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Older women with ESRD face higher mortality, compared with male counterparts
LOS ANGELES – In patients with end-stage renal disease, women older than 50 years have a significantly higher mortality, compared with their male counterparts, results from an analysis of national data showed.
“The racial and ethnic disparities in the prevalence, treatment, risks, and outcomes of [hypertension] in patients with CKD [chronic kidney disease], are well recognized,” the study’s senior author, Ricardo Correa, MD, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “Whites have better control of blood pressure, compared with Hispanics or African Americans with CKD, for example. On the other hand, gender differences in the outcome of blood pressure control and mortality across the different CKD stages have been very poorly studied, with conflicting results.”
The importance of gender difference has been mostly the focus in cardiovascular diseases, he continued, with compelling data revealing a higher incidence in men than in women of similar age, and a menopause-associated increase in cardiovascular disease in women.
“Whether the same can be said for hypertension, remains to be elucidated,” said Dr. Correa, an endocrinologist who directs the diabetes and metabolism fellowship at the University of Arizona in Phoenix.
In what he said is the first study of its kind, Dr. Correa and his colleagues set out to determine if gender in the U.S. population and menopausal age affect the inpatient survival rate in hypertensive patients across different stages of CKD. They drew from the 2005-2012 National Inpatient Sample to identify 2,121,750 hospitalized hypertensive patients and compared a number of factors between men and women, including crude mortality and mortality per CKD stage, menopausal age, length of stay, and total hospital charges.
Of the 2,121,750 patients, 1,092,931 (52%) were men and 1,028,819 (48%) were women; their mean age was 65 years. Among women, 32% had stage 3 CKD, 15% had stage 4 disease, 3% had stage 5 CKD, and 54% had end-stage renal disease (ESRD). Among men, 33% had stage 3 CKD, 13% had stage 4 disease, 3% had stage 5 CKD, and 51% had ESRD. The researchers observed that in-hospital crude mortality was significantly higher for men, compared with a matched group of women at CKD stages 3 and 4 (3.09% vs. 3.29% for CDK 3; P less than .0001 and 4.05% vs. 4.36% for CDK 4; P = .0004), yet was nonsignificant among those with ESRD (4.68% vs. 4.83%; P = .45).
When the researchers factored in menopausal age, they found that women with stage 3, 4, or 5 CKD who were aged 50 years or younger had a mortality rate similar to that of men with same stage disease, whereas women older than 50 years with ESRD had a significantly higher mortality, compared with their male counterparts, especially those of Asian, African American, and Hispanic descent (P less than .001, compared with those of white, non-Hispanic descent).
“One could hypothesize that cardiac remodeling in hemodialysis women may be different than that in hemodialysis men to the extent that it affects mortality,” Dr. Correa said. “However, it is unclear if the survival benefit for dialysis men is owing to the possibility of a selection bias or not. Dialysis women may not be receiving equal access to cardiovascular procedures or surgical interventions (arteriovenous fistula, for example) or women may not be offered adequate hemodialysis to the same extent as men are. Further investigations regarding sex-based differences in dialysis treatment are required.”
He acknowledged certain limitations of the study, including its observational design. “We lacked detailed information regarding the cause of death, dialysis efficiency, types of dialysis accesses, and left ventricular hypertrophy measurements. We did not account for transitions between different hemodialysis modalities [and] we do not have information about distances or traveling time to dialysis units.”
The study’s first author was Kelvin Tran, MD. The researchers reported having no financial disclosures.
LOS ANGELES – In patients with end-stage renal disease, women older than 50 years have a significantly higher mortality, compared with their male counterparts, results from an analysis of national data showed.
“The racial and ethnic disparities in the prevalence, treatment, risks, and outcomes of [hypertension] in patients with CKD [chronic kidney disease], are well recognized,” the study’s senior author, Ricardo Correa, MD, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “Whites have better control of blood pressure, compared with Hispanics or African Americans with CKD, for example. On the other hand, gender differences in the outcome of blood pressure control and mortality across the different CKD stages have been very poorly studied, with conflicting results.”
The importance of gender difference has been mostly the focus in cardiovascular diseases, he continued, with compelling data revealing a higher incidence in men than in women of similar age, and a menopause-associated increase in cardiovascular disease in women.
“Whether the same can be said for hypertension, remains to be elucidated,” said Dr. Correa, an endocrinologist who directs the diabetes and metabolism fellowship at the University of Arizona in Phoenix.
In what he said is the first study of its kind, Dr. Correa and his colleagues set out to determine if gender in the U.S. population and menopausal age affect the inpatient survival rate in hypertensive patients across different stages of CKD. They drew from the 2005-2012 National Inpatient Sample to identify 2,121,750 hospitalized hypertensive patients and compared a number of factors between men and women, including crude mortality and mortality per CKD stage, menopausal age, length of stay, and total hospital charges.
Of the 2,121,750 patients, 1,092,931 (52%) were men and 1,028,819 (48%) were women; their mean age was 65 years. Among women, 32% had stage 3 CKD, 15% had stage 4 disease, 3% had stage 5 CKD, and 54% had end-stage renal disease (ESRD). Among men, 33% had stage 3 CKD, 13% had stage 4 disease, 3% had stage 5 CKD, and 51% had ESRD. The researchers observed that in-hospital crude mortality was significantly higher for men, compared with a matched group of women at CKD stages 3 and 4 (3.09% vs. 3.29% for CDK 3; P less than .0001 and 4.05% vs. 4.36% for CDK 4; P = .0004), yet was nonsignificant among those with ESRD (4.68% vs. 4.83%; P = .45).
When the researchers factored in menopausal age, they found that women with stage 3, 4, or 5 CKD who were aged 50 years or younger had a mortality rate similar to that of men with same stage disease, whereas women older than 50 years with ESRD had a significantly higher mortality, compared with their male counterparts, especially those of Asian, African American, and Hispanic descent (P less than .001, compared with those of white, non-Hispanic descent).
“One could hypothesize that cardiac remodeling in hemodialysis women may be different than that in hemodialysis men to the extent that it affects mortality,” Dr. Correa said. “However, it is unclear if the survival benefit for dialysis men is owing to the possibility of a selection bias or not. Dialysis women may not be receiving equal access to cardiovascular procedures or surgical interventions (arteriovenous fistula, for example) or women may not be offered adequate hemodialysis to the same extent as men are. Further investigations regarding sex-based differences in dialysis treatment are required.”
He acknowledged certain limitations of the study, including its observational design. “We lacked detailed information regarding the cause of death, dialysis efficiency, types of dialysis accesses, and left ventricular hypertrophy measurements. We did not account for transitions between different hemodialysis modalities [and] we do not have information about distances or traveling time to dialysis units.”
The study’s first author was Kelvin Tran, MD. The researchers reported having no financial disclosures.
LOS ANGELES – In patients with end-stage renal disease, women older than 50 years have a significantly higher mortality, compared with their male counterparts, results from an analysis of national data showed.
“The racial and ethnic disparities in the prevalence, treatment, risks, and outcomes of [hypertension] in patients with CKD [chronic kidney disease], are well recognized,” the study’s senior author, Ricardo Correa, MD, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “Whites have better control of blood pressure, compared with Hispanics or African Americans with CKD, for example. On the other hand, gender differences in the outcome of blood pressure control and mortality across the different CKD stages have been very poorly studied, with conflicting results.”
The importance of gender difference has been mostly the focus in cardiovascular diseases, he continued, with compelling data revealing a higher incidence in men than in women of similar age, and a menopause-associated increase in cardiovascular disease in women.
“Whether the same can be said for hypertension, remains to be elucidated,” said Dr. Correa, an endocrinologist who directs the diabetes and metabolism fellowship at the University of Arizona in Phoenix.
In what he said is the first study of its kind, Dr. Correa and his colleagues set out to determine if gender in the U.S. population and menopausal age affect the inpatient survival rate in hypertensive patients across different stages of CKD. They drew from the 2005-2012 National Inpatient Sample to identify 2,121,750 hospitalized hypertensive patients and compared a number of factors between men and women, including crude mortality and mortality per CKD stage, menopausal age, length of stay, and total hospital charges.
Of the 2,121,750 patients, 1,092,931 (52%) were men and 1,028,819 (48%) were women; their mean age was 65 years. Among women, 32% had stage 3 CKD, 15% had stage 4 disease, 3% had stage 5 CKD, and 54% had end-stage renal disease (ESRD). Among men, 33% had stage 3 CKD, 13% had stage 4 disease, 3% had stage 5 CKD, and 51% had ESRD. The researchers observed that in-hospital crude mortality was significantly higher for men, compared with a matched group of women at CKD stages 3 and 4 (3.09% vs. 3.29% for CDK 3; P less than .0001 and 4.05% vs. 4.36% for CDK 4; P = .0004), yet was nonsignificant among those with ESRD (4.68% vs. 4.83%; P = .45).
When the researchers factored in menopausal age, they found that women with stage 3, 4, or 5 CKD who were aged 50 years or younger had a mortality rate similar to that of men with same stage disease, whereas women older than 50 years with ESRD had a significantly higher mortality, compared with their male counterparts, especially those of Asian, African American, and Hispanic descent (P less than .001, compared with those of white, non-Hispanic descent).
“One could hypothesize that cardiac remodeling in hemodialysis women may be different than that in hemodialysis men to the extent that it affects mortality,” Dr. Correa said. “However, it is unclear if the survival benefit for dialysis men is owing to the possibility of a selection bias or not. Dialysis women may not be receiving equal access to cardiovascular procedures or surgical interventions (arteriovenous fistula, for example) or women may not be offered adequate hemodialysis to the same extent as men are. Further investigations regarding sex-based differences in dialysis treatment are required.”
He acknowledged certain limitations of the study, including its observational design. “We lacked detailed information regarding the cause of death, dialysis efficiency, types of dialysis accesses, and left ventricular hypertrophy measurements. We did not account for transitions between different hemodialysis modalities [and] we do not have information about distances or traveling time to dialysis units.”
The study’s first author was Kelvin Tran, MD. The researchers reported having no financial disclosures.
REPORTING FROM AACE 2019
Key clinical point: .
Major finding: Women older than 50 years with end-stage renal disease had significantly higher mortality, compared with their male counterparts, especially those of Asian, African American, and Hispanic descent (P less than .001 vs. those of white, non-Hispanic descent).
Study details: An observational study of more than 2 million hypertensive patients from the Nationwide Inpatient Sample.
Disclosures: Dr. Correa reported having no financial disclosures.
Alirocumab gains indication to reduce cardiovascular risks
Alirocumab has received an updated indication from the Food and Drug Administration for reducing the overall risk of major adverse cardiovascular events in patients with a recent acute coronary event.
Alirocumab is designed to inhibit the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to LDL receptors, thereby lowering LDL cholesterol, according to manufacturer Regeneron, which is developing alirocumab in partnership with Sanofi.
The drug was previously approved in the United States as an adjunct treatment along with diet and maximally tolerated statin therapy to help lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.
The approval of the supplemental Biologics License Application was supported by data from the ODYSSEY Outcomes trial in which 18,924 patients who had an acute coronary syndrome were randomized to alirocumab or placebo plus background high-intensity statin therapy starting at a median of 2.6 months after the event. Over 3 years’ follow-up, a composite endpoint outcome including death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, or unstable angina occurred in 9.5% of alirocumab patients and 11.1% of placebo patients.
In the study, patients received subcutaneous dose of 75 mg of alirocumab every 2 weeks, which was adjusted to achieve an LDL cholesterol level of 25-50 mg/dL. The most significant benefits occurred among patients with a baseline LDL cholesterol of 100 mg/dL or higher who were taking high-intensity statins, which supports the role of LDL cholesterol reduction in improving outcomes for coronary syndrome patients, according to study investigators.
Alirocumab is given as a subcutaneous injection. The most common side effects include pain and tenderness at the injection site, and redness, itching, or swelling; some patients have reported symptoms of a common cold or flu.
More details of the ODYSSEY Outcomes trial were presented at the annual meeting of the American College of Cardiology.
Alirocumab has received an updated indication from the Food and Drug Administration for reducing the overall risk of major adverse cardiovascular events in patients with a recent acute coronary event.
Alirocumab is designed to inhibit the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to LDL receptors, thereby lowering LDL cholesterol, according to manufacturer Regeneron, which is developing alirocumab in partnership with Sanofi.
The drug was previously approved in the United States as an adjunct treatment along with diet and maximally tolerated statin therapy to help lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.
The approval of the supplemental Biologics License Application was supported by data from the ODYSSEY Outcomes trial in which 18,924 patients who had an acute coronary syndrome were randomized to alirocumab or placebo plus background high-intensity statin therapy starting at a median of 2.6 months after the event. Over 3 years’ follow-up, a composite endpoint outcome including death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, or unstable angina occurred in 9.5% of alirocumab patients and 11.1% of placebo patients.
In the study, patients received subcutaneous dose of 75 mg of alirocumab every 2 weeks, which was adjusted to achieve an LDL cholesterol level of 25-50 mg/dL. The most significant benefits occurred among patients with a baseline LDL cholesterol of 100 mg/dL or higher who were taking high-intensity statins, which supports the role of LDL cholesterol reduction in improving outcomes for coronary syndrome patients, according to study investigators.
Alirocumab is given as a subcutaneous injection. The most common side effects include pain and tenderness at the injection site, and redness, itching, or swelling; some patients have reported symptoms of a common cold or flu.
More details of the ODYSSEY Outcomes trial were presented at the annual meeting of the American College of Cardiology.
Alirocumab has received an updated indication from the Food and Drug Administration for reducing the overall risk of major adverse cardiovascular events in patients with a recent acute coronary event.
Alirocumab is designed to inhibit the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to LDL receptors, thereby lowering LDL cholesterol, according to manufacturer Regeneron, which is developing alirocumab in partnership with Sanofi.
The drug was previously approved in the United States as an adjunct treatment along with diet and maximally tolerated statin therapy to help lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.
The approval of the supplemental Biologics License Application was supported by data from the ODYSSEY Outcomes trial in which 18,924 patients who had an acute coronary syndrome were randomized to alirocumab or placebo plus background high-intensity statin therapy starting at a median of 2.6 months after the event. Over 3 years’ follow-up, a composite endpoint outcome including death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, or unstable angina occurred in 9.5% of alirocumab patients and 11.1% of placebo patients.
In the study, patients received subcutaneous dose of 75 mg of alirocumab every 2 weeks, which was adjusted to achieve an LDL cholesterol level of 25-50 mg/dL. The most significant benefits occurred among patients with a baseline LDL cholesterol of 100 mg/dL or higher who were taking high-intensity statins, which supports the role of LDL cholesterol reduction in improving outcomes for coronary syndrome patients, according to study investigators.
Alirocumab is given as a subcutaneous injection. The most common side effects include pain and tenderness at the injection site, and redness, itching, or swelling; some patients have reported symptoms of a common cold or flu.
More details of the ODYSSEY Outcomes trial were presented at the annual meeting of the American College of Cardiology.
Which Comes First: The Mood Disorder or the Inflammation?
Mood disorders and cardiovascular disease (CVD) are often linked—1 mechanism may be common underlying low-grade inflammation. Specifically, studies have found a consistent association between circulating levels of pro-inflammatory cytokines with both mood disorders and CVD, say researchers from Lausanne University Hospital and Bern University Hospital, in Switzerland and National Institute of Mental Health in Maryland. They suggest that influence may be oneway: Mood disorders may lead to inflammation, but inflammation may not be a risk factor for the onset of mood disorders.
Noting that much of the research on inflammatory markers and CVD has focused on dysthymia, the researchers decided to conduct a study to investigate any association between atypical subtype of dysthymia and increased levels of inflammatory markers. They analyzed data from 3,118 participants who underwent comprehensive somatic and psychiatric evaluations at baseline and a mean of 5.5 years later. Current and remitted mood disorders included bipolar and major depressive disorders (MDD); subtypes included atypical, melancholic, and combinations of those.
After adjusting for confounders, they found current combined MDD was associated with increased high sensitivity C-reactive protein (hsCRP) levels and decreased IL-6 levels. Current atypical MDD was associated with increased hsCRP levels at follow-up. Moreover, remitted melancholic MDD was associated with decreased IL-6 levels at follow-up.
The major finding, the researchers say, was the association between the current atypical subtype of MDD at baseline with increased levels of hsCRP at follow-up. By contrast, inflammatory levels at baseline were not associated with subsequent atypical MDD at follow-up. What this suggests is that the disorder is causally related to increased inflammation, rather than inflammation increasing the mood disorder.
The finding of unidirectional association seems to be specific to the atypical subtype of MDD, the researchers add, which is characterized by somatic symptoms, including sleep, energy, and eating behavior.
Mood disorders and cardiovascular disease (CVD) are often linked—1 mechanism may be common underlying low-grade inflammation. Specifically, studies have found a consistent association between circulating levels of pro-inflammatory cytokines with both mood disorders and CVD, say researchers from Lausanne University Hospital and Bern University Hospital, in Switzerland and National Institute of Mental Health in Maryland. They suggest that influence may be oneway: Mood disorders may lead to inflammation, but inflammation may not be a risk factor for the onset of mood disorders.
Noting that much of the research on inflammatory markers and CVD has focused on dysthymia, the researchers decided to conduct a study to investigate any association between atypical subtype of dysthymia and increased levels of inflammatory markers. They analyzed data from 3,118 participants who underwent comprehensive somatic and psychiatric evaluations at baseline and a mean of 5.5 years later. Current and remitted mood disorders included bipolar and major depressive disorders (MDD); subtypes included atypical, melancholic, and combinations of those.
After adjusting for confounders, they found current combined MDD was associated with increased high sensitivity C-reactive protein (hsCRP) levels and decreased IL-6 levels. Current atypical MDD was associated with increased hsCRP levels at follow-up. Moreover, remitted melancholic MDD was associated with decreased IL-6 levels at follow-up.
The major finding, the researchers say, was the association between the current atypical subtype of MDD at baseline with increased levels of hsCRP at follow-up. By contrast, inflammatory levels at baseline were not associated with subsequent atypical MDD at follow-up. What this suggests is that the disorder is causally related to increased inflammation, rather than inflammation increasing the mood disorder.
The finding of unidirectional association seems to be specific to the atypical subtype of MDD, the researchers add, which is characterized by somatic symptoms, including sleep, energy, and eating behavior.
Mood disorders and cardiovascular disease (CVD) are often linked—1 mechanism may be common underlying low-grade inflammation. Specifically, studies have found a consistent association between circulating levels of pro-inflammatory cytokines with both mood disorders and CVD, say researchers from Lausanne University Hospital and Bern University Hospital, in Switzerland and National Institute of Mental Health in Maryland. They suggest that influence may be oneway: Mood disorders may lead to inflammation, but inflammation may not be a risk factor for the onset of mood disorders.
Noting that much of the research on inflammatory markers and CVD has focused on dysthymia, the researchers decided to conduct a study to investigate any association between atypical subtype of dysthymia and increased levels of inflammatory markers. They analyzed data from 3,118 participants who underwent comprehensive somatic and psychiatric evaluations at baseline and a mean of 5.5 years later. Current and remitted mood disorders included bipolar and major depressive disorders (MDD); subtypes included atypical, melancholic, and combinations of those.
After adjusting for confounders, they found current combined MDD was associated with increased high sensitivity C-reactive protein (hsCRP) levels and decreased IL-6 levels. Current atypical MDD was associated with increased hsCRP levels at follow-up. Moreover, remitted melancholic MDD was associated with decreased IL-6 levels at follow-up.
The major finding, the researchers say, was the association between the current atypical subtype of MDD at baseline with increased levels of hsCRP at follow-up. By contrast, inflammatory levels at baseline were not associated with subsequent atypical MDD at follow-up. What this suggests is that the disorder is causally related to increased inflammation, rather than inflammation increasing the mood disorder.
The finding of unidirectional association seems to be specific to the atypical subtype of MDD, the researchers add, which is characterized by somatic symptoms, including sleep, energy, and eating behavior.
‘Mammogram of the heart’: Inside coronary artery calcium scores
LOS ANGELES – according to a cardiologist who urged that endocrinologists embrace the tests when appropriate and use them to inform treatment decisions.
In the big picture, “you might want to think of this as the mammogram of the heart,” said Matthew J. Budoff, MD, professor of medicine at the University of California, Los Angeles, in a presentation at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.
“If we find a lot of plaque, we act on it,” Dr. Budoff said. “If we don’t, we reassure [patients] and test them down the road.”
According to Dr. Budoff, research confirms that the tests correlate with plaque progression and atherosclerotic burden and offer important insight into treatment decisions for diabetes. “Not all people with diabetes have atherosclerosis, and not all deserve the same therapy,” he said.
In other words, not every patient with diabetes needs to be on the same regimen, such as a statin.
Dr. Budoff pointed to recent research that revealed coronary artery calcium (CAC) scores of zero Agatston units are signs of excellent cardiac health in terms of clogged arteries – regardless of whether a patient is diabetic or not.
“Even patients with a score of zero in the setting of diabetes do very well,” said Dr. Budoff, who normally wouldn’t recommend a statin for those patients even though they have diabetes. “If you see a person without coronary calcium, their cardiovascular death rate is really, really low. Maybe you don’t have to be as aggressive with atherosclerosis. You can wait 5 years after a score of zero and reassess the risk.”
And this advice holds up regardless of the gender, age, or ethnicity of a patient.
However, Dr. Budoff cautioned against waiting too long for another assessment. “I don’t think we want to wait 10 years. A lot of things change over a decade: Our blood pressure and LDL cholesterol go up, our triglycerides and [hemoglobin] A1Cs go up – our risk factors progress with age. I’d encourage you to not wait more than 5 years to retest [a patient] to see what’s going on.”
What if a CAC score is higher than zero? A score of more than 100 is a danger signal, Dr. Budoff said. “No matter how you look at the data, a patient with a high score has higher risk of cardiovascular death or dying in general.” This is especially true among women with diabetes for reasons that are not clear.
What to do if a patient’s score is over 100? “Get them on a baby aspirin and on a statin,” he said.
CAC scores lower than 100 are less worrisome in older people and more worrisome in younger people. An age-adjusted score of 5 in a 45-year-old woman, for example, is a cause for concern because any atherosclerosis is a problem at that age.
“If they have some plaque in their coronaries at age 40 or 45, it will grow over time,” he added.
Dr. Budoff offered other insights into CAC and diabetes.
First, based on CAC scores, asymptomatic, middle-aged patients with type 1 diabetes don’t seem to be at higher risk of coronary artery disease than the general population. About 70% of 1,205 patients followed for an average of 11 years had a CAC score of zero, according to findings from a study led by Dr. Budoff (JACC Cardiovasc Imaging. 2019 Mar 8. doi: 10.1016/j.jcmg.2019.01.014).
However, positive scores translate to more risk, and “the higher the score, the higher the risk,” he emphasized.
Second, CAC screening by itself can be a motivator for lifestyle changes in people with diabetes. A randomized, controlled trial reported in 2011 found that patients who were told about their scores improved on several health measures, including blood pressure, cholesterol levels, and weight (J Am Coll Cardiol. 2011 Apr 12;57[15]:1622-32).
“They were [more] willing to take their medicines. They lost weight, and they were better at diet and exercise,” Dr. Budoff said. “Showing them a calcium score and what it means was a big motivation.”
The study also found major reductions in medication and procedure cost among patients who got the CAC results. About half of them had a CAC score of zero, he said, and that means “we’re not going to run them on a treadmill or put them on a statin.”
Dr. Budoff reported receiving grant funding from GE Healthcare.
LOS ANGELES – according to a cardiologist who urged that endocrinologists embrace the tests when appropriate and use them to inform treatment decisions.
In the big picture, “you might want to think of this as the mammogram of the heart,” said Matthew J. Budoff, MD, professor of medicine at the University of California, Los Angeles, in a presentation at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.
“If we find a lot of plaque, we act on it,” Dr. Budoff said. “If we don’t, we reassure [patients] and test them down the road.”
According to Dr. Budoff, research confirms that the tests correlate with plaque progression and atherosclerotic burden and offer important insight into treatment decisions for diabetes. “Not all people with diabetes have atherosclerosis, and not all deserve the same therapy,” he said.
In other words, not every patient with diabetes needs to be on the same regimen, such as a statin.
Dr. Budoff pointed to recent research that revealed coronary artery calcium (CAC) scores of zero Agatston units are signs of excellent cardiac health in terms of clogged arteries – regardless of whether a patient is diabetic or not.
“Even patients with a score of zero in the setting of diabetes do very well,” said Dr. Budoff, who normally wouldn’t recommend a statin for those patients even though they have diabetes. “If you see a person without coronary calcium, their cardiovascular death rate is really, really low. Maybe you don’t have to be as aggressive with atherosclerosis. You can wait 5 years after a score of zero and reassess the risk.”
And this advice holds up regardless of the gender, age, or ethnicity of a patient.
However, Dr. Budoff cautioned against waiting too long for another assessment. “I don’t think we want to wait 10 years. A lot of things change over a decade: Our blood pressure and LDL cholesterol go up, our triglycerides and [hemoglobin] A1Cs go up – our risk factors progress with age. I’d encourage you to not wait more than 5 years to retest [a patient] to see what’s going on.”
What if a CAC score is higher than zero? A score of more than 100 is a danger signal, Dr. Budoff said. “No matter how you look at the data, a patient with a high score has higher risk of cardiovascular death or dying in general.” This is especially true among women with diabetes for reasons that are not clear.
What to do if a patient’s score is over 100? “Get them on a baby aspirin and on a statin,” he said.
CAC scores lower than 100 are less worrisome in older people and more worrisome in younger people. An age-adjusted score of 5 in a 45-year-old woman, for example, is a cause for concern because any atherosclerosis is a problem at that age.
“If they have some plaque in their coronaries at age 40 or 45, it will grow over time,” he added.
Dr. Budoff offered other insights into CAC and diabetes.
First, based on CAC scores, asymptomatic, middle-aged patients with type 1 diabetes don’t seem to be at higher risk of coronary artery disease than the general population. About 70% of 1,205 patients followed for an average of 11 years had a CAC score of zero, according to findings from a study led by Dr. Budoff (JACC Cardiovasc Imaging. 2019 Mar 8. doi: 10.1016/j.jcmg.2019.01.014).
However, positive scores translate to more risk, and “the higher the score, the higher the risk,” he emphasized.
Second, CAC screening by itself can be a motivator for lifestyle changes in people with diabetes. A randomized, controlled trial reported in 2011 found that patients who were told about their scores improved on several health measures, including blood pressure, cholesterol levels, and weight (J Am Coll Cardiol. 2011 Apr 12;57[15]:1622-32).
“They were [more] willing to take their medicines. They lost weight, and they were better at diet and exercise,” Dr. Budoff said. “Showing them a calcium score and what it means was a big motivation.”
The study also found major reductions in medication and procedure cost among patients who got the CAC results. About half of them had a CAC score of zero, he said, and that means “we’re not going to run them on a treadmill or put them on a statin.”
Dr. Budoff reported receiving grant funding from GE Healthcare.
LOS ANGELES – according to a cardiologist who urged that endocrinologists embrace the tests when appropriate and use them to inform treatment decisions.
In the big picture, “you might want to think of this as the mammogram of the heart,” said Matthew J. Budoff, MD, professor of medicine at the University of California, Los Angeles, in a presentation at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.
“If we find a lot of plaque, we act on it,” Dr. Budoff said. “If we don’t, we reassure [patients] and test them down the road.”
According to Dr. Budoff, research confirms that the tests correlate with plaque progression and atherosclerotic burden and offer important insight into treatment decisions for diabetes. “Not all people with diabetes have atherosclerosis, and not all deserve the same therapy,” he said.
In other words, not every patient with diabetes needs to be on the same regimen, such as a statin.
Dr. Budoff pointed to recent research that revealed coronary artery calcium (CAC) scores of zero Agatston units are signs of excellent cardiac health in terms of clogged arteries – regardless of whether a patient is diabetic or not.
“Even patients with a score of zero in the setting of diabetes do very well,” said Dr. Budoff, who normally wouldn’t recommend a statin for those patients even though they have diabetes. “If you see a person without coronary calcium, their cardiovascular death rate is really, really low. Maybe you don’t have to be as aggressive with atherosclerosis. You can wait 5 years after a score of zero and reassess the risk.”
And this advice holds up regardless of the gender, age, or ethnicity of a patient.
However, Dr. Budoff cautioned against waiting too long for another assessment. “I don’t think we want to wait 10 years. A lot of things change over a decade: Our blood pressure and LDL cholesterol go up, our triglycerides and [hemoglobin] A1Cs go up – our risk factors progress with age. I’d encourage you to not wait more than 5 years to retest [a patient] to see what’s going on.”
What if a CAC score is higher than zero? A score of more than 100 is a danger signal, Dr. Budoff said. “No matter how you look at the data, a patient with a high score has higher risk of cardiovascular death or dying in general.” This is especially true among women with diabetes for reasons that are not clear.
What to do if a patient’s score is over 100? “Get them on a baby aspirin and on a statin,” he said.
CAC scores lower than 100 are less worrisome in older people and more worrisome in younger people. An age-adjusted score of 5 in a 45-year-old woman, for example, is a cause for concern because any atherosclerosis is a problem at that age.
“If they have some plaque in their coronaries at age 40 or 45, it will grow over time,” he added.
Dr. Budoff offered other insights into CAC and diabetes.
First, based on CAC scores, asymptomatic, middle-aged patients with type 1 diabetes don’t seem to be at higher risk of coronary artery disease than the general population. About 70% of 1,205 patients followed for an average of 11 years had a CAC score of zero, according to findings from a study led by Dr. Budoff (JACC Cardiovasc Imaging. 2019 Mar 8. doi: 10.1016/j.jcmg.2019.01.014).
However, positive scores translate to more risk, and “the higher the score, the higher the risk,” he emphasized.
Second, CAC screening by itself can be a motivator for lifestyle changes in people with diabetes. A randomized, controlled trial reported in 2011 found that patients who were told about their scores improved on several health measures, including blood pressure, cholesterol levels, and weight (J Am Coll Cardiol. 2011 Apr 12;57[15]:1622-32).
“They were [more] willing to take their medicines. They lost weight, and they were better at diet and exercise,” Dr. Budoff said. “Showing them a calcium score and what it means was a big motivation.”
The study also found major reductions in medication and procedure cost among patients who got the CAC results. About half of them had a CAC score of zero, he said, and that means “we’re not going to run them on a treadmill or put them on a statin.”
Dr. Budoff reported receiving grant funding from GE Healthcare.
REPORTING FROM AACE 2019
Cardiac PET/CT can guide CAD therapy
NEW ORLEANS – A PET/CT-derived myocardial ischemic burden in excess of 10% defines a subset of patients with symptomatic CAD who derive significantly greater benefit from an invasive management strategy than a noninvasive one, Kent G. Meredith, MD, reported at the annual meeting of the American College of Cardiology.
Conversely, patients with an ischemia burden of 10% or less have a lower major adverse event rate if they undergo noninvasive treatment.
“We see that cardiac PET/CT-derived ischemic burden provides a convenient and useful tool for predicting clinical outcomes of invasive and noninvasive treatment strategies,”said Dr. Meredith, a cardiologist at Intermountain Medical Center in Murray, Utah.
He presented a retrospective single-center study of 5,528 consecutive patients with symptomatic CAD referred for PET/CT at Intermountain. As a condition for study inclusion, they needed to survive for at least 90 days after imaging, have no elevation of troponin, and have no prior history of CAD.
This was a study of real-world clinical practice featuring standardized institutional protocols. Dr. Meredith explained that the 10% ischemic burden threshold used by cardiologists at Intermountain to help determine an individual’s optimal treatment strategy is based upon “a very important study” in which investigators at Cedars-Sinai Medical Center in Los Angeles showed 16 years ago, in nearly 11,000 consecutive patients, that revascularization had a survival benefit over medical therapy alone at an ischemic burden in excess of 10% as measured by stress myocardial perfusion single photon emission CT (Circulation. 2003 Jun 17;107[23]:2900-7).
Dr. Meredith and his coinvestigators carried out their study to make sure this ischemic burden cutoff is still valid today in view of the considerable changes in imaging technology and optimal medical therapy in the intervening years.
Among the study population, 203 patients had a PET/CT-derived ischemic burden greater than 10% using a well-established scoring system (J Nucl Cardiol. 2006 Nov;13[6]:e157-71), while 5,325 had a lesser ischemic burden. Fifty-six percent of patients with an ischemic burden above the 10% threshold underwent coronary revascularization, 26% had coronary angiography without revascularization, and 18% were managed by optimal medical therapy alone.
The group with an ischemic burden of 10% or less was managed very differently: One percent had revascularization, 3% had angiography without revascularization, and 96% were managed medically.
The higher a patient’s baseline ischemic burden, the higher the major adverse cardiovascular event (MACE) rate during 1-4 years of follow-up. The composite MACE rate, comprising death, hospitalization for acute MI, or late revascularization after 90 days, was 3.9% in patients with an ischemic burden of 10% of less, compared with 8.9% in those above the 10% threshold.
In a multivariate analysis adjusted for demographics, hyperlipidemia, heart failure, and diabetes, patients with an ischemic burden greater than 10% had a 4.6-fold greater risk of MACE if managed medically than if they underwent revascularization. And among those with an ischemic burden of 10% or less, the adjusted risk of MACE was increased 2.8-fold if they received revascularization instead of medical management.
Dr. Meredith reported having no financial conflicts regarding his study, conducted free of commercial sponsorship.
NEW ORLEANS – A PET/CT-derived myocardial ischemic burden in excess of 10% defines a subset of patients with symptomatic CAD who derive significantly greater benefit from an invasive management strategy than a noninvasive one, Kent G. Meredith, MD, reported at the annual meeting of the American College of Cardiology.
Conversely, patients with an ischemia burden of 10% or less have a lower major adverse event rate if they undergo noninvasive treatment.
“We see that cardiac PET/CT-derived ischemic burden provides a convenient and useful tool for predicting clinical outcomes of invasive and noninvasive treatment strategies,”said Dr. Meredith, a cardiologist at Intermountain Medical Center in Murray, Utah.
He presented a retrospective single-center study of 5,528 consecutive patients with symptomatic CAD referred for PET/CT at Intermountain. As a condition for study inclusion, they needed to survive for at least 90 days after imaging, have no elevation of troponin, and have no prior history of CAD.
This was a study of real-world clinical practice featuring standardized institutional protocols. Dr. Meredith explained that the 10% ischemic burden threshold used by cardiologists at Intermountain to help determine an individual’s optimal treatment strategy is based upon “a very important study” in which investigators at Cedars-Sinai Medical Center in Los Angeles showed 16 years ago, in nearly 11,000 consecutive patients, that revascularization had a survival benefit over medical therapy alone at an ischemic burden in excess of 10% as measured by stress myocardial perfusion single photon emission CT (Circulation. 2003 Jun 17;107[23]:2900-7).
Dr. Meredith and his coinvestigators carried out their study to make sure this ischemic burden cutoff is still valid today in view of the considerable changes in imaging technology and optimal medical therapy in the intervening years.
Among the study population, 203 patients had a PET/CT-derived ischemic burden greater than 10% using a well-established scoring system (J Nucl Cardiol. 2006 Nov;13[6]:e157-71), while 5,325 had a lesser ischemic burden. Fifty-six percent of patients with an ischemic burden above the 10% threshold underwent coronary revascularization, 26% had coronary angiography without revascularization, and 18% were managed by optimal medical therapy alone.
The group with an ischemic burden of 10% or less was managed very differently: One percent had revascularization, 3% had angiography without revascularization, and 96% were managed medically.
The higher a patient’s baseline ischemic burden, the higher the major adverse cardiovascular event (MACE) rate during 1-4 years of follow-up. The composite MACE rate, comprising death, hospitalization for acute MI, or late revascularization after 90 days, was 3.9% in patients with an ischemic burden of 10% of less, compared with 8.9% in those above the 10% threshold.
In a multivariate analysis adjusted for demographics, hyperlipidemia, heart failure, and diabetes, patients with an ischemic burden greater than 10% had a 4.6-fold greater risk of MACE if managed medically than if they underwent revascularization. And among those with an ischemic burden of 10% or less, the adjusted risk of MACE was increased 2.8-fold if they received revascularization instead of medical management.
Dr. Meredith reported having no financial conflicts regarding his study, conducted free of commercial sponsorship.
NEW ORLEANS – A PET/CT-derived myocardial ischemic burden in excess of 10% defines a subset of patients with symptomatic CAD who derive significantly greater benefit from an invasive management strategy than a noninvasive one, Kent G. Meredith, MD, reported at the annual meeting of the American College of Cardiology.
Conversely, patients with an ischemia burden of 10% or less have a lower major adverse event rate if they undergo noninvasive treatment.
“We see that cardiac PET/CT-derived ischemic burden provides a convenient and useful tool for predicting clinical outcomes of invasive and noninvasive treatment strategies,”said Dr. Meredith, a cardiologist at Intermountain Medical Center in Murray, Utah.
He presented a retrospective single-center study of 5,528 consecutive patients with symptomatic CAD referred for PET/CT at Intermountain. As a condition for study inclusion, they needed to survive for at least 90 days after imaging, have no elevation of troponin, and have no prior history of CAD.
This was a study of real-world clinical practice featuring standardized institutional protocols. Dr. Meredith explained that the 10% ischemic burden threshold used by cardiologists at Intermountain to help determine an individual’s optimal treatment strategy is based upon “a very important study” in which investigators at Cedars-Sinai Medical Center in Los Angeles showed 16 years ago, in nearly 11,000 consecutive patients, that revascularization had a survival benefit over medical therapy alone at an ischemic burden in excess of 10% as measured by stress myocardial perfusion single photon emission CT (Circulation. 2003 Jun 17;107[23]:2900-7).
Dr. Meredith and his coinvestigators carried out their study to make sure this ischemic burden cutoff is still valid today in view of the considerable changes in imaging technology and optimal medical therapy in the intervening years.
Among the study population, 203 patients had a PET/CT-derived ischemic burden greater than 10% using a well-established scoring system (J Nucl Cardiol. 2006 Nov;13[6]:e157-71), while 5,325 had a lesser ischemic burden. Fifty-six percent of patients with an ischemic burden above the 10% threshold underwent coronary revascularization, 26% had coronary angiography without revascularization, and 18% were managed by optimal medical therapy alone.
The group with an ischemic burden of 10% or less was managed very differently: One percent had revascularization, 3% had angiography without revascularization, and 96% were managed medically.
The higher a patient’s baseline ischemic burden, the higher the major adverse cardiovascular event (MACE) rate during 1-4 years of follow-up. The composite MACE rate, comprising death, hospitalization for acute MI, or late revascularization after 90 days, was 3.9% in patients with an ischemic burden of 10% of less, compared with 8.9% in those above the 10% threshold.
In a multivariate analysis adjusted for demographics, hyperlipidemia, heart failure, and diabetes, patients with an ischemic burden greater than 10% had a 4.6-fold greater risk of MACE if managed medically than if they underwent revascularization. And among those with an ischemic burden of 10% or less, the adjusted risk of MACE was increased 2.8-fold if they received revascularization instead of medical management.
Dr. Meredith reported having no financial conflicts regarding his study, conducted free of commercial sponsorship.
REPORTING FROM ACC 19
When to transition heart failure patient to alternative loop diuretic
PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.
“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.
When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.
The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.
he added.
The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.
“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.
Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.
The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”
The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.
“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”
If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.
“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.
If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.
Dr. McKie reported no relevant disclosures.
PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.
“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.
When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.
The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.
he added.
The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.
“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.
Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.
The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”
The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.
“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”
If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.
“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.
If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.
Dr. McKie reported no relevant disclosures.
PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.
“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.
When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.
The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.
he added.
The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.
“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.
Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.
The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”
The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.
“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”
If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.
“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.
If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.
Dr. McKie reported no relevant disclosures.
REPORTING FROM INTERNAL MEDICINE 2019
Plant-based diet lowers risk of heart failure
according to an analysis published online in the Journal of the American College of Cardiology.
Conversely, a Southern diet, defined as favoring fried and processed foods, is associated with an increased risk of heart failure. The results support a population-based dietary strategy for decreasing the risk of incident heart failure, according to the investigators.
Campaigns to prevent heart failure often emphasize the maintenance of a healthy diet and weight; however, little research has examined the relationship between dietary patterns and incident heart failure in patients without coronary heart disease.
Kyla M. Lara, MD, postgraduate fellow of cardiology and general internal medicine at the Icahn School of Medicine at Mount Sinai, New York, and colleagues sought to analyze the associations between five dietary patterns and incident hospitalizations for heart failure among adults in the United States. They examined data from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) trial, a prospective study of black and white adults who were followed from 2003-2007 to 2014. Eligible participants completed a food frequency questionnaire and had no coronary heart disease or heart failure at baseline.
The REGARDS researchers’ principal component analysis identified the following five dietary patterns: convenience (for example, Mexican and Chinese dishes and fast food), plant based (for example, vegetables, fruit, and fish), sweets (for example, desserts, breads, and candy), Southern (for example, fried food, processed meats, and sugary beverages), and alcohol/salads. Dr. Lara and colleagues chose incident heart failure hospitalization as their primary endpoint.
The investigators included 16,068 participants in their analysis. Mean age was 64 years, roughly 59% of the sample were women, and 34% were black.
After a median 8.7 years of follow-up, 363 participants had incident heart failure hospitalizations. The highest quartile of adherence to the plant-based dietary pattern was associated with a 41% lower risk of heart failure in multivariate models, compared with the lowest quartile. The highest adherence to the Southern dietary pattern was linked with a 72% higher risk of heart failure after adjustments for age, sex, race, and other potential confounders such as education, income, smoking, and physical activity.
After further adjustments for body mass index, waist circumference, hypertension, dyslipidemia, diabetes mellitus, atrial fibrillation, and chronic kidney disease, the association was attenuated and no longer statistically significant. Dr. Lara and colleagues found no statistically significant associations between incident heart failure with reduced or preserved ejection fraction hospitalizations and the dietary patterns. They also found no associations with the other three dietary patterns.
One researcher reported receiving research funding from Amgen and has consulted for Novartis. The other researchers reported no relevant conflicts.
SOURCE: Lara KM et al. J Am Coll Cardiol. 2019 Apr 30;73(16):2036-45.
This analysis of the REGARDS study contributes toward creating a strong evidence base for the prevention of heart failure through dietary measures, wrote Dong D. Wang, SCD, MD, a visiting scientist at Harvard School of Public Health, Boston, in an accompanying editorial. Empirically derived dietary patterns, such as those described in this study, can form the basis for recommendations easily, he added. “We usually have greater confidence when interpreting the associations with dietary patterns as causal than we have for the associations with specific nutrients or foods. Furthermore, the findings are particularly useful for making recommendations to a general population because of their use of a baseline coronary heart disease–free study population and the inclusion of black participants with greater susceptibility to heart failure. Thus, this study possesses a great potential of informing the population-level strategies for the prevention of heart failure.”
Nutritional epidemiologic studies examining subtypes of heart failure are valuable in light of the disease’s phenotypic and pathophysiological heterogeneity, Dr. Wang wrote. “These findings, if confirmed in future studies, will not only contribute to in-depth biological understanding and phenotypic refinement of heart failure, but also inform dietary prevention approaches customized for specific heart failure phenotypes. In addition, they perfectly fit into key missions of precision medicine [i.e., understanding large variability between individuals in both the development and the clinical manifestations of the specific disease, as well as variability in individual’s response to dietary, lifestyle, and pharmacological interventions].”
Dr. Wang reported no relationships relevant to the contents of this paper.
This analysis of the REGARDS study contributes toward creating a strong evidence base for the prevention of heart failure through dietary measures, wrote Dong D. Wang, SCD, MD, a visiting scientist at Harvard School of Public Health, Boston, in an accompanying editorial. Empirically derived dietary patterns, such as those described in this study, can form the basis for recommendations easily, he added. “We usually have greater confidence when interpreting the associations with dietary patterns as causal than we have for the associations with specific nutrients or foods. Furthermore, the findings are particularly useful for making recommendations to a general population because of their use of a baseline coronary heart disease–free study population and the inclusion of black participants with greater susceptibility to heart failure. Thus, this study possesses a great potential of informing the population-level strategies for the prevention of heart failure.”
Nutritional epidemiologic studies examining subtypes of heart failure are valuable in light of the disease’s phenotypic and pathophysiological heterogeneity, Dr. Wang wrote. “These findings, if confirmed in future studies, will not only contribute to in-depth biological understanding and phenotypic refinement of heart failure, but also inform dietary prevention approaches customized for specific heart failure phenotypes. In addition, they perfectly fit into key missions of precision medicine [i.e., understanding large variability between individuals in both the development and the clinical manifestations of the specific disease, as well as variability in individual’s response to dietary, lifestyle, and pharmacological interventions].”
Dr. Wang reported no relationships relevant to the contents of this paper.
This analysis of the REGARDS study contributes toward creating a strong evidence base for the prevention of heart failure through dietary measures, wrote Dong D. Wang, SCD, MD, a visiting scientist at Harvard School of Public Health, Boston, in an accompanying editorial. Empirically derived dietary patterns, such as those described in this study, can form the basis for recommendations easily, he added. “We usually have greater confidence when interpreting the associations with dietary patterns as causal than we have for the associations with specific nutrients or foods. Furthermore, the findings are particularly useful for making recommendations to a general population because of their use of a baseline coronary heart disease–free study population and the inclusion of black participants with greater susceptibility to heart failure. Thus, this study possesses a great potential of informing the population-level strategies for the prevention of heart failure.”
Nutritional epidemiologic studies examining subtypes of heart failure are valuable in light of the disease’s phenotypic and pathophysiological heterogeneity, Dr. Wang wrote. “These findings, if confirmed in future studies, will not only contribute to in-depth biological understanding and phenotypic refinement of heart failure, but also inform dietary prevention approaches customized for specific heart failure phenotypes. In addition, they perfectly fit into key missions of precision medicine [i.e., understanding large variability between individuals in both the development and the clinical manifestations of the specific disease, as well as variability in individual’s response to dietary, lifestyle, and pharmacological interventions].”
Dr. Wang reported no relationships relevant to the contents of this paper.
according to an analysis published online in the Journal of the American College of Cardiology.
Conversely, a Southern diet, defined as favoring fried and processed foods, is associated with an increased risk of heart failure. The results support a population-based dietary strategy for decreasing the risk of incident heart failure, according to the investigators.
Campaigns to prevent heart failure often emphasize the maintenance of a healthy diet and weight; however, little research has examined the relationship between dietary patterns and incident heart failure in patients without coronary heart disease.
Kyla M. Lara, MD, postgraduate fellow of cardiology and general internal medicine at the Icahn School of Medicine at Mount Sinai, New York, and colleagues sought to analyze the associations between five dietary patterns and incident hospitalizations for heart failure among adults in the United States. They examined data from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) trial, a prospective study of black and white adults who were followed from 2003-2007 to 2014. Eligible participants completed a food frequency questionnaire and had no coronary heart disease or heart failure at baseline.
The REGARDS researchers’ principal component analysis identified the following five dietary patterns: convenience (for example, Mexican and Chinese dishes and fast food), plant based (for example, vegetables, fruit, and fish), sweets (for example, desserts, breads, and candy), Southern (for example, fried food, processed meats, and sugary beverages), and alcohol/salads. Dr. Lara and colleagues chose incident heart failure hospitalization as their primary endpoint.
The investigators included 16,068 participants in their analysis. Mean age was 64 years, roughly 59% of the sample were women, and 34% were black.
After a median 8.7 years of follow-up, 363 participants had incident heart failure hospitalizations. The highest quartile of adherence to the plant-based dietary pattern was associated with a 41% lower risk of heart failure in multivariate models, compared with the lowest quartile. The highest adherence to the Southern dietary pattern was linked with a 72% higher risk of heart failure after adjustments for age, sex, race, and other potential confounders such as education, income, smoking, and physical activity.
After further adjustments for body mass index, waist circumference, hypertension, dyslipidemia, diabetes mellitus, atrial fibrillation, and chronic kidney disease, the association was attenuated and no longer statistically significant. Dr. Lara and colleagues found no statistically significant associations between incident heart failure with reduced or preserved ejection fraction hospitalizations and the dietary patterns. They also found no associations with the other three dietary patterns.
One researcher reported receiving research funding from Amgen and has consulted for Novartis. The other researchers reported no relevant conflicts.
SOURCE: Lara KM et al. J Am Coll Cardiol. 2019 Apr 30;73(16):2036-45.
according to an analysis published online in the Journal of the American College of Cardiology.
Conversely, a Southern diet, defined as favoring fried and processed foods, is associated with an increased risk of heart failure. The results support a population-based dietary strategy for decreasing the risk of incident heart failure, according to the investigators.
Campaigns to prevent heart failure often emphasize the maintenance of a healthy diet and weight; however, little research has examined the relationship between dietary patterns and incident heart failure in patients without coronary heart disease.
Kyla M. Lara, MD, postgraduate fellow of cardiology and general internal medicine at the Icahn School of Medicine at Mount Sinai, New York, and colleagues sought to analyze the associations between five dietary patterns and incident hospitalizations for heart failure among adults in the United States. They examined data from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) trial, a prospective study of black and white adults who were followed from 2003-2007 to 2014. Eligible participants completed a food frequency questionnaire and had no coronary heart disease or heart failure at baseline.
The REGARDS researchers’ principal component analysis identified the following five dietary patterns: convenience (for example, Mexican and Chinese dishes and fast food), plant based (for example, vegetables, fruit, and fish), sweets (for example, desserts, breads, and candy), Southern (for example, fried food, processed meats, and sugary beverages), and alcohol/salads. Dr. Lara and colleagues chose incident heart failure hospitalization as their primary endpoint.
The investigators included 16,068 participants in their analysis. Mean age was 64 years, roughly 59% of the sample were women, and 34% were black.
After a median 8.7 years of follow-up, 363 participants had incident heart failure hospitalizations. The highest quartile of adherence to the plant-based dietary pattern was associated with a 41% lower risk of heart failure in multivariate models, compared with the lowest quartile. The highest adherence to the Southern dietary pattern was linked with a 72% higher risk of heart failure after adjustments for age, sex, race, and other potential confounders such as education, income, smoking, and physical activity.
After further adjustments for body mass index, waist circumference, hypertension, dyslipidemia, diabetes mellitus, atrial fibrillation, and chronic kidney disease, the association was attenuated and no longer statistically significant. Dr. Lara and colleagues found no statistically significant associations between incident heart failure with reduced or preserved ejection fraction hospitalizations and the dietary patterns. They also found no associations with the other three dietary patterns.
One researcher reported receiving research funding from Amgen and has consulted for Novartis. The other researchers reported no relevant conflicts.
SOURCE: Lara KM et al. J Am Coll Cardiol. 2019 Apr 30;73(16):2036-45.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Plant-based and Southern diets influence the risk of heart failure.
Major finding: Adherence to a plant-based diet reduces the risk of heart failure by 41%.
Study details: An analysis of data for 16,068 participants in the REGARDS study.
Disclosures: One coauthor reported receiving research funding from Amgen and has consulted for Novartis.
Source: Lara KM et al. J Am Coll Cardiol. 2019 Apr 30;73(16):2036-45.
Ventricular Arrhythmia Due to MS Treatment
Fingolimod, a sphingosine-1-phosphate receptor modulator, has been used to treat > 55,000 patients in the US, according to the manufacturer (Gilenya/Novartis). It is believed to work by keeping lymphocytes from migrating into the CNS, sequestering them in the lymph nodes.
Although it has been found effective in randomized controlled trials, fingolimod is also known to have a wide range of adverse effects (AEs), including some that are serious and even life-threatening, such as bradycardia and atrioventricular block. The drug is contraindicated for patients who have had myocardial infarction, unstable angina, or heart failure, among other conditions. Ventricular tachycardia has been reported only once, but clinicians from Hurley Medical Center in Flint, Michigan, suggest that it may actually be an underrecognized cause of sudden death.
They describe the case of their patient, a 63-year-old woman with relapsing-remitting multiple sclerosis and hypertension who was about to start fingolomod. She underwent a basal ECG to be cleared before starting treatment. She received her first dose of fingolimod at the cardiology office, was monitored for 6 hours, and went home with a surface-mounted Holter monitor.
Two weeks later, she was in the emergency department because the monitor had captured ventricular tachycardia, and she was reporting palpitations.
Lab work was normal; the echocardiogram was normal. Cardiac monitoring showed no other evidence of cardiac arrhythmias. Her only other medication was amlodipine. The fingolimod was held back. She was observed for4 days then discharged in a stable condition. Her clinicians followed her for 2 months but the arrhythmia did not return.
Although this patient had no further arrhythmias, the authors warn that serious outcomes are possible. They urge health care practitioners to let patients know of this potential AE and advise them to report symptoms such as palpitations immediately.
Fingolimod, a sphingosine-1-phosphate receptor modulator, has been used to treat > 55,000 patients in the US, according to the manufacturer (Gilenya/Novartis). It is believed to work by keeping lymphocytes from migrating into the CNS, sequestering them in the lymph nodes.
Although it has been found effective in randomized controlled trials, fingolimod is also known to have a wide range of adverse effects (AEs), including some that are serious and even life-threatening, such as bradycardia and atrioventricular block. The drug is contraindicated for patients who have had myocardial infarction, unstable angina, or heart failure, among other conditions. Ventricular tachycardia has been reported only once, but clinicians from Hurley Medical Center in Flint, Michigan, suggest that it may actually be an underrecognized cause of sudden death.
They describe the case of their patient, a 63-year-old woman with relapsing-remitting multiple sclerosis and hypertension who was about to start fingolomod. She underwent a basal ECG to be cleared before starting treatment. She received her first dose of fingolimod at the cardiology office, was monitored for 6 hours, and went home with a surface-mounted Holter monitor.
Two weeks later, she was in the emergency department because the monitor had captured ventricular tachycardia, and she was reporting palpitations.
Lab work was normal; the echocardiogram was normal. Cardiac monitoring showed no other evidence of cardiac arrhythmias. Her only other medication was amlodipine. The fingolimod was held back. She was observed for4 days then discharged in a stable condition. Her clinicians followed her for 2 months but the arrhythmia did not return.
Although this patient had no further arrhythmias, the authors warn that serious outcomes are possible. They urge health care practitioners to let patients know of this potential AE and advise them to report symptoms such as palpitations immediately.
Fingolimod, a sphingosine-1-phosphate receptor modulator, has been used to treat > 55,000 patients in the US, according to the manufacturer (Gilenya/Novartis). It is believed to work by keeping lymphocytes from migrating into the CNS, sequestering them in the lymph nodes.
Although it has been found effective in randomized controlled trials, fingolimod is also known to have a wide range of adverse effects (AEs), including some that are serious and even life-threatening, such as bradycardia and atrioventricular block. The drug is contraindicated for patients who have had myocardial infarction, unstable angina, or heart failure, among other conditions. Ventricular tachycardia has been reported only once, but clinicians from Hurley Medical Center in Flint, Michigan, suggest that it may actually be an underrecognized cause of sudden death.
They describe the case of their patient, a 63-year-old woman with relapsing-remitting multiple sclerosis and hypertension who was about to start fingolomod. She underwent a basal ECG to be cleared before starting treatment. She received her first dose of fingolimod at the cardiology office, was monitored for 6 hours, and went home with a surface-mounted Holter monitor.
Two weeks later, she was in the emergency department because the monitor had captured ventricular tachycardia, and she was reporting palpitations.
Lab work was normal; the echocardiogram was normal. Cardiac monitoring showed no other evidence of cardiac arrhythmias. Her only other medication was amlodipine. The fingolimod was held back. She was observed for4 days then discharged in a stable condition. Her clinicians followed her for 2 months but the arrhythmia did not return.
Although this patient had no further arrhythmias, the authors warn that serious outcomes are possible. They urge health care practitioners to let patients know of this potential AE and advise them to report symptoms such as palpitations immediately.
Dr. Douglas Paauw gives updates on antihypertensives, statins, SGLT2 inhibitors
PHILADELPHIA – in a video interview at the annual meeting of the American College of Physicians.
Dr. Paauw, professor of medicine at the University of Washington, Seattle, began by discussing some of the issues that occurred with antihypertensive drugs in the past year. These included the link between hydrochlorothiazide use and the increased risk of nonmelanoma skin cancers, the recalls of many drug lots of angiotensin II receptor blockers, and a study that found an increased risk of lung cancer in people who were taking ACE inhibitors.
He then described the findings of studies that examined the links between statins and muscle pain and other new research on these drugs.
He also warned physicians to be particularity cautious about prescribing sodium-glucose cotransporter 2 inhibitors to certain kinds of patients.
Dr. Paauw concluded by explaining why clarithromycin is his most hated drug.
Dr. Paauw is also the Rathmann Family Foundation Endowed Chair for Patient-Centered Clinical Education and the medicine clerkship director at the University of Washington.
klennon@mdedge.com
PHILADELPHIA – in a video interview at the annual meeting of the American College of Physicians.
Dr. Paauw, professor of medicine at the University of Washington, Seattle, began by discussing some of the issues that occurred with antihypertensive drugs in the past year. These included the link between hydrochlorothiazide use and the increased risk of nonmelanoma skin cancers, the recalls of many drug lots of angiotensin II receptor blockers, and a study that found an increased risk of lung cancer in people who were taking ACE inhibitors.
He then described the findings of studies that examined the links between statins and muscle pain and other new research on these drugs.
He also warned physicians to be particularity cautious about prescribing sodium-glucose cotransporter 2 inhibitors to certain kinds of patients.
Dr. Paauw concluded by explaining why clarithromycin is his most hated drug.
Dr. Paauw is also the Rathmann Family Foundation Endowed Chair for Patient-Centered Clinical Education and the medicine clerkship director at the University of Washington.
klennon@mdedge.com
PHILADELPHIA – in a video interview at the annual meeting of the American College of Physicians.
Dr. Paauw, professor of medicine at the University of Washington, Seattle, began by discussing some of the issues that occurred with antihypertensive drugs in the past year. These included the link between hydrochlorothiazide use and the increased risk of nonmelanoma skin cancers, the recalls of many drug lots of angiotensin II receptor blockers, and a study that found an increased risk of lung cancer in people who were taking ACE inhibitors.
He then described the findings of studies that examined the links between statins and muscle pain and other new research on these drugs.
He also warned physicians to be particularity cautious about prescribing sodium-glucose cotransporter 2 inhibitors to certain kinds of patients.
Dr. Paauw concluded by explaining why clarithromycin is his most hated drug.
Dr. Paauw is also the Rathmann Family Foundation Endowed Chair for Patient-Centered Clinical Education and the medicine clerkship director at the University of Washington.
klennon@mdedge.com
REPORTING FROM INTERNAL MEDICINE 2019
Dr. Joseph Vassalotti: Cancer risk minimal with ARBs
PHILADELPHIA – according to a senior officer of the National Kidney Foundation.
“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.
“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.
Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.
Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.
He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.
“There may be variable effects,” he said.
If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.
Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.
Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.
“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.
The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.
As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.
“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”
Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.
PHILADELPHIA – according to a senior officer of the National Kidney Foundation.
“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.
“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.
Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.
Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.
He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.
“There may be variable effects,” he said.
If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.
Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.
Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.
“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.
The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.
As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.
“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”
Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.
PHILADELPHIA – according to a senior officer of the National Kidney Foundation.
“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.
“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.
Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.
Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.
He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.
“There may be variable effects,” he said.
If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.
Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.
Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.
“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.
The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.
As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.
“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”
Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.
FROM INTERNAL MEDICINE 2019