Guidelines

Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
 

“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.

“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.

The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.

Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.

The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.

The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.



Among the key findings:

• In patients with breast cancer,  has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
• Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
• The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
• The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
• Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
• Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.

The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.

The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.

“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.

The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
 

“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.

“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.

The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.

Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.

The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.

The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.



Among the key findings:

• In patients with breast cancer,  has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
• Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
• The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
• The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
• Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
• Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.

The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.

The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.

“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.

The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
 

“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.

“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.

The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.

Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.

The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.

The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.



Among the key findings:

• In patients with breast cancer,  has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
• Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
• The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
• The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
• Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
• Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.

The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.

The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.

“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.

The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

An updated American Heart Association scientific statement on the role of obesity in cardiovascular disease provides the first new guidance in 15 years, drawing on evidence that’s emerged in that time to clarify the potential of newer drug therapies and interventions like bariatric surgery and lifestyle modifications to curtail cardiovascular disease risks.

“The timing of this information is important because the obesity epidemic contributes significantly to the global burden of cardiovascular disease and numerous chronic health conditions that also impact heart disease,” said Tiffany Powell-Wiley, MD, MPH, chair of the volunteer statement writing group.

“One of the big takeaways that I hope people get from the statement is really making it clear that obesity is a complex disease, and that it is multifactorial,” Dr. Powell-Wiley said in an interview. “There are not just biological reasons why individuals have obesity, but there are environmental, psychosocial, and really multilevel factors that contribute to the development and course of obesity.”

Most significantly, Dr. Powell-Wiley said, “we want to emphasize that we really want to have cardiologists think about and focus on abdominal obesity in particular.”

A metric for cardiovascular risk that seems to gain credibility in the statement is the relationship of waist circumference to height regardless of overall weight. “That is a very important finding that we can now really think of waist circumference as an important measure in our clinical practice,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory in the division of intramural research at the National Heart, Lung, and Blood Institute. “We want to get across to providers that this is something that should be measured and should be followed over time, based on data from the last 15 years that waist circumference and abdominal obesity are associated with higher cardiovascular risk regardless of body mass index.”

The statement provides potentially groundbreaking advice on atrial fibrillation as a consequence of weight, noted Dr. Powell-Wiley. “Up until recently, we haven’t really thought about weight management as a part of managing Afib [atrial fibrillation],” she said. “This statement highlights the need to think about weight management in addition to anticoagulation as part of the pieces for managing Afib.”
 

Evidence on interventions

The statement, published in Circulation, also dives into the evidence surrounding the varied interventions for managing weight.

American Heart Association

“The biggest area where there’s much more data is bariatric surgery,” said Dr. Powell-Wiley. “There’s clear evidence that bariatric surgery lowers cardio mortality and all-cause mortality for patients, but we’ve also seen data around lifestyle interventions, with the Look AHEAD trial, which showed that while there were improvements in CV [cardiovascular] risk factors, we didn’t see the reduction in CV mortality that we wanted to see.”

The statement noted that the Look AHEAD trial (for Action for Health in Diabetes) of people with type 2 diabetes failed to show a significant reduction in major adverse cardiac events or CV mortality after almost 10 years of an intensive weight-loss intervention. Dr. Powell-Wiley added that the result seemed to be related more to the lack of weight loss with lifestyle interventions when compared with bariatric surgery.

The statement also addressed the effectiveness of drug treatments for weight control in managing CV risk, and while the evidence supporting pharmacotherapy specifically for weight loss has been mixed, emerging treatments have shown promise, Dr. Powell-Wiley said. “I think we now have some bright spots with new therapies that have been developed for diabetes and heart failure, such as the SGLT2 inhibitors as well as the GLP-1 agonists, and how they can also appear to improve weight and likely will improve CV mortality in patients with obesity.”

The “obesity paradox,” which Dr. Powell-Wiley noted is “definitely a controversial topic,” is also addressed in the statement. “We try to explain what it is and what we know about it right now,” she said. “We know for instance that patients with obesity, particularly those who have class 1 obesity or patients who are overweight, seem to do better in the short term in relation to coronary artery disease and heart failure, but the reasons for that are not necessarily clear.”

The statement also provides evidence-based insights on the use of diagnostic tools, including stress echocardiography and cardiac MRI as well as coronary angiography, and the clinical significance of specific echocardiographic changes in obese patients.

The writing committee also identified areas that need future research. “It’s really important to emphasize what we learned about the complexity of obesity over this time period,” Dr. Powell-Wiley said. “But again, we don’t have all the answers; there’s a lot more work to be done to understand what type of lifestyle intervention might be most beneficial, especially with addressing abdominal obesity, and how these new therapeutics around heart failure and diabetes may be useful in patients with obesity.

Obesity in adolescents is another area that needs further research, Dr. Powell-Wiley said. “How do we prevent obesity in those populations when we know they’re at risk for so much as they get older? Once you have obesity it’s hard to change that trajectory.”

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Clinical Cardiology, the Council on Epidemiology and Prevention, and the Stroke Council. Committee vice chair Paul Poirier, MD, PhD, reported financial relationships with Abbott, Amgen, AstraZeneca, Bausch Health, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, Novo Nordisk, Sanofi, Servier, and HLS Therapeutics. One committee member disclosed a financial relationship with AstraZeneca. Dr. Powell-Wiley and the other committee members have no relationships to disclose.

An updated American Heart Association scientific statement on the role of obesity in cardiovascular disease provides the first new guidance in 15 years, drawing on evidence that’s emerged in that time to clarify the potential of newer drug therapies and interventions like bariatric surgery and lifestyle modifications to curtail cardiovascular disease risks.

“The timing of this information is important because the obesity epidemic contributes significantly to the global burden of cardiovascular disease and numerous chronic health conditions that also impact heart disease,” said Tiffany Powell-Wiley, MD, MPH, chair of the volunteer statement writing group.

“One of the big takeaways that I hope people get from the statement is really making it clear that obesity is a complex disease, and that it is multifactorial,” Dr. Powell-Wiley said in an interview. “There are not just biological reasons why individuals have obesity, but there are environmental, psychosocial, and really multilevel factors that contribute to the development and course of obesity.”

Most significantly, Dr. Powell-Wiley said, “we want to emphasize that we really want to have cardiologists think about and focus on abdominal obesity in particular.”

A metric for cardiovascular risk that seems to gain credibility in the statement is the relationship of waist circumference to height regardless of overall weight. “That is a very important finding that we can now really think of waist circumference as an important measure in our clinical practice,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory in the division of intramural research at the National Heart, Lung, and Blood Institute. “We want to get across to providers that this is something that should be measured and should be followed over time, based on data from the last 15 years that waist circumference and abdominal obesity are associated with higher cardiovascular risk regardless of body mass index.”

The statement provides potentially groundbreaking advice on atrial fibrillation as a consequence of weight, noted Dr. Powell-Wiley. “Up until recently, we haven’t really thought about weight management as a part of managing Afib [atrial fibrillation],” she said. “This statement highlights the need to think about weight management in addition to anticoagulation as part of the pieces for managing Afib.”
 

Evidence on interventions

The statement, published in Circulation, also dives into the evidence surrounding the varied interventions for managing weight.

American Heart Association

“The biggest area where there’s much more data is bariatric surgery,” said Dr. Powell-Wiley. “There’s clear evidence that bariatric surgery lowers cardio mortality and all-cause mortality for patients, but we’ve also seen data around lifestyle interventions, with the Look AHEAD trial, which showed that while there were improvements in CV [cardiovascular] risk factors, we didn’t see the reduction in CV mortality that we wanted to see.”

The statement noted that the Look AHEAD trial (for Action for Health in Diabetes) of people with type 2 diabetes failed to show a significant reduction in major adverse cardiac events or CV mortality after almost 10 years of an intensive weight-loss intervention. Dr. Powell-Wiley added that the result seemed to be related more to the lack of weight loss with lifestyle interventions when compared with bariatric surgery.

The statement also addressed the effectiveness of drug treatments for weight control in managing CV risk, and while the evidence supporting pharmacotherapy specifically for weight loss has been mixed, emerging treatments have shown promise, Dr. Powell-Wiley said. “I think we now have some bright spots with new therapies that have been developed for diabetes and heart failure, such as the SGLT2 inhibitors as well as the GLP-1 agonists, and how they can also appear to improve weight and likely will improve CV mortality in patients with obesity.”

The “obesity paradox,” which Dr. Powell-Wiley noted is “definitely a controversial topic,” is also addressed in the statement. “We try to explain what it is and what we know about it right now,” she said. “We know for instance that patients with obesity, particularly those who have class 1 obesity or patients who are overweight, seem to do better in the short term in relation to coronary artery disease and heart failure, but the reasons for that are not necessarily clear.”

The statement also provides evidence-based insights on the use of diagnostic tools, including stress echocardiography and cardiac MRI as well as coronary angiography, and the clinical significance of specific echocardiographic changes in obese patients.

The writing committee also identified areas that need future research. “It’s really important to emphasize what we learned about the complexity of obesity over this time period,” Dr. Powell-Wiley said. “But again, we don’t have all the answers; there’s a lot more work to be done to understand what type of lifestyle intervention might be most beneficial, especially with addressing abdominal obesity, and how these new therapeutics around heart failure and diabetes may be useful in patients with obesity.

Obesity in adolescents is another area that needs further research, Dr. Powell-Wiley said. “How do we prevent obesity in those populations when we know they’re at risk for so much as they get older? Once you have obesity it’s hard to change that trajectory.”

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Clinical Cardiology, the Council on Epidemiology and Prevention, and the Stroke Council. Committee vice chair Paul Poirier, MD, PhD, reported financial relationships with Abbott, Amgen, AstraZeneca, Bausch Health, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, Novo Nordisk, Sanofi, Servier, and HLS Therapeutics. One committee member disclosed a financial relationship with AstraZeneca. Dr. Powell-Wiley and the other committee members have no relationships to disclose.

An updated American Heart Association scientific statement on the role of obesity in cardiovascular disease provides the first new guidance in 15 years, drawing on evidence that’s emerged in that time to clarify the potential of newer drug therapies and interventions like bariatric surgery and lifestyle modifications to curtail cardiovascular disease risks.

“The timing of this information is important because the obesity epidemic contributes significantly to the global burden of cardiovascular disease and numerous chronic health conditions that also impact heart disease,” said Tiffany Powell-Wiley, MD, MPH, chair of the volunteer statement writing group.

“One of the big takeaways that I hope people get from the statement is really making it clear that obesity is a complex disease, and that it is multifactorial,” Dr. Powell-Wiley said in an interview. “There are not just biological reasons why individuals have obesity, but there are environmental, psychosocial, and really multilevel factors that contribute to the development and course of obesity.”

Most significantly, Dr. Powell-Wiley said, “we want to emphasize that we really want to have cardiologists think about and focus on abdominal obesity in particular.”

A metric for cardiovascular risk that seems to gain credibility in the statement is the relationship of waist circumference to height regardless of overall weight. “That is a very important finding that we can now really think of waist circumference as an important measure in our clinical practice,” said Dr. Powell-Wiley, chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory in the division of intramural research at the National Heart, Lung, and Blood Institute. “We want to get across to providers that this is something that should be measured and should be followed over time, based on data from the last 15 years that waist circumference and abdominal obesity are associated with higher cardiovascular risk regardless of body mass index.”

The statement provides potentially groundbreaking advice on atrial fibrillation as a consequence of weight, noted Dr. Powell-Wiley. “Up until recently, we haven’t really thought about weight management as a part of managing Afib [atrial fibrillation],” she said. “This statement highlights the need to think about weight management in addition to anticoagulation as part of the pieces for managing Afib.”
 

Evidence on interventions

The statement, published in Circulation, also dives into the evidence surrounding the varied interventions for managing weight.

American Heart Association

“The biggest area where there’s much more data is bariatric surgery,” said Dr. Powell-Wiley. “There’s clear evidence that bariatric surgery lowers cardio mortality and all-cause mortality for patients, but we’ve also seen data around lifestyle interventions, with the Look AHEAD trial, which showed that while there were improvements in CV [cardiovascular] risk factors, we didn’t see the reduction in CV mortality that we wanted to see.”

The statement noted that the Look AHEAD trial (for Action for Health in Diabetes) of people with type 2 diabetes failed to show a significant reduction in major adverse cardiac events or CV mortality after almost 10 years of an intensive weight-loss intervention. Dr. Powell-Wiley added that the result seemed to be related more to the lack of weight loss with lifestyle interventions when compared with bariatric surgery.

The statement also addressed the effectiveness of drug treatments for weight control in managing CV risk, and while the evidence supporting pharmacotherapy specifically for weight loss has been mixed, emerging treatments have shown promise, Dr. Powell-Wiley said. “I think we now have some bright spots with new therapies that have been developed for diabetes and heart failure, such as the SGLT2 inhibitors as well as the GLP-1 agonists, and how they can also appear to improve weight and likely will improve CV mortality in patients with obesity.”

The “obesity paradox,” which Dr. Powell-Wiley noted is “definitely a controversial topic,” is also addressed in the statement. “We try to explain what it is and what we know about it right now,” she said. “We know for instance that patients with obesity, particularly those who have class 1 obesity or patients who are overweight, seem to do better in the short term in relation to coronary artery disease and heart failure, but the reasons for that are not necessarily clear.”

The statement also provides evidence-based insights on the use of diagnostic tools, including stress echocardiography and cardiac MRI as well as coronary angiography, and the clinical significance of specific echocardiographic changes in obese patients.

The writing committee also identified areas that need future research. “It’s really important to emphasize what we learned about the complexity of obesity over this time period,” Dr. Powell-Wiley said. “But again, we don’t have all the answers; there’s a lot more work to be done to understand what type of lifestyle intervention might be most beneficial, especially with addressing abdominal obesity, and how these new therapeutics around heart failure and diabetes may be useful in patients with obesity.

Obesity in adolescents is another area that needs further research, Dr. Powell-Wiley said. “How do we prevent obesity in those populations when we know they’re at risk for so much as they get older? Once you have obesity it’s hard to change that trajectory.”

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Clinical Cardiology, the Council on Epidemiology and Prevention, and the Stroke Council. Committee vice chair Paul Poirier, MD, PhD, reported financial relationships with Abbott, Amgen, AstraZeneca, Bausch Health, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, Novo Nordisk, Sanofi, Servier, and HLS Therapeutics. One committee member disclosed a financial relationship with AstraZeneca. Dr. Powell-Wiley and the other committee members have no relationships to disclose.

Seven years after concluding that evidence was insufficient to recommend screening for vitamin D deficiency in the general population, the United States Preventive Services Task Force (USPSTF) has revisited the issue – and come up with the same conclusion.

Overall, “the current evidence is inadequate to determine whether screening for and treatment of asymptomatic low 25(OH)D levels improve clinical outcomes in community dwelling adults,” the task force concluded in its statement, recommending an “I” for insufficient.

The statement was published online April 13 in JAMA.

In the absence of screening recommendations, clinicians may be best advised to instead focus on diet and supplementation for those considered at risk, said Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia.

“Rather than posing the question of screening the general population for vitamin D deficiency, let’s focus on ensuring that everyone consumes the age-based recommended daily allowance of vitamin D instead,” Dr. Cappola, a coauthor of the accompanying editorial, said in an interview.
 

No studies have directly evaluated benefits of screening

The latest USPSTF recommendation is based on a systematic review of the benefits and harms of screening and early treatment for vitamin D deficiency in asymptomatic, community-dwelling nonpregnant adults aged 18 or older in the primary care setting with no signs or symptoms of deficiency.

The review found no studies that directly evaluated the benefits of screening for vitamin D deficiency.

However, 26 randomized clinical trials and one nested case-control study evaluated the effectiveness of treatment of vitamin D deficiency with supplementation.

And while observational studies have linked lower vitamin D levels with a multitude of conditions and risks, evidence of any benefit was inconsistent, with none identified for most major outcomes in asymptomatic adults – the focus of the Task Force recommendation.

“Among asymptomatic, community-dwelling populations with low vitamin D levels, the evidence suggests that treatment with vitamin D has no effect on mortality or the incidence of fractures, falls, depression, diabetes, cardiovascular disease, cancer, or adverse events,” the review authors stress.

“The evidence is inconclusive about the effect of treatment on physical functioning and infection.”
 

One in four are vitamin D deficient

In terms of the further question of the potential harms of vitamin D screening of asymptomatic individuals, a key concern is the potential for misclassification and over- or underdiagnosis due to inconsistent cutoffs and variability of different screening assays, the review concluded.

However, with the rare exception of vitamin D toxicity from supplementation well above sufficient levels, treatment with vitamin D supplementation appears relatively safe.

With a lack of consensus even over the basic cutoff for vitamin D deficiency, the National Academy of Medicine determined in 2011 that hydroxyvitamin D (25[OH]D) levels below 20 ng/mL are deficient for bone health, with no evidence of different thresholds for any other health condition.

Based on that cutoff, the National Health and Nutrition Examination Survey (NHANES), reported in 2014 that 25% of the U.S. population over the age of 1 was vitamin D deficient, with 18% of the population having 25(OH)D levels of 12-19 ng/mL and 5% having very low levels (< 12 ng/mL).
 

More work needed to determine groups at risk

While the task force report did not delve into testing or treatment recommendations for symptomatic adults, key established risk factors that may help clinicians identify those who are vitamin D deficient include obesity, receiving little or no UVB light exposure, and older age.

In general, obesity is associated with a 1.3- to 2-fold risk of being vitamin D deficient based on the criteria used, while non-Hispanic Blacks are 2-10 times more likely to be deficient compared with non-Hispanic White patients, the task force noted.

However, the implications of vitamin D deficiency in certain populations can vary. For instance, non-Hispanic Black people, despite having a higher prevalence of lower vitamin D levels compared with White people, in fact, have lower reported rates of fractures.

To address the various issues and gain a better understanding of the complexities of vitamin D deficiency, the task force calls for further research in key areas.

“More research is needed to determine whether total serum 25(OH)D levels are the best measure of vitamin D deficiency and whether the best measure of vitamin D deficiency varies by subgroups defined by race, ethnicity, or sex,” the authors indicated.

Furthermore, “more research is needed to determine the cutoff that defines vitamin D deficiency and whether that cutoff varies by specific clinical outcome or by subgroups defined by race, ethnicity, or sex.”
 

No support for population-based screening in guidelines

With the lack of conclusive evidence, no organizations currently recommend population-based screening for vitamin D deficiency in asymptomatic patients, and the American Society for Clinical Pathology endorses this stance.

The Endocrine Society and the American Association of Clinical Endocrinologists meanwhile do recommend screening for vitamin D deficiency in patients considered at risk.

Data show there was as much as an 80-fold increase in Medicare reimbursement volumes for vitamin D testing among clinicians from 2000 to 2010; however, that rate may have leveled off after the National Academy of Medicine reported on set deficiency levels, said Sherri-Ann M. Burnett-Bowie, MD, MPH, Dr. Cappola’s editorial coauthor.

Dr. Burnett-Bowie noted that she regularly tests her patients’ vitamin D levels, however most of her patients have osteoporosis or fractures.

“I do screen them for vitamin D deficiency since optimizing their vitamin D will improve calcium absorption, which is important for treating their osteoporosis,” Dr. Burnett-Bowie, of the endocrine division, department of medicine, Massachusetts General Hospital, Boston, said in an interview.

In terms of broader testing of asymptomatic patients in the general population, however, any changes in screening will likely be contingent on developments in the effects of treatment, she said.

“Given the challenge in finding benefits of vitamin D supplementation in those who are deficient, it will likely be more challenging to find benefits from wider screening,” she concluded.

The USPSTF and editorialists reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Seven years after concluding that evidence was insufficient to recommend screening for vitamin D deficiency in the general population, the United States Preventive Services Task Force (USPSTF) has revisited the issue – and come up with the same conclusion.

Overall, “the current evidence is inadequate to determine whether screening for and treatment of asymptomatic low 25(OH)D levels improve clinical outcomes in community dwelling adults,” the task force concluded in its statement, recommending an “I” for insufficient.

The statement was published online April 13 in JAMA.

In the absence of screening recommendations, clinicians may be best advised to instead focus on diet and supplementation for those considered at risk, said Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia.

“Rather than posing the question of screening the general population for vitamin D deficiency, let’s focus on ensuring that everyone consumes the age-based recommended daily allowance of vitamin D instead,” Dr. Cappola, a coauthor of the accompanying editorial, said in an interview.
 

No studies have directly evaluated benefits of screening

The latest USPSTF recommendation is based on a systematic review of the benefits and harms of screening and early treatment for vitamin D deficiency in asymptomatic, community-dwelling nonpregnant adults aged 18 or older in the primary care setting with no signs or symptoms of deficiency.

The review found no studies that directly evaluated the benefits of screening for vitamin D deficiency.

However, 26 randomized clinical trials and one nested case-control study evaluated the effectiveness of treatment of vitamin D deficiency with supplementation.

And while observational studies have linked lower vitamin D levels with a multitude of conditions and risks, evidence of any benefit was inconsistent, with none identified for most major outcomes in asymptomatic adults – the focus of the Task Force recommendation.

“Among asymptomatic, community-dwelling populations with low vitamin D levels, the evidence suggests that treatment with vitamin D has no effect on mortality or the incidence of fractures, falls, depression, diabetes, cardiovascular disease, cancer, or adverse events,” the review authors stress.

“The evidence is inconclusive about the effect of treatment on physical functioning and infection.”
 

One in four are vitamin D deficient

In terms of the further question of the potential harms of vitamin D screening of asymptomatic individuals, a key concern is the potential for misclassification and over- or underdiagnosis due to inconsistent cutoffs and variability of different screening assays, the review concluded.

However, with the rare exception of vitamin D toxicity from supplementation well above sufficient levels, treatment with vitamin D supplementation appears relatively safe.

With a lack of consensus even over the basic cutoff for vitamin D deficiency, the National Academy of Medicine determined in 2011 that hydroxyvitamin D (25[OH]D) levels below 20 ng/mL are deficient for bone health, with no evidence of different thresholds for any other health condition.

Based on that cutoff, the National Health and Nutrition Examination Survey (NHANES), reported in 2014 that 25% of the U.S. population over the age of 1 was vitamin D deficient, with 18% of the population having 25(OH)D levels of 12-19 ng/mL and 5% having very low levels (< 12 ng/mL).
 

More work needed to determine groups at risk

While the task force report did not delve into testing or treatment recommendations for symptomatic adults, key established risk factors that may help clinicians identify those who are vitamin D deficient include obesity, receiving little or no UVB light exposure, and older age.

In general, obesity is associated with a 1.3- to 2-fold risk of being vitamin D deficient based on the criteria used, while non-Hispanic Blacks are 2-10 times more likely to be deficient compared with non-Hispanic White patients, the task force noted.

However, the implications of vitamin D deficiency in certain populations can vary. For instance, non-Hispanic Black people, despite having a higher prevalence of lower vitamin D levels compared with White people, in fact, have lower reported rates of fractures.

To address the various issues and gain a better understanding of the complexities of vitamin D deficiency, the task force calls for further research in key areas.

“More research is needed to determine whether total serum 25(OH)D levels are the best measure of vitamin D deficiency and whether the best measure of vitamin D deficiency varies by subgroups defined by race, ethnicity, or sex,” the authors indicated.

Furthermore, “more research is needed to determine the cutoff that defines vitamin D deficiency and whether that cutoff varies by specific clinical outcome or by subgroups defined by race, ethnicity, or sex.”
 

No support for population-based screening in guidelines

With the lack of conclusive evidence, no organizations currently recommend population-based screening for vitamin D deficiency in asymptomatic patients, and the American Society for Clinical Pathology endorses this stance.

The Endocrine Society and the American Association of Clinical Endocrinologists meanwhile do recommend screening for vitamin D deficiency in patients considered at risk.

Data show there was as much as an 80-fold increase in Medicare reimbursement volumes for vitamin D testing among clinicians from 2000 to 2010; however, that rate may have leveled off after the National Academy of Medicine reported on set deficiency levels, said Sherri-Ann M. Burnett-Bowie, MD, MPH, Dr. Cappola’s editorial coauthor.

Dr. Burnett-Bowie noted that she regularly tests her patients’ vitamin D levels, however most of her patients have osteoporosis or fractures.

“I do screen them for vitamin D deficiency since optimizing their vitamin D will improve calcium absorption, which is important for treating their osteoporosis,” Dr. Burnett-Bowie, of the endocrine division, department of medicine, Massachusetts General Hospital, Boston, said in an interview.

In terms of broader testing of asymptomatic patients in the general population, however, any changes in screening will likely be contingent on developments in the effects of treatment, she said.

“Given the challenge in finding benefits of vitamin D supplementation in those who are deficient, it will likely be more challenging to find benefits from wider screening,” she concluded.

The USPSTF and editorialists reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Seven years after concluding that evidence was insufficient to recommend screening for vitamin D deficiency in the general population, the United States Preventive Services Task Force (USPSTF) has revisited the issue – and come up with the same conclusion.

Overall, “the current evidence is inadequate to determine whether screening for and treatment of asymptomatic low 25(OH)D levels improve clinical outcomes in community dwelling adults,” the task force concluded in its statement, recommending an “I” for insufficient.

The statement was published online April 13 in JAMA.

In the absence of screening recommendations, clinicians may be best advised to instead focus on diet and supplementation for those considered at risk, said Anne R. Cappola, MD, of the University of Pennsylvania, Philadelphia.

“Rather than posing the question of screening the general population for vitamin D deficiency, let’s focus on ensuring that everyone consumes the age-based recommended daily allowance of vitamin D instead,” Dr. Cappola, a coauthor of the accompanying editorial, said in an interview.
 

No studies have directly evaluated benefits of screening

The latest USPSTF recommendation is based on a systematic review of the benefits and harms of screening and early treatment for vitamin D deficiency in asymptomatic, community-dwelling nonpregnant adults aged 18 or older in the primary care setting with no signs or symptoms of deficiency.

The review found no studies that directly evaluated the benefits of screening for vitamin D deficiency.

However, 26 randomized clinical trials and one nested case-control study evaluated the effectiveness of treatment of vitamin D deficiency with supplementation.

And while observational studies have linked lower vitamin D levels with a multitude of conditions and risks, evidence of any benefit was inconsistent, with none identified for most major outcomes in asymptomatic adults – the focus of the Task Force recommendation.

“Among asymptomatic, community-dwelling populations with low vitamin D levels, the evidence suggests that treatment with vitamin D has no effect on mortality or the incidence of fractures, falls, depression, diabetes, cardiovascular disease, cancer, or adverse events,” the review authors stress.

“The evidence is inconclusive about the effect of treatment on physical functioning and infection.”
 

One in four are vitamin D deficient

In terms of the further question of the potential harms of vitamin D screening of asymptomatic individuals, a key concern is the potential for misclassification and over- or underdiagnosis due to inconsistent cutoffs and variability of different screening assays, the review concluded.

However, with the rare exception of vitamin D toxicity from supplementation well above sufficient levels, treatment with vitamin D supplementation appears relatively safe.

With a lack of consensus even over the basic cutoff for vitamin D deficiency, the National Academy of Medicine determined in 2011 that hydroxyvitamin D (25[OH]D) levels below 20 ng/mL are deficient for bone health, with no evidence of different thresholds for any other health condition.

Based on that cutoff, the National Health and Nutrition Examination Survey (NHANES), reported in 2014 that 25% of the U.S. population over the age of 1 was vitamin D deficient, with 18% of the population having 25(OH)D levels of 12-19 ng/mL and 5% having very low levels (< 12 ng/mL).
 

More work needed to determine groups at risk

While the task force report did not delve into testing or treatment recommendations for symptomatic adults, key established risk factors that may help clinicians identify those who are vitamin D deficient include obesity, receiving little or no UVB light exposure, and older age.

In general, obesity is associated with a 1.3- to 2-fold risk of being vitamin D deficient based on the criteria used, while non-Hispanic Blacks are 2-10 times more likely to be deficient compared with non-Hispanic White patients, the task force noted.

However, the implications of vitamin D deficiency in certain populations can vary. For instance, non-Hispanic Black people, despite having a higher prevalence of lower vitamin D levels compared with White people, in fact, have lower reported rates of fractures.

To address the various issues and gain a better understanding of the complexities of vitamin D deficiency, the task force calls for further research in key areas.

“More research is needed to determine whether total serum 25(OH)D levels are the best measure of vitamin D deficiency and whether the best measure of vitamin D deficiency varies by subgroups defined by race, ethnicity, or sex,” the authors indicated.

Furthermore, “more research is needed to determine the cutoff that defines vitamin D deficiency and whether that cutoff varies by specific clinical outcome or by subgroups defined by race, ethnicity, or sex.”
 

No support for population-based screening in guidelines

With the lack of conclusive evidence, no organizations currently recommend population-based screening for vitamin D deficiency in asymptomatic patients, and the American Society for Clinical Pathology endorses this stance.

The Endocrine Society and the American Association of Clinical Endocrinologists meanwhile do recommend screening for vitamin D deficiency in patients considered at risk.

Data show there was as much as an 80-fold increase in Medicare reimbursement volumes for vitamin D testing among clinicians from 2000 to 2010; however, that rate may have leveled off after the National Academy of Medicine reported on set deficiency levels, said Sherri-Ann M. Burnett-Bowie, MD, MPH, Dr. Cappola’s editorial coauthor.

Dr. Burnett-Bowie noted that she regularly tests her patients’ vitamin D levels, however most of her patients have osteoporosis or fractures.

“I do screen them for vitamin D deficiency since optimizing their vitamin D will improve calcium absorption, which is important for treating their osteoporosis,” Dr. Burnett-Bowie, of the endocrine division, department of medicine, Massachusetts General Hospital, Boston, said in an interview.

In terms of broader testing of asymptomatic patients in the general population, however, any changes in screening will likely be contingent on developments in the effects of treatment, she said.

“Given the challenge in finding benefits of vitamin D supplementation in those who are deficient, it will likely be more challenging to find benefits from wider screening,” she concluded.

The USPSTF and editorialists reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Recommendations for prescribing exercise to control high blood pressure have been put forward by various medical organizations and expert panels, but finding the bandwidth to craft personalized exercise training for their patients poses a challenge for clinicians.

Now, European cardiology societies have issued a consensus statement that offers an algorithm of sorts for developing personalized exercise programs as part of overall management approach for patients with or at risk of high BP.

The statement, published in the European Journal of Preventive Cardiology and issued by the European Association of Preventive Cardiology and the European Society of Cardiology Council on Hypertension, claims to be the first document to focus on personalized exercise for BP.

The statement draws on a systematic review, including meta-analyses, to produce guidance on how to lower BP in three specific types of patients: Those with hypertension (>140/90 mm Hg), high-normal blood pressure (130-139/85-89 mm Hg), and normal blood pressure (<130/84 mm Hg).

By making recommendations for these three specific groups, along with providing guidance for combined exercise – that is, blending aerobic exercise with resistance training (RT) – the consensus statement goes one step further than recommendations other organizations have issued, Matthew W. Martinez, MD, said in an interview.

“What it adds is an algorithmic approach, if you will,” said Dr. Martinez, a sports medicine cardiologist at Morristown (N.J.) Medical Center. “There are some recommendations to help the clinicians to decide what they’re going to offer individuals, but what’s a challenge for us when seeing patients is finding the time to deliver the message and explain how valuable nutrition and exercise are.”

Guidelines, updates, and statements that include the role of exercise in BP control have been issued by the European Society of Cardiology, American Heart Association, and American College of Sports Medicine (Med Sci Sports Exercise. 2019;51:1314-23).

The European consensus statement includes the expected range of BP lowering for each activity. For example, aerobic exercise for patients with hypertension should lead to a reduction from –4.9 to –12 mm Hg systolic and –3.4 to –5.8 mm Hg diastolic.

The consensus statement recommends the following exercise priorities based on a patient’s blood pressure:

• Hypertension: Aerobic training (AT) as a first-line exercise therapy; and low- to moderate-intensity RT – equally using dynamic and isometric RT – as second-line therapy. In non-White patients, dynamic RT should be considered as a first-line therapy. RT can be combined with aerobic exercise on an individual basis if the clinician determines either form of RT would provide a metabolic benefit.
• High-to-normal BP: Dynamic RT as a first-line exercise, which the systematic review determined led to greater BP reduction than that of aerobic training. “Isometric RT is likely to elicit similar if not superior BP-lowering effects as [dynamic RT], but the level of evidence is low and the available data are scarce,” wrote first author Henner Hanssen, MD, of the University of Basel, Switzerland, and coauthors. Combining dynamic resistance training with aerobic training “may be preferable” to dynamic RT alone in patients with a combination of cardiovascular risk factors.
• Normal BP: Isometric RT may be indicated as a first-line intervention in individuals with a family or gestational history or obese or overweight people currently with normal BP. This advice includes a caveat: “The number of studies is limited and the 95% confidence intervals are large,” Dr. Hanssen and coauthors noted. AT is also an option in these patients, with more high-quality meta-analyses than the recommendation for isometric RT. “Hence, the BP-lowering effects of [isometric RT] as compared to AT may be overestimated and both exercise modalities may have similar BP-lowering effects in individuals with normotension,” wrote the consensus statement authors.

They note that more research is needed to validate the BP-lowering effects of combined exercise.

The statement acknowledges the difficulty clinicians face in managing patients with high blood pressure. “From a socioeconomic health perspective, it is a major challenge to develop, promote, and implement individually tailored exercise programs for patients with hypertension under consideration of sustainable costs,” wrote Dr. Hanssen and coauthors.

Dr. Martinez noted that one strength of the consensus statement is that it addresses the impact exercise can have on vascular health and metabolic function. And, it points out existing knowledge gaps.

“Are we going to see greater applicability of this as we use IT health technology?” he asked. “Are wearables and telehealth going to help deliver this message more easily, more frequently? Is there work to be done in terms of differences in gender? Do men and women respond differently, and is there a different exercise prescription based on that as well as ethnicity? We well know there’s a different treatment for African Americans compared to other ethnic groups.”

The statement also raises the stakes for using exercise as part of a multifaceted, integrated approach to hypertension management, he said.

“It’s not enough to talk just about exercise or nutrition, or to just give an antihypertension medicine,” Dr. Martinez said. “Perhaps the sweet spot is in integrating an approach that includes all three.”

Consensus statement coauthor Antonio Coca, MD, reported financial relationships with Abbott, Berlin-Chemie, Biolab, Boehringer-Ingelheim, Ferrer, Menarini, Merck, Novartis and Sanofi-Aventis. Coauthor Maria Simonenko, MD, reported financial relationships with Novartis and Sanofi-Aventis. Linda Pescatello, PhD, is lead author of the American College of Sports Medicine 2019 statement. Dr. Hanssen and all other authors have no disclosures. Dr. Martinez has no relevant relationships to disclose.

Recommendations for prescribing exercise to control high blood pressure have been put forward by various medical organizations and expert panels, but finding the bandwidth to craft personalized exercise training for their patients poses a challenge for clinicians.

Now, European cardiology societies have issued a consensus statement that offers an algorithm of sorts for developing personalized exercise programs as part of overall management approach for patients with or at risk of high BP.

The statement, published in the European Journal of Preventive Cardiology and issued by the European Association of Preventive Cardiology and the European Society of Cardiology Council on Hypertension, claims to be the first document to focus on personalized exercise for BP.

The statement draws on a systematic review, including meta-analyses, to produce guidance on how to lower BP in three specific types of patients: Those with hypertension (>140/90 mm Hg), high-normal blood pressure (130-139/85-89 mm Hg), and normal blood pressure (<130/84 mm Hg).

By making recommendations for these three specific groups, along with providing guidance for combined exercise – that is, blending aerobic exercise with resistance training (RT) – the consensus statement goes one step further than recommendations other organizations have issued, Matthew W. Martinez, MD, said in an interview.

“What it adds is an algorithmic approach, if you will,” said Dr. Martinez, a sports medicine cardiologist at Morristown (N.J.) Medical Center. “There are some recommendations to help the clinicians to decide what they’re going to offer individuals, but what’s a challenge for us when seeing patients is finding the time to deliver the message and explain how valuable nutrition and exercise are.”

Guidelines, updates, and statements that include the role of exercise in BP control have been issued by the European Society of Cardiology, American Heart Association, and American College of Sports Medicine (Med Sci Sports Exercise. 2019;51:1314-23).

The European consensus statement includes the expected range of BP lowering for each activity. For example, aerobic exercise for patients with hypertension should lead to a reduction from –4.9 to –12 mm Hg systolic and –3.4 to –5.8 mm Hg diastolic.

The consensus statement recommends the following exercise priorities based on a patient’s blood pressure:

• Hypertension: Aerobic training (AT) as a first-line exercise therapy; and low- to moderate-intensity RT – equally using dynamic and isometric RT – as second-line therapy. In non-White patients, dynamic RT should be considered as a first-line therapy. RT can be combined with aerobic exercise on an individual basis if the clinician determines either form of RT would provide a metabolic benefit.
• High-to-normal BP: Dynamic RT as a first-line exercise, which the systematic review determined led to greater BP reduction than that of aerobic training. “Isometric RT is likely to elicit similar if not superior BP-lowering effects as [dynamic RT], but the level of evidence is low and the available data are scarce,” wrote first author Henner Hanssen, MD, of the University of Basel, Switzerland, and coauthors. Combining dynamic resistance training with aerobic training “may be preferable” to dynamic RT alone in patients with a combination of cardiovascular risk factors.
• Normal BP: Isometric RT may be indicated as a first-line intervention in individuals with a family or gestational history or obese or overweight people currently with normal BP. This advice includes a caveat: “The number of studies is limited and the 95% confidence intervals are large,” Dr. Hanssen and coauthors noted. AT is also an option in these patients, with more high-quality meta-analyses than the recommendation for isometric RT. “Hence, the BP-lowering effects of [isometric RT] as compared to AT may be overestimated and both exercise modalities may have similar BP-lowering effects in individuals with normotension,” wrote the consensus statement authors.

They note that more research is needed to validate the BP-lowering effects of combined exercise.

The statement acknowledges the difficulty clinicians face in managing patients with high blood pressure. “From a socioeconomic health perspective, it is a major challenge to develop, promote, and implement individually tailored exercise programs for patients with hypertension under consideration of sustainable costs,” wrote Dr. Hanssen and coauthors.

Dr. Martinez noted that one strength of the consensus statement is that it addresses the impact exercise can have on vascular health and metabolic function. And, it points out existing knowledge gaps.

“Are we going to see greater applicability of this as we use IT health technology?” he asked. “Are wearables and telehealth going to help deliver this message more easily, more frequently? Is there work to be done in terms of differences in gender? Do men and women respond differently, and is there a different exercise prescription based on that as well as ethnicity? We well know there’s a different treatment for African Americans compared to other ethnic groups.”

The statement also raises the stakes for using exercise as part of a multifaceted, integrated approach to hypertension management, he said.

“It’s not enough to talk just about exercise or nutrition, or to just give an antihypertension medicine,” Dr. Martinez said. “Perhaps the sweet spot is in integrating an approach that includes all three.”

Consensus statement coauthor Antonio Coca, MD, reported financial relationships with Abbott, Berlin-Chemie, Biolab, Boehringer-Ingelheim, Ferrer, Menarini, Merck, Novartis and Sanofi-Aventis. Coauthor Maria Simonenko, MD, reported financial relationships with Novartis and Sanofi-Aventis. Linda Pescatello, PhD, is lead author of the American College of Sports Medicine 2019 statement. Dr. Hanssen and all other authors have no disclosures. Dr. Martinez has no relevant relationships to disclose.

Recommendations for prescribing exercise to control high blood pressure have been put forward by various medical organizations and expert panels, but finding the bandwidth to craft personalized exercise training for their patients poses a challenge for clinicians.

Now, European cardiology societies have issued a consensus statement that offers an algorithm of sorts for developing personalized exercise programs as part of overall management approach for patients with or at risk of high BP.

The statement, published in the European Journal of Preventive Cardiology and issued by the European Association of Preventive Cardiology and the European Society of Cardiology Council on Hypertension, claims to be the first document to focus on personalized exercise for BP.

The statement draws on a systematic review, including meta-analyses, to produce guidance on how to lower BP in three specific types of patients: Those with hypertension (>140/90 mm Hg), high-normal blood pressure (130-139/85-89 mm Hg), and normal blood pressure (<130/84 mm Hg).

By making recommendations for these three specific groups, along with providing guidance for combined exercise – that is, blending aerobic exercise with resistance training (RT) – the consensus statement goes one step further than recommendations other organizations have issued, Matthew W. Martinez, MD, said in an interview.

“What it adds is an algorithmic approach, if you will,” said Dr. Martinez, a sports medicine cardiologist at Morristown (N.J.) Medical Center. “There are some recommendations to help the clinicians to decide what they’re going to offer individuals, but what’s a challenge for us when seeing patients is finding the time to deliver the message and explain how valuable nutrition and exercise are.”

Guidelines, updates, and statements that include the role of exercise in BP control have been issued by the European Society of Cardiology, American Heart Association, and American College of Sports Medicine (Med Sci Sports Exercise. 2019;51:1314-23).

The European consensus statement includes the expected range of BP lowering for each activity. For example, aerobic exercise for patients with hypertension should lead to a reduction from –4.9 to –12 mm Hg systolic and –3.4 to –5.8 mm Hg diastolic.

The consensus statement recommends the following exercise priorities based on a patient’s blood pressure:

• Hypertension: Aerobic training (AT) as a first-line exercise therapy; and low- to moderate-intensity RT – equally using dynamic and isometric RT – as second-line therapy. In non-White patients, dynamic RT should be considered as a first-line therapy. RT can be combined with aerobic exercise on an individual basis if the clinician determines either form of RT would provide a metabolic benefit.
• High-to-normal BP: Dynamic RT as a first-line exercise, which the systematic review determined led to greater BP reduction than that of aerobic training. “Isometric RT is likely to elicit similar if not superior BP-lowering effects as [dynamic RT], but the level of evidence is low and the available data are scarce,” wrote first author Henner Hanssen, MD, of the University of Basel, Switzerland, and coauthors. Combining dynamic resistance training with aerobic training “may be preferable” to dynamic RT alone in patients with a combination of cardiovascular risk factors.
• Normal BP: Isometric RT may be indicated as a first-line intervention in individuals with a family or gestational history or obese or overweight people currently with normal BP. This advice includes a caveat: “The number of studies is limited and the 95% confidence intervals are large,” Dr. Hanssen and coauthors noted. AT is also an option in these patients, with more high-quality meta-analyses than the recommendation for isometric RT. “Hence, the BP-lowering effects of [isometric RT] as compared to AT may be overestimated and both exercise modalities may have similar BP-lowering effects in individuals with normotension,” wrote the consensus statement authors.

They note that more research is needed to validate the BP-lowering effects of combined exercise.

The statement acknowledges the difficulty clinicians face in managing patients with high blood pressure. “From a socioeconomic health perspective, it is a major challenge to develop, promote, and implement individually tailored exercise programs for patients with hypertension under consideration of sustainable costs,” wrote Dr. Hanssen and coauthors.

Dr. Martinez noted that one strength of the consensus statement is that it addresses the impact exercise can have on vascular health and metabolic function. And, it points out existing knowledge gaps.

“Are we going to see greater applicability of this as we use IT health technology?” he asked. “Are wearables and telehealth going to help deliver this message more easily, more frequently? Is there work to be done in terms of differences in gender? Do men and women respond differently, and is there a different exercise prescription based on that as well as ethnicity? We well know there’s a different treatment for African Americans compared to other ethnic groups.”

The statement also raises the stakes for using exercise as part of a multifaceted, integrated approach to hypertension management, he said.

“It’s not enough to talk just about exercise or nutrition, or to just give an antihypertension medicine,” Dr. Martinez said. “Perhaps the sweet spot is in integrating an approach that includes all three.”

Consensus statement coauthor Antonio Coca, MD, reported financial relationships with Abbott, Berlin-Chemie, Biolab, Boehringer-Ingelheim, Ferrer, Menarini, Merck, Novartis and Sanofi-Aventis. Coauthor Maria Simonenko, MD, reported financial relationships with Novartis and Sanofi-Aventis. Linda Pescatello, PhD, is lead author of the American College of Sports Medicine 2019 statement. Dr. Hanssen and all other authors have no disclosures. Dr. Martinez has no relevant relationships to disclose.

The American Academy of Pediatrics recently issued five recommendations for the most common dermatologic problems in primary care pediatrics.

Topics include diagnostic and management strategies for a variety of conditions, including atopic dermatitis, fungal infections, and autoimmune conditions.

The AAP Section on Dermatology created the recommendations, which were then reviewed and approved by “more than a dozen relevant AAP committees, councils, and sections,” before final approval by the AAP executive committee and board of directors.

The final list represents a collaborative effort with the Choosing Wisely initiative of the American Board of Internal Medicine Foundation, which aims “to promote conversations between clinicians and patients by helping patients choose care that is supported by evidence, not duplicative of other tests or procedures already received, free from harm, [and] truly necessary.”

Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, said that the recommendations are “a fine set of suggestions to help health care providers with some of their pediatric dermatology issues.”

• To begin, the AAP recommended against use of combination topical steroid antifungals for candida skin infections, diaper dermatitis, and tinea corporis, despite approvals for these indications.

“Many providers are unaware that the combination products contain a relatively high-potency topical steroid,” the AAP wrote, noting that “combination products are also often expensive and not covered by pharmacy plans.”

Diaper dermatitis responds best to barrier creams and ointments alone, according to the AAP. If needed, a topical, low-potency steroid may be used no more than twice a day, and tapered with improvement. Similarly, the AAP recommended a separate, low-potency steroid for tinea corporis if pruritus is severe.

• In contrast with this call for minimal treatment intensity, the AAP recommended a more intensive approach to tinea capitis, advising against topical medications alone.

“Topical treatments cannot penetrate the hair shaft itself, which is where the infection lies; thus, monotherapy with topical medications is insufficient to effectively treat the infection,” the AAP wrote. “This insufficient treatment can lead to increased health care costs resulting from multiple visits and the prescribing of ineffective medications.”

While medicated shampoos may still be used as adjunctive treatments for tinea capitis, the AAP recommended primary therapy with either griseofulvin or terbinafine, slightly favoring terbinafine because of adequate efficacy, lesser expense, and shorter regimen.

According to Dr. Eichenfield, a more thorough workup should also be considered.

“Consider culturing possible tinea capitis, so that oral antifungals can be used judiciously and not used for other scaling scalp diagnoses,” he said.

• For most cases of atopic dermatitis, the AAP advised against oral or injected corticosteroids, despite rapid efficacy, because of potential for adverse events, such as adrenal suppression, growth retardation, and disease worsening upon discontinuation. Instead, they recommended topical therapies, “good skin care practices,” and if necessary, “phototherapy and/or steroid-sparing systemic agents.”

“Systemic corticosteroids should only be prescribed for severe flares once all other treatment options have been exhausted and should be limited to a short course for the purpose of bridging to a steroid-sparing agent,” the AAP wrote.

Dr. Eichenfield emphasized this point, noting that new therapies have expanded treatment options.

“Be aware of the advances in atopic dermatitis,” he said, “with newer topical medications and with a new systemic biologic agent approved for moderate to severe refractory atopic dermatitis for ages 6 and older.”

• Turning to diagnostic strategies, the AAP recommended against routine laboratory testing for associated autoimmune diseases among patients with vitiligo, unless clinical signs and/or symptoms of such diseases are present.

“There is no convincing evidence that extensive workups in the absence of specific clinical suspicion improves outcomes for patients and may in fact beget additional costs and harms,” the AAP wrote. “Although many studies suggest ordering these tests, it is based largely on the increased cosegregation of vitiligo and thyroid disease and not on improved outcomes from having identified an abnormal laboratory test result.”

• Similarly, the AAP advised practitioners to avoid routinely testing patients with alopecia areata for other diseases if relevant symptoms and signs aren’t present.

“As in the case of vitiligo, it is more common to find thyroid autoantibodies or subclinical hypothyroidism than overt thyroid disease, unless there are clinically suspicious findings,” the AAP wrote. “Patients identified as having subclinical hypothyroidism are not currently treated and may even have resolution of the abnormal TSH.”

Before drawing blood, Dr. Eichenfield suggested that clinicians first ask the right questions.

“Be comfortable with screening questions about growth, weight, or activity changes to assist with decisions for thyroid screening in a patient with vitiligo or alopecia areata,” he said.

Choosing Wisely is an initiative of the American Board of Internal Medicine. The AAP and Dr. Eichenfield reported no conflicts of interest.

The American Academy of Pediatrics recently issued five recommendations for the most common dermatologic problems in primary care pediatrics.

Topics include diagnostic and management strategies for a variety of conditions, including atopic dermatitis, fungal infections, and autoimmune conditions.

The AAP Section on Dermatology created the recommendations, which were then reviewed and approved by “more than a dozen relevant AAP committees, councils, and sections,” before final approval by the AAP executive committee and board of directors.

The final list represents a collaborative effort with the Choosing Wisely initiative of the American Board of Internal Medicine Foundation, which aims “to promote conversations between clinicians and patients by helping patients choose care that is supported by evidence, not duplicative of other tests or procedures already received, free from harm, [and] truly necessary.”

Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, said that the recommendations are “a fine set of suggestions to help health care providers with some of their pediatric dermatology issues.”

• To begin, the AAP recommended against use of combination topical steroid antifungals for candida skin infections, diaper dermatitis, and tinea corporis, despite approvals for these indications.

“Many providers are unaware that the combination products contain a relatively high-potency topical steroid,” the AAP wrote, noting that “combination products are also often expensive and not covered by pharmacy plans.”

Diaper dermatitis responds best to barrier creams and ointments alone, according to the AAP. If needed, a topical, low-potency steroid may be used no more than twice a day, and tapered with improvement. Similarly, the AAP recommended a separate, low-potency steroid for tinea corporis if pruritus is severe.

• In contrast with this call for minimal treatment intensity, the AAP recommended a more intensive approach to tinea capitis, advising against topical medications alone.

“Topical treatments cannot penetrate the hair shaft itself, which is where the infection lies; thus, monotherapy with topical medications is insufficient to effectively treat the infection,” the AAP wrote. “This insufficient treatment can lead to increased health care costs resulting from multiple visits and the prescribing of ineffective medications.”

While medicated shampoos may still be used as adjunctive treatments for tinea capitis, the AAP recommended primary therapy with either griseofulvin or terbinafine, slightly favoring terbinafine because of adequate efficacy, lesser expense, and shorter regimen.

According to Dr. Eichenfield, a more thorough workup should also be considered.

“Consider culturing possible tinea capitis, so that oral antifungals can be used judiciously and not used for other scaling scalp diagnoses,” he said.

• For most cases of atopic dermatitis, the AAP advised against oral or injected corticosteroids, despite rapid efficacy, because of potential for adverse events, such as adrenal suppression, growth retardation, and disease worsening upon discontinuation. Instead, they recommended topical therapies, “good skin care practices,” and if necessary, “phototherapy and/or steroid-sparing systemic agents.”

“Systemic corticosteroids should only be prescribed for severe flares once all other treatment options have been exhausted and should be limited to a short course for the purpose of bridging to a steroid-sparing agent,” the AAP wrote.

Dr. Eichenfield emphasized this point, noting that new therapies have expanded treatment options.

“Be aware of the advances in atopic dermatitis,” he said, “with newer topical medications and with a new systemic biologic agent approved for moderate to severe refractory atopic dermatitis for ages 6 and older.”

• Turning to diagnostic strategies, the AAP recommended against routine laboratory testing for associated autoimmune diseases among patients with vitiligo, unless clinical signs and/or symptoms of such diseases are present.

“There is no convincing evidence that extensive workups in the absence of specific clinical suspicion improves outcomes for patients and may in fact beget additional costs and harms,” the AAP wrote. “Although many studies suggest ordering these tests, it is based largely on the increased cosegregation of vitiligo and thyroid disease and not on improved outcomes from having identified an abnormal laboratory test result.”

• Similarly, the AAP advised practitioners to avoid routinely testing patients with alopecia areata for other diseases if relevant symptoms and signs aren’t present.

“As in the case of vitiligo, it is more common to find thyroid autoantibodies or subclinical hypothyroidism than overt thyroid disease, unless there are clinically suspicious findings,” the AAP wrote. “Patients identified as having subclinical hypothyroidism are not currently treated and may even have resolution of the abnormal TSH.”

Before drawing blood, Dr. Eichenfield suggested that clinicians first ask the right questions.

“Be comfortable with screening questions about growth, weight, or activity changes to assist with decisions for thyroid screening in a patient with vitiligo or alopecia areata,” he said.

Choosing Wisely is an initiative of the American Board of Internal Medicine. The AAP and Dr. Eichenfield reported no conflicts of interest.

The American Academy of Pediatrics recently issued five recommendations for the most common dermatologic problems in primary care pediatrics.

Topics include diagnostic and management strategies for a variety of conditions, including atopic dermatitis, fungal infections, and autoimmune conditions.

The AAP Section on Dermatology created the recommendations, which were then reviewed and approved by “more than a dozen relevant AAP committees, councils, and sections,” before final approval by the AAP executive committee and board of directors.

The final list represents a collaborative effort with the Choosing Wisely initiative of the American Board of Internal Medicine Foundation, which aims “to promote conversations between clinicians and patients by helping patients choose care that is supported by evidence, not duplicative of other tests or procedures already received, free from harm, [and] truly necessary.”

Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, said that the recommendations are “a fine set of suggestions to help health care providers with some of their pediatric dermatology issues.”

• To begin, the AAP recommended against use of combination topical steroid antifungals for candida skin infections, diaper dermatitis, and tinea corporis, despite approvals for these indications.

“Many providers are unaware that the combination products contain a relatively high-potency topical steroid,” the AAP wrote, noting that “combination products are also often expensive and not covered by pharmacy plans.”

Diaper dermatitis responds best to barrier creams and ointments alone, according to the AAP. If needed, a topical, low-potency steroid may be used no more than twice a day, and tapered with improvement. Similarly, the AAP recommended a separate, low-potency steroid for tinea corporis if pruritus is severe.

• In contrast with this call for minimal treatment intensity, the AAP recommended a more intensive approach to tinea capitis, advising against topical medications alone.

“Topical treatments cannot penetrate the hair shaft itself, which is where the infection lies; thus, monotherapy with topical medications is insufficient to effectively treat the infection,” the AAP wrote. “This insufficient treatment can lead to increased health care costs resulting from multiple visits and the prescribing of ineffective medications.”

While medicated shampoos may still be used as adjunctive treatments for tinea capitis, the AAP recommended primary therapy with either griseofulvin or terbinafine, slightly favoring terbinafine because of adequate efficacy, lesser expense, and shorter regimen.

According to Dr. Eichenfield, a more thorough workup should also be considered.

“Consider culturing possible tinea capitis, so that oral antifungals can be used judiciously and not used for other scaling scalp diagnoses,” he said.

• For most cases of atopic dermatitis, the AAP advised against oral or injected corticosteroids, despite rapid efficacy, because of potential for adverse events, such as adrenal suppression, growth retardation, and disease worsening upon discontinuation. Instead, they recommended topical therapies, “good skin care practices,” and if necessary, “phototherapy and/or steroid-sparing systemic agents.”

“Systemic corticosteroids should only be prescribed for severe flares once all other treatment options have been exhausted and should be limited to a short course for the purpose of bridging to a steroid-sparing agent,” the AAP wrote.

Dr. Eichenfield emphasized this point, noting that new therapies have expanded treatment options.

“Be aware of the advances in atopic dermatitis,” he said, “with newer topical medications and with a new systemic biologic agent approved for moderate to severe refractory atopic dermatitis for ages 6 and older.”

• Turning to diagnostic strategies, the AAP recommended against routine laboratory testing for associated autoimmune diseases among patients with vitiligo, unless clinical signs and/or symptoms of such diseases are present.

“There is no convincing evidence that extensive workups in the absence of specific clinical suspicion improves outcomes for patients and may in fact beget additional costs and harms,” the AAP wrote. “Although many studies suggest ordering these tests, it is based largely on the increased cosegregation of vitiligo and thyroid disease and not on improved outcomes from having identified an abnormal laboratory test result.”

• Similarly, the AAP advised practitioners to avoid routinely testing patients with alopecia areata for other diseases if relevant symptoms and signs aren’t present.

“As in the case of vitiligo, it is more common to find thyroid autoantibodies or subclinical hypothyroidism than overt thyroid disease, unless there are clinically suspicious findings,” the AAP wrote. “Patients identified as having subclinical hypothyroidism are not currently treated and may even have resolution of the abnormal TSH.”

Before drawing blood, Dr. Eichenfield suggested that clinicians first ask the right questions.

“Be comfortable with screening questions about growth, weight, or activity changes to assist with decisions for thyroid screening in a patient with vitiligo or alopecia areata,” he said.

Choosing Wisely is an initiative of the American Board of Internal Medicine. The AAP and Dr. Eichenfield reported no conflicts of interest.

The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”

This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.

The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.

In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.

“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.

The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
 

First, ‘take blood pressure well’

The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”

First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.

Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”

The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.

In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.

In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.

Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
 

Second, target 120, properly measured

“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.

“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.

“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.

“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
 

Still need individual treatment

Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.

“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.

“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.

“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”

“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
 

ACE inhibitors and ARBs beneficial in albuminuria, underused

“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.

“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”

Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.

“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
 

Public health implications

SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.

They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.

The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m² or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.

Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.

On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.

These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.

“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”

Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.

A version of this article first appeared on Medscape.com.

The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”

This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.

The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.

In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.

“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.

The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
 

First, ‘take blood pressure well’

The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”

First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.

Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”

The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.

In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.

In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.

Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
 

Second, target 120, properly measured

“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.

“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.

“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.

“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
 

Still need individual treatment

Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.

“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.

“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.

“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”

“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
 

ACE inhibitors and ARBs beneficial in albuminuria, underused

“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.

“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”

Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.

“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
 

Public health implications

SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.

They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.

The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m² or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.

Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.

On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.

These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.

“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”

Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.

A version of this article first appeared on Medscape.com.

The new 2021 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline for blood pressure management for adults with chronic kidney disease (CKD) who are not receiving dialysis advises treating to a target systolic blood pressure of less than 120 mm Hg, provided measurements are “standardized” and that blood pressure is “measured properly.”

This blood pressure target – largely based on evidence from the Systolic Blood Pressure Intervention Trial (SPRINT) – represents “a major update” from the 2012 KDIGO guideline, which advised clinicians to treat to a target blood pressure of less than or equal to 130/80 mm Hg for patients with albuminuria or less than or equal to 140/90 mm Hg for patients without albuminuria.

The new goal is also lower than the less than 130/80 mm Hg target in the 2017 American College of Cardiology/American Heart Association guideline.

In a study of the public health implications of the guideline, Kathryn Foti, PhD, and colleagues determined that 70% of U.S. adults with CKD would now be eligible for treatment to lower blood pressure, as opposed to 50% under the previous KDIGO guideline and 56% under the ACC/AHA guideline.

“This is a major update of an influential set of guidelines for chronic kidney disease patients” at a time when blood pressure control is worsening in the United States, Dr. Foti, a postdoctoral researcher in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in a statement from her institution.

The 2021 KDIGO blood pressure guideline and executive summary and the public health implications study are published online in Kidney International.
 

First, ‘take blood pressure well’

The cochair of the new KDIGO guidelines, Alfred K. Cheung, MD, from the University of Utah, Salt Lake City, said in an interview that the guideline has “two important points.”

First, “take that blood pressure well,” he said. “That has a lot to do with patient preparation rather than any fancy instrument,” he emphasized.

Second, the guideline proposes a systolic blood pressure target of less than 120 mm Hg for most people with CKD not receiving dialysis, except for children and kidney transplant recipients. This target is “contingent on ‘standardized’ blood pressure measurement.”

The document provides a checklist for obtaining a standardized blood pressure measurement, adapted from the 2017 ACC/AHA blood pressure guidelines. It starts with the patient relaxed and sitting on a chair for more than 5 minutes.

In contrast to this measurement, a “routine” or “casual” office blood pressure measurement could be off by plus or minus 10 mm Hg, Dr. Cheung noted.

In a typical scenario, he continued, a patient cannot find a place to park, rushes into the clinic, and has his or her blood pressure checked right away, which would provide a “totally unreliable” reading. Adding a “fudge factor” (correction factor) would not provide an accurate reading.

Clinicians “would not settle for a potassium measurement that is 5.0 mmol/L plus or minus a few decimal points” to guide treatment, he pointed out.
 

Second, target 120, properly measured

“The very first chapter of the guidelines is devoted to blood pressure measurement, because we recognize if we’re going to do 120 [mm Hg] – the emphasis is on 120 measured properly – so we try to drive that point home,” Tara I. Chang, MD, guideline second author and a coauthor of the public health implications study, pointed out in an interview.

“There are a lot of other things that we base clinical decisions on where we really require some degree of precision, and blood pressure is important enough that to us it’s kind of in the same boat,” said Dr. Chang, from Stanford (Calif.) University.

“In SPRINT, people were randomized to less than less than 120 vs. less than 140 (they weren’t randomized to <130),” she noted.

“The recommendation should be widely adopted in clinical practice,” the guideline authors write, “since accurate measurements will ensure that proper guidance is being applied to the management of BP, as it is to the management of other risk factors.”
 

Still need individual treatment

Nevertheless, patients still need individualized treatment, the document stresses. “Not every patient with CKD will be appropriate to target to less than 120,” Dr. Chang said. However, “we want people to at least consider less than 120,” she added, to avoid therapeutic inertia.

“If you take the blood pressure in a standardized manner – such as in the ACCORD trial and in the SPRINT trial – even patients over 75 years old, or people over 80 years old, they have very little side effects,” Dr. Cheung noted.

“In the overall cohort,” he continued, “they do not have a significant increase in serious adverse events, do not have adverse events of postural hypotension, syncope, bradycardia, injurious falls – so people are worried about it, but it’s not borne out by the data.

“That said, I have two cautions,” Dr. Cheung noted. “One. If you drop somebody’s blood pressure rapidly over a week, you may be more likely to get in trouble. If you drop the blood pressure gradually over several weeks, several months, you’re much less likely to get into trouble.”

“Two. If the patient is old, you know the patient has carotid stenosis and already has postural dizziness, you may not want to try on that patient – but just because the patient is old is not the reason not to target 120.”
 

ACE inhibitors and ARBs beneficial in albuminuria, underused

“How do you get to less than 120? The short answer is, use whatever medications you need to – there is no necessarily right cocktail,” Dr. Chang said.

“We’ve known that angiotensin-converting enzyme (ACE) inhibitors and ARBs [angiotensin II receptor blockers] are beneficial in patients with CKD and in particular those with heavier albuminuria,” she continued. “We’ve known this for over 20 years.”

Yet, the study identified underutilization – “a persistent gap, just like blood pressure control and awareness,” she noted. “We’re just not making much headway.

“We are not recommending ACE inhibitors or ARBs for all the patients,” Dr. Cheung clarified. “If you are diabetic and have heavy proteinuria, that’s when the use of ACE inhibitors and ARBs are most indicated.”
 

Public health implications

SPRINT showed that treating to a systolic blood pressure of less than 120 mm Hg vs. less than 140 mm Hg reduced the risk for cardiovascular disease by 25% and all-cause mortality by 27% for participants with and those without CKD, Dr. Foti and colleagues stress.

They aimed to estimate how the new guideline would affect (1) the number of U.S. patients with CKD who would be eligible for blood pressure lowering treatment, and (2) the proportion of those with albuminuria who would be eligible for an ACE inhibitor or an ARB.

The researchers analyzed data from 1,699 adults with CKD (estimated glomerular filtration rate, 15-59 mL/min/1.73 m² or a urinary albumin-to-creatinine ratio of ≥30 mg/g) who participated in the 2015-2018 National Health and Nutrition Examination Survey.

Both the 2021 and 2012 KDIGO guidelines recommend that patients with albuminuria and blood pressure higher than the target value who are not kidney transplant recipients should be treated with an ACE inhibitor or an ARB.

On the basis of the new target, 78% of patients with CKD and albuminuria were eligible for ACE inhibitor/ARB treatment by the 2021 KDIGO guideline, compared with 71% by the 2012 KDIGO guideline. However, only 39% were taking one of these drugs.

These findings show that “with the new guideline and with the lower blood pressure target, you potentially have an even larger pool of people who have blood pressure that’s not under control, and a potential larger group of people who may benefit from ACE inhibitors and ARBs,” Dr. Chang said.

“Our paper is not the only one to show that we haven’t made a whole lot of progress,” she said, “and now that the bar has been lowered, there [have] to be some renewed efforts on controlling blood pressure, because we know that blood pressure control is such an important risk factor for cardiovascular outcomes.”

Dr. Foti is supported by an NIH/National Heart, Lung, and Blood Institute grant. Dr. Cheung has received consultancy fees from Amgen, Bard, Boehringer Ingelheim, Calliditas, Tricida, and UpToDate, and grant/research support from the National Institutes of Health for SPRINT (monies paid to institution). Dr. Chang has received consultancy fees from Bayer, Gilead, Janssen Research and Development, Novo Nordisk, Tricida, and Vascular Dynamics; grant/research support from AstraZeneca and Satellite Healthcare (monies paid to institution), the NIH, and the American Heart Association; is on advisory boards for AstraZeneca and Fresenius Medical Care Renal Therapies Group; and has received workshop honoraria from Fresenius. Disclosures of relevant financial relationships of the other authors are listed in the original articles.

A version of this article first appeared on Medscape.com.

Osimertinib is the optimal first-line treatment for stage IV non–small cell lung cancer (NSCLC) with activating EGFR mutations, and alectinib or brigatinib are optimal first-line treatments for stage IV NSCLC with ALK fusions, according to new guidelines.

The guidelines, jointly released by the American Society of Clinical Oncology (ASCO) and Ontario Health (OH), were published in the Journal of Clinical Oncology. The recommendations are based on results from 54 studies published or presented from Dec. 2015 to May 2020.

The new guidelines supplant ASCO’s 2017 guidelines on stage IV NSCLC. Several driver mutations were touched upon in the 2017 document, but their corresponding targeted therapies were not recommended as first-line treatment.

With substantial progress in targeted therapies since 2017, treatment decision-making in 2021 focuses on the molecular signatures of tumors and PD-L1 score, according to the authors of the current guidelines, Nasser Hanna, MD, of Indiana University, Indianapolis, and colleagues.

“All patients with nonsquamous NSCLC should have the results of testing for potentially targetable mutations (alterations) before implementing therapy for advanced lung cancer, regardless of smoking status recommendations,” the authors wrote.

They noted that about a third of patients with NSCLC have known targetable genetic alterations. The Food and Drug Administration has approved therapeutics targeting seven alterations: EGFR and ALK alterations, ROS-1 fusions, BRAF V600e mutations, RET fusions, MET exon 14 skipping mutations, and NTRK fusions.
 

EGFR-mutant NSCLC

The authors’ recommendation for osimertinib as first-line therapy applies to patients who have EGFR-activating mutations in exon 19 (deletion), exon 21 L858R, or exon 20 T790M.

The authors also said osimertinib is an option for patients with other EGFR mutations. Alternatively, these patients can receive afatinib or treatments outlined in the ASCO/OH nondriver mutation guideline, which was published in the Journal of Clinical Oncology in 2020.

If osimertinib is not available for first-line treatment, other options include gefitinib, erlotinib, icotinib, gefitinib plus chemotherapy, dacomitinib, afatinib, erlotinib plus bevacizumab, or erlotinib plus ramucirumab.

The authors recommend osimertinib in the second-line setting for patients who did not receive osimertinib initially and who have a T790M mutation at the time of progression. For patients who have progressed on EGFR tyrosine kinase inhibitors and have no T790M mutation or if their disease has progressed on osimertinib, second-line treatment should be based on the ASCO/OH nondriver mutation guideline, according to Dr. Hanna and colleagues.
 

ALK-mutant NSCLC

For patients with ALK alterations, the authors recommend alectinib or brigatinib as first-line treatment. If these agents are not available, ceritinib or crizotinib should be offered.

In the second-line setting, if alectinib or brigatinib were given initially, lorlatinib may be offered. If crizotinib was given as first-line therapy, then alectinib, brigatinib, or ceritinib should be offered.

If crizotinib was given in the first-line setting and alectinib, brigatinib, or ceritinib were given in the second-line setting, third-line treatment should be lorlatinib or standard treatment based on the ASCO/OH nondriver mutation guideline.
 

Other mutations

For stage IV NSCLC patients with alterations in ROS1, BRAF, RET, MET, or NTRK, the authors recommend either targeted or standard nontargeted therapy upfront, with the approach not given first-line used in the second line.

“It is unknown if improved outcomes would be seen when comparing standard nondriver mutation treatment with using the targeted therapy in the first- or second-line setting,” the authors wrote.

They noted that the recommendations for EGFR-activating mutations and ALK fusions are based on results from phase 3 trials, but recommendations for other targetable mutations are supported by phase 2 single-arm data.

The authors also noted promising reports for agents aimed at other molecular targets, including aberrations in KRAS, HER2, and NRG-1.

“Although there are insufficient data to recommend targeted therapy in these and other subgroups at the time of this guideline update, we anticipate rapid evolution of the evidence and availability of targeted therapies in these subgroups of patients soon,” the authors wrote.
 

Cost considerations

The authors noted that cost is a consideration when deciding on treatment, and costs can vary widely. According to 2020 Medicare drug prices, the monthly cost of ramucirumab was $61, while the monthly cost of ceritinib was $21,107.

“Increasingly, individuals with cancer are required to pay a larger proportion of their treatment costs through deductibles and coinsurance. Higher patient out-of-pocket costs have been shown to be a barrier to initiating and adhering to recommended cancer treatments,” the authors wrote.

“Discussion of cost can be an important part of shared decision-making. Clinicians should discuss with patients the use of less expensive alternatives when it is practical and feasible for treatment of the patient’s disease,” they added.

The guidelines were funded by ASCO. The authors had numerous disclosures, including Dr. Hanna, who disclosed relationships with UpToDate, Merck KGaA, Bristol-Myers Squibb, AstraZeneca/MedImmune, Genentech, and BeyondSpring Pharmaceuticals.

[email protected]

Osimertinib is the optimal first-line treatment for stage IV non–small cell lung cancer (NSCLC) with activating EGFR mutations, and alectinib or brigatinib are optimal first-line treatments for stage IV NSCLC with ALK fusions, according to new guidelines.

The guidelines, jointly released by the American Society of Clinical Oncology (ASCO) and Ontario Health (OH), were published in the Journal of Clinical Oncology. The recommendations are based on results from 54 studies published or presented from Dec. 2015 to May 2020.

The new guidelines supplant ASCO’s 2017 guidelines on stage IV NSCLC. Several driver mutations were touched upon in the 2017 document, but their corresponding targeted therapies were not recommended as first-line treatment.

With substantial progress in targeted therapies since 2017, treatment decision-making in 2021 focuses on the molecular signatures of tumors and PD-L1 score, according to the authors of the current guidelines, Nasser Hanna, MD, of Indiana University, Indianapolis, and colleagues.

“All patients with nonsquamous NSCLC should have the results of testing for potentially targetable mutations (alterations) before implementing therapy for advanced lung cancer, regardless of smoking status recommendations,” the authors wrote.

They noted that about a third of patients with NSCLC have known targetable genetic alterations. The Food and Drug Administration has approved therapeutics targeting seven alterations: EGFR and ALK alterations, ROS-1 fusions, BRAF V600e mutations, RET fusions, MET exon 14 skipping mutations, and NTRK fusions.
 

EGFR-mutant NSCLC

The authors’ recommendation for osimertinib as first-line therapy applies to patients who have EGFR-activating mutations in exon 19 (deletion), exon 21 L858R, or exon 20 T790M.

The authors also said osimertinib is an option for patients with other EGFR mutations. Alternatively, these patients can receive afatinib or treatments outlined in the ASCO/OH nondriver mutation guideline, which was published in the Journal of Clinical Oncology in 2020.

If osimertinib is not available for first-line treatment, other options include gefitinib, erlotinib, icotinib, gefitinib plus chemotherapy, dacomitinib, afatinib, erlotinib plus bevacizumab, or erlotinib plus ramucirumab.

The authors recommend osimertinib in the second-line setting for patients who did not receive osimertinib initially and who have a T790M mutation at the time of progression. For patients who have progressed on EGFR tyrosine kinase inhibitors and have no T790M mutation or if their disease has progressed on osimertinib, second-line treatment should be based on the ASCO/OH nondriver mutation guideline, according to Dr. Hanna and colleagues.
 

ALK-mutant NSCLC

For patients with ALK alterations, the authors recommend alectinib or brigatinib as first-line treatment. If these agents are not available, ceritinib or crizotinib should be offered.

In the second-line setting, if alectinib or brigatinib were given initially, lorlatinib may be offered. If crizotinib was given as first-line therapy, then alectinib, brigatinib, or ceritinib should be offered.

If crizotinib was given in the first-line setting and alectinib, brigatinib, or ceritinib were given in the second-line setting, third-line treatment should be lorlatinib or standard treatment based on the ASCO/OH nondriver mutation guideline.
 

Other mutations

For stage IV NSCLC patients with alterations in ROS1, BRAF, RET, MET, or NTRK, the authors recommend either targeted or standard nontargeted therapy upfront, with the approach not given first-line used in the second line.

“It is unknown if improved outcomes would be seen when comparing standard nondriver mutation treatment with using the targeted therapy in the first- or second-line setting,” the authors wrote.

They noted that the recommendations for EGFR-activating mutations and ALK fusions are based on results from phase 3 trials, but recommendations for other targetable mutations are supported by phase 2 single-arm data.

The authors also noted promising reports for agents aimed at other molecular targets, including aberrations in KRAS, HER2, and NRG-1.

“Although there are insufficient data to recommend targeted therapy in these and other subgroups at the time of this guideline update, we anticipate rapid evolution of the evidence and availability of targeted therapies in these subgroups of patients soon,” the authors wrote.
 

Cost considerations

The authors noted that cost is a consideration when deciding on treatment, and costs can vary widely. According to 2020 Medicare drug prices, the monthly cost of ramucirumab was $61, while the monthly cost of ceritinib was $21,107.

“Increasingly, individuals with cancer are required to pay a larger proportion of their treatment costs through deductibles and coinsurance. Higher patient out-of-pocket costs have been shown to be a barrier to initiating and adhering to recommended cancer treatments,” the authors wrote.

“Discussion of cost can be an important part of shared decision-making. Clinicians should discuss with patients the use of less expensive alternatives when it is practical and feasible for treatment of the patient’s disease,” they added.

The guidelines were funded by ASCO. The authors had numerous disclosures, including Dr. Hanna, who disclosed relationships with UpToDate, Merck KGaA, Bristol-Myers Squibb, AstraZeneca/MedImmune, Genentech, and BeyondSpring Pharmaceuticals.

[email protected]

Osimertinib is the optimal first-line treatment for stage IV non–small cell lung cancer (NSCLC) with activating EGFR mutations, and alectinib or brigatinib are optimal first-line treatments for stage IV NSCLC with ALK fusions, according to new guidelines.

The guidelines, jointly released by the American Society of Clinical Oncology (ASCO) and Ontario Health (OH), were published in the Journal of Clinical Oncology. The recommendations are based on results from 54 studies published or presented from Dec. 2015 to May 2020.

The new guidelines supplant ASCO’s 2017 guidelines on stage IV NSCLC. Several driver mutations were touched upon in the 2017 document, but their corresponding targeted therapies were not recommended as first-line treatment.

With substantial progress in targeted therapies since 2017, treatment decision-making in 2021 focuses on the molecular signatures of tumors and PD-L1 score, according to the authors of the current guidelines, Nasser Hanna, MD, of Indiana University, Indianapolis, and colleagues.

“All patients with nonsquamous NSCLC should have the results of testing for potentially targetable mutations (alterations) before implementing therapy for advanced lung cancer, regardless of smoking status recommendations,” the authors wrote.

They noted that about a third of patients with NSCLC have known targetable genetic alterations. The Food and Drug Administration has approved therapeutics targeting seven alterations: EGFR and ALK alterations, ROS-1 fusions, BRAF V600e mutations, RET fusions, MET exon 14 skipping mutations, and NTRK fusions.
 

EGFR-mutant NSCLC

The authors’ recommendation for osimertinib as first-line therapy applies to patients who have EGFR-activating mutations in exon 19 (deletion), exon 21 L858R, or exon 20 T790M.

The authors also said osimertinib is an option for patients with other EGFR mutations. Alternatively, these patients can receive afatinib or treatments outlined in the ASCO/OH nondriver mutation guideline, which was published in the Journal of Clinical Oncology in 2020.

If osimertinib is not available for first-line treatment, other options include gefitinib, erlotinib, icotinib, gefitinib plus chemotherapy, dacomitinib, afatinib, erlotinib plus bevacizumab, or erlotinib plus ramucirumab.

The authors recommend osimertinib in the second-line setting for patients who did not receive osimertinib initially and who have a T790M mutation at the time of progression. For patients who have progressed on EGFR tyrosine kinase inhibitors and have no T790M mutation or if their disease has progressed on osimertinib, second-line treatment should be based on the ASCO/OH nondriver mutation guideline, according to Dr. Hanna and colleagues.
 

ALK-mutant NSCLC

For patients with ALK alterations, the authors recommend alectinib or brigatinib as first-line treatment. If these agents are not available, ceritinib or crizotinib should be offered.

In the second-line setting, if alectinib or brigatinib were given initially, lorlatinib may be offered. If crizotinib was given as first-line therapy, then alectinib, brigatinib, or ceritinib should be offered.

If crizotinib was given in the first-line setting and alectinib, brigatinib, or ceritinib were given in the second-line setting, third-line treatment should be lorlatinib or standard treatment based on the ASCO/OH nondriver mutation guideline.
 

Other mutations

For stage IV NSCLC patients with alterations in ROS1, BRAF, RET, MET, or NTRK, the authors recommend either targeted or standard nontargeted therapy upfront, with the approach not given first-line used in the second line.

“It is unknown if improved outcomes would be seen when comparing standard nondriver mutation treatment with using the targeted therapy in the first- or second-line setting,” the authors wrote.

They noted that the recommendations for EGFR-activating mutations and ALK fusions are based on results from phase 3 trials, but recommendations for other targetable mutations are supported by phase 2 single-arm data.

The authors also noted promising reports for agents aimed at other molecular targets, including aberrations in KRAS, HER2, and NRG-1.

“Although there are insufficient data to recommend targeted therapy in these and other subgroups at the time of this guideline update, we anticipate rapid evolution of the evidence and availability of targeted therapies in these subgroups of patients soon,” the authors wrote.
 

Cost considerations

The authors noted that cost is a consideration when deciding on treatment, and costs can vary widely. According to 2020 Medicare drug prices, the monthly cost of ramucirumab was $61, while the monthly cost of ceritinib was $21,107.

“Increasingly, individuals with cancer are required to pay a larger proportion of their treatment costs through deductibles and coinsurance. Higher patient out-of-pocket costs have been shown to be a barrier to initiating and adhering to recommended cancer treatments,” the authors wrote.

“Discussion of cost can be an important part of shared decision-making. Clinicians should discuss with patients the use of less expensive alternatives when it is practical and feasible for treatment of the patient’s disease,” they added.

The guidelines were funded by ASCO. The authors had numerous disclosures, including Dr. Hanna, who disclosed relationships with UpToDate, Merck KGaA, Bristol-Myers Squibb, AstraZeneca/MedImmune, Genentech, and BeyondSpring Pharmaceuticals.

[email protected]

Colorectal cancer (CRC) screening is now recommended for average-risk individuals starting at age 45 years, according to the American College of Gastroenterology’s updated guideline.

The starting age was previously 50 years for most patients. However, for Black patients, the starting age was lowered to 45 years in 2005.

The new guidance brings the ACG in line with recommendations of the American Cancer Society, which lowered the starting age to 45 years for average-risk individuals in 2018.

However, the U.S. Preventive Services Task Force, the Multi-Specialty Task Force, and the American College of Physicians still recommend that CRC screening begin at the age of 50.

The new ACG guideline were published in March 2021 in the American Journal of Gastroenterology. The last time they were updated was in 2009.

The ACG said that the move was made in light of reports of an increase in the incidence of CRC in adults younger than 50.

“It has been estimated that [in the United States] persons born around 1990 have twice the risk of colon cancer and four times the risk of rectal cancer, compared with those born around 1950,” guideline author Aasma Shaukat, MD, MPH, University of Minnesota, Minneapolis, and colleagues pointed out.

“The fact that other developed countries are reporting similar increases in early-onset CRC and birth-cohort effects suggests that the Western lifestyle (especially exemplified by the obesity epidemic) is a significant contributor,” the authors added.

The new ACG guideline emphasize the importance of initiating CRC screening for average-risk patients aged 50-75 years. “Given that current rates of screening uptake are close to 60% (57.9% ages 50-64 and 62.4% ages 50-75), expanding the population to be screened may reduce these rates as emphasis shifts to screening 45- to 49-year-olds at the expense of efforts to screen the unscreened 50- to 75-year-olds,” the authors commented.

Now, however, the guideline suggests that the decision to continue screening after age 75 should be individualized. It notes that the benefits of screening are limited for those who are not expected to live for another 7-10 years. For patients with a family history of CRC, the guideline authors recommended initiating CRC screening at the age of 40 for patients with one or two first-degree relatives with either CRC or advanced colorectal polyps.

They also recommend screening colonoscopy over any other screening modality if the first-degree relative is younger than 60 or if two or more first-degree relatives of any age have CRC or advanced colorectal polyps. For such patients, screening should be repeated every 5 years.

For screening average-risk individuals, either colonoscopy or fecal immunochemical testing (FIT) is recommended. If colonoscopy is used, it should be repeated every 10 years. FIT should be conducted on an annual basis.

This is somewhat in contrast to recent changes proposed by the American Gastroenterological Association. The AGA recommends greater use of noninvasive testing, such as with fecal occult blood tests, initially. It recommends that initial colonoscopy be used only for patients at high risk for CRC.

For individuals unwilling or unable to undergo colonoscopy or FIT, the ACG suggests flexible sigmoidoscopy, multitarget stool DNA testing, CT colonography, or colon capsule. Only colonoscopy is a single-step test; all other screening modalities require a follow-up colonoscopy if test results are positive.

“We recommend against the use of aspirin as a substitute for CRC screening,” the ACG members emphasized. Rather, they suggest that the use of low-dose aspirin be considered only for patients aged 50-69 years whose risk for cardiovascular disease over the next 10 years is at least 10% and who are at low risk for bleeding.

To reduce their risk for CRC, patients need to take aspirin for at least 10 years, they pointed out.
 

Quality indicators

For endoscopists who perform colonoscopy, the ACG recommended that all operators determine their individual cecal intubation rates, adenoma detection rates, and withdrawal times. They also recommended that endoscopists spend at least 6 minutes inspecting the mucosa during withdrawal and achieve a cecal intubation rate of at least 95% for all patients screened.

The ACG recommended remedial training for any provider whose adenoma detection rate is less than 25%.
 

Screening rates dropped during pandemic

The authors of the new recommendations also pointed out that, despite public health initiatives to boost CRC screening in the United States and the availability of multiple screening modalities, almost one-third of individuals who are eligible for CRC screening do not undergo screening.

Moreover, the proportion of individuals not being screened has reportedly increased during the pandemic. In one report, claims data for colonoscopies dropped by 90% during April. “Colorectal cancer screening rates must be optimized to reach the aspirational target of >80%,” the authors emphasized.

“A recommendation to be screened by a PCP [primary care provider] – who is known and trusted by the person – is clearly effective in raising participation,” they added.

Dr. Shaukat has served as a scientific consultant for Iterative Scopes and Freenome. Other ACG guideline authors reported numerous financial relationships.

A version of this article first appeared on Medscape.com.

Colorectal cancer (CRC) screening is now recommended for average-risk individuals starting at age 45 years, according to the American College of Gastroenterology’s updated guideline.

The starting age was previously 50 years for most patients. However, for Black patients, the starting age was lowered to 45 years in 2005.

The new guidance brings the ACG in line with recommendations of the American Cancer Society, which lowered the starting age to 45 years for average-risk individuals in 2018.

However, the U.S. Preventive Services Task Force, the Multi-Specialty Task Force, and the American College of Physicians still recommend that CRC screening begin at the age of 50.

The new ACG guideline were published in March 2021 in the American Journal of Gastroenterology. The last time they were updated was in 2009.

The ACG said that the move was made in light of reports of an increase in the incidence of CRC in adults younger than 50.

“It has been estimated that [in the United States] persons born around 1990 have twice the risk of colon cancer and four times the risk of rectal cancer, compared with those born around 1950,” guideline author Aasma Shaukat, MD, MPH, University of Minnesota, Minneapolis, and colleagues pointed out.

“The fact that other developed countries are reporting similar increases in early-onset CRC and birth-cohort effects suggests that the Western lifestyle (especially exemplified by the obesity epidemic) is a significant contributor,” the authors added.

The new ACG guideline emphasize the importance of initiating CRC screening for average-risk patients aged 50-75 years. “Given that current rates of screening uptake are close to 60% (57.9% ages 50-64 and 62.4% ages 50-75), expanding the population to be screened may reduce these rates as emphasis shifts to screening 45- to 49-year-olds at the expense of efforts to screen the unscreened 50- to 75-year-olds,” the authors commented.

Now, however, the guideline suggests that the decision to continue screening after age 75 should be individualized. It notes that the benefits of screening are limited for those who are not expected to live for another 7-10 years. For patients with a family history of CRC, the guideline authors recommended initiating CRC screening at the age of 40 for patients with one or two first-degree relatives with either CRC or advanced colorectal polyps.

They also recommend screening colonoscopy over any other screening modality if the first-degree relative is younger than 60 or if two or more first-degree relatives of any age have CRC or advanced colorectal polyps. For such patients, screening should be repeated every 5 years.

For screening average-risk individuals, either colonoscopy or fecal immunochemical testing (FIT) is recommended. If colonoscopy is used, it should be repeated every 10 years. FIT should be conducted on an annual basis.

This is somewhat in contrast to recent changes proposed by the American Gastroenterological Association. The AGA recommends greater use of noninvasive testing, such as with fecal occult blood tests, initially. It recommends that initial colonoscopy be used only for patients at high risk for CRC.

For individuals unwilling or unable to undergo colonoscopy or FIT, the ACG suggests flexible sigmoidoscopy, multitarget stool DNA testing, CT colonography, or colon capsule. Only colonoscopy is a single-step test; all other screening modalities require a follow-up colonoscopy if test results are positive.

“We recommend against the use of aspirin as a substitute for CRC screening,” the ACG members emphasized. Rather, they suggest that the use of low-dose aspirin be considered only for patients aged 50-69 years whose risk for cardiovascular disease over the next 10 years is at least 10% and who are at low risk for bleeding.

To reduce their risk for CRC, patients need to take aspirin for at least 10 years, they pointed out.
 

Quality indicators

For endoscopists who perform colonoscopy, the ACG recommended that all operators determine their individual cecal intubation rates, adenoma detection rates, and withdrawal times. They also recommended that endoscopists spend at least 6 minutes inspecting the mucosa during withdrawal and achieve a cecal intubation rate of at least 95% for all patients screened.

The ACG recommended remedial training for any provider whose adenoma detection rate is less than 25%.
 

Screening rates dropped during pandemic

The authors of the new recommendations also pointed out that, despite public health initiatives to boost CRC screening in the United States and the availability of multiple screening modalities, almost one-third of individuals who are eligible for CRC screening do not undergo screening.

Moreover, the proportion of individuals not being screened has reportedly increased during the pandemic. In one report, claims data for colonoscopies dropped by 90% during April. “Colorectal cancer screening rates must be optimized to reach the aspirational target of >80%,” the authors emphasized.

“A recommendation to be screened by a PCP [primary care provider] – who is known and trusted by the person – is clearly effective in raising participation,” they added.

Dr. Shaukat has served as a scientific consultant for Iterative Scopes and Freenome. Other ACG guideline authors reported numerous financial relationships.

A version of this article first appeared on Medscape.com.

Colorectal cancer (CRC) screening is now recommended for average-risk individuals starting at age 45 years, according to the American College of Gastroenterology’s updated guideline.

The starting age was previously 50 years for most patients. However, for Black patients, the starting age was lowered to 45 years in 2005.

The new guidance brings the ACG in line with recommendations of the American Cancer Society, which lowered the starting age to 45 years for average-risk individuals in 2018.

However, the U.S. Preventive Services Task Force, the Multi-Specialty Task Force, and the American College of Physicians still recommend that CRC screening begin at the age of 50.

The new ACG guideline were published in March 2021 in the American Journal of Gastroenterology. The last time they were updated was in 2009.

The ACG said that the move was made in light of reports of an increase in the incidence of CRC in adults younger than 50.

“It has been estimated that [in the United States] persons born around 1990 have twice the risk of colon cancer and four times the risk of rectal cancer, compared with those born around 1950,” guideline author Aasma Shaukat, MD, MPH, University of Minnesota, Minneapolis, and colleagues pointed out.

“The fact that other developed countries are reporting similar increases in early-onset CRC and birth-cohort effects suggests that the Western lifestyle (especially exemplified by the obesity epidemic) is a significant contributor,” the authors added.

The new ACG guideline emphasize the importance of initiating CRC screening for average-risk patients aged 50-75 years. “Given that current rates of screening uptake are close to 60% (57.9% ages 50-64 and 62.4% ages 50-75), expanding the population to be screened may reduce these rates as emphasis shifts to screening 45- to 49-year-olds at the expense of efforts to screen the unscreened 50- to 75-year-olds,” the authors commented.

Now, however, the guideline suggests that the decision to continue screening after age 75 should be individualized. It notes that the benefits of screening are limited for those who are not expected to live for another 7-10 years. For patients with a family history of CRC, the guideline authors recommended initiating CRC screening at the age of 40 for patients with one or two first-degree relatives with either CRC or advanced colorectal polyps.

They also recommend screening colonoscopy over any other screening modality if the first-degree relative is younger than 60 or if two or more first-degree relatives of any age have CRC or advanced colorectal polyps. For such patients, screening should be repeated every 5 years.

For screening average-risk individuals, either colonoscopy or fecal immunochemical testing (FIT) is recommended. If colonoscopy is used, it should be repeated every 10 years. FIT should be conducted on an annual basis.

This is somewhat in contrast to recent changes proposed by the American Gastroenterological Association. The AGA recommends greater use of noninvasive testing, such as with fecal occult blood tests, initially. It recommends that initial colonoscopy be used only for patients at high risk for CRC.

For individuals unwilling or unable to undergo colonoscopy or FIT, the ACG suggests flexible sigmoidoscopy, multitarget stool DNA testing, CT colonography, or colon capsule. Only colonoscopy is a single-step test; all other screening modalities require a follow-up colonoscopy if test results are positive.

“We recommend against the use of aspirin as a substitute for CRC screening,” the ACG members emphasized. Rather, they suggest that the use of low-dose aspirin be considered only for patients aged 50-69 years whose risk for cardiovascular disease over the next 10 years is at least 10% and who are at low risk for bleeding.

To reduce their risk for CRC, patients need to take aspirin for at least 10 years, they pointed out.
 

Quality indicators

For endoscopists who perform colonoscopy, the ACG recommended that all operators determine their individual cecal intubation rates, adenoma detection rates, and withdrawal times. They also recommended that endoscopists spend at least 6 minutes inspecting the mucosa during withdrawal and achieve a cecal intubation rate of at least 95% for all patients screened.

The ACG recommended remedial training for any provider whose adenoma detection rate is less than 25%.
 

Screening rates dropped during pandemic

The authors of the new recommendations also pointed out that, despite public health initiatives to boost CRC screening in the United States and the availability of multiple screening modalities, almost one-third of individuals who are eligible for CRC screening do not undergo screening.

Moreover, the proportion of individuals not being screened has reportedly increased during the pandemic. In one report, claims data for colonoscopies dropped by 90% during April. “Colorectal cancer screening rates must be optimized to reach the aspirational target of >80%,” the authors emphasized.

“A recommendation to be screened by a PCP [primary care provider] – who is known and trusted by the person – is clearly effective in raising participation,” they added.

Dr. Shaukat has served as a scientific consultant for Iterative Scopes and Freenome. Other ACG guideline authors reported numerous financial relationships.

A version of this article first appeared on Medscape.com.

COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.

They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.

The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.

There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”

There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.

There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.

A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.

copyright DesignPics/Thinkstock

No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.

The guidance includes some recommendations for specific osteoporosis medications.

• Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
• Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
• Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
• Teriparatide and abaloparatide should be continued.
• Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
• Raloxifene should be continued in patients receiving COVID-19 vaccination.

Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

Dr. Jan De Beur has no relevant financial disclosures.

COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.

They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.

The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.

There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”

There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.

There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.

A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.

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No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.

The guidance includes some recommendations for specific osteoporosis medications.

• Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
• Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
• Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
• Teriparatide and abaloparatide should be continued.
• Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
• Raloxifene should be continued in patients receiving COVID-19 vaccination.

Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

Dr. Jan De Beur has no relevant financial disclosures.

COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.

They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.

The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.

There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”

There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.

There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.

A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.

copyright DesignPics/Thinkstock

No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.

The guidance includes some recommendations for specific osteoporosis medications.

• Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
• Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
• Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
• Teriparatide and abaloparatide should be continued.
• Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
• Raloxifene should be continued in patients receiving COVID-19 vaccination.

Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

Dr. Jan De Beur has no relevant financial disclosures.

New evidence-based recommendations provide guidance on when to give radiotherapy and chemotherapy to patients with nasopharyngeal carcinoma.

The guidelines, based on data from more than 100 studies, support offering intensity-modulated radiotherapy to all patients with stage II-IVA nasopharyngeal carcinoma. Recommendations for chemotherapy vary according to disease stage, tumor size, number of nodes, and contraindications.

The guidelines, released jointly by the Chinese Society of Clinical Oncology (CSCO) and the American Society of Clinical Oncology (ASCO), were published in the Journal of Clinical Oncology.

“For practicing oncologists in the United States, who often lack experience treating nasopharyngeal cancer, this guideline provides a useful, succinct summary of available evidence and expert recommendations. Nasopharyngeal cancer can be a technically and medically challenging disease to manage, and a multidisciplinary approach should be strongly encouraged,” said ASCO expert Randall J. Kimple, MD, PhD, of the University of Wisconsin–Madison.

“Much of the data guiding our treatment of these patients comes from endemic regions,” he continued. “How these data apply to patients in the U.S. remains a subject of ongoing study. Patients and providers should be encouraged to seek the opinion of a provider with expertise in the management of nasopharyngeal cancer.”

To compile “best practices” for treating nasopharyngeal carcinoma, the ASCO/CSCO expert panel conducted a literature search that included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2020. The panel identified 108 relevant studies and formulated their guidelines based on the evidence.
 

Recommendations

For all patients with stage II-IVA nasopharyngeal carcinoma, the guidelines recommend intensity-modulated radiation therapy with daily image guidance. The recommended dose is 70 Gy in 33-35 fractions over 7 weeks.

“This has been the standard approach at most institutions that treat a sufficient number of nasopharyngeal cancer patients each year,” Dr. Kimple said.

When adding chemotherapy to radiotherapy, two approaches are recommended. The first is induction chemotherapy followed by chemoradiation, and the second is chemoradiation followed by adjuvant chemotherapy.

“There are divergent opinions regarding the optimal approach in these patients, with slightly stronger data supporting the use of induction chemotherapy,” Dr. Kimple said. “For patients with earlier stage nasopharyngeal cancer (T1-2N1 or T2N0), chemotherapy can be offered, and is more strongly recommended for those with more advanced disease (T2N1, bulky disease, high EBV load).”

For patients receiving concurrent chemotherapy and radiotherapy, the recommended regimen is cisplatin given either weekly (40 mg/m²) or triweekly (100 mg/m²).

“The stated goal is to achieve a cumulative cisplatin dose in excess of 200 mg/m² regardless of the approach taken. Several options were provided for patients with a contraindication to cisplatin,” Dr. Kimple said.

Patients with contraindications can receive nedaplatin (100 mg/m² triweekly), carboplatin (area under curve, 5-6 triweekly), oxaliplatin (70 mg/m² weekly), or fluoropyrimidines (capecitabine, 5-fluorouracil, or tegafur).

For induction, the guidelines recommend platinum-based chemotherapy. Options include gemcitabine plus cisplatin, cisplatin plus 5-fluorouracil, cisplatin plus capecitabine, docetaxel plus cisplatin, and docetaxel plus cisplatin and 5-fluorouracil.

“[T]here is less strong evidence regarding the optimal induction chemotherapy approach for patients with nasopharyngeal cancer. Several possible regimens (doublet or triplet) are offered, with the use of platinum-based regimens being the common theme,” Dr. Kimple said.

For adjuvant chemotherapy, the guidelines recommend cisplatin plus 5-fluorouracil or carboplatin plus 5-fluorouracil.

The guidelines also suggest that clinicians take into account a patient’s other chronic conditions when formulating the treatment and follow-up plan.

“Patients with multiple chronic conditions pose a particular challenge to guideline-based care due to being commonly excluded from clinical trials,” Dr. Kimple said. “Shared decision-making plays a key role in the recommendations for patients with multiple chronic conditions. In addition, nasopharyngeal cancer patients often have long-term toxicity associated with their care, and, thus, the availability of expertise and resources in management of this disease is important.”

Dr. Kimple disclosed relationships with Galera Therapeutics, Mele Associates, and Guidepoint Global. The guideline authors disclosed relationships with a range of pharmaceutical companies, as listed in the article.

New evidence-based recommendations provide guidance on when to give radiotherapy and chemotherapy to patients with nasopharyngeal carcinoma.

The guidelines, based on data from more than 100 studies, support offering intensity-modulated radiotherapy to all patients with stage II-IVA nasopharyngeal carcinoma. Recommendations for chemotherapy vary according to disease stage, tumor size, number of nodes, and contraindications.

The guidelines, released jointly by the Chinese Society of Clinical Oncology (CSCO) and the American Society of Clinical Oncology (ASCO), were published in the Journal of Clinical Oncology.

“For practicing oncologists in the United States, who often lack experience treating nasopharyngeal cancer, this guideline provides a useful, succinct summary of available evidence and expert recommendations. Nasopharyngeal cancer can be a technically and medically challenging disease to manage, and a multidisciplinary approach should be strongly encouraged,” said ASCO expert Randall J. Kimple, MD, PhD, of the University of Wisconsin–Madison.

“Much of the data guiding our treatment of these patients comes from endemic regions,” he continued. “How these data apply to patients in the U.S. remains a subject of ongoing study. Patients and providers should be encouraged to seek the opinion of a provider with expertise in the management of nasopharyngeal cancer.”

To compile “best practices” for treating nasopharyngeal carcinoma, the ASCO/CSCO expert panel conducted a literature search that included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2020. The panel identified 108 relevant studies and formulated their guidelines based on the evidence.
 

Recommendations

For all patients with stage II-IVA nasopharyngeal carcinoma, the guidelines recommend intensity-modulated radiation therapy with daily image guidance. The recommended dose is 70 Gy in 33-35 fractions over 7 weeks.

“This has been the standard approach at most institutions that treat a sufficient number of nasopharyngeal cancer patients each year,” Dr. Kimple said.

When adding chemotherapy to radiotherapy, two approaches are recommended. The first is induction chemotherapy followed by chemoradiation, and the second is chemoradiation followed by adjuvant chemotherapy.

“There are divergent opinions regarding the optimal approach in these patients, with slightly stronger data supporting the use of induction chemotherapy,” Dr. Kimple said. “For patients with earlier stage nasopharyngeal cancer (T1-2N1 or T2N0), chemotherapy can be offered, and is more strongly recommended for those with more advanced disease (T2N1, bulky disease, high EBV load).”

For patients receiving concurrent chemotherapy and radiotherapy, the recommended regimen is cisplatin given either weekly (40 mg/m²) or triweekly (100 mg/m²).

“The stated goal is to achieve a cumulative cisplatin dose in excess of 200 mg/m² regardless of the approach taken. Several options were provided for patients with a contraindication to cisplatin,” Dr. Kimple said.

Patients with contraindications can receive nedaplatin (100 mg/m² triweekly), carboplatin (area under curve, 5-6 triweekly), oxaliplatin (70 mg/m² weekly), or fluoropyrimidines (capecitabine, 5-fluorouracil, or tegafur).

For induction, the guidelines recommend platinum-based chemotherapy. Options include gemcitabine plus cisplatin, cisplatin plus 5-fluorouracil, cisplatin plus capecitabine, docetaxel plus cisplatin, and docetaxel plus cisplatin and 5-fluorouracil.

“[T]here is less strong evidence regarding the optimal induction chemotherapy approach for patients with nasopharyngeal cancer. Several possible regimens (doublet or triplet) are offered, with the use of platinum-based regimens being the common theme,” Dr. Kimple said.

For adjuvant chemotherapy, the guidelines recommend cisplatin plus 5-fluorouracil or carboplatin plus 5-fluorouracil.

The guidelines also suggest that clinicians take into account a patient’s other chronic conditions when formulating the treatment and follow-up plan.

“Patients with multiple chronic conditions pose a particular challenge to guideline-based care due to being commonly excluded from clinical trials,” Dr. Kimple said. “Shared decision-making plays a key role in the recommendations for patients with multiple chronic conditions. In addition, nasopharyngeal cancer patients often have long-term toxicity associated with their care, and, thus, the availability of expertise and resources in management of this disease is important.”

Dr. Kimple disclosed relationships with Galera Therapeutics, Mele Associates, and Guidepoint Global. The guideline authors disclosed relationships with a range of pharmaceutical companies, as listed in the article.

New evidence-based recommendations provide guidance on when to give radiotherapy and chemotherapy to patients with nasopharyngeal carcinoma.

The guidelines, based on data from more than 100 studies, support offering intensity-modulated radiotherapy to all patients with stage II-IVA nasopharyngeal carcinoma. Recommendations for chemotherapy vary according to disease stage, tumor size, number of nodes, and contraindications.

The guidelines, released jointly by the Chinese Society of Clinical Oncology (CSCO) and the American Society of Clinical Oncology (ASCO), were published in the Journal of Clinical Oncology.

“For practicing oncologists in the United States, who often lack experience treating nasopharyngeal cancer, this guideline provides a useful, succinct summary of available evidence and expert recommendations. Nasopharyngeal cancer can be a technically and medically challenging disease to manage, and a multidisciplinary approach should be strongly encouraged,” said ASCO expert Randall J. Kimple, MD, PhD, of the University of Wisconsin–Madison.

“Much of the data guiding our treatment of these patients comes from endemic regions,” he continued. “How these data apply to patients in the U.S. remains a subject of ongoing study. Patients and providers should be encouraged to seek the opinion of a provider with expertise in the management of nasopharyngeal cancer.”

To compile “best practices” for treating nasopharyngeal carcinoma, the ASCO/CSCO expert panel conducted a literature search that included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2020. The panel identified 108 relevant studies and formulated their guidelines based on the evidence.
 

Recommendations

For all patients with stage II-IVA nasopharyngeal carcinoma, the guidelines recommend intensity-modulated radiation therapy with daily image guidance. The recommended dose is 70 Gy in 33-35 fractions over 7 weeks.

“This has been the standard approach at most institutions that treat a sufficient number of nasopharyngeal cancer patients each year,” Dr. Kimple said.

When adding chemotherapy to radiotherapy, two approaches are recommended. The first is induction chemotherapy followed by chemoradiation, and the second is chemoradiation followed by adjuvant chemotherapy.

“There are divergent opinions regarding the optimal approach in these patients, with slightly stronger data supporting the use of induction chemotherapy,” Dr. Kimple said. “For patients with earlier stage nasopharyngeal cancer (T1-2N1 or T2N0), chemotherapy can be offered, and is more strongly recommended for those with more advanced disease (T2N1, bulky disease, high EBV load).”

For patients receiving concurrent chemotherapy and radiotherapy, the recommended regimen is cisplatin given either weekly (40 mg/m²) or triweekly (100 mg/m²).

“The stated goal is to achieve a cumulative cisplatin dose in excess of 200 mg/m² regardless of the approach taken. Several options were provided for patients with a contraindication to cisplatin,” Dr. Kimple said.

Patients with contraindications can receive nedaplatin (100 mg/m² triweekly), carboplatin (area under curve, 5-6 triweekly), oxaliplatin (70 mg/m² weekly), or fluoropyrimidines (capecitabine, 5-fluorouracil, or tegafur).

For induction, the guidelines recommend platinum-based chemotherapy. Options include gemcitabine plus cisplatin, cisplatin plus 5-fluorouracil, cisplatin plus capecitabine, docetaxel plus cisplatin, and docetaxel plus cisplatin and 5-fluorouracil.

“[T]here is less strong evidence regarding the optimal induction chemotherapy approach for patients with nasopharyngeal cancer. Several possible regimens (doublet or triplet) are offered, with the use of platinum-based regimens being the common theme,” Dr. Kimple said.

For adjuvant chemotherapy, the guidelines recommend cisplatin plus 5-fluorouracil or carboplatin plus 5-fluorouracil.

The guidelines also suggest that clinicians take into account a patient’s other chronic conditions when formulating the treatment and follow-up plan.

“Patients with multiple chronic conditions pose a particular challenge to guideline-based care due to being commonly excluded from clinical trials,” Dr. Kimple said. “Shared decision-making plays a key role in the recommendations for patients with multiple chronic conditions. In addition, nasopharyngeal cancer patients often have long-term toxicity associated with their care, and, thus, the availability of expertise and resources in management of this disease is important.”

Dr. Kimple disclosed relationships with Galera Therapeutics, Mele Associates, and Guidepoint Global. The guideline authors disclosed relationships with a range of pharmaceutical companies, as listed in the article.