outcome of interest was gray-scale median (GSM, unitless), a qualitative measure of atherosclerosis based on echogenicity obtained by high-resolution ultrasonography of the common carotid arterial wall. Whereas higher GSM values result with plaques rich in calcium and fibrous tissue, lower GSM values indicate more lipid deposition.
Dr. Karim, an associate professor of clinical preventive medicine at the University of Southern California, Los Angeles, and colleagues assessed GSM and serum concentrations of estradiol every 6 months over a median 5-year trial period, and used linear mixed effects regression models to compare the rate of GSM progression between the randomized groups within time-since-menopause strata.
The researchers found that effect of estradiol on the annual rate of GSM progression significantly differed between women in the early and late postmenopause groups (P for interaction = .006). Specifically, the annual GSM progression rate among women in early postmenopause fell by 0.30 per year in women taking estradiol, compared with 1.41 per year in those in the placebo group (P less than .0001), indicating significantly more atherosclerosis in the placebo group. On the other hand, the annual GSM progression rate was not significantly different between the estradiol and placebo groups among the late postmenopausal women (P = .37).
“I think this should comfort clinicians in terms of prescribing estradiol therapy to women who don’t have any contraindications and who are within 6 years of menopause,” Dr. Karim said. “Accumulation of lipids is the key event for atherosclerosis progression.” She and her colleagues also observed that the positive association between mean on-trial serum estradiol levels and GSM progression rate was stronger and significant among early postmenopausal women (P = .008), compared with women in the late postmenopausal group (P = .003). However, this differential association between estradiol level and GSM progression rate was not statistically significant (P for interaction = .33).
“This study is important and raises a critical question: Is there a time period where getting hormone therapy would be most beneficial for the heart?” Nieca Goldberg, MD, medical director of the New York University women’s heart program and senior advisor for women’s health strategy at NYU Langone Health, said in an interview. “I think more studies and more analyses are needed, but we haven’t changed the indications for estradiol. We’re not giving estradiol to prevent progression of heart disease. We use estradiol hormone therapy as indicated for women who are having menopausal symptoms.”
Dr. Karim and colleagues plan to conduct a follow-up analysis from the same cohort of ELITE study participants to validate the findings by assessing lipid particles and markers of inflammation.
She reported having no financial disclosures. The study was funded by the National Institute on Aging.
SOURCE: Karim R et al. Epi/Lifestyle 2020, Abstract MP09.
PHOENIX – Oral estrogen therapy taken within 6 years after the onset of menopause significantly reduced progression of lipid deposition in the carotid arterial wall, compared with placebo. However, starting oral estrogen 10 years after menopause did not confer a similar benefit.
“The clinical practice of estradiol therapy has been nothing short of a roller coaster ride,” lead study author Roksana Karim, PhD, MBBS, said in an interview at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting sponsored by the American Heart Association. “Clinicians have been sort of conservative in terms of prescribing estradiol therapy. But over the last 2 decades things have changed, and eventually the timing hypothesis evolved based on the final analysis of the Women’s Health Initiative results as well.”
The findings come from a secondary analysis of the Early Versus Late Intervention Trial With Estradiol (ELITE), which examined the effects of oral 17-beta-estradiol (estrogen) on the progression of early atherosclerosis and cognitive decline in healthy postmenopausal women.
In the original trial, 643 healthy postmenopausal women were randomized to receive 1 mg/day of estradiol or a placebo pill either within 6 years after the onset of menopause or more than a decade after menopause (N Engl J Med 2016;374[13]:1221-31). All study participants took estradiol or placebo daily for an average of 5 years. The study’s initial findings showed that the mean carotid intima-media thickness progression rate was decreased by 0.0034 mm per year with estradiol, compared with placebo, but only in women who initiated hormone therapy within 6 years of menopause onset.
For the current analysis, researchers led by Dr. Karim looked further into estradiol’s impact on heart health by using echogenicity to analyze lipids in the arterial wall among the ELITE participants. The main outcome of interest was gray-scale median (GSM, unitless), a qualitative measure of atherosclerosis based on echogenicity obtained by high-resolution ultrasonography of the common carotid arterial wall. Whereas higher GSM values result with plaques rich in calcium and fibrous tissue, lower GSM values indicate more lipid deposition.
Dr. Karim, an associate professor of clinical preventive medicine at the University of Southern California, Los Angeles, and colleagues assessed GSM and serum concentrations of estradiol every 6 months over a median 5-year trial period, and used linear mixed effects regression models to compare the rate of GSM progression between the randomized groups within time-since-menopause strata.
The researchers found that effect of estradiol on the annual rate of GSM progression significantly differed between women in the early and late postmenopause groups (P for interaction = .006). Specifically, the annual GSM progression rate among women in early postmenopause fell by 0.30 per year in women taking estradiol, compared with 1.41 per year in those in the placebo group (P less than .0001), indicating significantly more atherosclerosis in the placebo group. On the other hand, the annual GSM progression rate was not significantly different between the estradiol and placebo groups among the late postmenopausal women (P = .37).
“I think this should comfort clinicians in terms of prescribing estradiol therapy to women who don’t have any contraindications and who are within 6 years of menopause,” Dr. Karim said. “Accumulation of lipids is the key event for atherosclerosis progression.” She and her colleagues also observed that the positive association between mean on-trial serum estradiol levels and GSM progression rate was stronger and significant among early postmenopausal women (P = .008), compared with women in the late postmenopausal group (P = .003). However, this differential association between estradiol level and GSM progression rate was not statistically significant (P for interaction = .33).
“This study is important and raises a critical question: Is there a time period where getting hormone therapy would be most beneficial for the heart?” Nieca Goldberg, MD, medical director of the New York University women’s heart program and senior advisor for women’s health strategy at NYU Langone Health, said in an interview. “I think more studies and more analyses are needed, but we haven’t changed the indications for estradiol. We’re not giving estradiol to prevent progression of heart disease. We use estradiol hormone therapy as indicated for women who are having menopausal symptoms.”
Dr. Karim and colleagues plan to conduct a follow-up analysis from the same cohort of ELITE study participants to validate the findings by assessing lipid particles and markers of inflammation.
She reported having no financial disclosures. The study was funded by the National Institute on Aging.
SOURCE: Karim R et al. Epi/Lifestyle 2020, Abstract MP09.
PHOENIX – Oral estrogen therapy taken within 6 years after the onset of menopause significantly reduced progression of lipid deposition in the carotid arterial wall, compared with placebo. However, starting oral estrogen 10 years after menopause did not confer a similar benefit.
“The clinical practice of estradiol therapy has been nothing short of a roller coaster ride,” lead study author Roksana Karim, PhD, MBBS, said in an interview at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting sponsored by the American Heart Association. “Clinicians have been sort of conservative in terms of prescribing estradiol therapy. But over the last 2 decades things have changed, and eventually the timing hypothesis evolved based on the final analysis of the Women’s Health Initiative results as well.”
The findings come from a secondary analysis of the Early Versus Late Intervention Trial With Estradiol (ELITE), which examined the effects of oral 17-beta-estradiol (estrogen) on the progression of early atherosclerosis and cognitive decline in healthy postmenopausal women.
In the original trial, 643 healthy postmenopausal women were randomized to receive 1 mg/day of estradiol or a placebo pill either within 6 years after the onset of menopause or more than a decade after menopause (N Engl J Med 2016;374[13]:1221-31). All study participants took estradiol or placebo daily for an average of 5 years. The study’s initial findings showed that the mean carotid intima-media thickness progression rate was decreased by 0.0034 mm per year with estradiol, compared with placebo, but only in women who initiated hormone therapy within 6 years of menopause onset.
For the current analysis, researchers led by Dr. Karim looked further into estradiol’s impact on heart health by using echogenicity to analyze lipids in the arterial wall among the ELITE participants. The main outcome of interest was gray-scale median (GSM, unitless), a qualitative measure of atherosclerosis based on echogenicity obtained by high-resolution ultrasonography of the common carotid arterial wall. Whereas higher GSM values result with plaques rich in calcium and fibrous tissue, lower GSM values indicate more lipid deposition.
Dr. Karim, an associate professor of clinical preventive medicine at the University of Southern California, Los Angeles, and colleagues assessed GSM and serum concentrations of estradiol every 6 months over a median 5-year trial period, and used linear mixed effects regression models to compare the rate of GSM progression between the randomized groups within time-since-menopause strata.
The researchers found that effect of estradiol on the annual rate of GSM progression significantly differed between women in the early and late postmenopause groups (P for interaction = .006). Specifically, the annual GSM progression rate among women in early postmenopause fell by 0.30 per year in women taking estradiol, compared with 1.41 per year in those in the placebo group (P less than .0001), indicating significantly more atherosclerosis in the placebo group. On the other hand, the annual GSM progression rate was not significantly different between the estradiol and placebo groups among the late postmenopausal women (P = .37).
“I think this should comfort clinicians in terms of prescribing estradiol therapy to women who don’t have any contraindications and who are within 6 years of menopause,” Dr. Karim said. “Accumulation of lipids is the key event for atherosclerosis progression.” She and her colleagues also observed that the positive association between mean on-trial serum estradiol levels and GSM progression rate was stronger and significant among early postmenopausal women (P = .008), compared with women in the late postmenopausal group (P = .003). However, this differential association between estradiol level and GSM progression rate was not statistically significant (P for interaction = .33).
“This study is important and raises a critical question: Is there a time period where getting hormone therapy would be most beneficial for the heart?” Nieca Goldberg, MD, medical director of the New York University women’s heart program and senior advisor for women’s health strategy at NYU Langone Health, said in an interview. “I think more studies and more analyses are needed, but we haven’t changed the indications for estradiol. We’re not giving estradiol to prevent progression of heart disease. We use estradiol hormone therapy as indicated for women who are having menopausal symptoms.”
Dr. Karim and colleagues plan to conduct a follow-up analysis from the same cohort of ELITE study participants to validate the findings by assessing lipid particles and markers of inflammation.
She reported having no financial disclosures. The study was funded by the National Institute on Aging.
SOURCE: Karim R et al. Epi/Lifestyle 2020, Abstract MP09.
REPORTING FROM EPI/LIFESTYLE 2020
rTMS for depression continues to evolve
LAS VEGAS – Repetitive transcranial magnetic stimulation methods for treatment-resistant depression continue to be refined.
“Original studies have relatively low response rates, but we’re seeing better response rates as we figure out the localization, the parameters, the wave form, and how frequently you can give it,” Alan F. Schatzberg, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
Repetitive transcranial magnetic stimulation (rTMS) involves the application of a magnetic field to a particular area of the brain, typically the dorsal lateral aspect of the prefrontal cortex. “It’s a weaker stimulant than electroconvulsive therapy, but it’s more focused and a lot safer,” said Dr. Schatzberg, professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “It does not require anesthesia. In fact, it does seem to have some antidepressant effects.”
The original trial that applied this technology was conducted in 301 medication-free patients with major depression who had not benefited from prior treatment (Biol Psychiatry. 2007;62[11]:1208-16). Of the 301 patients, 155 received active rTMS, while 146 received sham rTMS. Treatment sessions were conducted five times per week for 4-6 weeks. The primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD), and response and remission rates with the MADRS and HAMD.
Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). “The response rate for patients receiving active treatment was about 20%, and the remission at 6 weeks was about 18%,” said Dr. Schatzberg, who was an adviser to the study. “It was about twofold higher than in the sham group. It’s not dramatically effective, but it certainly is better than the sham control.” The MADRS score dropped about 6 points in the rTMS group, compared with about 2 points in the sham group, while the HAMD 24 score dropped about 7 points in the rTMS group, compared with about 3.5 points in the sham group.
In a separate, multisite, sham-controlled trial supported by the National Institutes of Health, researchers enrolled 199 antidepressant drug-free patients to determine whether daily left prefrontal rTMS safely and effectively treats major depressive disorder (Arch Gen Psychiatry. 2010;67[5]:507-16). Over the course of 3 weeks, the researchers delivered rTMS to the left prefrontal cortex for 37.5 minutes (3,000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations. The retention rate was 88%, and no device-related serious adverse events were reported. A significantly greater proportion of patients treated with rTMS achieved remission, compared with those in the sham group (15% vs. 5%, respectively; P = .02). The odds of attaining remission were 4.2 times greater with active rTMS than with the sham treatment.
“These are not huge remission and response rates,” Dr. Schatzberg said of the results from this and other studies. “What can we do to start increasing efficacy? One thing you can do is design a better coil. You can alter the site of application, and you can change the pulse frequency and the pulse number. You can also change the brain wave focus. Theta seems to be mostly associated with hippocampal function around memory. Because of that, a number of groups starting giving theta waves.”
In one such study, researchers used accelerated, high-dose intermittent theta burst stimulation (iTBS) to treat highly treatment-resistant depression patients (Brain. 2018;141[3]:e18). The treatment lasted 5 days and consisted of 10 sessions per day, with 50 minutes between each session. “It’s a much more intensive system that delivers about 90,000 pulses,” said Dr. Schatzberg, who directs the Stanford Mood Disorders Center. Most patients remitted, but the durability of therapeutic response was weak, and all patients relapsed within 2 weeks post treatment.
“There’s more work to be done, but rTMS is really a good technology,” he concluded. “I think we will achieve much higher rates of success with this treatment once we push the envelope a little bit.”
Dr. Schatzberg disclosed that he has served a consultant to Alkermes, Avanir, Bracket, Compass, Delpor, Epiodyne, Janssen, Jazz, Lundbeck, McKinsey, Merck, Myriad Genetics, Owl, Neuronetics, Pfizer, Sage, and Sunovion. He has received research funding from Janssen and also holds an ownership interest in Corcept, Dermira, Delpor, Epiodyne, Incyte Genetics, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale.
LAS VEGAS – Repetitive transcranial magnetic stimulation methods for treatment-resistant depression continue to be refined.
“Original studies have relatively low response rates, but we’re seeing better response rates as we figure out the localization, the parameters, the wave form, and how frequently you can give it,” Alan F. Schatzberg, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
Repetitive transcranial magnetic stimulation (rTMS) involves the application of a magnetic field to a particular area of the brain, typically the dorsal lateral aspect of the prefrontal cortex. “It’s a weaker stimulant than electroconvulsive therapy, but it’s more focused and a lot safer,” said Dr. Schatzberg, professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “It does not require anesthesia. In fact, it does seem to have some antidepressant effects.”
The original trial that applied this technology was conducted in 301 medication-free patients with major depression who had not benefited from prior treatment (Biol Psychiatry. 2007;62[11]:1208-16). Of the 301 patients, 155 received active rTMS, while 146 received sham rTMS. Treatment sessions were conducted five times per week for 4-6 weeks. The primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD), and response and remission rates with the MADRS and HAMD.
Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). “The response rate for patients receiving active treatment was about 20%, and the remission at 6 weeks was about 18%,” said Dr. Schatzberg, who was an adviser to the study. “It was about twofold higher than in the sham group. It’s not dramatically effective, but it certainly is better than the sham control.” The MADRS score dropped about 6 points in the rTMS group, compared with about 2 points in the sham group, while the HAMD 24 score dropped about 7 points in the rTMS group, compared with about 3.5 points in the sham group.
In a separate, multisite, sham-controlled trial supported by the National Institutes of Health, researchers enrolled 199 antidepressant drug-free patients to determine whether daily left prefrontal rTMS safely and effectively treats major depressive disorder (Arch Gen Psychiatry. 2010;67[5]:507-16). Over the course of 3 weeks, the researchers delivered rTMS to the left prefrontal cortex for 37.5 minutes (3,000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations. The retention rate was 88%, and no device-related serious adverse events were reported. A significantly greater proportion of patients treated with rTMS achieved remission, compared with those in the sham group (15% vs. 5%, respectively; P = .02). The odds of attaining remission were 4.2 times greater with active rTMS than with the sham treatment.
“These are not huge remission and response rates,” Dr. Schatzberg said of the results from this and other studies. “What can we do to start increasing efficacy? One thing you can do is design a better coil. You can alter the site of application, and you can change the pulse frequency and the pulse number. You can also change the brain wave focus. Theta seems to be mostly associated with hippocampal function around memory. Because of that, a number of groups starting giving theta waves.”
In one such study, researchers used accelerated, high-dose intermittent theta burst stimulation (iTBS) to treat highly treatment-resistant depression patients (Brain. 2018;141[3]:e18). The treatment lasted 5 days and consisted of 10 sessions per day, with 50 minutes between each session. “It’s a much more intensive system that delivers about 90,000 pulses,” said Dr. Schatzberg, who directs the Stanford Mood Disorders Center. Most patients remitted, but the durability of therapeutic response was weak, and all patients relapsed within 2 weeks post treatment.
“There’s more work to be done, but rTMS is really a good technology,” he concluded. “I think we will achieve much higher rates of success with this treatment once we push the envelope a little bit.”
Dr. Schatzberg disclosed that he has served a consultant to Alkermes, Avanir, Bracket, Compass, Delpor, Epiodyne, Janssen, Jazz, Lundbeck, McKinsey, Merck, Myriad Genetics, Owl, Neuronetics, Pfizer, Sage, and Sunovion. He has received research funding from Janssen and also holds an ownership interest in Corcept, Dermira, Delpor, Epiodyne, Incyte Genetics, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale.
LAS VEGAS – Repetitive transcranial magnetic stimulation methods for treatment-resistant depression continue to be refined.
“Original studies have relatively low response rates, but we’re seeing better response rates as we figure out the localization, the parameters, the wave form, and how frequently you can give it,” Alan F. Schatzberg, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
Repetitive transcranial magnetic stimulation (rTMS) involves the application of a magnetic field to a particular area of the brain, typically the dorsal lateral aspect of the prefrontal cortex. “It’s a weaker stimulant than electroconvulsive therapy, but it’s more focused and a lot safer,” said Dr. Schatzberg, professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “It does not require anesthesia. In fact, it does seem to have some antidepressant effects.”
The original trial that applied this technology was conducted in 301 medication-free patients with major depression who had not benefited from prior treatment (Biol Psychiatry. 2007;62[11]:1208-16). Of the 301 patients, 155 received active rTMS, while 146 received sham rTMS. Treatment sessions were conducted five times per week for 4-6 weeks. The primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD), and response and remission rates with the MADRS and HAMD.
Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). “The response rate for patients receiving active treatment was about 20%, and the remission at 6 weeks was about 18%,” said Dr. Schatzberg, who was an adviser to the study. “It was about twofold higher than in the sham group. It’s not dramatically effective, but it certainly is better than the sham control.” The MADRS score dropped about 6 points in the rTMS group, compared with about 2 points in the sham group, while the HAMD 24 score dropped about 7 points in the rTMS group, compared with about 3.5 points in the sham group.
In a separate, multisite, sham-controlled trial supported by the National Institutes of Health, researchers enrolled 199 antidepressant drug-free patients to determine whether daily left prefrontal rTMS safely and effectively treats major depressive disorder (Arch Gen Psychiatry. 2010;67[5]:507-16). Over the course of 3 weeks, the researchers delivered rTMS to the left prefrontal cortex for 37.5 minutes (3,000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations. The retention rate was 88%, and no device-related serious adverse events were reported. A significantly greater proportion of patients treated with rTMS achieved remission, compared with those in the sham group (15% vs. 5%, respectively; P = .02). The odds of attaining remission were 4.2 times greater with active rTMS than with the sham treatment.
“These are not huge remission and response rates,” Dr. Schatzberg said of the results from this and other studies. “What can we do to start increasing efficacy? One thing you can do is design a better coil. You can alter the site of application, and you can change the pulse frequency and the pulse number. You can also change the brain wave focus. Theta seems to be mostly associated with hippocampal function around memory. Because of that, a number of groups starting giving theta waves.”
In one such study, researchers used accelerated, high-dose intermittent theta burst stimulation (iTBS) to treat highly treatment-resistant depression patients (Brain. 2018;141[3]:e18). The treatment lasted 5 days and consisted of 10 sessions per day, with 50 minutes between each session. “It’s a much more intensive system that delivers about 90,000 pulses,” said Dr. Schatzberg, who directs the Stanford Mood Disorders Center. Most patients remitted, but the durability of therapeutic response was weak, and all patients relapsed within 2 weeks post treatment.
“There’s more work to be done, but rTMS is really a good technology,” he concluded. “I think we will achieve much higher rates of success with this treatment once we push the envelope a little bit.”
Dr. Schatzberg disclosed that he has served a consultant to Alkermes, Avanir, Bracket, Compass, Delpor, Epiodyne, Janssen, Jazz, Lundbeck, McKinsey, Merck, Myriad Genetics, Owl, Neuronetics, Pfizer, Sage, and Sunovion. He has received research funding from Janssen and also holds an ownership interest in Corcept, Dermira, Delpor, Epiodyne, Incyte Genetics, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale.
REPORTING FROM NPA 2020