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Medical societies advise on vitamin D in midst of COVID-19
Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.
The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.
They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.
The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”
It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”
The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.
Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
What role for vitamin D in COVID-19?
Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.
During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.
However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.
“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.
Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”
Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.
A version of this article originally appeared on Medscape.com.
Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.
The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.
They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.
The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”
It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”
The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.
Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
What role for vitamin D in COVID-19?
Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.
During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.
However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.
“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.
Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”
Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.
A version of this article originally appeared on Medscape.com.
Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.
The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.
They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.
The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”
It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”
The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.
Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
What role for vitamin D in COVID-19?
Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.
During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.
However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.
“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.
Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”
Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.
A version of this article originally appeared on Medscape.com.
Hyperglycemia predicts COVID-19 death even without diabetes
new research indicates.
The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.
Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.
Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.
Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.
“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.
“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
Hyperglycemia predicts COVID-19 death, complications
The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.
Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.
“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.
Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications.
The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.
Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.
In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).
Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).
Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.
Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.
Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.
The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
new research indicates.
The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.
Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.
Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.
Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.
“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.
“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
Hyperglycemia predicts COVID-19 death, complications
The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.
Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.
“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.
Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications.
The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.
Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.
In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).
Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).
Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.
Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.
Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.
The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
new research indicates.
The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.
Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.
Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.
Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.
“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.
“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
Hyperglycemia predicts COVID-19 death, complications
The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.
Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.
“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.
Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications.
The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.
Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.
In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).
Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).
Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.
Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.
Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.
The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Delayed diagnoses seen in children during COVID-19
There were also nine deaths where delayed presentation was considered a contributing factor, resulting mainly from sepsis and malignancy.
By comparison, over the same 2-week period of the survey there were three child deaths from COVID-19 directly, according to senior study author Shamez Ladhani, MRCPCH, PhD, chair of the British Paediatric Surveillance Unit (BPSU), Royal College of Paediatrics and Child Health, London.
“The unintended consequences of COVID are far greater, in children, than the disease itself. The way we are trying to prevent this is causing more harm than the disease,” he lamented.
One-third of senior U.K. pediatric specialists who responded to the survey reported dealing with so-called emergency delayed presentations in children who they would normally have expected to present much earlier.
After diabetes, the most commonly reported delayed diagnoses were sepsis and child protection issues. Cancer also featured prominently.
“We’ve found that there is great concern that children are not accessing healthcare as they should during lockdown and after,” Dr. Ladhani stressed. “Our emergency departments saw a 50% reduction during the peak, and now it is still 40% less than expected. The problem is improving but it remains.”
The survey findings were recently published online in Archives of Disease in Childhood, by first author Richard M. Lynn, MSc, of the Institute of Child Health, department of epidemiology and public health, University College London Research, and colleagues.
New diabetes cases presented very late during lockdown
Over the 2-week reporting period in mid-April 2020, type 1 diabetes was the most frequently reported delayed diagnosis, with 44 cases overall, 23 of which involved diabetic ketoacidosis.
“If you talk to the diabetes specialists, they tell us that generally, most cases of new diabetes arrive late because it has very nonspecific symptoms,” Dr. Ladhani explained.
However, he added, “pediatricians on the frontline know what to expect with diabetes. Those children who would have come in late prior to the pandemic are now arriving very late. Those consultants surveyed were not junior doctors but consultant pediatricians with many years of experience.”
In a recent article looking at pediatric delayed presentations, one patient with diabetes entered intensive care, and the BPSU report recorded one death possibly associated with diabetes, Dr. Ladhani pointed out.
“Pediatricians are worried that children are coming in late. We need to raise awareness that parents need to access healthcare and this message needs to go out now,” he said. “We can’t wait until a second wave. It has to be now because A&E [accident and emergency] attendance is still 40% [lower than] ... expected.”
BPSU survey covers over 90% of pediatricians in U.K. and Ireland
After numerous anecdotal reports of delayed presentations in the United Kingdom and abroad, the snapshot survey was conducted as part of routine monthly reports where pediatricians are asked to document any cases of rare conditions seen.
“We had heard stories of delayed presentations, but we wanted to know was this a real problem or just anecdotal?” Dr. Ladhani said.
The regular BPSU survey covers over 90% of U.K.- and Ireland-based pediatric consultants (numbering 4,075). On the back of this established communication, the BPSU decided to gauge the extent of delayed presentations during the peak weeks of the COVID-19 pandemic.
Over the next 7 days, 2,433 pediatricians, representing 60% of BPSU participants, responded.
“This response rate in 7 days highlights the importance given to the survey by pediatricians ... and the widespread professional concern about delayed presentations,” the authors wrote.
Participants were asked whether they had seen any children during the previous 14 days who, in their opinion, presented later than they would have expected prior to the COVID-19 pandemic.
“There’s no one definition for this but these senior clinicians know when something is unusual,” said Dr. Ladhani.
ED attendances were compared with figures for the same period last year. Overall, a total of 32% of 752 pediatricians working in EDs and pediatric assessment units reported witnessing delayed presentations, with 57 (8%) reporting at least three patients with delayed presentation.
“It was clear that those doctors on the frontline were seeing a lot of delayed presentations. Also, neonatologists reported women arriving late for labor, and community physicians said they just weren’t witnessing child protection cases anymore,” added Dr. Ladhani.
Other issues included early discharges following births because of COVID-19 concerns, before feeding had been established, prompting return visits because of feeding problems and dehydration.
The top five delayed diagnoses were diabetes (n = 44), sepsis (n = 21), child protection (n = 14), malignancy (n = 8), and appendicitis (n = 6). There were 10 delayed perinatal presentations.
Of the nine deaths, for which delayed presentation was considered to play a role, three were caused by sepsis, three were caused by new malignancy diagnoses, one was caused by new diagnosis of metabolic disease, and two did not have the cause reported.
The delays in presentation are likely to have been influenced by the U.K. government’s message to “stay at home” during the strict lockdown period, which perhaps was sometimes interpreted too literally, Dr. Ladhani suggested. “It was the right message socially, but not medically.”
Russell Viner, MB, PhD, president of the Royal College of Paediatrics and Child Health, said in a statement: “The impact for children is what we call ‘collateral damage’, including long absences from school and delays or interruptions to vital services. We know that parents adhered very strongly to the ‘stay at home’ [message] and we need to say clearly that this doesn’t apply if your child is very sick. Should we experience a second wave or regional outbreaks, it is vital that we get the message out to parents that we want to see unwell children at the earliest possible stage.”
Dr. Ladhani reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
There were also nine deaths where delayed presentation was considered a contributing factor, resulting mainly from sepsis and malignancy.
By comparison, over the same 2-week period of the survey there were three child deaths from COVID-19 directly, according to senior study author Shamez Ladhani, MRCPCH, PhD, chair of the British Paediatric Surveillance Unit (BPSU), Royal College of Paediatrics and Child Health, London.
“The unintended consequences of COVID are far greater, in children, than the disease itself. The way we are trying to prevent this is causing more harm than the disease,” he lamented.
One-third of senior U.K. pediatric specialists who responded to the survey reported dealing with so-called emergency delayed presentations in children who they would normally have expected to present much earlier.
After diabetes, the most commonly reported delayed diagnoses were sepsis and child protection issues. Cancer also featured prominently.
“We’ve found that there is great concern that children are not accessing healthcare as they should during lockdown and after,” Dr. Ladhani stressed. “Our emergency departments saw a 50% reduction during the peak, and now it is still 40% less than expected. The problem is improving but it remains.”
The survey findings were recently published online in Archives of Disease in Childhood, by first author Richard M. Lynn, MSc, of the Institute of Child Health, department of epidemiology and public health, University College London Research, and colleagues.
New diabetes cases presented very late during lockdown
Over the 2-week reporting period in mid-April 2020, type 1 diabetes was the most frequently reported delayed diagnosis, with 44 cases overall, 23 of which involved diabetic ketoacidosis.
“If you talk to the diabetes specialists, they tell us that generally, most cases of new diabetes arrive late because it has very nonspecific symptoms,” Dr. Ladhani explained.
However, he added, “pediatricians on the frontline know what to expect with diabetes. Those children who would have come in late prior to the pandemic are now arriving very late. Those consultants surveyed were not junior doctors but consultant pediatricians with many years of experience.”
In a recent article looking at pediatric delayed presentations, one patient with diabetes entered intensive care, and the BPSU report recorded one death possibly associated with diabetes, Dr. Ladhani pointed out.
“Pediatricians are worried that children are coming in late. We need to raise awareness that parents need to access healthcare and this message needs to go out now,” he said. “We can’t wait until a second wave. It has to be now because A&E [accident and emergency] attendance is still 40% [lower than] ... expected.”
BPSU survey covers over 90% of pediatricians in U.K. and Ireland
After numerous anecdotal reports of delayed presentations in the United Kingdom and abroad, the snapshot survey was conducted as part of routine monthly reports where pediatricians are asked to document any cases of rare conditions seen.
“We had heard stories of delayed presentations, but we wanted to know was this a real problem or just anecdotal?” Dr. Ladhani said.
The regular BPSU survey covers over 90% of U.K.- and Ireland-based pediatric consultants (numbering 4,075). On the back of this established communication, the BPSU decided to gauge the extent of delayed presentations during the peak weeks of the COVID-19 pandemic.
Over the next 7 days, 2,433 pediatricians, representing 60% of BPSU participants, responded.
“This response rate in 7 days highlights the importance given to the survey by pediatricians ... and the widespread professional concern about delayed presentations,” the authors wrote.
Participants were asked whether they had seen any children during the previous 14 days who, in their opinion, presented later than they would have expected prior to the COVID-19 pandemic.
“There’s no one definition for this but these senior clinicians know when something is unusual,” said Dr. Ladhani.
ED attendances were compared with figures for the same period last year. Overall, a total of 32% of 752 pediatricians working in EDs and pediatric assessment units reported witnessing delayed presentations, with 57 (8%) reporting at least three patients with delayed presentation.
“It was clear that those doctors on the frontline were seeing a lot of delayed presentations. Also, neonatologists reported women arriving late for labor, and community physicians said they just weren’t witnessing child protection cases anymore,” added Dr. Ladhani.
Other issues included early discharges following births because of COVID-19 concerns, before feeding had been established, prompting return visits because of feeding problems and dehydration.
The top five delayed diagnoses were diabetes (n = 44), sepsis (n = 21), child protection (n = 14), malignancy (n = 8), and appendicitis (n = 6). There were 10 delayed perinatal presentations.
Of the nine deaths, for which delayed presentation was considered to play a role, three were caused by sepsis, three were caused by new malignancy diagnoses, one was caused by new diagnosis of metabolic disease, and two did not have the cause reported.
The delays in presentation are likely to have been influenced by the U.K. government’s message to “stay at home” during the strict lockdown period, which perhaps was sometimes interpreted too literally, Dr. Ladhani suggested. “It was the right message socially, but not medically.”
Russell Viner, MB, PhD, president of the Royal College of Paediatrics and Child Health, said in a statement: “The impact for children is what we call ‘collateral damage’, including long absences from school and delays or interruptions to vital services. We know that parents adhered very strongly to the ‘stay at home’ [message] and we need to say clearly that this doesn’t apply if your child is very sick. Should we experience a second wave or regional outbreaks, it is vital that we get the message out to parents that we want to see unwell children at the earliest possible stage.”
Dr. Ladhani reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
There were also nine deaths where delayed presentation was considered a contributing factor, resulting mainly from sepsis and malignancy.
By comparison, over the same 2-week period of the survey there were three child deaths from COVID-19 directly, according to senior study author Shamez Ladhani, MRCPCH, PhD, chair of the British Paediatric Surveillance Unit (BPSU), Royal College of Paediatrics and Child Health, London.
“The unintended consequences of COVID are far greater, in children, than the disease itself. The way we are trying to prevent this is causing more harm than the disease,” he lamented.
One-third of senior U.K. pediatric specialists who responded to the survey reported dealing with so-called emergency delayed presentations in children who they would normally have expected to present much earlier.
After diabetes, the most commonly reported delayed diagnoses were sepsis and child protection issues. Cancer also featured prominently.
“We’ve found that there is great concern that children are not accessing healthcare as they should during lockdown and after,” Dr. Ladhani stressed. “Our emergency departments saw a 50% reduction during the peak, and now it is still 40% less than expected. The problem is improving but it remains.”
The survey findings were recently published online in Archives of Disease in Childhood, by first author Richard M. Lynn, MSc, of the Institute of Child Health, department of epidemiology and public health, University College London Research, and colleagues.
New diabetes cases presented very late during lockdown
Over the 2-week reporting period in mid-April 2020, type 1 diabetes was the most frequently reported delayed diagnosis, with 44 cases overall, 23 of which involved diabetic ketoacidosis.
“If you talk to the diabetes specialists, they tell us that generally, most cases of new diabetes arrive late because it has very nonspecific symptoms,” Dr. Ladhani explained.
However, he added, “pediatricians on the frontline know what to expect with diabetes. Those children who would have come in late prior to the pandemic are now arriving very late. Those consultants surveyed were not junior doctors but consultant pediatricians with many years of experience.”
In a recent article looking at pediatric delayed presentations, one patient with diabetes entered intensive care, and the BPSU report recorded one death possibly associated with diabetes, Dr. Ladhani pointed out.
“Pediatricians are worried that children are coming in late. We need to raise awareness that parents need to access healthcare and this message needs to go out now,” he said. “We can’t wait until a second wave. It has to be now because A&E [accident and emergency] attendance is still 40% [lower than] ... expected.”
BPSU survey covers over 90% of pediatricians in U.K. and Ireland
After numerous anecdotal reports of delayed presentations in the United Kingdom and abroad, the snapshot survey was conducted as part of routine monthly reports where pediatricians are asked to document any cases of rare conditions seen.
“We had heard stories of delayed presentations, but we wanted to know was this a real problem or just anecdotal?” Dr. Ladhani said.
The regular BPSU survey covers over 90% of U.K.- and Ireland-based pediatric consultants (numbering 4,075). On the back of this established communication, the BPSU decided to gauge the extent of delayed presentations during the peak weeks of the COVID-19 pandemic.
Over the next 7 days, 2,433 pediatricians, representing 60% of BPSU participants, responded.
“This response rate in 7 days highlights the importance given to the survey by pediatricians ... and the widespread professional concern about delayed presentations,” the authors wrote.
Participants were asked whether they had seen any children during the previous 14 days who, in their opinion, presented later than they would have expected prior to the COVID-19 pandemic.
“There’s no one definition for this but these senior clinicians know when something is unusual,” said Dr. Ladhani.
ED attendances were compared with figures for the same period last year. Overall, a total of 32% of 752 pediatricians working in EDs and pediatric assessment units reported witnessing delayed presentations, with 57 (8%) reporting at least three patients with delayed presentation.
“It was clear that those doctors on the frontline were seeing a lot of delayed presentations. Also, neonatologists reported women arriving late for labor, and community physicians said they just weren’t witnessing child protection cases anymore,” added Dr. Ladhani.
Other issues included early discharges following births because of COVID-19 concerns, before feeding had been established, prompting return visits because of feeding problems and dehydration.
The top five delayed diagnoses were diabetes (n = 44), sepsis (n = 21), child protection (n = 14), malignancy (n = 8), and appendicitis (n = 6). There were 10 delayed perinatal presentations.
Of the nine deaths, for which delayed presentation was considered to play a role, three were caused by sepsis, three were caused by new malignancy diagnoses, one was caused by new diagnosis of metabolic disease, and two did not have the cause reported.
The delays in presentation are likely to have been influenced by the U.K. government’s message to “stay at home” during the strict lockdown period, which perhaps was sometimes interpreted too literally, Dr. Ladhani suggested. “It was the right message socially, but not medically.”
Russell Viner, MB, PhD, president of the Royal College of Paediatrics and Child Health, said in a statement: “The impact for children is what we call ‘collateral damage’, including long absences from school and delays or interruptions to vital services. We know that parents adhered very strongly to the ‘stay at home’ [message] and we need to say clearly that this doesn’t apply if your child is very sick. Should we experience a second wave or regional outbreaks, it is vital that we get the message out to parents that we want to see unwell children at the earliest possible stage.”
Dr. Ladhani reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Captopril questioned for diabetes patients in COVID-19 setting
Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.
The study was published online in the Journal of the American Pharmacists Association.
The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.
“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.
“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.
For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).
Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).
“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.
They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”
“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.
They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.
“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.
Questioning safety in COVID-19 an “overreach”
Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.
“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.
“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”
But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”
This article first appeared on Medscape.com.
Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.
The study was published online in the Journal of the American Pharmacists Association.
The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.
“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.
“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.
For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).
Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).
“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.
They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”
“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.
They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.
“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.
Questioning safety in COVID-19 an “overreach”
Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.
“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.
“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”
But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”
This article first appeared on Medscape.com.
Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.
The study was published online in the Journal of the American Pharmacists Association.
The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.
“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.
“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.
For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).
Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).
“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.
They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”
“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.
They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.
“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.
Questioning safety in COVID-19 an “overreach”
Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.
“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.
“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”
But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”
This article first appeared on Medscape.com.
Cushing’s and COVID-19: Nontraditional symptoms keys to assessment, treatments
Do not rely on more traditional signs and symptoms of COVID-19 like fever and dyspnea when assessing patients with Cushing’s syndrome for the novel coronavirus, Rosario Pivonello, MD, PhD, and colleagues urged.
Physicians evaluating patients with Cushing’s syndrome for COVID-19 “should be suspicious of any change in health status of their patients with Cushing’s syndrome, rather than relying on fever and [dyspnea] as typical features,” Dr. Pivonello, an endocrinologist with the University of Naples (Italy) Federico II, and colleagues wrote in a commentary published in The Lancet Diabetes & Endocrinology.
COVID-19 symptoms are a unique concern among patients with Cushing’s syndrome because many of the cardiometabolic and immune impairments that place someone at higher risk of more severe disease or mortality for the novel coronavirus – such as obesity, hypertension, diabetes, and immunodeficiency syndromes – are also shared with Cushing’s syndrome.
Increased cardiovascular risk factors and susceptibility to severe infection are “two leading causes of death” for patients with Cushing’s syndrome, Dr. Pivonello and colleagues noted.
The immunocompromised state of patients with Cushing’s syndrome may make detection of COVID-19 infection difficult, the authors say. For example, fever is a common symptom of patients with COVID-19, but in patients with active Cushing’s syndrome, “low-grade chronic inflammation and the poor immune response might limit febrile response in the early phase of infection,” Dr. Pivonello and colleagues wrote.
In other cases, because Cushing’s syndrome and COVID-19 have overlapping symptoms, it may be difficult to attribute a particular symptom to either disease. Dyspnea is a common symptom of COVID-19, but may present in Cushing’s syndrome because of “cardiac insufficiency or weakness of respiratory muscles,” the authors wrote. Instead, physicians should look to other COVID-19 symptoms, such as cough, dysgeusia, anosmia, and diarrhea, for signs of the disease.
Patients with Cushing’s syndrome may also be predisposed to a more severe course of COVID-19 because of the prevalence of obesity, hypertension, or diabetes in these patients, which have been identified as comorbidities that increase the likelihood of severe COVID-19 and progression to acute respiratory distress syndrome (ARDS). “However, a key element in the development of ARDS during COVID-19 is the exaggerated cellular response induced by the cytokine increase, leading to massive alveolar–capillary wall damage and a decline in gas exchange,” Dr. Pivonello and colleagues wrote. “Because patients with Cushing’s syndrome might not mount a normal cytokine response, these patients might [paradoxically] be less prone to develop severe ARDS with COVID-19.”
As both Cushing’s syndrome and COVID-19 are associated with hypercoagulability, the authors “strongly advise” using low-molecular-weight heparin in hospitalized patients with active Cushing’s syndrome who develop COVID-19. In both diseases, there is also a risk of longer duration of viral infections and opportunistic infections such as atypical bacterial and invasive fungal infections. For this reason, the authors also recommended patients with Cushing’s syndrome who have COVID-19 be placed on prolonged antiviral and broad-spectrum antibiotic treatment as a prophylactic measure.
During the pandemic, avoiding surgery for Cushing’s syndrome should be considered to reduce the likelihood of acquiring COVID-19 in a hospital setting, the authors wrote. Medical therapy can be temporarily used where appropriate, such as using ketoconazole, metyrapone, osilodrostat, and etomidate to lower cortisol levels. They acknowledge that some cases of malignant Cushing’s syndrome may require “expeditious definitive diagnosis and proper surgical resolution.”
After remission, while infection risk should be significantly lowered, other comorbidities like obesity, hypertension, diabetes, and thromboembolic diathesis may remain. “Because these are features associated with an increased death risk in patients with COVID-19, patients with Cushing’s syndrome in remission should be considered a high-risk population and consequently adopt adequate self-protection strategies to [minimize] contagion risk,” the authors wrote.
Dr. Pivonello reported relationships with Novartis, Strongbridge Biopharma, HRA Pharma, Ipsen, Shire, and Pfizer, Corcept Therapeutics, IBSA Farmaceutici, Ferring, and Italfarmaco in the form of receiving grants and/or personal fees. One coauthor reported receiving grants and/or nonfinancial support from Takeda, Ipsen, Shire, Pfizer, and Corcept Therapeutics. One coauthor reported receiving grants and personal fees from Novartis and Strongbridge, and grants from Millendo Therapeutics. Another coauthor reported receiving grants and/or personal fees from Novartis, Ipsen, Shire, Pfizer, Italfarmaco, Lilly, Merck, and Novo Nordisk. The other authors reported no relevant conflicts of interest.
SOURCE: Pivonello R et al. Lancet Diabetes Endocrinol. 2020 Jun 9. doi: 10.1016/S2213-8587(20)30215-1.
Do not rely on more traditional signs and symptoms of COVID-19 like fever and dyspnea when assessing patients with Cushing’s syndrome for the novel coronavirus, Rosario Pivonello, MD, PhD, and colleagues urged.
Physicians evaluating patients with Cushing’s syndrome for COVID-19 “should be suspicious of any change in health status of their patients with Cushing’s syndrome, rather than relying on fever and [dyspnea] as typical features,” Dr. Pivonello, an endocrinologist with the University of Naples (Italy) Federico II, and colleagues wrote in a commentary published in The Lancet Diabetes & Endocrinology.
COVID-19 symptoms are a unique concern among patients with Cushing’s syndrome because many of the cardiometabolic and immune impairments that place someone at higher risk of more severe disease or mortality for the novel coronavirus – such as obesity, hypertension, diabetes, and immunodeficiency syndromes – are also shared with Cushing’s syndrome.
Increased cardiovascular risk factors and susceptibility to severe infection are “two leading causes of death” for patients with Cushing’s syndrome, Dr. Pivonello and colleagues noted.
The immunocompromised state of patients with Cushing’s syndrome may make detection of COVID-19 infection difficult, the authors say. For example, fever is a common symptom of patients with COVID-19, but in patients with active Cushing’s syndrome, “low-grade chronic inflammation and the poor immune response might limit febrile response in the early phase of infection,” Dr. Pivonello and colleagues wrote.
In other cases, because Cushing’s syndrome and COVID-19 have overlapping symptoms, it may be difficult to attribute a particular symptom to either disease. Dyspnea is a common symptom of COVID-19, but may present in Cushing’s syndrome because of “cardiac insufficiency or weakness of respiratory muscles,” the authors wrote. Instead, physicians should look to other COVID-19 symptoms, such as cough, dysgeusia, anosmia, and diarrhea, for signs of the disease.
Patients with Cushing’s syndrome may also be predisposed to a more severe course of COVID-19 because of the prevalence of obesity, hypertension, or diabetes in these patients, which have been identified as comorbidities that increase the likelihood of severe COVID-19 and progression to acute respiratory distress syndrome (ARDS). “However, a key element in the development of ARDS during COVID-19 is the exaggerated cellular response induced by the cytokine increase, leading to massive alveolar–capillary wall damage and a decline in gas exchange,” Dr. Pivonello and colleagues wrote. “Because patients with Cushing’s syndrome might not mount a normal cytokine response, these patients might [paradoxically] be less prone to develop severe ARDS with COVID-19.”
As both Cushing’s syndrome and COVID-19 are associated with hypercoagulability, the authors “strongly advise” using low-molecular-weight heparin in hospitalized patients with active Cushing’s syndrome who develop COVID-19. In both diseases, there is also a risk of longer duration of viral infections and opportunistic infections such as atypical bacterial and invasive fungal infections. For this reason, the authors also recommended patients with Cushing’s syndrome who have COVID-19 be placed on prolonged antiviral and broad-spectrum antibiotic treatment as a prophylactic measure.
During the pandemic, avoiding surgery for Cushing’s syndrome should be considered to reduce the likelihood of acquiring COVID-19 in a hospital setting, the authors wrote. Medical therapy can be temporarily used where appropriate, such as using ketoconazole, metyrapone, osilodrostat, and etomidate to lower cortisol levels. They acknowledge that some cases of malignant Cushing’s syndrome may require “expeditious definitive diagnosis and proper surgical resolution.”
After remission, while infection risk should be significantly lowered, other comorbidities like obesity, hypertension, diabetes, and thromboembolic diathesis may remain. “Because these are features associated with an increased death risk in patients with COVID-19, patients with Cushing’s syndrome in remission should be considered a high-risk population and consequently adopt adequate self-protection strategies to [minimize] contagion risk,” the authors wrote.
Dr. Pivonello reported relationships with Novartis, Strongbridge Biopharma, HRA Pharma, Ipsen, Shire, and Pfizer, Corcept Therapeutics, IBSA Farmaceutici, Ferring, and Italfarmaco in the form of receiving grants and/or personal fees. One coauthor reported receiving grants and/or nonfinancial support from Takeda, Ipsen, Shire, Pfizer, and Corcept Therapeutics. One coauthor reported receiving grants and personal fees from Novartis and Strongbridge, and grants from Millendo Therapeutics. Another coauthor reported receiving grants and/or personal fees from Novartis, Ipsen, Shire, Pfizer, Italfarmaco, Lilly, Merck, and Novo Nordisk. The other authors reported no relevant conflicts of interest.
SOURCE: Pivonello R et al. Lancet Diabetes Endocrinol. 2020 Jun 9. doi: 10.1016/S2213-8587(20)30215-1.
Do not rely on more traditional signs and symptoms of COVID-19 like fever and dyspnea when assessing patients with Cushing’s syndrome for the novel coronavirus, Rosario Pivonello, MD, PhD, and colleagues urged.
Physicians evaluating patients with Cushing’s syndrome for COVID-19 “should be suspicious of any change in health status of their patients with Cushing’s syndrome, rather than relying on fever and [dyspnea] as typical features,” Dr. Pivonello, an endocrinologist with the University of Naples (Italy) Federico II, and colleagues wrote in a commentary published in The Lancet Diabetes & Endocrinology.
COVID-19 symptoms are a unique concern among patients with Cushing’s syndrome because many of the cardiometabolic and immune impairments that place someone at higher risk of more severe disease or mortality for the novel coronavirus – such as obesity, hypertension, diabetes, and immunodeficiency syndromes – are also shared with Cushing’s syndrome.
Increased cardiovascular risk factors and susceptibility to severe infection are “two leading causes of death” for patients with Cushing’s syndrome, Dr. Pivonello and colleagues noted.
The immunocompromised state of patients with Cushing’s syndrome may make detection of COVID-19 infection difficult, the authors say. For example, fever is a common symptom of patients with COVID-19, but in patients with active Cushing’s syndrome, “low-grade chronic inflammation and the poor immune response might limit febrile response in the early phase of infection,” Dr. Pivonello and colleagues wrote.
In other cases, because Cushing’s syndrome and COVID-19 have overlapping symptoms, it may be difficult to attribute a particular symptom to either disease. Dyspnea is a common symptom of COVID-19, but may present in Cushing’s syndrome because of “cardiac insufficiency or weakness of respiratory muscles,” the authors wrote. Instead, physicians should look to other COVID-19 symptoms, such as cough, dysgeusia, anosmia, and diarrhea, for signs of the disease.
Patients with Cushing’s syndrome may also be predisposed to a more severe course of COVID-19 because of the prevalence of obesity, hypertension, or diabetes in these patients, which have been identified as comorbidities that increase the likelihood of severe COVID-19 and progression to acute respiratory distress syndrome (ARDS). “However, a key element in the development of ARDS during COVID-19 is the exaggerated cellular response induced by the cytokine increase, leading to massive alveolar–capillary wall damage and a decline in gas exchange,” Dr. Pivonello and colleagues wrote. “Because patients with Cushing’s syndrome might not mount a normal cytokine response, these patients might [paradoxically] be less prone to develop severe ARDS with COVID-19.”
As both Cushing’s syndrome and COVID-19 are associated with hypercoagulability, the authors “strongly advise” using low-molecular-weight heparin in hospitalized patients with active Cushing’s syndrome who develop COVID-19. In both diseases, there is also a risk of longer duration of viral infections and opportunistic infections such as atypical bacterial and invasive fungal infections. For this reason, the authors also recommended patients with Cushing’s syndrome who have COVID-19 be placed on prolonged antiviral and broad-spectrum antibiotic treatment as a prophylactic measure.
During the pandemic, avoiding surgery for Cushing’s syndrome should be considered to reduce the likelihood of acquiring COVID-19 in a hospital setting, the authors wrote. Medical therapy can be temporarily used where appropriate, such as using ketoconazole, metyrapone, osilodrostat, and etomidate to lower cortisol levels. They acknowledge that some cases of malignant Cushing’s syndrome may require “expeditious definitive diagnosis and proper surgical resolution.”
After remission, while infection risk should be significantly lowered, other comorbidities like obesity, hypertension, diabetes, and thromboembolic diathesis may remain. “Because these are features associated with an increased death risk in patients with COVID-19, patients with Cushing’s syndrome in remission should be considered a high-risk population and consequently adopt adequate self-protection strategies to [minimize] contagion risk,” the authors wrote.
Dr. Pivonello reported relationships with Novartis, Strongbridge Biopharma, HRA Pharma, Ipsen, Shire, and Pfizer, Corcept Therapeutics, IBSA Farmaceutici, Ferring, and Italfarmaco in the form of receiving grants and/or personal fees. One coauthor reported receiving grants and/or nonfinancial support from Takeda, Ipsen, Shire, Pfizer, and Corcept Therapeutics. One coauthor reported receiving grants and personal fees from Novartis and Strongbridge, and grants from Millendo Therapeutics. Another coauthor reported receiving grants and/or personal fees from Novartis, Ipsen, Shire, Pfizer, Italfarmaco, Lilly, Merck, and Novo Nordisk. The other authors reported no relevant conflicts of interest.
SOURCE: Pivonello R et al. Lancet Diabetes Endocrinol. 2020 Jun 9. doi: 10.1016/S2213-8587(20)30215-1.
FROM THE LANCET DIABETES & ENDOCRINOLOGY
Part 2: Controlling BP in Diabetes Patients
Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.
CASE CONTINUED
Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.
Reducing the Risk for Cardiovascular Conditions
The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.2 Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.2,7
Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.2,7
Setting and Meeting BP Goals
Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.17 Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.18 Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.19,20
How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.7 A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.7,8,21,22
Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).2 Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.24
Continue to: Monitor the patient's BP
Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.28
In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.
CASE CONTINUED
Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.
Reducing the Risk for Cardiovascular Conditions
The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.2 Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.2,7
Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.2,7
Setting and Meeting BP Goals
Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.17 Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.18 Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.19,20
How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.7 A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.7,8,21,22
Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).2 Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.24
Continue to: Monitor the patient's BP
Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.28
In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.
Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.
CASE CONTINUED
Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.
Reducing the Risk for Cardiovascular Conditions
The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.2 Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.2,7
Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.2,7
Setting and Meeting BP Goals
Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.17 Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.18 Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.19,20
How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.7 A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.7,8,21,22
Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).2 Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.24
Continue to: Monitor the patient's BP
Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.28
In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
Canagliflozin protects diabetic kidneys
Background: Type 2 diabetes is the leading cause of kidney failure worldwide. Few treatment options exist to help improve on this outcome in patients with chronic kidney disease.
Study design: CREDENCE (industry-sponsored) double-blind, randomized placebo-controlled trial.
Setting: 695 sites in 34 countries, 4,401 patients.
Synopsis: The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. Canagliflozin reduced serious adverse renal events or death from renal or cardiovascular causes at 2.62 years (11.1% vs. 15.5% with placebo; number needed to treat, 23).Bottom line: Canagliflozin lowered serious adverse renal events people with type 2 diabetics who also had chronic kidney disease.
Citation: Perkovic V et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019 Apr 14. doi: 10-1056/NEJMoa1811744.
Dr. Hoegh is a hospitalist at the University of Colorado at Denver, Aurora.
Background: Type 2 diabetes is the leading cause of kidney failure worldwide. Few treatment options exist to help improve on this outcome in patients with chronic kidney disease.
Study design: CREDENCE (industry-sponsored) double-blind, randomized placebo-controlled trial.
Setting: 695 sites in 34 countries, 4,401 patients.
Synopsis: The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. Canagliflozin reduced serious adverse renal events or death from renal or cardiovascular causes at 2.62 years (11.1% vs. 15.5% with placebo; number needed to treat, 23).Bottom line: Canagliflozin lowered serious adverse renal events people with type 2 diabetics who also had chronic kidney disease.
Citation: Perkovic V et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019 Apr 14. doi: 10-1056/NEJMoa1811744.
Dr. Hoegh is a hospitalist at the University of Colorado at Denver, Aurora.
Background: Type 2 diabetes is the leading cause of kidney failure worldwide. Few treatment options exist to help improve on this outcome in patients with chronic kidney disease.
Study design: CREDENCE (industry-sponsored) double-blind, randomized placebo-controlled trial.
Setting: 695 sites in 34 countries, 4,401 patients.
Synopsis: The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. Canagliflozin reduced serious adverse renal events or death from renal or cardiovascular causes at 2.62 years (11.1% vs. 15.5% with placebo; number needed to treat, 23).Bottom line: Canagliflozin lowered serious adverse renal events people with type 2 diabetics who also had chronic kidney disease.
Citation: Perkovic V et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019 Apr 14. doi: 10-1056/NEJMoa1811744.
Dr. Hoegh is a hospitalist at the University of Colorado at Denver, Aurora.
Zoledronic acid fails to impact abdominal aortic calcification
A single yearly dose of zoledronic acid had no impact on the progression of abdominal aortic calcification in postmenopausal women with osteoporosis, based on data from 502 women.
Although bisphosphonates have been shown to reduce the formation and progression of vascular calcification in animal studies, the impact on aortic calcification in humans has not been studied, wrote Guoqi Cai, PhD, of the University of Tasmania, Australia, and colleagues.
In a post hoc analysis published in Osteoporosis International, the researchers reviewed data from the HORIZON Pivotal Fracture trial of women with osteoporosis.
The study population included 234 postmenopausal women with osteoporosis who received an annual infusion of 5 mg zoledronic acid (ZA) and 268 who received a placebo. The mean age of the women was 72.5 years. Overall, abdominal aortic calcification (AAC) was present in 292 women (58%) at baseline, defined as an AAC score greater than 0, and AAC scores were similar between the intervention and placebo groups.
Over 3 years, AAC progressed similarly between the ZA and placebo groups (29% and 31%, respectively). Progression was defined as an increase in AAC score, which was measured by comparing spinal x-rays at baseline and after 3 years. In a subgroup analysis, progression of AAC was similar between the ZA and placebo groups with and without baseline AAC.
“The lack of effect on the progression of vascular calcification with zoledronic acid treatment in this study does not rule out a potential role of bisphosphonates in reducing cardiovascular mortality mediated through other mechanisms,” the researchers noted.
No correlation appeared between change in AAC score and change in bone mineral density at the total hip and femoral neck during the study period in any of the groups.
The study findings were limited by several factors including the post hoc analysis, potential lack of sensitivity of the AAC-8 scale in measuring small AAC changes, and homogenous study population, the researchers noted.
However, the study is the first to examine the impact of zoledronic acid on aortic calcification in humans, and was strengthened by the randomized design, the researchers said. Although other studies on the impact of bisphosphonates on vascular calcification have been inconsistent, the “finding that zoledronic acid was not protective against vascular calcification agrees with previous trials of nitrogen-containing bisphosphonates conducted in postmenopausal women with osteoporosis,” as well as chronic kidney disease patients and renal transplant patients, they said.
“Thus, our findings do not support the use of zoledronic acid for the treatment of vascular calcification,” they concluded.
The study was supported by Novartis. Dr. Cai had no financial conflicts to disclose.
SOURCE: Cai G. et al. Osteoporosis Int. 2020 May 2. doi: 10.1007/s00198-020-05430-z.
A single yearly dose of zoledronic acid had no impact on the progression of abdominal aortic calcification in postmenopausal women with osteoporosis, based on data from 502 women.
Although bisphosphonates have been shown to reduce the formation and progression of vascular calcification in animal studies, the impact on aortic calcification in humans has not been studied, wrote Guoqi Cai, PhD, of the University of Tasmania, Australia, and colleagues.
In a post hoc analysis published in Osteoporosis International, the researchers reviewed data from the HORIZON Pivotal Fracture trial of women with osteoporosis.
The study population included 234 postmenopausal women with osteoporosis who received an annual infusion of 5 mg zoledronic acid (ZA) and 268 who received a placebo. The mean age of the women was 72.5 years. Overall, abdominal aortic calcification (AAC) was present in 292 women (58%) at baseline, defined as an AAC score greater than 0, and AAC scores were similar between the intervention and placebo groups.
Over 3 years, AAC progressed similarly between the ZA and placebo groups (29% and 31%, respectively). Progression was defined as an increase in AAC score, which was measured by comparing spinal x-rays at baseline and after 3 years. In a subgroup analysis, progression of AAC was similar between the ZA and placebo groups with and without baseline AAC.
“The lack of effect on the progression of vascular calcification with zoledronic acid treatment in this study does not rule out a potential role of bisphosphonates in reducing cardiovascular mortality mediated through other mechanisms,” the researchers noted.
No correlation appeared between change in AAC score and change in bone mineral density at the total hip and femoral neck during the study period in any of the groups.
The study findings were limited by several factors including the post hoc analysis, potential lack of sensitivity of the AAC-8 scale in measuring small AAC changes, and homogenous study population, the researchers noted.
However, the study is the first to examine the impact of zoledronic acid on aortic calcification in humans, and was strengthened by the randomized design, the researchers said. Although other studies on the impact of bisphosphonates on vascular calcification have been inconsistent, the “finding that zoledronic acid was not protective against vascular calcification agrees with previous trials of nitrogen-containing bisphosphonates conducted in postmenopausal women with osteoporosis,” as well as chronic kidney disease patients and renal transplant patients, they said.
“Thus, our findings do not support the use of zoledronic acid for the treatment of vascular calcification,” they concluded.
The study was supported by Novartis. Dr. Cai had no financial conflicts to disclose.
SOURCE: Cai G. et al. Osteoporosis Int. 2020 May 2. doi: 10.1007/s00198-020-05430-z.
A single yearly dose of zoledronic acid had no impact on the progression of abdominal aortic calcification in postmenopausal women with osteoporosis, based on data from 502 women.
Although bisphosphonates have been shown to reduce the formation and progression of vascular calcification in animal studies, the impact on aortic calcification in humans has not been studied, wrote Guoqi Cai, PhD, of the University of Tasmania, Australia, and colleagues.
In a post hoc analysis published in Osteoporosis International, the researchers reviewed data from the HORIZON Pivotal Fracture trial of women with osteoporosis.
The study population included 234 postmenopausal women with osteoporosis who received an annual infusion of 5 mg zoledronic acid (ZA) and 268 who received a placebo. The mean age of the women was 72.5 years. Overall, abdominal aortic calcification (AAC) was present in 292 women (58%) at baseline, defined as an AAC score greater than 0, and AAC scores were similar between the intervention and placebo groups.
Over 3 years, AAC progressed similarly between the ZA and placebo groups (29% and 31%, respectively). Progression was defined as an increase in AAC score, which was measured by comparing spinal x-rays at baseline and after 3 years. In a subgroup analysis, progression of AAC was similar between the ZA and placebo groups with and without baseline AAC.
“The lack of effect on the progression of vascular calcification with zoledronic acid treatment in this study does not rule out a potential role of bisphosphonates in reducing cardiovascular mortality mediated through other mechanisms,” the researchers noted.
No correlation appeared between change in AAC score and change in bone mineral density at the total hip and femoral neck during the study period in any of the groups.
The study findings were limited by several factors including the post hoc analysis, potential lack of sensitivity of the AAC-8 scale in measuring small AAC changes, and homogenous study population, the researchers noted.
However, the study is the first to examine the impact of zoledronic acid on aortic calcification in humans, and was strengthened by the randomized design, the researchers said. Although other studies on the impact of bisphosphonates on vascular calcification have been inconsistent, the “finding that zoledronic acid was not protective against vascular calcification agrees with previous trials of nitrogen-containing bisphosphonates conducted in postmenopausal women with osteoporosis,” as well as chronic kidney disease patients and renal transplant patients, they said.
“Thus, our findings do not support the use of zoledronic acid for the treatment of vascular calcification,” they concluded.
The study was supported by Novartis. Dr. Cai had no financial conflicts to disclose.
SOURCE: Cai G. et al. Osteoporosis Int. 2020 May 2. doi: 10.1007/s00198-020-05430-z.
FROM OSTEOPOROSIS INTERNATIONAL
FDA approves first oral somatostatin analog for acromegaly
who previously responded to and tolerated octreotide or lanreotide injections.
“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.
“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.
Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.
The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.
The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.
The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.
The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.
The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.
Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.
Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.
“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.
Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.
The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.
Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.
The CHIASMA OPTIMAL trial was funded by Chiasma.
A version of this article originally appeared on Medscape.com.
who previously responded to and tolerated octreotide or lanreotide injections.
“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.
“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.
Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.
The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.
The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.
The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.
The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.
The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.
Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.
Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.
“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.
Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.
The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.
Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.
The CHIASMA OPTIMAL trial was funded by Chiasma.
A version of this article originally appeared on Medscape.com.
who previously responded to and tolerated octreotide or lanreotide injections.
“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.
“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.
Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.
The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.
The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.
The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.
The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.
The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.
Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.
Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.
“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.
Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.
The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.
Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.
The CHIASMA OPTIMAL trial was funded by Chiasma.
A version of this article originally appeared on Medscape.com.
High-impact training can build bone in older women
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.
“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”
“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.
In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.
Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.
Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).
However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.
Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.
“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.
Jump more, lose less bone density
Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”
The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.
This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.
“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”
Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.
This article first appeared on Medscape.com.
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.
“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”
“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.
In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.
Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.
Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).
However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.
Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.
“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.
Jump more, lose less bone density
Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”
The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.
This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.
“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”
Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.
This article first appeared on Medscape.com.
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.
“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”
“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.
In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.
Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.
Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).
However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.
Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.
“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.
Jump more, lose less bone density
Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”
The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.
This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.
“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”
Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.
This article first appeared on Medscape.com.