Clinician Reviews

After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. As a prerequisite for the use of the anti-CD3 antibody teplizumab, patients must undergo a general screening for type 1 diabetes. Whether this prerequisite makes sense was the subject of hot debate among experts at the Diabetes Congress in Berlin.

Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
 

Two autoantibodies

One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”

The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:

• Early stage 1: Two or more islet autoantibodies and normoglycemia.
• Early stage 2: Two or more islet autoantibodies and dysglycemia.
• Early stage 3: Symptoms, hyperglycemia, insulin therapy.

The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
 

Education and care

The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.

The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.

“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”

The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
 

Dubious benefits?

The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.

In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.

Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
 

Severe side effects

Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.

“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
 

Education reduces ketoacidosis

“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.

Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.

Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.

“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
 

New therapeutic options

Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.

For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”

This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.

After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. As a prerequisite for the use of the anti-CD3 antibody teplizumab, patients must undergo a general screening for type 1 diabetes. Whether this prerequisite makes sense was the subject of hot debate among experts at the Diabetes Congress in Berlin.

Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
 

Two autoantibodies

One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”

The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:

• Early stage 1: Two or more islet autoantibodies and normoglycemia.
• Early stage 2: Two or more islet autoantibodies and dysglycemia.
• Early stage 3: Symptoms, hyperglycemia, insulin therapy.

The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
 

Education and care

The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.

The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.

“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”

The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
 

Dubious benefits?

The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.

In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.

Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
 

Severe side effects

Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.

“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
 

Education reduces ketoacidosis

“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.

Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.

Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.

“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
 

New therapeutic options

Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.

For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”

This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.

After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. As a prerequisite for the use of the anti-CD3 antibody teplizumab, patients must undergo a general screening for type 1 diabetes. Whether this prerequisite makes sense was the subject of hot debate among experts at the Diabetes Congress in Berlin.

Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
 

Two autoantibodies

One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”

The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:

• Early stage 1: Two or more islet autoantibodies and normoglycemia.
• Early stage 2: Two or more islet autoantibodies and dysglycemia.
• Early stage 3: Symptoms, hyperglycemia, insulin therapy.

The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
 

Education and care

The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.

The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.

“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”

The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
 

Dubious benefits?

The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.

In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.

Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
 

Severe side effects

Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.

“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
 

Education reduces ketoacidosis

“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.

Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.

Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.

“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
 

New therapeutic options

Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.

For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”

This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.

Is it time to start recommending regular sauna bathing to improve heart health?

Mounting evidence shows that hitting the heated chambers can produce some of the same cardiovascular benefits as aerobic exercise. While a post-workout sauna can compound the benefits of exercise, the hormetic effects of heat therapy alone can produce significant gains for microvascular and endothelial function, no workout required.

“There’s enough evidence to say that regular sauna use improves cardiovascular health,” Matthew S. Ganio, PhD, a professor of exercise science at the University of Arkansas in Fayetteville, who studies thermoregulatory responses and cardiovascular health, said.

“The more they used it, the greater the reduction in cardiovascular events like heart attack. But you don’t need to be in there more than 20-30 minutes. That’s where it seemed to have the best effect,” Dr. Ganio said, adding that studies have shown a dose-response.

A prospective cohort study published in 2015 in JAMA Internal Medicine included 20 years of data on more than 2,300 Finnish men who regularly sauna bathed. The researchers found that among participants who sat in saunas more frequently, rates of death from heart disease and stroke were lower than among those who did so less often.
 

Cutaneous vasodilation

The body experiences several physiologic changes when exposed to heat therapy of any kind, including sauna, hot water submerging, shortwave diathermy, and heat wrapping. Many of these changes involve elements of the cardiovascular system, said Earric Lee, PhD, an exercise physiologist and postdoctoral researcher at the University of Jyväskylä in Finland, who has studied the effects of sauna on cardiovascular health.

The mechanisms by which heat therapy improves cardiovascular fitness have not been determined, as few studies of sauna bathing have been conducted to this degree. One driver appears to be cutaneous vasodilation. To cool the body when exposed to extreme external heat, cutaneous vessels dilate and push blood to the skin, which lowers body temperature, increases heart rate, and delivers oxygen to muscles in the limbs in a way similar to aerobic exercise.

Sauna bathing has similar effects on heart rate and cardiac output. Studies have shown it can improve the circulation of blood through the body, as well as vascular endothelial function, which is closely tied to vascular tone.

“Increased cardiac output is one of the physiologic reasons sauna is good for heart health,” Dr. Ganio said.

During a sauna session, cardiac output can increase by as much as 70% in relation to elevated heart rate. And while heart rate and cardiac output rise, stroke volume remains stable. As stroke volume increases, the effort that muscle must exert increases. When heart rate rises, stroke volume often falls, which subjects the heart to less of a workout and reduces the amount of oxygen and blood circulating throughout the body.

Heat therapy also temporarily increases blood pressure, but in a way similar to exercise, which supports better long-term heart health, said Christopher Minson, PhD, the Kenneth M. and Kenda H. Singer Endowed Professor of Human Physiology at the University of Oregon in Eugene.

A small study of 19 healthy adults that was published in Complementary Therapies in Medicine in 2019 found that blood pressure and heart rate rose during a 25-minute sauna session as they might during moderate exercise, equivalent to an exercise load of about 60-100 watts. These parameters then steadily decreased for 30 minutes after the sauna. An earlier study found that in the long term, blood pressure was lower after a sauna than before a sauna.
 

Upregulated heat shock proteins

Both aerobic exercise and heat stress from sauna bathing increase the activity of heat shock proteins. A 2021 review published in Experimental Gerontology found that heat shock proteins become elevated in cells within 30 minutes of exposure to heat and remain elevated over time – an effect similar to exercise.

“Saunas increase heat shock proteins that break down old, dysfunctional proteins and then protect new proteins from becoming dysfunctional,” Hunter S. Waldman, PhD, an assistant professor of exercise science at the University of North Alabama in Florence, said. This effect is one way sauna bathing may quell systemic inflammation, Dr. Waldman said.

According to a 2018 review published in BioMed Research International, an abundance of heat shock proteins may increase exercise tolerance. The researchers concluded that the positive stress associated with elevated body temperature could help people be physically active for longer periods.

Added stress, especially heat-related strain, is not good for everyone, however. Dr. Waldman cautioned that heat exposure, be it through a sauna, hot tub, or other source, can be harmful for pregnant women and children and can be dangerous for people who have low blood pressure, since blood pressure often drops to rates that are lower than before taking a sauna. It also can impair semen quality for months after exposure, so people who are trying to conceive should avoid sauna bathing.

Anyone who has been diagnosed with a heart condition, including cardiac arrhythmia, coronary artery disease, and congestive heart failure, should always consult their physician prior to using sauna for the first time or before using it habitually, Dr. Lee said.
 

Effects compounded by exercise

Dr. Minson stressed that any type of heat therapy should be part of a lifestyle that includes mostly healthy habits overall, especially a regular exercise regime when possible.

“You have to have everything else working as well: finding time to relax, not being overly stressed, staying hydrated – all those things are critical with any exercise training and heat therapy program,” he said.

Dr. Lee said it’s easy to overhype the benefits of sauna bathing and agreed the practice should be used in tandem with other therapies, not as a replacement. So far, stacking research has shown it to be an effective extension of aerobic exercise.

A June 2023 review published in Mayo Clinic Proceedings found that while sauna bathing can produce benefits on its own, a post-workout sauna can extend the benefits of exercise. As a result, the researchers concluded, saunas likely provide the most benefit when combined with aerobic and strength training.

While some of the benefits of exercise overlap those associated with sauna bathing, “you’re going to get some benefits with exercise that you’re never going to get with sauna,” Dr. Ganio said.

For instance, strength training or aerobic exercise usually results in muscle contractions, which sauna bathing does not produce.

If a person is impaired in a way that makes exercise difficult, taking a sauna after aerobic activity can extend the cardiovascular benefits of the workout, even if muscle-building does not occur, Dr. Lee said.

“All other things considered, especially with aerobic exercise, it is very comparable, so we can look at adding sauna bathing post exercise as a way to lengthen the aerobic exercise workout,” he said. “It’s not to the same degree, but you can get many of the ranging benefits of exercising simply by going into the sauna.”

The authors have disclosed no relevant financial relationships.

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

Is it time to start recommending regular sauna bathing to improve heart health?

Mounting evidence shows that hitting the heated chambers can produce some of the same cardiovascular benefits as aerobic exercise. While a post-workout sauna can compound the benefits of exercise, the hormetic effects of heat therapy alone can produce significant gains for microvascular and endothelial function, no workout required.

“There’s enough evidence to say that regular sauna use improves cardiovascular health,” Matthew S. Ganio, PhD, a professor of exercise science at the University of Arkansas in Fayetteville, who studies thermoregulatory responses and cardiovascular health, said.

“The more they used it, the greater the reduction in cardiovascular events like heart attack. But you don’t need to be in there more than 20-30 minutes. That’s where it seemed to have the best effect,” Dr. Ganio said, adding that studies have shown a dose-response.

A prospective cohort study published in 2015 in JAMA Internal Medicine included 20 years of data on more than 2,300 Finnish men who regularly sauna bathed. The researchers found that among participants who sat in saunas more frequently, rates of death from heart disease and stroke were lower than among those who did so less often.
 

Cutaneous vasodilation

The body experiences several physiologic changes when exposed to heat therapy of any kind, including sauna, hot water submerging, shortwave diathermy, and heat wrapping. Many of these changes involve elements of the cardiovascular system, said Earric Lee, PhD, an exercise physiologist and postdoctoral researcher at the University of Jyväskylä in Finland, who has studied the effects of sauna on cardiovascular health.

The mechanisms by which heat therapy improves cardiovascular fitness have not been determined, as few studies of sauna bathing have been conducted to this degree. One driver appears to be cutaneous vasodilation. To cool the body when exposed to extreme external heat, cutaneous vessels dilate and push blood to the skin, which lowers body temperature, increases heart rate, and delivers oxygen to muscles in the limbs in a way similar to aerobic exercise.

Sauna bathing has similar effects on heart rate and cardiac output. Studies have shown it can improve the circulation of blood through the body, as well as vascular endothelial function, which is closely tied to vascular tone.

“Increased cardiac output is one of the physiologic reasons sauna is good for heart health,” Dr. Ganio said.

During a sauna session, cardiac output can increase by as much as 70% in relation to elevated heart rate. And while heart rate and cardiac output rise, stroke volume remains stable. As stroke volume increases, the effort that muscle must exert increases. When heart rate rises, stroke volume often falls, which subjects the heart to less of a workout and reduces the amount of oxygen and blood circulating throughout the body.

Heat therapy also temporarily increases blood pressure, but in a way similar to exercise, which supports better long-term heart health, said Christopher Minson, PhD, the Kenneth M. and Kenda H. Singer Endowed Professor of Human Physiology at the University of Oregon in Eugene.

A small study of 19 healthy adults that was published in Complementary Therapies in Medicine in 2019 found that blood pressure and heart rate rose during a 25-minute sauna session as they might during moderate exercise, equivalent to an exercise load of about 60-100 watts. These parameters then steadily decreased for 30 minutes after the sauna. An earlier study found that in the long term, blood pressure was lower after a sauna than before a sauna.
 

Upregulated heat shock proteins

Both aerobic exercise and heat stress from sauna bathing increase the activity of heat shock proteins. A 2021 review published in Experimental Gerontology found that heat shock proteins become elevated in cells within 30 minutes of exposure to heat and remain elevated over time – an effect similar to exercise.

“Saunas increase heat shock proteins that break down old, dysfunctional proteins and then protect new proteins from becoming dysfunctional,” Hunter S. Waldman, PhD, an assistant professor of exercise science at the University of North Alabama in Florence, said. This effect is one way sauna bathing may quell systemic inflammation, Dr. Waldman said.

According to a 2018 review published in BioMed Research International, an abundance of heat shock proteins may increase exercise tolerance. The researchers concluded that the positive stress associated with elevated body temperature could help people be physically active for longer periods.

Added stress, especially heat-related strain, is not good for everyone, however. Dr. Waldman cautioned that heat exposure, be it through a sauna, hot tub, or other source, can be harmful for pregnant women and children and can be dangerous for people who have low blood pressure, since blood pressure often drops to rates that are lower than before taking a sauna. It also can impair semen quality for months after exposure, so people who are trying to conceive should avoid sauna bathing.

Anyone who has been diagnosed with a heart condition, including cardiac arrhythmia, coronary artery disease, and congestive heart failure, should always consult their physician prior to using sauna for the first time or before using it habitually, Dr. Lee said.
 

Effects compounded by exercise

Dr. Minson stressed that any type of heat therapy should be part of a lifestyle that includes mostly healthy habits overall, especially a regular exercise regime when possible.

“You have to have everything else working as well: finding time to relax, not being overly stressed, staying hydrated – all those things are critical with any exercise training and heat therapy program,” he said.

Dr. Lee said it’s easy to overhype the benefits of sauna bathing and agreed the practice should be used in tandem with other therapies, not as a replacement. So far, stacking research has shown it to be an effective extension of aerobic exercise.

A June 2023 review published in Mayo Clinic Proceedings found that while sauna bathing can produce benefits on its own, a post-workout sauna can extend the benefits of exercise. As a result, the researchers concluded, saunas likely provide the most benefit when combined with aerobic and strength training.

While some of the benefits of exercise overlap those associated with sauna bathing, “you’re going to get some benefits with exercise that you’re never going to get with sauna,” Dr. Ganio said.

For instance, strength training or aerobic exercise usually results in muscle contractions, which sauna bathing does not produce.

If a person is impaired in a way that makes exercise difficult, taking a sauna after aerobic activity can extend the cardiovascular benefits of the workout, even if muscle-building does not occur, Dr. Lee said.

“All other things considered, especially with aerobic exercise, it is very comparable, so we can look at adding sauna bathing post exercise as a way to lengthen the aerobic exercise workout,” he said. “It’s not to the same degree, but you can get many of the ranging benefits of exercising simply by going into the sauna.”

The authors have disclosed no relevant financial relationships.

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

Is it time to start recommending regular sauna bathing to improve heart health?

Mounting evidence shows that hitting the heated chambers can produce some of the same cardiovascular benefits as aerobic exercise. While a post-workout sauna can compound the benefits of exercise, the hormetic effects of heat therapy alone can produce significant gains for microvascular and endothelial function, no workout required.

“There’s enough evidence to say that regular sauna use improves cardiovascular health,” Matthew S. Ganio, PhD, a professor of exercise science at the University of Arkansas in Fayetteville, who studies thermoregulatory responses and cardiovascular health, said.

“The more they used it, the greater the reduction in cardiovascular events like heart attack. But you don’t need to be in there more than 20-30 minutes. That’s where it seemed to have the best effect,” Dr. Ganio said, adding that studies have shown a dose-response.

A prospective cohort study published in 2015 in JAMA Internal Medicine included 20 years of data on more than 2,300 Finnish men who regularly sauna bathed. The researchers found that among participants who sat in saunas more frequently, rates of death from heart disease and stroke were lower than among those who did so less often.
 

Cutaneous vasodilation

The body experiences several physiologic changes when exposed to heat therapy of any kind, including sauna, hot water submerging, shortwave diathermy, and heat wrapping. Many of these changes involve elements of the cardiovascular system, said Earric Lee, PhD, an exercise physiologist and postdoctoral researcher at the University of Jyväskylä in Finland, who has studied the effects of sauna on cardiovascular health.

The mechanisms by which heat therapy improves cardiovascular fitness have not been determined, as few studies of sauna bathing have been conducted to this degree. One driver appears to be cutaneous vasodilation. To cool the body when exposed to extreme external heat, cutaneous vessels dilate and push blood to the skin, which lowers body temperature, increases heart rate, and delivers oxygen to muscles in the limbs in a way similar to aerobic exercise.

Sauna bathing has similar effects on heart rate and cardiac output. Studies have shown it can improve the circulation of blood through the body, as well as vascular endothelial function, which is closely tied to vascular tone.

“Increased cardiac output is one of the physiologic reasons sauna is good for heart health,” Dr. Ganio said.

During a sauna session, cardiac output can increase by as much as 70% in relation to elevated heart rate. And while heart rate and cardiac output rise, stroke volume remains stable. As stroke volume increases, the effort that muscle must exert increases. When heart rate rises, stroke volume often falls, which subjects the heart to less of a workout and reduces the amount of oxygen and blood circulating throughout the body.

Heat therapy also temporarily increases blood pressure, but in a way similar to exercise, which supports better long-term heart health, said Christopher Minson, PhD, the Kenneth M. and Kenda H. Singer Endowed Professor of Human Physiology at the University of Oregon in Eugene.

A small study of 19 healthy adults that was published in Complementary Therapies in Medicine in 2019 found that blood pressure and heart rate rose during a 25-minute sauna session as they might during moderate exercise, equivalent to an exercise load of about 60-100 watts. These parameters then steadily decreased for 30 minutes after the sauna. An earlier study found that in the long term, blood pressure was lower after a sauna than before a sauna.
 

Upregulated heat shock proteins

Both aerobic exercise and heat stress from sauna bathing increase the activity of heat shock proteins. A 2021 review published in Experimental Gerontology found that heat shock proteins become elevated in cells within 30 minutes of exposure to heat and remain elevated over time – an effect similar to exercise.

“Saunas increase heat shock proteins that break down old, dysfunctional proteins and then protect new proteins from becoming dysfunctional,” Hunter S. Waldman, PhD, an assistant professor of exercise science at the University of North Alabama in Florence, said. This effect is one way sauna bathing may quell systemic inflammation, Dr. Waldman said.

According to a 2018 review published in BioMed Research International, an abundance of heat shock proteins may increase exercise tolerance. The researchers concluded that the positive stress associated with elevated body temperature could help people be physically active for longer periods.

Added stress, especially heat-related strain, is not good for everyone, however. Dr. Waldman cautioned that heat exposure, be it through a sauna, hot tub, or other source, can be harmful for pregnant women and children and can be dangerous for people who have low blood pressure, since blood pressure often drops to rates that are lower than before taking a sauna. It also can impair semen quality for months after exposure, so people who are trying to conceive should avoid sauna bathing.

Anyone who has been diagnosed with a heart condition, including cardiac arrhythmia, coronary artery disease, and congestive heart failure, should always consult their physician prior to using sauna for the first time or before using it habitually, Dr. Lee said.
 

Effects compounded by exercise

Dr. Minson stressed that any type of heat therapy should be part of a lifestyle that includes mostly healthy habits overall, especially a regular exercise regime when possible.

“You have to have everything else working as well: finding time to relax, not being overly stressed, staying hydrated – all those things are critical with any exercise training and heat therapy program,” he said.

Dr. Lee said it’s easy to overhype the benefits of sauna bathing and agreed the practice should be used in tandem with other therapies, not as a replacement. So far, stacking research has shown it to be an effective extension of aerobic exercise.

A June 2023 review published in Mayo Clinic Proceedings found that while sauna bathing can produce benefits on its own, a post-workout sauna can extend the benefits of exercise. As a result, the researchers concluded, saunas likely provide the most benefit when combined with aerobic and strength training.

While some of the benefits of exercise overlap those associated with sauna bathing, “you’re going to get some benefits with exercise that you’re never going to get with sauna,” Dr. Ganio said.

For instance, strength training or aerobic exercise usually results in muscle contractions, which sauna bathing does not produce.

If a person is impaired in a way that makes exercise difficult, taking a sauna after aerobic activity can extend the cardiovascular benefits of the workout, even if muscle-building does not occur, Dr. Lee said.

“All other things considered, especially with aerobic exercise, it is very comparable, so we can look at adding sauna bathing post exercise as a way to lengthen the aerobic exercise workout,” he said. “It’s not to the same degree, but you can get many of the ranging benefits of exercising simply by going into the sauna.”

The authors have disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved empagliflozin (Jardiance, Boehringer Ingelheim) and empagliflozin combined with metformin (Synjardy, BI) for the treatment of type 2 diabetes in children aged 10 years and older.

This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.

Olivier Le Moal/Getty Images

Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).

Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.

“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
 

Type 2 diabetes rising exponentially in children, mainly non-Whites

Type 2 diabetes is rising exponentially in children and adolescents in the United States.

Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and  it continues to rise.

A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.

Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.

At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.

Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.

Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).

“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.

“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.

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

The Food and Drug Administration has approved empagliflozin (Jardiance, Boehringer Ingelheim) and empagliflozin combined with metformin (Synjardy, BI) for the treatment of type 2 diabetes in children aged 10 years and older.

This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.

Olivier Le Moal/Getty Images

Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).

Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.

“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
 

Type 2 diabetes rising exponentially in children, mainly non-Whites

Type 2 diabetes is rising exponentially in children and adolescents in the United States.

Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and  it continues to rise.

A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.

Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.

At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.

Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.

Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).

“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.

“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.

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

The Food and Drug Administration has approved empagliflozin (Jardiance, Boehringer Ingelheim) and empagliflozin combined with metformin (Synjardy, BI) for the treatment of type 2 diabetes in children aged 10 years and older.

This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.

Olivier Le Moal/Getty Images

Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).

Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.

“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
 

Type 2 diabetes rising exponentially in children, mainly non-Whites

Type 2 diabetes is rising exponentially in children and adolescents in the United States.

Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and  it continues to rise.

A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.

Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.

At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.

Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.

Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).

“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.

“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.

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

While increases in colorectal cancer screening have been linked to drops in disease incidence, marginalized racial and ethnic populations in the United States continue to see lower screening rates along with higher disease incidence and mortality. Disparities in colorectal screening represent a serious public health challenge, say the authors of a new literature review that describes specific areas of concern and recommendations for improvement.

For their research, published in Techniques and Innovations in Gastrointestinal Endoscopy, gastroenterologists Abraham Segura, MD, and Shazia Mehmood Siddique, MD, of the University of Pennsylvania, Philadelphia, sought to identify studies that shed light on ethnicity or race-based differences in screening uptake, as well as known barriers and facilitators to screening.

Significant racial and ethnic disparities can be seen in rates of colonoscopy selection as a screening method, and of screening completion, Dr. Segura and Dr. Siddique noted, with White individuals who chose the method three times more likely to complete screening as Asian, Hispanic, or Black individuals. Disparities were also seen reflected in people’s choice of screening method, with non–English-speaking Hispanic individuals less likely to choose colonoscopy compared with other groups.

Use of stool-based screening methods, such as the fecal occult blood test (FOBT) and fecal immunochemical test (FIT), has risen over time across ethnic and racial groups. However, Hispanic and Asian individuals were more likely to complete and adhere to the FOBT, compared with non-Hispanic White individuals. Follow-up colonoscopy rates after FOBT or FIT also differ along ethnic and racial lines, Dr. Segura and Dr. Siddique noted, with Asian and American Indian groups less likely to complete follow-up after an abnormal result.

The study authors pointed to structural racism at the root of some observed disparities, citing barriers to healthcare access and quality that include higher rates of noninsurance among Black and Hispanic populations and a lower likelihood of the same populations to receive physician counseling regarding screening.

Barriers to economic stability, including living in impoverished neighborhoods, were also cited as contributors to lower colorectal screening. Patients covered by Medicaid were more than twice as likely as non-Medicaid patients to have suboptimal bowel preparation at screening, the authors noted. Access to transportation remained another frequently observed barrier to completing recommended testing and follow-up.

Mistrust of doctors has been linked to lower screening uptake among Black men. “Longstanding conscious and implicit racism, differences in communication, and socioeconomic context ... engender medical mistrust among racial and ethnic groups,” the authors wrote. Reversing it “ultimately requires vast societal change, and we as physicians can facilitate this by encouraging patient-centered discussions that humanize and empower traditionally marginalized populations.”

Dr. Segura and Dr. Siddique described strategies that have been shown to result in better uptake in specific populations, including removing out-of-pocket costs for screening and follow-up, and designing faith-based or culturally specific outreach delivered through churches and local businesses.

They recommended that researchers change how they study the disparities that bear on colorectal screening and outcomes. “Collection and use of data on race and ethnicity must be optimized and standardized to ensure that all groups are adequately captured,” they wrote. Standardizing self-reporting of race and ethnicity would help address issues of misclassification.

The authors also advised designing studies with longer follow-up, noting that “we must better understand the mechanisms of long-term adherence.” Additional research is needed, they said, to evaluate the efficacy of older outreach strategies after societal changes resulting from the COVID-19 pandemic. Efforts to increase the number of Black, Hispanic, Asian, and Alaskan Native/American Indian groups in CRC screening interventions and studies “must be prioritized.”

Dr. Segura’s and Dr. Siddique’s study was funded with grants from the National Institutes of Health. They disclosed no conflicts of interest.
 

While increases in colorectal cancer screening have been linked to drops in disease incidence, marginalized racial and ethnic populations in the United States continue to see lower screening rates along with higher disease incidence and mortality. Disparities in colorectal screening represent a serious public health challenge, say the authors of a new literature review that describes specific areas of concern and recommendations for improvement.

For their research, published in Techniques and Innovations in Gastrointestinal Endoscopy, gastroenterologists Abraham Segura, MD, and Shazia Mehmood Siddique, MD, of the University of Pennsylvania, Philadelphia, sought to identify studies that shed light on ethnicity or race-based differences in screening uptake, as well as known barriers and facilitators to screening.

Significant racial and ethnic disparities can be seen in rates of colonoscopy selection as a screening method, and of screening completion, Dr. Segura and Dr. Siddique noted, with White individuals who chose the method three times more likely to complete screening as Asian, Hispanic, or Black individuals. Disparities were also seen reflected in people’s choice of screening method, with non–English-speaking Hispanic individuals less likely to choose colonoscopy compared with other groups.

Use of stool-based screening methods, such as the fecal occult blood test (FOBT) and fecal immunochemical test (FIT), has risen over time across ethnic and racial groups. However, Hispanic and Asian individuals were more likely to complete and adhere to the FOBT, compared with non-Hispanic White individuals. Follow-up colonoscopy rates after FOBT or FIT also differ along ethnic and racial lines, Dr. Segura and Dr. Siddique noted, with Asian and American Indian groups less likely to complete follow-up after an abnormal result.

The study authors pointed to structural racism at the root of some observed disparities, citing barriers to healthcare access and quality that include higher rates of noninsurance among Black and Hispanic populations and a lower likelihood of the same populations to receive physician counseling regarding screening.

Barriers to economic stability, including living in impoverished neighborhoods, were also cited as contributors to lower colorectal screening. Patients covered by Medicaid were more than twice as likely as non-Medicaid patients to have suboptimal bowel preparation at screening, the authors noted. Access to transportation remained another frequently observed barrier to completing recommended testing and follow-up.

Mistrust of doctors has been linked to lower screening uptake among Black men. “Longstanding conscious and implicit racism, differences in communication, and socioeconomic context ... engender medical mistrust among racial and ethnic groups,” the authors wrote. Reversing it “ultimately requires vast societal change, and we as physicians can facilitate this by encouraging patient-centered discussions that humanize and empower traditionally marginalized populations.”

Dr. Segura and Dr. Siddique described strategies that have been shown to result in better uptake in specific populations, including removing out-of-pocket costs for screening and follow-up, and designing faith-based or culturally specific outreach delivered through churches and local businesses.

They recommended that researchers change how they study the disparities that bear on colorectal screening and outcomes. “Collection and use of data on race and ethnicity must be optimized and standardized to ensure that all groups are adequately captured,” they wrote. Standardizing self-reporting of race and ethnicity would help address issues of misclassification.

The authors also advised designing studies with longer follow-up, noting that “we must better understand the mechanisms of long-term adherence.” Additional research is needed, they said, to evaluate the efficacy of older outreach strategies after societal changes resulting from the COVID-19 pandemic. Efforts to increase the number of Black, Hispanic, Asian, and Alaskan Native/American Indian groups in CRC screening interventions and studies “must be prioritized.”

Dr. Segura’s and Dr. Siddique’s study was funded with grants from the National Institutes of Health. They disclosed no conflicts of interest.
 

While increases in colorectal cancer screening have been linked to drops in disease incidence, marginalized racial and ethnic populations in the United States continue to see lower screening rates along with higher disease incidence and mortality. Disparities in colorectal screening represent a serious public health challenge, say the authors of a new literature review that describes specific areas of concern and recommendations for improvement.

For their research, published in Techniques and Innovations in Gastrointestinal Endoscopy, gastroenterologists Abraham Segura, MD, and Shazia Mehmood Siddique, MD, of the University of Pennsylvania, Philadelphia, sought to identify studies that shed light on ethnicity or race-based differences in screening uptake, as well as known barriers and facilitators to screening.

Significant racial and ethnic disparities can be seen in rates of colonoscopy selection as a screening method, and of screening completion, Dr. Segura and Dr. Siddique noted, with White individuals who chose the method three times more likely to complete screening as Asian, Hispanic, or Black individuals. Disparities were also seen reflected in people’s choice of screening method, with non–English-speaking Hispanic individuals less likely to choose colonoscopy compared with other groups.

Use of stool-based screening methods, such as the fecal occult blood test (FOBT) and fecal immunochemical test (FIT), has risen over time across ethnic and racial groups. However, Hispanic and Asian individuals were more likely to complete and adhere to the FOBT, compared with non-Hispanic White individuals. Follow-up colonoscopy rates after FOBT or FIT also differ along ethnic and racial lines, Dr. Segura and Dr. Siddique noted, with Asian and American Indian groups less likely to complete follow-up after an abnormal result.

The study authors pointed to structural racism at the root of some observed disparities, citing barriers to healthcare access and quality that include higher rates of noninsurance among Black and Hispanic populations and a lower likelihood of the same populations to receive physician counseling regarding screening.

Barriers to economic stability, including living in impoverished neighborhoods, were also cited as contributors to lower colorectal screening. Patients covered by Medicaid were more than twice as likely as non-Medicaid patients to have suboptimal bowel preparation at screening, the authors noted. Access to transportation remained another frequently observed barrier to completing recommended testing and follow-up.

Mistrust of doctors has been linked to lower screening uptake among Black men. “Longstanding conscious and implicit racism, differences in communication, and socioeconomic context ... engender medical mistrust among racial and ethnic groups,” the authors wrote. Reversing it “ultimately requires vast societal change, and we as physicians can facilitate this by encouraging patient-centered discussions that humanize and empower traditionally marginalized populations.”

Dr. Segura and Dr. Siddique described strategies that have been shown to result in better uptake in specific populations, including removing out-of-pocket costs for screening and follow-up, and designing faith-based or culturally specific outreach delivered through churches and local businesses.

They recommended that researchers change how they study the disparities that bear on colorectal screening and outcomes. “Collection and use of data on race and ethnicity must be optimized and standardized to ensure that all groups are adequately captured,” they wrote. Standardizing self-reporting of race and ethnicity would help address issues of misclassification.

The authors also advised designing studies with longer follow-up, noting that “we must better understand the mechanisms of long-term adherence.” Additional research is needed, they said, to evaluate the efficacy of older outreach strategies after societal changes resulting from the COVID-19 pandemic. Efforts to increase the number of Black, Hispanic, Asian, and Alaskan Native/American Indian groups in CRC screening interventions and studies “must be prioritized.”

Dr. Segura’s and Dr. Siddique’s study was funded with grants from the National Institutes of Health. They disclosed no conflicts of interest.
 

Warts in children with cancer who are undergoing active treatment are particularly difficult to eradicate, new findings show.

Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.

In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.

David Carillet/Dreamstime

“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.

In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.

Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.

The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.

Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.

The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.

The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.

Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.

The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”

Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.

The authors declared no conflict of interest. No outside funding source was listed.

Warts in children with cancer who are undergoing active treatment are particularly difficult to eradicate, new findings show.

Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.

In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.

David Carillet/Dreamstime

“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.

In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.

Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.

The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.

Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.

The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.

The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.

Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.

The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”

Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.

The authors declared no conflict of interest. No outside funding source was listed.

Warts in children with cancer who are undergoing active treatment are particularly difficult to eradicate, new findings show.

Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.

In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.

David Carillet/Dreamstime

“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.

In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.

Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.

The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.

Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.

The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.

The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.

Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.

The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”

Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.

The authors declared no conflict of interest. No outside funding source was listed.

The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications. 

Olivier Le Moal/Getty Images

The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.

Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.

Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.

In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI. 

Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
 

‘A very big day for cardiology’

“This is a very big day for cardiology,” Dr. Ridker said in an interview.

“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.

Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.

He pointed out that the indication for Lodoco was very broad, simply stating that it can be used in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.

But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.

“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.

Dr. Ridker believes that physicians will need time to feel comfortable with this new approach. 

“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.

Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.

The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.

Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.

More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.

The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.

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

The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications. 

Olivier Le Moal/Getty Images

The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.

Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.

Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.

In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI. 

Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
 

‘A very big day for cardiology’

“This is a very big day for cardiology,” Dr. Ridker said in an interview.

“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.

Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.

He pointed out that the indication for Lodoco was very broad, simply stating that it can be used in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.

But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.

“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.

Dr. Ridker believes that physicians will need time to feel comfortable with this new approach. 

“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.

Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.

The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.

Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.

More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.

The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.

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

The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications. 

Olivier Le Moal/Getty Images

The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.

Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.

Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.

In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI. 

Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
 

‘A very big day for cardiology’

“This is a very big day for cardiology,” Dr. Ridker said in an interview.

“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.

Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.

He pointed out that the indication for Lodoco was very broad, simply stating that it can be used in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.

But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.

“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.

Dr. Ridker believes that physicians will need time to feel comfortable with this new approach. 

“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.

Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.

The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.

Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.

More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.

The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.

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

People with nonalcoholic fatty liver disease (NAFLD) are more likely to develop severe infections requiring hospitalization, according to findings from a large Swedish cohort study.

The increased risk was equal to one extra severe infection in every six patients with NAFLD by 20 years after diagnosis, wrote Fahim Ebrahimi, MD, of the Karolinska Institute in Stockholm, and coauthors.

“Accumulating evidence suggests that NAFLD can affect multiple organ systems, which is not surprising, as the liver has multiple functions – regulating metabolism and being a central organ of the immune system,” Dr. Ebrahimi said in an interview.

The study was published online in Clinical Gastroenterology and Hepatology.

“Up to a fifth of cells in the liver are immune cells that process numerous antigens and pathogens from the gastrointestinal tract,” Dr. Ebrahimi noted. “We were intrigued by experimental studies showing that, in NAFLD, many of these key immune cells become dysfunctional at various levels, which may affect disease progression, but at the same time also increase the susceptibility to viral, bacterial, and fungal infections.”

Patients with NAFLD have metabolic risk factors known to increase infection risk, but a smaller study by a different research group had found that NAFLD could independently predispose patients to bacterial infections.

To further explore a connection between NAFLD and infection risk, the researchers looked at data for 12,133 Swedish adults with simple steatosis, nonfibrotic steatohepatitis, noncirrhotic fibrosis, or cirrhosis caused by NAFLD confirmed by liver biopsies performed between 1969 and 2017.

Each patient was matched to five or more contemporary controls from the general population by age, sex, and region of residence. The authors conducted an additional analysis that also adjusted for education, country of birth, and baseline clinical comorbidities, including diabetes, obesity, dyslipidemia, and hypertension, as well as hospitalization preceding the biopsy and chronic obstructive pulmonary disease.

The primary endpoint was severe infections requiring hospital admission. Secondary endpoints included seven prespecified infection subgroups: sepsis; respiratory tract; most gastrointestinal infections; bacterial peritonitis; urogenital; muscle, skin, and soft tissue; and other infections.
 

Elevated risk at all NAFLD stages

Dr. Ebrahimi and colleagues found that over a median follow-up of 14 years, patients with NAFLD had a higher incidence of severe infections – most often respiratory or urinary tract infections – compared with those without NAFLD (32% vs. 17%, respectively).

Biopsy-confirmed NAFLD was also associated with a 71% higher hazard and a 20-year absolute excess risk of 17.3% for severe infections requiring hospital admission versus comparators. The elevated risk showed up in patients with steatosis and increased with the severity of NAFLD. Simple steatosis saw a 64% higher risk (adjusted hazard ratio, 1.64; 95% confidence interval, 1.55-1.73), whereas patients with cirrhosis saw a more than twofold higher risk, compared with controls (aHR, 2.32; 95% CI, 1.92-2.82).

When Dr. Ebrahimi and colleagues adjusted for parameters of the metabolic syndrome, they found an independent increased risk for severe infection. For patients with NAFLD, the increased risk may come from greater susceptibility to infections in general or to a more severe course of infections.

“Our study clearly demonstrates the complexity and high disease burden associated with NAFLD,” Dr. Ebrahimi said. “We are beginning to understand the different layers involved and will eventually move away from a liver-centric view to a more holistic view of the disease.”

Clinicians caring for patients with NAFLD need to be aware of the increased risk for infection, Dr. Ebrahimi said. They also should assess their patients’ vaccination status, and seek to control modifiable risk factors, such as diabetes.

Nancy Reau, MD, of Rush University, Chicago, described the study’s message as important.

“Patients with NAFLD and advancing liver disease are at risk for severe infections,” Dr. Reau said. “When we consider the fact that patients with advanced liver disease tend to die from infectious complications, awareness leading to early recognition and efficient treatment is imperative.”

The authors acknowledged the following limitations: only severe infections requiring hospitalization could be captured; whether infection led to decompensation or vice versa among patients with cirrhosis could not be determined; and detailed data on smoking, alcohol, vaccinations, body mass, and other potentially relevant measures were not available.

The Swiss National Science Foundation, Syskonen Svensson Foundation, and Bengt Ihre Foundation provided grants to Dr. Ebrahimi or coauthors. One coauthor disclosed previous research funding from Janssen and MSD. Dr. Reau disclosed receiving research support and consulting fees from AbbVie and Gilead, as well as consulting fees from Arbutus, Intercept, and Salix.

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

People with nonalcoholic fatty liver disease (NAFLD) are more likely to develop severe infections requiring hospitalization, according to findings from a large Swedish cohort study.

The increased risk was equal to one extra severe infection in every six patients with NAFLD by 20 years after diagnosis, wrote Fahim Ebrahimi, MD, of the Karolinska Institute in Stockholm, and coauthors.

“Accumulating evidence suggests that NAFLD can affect multiple organ systems, which is not surprising, as the liver has multiple functions – regulating metabolism and being a central organ of the immune system,” Dr. Ebrahimi said in an interview.

The study was published online in Clinical Gastroenterology and Hepatology.

“Up to a fifth of cells in the liver are immune cells that process numerous antigens and pathogens from the gastrointestinal tract,” Dr. Ebrahimi noted. “We were intrigued by experimental studies showing that, in NAFLD, many of these key immune cells become dysfunctional at various levels, which may affect disease progression, but at the same time also increase the susceptibility to viral, bacterial, and fungal infections.”

Patients with NAFLD have metabolic risk factors known to increase infection risk, but a smaller study by a different research group had found that NAFLD could independently predispose patients to bacterial infections.

To further explore a connection between NAFLD and infection risk, the researchers looked at data for 12,133 Swedish adults with simple steatosis, nonfibrotic steatohepatitis, noncirrhotic fibrosis, or cirrhosis caused by NAFLD confirmed by liver biopsies performed between 1969 and 2017.

Each patient was matched to five or more contemporary controls from the general population by age, sex, and region of residence. The authors conducted an additional analysis that also adjusted for education, country of birth, and baseline clinical comorbidities, including diabetes, obesity, dyslipidemia, and hypertension, as well as hospitalization preceding the biopsy and chronic obstructive pulmonary disease.

The primary endpoint was severe infections requiring hospital admission. Secondary endpoints included seven prespecified infection subgroups: sepsis; respiratory tract; most gastrointestinal infections; bacterial peritonitis; urogenital; muscle, skin, and soft tissue; and other infections.
 

Elevated risk at all NAFLD stages

Dr. Ebrahimi and colleagues found that over a median follow-up of 14 years, patients with NAFLD had a higher incidence of severe infections – most often respiratory or urinary tract infections – compared with those without NAFLD (32% vs. 17%, respectively).

Biopsy-confirmed NAFLD was also associated with a 71% higher hazard and a 20-year absolute excess risk of 17.3% for severe infections requiring hospital admission versus comparators. The elevated risk showed up in patients with steatosis and increased with the severity of NAFLD. Simple steatosis saw a 64% higher risk (adjusted hazard ratio, 1.64; 95% confidence interval, 1.55-1.73), whereas patients with cirrhosis saw a more than twofold higher risk, compared with controls (aHR, 2.32; 95% CI, 1.92-2.82).

When Dr. Ebrahimi and colleagues adjusted for parameters of the metabolic syndrome, they found an independent increased risk for severe infection. For patients with NAFLD, the increased risk may come from greater susceptibility to infections in general or to a more severe course of infections.

“Our study clearly demonstrates the complexity and high disease burden associated with NAFLD,” Dr. Ebrahimi said. “We are beginning to understand the different layers involved and will eventually move away from a liver-centric view to a more holistic view of the disease.”

Clinicians caring for patients with NAFLD need to be aware of the increased risk for infection, Dr. Ebrahimi said. They also should assess their patients’ vaccination status, and seek to control modifiable risk factors, such as diabetes.

Nancy Reau, MD, of Rush University, Chicago, described the study’s message as important.

“Patients with NAFLD and advancing liver disease are at risk for severe infections,” Dr. Reau said. “When we consider the fact that patients with advanced liver disease tend to die from infectious complications, awareness leading to early recognition and efficient treatment is imperative.”

The authors acknowledged the following limitations: only severe infections requiring hospitalization could be captured; whether infection led to decompensation or vice versa among patients with cirrhosis could not be determined; and detailed data on smoking, alcohol, vaccinations, body mass, and other potentially relevant measures were not available.

The Swiss National Science Foundation, Syskonen Svensson Foundation, and Bengt Ihre Foundation provided grants to Dr. Ebrahimi or coauthors. One coauthor disclosed previous research funding from Janssen and MSD. Dr. Reau disclosed receiving research support and consulting fees from AbbVie and Gilead, as well as consulting fees from Arbutus, Intercept, and Salix.

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

People with nonalcoholic fatty liver disease (NAFLD) are more likely to develop severe infections requiring hospitalization, according to findings from a large Swedish cohort study.

The increased risk was equal to one extra severe infection in every six patients with NAFLD by 20 years after diagnosis, wrote Fahim Ebrahimi, MD, of the Karolinska Institute in Stockholm, and coauthors.

“Accumulating evidence suggests that NAFLD can affect multiple organ systems, which is not surprising, as the liver has multiple functions – regulating metabolism and being a central organ of the immune system,” Dr. Ebrahimi said in an interview.

The study was published online in Clinical Gastroenterology and Hepatology.

“Up to a fifth of cells in the liver are immune cells that process numerous antigens and pathogens from the gastrointestinal tract,” Dr. Ebrahimi noted. “We were intrigued by experimental studies showing that, in NAFLD, many of these key immune cells become dysfunctional at various levels, which may affect disease progression, but at the same time also increase the susceptibility to viral, bacterial, and fungal infections.”

Patients with NAFLD have metabolic risk factors known to increase infection risk, but a smaller study by a different research group had found that NAFLD could independently predispose patients to bacterial infections.

To further explore a connection between NAFLD and infection risk, the researchers looked at data for 12,133 Swedish adults with simple steatosis, nonfibrotic steatohepatitis, noncirrhotic fibrosis, or cirrhosis caused by NAFLD confirmed by liver biopsies performed between 1969 and 2017.

Each patient was matched to five or more contemporary controls from the general population by age, sex, and region of residence. The authors conducted an additional analysis that also adjusted for education, country of birth, and baseline clinical comorbidities, including diabetes, obesity, dyslipidemia, and hypertension, as well as hospitalization preceding the biopsy and chronic obstructive pulmonary disease.

The primary endpoint was severe infections requiring hospital admission. Secondary endpoints included seven prespecified infection subgroups: sepsis; respiratory tract; most gastrointestinal infections; bacterial peritonitis; urogenital; muscle, skin, and soft tissue; and other infections.
 

Elevated risk at all NAFLD stages

Dr. Ebrahimi and colleagues found that over a median follow-up of 14 years, patients with NAFLD had a higher incidence of severe infections – most often respiratory or urinary tract infections – compared with those without NAFLD (32% vs. 17%, respectively).

Biopsy-confirmed NAFLD was also associated with a 71% higher hazard and a 20-year absolute excess risk of 17.3% for severe infections requiring hospital admission versus comparators. The elevated risk showed up in patients with steatosis and increased with the severity of NAFLD. Simple steatosis saw a 64% higher risk (adjusted hazard ratio, 1.64; 95% confidence interval, 1.55-1.73), whereas patients with cirrhosis saw a more than twofold higher risk, compared with controls (aHR, 2.32; 95% CI, 1.92-2.82).

When Dr. Ebrahimi and colleagues adjusted for parameters of the metabolic syndrome, they found an independent increased risk for severe infection. For patients with NAFLD, the increased risk may come from greater susceptibility to infections in general or to a more severe course of infections.

“Our study clearly demonstrates the complexity and high disease burden associated with NAFLD,” Dr. Ebrahimi said. “We are beginning to understand the different layers involved and will eventually move away from a liver-centric view to a more holistic view of the disease.”

Clinicians caring for patients with NAFLD need to be aware of the increased risk for infection, Dr. Ebrahimi said. They also should assess their patients’ vaccination status, and seek to control modifiable risk factors, such as diabetes.

Nancy Reau, MD, of Rush University, Chicago, described the study’s message as important.

“Patients with NAFLD and advancing liver disease are at risk for severe infections,” Dr. Reau said. “When we consider the fact that patients with advanced liver disease tend to die from infectious complications, awareness leading to early recognition and efficient treatment is imperative.”

The authors acknowledged the following limitations: only severe infections requiring hospitalization could be captured; whether infection led to decompensation or vice versa among patients with cirrhosis could not be determined; and detailed data on smoking, alcohol, vaccinations, body mass, and other potentially relevant measures were not available.

The Swiss National Science Foundation, Syskonen Svensson Foundation, and Bengt Ihre Foundation provided grants to Dr. Ebrahimi or coauthors. One coauthor disclosed previous research funding from Janssen and MSD. Dr. Reau disclosed receiving research support and consulting fees from AbbVie and Gilead, as well as consulting fees from Arbutus, Intercept, and Salix.

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

Older people who take daily low-dose aspirin have at 20% higher risk of developing anemia even without having already had a major bleeding event, according to results from a new randomized controlled trial.

In the study, which was published in Annals of Internal Medicine, investigators analyzed data from the Aspirin in Reducing Events in the Elderly (ASPREE) trial and examined hemoglobin concentrations among 19,114 healthy, community-dwelling older patients.

“We knew from large clinical trials, including our ASPREE trial, that daily low-dose aspirin increased the risk of clinically significant bleeding,” said Zoe McQuilten, MBBS, PhD, a hematologist at Monash University in Australia and the study’s lead author. “From our study, we found that low-dose aspirin also increased the risk of anemia during the trial, and this was most likely due to bleeding that was not clinically apparent.”

Anemia is common among elderly patients. It can cause fatigue, fast or irregular heartbeat, headache, chest pain, and pounding or whooshing sounds in the ear, according to the Cleveland Clinic. It can also worsen conditions such as heart failure, cognitive impairment, and depression in people aged 65 and older.

The U.S. Preventive Services Task Force changed its recommendation on aspirin for the primary prevention of cardiovascular disease in 2022, recommending against initiating low-dose aspirin for adults aged 60 years or older. For adults aged 40-59 who have a 10% or greater 10-year risk for cardiovascular disease, the agency recommends that patients and clinicians make the decision to initiate low-dose aspirin use on a case-by-case basis, as the net benefit is small.

Dr. McQuilten said she spent the last 5 years designing substages of anemia and conditions such as blood cancer. In many cases of anemia, doctors are unable to determine the underlying cause, she said. One study published in the Journal of American Geriatrics Society in 2021 found that in about one-third of anemia cases, the etiology was not clear.

About 50% of people older than 60 who were involved in the latest study took aspirin for prevention from 2011 to 2018. That number likely dropped after changes were made to the guidelines in 2022, according to Dr. McQuilten, but long-term use may have continued among older patients. The researchers also examined ferritin levels, which serve as a proxy for iron levels, at baseline and after 3 years.

The incidence of anemia was 51 events per 1,000 person-years in the aspirin group compared with 43 events per 1,000 person-years in the placebo group, according to the researchers. The estimated probability of experiencing anemia within 5 years was 23.5% (95% confidence interval [CI], 22.4%-24.6%) in the aspirin group and 20.3% (95% CI: 19.3% to 21.4%) in the placebo group. Aspirin therapy resulted in a 20% increase in the risk for anemia (95% CI, 1.12-1.29).

People who took aspirin were more likely to have lower serum levels of ferritin at the 3-year mark than were those who received placebo. The average decrease in ferritin among participants who took aspirin was 11.5% greater (95% CI, 9.3%-13.7%) than among those who took placebo.

Basil Eldadah, MD, PhD, supervisory medical officer at the National Institute on Aging, part of the National Institutes of Health, said the findings should encourage clinicians to pay closer attention to hemoglobin levels and have conversations with patients to discuss their need for taking aspirin.

“If somebody is already taking aspirin for any reason, keep an eye on hemoglobin,” said Dr. Eldadah, who was not involved in the study. “For somebody who’s taking aspirin and who’s older, and it’s not for an indication like cardiovascular disease, consider seriously whether that’s the best treatment option.”

The study did not examine the functional consequences of anemia on participants, which Dr. Eldadah said could be fodder for future research. The researchers said one limitation was that it was not clear whether anemia was sufficient to cause symptoms that affected participants’ quality of life or whether occult bleeding caused the anemia. The researchers also did not document whether patients saw their regular physicians and received treatment for anemia over the course of the trial.

The study was funded through grants from the National Health and Medical Research Council and the Bill and Melinda Gates Foundation. The authors reported receiving consulting fees, honoraria, and stock options, and have participated on data monitoring boards not related to the study for Vifor Pharma, ITL Biomedical, Pfizer, Boehringer Ingelheim, Bayer Healthcare, AbbVie, and Abbott Diagnostics.

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

Older people who take daily low-dose aspirin have at 20% higher risk of developing anemia even without having already had a major bleeding event, according to results from a new randomized controlled trial.

In the study, which was published in Annals of Internal Medicine, investigators analyzed data from the Aspirin in Reducing Events in the Elderly (ASPREE) trial and examined hemoglobin concentrations among 19,114 healthy, community-dwelling older patients.

“We knew from large clinical trials, including our ASPREE trial, that daily low-dose aspirin increased the risk of clinically significant bleeding,” said Zoe McQuilten, MBBS, PhD, a hematologist at Monash University in Australia and the study’s lead author. “From our study, we found that low-dose aspirin also increased the risk of anemia during the trial, and this was most likely due to bleeding that was not clinically apparent.”

Anemia is common among elderly patients. It can cause fatigue, fast or irregular heartbeat, headache, chest pain, and pounding or whooshing sounds in the ear, according to the Cleveland Clinic. It can also worsen conditions such as heart failure, cognitive impairment, and depression in people aged 65 and older.

The U.S. Preventive Services Task Force changed its recommendation on aspirin for the primary prevention of cardiovascular disease in 2022, recommending against initiating low-dose aspirin for adults aged 60 years or older. For adults aged 40-59 who have a 10% or greater 10-year risk for cardiovascular disease, the agency recommends that patients and clinicians make the decision to initiate low-dose aspirin use on a case-by-case basis, as the net benefit is small.

Dr. McQuilten said she spent the last 5 years designing substages of anemia and conditions such as blood cancer. In many cases of anemia, doctors are unable to determine the underlying cause, she said. One study published in the Journal of American Geriatrics Society in 2021 found that in about one-third of anemia cases, the etiology was not clear.

About 50% of people older than 60 who were involved in the latest study took aspirin for prevention from 2011 to 2018. That number likely dropped after changes were made to the guidelines in 2022, according to Dr. McQuilten, but long-term use may have continued among older patients. The researchers also examined ferritin levels, which serve as a proxy for iron levels, at baseline and after 3 years.

The incidence of anemia was 51 events per 1,000 person-years in the aspirin group compared with 43 events per 1,000 person-years in the placebo group, according to the researchers. The estimated probability of experiencing anemia within 5 years was 23.5% (95% confidence interval [CI], 22.4%-24.6%) in the aspirin group and 20.3% (95% CI: 19.3% to 21.4%) in the placebo group. Aspirin therapy resulted in a 20% increase in the risk for anemia (95% CI, 1.12-1.29).

People who took aspirin were more likely to have lower serum levels of ferritin at the 3-year mark than were those who received placebo. The average decrease in ferritin among participants who took aspirin was 11.5% greater (95% CI, 9.3%-13.7%) than among those who took placebo.

Basil Eldadah, MD, PhD, supervisory medical officer at the National Institute on Aging, part of the National Institutes of Health, said the findings should encourage clinicians to pay closer attention to hemoglobin levels and have conversations with patients to discuss their need for taking aspirin.

“If somebody is already taking aspirin for any reason, keep an eye on hemoglobin,” said Dr. Eldadah, who was not involved in the study. “For somebody who’s taking aspirin and who’s older, and it’s not for an indication like cardiovascular disease, consider seriously whether that’s the best treatment option.”

The study did not examine the functional consequences of anemia on participants, which Dr. Eldadah said could be fodder for future research. The researchers said one limitation was that it was not clear whether anemia was sufficient to cause symptoms that affected participants’ quality of life or whether occult bleeding caused the anemia. The researchers also did not document whether patients saw their regular physicians and received treatment for anemia over the course of the trial.

The study was funded through grants from the National Health and Medical Research Council and the Bill and Melinda Gates Foundation. The authors reported receiving consulting fees, honoraria, and stock options, and have participated on data monitoring boards not related to the study for Vifor Pharma, ITL Biomedical, Pfizer, Boehringer Ingelheim, Bayer Healthcare, AbbVie, and Abbott Diagnostics.

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

Older people who take daily low-dose aspirin have at 20% higher risk of developing anemia even without having already had a major bleeding event, according to results from a new randomized controlled trial.

In the study, which was published in Annals of Internal Medicine, investigators analyzed data from the Aspirin in Reducing Events in the Elderly (ASPREE) trial and examined hemoglobin concentrations among 19,114 healthy, community-dwelling older patients.

“We knew from large clinical trials, including our ASPREE trial, that daily low-dose aspirin increased the risk of clinically significant bleeding,” said Zoe McQuilten, MBBS, PhD, a hematologist at Monash University in Australia and the study’s lead author. “From our study, we found that low-dose aspirin also increased the risk of anemia during the trial, and this was most likely due to bleeding that was not clinically apparent.”

Anemia is common among elderly patients. It can cause fatigue, fast or irregular heartbeat, headache, chest pain, and pounding or whooshing sounds in the ear, according to the Cleveland Clinic. It can also worsen conditions such as heart failure, cognitive impairment, and depression in people aged 65 and older.

The U.S. Preventive Services Task Force changed its recommendation on aspirin for the primary prevention of cardiovascular disease in 2022, recommending against initiating low-dose aspirin for adults aged 60 years or older. For adults aged 40-59 who have a 10% or greater 10-year risk for cardiovascular disease, the agency recommends that patients and clinicians make the decision to initiate low-dose aspirin use on a case-by-case basis, as the net benefit is small.

Dr. McQuilten said she spent the last 5 years designing substages of anemia and conditions such as blood cancer. In many cases of anemia, doctors are unable to determine the underlying cause, she said. One study published in the Journal of American Geriatrics Society in 2021 found that in about one-third of anemia cases, the etiology was not clear.

About 50% of people older than 60 who were involved in the latest study took aspirin for prevention from 2011 to 2018. That number likely dropped after changes were made to the guidelines in 2022, according to Dr. McQuilten, but long-term use may have continued among older patients. The researchers also examined ferritin levels, which serve as a proxy for iron levels, at baseline and after 3 years.

The incidence of anemia was 51 events per 1,000 person-years in the aspirin group compared with 43 events per 1,000 person-years in the placebo group, according to the researchers. The estimated probability of experiencing anemia within 5 years was 23.5% (95% confidence interval [CI], 22.4%-24.6%) in the aspirin group and 20.3% (95% CI: 19.3% to 21.4%) in the placebo group. Aspirin therapy resulted in a 20% increase in the risk for anemia (95% CI, 1.12-1.29).

People who took aspirin were more likely to have lower serum levels of ferritin at the 3-year mark than were those who received placebo. The average decrease in ferritin among participants who took aspirin was 11.5% greater (95% CI, 9.3%-13.7%) than among those who took placebo.

Basil Eldadah, MD, PhD, supervisory medical officer at the National Institute on Aging, part of the National Institutes of Health, said the findings should encourage clinicians to pay closer attention to hemoglobin levels and have conversations with patients to discuss their need for taking aspirin.

“If somebody is already taking aspirin for any reason, keep an eye on hemoglobin,” said Dr. Eldadah, who was not involved in the study. “For somebody who’s taking aspirin and who’s older, and it’s not for an indication like cardiovascular disease, consider seriously whether that’s the best treatment option.”

The study did not examine the functional consequences of anemia on participants, which Dr. Eldadah said could be fodder for future research. The researchers said one limitation was that it was not clear whether anemia was sufficient to cause symptoms that affected participants’ quality of life or whether occult bleeding caused the anemia. The researchers also did not document whether patients saw their regular physicians and received treatment for anemia over the course of the trial.

The study was funded through grants from the National Health and Medical Research Council and the Bill and Melinda Gates Foundation. The authors reported receiving consulting fees, honoraria, and stock options, and have participated on data monitoring boards not related to the study for Vifor Pharma, ITL Biomedical, Pfizer, Boehringer Ingelheim, Bayer Healthcare, AbbVie, and Abbott Diagnostics.

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

Semaglutide and related drugs for weight loss have co-opted bariatric medicine in recent months. They have also raised serious questions for hospital-based clinicians who wonder whether the drugs may pose risks to surgery patients undergoing anesthesia.

Holding Ozempic (semaglutide) before elective surgery – and if so, for how long – remains largely a judgment call at this point. Official guidance on best practices has not yet caught up to surging popularity of this and other glucagon-like peptide-1 (GLP-1) agonists for weight loss.

Ozempic is indicated for treating type 2 diabetes but also is prescribed off-label for weight loss. Other GLP-1 agents from Novo Nordisk, Wegovy (semaglutide) and Saxenda (liraglutide) injections, are Food and Drug Administration–approved for weight loss. These medications work by decreasing hunger and lowering how much people eat. Semaglutide also is available as a once-daily tablet for type 2 diabetes (Rybelsus).

The American Society of Anesthesiologists (ASA) has been working on guidance on the drugs. “It’s a really hot issue now. We are getting emails from our members looking for guidance,” ASA president Michael Champeau, MD, said in an interview.

But despite the interest in how the medications might affect surgery patients and interact with anesthesia, relatively little evidence exists in the literature beyond case studies. So the society is not issuing official recommendations at this point.

“We’re going to just be calling it ‘guidance’ for right now because of the paucity of the scientific literature,” said Dr. Champeau, adjunct clinical professor of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. “It’s probably not going to have words like ‘must; it will probably have words like ‘should’ or ‘should consider.’ “

The ASA guidance could be out in written form soon, Dr. Champeau added.

Meanwhile, whether physicians should advise stopping these medications 24 hours, 48 hours, or up to 2 weeks before surgery remains unknown.

In search of some consensus, John Shields, MD, an orthopedic surgeon at Atrium Health Wake Forest Baptist Davie Medical Center in Bermuda Run, N.C., asked colleagues on #MedTwitter: “Anyone have guidelines for ozempic around time of surgery? – holding med? – how long NPO?”

Because a full stomach can interfere with anesthesia, clinicians often advise people to stop eating and drinking 12-24 hours before elective procedures (NPO). In the case of once-weekly GLP-1 injections, which can slow gastric emptying, the optimal timeframe remains an open question. The main concern is aspiration, where a patient actively vomits while under anesthesia or their stomach contents passively come back up.

Dr. Shields’ Twitter post garnered significant reaction and comments. Within 4 days, the post was retweeted 30 times and received 72 replies and comments. Dr. Shields noted the general consensus was to hold semaglutide for 1-2 weeks before a procedure. Other suggestions included recommending a liquid diet only for 24-48 hours before surgery, recommending an NPO protocol 24-36 hours in advance, or adjusting the weekly injection so the last dose is taken 5-6 days before surgery.

Anesthesiologist Cliff Gevirtz, MD, has encountered only a few surgical patients so far taking a GLP-1 for weight loss. “And thankfully no aspiration,” added Dr. Gevirtz, clinical director of office-based ambulatory anesthesia services at Somnia Anesthesia in Harrison, N.Y.

To minimize risk, some physicians will perform an ultrasound scan to assess the contents of the stomach. If surgery is elective in a patient with a full stomach, the procedure can get postponed. Another option is to proceed with the case but treat the patient as anesthesiologists approach an emergency procedure. To be safe, many will treat the case as if the patient has a full stomach.

Dr. Gevirtz said he would treat the patient as a ‘full stomach’ and perform a rapid sequence induction with cricoid pressure. He would then extubate the patient once laryngeal reflexes return.

A rapid-sequence induction involves giving the medicine that makes a patient go to sleep, giving another medicine that paralyzes them quickly, then inserting a breathing tube – all within about 30 seconds. Cricoid pressure involves pushing on the neck during intubation to try to seal off the top of the esophagus and again minimize the chances of food coming back up.

Giving metoclopramide 30 minutes before surgery is another option, Dr. Gevirtz said. Metoclopramide can hasten the emptying of stomach contents. Administration in advance is important because waiting for the drug to work can prolong time in the operating room.

Is holding semaglutide before surgery a relevant clinical question? “Yes, very much so,” said Ronnie Fass, MD, division director of gastroenterology and hepatology and the medical director of the Digestive Health Center at The MetroHealth System in Cleveland.

Dr. Fass recommended different strategies based on the semaglutide indication. Currently, clinicians at MetroHealth instruct patients to discontinue diabetic medications the day of surgery. For those who take semaglutide for diabetes, and because the medication is taken once a week, “there is growing discussion among surgeons that the medication should not be stopped prior to surgery. This is to ensure that patients’ diabetes is well controlled before and during surgery,” Dr. Fass said.

In patients taking semaglutide for weight loss only, “there is no clear answer at this point,” he said.

Dr. Fass said the question is complicated by the fact that the medication is taken once a week. “It brings up important questions about the use of the medication during surgery, which may increase the likelihood of side effects in general and for certain types of surgery. Personally, if a patient is taking [semaglutide] for weight loss only, I would consider stopping the medication before surgery.”

The ASA was able to act quickly because it already had an expert task force review how long people should fast before surgery last year – before the explosion in popularity of the GLP-1 agonists.

Although it is still a work in progress, Dr. Champeau offered “a peek” at the recommendations. “The guidance is going to look at how far in advance the drugs should be stopped, rather than looking at making people fast even longer” before surgery, he said. “There’s just no data on that latter question.”

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

Semaglutide and related drugs for weight loss have co-opted bariatric medicine in recent months. They have also raised serious questions for hospital-based clinicians who wonder whether the drugs may pose risks to surgery patients undergoing anesthesia.

Holding Ozempic (semaglutide) before elective surgery – and if so, for how long – remains largely a judgment call at this point. Official guidance on best practices has not yet caught up to surging popularity of this and other glucagon-like peptide-1 (GLP-1) agonists for weight loss.

Ozempic is indicated for treating type 2 diabetes but also is prescribed off-label for weight loss. Other GLP-1 agents from Novo Nordisk, Wegovy (semaglutide) and Saxenda (liraglutide) injections, are Food and Drug Administration–approved for weight loss. These medications work by decreasing hunger and lowering how much people eat. Semaglutide also is available as a once-daily tablet for type 2 diabetes (Rybelsus).

The American Society of Anesthesiologists (ASA) has been working on guidance on the drugs. “It’s a really hot issue now. We are getting emails from our members looking for guidance,” ASA president Michael Champeau, MD, said in an interview.

But despite the interest in how the medications might affect surgery patients and interact with anesthesia, relatively little evidence exists in the literature beyond case studies. So the society is not issuing official recommendations at this point.

“We’re going to just be calling it ‘guidance’ for right now because of the paucity of the scientific literature,” said Dr. Champeau, adjunct clinical professor of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. “It’s probably not going to have words like ‘must; it will probably have words like ‘should’ or ‘should consider.’ “

The ASA guidance could be out in written form soon, Dr. Champeau added.

Meanwhile, whether physicians should advise stopping these medications 24 hours, 48 hours, or up to 2 weeks before surgery remains unknown.

In search of some consensus, John Shields, MD, an orthopedic surgeon at Atrium Health Wake Forest Baptist Davie Medical Center in Bermuda Run, N.C., asked colleagues on #MedTwitter: “Anyone have guidelines for ozempic around time of surgery? – holding med? – how long NPO?”

Because a full stomach can interfere with anesthesia, clinicians often advise people to stop eating and drinking 12-24 hours before elective procedures (NPO). In the case of once-weekly GLP-1 injections, which can slow gastric emptying, the optimal timeframe remains an open question. The main concern is aspiration, where a patient actively vomits while under anesthesia or their stomach contents passively come back up.

Dr. Shields’ Twitter post garnered significant reaction and comments. Within 4 days, the post was retweeted 30 times and received 72 replies and comments. Dr. Shields noted the general consensus was to hold semaglutide for 1-2 weeks before a procedure. Other suggestions included recommending a liquid diet only for 24-48 hours before surgery, recommending an NPO protocol 24-36 hours in advance, or adjusting the weekly injection so the last dose is taken 5-6 days before surgery.

Anesthesiologist Cliff Gevirtz, MD, has encountered only a few surgical patients so far taking a GLP-1 for weight loss. “And thankfully no aspiration,” added Dr. Gevirtz, clinical director of office-based ambulatory anesthesia services at Somnia Anesthesia in Harrison, N.Y.

To minimize risk, some physicians will perform an ultrasound scan to assess the contents of the stomach. If surgery is elective in a patient with a full stomach, the procedure can get postponed. Another option is to proceed with the case but treat the patient as anesthesiologists approach an emergency procedure. To be safe, many will treat the case as if the patient has a full stomach.

Dr. Gevirtz said he would treat the patient as a ‘full stomach’ and perform a rapid sequence induction with cricoid pressure. He would then extubate the patient once laryngeal reflexes return.

A rapid-sequence induction involves giving the medicine that makes a patient go to sleep, giving another medicine that paralyzes them quickly, then inserting a breathing tube – all within about 30 seconds. Cricoid pressure involves pushing on the neck during intubation to try to seal off the top of the esophagus and again minimize the chances of food coming back up.

Giving metoclopramide 30 minutes before surgery is another option, Dr. Gevirtz said. Metoclopramide can hasten the emptying of stomach contents. Administration in advance is important because waiting for the drug to work can prolong time in the operating room.

Is holding semaglutide before surgery a relevant clinical question? “Yes, very much so,” said Ronnie Fass, MD, division director of gastroenterology and hepatology and the medical director of the Digestive Health Center at The MetroHealth System in Cleveland.

Dr. Fass recommended different strategies based on the semaglutide indication. Currently, clinicians at MetroHealth instruct patients to discontinue diabetic medications the day of surgery. For those who take semaglutide for diabetes, and because the medication is taken once a week, “there is growing discussion among surgeons that the medication should not be stopped prior to surgery. This is to ensure that patients’ diabetes is well controlled before and during surgery,” Dr. Fass said.

In patients taking semaglutide for weight loss only, “there is no clear answer at this point,” he said.

Dr. Fass said the question is complicated by the fact that the medication is taken once a week. “It brings up important questions about the use of the medication during surgery, which may increase the likelihood of side effects in general and for certain types of surgery. Personally, if a patient is taking [semaglutide] for weight loss only, I would consider stopping the medication before surgery.”

The ASA was able to act quickly because it already had an expert task force review how long people should fast before surgery last year – before the explosion in popularity of the GLP-1 agonists.

Although it is still a work in progress, Dr. Champeau offered “a peek” at the recommendations. “The guidance is going to look at how far in advance the drugs should be stopped, rather than looking at making people fast even longer” before surgery, he said. “There’s just no data on that latter question.”

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

Semaglutide and related drugs for weight loss have co-opted bariatric medicine in recent months. They have also raised serious questions for hospital-based clinicians who wonder whether the drugs may pose risks to surgery patients undergoing anesthesia.

Holding Ozempic (semaglutide) before elective surgery – and if so, for how long – remains largely a judgment call at this point. Official guidance on best practices has not yet caught up to surging popularity of this and other glucagon-like peptide-1 (GLP-1) agonists for weight loss.

Ozempic is indicated for treating type 2 diabetes but also is prescribed off-label for weight loss. Other GLP-1 agents from Novo Nordisk, Wegovy (semaglutide) and Saxenda (liraglutide) injections, are Food and Drug Administration–approved for weight loss. These medications work by decreasing hunger and lowering how much people eat. Semaglutide also is available as a once-daily tablet for type 2 diabetes (Rybelsus).

The American Society of Anesthesiologists (ASA) has been working on guidance on the drugs. “It’s a really hot issue now. We are getting emails from our members looking for guidance,” ASA president Michael Champeau, MD, said in an interview.

But despite the interest in how the medications might affect surgery patients and interact with anesthesia, relatively little evidence exists in the literature beyond case studies. So the society is not issuing official recommendations at this point.

“We’re going to just be calling it ‘guidance’ for right now because of the paucity of the scientific literature,” said Dr. Champeau, adjunct clinical professor of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. “It’s probably not going to have words like ‘must; it will probably have words like ‘should’ or ‘should consider.’ “

The ASA guidance could be out in written form soon, Dr. Champeau added.

Meanwhile, whether physicians should advise stopping these medications 24 hours, 48 hours, or up to 2 weeks before surgery remains unknown.

In search of some consensus, John Shields, MD, an orthopedic surgeon at Atrium Health Wake Forest Baptist Davie Medical Center in Bermuda Run, N.C., asked colleagues on #MedTwitter: “Anyone have guidelines for ozempic around time of surgery? – holding med? – how long NPO?”

Because a full stomach can interfere with anesthesia, clinicians often advise people to stop eating and drinking 12-24 hours before elective procedures (NPO). In the case of once-weekly GLP-1 injections, which can slow gastric emptying, the optimal timeframe remains an open question. The main concern is aspiration, where a patient actively vomits while under anesthesia or their stomach contents passively come back up.

Dr. Shields’ Twitter post garnered significant reaction and comments. Within 4 days, the post was retweeted 30 times and received 72 replies and comments. Dr. Shields noted the general consensus was to hold semaglutide for 1-2 weeks before a procedure. Other suggestions included recommending a liquid diet only for 24-48 hours before surgery, recommending an NPO protocol 24-36 hours in advance, or adjusting the weekly injection so the last dose is taken 5-6 days before surgery.

Anesthesiologist Cliff Gevirtz, MD, has encountered only a few surgical patients so far taking a GLP-1 for weight loss. “And thankfully no aspiration,” added Dr. Gevirtz, clinical director of office-based ambulatory anesthesia services at Somnia Anesthesia in Harrison, N.Y.

To minimize risk, some physicians will perform an ultrasound scan to assess the contents of the stomach. If surgery is elective in a patient with a full stomach, the procedure can get postponed. Another option is to proceed with the case but treat the patient as anesthesiologists approach an emergency procedure. To be safe, many will treat the case as if the patient has a full stomach.

Dr. Gevirtz said he would treat the patient as a ‘full stomach’ and perform a rapid sequence induction with cricoid pressure. He would then extubate the patient once laryngeal reflexes return.

A rapid-sequence induction involves giving the medicine that makes a patient go to sleep, giving another medicine that paralyzes them quickly, then inserting a breathing tube – all within about 30 seconds. Cricoid pressure involves pushing on the neck during intubation to try to seal off the top of the esophagus and again minimize the chances of food coming back up.

Giving metoclopramide 30 minutes before surgery is another option, Dr. Gevirtz said. Metoclopramide can hasten the emptying of stomach contents. Administration in advance is important because waiting for the drug to work can prolong time in the operating room.

Is holding semaglutide before surgery a relevant clinical question? “Yes, very much so,” said Ronnie Fass, MD, division director of gastroenterology and hepatology and the medical director of the Digestive Health Center at The MetroHealth System in Cleveland.

Dr. Fass recommended different strategies based on the semaglutide indication. Currently, clinicians at MetroHealth instruct patients to discontinue diabetic medications the day of surgery. For those who take semaglutide for diabetes, and because the medication is taken once a week, “there is growing discussion among surgeons that the medication should not be stopped prior to surgery. This is to ensure that patients’ diabetes is well controlled before and during surgery,” Dr. Fass said.

In patients taking semaglutide for weight loss only, “there is no clear answer at this point,” he said.

Dr. Fass said the question is complicated by the fact that the medication is taken once a week. “It brings up important questions about the use of the medication during surgery, which may increase the likelihood of side effects in general and for certain types of surgery. Personally, if a patient is taking [semaglutide] for weight loss only, I would consider stopping the medication before surgery.”

The ASA was able to act quickly because it already had an expert task force review how long people should fast before surgery last year – before the explosion in popularity of the GLP-1 agonists.

Although it is still a work in progress, Dr. Champeau offered “a peek” at the recommendations. “The guidance is going to look at how far in advance the drugs should be stopped, rather than looking at making people fast even longer” before surgery, he said. “There’s just no data on that latter question.”

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

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

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

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

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

Two Boston doctors associated with Salem Hospital, a clinical affiliate of Massachusetts General Hospital, must pay nearly $29 million to the family of a man whose aortic aneurysm and dissection went undiagnosed and untreated, according to a story posted on Boston.com, among other news sites.

On the morning of Jan. 13, 2018, Joseph Brown awoke with shortness of breath and upper abdominal pain, which eventually spread to his chest and back. Taken to Salem Hospital’s emergency department, Mr. Brown was seen by Steven D. Browell, MD, an emergency medicine specialist.

Dr. Browell ordered tests that ruled out both a heart attack and a pulmonary embolism. He called for a blood test, which indicated that the patient’s white blood count was elevated. Suspecting an infection, Dr. Browell ordered that Mr. Brown be admitted to the hospital.

Accepting Mr. Brown’s admission was William D. Kenyon, MD, a hospitalist, who also examined the patient and concurred with Dr. Browell’s probable diagnosis. The patient was then sent to the medical floor.

There he underwent additional testing, including a chest x-ray, which proved negative except for one finding: a “mild hazy interstitial opacity that could represent a small airway inflammation or developing/early pneumonia.” Because Mr. Brown had reported that he had punctured his foot several days earlier, he also underwent a foot x-ray, which showed a possible foreign body. It was thought that might be the source of his infection.

Neither Dr. Browell nor Dr. Kenyon had completely ruled out a possible aortic aneurysm and dissection. Mr. Brown’s symptoms, after all, were in some ways suggestive of those conditions. Then again, he was very young – only 43 at the time – and his pain, while severe, didn’t correspond to the “searing” pain that, at trial, Dr. Kenyon described as typical of an aneurysm and dissection. As the hospitalist testified at trial, Mr. Brown had “a constellation of nonspecific symptoms” and an “unusual presentation of a rare condition,” typically seen in patients aged 65 and older.

Given these factors – and the results of Mr. Brown’s tests, lab studies, and physical exam – Dr. Kenyon didn’t think that the case warranted a CT scan to rule out an aortic aneurysm or aortic dissection.

By early the next morning, though, Mr. Brown’s shortness of breath and pain had intensified significantly. The on-duty doctor ordered a CT scan, which showed “a massive aneurysm at the beginning of [the patient’s] aorta and a dissection extending through most of his aorta.”

Mr. Brown was flown to Boston to undergo emergency surgery. En route to the helicopter, his aorta ruptured, stopping his heart and causing his death.

During the 8-day trial, each side introduced expert witnesses. Speaking for the plaintiffs, experts in cardiothoracic surgery and emergency medicine testified that the treating physicians were negligent in failing to order a CT scan on Jan. 13. Had they done so, the patient would have almost certainly undergone surgery earlier, which would have prevented his death.

Experts for the defense saw things differently. They testified that, given the evidence, it was reasonable and appropriate for Dr. Browell and Dr. Kenyon to have treated their patient for an infection rather than an aneurysm or dissection.

The jury found the defense’s arguments unconvincing, however. After deliberating 3 hours, it awarded the plaintiffs $20,000,000, to be paid out over time largely to Mr. Brown’s two daughters, who were aged 12 and 18 when he died. Including interest, the total award is close to $29 million.

In a statement following the verdict, lead plaintiff’s attorney Robert M. Higgins, of Lubin & Meyer, Boston, said the takeaway from the case was: “If you just treat people based on what the likelihood is, statistically, you’re going to miss a lot of life-threatening conditions. And that’s what happened in this case.”
 

Urologists typically prevail in BPH suits

Malpractice claims following surgery for benign prostatic hyperplasia (BPH) tend to be limited in scope and are typically resolved in favor of the surgeon-defendant, as a study in The Cureus Journal of Medical Science makes clear.

The study – conducted by a team of researchers that included Joao G. Porto, MD, of the Desai Sethi Urology Institute, University of Miami – investigated whether such surgeries pose a significant malpractice risk for urologists.

With information gleaned from two well-known legal databases, the team used a variety of key terms to identify BPH-related claims from January 2000 to December 2021.

Within this universe of claims, researchers identified several significant trends:

• Among BPH-related procedures, transurethral resection of the prostate was the most frequently identified (37%);
• Among the most-often cited reasons cited for a claim, allegations of inadequate postoperative care were the most common (33%);
• Of possible postsurgical complications, those that led to the greatest number of suits were urinary incontinence (23%), erectile dysfunction (13%), and urinary retention (13%); and,
• Not unexpectedly, the specialist most frequently named in a suit was a urologist (57%).

Interestingly, in all but two of the claims, the verdict favored the doctor-defendant. In the two cases in which the plaintiff prevailed, each involved unexpected and serious postsurgical complications.

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