What characteristics or symptoms do you look for to identify patients who are at risk for exocrine pancreatic insufficiency (EPI)?

Dr. Barkin: The first thing we have to understand is which patient populations we should consider. EPI traditionally has been a disease associated with chronic pancreatitis, and that still makes up the majority of patients. But in addition to those with chronic pancreatitis, we have to think about patients who have had severe acute pancreatitis and who may have had loss of functional pancreatic parenchyma or pancreatic surgery, as well as patients with pancreatic cancer that may cause both ductal obstruction and parenchyma loss.

This might also include patients with foregut surgery who may develop postcibal dyskinesia, meaning they do not get appropriate mixing of the gastric chyme and food contents with the pancreatic enzymes and pancreatic juice in the duodenum. For example, this might be evident in patients who have had a Roux-en-Y gastric bypass, or in patients with untreated celiac disease, who do not get stimulation for pancreatic secretion based on the amount of small bowel mucosal damage.

A series of other conditions may present with EPI, such as inflammatory bowel disease, although these make up the minority of cases. When we think about symptoms, the end symptom of EPI from fat malabsorption is gross steatorrhea. Unfortunately, by the time the patient gets to that point, the cat is out of the bag—especially in patients with chronic pancreatitis. So, we want to try to identify these patients earlier.

Realistically, a series of symptoms can be seen far earlier than gross steatorrhea. In fact, most patients will present with symptoms like increased stool frequency or decreased stool consistency in their daily life. Some abdominal discomfort or bloating may be seen that is associated with maldigestion of  food, among other factors.

In some patients, night vision changes from fat-soluble vitamin deficiencies may be the first or an early presenting symptom if they have other conditions masking their diarrheal symptoms. Patients who do not feel well when they are eating or feel uncomfortable after they eat may avoid certain types of foods. You may see weight loss in these populations because they are avoiding foods, feeling sitophobia, or not appropriately digesting their food.

Unfortunately, even before we see clinically relevant symptoms, we may see micronutrient deficiencies and fat-soluble vitamin deficiencies. That is why it is so important, for example, in the chronic pancreatitis population, to screen these patients on a regular basis for the presence of EPI, whether with symptom questionnaires or by testing.

Can you expand on some of the risk factors and the importance of screening, particularly for malnutrition?

Dr. Barkin: The risk factors usually involve patients who have had some kind of damage to the gland. For example, many patients with cystic fibrosis are actually exocrine pancreatic insufficient from early in life to diagnosis. They have loss of the gland and loss of function at the gland.

Our patients with chronic pancreatitis, who may have had either recurrent acute pancreatitis or chronic pancreatitis for a variety of reasons, are screened for EPI on a regular basis. That may mean that you ask them a symptom questionnaire at each clinic visit and check a fecal elastase level on a regular basis. It is not just the symptoms that we have to worry about; we have to think about the effects of maldigestion on a patient’s weight and nutritional status and the impact of micronutrient deficiencies.

A series of new studies has looked at the impact of exocrine insufficiency. For example, a study from Spain found an increased risk of all-cause mortality with exocrine insufficiency. When we think about metabolic bone disease in this population with exocrine insufficiency, we see that there is decreased bone density and increased risk of pathologic low-trauma fractures. For example, the patient who has fallen from a standing position at home and suddenly has a hip fracture has substantial morbidity and mortality associated with that fracture. The decreases in bone density and increased risk of fracture are reversed when we identify EPI and treat it appropriately.

What is your approach to diagnosing EPI?

Dr. Barkin: For a patient who walks in the door with an obvious diagnosis or prior diagnosis of chronic pancreatitis, it is relatively easy to ask them a series of questions about whether they have symptoms that may be associated with EPI. So, first, I ask them about their bowel habits and stool frequency and consistency.

A couple of years ago, we showed that if you treat a patient with EPI using pancreatic enzyme replacement therapy, their stool consistency and frequency are the two reliable markers that get better. They not only get better, but these improvements directly correlate with objective stool markers of improvement in fat maldigestion.

Obviously, we want improvement in other symptoms—abdominal discomfort, bloating, etc.—but I have to set very realistic expectations for patients. Along with stool frequency and consistency, there should be subsequent improvement of steatorrhea. I talk to them about the importance of taking a multivitamin to prevent those micronutrient deficiencies. We check for micronutrient deficiencies and fat-soluble vitamin deficiencies routinely.

Patients who do not have obvious chronic pancreatitis who get diagnosed with EPI are a little bit harder to parse out. I want to make sure that they do not have celiac disease, or that they do not have a concomitant mimicking symptom that may result in, for example, a low fecal elastase level. I also check for small intestinal bacterial overgrowth (SIBO) as a mimicking condition.

Regarding fecal elastase testing, the gold standard for diagnosis of EPI was historically a 72-hour fecal fat collection on a standardized-fat-intake diet. That required patient confinement in the hospital. It is cumbersome, not widely available, and not realistic in practice.

In some centers, endoscopic pancreatic function testing, secretin-enhanced magnetic resonance cholangiopancreatography (MRCP), or breath testing, as is done in Europe, may be options to help diagnose EPI, but these tests are not widely available. Unfortunately, we do not have a great diagnostic test for exocrine insufficiency. As a result, we use fecal elastase level. If you have a patient who has a high pretest probability of having EPI, it is a relatively good test. If they have a low pretest probability, then a series of false-positive test results may occur in this patient population. That means they may not actually have exocrine insufficiency.

If a diarrheal stool is submitted for testing, a false-positive fecal elastase test may result. That is really key, because I see a number of patients with potentially functional diarrheal symptoms who also have low fecal elastase levels. As a result, they have been labeled as exocrine insufficient when, in fact, they may not actually have the disease, which is why it is so important to understand and think about that.

How do you choose the appropriate approach to managing EPI, and how do you consider the impact it has on the quality of life overall?

Dr. Barkin: There are two key points. The treatment for EPI is not to tell your patient to not eat fat and hope that it gets better. Rather, it is appropriate supplementation of pancreatic enzymes. This is done with pancreatic enzyme replacement therapy. A few FDA-approved medications are on the market. I recommend against the ones that have been labeled as pancreatic enzyme digestive aids that are available online. Those are not pancreatic enzymes; a regulatory push about 15 to 20 years ago got these digestive aids appropriately regulated.

The FDA-approved medications are dosed at approximately 40,000 to 50,000 lipase units per meal to start, according to the guidelines. Some of us may prescribe higher doses than that to start. These are taken with meals and about a half-dose with snacks.

If you have a patient who is taking, for example, two pills per meal or two capsules per meal, it is important that they take one at the very beginning of the meal and one about halfway through the meal. The pills should not be taken a half hour before or a half hour after the meal. The goal is to simulate normal pancreatic function as much as possible to get the food contents mixing.

The pancreatic enzymes come in a coated version that does not require coadministration with proton pump inhibitors or an uncoated version that does require coadministration of proton pump inhibitors to prevent degradation by gastric acid. Patients need to understand that, although they may take a large number of pills per day, adhering to this regimen is important, not only for treating their symptoms, but also for combating long-term morbidity and mortality.

I use the symptomatic response to assess response to therapy because, as discussed, there is a direct correlation between improvements in stool frequency and consistency and objective markers of response to therapy.

If a patient is not responding, we first check to make sure that there are no adherence issues and that they are able to access therapy, because sometimes there are issues with cost or insurance approvals. Second, I make sure that patients are taking it correctly, and that they understand the difference between a meal and a snack. For example, if somebody says, “Oh, I just had a small cheeseburger and that's my snack,” that is actually a meal and may require more enzymes. Once we ensure that those are not issues, I make sure again, as part of my approach, that there are no comorbid conditions that may be driving some of the symptoms, such as celiac disease or SIBO, with SIBO being very common in this population.

Then we have to decide whether we need to change the dose. Do we need to increase the dose? Some of us start a little bit higher than the 40,000 to 50,000 units of lipase per meal, as suggested in some of our national and international guidelines, and go from there.

What characteristics or symptoms do you look for to identify patients who are at risk for exocrine pancreatic insufficiency (EPI)?

Dr. Barkin: The first thing we have to understand is which patient populations we should consider. EPI traditionally has been a disease associated with chronic pancreatitis, and that still makes up the majority of patients. But in addition to those with chronic pancreatitis, we have to think about patients who have had severe acute pancreatitis and who may have had loss of functional pancreatic parenchyma or pancreatic surgery, as well as patients with pancreatic cancer that may cause both ductal obstruction and parenchyma loss.

This might also include patients with foregut surgery who may develop postcibal dyskinesia, meaning they do not get appropriate mixing of the gastric chyme and food contents with the pancreatic enzymes and pancreatic juice in the duodenum. For example, this might be evident in patients who have had a Roux-en-Y gastric bypass, or in patients with untreated celiac disease, who do not get stimulation for pancreatic secretion based on the amount of small bowel mucosal damage.

A series of other conditions may present with EPI, such as inflammatory bowel disease, although these make up the minority of cases. When we think about symptoms, the end symptom of EPI from fat malabsorption is gross steatorrhea. Unfortunately, by the time the patient gets to that point, the cat is out of the bag—especially in patients with chronic pancreatitis. So, we want to try to identify these patients earlier.

Realistically, a series of symptoms can be seen far earlier than gross steatorrhea. In fact, most patients will present with symptoms like increased stool frequency or decreased stool consistency in their daily life. Some abdominal discomfort or bloating may be seen that is associated with maldigestion of  food, among other factors.

In some patients, night vision changes from fat-soluble vitamin deficiencies may be the first or an early presenting symptom if they have other conditions masking their diarrheal symptoms. Patients who do not feel well when they are eating or feel uncomfortable after they eat may avoid certain types of foods. You may see weight loss in these populations because they are avoiding foods, feeling sitophobia, or not appropriately digesting their food.

Unfortunately, even before we see clinically relevant symptoms, we may see micronutrient deficiencies and fat-soluble vitamin deficiencies. That is why it is so important, for example, in the chronic pancreatitis population, to screen these patients on a regular basis for the presence of EPI, whether with symptom questionnaires or by testing.

Can you expand on some of the risk factors and the importance of screening, particularly for malnutrition?

Dr. Barkin: The risk factors usually involve patients who have had some kind of damage to the gland. For example, many patients with cystic fibrosis are actually exocrine pancreatic insufficient from early in life to diagnosis. They have loss of the gland and loss of function at the gland.

Our patients with chronic pancreatitis, who may have had either recurrent acute pancreatitis or chronic pancreatitis for a variety of reasons, are screened for EPI on a regular basis. That may mean that you ask them a symptom questionnaire at each clinic visit and check a fecal elastase level on a regular basis. It is not just the symptoms that we have to worry about; we have to think about the effects of maldigestion on a patient’s weight and nutritional status and the impact of micronutrient deficiencies.

A series of new studies has looked at the impact of exocrine insufficiency. For example, a study from Spain found an increased risk of all-cause mortality with exocrine insufficiency. When we think about metabolic bone disease in this population with exocrine insufficiency, we see that there is decreased bone density and increased risk of pathologic low-trauma fractures. For example, the patient who has fallen from a standing position at home and suddenly has a hip fracture has substantial morbidity and mortality associated with that fracture. The decreases in bone density and increased risk of fracture are reversed when we identify EPI and treat it appropriately.

What is your approach to diagnosing EPI?

Dr. Barkin: For a patient who walks in the door with an obvious diagnosis or prior diagnosis of chronic pancreatitis, it is relatively easy to ask them a series of questions about whether they have symptoms that may be associated with EPI. So, first, I ask them about their bowel habits and stool frequency and consistency.

A couple of years ago, we showed that if you treat a patient with EPI using pancreatic enzyme replacement therapy, their stool consistency and frequency are the two reliable markers that get better. They not only get better, but these improvements directly correlate with objective stool markers of improvement in fat maldigestion.

Obviously, we want improvement in other symptoms—abdominal discomfort, bloating, etc.—but I have to set very realistic expectations for patients. Along with stool frequency and consistency, there should be subsequent improvement of steatorrhea. I talk to them about the importance of taking a multivitamin to prevent those micronutrient deficiencies. We check for micronutrient deficiencies and fat-soluble vitamin deficiencies routinely.

Patients who do not have obvious chronic pancreatitis who get diagnosed with EPI are a little bit harder to parse out. I want to make sure that they do not have celiac disease, or that they do not have a concomitant mimicking symptom that may result in, for example, a low fecal elastase level. I also check for small intestinal bacterial overgrowth (SIBO) as a mimicking condition.

Regarding fecal elastase testing, the gold standard for diagnosis of EPI was historically a 72-hour fecal fat collection on a standardized-fat-intake diet. That required patient confinement in the hospital. It is cumbersome, not widely available, and not realistic in practice.

In some centers, endoscopic pancreatic function testing, secretin-enhanced magnetic resonance cholangiopancreatography (MRCP), or breath testing, as is done in Europe, may be options to help diagnose EPI, but these tests are not widely available. Unfortunately, we do not have a great diagnostic test for exocrine insufficiency. As a result, we use fecal elastase level. If you have a patient who has a high pretest probability of having EPI, it is a relatively good test. If they have a low pretest probability, then a series of false-positive test results may occur in this patient population. That means they may not actually have exocrine insufficiency.

If a diarrheal stool is submitted for testing, a false-positive fecal elastase test may result. That is really key, because I see a number of patients with potentially functional diarrheal symptoms who also have low fecal elastase levels. As a result, they have been labeled as exocrine insufficient when, in fact, they may not actually have the disease, which is why it is so important to understand and think about that.

How do you choose the appropriate approach to managing EPI, and how do you consider the impact it has on the quality of life overall?

Dr. Barkin: There are two key points. The treatment for EPI is not to tell your patient to not eat fat and hope that it gets better. Rather, it is appropriate supplementation of pancreatic enzymes. This is done with pancreatic enzyme replacement therapy. A few FDA-approved medications are on the market. I recommend against the ones that have been labeled as pancreatic enzyme digestive aids that are available online. Those are not pancreatic enzymes; a regulatory push about 15 to 20 years ago got these digestive aids appropriately regulated.

The FDA-approved medications are dosed at approximately 40,000 to 50,000 lipase units per meal to start, according to the guidelines. Some of us may prescribe higher doses than that to start. These are taken with meals and about a half-dose with snacks.

If you have a patient who is taking, for example, two pills per meal or two capsules per meal, it is important that they take one at the very beginning of the meal and one about halfway through the meal. The pills should not be taken a half hour before or a half hour after the meal. The goal is to simulate normal pancreatic function as much as possible to get the food contents mixing.

The pancreatic enzymes come in a coated version that does not require coadministration with proton pump inhibitors or an uncoated version that does require coadministration of proton pump inhibitors to prevent degradation by gastric acid. Patients need to understand that, although they may take a large number of pills per day, adhering to this regimen is important, not only for treating their symptoms, but also for combating long-term morbidity and mortality.

I use the symptomatic response to assess response to therapy because, as discussed, there is a direct correlation between improvements in stool frequency and consistency and objective markers of response to therapy.

If a patient is not responding, we first check to make sure that there are no adherence issues and that they are able to access therapy, because sometimes there are issues with cost or insurance approvals. Second, I make sure that patients are taking it correctly, and that they understand the difference between a meal and a snack. For example, if somebody says, “Oh, I just had a small cheeseburger and that's my snack,” that is actually a meal and may require more enzymes. Once we ensure that those are not issues, I make sure again, as part of my approach, that there are no comorbid conditions that may be driving some of the symptoms, such as celiac disease or SIBO, with SIBO being very common in this population.

Then we have to decide whether we need to change the dose. Do we need to increase the dose? Some of us start a little bit higher than the 40,000 to 50,000 units of lipase per meal, as suggested in some of our national and international guidelines, and go from there.

What characteristics or symptoms do you look for to identify patients who are at risk for exocrine pancreatic insufficiency (EPI)?

Dr. Barkin: The first thing we have to understand is which patient populations we should consider. EPI traditionally has been a disease associated with chronic pancreatitis, and that still makes up the majority of patients. But in addition to those with chronic pancreatitis, we have to think about patients who have had severe acute pancreatitis and who may have had loss of functional pancreatic parenchyma or pancreatic surgery, as well as patients with pancreatic cancer that may cause both ductal obstruction and parenchyma loss.

This might also include patients with foregut surgery who may develop postcibal dyskinesia, meaning they do not get appropriate mixing of the gastric chyme and food contents with the pancreatic enzymes and pancreatic juice in the duodenum. For example, this might be evident in patients who have had a Roux-en-Y gastric bypass, or in patients with untreated celiac disease, who do not get stimulation for pancreatic secretion based on the amount of small bowel mucosal damage.

A series of other conditions may present with EPI, such as inflammatory bowel disease, although these make up the minority of cases. When we think about symptoms, the end symptom of EPI from fat malabsorption is gross steatorrhea. Unfortunately, by the time the patient gets to that point, the cat is out of the bag—especially in patients with chronic pancreatitis. So, we want to try to identify these patients earlier.

Realistically, a series of symptoms can be seen far earlier than gross steatorrhea. In fact, most patients will present with symptoms like increased stool frequency or decreased stool consistency in their daily life. Some abdominal discomfort or bloating may be seen that is associated with maldigestion of  food, among other factors.

In some patients, night vision changes from fat-soluble vitamin deficiencies may be the first or an early presenting symptom if they have other conditions masking their diarrheal symptoms. Patients who do not feel well when they are eating or feel uncomfortable after they eat may avoid certain types of foods. You may see weight loss in these populations because they are avoiding foods, feeling sitophobia, or not appropriately digesting their food.

Unfortunately, even before we see clinically relevant symptoms, we may see micronutrient deficiencies and fat-soluble vitamin deficiencies. That is why it is so important, for example, in the chronic pancreatitis population, to screen these patients on a regular basis for the presence of EPI, whether with symptom questionnaires or by testing.

Can you expand on some of the risk factors and the importance of screening, particularly for malnutrition?

Dr. Barkin: The risk factors usually involve patients who have had some kind of damage to the gland. For example, many patients with cystic fibrosis are actually exocrine pancreatic insufficient from early in life to diagnosis. They have loss of the gland and loss of function at the gland.

Our patients with chronic pancreatitis, who may have had either recurrent acute pancreatitis or chronic pancreatitis for a variety of reasons, are screened for EPI on a regular basis. That may mean that you ask them a symptom questionnaire at each clinic visit and check a fecal elastase level on a regular basis. It is not just the symptoms that we have to worry about; we have to think about the effects of maldigestion on a patient’s weight and nutritional status and the impact of micronutrient deficiencies.

A series of new studies has looked at the impact of exocrine insufficiency. For example, a study from Spain found an increased risk of all-cause mortality with exocrine insufficiency. When we think about metabolic bone disease in this population with exocrine insufficiency, we see that there is decreased bone density and increased risk of pathologic low-trauma fractures. For example, the patient who has fallen from a standing position at home and suddenly has a hip fracture has substantial morbidity and mortality associated with that fracture. The decreases in bone density and increased risk of fracture are reversed when we identify EPI and treat it appropriately.

What is your approach to diagnosing EPI?

Dr. Barkin: For a patient who walks in the door with an obvious diagnosis or prior diagnosis of chronic pancreatitis, it is relatively easy to ask them a series of questions about whether they have symptoms that may be associated with EPI. So, first, I ask them about their bowel habits and stool frequency and consistency.

A couple of years ago, we showed that if you treat a patient with EPI using pancreatic enzyme replacement therapy, their stool consistency and frequency are the two reliable markers that get better. They not only get better, but these improvements directly correlate with objective stool markers of improvement in fat maldigestion.

Obviously, we want improvement in other symptoms—abdominal discomfort, bloating, etc.—but I have to set very realistic expectations for patients. Along with stool frequency and consistency, there should be subsequent improvement of steatorrhea. I talk to them about the importance of taking a multivitamin to prevent those micronutrient deficiencies. We check for micronutrient deficiencies and fat-soluble vitamin deficiencies routinely.

Patients who do not have obvious chronic pancreatitis who get diagnosed with EPI are a little bit harder to parse out. I want to make sure that they do not have celiac disease, or that they do not have a concomitant mimicking symptom that may result in, for example, a low fecal elastase level. I also check for small intestinal bacterial overgrowth (SIBO) as a mimicking condition.

Regarding fecal elastase testing, the gold standard for diagnosis of EPI was historically a 72-hour fecal fat collection on a standardized-fat-intake diet. That required patient confinement in the hospital. It is cumbersome, not widely available, and not realistic in practice.

In some centers, endoscopic pancreatic function testing, secretin-enhanced magnetic resonance cholangiopancreatography (MRCP), or breath testing, as is done in Europe, may be options to help diagnose EPI, but these tests are not widely available. Unfortunately, we do not have a great diagnostic test for exocrine insufficiency. As a result, we use fecal elastase level. If you have a patient who has a high pretest probability of having EPI, it is a relatively good test. If they have a low pretest probability, then a series of false-positive test results may occur in this patient population. That means they may not actually have exocrine insufficiency.

If a diarrheal stool is submitted for testing, a false-positive fecal elastase test may result. That is really key, because I see a number of patients with potentially functional diarrheal symptoms who also have low fecal elastase levels. As a result, they have been labeled as exocrine insufficient when, in fact, they may not actually have the disease, which is why it is so important to understand and think about that.

How do you choose the appropriate approach to managing EPI, and how do you consider the impact it has on the quality of life overall?

Dr. Barkin: There are two key points. The treatment for EPI is not to tell your patient to not eat fat and hope that it gets better. Rather, it is appropriate supplementation of pancreatic enzymes. This is done with pancreatic enzyme replacement therapy. A few FDA-approved medications are on the market. I recommend against the ones that have been labeled as pancreatic enzyme digestive aids that are available online. Those are not pancreatic enzymes; a regulatory push about 15 to 20 years ago got these digestive aids appropriately regulated.

The FDA-approved medications are dosed at approximately 40,000 to 50,000 lipase units per meal to start, according to the guidelines. Some of us may prescribe higher doses than that to start. These are taken with meals and about a half-dose with snacks.

If you have a patient who is taking, for example, two pills per meal or two capsules per meal, it is important that they take one at the very beginning of the meal and one about halfway through the meal. The pills should not be taken a half hour before or a half hour after the meal. The goal is to simulate normal pancreatic function as much as possible to get the food contents mixing.

The pancreatic enzymes come in a coated version that does not require coadministration with proton pump inhibitors or an uncoated version that does require coadministration of proton pump inhibitors to prevent degradation by gastric acid. Patients need to understand that, although they may take a large number of pills per day, adhering to this regimen is important, not only for treating their symptoms, but also for combating long-term morbidity and mortality.

I use the symptomatic response to assess response to therapy because, as discussed, there is a direct correlation between improvements in stool frequency and consistency and objective markers of response to therapy.

If a patient is not responding, we first check to make sure that there are no adherence issues and that they are able to access therapy, because sometimes there are issues with cost or insurance approvals. Second, I make sure that patients are taking it correctly, and that they understand the difference between a meal and a snack. For example, if somebody says, “Oh, I just had a small cheeseburger and that's my snack,” that is actually a meal and may require more enzymes. Once we ensure that those are not issues, I make sure again, as part of my approach, that there are no comorbid conditions that may be driving some of the symptoms, such as celiac disease or SIBO, with SIBO being very common in this population.

Then we have to decide whether we need to change the dose. Do we need to increase the dose? Some of us start a little bit higher than the 40,000 to 50,000 units of lipase per meal, as suggested in some of our national and international guidelines, and go from there.

Patients with chronic obstructive pulmonary disease (COPD) typically have emphysema, which involves destruction of alveoli and reduction of elasticity leading to airflow obstruction, air trapping, and hyperinflation. Over time, these changes cause low respiratory reserve volume and increased residual volume, which cause dyspnea.  

One of the newest treatment options for patients who have advanced COPD with severe emphysema is a minimally invasive procedure called bronchoscopic lung volume reduction (BLVR). Most recently, the FDA approved the use of endobronchial valves for this procedure, which are implanted in the airways of the lungs to reduce air trapping and hyperinflation. 

In certain patients, BLVR has been shown to improve lung function, facilitate easier breathing, enhance exercise tolerance, and lead to better quality of life. 

In this ReCAP, Dr. Javier Diaz-Mendoza, program director of the Interventional Pulmonology Fellowship at Henry Ford Health System in Detroit, discusses the benefits of BLVR in patients who have advanced COPD with emphysema. He discusses the procedure, patient outcomes, and which patients should be considered for BLVR.  

--

Associate Professor of Medicine, Henry Ford Hospital, Wayne State University; Program Director, Interventional Pulmonology Fellowship, Henry Ford Health System, Detroit, MI

Javier Diaz-Mendoza, MD, FCCP, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Ion Intuitive Serve(d) as a speaker or a member of a speakers bureau for: Association of Interventional Pulmonology Program Directors

Patients with chronic obstructive pulmonary disease (COPD) typically have emphysema, which involves destruction of alveoli and reduction of elasticity leading to airflow obstruction, air trapping, and hyperinflation. Over time, these changes cause low respiratory reserve volume and increased residual volume, which cause dyspnea.  

One of the newest treatment options for patients who have advanced COPD with severe emphysema is a minimally invasive procedure called bronchoscopic lung volume reduction (BLVR). Most recently, the FDA approved the use of endobronchial valves for this procedure, which are implanted in the airways of the lungs to reduce air trapping and hyperinflation. 

In certain patients, BLVR has been shown to improve lung function, facilitate easier breathing, enhance exercise tolerance, and lead to better quality of life. 

In this ReCAP, Dr. Javier Diaz-Mendoza, program director of the Interventional Pulmonology Fellowship at Henry Ford Health System in Detroit, discusses the benefits of BLVR in patients who have advanced COPD with emphysema. He discusses the procedure, patient outcomes, and which patients should be considered for BLVR.  

--

Associate Professor of Medicine, Henry Ford Hospital, Wayne State University; Program Director, Interventional Pulmonology Fellowship, Henry Ford Health System, Detroit, MI

Javier Diaz-Mendoza, MD, FCCP, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Ion Intuitive Serve(d) as a speaker or a member of a speakers bureau for: Association of Interventional Pulmonology Program Directors

Patients with chronic obstructive pulmonary disease (COPD) typically have emphysema, which involves destruction of alveoli and reduction of elasticity leading to airflow obstruction, air trapping, and hyperinflation. Over time, these changes cause low respiratory reserve volume and increased residual volume, which cause dyspnea.  

One of the newest treatment options for patients who have advanced COPD with severe emphysema is a minimally invasive procedure called bronchoscopic lung volume reduction (BLVR). Most recently, the FDA approved the use of endobronchial valves for this procedure, which are implanted in the airways of the lungs to reduce air trapping and hyperinflation. 

In certain patients, BLVR has been shown to improve lung function, facilitate easier breathing, enhance exercise tolerance, and lead to better quality of life. 

In this ReCAP, Dr. Javier Diaz-Mendoza, program director of the Interventional Pulmonology Fellowship at Henry Ford Health System in Detroit, discusses the benefits of BLVR in patients who have advanced COPD with emphysema. He discusses the procedure, patient outcomes, and which patients should be considered for BLVR.  

--

Associate Professor of Medicine, Henry Ford Hospital, Wayne State University; Program Director, Interventional Pulmonology Fellowship, Henry Ford Health System, Detroit, MI

Javier Diaz-Mendoza, MD, FCCP, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Ion Intuitive Serve(d) as a speaker or a member of a speakers bureau for: Association of Interventional Pulmonology Program Directors

Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.

The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.

The drug has been through a teeter totter of regulations since its inception.

When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.

Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.

Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.

“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.

Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.

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

Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.

The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.

The drug has been through a teeter totter of regulations since its inception.

When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.

Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.

Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.

“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.

Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.

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

Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.

The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.

The drug has been through a teeter totter of regulations since its inception.

When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.

Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.

Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.

“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.

Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.

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

The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

A version of this article first appeared on Medscape.com

The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

A version of this article first appeared on Medscape.com

The U.S. Food and Drug Administration issued a warning today that the cancer drug duvelisib (Copiktra, Verastem), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib, compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced that it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib following a voluntary request by the drug manufacturer Secura Bio.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by this news organization, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

A version of this article first appeared on Medscape.com

Children and adolescents with migraine are about twice as likely to have an anxiety or depressive disorder as those without migraine, results from a new review and meta-analysis suggest.

“This is compelling, high-level evidence showing there’s this established comorbidity between migraine and anxiety and depressive symptoms and disorders in this age group,” co-investigator Serena L. Orr, MD, a pediatric neurologist and headache specialist at Alberta Children’s Hospital and assistant professor in the department of pediatrics, University of Calgary (Alta.), told this news organization.

The results “should compel every clinician who is seeing a child or adolescent with migraine to screen for anxiety and depression and to manage that if it’s present. That should be the standard of care with this level of evidence,” Dr. Orr said.

The findings were presented at the American Headache Society (AHS) Annual Meeting 2022.
 

Incidence divergence

Previous studies have suggested that 10%-20% of children and adolescents will experience migraine at some point before adulthood, with the prevalence increasing after puberty.

While the female-to-male ratio is about 1:1 before puberty, there is a “big divergence in incidence curves” afterward – with the female-to-male ratio reaching 2-3:1 in adulthood, Dr. Orr noted. Experts believe hormones drive this divergence, she said, noting that male adults with migraine have lower testosterone levels than male adults without migraine.

Dr. Orr and her colleagues were keen to investigate the relationship between child migraine and anxiety symptoms and disorders, as well as between child migraine and depression symptoms and disorders. They searched the literature for related case-control, cross-sectional, and cohort studies with participants of ages up to 18 years.

The researchers selected 80 studies to include in the review. Most of the studies were carried out in the past 30 to 40 years and were in English and other languages. Both community-based and clinical studies were included.

Of the total, 73 studies reported on the association between the exposures and migraine, and 51 were amenable to quantitative pooling.

Results from a meta-analysis that included 16 studies that compared children and adolescents who had migraine with their healthy peers showed a significant association between migraine and anxiety symptoms (standardized mean difference, 1.13; 95% confidence interval, 0.64-1.63; P < .0001).

Compared with children who did not have migraine, those with migraine had almost twice the odds of an anxiety disorder in 15 studies (odds ratio, 1.93; 95% CI, 1.49-2.50; P < .0001).

In addition, there was an association between migraine and depressive symptoms in 17 relevant studies (SMD, 0.67; 95% CI, 0.46-0.87; P < .0001). Participants with versus without migraine also had higher odds of depressive disorders in 18 studies (OR, 2.01; 95% CI, 1.46-2.78; P < .0001).

Effect sizes were similar between community-based and clinic studies. Dr. Orr said it is important to note that the analysis wasn’t restricted to studies with “just kids with really high disease burden who are going to naturally be more predisposed to psychiatric comorbidity.”
 

‘Shocking’ lack of research

The researchers were also interested in determining whether having migraine along with anxiety or depression symptoms or disorders could affect headache-specific outcomes and whether such patients’ conditions would be more refractory to treatment. However, these outcomes were “all over the place” in the 18 relevant studies, Dr. Orr reported.

“Some looked at headache frequency, some at disability, some at school functioning; so, we were not able to put them into a meta-analysis,” she said.

Only two studies examined whether anxiety or depression earlier in childhood predisposes to subsequent migraine, so that issue is still unresolved, Dr. Orr added.

The investigators also assessed whether outcomes with migraine are similar to those with other headache types, such as tension-type headaches. “We did not find a difference at the symptom or disorder level, but there were fewer of those studies” – and these, too, were heterogeneous, said Dr. Orr.

The researchers did not find any studies of the association between migraine and trauma, which Dr. Orr said was “shocking.”

“In the broader pediatric chronic-pain literature, there’s research showing that having a trauma or stress-related disorder is associated with more chronic pain and worse chronic pain outcomes, but we could not find a study that specifically looked at that question in migraine,” she added.

Emerging evidence suggests there may be a bidirectional relationship between migraine and anxiety/depression, at least in adults. Dr. Orr said having these symptoms appears to raise the risk for migraine, but whether that’s environmental or driven by shared genetics isn’t clear.

Experiencing chronic pain may also predispose individuals to anxiety and depression, “but we need more studies on this.”

In addition to screening children with migraine for anxiety and depression, clinicians should advocate for better access to mental health resources for patients with these comorbidities, Dr. Orr noted.

She added that a limitation of the review was that 82.5% of the studies reported unadjusted associations and that 26.3% of the studies were of low quality.
 

High-level evidence

Sara Pavitt, MD, chief of the Pediatric Headache Program and assistant professor in the department of neurology, the University of Texas at Austin, said the investigators “should be applauded” for providing “high-level evidence” to better understand the relationship between migraine and anxiety and depression in pediatric patients.

Such information has been “lacking” for this patient population, said Dr. Pavitt, who was not involved with the research.

She noted that screening kids for mood disorders is challenging, given the relatively few pediatric mental health care providers. A referral for a psychiatric follow-up can mean a 9- to 12-month wait – or even longer for children who do not have insurance or use Medicare.

“Providers need to have more incentives to care for patients with Medicare or lack of insurance – these patients are often excluded from practices because reimbursement is so poor,” Dr. Pavitt said.

Additional pediatric studies are needed to understand how other mental health disorders, such as panic disorder, phobias, and posttraumatic stress disorder, may be related to migraine, she added.

The study received no outside funding. Dr. Orr has received grants from the Canadian Institutes of Health Research and royalties from Cambridge University Press for book publication, and she is on editorial boards of Headache, Neurology, and the American Migraine Foundation. Dr. Pavitt serves on an advisory board for Theranica, which produces a neuromodulation device for acute migraine treatment, although this is not directly relevant to this review.

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

Children and adolescents with migraine are about twice as likely to have an anxiety or depressive disorder as those without migraine, results from a new review and meta-analysis suggest.

“This is compelling, high-level evidence showing there’s this established comorbidity between migraine and anxiety and depressive symptoms and disorders in this age group,” co-investigator Serena L. Orr, MD, a pediatric neurologist and headache specialist at Alberta Children’s Hospital and assistant professor in the department of pediatrics, University of Calgary (Alta.), told this news organization.

The results “should compel every clinician who is seeing a child or adolescent with migraine to screen for anxiety and depression and to manage that if it’s present. That should be the standard of care with this level of evidence,” Dr. Orr said.

The findings were presented at the American Headache Society (AHS) Annual Meeting 2022.
 

Incidence divergence

Previous studies have suggested that 10%-20% of children and adolescents will experience migraine at some point before adulthood, with the prevalence increasing after puberty.

While the female-to-male ratio is about 1:1 before puberty, there is a “big divergence in incidence curves” afterward – with the female-to-male ratio reaching 2-3:1 in adulthood, Dr. Orr noted. Experts believe hormones drive this divergence, she said, noting that male adults with migraine have lower testosterone levels than male adults without migraine.

Dr. Orr and her colleagues were keen to investigate the relationship between child migraine and anxiety symptoms and disorders, as well as between child migraine and depression symptoms and disorders. They searched the literature for related case-control, cross-sectional, and cohort studies with participants of ages up to 18 years.

The researchers selected 80 studies to include in the review. Most of the studies were carried out in the past 30 to 40 years and were in English and other languages. Both community-based and clinical studies were included.

Of the total, 73 studies reported on the association between the exposures and migraine, and 51 were amenable to quantitative pooling.

Results from a meta-analysis that included 16 studies that compared children and adolescents who had migraine with their healthy peers showed a significant association between migraine and anxiety symptoms (standardized mean difference, 1.13; 95% confidence interval, 0.64-1.63; P < .0001).

Compared with children who did not have migraine, those with migraine had almost twice the odds of an anxiety disorder in 15 studies (odds ratio, 1.93; 95% CI, 1.49-2.50; P < .0001).

In addition, there was an association between migraine and depressive symptoms in 17 relevant studies (SMD, 0.67; 95% CI, 0.46-0.87; P < .0001). Participants with versus without migraine also had higher odds of depressive disorders in 18 studies (OR, 2.01; 95% CI, 1.46-2.78; P < .0001).

Effect sizes were similar between community-based and clinic studies. Dr. Orr said it is important to note that the analysis wasn’t restricted to studies with “just kids with really high disease burden who are going to naturally be more predisposed to psychiatric comorbidity.”
 

‘Shocking’ lack of research

The researchers were also interested in determining whether having migraine along with anxiety or depression symptoms or disorders could affect headache-specific outcomes and whether such patients’ conditions would be more refractory to treatment. However, these outcomes were “all over the place” in the 18 relevant studies, Dr. Orr reported.

“Some looked at headache frequency, some at disability, some at school functioning; so, we were not able to put them into a meta-analysis,” she said.

Only two studies examined whether anxiety or depression earlier in childhood predisposes to subsequent migraine, so that issue is still unresolved, Dr. Orr added.

The investigators also assessed whether outcomes with migraine are similar to those with other headache types, such as tension-type headaches. “We did not find a difference at the symptom or disorder level, but there were fewer of those studies” – and these, too, were heterogeneous, said Dr. Orr.

The researchers did not find any studies of the association between migraine and trauma, which Dr. Orr said was “shocking.”

“In the broader pediatric chronic-pain literature, there’s research showing that having a trauma or stress-related disorder is associated with more chronic pain and worse chronic pain outcomes, but we could not find a study that specifically looked at that question in migraine,” she added.

Emerging evidence suggests there may be a bidirectional relationship between migraine and anxiety/depression, at least in adults. Dr. Orr said having these symptoms appears to raise the risk for migraine, but whether that’s environmental or driven by shared genetics isn’t clear.

Experiencing chronic pain may also predispose individuals to anxiety and depression, “but we need more studies on this.”

In addition to screening children with migraine for anxiety and depression, clinicians should advocate for better access to mental health resources for patients with these comorbidities, Dr. Orr noted.

She added that a limitation of the review was that 82.5% of the studies reported unadjusted associations and that 26.3% of the studies were of low quality.
 

High-level evidence

Sara Pavitt, MD, chief of the Pediatric Headache Program and assistant professor in the department of neurology, the University of Texas at Austin, said the investigators “should be applauded” for providing “high-level evidence” to better understand the relationship between migraine and anxiety and depression in pediatric patients.

Such information has been “lacking” for this patient population, said Dr. Pavitt, who was not involved with the research.

She noted that screening kids for mood disorders is challenging, given the relatively few pediatric mental health care providers. A referral for a psychiatric follow-up can mean a 9- to 12-month wait – or even longer for children who do not have insurance or use Medicare.

“Providers need to have more incentives to care for patients with Medicare or lack of insurance – these patients are often excluded from practices because reimbursement is so poor,” Dr. Pavitt said.

Additional pediatric studies are needed to understand how other mental health disorders, such as panic disorder, phobias, and posttraumatic stress disorder, may be related to migraine, she added.

The study received no outside funding. Dr. Orr has received grants from the Canadian Institutes of Health Research and royalties from Cambridge University Press for book publication, and she is on editorial boards of Headache, Neurology, and the American Migraine Foundation. Dr. Pavitt serves on an advisory board for Theranica, which produces a neuromodulation device for acute migraine treatment, although this is not directly relevant to this review.

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

Children and adolescents with migraine are about twice as likely to have an anxiety or depressive disorder as those without migraine, results from a new review and meta-analysis suggest.

“This is compelling, high-level evidence showing there’s this established comorbidity between migraine and anxiety and depressive symptoms and disorders in this age group,” co-investigator Serena L. Orr, MD, a pediatric neurologist and headache specialist at Alberta Children’s Hospital and assistant professor in the department of pediatrics, University of Calgary (Alta.), told this news organization.

The results “should compel every clinician who is seeing a child or adolescent with migraine to screen for anxiety and depression and to manage that if it’s present. That should be the standard of care with this level of evidence,” Dr. Orr said.

The findings were presented at the American Headache Society (AHS) Annual Meeting 2022.
 

Incidence divergence

Previous studies have suggested that 10%-20% of children and adolescents will experience migraine at some point before adulthood, with the prevalence increasing after puberty.

While the female-to-male ratio is about 1:1 before puberty, there is a “big divergence in incidence curves” afterward – with the female-to-male ratio reaching 2-3:1 in adulthood, Dr. Orr noted. Experts believe hormones drive this divergence, she said, noting that male adults with migraine have lower testosterone levels than male adults without migraine.

Dr. Orr and her colleagues were keen to investigate the relationship between child migraine and anxiety symptoms and disorders, as well as between child migraine and depression symptoms and disorders. They searched the literature for related case-control, cross-sectional, and cohort studies with participants of ages up to 18 years.

The researchers selected 80 studies to include in the review. Most of the studies were carried out in the past 30 to 40 years and were in English and other languages. Both community-based and clinical studies were included.

Of the total, 73 studies reported on the association between the exposures and migraine, and 51 were amenable to quantitative pooling.

Results from a meta-analysis that included 16 studies that compared children and adolescents who had migraine with their healthy peers showed a significant association between migraine and anxiety symptoms (standardized mean difference, 1.13; 95% confidence interval, 0.64-1.63; P < .0001).

Compared with children who did not have migraine, those with migraine had almost twice the odds of an anxiety disorder in 15 studies (odds ratio, 1.93; 95% CI, 1.49-2.50; P < .0001).

In addition, there was an association between migraine and depressive symptoms in 17 relevant studies (SMD, 0.67; 95% CI, 0.46-0.87; P < .0001). Participants with versus without migraine also had higher odds of depressive disorders in 18 studies (OR, 2.01; 95% CI, 1.46-2.78; P < .0001).

Effect sizes were similar between community-based and clinic studies. Dr. Orr said it is important to note that the analysis wasn’t restricted to studies with “just kids with really high disease burden who are going to naturally be more predisposed to psychiatric comorbidity.”
 

‘Shocking’ lack of research

The researchers were also interested in determining whether having migraine along with anxiety or depression symptoms or disorders could affect headache-specific outcomes and whether such patients’ conditions would be more refractory to treatment. However, these outcomes were “all over the place” in the 18 relevant studies, Dr. Orr reported.

“Some looked at headache frequency, some at disability, some at school functioning; so, we were not able to put them into a meta-analysis,” she said.

Only two studies examined whether anxiety or depression earlier in childhood predisposes to subsequent migraine, so that issue is still unresolved, Dr. Orr added.

The investigators also assessed whether outcomes with migraine are similar to those with other headache types, such as tension-type headaches. “We did not find a difference at the symptom or disorder level, but there were fewer of those studies” – and these, too, were heterogeneous, said Dr. Orr.

The researchers did not find any studies of the association between migraine and trauma, which Dr. Orr said was “shocking.”

“In the broader pediatric chronic-pain literature, there’s research showing that having a trauma or stress-related disorder is associated with more chronic pain and worse chronic pain outcomes, but we could not find a study that specifically looked at that question in migraine,” she added.

Emerging evidence suggests there may be a bidirectional relationship between migraine and anxiety/depression, at least in adults. Dr. Orr said having these symptoms appears to raise the risk for migraine, but whether that’s environmental or driven by shared genetics isn’t clear.

Experiencing chronic pain may also predispose individuals to anxiety and depression, “but we need more studies on this.”

In addition to screening children with migraine for anxiety and depression, clinicians should advocate for better access to mental health resources for patients with these comorbidities, Dr. Orr noted.

She added that a limitation of the review was that 82.5% of the studies reported unadjusted associations and that 26.3% of the studies were of low quality.
 

High-level evidence

Sara Pavitt, MD, chief of the Pediatric Headache Program and assistant professor in the department of neurology, the University of Texas at Austin, said the investigators “should be applauded” for providing “high-level evidence” to better understand the relationship between migraine and anxiety and depression in pediatric patients.

Such information has been “lacking” for this patient population, said Dr. Pavitt, who was not involved with the research.

She noted that screening kids for mood disorders is challenging, given the relatively few pediatric mental health care providers. A referral for a psychiatric follow-up can mean a 9- to 12-month wait – or even longer for children who do not have insurance or use Medicare.

“Providers need to have more incentives to care for patients with Medicare or lack of insurance – these patients are often excluded from practices because reimbursement is so poor,” Dr. Pavitt said.

Additional pediatric studies are needed to understand how other mental health disorders, such as panic disorder, phobias, and posttraumatic stress disorder, may be related to migraine, she added.

The study received no outside funding. Dr. Orr has received grants from the Canadian Institutes of Health Research and royalties from Cambridge University Press for book publication, and she is on editorial boards of Headache, Neurology, and the American Migraine Foundation. Dr. Pavitt serves on an advisory board for Theranica, which produces a neuromodulation device for acute migraine treatment, although this is not directly relevant to this review.

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

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Devices that help children control their diabetes and lead fuller lives may also give them contact dermatitis, report the authors of a new study that calls for mandatory labeling of ingredients for allergy patch testing.

“A high share of patients showed positive reactions to isobornyl acrylate adhesive (IBOA) and/or their medical devices (insulin pumps or glucose devices),” the study authors write in Contact Dermatitis. “A third of patients showed positive reactions to benzoyl peroxide (BP),” used in adhesives.

“The presence of additional unidentified allergens cannot be excluded,” they add. “Overall, our experience once more highlights the importance of having access to a full description of the chemical composition of diabetes devices and related medical devices to efficiently manage patients (including children) who experience adverse skin reactions from such devices.”

Lead study author Catarina Alves da Silva, MD, of the department of dermatology and venereology of Aarhus (Denmark) University Hospital, and her colleagues conducted a retrospective study of 15 referred patients younger than 18 years who had type 1 diabetes. The children were patch tested in the university’s dermatology clinic between 2018 and 2020 in a study of skin reactions linked with diabetes devices.
 

Contact dermatitis from device-related allergens may be common

Many children in the study reacted to chemical compounds related to their devices.

• Of the 15 patients, seven showed positive patch test reactions to IBOA, and five showed positive reactions to BP.
• Ten children had positive patch test reactions to materials from glucose sensors and insulin pumps.
• Three showed positive reactions to adhesive remover wipes.
• Five reacted to .

Marcia Hogeling, MD, a pediatric dermatologist at UCLA Health in Santa Monica, Calif., told this news organization that she expected acrylates to cause problems but was surprised that BP caused positive patch test reactions.

BP is known to be a strong irritant but a weak allergen, the authors wrote.

“It was important to identify the allergens in these devices. Hopefully, this information will be used by manufacturers to create safer products for patients,” Dr. Hogeling, who was not involved in the study, said in an email.

Dr. Hogeling acknowledged that the small sample size is a weakness of the study, although she added that the findings may help providers select devices that do not contain their patients’ contact allergens.

Ryan J. McDonough, DO, a pediatric endocrinologist and the codirector of the Diabetes Center at Children’s Mercy Kansas City (Mo.), said in an email that, despite the small sample size, the study “highlights important device-related experiences of those living with type 1 diabetes that clinicians often encounter.

“We often spend considerable time aiding patients and their families in finding ways to mitigate the reactions,” he explained. “Having a broader understanding of these chemical compositions would help clinicians choose the right devices for their patients and prevent and treat these types of reactions.”

Dr. McDonough, who was not involved in the study, noted that the patients were in Denmark, and they were able to easily transition between insulin pumps and glucose monitoring devices.

“In the U.S., it is often more challenging to switch between devices, due to insurance-related concerns.

“The true rates of reaction in the broad type 1 diabetes population are difficult to assess,” Dr. McDonough said. “The study participants were drawn from patients referred to a dermatology clinic for evaluation of reaction. Many patients either don’t develop reactions or are treated for mild symptoms locally by their endocrinologists.

“This study should serve as a call to action for continued improvements in the transparency of the components that make up the devices and adhesives, and it can provide an opportunity to develop additional interventions to prevent these reactions,” he advised.

No information regarding funding for the study was provided. The authors, Dr. Hogeling, and Dr. McDonough reported no relevant financial relationships.

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

Devices that help children control their diabetes and lead fuller lives may also give them contact dermatitis, report the authors of a new study that calls for mandatory labeling of ingredients for allergy patch testing.

“A high share of patients showed positive reactions to isobornyl acrylate adhesive (IBOA) and/or their medical devices (insulin pumps or glucose devices),” the study authors write in Contact Dermatitis. “A third of patients showed positive reactions to benzoyl peroxide (BP),” used in adhesives.

“The presence of additional unidentified allergens cannot be excluded,” they add. “Overall, our experience once more highlights the importance of having access to a full description of the chemical composition of diabetes devices and related medical devices to efficiently manage patients (including children) who experience adverse skin reactions from such devices.”

Lead study author Catarina Alves da Silva, MD, of the department of dermatology and venereology of Aarhus (Denmark) University Hospital, and her colleagues conducted a retrospective study of 15 referred patients younger than 18 years who had type 1 diabetes. The children were patch tested in the university’s dermatology clinic between 2018 and 2020 in a study of skin reactions linked with diabetes devices.
 

Contact dermatitis from device-related allergens may be common

Many children in the study reacted to chemical compounds related to their devices.

• Of the 15 patients, seven showed positive patch test reactions to IBOA, and five showed positive reactions to BP.
• Ten children had positive patch test reactions to materials from glucose sensors and insulin pumps.
• Three showed positive reactions to adhesive remover wipes.
• Five reacted to .

Marcia Hogeling, MD, a pediatric dermatologist at UCLA Health in Santa Monica, Calif., told this news organization that she expected acrylates to cause problems but was surprised that BP caused positive patch test reactions.

BP is known to be a strong irritant but a weak allergen, the authors wrote.

“It was important to identify the allergens in these devices. Hopefully, this information will be used by manufacturers to create safer products for patients,” Dr. Hogeling, who was not involved in the study, said in an email.

Dr. Hogeling acknowledged that the small sample size is a weakness of the study, although she added that the findings may help providers select devices that do not contain their patients’ contact allergens.

Ryan J. McDonough, DO, a pediatric endocrinologist and the codirector of the Diabetes Center at Children’s Mercy Kansas City (Mo.), said in an email that, despite the small sample size, the study “highlights important device-related experiences of those living with type 1 diabetes that clinicians often encounter.

“We often spend considerable time aiding patients and their families in finding ways to mitigate the reactions,” he explained. “Having a broader understanding of these chemical compositions would help clinicians choose the right devices for their patients and prevent and treat these types of reactions.”

Dr. McDonough, who was not involved in the study, noted that the patients were in Denmark, and they were able to easily transition between insulin pumps and glucose monitoring devices.

“In the U.S., it is often more challenging to switch between devices, due to insurance-related concerns.

“The true rates of reaction in the broad type 1 diabetes population are difficult to assess,” Dr. McDonough said. “The study participants were drawn from patients referred to a dermatology clinic for evaluation of reaction. Many patients either don’t develop reactions or are treated for mild symptoms locally by their endocrinologists.

“This study should serve as a call to action for continued improvements in the transparency of the components that make up the devices and adhesives, and it can provide an opportunity to develop additional interventions to prevent these reactions,” he advised.

No information regarding funding for the study was provided. The authors, Dr. Hogeling, and Dr. McDonough reported no relevant financial relationships.

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

Devices that help children control their diabetes and lead fuller lives may also give them contact dermatitis, report the authors of a new study that calls for mandatory labeling of ingredients for allergy patch testing.

“A high share of patients showed positive reactions to isobornyl acrylate adhesive (IBOA) and/or their medical devices (insulin pumps or glucose devices),” the study authors write in Contact Dermatitis. “A third of patients showed positive reactions to benzoyl peroxide (BP),” used in adhesives.

“The presence of additional unidentified allergens cannot be excluded,” they add. “Overall, our experience once more highlights the importance of having access to a full description of the chemical composition of diabetes devices and related medical devices to efficiently manage patients (including children) who experience adverse skin reactions from such devices.”

Lead study author Catarina Alves da Silva, MD, of the department of dermatology and venereology of Aarhus (Denmark) University Hospital, and her colleagues conducted a retrospective study of 15 referred patients younger than 18 years who had type 1 diabetes. The children were patch tested in the university’s dermatology clinic between 2018 and 2020 in a study of skin reactions linked with diabetes devices.
 

Contact dermatitis from device-related allergens may be common

Many children in the study reacted to chemical compounds related to their devices.

• Of the 15 patients, seven showed positive patch test reactions to IBOA, and five showed positive reactions to BP.
• Ten children had positive patch test reactions to materials from glucose sensors and insulin pumps.
• Three showed positive reactions to adhesive remover wipes.
• Five reacted to .

Marcia Hogeling, MD, a pediatric dermatologist at UCLA Health in Santa Monica, Calif., told this news organization that she expected acrylates to cause problems but was surprised that BP caused positive patch test reactions.

BP is known to be a strong irritant but a weak allergen, the authors wrote.

“It was important to identify the allergens in these devices. Hopefully, this information will be used by manufacturers to create safer products for patients,” Dr. Hogeling, who was not involved in the study, said in an email.

Dr. Hogeling acknowledged that the small sample size is a weakness of the study, although she added that the findings may help providers select devices that do not contain their patients’ contact allergens.

Ryan J. McDonough, DO, a pediatric endocrinologist and the codirector of the Diabetes Center at Children’s Mercy Kansas City (Mo.), said in an email that, despite the small sample size, the study “highlights important device-related experiences of those living with type 1 diabetes that clinicians often encounter.

“We often spend considerable time aiding patients and their families in finding ways to mitigate the reactions,” he explained. “Having a broader understanding of these chemical compositions would help clinicians choose the right devices for their patients and prevent and treat these types of reactions.”

Dr. McDonough, who was not involved in the study, noted that the patients were in Denmark, and they were able to easily transition between insulin pumps and glucose monitoring devices.

“In the U.S., it is often more challenging to switch between devices, due to insurance-related concerns.

“The true rates of reaction in the broad type 1 diabetes population are difficult to assess,” Dr. McDonough said. “The study participants were drawn from patients referred to a dermatology clinic for evaluation of reaction. Many patients either don’t develop reactions or are treated for mild symptoms locally by their endocrinologists.

“This study should serve as a call to action for continued improvements in the transparency of the components that make up the devices and adhesives, and it can provide an opportunity to develop additional interventions to prevent these reactions,” he advised.

No information regarding funding for the study was provided. The authors, Dr. Hogeling, and Dr. McDonough reported no relevant financial relationships.

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

Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.

Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).

amriphoto/E+/Getty Images

From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.

Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.

“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.

“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.

Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”

The results were published online in the Canadian Journal of Cardiology.

“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.

“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.

Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.

“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.

Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
 

Cardiac rehabilitation

The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.

Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.

The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.

Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.

From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).

Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).

Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.

Other data indicated the following:

• From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
• During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
• After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
• Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.

Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.

“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.

Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.

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

Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.

Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).

amriphoto/E+/Getty Images

From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.

Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.

“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.

“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.

Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”

The results were published online in the Canadian Journal of Cardiology.

“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.

“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.

Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.

“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.

Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
 

Cardiac rehabilitation

The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.

Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.

The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.

Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.

From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).

Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).

Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.

Other data indicated the following:

• From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
• During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
• After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
• Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.

Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.

“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.

Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.

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

Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.

Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).

amriphoto/E+/Getty Images

From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.

Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.

“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.

“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.

Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”

The results were published online in the Canadian Journal of Cardiology.

“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.

“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.

Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.

“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.

Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
 

Cardiac rehabilitation

The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.

Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.

The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.

Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.

From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).

Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).

Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.

Other data indicated the following:

• From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
• During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
• After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
• Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.

Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.

“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.

Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.

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

Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.

There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.

“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”

“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”

Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online  in JAMA Cardiology.

In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.

The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.

For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.

There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.

Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.

Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.

Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
 

Safety not proven

There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).

Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”

Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
 

Questions remain

Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”

That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”

Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”

“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.

“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”

The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.

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

Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.

There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.

“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”

“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”

Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online  in JAMA Cardiology.

In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.

The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.

For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.

There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.

Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.

Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.

Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
 

Safety not proven

There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).

Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”

Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
 

Questions remain

Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”

That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”

Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”

“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.

“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”

The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.

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

Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.

There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.

“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”

“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”

Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online  in JAMA Cardiology.

In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.

The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.

For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.

There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.

Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.

Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.

Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
 

Safety not proven

There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).

Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”

Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
 

Questions remain

Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”

That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”

Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”

“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.

“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”

The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.

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