AI technology meets AFib detection

AI plus ECG could eventually reduce health care burden
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An artificial intelligence-enabled ECG model identified patients with intermittent atrial fibrillation in a 10-second test with 83% accuracy, based on data from more than 180,000 individuals.

“We have previously shown convolution neural networks can evaluate the resting ECG for detection of antiarrhythmic drug levels, abnormal electrolytes levels, and detection of asymptomatic left ventricular dysfunction, providing proof of concept that clinically important phenomena can be detected with artificial intelligence (AI) applications to the ECG,” wrote Zachi I. Attia, an electrical engineer and a primary author of the study, is with the Mayo Clinic, Rochester, Minn., and colleagues.

In a study published in the Lancet, the researchers reviewed data from 649,931 normal sinus rhythm ECGs collected from 180,922 adults between December 1993 and July 2017.

The ECGs were divided into three groups: training (454,789 ECGs from 126,526 patients) internal validation (64,340 ECGs from 18,116 patients) and testing (130,802 ECGs from 36,280 patients). The primary outcome was whether the AI-programmed ECG could identify AFib in a total of 3,051 patients in the testing data set who had verified AFib before being tested with the AI device. The AI-enabled ECG was designed to detect subtle changes using neural network technology previously used by the researchers to identify ventricular dysfunction.

Overall, a single ECG scan identified AFib with an accuracy of 79.4%, an area under the curve (AUC) of 0.87, sensitivity of 79.0%, and specificity of 79.5%. When researchers reviewed multiple ECGs from a 1-month window of either the study start date or 31 days before the first AFib, the accuracy increased to 83.3%, with an AUC of 0.90, sensitivity of 82.3%, and specificity of 83.4%.



The results support the use of subtle changes on normal sinus rhythm ECG to identify patient with potentially undetected AFib, and suggest that AI-enabled ECGs could be used at the point of care to identify patients at risk after unexplained strokes, also known as embolic stroke of undetermined source (ESUS), or heart failure, the researchers noted.

“Although it would require further study, it is possible that this algorithm could identify a high-risk subset of patients with ESUS who could benefit from empirical anticoagulation,” the researchers said.

The study findings were limited by several factors, including possible mislabeling of patients with unidentified atrial fibrillation who were classified negative. In addition, the prevalence of AFib in the study population may be higher than in the general population, they said.

However, the results suggest that use a noninvasive, widely available, point of care test to identify AFib “could have important implications for atrial fibrillation screening and for the management of patients with unexplained stroke,” they concluded.

This study was funded by internal resources of the Mayo Clinic. The researchers had no financial conflicts to disclose.

SOURCE: Attia ZI et al. Lancet. 2019 Aug 1. doi. org/10.1016/S0140-6736(19)31721-0.

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This artificial intelligence-enabled ECG interpretation is groundbreaking in creating an algorithm to reveal the likelihood of atrial fibrillation in ECGs showing sinus rhythm.

AFib is now considered a global pandemic and needs to be detected not only to manage the arrhythmia but also to prevent comorbidities and death.

A 10-second, 12-lead ECG in current clinical practice is unlikely to reveal possible AFib if not present in this short monitoring time. However, the findings have clinical importance, particularly in identifying silent AFib and may have important implications for secondary prevention of patients with embolic stroke of undetermined source in terms of providing appropriate oral anticoagulation to prevent recurrences of stroke. The AI-enabled algorithm would require further validation in a different patient cohort, testing a healthier out-of-hospital population, as well as a rigorous prospective clinical trial assessment.

Future research areas include combining ECG algorithms with demographic variables, clinical features, and biomarkers, as well as exploring the use of wearable devices linking these variables and AI for smart monitoring to diagnose AFib.
 

Jeroen Hendriks, MD, of the University of Adelaide (Australia), and Larissa Fabritz, MD, of the University of Birmingham (England), made these comments in an accompanying editorial. Dr. Hendriks disclosed lecture or consulting fees from Medtronic and Pfizer/Bristol-Myers Squibb. Dr. Fabritz is the inventor of two patents and disclosed research grants and nonfinancial support from European research institutions and Gilead.

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This artificial intelligence-enabled ECG interpretation is groundbreaking in creating an algorithm to reveal the likelihood of atrial fibrillation in ECGs showing sinus rhythm.

AFib is now considered a global pandemic and needs to be detected not only to manage the arrhythmia but also to prevent comorbidities and death.

A 10-second, 12-lead ECG in current clinical practice is unlikely to reveal possible AFib if not present in this short monitoring time. However, the findings have clinical importance, particularly in identifying silent AFib and may have important implications for secondary prevention of patients with embolic stroke of undetermined source in terms of providing appropriate oral anticoagulation to prevent recurrences of stroke. The AI-enabled algorithm would require further validation in a different patient cohort, testing a healthier out-of-hospital population, as well as a rigorous prospective clinical trial assessment.

Future research areas include combining ECG algorithms with demographic variables, clinical features, and biomarkers, as well as exploring the use of wearable devices linking these variables and AI for smart monitoring to diagnose AFib.
 

Jeroen Hendriks, MD, of the University of Adelaide (Australia), and Larissa Fabritz, MD, of the University of Birmingham (England), made these comments in an accompanying editorial. Dr. Hendriks disclosed lecture or consulting fees from Medtronic and Pfizer/Bristol-Myers Squibb. Dr. Fabritz is the inventor of two patents and disclosed research grants and nonfinancial support from European research institutions and Gilead.

Body

 

This artificial intelligence-enabled ECG interpretation is groundbreaking in creating an algorithm to reveal the likelihood of atrial fibrillation in ECGs showing sinus rhythm.

AFib is now considered a global pandemic and needs to be detected not only to manage the arrhythmia but also to prevent comorbidities and death.

A 10-second, 12-lead ECG in current clinical practice is unlikely to reveal possible AFib if not present in this short monitoring time. However, the findings have clinical importance, particularly in identifying silent AFib and may have important implications for secondary prevention of patients with embolic stroke of undetermined source in terms of providing appropriate oral anticoagulation to prevent recurrences of stroke. The AI-enabled algorithm would require further validation in a different patient cohort, testing a healthier out-of-hospital population, as well as a rigorous prospective clinical trial assessment.

Future research areas include combining ECG algorithms with demographic variables, clinical features, and biomarkers, as well as exploring the use of wearable devices linking these variables and AI for smart monitoring to diagnose AFib.
 

Jeroen Hendriks, MD, of the University of Adelaide (Australia), and Larissa Fabritz, MD, of the University of Birmingham (England), made these comments in an accompanying editorial. Dr. Hendriks disclosed lecture or consulting fees from Medtronic and Pfizer/Bristol-Myers Squibb. Dr. Fabritz is the inventor of two patents and disclosed research grants and nonfinancial support from European research institutions and Gilead.

Title
AI plus ECG could eventually reduce health care burden
AI plus ECG could eventually reduce health care burden

 

An artificial intelligence-enabled ECG model identified patients with intermittent atrial fibrillation in a 10-second test with 83% accuracy, based on data from more than 180,000 individuals.

“We have previously shown convolution neural networks can evaluate the resting ECG for detection of antiarrhythmic drug levels, abnormal electrolytes levels, and detection of asymptomatic left ventricular dysfunction, providing proof of concept that clinically important phenomena can be detected with artificial intelligence (AI) applications to the ECG,” wrote Zachi I. Attia, an electrical engineer and a primary author of the study, is with the Mayo Clinic, Rochester, Minn., and colleagues.

In a study published in the Lancet, the researchers reviewed data from 649,931 normal sinus rhythm ECGs collected from 180,922 adults between December 1993 and July 2017.

The ECGs were divided into three groups: training (454,789 ECGs from 126,526 patients) internal validation (64,340 ECGs from 18,116 patients) and testing (130,802 ECGs from 36,280 patients). The primary outcome was whether the AI-programmed ECG could identify AFib in a total of 3,051 patients in the testing data set who had verified AFib before being tested with the AI device. The AI-enabled ECG was designed to detect subtle changes using neural network technology previously used by the researchers to identify ventricular dysfunction.

Overall, a single ECG scan identified AFib with an accuracy of 79.4%, an area under the curve (AUC) of 0.87, sensitivity of 79.0%, and specificity of 79.5%. When researchers reviewed multiple ECGs from a 1-month window of either the study start date or 31 days before the first AFib, the accuracy increased to 83.3%, with an AUC of 0.90, sensitivity of 82.3%, and specificity of 83.4%.



The results support the use of subtle changes on normal sinus rhythm ECG to identify patient with potentially undetected AFib, and suggest that AI-enabled ECGs could be used at the point of care to identify patients at risk after unexplained strokes, also known as embolic stroke of undetermined source (ESUS), or heart failure, the researchers noted.

“Although it would require further study, it is possible that this algorithm could identify a high-risk subset of patients with ESUS who could benefit from empirical anticoagulation,” the researchers said.

The study findings were limited by several factors, including possible mislabeling of patients with unidentified atrial fibrillation who were classified negative. In addition, the prevalence of AFib in the study population may be higher than in the general population, they said.

However, the results suggest that use a noninvasive, widely available, point of care test to identify AFib “could have important implications for atrial fibrillation screening and for the management of patients with unexplained stroke,” they concluded.

This study was funded by internal resources of the Mayo Clinic. The researchers had no financial conflicts to disclose.

SOURCE: Attia ZI et al. Lancet. 2019 Aug 1. doi. org/10.1016/S0140-6736(19)31721-0.

 

An artificial intelligence-enabled ECG model identified patients with intermittent atrial fibrillation in a 10-second test with 83% accuracy, based on data from more than 180,000 individuals.

“We have previously shown convolution neural networks can evaluate the resting ECG for detection of antiarrhythmic drug levels, abnormal electrolytes levels, and detection of asymptomatic left ventricular dysfunction, providing proof of concept that clinically important phenomena can be detected with artificial intelligence (AI) applications to the ECG,” wrote Zachi I. Attia, an electrical engineer and a primary author of the study, is with the Mayo Clinic, Rochester, Minn., and colleagues.

In a study published in the Lancet, the researchers reviewed data from 649,931 normal sinus rhythm ECGs collected from 180,922 adults between December 1993 and July 2017.

The ECGs were divided into three groups: training (454,789 ECGs from 126,526 patients) internal validation (64,340 ECGs from 18,116 patients) and testing (130,802 ECGs from 36,280 patients). The primary outcome was whether the AI-programmed ECG could identify AFib in a total of 3,051 patients in the testing data set who had verified AFib before being tested with the AI device. The AI-enabled ECG was designed to detect subtle changes using neural network technology previously used by the researchers to identify ventricular dysfunction.

Overall, a single ECG scan identified AFib with an accuracy of 79.4%, an area under the curve (AUC) of 0.87, sensitivity of 79.0%, and specificity of 79.5%. When researchers reviewed multiple ECGs from a 1-month window of either the study start date or 31 days before the first AFib, the accuracy increased to 83.3%, with an AUC of 0.90, sensitivity of 82.3%, and specificity of 83.4%.



The results support the use of subtle changes on normal sinus rhythm ECG to identify patient with potentially undetected AFib, and suggest that AI-enabled ECGs could be used at the point of care to identify patients at risk after unexplained strokes, also known as embolic stroke of undetermined source (ESUS), or heart failure, the researchers noted.

“Although it would require further study, it is possible that this algorithm could identify a high-risk subset of patients with ESUS who could benefit from empirical anticoagulation,” the researchers said.

The study findings were limited by several factors, including possible mislabeling of patients with unidentified atrial fibrillation who were classified negative. In addition, the prevalence of AFib in the study population may be higher than in the general population, they said.

However, the results suggest that use a noninvasive, widely available, point of care test to identify AFib “could have important implications for atrial fibrillation screening and for the management of patients with unexplained stroke,” they concluded.

This study was funded by internal resources of the Mayo Clinic. The researchers had no financial conflicts to disclose.

SOURCE: Attia ZI et al. Lancet. 2019 Aug 1. doi. org/10.1016/S0140-6736(19)31721-0.

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Endocrine Society advises on diabetes care for older adults

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Diabetes management in adults aged 65 years and older involves special considerations, because the effects of aging on metabolic regulation can exacerbate the disease and accelerate the development of common complications, according to a new guideline on diabetes care for older adults issued by the Endocrine Society.

“The prevalence of diabetes in the United States is projected to increase dramatically during the next 3 decades as the population ages, the numbers of higher-risk minority groups increase, and people with diabetes live longer because of decreasing rates of cardiovascular deaths,” wrote Derek LeRoith, MD, of Icahn School of Medicine at Mount Sinai, New York, and his writing committee colleagues. They said their goal was to provide health care providers with guidance for the management of type 1 or type 2 diabetes in older patients, with a focus on simplifying medication regimens and management strategies to avoid “unnecessary and/or harmful adverse effects.”

The guideline, published in the Journal of Clinical Endocrinology & Metabolism, is based mainly on evidence from controlled trials in two systematic reviews that specifically focused on adults aged 65 years and older. The guideline addresses six areas of consideration for this patient population:

  • Role of the endocrinologist and diabetes care specialist.
  • Screening for diabetes and prediabetes, and diabetes prevention.
  • Assessment of older patients with diabetes.
  • Treatment of hyperglycemia.
  • Treating complications of diabetes.
  • Special settings and populations.

Partnerships and screening

The guideline recommends that primary care providers partner with an endocrinologist or diabetes specialist in the care of patients aged 65 and older with newly diagnosed diabetes, and that the specialist take primary responsibility for diabetes care of patients with type 1 diabetes or those who need more complex intervention to achieve treatment goals.

Screening for diabetes in adults aged 65 years and older using fasting plasma glucose and/or hemoglobin A1c should occur every 2 years, but that schedule should be adjusted based on shared decision making with the patient, the committee said. Providers are advised to assess the patient’s overall health and personal values before settling on treatment goals and strategies. The writing group also recommends periodic cognitive screening and that medication regimens be simplified as much as possible.
 

Tackling hyperglycemia

For treatment of hyperglycemia, the guideline recommends outpatient strategies to minimize hypoglycemia and periodic or continuous glucose monitoring. The strategies include lifestyle modifications as a first-line intervention for ambulatory patients, as well as nutritional assessment. A high-protein diet is recommended for older patients with frailty, but no restrictions on diet are advised for patients who cannot meet glycemic targets with lifestyle modification and who are at risk for malnutrition.

Metformin is the first-choice recommendation for patients with diabetes aged 65 and older who need medical management in addition to lifestyle modification, but it is not recommended for individuals with impaired kidney function or gastrointestinal intolerance, according to the guideline. Oral and injectable drugs and/or insulin are recommended if metformin and lifestyle changes are insufficient to meet glycemic targets, the writers noted.
 

 

 

Managing complications

Hypertension is among the diabetes-related complications that need to be managed in older adults, and the guideline recommends a target blood pressure of 140/90 mm Hg, but other targets – based on patient-provider shared decision making – may be considered for patients in high-risk groups.

The guideline calls for management of hyperlipidemia with statin therapy and “use of an annual lipid profile to achieve the recommended levels for reducing absolute cardiovascular disease events and all-cause mortality.” The committee does not specify low-density lipoprotein cholesterol targets because of insufficient evidence, but recommends alternative treatments, including ezetimibe or proprotein convertase subtilisin/kexin type 9 inhibitors, if statin therapy is not enough to help the patients meet goals. The writers also advocate fish oil and/or fenofibrate for patients with fasting triglycerides of more than 500 mg/dL.

To manage congestive heart failure in older patients with diabetes, the guideline recommends following standard clinical practice guidelines for the condition, and cautious use of oral hypoglycemic agents, including glinides, rosiglitazone, pioglitazone, and dipeptidyl peptidase–4 inhibitors. The writers noted that low-dose aspirin is recommended for patients with diabetes with a history of atherosclerotic cardiovascular disease.

The committee also recommends an annual comprehensive eye exam for patients with diabetes aged 65 years and older to identify retinal disease and suggests that actions, such as physical therapy and reduced use of sedatives, be taken to minimize the risk of falls in patients with neuropathy or problems with balance and gait.

Older patients with diabetes also should be screened annually for chronic kidney disease, and the dosage of diabetes medications should be adjusted to minimize side effects in patients with kidney problems.
 

Tailoring care to setting

Finally, the guideline addresses special settings and populations, including managing diabetes in hospitals or nursing homes, or in patients who are transitioning to homes or long-term care facilities. Recommendations in this category include simplifying medications for older adults with terminal illness or severe comorbidities, as well as setting glycemic targets as part of a hospital discharge plan.

“The most important aspect of successful transition is effective, detailed, and thorough bidirectional communication between the discharging and receiving teams of health care providers,” the writers emphasized.

The guideline is cosponsored by the European Society of Endocrinology, the Gerontological Society of America, and the Obesity Society. The chair of the committee had no relevant financial conflicts to disclose, and at least 50% of the committee members were free of relevant conflicts of interest.

SOURCE: LeRoith D et al. J Clin Endocrinol Metab. 2019;104:1520-74.

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Diabetes management in adults aged 65 years and older involves special considerations, because the effects of aging on metabolic regulation can exacerbate the disease and accelerate the development of common complications, according to a new guideline on diabetes care for older adults issued by the Endocrine Society.

“The prevalence of diabetes in the United States is projected to increase dramatically during the next 3 decades as the population ages, the numbers of higher-risk minority groups increase, and people with diabetes live longer because of decreasing rates of cardiovascular deaths,” wrote Derek LeRoith, MD, of Icahn School of Medicine at Mount Sinai, New York, and his writing committee colleagues. They said their goal was to provide health care providers with guidance for the management of type 1 or type 2 diabetes in older patients, with a focus on simplifying medication regimens and management strategies to avoid “unnecessary and/or harmful adverse effects.”

The guideline, published in the Journal of Clinical Endocrinology & Metabolism, is based mainly on evidence from controlled trials in two systematic reviews that specifically focused on adults aged 65 years and older. The guideline addresses six areas of consideration for this patient population:

  • Role of the endocrinologist and diabetes care specialist.
  • Screening for diabetes and prediabetes, and diabetes prevention.
  • Assessment of older patients with diabetes.
  • Treatment of hyperglycemia.
  • Treating complications of diabetes.
  • Special settings and populations.

Partnerships and screening

The guideline recommends that primary care providers partner with an endocrinologist or diabetes specialist in the care of patients aged 65 and older with newly diagnosed diabetes, and that the specialist take primary responsibility for diabetes care of patients with type 1 diabetes or those who need more complex intervention to achieve treatment goals.

Screening for diabetes in adults aged 65 years and older using fasting plasma glucose and/or hemoglobin A1c should occur every 2 years, but that schedule should be adjusted based on shared decision making with the patient, the committee said. Providers are advised to assess the patient’s overall health and personal values before settling on treatment goals and strategies. The writing group also recommends periodic cognitive screening and that medication regimens be simplified as much as possible.
 

Tackling hyperglycemia

For treatment of hyperglycemia, the guideline recommends outpatient strategies to minimize hypoglycemia and periodic or continuous glucose monitoring. The strategies include lifestyle modifications as a first-line intervention for ambulatory patients, as well as nutritional assessment. A high-protein diet is recommended for older patients with frailty, but no restrictions on diet are advised for patients who cannot meet glycemic targets with lifestyle modification and who are at risk for malnutrition.

Metformin is the first-choice recommendation for patients with diabetes aged 65 and older who need medical management in addition to lifestyle modification, but it is not recommended for individuals with impaired kidney function or gastrointestinal intolerance, according to the guideline. Oral and injectable drugs and/or insulin are recommended if metformin and lifestyle changes are insufficient to meet glycemic targets, the writers noted.
 

 

 

Managing complications

Hypertension is among the diabetes-related complications that need to be managed in older adults, and the guideline recommends a target blood pressure of 140/90 mm Hg, but other targets – based on patient-provider shared decision making – may be considered for patients in high-risk groups.

The guideline calls for management of hyperlipidemia with statin therapy and “use of an annual lipid profile to achieve the recommended levels for reducing absolute cardiovascular disease events and all-cause mortality.” The committee does not specify low-density lipoprotein cholesterol targets because of insufficient evidence, but recommends alternative treatments, including ezetimibe or proprotein convertase subtilisin/kexin type 9 inhibitors, if statin therapy is not enough to help the patients meet goals. The writers also advocate fish oil and/or fenofibrate for patients with fasting triglycerides of more than 500 mg/dL.

To manage congestive heart failure in older patients with diabetes, the guideline recommends following standard clinical practice guidelines for the condition, and cautious use of oral hypoglycemic agents, including glinides, rosiglitazone, pioglitazone, and dipeptidyl peptidase–4 inhibitors. The writers noted that low-dose aspirin is recommended for patients with diabetes with a history of atherosclerotic cardiovascular disease.

The committee also recommends an annual comprehensive eye exam for patients with diabetes aged 65 years and older to identify retinal disease and suggests that actions, such as physical therapy and reduced use of sedatives, be taken to minimize the risk of falls in patients with neuropathy or problems with balance and gait.

Older patients with diabetes also should be screened annually for chronic kidney disease, and the dosage of diabetes medications should be adjusted to minimize side effects in patients with kidney problems.
 

Tailoring care to setting

Finally, the guideline addresses special settings and populations, including managing diabetes in hospitals or nursing homes, or in patients who are transitioning to homes or long-term care facilities. Recommendations in this category include simplifying medications for older adults with terminal illness or severe comorbidities, as well as setting glycemic targets as part of a hospital discharge plan.

“The most important aspect of successful transition is effective, detailed, and thorough bidirectional communication between the discharging and receiving teams of health care providers,” the writers emphasized.

The guideline is cosponsored by the European Society of Endocrinology, the Gerontological Society of America, and the Obesity Society. The chair of the committee had no relevant financial conflicts to disclose, and at least 50% of the committee members were free of relevant conflicts of interest.

SOURCE: LeRoith D et al. J Clin Endocrinol Metab. 2019;104:1520-74.

 

Diabetes management in adults aged 65 years and older involves special considerations, because the effects of aging on metabolic regulation can exacerbate the disease and accelerate the development of common complications, according to a new guideline on diabetes care for older adults issued by the Endocrine Society.

“The prevalence of diabetes in the United States is projected to increase dramatically during the next 3 decades as the population ages, the numbers of higher-risk minority groups increase, and people with diabetes live longer because of decreasing rates of cardiovascular deaths,” wrote Derek LeRoith, MD, of Icahn School of Medicine at Mount Sinai, New York, and his writing committee colleagues. They said their goal was to provide health care providers with guidance for the management of type 1 or type 2 diabetes in older patients, with a focus on simplifying medication regimens and management strategies to avoid “unnecessary and/or harmful adverse effects.”

The guideline, published in the Journal of Clinical Endocrinology & Metabolism, is based mainly on evidence from controlled trials in two systematic reviews that specifically focused on adults aged 65 years and older. The guideline addresses six areas of consideration for this patient population:

  • Role of the endocrinologist and diabetes care specialist.
  • Screening for diabetes and prediabetes, and diabetes prevention.
  • Assessment of older patients with diabetes.
  • Treatment of hyperglycemia.
  • Treating complications of diabetes.
  • Special settings and populations.

Partnerships and screening

The guideline recommends that primary care providers partner with an endocrinologist or diabetes specialist in the care of patients aged 65 and older with newly diagnosed diabetes, and that the specialist take primary responsibility for diabetes care of patients with type 1 diabetes or those who need more complex intervention to achieve treatment goals.

Screening for diabetes in adults aged 65 years and older using fasting plasma glucose and/or hemoglobin A1c should occur every 2 years, but that schedule should be adjusted based on shared decision making with the patient, the committee said. Providers are advised to assess the patient’s overall health and personal values before settling on treatment goals and strategies. The writing group also recommends periodic cognitive screening and that medication regimens be simplified as much as possible.
 

Tackling hyperglycemia

For treatment of hyperglycemia, the guideline recommends outpatient strategies to minimize hypoglycemia and periodic or continuous glucose monitoring. The strategies include lifestyle modifications as a first-line intervention for ambulatory patients, as well as nutritional assessment. A high-protein diet is recommended for older patients with frailty, but no restrictions on diet are advised for patients who cannot meet glycemic targets with lifestyle modification and who are at risk for malnutrition.

Metformin is the first-choice recommendation for patients with diabetes aged 65 and older who need medical management in addition to lifestyle modification, but it is not recommended for individuals with impaired kidney function or gastrointestinal intolerance, according to the guideline. Oral and injectable drugs and/or insulin are recommended if metformin and lifestyle changes are insufficient to meet glycemic targets, the writers noted.
 

 

 

Managing complications

Hypertension is among the diabetes-related complications that need to be managed in older adults, and the guideline recommends a target blood pressure of 140/90 mm Hg, but other targets – based on patient-provider shared decision making – may be considered for patients in high-risk groups.

The guideline calls for management of hyperlipidemia with statin therapy and “use of an annual lipid profile to achieve the recommended levels for reducing absolute cardiovascular disease events and all-cause mortality.” The committee does not specify low-density lipoprotein cholesterol targets because of insufficient evidence, but recommends alternative treatments, including ezetimibe or proprotein convertase subtilisin/kexin type 9 inhibitors, if statin therapy is not enough to help the patients meet goals. The writers also advocate fish oil and/or fenofibrate for patients with fasting triglycerides of more than 500 mg/dL.

To manage congestive heart failure in older patients with diabetes, the guideline recommends following standard clinical practice guidelines for the condition, and cautious use of oral hypoglycemic agents, including glinides, rosiglitazone, pioglitazone, and dipeptidyl peptidase–4 inhibitors. The writers noted that low-dose aspirin is recommended for patients with diabetes with a history of atherosclerotic cardiovascular disease.

The committee also recommends an annual comprehensive eye exam for patients with diabetes aged 65 years and older to identify retinal disease and suggests that actions, such as physical therapy and reduced use of sedatives, be taken to minimize the risk of falls in patients with neuropathy or problems with balance and gait.

Older patients with diabetes also should be screened annually for chronic kidney disease, and the dosage of diabetes medications should be adjusted to minimize side effects in patients with kidney problems.
 

Tailoring care to setting

Finally, the guideline addresses special settings and populations, including managing diabetes in hospitals or nursing homes, or in patients who are transitioning to homes or long-term care facilities. Recommendations in this category include simplifying medications for older adults with terminal illness or severe comorbidities, as well as setting glycemic targets as part of a hospital discharge plan.

“The most important aspect of successful transition is effective, detailed, and thorough bidirectional communication between the discharging and receiving teams of health care providers,” the writers emphasized.

The guideline is cosponsored by the European Society of Endocrinology, the Gerontological Society of America, and the Obesity Society. The chair of the committee had no relevant financial conflicts to disclose, and at least 50% of the committee members were free of relevant conflicts of interest.

SOURCE: LeRoith D et al. J Clin Endocrinol Metab. 2019;104:1520-74.

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AAD, NPF update use of phototherapy for psoriasis

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Phototherapy remains a viable element of psoriasis care for many patients, used alone or in conjunction with other treatments, according to updated guidelines issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

Dr. Craig A. Elmets

“Phototherapy serves as a reasonable and effective treatment option for patients requiring more than topical medications and/or those wishing to avoid systemic medications or simply seeking an adjunct to a failing regimen,” wrote working group cochair Craig A. Elmets, MD, professor of dermatology at the University of Alabama at Birmingham, and coauthors.

The guidelines, which focus on phototherapy for adults with psoriasis, join a multipart series on psoriasis being published this year in the Journal of the American Academy of Dermatology.

The working group used an evidence-based model to examine efficacy, effectiveness, and adverse effects of the following modalities: narrow-band ultraviolet B (NB-UVB); broadband ultraviolet B (BB-UVB); targeted phototherapy using excimer laser and excimer lamp; psoralen plus ultraviolet A (PUVA) therapy, including topical, oral, and bath PUVA; photodynamic therapy (PDT), grenz ray therapy, climatotherapy; visible light therapy; Goeckerman therapy; and pulsed dye laser/intense pulsed light.

NB-UVB, which can be used to treat generalized plaque psoriasis, refers to wavelengths of 311-313 nm. The recommended treatment is two or three times a week, with a starting dose based on skin phenotype or minimal erythema dose. Although oral PUVA has shown higher clearance rates, compared with NB-UVB, NB-UVB has demonstrated fewer side effects. NB-UVB also has shown effectiveness for psoriasis in combination with medications including oral retinoids, “particularly useful in patients at increased risk for skin cancer,” the working group wrote. Genital shielding and eye protection are recommended during all phototherapy sessions to reduce the risk of cancer and cataracts, they emphasized.

BB-UVB, an older version of NB-UVB, is still effective for generalized plaque psoriasis as monotherapy, but evidence does not support additional benefit in combination with other treatments, and overall BB-UVB is less effective than either NB-UVB or oral PUVA, the working group said.

For treatment of localized psoriatic lesions, some evidence supports the ability of targeted UVB therapy to improve lesions in fewer treatments and at a lower cumulative dose, compared with nontargeted phototherapy, for palmoplantar plaque psoriasis and palmoplantar pustulosis. Excimer lasers also have shown effectiveness against scalp psoriasis, the working group noted. However, “there is insufficient evidence to recommend the excimer laser rather than topical PUVA for treatment of localized plaque psoriasis,” they said.



PUVA treatments are available as topical creams, or they can be taken orally, or mixed with bath water. All forms of PUVA include psoralens, photosensitizing agents that prepare target cells for the effects of UVA light. Topical PUVA has demonstrated particular effectiveness for palmoplantar psoriasis, the working group noted, but there is a risk of phototoxicity, so it has become less popular, they added. Similarly, evidence supports effectiveness of oral and bath PUVA, but all forms are used less frequently because of the increased availability of NB-UVB phototherapy, they said.

PDT is primarily used to destroy premalignant or malignant cells, and in theory “PDT-induced apoptosis of T lymphocytes could lead to reductions in inflammatory cytokines and, in turn, to improvement of psoriasis,” the working group noted. However, “clinical studies have failed to find significant benefit” of PDT using either 5-aminolevulinic acid (ALA) or methyl aminolevulinic acid (MAL) for psoriasis, or any significant benefits of MAL-PDT for nail psoriasis.

The grenz ray is an effective, but rarely used treatment in which 75% of long-wavelength ionizing radiation is absorbed by the first 1 mm of skin and 95% is absorbed within the first 3 mm of skin to protect the deeper tissues from radiation. Although more alternatives are available, grenz rays can be used for psoriasis patients unable to tolerate UV therapy, according to the working group.

Climatotherapy involves temporary or permanent relocation of the patient to a part of the world with a climate that could be favorable for psoriasis because of the unique effects of environmental factors in those areas. The evidence to support climatotherapy is both subjective and objective, but considered safe.

Visible light has been associated with improvement in erythema in psoriasis, with hyperpigmentation as the only notable side effect based on the evidence reviewed. However, the working group found the current evidence insufficient to recommend the use of intense pulsed light for treating psoriasis.

Dr. Alan Menter

Goeckerman therapy, a method that combines coal tar and UVB phototherapy, has shown safety and effectiveness for patients with recalcitrant or severe psoriasis, and remains a recommended treatment, according to the working group research. However, this method is underused, especially in the United States, because of the messiness of the application, challenge of insurance reimbursement, and investment of time for outpatient care, the work group noted.

Pulsed dye laser treatment is effective for nail psoriasis, and reported adverse effects have been mild, according to the working group.

Overall, the guidelines emphasize that quality of life and disease severity should be considered and discussed with patients along with efficacy and safety information so they can make informed decisions about adding phototherapy to a current regimen or switching among modalities.

The guidelines have no funding sources. Several coauthors disclosed relationships with multiple companies, including manufacturers of psoriasis products; however, a minimum of 51% of the work group had no relevant financial conflicts to disclose, in accordance with AAD policy. Work group members with potential conflicts recused themselves from discussion and drafting of recommendations in the relevant topic areas. Alan Menter, MD, chairman of the division of dermatology, Baylor University Medical Center, Dallas, is the other cochair of the work group.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2019 Jul 18. doi: 10.1016/j.jaad.2019.04.042.

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Phototherapy remains a viable element of psoriasis care for many patients, used alone or in conjunction with other treatments, according to updated guidelines issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

Dr. Craig A. Elmets

“Phototherapy serves as a reasonable and effective treatment option for patients requiring more than topical medications and/or those wishing to avoid systemic medications or simply seeking an adjunct to a failing regimen,” wrote working group cochair Craig A. Elmets, MD, professor of dermatology at the University of Alabama at Birmingham, and coauthors.

The guidelines, which focus on phototherapy for adults with psoriasis, join a multipart series on psoriasis being published this year in the Journal of the American Academy of Dermatology.

The working group used an evidence-based model to examine efficacy, effectiveness, and adverse effects of the following modalities: narrow-band ultraviolet B (NB-UVB); broadband ultraviolet B (BB-UVB); targeted phototherapy using excimer laser and excimer lamp; psoralen plus ultraviolet A (PUVA) therapy, including topical, oral, and bath PUVA; photodynamic therapy (PDT), grenz ray therapy, climatotherapy; visible light therapy; Goeckerman therapy; and pulsed dye laser/intense pulsed light.

NB-UVB, which can be used to treat generalized plaque psoriasis, refers to wavelengths of 311-313 nm. The recommended treatment is two or three times a week, with a starting dose based on skin phenotype or minimal erythema dose. Although oral PUVA has shown higher clearance rates, compared with NB-UVB, NB-UVB has demonstrated fewer side effects. NB-UVB also has shown effectiveness for psoriasis in combination with medications including oral retinoids, “particularly useful in patients at increased risk for skin cancer,” the working group wrote. Genital shielding and eye protection are recommended during all phototherapy sessions to reduce the risk of cancer and cataracts, they emphasized.

BB-UVB, an older version of NB-UVB, is still effective for generalized plaque psoriasis as monotherapy, but evidence does not support additional benefit in combination with other treatments, and overall BB-UVB is less effective than either NB-UVB or oral PUVA, the working group said.

For treatment of localized psoriatic lesions, some evidence supports the ability of targeted UVB therapy to improve lesions in fewer treatments and at a lower cumulative dose, compared with nontargeted phototherapy, for palmoplantar plaque psoriasis and palmoplantar pustulosis. Excimer lasers also have shown effectiveness against scalp psoriasis, the working group noted. However, “there is insufficient evidence to recommend the excimer laser rather than topical PUVA for treatment of localized plaque psoriasis,” they said.



PUVA treatments are available as topical creams, or they can be taken orally, or mixed with bath water. All forms of PUVA include psoralens, photosensitizing agents that prepare target cells for the effects of UVA light. Topical PUVA has demonstrated particular effectiveness for palmoplantar psoriasis, the working group noted, but there is a risk of phototoxicity, so it has become less popular, they added. Similarly, evidence supports effectiveness of oral and bath PUVA, but all forms are used less frequently because of the increased availability of NB-UVB phototherapy, they said.

PDT is primarily used to destroy premalignant or malignant cells, and in theory “PDT-induced apoptosis of T lymphocytes could lead to reductions in inflammatory cytokines and, in turn, to improvement of psoriasis,” the working group noted. However, “clinical studies have failed to find significant benefit” of PDT using either 5-aminolevulinic acid (ALA) or methyl aminolevulinic acid (MAL) for psoriasis, or any significant benefits of MAL-PDT for nail psoriasis.

The grenz ray is an effective, but rarely used treatment in which 75% of long-wavelength ionizing radiation is absorbed by the first 1 mm of skin and 95% is absorbed within the first 3 mm of skin to protect the deeper tissues from radiation. Although more alternatives are available, grenz rays can be used for psoriasis patients unable to tolerate UV therapy, according to the working group.

Climatotherapy involves temporary or permanent relocation of the patient to a part of the world with a climate that could be favorable for psoriasis because of the unique effects of environmental factors in those areas. The evidence to support climatotherapy is both subjective and objective, but considered safe.

Visible light has been associated with improvement in erythema in psoriasis, with hyperpigmentation as the only notable side effect based on the evidence reviewed. However, the working group found the current evidence insufficient to recommend the use of intense pulsed light for treating psoriasis.

Dr. Alan Menter

Goeckerman therapy, a method that combines coal tar and UVB phototherapy, has shown safety and effectiveness for patients with recalcitrant or severe psoriasis, and remains a recommended treatment, according to the working group research. However, this method is underused, especially in the United States, because of the messiness of the application, challenge of insurance reimbursement, and investment of time for outpatient care, the work group noted.

Pulsed dye laser treatment is effective for nail psoriasis, and reported adverse effects have been mild, according to the working group.

Overall, the guidelines emphasize that quality of life and disease severity should be considered and discussed with patients along with efficacy and safety information so they can make informed decisions about adding phototherapy to a current regimen or switching among modalities.

The guidelines have no funding sources. Several coauthors disclosed relationships with multiple companies, including manufacturers of psoriasis products; however, a minimum of 51% of the work group had no relevant financial conflicts to disclose, in accordance with AAD policy. Work group members with potential conflicts recused themselves from discussion and drafting of recommendations in the relevant topic areas. Alan Menter, MD, chairman of the division of dermatology, Baylor University Medical Center, Dallas, is the other cochair of the work group.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2019 Jul 18. doi: 10.1016/j.jaad.2019.04.042.

 

Phototherapy remains a viable element of psoriasis care for many patients, used alone or in conjunction with other treatments, according to updated guidelines issued jointly by the American Academy of Dermatology and the National Psoriasis Foundation.

Dr. Craig A. Elmets

“Phototherapy serves as a reasonable and effective treatment option for patients requiring more than topical medications and/or those wishing to avoid systemic medications or simply seeking an adjunct to a failing regimen,” wrote working group cochair Craig A. Elmets, MD, professor of dermatology at the University of Alabama at Birmingham, and coauthors.

The guidelines, which focus on phototherapy for adults with psoriasis, join a multipart series on psoriasis being published this year in the Journal of the American Academy of Dermatology.

The working group used an evidence-based model to examine efficacy, effectiveness, and adverse effects of the following modalities: narrow-band ultraviolet B (NB-UVB); broadband ultraviolet B (BB-UVB); targeted phototherapy using excimer laser and excimer lamp; psoralen plus ultraviolet A (PUVA) therapy, including topical, oral, and bath PUVA; photodynamic therapy (PDT), grenz ray therapy, climatotherapy; visible light therapy; Goeckerman therapy; and pulsed dye laser/intense pulsed light.

NB-UVB, which can be used to treat generalized plaque psoriasis, refers to wavelengths of 311-313 nm. The recommended treatment is two or three times a week, with a starting dose based on skin phenotype or minimal erythema dose. Although oral PUVA has shown higher clearance rates, compared with NB-UVB, NB-UVB has demonstrated fewer side effects. NB-UVB also has shown effectiveness for psoriasis in combination with medications including oral retinoids, “particularly useful in patients at increased risk for skin cancer,” the working group wrote. Genital shielding and eye protection are recommended during all phototherapy sessions to reduce the risk of cancer and cataracts, they emphasized.

BB-UVB, an older version of NB-UVB, is still effective for generalized plaque psoriasis as monotherapy, but evidence does not support additional benefit in combination with other treatments, and overall BB-UVB is less effective than either NB-UVB or oral PUVA, the working group said.

For treatment of localized psoriatic lesions, some evidence supports the ability of targeted UVB therapy to improve lesions in fewer treatments and at a lower cumulative dose, compared with nontargeted phototherapy, for palmoplantar plaque psoriasis and palmoplantar pustulosis. Excimer lasers also have shown effectiveness against scalp psoriasis, the working group noted. However, “there is insufficient evidence to recommend the excimer laser rather than topical PUVA for treatment of localized plaque psoriasis,” they said.



PUVA treatments are available as topical creams, or they can be taken orally, or mixed with bath water. All forms of PUVA include psoralens, photosensitizing agents that prepare target cells for the effects of UVA light. Topical PUVA has demonstrated particular effectiveness for palmoplantar psoriasis, the working group noted, but there is a risk of phototoxicity, so it has become less popular, they added. Similarly, evidence supports effectiveness of oral and bath PUVA, but all forms are used less frequently because of the increased availability of NB-UVB phototherapy, they said.

PDT is primarily used to destroy premalignant or malignant cells, and in theory “PDT-induced apoptosis of T lymphocytes could lead to reductions in inflammatory cytokines and, in turn, to improvement of psoriasis,” the working group noted. However, “clinical studies have failed to find significant benefit” of PDT using either 5-aminolevulinic acid (ALA) or methyl aminolevulinic acid (MAL) for psoriasis, or any significant benefits of MAL-PDT for nail psoriasis.

The grenz ray is an effective, but rarely used treatment in which 75% of long-wavelength ionizing radiation is absorbed by the first 1 mm of skin and 95% is absorbed within the first 3 mm of skin to protect the deeper tissues from radiation. Although more alternatives are available, grenz rays can be used for psoriasis patients unable to tolerate UV therapy, according to the working group.

Climatotherapy involves temporary or permanent relocation of the patient to a part of the world with a climate that could be favorable for psoriasis because of the unique effects of environmental factors in those areas. The evidence to support climatotherapy is both subjective and objective, but considered safe.

Visible light has been associated with improvement in erythema in psoriasis, with hyperpigmentation as the only notable side effect based on the evidence reviewed. However, the working group found the current evidence insufficient to recommend the use of intense pulsed light for treating psoriasis.

Dr. Alan Menter

Goeckerman therapy, a method that combines coal tar and UVB phototherapy, has shown safety and effectiveness for patients with recalcitrant or severe psoriasis, and remains a recommended treatment, according to the working group research. However, this method is underused, especially in the United States, because of the messiness of the application, challenge of insurance reimbursement, and investment of time for outpatient care, the work group noted.

Pulsed dye laser treatment is effective for nail psoriasis, and reported adverse effects have been mild, according to the working group.

Overall, the guidelines emphasize that quality of life and disease severity should be considered and discussed with patients along with efficacy and safety information so they can make informed decisions about adding phototherapy to a current regimen or switching among modalities.

The guidelines have no funding sources. Several coauthors disclosed relationships with multiple companies, including manufacturers of psoriasis products; however, a minimum of 51% of the work group had no relevant financial conflicts to disclose, in accordance with AAD policy. Work group members with potential conflicts recused themselves from discussion and drafting of recommendations in the relevant topic areas. Alan Menter, MD, chairman of the division of dermatology, Baylor University Medical Center, Dallas, is the other cochair of the work group.
 

SOURCE: Elmets CA et al. J Am Acad Dermatol. 2019 Jul 18. doi: 10.1016/j.jaad.2019.04.042.

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Acupuncture cuts attacks in chronic angina

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Adults with chronic stable angina who had acupuncture as an adjunct treatment had fewer angina attacks, compared with controls, based on data from a randomized trial of 398 patients in China.

“Acupuncture has been used as nonpharmacologic treatment for several decades, especially to relieve symptoms of myocardial ischemia, improve cardiac function, and prevent recurrence,” and several small studies have reported benefits in angina patients, wrote Ling Zhao, PhD, of Chengdu (China) University of Traditional Chinese Medicine and colleagues.

In a study published in JAMA Internal Medicine, the researchers randomized patients aged 35-80 years with chronic stable angina into four groups: treatment on the disease-affected meridian (DAM), treatment on the nonaffected meridian (NAM), sham acupuncture (SA), and no acupuncture (wait list, or WL).

Chronic stable angina is defined by the American College of Cardiology and the American Heart Association as angina at least twice a week. Patients with other serious conditions including a history of MI, severe heart failure, valvular heart disease, and poorly controlled blood pressure or diabetes were excluded.

Each treatment group received three acupuncture sessions for 30 minutes each week for 4 weeks. Patients kept diaries of angina attacks and were assessed every 4 weeks for 16 weeks. After 16 weeks, the DAM patients had a significantly greater reduction in angina attacks, compared with the NAM group (4.1 fewer attacks), the SA group (5.2 fewer attacks), and the WL group (5.6 fewer attacks).

Overall, 16 patients reported adverse events related to acupuncture, including 5 cases of subcutaneous hemorrhage at the insertion point, 3 reports of tingling at the insertion point, and 8 reports of sleeplessness during the study period, but no patients discontinued the study because of these events. One patient in the WL group died of an acute MI and received no acupuncture treatment.

“We found that acupuncture on the DAM had superior and clinically relevant benefits in reducing angina frequency and pain intensity to a greater degree than acupuncture on a NAM, SA, or no acupuncture,” the researchers wrote. They found improvements in DAM patients on most metrics, including the Seattle Angina Questionnaire, compared with the other groups.

In addition, “compared with SA and no acupuncture, acupuncture on the DAM resulted in better regulation of anxiety and depression within the 12 weeks after treatment than at the end of the treatment period,” they wrote. “Acupuncture on the DAM causes autonomic remodeling by improving the balance between the vagus nerve and sympathetic nervous system during treatment.”

The findings were limited by several factors including the small sample size, potential performance bias based on variation in the acupuncturists’ experience, lack of analysis of doses of rescue medication, and lack of subgroup analysis, the researchers noted. However, the results are consistent with previous studies and support acupuncture as a potential adjunct treatment for patients with mild to moderate chronic angina.

The researchers had no financial conflicts to disclose. The study was funded by the National Natural Science Foundation of China and the State Key Program for Basic Research of China.

SOURCE: Zhao L et al. JAMA Intern Med. 2019 Jul 29. doi: 10.1001/jamainternmed.2019.2407.

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Adults with chronic stable angina who had acupuncture as an adjunct treatment had fewer angina attacks, compared with controls, based on data from a randomized trial of 398 patients in China.

“Acupuncture has been used as nonpharmacologic treatment for several decades, especially to relieve symptoms of myocardial ischemia, improve cardiac function, and prevent recurrence,” and several small studies have reported benefits in angina patients, wrote Ling Zhao, PhD, of Chengdu (China) University of Traditional Chinese Medicine and colleagues.

In a study published in JAMA Internal Medicine, the researchers randomized patients aged 35-80 years with chronic stable angina into four groups: treatment on the disease-affected meridian (DAM), treatment on the nonaffected meridian (NAM), sham acupuncture (SA), and no acupuncture (wait list, or WL).

Chronic stable angina is defined by the American College of Cardiology and the American Heart Association as angina at least twice a week. Patients with other serious conditions including a history of MI, severe heart failure, valvular heart disease, and poorly controlled blood pressure or diabetes were excluded.

Each treatment group received three acupuncture sessions for 30 minutes each week for 4 weeks. Patients kept diaries of angina attacks and were assessed every 4 weeks for 16 weeks. After 16 weeks, the DAM patients had a significantly greater reduction in angina attacks, compared with the NAM group (4.1 fewer attacks), the SA group (5.2 fewer attacks), and the WL group (5.6 fewer attacks).

Overall, 16 patients reported adverse events related to acupuncture, including 5 cases of subcutaneous hemorrhage at the insertion point, 3 reports of tingling at the insertion point, and 8 reports of sleeplessness during the study period, but no patients discontinued the study because of these events. One patient in the WL group died of an acute MI and received no acupuncture treatment.

“We found that acupuncture on the DAM had superior and clinically relevant benefits in reducing angina frequency and pain intensity to a greater degree than acupuncture on a NAM, SA, or no acupuncture,” the researchers wrote. They found improvements in DAM patients on most metrics, including the Seattle Angina Questionnaire, compared with the other groups.

In addition, “compared with SA and no acupuncture, acupuncture on the DAM resulted in better regulation of anxiety and depression within the 12 weeks after treatment than at the end of the treatment period,” they wrote. “Acupuncture on the DAM causes autonomic remodeling by improving the balance between the vagus nerve and sympathetic nervous system during treatment.”

The findings were limited by several factors including the small sample size, potential performance bias based on variation in the acupuncturists’ experience, lack of analysis of doses of rescue medication, and lack of subgroup analysis, the researchers noted. However, the results are consistent with previous studies and support acupuncture as a potential adjunct treatment for patients with mild to moderate chronic angina.

The researchers had no financial conflicts to disclose. The study was funded by the National Natural Science Foundation of China and the State Key Program for Basic Research of China.

SOURCE: Zhao L et al. JAMA Intern Med. 2019 Jul 29. doi: 10.1001/jamainternmed.2019.2407.

 

Adults with chronic stable angina who had acupuncture as an adjunct treatment had fewer angina attacks, compared with controls, based on data from a randomized trial of 398 patients in China.

“Acupuncture has been used as nonpharmacologic treatment for several decades, especially to relieve symptoms of myocardial ischemia, improve cardiac function, and prevent recurrence,” and several small studies have reported benefits in angina patients, wrote Ling Zhao, PhD, of Chengdu (China) University of Traditional Chinese Medicine and colleagues.

In a study published in JAMA Internal Medicine, the researchers randomized patients aged 35-80 years with chronic stable angina into four groups: treatment on the disease-affected meridian (DAM), treatment on the nonaffected meridian (NAM), sham acupuncture (SA), and no acupuncture (wait list, or WL).

Chronic stable angina is defined by the American College of Cardiology and the American Heart Association as angina at least twice a week. Patients with other serious conditions including a history of MI, severe heart failure, valvular heart disease, and poorly controlled blood pressure or diabetes were excluded.

Each treatment group received three acupuncture sessions for 30 minutes each week for 4 weeks. Patients kept diaries of angina attacks and were assessed every 4 weeks for 16 weeks. After 16 weeks, the DAM patients had a significantly greater reduction in angina attacks, compared with the NAM group (4.1 fewer attacks), the SA group (5.2 fewer attacks), and the WL group (5.6 fewer attacks).

Overall, 16 patients reported adverse events related to acupuncture, including 5 cases of subcutaneous hemorrhage at the insertion point, 3 reports of tingling at the insertion point, and 8 reports of sleeplessness during the study period, but no patients discontinued the study because of these events. One patient in the WL group died of an acute MI and received no acupuncture treatment.

“We found that acupuncture on the DAM had superior and clinically relevant benefits in reducing angina frequency and pain intensity to a greater degree than acupuncture on a NAM, SA, or no acupuncture,” the researchers wrote. They found improvements in DAM patients on most metrics, including the Seattle Angina Questionnaire, compared with the other groups.

In addition, “compared with SA and no acupuncture, acupuncture on the DAM resulted in better regulation of anxiety and depression within the 12 weeks after treatment than at the end of the treatment period,” they wrote. “Acupuncture on the DAM causes autonomic remodeling by improving the balance between the vagus nerve and sympathetic nervous system during treatment.”

The findings were limited by several factors including the small sample size, potential performance bias based on variation in the acupuncturists’ experience, lack of analysis of doses of rescue medication, and lack of subgroup analysis, the researchers noted. However, the results are consistent with previous studies and support acupuncture as a potential adjunct treatment for patients with mild to moderate chronic angina.

The researchers had no financial conflicts to disclose. The study was funded by the National Natural Science Foundation of China and the State Key Program for Basic Research of China.

SOURCE: Zhao L et al. JAMA Intern Med. 2019 Jul 29. doi: 10.1001/jamainternmed.2019.2407.

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Key clinical point: Adults with chronic stable angina who were treated with acupuncture had significantly fewer attacks than either those treated with sham acupuncture or controls who received no acupuncture.

Major finding: The reduction in angina attacks was 4.07 in disease-affected meridian versus an unaffected meridian, 5.18 versus a sham group, and 5.63 versus untreated controls.

Study details: The data come from a randomized trial of 398 patients at five clinical centers in China.

Disclosures: The researchers had no financial conflicts to disclose. The study was funded by the National Natural Science Foundation of China and the State Key Program for Basic Research of China.

Source: Zhao L et al. JAMA Intern Med. 2019 Jul 29. doi: 10.1001/jamainternmed.2019.2407.

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More awareness needed of compensation in autism

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Understanding benefits, costs of strategies could guide diagnoses

 

Individuals with undiagnosed autism spectrum disorders and those with a formal diagnosis employ similar compensation behaviors to manage social and cognitive difficulties, and undiagnosed individuals may go unrecognized, data from an online survey of 136 adults suggest.

Unlike other adaptive behaviors in psychiatry, “autistic compensators, despite apparent lack of observable autistic behavior, continue being autistic at the neurocognitive level,” wrote Lucy Anne Livingston of Kings College London, and colleagues. “Because autism spectrum disorder is diagnosed by behavior alone, compensators might not receive a diagnosis and support until later in life, if at all. “

The researchers compared compensation behaviors in adults with and without an autism diagnosis. They recruited adults aged 18 years and older through an online advertisement distributed through social media and the U.K. National Autistic Society. Participants completed an online survey during Oct. 19, 2017–Jan. 2, 2018. The study was published in the Lancet Psychiatry.

“Compensation involved using intellectual and executive functions to regulate social behavior, such as intellectually conceived patterns about social norms (e.g., making eye contact), preplanning social niceties (e.g., asking others questions about themselves), and switching between social rules,” the researchers wrote.

The study population included 58 individuals with a clinical diagnosis of autism, 19 of whom self-identified as autistic but were not formally diagnosed, and 59 of whom reported social difficulties but had no formal diagnosis and did not self-identify as autistic. The average age of the three groups was 36 years, 40 years, and 34 years, respectively, and the average age at diagnosis for the diagnosed group was 30 years. Most of the individuals in each group were women (64%, 47%, and 86%, respectively). Responses were examined using a thematic analysis and thematic map.

In general, participants reported that compensation was a cognitively taxing process that served as a secondary route for social interaction because the primary route was unavailable, but that compensation strategies fell short in certain situations, such as unexpected turns of conversation. Overall, 38% of the respondents said their compensation strategies were “extremely successful” and 56% reported “somewhat successful.” However, 12% also reported their strategies were “extremely tiring,” and 36% reported “somewhat tiring.”

Factors affecting the participants’ abilities to compensate included environmental and sensory factors such as bright lights, loud noise, and large groups with unstructured social settings, such as parties. Also, transition to living independently as an adult led to problems, because compensation had allowed individuals to grow up appearing normal but lacking in additional support and strategies, the researchers noted.

Factors that contributed to successful interactions included similar interests with an interaction partner, and motivation to develop meaningful relationships. Participants also said they viewed compensation as a way to avoid ostracism and bullying. In addition, “fitting neurotypical peoples’ interaction style (e.g., eye contact or small talk) was viewed as vital for achieving life goals (e.g., independence and employment),” the researchers wrote.

In an accompanying editorial, Julia Parish-Morris, PhD, suggested the observation made by Ms. Livingston, a researcher at the Institute of Psychiatry, Psychology and Neuroscience at the college, and associates that compensation also occurs in people who do not have autism suggests that compensation might be a “general social lubricant that facilitates community living and is therefore a potentially useful tool.”

“In other words, perhaps raising awareness about compensation in autism spectrum disorder is an important first step toward eliminating the need for it,” wrote Dr. Parish-Morris, of the Center for Autism Research at Children’s Hospital of Philadelphia (Lancet Psychiatry. 2019 Jul 23. doi: 10.1016/S2215-0366[19]30294-9).

The study data were limited by the prevalence of female, well-educated, late-diagnosed individuals in the study population, which might limit the generalizability of the findings, and the lack of data on subconscious compensation because of the use of self-reports, the researchers noted.

However, “Given the individual differences found in this study, we tentatively suggest that clinicians take an individualized approach when assessing and discussing compensatory strategies with people with autism,” they said. “It will be important to establish which compensatory strategies are most beneficial, and how their success might be maximized with changes to external environments irrespective of clinical intervention.”

The researchers had no financial interests to disclose.

SOURCE: Livingston LA et al. Lancet Psychiatry. 2019 Jul 23. doi. org/10.1016/S2215-0366(19)30224-X.

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Understanding benefits, costs of strategies could guide diagnoses

Understanding benefits, costs of strategies could guide diagnoses

 

Individuals with undiagnosed autism spectrum disorders and those with a formal diagnosis employ similar compensation behaviors to manage social and cognitive difficulties, and undiagnosed individuals may go unrecognized, data from an online survey of 136 adults suggest.

Unlike other adaptive behaviors in psychiatry, “autistic compensators, despite apparent lack of observable autistic behavior, continue being autistic at the neurocognitive level,” wrote Lucy Anne Livingston of Kings College London, and colleagues. “Because autism spectrum disorder is diagnosed by behavior alone, compensators might not receive a diagnosis and support until later in life, if at all. “

The researchers compared compensation behaviors in adults with and without an autism diagnosis. They recruited adults aged 18 years and older through an online advertisement distributed through social media and the U.K. National Autistic Society. Participants completed an online survey during Oct. 19, 2017–Jan. 2, 2018. The study was published in the Lancet Psychiatry.

“Compensation involved using intellectual and executive functions to regulate social behavior, such as intellectually conceived patterns about social norms (e.g., making eye contact), preplanning social niceties (e.g., asking others questions about themselves), and switching between social rules,” the researchers wrote.

The study population included 58 individuals with a clinical diagnosis of autism, 19 of whom self-identified as autistic but were not formally diagnosed, and 59 of whom reported social difficulties but had no formal diagnosis and did not self-identify as autistic. The average age of the three groups was 36 years, 40 years, and 34 years, respectively, and the average age at diagnosis for the diagnosed group was 30 years. Most of the individuals in each group were women (64%, 47%, and 86%, respectively). Responses were examined using a thematic analysis and thematic map.

In general, participants reported that compensation was a cognitively taxing process that served as a secondary route for social interaction because the primary route was unavailable, but that compensation strategies fell short in certain situations, such as unexpected turns of conversation. Overall, 38% of the respondents said their compensation strategies were “extremely successful” and 56% reported “somewhat successful.” However, 12% also reported their strategies were “extremely tiring,” and 36% reported “somewhat tiring.”

Factors affecting the participants’ abilities to compensate included environmental and sensory factors such as bright lights, loud noise, and large groups with unstructured social settings, such as parties. Also, transition to living independently as an adult led to problems, because compensation had allowed individuals to grow up appearing normal but lacking in additional support and strategies, the researchers noted.

Factors that contributed to successful interactions included similar interests with an interaction partner, and motivation to develop meaningful relationships. Participants also said they viewed compensation as a way to avoid ostracism and bullying. In addition, “fitting neurotypical peoples’ interaction style (e.g., eye contact or small talk) was viewed as vital for achieving life goals (e.g., independence and employment),” the researchers wrote.

In an accompanying editorial, Julia Parish-Morris, PhD, suggested the observation made by Ms. Livingston, a researcher at the Institute of Psychiatry, Psychology and Neuroscience at the college, and associates that compensation also occurs in people who do not have autism suggests that compensation might be a “general social lubricant that facilitates community living and is therefore a potentially useful tool.”

“In other words, perhaps raising awareness about compensation in autism spectrum disorder is an important first step toward eliminating the need for it,” wrote Dr. Parish-Morris, of the Center for Autism Research at Children’s Hospital of Philadelphia (Lancet Psychiatry. 2019 Jul 23. doi: 10.1016/S2215-0366[19]30294-9).

The study data were limited by the prevalence of female, well-educated, late-diagnosed individuals in the study population, which might limit the generalizability of the findings, and the lack of data on subconscious compensation because of the use of self-reports, the researchers noted.

However, “Given the individual differences found in this study, we tentatively suggest that clinicians take an individualized approach when assessing and discussing compensatory strategies with people with autism,” they said. “It will be important to establish which compensatory strategies are most beneficial, and how their success might be maximized with changes to external environments irrespective of clinical intervention.”

The researchers had no financial interests to disclose.

SOURCE: Livingston LA et al. Lancet Psychiatry. 2019 Jul 23. doi. org/10.1016/S2215-0366(19)30224-X.

 

Individuals with undiagnosed autism spectrum disorders and those with a formal diagnosis employ similar compensation behaviors to manage social and cognitive difficulties, and undiagnosed individuals may go unrecognized, data from an online survey of 136 adults suggest.

Unlike other adaptive behaviors in psychiatry, “autistic compensators, despite apparent lack of observable autistic behavior, continue being autistic at the neurocognitive level,” wrote Lucy Anne Livingston of Kings College London, and colleagues. “Because autism spectrum disorder is diagnosed by behavior alone, compensators might not receive a diagnosis and support until later in life, if at all. “

The researchers compared compensation behaviors in adults with and without an autism diagnosis. They recruited adults aged 18 years and older through an online advertisement distributed through social media and the U.K. National Autistic Society. Participants completed an online survey during Oct. 19, 2017–Jan. 2, 2018. The study was published in the Lancet Psychiatry.

“Compensation involved using intellectual and executive functions to regulate social behavior, such as intellectually conceived patterns about social norms (e.g., making eye contact), preplanning social niceties (e.g., asking others questions about themselves), and switching between social rules,” the researchers wrote.

The study population included 58 individuals with a clinical diagnosis of autism, 19 of whom self-identified as autistic but were not formally diagnosed, and 59 of whom reported social difficulties but had no formal diagnosis and did not self-identify as autistic. The average age of the three groups was 36 years, 40 years, and 34 years, respectively, and the average age at diagnosis for the diagnosed group was 30 years. Most of the individuals in each group were women (64%, 47%, and 86%, respectively). Responses were examined using a thematic analysis and thematic map.

In general, participants reported that compensation was a cognitively taxing process that served as a secondary route for social interaction because the primary route was unavailable, but that compensation strategies fell short in certain situations, such as unexpected turns of conversation. Overall, 38% of the respondents said their compensation strategies were “extremely successful” and 56% reported “somewhat successful.” However, 12% also reported their strategies were “extremely tiring,” and 36% reported “somewhat tiring.”

Factors affecting the participants’ abilities to compensate included environmental and sensory factors such as bright lights, loud noise, and large groups with unstructured social settings, such as parties. Also, transition to living independently as an adult led to problems, because compensation had allowed individuals to grow up appearing normal but lacking in additional support and strategies, the researchers noted.

Factors that contributed to successful interactions included similar interests with an interaction partner, and motivation to develop meaningful relationships. Participants also said they viewed compensation as a way to avoid ostracism and bullying. In addition, “fitting neurotypical peoples’ interaction style (e.g., eye contact or small talk) was viewed as vital for achieving life goals (e.g., independence and employment),” the researchers wrote.

In an accompanying editorial, Julia Parish-Morris, PhD, suggested the observation made by Ms. Livingston, a researcher at the Institute of Psychiatry, Psychology and Neuroscience at the college, and associates that compensation also occurs in people who do not have autism suggests that compensation might be a “general social lubricant that facilitates community living and is therefore a potentially useful tool.”

“In other words, perhaps raising awareness about compensation in autism spectrum disorder is an important first step toward eliminating the need for it,” wrote Dr. Parish-Morris, of the Center for Autism Research at Children’s Hospital of Philadelphia (Lancet Psychiatry. 2019 Jul 23. doi: 10.1016/S2215-0366[19]30294-9).

The study data were limited by the prevalence of female, well-educated, late-diagnosed individuals in the study population, which might limit the generalizability of the findings, and the lack of data on subconscious compensation because of the use of self-reports, the researchers noted.

However, “Given the individual differences found in this study, we tentatively suggest that clinicians take an individualized approach when assessing and discussing compensatory strategies with people with autism,” they said. “It will be important to establish which compensatory strategies are most beneficial, and how their success might be maximized with changes to external environments irrespective of clinical intervention.”

The researchers had no financial interests to disclose.

SOURCE: Livingston LA et al. Lancet Psychiatry. 2019 Jul 23. doi. org/10.1016/S2215-0366(19)30224-X.

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Key clinical point: Individuals with social difficulties use similar compensation strategies to manage social situations whether or not they have an autism diagnosis.

Major finding: A total of 38% of respondents said their compensation behaviors were “extremely successful,” but 12% also reported those strategies were “extremely tiring.”

Study details: The data come from 136 adults who responded to an online survey; 58 diagnosed with autism, 19 self-identified, and 59 reported social difficulties without self-identification or diagnosis.

Disclosures: The researchers had no financial conflicts to disclose.

Source: Livingston LA et al. Lancet Psychiatry. 2019 Jul 23. doi: 10.1016/S2215-0366(19)30224-X.

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Atherosclerotic disease risk persists decades after smoking cessation

Keep encouraging all smokers to quit
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Adults who quit smoking reduced their risk for peripheral artery disease in the short term, but remained at increased risk for up to 30 years, compared with never-smokers, based on data from more than 13,000 adults in a community-based study.

Courtesy Journal of the American College of Cardiology

Most reports on the impact of smoking cessation on cardiovascular disease have focused on coronary heart disease (CHD), and stroke, while data on the effects of smoking cessation on peripheral artery disease (PAD) are limited, wrote Ning Ding, MBBS, SCM, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, Md., and colleagues.

To compare the impact of smoking on PAD, CHD, and stroke, the researchers used data from the Atherosclerosis Risk in Communities (ARIC) study, which included 15,792 adults aged 45-64 years in four communities. The findings were published in the Journal of the American College of Cardiology.

The study population of 13,355 individuals had no baseline history of PAD, CHD, or stroke. Over a median 26 years of follow-up, the researchers identified 492 cases of PAD, 1,798 cases of CHD, and 1,106 cases of stroke.

The risk of all three conditions began to decline within 5 years of smoking cessation, which could be encouraging to smokers who wish to quit, the researchers noted. In addition, the longer the duration of smoking cessation, the lower the risk for all three conditions (See central illustration).



However, a significantly elevated risk remained for PAD for up to 30 years after smoking cessation and for CHD for up to 20 years after smoking cessation, compared with never-smokers.

The researchers also found a roughly fourfold increased risk for PAD for smokers who smoked for 40 or more pack-years, compared with never-smokers, which was greater than the 2.1 hazard ratio for CHD and 1.8 HR for stroke. In addition, current smokers of at least one pack per day had a significantly greater risk of PAD, compared with never-smokers (HR, 5.36) that was higher than the risk for CHD or stroke (HR, 2.38 and HR, 1.88, respectively).

The study findings were limited by several factors including the reliance on self-reports, potential misclassification of data, and the potential exclusion of mild PAD cases that did not require hospitalization, the researchers noted. However, the results support the value of encouraging smokers to quit and support the need to include PAD risk in public health information, they said. “Although public statements about smoking and [cardiovascular disease] have been focusing on CHD and stroke, our results indicate the need to take account of PAD as well for comprehensively acknowledging the effect of smoking on overall cardiovascular health,” they added.

The ARIC study was funded by the National Heart, Lung, and Blood Institute, National Institutes of Health. Lead author Dr. Ding had no financial conflicts to disclose; coauthors disclosed relationships with Bristol-Myers Squibb and Fukuda Denshi.

SOURCE: Ding N et al. J Am Coll Cardiol. 2019 Jul 22;74:498-507. doi: 10.1016/j.jacc.2019.06.003.

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Although the pathophysiology of smoking and cardiovascular disease has yet to be teased out, the current study findings support the public health message that any and all smokers can improve their health by quitting any time: “It is never too early or too late to benefit from quitting,” wrote Nancy A. Rigotti, MD, and Mary M. McDermott, MD, in an accompanying editorial. The editorialists questioned whether the findings were generalizable to patients with mild PAD or those who are not hospitalized. However, they found the data consistent with previous studies suggesting that atherosclerosis is not homogeneous. “Differences in shear stress and hemodynamic forces among the femoral, coronary, and carotid arterial beds may also explain variability in associations of smoking and smoking cessation with the incidence of PAD versus myocardial infarction or stroke,” they said.

The findings also support the need to emphasize PAD in public health messages and provide an opportunity to educate patients about the risks of limb loss and impaired mobility associated with PAD, they said.

Many clinicians put a low priority on smoking cessation, the editorialists wrote, but “long-term tobacco abstinence is achievable using a chronic disease management approach resembling the strategies used to manage other risk factors,” they said. They cited the American College of Cardiology’s recently released “Expert Consensus Decision Pathway on Tobacco Cessation Treatment.” The pathway outlines advice for clinicians, including how to provide a brief intervention and resources along with advice to quit smoking.

Dr. Rigotti is affiliated with Harvard Medical School, Boston. Dr. McDermott is affiliated with Northwestern University, Chicago. Dr. Rigotti disclosed royalties from UpToDate, serving as a consultant for Achieve Life Sciences, and travel expenses from Pfizer for unpaid consulting. Dr. McDermott disclosed research funding from Regeneron, the National Heart, Lung, and Blood Institute, the National Institute on Aging, and the American Heart Association, plus research support from Chromadex, ReserveAge, Hershey, and ViroMed.

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Although the pathophysiology of smoking and cardiovascular disease has yet to be teased out, the current study findings support the public health message that any and all smokers can improve their health by quitting any time: “It is never too early or too late to benefit from quitting,” wrote Nancy A. Rigotti, MD, and Mary M. McDermott, MD, in an accompanying editorial. The editorialists questioned whether the findings were generalizable to patients with mild PAD or those who are not hospitalized. However, they found the data consistent with previous studies suggesting that atherosclerosis is not homogeneous. “Differences in shear stress and hemodynamic forces among the femoral, coronary, and carotid arterial beds may also explain variability in associations of smoking and smoking cessation with the incidence of PAD versus myocardial infarction or stroke,” they said.

The findings also support the need to emphasize PAD in public health messages and provide an opportunity to educate patients about the risks of limb loss and impaired mobility associated with PAD, they said.

Many clinicians put a low priority on smoking cessation, the editorialists wrote, but “long-term tobacco abstinence is achievable using a chronic disease management approach resembling the strategies used to manage other risk factors,” they said. They cited the American College of Cardiology’s recently released “Expert Consensus Decision Pathway on Tobacco Cessation Treatment.” The pathway outlines advice for clinicians, including how to provide a brief intervention and resources along with advice to quit smoking.

Dr. Rigotti is affiliated with Harvard Medical School, Boston. Dr. McDermott is affiliated with Northwestern University, Chicago. Dr. Rigotti disclosed royalties from UpToDate, serving as a consultant for Achieve Life Sciences, and travel expenses from Pfizer for unpaid consulting. Dr. McDermott disclosed research funding from Regeneron, the National Heart, Lung, and Blood Institute, the National Institute on Aging, and the American Heart Association, plus research support from Chromadex, ReserveAge, Hershey, and ViroMed.

Body

 

Although the pathophysiology of smoking and cardiovascular disease has yet to be teased out, the current study findings support the public health message that any and all smokers can improve their health by quitting any time: “It is never too early or too late to benefit from quitting,” wrote Nancy A. Rigotti, MD, and Mary M. McDermott, MD, in an accompanying editorial. The editorialists questioned whether the findings were generalizable to patients with mild PAD or those who are not hospitalized. However, they found the data consistent with previous studies suggesting that atherosclerosis is not homogeneous. “Differences in shear stress and hemodynamic forces among the femoral, coronary, and carotid arterial beds may also explain variability in associations of smoking and smoking cessation with the incidence of PAD versus myocardial infarction or stroke,” they said.

The findings also support the need to emphasize PAD in public health messages and provide an opportunity to educate patients about the risks of limb loss and impaired mobility associated with PAD, they said.

Many clinicians put a low priority on smoking cessation, the editorialists wrote, but “long-term tobacco abstinence is achievable using a chronic disease management approach resembling the strategies used to manage other risk factors,” they said. They cited the American College of Cardiology’s recently released “Expert Consensus Decision Pathway on Tobacco Cessation Treatment.” The pathway outlines advice for clinicians, including how to provide a brief intervention and resources along with advice to quit smoking.

Dr. Rigotti is affiliated with Harvard Medical School, Boston. Dr. McDermott is affiliated with Northwestern University, Chicago. Dr. Rigotti disclosed royalties from UpToDate, serving as a consultant for Achieve Life Sciences, and travel expenses from Pfizer for unpaid consulting. Dr. McDermott disclosed research funding from Regeneron, the National Heart, Lung, and Blood Institute, the National Institute on Aging, and the American Heart Association, plus research support from Chromadex, ReserveAge, Hershey, and ViroMed.

Title
Keep encouraging all smokers to quit
Keep encouraging all smokers to quit

 

Adults who quit smoking reduced their risk for peripheral artery disease in the short term, but remained at increased risk for up to 30 years, compared with never-smokers, based on data from more than 13,000 adults in a community-based study.

Courtesy Journal of the American College of Cardiology

Most reports on the impact of smoking cessation on cardiovascular disease have focused on coronary heart disease (CHD), and stroke, while data on the effects of smoking cessation on peripheral artery disease (PAD) are limited, wrote Ning Ding, MBBS, SCM, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, Md., and colleagues.

To compare the impact of smoking on PAD, CHD, and stroke, the researchers used data from the Atherosclerosis Risk in Communities (ARIC) study, which included 15,792 adults aged 45-64 years in four communities. The findings were published in the Journal of the American College of Cardiology.

The study population of 13,355 individuals had no baseline history of PAD, CHD, or stroke. Over a median 26 years of follow-up, the researchers identified 492 cases of PAD, 1,798 cases of CHD, and 1,106 cases of stroke.

The risk of all three conditions began to decline within 5 years of smoking cessation, which could be encouraging to smokers who wish to quit, the researchers noted. In addition, the longer the duration of smoking cessation, the lower the risk for all three conditions (See central illustration).



However, a significantly elevated risk remained for PAD for up to 30 years after smoking cessation and for CHD for up to 20 years after smoking cessation, compared with never-smokers.

The researchers also found a roughly fourfold increased risk for PAD for smokers who smoked for 40 or more pack-years, compared with never-smokers, which was greater than the 2.1 hazard ratio for CHD and 1.8 HR for stroke. In addition, current smokers of at least one pack per day had a significantly greater risk of PAD, compared with never-smokers (HR, 5.36) that was higher than the risk for CHD or stroke (HR, 2.38 and HR, 1.88, respectively).

The study findings were limited by several factors including the reliance on self-reports, potential misclassification of data, and the potential exclusion of mild PAD cases that did not require hospitalization, the researchers noted. However, the results support the value of encouraging smokers to quit and support the need to include PAD risk in public health information, they said. “Although public statements about smoking and [cardiovascular disease] have been focusing on CHD and stroke, our results indicate the need to take account of PAD as well for comprehensively acknowledging the effect of smoking on overall cardiovascular health,” they added.

The ARIC study was funded by the National Heart, Lung, and Blood Institute, National Institutes of Health. Lead author Dr. Ding had no financial conflicts to disclose; coauthors disclosed relationships with Bristol-Myers Squibb and Fukuda Denshi.

SOURCE: Ding N et al. J Am Coll Cardiol. 2019 Jul 22;74:498-507. doi: 10.1016/j.jacc.2019.06.003.

 

Adults who quit smoking reduced their risk for peripheral artery disease in the short term, but remained at increased risk for up to 30 years, compared with never-smokers, based on data from more than 13,000 adults in a community-based study.

Courtesy Journal of the American College of Cardiology

Most reports on the impact of smoking cessation on cardiovascular disease have focused on coronary heart disease (CHD), and stroke, while data on the effects of smoking cessation on peripheral artery disease (PAD) are limited, wrote Ning Ding, MBBS, SCM, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, Md., and colleagues.

To compare the impact of smoking on PAD, CHD, and stroke, the researchers used data from the Atherosclerosis Risk in Communities (ARIC) study, which included 15,792 adults aged 45-64 years in four communities. The findings were published in the Journal of the American College of Cardiology.

The study population of 13,355 individuals had no baseline history of PAD, CHD, or stroke. Over a median 26 years of follow-up, the researchers identified 492 cases of PAD, 1,798 cases of CHD, and 1,106 cases of stroke.

The risk of all three conditions began to decline within 5 years of smoking cessation, which could be encouraging to smokers who wish to quit, the researchers noted. In addition, the longer the duration of smoking cessation, the lower the risk for all three conditions (See central illustration).



However, a significantly elevated risk remained for PAD for up to 30 years after smoking cessation and for CHD for up to 20 years after smoking cessation, compared with never-smokers.

The researchers also found a roughly fourfold increased risk for PAD for smokers who smoked for 40 or more pack-years, compared with never-smokers, which was greater than the 2.1 hazard ratio for CHD and 1.8 HR for stroke. In addition, current smokers of at least one pack per day had a significantly greater risk of PAD, compared with never-smokers (HR, 5.36) that was higher than the risk for CHD or stroke (HR, 2.38 and HR, 1.88, respectively).

The study findings were limited by several factors including the reliance on self-reports, potential misclassification of data, and the potential exclusion of mild PAD cases that did not require hospitalization, the researchers noted. However, the results support the value of encouraging smokers to quit and support the need to include PAD risk in public health information, they said. “Although public statements about smoking and [cardiovascular disease] have been focusing on CHD and stroke, our results indicate the need to take account of PAD as well for comprehensively acknowledging the effect of smoking on overall cardiovascular health,” they added.

The ARIC study was funded by the National Heart, Lung, and Blood Institute, National Institutes of Health. Lead author Dr. Ding had no financial conflicts to disclose; coauthors disclosed relationships with Bristol-Myers Squibb and Fukuda Denshi.

SOURCE: Ding N et al. J Am Coll Cardiol. 2019 Jul 22;74:498-507. doi: 10.1016/j.jacc.2019.06.003.

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Statin use linked to less depression, anxiety in ACOS patients

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Adults with asthma–chronic obstructive pulmonary disease overlap syndrome who took statins had lower rates of anxiety and depression than did those not on statins, based on data from approximately 9,000 patients.

Although asthma–COPD overlap syndrome (ACOS) has been associated with depression, the effects of oral and inhaled corticosteroids on anxiety and depression in these patients have not been well investigated, wrote Jun-Jun Yeh, MD, of Ditmanson Medical Foundation Chia-Yi (Taiwan) Christian Hospital, and colleagues.

In a study published in the Journal of Affective Disorders, the researchers analyzed 9,139 ACOS patients including 1,252 statin users and 7,887 nonstatin users; 62% were male.

The statin users had significantly lower risk of both anxiety and depression than did the nonstatin users (adjusted hazard ratio 0.34 for anxiety and 0.36 for depression) after researchers controlled for factors including age, sex, comorbidities, and medications. Statin users experienced a total of 109 anxiety or depression events over an average of 8 years’ follow-up, while nonstatin users experienced a total of 1,333 anxiety or depression events over an average of 5 years’ follow-up.

The incidence density rate of anxiety was 11/1,000 person-years for statin users and 33/1,000 person-years for nonstatin users. The incidence density rate of depression was 3/1,000 person-years for statin users and 9/1,000 person-years for nonstatin users.

Significantly lower risk of anxiety and depression also were observed in statin users, compared with nonstatin users, in subgroups of men, women, patients younger than 50 years, and patients aged 50 years and older. The risks of anxiety and depression were lower in statin users versus nonstatin users across all subgroups with or without inhaled or oral corticosteroids.

Overall, the statin users were significantly younger, had more comorbidities, and were more likely to use inhaled or oral corticosteroids than were the nonstatin users.

The findings were limited by several factors including the retrospective nature of the study and a lack of information on prescribed daily doses of medication, the researchers noted. However, the results support those from previous studies and suggest that “the anti-inflammatory effect of statins may attenuate anxiety and depression in ACOS patients, even in the late stages of the disease,” although the exact mechanism of action remains unknown and larger, randomized, controlled trials are needed, they said.

The study was supported by grants from a variety of organizations in Taiwan, China, and Japan. The researchers had no financial conflicts to disclose.

SOURCE: Yeh JJ et al. J Affect Disord. 2019 Jun 15; 253:277-84.

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Adults with asthma–chronic obstructive pulmonary disease overlap syndrome who took statins had lower rates of anxiety and depression than did those not on statins, based on data from approximately 9,000 patients.

Although asthma–COPD overlap syndrome (ACOS) has been associated with depression, the effects of oral and inhaled corticosteroids on anxiety and depression in these patients have not been well investigated, wrote Jun-Jun Yeh, MD, of Ditmanson Medical Foundation Chia-Yi (Taiwan) Christian Hospital, and colleagues.

In a study published in the Journal of Affective Disorders, the researchers analyzed 9,139 ACOS patients including 1,252 statin users and 7,887 nonstatin users; 62% were male.

The statin users had significantly lower risk of both anxiety and depression than did the nonstatin users (adjusted hazard ratio 0.34 for anxiety and 0.36 for depression) after researchers controlled for factors including age, sex, comorbidities, and medications. Statin users experienced a total of 109 anxiety or depression events over an average of 8 years’ follow-up, while nonstatin users experienced a total of 1,333 anxiety or depression events over an average of 5 years’ follow-up.

The incidence density rate of anxiety was 11/1,000 person-years for statin users and 33/1,000 person-years for nonstatin users. The incidence density rate of depression was 3/1,000 person-years for statin users and 9/1,000 person-years for nonstatin users.

Significantly lower risk of anxiety and depression also were observed in statin users, compared with nonstatin users, in subgroups of men, women, patients younger than 50 years, and patients aged 50 years and older. The risks of anxiety and depression were lower in statin users versus nonstatin users across all subgroups with or without inhaled or oral corticosteroids.

Overall, the statin users were significantly younger, had more comorbidities, and were more likely to use inhaled or oral corticosteroids than were the nonstatin users.

The findings were limited by several factors including the retrospective nature of the study and a lack of information on prescribed daily doses of medication, the researchers noted. However, the results support those from previous studies and suggest that “the anti-inflammatory effect of statins may attenuate anxiety and depression in ACOS patients, even in the late stages of the disease,” although the exact mechanism of action remains unknown and larger, randomized, controlled trials are needed, they said.

The study was supported by grants from a variety of organizations in Taiwan, China, and Japan. The researchers had no financial conflicts to disclose.

SOURCE: Yeh JJ et al. J Affect Disord. 2019 Jun 15; 253:277-84.

Adults with asthma–chronic obstructive pulmonary disease overlap syndrome who took statins had lower rates of anxiety and depression than did those not on statins, based on data from approximately 9,000 patients.

Although asthma–COPD overlap syndrome (ACOS) has been associated with depression, the effects of oral and inhaled corticosteroids on anxiety and depression in these patients have not been well investigated, wrote Jun-Jun Yeh, MD, of Ditmanson Medical Foundation Chia-Yi (Taiwan) Christian Hospital, and colleagues.

In a study published in the Journal of Affective Disorders, the researchers analyzed 9,139 ACOS patients including 1,252 statin users and 7,887 nonstatin users; 62% were male.

The statin users had significantly lower risk of both anxiety and depression than did the nonstatin users (adjusted hazard ratio 0.34 for anxiety and 0.36 for depression) after researchers controlled for factors including age, sex, comorbidities, and medications. Statin users experienced a total of 109 anxiety or depression events over an average of 8 years’ follow-up, while nonstatin users experienced a total of 1,333 anxiety or depression events over an average of 5 years’ follow-up.

The incidence density rate of anxiety was 11/1,000 person-years for statin users and 33/1,000 person-years for nonstatin users. The incidence density rate of depression was 3/1,000 person-years for statin users and 9/1,000 person-years for nonstatin users.

Significantly lower risk of anxiety and depression also were observed in statin users, compared with nonstatin users, in subgroups of men, women, patients younger than 50 years, and patients aged 50 years and older. The risks of anxiety and depression were lower in statin users versus nonstatin users across all subgroups with or without inhaled or oral corticosteroids.

Overall, the statin users were significantly younger, had more comorbidities, and were more likely to use inhaled or oral corticosteroids than were the nonstatin users.

The findings were limited by several factors including the retrospective nature of the study and a lack of information on prescribed daily doses of medication, the researchers noted. However, the results support those from previous studies and suggest that “the anti-inflammatory effect of statins may attenuate anxiety and depression in ACOS patients, even in the late stages of the disease,” although the exact mechanism of action remains unknown and larger, randomized, controlled trials are needed, they said.

The study was supported by grants from a variety of organizations in Taiwan, China, and Japan. The researchers had no financial conflicts to disclose.

SOURCE: Yeh JJ et al. J Affect Disord. 2019 Jun 15; 253:277-84.

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NOACs benefit early stage chronic kidney disease patients

Consider NOACs for early chronic kidney disease
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Non–vitamin K oral anticoagulants (NOACs) significantly reduced the risk of stroke or systemic embolism compared to vitamin K antagonists (VKAs) for patients in the early stages of chronic kidney disease and comorbid atrial fibrillation, based on data from a meta-analysis of roughly 34,000 patients.

Chronic kidney disease increases the risk of complications including stroke, congestive heart failure, and death in patients who also have atrial fibrillation, but most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients, wrote Jeffrey T. Ha, MBBS, of the George Institute for Global Health, Newtown, Australia, and colleagues.

To assess the benefits and harms of oral anticoagulants for multiple indications in chronic kidney disease patients, the researchers conducted a meta-analysis of 45 studies including 34,082 individuals. The findings were published in the Annals of Internal Medicine. The analysis included 8 trials of end stage kidney disease patients on dialysis; the remaining trials excluded patients with creatinine clearance less than 20 mL/min or an estimated glomerular filtration rate less than 15 mL/min per 1.73 m2. The interventional agents were rivaroxaban, dabigatran, apixaban, edoxaban, betrixaban, warfarin, and acenocoumarol.

A notable finding was the significant reduction in relative risk of stroke or systemic embolism (21%), hemorrhagic stroke (52%), and intracranial hemorrhage (51%) for early-stage chronic kidney disease patients with atrial fibrillation given NOACs, compared with those given VKAs.

The evidence for the superiority of NOACs over VKAs for reducing risk of venous thromboembolism (VTE) or VTE-related death was uncertain, as was the evidence to draw any conclusions about benefits and harms of either NOACs or VKAs for patients with advanced or end-stage kidney disease.

Across all trials, NOACs appeared to reduce the relative risk of major bleeding, compared with VKAs by roughly 25%, but the difference was not statistically significant, the researchers noted.

The findings were limited by the lack of evidence for oral anticoagulant use in patients with advanced chronic or end-stage kidney disease, as well as inability to assess differences among NOACs, the researchers noted. However, the results suggest that NOACs may be recommended over VKAs for the subgroup of early-stage chronic kidney disease patients with atrial fibrillation, they said.

Several additional trials are in progress, and future trials “should include not only participants with dialysis-dependent ESKD [end-stage kidney disease] but also those with CrCl [creatinine clearance of] less than 25 mL/min,” and compare NOACs with placebo as well, they noted.

Lead author Dr. Ha is supported by a University Postgraduate Award from University of New South Wales, Sydney, but had no financial conflicts to disclose; coauthors disclosed support from various organizations as well as pharmaceutical companies including Baxter, Amgen, Eli Lilly, Boehringer Ingelheim, Vifor Pharma, Janssen, Pfizer, Bristol-Myers Squibb, and GlaxoSmithKline.
 

SOURCE: Ha JT et al. Ann Intern Med. 2019 July 15. doi: 10.7326/M19-0087

Body

The significant reduction in risk of hemorrhagic stroke, recurrent venous thromboembolism, and VTE-related deaths in patients with early-stage chronic kidney disease given a NOAC [non–vitamin K oral anticoagulants] in a meta-analysis supports clinical application, but is there a level of renal dysfunction for which clinicians should apply greater caution in extrapolating these findings? As the evidence supporting the safety and effectiveness of NOACs in the general population increases, there is a renewed interest in defining the role of anticoagulant therapy to prevent stroke and VTE in patients with chronic kidney disease and end-stage kidney disease. This interest is driven in part by uncertainty as to the benefits vs. harms of warfarin for patients with chronic kidney disease. The data in the meta-analysis by Ha and colleagues do not support any benefits for patients with end-stage disease, but the results of two ongoing clinical trials of patients with atrial fibrillation and end-stage kidney disease may offer insights.

Until the results of these trials become available, the decision to use anticoagulant therapy in patients with end-stage kidney disease will continue to require an individualized approach that balances potential benefits and harms.
 

Ainslie Hildebrand, MD, of University of Alberta, Edmonton; Christine Ribic, MD, of McMaster University, Hamilton, Ont.; and Deborah Zimmerman, MD, of the University of Ottawa, made these comments in an accompanying editorial (Ann Intern Med. 2019 July 15. doi:10.7326/M19-1504). Dr. Ribic disclosed grants from Pfizer, Leo Pharma, and Astellas Pharma. Dr. Hildebrand and Dr. Zimmerman had no financial conflicts to disclose.

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The significant reduction in risk of hemorrhagic stroke, recurrent venous thromboembolism, and VTE-related deaths in patients with early-stage chronic kidney disease given a NOAC [non–vitamin K oral anticoagulants] in a meta-analysis supports clinical application, but is there a level of renal dysfunction for which clinicians should apply greater caution in extrapolating these findings? As the evidence supporting the safety and effectiveness of NOACs in the general population increases, there is a renewed interest in defining the role of anticoagulant therapy to prevent stroke and VTE in patients with chronic kidney disease and end-stage kidney disease. This interest is driven in part by uncertainty as to the benefits vs. harms of warfarin for patients with chronic kidney disease. The data in the meta-analysis by Ha and colleagues do not support any benefits for patients with end-stage disease, but the results of two ongoing clinical trials of patients with atrial fibrillation and end-stage kidney disease may offer insights.

Until the results of these trials become available, the decision to use anticoagulant therapy in patients with end-stage kidney disease will continue to require an individualized approach that balances potential benefits and harms.
 

Ainslie Hildebrand, MD, of University of Alberta, Edmonton; Christine Ribic, MD, of McMaster University, Hamilton, Ont.; and Deborah Zimmerman, MD, of the University of Ottawa, made these comments in an accompanying editorial (Ann Intern Med. 2019 July 15. doi:10.7326/M19-1504). Dr. Ribic disclosed grants from Pfizer, Leo Pharma, and Astellas Pharma. Dr. Hildebrand and Dr. Zimmerman had no financial conflicts to disclose.

Body

The significant reduction in risk of hemorrhagic stroke, recurrent venous thromboembolism, and VTE-related deaths in patients with early-stage chronic kidney disease given a NOAC [non–vitamin K oral anticoagulants] in a meta-analysis supports clinical application, but is there a level of renal dysfunction for which clinicians should apply greater caution in extrapolating these findings? As the evidence supporting the safety and effectiveness of NOACs in the general population increases, there is a renewed interest in defining the role of anticoagulant therapy to prevent stroke and VTE in patients with chronic kidney disease and end-stage kidney disease. This interest is driven in part by uncertainty as to the benefits vs. harms of warfarin for patients with chronic kidney disease. The data in the meta-analysis by Ha and colleagues do not support any benefits for patients with end-stage disease, but the results of two ongoing clinical trials of patients with atrial fibrillation and end-stage kidney disease may offer insights.

Until the results of these trials become available, the decision to use anticoagulant therapy in patients with end-stage kidney disease will continue to require an individualized approach that balances potential benefits and harms.
 

Ainslie Hildebrand, MD, of University of Alberta, Edmonton; Christine Ribic, MD, of McMaster University, Hamilton, Ont.; and Deborah Zimmerman, MD, of the University of Ottawa, made these comments in an accompanying editorial (Ann Intern Med. 2019 July 15. doi:10.7326/M19-1504). Dr. Ribic disclosed grants from Pfizer, Leo Pharma, and Astellas Pharma. Dr. Hildebrand and Dr. Zimmerman had no financial conflicts to disclose.

Title
Consider NOACs for early chronic kidney disease
Consider NOACs for early chronic kidney disease

Non–vitamin K oral anticoagulants (NOACs) significantly reduced the risk of stroke or systemic embolism compared to vitamin K antagonists (VKAs) for patients in the early stages of chronic kidney disease and comorbid atrial fibrillation, based on data from a meta-analysis of roughly 34,000 patients.

Chronic kidney disease increases the risk of complications including stroke, congestive heart failure, and death in patients who also have atrial fibrillation, but most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients, wrote Jeffrey T. Ha, MBBS, of the George Institute for Global Health, Newtown, Australia, and colleagues.

To assess the benefits and harms of oral anticoagulants for multiple indications in chronic kidney disease patients, the researchers conducted a meta-analysis of 45 studies including 34,082 individuals. The findings were published in the Annals of Internal Medicine. The analysis included 8 trials of end stage kidney disease patients on dialysis; the remaining trials excluded patients with creatinine clearance less than 20 mL/min or an estimated glomerular filtration rate less than 15 mL/min per 1.73 m2. The interventional agents were rivaroxaban, dabigatran, apixaban, edoxaban, betrixaban, warfarin, and acenocoumarol.

A notable finding was the significant reduction in relative risk of stroke or systemic embolism (21%), hemorrhagic stroke (52%), and intracranial hemorrhage (51%) for early-stage chronic kidney disease patients with atrial fibrillation given NOACs, compared with those given VKAs.

The evidence for the superiority of NOACs over VKAs for reducing risk of venous thromboembolism (VTE) or VTE-related death was uncertain, as was the evidence to draw any conclusions about benefits and harms of either NOACs or VKAs for patients with advanced or end-stage kidney disease.

Across all trials, NOACs appeared to reduce the relative risk of major bleeding, compared with VKAs by roughly 25%, but the difference was not statistically significant, the researchers noted.

The findings were limited by the lack of evidence for oral anticoagulant use in patients with advanced chronic or end-stage kidney disease, as well as inability to assess differences among NOACs, the researchers noted. However, the results suggest that NOACs may be recommended over VKAs for the subgroup of early-stage chronic kidney disease patients with atrial fibrillation, they said.

Several additional trials are in progress, and future trials “should include not only participants with dialysis-dependent ESKD [end-stage kidney disease] but also those with CrCl [creatinine clearance of] less than 25 mL/min,” and compare NOACs with placebo as well, they noted.

Lead author Dr. Ha is supported by a University Postgraduate Award from University of New South Wales, Sydney, but had no financial conflicts to disclose; coauthors disclosed support from various organizations as well as pharmaceutical companies including Baxter, Amgen, Eli Lilly, Boehringer Ingelheim, Vifor Pharma, Janssen, Pfizer, Bristol-Myers Squibb, and GlaxoSmithKline.
 

SOURCE: Ha JT et al. Ann Intern Med. 2019 July 15. doi: 10.7326/M19-0087

Non–vitamin K oral anticoagulants (NOACs) significantly reduced the risk of stroke or systemic embolism compared to vitamin K antagonists (VKAs) for patients in the early stages of chronic kidney disease and comorbid atrial fibrillation, based on data from a meta-analysis of roughly 34,000 patients.

Chronic kidney disease increases the risk of complications including stroke, congestive heart failure, and death in patients who also have atrial fibrillation, but most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients, wrote Jeffrey T. Ha, MBBS, of the George Institute for Global Health, Newtown, Australia, and colleagues.

To assess the benefits and harms of oral anticoagulants for multiple indications in chronic kidney disease patients, the researchers conducted a meta-analysis of 45 studies including 34,082 individuals. The findings were published in the Annals of Internal Medicine. The analysis included 8 trials of end stage kidney disease patients on dialysis; the remaining trials excluded patients with creatinine clearance less than 20 mL/min or an estimated glomerular filtration rate less than 15 mL/min per 1.73 m2. The interventional agents were rivaroxaban, dabigatran, apixaban, edoxaban, betrixaban, warfarin, and acenocoumarol.

A notable finding was the significant reduction in relative risk of stroke or systemic embolism (21%), hemorrhagic stroke (52%), and intracranial hemorrhage (51%) for early-stage chronic kidney disease patients with atrial fibrillation given NOACs, compared with those given VKAs.

The evidence for the superiority of NOACs over VKAs for reducing risk of venous thromboembolism (VTE) or VTE-related death was uncertain, as was the evidence to draw any conclusions about benefits and harms of either NOACs or VKAs for patients with advanced or end-stage kidney disease.

Across all trials, NOACs appeared to reduce the relative risk of major bleeding, compared with VKAs by roughly 25%, but the difference was not statistically significant, the researchers noted.

The findings were limited by the lack of evidence for oral anticoagulant use in patients with advanced chronic or end-stage kidney disease, as well as inability to assess differences among NOACs, the researchers noted. However, the results suggest that NOACs may be recommended over VKAs for the subgroup of early-stage chronic kidney disease patients with atrial fibrillation, they said.

Several additional trials are in progress, and future trials “should include not only participants with dialysis-dependent ESKD [end-stage kidney disease] but also those with CrCl [creatinine clearance of] less than 25 mL/min,” and compare NOACs with placebo as well, they noted.

Lead author Dr. Ha is supported by a University Postgraduate Award from University of New South Wales, Sydney, but had no financial conflicts to disclose; coauthors disclosed support from various organizations as well as pharmaceutical companies including Baxter, Amgen, Eli Lilly, Boehringer Ingelheim, Vifor Pharma, Janssen, Pfizer, Bristol-Myers Squibb, and GlaxoSmithKline.
 

SOURCE: Ha JT et al. Ann Intern Med. 2019 July 15. doi: 10.7326/M19-0087

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Another study supports safety of 2-cm margins for thick melanomas

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Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.



The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

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Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.



The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

 

Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.



The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

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Opioid exposure leads to poor perinatal and postnatal outcomes

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Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

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Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

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