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PCOS incidence is on the rise, but it remains underdiagnosed and undermanaged
SAN DIEGO – The incidence of polycystic ovary syndrome (PCOS) is on the rise, and a nurse practitioner urged her colleagues to give it full attention because of the danger it poses to patients.
“Underdiagnosed and undermanaged, it’s complex and a more serious condition than ever before because of the complications that can occur,” said R. Mimi Secor, DNP, FNP-BC, FAANP, FAAN, who spoke at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
PCOS is the most common reproductive endocrine disorder in the United States, affecting more than 5 million women, or an estimated 6%-10% of the population. Obesity is a risk factor, although lean women account for 10% of cases for reasons that are not understood, according to Dr. Secor, a senior lecturer at Advanced Practice Education Associates in Onset, Mass. In addition, the condition is linked to many sequelae, including multiple sclerosis, diabetes, cardiovascular disease, infertility, mental health problems, and cancer, she said.
Dr. Secor offered these pearls about PCOS:
- Understand the predictive value of oligomenorrhea (infrequent menstrual periods) as a sign of PCOS. “If you’re working in a low-income clinic, you can do well to make a diagnosis without a lot of expensive tests,” she said.
- Urge women with PCOS to get pregnant early if they want to have children. “Infertility is a big problem [among these women],” she said. “They shouldn’t wait until they’re 35 to have babies. They should have them in their 20s.”
- Use insulin control as a tool. “Insulin stimulates ovarian production of testosterone. If we can manage patients around insulin, that can be very helpful.” Losing just 5% of body weight can make a difference in insulin control, Dr. Secor said. “Go for a small change, and help [the patient] maintain that.”
- Monitor patients carefully for cancer. Women who don’t ovulate regularly on a monthly basis face a higher risk of uterine cancer, compared with women who ovulate monthly, she said, and tumors can develop with few symptoms. “If [there is] one drop of bleeding more than a year after menopause,” you need to get a mandatory workup to make sure the patient doesn’t have uterine cancer. Biopsy remains the “gold standard” as a diagnostic tool, she reminded attendees.
- Watch for mental health conditions, especially anxiety, in patients with PCOS. “They seem to be wired for anxiety, and they need a lot of emotional support,” Dr. Secor said.
- Hormonal contraceptives can be safe and effective as a treatment for PCOS in women who don’t wish to become pregnant, she said. But be aware that combination contraceptive drugs can affect women emotionally.
Global Academy and this news organization are owned by the same parent company. Dr. Secor disclosed speaker relationships with Duchesnay and Osphena.
SAN DIEGO – The incidence of polycystic ovary syndrome (PCOS) is on the rise, and a nurse practitioner urged her colleagues to give it full attention because of the danger it poses to patients.
“Underdiagnosed and undermanaged, it’s complex and a more serious condition than ever before because of the complications that can occur,” said R. Mimi Secor, DNP, FNP-BC, FAANP, FAAN, who spoke at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
PCOS is the most common reproductive endocrine disorder in the United States, affecting more than 5 million women, or an estimated 6%-10% of the population. Obesity is a risk factor, although lean women account for 10% of cases for reasons that are not understood, according to Dr. Secor, a senior lecturer at Advanced Practice Education Associates in Onset, Mass. In addition, the condition is linked to many sequelae, including multiple sclerosis, diabetes, cardiovascular disease, infertility, mental health problems, and cancer, she said.
Dr. Secor offered these pearls about PCOS:
- Understand the predictive value of oligomenorrhea (infrequent menstrual periods) as a sign of PCOS. “If you’re working in a low-income clinic, you can do well to make a diagnosis without a lot of expensive tests,” she said.
- Urge women with PCOS to get pregnant early if they want to have children. “Infertility is a big problem [among these women],” she said. “They shouldn’t wait until they’re 35 to have babies. They should have them in their 20s.”
- Use insulin control as a tool. “Insulin stimulates ovarian production of testosterone. If we can manage patients around insulin, that can be very helpful.” Losing just 5% of body weight can make a difference in insulin control, Dr. Secor said. “Go for a small change, and help [the patient] maintain that.”
- Monitor patients carefully for cancer. Women who don’t ovulate regularly on a monthly basis face a higher risk of uterine cancer, compared with women who ovulate monthly, she said, and tumors can develop with few symptoms. “If [there is] one drop of bleeding more than a year after menopause,” you need to get a mandatory workup to make sure the patient doesn’t have uterine cancer. Biopsy remains the “gold standard” as a diagnostic tool, she reminded attendees.
- Watch for mental health conditions, especially anxiety, in patients with PCOS. “They seem to be wired for anxiety, and they need a lot of emotional support,” Dr. Secor said.
- Hormonal contraceptives can be safe and effective as a treatment for PCOS in women who don’t wish to become pregnant, she said. But be aware that combination contraceptive drugs can affect women emotionally.
Global Academy and this news organization are owned by the same parent company. Dr. Secor disclosed speaker relationships with Duchesnay and Osphena.
SAN DIEGO – The incidence of polycystic ovary syndrome (PCOS) is on the rise, and a nurse practitioner urged her colleagues to give it full attention because of the danger it poses to patients.
“Underdiagnosed and undermanaged, it’s complex and a more serious condition than ever before because of the complications that can occur,” said R. Mimi Secor, DNP, FNP-BC, FAANP, FAAN, who spoke at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
PCOS is the most common reproductive endocrine disorder in the United States, affecting more than 5 million women, or an estimated 6%-10% of the population. Obesity is a risk factor, although lean women account for 10% of cases for reasons that are not understood, according to Dr. Secor, a senior lecturer at Advanced Practice Education Associates in Onset, Mass. In addition, the condition is linked to many sequelae, including multiple sclerosis, diabetes, cardiovascular disease, infertility, mental health problems, and cancer, she said.
Dr. Secor offered these pearls about PCOS:
- Understand the predictive value of oligomenorrhea (infrequent menstrual periods) as a sign of PCOS. “If you’re working in a low-income clinic, you can do well to make a diagnosis without a lot of expensive tests,” she said.
- Urge women with PCOS to get pregnant early if they want to have children. “Infertility is a big problem [among these women],” she said. “They shouldn’t wait until they’re 35 to have babies. They should have them in their 20s.”
- Use insulin control as a tool. “Insulin stimulates ovarian production of testosterone. If we can manage patients around insulin, that can be very helpful.” Losing just 5% of body weight can make a difference in insulin control, Dr. Secor said. “Go for a small change, and help [the patient] maintain that.”
- Monitor patients carefully for cancer. Women who don’t ovulate regularly on a monthly basis face a higher risk of uterine cancer, compared with women who ovulate monthly, she said, and tumors can develop with few symptoms. “If [there is] one drop of bleeding more than a year after menopause,” you need to get a mandatory workup to make sure the patient doesn’t have uterine cancer. Biopsy remains the “gold standard” as a diagnostic tool, she reminded attendees.
- Watch for mental health conditions, especially anxiety, in patients with PCOS. “They seem to be wired for anxiety, and they need a lot of emotional support,” Dr. Secor said.
- Hormonal contraceptives can be safe and effective as a treatment for PCOS in women who don’t wish to become pregnant, she said. But be aware that combination contraceptive drugs can affect women emotionally.
Global Academy and this news organization are owned by the same parent company. Dr. Secor disclosed speaker relationships with Duchesnay and Osphena.
REPORTING FROM MEDS 2019
Perils of ‘type’-casting: When adult-onset diabetes isn’t what you think it is
SAN DIEGO – We all know about type 1 and type 2 diabetes. But when an adult patient comes in with symptoms suggestive of diabetes, it is never a good idea to assume it’s either one or the other. In fact, said physician assistant Ji Hyun “CJ” Chun, PA-C, MPAS, BC-ADM, there are plenty of other possibilities from cancer, to monogenetic diabetes, to a condition informally known as type 1.5.
“In most cases, it will be type 1 or type 2, but don’t default everything,” Mr. Chun said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
He offered the following advice on the diagnosis of adult-onset diabetes:
- Don’t forget the 5% ... and the other 5%. In adults, an estimated 90% of cases of diabetes are type 2, but 5% are type 1 and another 5% are secondary to other conditions, said Mr. Chun, who is based at OptumCare Medical Group, Laguna Niguel, Calif., and has served as president of the American Society of Endocrine PAs. In the past, age seemed to be an important tool for diagnosis, because younger patients typically had type 1 diabetes and older patients typically had type 2, he said. But age alone is no longer useful for diagnosis. Cases of type 2 diabetes are much more common in children these days because of the prevalence of obesity in that population, and an estimated 60% of cases of type 1 disease are diagnosed after the age of 20. In fact, patients may develop type 1 into their 30s, 40s, or 50s, he said, depending on the severity of their autoimmunity.
- Keep ‘type 1.5’ in mind. Latent autoimmune diabetes in adults (LADA), also known as type 1.5, is a slowly developing subtype of type 1 diabetes, Mr. Chun said. There is reason to suspect LADA in lean patients, those younger than 50, and those with personal or family histories of autoimmunity, Mr. Chun said.
- Consider monogenetic diabetes. Many conditions can cause secondary diabetes, among them, monogenetic diabetes, which is caused by a single genetic mutation, whereas type 1 and type 2 diabetes are caused by multiple mutations. Monogenetic diabetes causes an estimated 1%-2% of diabetes cases, said Mr. Chun. Research findings have suggested that it is most likely to be misdiagnosed in younger adults, and that patients may go many years without receiving a correct diagnosis. Maturity-onset diabetes of the young (MODY) is a kind of monogenetic diabetes and typically occurs before the age of 25. There are many subtypes, of which one – MODY 2 – requires no treatment at all. In those patients, said Mr. Chun, “you do nothing. You leave them alone.” It is important to keep in mind that the genetic testing for MODY is expensive, Mr Chun cautioned. Some labs charge between $5,000 and $7,000 for panels, so “look for labs that perform cheaper tests,” he advised, adding that he has found a lab that charges just $250.
- Watch out for cancer. There is a long list of other possible causes of secondary diabetes, including Cushing’s syndrome, hyperthyroidism, hemochromatosis (iron overload), and pancreatic cancer. Mr. Chun said he has lost three patients to pancreatic cancer, while two other patients did well. “Keep in mind that these cases aren’t that common, but they’re there.” He suggested that pancreatic cancer should be considered in patients with rapid onset or worsening of diabetes without known cause, abnormal weight loss, abnormal liver/biliary studies, and jaundice.
Global Academy and this news organization are owned by the same parent company. Mr. Chun disclosed that he is on the AstraZeneca speakers bureau and the Sanofi advisory board.
SAN DIEGO – We all know about type 1 and type 2 diabetes. But when an adult patient comes in with symptoms suggestive of diabetes, it is never a good idea to assume it’s either one or the other. In fact, said physician assistant Ji Hyun “CJ” Chun, PA-C, MPAS, BC-ADM, there are plenty of other possibilities from cancer, to monogenetic diabetes, to a condition informally known as type 1.5.
“In most cases, it will be type 1 or type 2, but don’t default everything,” Mr. Chun said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
He offered the following advice on the diagnosis of adult-onset diabetes:
- Don’t forget the 5% ... and the other 5%. In adults, an estimated 90% of cases of diabetes are type 2, but 5% are type 1 and another 5% are secondary to other conditions, said Mr. Chun, who is based at OptumCare Medical Group, Laguna Niguel, Calif., and has served as president of the American Society of Endocrine PAs. In the past, age seemed to be an important tool for diagnosis, because younger patients typically had type 1 diabetes and older patients typically had type 2, he said. But age alone is no longer useful for diagnosis. Cases of type 2 diabetes are much more common in children these days because of the prevalence of obesity in that population, and an estimated 60% of cases of type 1 disease are diagnosed after the age of 20. In fact, patients may develop type 1 into their 30s, 40s, or 50s, he said, depending on the severity of their autoimmunity.
- Keep ‘type 1.5’ in mind. Latent autoimmune diabetes in adults (LADA), also known as type 1.5, is a slowly developing subtype of type 1 diabetes, Mr. Chun said. There is reason to suspect LADA in lean patients, those younger than 50, and those with personal or family histories of autoimmunity, Mr. Chun said.
- Consider monogenetic diabetes. Many conditions can cause secondary diabetes, among them, monogenetic diabetes, which is caused by a single genetic mutation, whereas type 1 and type 2 diabetes are caused by multiple mutations. Monogenetic diabetes causes an estimated 1%-2% of diabetes cases, said Mr. Chun. Research findings have suggested that it is most likely to be misdiagnosed in younger adults, and that patients may go many years without receiving a correct diagnosis. Maturity-onset diabetes of the young (MODY) is a kind of monogenetic diabetes and typically occurs before the age of 25. There are many subtypes, of which one – MODY 2 – requires no treatment at all. In those patients, said Mr. Chun, “you do nothing. You leave them alone.” It is important to keep in mind that the genetic testing for MODY is expensive, Mr Chun cautioned. Some labs charge between $5,000 and $7,000 for panels, so “look for labs that perform cheaper tests,” he advised, adding that he has found a lab that charges just $250.
- Watch out for cancer. There is a long list of other possible causes of secondary diabetes, including Cushing’s syndrome, hyperthyroidism, hemochromatosis (iron overload), and pancreatic cancer. Mr. Chun said he has lost three patients to pancreatic cancer, while two other patients did well. “Keep in mind that these cases aren’t that common, but they’re there.” He suggested that pancreatic cancer should be considered in patients with rapid onset or worsening of diabetes without known cause, abnormal weight loss, abnormal liver/biliary studies, and jaundice.
Global Academy and this news organization are owned by the same parent company. Mr. Chun disclosed that he is on the AstraZeneca speakers bureau and the Sanofi advisory board.
SAN DIEGO – We all know about type 1 and type 2 diabetes. But when an adult patient comes in with symptoms suggestive of diabetes, it is never a good idea to assume it’s either one or the other. In fact, said physician assistant Ji Hyun “CJ” Chun, PA-C, MPAS, BC-ADM, there are plenty of other possibilities from cancer, to monogenetic diabetes, to a condition informally known as type 1.5.
“In most cases, it will be type 1 or type 2, but don’t default everything,” Mr. Chun said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
He offered the following advice on the diagnosis of adult-onset diabetes:
- Don’t forget the 5% ... and the other 5%. In adults, an estimated 90% of cases of diabetes are type 2, but 5% are type 1 and another 5% are secondary to other conditions, said Mr. Chun, who is based at OptumCare Medical Group, Laguna Niguel, Calif., and has served as president of the American Society of Endocrine PAs. In the past, age seemed to be an important tool for diagnosis, because younger patients typically had type 1 diabetes and older patients typically had type 2, he said. But age alone is no longer useful for diagnosis. Cases of type 2 diabetes are much more common in children these days because of the prevalence of obesity in that population, and an estimated 60% of cases of type 1 disease are diagnosed after the age of 20. In fact, patients may develop type 1 into their 30s, 40s, or 50s, he said, depending on the severity of their autoimmunity.
- Keep ‘type 1.5’ in mind. Latent autoimmune diabetes in adults (LADA), also known as type 1.5, is a slowly developing subtype of type 1 diabetes, Mr. Chun said. There is reason to suspect LADA in lean patients, those younger than 50, and those with personal or family histories of autoimmunity, Mr. Chun said.
- Consider monogenetic diabetes. Many conditions can cause secondary diabetes, among them, monogenetic diabetes, which is caused by a single genetic mutation, whereas type 1 and type 2 diabetes are caused by multiple mutations. Monogenetic diabetes causes an estimated 1%-2% of diabetes cases, said Mr. Chun. Research findings have suggested that it is most likely to be misdiagnosed in younger adults, and that patients may go many years without receiving a correct diagnosis. Maturity-onset diabetes of the young (MODY) is a kind of monogenetic diabetes and typically occurs before the age of 25. There are many subtypes, of which one – MODY 2 – requires no treatment at all. In those patients, said Mr. Chun, “you do nothing. You leave them alone.” It is important to keep in mind that the genetic testing for MODY is expensive, Mr Chun cautioned. Some labs charge between $5,000 and $7,000 for panels, so “look for labs that perform cheaper tests,” he advised, adding that he has found a lab that charges just $250.
- Watch out for cancer. There is a long list of other possible causes of secondary diabetes, including Cushing’s syndrome, hyperthyroidism, hemochromatosis (iron overload), and pancreatic cancer. Mr. Chun said he has lost three patients to pancreatic cancer, while two other patients did well. “Keep in mind that these cases aren’t that common, but they’re there.” He suggested that pancreatic cancer should be considered in patients with rapid onset or worsening of diabetes without known cause, abnormal weight loss, abnormal liver/biliary studies, and jaundice.
Global Academy and this news organization are owned by the same parent company. Mr. Chun disclosed that he is on the AstraZeneca speakers bureau and the Sanofi advisory board.
REPORTING FROM MEDS 2019
Go easy on the testosterone when treating hypogonadism
SAN DIEGO – A physician assistant urged colleagues to cast a skeptical eye on male patients who try to jump on board the testosterone therapy train.
“I see many patients getting onto testosterone without having had an adequate evaluation. And I see many patients who might not need testosterone replacement,” Ji Hyun “CJ” Chun, PA-C, MPAS, BC-ADM, said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
Mr. Chun, who is based at OptumCare Medical Group, Laguna Niguel, Calif., and has served as president of the American Society of Endocrine PAs, offered this advice on evaluating male patients for testosterone therapy:
- Pinpoint the type of hypogonadism. After hypogonadism has been confirmed with lab tests, additional testing should be done to distinguish primary from secondary hypogonadism. Primary hypogonadism refers to the failure of the testes to properly produce testosterone and sperm and is indicated by elevated levels of LH and FSH. Secondary hypogonadism is caused by failures of the hypothalamus, the pituitary, or both, to stimulate the testes to produce testosterone and sperm. It is indicated by low or low-normal levels of LH and FSH.
- Determine the cause of hypogonadism. Cases of hypogonadism are either organic or functional. Diagnostic guidelines provided by the Endocrine Society are helpful in determining the proper category, Mr. Chun said (J Clin Endocrinol Metab. 2018;103[5]:1715-44). Functional hypogonadism is caused by some medications; opioids; abuse of steroids, alcohol, or marijuana; and obesity, which also greatly increases the risk of secondary hypogonadism. These factors – and functional hypogonadism itself – can conceivably be stopped and/or reversed. This form of hypogonadism tends to be mild, compared with organic or “classic” hypogonadism, which is permanent and caused by factors such as advanced age, some types of chemotherapy, and testicle removal. “Organic male hypogonadism mimics female menopause,” Mr. Chun said, in areas such as rate of hormonal decline, which is typically rapid, and hormone deficiency, which is profound. When it comes to treatment, “the benefits far outweigh the risks in organic hypogonadism. But if [a patient has] late-onset [functional] hypogonadism, it gets more complicated.”
- Late-onset hypogonadism treatment. What should be done for patients who have late-onset, organic hypogonadism? According to Mr. Chun, the data regarding testosterone therapy in this population are mixed. The Food and Drug Administration has approved testosterone therapy only for men with organic hypogonadism, he said, noting that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.” However, the Endocrine Society guidelines are less restrictive. In its 2018 guidelines, the society frowned on testosterone therapy for men younger than 65 years with age-related hypogonadism. As for older men, it said that for those “who have symptoms or conditions suggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistently and unequivocally low morning testosterone concentrations, we suggest that clinicians offer testosterone therapy on an individualized basis after explicit discussion of the potential risks and benefits.”
- Don’t push for high testosterone levels. When treating patients, “you want to restore the testosterone to an adequate level,” Mr. Chun said. “What’s an adequate level? We don’t know.” He urged colleagues to not overdo it and to consider aiming for a testosterone level ranging between 350 ng/dL and 700 ng/dL. “I get [the levels] to the lowest level at which the patient is symptomatically fine.”
Global Academy and this news organization are owned by the same parent company. Mr. Chun disclosed that he is on the AstraZeneca speakers bureau and the Sanofi advisory board.
SAN DIEGO – A physician assistant urged colleagues to cast a skeptical eye on male patients who try to jump on board the testosterone therapy train.
“I see many patients getting onto testosterone without having had an adequate evaluation. And I see many patients who might not need testosterone replacement,” Ji Hyun “CJ” Chun, PA-C, MPAS, BC-ADM, said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
Mr. Chun, who is based at OptumCare Medical Group, Laguna Niguel, Calif., and has served as president of the American Society of Endocrine PAs, offered this advice on evaluating male patients for testosterone therapy:
- Pinpoint the type of hypogonadism. After hypogonadism has been confirmed with lab tests, additional testing should be done to distinguish primary from secondary hypogonadism. Primary hypogonadism refers to the failure of the testes to properly produce testosterone and sperm and is indicated by elevated levels of LH and FSH. Secondary hypogonadism is caused by failures of the hypothalamus, the pituitary, or both, to stimulate the testes to produce testosterone and sperm. It is indicated by low or low-normal levels of LH and FSH.
- Determine the cause of hypogonadism. Cases of hypogonadism are either organic or functional. Diagnostic guidelines provided by the Endocrine Society are helpful in determining the proper category, Mr. Chun said (J Clin Endocrinol Metab. 2018;103[5]:1715-44). Functional hypogonadism is caused by some medications; opioids; abuse of steroids, alcohol, or marijuana; and obesity, which also greatly increases the risk of secondary hypogonadism. These factors – and functional hypogonadism itself – can conceivably be stopped and/or reversed. This form of hypogonadism tends to be mild, compared with organic or “classic” hypogonadism, which is permanent and caused by factors such as advanced age, some types of chemotherapy, and testicle removal. “Organic male hypogonadism mimics female menopause,” Mr. Chun said, in areas such as rate of hormonal decline, which is typically rapid, and hormone deficiency, which is profound. When it comes to treatment, “the benefits far outweigh the risks in organic hypogonadism. But if [a patient has] late-onset [functional] hypogonadism, it gets more complicated.”
- Late-onset hypogonadism treatment. What should be done for patients who have late-onset, organic hypogonadism? According to Mr. Chun, the data regarding testosterone therapy in this population are mixed. The Food and Drug Administration has approved testosterone therapy only for men with organic hypogonadism, he said, noting that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.” However, the Endocrine Society guidelines are less restrictive. In its 2018 guidelines, the society frowned on testosterone therapy for men younger than 65 years with age-related hypogonadism. As for older men, it said that for those “who have symptoms or conditions suggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistently and unequivocally low morning testosterone concentrations, we suggest that clinicians offer testosterone therapy on an individualized basis after explicit discussion of the potential risks and benefits.”
- Don’t push for high testosterone levels. When treating patients, “you want to restore the testosterone to an adequate level,” Mr. Chun said. “What’s an adequate level? We don’t know.” He urged colleagues to not overdo it and to consider aiming for a testosterone level ranging between 350 ng/dL and 700 ng/dL. “I get [the levels] to the lowest level at which the patient is symptomatically fine.”
Global Academy and this news organization are owned by the same parent company. Mr. Chun disclosed that he is on the AstraZeneca speakers bureau and the Sanofi advisory board.
SAN DIEGO – A physician assistant urged colleagues to cast a skeptical eye on male patients who try to jump on board the testosterone therapy train.
“I see many patients getting onto testosterone without having had an adequate evaluation. And I see many patients who might not need testosterone replacement,” Ji Hyun “CJ” Chun, PA-C, MPAS, BC-ADM, said at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.
Mr. Chun, who is based at OptumCare Medical Group, Laguna Niguel, Calif., and has served as president of the American Society of Endocrine PAs, offered this advice on evaluating male patients for testosterone therapy:
- Pinpoint the type of hypogonadism. After hypogonadism has been confirmed with lab tests, additional testing should be done to distinguish primary from secondary hypogonadism. Primary hypogonadism refers to the failure of the testes to properly produce testosterone and sperm and is indicated by elevated levels of LH and FSH. Secondary hypogonadism is caused by failures of the hypothalamus, the pituitary, or both, to stimulate the testes to produce testosterone and sperm. It is indicated by low or low-normal levels of LH and FSH.
- Determine the cause of hypogonadism. Cases of hypogonadism are either organic or functional. Diagnostic guidelines provided by the Endocrine Society are helpful in determining the proper category, Mr. Chun said (J Clin Endocrinol Metab. 2018;103[5]:1715-44). Functional hypogonadism is caused by some medications; opioids; abuse of steroids, alcohol, or marijuana; and obesity, which also greatly increases the risk of secondary hypogonadism. These factors – and functional hypogonadism itself – can conceivably be stopped and/or reversed. This form of hypogonadism tends to be mild, compared with organic or “classic” hypogonadism, which is permanent and caused by factors such as advanced age, some types of chemotherapy, and testicle removal. “Organic male hypogonadism mimics female menopause,” Mr. Chun said, in areas such as rate of hormonal decline, which is typically rapid, and hormone deficiency, which is profound. When it comes to treatment, “the benefits far outweigh the risks in organic hypogonadism. But if [a patient has] late-onset [functional] hypogonadism, it gets more complicated.”
- Late-onset hypogonadism treatment. What should be done for patients who have late-onset, organic hypogonadism? According to Mr. Chun, the data regarding testosterone therapy in this population are mixed. The Food and Drug Administration has approved testosterone therapy only for men with organic hypogonadism, he said, noting that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.” However, the Endocrine Society guidelines are less restrictive. In its 2018 guidelines, the society frowned on testosterone therapy for men younger than 65 years with age-related hypogonadism. As for older men, it said that for those “who have symptoms or conditions suggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistently and unequivocally low morning testosterone concentrations, we suggest that clinicians offer testosterone therapy on an individualized basis after explicit discussion of the potential risks and benefits.”
- Don’t push for high testosterone levels. When treating patients, “you want to restore the testosterone to an adequate level,” Mr. Chun said. “What’s an adequate level? We don’t know.” He urged colleagues to not overdo it and to consider aiming for a testosterone level ranging between 350 ng/dL and 700 ng/dL. “I get [the levels] to the lowest level at which the patient is symptomatically fine.”
Global Academy and this news organization are owned by the same parent company. Mr. Chun disclosed that he is on the AstraZeneca speakers bureau and the Sanofi advisory board.
REPORTING FROM MEDS 2019
NAFLD unchecked is a ‘harbinger of deadly dysmetabolism’
SAN DIEGO – When it comes to metabolic and endocrine health, nonalcoholic fatty liver disease (NAFLD) is the furthest thing from a nonissue – it’s “a harbinger of deadly dysmetabolism,” said Christine Kessler, MN, ANP-BC, CNS, BC-ADM, FAANP, a nurse practitioner and founder of Metabolic Medicine Associates, King George, Va.
“I chase it, I follow it, I worry about it. Never look at it again as a benign thing,” Ms. Kessler said in a presentation at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education. “It’s the most common chronic liver disease in the United States – move over, hep C ... and it’ll be the number one cause of liver transplant within 20 years.”
But the news isn’t all grim: NAFLD can be reversible, because the liver is one organ that can “take a licking and keep on ticking,” she said.
An estimated 30%-40% of adults in the United States have NAFLD, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The most severe form of the disease, nonalcoholic steatohepatitis (NASH), causes liver cell damage and affects an estimated 3%-12% of adults.
Why worry about NAFLD? Because it can boost cardiovascular risk (especially in conjunction with metabolic syndrome) and the risk for liver cancer, said Ms. Kessler.
Among the risk factors for NAFLD are obesity, type 2 diabetes, metabolic syndrome, polycystic ovary syndrome, and many others, including medications such as methotrexate, corticosteroids, and tetracyclines. Men, and Latino and Asian individuals are especially vulnerable, whereas black individuals may have protection against it.
Researchers are exploring the possibility that NAFLD is a “multihit” condition that is linked to multiple causes, possibly including overgrowth of bacteria in the gut, Ms. Kessler noted. It is not clear, however, whether regulation of gut microbiota would be helpful in preventing the condition.
Ms. Kessler urged her colleagues to consider workups in the following situations: when an incidental finding is noticed during imaging, when liver enzymes are abnormal (although they can misleadingly appear normal), and when there are overt symptoms of liver diseases. Causes such as alcohol use, medications, and hepatitis must first be ruled out, she said, and patients should be referred to a gastroenterologist if NAFLD is confirmed.
In regard to treatment, weight and diet control are crucial because they can have a significant impact in a patient with NAFLD. “You don’t come down with NAFLD, and then NASH, and then cirrhosis,” she explained. “It goes back and forth. You can go from normal liver to fatty liver, and back to normal. We’ve all seen it.”
Reduce weight, blood pressure, and blood sugar, she said, “and you’ll see NASH go to fatty liver, and fatty liver go over to normal. If you can have someone lose between 9% and 10% of their weight, you can turn around NASH. This is huge.”
As for medications, she said, “there is no one drug for fatty liver disease.” No medication has been approved by the Food and Drug Administration for the treatment of NAFLD or NASH, but there are several treatments that seem to be helpful, she said.
They include statins, though not for patients with decompensated cirrhosis, and some of the diabetes drugs – pioglitazone (Actos; to treat steatohepatitis in patients with or without type 2 diabetes who have biopsy-proven NASH); metformin (only in patients with diabetes); and the glucagon-like peptide-1 receptor agonists.
Also included among the therapies are vitamin E 800 IU/day and omega-3 fatty acids for patients who have a high levels of triglycerides, as well as lower-dose vitamin E (600 IU/day) and vitamin C (500 mg/day), which are best when used with lifestyle changes; increased choline intake – which supports liver health in menopausal women – from foods such as eggs; and milk thistle, which helps decrease liver inflammation.
Patients without chronic liver disease may find another helpful preventive tool on the shelves of their local liquor store: red wine, but with moderation, Ms. Kessler cautioned.
Global Academy and this news organization are owned by the same parent company. Ms. Kessler disclosed relationships as an adviser and speaker with Novo Nordisk, and with Clarion Brands.
SAN DIEGO – When it comes to metabolic and endocrine health, nonalcoholic fatty liver disease (NAFLD) is the furthest thing from a nonissue – it’s “a harbinger of deadly dysmetabolism,” said Christine Kessler, MN, ANP-BC, CNS, BC-ADM, FAANP, a nurse practitioner and founder of Metabolic Medicine Associates, King George, Va.
“I chase it, I follow it, I worry about it. Never look at it again as a benign thing,” Ms. Kessler said in a presentation at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education. “It’s the most common chronic liver disease in the United States – move over, hep C ... and it’ll be the number one cause of liver transplant within 20 years.”
But the news isn’t all grim: NAFLD can be reversible, because the liver is one organ that can “take a licking and keep on ticking,” she said.
An estimated 30%-40% of adults in the United States have NAFLD, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The most severe form of the disease, nonalcoholic steatohepatitis (NASH), causes liver cell damage and affects an estimated 3%-12% of adults.
Why worry about NAFLD? Because it can boost cardiovascular risk (especially in conjunction with metabolic syndrome) and the risk for liver cancer, said Ms. Kessler.
Among the risk factors for NAFLD are obesity, type 2 diabetes, metabolic syndrome, polycystic ovary syndrome, and many others, including medications such as methotrexate, corticosteroids, and tetracyclines. Men, and Latino and Asian individuals are especially vulnerable, whereas black individuals may have protection against it.
Researchers are exploring the possibility that NAFLD is a “multihit” condition that is linked to multiple causes, possibly including overgrowth of bacteria in the gut, Ms. Kessler noted. It is not clear, however, whether regulation of gut microbiota would be helpful in preventing the condition.
Ms. Kessler urged her colleagues to consider workups in the following situations: when an incidental finding is noticed during imaging, when liver enzymes are abnormal (although they can misleadingly appear normal), and when there are overt symptoms of liver diseases. Causes such as alcohol use, medications, and hepatitis must first be ruled out, she said, and patients should be referred to a gastroenterologist if NAFLD is confirmed.
In regard to treatment, weight and diet control are crucial because they can have a significant impact in a patient with NAFLD. “You don’t come down with NAFLD, and then NASH, and then cirrhosis,” she explained. “It goes back and forth. You can go from normal liver to fatty liver, and back to normal. We’ve all seen it.”
Reduce weight, blood pressure, and blood sugar, she said, “and you’ll see NASH go to fatty liver, and fatty liver go over to normal. If you can have someone lose between 9% and 10% of their weight, you can turn around NASH. This is huge.”
As for medications, she said, “there is no one drug for fatty liver disease.” No medication has been approved by the Food and Drug Administration for the treatment of NAFLD or NASH, but there are several treatments that seem to be helpful, she said.
They include statins, though not for patients with decompensated cirrhosis, and some of the diabetes drugs – pioglitazone (Actos; to treat steatohepatitis in patients with or without type 2 diabetes who have biopsy-proven NASH); metformin (only in patients with diabetes); and the glucagon-like peptide-1 receptor agonists.
Also included among the therapies are vitamin E 800 IU/day and omega-3 fatty acids for patients who have a high levels of triglycerides, as well as lower-dose vitamin E (600 IU/day) and vitamin C (500 mg/day), which are best when used with lifestyle changes; increased choline intake – which supports liver health in menopausal women – from foods such as eggs; and milk thistle, which helps decrease liver inflammation.
Patients without chronic liver disease may find another helpful preventive tool on the shelves of their local liquor store: red wine, but with moderation, Ms. Kessler cautioned.
Global Academy and this news organization are owned by the same parent company. Ms. Kessler disclosed relationships as an adviser and speaker with Novo Nordisk, and with Clarion Brands.
SAN DIEGO – When it comes to metabolic and endocrine health, nonalcoholic fatty liver disease (NAFLD) is the furthest thing from a nonissue – it’s “a harbinger of deadly dysmetabolism,” said Christine Kessler, MN, ANP-BC, CNS, BC-ADM, FAANP, a nurse practitioner and founder of Metabolic Medicine Associates, King George, Va.
“I chase it, I follow it, I worry about it. Never look at it again as a benign thing,” Ms. Kessler said in a presentation at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education. “It’s the most common chronic liver disease in the United States – move over, hep C ... and it’ll be the number one cause of liver transplant within 20 years.”
But the news isn’t all grim: NAFLD can be reversible, because the liver is one organ that can “take a licking and keep on ticking,” she said.
An estimated 30%-40% of adults in the United States have NAFLD, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The most severe form of the disease, nonalcoholic steatohepatitis (NASH), causes liver cell damage and affects an estimated 3%-12% of adults.
Why worry about NAFLD? Because it can boost cardiovascular risk (especially in conjunction with metabolic syndrome) and the risk for liver cancer, said Ms. Kessler.
Among the risk factors for NAFLD are obesity, type 2 diabetes, metabolic syndrome, polycystic ovary syndrome, and many others, including medications such as methotrexate, corticosteroids, and tetracyclines. Men, and Latino and Asian individuals are especially vulnerable, whereas black individuals may have protection against it.
Researchers are exploring the possibility that NAFLD is a “multihit” condition that is linked to multiple causes, possibly including overgrowth of bacteria in the gut, Ms. Kessler noted. It is not clear, however, whether regulation of gut microbiota would be helpful in preventing the condition.
Ms. Kessler urged her colleagues to consider workups in the following situations: when an incidental finding is noticed during imaging, when liver enzymes are abnormal (although they can misleadingly appear normal), and when there are overt symptoms of liver diseases. Causes such as alcohol use, medications, and hepatitis must first be ruled out, she said, and patients should be referred to a gastroenterologist if NAFLD is confirmed.
In regard to treatment, weight and diet control are crucial because they can have a significant impact in a patient with NAFLD. “You don’t come down with NAFLD, and then NASH, and then cirrhosis,” she explained. “It goes back and forth. You can go from normal liver to fatty liver, and back to normal. We’ve all seen it.”
Reduce weight, blood pressure, and blood sugar, she said, “and you’ll see NASH go to fatty liver, and fatty liver go over to normal. If you can have someone lose between 9% and 10% of their weight, you can turn around NASH. This is huge.”
As for medications, she said, “there is no one drug for fatty liver disease.” No medication has been approved by the Food and Drug Administration for the treatment of NAFLD or NASH, but there are several treatments that seem to be helpful, she said.
They include statins, though not for patients with decompensated cirrhosis, and some of the diabetes drugs – pioglitazone (Actos; to treat steatohepatitis in patients with or without type 2 diabetes who have biopsy-proven NASH); metformin (only in patients with diabetes); and the glucagon-like peptide-1 receptor agonists.
Also included among the therapies are vitamin E 800 IU/day and omega-3 fatty acids for patients who have a high levels of triglycerides, as well as lower-dose vitamin E (600 IU/day) and vitamin C (500 mg/day), which are best when used with lifestyle changes; increased choline intake – which supports liver health in menopausal women – from foods such as eggs; and milk thistle, which helps decrease liver inflammation.
Patients without chronic liver disease may find another helpful preventive tool on the shelves of their local liquor store: red wine, but with moderation, Ms. Kessler cautioned.
Global Academy and this news organization are owned by the same parent company. Ms. Kessler disclosed relationships as an adviser and speaker with Novo Nordisk, and with Clarion Brands.
EXPERT ANALYSIS FROM MEDS 2019
Urine albumin testing is crucial for patients at risk for CKD, but drop the 24-hour urine test
SAN DIEGO – Whatever you do, don’t order a 24-hour urine test. Do encourage “pork holidays.” And choose between an ACE inhibitor and an ARB – don’t give them both to a single patient, according to Kim Zuber, PA-C, MS, a nephrology physician assistant from St. Petersburg, Fla., in a presentation about kidney disease, hypertension, and diabetes at the Metabolic & Endocrine Disease Summit, sponsored by Global Academy for Medical Education.
Ms. Zuber, who is the executive director of the American Academy of Nephrology PAs and the outreach chair of the National Kidney Foundation, outlined some approaches for the diagnosis, management, and treatment of chronic kidney disease (CKD) with comorbid hypertension and diabetes.
- Use the right urine test. Ms. Zuber said, although it’s often not performed. In fact, research suggests that most Medicare patients with diabetes, hypertension, or both do not have this test, she said. Order a urine albumin-to-creatinine ratio (UACR) test at least once a year in at-risk patients, she recommended, and more frequently if they show signs of abnormal values. But be aware, she said, some labs might refer to the test as microalbuminuria instead of UACR, and be prepared to calculate the UACR yourself if your institution provides only albumin and creatinine levels. Also watch out for mix-ups regarding UACR measurements. Nephrotic-range proteinuria starts at 3 g/dL or 3,000 mg/dL, she said, and residents often confuse those two sets of units. “Many have gotten in trouble with that,” she said.
- Don’t go near a 24-hour urine test. Thinking about ordering a 24-hour urine test that requires a patients to collect all their urine for a day? Think again. “We’ve been telling you almost 20 years not to do this,” Ms. Zuber said. These tests “are unreliable, and they don’t work.”
- Don’t focus on tight blood pressure control. Studies provide little insight into the ideal blood pressure readings for patients with diabetes and CKD, according to Ms. Zuber, but some findings suggest that tight control can be harmful to the kidneys. She urges her patients to treat hypertension in part by embracing lifestyle change. “I tell them that if you improve your lifestyle, you can give up one of your drugs. When they average 15 drugs a day, that becomes popular.” Physical activity, the DASH diet, salt restriction, moderate alcohol consumption, weight loss, stress reduction, and smoking cessation can all lower blood pressure, she added.
- Talk up the “pork holiday.” For patients with hypertension, “sodium restriction is huge,” Ms. Zuber said, especially among black patients. She urges her patients to take “pork holidays”, that is, eat pork only four times a year, on holidays such as the Fourth of July. She also urges them to prepare food in ways that begin with B, as in bake, boil, and barbecue. “You’ll notice that ‘fry’ doesn’t start with a B.”
- Try an ACE inhibitor or an ARB, but not both. In patients with hypertension plus diabetes and/or CKD, Ms. Zuber suggests using an angiotensin-converting enzyme inhibitor or angiotensin receptor blockers, but not both. One or the other can improve albuminuria, she said, but together they can boost risk of CKD, hyperkalemia, and hypotension.
Consider factors such as formularies and personal experience when trying to decide which drug to use, she said. If a patient still has hypertension, consider a diuretic and then move to a calcium channel or beta blocker. However, she cautioned, although beta blockers, they can cause erectile dysfunction.
Global Academy for Medical Education and this news organization are owned by the same parent company. Ms. Zuber reported no disclosures.
SAN DIEGO – Whatever you do, don’t order a 24-hour urine test. Do encourage “pork holidays.” And choose between an ACE inhibitor and an ARB – don’t give them both to a single patient, according to Kim Zuber, PA-C, MS, a nephrology physician assistant from St. Petersburg, Fla., in a presentation about kidney disease, hypertension, and diabetes at the Metabolic & Endocrine Disease Summit, sponsored by Global Academy for Medical Education.
Ms. Zuber, who is the executive director of the American Academy of Nephrology PAs and the outreach chair of the National Kidney Foundation, outlined some approaches for the diagnosis, management, and treatment of chronic kidney disease (CKD) with comorbid hypertension and diabetes.
- Use the right urine test. Ms. Zuber said, although it’s often not performed. In fact, research suggests that most Medicare patients with diabetes, hypertension, or both do not have this test, she said. Order a urine albumin-to-creatinine ratio (UACR) test at least once a year in at-risk patients, she recommended, and more frequently if they show signs of abnormal values. But be aware, she said, some labs might refer to the test as microalbuminuria instead of UACR, and be prepared to calculate the UACR yourself if your institution provides only albumin and creatinine levels. Also watch out for mix-ups regarding UACR measurements. Nephrotic-range proteinuria starts at 3 g/dL or 3,000 mg/dL, she said, and residents often confuse those two sets of units. “Many have gotten in trouble with that,” she said.
- Don’t go near a 24-hour urine test. Thinking about ordering a 24-hour urine test that requires a patients to collect all their urine for a day? Think again. “We’ve been telling you almost 20 years not to do this,” Ms. Zuber said. These tests “are unreliable, and they don’t work.”
- Don’t focus on tight blood pressure control. Studies provide little insight into the ideal blood pressure readings for patients with diabetes and CKD, according to Ms. Zuber, but some findings suggest that tight control can be harmful to the kidneys. She urges her patients to treat hypertension in part by embracing lifestyle change. “I tell them that if you improve your lifestyle, you can give up one of your drugs. When they average 15 drugs a day, that becomes popular.” Physical activity, the DASH diet, salt restriction, moderate alcohol consumption, weight loss, stress reduction, and smoking cessation can all lower blood pressure, she added.
- Talk up the “pork holiday.” For patients with hypertension, “sodium restriction is huge,” Ms. Zuber said, especially among black patients. She urges her patients to take “pork holidays”, that is, eat pork only four times a year, on holidays such as the Fourth of July. She also urges them to prepare food in ways that begin with B, as in bake, boil, and barbecue. “You’ll notice that ‘fry’ doesn’t start with a B.”
- Try an ACE inhibitor or an ARB, but not both. In patients with hypertension plus diabetes and/or CKD, Ms. Zuber suggests using an angiotensin-converting enzyme inhibitor or angiotensin receptor blockers, but not both. One or the other can improve albuminuria, she said, but together they can boost risk of CKD, hyperkalemia, and hypotension.
Consider factors such as formularies and personal experience when trying to decide which drug to use, she said. If a patient still has hypertension, consider a diuretic and then move to a calcium channel or beta blocker. However, she cautioned, although beta blockers, they can cause erectile dysfunction.
Global Academy for Medical Education and this news organization are owned by the same parent company. Ms. Zuber reported no disclosures.
SAN DIEGO – Whatever you do, don’t order a 24-hour urine test. Do encourage “pork holidays.” And choose between an ACE inhibitor and an ARB – don’t give them both to a single patient, according to Kim Zuber, PA-C, MS, a nephrology physician assistant from St. Petersburg, Fla., in a presentation about kidney disease, hypertension, and diabetes at the Metabolic & Endocrine Disease Summit, sponsored by Global Academy for Medical Education.
Ms. Zuber, who is the executive director of the American Academy of Nephrology PAs and the outreach chair of the National Kidney Foundation, outlined some approaches for the diagnosis, management, and treatment of chronic kidney disease (CKD) with comorbid hypertension and diabetes.
- Use the right urine test. Ms. Zuber said, although it’s often not performed. In fact, research suggests that most Medicare patients with diabetes, hypertension, or both do not have this test, she said. Order a urine albumin-to-creatinine ratio (UACR) test at least once a year in at-risk patients, she recommended, and more frequently if they show signs of abnormal values. But be aware, she said, some labs might refer to the test as microalbuminuria instead of UACR, and be prepared to calculate the UACR yourself if your institution provides only albumin and creatinine levels. Also watch out for mix-ups regarding UACR measurements. Nephrotic-range proteinuria starts at 3 g/dL or 3,000 mg/dL, she said, and residents often confuse those two sets of units. “Many have gotten in trouble with that,” she said.
- Don’t go near a 24-hour urine test. Thinking about ordering a 24-hour urine test that requires a patients to collect all their urine for a day? Think again. “We’ve been telling you almost 20 years not to do this,” Ms. Zuber said. These tests “are unreliable, and they don’t work.”
- Don’t focus on tight blood pressure control. Studies provide little insight into the ideal blood pressure readings for patients with diabetes and CKD, according to Ms. Zuber, but some findings suggest that tight control can be harmful to the kidneys. She urges her patients to treat hypertension in part by embracing lifestyle change. “I tell them that if you improve your lifestyle, you can give up one of your drugs. When they average 15 drugs a day, that becomes popular.” Physical activity, the DASH diet, salt restriction, moderate alcohol consumption, weight loss, stress reduction, and smoking cessation can all lower blood pressure, she added.
- Talk up the “pork holiday.” For patients with hypertension, “sodium restriction is huge,” Ms. Zuber said, especially among black patients. She urges her patients to take “pork holidays”, that is, eat pork only four times a year, on holidays such as the Fourth of July. She also urges them to prepare food in ways that begin with B, as in bake, boil, and barbecue. “You’ll notice that ‘fry’ doesn’t start with a B.”
- Try an ACE inhibitor or an ARB, but not both. In patients with hypertension plus diabetes and/or CKD, Ms. Zuber suggests using an angiotensin-converting enzyme inhibitor or angiotensin receptor blockers, but not both. One or the other can improve albuminuria, she said, but together they can boost risk of CKD, hyperkalemia, and hypotension.
Consider factors such as formularies and personal experience when trying to decide which drug to use, she said. If a patient still has hypertension, consider a diuretic and then move to a calcium channel or beta blocker. However, she cautioned, although beta blockers, they can cause erectile dysfunction.
Global Academy for Medical Education and this news organization are owned by the same parent company. Ms. Zuber reported no disclosures.
EXPERT ANALYSIS FROM MEDS 2019
Meeting just 2 of 7 ‘simple’ goals lowers HF risk
Turns out the American Heart Association is onto something when it urges people to embrace its “Life’s Simple 7” (LS7) recommendations, a series of strategies designed to boost cardiovascular health. A new European study finds that people who follow the recommendations were more than half as likely to develop heart failure (HF) and that mastering just two of the seven criteria makes a big difference, compared with mastering none at all.
“Focusing on particular components of the American Heart Association LS7 could be seen as a way to improve cardiovascular health,” wrote the authors of the study, which appears in JACC: Heart Failure.
The LS7 encourages the following strategies:
- Manage blood pressure.
- Control cholesterol.
- Reduce blood sugar.
- Get active.
- Eat better.
- Lose weight.
- Stop smoking.
For the new study, researchers led by Alicia Uijl, MSc, of University College London and University Medical Center Utrecht (the Netherlands) retrospectively tracked 37,803 participants in a prospective Dutch study of cancer and nutrition.
The subjects, 75% women, had a mean age of 49 years. The group was much thinner, with a mean body mass index of 25 kg/m2, than typical American men and women, whose mean BMIs are 29 and 30, per CDC statistics (Natl Health Stat Report. 2018 Dec;122:1-16)
Researchers gave the subjects an LS7 score (0-14) at baseline from 1993-1997. The score was based on whether they fully (2 points), partially (1) or not at all (0) met each of the LC7 criteria.
Most of the subjects failed to reach the ideal level of healthiness, which was defined as scores 11-14 and was achieved by 23%. The others were in the intermediate group (scores, 9-10 points; 35%) and inadequate group (scores, 0-8; 42%).
Over a median follow-up of 15 years, 2% of participants (690) developed HF. In an adjusted model, subjects in the top two groups (ideal and intermediate) were less likely to develop HF than were those in the lowest group (hazard ratios, 0.45 and 0.53, respectively).
The researchers found that diet, exercise, and cholesterol had lesser impacts on risk of HF than did the other elements. And they discovered that meeting the ideal level for just 2 of the 7 strategies would lower HF risk by 52%, compared with reaching no ideal levels.
What now? The high number of subjects in the lowest category suggests “there is ample room for improvements in healthy lifestyle behavior that may reduce HF in the general population,” the researchers wrote. “Given the robust associations between a healthy lifestyle and reduced incidence of HF, this study provides evidence that prevention of incident HF could be accomplished by implementing healthy lifestyle patterns.”
The study is funded by the European Commission, European Union/European Federation of Pharmaceutical Industries and Associations, and several other research organizations. The study authors reported no relevant disclosures.
SOURCE: Uijl A et al. JACC: Heart Fail. 2019 Jul 10. doi: 10.1016/j.jchf.2019.03.009
Christie M. Ballantyne, MD, and Vijay Nambi, MD, PhD, of Baylor College of Medicine, Houston, made these comments in an accompanying editorial. Dr. Ballantyne discloses grant/research support/consulting for Abbott and Roche and a provisional patent. Dr. Nambi discloses research site primary investigator work for Merck and a provisional patent.
Christie M. Ballantyne, MD, and Vijay Nambi, MD, PhD, of Baylor College of Medicine, Houston, made these comments in an accompanying editorial. Dr. Ballantyne discloses grant/research support/consulting for Abbott and Roche and a provisional patent. Dr. Nambi discloses research site primary investigator work for Merck and a provisional patent.
Christie M. Ballantyne, MD, and Vijay Nambi, MD, PhD, of Baylor College of Medicine, Houston, made these comments in an accompanying editorial. Dr. Ballantyne discloses grant/research support/consulting for Abbott and Roche and a provisional patent. Dr. Nambi discloses research site primary investigator work for Merck and a provisional patent.
Turns out the American Heart Association is onto something when it urges people to embrace its “Life’s Simple 7” (LS7) recommendations, a series of strategies designed to boost cardiovascular health. A new European study finds that people who follow the recommendations were more than half as likely to develop heart failure (HF) and that mastering just two of the seven criteria makes a big difference, compared with mastering none at all.
“Focusing on particular components of the American Heart Association LS7 could be seen as a way to improve cardiovascular health,” wrote the authors of the study, which appears in JACC: Heart Failure.
The LS7 encourages the following strategies:
- Manage blood pressure.
- Control cholesterol.
- Reduce blood sugar.
- Get active.
- Eat better.
- Lose weight.
- Stop smoking.
For the new study, researchers led by Alicia Uijl, MSc, of University College London and University Medical Center Utrecht (the Netherlands) retrospectively tracked 37,803 participants in a prospective Dutch study of cancer and nutrition.
The subjects, 75% women, had a mean age of 49 years. The group was much thinner, with a mean body mass index of 25 kg/m2, than typical American men and women, whose mean BMIs are 29 and 30, per CDC statistics (Natl Health Stat Report. 2018 Dec;122:1-16)
Researchers gave the subjects an LS7 score (0-14) at baseline from 1993-1997. The score was based on whether they fully (2 points), partially (1) or not at all (0) met each of the LC7 criteria.
Most of the subjects failed to reach the ideal level of healthiness, which was defined as scores 11-14 and was achieved by 23%. The others were in the intermediate group (scores, 9-10 points; 35%) and inadequate group (scores, 0-8; 42%).
Over a median follow-up of 15 years, 2% of participants (690) developed HF. In an adjusted model, subjects in the top two groups (ideal and intermediate) were less likely to develop HF than were those in the lowest group (hazard ratios, 0.45 and 0.53, respectively).
The researchers found that diet, exercise, and cholesterol had lesser impacts on risk of HF than did the other elements. And they discovered that meeting the ideal level for just 2 of the 7 strategies would lower HF risk by 52%, compared with reaching no ideal levels.
What now? The high number of subjects in the lowest category suggests “there is ample room for improvements in healthy lifestyle behavior that may reduce HF in the general population,” the researchers wrote. “Given the robust associations between a healthy lifestyle and reduced incidence of HF, this study provides evidence that prevention of incident HF could be accomplished by implementing healthy lifestyle patterns.”
The study is funded by the European Commission, European Union/European Federation of Pharmaceutical Industries and Associations, and several other research organizations. The study authors reported no relevant disclosures.
SOURCE: Uijl A et al. JACC: Heart Fail. 2019 Jul 10. doi: 10.1016/j.jchf.2019.03.009
Turns out the American Heart Association is onto something when it urges people to embrace its “Life’s Simple 7” (LS7) recommendations, a series of strategies designed to boost cardiovascular health. A new European study finds that people who follow the recommendations were more than half as likely to develop heart failure (HF) and that mastering just two of the seven criteria makes a big difference, compared with mastering none at all.
“Focusing on particular components of the American Heart Association LS7 could be seen as a way to improve cardiovascular health,” wrote the authors of the study, which appears in JACC: Heart Failure.
The LS7 encourages the following strategies:
- Manage blood pressure.
- Control cholesterol.
- Reduce blood sugar.
- Get active.
- Eat better.
- Lose weight.
- Stop smoking.
For the new study, researchers led by Alicia Uijl, MSc, of University College London and University Medical Center Utrecht (the Netherlands) retrospectively tracked 37,803 participants in a prospective Dutch study of cancer and nutrition.
The subjects, 75% women, had a mean age of 49 years. The group was much thinner, with a mean body mass index of 25 kg/m2, than typical American men and women, whose mean BMIs are 29 and 30, per CDC statistics (Natl Health Stat Report. 2018 Dec;122:1-16)
Researchers gave the subjects an LS7 score (0-14) at baseline from 1993-1997. The score was based on whether they fully (2 points), partially (1) or not at all (0) met each of the LC7 criteria.
Most of the subjects failed to reach the ideal level of healthiness, which was defined as scores 11-14 and was achieved by 23%. The others were in the intermediate group (scores, 9-10 points; 35%) and inadequate group (scores, 0-8; 42%).
Over a median follow-up of 15 years, 2% of participants (690) developed HF. In an adjusted model, subjects in the top two groups (ideal and intermediate) were less likely to develop HF than were those in the lowest group (hazard ratios, 0.45 and 0.53, respectively).
The researchers found that diet, exercise, and cholesterol had lesser impacts on risk of HF than did the other elements. And they discovered that meeting the ideal level for just 2 of the 7 strategies would lower HF risk by 52%, compared with reaching no ideal levels.
What now? The high number of subjects in the lowest category suggests “there is ample room for improvements in healthy lifestyle behavior that may reduce HF in the general population,” the researchers wrote. “Given the robust associations between a healthy lifestyle and reduced incidence of HF, this study provides evidence that prevention of incident HF could be accomplished by implementing healthy lifestyle patterns.”
The study is funded by the European Commission, European Union/European Federation of Pharmaceutical Industries and Associations, and several other research organizations. The study authors reported no relevant disclosures.
SOURCE: Uijl A et al. JACC: Heart Fail. 2019 Jul 10. doi: 10.1016/j.jchf.2019.03.009
FROM JACC: HEART FAILURE
Most preschoolers with signs of ADHD aren’t ready for primary school
Are preschoolers with signs of ADHD ready for school? A new study suggests they’re far from prepared.
A small sample of children with symptoms of moderate to severe ADHD scored markedly lower than comparable children on 8 of 10 measures of readiness for primary education in a study published in Pediatrics.
These children require early identification and intervention,” Hannah T. Perrin, MD, of Stanford University and associates wrote.
There’s sparse research into the prevalence of ADHD symptoms in preschoolers, but the Centers for Disease Control and Prevention reports that nearly half of children aged 4-5 years with the condition got no behavioral therapy from 2009 to 2010. About 25% received only medical treatment.
Dr. Perrin and colleagues recruited 93 children aged 4-6 years from the community. Their parents, who were compensated, took the Early Childhood Inventory-4 (ECI-4) questionnaire. It revealed that 80% (n = 45) of those diagnosed with ADHD had scores considered signs of moderate or severe ADHD symptom severity based on the parent ratings. Those with lower scores made up the comparison group (n = 48).
The groups were similar, about 60% male and more than 50% white; neither difference between groups was statistically significant. However, those in the comparison group were much more likely to have non-Latino/non-Hispanic ethnicity; 61% in ADHD group vs. 91% in comparison group, P = .001.
The children were tested for school readiness through several measures in two 1- to 1.5-hour sessions.
The researchers reported that 79% of children in the ADHD group were not ready for school (impaired) vs. 13% of the comparison group. (odds ratio, 21, 95% confidence interval, 5.67-77.77, P = .001).
“We found that preschool-aged children with ADHD symptoms demonstrated significantly worse performance on 8 of 10 school readiness measures,” the authors added, “and significantly greater odds of impairment in four of five domains and overall school readiness.”
Dr. Perrin and associates cautioned that the findings rely on a convenience sample, are based on parent – but not teacher – input, do not include Spanish speakers, and do not follow children over the long term.
Going forward, they wrote, “family dynamics and social-emotional functioning should be assessed for each preschool-aged child with ADHD symptoms, and appropriate therapeutic interventions and community supports should be prescribed to enhance school readiness.”
The study authors had no disclosures. Study funders include the Maternal and Child Health Bureau, the Katharine McCormick Faculty Scholar Award, Stanford Children’s Health and Child Health Research Institute Pilot Early Career Award, and the National Institutes of Health.
SOURCE: Perrin HT et al. Pediatrics. 2019 Aug. doi: 10.1542/peds.2019-0038.
Are preschoolers with signs of ADHD ready for school? A new study suggests they’re far from prepared.
A small sample of children with symptoms of moderate to severe ADHD scored markedly lower than comparable children on 8 of 10 measures of readiness for primary education in a study published in Pediatrics.
These children require early identification and intervention,” Hannah T. Perrin, MD, of Stanford University and associates wrote.
There’s sparse research into the prevalence of ADHD symptoms in preschoolers, but the Centers for Disease Control and Prevention reports that nearly half of children aged 4-5 years with the condition got no behavioral therapy from 2009 to 2010. About 25% received only medical treatment.
Dr. Perrin and colleagues recruited 93 children aged 4-6 years from the community. Their parents, who were compensated, took the Early Childhood Inventory-4 (ECI-4) questionnaire. It revealed that 80% (n = 45) of those diagnosed with ADHD had scores considered signs of moderate or severe ADHD symptom severity based on the parent ratings. Those with lower scores made up the comparison group (n = 48).
The groups were similar, about 60% male and more than 50% white; neither difference between groups was statistically significant. However, those in the comparison group were much more likely to have non-Latino/non-Hispanic ethnicity; 61% in ADHD group vs. 91% in comparison group, P = .001.
The children were tested for school readiness through several measures in two 1- to 1.5-hour sessions.
The researchers reported that 79% of children in the ADHD group were not ready for school (impaired) vs. 13% of the comparison group. (odds ratio, 21, 95% confidence interval, 5.67-77.77, P = .001).
“We found that preschool-aged children with ADHD symptoms demonstrated significantly worse performance on 8 of 10 school readiness measures,” the authors added, “and significantly greater odds of impairment in four of five domains and overall school readiness.”
Dr. Perrin and associates cautioned that the findings rely on a convenience sample, are based on parent – but not teacher – input, do not include Spanish speakers, and do not follow children over the long term.
Going forward, they wrote, “family dynamics and social-emotional functioning should be assessed for each preschool-aged child with ADHD symptoms, and appropriate therapeutic interventions and community supports should be prescribed to enhance school readiness.”
The study authors had no disclosures. Study funders include the Maternal and Child Health Bureau, the Katharine McCormick Faculty Scholar Award, Stanford Children’s Health and Child Health Research Institute Pilot Early Career Award, and the National Institutes of Health.
SOURCE: Perrin HT et al. Pediatrics. 2019 Aug. doi: 10.1542/peds.2019-0038.
Are preschoolers with signs of ADHD ready for school? A new study suggests they’re far from prepared.
A small sample of children with symptoms of moderate to severe ADHD scored markedly lower than comparable children on 8 of 10 measures of readiness for primary education in a study published in Pediatrics.
These children require early identification and intervention,” Hannah T. Perrin, MD, of Stanford University and associates wrote.
There’s sparse research into the prevalence of ADHD symptoms in preschoolers, but the Centers for Disease Control and Prevention reports that nearly half of children aged 4-5 years with the condition got no behavioral therapy from 2009 to 2010. About 25% received only medical treatment.
Dr. Perrin and colleagues recruited 93 children aged 4-6 years from the community. Their parents, who were compensated, took the Early Childhood Inventory-4 (ECI-4) questionnaire. It revealed that 80% (n = 45) of those diagnosed with ADHD had scores considered signs of moderate or severe ADHD symptom severity based on the parent ratings. Those with lower scores made up the comparison group (n = 48).
The groups were similar, about 60% male and more than 50% white; neither difference between groups was statistically significant. However, those in the comparison group were much more likely to have non-Latino/non-Hispanic ethnicity; 61% in ADHD group vs. 91% in comparison group, P = .001.
The children were tested for school readiness through several measures in two 1- to 1.5-hour sessions.
The researchers reported that 79% of children in the ADHD group were not ready for school (impaired) vs. 13% of the comparison group. (odds ratio, 21, 95% confidence interval, 5.67-77.77, P = .001).
“We found that preschool-aged children with ADHD symptoms demonstrated significantly worse performance on 8 of 10 school readiness measures,” the authors added, “and significantly greater odds of impairment in four of five domains and overall school readiness.”
Dr. Perrin and associates cautioned that the findings rely on a convenience sample, are based on parent – but not teacher – input, do not include Spanish speakers, and do not follow children over the long term.
Going forward, they wrote, “family dynamics and social-emotional functioning should be assessed for each preschool-aged child with ADHD symptoms, and appropriate therapeutic interventions and community supports should be prescribed to enhance school readiness.”
The study authors had no disclosures. Study funders include the Maternal and Child Health Bureau, the Katharine McCormick Faculty Scholar Award, Stanford Children’s Health and Child Health Research Institute Pilot Early Career Award, and the National Institutes of Health.
SOURCE: Perrin HT et al. Pediatrics. 2019 Aug. doi: 10.1542/peds.2019-0038.
FROM PEDIATRICS
Adjuvanted flu vaccine performs better than others in young children
according to an industry-funded synthesis of six studies.
The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”
Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).
Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.
Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.
In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.
Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”
As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”
For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.
In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.
They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”
Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”
According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.
The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.
SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.
according to an industry-funded synthesis of six studies.
The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”
Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).
Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.
Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.
In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.
Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”
As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”
For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.
In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.
They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”
Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”
According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.
The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.
SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.
according to an industry-funded synthesis of six studies.
The vaccine “offers significant advances over conventional inactivated influenza vaccines and presents an acceptable safety profile in children 6 months through 5 years of age,” Sanjay S. Patel, PhD, of Novartis Vaccines and Diagnostics, Cambridge, Mass., and associates wrote in the analysis, published in the International Journal of Infectious Diseases. “The noteworthy increases in antibody responses and decreases in influenza cases following vaccination suggest an alternative for use in a population that is heavily impacted by influenza disease.”
Children are, of course, vulnerable to flu. The Centers for Disease Control and Prevention reported that 186 children died of flu during the landmark 2017-2018 flu season. That’s the highest number of pediatric flu deaths since they became a notifiable condition in 2004 (exclusive of the 2009 pandemic, when 358 pediatric deaths were reported from April 15, 2009, to October 2, 2010).The CDC said the vaccine during that flu season had an overall effectiveness level of 40%. According to research of others, however, flu vaccines are less effective in younger children than in adolescents and adults (Vaccine. 2014;32[31]:3886-94; Cochrane Database Syst Rev. 2008. doi: 10.1002/14651858.CD004879.pub3).
Fluad – a MF59-adjuvanted inactivated trivalent seasonal influenza vaccine – is used in adults over 65 in the United States and 29 other countries, and it is approved for children aged 6 months through 23 months in Canada.
Dr. Patel and associates examined the results of six studies – one phase 1b, three phase 2, and two phase 3 – that tested Fluad with or without other vaccines in 11,942 children aged 6 months to 5 years. The studies, mostly multicenter, were conducted in various countries, mainly in Europe and South and Central America, from 2006 to 2012.
In general, children in the intervention groups in the studies received two doses of the Fluad vaccine 4 weeks apart: two 0.25-mL doses for children aged 6-35 months and two 0.5-mL doses for those aged 3 years or older. In most of the studies, parallel control groups received nonadjuvanted trivalent or quadrivalent influenza vaccines.
Most participants (93%-94%) completed the studies. Solicited adverse effects were common in all groups (72% in the Fluad group vs. 67% who received IIV3 vaccines), and generally mild to moderate and resolved in 1-3 days. Unsolicited adverse effects were similar (55% and 62%, respectively) in the two flu vaccine groups. The authors wrote that “these data reflect a safety profile consistent with other licensed inactivated influenza vaccines administered to children.”
As for results, Dr. Patel and colleagues said, “HI [hemagglutination inhibition] antibody responses to both homologous and heterologous influenza strains are higher following vaccination with aIIV3, and this increase in immunogenicity is observed across all age subgroups in children aged 6 months through 5 years, and most profound in the children 6 to 36 months.”
For example, in one of the phase 3 studies when the influenza viruses were antigenically matched (homologous) for A/H1N1 among the children aged 6-35 months seroconversion was 100% for allV3 (Fluad) and 38% for IIV3-1/IIV3-4 (trivalent/quadrivalent flu vaccines); among children aged 3-5 years seroconversion was 100% for allV3 and 82% for IIV3-1/IIV3-4. For AH3N2 homologous among children aged 6-35 months, seroconversion was 98% for allV3 and 44% for IIV3-1/IIV3-4. For the B strain homologous among children aged 6-35 months, seroconversion was 88% for allV3 and 19% for IIV3-1/IIV3-4; among children aged 3-5 years seroconversion for B was 99% for allV3 and 59% for IIV3-1/IIV3-4.
In the same study when the influenza viruses were antigenically mismatched (heterologous) for A/H1N1 among children of all ages 6 months to greater than 72 months, seroconversion was 96% for allV3 (Fluad) and 44% for IIV3-1/IIV3-4; for A/H3N2 it was 98% for allV3 and 49% for IIV3-1/IIV3-4, and for the B strain it was 10% for allV3 and 3% for IIV3-1/IIV3-4.
They added that “in addition, aIIV3 had the fastest onset of immunogenicity and longest persistence of immune response, which has implications for the real-world clinical setting, where the influenza season might start earlier than expected or last longer, and second (follow-up) vaccinations may be missed.”
Dr. Patel and associates said the MF59 adjuvant in Fluad “recruits immune cells (primarily monocytes, macrophages, neutrophils, and dendritic cells) at the site of injection and differentiates them into antigen-presenting cells. With an MF59-adjuvanted vaccine, more antigen is transported from the injection site to the draining lymph node, wherein MF59 leads to T-cell activation and an increased B-cell expansion and a greater number and diversity of antibodies.”
According to goodrx.com, one syringe of Fluad 0.5 mL costs $45-$74 with coupon. The same dose of Fluzone Quadrivalent, a flu vaccine recently approved by the Food and Drug Administration for use in young children aged 6-35 months, costs $31 with coupon.
The study was funded by Novartis Vaccines and Diagnostics and Seqirus (formerly part of Novartis Vaccines and Diagnostics). The study authors disclosed employment by Novartis and Seqirus.
SOURCE: Patel SS et al. Int J Infect Dis. 2019. doi: 10.1016/j.ijid.2019.05.009.
FROM INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Plant-based foods could keep type 2 diabetes at bay
according to a new systematic review and meta-analysis of nine observational studies.
The findings aren’t conclusive, but the study authors wrote in JAMA Internal Medicine that they suggest that “plant-based dietary patterns were associated with lower risk of type 2 diabetes, even after adjustment for [body mass index].”
According to 2015 figures provided by the American Diabetes Association, about 29 million people in the United States have type 2 diabetes. Overall, diabetes contributes to hundreds of thousands of deaths each year, which makes it the seventh-leading cause of death in the nation.
For the new analysis, researchers led by Frank Qian, MPH, of Harvard T.H. Chan School of Public Health included nine studies that examined diet and type 2 diabetes. In all, the studies included 307,099 participants, and there were 23,544 cases of incident type 2 diabetes. They were conducted in five countries, including the United States, and tracked participants for 2-28 years; the studies were all published within the last 11 years. The mean ages of participants ranged from 36-65 years.
The meta-analysis linked higher consumption of plant-based foods to a 23% reduced risk of type 2 diabetes, compared with lower consumption (relative risk, 0.77; 95% confidence interval, 0.71-0.84; P = .07 for heterogeneity). The risk dipped even further (down to 30%) when the researchers analyzed four studies that focused on healthy plant-based foods, such as fruits and vegetables, instead of foods such as refined grains, starches, and sugars (RR, 0.70; 95% CI, 0.62-0.79).
The researchers suggested that plant-based diets may lower the risk of diabetes type 2 by limiting weight gain. They also noted various limitations to their analysis, such as the reliance on self-reports and the observational nature of the studies.
Still, “in general populations that do not practice strict vegetarian or vegan diets, replacing animal products with healthful plant-based foods is likely to exert a significant reduction in the risk of diabetes,” the authors wrote.
The study was funded by the National Institutes of Health, and one author received support from the National Institute of Diabetes and Digestive and Kidney Diseases. The remaining authors reported no conflicts of interest withing the scope of this study.
SOURCE: Qian F et al. JAMA Internal Medicine. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2195.
according to a new systematic review and meta-analysis of nine observational studies.
The findings aren’t conclusive, but the study authors wrote in JAMA Internal Medicine that they suggest that “plant-based dietary patterns were associated with lower risk of type 2 diabetes, even after adjustment for [body mass index].”
According to 2015 figures provided by the American Diabetes Association, about 29 million people in the United States have type 2 diabetes. Overall, diabetes contributes to hundreds of thousands of deaths each year, which makes it the seventh-leading cause of death in the nation.
For the new analysis, researchers led by Frank Qian, MPH, of Harvard T.H. Chan School of Public Health included nine studies that examined diet and type 2 diabetes. In all, the studies included 307,099 participants, and there were 23,544 cases of incident type 2 diabetes. They were conducted in five countries, including the United States, and tracked participants for 2-28 years; the studies were all published within the last 11 years. The mean ages of participants ranged from 36-65 years.
The meta-analysis linked higher consumption of plant-based foods to a 23% reduced risk of type 2 diabetes, compared with lower consumption (relative risk, 0.77; 95% confidence interval, 0.71-0.84; P = .07 for heterogeneity). The risk dipped even further (down to 30%) when the researchers analyzed four studies that focused on healthy plant-based foods, such as fruits and vegetables, instead of foods such as refined grains, starches, and sugars (RR, 0.70; 95% CI, 0.62-0.79).
The researchers suggested that plant-based diets may lower the risk of diabetes type 2 by limiting weight gain. They also noted various limitations to their analysis, such as the reliance on self-reports and the observational nature of the studies.
Still, “in general populations that do not practice strict vegetarian or vegan diets, replacing animal products with healthful plant-based foods is likely to exert a significant reduction in the risk of diabetes,” the authors wrote.
The study was funded by the National Institutes of Health, and one author received support from the National Institute of Diabetes and Digestive and Kidney Diseases. The remaining authors reported no conflicts of interest withing the scope of this study.
SOURCE: Qian F et al. JAMA Internal Medicine. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2195.
according to a new systematic review and meta-analysis of nine observational studies.
The findings aren’t conclusive, but the study authors wrote in JAMA Internal Medicine that they suggest that “plant-based dietary patterns were associated with lower risk of type 2 diabetes, even after adjustment for [body mass index].”
According to 2015 figures provided by the American Diabetes Association, about 29 million people in the United States have type 2 diabetes. Overall, diabetes contributes to hundreds of thousands of deaths each year, which makes it the seventh-leading cause of death in the nation.
For the new analysis, researchers led by Frank Qian, MPH, of Harvard T.H. Chan School of Public Health included nine studies that examined diet and type 2 diabetes. In all, the studies included 307,099 participants, and there were 23,544 cases of incident type 2 diabetes. They were conducted in five countries, including the United States, and tracked participants for 2-28 years; the studies were all published within the last 11 years. The mean ages of participants ranged from 36-65 years.
The meta-analysis linked higher consumption of plant-based foods to a 23% reduced risk of type 2 diabetes, compared with lower consumption (relative risk, 0.77; 95% confidence interval, 0.71-0.84; P = .07 for heterogeneity). The risk dipped even further (down to 30%) when the researchers analyzed four studies that focused on healthy plant-based foods, such as fruits and vegetables, instead of foods such as refined grains, starches, and sugars (RR, 0.70; 95% CI, 0.62-0.79).
The researchers suggested that plant-based diets may lower the risk of diabetes type 2 by limiting weight gain. They also noted various limitations to their analysis, such as the reliance on self-reports and the observational nature of the studies.
Still, “in general populations that do not practice strict vegetarian or vegan diets, replacing animal products with healthful plant-based foods is likely to exert a significant reduction in the risk of diabetes,” the authors wrote.
The study was funded by the National Institutes of Health, and one author received support from the National Institute of Diabetes and Digestive and Kidney Diseases. The remaining authors reported no conflicts of interest withing the scope of this study.
SOURCE: Qian F et al. JAMA Internal Medicine. 2019 Jul 22. doi: 10.1001/jamainternmed.2019.2195.
FROM JAMA INTERNAL MEDICINE
Skin safety gap divides white, older from nonwhite, younger
of passersby and skin-cancer screening attendees in Washington, D.C.
“These findings highlight the importance of tailoring free skin cancer screening events for nonwhite and younger populations,” senior author Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said in a statement provided by the institution. “While free screening events are important, we also have to think about comprehensive, community-based solutions that reach broader demographic populations than skin cancer screenings alone.”
For the new study, which appears in the July 2019 issue of Journal of Drugs in Dermatology, researchers led by Emily C. Murphy, BS, of George Washington University, sought to better understand skin safety precautions in the population beyond those who attend skin cancer screenings (J Drugs Dermatol. 2019;18[7]:649-53).
The study authors surveyed 285 passersby at six locations in Washington, D.C. (65% were female, 47% were under age 31, 48% were white, and 29% were black) and 144 attendees at a free skin cancer screening at George Washington University (70% were female, 16% were under 31, 44% were over 60, 73% were white, and 14% were black).
The attendees at the screening event were much more likely to engage in sun safety habits that are linked to lower risk of squamous cell carcinoma, basal cell carcinoma, and melanoma: 34% always used sunscreen vs. 19% of the public group (P = .001), and 52% always sought shade vs. 32% of the public group (P = .002). Seventeen percent of the public group never used sunscreen compared with 8% of the screening group.
Whites and older subjects were more likely to embrace sun-safety practices. When the groups were combined, 84% of whites and 52% of blacks always or sometimes used sunscreen (P less than .0001). Those over 60 were much more likely to always seek shade than were those under 31 (53% vs. 24%, P less than .0001).
“The screening group was older and included more individuals with fair skin, highlighting the need to target younger and nonwhite populations for sun safety education,” the researchers wrote. “Encouraging sun safety in younger populations will decrease the risk of skin cancer for patients now and later in their lives. That said, educating populations who seek skin cancer screenings is still important given 22% of our screening cohort reported rarely or never wearing sunscreen, underscoring this program’s value.”
The researchers noted that the study’s limitations include its small size, the possibility that the public group had higher education rates because they were near a university, and the lack of insight into whether the public group represented the general population.
No study funding was reported. The study authors reported no relevant disclosures.
of passersby and skin-cancer screening attendees in Washington, D.C.
“These findings highlight the importance of tailoring free skin cancer screening events for nonwhite and younger populations,” senior author Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said in a statement provided by the institution. “While free screening events are important, we also have to think about comprehensive, community-based solutions that reach broader demographic populations than skin cancer screenings alone.”
For the new study, which appears in the July 2019 issue of Journal of Drugs in Dermatology, researchers led by Emily C. Murphy, BS, of George Washington University, sought to better understand skin safety precautions in the population beyond those who attend skin cancer screenings (J Drugs Dermatol. 2019;18[7]:649-53).
The study authors surveyed 285 passersby at six locations in Washington, D.C. (65% were female, 47% were under age 31, 48% were white, and 29% were black) and 144 attendees at a free skin cancer screening at George Washington University (70% were female, 16% were under 31, 44% were over 60, 73% were white, and 14% were black).
The attendees at the screening event were much more likely to engage in sun safety habits that are linked to lower risk of squamous cell carcinoma, basal cell carcinoma, and melanoma: 34% always used sunscreen vs. 19% of the public group (P = .001), and 52% always sought shade vs. 32% of the public group (P = .002). Seventeen percent of the public group never used sunscreen compared with 8% of the screening group.
Whites and older subjects were more likely to embrace sun-safety practices. When the groups were combined, 84% of whites and 52% of blacks always or sometimes used sunscreen (P less than .0001). Those over 60 were much more likely to always seek shade than were those under 31 (53% vs. 24%, P less than .0001).
“The screening group was older and included more individuals with fair skin, highlighting the need to target younger and nonwhite populations for sun safety education,” the researchers wrote. “Encouraging sun safety in younger populations will decrease the risk of skin cancer for patients now and later in their lives. That said, educating populations who seek skin cancer screenings is still important given 22% of our screening cohort reported rarely or never wearing sunscreen, underscoring this program’s value.”
The researchers noted that the study’s limitations include its small size, the possibility that the public group had higher education rates because they were near a university, and the lack of insight into whether the public group represented the general population.
No study funding was reported. The study authors reported no relevant disclosures.
of passersby and skin-cancer screening attendees in Washington, D.C.
“These findings highlight the importance of tailoring free skin cancer screening events for nonwhite and younger populations,” senior author Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said in a statement provided by the institution. “While free screening events are important, we also have to think about comprehensive, community-based solutions that reach broader demographic populations than skin cancer screenings alone.”
For the new study, which appears in the July 2019 issue of Journal of Drugs in Dermatology, researchers led by Emily C. Murphy, BS, of George Washington University, sought to better understand skin safety precautions in the population beyond those who attend skin cancer screenings (J Drugs Dermatol. 2019;18[7]:649-53).
The study authors surveyed 285 passersby at six locations in Washington, D.C. (65% were female, 47% were under age 31, 48% were white, and 29% were black) and 144 attendees at a free skin cancer screening at George Washington University (70% were female, 16% were under 31, 44% were over 60, 73% were white, and 14% were black).
The attendees at the screening event were much more likely to engage in sun safety habits that are linked to lower risk of squamous cell carcinoma, basal cell carcinoma, and melanoma: 34% always used sunscreen vs. 19% of the public group (P = .001), and 52% always sought shade vs. 32% of the public group (P = .002). Seventeen percent of the public group never used sunscreen compared with 8% of the screening group.
Whites and older subjects were more likely to embrace sun-safety practices. When the groups were combined, 84% of whites and 52% of blacks always or sometimes used sunscreen (P less than .0001). Those over 60 were much more likely to always seek shade than were those under 31 (53% vs. 24%, P less than .0001).
“The screening group was older and included more individuals with fair skin, highlighting the need to target younger and nonwhite populations for sun safety education,” the researchers wrote. “Encouraging sun safety in younger populations will decrease the risk of skin cancer for patients now and later in their lives. That said, educating populations who seek skin cancer screenings is still important given 22% of our screening cohort reported rarely or never wearing sunscreen, underscoring this program’s value.”
The researchers noted that the study’s limitations include its small size, the possibility that the public group had higher education rates because they were near a university, and the lack of insight into whether the public group represented the general population.
No study funding was reported. The study authors reported no relevant disclosures.
FROM THE JOURNAL OF DRUGS IN DERMATOLOGY