STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.
“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.
baibaz/iStock/Getty Images
She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.
The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.
Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.
“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.
The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.
Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”
And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.
“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
Red meat damages, dairy protects
The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.
Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).
The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).
Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.
And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.
Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
What are the mechanisms?
The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.
In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”
Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”
Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”
And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.
What about vegan diets? The devil is in the details
Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”
“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”
Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.
“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.
baibaz/iStock/Getty Images
She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.
The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.
Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.
“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.
The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.
Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”
And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.
“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
Red meat damages, dairy protects
The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.
Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).
The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).
Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.
And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.
Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
What are the mechanisms?
The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.
In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”
Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”
Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”
And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.
What about vegan diets? The devil is in the details
Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”
“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”
Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Among animal protein foods, low-fat dairy consumption may minimize the risk of developing type 2 diabetes while red meat raises that risk, a new analysis finds.
“A plant-based dietary pattern with limited intake of meat, moderate intake of fish, eggs, and full-fat dairy, and habitual consumption of yogurt, milk, or low-fat dairy, might represent the most feasible, sustainable, and successful population strategy to optimize the prevention of type 2 diabetes,” lead author Annalisa Giosuè, MD, of the University of Naples (Italy) Federico II, told this news organization.
baibaz/iStock/Getty Images
She presented the findings from an umbrella review of 13 dose-response meta-analyses of prospective cohort studies at the annual meeting of the European Association for the Study of Diabetes.
The study is believed to be the first comprehensive overview of the available evidence from all published meta-analyses on the relationship between well-defined amounts of animal-origin foods and the risk of type 2 diabetes.
Dr. Giosuè and colleagues focused on animal-based foods because they represent a gap in most guidelines for type 2 diabetes prevention, she explained.
“The existing evidence and dietary recommendations for type 2 diabetes prevention are mainly based on the appropriate consumption of plant foods: high amounts of the fiber-rich ones and low consumption of the refined ones as well as those rich in free sugars. And also on the adequate choice among fat sources – reduction of saturated fat sources like butter and cream and replacement with plant-based poly- and monounsaturated fat sources like nontropical vegetable oils. But not on the most suitable choices among different animal foods for the prevention of type 2 diabetes,” she explained.
The new findings are in line with the Mediterranean diet in that, while plant based, it also limits red-meat consumption, but not all animal-based foods, and has consistently been associated with a reduced risk of type 2 diabetes. Vegetarian diets have also been associated with a reduced risk of type 2 diabetes, but far less evidence is available for that, she said.
Asked for comment, session moderator Matthias Schulze, MD, head of the department of molecular epidemiology at the German Institute of Human Nutrition, Berlin, said: “Decreasing intake of red and processed meat is already a strong recommendation, and these data support that. You have to make choices for and against [certain] foods. So, if you decide to eat less red meat, then the question is what do you eat instead? This study shows that specifically other animal products, like dairy and ... fish or white meat sources ... are healthy among the animal-based foods. But you could also obviously look at plant-based foods as protein sources as well.”
And Dr. Schulze noted that the data suggest another dimension to type 2 diabetes prevention beyond simply focusing on weight loss.
“You can achieve weight loss with very different diets. Diet quality plays an important role. These data support that if you look at diabetes prevention, then you would focus on people with high intakes of specific animal-based foods, besides looking at overweight and obesity. Then you could intervene to reduce this intake, with potential substitutions with other animal foods like fish or white meat, or plant-based sources of proteins.”
Red meat damages, dairy protects
The 13 meta-analyses included 175 summary risk ratios for type 2 diabetes incidence for the consumption of total meat, red meat, white meat, processed meats, fish, total dairy, full-fat dairy, low-fat dairy, milk, cheese, yogurt, or eggs.
Significant increases in the risk of developing type 2 diabetes were found for consumption of 100 g/day of total meat (SRR, 1.20; 20% increase) and red meat (SRR, 1.22, 22% increase) and with 50 g/day of processed meats (SRR, 1.30; 30% increase). A borderline increased risk was also seen for 50 g/day of white meat (SRR, 1.04; 4% increase).
The opposite was found for dairy foods. Inverse associations for type 2 diabetes development were found for an intake of 200 g/day of total dairy (SRR, 0.95; 5% reduction), low-fat dairy (SRR, 0.96; 4% reduction), milk (SRR, 0.90; 10% reduction), and for 100 g/day of yogurt (SRR, 0.94, 6% reduction).
Neutral (nonsignificant) effects were found for 200 g/day of full-fat dairy (SRR, 0.98) and for 30 g/day of cheese (SRR, 0.97). Fish consumption also had a neutral association with type 2 diabetes risk (SRR, 1.04 for 100 g/day) as did one egg per day (SRR, 1.07), but evidence quality was low.
And, Dr. Giosuè noted during her presentation, these relationships could change with alterations in the amounts consumed.
Dr. Schulze commented: “Fish is more clearly related to reduced cardiovascular risk than for preventing type 2 diabetes, where we’ve had mixed results. They might not always be the same.”
What are the mechanisms?
The reasons for these positive and negative associations aren’t entirely clear, but Dr. Giosuè noted that dairy products contain several nutrients, vitamins, and other components, such as calcium and vitamin D, that have potential beneficial effects on glucose metabolism.
In particular, she said, “Whey proteins in milk have a well-known beneficial effect on the regulation of the rise of glucose levels in the blood after meals, and also on the control of appetite and body weight.”
Moreover, probiotics found in yogurt have been linked to protective effects against weight gain and obesity, which “may in part [explain] the beneficial role of yogurt in type 2 diabetes prevention.”
Meat, in contrast, is full of cholesterol, saturated fatty acids, and heme iron, which can promote subclinical inflammation and oxidative stress, which may in turn, affect insulin sensitivity, Dr. Giosuè explained. What’s more, “processed meats also contain nitrates, nitrites, and sodium that can contribute to pancreatic cell damage and vascular dysfunction, thus affecting insulin sensitivity.”
And white meat (poultry) has a lower fat content than red meats such as beef, lamb, and pork, as well as a more favorable fatty acid profile and a lower heme-iron content, she said in an interview.
What about vegan diets? The devil is in the details
Asked about the relative health benefits of diets that completely eliminate animal-based foods, Dr. Giosuè replied: “What is important to keep in mind when hearing about the potential of vegan diets to prevent, or manage, or induce the remission of type 2 diabetes, is that the inclusion in the diet of solely foods of plant origin does not mean ‘automatically’ to eat only foods that are good for diabetes prevention.”
“Just like the exclusion of all foods of animal origin is not equivalent to reduce the risk of type 2 diabetes ... Solid evidence has demonstrated that plant foods which are refined and/or rich in free sugars like white bread, biscuits, and sweetened beverages are as harmful as red and processed meats for diabetes incidence and progression.”
Dr. Giosuè and Dr. Schulze have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients with iron overload – serum ferritin greater than 1,000 mcg/L or a diagnosis of hemochromatosis or thalassemia – were 60% more likely to have an osteoporotic fracture during an up to 10-year follow-up than matched control patients, in a large study.
Compared with control patients, those with iron overload had a roughly twofold increased risk of a vertebral fracture, as well as an increased risk of a hip or humerus fracture, but not a forearm fracture.
The increased risk of fracture in men with iron overload (compared with other matched men) was greater than the increased risk of fracture in women with iron overload (compared with other matched women).
Andrea Burden, PhD, presented the findings during a late-breaking clinical science session at the annual meeting of the American Society of Bone and Mineral Research.
‘We should worry about the bones as well as the liver’
Based on these results, clinicians should probably do earlier bone mineral density (BMD) determinations to screen for osteoporosis and perhaps consider prophylaxis with vitamin D and calcium, said Dr. Burden, assistant professor, Institute of Pharmaceutical Sciences, ETH Zürich.
“However, I say that with a bunch of caution,” she added, “because we actually don’t have much evidence of the impact of these treatment differences on fracture risk.”
“This is the first large population study on this topic,” although there have been a few case reports, Dr. Burden explained in an interview.
However, “the high iron overload of greater than 1,000 mcg/L is not common, and hereditary hemochromatosis or thalassemia also are very rare,” she noted.
“The study shows that, once patients have an iron overload of more than 1,000 mcg/L, we need to be doing regular checks for their BMD and figuring how to best minimize their fracture risk,” she said.
“A twofold risk for a vertebral fracture” in patients with iron overload “is really high,” she noted. It is known that men with iron overload have loss of testosterone, but it may be less well known that they have an increased fracture risk.
“We worry about the liver,” she said, “not so much about the bones, and this shows us that we really should.”
Session comoderator Michael J. Econs, MD, who was not involved with the research, agreed. “Iron overload does occur, and it is a clinically important problem and can lead to hemochromatosis, which can lead to a whole host of diseases, but the most common is liver disease,” he told this news organization.
“So, it is a clinically important problem, not only in people who are genetically predisposed but in people who get frequent transfusion,” said Dr. Econs, distinguished professor of medicine and medical and molecular genetics at Indiana University, Indianapolis.
Now this new study has found an increase in fractures in such people, he noted.
Large case-control study used U.K. database
Using data from the IQVIA Medical Research Database, researchers identified 21,166 iron overload patients aged 18 years and older who saw a general practitioner in the United Kingdom between 2010 and 2020 and had a serum ferritin level above 1,000 mcg/L or a diagnostic code for hemochromatosis or nonanemic thalassemia.
They matched each iron overload patient with up to 10 control patients based on age, sex, year, and general practitioner, for a total of 198,037 control patients.
Patients were a mean age of 59 years and 59% were men.
During follow-up there were 777 fractures in the iron-overload patients (9.61 fractures per 1,000 patient-years) and 4,344 fractures in the control group (4.68 fractures per 1,000 patient-years).
In adjusted hazard ratio models, researchers adjusted for age, sex, body mass index, alcohol, smoking, history of fractures earlier than 365 days prior to study entry, hypogonadism, osteoporosis, medications, and comorbidities.
Overall, patients in the iron overload group had a 60% higher risk of an osteoporotic fracture (aHR, 1.60).
Among women, the incidence of osteoporotic fracture was 12.63 per 1,000 patient-years in the iron overload group and 7.09 per 1,000 patient-years in the control group.
Women with iron overload had a 48% higher risk of osteoporotic fracture, compared with other women (aHR, 1.48).
Among men, the incidence of osteoporotic fracture was 6.71 per 1,000 patient-years in the iron overload group and 3.01 per 1,000 patient-years in the control group.
Men with iron overload therefore had an 82% higher risk of osteoporotic fracture, compared with other men (aHR, 1.82).
Compared with patients without iron overload, patients with iron overload had an increased risk of a vertebral (aHR, 2.18), hip (aHR, 1.60), and humerus (aHR, 1.82) fracture but not a forearm fracture.
The researchers acknowledge that study limitations include they did not look at phlebotomy or changes in ferritin levels, and they excluded patients with hereditary hemochromatosis diagnosed before age 18.
The work was funded by the German Research Foundation. One of the researchers has reported receiving an independent grant from Pharmacosmos. The other researchers as well as Dr. Econs have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients with iron overload – serum ferritin greater than 1,000 mcg/L or a diagnosis of hemochromatosis or thalassemia – were 60% more likely to have an osteoporotic fracture during an up to 10-year follow-up than matched control patients, in a large study.
Compared with control patients, those with iron overload had a roughly twofold increased risk of a vertebral fracture, as well as an increased risk of a hip or humerus fracture, but not a forearm fracture.
The increased risk of fracture in men with iron overload (compared with other matched men) was greater than the increased risk of fracture in women with iron overload (compared with other matched women).
Andrea Burden, PhD, presented the findings during a late-breaking clinical science session at the annual meeting of the American Society of Bone and Mineral Research.
‘We should worry about the bones as well as the liver’
Based on these results, clinicians should probably do earlier bone mineral density (BMD) determinations to screen for osteoporosis and perhaps consider prophylaxis with vitamin D and calcium, said Dr. Burden, assistant professor, Institute of Pharmaceutical Sciences, ETH Zürich.
“However, I say that with a bunch of caution,” she added, “because we actually don’t have much evidence of the impact of these treatment differences on fracture risk.”
“This is the first large population study on this topic,” although there have been a few case reports, Dr. Burden explained in an interview.
However, “the high iron overload of greater than 1,000 mcg/L is not common, and hereditary hemochromatosis or thalassemia also are very rare,” she noted.
“The study shows that, once patients have an iron overload of more than 1,000 mcg/L, we need to be doing regular checks for their BMD and figuring how to best minimize their fracture risk,” she said.
“A twofold risk for a vertebral fracture” in patients with iron overload “is really high,” she noted. It is known that men with iron overload have loss of testosterone, but it may be less well known that they have an increased fracture risk.
“We worry about the liver,” she said, “not so much about the bones, and this shows us that we really should.”
Session comoderator Michael J. Econs, MD, who was not involved with the research, agreed. “Iron overload does occur, and it is a clinically important problem and can lead to hemochromatosis, which can lead to a whole host of diseases, but the most common is liver disease,” he told this news organization.
“So, it is a clinically important problem, not only in people who are genetically predisposed but in people who get frequent transfusion,” said Dr. Econs, distinguished professor of medicine and medical and molecular genetics at Indiana University, Indianapolis.
Now this new study has found an increase in fractures in such people, he noted.
Large case-control study used U.K. database
Using data from the IQVIA Medical Research Database, researchers identified 21,166 iron overload patients aged 18 years and older who saw a general practitioner in the United Kingdom between 2010 and 2020 and had a serum ferritin level above 1,000 mcg/L or a diagnostic code for hemochromatosis or nonanemic thalassemia.
They matched each iron overload patient with up to 10 control patients based on age, sex, year, and general practitioner, for a total of 198,037 control patients.
Patients were a mean age of 59 years and 59% were men.
During follow-up there were 777 fractures in the iron-overload patients (9.61 fractures per 1,000 patient-years) and 4,344 fractures in the control group (4.68 fractures per 1,000 patient-years).
In adjusted hazard ratio models, researchers adjusted for age, sex, body mass index, alcohol, smoking, history of fractures earlier than 365 days prior to study entry, hypogonadism, osteoporosis, medications, and comorbidities.
Overall, patients in the iron overload group had a 60% higher risk of an osteoporotic fracture (aHR, 1.60).
Among women, the incidence of osteoporotic fracture was 12.63 per 1,000 patient-years in the iron overload group and 7.09 per 1,000 patient-years in the control group.
Women with iron overload had a 48% higher risk of osteoporotic fracture, compared with other women (aHR, 1.48).
Among men, the incidence of osteoporotic fracture was 6.71 per 1,000 patient-years in the iron overload group and 3.01 per 1,000 patient-years in the control group.
Men with iron overload therefore had an 82% higher risk of osteoporotic fracture, compared with other men (aHR, 1.82).
Compared with patients without iron overload, patients with iron overload had an increased risk of a vertebral (aHR, 2.18), hip (aHR, 1.60), and humerus (aHR, 1.82) fracture but not a forearm fracture.
The researchers acknowledge that study limitations include they did not look at phlebotomy or changes in ferritin levels, and they excluded patients with hereditary hemochromatosis diagnosed before age 18.
The work was funded by the German Research Foundation. One of the researchers has reported receiving an independent grant from Pharmacosmos. The other researchers as well as Dr. Econs have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients with iron overload – serum ferritin greater than 1,000 mcg/L or a diagnosis of hemochromatosis or thalassemia – were 60% more likely to have an osteoporotic fracture during an up to 10-year follow-up than matched control patients, in a large study.
Compared with control patients, those with iron overload had a roughly twofold increased risk of a vertebral fracture, as well as an increased risk of a hip or humerus fracture, but not a forearm fracture.
The increased risk of fracture in men with iron overload (compared with other matched men) was greater than the increased risk of fracture in women with iron overload (compared with other matched women).
Andrea Burden, PhD, presented the findings during a late-breaking clinical science session at the annual meeting of the American Society of Bone and Mineral Research.
‘We should worry about the bones as well as the liver’
Based on these results, clinicians should probably do earlier bone mineral density (BMD) determinations to screen for osteoporosis and perhaps consider prophylaxis with vitamin D and calcium, said Dr. Burden, assistant professor, Institute of Pharmaceutical Sciences, ETH Zürich.
“However, I say that with a bunch of caution,” she added, “because we actually don’t have much evidence of the impact of these treatment differences on fracture risk.”
“This is the first large population study on this topic,” although there have been a few case reports, Dr. Burden explained in an interview.
However, “the high iron overload of greater than 1,000 mcg/L is not common, and hereditary hemochromatosis or thalassemia also are very rare,” she noted.
“The study shows that, once patients have an iron overload of more than 1,000 mcg/L, we need to be doing regular checks for their BMD and figuring how to best minimize their fracture risk,” she said.
“A twofold risk for a vertebral fracture” in patients with iron overload “is really high,” she noted. It is known that men with iron overload have loss of testosterone, but it may be less well known that they have an increased fracture risk.
“We worry about the liver,” she said, “not so much about the bones, and this shows us that we really should.”
Session comoderator Michael J. Econs, MD, who was not involved with the research, agreed. “Iron overload does occur, and it is a clinically important problem and can lead to hemochromatosis, which can lead to a whole host of diseases, but the most common is liver disease,” he told this news organization.
“So, it is a clinically important problem, not only in people who are genetically predisposed but in people who get frequent transfusion,” said Dr. Econs, distinguished professor of medicine and medical and molecular genetics at Indiana University, Indianapolis.
Now this new study has found an increase in fractures in such people, he noted.
Large case-control study used U.K. database
Using data from the IQVIA Medical Research Database, researchers identified 21,166 iron overload patients aged 18 years and older who saw a general practitioner in the United Kingdom between 2010 and 2020 and had a serum ferritin level above 1,000 mcg/L or a diagnostic code for hemochromatosis or nonanemic thalassemia.
They matched each iron overload patient with up to 10 control patients based on age, sex, year, and general practitioner, for a total of 198,037 control patients.
Patients were a mean age of 59 years and 59% were men.
During follow-up there were 777 fractures in the iron-overload patients (9.61 fractures per 1,000 patient-years) and 4,344 fractures in the control group (4.68 fractures per 1,000 patient-years).
In adjusted hazard ratio models, researchers adjusted for age, sex, body mass index, alcohol, smoking, history of fractures earlier than 365 days prior to study entry, hypogonadism, osteoporosis, medications, and comorbidities.
Overall, patients in the iron overload group had a 60% higher risk of an osteoporotic fracture (aHR, 1.60).
Among women, the incidence of osteoporotic fracture was 12.63 per 1,000 patient-years in the iron overload group and 7.09 per 1,000 patient-years in the control group.
Women with iron overload had a 48% higher risk of osteoporotic fracture, compared with other women (aHR, 1.48).
Among men, the incidence of osteoporotic fracture was 6.71 per 1,000 patient-years in the iron overload group and 3.01 per 1,000 patient-years in the control group.
Men with iron overload therefore had an 82% higher risk of osteoporotic fracture, compared with other men (aHR, 1.82).
Compared with patients without iron overload, patients with iron overload had an increased risk of a vertebral (aHR, 2.18), hip (aHR, 1.60), and humerus (aHR, 1.82) fracture but not a forearm fracture.
The researchers acknowledge that study limitations include they did not look at phlebotomy or changes in ferritin levels, and they excluded patients with hereditary hemochromatosis diagnosed before age 18.
The work was funded by the German Research Foundation. One of the researchers has reported receiving an independent grant from Pharmacosmos. The other researchers as well as Dr. Econs have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Children born after frozen-thawed embryo transfer (FET) may have a higher risk of cancer than children born through fresh embryo transfer or spontaneous conception, a large registry study suggests.
The results, however, “should be interpreted cautiously,” the authors noted, given the low number of cancer cases reported among children born using FET.
Still, the findings do “raise concerns considering the increasing use of FET, in particular freeze-all strategies without clear medical indications,” the authors concluded.
The number of children born after FET has increased globally and even exceeds the number of those born after fresh embryo transfer in many countries. In the United States, for instance, the FET rate has doubled since 2015; FETs constituted almost 80% of all embryo transfers using assisted reproductive technology (ART) without a donor in 2019.
Despite the benefits associated with FET, which include improved embryo survival and higher live birth rates, some previous research has hinted at a higher risk of childhood cancer in this population.
In the current study, researchers from the University of Gothenburg, Sweden, wanted to better understand the risk of childhood cancer following FET. The investigators analyzed data from 171,774 children born via ART, including 22,630 born after FET, as well as roughly 7.7 million children born after spontaneous conception in Denmark, Finland, Norway, and Sweden.
After a mean follow-up of about 10 years, the incidence rate of cancer diagnosed before age 18 years was 16.7 per 100,000 person-years for children born after spontaneous conception (16,184 cases) and 19.3 per 100,000 person-years for children born after ART (329 cases).
The researchers found no increased risk of cancer before age 18 years in the group of children conceived via ART compared with those conceived spontaneously.
However, children born after FET had a significantly higher risk of cancer compared with children born after fresh embryo transfer (adjusted hazard ratio [aHR], 1.59) and spontaneous conception (aHR, 1.65). Specifically with regard to ART, the incidence rate for those born after FET was 30.1 per 100,000 person-years – 48 total cases – compared with 18.8 per 1000,000 person-years after fresh embryo transfer.
Adjustment for macrosomia, birth weight, or major birth defects influenced the association only marginally.
For specific cancer types, children born after FET had more than a twofold higher risk for leukemia in comparison with those born after fresh embryo transfer (aHR, 2.25) and spontaneous conception (aHR, 2.22).
Still, the authors said these results should be interpreted “cautiously,” given the small number of children diagnosed with cancer after FET. The researchers also acknowledged that they do not know why children born after FET would face a higher risk of cancer.
These findings, however, do align with those from a 2019 Dutch population-based study. In the Dutch study, which included more than 24,000 ART-conceived children and more than 23,000 naturally conceived children, the risk of cancer after ART was not higher overall, but it was greater when only those conceived after FET were considered (aHR 1.80); this increased risk, however, was not statistically significant.
“Since the use of FET is substantially increasing, it is important to tease out whether the increased cancer risk is a true risk increase due to the ART procedures using FET, or due to chance or confounding by other factors,” authors of the 2019 Dutch study, Mandy Spaan, PhD, and Flora E. van Leeuwen, PhD, said in an interview.
“But, as childhood cancer is (fortunately) a rare disease, it is very difficult to study this research question among ART children due to limited numbers,” said Dr. Spaan and Dr. van Leeuwen, who are with the Netherlands Cancer Institute.
Given this, the two experts call for additional large population-based cohort studies to investigate the risk of cancer after ART, especially FET, and for a subsequent analysis that pools these data. They hope this strategy “will lead to reliable estimates” and provide information on the risks of FET in comparison with approaches that involve fresh embryos.
The current study had no commercial funding. The study authors as well as Dr. Spaan and Dr. van Leeuwen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Children born after frozen-thawed embryo transfer (FET) may have a higher risk of cancer than children born through fresh embryo transfer or spontaneous conception, a large registry study suggests.
The results, however, “should be interpreted cautiously,” the authors noted, given the low number of cancer cases reported among children born using FET.
Still, the findings do “raise concerns considering the increasing use of FET, in particular freeze-all strategies without clear medical indications,” the authors concluded.
The number of children born after FET has increased globally and even exceeds the number of those born after fresh embryo transfer in many countries. In the United States, for instance, the FET rate has doubled since 2015; FETs constituted almost 80% of all embryo transfers using assisted reproductive technology (ART) without a donor in 2019.
Despite the benefits associated with FET, which include improved embryo survival and higher live birth rates, some previous research has hinted at a higher risk of childhood cancer in this population.
In the current study, researchers from the University of Gothenburg, Sweden, wanted to better understand the risk of childhood cancer following FET. The investigators analyzed data from 171,774 children born via ART, including 22,630 born after FET, as well as roughly 7.7 million children born after spontaneous conception in Denmark, Finland, Norway, and Sweden.
After a mean follow-up of about 10 years, the incidence rate of cancer diagnosed before age 18 years was 16.7 per 100,000 person-years for children born after spontaneous conception (16,184 cases) and 19.3 per 100,000 person-years for children born after ART (329 cases).
The researchers found no increased risk of cancer before age 18 years in the group of children conceived via ART compared with those conceived spontaneously.
However, children born after FET had a significantly higher risk of cancer compared with children born after fresh embryo transfer (adjusted hazard ratio [aHR], 1.59) and spontaneous conception (aHR, 1.65). Specifically with regard to ART, the incidence rate for those born after FET was 30.1 per 100,000 person-years – 48 total cases – compared with 18.8 per 1000,000 person-years after fresh embryo transfer.
Adjustment for macrosomia, birth weight, or major birth defects influenced the association only marginally.
For specific cancer types, children born after FET had more than a twofold higher risk for leukemia in comparison with those born after fresh embryo transfer (aHR, 2.25) and spontaneous conception (aHR, 2.22).
Still, the authors said these results should be interpreted “cautiously,” given the small number of children diagnosed with cancer after FET. The researchers also acknowledged that they do not know why children born after FET would face a higher risk of cancer.
These findings, however, do align with those from a 2019 Dutch population-based study. In the Dutch study, which included more than 24,000 ART-conceived children and more than 23,000 naturally conceived children, the risk of cancer after ART was not higher overall, but it was greater when only those conceived after FET were considered (aHR 1.80); this increased risk, however, was not statistically significant.
“Since the use of FET is substantially increasing, it is important to tease out whether the increased cancer risk is a true risk increase due to the ART procedures using FET, or due to chance or confounding by other factors,” authors of the 2019 Dutch study, Mandy Spaan, PhD, and Flora E. van Leeuwen, PhD, said in an interview.
“But, as childhood cancer is (fortunately) a rare disease, it is very difficult to study this research question among ART children due to limited numbers,” said Dr. Spaan and Dr. van Leeuwen, who are with the Netherlands Cancer Institute.
Given this, the two experts call for additional large population-based cohort studies to investigate the risk of cancer after ART, especially FET, and for a subsequent analysis that pools these data. They hope this strategy “will lead to reliable estimates” and provide information on the risks of FET in comparison with approaches that involve fresh embryos.
The current study had no commercial funding. The study authors as well as Dr. Spaan and Dr. van Leeuwen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Children born after frozen-thawed embryo transfer (FET) may have a higher risk of cancer than children born through fresh embryo transfer or spontaneous conception, a large registry study suggests.
The results, however, “should be interpreted cautiously,” the authors noted, given the low number of cancer cases reported among children born using FET.
Still, the findings do “raise concerns considering the increasing use of FET, in particular freeze-all strategies without clear medical indications,” the authors concluded.
The number of children born after FET has increased globally and even exceeds the number of those born after fresh embryo transfer in many countries. In the United States, for instance, the FET rate has doubled since 2015; FETs constituted almost 80% of all embryo transfers using assisted reproductive technology (ART) without a donor in 2019.
Despite the benefits associated with FET, which include improved embryo survival and higher live birth rates, some previous research has hinted at a higher risk of childhood cancer in this population.
In the current study, researchers from the University of Gothenburg, Sweden, wanted to better understand the risk of childhood cancer following FET. The investigators analyzed data from 171,774 children born via ART, including 22,630 born after FET, as well as roughly 7.7 million children born after spontaneous conception in Denmark, Finland, Norway, and Sweden.
After a mean follow-up of about 10 years, the incidence rate of cancer diagnosed before age 18 years was 16.7 per 100,000 person-years for children born after spontaneous conception (16,184 cases) and 19.3 per 100,000 person-years for children born after ART (329 cases).
The researchers found no increased risk of cancer before age 18 years in the group of children conceived via ART compared with those conceived spontaneously.
However, children born after FET had a significantly higher risk of cancer compared with children born after fresh embryo transfer (adjusted hazard ratio [aHR], 1.59) and spontaneous conception (aHR, 1.65). Specifically with regard to ART, the incidence rate for those born after FET was 30.1 per 100,000 person-years – 48 total cases – compared with 18.8 per 1000,000 person-years after fresh embryo transfer.
Adjustment for macrosomia, birth weight, or major birth defects influenced the association only marginally.
For specific cancer types, children born after FET had more than a twofold higher risk for leukemia in comparison with those born after fresh embryo transfer (aHR, 2.25) and spontaneous conception (aHR, 2.22).
Still, the authors said these results should be interpreted “cautiously,” given the small number of children diagnosed with cancer after FET. The researchers also acknowledged that they do not know why children born after FET would face a higher risk of cancer.
These findings, however, do align with those from a 2019 Dutch population-based study. In the Dutch study, which included more than 24,000 ART-conceived children and more than 23,000 naturally conceived children, the risk of cancer after ART was not higher overall, but it was greater when only those conceived after FET were considered (aHR 1.80); this increased risk, however, was not statistically significant.
“Since the use of FET is substantially increasing, it is important to tease out whether the increased cancer risk is a true risk increase due to the ART procedures using FET, or due to chance or confounding by other factors,” authors of the 2019 Dutch study, Mandy Spaan, PhD, and Flora E. van Leeuwen, PhD, said in an interview.
“But, as childhood cancer is (fortunately) a rare disease, it is very difficult to study this research question among ART children due to limited numbers,” said Dr. Spaan and Dr. van Leeuwen, who are with the Netherlands Cancer Institute.
Given this, the two experts call for additional large population-based cohort studies to investigate the risk of cancer after ART, especially FET, and for a subsequent analysis that pools these data. They hope this strategy “will lead to reliable estimates” and provide information on the risks of FET in comparison with approaches that involve fresh embryos.
The current study had no commercial funding. The study authors as well as Dr. Spaan and Dr. van Leeuwen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The U.S. Preventive Services Task Force posted for public comment on Sept. 20 draft recommendations on screening for anxiety, depression, and suicide risk in adults.
For the first time, the task force is recommending screening all adults aged 64 and younger for anxiety – including pregnant and postpartum women.
This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit, the task force notes in a draft recommendation statement posted on its website.
The recommendation applies to adults aged 19-64 years who do not have a diagnosed mental health disorder or are not showing recognized signs or symptoms of anxiety.
Anxiety disorders are common and often go unrecognized in primary care, leading to long delays in treatment, the task force writes. They add that more evidence is needed to identify ideal screening intervals for all populations.
“A pragmatic approach in the absence of data might include screening all adults who have not been screened previously and using clinical judgment in consideration of risk factors, comorbid conditions, and life events to determine if additional screening of high-risk patients is warranted,” they write.
For adults aged 65 and older, the task force found “insufficient” evidence on the benefits and potential harms of screening for anxiety.
“Evidence on the accuracy of screening tools and the benefits and harms of screening and treatment of screen-detected anxiety in older adults is lacking, and the balance of benefits and harms cannot be determined,” they write.
Jury out on screening for suicide risk
The task force is continuing to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.
However, they note there is not enough evidence to recommend for or against screening for suicide risk in all adults.
They therefore issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.
“To address the critical need for supporting the mental health of adults in primary care, the Task Force reviewed the evidence on screening for anxiety, depression, and suicide risk,” task force member Lori Pbert, PhD, University of Massachusetts, Worcester, said in a news release.
“The good news is that screening all adults for depression, including those who are pregnant and postpartum, and screening adults younger than 65 for anxiety can help identify these conditions early so people can be connected to care,” Dr. Pbert said.
“Unfortunately, evidence is limited on screening adults 65 or older for anxiety and screening all adults for suicide risk, so we are urgently calling for more research,” added task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health.
Dr. Ogedegbe, also a professor at New York University, noted that “in the absence of evidence, health care professionals should use their judgment based on individual patient circumstances when determining whether or not to screen.”
The U.S. Preventive Services Task Force posted for public comment on Sept. 20 draft recommendations on screening for anxiety, depression, and suicide risk in adults.
For the first time, the task force is recommending screening all adults aged 64 and younger for anxiety – including pregnant and postpartum women.
This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit, the task force notes in a draft recommendation statement posted on its website.
The recommendation applies to adults aged 19-64 years who do not have a diagnosed mental health disorder or are not showing recognized signs or symptoms of anxiety.
Anxiety disorders are common and often go unrecognized in primary care, leading to long delays in treatment, the task force writes. They add that more evidence is needed to identify ideal screening intervals for all populations.
“A pragmatic approach in the absence of data might include screening all adults who have not been screened previously and using clinical judgment in consideration of risk factors, comorbid conditions, and life events to determine if additional screening of high-risk patients is warranted,” they write.
For adults aged 65 and older, the task force found “insufficient” evidence on the benefits and potential harms of screening for anxiety.
“Evidence on the accuracy of screening tools and the benefits and harms of screening and treatment of screen-detected anxiety in older adults is lacking, and the balance of benefits and harms cannot be determined,” they write.
Jury out on screening for suicide risk
The task force is continuing to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.
However, they note there is not enough evidence to recommend for or against screening for suicide risk in all adults.
They therefore issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.
“To address the critical need for supporting the mental health of adults in primary care, the Task Force reviewed the evidence on screening for anxiety, depression, and suicide risk,” task force member Lori Pbert, PhD, University of Massachusetts, Worcester, said in a news release.
“The good news is that screening all adults for depression, including those who are pregnant and postpartum, and screening adults younger than 65 for anxiety can help identify these conditions early so people can be connected to care,” Dr. Pbert said.
“Unfortunately, evidence is limited on screening adults 65 or older for anxiety and screening all adults for suicide risk, so we are urgently calling for more research,” added task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health.
Dr. Ogedegbe, also a professor at New York University, noted that “in the absence of evidence, health care professionals should use their judgment based on individual patient circumstances when determining whether or not to screen.”
A version of this article first appeared on Medscape.com.
The U.S. Preventive Services Task Force posted for public comment on Sept. 20 draft recommendations on screening for anxiety, depression, and suicide risk in adults.
For the first time, the task force is recommending screening all adults aged 64 and younger for anxiety – including pregnant and postpartum women.
This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit, the task force notes in a draft recommendation statement posted on its website.
The recommendation applies to adults aged 19-64 years who do not have a diagnosed mental health disorder or are not showing recognized signs or symptoms of anxiety.
Anxiety disorders are common and often go unrecognized in primary care, leading to long delays in treatment, the task force writes. They add that more evidence is needed to identify ideal screening intervals for all populations.
“A pragmatic approach in the absence of data might include screening all adults who have not been screened previously and using clinical judgment in consideration of risk factors, comorbid conditions, and life events to determine if additional screening of high-risk patients is warranted,” they write.
For adults aged 65 and older, the task force found “insufficient” evidence on the benefits and potential harms of screening for anxiety.
“Evidence on the accuracy of screening tools and the benefits and harms of screening and treatment of screen-detected anxiety in older adults is lacking, and the balance of benefits and harms cannot be determined,” they write.
Jury out on screening for suicide risk
The task force is continuing to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.
However, they note there is not enough evidence to recommend for or against screening for suicide risk in all adults.
They therefore issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.
“To address the critical need for supporting the mental health of adults in primary care, the Task Force reviewed the evidence on screening for anxiety, depression, and suicide risk,” task force member Lori Pbert, PhD, University of Massachusetts, Worcester, said in a news release.
“The good news is that screening all adults for depression, including those who are pregnant and postpartum, and screening adults younger than 65 for anxiety can help identify these conditions early so people can be connected to care,” Dr. Pbert said.
“Unfortunately, evidence is limited on screening adults 65 or older for anxiety and screening all adults for suicide risk, so we are urgently calling for more research,” added task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health.
Dr. Ogedegbe, also a professor at New York University, noted that “in the absence of evidence, health care professionals should use their judgment based on individual patient circumstances when determining whether or not to screen.”
Drinking two or more sugar-sweetened beverages daily may raise the risk of dying from obesity-related cancers, new research shows.
The study, which included more than 900,000 participants, contributes to previous research suggesting that sugary beverages increase the risk of cancer and cancer-related mortality.
A more surprising finding is that consuming artificially sweetened beverages was linked to an increased risk of death from pancreatic cancer.
American Heart Association
“This finding is very interesting,” said Marjorie McCullough, ScD, RD, senior scientific director of epidemiology research, American Cancer Society. She noted that other studies that examined an association between artificially sweetened beverages and pancreatic cancer did not reveal a statistically significant association.
“Our study is the first, to our knowledge, that has found a statistically significant positive association, and it will be important to replicate this finding,” said Dr. McCullough.
The study was published online in Cancer, Epidemiology, Biomarkers, and Prevention.
In the study, Dr. McCullough and colleagues examined associations between drinking sugar-sweetened and artificially sweetened beverages and dying from any cancer or any obesity-related cancers. The researchers also examined this association for 20 individual cancer types.
Participants included 934,777 cancer-free adults from the Cancer Prevention Study-II (CPS-II) prospective cohort. At baseline, adults completed a questionnaire on their medical history, lifestyle exposures, and habits, including how many sugar-sweetened or artificially sweetened drinks they typically consumed each day.
Over a median 28-year follow-up, 135,093 participants died from cancer.
Overall, the researchers determined that consuming two or more sugar-sweetened beverages daily (vs. consuming none) was not associated with all-cancer mortality.
Regarding obesity-related cancers, Dr. McCullough and colleagues found a significant 5% increased risk of death from these cancer (hazard ratio, 1.05); however, this association disappeared after controlling for body mass index (BMI). According to Dr. McCullough, this finding may signal that the association between sugary drinks and obesity-related cancer deaths is at least partly mediated by higher BMI, or excess body fat.
“Weight control is key to cancer prevention,” noted Linda Van Horn, RD, chief of the nutrition division at the Feinberg School of Medicine, Northwestern University, Chicago, who wasn’t involved in the study.
However, with regard to individual cancers, consuming two or more sugar-sweetened drinks each day was associated with an increased risk of dying from colorectal cancer (HR, 1.09) and kidney cancer (HR, 1.17) after adjusting for BMI.
Unexpectedly, sugary beverage intake was associated with a lower risk of esophageal and lung cancer mortality. This association held for lung cancer but not esophageal cancer after restricting the analysis to never-smoking participants (HR, 0.81; 95% confidence interval, 0.70-0.94).
Artificial sweetener and pancreatic cancer?
With respect to artificially sweetened drinks, consuming two or more beverages daily was associated with a 5% increased risk of death from obesity-related cancers (HR, 1.05), but that association became null after controlling for BMI.
However, the link to pancreatic cancer mortality remained after adjusting for BMI (HR, 1.11). This association should be studied further, the researchers say. They say there is a possibility that undiagnosed diabetes influenced the results.
“Continued research on the impact of both beverage types with cancer risk and mortality is warranted to determine whether these associations are causal or confounded by other lifestyle factors and whether they are mediated through BMI,” the researchers write.
Reached for comment, Marcus DaSilva Goncalves, MD, PhD, with Weill Cornell Medicine, New York, noted that the association with colorectal cancer has been previously reported, and he agreed that these “findings strengthen the available evidence of an association between sugar-sweetened beverages and colorectal cancer mortality.”
“Data from my lab in mice have shown that sugar-sweetened beverages deliver fructose directly to colon tumors, which stimulates the survival of cancer cells and growth of tumors,” Dr. Goncalves said.
There are also recent clinical data suggesting that exposure to sugar-sweetened beverages during adolescence and adulthood promotes adenoma formation, the precursor to colorectal cancer, he said.
Regarding artificially sweetened beverage intake, Dr. Goncalves said the effect with pancreatic cancer is “surprising” and that he is not aware of other data, including data from several large studies, that support this relationship.
No specific funding for study has been reported. Dr. McCullough, Ms. Van Horn, and Dr. Goncalves have disclosed no relevant disclosures relationships.
A version of this article first appeared on Medscape.com.
Drinking two or more sugar-sweetened beverages daily may raise the risk of dying from obesity-related cancers, new research shows.
The study, which included more than 900,000 participants, contributes to previous research suggesting that sugary beverages increase the risk of cancer and cancer-related mortality.
A more surprising finding is that consuming artificially sweetened beverages was linked to an increased risk of death from pancreatic cancer.
American Heart Association
“This finding is very interesting,” said Marjorie McCullough, ScD, RD, senior scientific director of epidemiology research, American Cancer Society. She noted that other studies that examined an association between artificially sweetened beverages and pancreatic cancer did not reveal a statistically significant association.
“Our study is the first, to our knowledge, that has found a statistically significant positive association, and it will be important to replicate this finding,” said Dr. McCullough.
The study was published online in Cancer, Epidemiology, Biomarkers, and Prevention.
In the study, Dr. McCullough and colleagues examined associations between drinking sugar-sweetened and artificially sweetened beverages and dying from any cancer or any obesity-related cancers. The researchers also examined this association for 20 individual cancer types.
Participants included 934,777 cancer-free adults from the Cancer Prevention Study-II (CPS-II) prospective cohort. At baseline, adults completed a questionnaire on their medical history, lifestyle exposures, and habits, including how many sugar-sweetened or artificially sweetened drinks they typically consumed each day.
Over a median 28-year follow-up, 135,093 participants died from cancer.
Overall, the researchers determined that consuming two or more sugar-sweetened beverages daily (vs. consuming none) was not associated with all-cancer mortality.
Regarding obesity-related cancers, Dr. McCullough and colleagues found a significant 5% increased risk of death from these cancer (hazard ratio, 1.05); however, this association disappeared after controlling for body mass index (BMI). According to Dr. McCullough, this finding may signal that the association between sugary drinks and obesity-related cancer deaths is at least partly mediated by higher BMI, or excess body fat.
“Weight control is key to cancer prevention,” noted Linda Van Horn, RD, chief of the nutrition division at the Feinberg School of Medicine, Northwestern University, Chicago, who wasn’t involved in the study.
However, with regard to individual cancers, consuming two or more sugar-sweetened drinks each day was associated with an increased risk of dying from colorectal cancer (HR, 1.09) and kidney cancer (HR, 1.17) after adjusting for BMI.
Unexpectedly, sugary beverage intake was associated with a lower risk of esophageal and lung cancer mortality. This association held for lung cancer but not esophageal cancer after restricting the analysis to never-smoking participants (HR, 0.81; 95% confidence interval, 0.70-0.94).
Artificial sweetener and pancreatic cancer?
With respect to artificially sweetened drinks, consuming two or more beverages daily was associated with a 5% increased risk of death from obesity-related cancers (HR, 1.05), but that association became null after controlling for BMI.
However, the link to pancreatic cancer mortality remained after adjusting for BMI (HR, 1.11). This association should be studied further, the researchers say. They say there is a possibility that undiagnosed diabetes influenced the results.
“Continued research on the impact of both beverage types with cancer risk and mortality is warranted to determine whether these associations are causal or confounded by other lifestyle factors and whether they are mediated through BMI,” the researchers write.
Reached for comment, Marcus DaSilva Goncalves, MD, PhD, with Weill Cornell Medicine, New York, noted that the association with colorectal cancer has been previously reported, and he agreed that these “findings strengthen the available evidence of an association between sugar-sweetened beverages and colorectal cancer mortality.”
“Data from my lab in mice have shown that sugar-sweetened beverages deliver fructose directly to colon tumors, which stimulates the survival of cancer cells and growth of tumors,” Dr. Goncalves said.
There are also recent clinical data suggesting that exposure to sugar-sweetened beverages during adolescence and adulthood promotes adenoma formation, the precursor to colorectal cancer, he said.
Regarding artificially sweetened beverage intake, Dr. Goncalves said the effect with pancreatic cancer is “surprising” and that he is not aware of other data, including data from several large studies, that support this relationship.
No specific funding for study has been reported. Dr. McCullough, Ms. Van Horn, and Dr. Goncalves have disclosed no relevant disclosures relationships.
A version of this article first appeared on Medscape.com.
Drinking two or more sugar-sweetened beverages daily may raise the risk of dying from obesity-related cancers, new research shows.
The study, which included more than 900,000 participants, contributes to previous research suggesting that sugary beverages increase the risk of cancer and cancer-related mortality.
A more surprising finding is that consuming artificially sweetened beverages was linked to an increased risk of death from pancreatic cancer.
American Heart Association
“This finding is very interesting,” said Marjorie McCullough, ScD, RD, senior scientific director of epidemiology research, American Cancer Society. She noted that other studies that examined an association between artificially sweetened beverages and pancreatic cancer did not reveal a statistically significant association.
“Our study is the first, to our knowledge, that has found a statistically significant positive association, and it will be important to replicate this finding,” said Dr. McCullough.
The study was published online in Cancer, Epidemiology, Biomarkers, and Prevention.
In the study, Dr. McCullough and colleagues examined associations between drinking sugar-sweetened and artificially sweetened beverages and dying from any cancer or any obesity-related cancers. The researchers also examined this association for 20 individual cancer types.
Participants included 934,777 cancer-free adults from the Cancer Prevention Study-II (CPS-II) prospective cohort. At baseline, adults completed a questionnaire on their medical history, lifestyle exposures, and habits, including how many sugar-sweetened or artificially sweetened drinks they typically consumed each day.
Over a median 28-year follow-up, 135,093 participants died from cancer.
Overall, the researchers determined that consuming two or more sugar-sweetened beverages daily (vs. consuming none) was not associated with all-cancer mortality.
Regarding obesity-related cancers, Dr. McCullough and colleagues found a significant 5% increased risk of death from these cancer (hazard ratio, 1.05); however, this association disappeared after controlling for body mass index (BMI). According to Dr. McCullough, this finding may signal that the association between sugary drinks and obesity-related cancer deaths is at least partly mediated by higher BMI, or excess body fat.
“Weight control is key to cancer prevention,” noted Linda Van Horn, RD, chief of the nutrition division at the Feinberg School of Medicine, Northwestern University, Chicago, who wasn’t involved in the study.
However, with regard to individual cancers, consuming two or more sugar-sweetened drinks each day was associated with an increased risk of dying from colorectal cancer (HR, 1.09) and kidney cancer (HR, 1.17) after adjusting for BMI.
Unexpectedly, sugary beverage intake was associated with a lower risk of esophageal and lung cancer mortality. This association held for lung cancer but not esophageal cancer after restricting the analysis to never-smoking participants (HR, 0.81; 95% confidence interval, 0.70-0.94).
Artificial sweetener and pancreatic cancer?
With respect to artificially sweetened drinks, consuming two or more beverages daily was associated with a 5% increased risk of death from obesity-related cancers (HR, 1.05), but that association became null after controlling for BMI.
However, the link to pancreatic cancer mortality remained after adjusting for BMI (HR, 1.11). This association should be studied further, the researchers say. They say there is a possibility that undiagnosed diabetes influenced the results.
“Continued research on the impact of both beverage types with cancer risk and mortality is warranted to determine whether these associations are causal or confounded by other lifestyle factors and whether they are mediated through BMI,” the researchers write.
Reached for comment, Marcus DaSilva Goncalves, MD, PhD, with Weill Cornell Medicine, New York, noted that the association with colorectal cancer has been previously reported, and he agreed that these “findings strengthen the available evidence of an association between sugar-sweetened beverages and colorectal cancer mortality.”
“Data from my lab in mice have shown that sugar-sweetened beverages deliver fructose directly to colon tumors, which stimulates the survival of cancer cells and growth of tumors,” Dr. Goncalves said.
There are also recent clinical data suggesting that exposure to sugar-sweetened beverages during adolescence and adulthood promotes adenoma formation, the precursor to colorectal cancer, he said.
Regarding artificially sweetened beverage intake, Dr. Goncalves said the effect with pancreatic cancer is “surprising” and that he is not aware of other data, including data from several large studies, that support this relationship.
No specific funding for study has been reported. Dr. McCullough, Ms. Van Horn, and Dr. Goncalves have disclosed no relevant disclosures relationships.
A version of this article first appeared on Medscape.com.
A newly available transcatheter device for edge-to-edge mitral valve (MV) repair, named for a famed scientist-inventor, is similar to the long-available MitraClip (Abbott) for short-term efficacy and safety, suggests an interim but prespecified analysis from a randomized trial.
In its comparison with MitraClip, the PASCAL transcatheter valve repair system (Edwards Lifesciences) was noninferior with respect to 30-day major adverse events and to success at achieving mitral regurgitation (MR) of no more than moderate severity within 6 months. The trial had entered patients with significant, symptomatic degenerative MR considered too high-risk for surgical repair or replacement.
The interim analysis covers 180 of the 300 patients followed in the study, of whom 117 received the PASCAL device and 63 were given MitraClip. Both groups showed significant gains in functional class, symptom status, and quality of life over 6 months, reported D. Scott Lim, MD, University of Virginia Health System Hospital, Charlottesville, and Konstantinos Koulogiannis, MD, Morristown Medical Center, N.J., jointly on Sept. 17 at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 annual meeting in Boston.
Dr. Lim, one of the trial’s principal investigators, is also lead author on its same-day publication in JACC: Cardiovascular Interventions.
Based largely on those results from the CLASP IID pivotal trial, the U.S. Food and Drug Administration recently approved the PASCAL system for use in patients with degenerative MR, Edwards announced on Sept. 15. The device was approved in the European Union on Aug. 17.
MitraClip has been available in various iterations in the United States since 2013 and in Europe since 2008.
“It’s good for the field to be able to say we have two devices that are comparable,” giving clinicians more options, Vinod H. Thourani, MD, Piedmont Heart Institute, Atlanta, told this news organization.
The current analysis shows that “we’ve yet to figure out what patient pathologies will be beneficial” for each of the devices, Dr. Thourani said. “The goal will be to find out if there are certain anatomical considerations where one device is better than the other.”
It will be necessary to study “more patients, a larger cohort, with longer follow-up to allow us to see their true benefits,” he said, as well as to conduct more subgroup analyses. For now, the choice of device will probably be “operator-specific, which they feel comfortable with.”
Dr. Thourani, not an author on the current study, is the U.S. principal investigator for the CLASP IIF study looking at clinical outcomes with the two devices and says he consults for both Edwards and Abbott.
The findings are “preliminary for now,” said Michael Young, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., in part because, like most randomized trials, CLASP IID entered a select, not broadly representative population.
“They want to make, as best as they could, an apples-to-apples comparison, without confounding that might make it more difficult to interpret it afterwards,” Dr. Young, not associated with the trial, told this news organization.
But CLASP IID “did enroll patients that we do see and treat, so undoubtedly it’s a compelling study. We now have another device that is shown to be safe and effective. How we’re going to extrapolate it to all the patients that are being referred to our practices will, I think, be under debate and deliberation.”
The PASCAL and MitraClip devices each may be more suitable for different patients with varying mitral valve pathologies because of differences in their designs, Dr. Lim said. The PASCAL’s relative flexibility might make it preferable in patients with smaller mitral valves, and its ability to elongate during delivery could make it more suitable for patients with chordal-dense areas around the valve, he speculated.
MitraClip, Dr. Lim told this news organization, has a mechanical closure system for anchoring that may make it more appropriate for “more complicated, thicker leaflets with calcium.”
CLASP IID enrolled patients with grade 3+ or 4+ degenerative MR considered to be “at prohibitive surgical risk” at 43 sites in North America and Europe. It randomly assigned them 2-to-1 to receive the PASCAL device or MitraClip.
Either of two PASCAL versions were used, the original device or the “smaller, narrower” PASCAL Ace, Dr. Lim observed. Both versions are covered by the PASCAL Precision System FDA approval. About 40% of patients assigned to MitraClip received older versions of the device and about 60%, more recent versions, as they were entered into practice.
The mean procedure times were 88 minutes for PASCAL and 79 minutes for MitraClip (P = .023), with much of the difference attributable to the earliest PASCAL procedures. Procedure times for the device declined with greater operator experience, the published report states.
Rates of the primary safety endpoint of major adverse events at 30 days were 3.4% for PASCAL and 4.8% for MitraClip. The endpoint was a composite of cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, or nonelective MV reintervention.
The proportion of patients with MR grade 2+ or lower at 6 months, the primary effectiveness endpoint, assessed at a core laboratory, was 96.5% for the PASCAL group over a median follow-up of 179.5 days and 96.8% over a median of 184.5 days for those who received MitraClip.
Comparisons for both primary endpoints met the prespecified criteria for PASCAL noninferiority.
In a secondary analysis, the proportion of PASCAL patients with MR grade 1+ or less held about steady from postprocedure discharge out to 6 months, at 87.2% and 83.7%, respectively (P = .317).
But whereas 88.5% of MitraClip patients had MR grade 1+ or better at discharge, 71.2% were at that grade by 6 months (P = .003). That apparent hemodynamic deterioration raised some eyebrows at the TCT sessions as a potential sign that PASCAL functional results are more durable.
That sort of judgment is premature, offered Anita W. Asgar, MD, MSc, Montreal Heart Institute, Quebec City, as an invited discussant after the CLASP IID trial’s formal presentation at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The trial is notable in part for “showing how safe this procedure is and how successful it is for these patients – this is phenomenal,” she said, but “I would caution comparing one device being better than another with such a small number of patients.”
MitraClip, Dr. Young observed, “has been, up to this point, our only option for edge-to-edge repair of the mitral valve. And many of us have years of experience and a lot of patients that we treat with that device.” His center hasn’t yet used PASCAL, but that may change as the field gains more familiarity with the device. Operators may use either device in different cases, he said.
“Depending on the program, and depending on the volume of mitral patients that you see and edge-to-edge repair that you do, it could be that you stick with one, or switch to another, or you integrate both of them and try to decide which patients might be better suited for one or the other.”
CLASP IID was sponsored by Edwards Lifesciences. Dr. Lim discloses consulting for Philips, Venus, and Valgen and receiving research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Koulogiannis discloses consulting and serving on an advisory board for Edwards Lifesciences and as a speaker for Abbott and discloses holding equity, stocks, or stock options in 4C. Dr. Thourani discloses serving as a consultant to both Abbott and Edwards Lifesciences. Dr. Young discloses receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic. Dr. Asgar discloses receiving research support from or holding a research contract with Abbott Vascular and receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic, Edwards Lifesciences, and W. Gore & Associates.
A version of this article first appeared on Medscape.com.
A newly available transcatheter device for edge-to-edge mitral valve (MV) repair, named for a famed scientist-inventor, is similar to the long-available MitraClip (Abbott) for short-term efficacy and safety, suggests an interim but prespecified analysis from a randomized trial.
In its comparison with MitraClip, the PASCAL transcatheter valve repair system (Edwards Lifesciences) was noninferior with respect to 30-day major adverse events and to success at achieving mitral regurgitation (MR) of no more than moderate severity within 6 months. The trial had entered patients with significant, symptomatic degenerative MR considered too high-risk for surgical repair or replacement.
The interim analysis covers 180 of the 300 patients followed in the study, of whom 117 received the PASCAL device and 63 were given MitraClip. Both groups showed significant gains in functional class, symptom status, and quality of life over 6 months, reported D. Scott Lim, MD, University of Virginia Health System Hospital, Charlottesville, and Konstantinos Koulogiannis, MD, Morristown Medical Center, N.J., jointly on Sept. 17 at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 annual meeting in Boston.
Dr. Lim, one of the trial’s principal investigators, is also lead author on its same-day publication in JACC: Cardiovascular Interventions.
Based largely on those results from the CLASP IID pivotal trial, the U.S. Food and Drug Administration recently approved the PASCAL system for use in patients with degenerative MR, Edwards announced on Sept. 15. The device was approved in the European Union on Aug. 17.
MitraClip has been available in various iterations in the United States since 2013 and in Europe since 2008.
“It’s good for the field to be able to say we have two devices that are comparable,” giving clinicians more options, Vinod H. Thourani, MD, Piedmont Heart Institute, Atlanta, told this news organization.
The current analysis shows that “we’ve yet to figure out what patient pathologies will be beneficial” for each of the devices, Dr. Thourani said. “The goal will be to find out if there are certain anatomical considerations where one device is better than the other.”
It will be necessary to study “more patients, a larger cohort, with longer follow-up to allow us to see their true benefits,” he said, as well as to conduct more subgroup analyses. For now, the choice of device will probably be “operator-specific, which they feel comfortable with.”
Dr. Thourani, not an author on the current study, is the U.S. principal investigator for the CLASP IIF study looking at clinical outcomes with the two devices and says he consults for both Edwards and Abbott.
The findings are “preliminary for now,” said Michael Young, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., in part because, like most randomized trials, CLASP IID entered a select, not broadly representative population.
“They want to make, as best as they could, an apples-to-apples comparison, without confounding that might make it more difficult to interpret it afterwards,” Dr. Young, not associated with the trial, told this news organization.
But CLASP IID “did enroll patients that we do see and treat, so undoubtedly it’s a compelling study. We now have another device that is shown to be safe and effective. How we’re going to extrapolate it to all the patients that are being referred to our practices will, I think, be under debate and deliberation.”
The PASCAL and MitraClip devices each may be more suitable for different patients with varying mitral valve pathologies because of differences in their designs, Dr. Lim said. The PASCAL’s relative flexibility might make it preferable in patients with smaller mitral valves, and its ability to elongate during delivery could make it more suitable for patients with chordal-dense areas around the valve, he speculated.
MitraClip, Dr. Lim told this news organization, has a mechanical closure system for anchoring that may make it more appropriate for “more complicated, thicker leaflets with calcium.”
CLASP IID enrolled patients with grade 3+ or 4+ degenerative MR considered to be “at prohibitive surgical risk” at 43 sites in North America and Europe. It randomly assigned them 2-to-1 to receive the PASCAL device or MitraClip.
Either of two PASCAL versions were used, the original device or the “smaller, narrower” PASCAL Ace, Dr. Lim observed. Both versions are covered by the PASCAL Precision System FDA approval. About 40% of patients assigned to MitraClip received older versions of the device and about 60%, more recent versions, as they were entered into practice.
The mean procedure times were 88 minutes for PASCAL and 79 minutes for MitraClip (P = .023), with much of the difference attributable to the earliest PASCAL procedures. Procedure times for the device declined with greater operator experience, the published report states.
Rates of the primary safety endpoint of major adverse events at 30 days were 3.4% for PASCAL and 4.8% for MitraClip. The endpoint was a composite of cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, or nonelective MV reintervention.
The proportion of patients with MR grade 2+ or lower at 6 months, the primary effectiveness endpoint, assessed at a core laboratory, was 96.5% for the PASCAL group over a median follow-up of 179.5 days and 96.8% over a median of 184.5 days for those who received MitraClip.
Comparisons for both primary endpoints met the prespecified criteria for PASCAL noninferiority.
In a secondary analysis, the proportion of PASCAL patients with MR grade 1+ or less held about steady from postprocedure discharge out to 6 months, at 87.2% and 83.7%, respectively (P = .317).
But whereas 88.5% of MitraClip patients had MR grade 1+ or better at discharge, 71.2% were at that grade by 6 months (P = .003). That apparent hemodynamic deterioration raised some eyebrows at the TCT sessions as a potential sign that PASCAL functional results are more durable.
That sort of judgment is premature, offered Anita W. Asgar, MD, MSc, Montreal Heart Institute, Quebec City, as an invited discussant after the CLASP IID trial’s formal presentation at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The trial is notable in part for “showing how safe this procedure is and how successful it is for these patients – this is phenomenal,” she said, but “I would caution comparing one device being better than another with such a small number of patients.”
MitraClip, Dr. Young observed, “has been, up to this point, our only option for edge-to-edge repair of the mitral valve. And many of us have years of experience and a lot of patients that we treat with that device.” His center hasn’t yet used PASCAL, but that may change as the field gains more familiarity with the device. Operators may use either device in different cases, he said.
“Depending on the program, and depending on the volume of mitral patients that you see and edge-to-edge repair that you do, it could be that you stick with one, or switch to another, or you integrate both of them and try to decide which patients might be better suited for one or the other.”
CLASP IID was sponsored by Edwards Lifesciences. Dr. Lim discloses consulting for Philips, Venus, and Valgen and receiving research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Koulogiannis discloses consulting and serving on an advisory board for Edwards Lifesciences and as a speaker for Abbott and discloses holding equity, stocks, or stock options in 4C. Dr. Thourani discloses serving as a consultant to both Abbott and Edwards Lifesciences. Dr. Young discloses receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic. Dr. Asgar discloses receiving research support from or holding a research contract with Abbott Vascular and receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic, Edwards Lifesciences, and W. Gore & Associates.
A version of this article first appeared on Medscape.com.
A newly available transcatheter device for edge-to-edge mitral valve (MV) repair, named for a famed scientist-inventor, is similar to the long-available MitraClip (Abbott) for short-term efficacy and safety, suggests an interim but prespecified analysis from a randomized trial.
In its comparison with MitraClip, the PASCAL transcatheter valve repair system (Edwards Lifesciences) was noninferior with respect to 30-day major adverse events and to success at achieving mitral regurgitation (MR) of no more than moderate severity within 6 months. The trial had entered patients with significant, symptomatic degenerative MR considered too high-risk for surgical repair or replacement.
The interim analysis covers 180 of the 300 patients followed in the study, of whom 117 received the PASCAL device and 63 were given MitraClip. Both groups showed significant gains in functional class, symptom status, and quality of life over 6 months, reported D. Scott Lim, MD, University of Virginia Health System Hospital, Charlottesville, and Konstantinos Koulogiannis, MD, Morristown Medical Center, N.J., jointly on Sept. 17 at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 annual meeting in Boston.
Dr. Lim, one of the trial’s principal investigators, is also lead author on its same-day publication in JACC: Cardiovascular Interventions.
Based largely on those results from the CLASP IID pivotal trial, the U.S. Food and Drug Administration recently approved the PASCAL system for use in patients with degenerative MR, Edwards announced on Sept. 15. The device was approved in the European Union on Aug. 17.
MitraClip has been available in various iterations in the United States since 2013 and in Europe since 2008.
“It’s good for the field to be able to say we have two devices that are comparable,” giving clinicians more options, Vinod H. Thourani, MD, Piedmont Heart Institute, Atlanta, told this news organization.
The current analysis shows that “we’ve yet to figure out what patient pathologies will be beneficial” for each of the devices, Dr. Thourani said. “The goal will be to find out if there are certain anatomical considerations where one device is better than the other.”
It will be necessary to study “more patients, a larger cohort, with longer follow-up to allow us to see their true benefits,” he said, as well as to conduct more subgroup analyses. For now, the choice of device will probably be “operator-specific, which they feel comfortable with.”
Dr. Thourani, not an author on the current study, is the U.S. principal investigator for the CLASP IIF study looking at clinical outcomes with the two devices and says he consults for both Edwards and Abbott.
The findings are “preliminary for now,” said Michael Young, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., in part because, like most randomized trials, CLASP IID entered a select, not broadly representative population.
“They want to make, as best as they could, an apples-to-apples comparison, without confounding that might make it more difficult to interpret it afterwards,” Dr. Young, not associated with the trial, told this news organization.
But CLASP IID “did enroll patients that we do see and treat, so undoubtedly it’s a compelling study. We now have another device that is shown to be safe and effective. How we’re going to extrapolate it to all the patients that are being referred to our practices will, I think, be under debate and deliberation.”
The PASCAL and MitraClip devices each may be more suitable for different patients with varying mitral valve pathologies because of differences in their designs, Dr. Lim said. The PASCAL’s relative flexibility might make it preferable in patients with smaller mitral valves, and its ability to elongate during delivery could make it more suitable for patients with chordal-dense areas around the valve, he speculated.
MitraClip, Dr. Lim told this news organization, has a mechanical closure system for anchoring that may make it more appropriate for “more complicated, thicker leaflets with calcium.”
CLASP IID enrolled patients with grade 3+ or 4+ degenerative MR considered to be “at prohibitive surgical risk” at 43 sites in North America and Europe. It randomly assigned them 2-to-1 to receive the PASCAL device or MitraClip.
Either of two PASCAL versions were used, the original device or the “smaller, narrower” PASCAL Ace, Dr. Lim observed. Both versions are covered by the PASCAL Precision System FDA approval. About 40% of patients assigned to MitraClip received older versions of the device and about 60%, more recent versions, as they were entered into practice.
The mean procedure times were 88 minutes for PASCAL and 79 minutes for MitraClip (P = .023), with much of the difference attributable to the earliest PASCAL procedures. Procedure times for the device declined with greater operator experience, the published report states.
Rates of the primary safety endpoint of major adverse events at 30 days were 3.4% for PASCAL and 4.8% for MitraClip. The endpoint was a composite of cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, or nonelective MV reintervention.
The proportion of patients with MR grade 2+ or lower at 6 months, the primary effectiveness endpoint, assessed at a core laboratory, was 96.5% for the PASCAL group over a median follow-up of 179.5 days and 96.8% over a median of 184.5 days for those who received MitraClip.
Comparisons for both primary endpoints met the prespecified criteria for PASCAL noninferiority.
In a secondary analysis, the proportion of PASCAL patients with MR grade 1+ or less held about steady from postprocedure discharge out to 6 months, at 87.2% and 83.7%, respectively (P = .317).
But whereas 88.5% of MitraClip patients had MR grade 1+ or better at discharge, 71.2% were at that grade by 6 months (P = .003). That apparent hemodynamic deterioration raised some eyebrows at the TCT sessions as a potential sign that PASCAL functional results are more durable.
That sort of judgment is premature, offered Anita W. Asgar, MD, MSc, Montreal Heart Institute, Quebec City, as an invited discussant after the CLASP IID trial’s formal presentation at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The trial is notable in part for “showing how safe this procedure is and how successful it is for these patients – this is phenomenal,” she said, but “I would caution comparing one device being better than another with such a small number of patients.”
MitraClip, Dr. Young observed, “has been, up to this point, our only option for edge-to-edge repair of the mitral valve. And many of us have years of experience and a lot of patients that we treat with that device.” His center hasn’t yet used PASCAL, but that may change as the field gains more familiarity with the device. Operators may use either device in different cases, he said.
“Depending on the program, and depending on the volume of mitral patients that you see and edge-to-edge repair that you do, it could be that you stick with one, or switch to another, or you integrate both of them and try to decide which patients might be better suited for one or the other.”
CLASP IID was sponsored by Edwards Lifesciences. Dr. Lim discloses consulting for Philips, Venus, and Valgen and receiving research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Koulogiannis discloses consulting and serving on an advisory board for Edwards Lifesciences and as a speaker for Abbott and discloses holding equity, stocks, or stock options in 4C. Dr. Thourani discloses serving as a consultant to both Abbott and Edwards Lifesciences. Dr. Young discloses receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic. Dr. Asgar discloses receiving research support from or holding a research contract with Abbott Vascular and receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic, Edwards Lifesciences, and W. Gore & Associates.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM – Higher consumption of whole grains, fish, fiber, and omega-3 polyunsaturated fatty acids reduces deaths from all causes in people with type 2 diabetes, show new data.
Results from the systematic review and meta-analysis were presented at the annual meeting of the European Association for the Study of Diabetes by lead author Janett Barbaresko, PhD, a researcher from the German Diabetes Center in Düsseldorf.
Lisovskaya/iStock/Getty Images Plus
Adding just one serving (around 20 g/day) of whole grains from foods such as brown bread, brown rice, or breakfast cereals was associated with about a 16% reduction in all-cause mortality, and each portion of fish consumed per week was associated with a 5% lower risk of all-cause mortality. In addition, eating 5 g/day of fiber was associated with a 14% reduction in all-cause mortality, and 0.1 g/day of omega-3 polyunsaturated fatty acids with a 13% reduction.
Diet also has role in improving survival in those with type 2 diabetes
Dr. Barbaresko explained that most dietary recommendations for people with type 2 diabetes are not evidence based or are derived from studies of the general population, and that the degree to which different components of diet are associated with all-cause mortality, or indeed the prevention of morbidity and mortality, remains unknown.
By way of example, she noted the American Diabetes Association 2022 guidelines for the prevention and management of diabetes complications advises limited intake of saturated and trans fatty acids, higher intake of polyunsaturated fatty acids, and following the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets.
“Our findings show that dietary factors not only play a role in the prevention of type 2 diabetes, but also seem to be relevant for improving survival in people with diagnosed diabetes,” she said, adding that, “in particular, we found some key aspects of a healthy diet such as higher intakes of whole grains, fiber, fish, and omega-3 polyunsaturated fatty acids may improve survival of individuals with type 2 diabetes.”
She noted that individuals with type 2 diabetes are known to be more prone to circulatory diseases, dementia, cancer, and bone fractures, and that lifestyle modifications, including diet – with or without medications – underpin most management strategies.
“For the first time, we have provided a summary of all published studies on any dietary factor in association to all-cause mortality in individuals with type 2 diabetes,” said Dr. Barbaresko. “Moreover, the certainty of evidence has been evaluated for the first time.”
Matthias Schulze, MD, head of the German Institute of Human Nutrition, Berlin, moderated the session.
The new work “summarizes the available evidence, providing important dietary advice for patients with diabetes, for example, recommending whole grains,” he remarked. “However, the study also points to gaps in knowledge, so for many diet factors, we have either no or few studies, or study quality considered to be low, which calls for more research to fill the gap.”
High versus low intake of various dietary factors
The researchers performed meta-analyses based on published studies of all-cause mortality in individuals with type 2 diabetes aged 18 years and over, as associated with dietary patterns, macronutrients (carbohydrates, protein, fat), micronutrients (vitamins and minerals), secondary plant compounds (for example, polyphenols), and supplements.
Studies were conducted mainly in the United States and Europe with a mean follow-up of 10 years. Low and high intake were compared, and a dose-response relationship between different dietary factors and all-cause mortality was explored to generate summary risk ratios. The researchers also explored how the certainty of evidence was determined.
Decreased mortality from any cause was found for a higher intake of fish (SRR per serving/week, 0.95; over six studies); whole grain (SRR per 20 g/day, 0.84; two studies); fiber (SRR per 5 g/day, 0.86; three studies), and omega-3 polyunsaturated fatty acids (SRR per 0.1 g/day, 0.87; two studies).
A low certainty of evidence was found for an inverse association between all-cause mortality and vegetable consumption (SRR per 100 g/day, 0.88; two studies) and plant protein intake (SRR per 10 g/day, 0.91; three studies).
Eggs were associated with an increased risk of all-cause mortality (SRR per 10 g/day, 1.05; seven studies), as was dietary cholesterol (SRR per 300 mg/day, 1.19; two studies).
Regarding other dietary patterns, including the Mediterranean diet and low-carbohydrate diet, either no association was found and/or the evidence was very uncertain. Likewise, evidence was uncertain for foods including nuts, dairy, meat, sugar and sweets; macronutrients, including carbohydrates; and micronutrients, such as caffeine and vitamin D.
“With the Mediterranean diet, we saw an inverse association [with all-cause mortality] comparing high adherence with low adherence to the Mediterranean diet, but the certainty of evidence was very low, indicating a really uncertain meta-evidence,” remarked Dr. Barbaresko.
She concluded that a greater number of studies is needed to investigate the association of dietary factors with all-cause mortality in type 2 diabetes to strengthen the evidence for several other dietary factors. She also cautioned that meta-analyses are affected by unmeasured and residual confounding.
Dr. Barbaresko and Dr. Schulze reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signsreport from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signsreport from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signsreport from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
New evidence indicates that the use of “cracking” technology can significantly reduce the ambient levels of inhaled nitrous oxide (N2O) during labor, especially when women are coached on how best to use it.
The findings, from a quality improvement study conducted by anesthetists and midwives in the United Kingdom, appear to have implications for minimizing staff exposures and for lowering N2O’s environmental effect overall. The potent greenhouse gas has a carbon footprint that is 265 times larger than carbon dioxide.
“Our results indicate that cracking technology can reduce ambient nitrous oxide levels in the obstetric setting, with potential for reductions in environmental impacts and occupational exposure,” reported Annie Pinder, MBChB, a fellow in sustainable anesthesia at North West School of Anaesthesia, Manchester, England, and colleagues in Anaesthesia.
Proportionally, the United Kingdom is one of the largest users of inhaled N2O during labor, often for first-line pain control. A 2017 survey by the Care Quality Commission estimated that 77% of women in labor used inhaled N2O for pain, and that it didn’t preclude them from using other types of analgesia, including opioids, epidurals, and nonpharmacologic approaches.
Previous research has established the effectiveness of cracking, which uses a catalyst to convert N2O into nitrogen and oxygen. However, little is known about the effectiveness of scavenging devices that minimize waste N2O in a real-world setting, the authors said.
For the study, median ambient N2O levels were recorded for 36 women during the final 30 minutes of uncomplicated labor. Ambient N2O levels were initially recorded in 12 patients without use of three N2O scavenging devices, and then in three groups of eight patients using either a mouthpiece, a facemask with an air-filled cushion, or a low-profile facemask. Women were also coached on how to use the devices, and given feedback.
“Given that a similar magnitude of reduction in nitrous oxide levels was seen with mouthpieces and low-profile face masks, we suggest that pregnant women should be offered the option of either device when cracking is used,” the study authors wrote.
Staff feedback was generally positive, but some found use of the technology cumbersome. Sufficient staff engagement is the key to successful implementation, the researchers pointed out.
The results showed that when women consistently exhaled into the mouthpiece, median ambient N2O levels were 71% lower compared with levels recorded prior to use of the scavenging device. When women exhaled into a lightweight face mask with a flexible seal, median ambient N2O levels were 81% lower compared with baseline.
These data are consistent with the United Kingdom’s goal of achieving a net zero carbon footprint for the National Health Service by 2040, the researchers said. The study findings are also in keeping with predictions that cracking technology could reduce greenhouse gas emissions associated with N2O by an estimated 75%.
“Although cracking may make nitrous oxide ‘greener,’ it does not make it ‘green,’ ” noted Dr. Pinder and coauthor Cliff Shelton, MBChB, in an interview. Dr. Shelton is a senior clinical lecturer in anesthesia at Lancaster (England) University and a consultant anesthetist at Wythenshawe Hospital, Manchester.
Even with the use of cracking technology, the occupational effect of inhaled N2O is likely to remain higher than for other, more effective forms of anesthesia, such as epidurals and remifentanil (Ultiva), Dr. Pinder and Dr. Shelton said. Furthermore, ambient N2O levels are not a direct measure of the proportion of nitrous oxide cracked, “so there is scope for further work to more precisely understand the ‘carbon footprint’ impacts,” they pointed out.
Inhaled N20 is widely used for labor pain in the Scandinavian countries, as well as in Canada, Australia, and New Zealand. It’s also making a comeback in the United States, facilitated by the Food and Drug Administration’s (FDA) approval of a portable N2O delivery system in 2012.
The system, which delivers a mixture of 50% nitrous oxide and 50% oxygen, has offered a new option for laboring mothers, said Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, and coauthors in a 2014 report.
“Nitrous oxide works really well as an adjunct to other analgesia,” said Laura Goetzl, MD, MPH, professor of obstetrics, gynecology, and reproductive sciences at University of Texas at Houston Health Science Center. Women in labor really like having the option of inhaled N2O to manage pain, she said in an interview. “The more options that we have to offer, the better for women.”
“Not only does nitrous oxide help with perception of pain, it’s also highly effective for reducing patient anxiety,” Dr. Goetzl explained. “If a patient is waiting for an epidural, the use of nitrous oxide can be particularly helpful.”
Dr. Shelton reported that he is executive editor of Anaesthesia Reports. Dr. Pinder and the remaining coauthors disclosed having no conflicts of interest. Dr. Goetzl reported that she is on the medical advisory board of Mirvie.
New evidence indicates that the use of “cracking” technology can significantly reduce the ambient levels of inhaled nitrous oxide (N2O) during labor, especially when women are coached on how best to use it.
The findings, from a quality improvement study conducted by anesthetists and midwives in the United Kingdom, appear to have implications for minimizing staff exposures and for lowering N2O’s environmental effect overall. The potent greenhouse gas has a carbon footprint that is 265 times larger than carbon dioxide.
“Our results indicate that cracking technology can reduce ambient nitrous oxide levels in the obstetric setting, with potential for reductions in environmental impacts and occupational exposure,” reported Annie Pinder, MBChB, a fellow in sustainable anesthesia at North West School of Anaesthesia, Manchester, England, and colleagues in Anaesthesia.
Proportionally, the United Kingdom is one of the largest users of inhaled N2O during labor, often for first-line pain control. A 2017 survey by the Care Quality Commission estimated that 77% of women in labor used inhaled N2O for pain, and that it didn’t preclude them from using other types of analgesia, including opioids, epidurals, and nonpharmacologic approaches.
Previous research has established the effectiveness of cracking, which uses a catalyst to convert N2O into nitrogen and oxygen. However, little is known about the effectiveness of scavenging devices that minimize waste N2O in a real-world setting, the authors said.
For the study, median ambient N2O levels were recorded for 36 women during the final 30 minutes of uncomplicated labor. Ambient N2O levels were initially recorded in 12 patients without use of three N2O scavenging devices, and then in three groups of eight patients using either a mouthpiece, a facemask with an air-filled cushion, or a low-profile facemask. Women were also coached on how to use the devices, and given feedback.
“Given that a similar magnitude of reduction in nitrous oxide levels was seen with mouthpieces and low-profile face masks, we suggest that pregnant women should be offered the option of either device when cracking is used,” the study authors wrote.
Staff feedback was generally positive, but some found use of the technology cumbersome. Sufficient staff engagement is the key to successful implementation, the researchers pointed out.
The results showed that when women consistently exhaled into the mouthpiece, median ambient N2O levels were 71% lower compared with levels recorded prior to use of the scavenging device. When women exhaled into a lightweight face mask with a flexible seal, median ambient N2O levels were 81% lower compared with baseline.
These data are consistent with the United Kingdom’s goal of achieving a net zero carbon footprint for the National Health Service by 2040, the researchers said. The study findings are also in keeping with predictions that cracking technology could reduce greenhouse gas emissions associated with N2O by an estimated 75%.
“Although cracking may make nitrous oxide ‘greener,’ it does not make it ‘green,’ ” noted Dr. Pinder and coauthor Cliff Shelton, MBChB, in an interview. Dr. Shelton is a senior clinical lecturer in anesthesia at Lancaster (England) University and a consultant anesthetist at Wythenshawe Hospital, Manchester.
Even with the use of cracking technology, the occupational effect of inhaled N2O is likely to remain higher than for other, more effective forms of anesthesia, such as epidurals and remifentanil (Ultiva), Dr. Pinder and Dr. Shelton said. Furthermore, ambient N2O levels are not a direct measure of the proportion of nitrous oxide cracked, “so there is scope for further work to more precisely understand the ‘carbon footprint’ impacts,” they pointed out.
Inhaled N20 is widely used for labor pain in the Scandinavian countries, as well as in Canada, Australia, and New Zealand. It’s also making a comeback in the United States, facilitated by the Food and Drug Administration’s (FDA) approval of a portable N2O delivery system in 2012.
The system, which delivers a mixture of 50% nitrous oxide and 50% oxygen, has offered a new option for laboring mothers, said Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, and coauthors in a 2014 report.
“Nitrous oxide works really well as an adjunct to other analgesia,” said Laura Goetzl, MD, MPH, professor of obstetrics, gynecology, and reproductive sciences at University of Texas at Houston Health Science Center. Women in labor really like having the option of inhaled N2O to manage pain, she said in an interview. “The more options that we have to offer, the better for women.”
“Not only does nitrous oxide help with perception of pain, it’s also highly effective for reducing patient anxiety,” Dr. Goetzl explained. “If a patient is waiting for an epidural, the use of nitrous oxide can be particularly helpful.”
Dr. Shelton reported that he is executive editor of Anaesthesia Reports. Dr. Pinder and the remaining coauthors disclosed having no conflicts of interest. Dr. Goetzl reported that she is on the medical advisory board of Mirvie.
This story was updated on Sept. 27, 2022.
New evidence indicates that the use of “cracking” technology can significantly reduce the ambient levels of inhaled nitrous oxide (N2O) during labor, especially when women are coached on how best to use it.
The findings, from a quality improvement study conducted by anesthetists and midwives in the United Kingdom, appear to have implications for minimizing staff exposures and for lowering N2O’s environmental effect overall. The potent greenhouse gas has a carbon footprint that is 265 times larger than carbon dioxide.
“Our results indicate that cracking technology can reduce ambient nitrous oxide levels in the obstetric setting, with potential for reductions in environmental impacts and occupational exposure,” reported Annie Pinder, MBChB, a fellow in sustainable anesthesia at North West School of Anaesthesia, Manchester, England, and colleagues in Anaesthesia.
Proportionally, the United Kingdom is one of the largest users of inhaled N2O during labor, often for first-line pain control. A 2017 survey by the Care Quality Commission estimated that 77% of women in labor used inhaled N2O for pain, and that it didn’t preclude them from using other types of analgesia, including opioids, epidurals, and nonpharmacologic approaches.
Previous research has established the effectiveness of cracking, which uses a catalyst to convert N2O into nitrogen and oxygen. However, little is known about the effectiveness of scavenging devices that minimize waste N2O in a real-world setting, the authors said.
For the study, median ambient N2O levels were recorded for 36 women during the final 30 minutes of uncomplicated labor. Ambient N2O levels were initially recorded in 12 patients without use of three N2O scavenging devices, and then in three groups of eight patients using either a mouthpiece, a facemask with an air-filled cushion, or a low-profile facemask. Women were also coached on how to use the devices, and given feedback.
“Given that a similar magnitude of reduction in nitrous oxide levels was seen with mouthpieces and low-profile face masks, we suggest that pregnant women should be offered the option of either device when cracking is used,” the study authors wrote.
Staff feedback was generally positive, but some found use of the technology cumbersome. Sufficient staff engagement is the key to successful implementation, the researchers pointed out.
The results showed that when women consistently exhaled into the mouthpiece, median ambient N2O levels were 71% lower compared with levels recorded prior to use of the scavenging device. When women exhaled into a lightweight face mask with a flexible seal, median ambient N2O levels were 81% lower compared with baseline.
These data are consistent with the United Kingdom’s goal of achieving a net zero carbon footprint for the National Health Service by 2040, the researchers said. The study findings are also in keeping with predictions that cracking technology could reduce greenhouse gas emissions associated with N2O by an estimated 75%.
“Although cracking may make nitrous oxide ‘greener,’ it does not make it ‘green,’ ” noted Dr. Pinder and coauthor Cliff Shelton, MBChB, in an interview. Dr. Shelton is a senior clinical lecturer in anesthesia at Lancaster (England) University and a consultant anesthetist at Wythenshawe Hospital, Manchester.
Even with the use of cracking technology, the occupational effect of inhaled N2O is likely to remain higher than for other, more effective forms of anesthesia, such as epidurals and remifentanil (Ultiva), Dr. Pinder and Dr. Shelton said. Furthermore, ambient N2O levels are not a direct measure of the proportion of nitrous oxide cracked, “so there is scope for further work to more precisely understand the ‘carbon footprint’ impacts,” they pointed out.
Inhaled N20 is widely used for labor pain in the Scandinavian countries, as well as in Canada, Australia, and New Zealand. It’s also making a comeback in the United States, facilitated by the Food and Drug Administration’s (FDA) approval of a portable N2O delivery system in 2012.
The system, which delivers a mixture of 50% nitrous oxide and 50% oxygen, has offered a new option for laboring mothers, said Robert L. Barbieri, MD, chair of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, and coauthors in a 2014 report.
“Nitrous oxide works really well as an adjunct to other analgesia,” said Laura Goetzl, MD, MPH, professor of obstetrics, gynecology, and reproductive sciences at University of Texas at Houston Health Science Center. Women in labor really like having the option of inhaled N2O to manage pain, she said in an interview. “The more options that we have to offer, the better for women.”
“Not only does nitrous oxide help with perception of pain, it’s also highly effective for reducing patient anxiety,” Dr. Goetzl explained. “If a patient is waiting for an epidural, the use of nitrous oxide can be particularly helpful.”
Dr. Shelton reported that he is executive editor of Anaesthesia Reports. Dr. Pinder and the remaining coauthors disclosed having no conflicts of interest. Dr. Goetzl reported that she is on the medical advisory board of Mirvie.
Mitchel L. Zoler/MDedge News
