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Diet packed with fast food found hard on the liver
The study finds that getting one-fifth or more of total daily calories from fast food can increase the risk of nonalcoholic fatty liver disease, which can lead to cirrhosis and its complications, including liver failure and liver cancer.
Although the magnitude of association was modest among the general population, “striking” elevations in steatosis were evident among persons with obesity and diabetes who consumed fast food, in comparison with their counterparts who did not have obesity and diabetes, the researchers reported.
“My hope is that this study encourages people to seek out more nutritious, healthy food options and provides information that clinicians can use to counsel their patients, particularly those with underlying metabolic risk factors, of the importance of avoiding foods that are high in fat, carbohydrates, and processed sugars,” lead investigator Ani Kardashian, MD, hepatologist with the University of Southern California, Los Angeles, said in an interview.
“At a policy level, public health efforts are needed to improve access to affordable, healthy, and nutritious food options across the U.S. This is especially important as more people have turned to fast foods during the pandemic and as the price of food as risen dramatically over the past year due to food inflation,” Dr. Kardashian added.
The study was published online in Clinical Gastroenterology and Hepatology.
More fast food, greater steatosis
The findings are based on data from 3,954 adults who participated in the National Health and Nutrition Examination Survey (NHANES) of 2017-2018 and who underwent vibration-controlled transient elastography. Of these participants, data regarding 1- or 2-day dietary recall were available.
Steatosis, the primary outcome, was measured via controlled attenuation parameter (CAP). Two validated cutoffs were utilized (CAP ≥ 263 dB/m and CAP ≥ 285 dB/m).
Of those surveyed, 52% consumed any fast food, and 29% derived 20% or more of their daily calories from fast food.
Fast-food intake of 20% or more of daily calories was significantly associated with greater steatosis after multivariable adjustment, both as a continuous measure (4.6 dB/m higher CAP score) and with respect to the CAP ≥ 263 dB/m cutoff (odds ratio [OR], 1.45).
“The negative effects are particularly severe in people who already have diabetes and obesity,” Dr. Kardashian told this news organization.
For example, with diabetes and fast-food intake of 20% or more of daily calories, the ORs of meeting the CAP ≥ 263 dB/m cutoff and the CAP ≥ 285 dB/m cutoff were 2.3 and 2.48, respectively.
The researchers said their findings are particularly “alarming,” given the overall increase in fast-food consumption over the past 50 years in the United States, regardless of socioeconomic status.
Diet coaching
The finding that fast food has more deleterious impact on those with obesity and diabetes “emphasizes that it is not just one insult but multiple factors that contribute to overall health,” said Nancy Reau, MD, section chief of hepatology at Rush University Medical Center in Chicago.
“This is actually great news, because diet is modifiable, vs. your genetics, which you currently can’t change. This doesn’t mean if you’re lean you can eat whatever you want, but if you are overweight, being careful with your diet does have impact, even if it doesn’t lead to substantial weight changes,” said Dr. Reau, who is not affiliated with the study.
For people who have limited options and need to eat fast food, “there are healthy choices at most restaurants; you just need to be smart about reading labels, watching calories, and ordering the healthier options,” Dr. Reau said in an interview.
Fast food and fatty liver go “hand in hand,” Lisa Ganjhu, DO, gastroenterologist and hepatologist at NYU Langone Health in New York, told this news organization.
“I counsel and coach my patients on healthy diet and exercise, and I’ve been pretty successful,” said Dr. Ganjhu, who was not involved with the study.
“If my patient is eating at McDonald’s a lot, I basically walk through the menu with them and help them find something healthy. When patients see the benefits of cutting out fat and reducing carbohydrates, they are more apt to continue,” Dr. Ganjhu said.
The study was funded by the University of Southern California. Dr. Kardashian, Dr. Reau, and Dr. Ganjhu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The study finds that getting one-fifth or more of total daily calories from fast food can increase the risk of nonalcoholic fatty liver disease, which can lead to cirrhosis and its complications, including liver failure and liver cancer.
Although the magnitude of association was modest among the general population, “striking” elevations in steatosis were evident among persons with obesity and diabetes who consumed fast food, in comparison with their counterparts who did not have obesity and diabetes, the researchers reported.
“My hope is that this study encourages people to seek out more nutritious, healthy food options and provides information that clinicians can use to counsel their patients, particularly those with underlying metabolic risk factors, of the importance of avoiding foods that are high in fat, carbohydrates, and processed sugars,” lead investigator Ani Kardashian, MD, hepatologist with the University of Southern California, Los Angeles, said in an interview.
“At a policy level, public health efforts are needed to improve access to affordable, healthy, and nutritious food options across the U.S. This is especially important as more people have turned to fast foods during the pandemic and as the price of food as risen dramatically over the past year due to food inflation,” Dr. Kardashian added.
The study was published online in Clinical Gastroenterology and Hepatology.
More fast food, greater steatosis
The findings are based on data from 3,954 adults who participated in the National Health and Nutrition Examination Survey (NHANES) of 2017-2018 and who underwent vibration-controlled transient elastography. Of these participants, data regarding 1- or 2-day dietary recall were available.
Steatosis, the primary outcome, was measured via controlled attenuation parameter (CAP). Two validated cutoffs were utilized (CAP ≥ 263 dB/m and CAP ≥ 285 dB/m).
Of those surveyed, 52% consumed any fast food, and 29% derived 20% or more of their daily calories from fast food.
Fast-food intake of 20% or more of daily calories was significantly associated with greater steatosis after multivariable adjustment, both as a continuous measure (4.6 dB/m higher CAP score) and with respect to the CAP ≥ 263 dB/m cutoff (odds ratio [OR], 1.45).
“The negative effects are particularly severe in people who already have diabetes and obesity,” Dr. Kardashian told this news organization.
For example, with diabetes and fast-food intake of 20% or more of daily calories, the ORs of meeting the CAP ≥ 263 dB/m cutoff and the CAP ≥ 285 dB/m cutoff were 2.3 and 2.48, respectively.
The researchers said their findings are particularly “alarming,” given the overall increase in fast-food consumption over the past 50 years in the United States, regardless of socioeconomic status.
Diet coaching
The finding that fast food has more deleterious impact on those with obesity and diabetes “emphasizes that it is not just one insult but multiple factors that contribute to overall health,” said Nancy Reau, MD, section chief of hepatology at Rush University Medical Center in Chicago.
“This is actually great news, because diet is modifiable, vs. your genetics, which you currently can’t change. This doesn’t mean if you’re lean you can eat whatever you want, but if you are overweight, being careful with your diet does have impact, even if it doesn’t lead to substantial weight changes,” said Dr. Reau, who is not affiliated with the study.
For people who have limited options and need to eat fast food, “there are healthy choices at most restaurants; you just need to be smart about reading labels, watching calories, and ordering the healthier options,” Dr. Reau said in an interview.
Fast food and fatty liver go “hand in hand,” Lisa Ganjhu, DO, gastroenterologist and hepatologist at NYU Langone Health in New York, told this news organization.
“I counsel and coach my patients on healthy diet and exercise, and I’ve been pretty successful,” said Dr. Ganjhu, who was not involved with the study.
“If my patient is eating at McDonald’s a lot, I basically walk through the menu with them and help them find something healthy. When patients see the benefits of cutting out fat and reducing carbohydrates, they are more apt to continue,” Dr. Ganjhu said.
The study was funded by the University of Southern California. Dr. Kardashian, Dr. Reau, and Dr. Ganjhu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The study finds that getting one-fifth or more of total daily calories from fast food can increase the risk of nonalcoholic fatty liver disease, which can lead to cirrhosis and its complications, including liver failure and liver cancer.
Although the magnitude of association was modest among the general population, “striking” elevations in steatosis were evident among persons with obesity and diabetes who consumed fast food, in comparison with their counterparts who did not have obesity and diabetes, the researchers reported.
“My hope is that this study encourages people to seek out more nutritious, healthy food options and provides information that clinicians can use to counsel their patients, particularly those with underlying metabolic risk factors, of the importance of avoiding foods that are high in fat, carbohydrates, and processed sugars,” lead investigator Ani Kardashian, MD, hepatologist with the University of Southern California, Los Angeles, said in an interview.
“At a policy level, public health efforts are needed to improve access to affordable, healthy, and nutritious food options across the U.S. This is especially important as more people have turned to fast foods during the pandemic and as the price of food as risen dramatically over the past year due to food inflation,” Dr. Kardashian added.
The study was published online in Clinical Gastroenterology and Hepatology.
More fast food, greater steatosis
The findings are based on data from 3,954 adults who participated in the National Health and Nutrition Examination Survey (NHANES) of 2017-2018 and who underwent vibration-controlled transient elastography. Of these participants, data regarding 1- or 2-day dietary recall were available.
Steatosis, the primary outcome, was measured via controlled attenuation parameter (CAP). Two validated cutoffs were utilized (CAP ≥ 263 dB/m and CAP ≥ 285 dB/m).
Of those surveyed, 52% consumed any fast food, and 29% derived 20% or more of their daily calories from fast food.
Fast-food intake of 20% or more of daily calories was significantly associated with greater steatosis after multivariable adjustment, both as a continuous measure (4.6 dB/m higher CAP score) and with respect to the CAP ≥ 263 dB/m cutoff (odds ratio [OR], 1.45).
“The negative effects are particularly severe in people who already have diabetes and obesity,” Dr. Kardashian told this news organization.
For example, with diabetes and fast-food intake of 20% or more of daily calories, the ORs of meeting the CAP ≥ 263 dB/m cutoff and the CAP ≥ 285 dB/m cutoff were 2.3 and 2.48, respectively.
The researchers said their findings are particularly “alarming,” given the overall increase in fast-food consumption over the past 50 years in the United States, regardless of socioeconomic status.
Diet coaching
The finding that fast food has more deleterious impact on those with obesity and diabetes “emphasizes that it is not just one insult but multiple factors that contribute to overall health,” said Nancy Reau, MD, section chief of hepatology at Rush University Medical Center in Chicago.
“This is actually great news, because diet is modifiable, vs. your genetics, which you currently can’t change. This doesn’t mean if you’re lean you can eat whatever you want, but if you are overweight, being careful with your diet does have impact, even if it doesn’t lead to substantial weight changes,” said Dr. Reau, who is not affiliated with the study.
For people who have limited options and need to eat fast food, “there are healthy choices at most restaurants; you just need to be smart about reading labels, watching calories, and ordering the healthier options,” Dr. Reau said in an interview.
Fast food and fatty liver go “hand in hand,” Lisa Ganjhu, DO, gastroenterologist and hepatologist at NYU Langone Health in New York, told this news organization.
“I counsel and coach my patients on healthy diet and exercise, and I’ve been pretty successful,” said Dr. Ganjhu, who was not involved with the study.
“If my patient is eating at McDonald’s a lot, I basically walk through the menu with them and help them find something healthy. When patients see the benefits of cutting out fat and reducing carbohydrates, they are more apt to continue,” Dr. Ganjhu said.
The study was funded by the University of Southern California. Dr. Kardashian, Dr. Reau, and Dr. Ganjhu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Adverse events reported in one-quarter of inpatient admissions
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
HRT may prevent Alzheimer’s in high-risk women
new research suggests.
Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.
HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.
“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.
“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.
The findings were published online in Alzheimer’s Research and Therapy.
Personalized approaches
Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.
“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.
HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”
The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”
This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.
To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.
Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.
The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.
The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.
Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
‘Critical window’
The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).
Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).
“This large effect was found only in APOE4 carriers,” the investigators noted.
Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).
In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).
In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.
Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.
“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”
Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.
HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
Risk-benefit ratio
In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”
Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.
He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.
Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.
The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.
HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.
“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.
“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.
The findings were published online in Alzheimer’s Research and Therapy.
Personalized approaches
Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.
“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.
HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”
The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”
This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.
To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.
Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.
The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.
The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.
Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
‘Critical window’
The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).
Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).
“This large effect was found only in APOE4 carriers,” the investigators noted.
Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).
In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).
In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.
Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.
“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”
Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.
HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
Risk-benefit ratio
In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”
Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.
He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.
Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.
The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.
HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.
“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.
“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.
The findings were published online in Alzheimer’s Research and Therapy.
Personalized approaches
Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.
“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.
HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”
The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”
This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.
To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.
Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.
The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.
The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.
Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
‘Critical window’
The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).
Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).
“This large effect was found only in APOE4 carriers,” the investigators noted.
Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).
In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).
In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.
Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.
“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”
Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.
HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
Risk-benefit ratio
In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”
Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.
He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.
Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.
The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ALZHEIMER’S RESEARCH AND THERAPY
Does obesity blunt effects of vitamin D supplementation?
compared with normal-weight individuals in a new analysis of a randomized trial.
“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.
The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.
However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m2) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.
The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.
“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.
“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
New analysis examined vitamin D and biomarkers at baseline and 2 years
To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.
Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).
Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).
Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).
There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.
When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.
Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.
“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
Mechanisms?
Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.
“Our results are largely consistent with this hypothesis,” the authors noted.
They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.
Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.
Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.
“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.
The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.
A version of this article first appeared on Medscape.com.
compared with normal-weight individuals in a new analysis of a randomized trial.
“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.
The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.
However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m2) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.
The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.
“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.
“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
New analysis examined vitamin D and biomarkers at baseline and 2 years
To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.
Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).
Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).
Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).
There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.
When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.
Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.
“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
Mechanisms?
Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.
“Our results are largely consistent with this hypothesis,” the authors noted.
They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.
Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.
Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.
“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.
The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.
A version of this article first appeared on Medscape.com.
compared with normal-weight individuals in a new analysis of a randomized trial.
“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.
The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.
However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m2) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.
The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.
“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.
“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
New analysis examined vitamin D and biomarkers at baseline and 2 years
To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.
Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).
Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).
Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).
There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.
When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.
Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.
“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
Mechanisms?
Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.
“Our results are largely consistent with this hypothesis,” the authors noted.
They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.
Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.
Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.
“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.
The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
What the FTC’s proposed ban on noncompete agreements could mean for physicians, other clinicians
The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.
Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.
“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.
Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.
“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.
Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.
However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.
Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.
Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.
Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”
Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.
“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
A controversial policy
The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.
But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.
Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.
“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.
A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.
“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."
A version of this article first appeared on Medscape.com.
The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.
Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.
“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.
Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.
“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.
Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.
However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.
Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.
Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.
Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”
Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.
“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
A controversial policy
The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.
But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.
Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.
“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.
A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.
“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."
A version of this article first appeared on Medscape.com.
The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.
Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.
“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.
Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.
“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.
Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.
However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.
Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.
Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.
Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”
Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.
“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
A controversial policy
The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.
But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.
Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.
“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.
A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.
“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."
A version of this article first appeared on Medscape.com.
Components of coffee other than caffeine linked to reduced NAFLD severity
Increased intake of both regular and decaffeinated coffee was significantly associated with a reduced severity of NAFLD in the study, published in Nutrients. The study participants included 156 overweight adults, most of whom had type 2 diabetes.
A confluence of factors including diet and lifestyle changes and increased obesity have contributed to a rise in type 2 diabetes and of NAFLD, Margarida Coelho, of the Center for Neuroscience and Cell Biology at the University of Coimbra (Portugal), and colleagues wrote.
Previous studies support an association between coffee and protection against NAFLD, but the roles of the caffeine and noncaffeine components of coffee have not been examined, corresponding author John Griffith Jones, PhD, also of the Center for Neuroscience and Cell Biology at the University of Coimbra, said in an interview.
“There have been previous studies indicating a link between coffee intake and NAFLD amelioration, but these were entirely based on self-reporting questionnaire data, but the main limitation of this approach is that it does not provide any information on which components of coffee confer the beneficial effects,” Dr. Jones said. “The development of new analytical techniques allowing reliable profiling of coffee metabolites in urine allowed this limitation to be addressed.”
Dr. Jones and associates examined the relationship between consumption of regular and decaffeinated coffee on the fatty liver index (FLI), a validated predictor of NAFLD. They measured coffee intake of 156 overweight adults, 135 of whom had type 2 diabetes. The study population included 76 women and 80 men with a mean age of 59 years and a mean body mass index of 29 kg/m2.
The participants reported coffee intake via questionnaires, and 98 participants (all with type 2 diabetes) also provided urine samples for measurement of caffeine and noncaffeine metabolites (the products of the body breaking down coffee). NAFLD was assessed using the FLI and a scanning measure of fibrosis.
Overall, no associations appeared between self-reported coffee intake and NAFLD measures. However, urine caffeine metabolite levels were significantly higher among individuals with no liver fibrosis, compared with those with fibrosis, and noncaffeine metabolites showed a significant negative association with FLI measures.
In a multiple regression analysis of 89 individuals with type 2 diabetes, both caffeine and noncaffeine metabolites were negatively associated with FLI, which suggests less severe NAFLD, the researchers noted.
Although the mechanism of action remains unclear, the findings suggest that other noncaffeine coffee components such as polyphenols may reduce the risk of fibrosis by reducing oxidative stress on the liver, they said.
Benefits beyond caffeine
“The main surprise of the study was that both caffeine and noncaffeine metabolites had beneficial effects,” Dr. Jones said. “We had anticipated caffeine, based on its well-known effects on inhibiting liver fibrosis, but the effects of other components were less well described.”
Clinicians can encourage their patients with type 2 diabetes who drink coffee to continue to do so within a normal range (up to three to four cups per day) including decaffeinated coffee; however, “they should be strongly encouraged to drink coffee without added fats and sugars, otherwise the protective benefits [against more severe NAFLD] will not be realized,” Dr. Jones said.
Additional research is needed to extend the analysis to include more coffee compounds, especially those truly unique to coffee, since caffeine can be found in many other foods and beverages, Dr. Jones added.
Limitations include 24-hour time frame
The findings were limited by several factors, including the use of 24-hour urine sample, which may not represent an individual’s habitual coffee consumption, the researchers noted. The urine metabolites measured also may be derived from foods and beverages other than coffee. In addition, the assessment of NAFLD was based on serum markers and ultrasound/elastography, which are less precise than liver biopsy and magnetic resonance spectroscopy.
However, the study is the first known to use urine data to examine coffee’s protective effect against NAFLD and suggests that both caffeine and noncaffeine metabolites are associated with less severe disease, they concluded.
Findings intriguing but not ready for prime time
“The bottom line is that we have a major epidemic of NAFLD in the United States,” Victor L. Roberts, MD, professor of internal medicine at the University of Central Florida, Orlando, said in an interview. NAFLD has become the most common cause of chronic liver disease worldwide, and will become one of the leading causes of cirrhosis – surpassing infections as the main driver of end-stage liver disease.
“In this country, the epidemic of obesity compounds the problem, and risks for NAFLD include obesity and type 2 diabetes,” said Dr. Roberts.
The concept of coffee as beneficial is not new, but data suggest that the effects vary with insulin resistance, he said. If liver disease is advanced, coffee and its components may not have much benefit, but early on, it might have a role.
The likely mechanism of action for the benefits of coffee on the reduction in liver fibrosis is through a complex set of metabolic steps that interrupt the promotion of collagen production and reduce liver stiffness, said Dr. Roberts.
The current study authors were up front about the limitations, mainly the use of self-reports, although including the urine collection provided more scientific data, he said. More studies are needed in other populations, but the findings are interesting enough to merit additional research.
The take-home message for primary care, however, is that drinking coffee – regular or decaf – does not replace standard of care, Dr. Roberts emphasized.
“If a patient is a coffee drinker and they have NAFLD or are at risk, they could be encouraged to continue drinking coffee,” in reasonable amounts, said Dr. Roberts. “Anywhere from 1-3 cups a day is unlikely to be a problem, and there is some hope and interest in this area,” but the findings of the current study “should not be taken as gospel or advocacy as a solution for people with NAFLD.”
Instead, clinicians should focus on the standard of care for management of patients at risk for NAFLD, promoting lifestyle changes such as weight loss, diet, and exercise (challenging as that may be), and prescribing appropriate medications, he said.
The study was supported by the Institute for Scientific Information on Coffee, and the researchers received funding from the ISIC to conduct the study. Dr. Roberts had no financial conflicts to disclose, but he serves on the editorial advisory board of Internal Medicine News.
Increased intake of both regular and decaffeinated coffee was significantly associated with a reduced severity of NAFLD in the study, published in Nutrients. The study participants included 156 overweight adults, most of whom had type 2 diabetes.
A confluence of factors including diet and lifestyle changes and increased obesity have contributed to a rise in type 2 diabetes and of NAFLD, Margarida Coelho, of the Center for Neuroscience and Cell Biology at the University of Coimbra (Portugal), and colleagues wrote.
Previous studies support an association between coffee and protection against NAFLD, but the roles of the caffeine and noncaffeine components of coffee have not been examined, corresponding author John Griffith Jones, PhD, also of the Center for Neuroscience and Cell Biology at the University of Coimbra, said in an interview.
“There have been previous studies indicating a link between coffee intake and NAFLD amelioration, but these were entirely based on self-reporting questionnaire data, but the main limitation of this approach is that it does not provide any information on which components of coffee confer the beneficial effects,” Dr. Jones said. “The development of new analytical techniques allowing reliable profiling of coffee metabolites in urine allowed this limitation to be addressed.”
Dr. Jones and associates examined the relationship between consumption of regular and decaffeinated coffee on the fatty liver index (FLI), a validated predictor of NAFLD. They measured coffee intake of 156 overweight adults, 135 of whom had type 2 diabetes. The study population included 76 women and 80 men with a mean age of 59 years and a mean body mass index of 29 kg/m2.
The participants reported coffee intake via questionnaires, and 98 participants (all with type 2 diabetes) also provided urine samples for measurement of caffeine and noncaffeine metabolites (the products of the body breaking down coffee). NAFLD was assessed using the FLI and a scanning measure of fibrosis.
Overall, no associations appeared between self-reported coffee intake and NAFLD measures. However, urine caffeine metabolite levels were significantly higher among individuals with no liver fibrosis, compared with those with fibrosis, and noncaffeine metabolites showed a significant negative association with FLI measures.
In a multiple regression analysis of 89 individuals with type 2 diabetes, both caffeine and noncaffeine metabolites were negatively associated with FLI, which suggests less severe NAFLD, the researchers noted.
Although the mechanism of action remains unclear, the findings suggest that other noncaffeine coffee components such as polyphenols may reduce the risk of fibrosis by reducing oxidative stress on the liver, they said.
Benefits beyond caffeine
“The main surprise of the study was that both caffeine and noncaffeine metabolites had beneficial effects,” Dr. Jones said. “We had anticipated caffeine, based on its well-known effects on inhibiting liver fibrosis, but the effects of other components were less well described.”
Clinicians can encourage their patients with type 2 diabetes who drink coffee to continue to do so within a normal range (up to three to four cups per day) including decaffeinated coffee; however, “they should be strongly encouraged to drink coffee without added fats and sugars, otherwise the protective benefits [against more severe NAFLD] will not be realized,” Dr. Jones said.
Additional research is needed to extend the analysis to include more coffee compounds, especially those truly unique to coffee, since caffeine can be found in many other foods and beverages, Dr. Jones added.
Limitations include 24-hour time frame
The findings were limited by several factors, including the use of 24-hour urine sample, which may not represent an individual’s habitual coffee consumption, the researchers noted. The urine metabolites measured also may be derived from foods and beverages other than coffee. In addition, the assessment of NAFLD was based on serum markers and ultrasound/elastography, which are less precise than liver biopsy and magnetic resonance spectroscopy.
However, the study is the first known to use urine data to examine coffee’s protective effect against NAFLD and suggests that both caffeine and noncaffeine metabolites are associated with less severe disease, they concluded.
Findings intriguing but not ready for prime time
“The bottom line is that we have a major epidemic of NAFLD in the United States,” Victor L. Roberts, MD, professor of internal medicine at the University of Central Florida, Orlando, said in an interview. NAFLD has become the most common cause of chronic liver disease worldwide, and will become one of the leading causes of cirrhosis – surpassing infections as the main driver of end-stage liver disease.
“In this country, the epidemic of obesity compounds the problem, and risks for NAFLD include obesity and type 2 diabetes,” said Dr. Roberts.
The concept of coffee as beneficial is not new, but data suggest that the effects vary with insulin resistance, he said. If liver disease is advanced, coffee and its components may not have much benefit, but early on, it might have a role.
The likely mechanism of action for the benefits of coffee on the reduction in liver fibrosis is through a complex set of metabolic steps that interrupt the promotion of collagen production and reduce liver stiffness, said Dr. Roberts.
The current study authors were up front about the limitations, mainly the use of self-reports, although including the urine collection provided more scientific data, he said. More studies are needed in other populations, but the findings are interesting enough to merit additional research.
The take-home message for primary care, however, is that drinking coffee – regular or decaf – does not replace standard of care, Dr. Roberts emphasized.
“If a patient is a coffee drinker and they have NAFLD or are at risk, they could be encouraged to continue drinking coffee,” in reasonable amounts, said Dr. Roberts. “Anywhere from 1-3 cups a day is unlikely to be a problem, and there is some hope and interest in this area,” but the findings of the current study “should not be taken as gospel or advocacy as a solution for people with NAFLD.”
Instead, clinicians should focus on the standard of care for management of patients at risk for NAFLD, promoting lifestyle changes such as weight loss, diet, and exercise (challenging as that may be), and prescribing appropriate medications, he said.
The study was supported by the Institute for Scientific Information on Coffee, and the researchers received funding from the ISIC to conduct the study. Dr. Roberts had no financial conflicts to disclose, but he serves on the editorial advisory board of Internal Medicine News.
Increased intake of both regular and decaffeinated coffee was significantly associated with a reduced severity of NAFLD in the study, published in Nutrients. The study participants included 156 overweight adults, most of whom had type 2 diabetes.
A confluence of factors including diet and lifestyle changes and increased obesity have contributed to a rise in type 2 diabetes and of NAFLD, Margarida Coelho, of the Center for Neuroscience and Cell Biology at the University of Coimbra (Portugal), and colleagues wrote.
Previous studies support an association between coffee and protection against NAFLD, but the roles of the caffeine and noncaffeine components of coffee have not been examined, corresponding author John Griffith Jones, PhD, also of the Center for Neuroscience and Cell Biology at the University of Coimbra, said in an interview.
“There have been previous studies indicating a link between coffee intake and NAFLD amelioration, but these were entirely based on self-reporting questionnaire data, but the main limitation of this approach is that it does not provide any information on which components of coffee confer the beneficial effects,” Dr. Jones said. “The development of new analytical techniques allowing reliable profiling of coffee metabolites in urine allowed this limitation to be addressed.”
Dr. Jones and associates examined the relationship between consumption of regular and decaffeinated coffee on the fatty liver index (FLI), a validated predictor of NAFLD. They measured coffee intake of 156 overweight adults, 135 of whom had type 2 diabetes. The study population included 76 women and 80 men with a mean age of 59 years and a mean body mass index of 29 kg/m2.
The participants reported coffee intake via questionnaires, and 98 participants (all with type 2 diabetes) also provided urine samples for measurement of caffeine and noncaffeine metabolites (the products of the body breaking down coffee). NAFLD was assessed using the FLI and a scanning measure of fibrosis.
Overall, no associations appeared between self-reported coffee intake and NAFLD measures. However, urine caffeine metabolite levels were significantly higher among individuals with no liver fibrosis, compared with those with fibrosis, and noncaffeine metabolites showed a significant negative association with FLI measures.
In a multiple regression analysis of 89 individuals with type 2 diabetes, both caffeine and noncaffeine metabolites were negatively associated with FLI, which suggests less severe NAFLD, the researchers noted.
Although the mechanism of action remains unclear, the findings suggest that other noncaffeine coffee components such as polyphenols may reduce the risk of fibrosis by reducing oxidative stress on the liver, they said.
Benefits beyond caffeine
“The main surprise of the study was that both caffeine and noncaffeine metabolites had beneficial effects,” Dr. Jones said. “We had anticipated caffeine, based on its well-known effects on inhibiting liver fibrosis, but the effects of other components were less well described.”
Clinicians can encourage their patients with type 2 diabetes who drink coffee to continue to do so within a normal range (up to three to four cups per day) including decaffeinated coffee; however, “they should be strongly encouraged to drink coffee without added fats and sugars, otherwise the protective benefits [against more severe NAFLD] will not be realized,” Dr. Jones said.
Additional research is needed to extend the analysis to include more coffee compounds, especially those truly unique to coffee, since caffeine can be found in many other foods and beverages, Dr. Jones added.
Limitations include 24-hour time frame
The findings were limited by several factors, including the use of 24-hour urine sample, which may not represent an individual’s habitual coffee consumption, the researchers noted. The urine metabolites measured also may be derived from foods and beverages other than coffee. In addition, the assessment of NAFLD was based on serum markers and ultrasound/elastography, which are less precise than liver biopsy and magnetic resonance spectroscopy.
However, the study is the first known to use urine data to examine coffee’s protective effect against NAFLD and suggests that both caffeine and noncaffeine metabolites are associated with less severe disease, they concluded.
Findings intriguing but not ready for prime time
“The bottom line is that we have a major epidemic of NAFLD in the United States,” Victor L. Roberts, MD, professor of internal medicine at the University of Central Florida, Orlando, said in an interview. NAFLD has become the most common cause of chronic liver disease worldwide, and will become one of the leading causes of cirrhosis – surpassing infections as the main driver of end-stage liver disease.
“In this country, the epidemic of obesity compounds the problem, and risks for NAFLD include obesity and type 2 diabetes,” said Dr. Roberts.
The concept of coffee as beneficial is not new, but data suggest that the effects vary with insulin resistance, he said. If liver disease is advanced, coffee and its components may not have much benefit, but early on, it might have a role.
The likely mechanism of action for the benefits of coffee on the reduction in liver fibrosis is through a complex set of metabolic steps that interrupt the promotion of collagen production and reduce liver stiffness, said Dr. Roberts.
The current study authors were up front about the limitations, mainly the use of self-reports, although including the urine collection provided more scientific data, he said. More studies are needed in other populations, but the findings are interesting enough to merit additional research.
The take-home message for primary care, however, is that drinking coffee – regular or decaf – does not replace standard of care, Dr. Roberts emphasized.
“If a patient is a coffee drinker and they have NAFLD or are at risk, they could be encouraged to continue drinking coffee,” in reasonable amounts, said Dr. Roberts. “Anywhere from 1-3 cups a day is unlikely to be a problem, and there is some hope and interest in this area,” but the findings of the current study “should not be taken as gospel or advocacy as a solution for people with NAFLD.”
Instead, clinicians should focus on the standard of care for management of patients at risk for NAFLD, promoting lifestyle changes such as weight loss, diet, and exercise (challenging as that may be), and prescribing appropriate medications, he said.
The study was supported by the Institute for Scientific Information on Coffee, and the researchers received funding from the ISIC to conduct the study. Dr. Roberts had no financial conflicts to disclose, but he serves on the editorial advisory board of Internal Medicine News.
FROM NUTRIENTS
Pay an annual visit to your office
that your patients might see?
We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.
When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.
Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.
If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.
During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.
If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.
Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.
Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.
If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
that your patients might see?
We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.
When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.
Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.
If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.
During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.
If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.
Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.
Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.
If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
that your patients might see?
We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.
When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.
Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.
If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.
During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.
If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.
Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.
Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.
If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
Metformin monotherapy not always best start in type 2 diabetes
Metformin failure in people with type 2 diabetes is very common, particularly among those with high hemoglobin A1c levels at the time of diagnosis, new findings suggest.
An analysis of electronic health record data for more than 22,000 patients starting metformin at three U.S. clinical sites found that over 40% experienced metformin failure.
This was defined as either failure to achieve or maintain A1c less than 7% within 18 months or the use of additional glucose-lowering medications.
Other predictors that metformin use wouldn’t be successful included increasing age, male sex, and race/ethnicity. However, the latter ceased to be linked after adjustment for other clinical risk factors.
“Our study results suggest increased monitoring with potentially earlier treatment intensification to achieve glycemic control may be appropriate in patients with clinical parameters described in this paper,” Suzette J. Bielinski, PhD, and colleagues wrote.
“Further, these results call into question the ubiquitous use of metformin as the first-line therapy and suggest a more individualized approach may be needed to optimize therapy,” they added in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
The study is also noteworthy in that it demonstrated the feasibility of using EHR data with a machine-learning approach to discover risk biomarkers, Dr. Bielinski, professor of epidemiology at the Mayo Clinic, Rochester, Minn., said in an interview.
“We wanted to repurpose clinical data to answer questions ... I think more studies using these types of techniques repurposing data meant for one thing could potentially impact care in other domains. ... If we can get the bang for the buck from all these data that we generate on people I just think it will improve health care and maybe save health care dollars.”
Baseline A1c strongest predictor of metformin failure
The investigators identified a total of 22,047 metformin initiators from three clinical primary care sites: the University of Mississippi’s Jackson centers, which serves a mostly African American population, the Mountain Park Health Center in Arizona, a seven-clinic federally qualified community health center in Phoenix that serves a mostly Latino population, and the Rochester Epidemiology Project, which includes the Mayo Clinic and serves a primarily White population.
Overall, a total of 43% (9,407) of patients met one of two criteria for metformin failure by 18 months. Among those, median time to failure on metformin was 3.9 months.
Unadjusted failure rates were higher among African Americans, Hispanics, and other racial groups, compared with non-Hispanic White patients.
However, the racial groups also differed by baseline characteristics. Mean A1c was 7.7% overall, 8.1% for the African American group, 7.9% for Asians, and 8.2% for Hispanics, compared with 7.6% for non-Hispanic Whites.
Of 150 clinical factors examined, higher A1c was the strongest predictor of metformin failure, with a rapid increase in risk appearing between 7.5% and 8.0%.
“The slope is steep. It gives us some clinical guidance,” Dr. Bielinski said.
Other variables positively correlated with metformin failure included “diabetes with complications,” increased age, and higher levels of potassium, triglycerides, heart rate, and mean cell hemoglobin.
Factors inversely correlated with metformin failure were having received screening for other suspected conditions and medical examination/evaluation, and lower levels of sodium, albumin, and HDL cholesterol.
Three variables – body mass index, LDL cholesterol, and creatinine – had a U-shaped relationship with metformin failure, so that both high and low values were associated with increased risk.
“The racial/ethnic differences disappeared once other clinical factors were considered suggesting that the biological response to metformin is similar regardless of race/ethnicity,” Dr. Bielinski and colleagues wrote.
They also noted that the abnormal lab results which correlated with metformin failure “likely represent biomarkers for chronic illnesses. However, the effect size for lab abnormalities was small compared with that of baseline A1c.”
Dr. Bielinski urged caution in interpreting the findings. “Electronic health records data have limitations. We have evidence that these people were prescribed metformin. We have no idea if they took it. ... I would really be hesitant to be too strong in making clinical recommendations.”
However, she said that the data are “suggestive to say maybe we need to have some kind of threshold where if someone comes in with an A1c of X that they go on dual therapy right away. I think this is opening the door to that.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Metformin failure in people with type 2 diabetes is very common, particularly among those with high hemoglobin A1c levels at the time of diagnosis, new findings suggest.
An analysis of electronic health record data for more than 22,000 patients starting metformin at three U.S. clinical sites found that over 40% experienced metformin failure.
This was defined as either failure to achieve or maintain A1c less than 7% within 18 months or the use of additional glucose-lowering medications.
Other predictors that metformin use wouldn’t be successful included increasing age, male sex, and race/ethnicity. However, the latter ceased to be linked after adjustment for other clinical risk factors.
“Our study results suggest increased monitoring with potentially earlier treatment intensification to achieve glycemic control may be appropriate in patients with clinical parameters described in this paper,” Suzette J. Bielinski, PhD, and colleagues wrote.
“Further, these results call into question the ubiquitous use of metformin as the first-line therapy and suggest a more individualized approach may be needed to optimize therapy,” they added in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
The study is also noteworthy in that it demonstrated the feasibility of using EHR data with a machine-learning approach to discover risk biomarkers, Dr. Bielinski, professor of epidemiology at the Mayo Clinic, Rochester, Minn., said in an interview.
“We wanted to repurpose clinical data to answer questions ... I think more studies using these types of techniques repurposing data meant for one thing could potentially impact care in other domains. ... If we can get the bang for the buck from all these data that we generate on people I just think it will improve health care and maybe save health care dollars.”
Baseline A1c strongest predictor of metformin failure
The investigators identified a total of 22,047 metformin initiators from three clinical primary care sites: the University of Mississippi’s Jackson centers, which serves a mostly African American population, the Mountain Park Health Center in Arizona, a seven-clinic federally qualified community health center in Phoenix that serves a mostly Latino population, and the Rochester Epidemiology Project, which includes the Mayo Clinic and serves a primarily White population.
Overall, a total of 43% (9,407) of patients met one of two criteria for metformin failure by 18 months. Among those, median time to failure on metformin was 3.9 months.
Unadjusted failure rates were higher among African Americans, Hispanics, and other racial groups, compared with non-Hispanic White patients.
However, the racial groups also differed by baseline characteristics. Mean A1c was 7.7% overall, 8.1% for the African American group, 7.9% for Asians, and 8.2% for Hispanics, compared with 7.6% for non-Hispanic Whites.
Of 150 clinical factors examined, higher A1c was the strongest predictor of metformin failure, with a rapid increase in risk appearing between 7.5% and 8.0%.
“The slope is steep. It gives us some clinical guidance,” Dr. Bielinski said.
Other variables positively correlated with metformin failure included “diabetes with complications,” increased age, and higher levels of potassium, triglycerides, heart rate, and mean cell hemoglobin.
Factors inversely correlated with metformin failure were having received screening for other suspected conditions and medical examination/evaluation, and lower levels of sodium, albumin, and HDL cholesterol.
Three variables – body mass index, LDL cholesterol, and creatinine – had a U-shaped relationship with metformin failure, so that both high and low values were associated with increased risk.
“The racial/ethnic differences disappeared once other clinical factors were considered suggesting that the biological response to metformin is similar regardless of race/ethnicity,” Dr. Bielinski and colleagues wrote.
They also noted that the abnormal lab results which correlated with metformin failure “likely represent biomarkers for chronic illnesses. However, the effect size for lab abnormalities was small compared with that of baseline A1c.”
Dr. Bielinski urged caution in interpreting the findings. “Electronic health records data have limitations. We have evidence that these people were prescribed metformin. We have no idea if they took it. ... I would really be hesitant to be too strong in making clinical recommendations.”
However, she said that the data are “suggestive to say maybe we need to have some kind of threshold where if someone comes in with an A1c of X that they go on dual therapy right away. I think this is opening the door to that.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Metformin failure in people with type 2 diabetes is very common, particularly among those with high hemoglobin A1c levels at the time of diagnosis, new findings suggest.
An analysis of electronic health record data for more than 22,000 patients starting metformin at three U.S. clinical sites found that over 40% experienced metformin failure.
This was defined as either failure to achieve or maintain A1c less than 7% within 18 months or the use of additional glucose-lowering medications.
Other predictors that metformin use wouldn’t be successful included increasing age, male sex, and race/ethnicity. However, the latter ceased to be linked after adjustment for other clinical risk factors.
“Our study results suggest increased monitoring with potentially earlier treatment intensification to achieve glycemic control may be appropriate in patients with clinical parameters described in this paper,” Suzette J. Bielinski, PhD, and colleagues wrote.
“Further, these results call into question the ubiquitous use of metformin as the first-line therapy and suggest a more individualized approach may be needed to optimize therapy,” they added in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
The study is also noteworthy in that it demonstrated the feasibility of using EHR data with a machine-learning approach to discover risk biomarkers, Dr. Bielinski, professor of epidemiology at the Mayo Clinic, Rochester, Minn., said in an interview.
“We wanted to repurpose clinical data to answer questions ... I think more studies using these types of techniques repurposing data meant for one thing could potentially impact care in other domains. ... If we can get the bang for the buck from all these data that we generate on people I just think it will improve health care and maybe save health care dollars.”
Baseline A1c strongest predictor of metformin failure
The investigators identified a total of 22,047 metformin initiators from three clinical primary care sites: the University of Mississippi’s Jackson centers, which serves a mostly African American population, the Mountain Park Health Center in Arizona, a seven-clinic federally qualified community health center in Phoenix that serves a mostly Latino population, and the Rochester Epidemiology Project, which includes the Mayo Clinic and serves a primarily White population.
Overall, a total of 43% (9,407) of patients met one of two criteria for metformin failure by 18 months. Among those, median time to failure on metformin was 3.9 months.
Unadjusted failure rates were higher among African Americans, Hispanics, and other racial groups, compared with non-Hispanic White patients.
However, the racial groups also differed by baseline characteristics. Mean A1c was 7.7% overall, 8.1% for the African American group, 7.9% for Asians, and 8.2% for Hispanics, compared with 7.6% for non-Hispanic Whites.
Of 150 clinical factors examined, higher A1c was the strongest predictor of metformin failure, with a rapid increase in risk appearing between 7.5% and 8.0%.
“The slope is steep. It gives us some clinical guidance,” Dr. Bielinski said.
Other variables positively correlated with metformin failure included “diabetes with complications,” increased age, and higher levels of potassium, triglycerides, heart rate, and mean cell hemoglobin.
Factors inversely correlated with metformin failure were having received screening for other suspected conditions and medical examination/evaluation, and lower levels of sodium, albumin, and HDL cholesterol.
Three variables – body mass index, LDL cholesterol, and creatinine – had a U-shaped relationship with metformin failure, so that both high and low values were associated with increased risk.
“The racial/ethnic differences disappeared once other clinical factors were considered suggesting that the biological response to metformin is similar regardless of race/ethnicity,” Dr. Bielinski and colleagues wrote.
They also noted that the abnormal lab results which correlated with metformin failure “likely represent biomarkers for chronic illnesses. However, the effect size for lab abnormalities was small compared with that of baseline A1c.”
Dr. Bielinski urged caution in interpreting the findings. “Electronic health records data have limitations. We have evidence that these people were prescribed metformin. We have no idea if they took it. ... I would really be hesitant to be too strong in making clinical recommendations.”
However, she said that the data are “suggestive to say maybe we need to have some kind of threshold where if someone comes in with an A1c of X that they go on dual therapy right away. I think this is opening the door to that.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Oramed oral insulin fails to meet goal in type 2 diabetes
Oramed Pharmaceuticals’ investigational oral insulin failed to achieve its primary endpoint in a phase 3 trial, according to top-line results announced by the company.
“Therefore, Oramed expects to discontinue its oral insulin clinical activities for [type 2 diabetes],” according to a company statement.
, ORA-D-013-1, comparing the efficacy of the insulin product ORMD-0801 to placebo in 710 people with type 2 diabetes with inadequate glycemic control on two or three oral glucose-lowering agents.
The participants were randomized 2:2:1:1 into ORMD-0801 dosed at 8 mg once or twice daily, or placebo dosed once or twice daily. They completed a 21-day screening period, followed by a 26-week double-blind treatment period.
The product didn’t achieve the primary endpoint comparing reduction in hemoglobin A1c from baseline to 26 weeks, or the secondary endpoint of mean change in fasting plasma glucose at 26 weeks. There were no serious adverse events.
Oramed Pharmaceuticals specializes in developing oral delivery formulations of drugs currently delivered via injection. The company has offices in the United States and Israel.
Oramed CEO Nadav Kidron commented in the statement, “Today’s outcome is very disappointing, given the positive results from prior trials. Once full data from the studies are available, we expect to share relevant learnings and future plans. We thank all the patients, families, and health care professionals who participated in the trial.”
Insulin manufacturer Novo Nordisk had also been developing an oral insulin product. Successful phase 2a results were presented at the American Diabetes Association’s 2017 Scientific Sessions and full phase 2 feasibility results were published in Lancet Diabetes & Endocrinology in 2019.
However, Novo Nordisk, which manufactures the oral glucagon-like peptide-1 receptor agonist semaglutide (Rybelsus), subsequently discontinued development of their oral insulin product. According to a statement, “Initial results raised questions about truly addressing patients’ unmet needs with insulin therapy. Therefore, we discontinued this work to focus on projects that could in fact improve cardiometabolic outcomes for people living with diabetes.”
A version of this article first appeared on Medscape.com.
Oramed Pharmaceuticals’ investigational oral insulin failed to achieve its primary endpoint in a phase 3 trial, according to top-line results announced by the company.
“Therefore, Oramed expects to discontinue its oral insulin clinical activities for [type 2 diabetes],” according to a company statement.
, ORA-D-013-1, comparing the efficacy of the insulin product ORMD-0801 to placebo in 710 people with type 2 diabetes with inadequate glycemic control on two or three oral glucose-lowering agents.
The participants were randomized 2:2:1:1 into ORMD-0801 dosed at 8 mg once or twice daily, or placebo dosed once or twice daily. They completed a 21-day screening period, followed by a 26-week double-blind treatment period.
The product didn’t achieve the primary endpoint comparing reduction in hemoglobin A1c from baseline to 26 weeks, or the secondary endpoint of mean change in fasting plasma glucose at 26 weeks. There were no serious adverse events.
Oramed Pharmaceuticals specializes in developing oral delivery formulations of drugs currently delivered via injection. The company has offices in the United States and Israel.
Oramed CEO Nadav Kidron commented in the statement, “Today’s outcome is very disappointing, given the positive results from prior trials. Once full data from the studies are available, we expect to share relevant learnings and future plans. We thank all the patients, families, and health care professionals who participated in the trial.”
Insulin manufacturer Novo Nordisk had also been developing an oral insulin product. Successful phase 2a results were presented at the American Diabetes Association’s 2017 Scientific Sessions and full phase 2 feasibility results were published in Lancet Diabetes & Endocrinology in 2019.
However, Novo Nordisk, which manufactures the oral glucagon-like peptide-1 receptor agonist semaglutide (Rybelsus), subsequently discontinued development of their oral insulin product. According to a statement, “Initial results raised questions about truly addressing patients’ unmet needs with insulin therapy. Therefore, we discontinued this work to focus on projects that could in fact improve cardiometabolic outcomes for people living with diabetes.”
A version of this article first appeared on Medscape.com.
Oramed Pharmaceuticals’ investigational oral insulin failed to achieve its primary endpoint in a phase 3 trial, according to top-line results announced by the company.
“Therefore, Oramed expects to discontinue its oral insulin clinical activities for [type 2 diabetes],” according to a company statement.
, ORA-D-013-1, comparing the efficacy of the insulin product ORMD-0801 to placebo in 710 people with type 2 diabetes with inadequate glycemic control on two or three oral glucose-lowering agents.
The participants were randomized 2:2:1:1 into ORMD-0801 dosed at 8 mg once or twice daily, or placebo dosed once or twice daily. They completed a 21-day screening period, followed by a 26-week double-blind treatment period.
The product didn’t achieve the primary endpoint comparing reduction in hemoglobin A1c from baseline to 26 weeks, or the secondary endpoint of mean change in fasting plasma glucose at 26 weeks. There were no serious adverse events.
Oramed Pharmaceuticals specializes in developing oral delivery formulations of drugs currently delivered via injection. The company has offices in the United States and Israel.
Oramed CEO Nadav Kidron commented in the statement, “Today’s outcome is very disappointing, given the positive results from prior trials. Once full data from the studies are available, we expect to share relevant learnings and future plans. We thank all the patients, families, and health care professionals who participated in the trial.”
Insulin manufacturer Novo Nordisk had also been developing an oral insulin product. Successful phase 2a results were presented at the American Diabetes Association’s 2017 Scientific Sessions and full phase 2 feasibility results were published in Lancet Diabetes & Endocrinology in 2019.
However, Novo Nordisk, which manufactures the oral glucagon-like peptide-1 receptor agonist semaglutide (Rybelsus), subsequently discontinued development of their oral insulin product. According to a statement, “Initial results raised questions about truly addressing patients’ unmet needs with insulin therapy. Therefore, we discontinued this work to focus on projects that could in fact improve cardiometabolic outcomes for people living with diabetes.”
A version of this article first appeared on Medscape.com.
‘Clinical paradox’? Bariatric surgery may protect from GI cancers
In fact, an analysis of close to 1 million French adults suggests that the weight-loss surgery may offer some protection against these cancers.
The study results present a “clinical paradox,” according to authors of a commentary published this week along with the study in JAMA Surgery. A procedure known to increase the risk of gastroesophageal reflux disease (GERD), and potentially adenocarcinoma of the distal esophagus and gastroesophageal junction, may help shield patients from esophagogastric cancer.
The study marks “an important step toward improving the understanding of potential lifetime risks of bariatric surgery and overall major health benefits of surgically induced weight loss,” commentary authors Piotr Gorecki, MD, and Michael Zenilman, MD, with Weill Cornell Medicine in New York, write.
Recent data indicate that excess body weight is associated with nearly 8% of cancer cases and 6.5% of cancer deaths. Studies also show that bariatric surgery can reduce the risk of some cancers, but whether this extends to esophageal and gastric cancer remains unclear.
To investigate, the researchers used French national data to compare the incidence of esophageal and gastric cancer in 303,709 mostly female patients with obesity who underwent bariatric surgery and a matched group of 605,140 patients with obesity who did not undergo the surgery.
The mean age of the cohort was about 40 years. The mean period of follow-up was 6 years for the surgery group and 5.6 years for the control arm. A total of 337 patients underwent esophagogastric cancer – 83 in the surgical group and 254 in the control group. Gastric cancer was about two times more common than esophageal cancer (225 vs. 112 patients).
The incidence rate of esophagogastric cancer was higher in the control group than in the surgery group – 6.9 vs. 4.9 cases per 100,000 population per year, for an incidence rate ratio of 1.42 (P = .005).
Bariatric surgery was associated with a significant 24% lower risk of esophagogastric cancer (hazard ratio, 0.76; P = .03) and a 40% lower risk of overall in-hospital mortality, defined as “any death occurring during a hospital stay regardless of the cause” (HR, 0.60; P < .001).
The authors also found no significant difference in cancer outcomes and type of bariatric procedure, which included sleeve gastrectomy, gastric bypass, and adjustable gastric banding.
They note that key study limitations include the retrospective design, limited follow-up period, and lack of histologic data on the specific cancers. In addition, the study population was relatively young, whereas esophageal cancer is more common in older people.
But overall, the findings suggest that bariatric surgery can be performed to treat severe obesity without increasing the risk of esophageal and gastric cancer, the authors conclude.
“It seems that the balance between protective factors (weight loss, metabolic effects, and eradication of H. pylori infection) and risk factors (GERD and bile reflux) for cancer after bariatric surgery is in favor of protective factors,” the authors, led by Andrea Lazzati, MD, PhD, of Centre Hospitalier Intercommunal de Créteil, France, explain.
Although the potential protective mechanisms remain unclear, in their commentary, Dr. Gorecki and Dr. Zenilman suggest that a reduction in chronic inflammation and immunosuppression following bariatric surgery could help explain the results.
Although the study provides “reassurance of the protective clinical benefits of weight loss surgery,” more large-scale studies are needed to “better identify, elucidate, and address the pathophysiological processes of bariatric procedure,” Dr. Gorecki and Dr. Zenilman conclude.
No specific funding for the study was reported. Dr. Lazzati has received personal fees from Johnson & Johnson, Medtronic, and Gore. Dr. Zenilman has received personal fees from Academic Medical Professionals Insurance and Mohamed & Obaid Almulla Group.
A version of this article first appeared on Medscape.com.
In fact, an analysis of close to 1 million French adults suggests that the weight-loss surgery may offer some protection against these cancers.
The study results present a “clinical paradox,” according to authors of a commentary published this week along with the study in JAMA Surgery. A procedure known to increase the risk of gastroesophageal reflux disease (GERD), and potentially adenocarcinoma of the distal esophagus and gastroesophageal junction, may help shield patients from esophagogastric cancer.
The study marks “an important step toward improving the understanding of potential lifetime risks of bariatric surgery and overall major health benefits of surgically induced weight loss,” commentary authors Piotr Gorecki, MD, and Michael Zenilman, MD, with Weill Cornell Medicine in New York, write.
Recent data indicate that excess body weight is associated with nearly 8% of cancer cases and 6.5% of cancer deaths. Studies also show that bariatric surgery can reduce the risk of some cancers, but whether this extends to esophageal and gastric cancer remains unclear.
To investigate, the researchers used French national data to compare the incidence of esophageal and gastric cancer in 303,709 mostly female patients with obesity who underwent bariatric surgery and a matched group of 605,140 patients with obesity who did not undergo the surgery.
The mean age of the cohort was about 40 years. The mean period of follow-up was 6 years for the surgery group and 5.6 years for the control arm. A total of 337 patients underwent esophagogastric cancer – 83 in the surgical group and 254 in the control group. Gastric cancer was about two times more common than esophageal cancer (225 vs. 112 patients).
The incidence rate of esophagogastric cancer was higher in the control group than in the surgery group – 6.9 vs. 4.9 cases per 100,000 population per year, for an incidence rate ratio of 1.42 (P = .005).
Bariatric surgery was associated with a significant 24% lower risk of esophagogastric cancer (hazard ratio, 0.76; P = .03) and a 40% lower risk of overall in-hospital mortality, defined as “any death occurring during a hospital stay regardless of the cause” (HR, 0.60; P < .001).
The authors also found no significant difference in cancer outcomes and type of bariatric procedure, which included sleeve gastrectomy, gastric bypass, and adjustable gastric banding.
They note that key study limitations include the retrospective design, limited follow-up period, and lack of histologic data on the specific cancers. In addition, the study population was relatively young, whereas esophageal cancer is more common in older people.
But overall, the findings suggest that bariatric surgery can be performed to treat severe obesity without increasing the risk of esophageal and gastric cancer, the authors conclude.
“It seems that the balance between protective factors (weight loss, metabolic effects, and eradication of H. pylori infection) and risk factors (GERD and bile reflux) for cancer after bariatric surgery is in favor of protective factors,” the authors, led by Andrea Lazzati, MD, PhD, of Centre Hospitalier Intercommunal de Créteil, France, explain.
Although the potential protective mechanisms remain unclear, in their commentary, Dr. Gorecki and Dr. Zenilman suggest that a reduction in chronic inflammation and immunosuppression following bariatric surgery could help explain the results.
Although the study provides “reassurance of the protective clinical benefits of weight loss surgery,” more large-scale studies are needed to “better identify, elucidate, and address the pathophysiological processes of bariatric procedure,” Dr. Gorecki and Dr. Zenilman conclude.
No specific funding for the study was reported. Dr. Lazzati has received personal fees from Johnson & Johnson, Medtronic, and Gore. Dr. Zenilman has received personal fees from Academic Medical Professionals Insurance and Mohamed & Obaid Almulla Group.
A version of this article first appeared on Medscape.com.
In fact, an analysis of close to 1 million French adults suggests that the weight-loss surgery may offer some protection against these cancers.
The study results present a “clinical paradox,” according to authors of a commentary published this week along with the study in JAMA Surgery. A procedure known to increase the risk of gastroesophageal reflux disease (GERD), and potentially adenocarcinoma of the distal esophagus and gastroesophageal junction, may help shield patients from esophagogastric cancer.
The study marks “an important step toward improving the understanding of potential lifetime risks of bariatric surgery and overall major health benefits of surgically induced weight loss,” commentary authors Piotr Gorecki, MD, and Michael Zenilman, MD, with Weill Cornell Medicine in New York, write.
Recent data indicate that excess body weight is associated with nearly 8% of cancer cases and 6.5% of cancer deaths. Studies also show that bariatric surgery can reduce the risk of some cancers, but whether this extends to esophageal and gastric cancer remains unclear.
To investigate, the researchers used French national data to compare the incidence of esophageal and gastric cancer in 303,709 mostly female patients with obesity who underwent bariatric surgery and a matched group of 605,140 patients with obesity who did not undergo the surgery.
The mean age of the cohort was about 40 years. The mean period of follow-up was 6 years for the surgery group and 5.6 years for the control arm. A total of 337 patients underwent esophagogastric cancer – 83 in the surgical group and 254 in the control group. Gastric cancer was about two times more common than esophageal cancer (225 vs. 112 patients).
The incidence rate of esophagogastric cancer was higher in the control group than in the surgery group – 6.9 vs. 4.9 cases per 100,000 population per year, for an incidence rate ratio of 1.42 (P = .005).
Bariatric surgery was associated with a significant 24% lower risk of esophagogastric cancer (hazard ratio, 0.76; P = .03) and a 40% lower risk of overall in-hospital mortality, defined as “any death occurring during a hospital stay regardless of the cause” (HR, 0.60; P < .001).
The authors also found no significant difference in cancer outcomes and type of bariatric procedure, which included sleeve gastrectomy, gastric bypass, and adjustable gastric banding.
They note that key study limitations include the retrospective design, limited follow-up period, and lack of histologic data on the specific cancers. In addition, the study population was relatively young, whereas esophageal cancer is more common in older people.
But overall, the findings suggest that bariatric surgery can be performed to treat severe obesity without increasing the risk of esophageal and gastric cancer, the authors conclude.
“It seems that the balance between protective factors (weight loss, metabolic effects, and eradication of H. pylori infection) and risk factors (GERD and bile reflux) for cancer after bariatric surgery is in favor of protective factors,” the authors, led by Andrea Lazzati, MD, PhD, of Centre Hospitalier Intercommunal de Créteil, France, explain.
Although the potential protective mechanisms remain unclear, in their commentary, Dr. Gorecki and Dr. Zenilman suggest that a reduction in chronic inflammation and immunosuppression following bariatric surgery could help explain the results.
Although the study provides “reassurance of the protective clinical benefits of weight loss surgery,” more large-scale studies are needed to “better identify, elucidate, and address the pathophysiological processes of bariatric procedure,” Dr. Gorecki and Dr. Zenilman conclude.
No specific funding for the study was reported. Dr. Lazzati has received personal fees from Johnson & Johnson, Medtronic, and Gore. Dr. Zenilman has received personal fees from Academic Medical Professionals Insurance and Mohamed & Obaid Almulla Group.
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY