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Survey finds Mohs surgeons favor nicotinamide for chemoprevention
, in a survey of members of the American College of Mohs Surgeons.
Although nicotinamide, a vitamin B3 derivative, has been shown to reduce keratinocyte carcinoma (KC) in high-risk patients, it is not approved by the Food and Drug Administration for chemoprevention, and no safe upper limit has been established in clinical trials to date, wrote Sheena Desai of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
The investigators emailed an anonymous 12-question survey to 1,500 members of the American College of Mohs Surgeons. Of the 170 who responded, 10 were excluded for discordant responses, leaving 160 participants whose replies were included in a multiple logistic regression analysis. The respondents were mainly U.S. board-certified dermatologists and Mohs surgeons (99.4% for both); 86.9% were in clinical practice, including 78.8% in private practice, according to the report of the results, published in Dermatologic Surgery.
Overall, 76.9% of the respondents said they recommended nicotinamide for preventing KC, and 20% said they had recommended nicotinamide to more than 100 patients in the past year. In addition, 45% of respondents reported patients who had been taking nicotinamide for 2 years or more. Overall, 63.8% of the respondents expressed no concerns about long-term safety of nicotinamide, compared with 28.1% who said they were uncertain about long-term safety. Those who expressed concern or uncertainty about long-term safety were significantly less likely to recommend nicotinamide for KC prevention in the past year (odds ratio, 0.30; 95% confidence interval [CI] 0.13-0.71). Clinicians with more than 10 years in practice were significantly less likely to recommend nicotinamide for chemoprevention (OR, 0.20; 95% CI 0.05-0.82).
The study findings were limited by several factors, including the low number of responses and the potential lack of generalizability to clinicians other than Mohs surgeons, the researchers noted. “Additional studies on nicotinamide safety and use patterns, including cost-effectiveness analyses, are needed given the widespread use identified in this study,” they concluded.
Limited safety data highlight research gaps
The study is particularly important at this time because nicotinamide has been increasingly used for KC chemoprevention since a randomized, controlled trial published in 2015 in the New England Journal of Medicine showed benefits, corresponding author Rebecca I. Hartman, MD, of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, said in an interview. That study of high-risk patients found that nicotinamide, 500 mg twice a day, was safe and effective in lowering the rates of new nonmelanoma skin cancers and AKs after 12 months .
“However, because this is not a prescription medication, but rather an OTC vitamin supplement, data on its use are not available,” she said.
Dr. Hartman said she was not surprised that nicotinamide is being used frequently by a majority of the survey respondents. “Most are using this if someone has two KCs over 2 years, which is a quite common occurrence,” she noted. However, “I was a bit surprised that nearly two-thirds had no safety concerns with long-term use, even though this has not been well-studied,” she added.
“Like anything we recommend, we must consider the risks and benefits,” Dr. Hartman said of nicotinamide. “Unfortunately, we don’t know the risks well, since this hasn’t been well-characterized with regular long-term use in these doses,” and more research is needed, she said. “The risks are likely low, as this is a vitamin that has been used for years in various OTC supplements,” she added. “However, there are some data showing slightly increased all-cause mortality with similar doses of a related medicine, niacin, in cardiovascular patients. For this reason, I recommend the medication when a patient’s KCs are really becoming burdensome – several KCs in a year or two – or when they are high-risk due to immunosuppression,” she explained.
“We also must consider the individual patient. For a healthy younger patient who has a public-facing job and as a result is very averse to developing any KCs on his or her face and very motivated to try prevention, it may make sense to try nicotinamide,” Dr. Hartman said. But for an older patient with cardiovascular comorbidities who is not bothered by a KC on his or her back or extremities, “this medication may not have a favorable risk-benefit profile.”
To address safety concerns, “researchers need to examine whether there are any harms in long-term regular nicotinamide use for KC prevention,” Dr. Hartman said. “This is something we hope to do in our patients; however, it is challenging to study in a retrospective way since the harm is likely small and there are so many other features that influence mortality as an outcome,” she noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
, in a survey of members of the American College of Mohs Surgeons.
Although nicotinamide, a vitamin B3 derivative, has been shown to reduce keratinocyte carcinoma (KC) in high-risk patients, it is not approved by the Food and Drug Administration for chemoprevention, and no safe upper limit has been established in clinical trials to date, wrote Sheena Desai of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
The investigators emailed an anonymous 12-question survey to 1,500 members of the American College of Mohs Surgeons. Of the 170 who responded, 10 were excluded for discordant responses, leaving 160 participants whose replies were included in a multiple logistic regression analysis. The respondents were mainly U.S. board-certified dermatologists and Mohs surgeons (99.4% for both); 86.9% were in clinical practice, including 78.8% in private practice, according to the report of the results, published in Dermatologic Surgery.
Overall, 76.9% of the respondents said they recommended nicotinamide for preventing KC, and 20% said they had recommended nicotinamide to more than 100 patients in the past year. In addition, 45% of respondents reported patients who had been taking nicotinamide for 2 years or more. Overall, 63.8% of the respondents expressed no concerns about long-term safety of nicotinamide, compared with 28.1% who said they were uncertain about long-term safety. Those who expressed concern or uncertainty about long-term safety were significantly less likely to recommend nicotinamide for KC prevention in the past year (odds ratio, 0.30; 95% confidence interval [CI] 0.13-0.71). Clinicians with more than 10 years in practice were significantly less likely to recommend nicotinamide for chemoprevention (OR, 0.20; 95% CI 0.05-0.82).
The study findings were limited by several factors, including the low number of responses and the potential lack of generalizability to clinicians other than Mohs surgeons, the researchers noted. “Additional studies on nicotinamide safety and use patterns, including cost-effectiveness analyses, are needed given the widespread use identified in this study,” they concluded.
Limited safety data highlight research gaps
The study is particularly important at this time because nicotinamide has been increasingly used for KC chemoprevention since a randomized, controlled trial published in 2015 in the New England Journal of Medicine showed benefits, corresponding author Rebecca I. Hartman, MD, of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, said in an interview. That study of high-risk patients found that nicotinamide, 500 mg twice a day, was safe and effective in lowering the rates of new nonmelanoma skin cancers and AKs after 12 months .
“However, because this is not a prescription medication, but rather an OTC vitamin supplement, data on its use are not available,” she said.
Dr. Hartman said she was not surprised that nicotinamide is being used frequently by a majority of the survey respondents. “Most are using this if someone has two KCs over 2 years, which is a quite common occurrence,” she noted. However, “I was a bit surprised that nearly two-thirds had no safety concerns with long-term use, even though this has not been well-studied,” she added.
“Like anything we recommend, we must consider the risks and benefits,” Dr. Hartman said of nicotinamide. “Unfortunately, we don’t know the risks well, since this hasn’t been well-characterized with regular long-term use in these doses,” and more research is needed, she said. “The risks are likely low, as this is a vitamin that has been used for years in various OTC supplements,” she added. “However, there are some data showing slightly increased all-cause mortality with similar doses of a related medicine, niacin, in cardiovascular patients. For this reason, I recommend the medication when a patient’s KCs are really becoming burdensome – several KCs in a year or two – or when they are high-risk due to immunosuppression,” she explained.
“We also must consider the individual patient. For a healthy younger patient who has a public-facing job and as a result is very averse to developing any KCs on his or her face and very motivated to try prevention, it may make sense to try nicotinamide,” Dr. Hartman said. But for an older patient with cardiovascular comorbidities who is not bothered by a KC on his or her back or extremities, “this medication may not have a favorable risk-benefit profile.”
To address safety concerns, “researchers need to examine whether there are any harms in long-term regular nicotinamide use for KC prevention,” Dr. Hartman said. “This is something we hope to do in our patients; however, it is challenging to study in a retrospective way since the harm is likely small and there are so many other features that influence mortality as an outcome,” she noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
, in a survey of members of the American College of Mohs Surgeons.
Although nicotinamide, a vitamin B3 derivative, has been shown to reduce keratinocyte carcinoma (KC) in high-risk patients, it is not approved by the Food and Drug Administration for chemoprevention, and no safe upper limit has been established in clinical trials to date, wrote Sheena Desai of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
The investigators emailed an anonymous 12-question survey to 1,500 members of the American College of Mohs Surgeons. Of the 170 who responded, 10 were excluded for discordant responses, leaving 160 participants whose replies were included in a multiple logistic regression analysis. The respondents were mainly U.S. board-certified dermatologists and Mohs surgeons (99.4% for both); 86.9% were in clinical practice, including 78.8% in private practice, according to the report of the results, published in Dermatologic Surgery.
Overall, 76.9% of the respondents said they recommended nicotinamide for preventing KC, and 20% said they had recommended nicotinamide to more than 100 patients in the past year. In addition, 45% of respondents reported patients who had been taking nicotinamide for 2 years or more. Overall, 63.8% of the respondents expressed no concerns about long-term safety of nicotinamide, compared with 28.1% who said they were uncertain about long-term safety. Those who expressed concern or uncertainty about long-term safety were significantly less likely to recommend nicotinamide for KC prevention in the past year (odds ratio, 0.30; 95% confidence interval [CI] 0.13-0.71). Clinicians with more than 10 years in practice were significantly less likely to recommend nicotinamide for chemoprevention (OR, 0.20; 95% CI 0.05-0.82).
The study findings were limited by several factors, including the low number of responses and the potential lack of generalizability to clinicians other than Mohs surgeons, the researchers noted. “Additional studies on nicotinamide safety and use patterns, including cost-effectiveness analyses, are needed given the widespread use identified in this study,” they concluded.
Limited safety data highlight research gaps
The study is particularly important at this time because nicotinamide has been increasingly used for KC chemoprevention since a randomized, controlled trial published in 2015 in the New England Journal of Medicine showed benefits, corresponding author Rebecca I. Hartman, MD, of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, said in an interview. That study of high-risk patients found that nicotinamide, 500 mg twice a day, was safe and effective in lowering the rates of new nonmelanoma skin cancers and AKs after 12 months .
“However, because this is not a prescription medication, but rather an OTC vitamin supplement, data on its use are not available,” she said.
Dr. Hartman said she was not surprised that nicotinamide is being used frequently by a majority of the survey respondents. “Most are using this if someone has two KCs over 2 years, which is a quite common occurrence,” she noted. However, “I was a bit surprised that nearly two-thirds had no safety concerns with long-term use, even though this has not been well-studied,” she added.
“Like anything we recommend, we must consider the risks and benefits,” Dr. Hartman said of nicotinamide. “Unfortunately, we don’t know the risks well, since this hasn’t been well-characterized with regular long-term use in these doses,” and more research is needed, she said. “The risks are likely low, as this is a vitamin that has been used for years in various OTC supplements,” she added. “However, there are some data showing slightly increased all-cause mortality with similar doses of a related medicine, niacin, in cardiovascular patients. For this reason, I recommend the medication when a patient’s KCs are really becoming burdensome – several KCs in a year or two – or when they are high-risk due to immunosuppression,” she explained.
“We also must consider the individual patient. For a healthy younger patient who has a public-facing job and as a result is very averse to developing any KCs on his or her face and very motivated to try prevention, it may make sense to try nicotinamide,” Dr. Hartman said. But for an older patient with cardiovascular comorbidities who is not bothered by a KC on his or her back or extremities, “this medication may not have a favorable risk-benefit profile.”
To address safety concerns, “researchers need to examine whether there are any harms in long-term regular nicotinamide use for KC prevention,” Dr. Hartman said. “This is something we hope to do in our patients; however, it is challenging to study in a retrospective way since the harm is likely small and there are so many other features that influence mortality as an outcome,” she noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM DERMATOLOGIC SURGERY
Twenty percent of dialysis patients are hesitant about COVID-19 vaccine
Among U.S. patients who regularly undergo hemodialysis, 20% had some degree of hesitancy about receiving a COVID-19 vaccine in a survey of 1,515 patients conducted during January and February 2021.
The most frequently cited concern associated with hesitancy over vaccination against the SARS-CoV-2 virus was with regard to possible adverse effects. This was cited by more than half of the patients who were concerned about being vaccinated.
Hesitancy rates were highest among people aged 44 years or younger, women, people who identified as non-Hispanic Black or non-Hispanic other (generally Native American or Pacific Islander), those with less than some college education, and those without a history of influenza vaccination, Pablo Garcia, MD, reported at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings.
Hesitancy or access?
Overall, however, the findings suggest that the main barrier to COVID-19 vaccine uptake is “access rather than hesitancy,” explained Dr. Garcia, a nephrologist at Stanford (Calif.) University. He predicts that this barrier will soon resolve, in part because of a Centers for Disease Control and Prevention program launched in March 2021 that is supplying COVID-19 vaccine to U.S. dialysis centers to administer to their patients.
“This will facilitate access to the vaccine” for patients who regularly receive hemodialysis, Dr. Garcia said during his presentation.
“Administering vaccines in dialysis clinics will help. Patients are already accustomed to receiving influenza vaccine in the clinic,” said Joseph A. Vassalotti, MD, a nephrologist at Mount Sinai Hospital, New York, and chief medical officer for the NKF.
Dr. Vassalotti cited the importance of protecting the vulnerable population of people who regularly receive hemodialysis. Among those patients, there was a 37% spike in all-cause mortality during peak weeks of the pandemic compared with similar periods during 2017-2019.
Any level of vaccine hesitancy is concerning
In an interview, he said, “Vaccination is the key to reducing this burden, so any level of vaccine hesitancy is concerning” with regard to patients who regularly undergo dialysis.
Hesitancy among patients who undergo dialysis appears to be less than in the general U.S. population, according to a series of surveys conducted from April through December 2020. In that series, hesitancy rates approached 50% in a sample of more than 8,000 people.
Hesitancy among people overall may have recently increased, at least for the short term, because of concerns over rare thrombotic events among people who receive certain types of COVID-19 vaccine, Dr. Vassalotti noted.
Dr. Garcia and associates conducted their survey from Jan. 8 to Feb. 11, 2021, among patients who regularly received hemodialysis at any of 150 randomly selected dialysis clinics that treat 30 or more patients and are managed by U.S. Renal Care. The study enrolled patients in 22 states. Most of the patients were aged 45-79 years; 30% were non-Hispanic White; 30% were Black, and 24% were Hispanic. The survey included 24 questions and took about 10 minutes to complete.
In reply to the statement, “If COVID-19 vaccine was proven safe and effective for the general population I would seek to get it,” 20% gave a reply of definitely not, probably not, or unsure; 79% answered either probably or definitely yes.
Another question asked about willingness to receive a vaccine if it was shown to be safe and effective for people receiving dialysis. In answer to that question, 19% said definitely not, probably not, or unsure.
Possible adverse effects an issue
Asked the reason why they were hesitant to receive the vaccine, 53% cited possible adverse effects; 19% cited general unease about vaccines; 19% said they did not think the COVID-19 vaccines would work; 17% said they did not think they needed a COVID-19 vaccine; and 15% said they had read or heard that COVID-19 vaccines were dangerous.
A set of questions asked survey respondents about their primary source of information about COVID-19 vaccines. About three-quarters cited television news; about 35% cited members of their dialysis clinic staff; about 30% cited friends and family; 20% cited social media; 20% cited their nephrologists; and roughly 15% cited newspapers.
The results suggest that potentially effective interventions to promote vaccine uptake include showing informational videos to patients during dialysis sessions and encouraging the staff at dialysis centers to proactively educate patients about COVID-19 vaccines and to promote uptake, suggest Dr. Garcia and Dr. Vassalotti.
Dr. Vassalotti noted that in a recent single-center survey of 90 U.S. patients undergoing hemodialysis that included 75 (85%) Black persons, the prevalence of hesitancy about COVID-19 vaccines was 50%. Hesitancy was often linked with gaps in patient education.
“We need broad educational measures, as well as targeting specific demographic groups” among whom the level of hesitancy is high, said Dr. Vassalotti.
He noted that patients who undergo dialysis are receptive to messages from dialysis clinic staff members and that this offers an “opportunity to understand misconceptions that underlie hesitancy and address them on an individual basis.”
The NKF has prepared a fact sheet for educating patients with kidney disease about the efficacy and safety of COVID-19 vaccines, Dr. Vassalotti noted.
Dr. Garcia has disclosed no relevant financial relationships. Dr. Vassalotti is an adviser and consultant to Renalytix AI and is a consultant to Janssen.
A version of this article first appeared on Medscape.com.
Among U.S. patients who regularly undergo hemodialysis, 20% had some degree of hesitancy about receiving a COVID-19 vaccine in a survey of 1,515 patients conducted during January and February 2021.
The most frequently cited concern associated with hesitancy over vaccination against the SARS-CoV-2 virus was with regard to possible adverse effects. This was cited by more than half of the patients who were concerned about being vaccinated.
Hesitancy rates were highest among people aged 44 years or younger, women, people who identified as non-Hispanic Black or non-Hispanic other (generally Native American or Pacific Islander), those with less than some college education, and those without a history of influenza vaccination, Pablo Garcia, MD, reported at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings.
Hesitancy or access?
Overall, however, the findings suggest that the main barrier to COVID-19 vaccine uptake is “access rather than hesitancy,” explained Dr. Garcia, a nephrologist at Stanford (Calif.) University. He predicts that this barrier will soon resolve, in part because of a Centers for Disease Control and Prevention program launched in March 2021 that is supplying COVID-19 vaccine to U.S. dialysis centers to administer to their patients.
“This will facilitate access to the vaccine” for patients who regularly receive hemodialysis, Dr. Garcia said during his presentation.
“Administering vaccines in dialysis clinics will help. Patients are already accustomed to receiving influenza vaccine in the clinic,” said Joseph A. Vassalotti, MD, a nephrologist at Mount Sinai Hospital, New York, and chief medical officer for the NKF.
Dr. Vassalotti cited the importance of protecting the vulnerable population of people who regularly receive hemodialysis. Among those patients, there was a 37% spike in all-cause mortality during peak weeks of the pandemic compared with similar periods during 2017-2019.
Any level of vaccine hesitancy is concerning
In an interview, he said, “Vaccination is the key to reducing this burden, so any level of vaccine hesitancy is concerning” with regard to patients who regularly undergo dialysis.
Hesitancy among patients who undergo dialysis appears to be less than in the general U.S. population, according to a series of surveys conducted from April through December 2020. In that series, hesitancy rates approached 50% in a sample of more than 8,000 people.
Hesitancy among people overall may have recently increased, at least for the short term, because of concerns over rare thrombotic events among people who receive certain types of COVID-19 vaccine, Dr. Vassalotti noted.
Dr. Garcia and associates conducted their survey from Jan. 8 to Feb. 11, 2021, among patients who regularly received hemodialysis at any of 150 randomly selected dialysis clinics that treat 30 or more patients and are managed by U.S. Renal Care. The study enrolled patients in 22 states. Most of the patients were aged 45-79 years; 30% were non-Hispanic White; 30% were Black, and 24% were Hispanic. The survey included 24 questions and took about 10 minutes to complete.
In reply to the statement, “If COVID-19 vaccine was proven safe and effective for the general population I would seek to get it,” 20% gave a reply of definitely not, probably not, or unsure; 79% answered either probably or definitely yes.
Another question asked about willingness to receive a vaccine if it was shown to be safe and effective for people receiving dialysis. In answer to that question, 19% said definitely not, probably not, or unsure.
Possible adverse effects an issue
Asked the reason why they were hesitant to receive the vaccine, 53% cited possible adverse effects; 19% cited general unease about vaccines; 19% said they did not think the COVID-19 vaccines would work; 17% said they did not think they needed a COVID-19 vaccine; and 15% said they had read or heard that COVID-19 vaccines were dangerous.
A set of questions asked survey respondents about their primary source of information about COVID-19 vaccines. About three-quarters cited television news; about 35% cited members of their dialysis clinic staff; about 30% cited friends and family; 20% cited social media; 20% cited their nephrologists; and roughly 15% cited newspapers.
The results suggest that potentially effective interventions to promote vaccine uptake include showing informational videos to patients during dialysis sessions and encouraging the staff at dialysis centers to proactively educate patients about COVID-19 vaccines and to promote uptake, suggest Dr. Garcia and Dr. Vassalotti.
Dr. Vassalotti noted that in a recent single-center survey of 90 U.S. patients undergoing hemodialysis that included 75 (85%) Black persons, the prevalence of hesitancy about COVID-19 vaccines was 50%. Hesitancy was often linked with gaps in patient education.
“We need broad educational measures, as well as targeting specific demographic groups” among whom the level of hesitancy is high, said Dr. Vassalotti.
He noted that patients who undergo dialysis are receptive to messages from dialysis clinic staff members and that this offers an “opportunity to understand misconceptions that underlie hesitancy and address them on an individual basis.”
The NKF has prepared a fact sheet for educating patients with kidney disease about the efficacy and safety of COVID-19 vaccines, Dr. Vassalotti noted.
Dr. Garcia has disclosed no relevant financial relationships. Dr. Vassalotti is an adviser and consultant to Renalytix AI and is a consultant to Janssen.
A version of this article first appeared on Medscape.com.
Among U.S. patients who regularly undergo hemodialysis, 20% had some degree of hesitancy about receiving a COVID-19 vaccine in a survey of 1,515 patients conducted during January and February 2021.
The most frequently cited concern associated with hesitancy over vaccination against the SARS-CoV-2 virus was with regard to possible adverse effects. This was cited by more than half of the patients who were concerned about being vaccinated.
Hesitancy rates were highest among people aged 44 years or younger, women, people who identified as non-Hispanic Black or non-Hispanic other (generally Native American or Pacific Islander), those with less than some college education, and those without a history of influenza vaccination, Pablo Garcia, MD, reported at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings.
Hesitancy or access?
Overall, however, the findings suggest that the main barrier to COVID-19 vaccine uptake is “access rather than hesitancy,” explained Dr. Garcia, a nephrologist at Stanford (Calif.) University. He predicts that this barrier will soon resolve, in part because of a Centers for Disease Control and Prevention program launched in March 2021 that is supplying COVID-19 vaccine to U.S. dialysis centers to administer to their patients.
“This will facilitate access to the vaccine” for patients who regularly receive hemodialysis, Dr. Garcia said during his presentation.
“Administering vaccines in dialysis clinics will help. Patients are already accustomed to receiving influenza vaccine in the clinic,” said Joseph A. Vassalotti, MD, a nephrologist at Mount Sinai Hospital, New York, and chief medical officer for the NKF.
Dr. Vassalotti cited the importance of protecting the vulnerable population of people who regularly receive hemodialysis. Among those patients, there was a 37% spike in all-cause mortality during peak weeks of the pandemic compared with similar periods during 2017-2019.
Any level of vaccine hesitancy is concerning
In an interview, he said, “Vaccination is the key to reducing this burden, so any level of vaccine hesitancy is concerning” with regard to patients who regularly undergo dialysis.
Hesitancy among patients who undergo dialysis appears to be less than in the general U.S. population, according to a series of surveys conducted from April through December 2020. In that series, hesitancy rates approached 50% in a sample of more than 8,000 people.
Hesitancy among people overall may have recently increased, at least for the short term, because of concerns over rare thrombotic events among people who receive certain types of COVID-19 vaccine, Dr. Vassalotti noted.
Dr. Garcia and associates conducted their survey from Jan. 8 to Feb. 11, 2021, among patients who regularly received hemodialysis at any of 150 randomly selected dialysis clinics that treat 30 or more patients and are managed by U.S. Renal Care. The study enrolled patients in 22 states. Most of the patients were aged 45-79 years; 30% were non-Hispanic White; 30% were Black, and 24% were Hispanic. The survey included 24 questions and took about 10 minutes to complete.
In reply to the statement, “If COVID-19 vaccine was proven safe and effective for the general population I would seek to get it,” 20% gave a reply of definitely not, probably not, or unsure; 79% answered either probably or definitely yes.
Another question asked about willingness to receive a vaccine if it was shown to be safe and effective for people receiving dialysis. In answer to that question, 19% said definitely not, probably not, or unsure.
Possible adverse effects an issue
Asked the reason why they were hesitant to receive the vaccine, 53% cited possible adverse effects; 19% cited general unease about vaccines; 19% said they did not think the COVID-19 vaccines would work; 17% said they did not think they needed a COVID-19 vaccine; and 15% said they had read or heard that COVID-19 vaccines were dangerous.
A set of questions asked survey respondents about their primary source of information about COVID-19 vaccines. About three-quarters cited television news; about 35% cited members of their dialysis clinic staff; about 30% cited friends and family; 20% cited social media; 20% cited their nephrologists; and roughly 15% cited newspapers.
The results suggest that potentially effective interventions to promote vaccine uptake include showing informational videos to patients during dialysis sessions and encouraging the staff at dialysis centers to proactively educate patients about COVID-19 vaccines and to promote uptake, suggest Dr. Garcia and Dr. Vassalotti.
Dr. Vassalotti noted that in a recent single-center survey of 90 U.S. patients undergoing hemodialysis that included 75 (85%) Black persons, the prevalence of hesitancy about COVID-19 vaccines was 50%. Hesitancy was often linked with gaps in patient education.
“We need broad educational measures, as well as targeting specific demographic groups” among whom the level of hesitancy is high, said Dr. Vassalotti.
He noted that patients who undergo dialysis are receptive to messages from dialysis clinic staff members and that this offers an “opportunity to understand misconceptions that underlie hesitancy and address them on an individual basis.”
The NKF has prepared a fact sheet for educating patients with kidney disease about the efficacy and safety of COVID-19 vaccines, Dr. Vassalotti noted.
Dr. Garcia has disclosed no relevant financial relationships. Dr. Vassalotti is an adviser and consultant to Renalytix AI and is a consultant to Janssen.
A version of this article first appeared on Medscape.com.
Cardiologists can perform stroke thrombectomy to fill ‘unmet need’
Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.
Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.
The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.
The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.
The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.
The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.
Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.
Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.
The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.
“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.
“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”
The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.
Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.
“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”
But the major problem was the lack of neurointerventionalists.
“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.
They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.
Their hospital is a very busy center for myocardial infarction, percutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult. Actually, I think coronary angioplasty can be more difficult.”
Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”
He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.
“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”
Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.
“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.
Editorial strongly supportive
An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.
Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.
“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.
They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.
“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
Opposition in the United States
Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.
In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.
“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”
Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.
“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”
Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”
Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.
“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.”
He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.”
This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.
Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.
The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.
The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.
The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.
The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.
Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.
Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.
The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.
“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.
“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”
The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.
Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.
“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”
But the major problem was the lack of neurointerventionalists.
“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.
They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.
Their hospital is a very busy center for myocardial infarction, percutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult. Actually, I think coronary angioplasty can be more difficult.”
Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”
He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.
“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”
Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.
“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.
Editorial strongly supportive
An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.
Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.
“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.
They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.
“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
Opposition in the United States
Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.
In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.
“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”
Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.
“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”
Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”
Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.
“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.”
He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.”
This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cardiologists experienced in cardiac interventions can competently perform stroke thrombectomy after a short period of training, with outcomes comparable to those achieved by neuroradiology centers, a new study suggests.
“Using interventional cardiologists in this way will help address the huge unmet need for stroke thrombectomy that currently exists,” senior author Petr Widimsky, MD, said in an interview.
Although this may be a feasible way forward in Europe, there is strong opposition to such a proposal from U.S. neurointerventionalists.
The study, published in the April 12 issue of JACC: Cardiovascular Interventions, describes the establishment of a stroke thrombectomy program in University Hospital Kralovske Vinohrady, a large tertiary hospital in Prague, Czech Republic.
The hospital did not have a neurointerventional program until 2012 when a joint program was started involving an experienced team of cardiologists, angiologists, and one interventional radiologist who trained the cardiologists on the thrombectomy procedure.
The current paper reports on the outcomes of the 333 patients with large vessel occlusion stroke treated under this program between October 2012 and December 2019.
The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and CT angiographic findings.
Results show that functional clinical outcomes, assessed via the Modified Rankin Scale (mRS) score at 3 months, did not vary significantly across years 2012 to 2019, with a favorable outcome (mRS 0 to 2) achieved in 47.9% of patients.
Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%) and embolization in a new vascular territory occurred in 6 patients (1.8%), outcomes similar to those of neuroradiology centers.
The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect, they reported.
“These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists,” the authors concluded.
“Our main message is that our results were excellent from the beginning,” Dr. Widimsky said. “When centers prepare properly, they can achieve excellent results from the beginning with cardiologists who are experienced in interventional procedures and who have spent sufficient time learning about the brain.”
The authors noted that despite thrombectomy being an extremely beneficial treatment for severe stroke, many eligible patients remain untreated, largely because of a lack of neurointerventionalists in many regions worldwide. They estimate that about 15% of all stroke patients are eligible for thrombectomy but only around 2% of stroke patients in Europe actually receive such treatment.
Dr. Widimsky, an interventional cardiologist, first thought of the idea of using cardiologists to perform stroke thrombectomies after a good friend and colleague suffered a severe stroke in 2010.
“This made us realize that our hospital needed to be more active in the stroke field,” he said. “We decided that we needed to start doing stroke interventions.”
But the major problem was the lack of neurointerventionalists.
“There are not enough neurointerventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year whereas a neurointerventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” Dr. Widimsky said.
They hired one neurointerventionalist to lead the program. “He was our tutor, he taught us his skills,” Dr. Widimsky said. “The cath lab is open 24/7, but if we only have one neurointerventionalist we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can,” he added.
Their hospital is a very busy center for myocardial infarction, percutaneous coronary intervention, and carotid stenting, he noted. “It is not difficult to make the step from that to stroke thrombectomy. Interventional cardiologists are used to performing carotid and coronary artery stenting. Stroke thrombectomy is a similar technique. The thrombectomy procedure is different from coronary angioplasty but it is not more difficult. Actually, I think coronary angioplasty can be more difficult.”
Dr. Widimsky explained that cardiologists need to learn about the brain anatomy and physiology and learn the stroke imaging techniques. “I spent 1 month in the U.S. learning stroke interventions working with simulators,” he said. “I think interventional cardiologists can learn what they need to know in about 6 months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.”
He said this model is the way forward and hopes it will become routine. Thrombectomy is “tremendously effective” in improving outcomes in severe strokes, with a number needed to treat (NNT) of just 2.6 to prevent long-term disability in one patient, he said, while other procedures can have NNTs of 50 or more.
“But millions of patients with acute severe stroke are not getting this life-changing treatment,” he added. “We must do everything we can to make this service available to as many patients as possible.”
Dr. Widimsky acknowledges that there has been opposition to this idea from the neurointerventionalist professional bodies but this has lessened recently, at least in Europe. And a program that allows interventionalists with experience in extracranial carotid and vertebral endovascular procedures to “fast-track” technical training has now been proposed.
“There is an enormous unmet need for stroke thrombectomy in Europe, with some countries needing to increase the number of procedures done by 10 or 20 times. These include the U.K., Sweden, Italy, Spain, and Portugal. This cannot be done without cardiology,” Dr. Widimsky said.
Editorial strongly supportive
An accompanying editorial strongly endorses the idea of using interdisciplinary teams to deliver high standard stroke care.
Marius Hornung, MD, and Horst Sievert, MD, from CardioVascular Center Frankfurt (Germany), point out that many experienced cardiologists are trained in performing carotid artery interventions and are therefore experienced in accessing the supra-aortic arteries.
“To be able to guarantee optimized stroke therapy as soon as possible, disputes over competence among the individual medical societies involved must be ended,” they wrote.
They advocate for the creation of interdisciplinary teams, with diagnostics, patient selection, and follow-up care remaining the core competencies and tasks of neurology; in addition, they call for appropriately trained and experienced physicians – regardless of their specialties – performing acute stroke interventions and endovascular thrombectomy.
“Such a network must be installed as soon as possible to fulfill the mantra ‘time is brain’ ... and not losing unnecessary time to patient transfer, or continuing to offer only the second-best therapy,” they concluded.
Opposition in the United States
Dr. Widimsky explained that this proposal may not be so applicable to the United States, where the need for more clinicians capable of performing stroke thrombectomies does not appear to be as critical, possibly because vascular neurosurgeons as well as neuroradiologists are qualified to undertake these procedures.
In an interview, J. Mocco, MD, director of the cerebrovascular center, department of neurological surgery, at Mount Sinai Health System, New York, confirmed that this was the case.
“There is no legitimate data to support the claim that there is a lack of an adequate workforce to provide stroke thrombectomy, at least in the U.S.,” he said, adding that, rather, the primary limitation to patient access is a lack of adequate systems of care. “We should learn from the trauma model, which is strongly evidence based, and provide emergency stroke care in a similarly regionalized manner.”
Dr. Mocco, vice president of the Society of NeuroInterventional Surgery, was not impressed with the current study.
“This paper is a retrospective, single-center, unadjudicated, nonindependent assessor case series and therefore, as the authors acknowledge in the limitations section of their paper, it is invalid to compare these data to the results from high-quality, prospective, core-lab, and independent assessor adjudicated randomized trials,” he said. “The supposition that this trial provides evidence that the reported model should be widely considered lacks scientific rigor.”
Furthermore, “the interventional cardiology literature is replete with data regarding the importance of technical expertise and content knowledge,” he added. “Why would that community now propose that such expertise and knowledge is not necessary for the brain?”
Dr. Mocco argues that the concept that interventional cardiologists should be fast-tracked to perform stroke interventions because they use similar tools, navigate blood vessels, and are comfortable working in critical situations, does not hold up.
“Liver surgeons and brain surgeons are both familiar with tissue manipulation, are used to operating in critical situations, and use cautery, scissors, and scalpels; but no one would argue that a brain surgeon should be fast-tracked to perform liver surgery, or vice versa.”
He added: “Stroke patients do not have the luxury of choosing the physician who provides their thrombectomy. We should do everything reasonable to ensure that our systems of care are organized so that these vulnerable patients are treated by physicians who have appropriate knowledge and expertise.”
This study was supported by the Charles University Research program. The authors and editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pneumonia risk soars in heart failure patients, especially HFpEF
Patients with heart failure get pneumonia at a rate almost three times greater than expected and, once they do get pneumonia, have about a fourfold greater risk of death, investigators for a retrospective analysis of 13,000 patients from two landmark randomized HF trials have found.
The investigators also found that HF patients with preserved ejection fraction (HFpEF) are at the highest risk of developing pneumonia. The findings underscore the importance of patients with HF getting a pneumonia vaccination, they found.
The analysis showed that 6.3% of patients in the PARADIGM-HF trial and 10.6% of those in the PARAGON-HF trial developed pneumonia, reported the study authors, led by John J.V. McMurray, MD, of the British Heart Foundation Cardiovascular Research Center at the University of Glasgow in Scotland (J Am Coll Cardiol. 2021;77:1961-73).
“The main reason for doing this study was the fact that many heart failure patients are not vaccinated, as they should be, against pneumonia – both pneumococcus and influenza vaccination,” Dr. McMurray said in an interview. “We wanted to document the frequency and consequences of pneumonia in patients with heart failure to help highlight this deficiency in care.”
Dr. McMurray said he believes this is the first study to document the incidence of pneumonia and pneumonia-related outcomes according to the two major ejection fraction phenotypes.
PARADIGM-HF and PARAGON-HF
The post hoc analysis consisted of 8,399 patients with HF with reduced ejection fraction (HFrEF) in PARADIGM-HF (Eur J Heart Fail. 2013 Sep;15[9]:1062-73) and 4,796 patients with HFpEF in PARAGON-HF (N Engl J Med. 2014 Sep 11;371[11]:993-1004). The analysis focused on the 528 and 510 patients in each study, respectively, who developed pneumonia. Those rates translated to an incidence rate of 29 per 1,000 patient-years (95% confidence interval, 27-31) in PARADIGM-HF and 39 per 1,000 patient-years (95% CI, 36-42) in PARAGON-HF.
After pneumonia, the risk of death in patients increased substantially. In PARADIGM-HF, the adjusted hazard ratio for the risk of death from any cause after pneumonia was 4.34 (95% CI, 3.73-5.05). In PARAGON-HF, it was 3.76 (95% CI, 3.09-4.58). HF patients who contracted pneumonia also tended to have HF longer than their counterparts who didn’t develop pneumonia, but the frequency of previous hospitalization for HF didn’t vary between the pneumonia and no-pneumonia groups.
Patients who developed pneumonia tended to be older (average age of 66.9 years vs. 64.6 years, P < .001) and male (83.9% vs. 77.8%, P < .001). The mean age of patients in PARADIGM-HF was almost a decade younger than those in PARAGON-HF, 64 vs. 73 years.
Pneumonia patients also had worse Kansas City Cardiomyopathy Questionnaire scores (76 vs. 80 on average), but no difference in New York Heart Association functional class. “In general, patients who developed pneumonia had more symptoms and signs and HF than those who did not develop pneumonia,” Dr. McMurray and colleagues wrote.
Pneumonia patients also had higher rates of chronic obstructive pulmonary disease (26% vs. 12%), diabetes (43% vs. 34%), and atrial fibrillation (46% vs. 36%).
Another reason for conducting the study, Dr. McMurray said, “was the prior findings in patients with coronary disease and acute myocardial infarction that the risk associated with an episode of pneumonia [e.g., in subsequent vascular events and deaths] persisted long after the acute event. We wanted to see if this was also the case for heart failure, and indeed it was.”
For example, the adjusted HR for cardiovascular death or hospitalization in the first month following an episode of pneumonia was 9.48 (range of 6.85-13.12, P < .001), leveling off to 1.59 after 3 months or more.
Vaccination crucial in HF patients
Dr. McMurray noted that this study emphasizes the importance of pneumonia vaccination for patients with HF. “Given that we have so few treatments to offer patients with HFpEF, this makes the potential value of vaccination in these patients all the greater,” he said.
The COVID-19 pandemic, Dr. McMurray said, is a “good reminder of the dangers of a respiratory infection and the importance of vaccination in these patients. COVID-19 has interesting parallels in being a systemic disease and one with postacute, persisting effects.”
The persistent risk for adverse cardiovascular events 3 months and later after pneumonia is a novel finding of the study, wrote Donna Mancini, MD, and Gregory Gibson, MD, in an invited commentary (J Am Coll Cardiol. 2021;77:1974-6). Both are with the Icahn School of Medicine at Mt. Sinai in New York. The post hoc study also “serves as an important reminder” of pneumonia risk in patients with HF, especially during the pandemic, they wrote.
“Although vaccination alone appears unlikely to be a panacea, it is a readily accessible tool for mitigating disease severity and improving outcomes,” Dr. Mancini and Dr. Gibson wrote. “After all, an ounce of prevention is worth a pound of cure.”
Novartis provided funding for the PARADIGM-HF and PARAGON-HF trials, and Dr. McMurray and coauthors disclosed financial relationships with Novartis. Dr. Mancini and Dr. Gibson have no relevant financial relationships to disclose.
Patients with heart failure get pneumonia at a rate almost three times greater than expected and, once they do get pneumonia, have about a fourfold greater risk of death, investigators for a retrospective analysis of 13,000 patients from two landmark randomized HF trials have found.
The investigators also found that HF patients with preserved ejection fraction (HFpEF) are at the highest risk of developing pneumonia. The findings underscore the importance of patients with HF getting a pneumonia vaccination, they found.
The analysis showed that 6.3% of patients in the PARADIGM-HF trial and 10.6% of those in the PARAGON-HF trial developed pneumonia, reported the study authors, led by John J.V. McMurray, MD, of the British Heart Foundation Cardiovascular Research Center at the University of Glasgow in Scotland (J Am Coll Cardiol. 2021;77:1961-73).
“The main reason for doing this study was the fact that many heart failure patients are not vaccinated, as they should be, against pneumonia – both pneumococcus and influenza vaccination,” Dr. McMurray said in an interview. “We wanted to document the frequency and consequences of pneumonia in patients with heart failure to help highlight this deficiency in care.”
Dr. McMurray said he believes this is the first study to document the incidence of pneumonia and pneumonia-related outcomes according to the two major ejection fraction phenotypes.
PARADIGM-HF and PARAGON-HF
The post hoc analysis consisted of 8,399 patients with HF with reduced ejection fraction (HFrEF) in PARADIGM-HF (Eur J Heart Fail. 2013 Sep;15[9]:1062-73) and 4,796 patients with HFpEF in PARAGON-HF (N Engl J Med. 2014 Sep 11;371[11]:993-1004). The analysis focused on the 528 and 510 patients in each study, respectively, who developed pneumonia. Those rates translated to an incidence rate of 29 per 1,000 patient-years (95% confidence interval, 27-31) in PARADIGM-HF and 39 per 1,000 patient-years (95% CI, 36-42) in PARAGON-HF.
After pneumonia, the risk of death in patients increased substantially. In PARADIGM-HF, the adjusted hazard ratio for the risk of death from any cause after pneumonia was 4.34 (95% CI, 3.73-5.05). In PARAGON-HF, it was 3.76 (95% CI, 3.09-4.58). HF patients who contracted pneumonia also tended to have HF longer than their counterparts who didn’t develop pneumonia, but the frequency of previous hospitalization for HF didn’t vary between the pneumonia and no-pneumonia groups.
Patients who developed pneumonia tended to be older (average age of 66.9 years vs. 64.6 years, P < .001) and male (83.9% vs. 77.8%, P < .001). The mean age of patients in PARADIGM-HF was almost a decade younger than those in PARAGON-HF, 64 vs. 73 years.
Pneumonia patients also had worse Kansas City Cardiomyopathy Questionnaire scores (76 vs. 80 on average), but no difference in New York Heart Association functional class. “In general, patients who developed pneumonia had more symptoms and signs and HF than those who did not develop pneumonia,” Dr. McMurray and colleagues wrote.
Pneumonia patients also had higher rates of chronic obstructive pulmonary disease (26% vs. 12%), diabetes (43% vs. 34%), and atrial fibrillation (46% vs. 36%).
Another reason for conducting the study, Dr. McMurray said, “was the prior findings in patients with coronary disease and acute myocardial infarction that the risk associated with an episode of pneumonia [e.g., in subsequent vascular events and deaths] persisted long after the acute event. We wanted to see if this was also the case for heart failure, and indeed it was.”
For example, the adjusted HR for cardiovascular death or hospitalization in the first month following an episode of pneumonia was 9.48 (range of 6.85-13.12, P < .001), leveling off to 1.59 after 3 months or more.
Vaccination crucial in HF patients
Dr. McMurray noted that this study emphasizes the importance of pneumonia vaccination for patients with HF. “Given that we have so few treatments to offer patients with HFpEF, this makes the potential value of vaccination in these patients all the greater,” he said.
The COVID-19 pandemic, Dr. McMurray said, is a “good reminder of the dangers of a respiratory infection and the importance of vaccination in these patients. COVID-19 has interesting parallels in being a systemic disease and one with postacute, persisting effects.”
The persistent risk for adverse cardiovascular events 3 months and later after pneumonia is a novel finding of the study, wrote Donna Mancini, MD, and Gregory Gibson, MD, in an invited commentary (J Am Coll Cardiol. 2021;77:1974-6). Both are with the Icahn School of Medicine at Mt. Sinai in New York. The post hoc study also “serves as an important reminder” of pneumonia risk in patients with HF, especially during the pandemic, they wrote.
“Although vaccination alone appears unlikely to be a panacea, it is a readily accessible tool for mitigating disease severity and improving outcomes,” Dr. Mancini and Dr. Gibson wrote. “After all, an ounce of prevention is worth a pound of cure.”
Novartis provided funding for the PARADIGM-HF and PARAGON-HF trials, and Dr. McMurray and coauthors disclosed financial relationships with Novartis. Dr. Mancini and Dr. Gibson have no relevant financial relationships to disclose.
Patients with heart failure get pneumonia at a rate almost three times greater than expected and, once they do get pneumonia, have about a fourfold greater risk of death, investigators for a retrospective analysis of 13,000 patients from two landmark randomized HF trials have found.
The investigators also found that HF patients with preserved ejection fraction (HFpEF) are at the highest risk of developing pneumonia. The findings underscore the importance of patients with HF getting a pneumonia vaccination, they found.
The analysis showed that 6.3% of patients in the PARADIGM-HF trial and 10.6% of those in the PARAGON-HF trial developed pneumonia, reported the study authors, led by John J.V. McMurray, MD, of the British Heart Foundation Cardiovascular Research Center at the University of Glasgow in Scotland (J Am Coll Cardiol. 2021;77:1961-73).
“The main reason for doing this study was the fact that many heart failure patients are not vaccinated, as they should be, against pneumonia – both pneumococcus and influenza vaccination,” Dr. McMurray said in an interview. “We wanted to document the frequency and consequences of pneumonia in patients with heart failure to help highlight this deficiency in care.”
Dr. McMurray said he believes this is the first study to document the incidence of pneumonia and pneumonia-related outcomes according to the two major ejection fraction phenotypes.
PARADIGM-HF and PARAGON-HF
The post hoc analysis consisted of 8,399 patients with HF with reduced ejection fraction (HFrEF) in PARADIGM-HF (Eur J Heart Fail. 2013 Sep;15[9]:1062-73) and 4,796 patients with HFpEF in PARAGON-HF (N Engl J Med. 2014 Sep 11;371[11]:993-1004). The analysis focused on the 528 and 510 patients in each study, respectively, who developed pneumonia. Those rates translated to an incidence rate of 29 per 1,000 patient-years (95% confidence interval, 27-31) in PARADIGM-HF and 39 per 1,000 patient-years (95% CI, 36-42) in PARAGON-HF.
After pneumonia, the risk of death in patients increased substantially. In PARADIGM-HF, the adjusted hazard ratio for the risk of death from any cause after pneumonia was 4.34 (95% CI, 3.73-5.05). In PARAGON-HF, it was 3.76 (95% CI, 3.09-4.58). HF patients who contracted pneumonia also tended to have HF longer than their counterparts who didn’t develop pneumonia, but the frequency of previous hospitalization for HF didn’t vary between the pneumonia and no-pneumonia groups.
Patients who developed pneumonia tended to be older (average age of 66.9 years vs. 64.6 years, P < .001) and male (83.9% vs. 77.8%, P < .001). The mean age of patients in PARADIGM-HF was almost a decade younger than those in PARAGON-HF, 64 vs. 73 years.
Pneumonia patients also had worse Kansas City Cardiomyopathy Questionnaire scores (76 vs. 80 on average), but no difference in New York Heart Association functional class. “In general, patients who developed pneumonia had more symptoms and signs and HF than those who did not develop pneumonia,” Dr. McMurray and colleagues wrote.
Pneumonia patients also had higher rates of chronic obstructive pulmonary disease (26% vs. 12%), diabetes (43% vs. 34%), and atrial fibrillation (46% vs. 36%).
Another reason for conducting the study, Dr. McMurray said, “was the prior findings in patients with coronary disease and acute myocardial infarction that the risk associated with an episode of pneumonia [e.g., in subsequent vascular events and deaths] persisted long after the acute event. We wanted to see if this was also the case for heart failure, and indeed it was.”
For example, the adjusted HR for cardiovascular death or hospitalization in the first month following an episode of pneumonia was 9.48 (range of 6.85-13.12, P < .001), leveling off to 1.59 after 3 months or more.
Vaccination crucial in HF patients
Dr. McMurray noted that this study emphasizes the importance of pneumonia vaccination for patients with HF. “Given that we have so few treatments to offer patients with HFpEF, this makes the potential value of vaccination in these patients all the greater,” he said.
The COVID-19 pandemic, Dr. McMurray said, is a “good reminder of the dangers of a respiratory infection and the importance of vaccination in these patients. COVID-19 has interesting parallels in being a systemic disease and one with postacute, persisting effects.”
The persistent risk for adverse cardiovascular events 3 months and later after pneumonia is a novel finding of the study, wrote Donna Mancini, MD, and Gregory Gibson, MD, in an invited commentary (J Am Coll Cardiol. 2021;77:1974-6). Both are with the Icahn School of Medicine at Mt. Sinai in New York. The post hoc study also “serves as an important reminder” of pneumonia risk in patients with HF, especially during the pandemic, they wrote.
“Although vaccination alone appears unlikely to be a panacea, it is a readily accessible tool for mitigating disease severity and improving outcomes,” Dr. Mancini and Dr. Gibson wrote. “After all, an ounce of prevention is worth a pound of cure.”
Novartis provided funding for the PARADIGM-HF and PARAGON-HF trials, and Dr. McMurray and coauthors disclosed financial relationships with Novartis. Dr. Mancini and Dr. Gibson have no relevant financial relationships to disclose.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Eating more fat may boost borderline low testosterone
Low-fat diets appear to decrease testosterone levels in men, but further randomized, controlled trials are needed to confirm this effect, the authors of a meta-analysis of six small intervention studies concluded.
A total of 206 healthy men with normal testosterone received a high-fat diet followed by a low-fat diet (or vice versa), and their mean total testosterone levels were 10%-15% lower (but still in the normal range) during the low-fat diet.
The study by registered nutritionist Joseph Whittaker, MSc, University of Worcester (England), and statistician Kexin Wu, MSc, University of Warwick, Coventry, England, was published online in the Journal of Steroid Biochemistry and Molecular Biology.
“I think our results are consistent and fairly strong, but they are not strong enough to give blanket recommendations,” Mr. Whittaker said in an interview.
However, “if somebody has low testosterone, particularly borderline, they could try increasing their fat intake, maybe on a Mediterranean diet,” he said, and see if that works to increase their testosterone by 60 ng/dL, the weighted mean difference in total testosterone levels between the low-fat versus high-fat diet interventions in this meta-analysis.
“A Mediterranean diet is a good way to increase ‘healthy fats,’ mono- and polyunsaturated fatty acids, which will likely decrease cardiovascular disease risk, and boost testosterone at the same time,” Mr. Whittaker noted.
Olive oil has been shown to boost testosterone more than butter, and it also reduces CVD, he continued. Nuts are high in “healthy fats” and consistently decrease CVD and mortality and may boost testosterone. Other sources of “good fat” in a healthy diet include avocado, and red meat and poultry in moderation.
“It is controversial, but our results also indicate that foods with saturated fatty acids may boost testosterone,” he added, noting however that such foods are also associated with an increase in cholesterol.
Is waning testosterone explained by leaner diet?
Men need healthy testosterone levels for good physical performance, mental health, and sexual health, and low levels are associated with a higher risk of heart disease, diabetes, and Alzheimer’s disease, according to a statement about this research issued by the University of Worcester.
Although testosterone levels do decline with advancing age, there has also been an additional age-independent and persistent decline in testosterone levels that began roughly after nutrition guidelines began recommending a lower-fat diet in 1965.
Fat consumption dropped from 45% of the diet in 1965 to 35% of the diet in 1991, and stayed around that lower level through to 2011.
However, it is not clear if this decrease in dietary fat intake might explain part of the concurrent decline in men’s testosterone levels.
Mr. Whittaker and Mr. Wu conducted a systematic literature review and identified six crossover intervention studies that compared testosterone levels during low-fat versus high-fat diets – Dorgan 1996, Wang 2005, Hamalainen 1984, Hill 1980, Reed 1987, and Hill 1979 – and then they combined these studies in a meta-analysis.
Five studies each enrolled 6-43 healthy men from North America, the United Kingdom, and Scandinavia, and the sixth study (Hill 1980) enrolled 34 healthy men from North America and 39 farm laborers from South Africa.
Overall, on average, the men were aged 34-54 years and slightly overweight (a mean body mass index of roughly 27 kg/m2) with normal testosterone (i.e., >300 ng/dL, based on the 2018 American Urological Association guidelines criteria).
Most men received a high-fat diet (40% of calories from fat) first, followed by a low-fat diet (on average 20% of calories from fat; range, 7%-25%), but the subgroup of men from South Africa received the low-fat diet first.
To put this into context, U.K. guidelines recommend a fat intake of less than 35% of daily calories, and U.S. guidelines recommend a fat intake of 20%-35% of daily calories.
The low-and high-fat interventions ranged from 2 to 10 weeks.
Lowest testosterone levels with low-fat vegetarian diets
Overall, on average, the men’s total testosterone was 475 mg/dL when they were consuming a low-fat diet and 532 mg/dL when they were consuming a high-fat diet.
However, the South African men had higher testosterone levels when they consumed a low-fat diet. This suggests that “men with European ancestry may experience a greater decrease in testosterone in response to a low-fat diet,” the researchers wrote.
The decrease in total testosterone in the low-fat versus high-fat diet was largest (26%) in the two studies of men who consumed a vegetarian diet (Hill 1979 and Hill 1980). These diets may have been low in zinc, since a marginal zinc deficiency has been shown to decrease total testosterone, Mr. Whittaker and Mr. Wu speculated.
The meta-analysis also showed that levels of free testosterone, urinary testosterone, and dihydrotestosterone declined during the low-fat diet, whereas levels of luteinizing hormone or sex hormone binding globulin were similar with both diets.
Men with low testosterone and overweight, obesity
What nutritional advice should practitioners give to men who have low testosterone and overweight/obesity?
“If you are very overweight, losing weight is going to dramatically improve your testosterone,” Mr. Whittaker said.
However, proponents of various diets are often in stark disagreement about the merits of a low-fat versus low-carbohydrate diet to lose weight.
“In general,” he continued, “the literature shows low-carb (high-fat) diets are better for weight loss [although many will disagree with that statement].”
Although nutrition guidelines have stressed the importance of limiting fat intake, fat in the diet is also associated with lower triglyceride levels and blood pressure and higher HDL cholesterol levels, and now in this study, higher testosterone levels.
More research needed
The researchers acknowledge study limitations: The meta-analysis included just a few small studies with heterogeneous designs and findings, and there was possible bias from confounding variables.
“Ideally, we would like to see a few more studies to confirm our results,” Mr. Whittaker said in the statement. “However, these studies may never come; normally researchers want to find new results, not replicate old ones. In the meantime, men with low testosterone would be wise to avoid low-fat diets.”
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Low-fat diets appear to decrease testosterone levels in men, but further randomized, controlled trials are needed to confirm this effect, the authors of a meta-analysis of six small intervention studies concluded.
A total of 206 healthy men with normal testosterone received a high-fat diet followed by a low-fat diet (or vice versa), and their mean total testosterone levels were 10%-15% lower (but still in the normal range) during the low-fat diet.
The study by registered nutritionist Joseph Whittaker, MSc, University of Worcester (England), and statistician Kexin Wu, MSc, University of Warwick, Coventry, England, was published online in the Journal of Steroid Biochemistry and Molecular Biology.
“I think our results are consistent and fairly strong, but they are not strong enough to give blanket recommendations,” Mr. Whittaker said in an interview.
However, “if somebody has low testosterone, particularly borderline, they could try increasing their fat intake, maybe on a Mediterranean diet,” he said, and see if that works to increase their testosterone by 60 ng/dL, the weighted mean difference in total testosterone levels between the low-fat versus high-fat diet interventions in this meta-analysis.
“A Mediterranean diet is a good way to increase ‘healthy fats,’ mono- and polyunsaturated fatty acids, which will likely decrease cardiovascular disease risk, and boost testosterone at the same time,” Mr. Whittaker noted.
Olive oil has been shown to boost testosterone more than butter, and it also reduces CVD, he continued. Nuts are high in “healthy fats” and consistently decrease CVD and mortality and may boost testosterone. Other sources of “good fat” in a healthy diet include avocado, and red meat and poultry in moderation.
“It is controversial, but our results also indicate that foods with saturated fatty acids may boost testosterone,” he added, noting however that such foods are also associated with an increase in cholesterol.
Is waning testosterone explained by leaner diet?
Men need healthy testosterone levels for good physical performance, mental health, and sexual health, and low levels are associated with a higher risk of heart disease, diabetes, and Alzheimer’s disease, according to a statement about this research issued by the University of Worcester.
Although testosterone levels do decline with advancing age, there has also been an additional age-independent and persistent decline in testosterone levels that began roughly after nutrition guidelines began recommending a lower-fat diet in 1965.
Fat consumption dropped from 45% of the diet in 1965 to 35% of the diet in 1991, and stayed around that lower level through to 2011.
However, it is not clear if this decrease in dietary fat intake might explain part of the concurrent decline in men’s testosterone levels.
Mr. Whittaker and Mr. Wu conducted a systematic literature review and identified six crossover intervention studies that compared testosterone levels during low-fat versus high-fat diets – Dorgan 1996, Wang 2005, Hamalainen 1984, Hill 1980, Reed 1987, and Hill 1979 – and then they combined these studies in a meta-analysis.
Five studies each enrolled 6-43 healthy men from North America, the United Kingdom, and Scandinavia, and the sixth study (Hill 1980) enrolled 34 healthy men from North America and 39 farm laborers from South Africa.
Overall, on average, the men were aged 34-54 years and slightly overweight (a mean body mass index of roughly 27 kg/m2) with normal testosterone (i.e., >300 ng/dL, based on the 2018 American Urological Association guidelines criteria).
Most men received a high-fat diet (40% of calories from fat) first, followed by a low-fat diet (on average 20% of calories from fat; range, 7%-25%), but the subgroup of men from South Africa received the low-fat diet first.
To put this into context, U.K. guidelines recommend a fat intake of less than 35% of daily calories, and U.S. guidelines recommend a fat intake of 20%-35% of daily calories.
The low-and high-fat interventions ranged from 2 to 10 weeks.
Lowest testosterone levels with low-fat vegetarian diets
Overall, on average, the men’s total testosterone was 475 mg/dL when they were consuming a low-fat diet and 532 mg/dL when they were consuming a high-fat diet.
However, the South African men had higher testosterone levels when they consumed a low-fat diet. This suggests that “men with European ancestry may experience a greater decrease in testosterone in response to a low-fat diet,” the researchers wrote.
The decrease in total testosterone in the low-fat versus high-fat diet was largest (26%) in the two studies of men who consumed a vegetarian diet (Hill 1979 and Hill 1980). These diets may have been low in zinc, since a marginal zinc deficiency has been shown to decrease total testosterone, Mr. Whittaker and Mr. Wu speculated.
The meta-analysis also showed that levels of free testosterone, urinary testosterone, and dihydrotestosterone declined during the low-fat diet, whereas levels of luteinizing hormone or sex hormone binding globulin were similar with both diets.
Men with low testosterone and overweight, obesity
What nutritional advice should practitioners give to men who have low testosterone and overweight/obesity?
“If you are very overweight, losing weight is going to dramatically improve your testosterone,” Mr. Whittaker said.
However, proponents of various diets are often in stark disagreement about the merits of a low-fat versus low-carbohydrate diet to lose weight.
“In general,” he continued, “the literature shows low-carb (high-fat) diets are better for weight loss [although many will disagree with that statement].”
Although nutrition guidelines have stressed the importance of limiting fat intake, fat in the diet is also associated with lower triglyceride levels and blood pressure and higher HDL cholesterol levels, and now in this study, higher testosterone levels.
More research needed
The researchers acknowledge study limitations: The meta-analysis included just a few small studies with heterogeneous designs and findings, and there was possible bias from confounding variables.
“Ideally, we would like to see a few more studies to confirm our results,” Mr. Whittaker said in the statement. “However, these studies may never come; normally researchers want to find new results, not replicate old ones. In the meantime, men with low testosterone would be wise to avoid low-fat diets.”
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Low-fat diets appear to decrease testosterone levels in men, but further randomized, controlled trials are needed to confirm this effect, the authors of a meta-analysis of six small intervention studies concluded.
A total of 206 healthy men with normal testosterone received a high-fat diet followed by a low-fat diet (or vice versa), and their mean total testosterone levels were 10%-15% lower (but still in the normal range) during the low-fat diet.
The study by registered nutritionist Joseph Whittaker, MSc, University of Worcester (England), and statistician Kexin Wu, MSc, University of Warwick, Coventry, England, was published online in the Journal of Steroid Biochemistry and Molecular Biology.
“I think our results are consistent and fairly strong, but they are not strong enough to give blanket recommendations,” Mr. Whittaker said in an interview.
However, “if somebody has low testosterone, particularly borderline, they could try increasing their fat intake, maybe on a Mediterranean diet,” he said, and see if that works to increase their testosterone by 60 ng/dL, the weighted mean difference in total testosterone levels between the low-fat versus high-fat diet interventions in this meta-analysis.
“A Mediterranean diet is a good way to increase ‘healthy fats,’ mono- and polyunsaturated fatty acids, which will likely decrease cardiovascular disease risk, and boost testosterone at the same time,” Mr. Whittaker noted.
Olive oil has been shown to boost testosterone more than butter, and it also reduces CVD, he continued. Nuts are high in “healthy fats” and consistently decrease CVD and mortality and may boost testosterone. Other sources of “good fat” in a healthy diet include avocado, and red meat and poultry in moderation.
“It is controversial, but our results also indicate that foods with saturated fatty acids may boost testosterone,” he added, noting however that such foods are also associated with an increase in cholesterol.
Is waning testosterone explained by leaner diet?
Men need healthy testosterone levels for good physical performance, mental health, and sexual health, and low levels are associated with a higher risk of heart disease, diabetes, and Alzheimer’s disease, according to a statement about this research issued by the University of Worcester.
Although testosterone levels do decline with advancing age, there has also been an additional age-independent and persistent decline in testosterone levels that began roughly after nutrition guidelines began recommending a lower-fat diet in 1965.
Fat consumption dropped from 45% of the diet in 1965 to 35% of the diet in 1991, and stayed around that lower level through to 2011.
However, it is not clear if this decrease in dietary fat intake might explain part of the concurrent decline in men’s testosterone levels.
Mr. Whittaker and Mr. Wu conducted a systematic literature review and identified six crossover intervention studies that compared testosterone levels during low-fat versus high-fat diets – Dorgan 1996, Wang 2005, Hamalainen 1984, Hill 1980, Reed 1987, and Hill 1979 – and then they combined these studies in a meta-analysis.
Five studies each enrolled 6-43 healthy men from North America, the United Kingdom, and Scandinavia, and the sixth study (Hill 1980) enrolled 34 healthy men from North America and 39 farm laborers from South Africa.
Overall, on average, the men were aged 34-54 years and slightly overweight (a mean body mass index of roughly 27 kg/m2) with normal testosterone (i.e., >300 ng/dL, based on the 2018 American Urological Association guidelines criteria).
Most men received a high-fat diet (40% of calories from fat) first, followed by a low-fat diet (on average 20% of calories from fat; range, 7%-25%), but the subgroup of men from South Africa received the low-fat diet first.
To put this into context, U.K. guidelines recommend a fat intake of less than 35% of daily calories, and U.S. guidelines recommend a fat intake of 20%-35% of daily calories.
The low-and high-fat interventions ranged from 2 to 10 weeks.
Lowest testosterone levels with low-fat vegetarian diets
Overall, on average, the men’s total testosterone was 475 mg/dL when they were consuming a low-fat diet and 532 mg/dL when they were consuming a high-fat diet.
However, the South African men had higher testosterone levels when they consumed a low-fat diet. This suggests that “men with European ancestry may experience a greater decrease in testosterone in response to a low-fat diet,” the researchers wrote.
The decrease in total testosterone in the low-fat versus high-fat diet was largest (26%) in the two studies of men who consumed a vegetarian diet (Hill 1979 and Hill 1980). These diets may have been low in zinc, since a marginal zinc deficiency has been shown to decrease total testosterone, Mr. Whittaker and Mr. Wu speculated.
The meta-analysis also showed that levels of free testosterone, urinary testosterone, and dihydrotestosterone declined during the low-fat diet, whereas levels of luteinizing hormone or sex hormone binding globulin were similar with both diets.
Men with low testosterone and overweight, obesity
What nutritional advice should practitioners give to men who have low testosterone and overweight/obesity?
“If you are very overweight, losing weight is going to dramatically improve your testosterone,” Mr. Whittaker said.
However, proponents of various diets are often in stark disagreement about the merits of a low-fat versus low-carbohydrate diet to lose weight.
“In general,” he continued, “the literature shows low-carb (high-fat) diets are better for weight loss [although many will disagree with that statement].”
Although nutrition guidelines have stressed the importance of limiting fat intake, fat in the diet is also associated with lower triglyceride levels and blood pressure and higher HDL cholesterol levels, and now in this study, higher testosterone levels.
More research needed
The researchers acknowledge study limitations: The meta-analysis included just a few small studies with heterogeneous designs and findings, and there was possible bias from confounding variables.
“Ideally, we would like to see a few more studies to confirm our results,” Mr. Whittaker said in the statement. “However, these studies may never come; normally researchers want to find new results, not replicate old ones. In the meantime, men with low testosterone would be wise to avoid low-fat diets.”
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Study aims to enhance understanding of ‘tremendously understudied’ prurigo nodularis
compared with age-matched controls, as well those with atopic dermatitis and psoriasis.
Those are key findings from a retrospective analysis of claims data that was published online April 3, 2021, in the Journal of Investigative Dermatology.
“Prurigo nodularis is a tremendously understudied inflammatory skin disease,” one of the study’s cosenior authors, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said in an interview. “Prurigo nodularis patients have uncontrolled itch, which leads to reduced quality of life, and the association with many disease comorbidities. We focused on better understanding in this work the unique comorbidities of prurigo nodularis, compared to other inflammatory skin diseases.”
For the study, Dr. Kwatra, cosenior author Yevgeniy R. Semenov, MD, of the department of dermatology, Massachusetts General Hospital, Boston, and colleagues evaluated nationally representative, private insurance claims data from October 2015 to December 2019 to identify prurigo nodularis (PN) patients, who were defined as individuals with two or more medical claims for PN using ICD-10-CM codes. For comparison with patients with inflammatory skin diseases, they used the same claims data to identify patients with atopic dermatitis (AD) and psoriasis as well as to select controls who were age and gender matched to PN patients. Next, they quantified the overall comorbidity burden with the Charlson Comorbidity Index (CCI).
In 2016, the claims database included 2,658 patients with PN, 21,482 patients with AD, 21,073 patients with psoriasis, and 13,290 controls. The number of patients in each category rose each subsequent year, so that by the end of 2019 there were 9,426 patients with PN, 70,298 patients with AD, 59,509 patients with psoriasis, and 47,130 controls. Between 2016 and 2019 the mean age of PN patients increased from 57.5 to 59.8 years and the percent of male patients rose from 44.5% to 46.5%.
Between 2016 and 2019, the overall PN prevalence rates rose from 18 per 100,000 to 58 per 100,000, while the PN prevalence rates among adults increased from 22 per 100,000 to 70 per 100,000, and the rates among children rose grew from 2 per 100,000 to 7 per 100,000. “Our report shows an estimated disease prevalence of around 335,000 cases of PN in the United States,” said Dr. Kwatra, who was among a group of researchers to recently report on systemic Th22-polarized inflammation in PN patients.
The researchers also found that patients with PN had the highest mean CCI in both 2016 and 2019. In 2016, their mean CCI was 1.53, compared with 0.98 among controls, 0.53 among those with AD, and 1.16 among those with psoriasis. In 2019, the mean CCI had increased in all groups of patients, to 2.32 among those with PN, 1.57 among controls, 0.75 among those with AD patients, and 1.71 among those with psoriasis.
The top five medical specialties who cared for PN patients, defined as the estimated number of visits per year per patient, were internal medicine (2.01 visits), dermatology (1.87 visits), family practice (1.60 visits), cardiology or cardiovascular disease (0.85 visits), and orthopedics or orthopedic surgery (0.49 visits).
“If you encounter a patient with prurigo nodularis, it’s important to perform a screening for chronic kidney disease, diabetes, and liver disease,” Dr. Kwatra said. “These comorbidities along with emerging studies on circulating blood biomarkers suggest prurigo nodularis is a systemic inflammatory disorder; thus systemic agents are needed for most patients as part of multimodal therapy in prurigo nodularis.”
The researchers acknowledged certain limitations of the study, including its retrospective design and the identification of patients with PN with the ICD-10-CM code, which require further validation. “Furthermore, the increase in annual prevalence estimates for PN, AD, and psoriasis observed in the study could also be a result of increasing coding of these diagnoses in the claims data along with rising awareness by the medical profession,” they wrote.
Dr. Kwatra disclosed that he is an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals, and has received grant funding from Galderma, Pfizer, and Kiniksa. He has also received a Dermatology Foundation Medical Dermatology Career Development Award, a research grant from the Skin of Color Society, and is supported by the National Institutes of Health. One coauthor has been funded by NIH grants.
compared with age-matched controls, as well those with atopic dermatitis and psoriasis.
Those are key findings from a retrospective analysis of claims data that was published online April 3, 2021, in the Journal of Investigative Dermatology.
“Prurigo nodularis is a tremendously understudied inflammatory skin disease,” one of the study’s cosenior authors, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said in an interview. “Prurigo nodularis patients have uncontrolled itch, which leads to reduced quality of life, and the association with many disease comorbidities. We focused on better understanding in this work the unique comorbidities of prurigo nodularis, compared to other inflammatory skin diseases.”
For the study, Dr. Kwatra, cosenior author Yevgeniy R. Semenov, MD, of the department of dermatology, Massachusetts General Hospital, Boston, and colleagues evaluated nationally representative, private insurance claims data from October 2015 to December 2019 to identify prurigo nodularis (PN) patients, who were defined as individuals with two or more medical claims for PN using ICD-10-CM codes. For comparison with patients with inflammatory skin diseases, they used the same claims data to identify patients with atopic dermatitis (AD) and psoriasis as well as to select controls who were age and gender matched to PN patients. Next, they quantified the overall comorbidity burden with the Charlson Comorbidity Index (CCI).
In 2016, the claims database included 2,658 patients with PN, 21,482 patients with AD, 21,073 patients with psoriasis, and 13,290 controls. The number of patients in each category rose each subsequent year, so that by the end of 2019 there were 9,426 patients with PN, 70,298 patients with AD, 59,509 patients with psoriasis, and 47,130 controls. Between 2016 and 2019 the mean age of PN patients increased from 57.5 to 59.8 years and the percent of male patients rose from 44.5% to 46.5%.
Between 2016 and 2019, the overall PN prevalence rates rose from 18 per 100,000 to 58 per 100,000, while the PN prevalence rates among adults increased from 22 per 100,000 to 70 per 100,000, and the rates among children rose grew from 2 per 100,000 to 7 per 100,000. “Our report shows an estimated disease prevalence of around 335,000 cases of PN in the United States,” said Dr. Kwatra, who was among a group of researchers to recently report on systemic Th22-polarized inflammation in PN patients.
The researchers also found that patients with PN had the highest mean CCI in both 2016 and 2019. In 2016, their mean CCI was 1.53, compared with 0.98 among controls, 0.53 among those with AD, and 1.16 among those with psoriasis. In 2019, the mean CCI had increased in all groups of patients, to 2.32 among those with PN, 1.57 among controls, 0.75 among those with AD patients, and 1.71 among those with psoriasis.
The top five medical specialties who cared for PN patients, defined as the estimated number of visits per year per patient, were internal medicine (2.01 visits), dermatology (1.87 visits), family practice (1.60 visits), cardiology or cardiovascular disease (0.85 visits), and orthopedics or orthopedic surgery (0.49 visits).
“If you encounter a patient with prurigo nodularis, it’s important to perform a screening for chronic kidney disease, diabetes, and liver disease,” Dr. Kwatra said. “These comorbidities along with emerging studies on circulating blood biomarkers suggest prurigo nodularis is a systemic inflammatory disorder; thus systemic agents are needed for most patients as part of multimodal therapy in prurigo nodularis.”
The researchers acknowledged certain limitations of the study, including its retrospective design and the identification of patients with PN with the ICD-10-CM code, which require further validation. “Furthermore, the increase in annual prevalence estimates for PN, AD, and psoriasis observed in the study could also be a result of increasing coding of these diagnoses in the claims data along with rising awareness by the medical profession,” they wrote.
Dr. Kwatra disclosed that he is an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals, and has received grant funding from Galderma, Pfizer, and Kiniksa. He has also received a Dermatology Foundation Medical Dermatology Career Development Award, a research grant from the Skin of Color Society, and is supported by the National Institutes of Health. One coauthor has been funded by NIH grants.
compared with age-matched controls, as well those with atopic dermatitis and psoriasis.
Those are key findings from a retrospective analysis of claims data that was published online April 3, 2021, in the Journal of Investigative Dermatology.
“Prurigo nodularis is a tremendously understudied inflammatory skin disease,” one of the study’s cosenior authors, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said in an interview. “Prurigo nodularis patients have uncontrolled itch, which leads to reduced quality of life, and the association with many disease comorbidities. We focused on better understanding in this work the unique comorbidities of prurigo nodularis, compared to other inflammatory skin diseases.”
For the study, Dr. Kwatra, cosenior author Yevgeniy R. Semenov, MD, of the department of dermatology, Massachusetts General Hospital, Boston, and colleagues evaluated nationally representative, private insurance claims data from October 2015 to December 2019 to identify prurigo nodularis (PN) patients, who were defined as individuals with two or more medical claims for PN using ICD-10-CM codes. For comparison with patients with inflammatory skin diseases, they used the same claims data to identify patients with atopic dermatitis (AD) and psoriasis as well as to select controls who were age and gender matched to PN patients. Next, they quantified the overall comorbidity burden with the Charlson Comorbidity Index (CCI).
In 2016, the claims database included 2,658 patients with PN, 21,482 patients with AD, 21,073 patients with psoriasis, and 13,290 controls. The number of patients in each category rose each subsequent year, so that by the end of 2019 there were 9,426 patients with PN, 70,298 patients with AD, 59,509 patients with psoriasis, and 47,130 controls. Between 2016 and 2019 the mean age of PN patients increased from 57.5 to 59.8 years and the percent of male patients rose from 44.5% to 46.5%.
Between 2016 and 2019, the overall PN prevalence rates rose from 18 per 100,000 to 58 per 100,000, while the PN prevalence rates among adults increased from 22 per 100,000 to 70 per 100,000, and the rates among children rose grew from 2 per 100,000 to 7 per 100,000. “Our report shows an estimated disease prevalence of around 335,000 cases of PN in the United States,” said Dr. Kwatra, who was among a group of researchers to recently report on systemic Th22-polarized inflammation in PN patients.
The researchers also found that patients with PN had the highest mean CCI in both 2016 and 2019. In 2016, their mean CCI was 1.53, compared with 0.98 among controls, 0.53 among those with AD, and 1.16 among those with psoriasis. In 2019, the mean CCI had increased in all groups of patients, to 2.32 among those with PN, 1.57 among controls, 0.75 among those with AD patients, and 1.71 among those with psoriasis.
The top five medical specialties who cared for PN patients, defined as the estimated number of visits per year per patient, were internal medicine (2.01 visits), dermatology (1.87 visits), family practice (1.60 visits), cardiology or cardiovascular disease (0.85 visits), and orthopedics or orthopedic surgery (0.49 visits).
“If you encounter a patient with prurigo nodularis, it’s important to perform a screening for chronic kidney disease, diabetes, and liver disease,” Dr. Kwatra said. “These comorbidities along with emerging studies on circulating blood biomarkers suggest prurigo nodularis is a systemic inflammatory disorder; thus systemic agents are needed for most patients as part of multimodal therapy in prurigo nodularis.”
The researchers acknowledged certain limitations of the study, including its retrospective design and the identification of patients with PN with the ICD-10-CM code, which require further validation. “Furthermore, the increase in annual prevalence estimates for PN, AD, and psoriasis observed in the study could also be a result of increasing coding of these diagnoses in the claims data along with rising awareness by the medical profession,” they wrote.
Dr. Kwatra disclosed that he is an advisory board member/consultant for AbbVie, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals, and has received grant funding from Galderma, Pfizer, and Kiniksa. He has also received a Dermatology Foundation Medical Dermatology Career Development Award, a research grant from the Skin of Color Society, and is supported by the National Institutes of Health. One coauthor has been funded by NIH grants.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Say my name
Dr. Ben-a-bo?
Nope.
Ben-nabi?
Nope.
Ben-NO-bo?
Also no.
My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.
We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)
However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.
Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.
First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)
If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.
It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.
Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.
Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.
Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
Dr. Ben-a-bo?
Nope.
Ben-nabi?
Nope.
Ben-NO-bo?
Also no.
My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.
We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)
However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.
Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.
First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)
If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.
It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.
Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.
Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.
Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
Dr. Ben-a-bo?
Nope.
Ben-nabi?
Nope.
Ben-NO-bo?
Also no.
My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.
We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)
However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.
Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.
First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)
If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.
It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.
Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.
Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.
Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
FDA panel supports islet cell treatment for type 1 diabetes
A Food and Drug Administration advisory panel has endorsed a pancreatic islet cell transplant therapy for the treatment of people with type 1 diabetes that can’t be managed with current therapies.
On April 15, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 12 to 4 in favor of approval of donislecel (Lantidra). There was one abstention. The panel regarded the drug as having “an overall favorable benefit-risk profile for some patients with type 1 diabetes.” The product consists of purified allogeneic pancreatic islets of Langerhans derived from cadaveric donors and is infused into the portal vein of the liver.
Benefits of the treatment include the potential for insulin independence and elimination of severe hypoglycemia. Risks are those associated with the surgical procedure and with long-term immunosuppression.
The therapy is manufactured by CellTrans. According to Jose Oberholzer, MD, the founder of CellTrans, the proposed indication is for adults with “brittle” type 1 diabetes who meet the American Diabetes Association’s (ADA) criteria for whole-organ pancreas-alone transplant (i.e., transplant of pancreas but not kidney).
The ADA criteria include the following: frequent, severe hypoglycemia, hyperglycemia, and/or ketoacidosis that requires medical attention; clinical or emotional problems regarding the use of exogenous insulin; and consistent failure of insulin-based management to prevent acute diabetes complications.
Success in two-thirds of patients in small studies
Dr. Oberholzer presented data from two single-arm open-label studies: a phase 1/2 trial initiated in 2004 with 10 patients, and a phase 3 study with 20 patients that began in 2007. The inclusion criteria differed somewhat between the two studies, but all 30 patients had hypoglycemic unawareness. Mean follow-up was 7.8 years for the phase 1/2 trial and 4.7 years for the phase 3 trial.
For all of the patients, C-peptide levels were positive after transplant. The composite endpoint for success – an A1c level of ≤ 6.5% and the absence of severe hypoglycemic episodes for 1 year – was met by 19 patients (63.3%). For five patients (16.7%), the target A1c level was not achieved, and seven patients (23.3%) experienced a severe episode of hypoglycemia.
Twenty of the 30 patients achieved insulin independence for at least 1 year.
Improvements were also seen at 1 year in mixed meal test outcomes, fasting blood glucose levels, and overall glycemic control. Graft survival 10 years post transplant was achieved by 60% of patients, Dr. Oberholzer said.
Adverse events not unexpected, but still of concern
Two patients died, one as a result of fulminant sepsis at 20 months post transplant, and the other as a result of severe dementia 9 years post transplant. Three patients experienced four serious procedure-related events, including one liver laceration and two hepatic hematomas. Elevations in portal pressure occurred in two patients.
Most adverse events were associated with immunosuppression. These included 178 infections in 26 of the 30 patients. The most common of these were herpes virus infections, Epstein-Barr virus infections, oral candidiasis, and cytomegalovirus infections. Twelve infections were severe. Renal function declined persistently in two patients (20%), and six (20%) experienced new-onset proteinuria at 1 year.
The adverse events related to the procedure and the problems associated with immunosuppression were not unexpected and were consistent with those described for patients receiving whole pancreas transplants, FDA reviewer Patricia Beaston, MD, said in her review of the CellTrans data.
Panel members support treatment for a small group of patients
During the discussion, several panel members pointed out that the target patient population for this treatment will likely be smaller today than it was when the two studies were initiated, given advances in diabetes care. Those advances include continuous glucose monitoring devices with alarms and closed-loop insulin delivery systems – the “artificial pancreas” that automatically suspends insulin delivery to prevent hypoglycemia.
Panel chair Lisa Butterfield, PhD, a surgeon and immunologist at the University of California, San Francisco, voted in favor of approval. But, she added, “I do support postapproval gathering of data to learn more about the product. ... I don’t know how many patients will really benefit, but I think it’s to be determined.”
Christopher K. Breuer, MD, a general and pediatric surgeon at the Center for Regenerative Medicine, Nationwide Children’s Hospital, Columbus, Ohio, said he supported approval for “two very small subpopulations where it would provide the only viable therapy”: those who are eligible for pancreas transplant but cannot tolerate a major operation, and those who already use the latest automated insulin delivery systems and still do not achieve acceptable glycemic control.
Temporary voting member David Harlan, MD, director of the University of Massachusetts Diabetes Center of Excellence, Worcester, Mass., voted no.
He noted that only about 100 whole pancreas-only transplants are performed annually in the United States and that such transplants are “very effective, so we’re talking about patients who aren’t pancreas transplant candidates who might get this.”
Moreover, Dr. Harlan said, “I’ve seen the awful things that can happen in posttransplant recipients. It’s really hard to get that informed consent from someone when you’re asking them to consider a future that they don’t know. When it works, it’s great. When it doesn’t work, it can be catastrophic. I just worry about opening Pandora’s box.”
The only other diabetes specialist on the panel, temporary voting member Ellen Leschek, MD, said she “reluctantly voted yes because a few people could benefit, but I think it’s a much smaller number than the company may believe.”
Dr. Leschek, of the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md., said she’s concerned that “if it’s approved, too many people will get treated this way, when in fact, for a lot of those people, the risks will outweigh the benefits.”
Sandy Feng, MD, PhD, of the department of surgery at the University of California, San Francisco, pointed out that with regard to immunosuppressive therapy, “We’re concerned about the toxicity of what we currently use, but there are additional therapies being developed that might mitigate those toxicities that would be beneficial to this population.”
Dr. Feng, who voted yes, also said, “I do pancreas transplants. I can tell you that there is nothing that [patients with type 1 diabetes] like more than the freedom from dealing with the entire insulin issue. That has made a large impression on me over the last 20-plus years of clinical practice, so I do think this can help some people and will be incredibly meaningful to those people.”
FDA advisory panel members are vetted for conflicts of interest, and special waivers are granted if necessary. No such waivers were granted for this meeting.
A version of this article first appeared on Medscape.com.
A Food and Drug Administration advisory panel has endorsed a pancreatic islet cell transplant therapy for the treatment of people with type 1 diabetes that can’t be managed with current therapies.
On April 15, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 12 to 4 in favor of approval of donislecel (Lantidra). There was one abstention. The panel regarded the drug as having “an overall favorable benefit-risk profile for some patients with type 1 diabetes.” The product consists of purified allogeneic pancreatic islets of Langerhans derived from cadaveric donors and is infused into the portal vein of the liver.
Benefits of the treatment include the potential for insulin independence and elimination of severe hypoglycemia. Risks are those associated with the surgical procedure and with long-term immunosuppression.
The therapy is manufactured by CellTrans. According to Jose Oberholzer, MD, the founder of CellTrans, the proposed indication is for adults with “brittle” type 1 diabetes who meet the American Diabetes Association’s (ADA) criteria for whole-organ pancreas-alone transplant (i.e., transplant of pancreas but not kidney).
The ADA criteria include the following: frequent, severe hypoglycemia, hyperglycemia, and/or ketoacidosis that requires medical attention; clinical or emotional problems regarding the use of exogenous insulin; and consistent failure of insulin-based management to prevent acute diabetes complications.
Success in two-thirds of patients in small studies
Dr. Oberholzer presented data from two single-arm open-label studies: a phase 1/2 trial initiated in 2004 with 10 patients, and a phase 3 study with 20 patients that began in 2007. The inclusion criteria differed somewhat between the two studies, but all 30 patients had hypoglycemic unawareness. Mean follow-up was 7.8 years for the phase 1/2 trial and 4.7 years for the phase 3 trial.
For all of the patients, C-peptide levels were positive after transplant. The composite endpoint for success – an A1c level of ≤ 6.5% and the absence of severe hypoglycemic episodes for 1 year – was met by 19 patients (63.3%). For five patients (16.7%), the target A1c level was not achieved, and seven patients (23.3%) experienced a severe episode of hypoglycemia.
Twenty of the 30 patients achieved insulin independence for at least 1 year.
Improvements were also seen at 1 year in mixed meal test outcomes, fasting blood glucose levels, and overall glycemic control. Graft survival 10 years post transplant was achieved by 60% of patients, Dr. Oberholzer said.
Adverse events not unexpected, but still of concern
Two patients died, one as a result of fulminant sepsis at 20 months post transplant, and the other as a result of severe dementia 9 years post transplant. Three patients experienced four serious procedure-related events, including one liver laceration and two hepatic hematomas. Elevations in portal pressure occurred in two patients.
Most adverse events were associated with immunosuppression. These included 178 infections in 26 of the 30 patients. The most common of these were herpes virus infections, Epstein-Barr virus infections, oral candidiasis, and cytomegalovirus infections. Twelve infections were severe. Renal function declined persistently in two patients (20%), and six (20%) experienced new-onset proteinuria at 1 year.
The adverse events related to the procedure and the problems associated with immunosuppression were not unexpected and were consistent with those described for patients receiving whole pancreas transplants, FDA reviewer Patricia Beaston, MD, said in her review of the CellTrans data.
Panel members support treatment for a small group of patients
During the discussion, several panel members pointed out that the target patient population for this treatment will likely be smaller today than it was when the two studies were initiated, given advances in diabetes care. Those advances include continuous glucose monitoring devices with alarms and closed-loop insulin delivery systems – the “artificial pancreas” that automatically suspends insulin delivery to prevent hypoglycemia.
Panel chair Lisa Butterfield, PhD, a surgeon and immunologist at the University of California, San Francisco, voted in favor of approval. But, she added, “I do support postapproval gathering of data to learn more about the product. ... I don’t know how many patients will really benefit, but I think it’s to be determined.”
Christopher K. Breuer, MD, a general and pediatric surgeon at the Center for Regenerative Medicine, Nationwide Children’s Hospital, Columbus, Ohio, said he supported approval for “two very small subpopulations where it would provide the only viable therapy”: those who are eligible for pancreas transplant but cannot tolerate a major operation, and those who already use the latest automated insulin delivery systems and still do not achieve acceptable glycemic control.
Temporary voting member David Harlan, MD, director of the University of Massachusetts Diabetes Center of Excellence, Worcester, Mass., voted no.
He noted that only about 100 whole pancreas-only transplants are performed annually in the United States and that such transplants are “very effective, so we’re talking about patients who aren’t pancreas transplant candidates who might get this.”
Moreover, Dr. Harlan said, “I’ve seen the awful things that can happen in posttransplant recipients. It’s really hard to get that informed consent from someone when you’re asking them to consider a future that they don’t know. When it works, it’s great. When it doesn’t work, it can be catastrophic. I just worry about opening Pandora’s box.”
The only other diabetes specialist on the panel, temporary voting member Ellen Leschek, MD, said she “reluctantly voted yes because a few people could benefit, but I think it’s a much smaller number than the company may believe.”
Dr. Leschek, of the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md., said she’s concerned that “if it’s approved, too many people will get treated this way, when in fact, for a lot of those people, the risks will outweigh the benefits.”
Sandy Feng, MD, PhD, of the department of surgery at the University of California, San Francisco, pointed out that with regard to immunosuppressive therapy, “We’re concerned about the toxicity of what we currently use, but there are additional therapies being developed that might mitigate those toxicities that would be beneficial to this population.”
Dr. Feng, who voted yes, also said, “I do pancreas transplants. I can tell you that there is nothing that [patients with type 1 diabetes] like more than the freedom from dealing with the entire insulin issue. That has made a large impression on me over the last 20-plus years of clinical practice, so I do think this can help some people and will be incredibly meaningful to those people.”
FDA advisory panel members are vetted for conflicts of interest, and special waivers are granted if necessary. No such waivers were granted for this meeting.
A version of this article first appeared on Medscape.com.
A Food and Drug Administration advisory panel has endorsed a pancreatic islet cell transplant therapy for the treatment of people with type 1 diabetes that can’t be managed with current therapies.
On April 15, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 12 to 4 in favor of approval of donislecel (Lantidra). There was one abstention. The panel regarded the drug as having “an overall favorable benefit-risk profile for some patients with type 1 diabetes.” The product consists of purified allogeneic pancreatic islets of Langerhans derived from cadaveric donors and is infused into the portal vein of the liver.
Benefits of the treatment include the potential for insulin independence and elimination of severe hypoglycemia. Risks are those associated with the surgical procedure and with long-term immunosuppression.
The therapy is manufactured by CellTrans. According to Jose Oberholzer, MD, the founder of CellTrans, the proposed indication is for adults with “brittle” type 1 diabetes who meet the American Diabetes Association’s (ADA) criteria for whole-organ pancreas-alone transplant (i.e., transplant of pancreas but not kidney).
The ADA criteria include the following: frequent, severe hypoglycemia, hyperglycemia, and/or ketoacidosis that requires medical attention; clinical or emotional problems regarding the use of exogenous insulin; and consistent failure of insulin-based management to prevent acute diabetes complications.
Success in two-thirds of patients in small studies
Dr. Oberholzer presented data from two single-arm open-label studies: a phase 1/2 trial initiated in 2004 with 10 patients, and a phase 3 study with 20 patients that began in 2007. The inclusion criteria differed somewhat between the two studies, but all 30 patients had hypoglycemic unawareness. Mean follow-up was 7.8 years for the phase 1/2 trial and 4.7 years for the phase 3 trial.
For all of the patients, C-peptide levels were positive after transplant. The composite endpoint for success – an A1c level of ≤ 6.5% and the absence of severe hypoglycemic episodes for 1 year – was met by 19 patients (63.3%). For five patients (16.7%), the target A1c level was not achieved, and seven patients (23.3%) experienced a severe episode of hypoglycemia.
Twenty of the 30 patients achieved insulin independence for at least 1 year.
Improvements were also seen at 1 year in mixed meal test outcomes, fasting blood glucose levels, and overall glycemic control. Graft survival 10 years post transplant was achieved by 60% of patients, Dr. Oberholzer said.
Adverse events not unexpected, but still of concern
Two patients died, one as a result of fulminant sepsis at 20 months post transplant, and the other as a result of severe dementia 9 years post transplant. Three patients experienced four serious procedure-related events, including one liver laceration and two hepatic hematomas. Elevations in portal pressure occurred in two patients.
Most adverse events were associated with immunosuppression. These included 178 infections in 26 of the 30 patients. The most common of these were herpes virus infections, Epstein-Barr virus infections, oral candidiasis, and cytomegalovirus infections. Twelve infections were severe. Renal function declined persistently in two patients (20%), and six (20%) experienced new-onset proteinuria at 1 year.
The adverse events related to the procedure and the problems associated with immunosuppression were not unexpected and were consistent with those described for patients receiving whole pancreas transplants, FDA reviewer Patricia Beaston, MD, said in her review of the CellTrans data.
Panel members support treatment for a small group of patients
During the discussion, several panel members pointed out that the target patient population for this treatment will likely be smaller today than it was when the two studies were initiated, given advances in diabetes care. Those advances include continuous glucose monitoring devices with alarms and closed-loop insulin delivery systems – the “artificial pancreas” that automatically suspends insulin delivery to prevent hypoglycemia.
Panel chair Lisa Butterfield, PhD, a surgeon and immunologist at the University of California, San Francisco, voted in favor of approval. But, she added, “I do support postapproval gathering of data to learn more about the product. ... I don’t know how many patients will really benefit, but I think it’s to be determined.”
Christopher K. Breuer, MD, a general and pediatric surgeon at the Center for Regenerative Medicine, Nationwide Children’s Hospital, Columbus, Ohio, said he supported approval for “two very small subpopulations where it would provide the only viable therapy”: those who are eligible for pancreas transplant but cannot tolerate a major operation, and those who already use the latest automated insulin delivery systems and still do not achieve acceptable glycemic control.
Temporary voting member David Harlan, MD, director of the University of Massachusetts Diabetes Center of Excellence, Worcester, Mass., voted no.
He noted that only about 100 whole pancreas-only transplants are performed annually in the United States and that such transplants are “very effective, so we’re talking about patients who aren’t pancreas transplant candidates who might get this.”
Moreover, Dr. Harlan said, “I’ve seen the awful things that can happen in posttransplant recipients. It’s really hard to get that informed consent from someone when you’re asking them to consider a future that they don’t know. When it works, it’s great. When it doesn’t work, it can be catastrophic. I just worry about opening Pandora’s box.”
The only other diabetes specialist on the panel, temporary voting member Ellen Leschek, MD, said she “reluctantly voted yes because a few people could benefit, but I think it’s a much smaller number than the company may believe.”
Dr. Leschek, of the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md., said she’s concerned that “if it’s approved, too many people will get treated this way, when in fact, for a lot of those people, the risks will outweigh the benefits.”
Sandy Feng, MD, PhD, of the department of surgery at the University of California, San Francisco, pointed out that with regard to immunosuppressive therapy, “We’re concerned about the toxicity of what we currently use, but there are additional therapies being developed that might mitigate those toxicities that would be beneficial to this population.”
Dr. Feng, who voted yes, also said, “I do pancreas transplants. I can tell you that there is nothing that [patients with type 1 diabetes] like more than the freedom from dealing with the entire insulin issue. That has made a large impression on me over the last 20-plus years of clinical practice, so I do think this can help some people and will be incredibly meaningful to those people.”
FDA advisory panel members are vetted for conflicts of interest, and special waivers are granted if necessary. No such waivers were granted for this meeting.
A version of this article first appeared on Medscape.com.
Black patients with cutaneous sarcoidosis may have more systemic and CV disease
according to a retrospective chart review of patients seen at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.
Black patients were also significantly more likely to have two or more organs involved and have higher rates of cardiac involvement, the latter of which is associated with worse prognosis. “Our data suggest there may be substantial variations in organ involvement between racial groups of patients presenting with cutaneous sarcoidosis,” said medical student Kylee Kus, a medical student at Oakland University, Auburn Hills, Mich., who presented the findings with Bina Kassamali, a medical student at Harvard University, Boston, at the annual Skin of Color Society scientific symposium.
Sotonye Imadojemu, MD, MBE; Avery LeChance, MD, MPH; and Ruth Anne Vleugels, MD, MPH, MBA; of Brigham and Women’s Hospital, are cosenior authors of the abstract.
The researchers identified 111 patients who were diagnosed with cutaneous sarcoidosis over a 20-year period (January 2000–December 2019), 50 of whom presented without established extracutaneous disease. They examined the charts of these 50 patients for whether subsequent work-up revealed systemic disease.
Of the 50 patients, 9 were Black. Seven of these nine patients (77.8%), were found to have systemic involvement, compared with 14 of 41 (46.3%) non-Black patients – a 31.5% higher probability (P < .05). One-third of the nine Black patients were found to have disease in one organ, and 44.4% in two or more organs. In non-Black patients, these rates were 12.2% and 34.1%, respectively.
Cardiovascular involvement was not found in any of the non-Black patients who had extracutaneous disease, but was found in 29% of the Black patients with extracutaneous disease, a statistically significant difference.
Black patients are known to be at higher risk for sarcoidosis than non-Black patients, and because “there is an association between cardiac sarcoid involvement and poor prognosis largely due to manifestations such as heart block, arrhythmias, and heart failure ... the study helps demonstrate how this organ involvement can disproportionately affect the Black population,” Ms. Kassamali said in an interview after the meeting.
A separate, recently published analysis of data from the same patient population examined the work-ups that patients received after a dermatologist’s diagnosis of sarcoidosis and found that patients with no previous systemic work-up were subsequently assessed for cardiac involvement in only 58.3% of cases. Assessment for pulmonary and ocular disease was completed more than 90% of the time.
“Crucial testing for cardiac involvement fell short,” Dr. Imadojemu, of the department of dermatology, Brigham and Women’s Hospital, and coinvestigators wrote in the research letter.
“Because the cutaneous manifestations of sarcoidosis often present at disease onset, dermatologists may be the first physicians to diagnose a patient with sarcoidosis,” they wrote. “As such, dermatologists are often responsible for initiating the appropriate evaluation of patients with sarcoidosis.”
Pulmonary involvement occurs in nearly all cases of sarcoidosis, while ocular and cardiac disease develop in approximately 25% and 10% of patients, respectively. Cardiac sarcoidosis is usually asymptomatic and accounts for 13%-25% of sarcoidosis-related deaths in the United States, they wrote.
An electrocardiogram is the appropriate initial screening tool and “is warranted in all patients with sarcoidosis,” they advised.
according to a retrospective chart review of patients seen at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.
Black patients were also significantly more likely to have two or more organs involved and have higher rates of cardiac involvement, the latter of which is associated with worse prognosis. “Our data suggest there may be substantial variations in organ involvement between racial groups of patients presenting with cutaneous sarcoidosis,” said medical student Kylee Kus, a medical student at Oakland University, Auburn Hills, Mich., who presented the findings with Bina Kassamali, a medical student at Harvard University, Boston, at the annual Skin of Color Society scientific symposium.
Sotonye Imadojemu, MD, MBE; Avery LeChance, MD, MPH; and Ruth Anne Vleugels, MD, MPH, MBA; of Brigham and Women’s Hospital, are cosenior authors of the abstract.
The researchers identified 111 patients who were diagnosed with cutaneous sarcoidosis over a 20-year period (January 2000–December 2019), 50 of whom presented without established extracutaneous disease. They examined the charts of these 50 patients for whether subsequent work-up revealed systemic disease.
Of the 50 patients, 9 were Black. Seven of these nine patients (77.8%), were found to have systemic involvement, compared with 14 of 41 (46.3%) non-Black patients – a 31.5% higher probability (P < .05). One-third of the nine Black patients were found to have disease in one organ, and 44.4% in two or more organs. In non-Black patients, these rates were 12.2% and 34.1%, respectively.
Cardiovascular involvement was not found in any of the non-Black patients who had extracutaneous disease, but was found in 29% of the Black patients with extracutaneous disease, a statistically significant difference.
Black patients are known to be at higher risk for sarcoidosis than non-Black patients, and because “there is an association between cardiac sarcoid involvement and poor prognosis largely due to manifestations such as heart block, arrhythmias, and heart failure ... the study helps demonstrate how this organ involvement can disproportionately affect the Black population,” Ms. Kassamali said in an interview after the meeting.
A separate, recently published analysis of data from the same patient population examined the work-ups that patients received after a dermatologist’s diagnosis of sarcoidosis and found that patients with no previous systemic work-up were subsequently assessed for cardiac involvement in only 58.3% of cases. Assessment for pulmonary and ocular disease was completed more than 90% of the time.
“Crucial testing for cardiac involvement fell short,” Dr. Imadojemu, of the department of dermatology, Brigham and Women’s Hospital, and coinvestigators wrote in the research letter.
“Because the cutaneous manifestations of sarcoidosis often present at disease onset, dermatologists may be the first physicians to diagnose a patient with sarcoidosis,” they wrote. “As such, dermatologists are often responsible for initiating the appropriate evaluation of patients with sarcoidosis.”
Pulmonary involvement occurs in nearly all cases of sarcoidosis, while ocular and cardiac disease develop in approximately 25% and 10% of patients, respectively. Cardiac sarcoidosis is usually asymptomatic and accounts for 13%-25% of sarcoidosis-related deaths in the United States, they wrote.
An electrocardiogram is the appropriate initial screening tool and “is warranted in all patients with sarcoidosis,” they advised.
according to a retrospective chart review of patients seen at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.
Black patients were also significantly more likely to have two or more organs involved and have higher rates of cardiac involvement, the latter of which is associated with worse prognosis. “Our data suggest there may be substantial variations in organ involvement between racial groups of patients presenting with cutaneous sarcoidosis,” said medical student Kylee Kus, a medical student at Oakland University, Auburn Hills, Mich., who presented the findings with Bina Kassamali, a medical student at Harvard University, Boston, at the annual Skin of Color Society scientific symposium.
Sotonye Imadojemu, MD, MBE; Avery LeChance, MD, MPH; and Ruth Anne Vleugels, MD, MPH, MBA; of Brigham and Women’s Hospital, are cosenior authors of the abstract.
The researchers identified 111 patients who were diagnosed with cutaneous sarcoidosis over a 20-year period (January 2000–December 2019), 50 of whom presented without established extracutaneous disease. They examined the charts of these 50 patients for whether subsequent work-up revealed systemic disease.
Of the 50 patients, 9 were Black. Seven of these nine patients (77.8%), were found to have systemic involvement, compared with 14 of 41 (46.3%) non-Black patients – a 31.5% higher probability (P < .05). One-third of the nine Black patients were found to have disease in one organ, and 44.4% in two or more organs. In non-Black patients, these rates were 12.2% and 34.1%, respectively.
Cardiovascular involvement was not found in any of the non-Black patients who had extracutaneous disease, but was found in 29% of the Black patients with extracutaneous disease, a statistically significant difference.
Black patients are known to be at higher risk for sarcoidosis than non-Black patients, and because “there is an association between cardiac sarcoid involvement and poor prognosis largely due to manifestations such as heart block, arrhythmias, and heart failure ... the study helps demonstrate how this organ involvement can disproportionately affect the Black population,” Ms. Kassamali said in an interview after the meeting.
A separate, recently published analysis of data from the same patient population examined the work-ups that patients received after a dermatologist’s diagnosis of sarcoidosis and found that patients with no previous systemic work-up were subsequently assessed for cardiac involvement in only 58.3% of cases. Assessment for pulmonary and ocular disease was completed more than 90% of the time.
“Crucial testing for cardiac involvement fell short,” Dr. Imadojemu, of the department of dermatology, Brigham and Women’s Hospital, and coinvestigators wrote in the research letter.
“Because the cutaneous manifestations of sarcoidosis often present at disease onset, dermatologists may be the first physicians to diagnose a patient with sarcoidosis,” they wrote. “As such, dermatologists are often responsible for initiating the appropriate evaluation of patients with sarcoidosis.”
Pulmonary involvement occurs in nearly all cases of sarcoidosis, while ocular and cardiac disease develop in approximately 25% and 10% of patients, respectively. Cardiac sarcoidosis is usually asymptomatic and accounts for 13%-25% of sarcoidosis-related deaths in the United States, they wrote.
An electrocardiogram is the appropriate initial screening tool and “is warranted in all patients with sarcoidosis,” they advised.
FROM SOC SOCIETY 2021
HDL anti-inflammatory effects show prognostic potential
The high-density lipoprotein particle’s complexity as a mediator of cardiovascular risk was on display in a case-control study that, the researchers say, points to its anti-inflammatory capacity as potentially a worthy addition to standard CV risk assessments.
A measure of HDL anti-inflammatory capacity in a prospective community cohort was inversely related to future CV risk independent of HDL’s role in cholesterol transport, total cholesterol, and other established biomarkers, as well as any lipid-modifying therapy.
The current analysis “identified an impaired HDL anti-inflammatory capacity as a functional metric prospectively associated with increased cardiovascular risk in the general population,” observed the authors of the study, published April 12, 2021, in Circulation, led by Congzhuo Jia, MD, University of Groningen (the Netherlands).
“In contrast with the cholesterol efflux function of HDL that tracks moderately with HDL cholesterol levels,” they wrote, HDL anti-inflammatory capacity was not significantly correlated with actual levels of the lipoprotein or a major constituent, apolipoprotein A1 (apoA1). Nor was it correlated with levels of a more generalized inflammatory biomarker, C-reactive protein by high-sensitivity assay (hsCRP).
In a test of its independence as a prognosticator, HDL anti-inflammatory capacity significantly and meaningfully improved prediction of CV events in the study after it was added to the familiar Framingham risk equations.
Measurement of HDL anti-inflammatory properties, therefore, has the potential to improve current CV risk assessments in people without clinical heart disease, the authors proposed.
The study “adds to our understanding of the potential cardioprotective role of HDL,” Michael Miller, MD, University of Maryland, Baltimore, said in an interview.
“We’ve known for some time that HDL has anti-inflammatory properties in vitro, and my understanding is this is the first study to assess these anti-inflammatory properties in a clinical trial,” said Dr. Miller, who studies lipid metabolism and directs the Center for Preventive Cardiology at his center but isn’t an author of the report.
The study is part of a long line of research aiming to “untangle the complexities of HDL and try to get a better handle as to the properties that make it cardioprotective,” he said. For example, “high levels are not always associated with cardioprotection, and low levels don’t always imply increased risk.”
The current findings highlight a quality of HDL that might be prognostic but also independent of its concentrations, apoA1 content, or cholesterol efflux capacity, Dr. Miller noted. That makes HDL anti-inflammatory capacity a “promising feature” of HDL that, if confirmed in further studies, could potentially be brought into the mainstream for CV risk prediction. “But it’s too premature at this time.”
The study of participants in the population-based PREVEND cohort study compared 340 patients with a first CV event – CV death, ischemic heart disease, nonfatal MI, or coronary revascularization – over a median of about 10 years with the same number of participants without such events. The two cohorts of people from the same city in the Netherlands had been matched according to sex, smoking status, age, and HDL cholesterol levels at baseline.
No measured clinical or laboratory value, the group wrote, was significantly correlated with HDL anti-inflammatory capacity, defined here as ability to suppress vascular cell adhesion molecule-1 (VCAM-1) mRNA expression as induced by tumor necrosis factor–alpha in endothelial cells in vitro.
HDL anti-inflammatory capacity was significantly lower in the case cohort, compared with the control cohort (P < .001), and was inversely related to new CV events, at an odds ratio per 1 standard deviation of 0.74 (95% confidence interval, 0.61-0.90; P = .002). Covariate adjustments included body mass index; alcohol intake; diabetes and hypertension status; use of lipid-lowering medicine; levels of total cholesterol, apoA1, triglyceride, and hsCRP; and measures of renal function.
No significant association was seen between HDL anti-inflammatory capacity and cholesterol efflux capacity (coefficient of correlation, −0.02; P > .05). But both metrics were independently associated with CV disease events. The OR per 1 standard deviation was 0.74 (95% CI, 0.61-0.90; P = .002) for cholesterol efflux capacity and 0.66 (95% CI, 0.54-0.81; P < .001) for HDL anti-inflammatory capacity.
Adding HDL anti-inflammatory capacity to the Framingham risk score significantly improved its predictive power; its likelihood-ratio statistic rose from 10.50 to 20.40 (P = .002), the group wrote. The addition of cholesterol efflux capacity further elevated the risk score’s likelihood-ratio statistic to 32.84 (P = .0005).
The analysis has all the limitations of a case-control study, Dr. Miller said, but it does “show a potential reasonable association” between anti-inflammatory capacity and CV risk “that needs to be taken to the next level.”
For example, it could be explored in a controlled trial that tracks anti-inflammatory capacity in individuals who receive an intervention that is likely to improve the biomarker – such as weight loss, he proposed – and follows them for clinical outcomes.
“If you want to elevate the stature of the anti-inflammatory index,” Dr. Miller said, “you will need to show that it’s clinically meaningful.”
Dr. Jia reported no conflicts. Dr. Miller has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The high-density lipoprotein particle’s complexity as a mediator of cardiovascular risk was on display in a case-control study that, the researchers say, points to its anti-inflammatory capacity as potentially a worthy addition to standard CV risk assessments.
A measure of HDL anti-inflammatory capacity in a prospective community cohort was inversely related to future CV risk independent of HDL’s role in cholesterol transport, total cholesterol, and other established biomarkers, as well as any lipid-modifying therapy.
The current analysis “identified an impaired HDL anti-inflammatory capacity as a functional metric prospectively associated with increased cardiovascular risk in the general population,” observed the authors of the study, published April 12, 2021, in Circulation, led by Congzhuo Jia, MD, University of Groningen (the Netherlands).
“In contrast with the cholesterol efflux function of HDL that tracks moderately with HDL cholesterol levels,” they wrote, HDL anti-inflammatory capacity was not significantly correlated with actual levels of the lipoprotein or a major constituent, apolipoprotein A1 (apoA1). Nor was it correlated with levels of a more generalized inflammatory biomarker, C-reactive protein by high-sensitivity assay (hsCRP).
In a test of its independence as a prognosticator, HDL anti-inflammatory capacity significantly and meaningfully improved prediction of CV events in the study after it was added to the familiar Framingham risk equations.
Measurement of HDL anti-inflammatory properties, therefore, has the potential to improve current CV risk assessments in people without clinical heart disease, the authors proposed.
The study “adds to our understanding of the potential cardioprotective role of HDL,” Michael Miller, MD, University of Maryland, Baltimore, said in an interview.
“We’ve known for some time that HDL has anti-inflammatory properties in vitro, and my understanding is this is the first study to assess these anti-inflammatory properties in a clinical trial,” said Dr. Miller, who studies lipid metabolism and directs the Center for Preventive Cardiology at his center but isn’t an author of the report.
The study is part of a long line of research aiming to “untangle the complexities of HDL and try to get a better handle as to the properties that make it cardioprotective,” he said. For example, “high levels are not always associated with cardioprotection, and low levels don’t always imply increased risk.”
The current findings highlight a quality of HDL that might be prognostic but also independent of its concentrations, apoA1 content, or cholesterol efflux capacity, Dr. Miller noted. That makes HDL anti-inflammatory capacity a “promising feature” of HDL that, if confirmed in further studies, could potentially be brought into the mainstream for CV risk prediction. “But it’s too premature at this time.”
The study of participants in the population-based PREVEND cohort study compared 340 patients with a first CV event – CV death, ischemic heart disease, nonfatal MI, or coronary revascularization – over a median of about 10 years with the same number of participants without such events. The two cohorts of people from the same city in the Netherlands had been matched according to sex, smoking status, age, and HDL cholesterol levels at baseline.
No measured clinical or laboratory value, the group wrote, was significantly correlated with HDL anti-inflammatory capacity, defined here as ability to suppress vascular cell adhesion molecule-1 (VCAM-1) mRNA expression as induced by tumor necrosis factor–alpha in endothelial cells in vitro.
HDL anti-inflammatory capacity was significantly lower in the case cohort, compared with the control cohort (P < .001), and was inversely related to new CV events, at an odds ratio per 1 standard deviation of 0.74 (95% confidence interval, 0.61-0.90; P = .002). Covariate adjustments included body mass index; alcohol intake; diabetes and hypertension status; use of lipid-lowering medicine; levels of total cholesterol, apoA1, triglyceride, and hsCRP; and measures of renal function.
No significant association was seen between HDL anti-inflammatory capacity and cholesterol efflux capacity (coefficient of correlation, −0.02; P > .05). But both metrics were independently associated with CV disease events. The OR per 1 standard deviation was 0.74 (95% CI, 0.61-0.90; P = .002) for cholesterol efflux capacity and 0.66 (95% CI, 0.54-0.81; P < .001) for HDL anti-inflammatory capacity.
Adding HDL anti-inflammatory capacity to the Framingham risk score significantly improved its predictive power; its likelihood-ratio statistic rose from 10.50 to 20.40 (P = .002), the group wrote. The addition of cholesterol efflux capacity further elevated the risk score’s likelihood-ratio statistic to 32.84 (P = .0005).
The analysis has all the limitations of a case-control study, Dr. Miller said, but it does “show a potential reasonable association” between anti-inflammatory capacity and CV risk “that needs to be taken to the next level.”
For example, it could be explored in a controlled trial that tracks anti-inflammatory capacity in individuals who receive an intervention that is likely to improve the biomarker – such as weight loss, he proposed – and follows them for clinical outcomes.
“If you want to elevate the stature of the anti-inflammatory index,” Dr. Miller said, “you will need to show that it’s clinically meaningful.”
Dr. Jia reported no conflicts. Dr. Miller has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The high-density lipoprotein particle’s complexity as a mediator of cardiovascular risk was on display in a case-control study that, the researchers say, points to its anti-inflammatory capacity as potentially a worthy addition to standard CV risk assessments.
A measure of HDL anti-inflammatory capacity in a prospective community cohort was inversely related to future CV risk independent of HDL’s role in cholesterol transport, total cholesterol, and other established biomarkers, as well as any lipid-modifying therapy.
The current analysis “identified an impaired HDL anti-inflammatory capacity as a functional metric prospectively associated with increased cardiovascular risk in the general population,” observed the authors of the study, published April 12, 2021, in Circulation, led by Congzhuo Jia, MD, University of Groningen (the Netherlands).
“In contrast with the cholesterol efflux function of HDL that tracks moderately with HDL cholesterol levels,” they wrote, HDL anti-inflammatory capacity was not significantly correlated with actual levels of the lipoprotein or a major constituent, apolipoprotein A1 (apoA1). Nor was it correlated with levels of a more generalized inflammatory biomarker, C-reactive protein by high-sensitivity assay (hsCRP).
In a test of its independence as a prognosticator, HDL anti-inflammatory capacity significantly and meaningfully improved prediction of CV events in the study after it was added to the familiar Framingham risk equations.
Measurement of HDL anti-inflammatory properties, therefore, has the potential to improve current CV risk assessments in people without clinical heart disease, the authors proposed.
The study “adds to our understanding of the potential cardioprotective role of HDL,” Michael Miller, MD, University of Maryland, Baltimore, said in an interview.
“We’ve known for some time that HDL has anti-inflammatory properties in vitro, and my understanding is this is the first study to assess these anti-inflammatory properties in a clinical trial,” said Dr. Miller, who studies lipid metabolism and directs the Center for Preventive Cardiology at his center but isn’t an author of the report.
The study is part of a long line of research aiming to “untangle the complexities of HDL and try to get a better handle as to the properties that make it cardioprotective,” he said. For example, “high levels are not always associated with cardioprotection, and low levels don’t always imply increased risk.”
The current findings highlight a quality of HDL that might be prognostic but also independent of its concentrations, apoA1 content, or cholesterol efflux capacity, Dr. Miller noted. That makes HDL anti-inflammatory capacity a “promising feature” of HDL that, if confirmed in further studies, could potentially be brought into the mainstream for CV risk prediction. “But it’s too premature at this time.”
The study of participants in the population-based PREVEND cohort study compared 340 patients with a first CV event – CV death, ischemic heart disease, nonfatal MI, or coronary revascularization – over a median of about 10 years with the same number of participants without such events. The two cohorts of people from the same city in the Netherlands had been matched according to sex, smoking status, age, and HDL cholesterol levels at baseline.
No measured clinical or laboratory value, the group wrote, was significantly correlated with HDL anti-inflammatory capacity, defined here as ability to suppress vascular cell adhesion molecule-1 (VCAM-1) mRNA expression as induced by tumor necrosis factor–alpha in endothelial cells in vitro.
HDL anti-inflammatory capacity was significantly lower in the case cohort, compared with the control cohort (P < .001), and was inversely related to new CV events, at an odds ratio per 1 standard deviation of 0.74 (95% confidence interval, 0.61-0.90; P = .002). Covariate adjustments included body mass index; alcohol intake; diabetes and hypertension status; use of lipid-lowering medicine; levels of total cholesterol, apoA1, triglyceride, and hsCRP; and measures of renal function.
No significant association was seen between HDL anti-inflammatory capacity and cholesterol efflux capacity (coefficient of correlation, −0.02; P > .05). But both metrics were independently associated with CV disease events. The OR per 1 standard deviation was 0.74 (95% CI, 0.61-0.90; P = .002) for cholesterol efflux capacity and 0.66 (95% CI, 0.54-0.81; P < .001) for HDL anti-inflammatory capacity.
Adding HDL anti-inflammatory capacity to the Framingham risk score significantly improved its predictive power; its likelihood-ratio statistic rose from 10.50 to 20.40 (P = .002), the group wrote. The addition of cholesterol efflux capacity further elevated the risk score’s likelihood-ratio statistic to 32.84 (P = .0005).
The analysis has all the limitations of a case-control study, Dr. Miller said, but it does “show a potential reasonable association” between anti-inflammatory capacity and CV risk “that needs to be taken to the next level.”
For example, it could be explored in a controlled trial that tracks anti-inflammatory capacity in individuals who receive an intervention that is likely to improve the biomarker – such as weight loss, he proposed – and follows them for clinical outcomes.
“If you want to elevate the stature of the anti-inflammatory index,” Dr. Miller said, “you will need to show that it’s clinically meaningful.”
Dr. Jia reported no conflicts. Dr. Miller has no relevant disclosures.
A version of this article first appeared on Medscape.com.