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EASD: Precision in diabetes management and impact of COVID-19
The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.
The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.
“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.
He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative
As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.
New data from previously reported trials
There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.
New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.
And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.
“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.
Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
Consensus on type 1 diabetes management: Special considerations
Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.
The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.
Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”
And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”
But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
Diabetes in 2021: It’s personal
Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).
According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”
An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”
The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.
And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
Next-generation incretin therapy: Is weight loss the treatment?
New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.
A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.
The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.
Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”
Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”
A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
COVID-19, hypoglycemia, bone, and much more
As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia.
A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy.
Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”
Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.
A version of this article first appeared on Medscape.com.
The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.
The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.
“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.
He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative
As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.
New data from previously reported trials
There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.
New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.
And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.
“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.
Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
Consensus on type 1 diabetes management: Special considerations
Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.
The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.
Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”
And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”
But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
Diabetes in 2021: It’s personal
Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).
According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”
An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”
The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.
And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
Next-generation incretin therapy: Is weight loss the treatment?
New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.
A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.
The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.
Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”
Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”
A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
COVID-19, hypoglycemia, bone, and much more
As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia.
A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy.
Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”
Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.
A version of this article first appeared on Medscape.com.
The annual meeting of the European Association for the Study of Diabetes 2021 will delve into individualized approaches in diabetes management, particularly with regard to tailoring drug therapy for type 2 diabetes and management of type 1 diabetes.
The virtual meeting, taking place Sept. 28 to Oct. 1 in Central European Summer Time, will feature results from TriMASTER (a three-way cross-over trial of precision medicine strategy of second-/third-line therapy in type 2 diabetes), new subgroup analyses from the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) study, the final version of a consensus statement on type 1 diabetes management, and new data on the dual incretin agonist tirzepatide, as well as much more.
“I’m a strong believer in personalization. I don’t think the big blockbuster [drugs] will serve the entire community with diabetes. Even in type 1 diabetes, there’s evidence of heterogeneity. ... We need a better way to identify individual needs. I think that’s where we’re going. ... It’s one of the themes of the conference,” EASD President Stefano Del Prato, MD, professor of endocrinology at the University of Pisa (Italy), told this news organization.
He noted that EASD and the American Diabetes Association have recently teamed up with other organizations to form the Precision Medicine in Diabetes Initiative
As would be expected, the meeting will also feature numerous presentations on the COVID-19 pandemic, including studies looking at how people with COVID-19 and diabetes have fared; how the pandemic has affected diabetes care; and the still unclear impact of SARS-CoV-2 on pancreatic beta cells and whether, in some instances, it triggers new-onset diabetes.
New data from previously reported trials
There will be new data from several previously reported trials focusing on specific groups of patients with type 2 diabetes. One is the EMPEROR-Preserved study of empagliflozin (Jardiance) in individuals with heart failure and preserved ejection fraction. Initially presented in August 2021 at the annual congress of the European Society of Cardiology, the new data will focus on patient subpopulations, efficacy endpoints, and safety in patients with and without diabetes. A companion study, EMPEROR-Reduced, in those with heart failure and reduced ejection fraction, was presented at the ESC Congress in August 2020.
New findings will also be presented from the DAPA-CKD study of dapagliflozin (Farxiga) in patients with chronic kidney disease. The study was stopped early in March 2020 because of overwhelming efficacy of the drug in preventing CKD. Now, the data will be analyzed in terms of metabolic, nephrology, and cardiology parameters.
And from FIDELIO-DKD and FIGARO-DKD, trials of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia), new data will also focus on a variety of subgroups of individuals with type 2 diabetes and chronic kidney disease.
“Our goal is to cover most aspects of what’s happening in the type 2 diabetes field,” EASD Honorary Secretary Mikael Rydén, MD, PhD, professor and senior consultant in endocrinology at the Karolinska Institute and Karolinska University Hospital, Stockholm, said in an interview.
Dr. Rydén, who chairs the meeting’s scientific program committee, added: “We can only focus on so much every year but we try to be active and changing from year to year. I’m convinced that a clinician or translational researcher will definitely have a number of very interesting symposia to follow and learn new things. If you follow all of these things, you will know a lot about what’s cooking in the diabetes world.”
Consensus on type 1 diabetes management: Special considerations
Both Dr. Del Prato and Dr. Rydén cited presentation of the new type 1 diabetes ADA/EASD consensus report as among the most clinically important of the conference. Initially presented in draft form at the ADA Scientific Sessions in June 2021, the document aims to move away from routinely applying principles derived from studies of patients with type 2 diabetes to those with type 1 diabetes, an autoimmune disease with unique characteristics.
The final version of the document is expected to include information on goals of therapy, glycemic targets, prevention and management of hypoglycemia and diabetic ketoacidosis, psychosocial care, and special populations, among other issues. It is also expected to include a section dedicated to adjunctive treatments beyond insulin, including metformin, pramlintide, glucagonlike peptide–1 agonists, and sodium-glucose cotransporter 2 inhibitors for certain patients.
Dr. Del Prato noted, “From a clinical point of view, this is quite an important step that two major organizations came together recommending some strategies for treating type 2 diabetes ... It really deals with a big problem and tries to provide the tools for improving homogenization of the treatment of type 1 diabetes across the different health systems.”
And Dr. Rydén commented: “I think it’s really important to have, since there’s been so much focus on type 2 diabetes for the last few years, and to have the ADA and EASD getting together and actually write this.”
But Dr. Rydén also pointed out that outcomes data are much more conclusive for drugs in type 2 diabetes to inform international guidelines, whereas “this is much more difficult to demonstrate with type 1 diabetes. With a new pump or [continuous glucose monitor (CGM)] you might show a reduction in [hemoglobin] A1c of X percent or X mmol/mol or hypoglycemia events, but it’s much harder to show improvements in hard outcomes like deaths and cardiovascular events. I’m really looking forward to having this presented.”
Diabetes in 2021: It’s personal
Several meeting sessions will specifically address precision medicine approaches, including the TriMASTER study, which aims to identify subgroups of patients with type 2 diabetes who respond well or poorly to particular drugs based on clinical characteristics so that treatments can be better targeted to individuals. In total, 600 patients with type 2 diabetes and suboptimal glycemic control with metformin were randomized to a dipeptidyl peptidase–4 inhibitor, an SGLT2 inhibitor, or thiazolidinedione (TZD).
According to Dr. Rydén, “The TriMASTER final results will be interesting. TZDs still have a place. ... You can’t give them to people with heart failure, but I think like a carpenter you have to have many tools in your toolbox. And I still think that there are some individuals who respond well to pioglitazone. [The study findings] could be influential, depending on the results.”
An EASD/ADA symposium entitled “Optimizing diabetes diagnosis, prevention, and care: Is precision medicine the answer?” will offer three distinct perspectives, with one speaker arguing it’s the future of diabetes medicine, another that it isn’t, and a third explaining that “the devil is in the details.”
The Diabetologia symposium will focus on a related concept: The use of artificial intelligence in diabetes research and care, with particular application to glucose control, neuropathy, and wound healing.
And during the 36th Camillo Golgi Lecture, kidney disease expert H.J. Lambers Heerspink, PhD, of the University of Groningen (the Netherlands), will speak about personalizing treatment for patients with type 2 diabetes, arguing that “the mean is meaningless.”
Next-generation incretin therapy: Is weight loss the treatment?
New data will continue the buzz from the ADA meeting surrounding tirzepatide, the dual GLP-1 receptor agonist and glucose-dependent insulinotropic polypeptide agent.
A session will add new data from SURPASS-3 CGM, looking at the effect of the drug captured by continuous glucose monitoring in patients with type 2 diabetes; SURPASS-3 MRI, examining the effect of the drug on liver fat content and abdominal adipose tissue; and SURPASS-4, investigating efficacy and safety of tirzepatide once-weekly versus insulin glargine in patients with type 2 diabetes and increased cardiovascular risk.
The drug is notable for its dramatic reductions in both A1c and weight, although questions remain about the incidence of gastrointestinal side effects and effects on long-term cardiovascular and renal outcomes.
Dr. Rydén commented: “Given its effects on A1c and body weight, we would expect a positive result, but one never knows. It’s at least safe, that’s for sure. I think this mode of action is extremely interesting.”
Dr. Del Prato noted that tirzepatide could also “open up a new area of intervention for type 1 diabetes. The initial data were promising. ... It’s worth keeping an eye on.”
A related symposium will address the future of incretin-based treatments overall, while the EASD-Lancet symposium will examine whether the treatment of obesity is the «future» of diabetes treatment.
COVID-19, hypoglycemia, bone, and much more
As always, there’s much more on the agenda. Other noteworthy sessions include those addressing hypoglycemia management; a joint EASD/European Society of Endocrinology session on diabetes and bone; a debate about whether women with diabetes are at higher cardiovascular risk than men; and in-hospital management of hyperglycemia.
A new feature of the meeting will be a daily roundup/wrap-up, where members of the program committee and speakers will summarize the day’s highlights. And another feature, “EASD e-Learning,” has been expanded to include more clinical topics around insulin use, nonalcoholic fatty liver disease, obesity, and neuropathy.
Overall, Dr. Del Prato said, “it’s a very populated program, with more than 700 presenters, 162 invited symposia speakers, and 53 chairs. It’s covering widely different areas from basic to clinical research. ... It’s a lot of stuff going on.”
Both Dr. Rydén and Dr. Del Prato have disclosures with multiple manufacturers of diabetes-related products.
A version of this article first appeared on Medscape.com.
Smart watch glucose monitoring on the horizon
Earlier this year, technology news sites reported that the Apple Watch Series 7 and the Samsung Galaxy Watch 4 were going to have integrated optical sensors for checking interstitial fluid glucose levels with no blood sampling needed. By the summer, new articles indicated that the glucose sensing watches would not be released this year for either Apple or Samsung.
For now, the newest technology available for monitoring glucose is continuous glucose monitoring (CGM), which involves a tiny sensor being inserted under the skin. The sensor tests glucose every few minutes, and a transmitter wirelessly sends the information to a monitor, which may be part of an insulin pump or a separate device. Some CGMs send information directly to a smartphone or tablet, according to the National Institutes of Health.
In 1999 the Food and Drug Administration approved the first CGM, which was only approved for downloading 3 days of data at a doctor’s office. Interestingly, the first real-time CGM device for patients to use on their own was a watch, the Glucowatch Biographer. Because of irritation and other issues, that watch never caught on. In 2006 and 2008, Dexcom and then Abbott released the first real-time CGMs that allowed patients to frequently check their own blood sugars.1,2
How CGM has advanced diabetes management
The advent of CGM has advanced the field of diabetes management in many ways.
It has allowed patients to get real time feedback on how their behavior affects their blood sugar. The use of CGM along with the ensuing behavioral changes actually leads to a decrease in hemoglobin A1c, along with a lower risk of hypoglycemia. CGM has also resulted in patients having a better understanding of several aspects of glucose control, including glucose variability and nocturnal hypoglycemia.
Affordable, readily accessible CGM monitors that allow patients to intermittently use CGM have become available over the last 3 years.
In the United States alone, 34.2 million people have diabetes – nearly 1 in every 10 people. Many do not do self-monitoring of blood glucose and most do not use CGM. The current alternative to CGM – self monitoring of blood glucose – is cumbersome, and, since it requires regular finger sticks, is painful. Also, there is significant cost to each test strip that is used to self-monitor, and most insurance limits the number of times a day a patient can check their blood sugar. CGM used to be reserved only for patients who use multiple doses of insulin daily, and only began being approved for use for patients on basal insulin alone in June 2021.3
Most primary care doctors are just beginning to learn how to interpret CGM data.
Smart watch glucose monitoring predictions
When smart watch glucose monitoring arrives, it will suddenly change the playing field for patients with diabetes and their doctors alike.
We expect it to bring down the price of CGM and make it readily available to any patient who owns a smart watch with that function.
For doctors, the new technology will result in them suddenly being asked to advise their patients on how to use the data generated by watch-based CGM.
Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece. Dr. Persampiere is a second-year resident in the family medicine residency program at Abington Jefferson Health. You can contact them at [email protected].
References
1. Hirsh I. Introduction: History of Glucose Monitoring, in “Role of Continuous Glucose Monitoring in Diabetes Treatment.” American Diabetes Association. 2018.
2. Peters A. The Evidence Base for Continuous Glucose Monitoring, in “Role of Continuous Glucose Monitoring in Diabetes Treatment.” American Diabetes Association 2018.
3. “Medicare Loosening Restrictions for Continuous Glucose Monitor (CGM) Coverage,” Healthline. 2021 Jul 13.
Earlier this year, technology news sites reported that the Apple Watch Series 7 and the Samsung Galaxy Watch 4 were going to have integrated optical sensors for checking interstitial fluid glucose levels with no blood sampling needed. By the summer, new articles indicated that the glucose sensing watches would not be released this year for either Apple or Samsung.
For now, the newest technology available for monitoring glucose is continuous glucose monitoring (CGM), which involves a tiny sensor being inserted under the skin. The sensor tests glucose every few minutes, and a transmitter wirelessly sends the information to a monitor, which may be part of an insulin pump or a separate device. Some CGMs send information directly to a smartphone or tablet, according to the National Institutes of Health.
In 1999 the Food and Drug Administration approved the first CGM, which was only approved for downloading 3 days of data at a doctor’s office. Interestingly, the first real-time CGM device for patients to use on their own was a watch, the Glucowatch Biographer. Because of irritation and other issues, that watch never caught on. In 2006 and 2008, Dexcom and then Abbott released the first real-time CGMs that allowed patients to frequently check their own blood sugars.1,2
How CGM has advanced diabetes management
The advent of CGM has advanced the field of diabetes management in many ways.
It has allowed patients to get real time feedback on how their behavior affects their blood sugar. The use of CGM along with the ensuing behavioral changes actually leads to a decrease in hemoglobin A1c, along with a lower risk of hypoglycemia. CGM has also resulted in patients having a better understanding of several aspects of glucose control, including glucose variability and nocturnal hypoglycemia.
Affordable, readily accessible CGM monitors that allow patients to intermittently use CGM have become available over the last 3 years.
In the United States alone, 34.2 million people have diabetes – nearly 1 in every 10 people. Many do not do self-monitoring of blood glucose and most do not use CGM. The current alternative to CGM – self monitoring of blood glucose – is cumbersome, and, since it requires regular finger sticks, is painful. Also, there is significant cost to each test strip that is used to self-monitor, and most insurance limits the number of times a day a patient can check their blood sugar. CGM used to be reserved only for patients who use multiple doses of insulin daily, and only began being approved for use for patients on basal insulin alone in June 2021.3
Most primary care doctors are just beginning to learn how to interpret CGM data.
Smart watch glucose monitoring predictions
When smart watch glucose monitoring arrives, it will suddenly change the playing field for patients with diabetes and their doctors alike.
We expect it to bring down the price of CGM and make it readily available to any patient who owns a smart watch with that function.
For doctors, the new technology will result in them suddenly being asked to advise their patients on how to use the data generated by watch-based CGM.
Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece. Dr. Persampiere is a second-year resident in the family medicine residency program at Abington Jefferson Health. You can contact them at [email protected].
References
1. Hirsh I. Introduction: History of Glucose Monitoring, in “Role of Continuous Glucose Monitoring in Diabetes Treatment.” American Diabetes Association. 2018.
2. Peters A. The Evidence Base for Continuous Glucose Monitoring, in “Role of Continuous Glucose Monitoring in Diabetes Treatment.” American Diabetes Association 2018.
3. “Medicare Loosening Restrictions for Continuous Glucose Monitor (CGM) Coverage,” Healthline. 2021 Jul 13.
Earlier this year, technology news sites reported that the Apple Watch Series 7 and the Samsung Galaxy Watch 4 were going to have integrated optical sensors for checking interstitial fluid glucose levels with no blood sampling needed. By the summer, new articles indicated that the glucose sensing watches would not be released this year for either Apple or Samsung.
For now, the newest technology available for monitoring glucose is continuous glucose monitoring (CGM), which involves a tiny sensor being inserted under the skin. The sensor tests glucose every few minutes, and a transmitter wirelessly sends the information to a monitor, which may be part of an insulin pump or a separate device. Some CGMs send information directly to a smartphone or tablet, according to the National Institutes of Health.
In 1999 the Food and Drug Administration approved the first CGM, which was only approved for downloading 3 days of data at a doctor’s office. Interestingly, the first real-time CGM device for patients to use on their own was a watch, the Glucowatch Biographer. Because of irritation and other issues, that watch never caught on. In 2006 and 2008, Dexcom and then Abbott released the first real-time CGMs that allowed patients to frequently check their own blood sugars.1,2
How CGM has advanced diabetes management
The advent of CGM has advanced the field of diabetes management in many ways.
It has allowed patients to get real time feedback on how their behavior affects their blood sugar. The use of CGM along with the ensuing behavioral changes actually leads to a decrease in hemoglobin A1c, along with a lower risk of hypoglycemia. CGM has also resulted in patients having a better understanding of several aspects of glucose control, including glucose variability and nocturnal hypoglycemia.
Affordable, readily accessible CGM monitors that allow patients to intermittently use CGM have become available over the last 3 years.
In the United States alone, 34.2 million people have diabetes – nearly 1 in every 10 people. Many do not do self-monitoring of blood glucose and most do not use CGM. The current alternative to CGM – self monitoring of blood glucose – is cumbersome, and, since it requires regular finger sticks, is painful. Also, there is significant cost to each test strip that is used to self-monitor, and most insurance limits the number of times a day a patient can check their blood sugar. CGM used to be reserved only for patients who use multiple doses of insulin daily, and only began being approved for use for patients on basal insulin alone in June 2021.3
Most primary care doctors are just beginning to learn how to interpret CGM data.
Smart watch glucose monitoring predictions
When smart watch glucose monitoring arrives, it will suddenly change the playing field for patients with diabetes and their doctors alike.
We expect it to bring down the price of CGM and make it readily available to any patient who owns a smart watch with that function.
For doctors, the new technology will result in them suddenly being asked to advise their patients on how to use the data generated by watch-based CGM.
Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece. Dr. Persampiere is a second-year resident in the family medicine residency program at Abington Jefferson Health. You can contact them at [email protected].
References
1. Hirsh I. Introduction: History of Glucose Monitoring, in “Role of Continuous Glucose Monitoring in Diabetes Treatment.” American Diabetes Association. 2018.
2. Peters A. The Evidence Base for Continuous Glucose Monitoring, in “Role of Continuous Glucose Monitoring in Diabetes Treatment.” American Diabetes Association 2018.
3. “Medicare Loosening Restrictions for Continuous Glucose Monitor (CGM) Coverage,” Healthline. 2021 Jul 13.
New AHA guidance targets obesity-related hypertension
Whereas previous scientific statements from the American Heart Association have addressed how diet, physical activity, and weight control can help prevent and manage hypertension, a new AHA statement focuses on obesity-related hypertension.
The document, which was published online Sept. 20, 2021, in Hypertension, also identifies knowledge gaps and suggests future research directions.
“Given [that] obesity is a major risk factor for hypertension, and hypertension is one of the greatest (if not the greatest) attributable risk factors for most cardiovascular diseases, we thought it was important to focus on weight loss strategies and update what we know about the treatment options that are available to treat obesity hypertension,” writing group chair Michael E. Hall, MD, told this news organization.
“Medical and surgical strategies may help with long-term weight and blood pressure improvement, in addition to a heart-healthy diet and physical activity,” he noted in a press release from the AHA. “We often don’t consider medications or metabolic surgery until after there has been target organ damage, such as heart injury or having a stroke.”
However, by acting earlier, “we may be able to prevent these complications,” added Dr. Hall, associate division director for cardiovascular diseases at the University of Mississippi Medical Center in Jackson.
“This is not a call for greater use of one specific therapy,” he clarified. “However, we do know that more aggressive treatments including antiobesity medications or metabolic surgery are underutilized.”
According to Dr. Hall, “we treat the secondary problem [i.e., the hypertension or diabetes], but we are not treating the root cause [obesity] as aggressively.”
“Hopefully this statement will increase awareness that there are several [treatment] options [and] bring attention to this major health issue,” he said.
He added that the most important question, in his mind, is how best to tackle obesity among children and adolescents to lower their risk of hypertension and other associated complications.
The statement is aimed at both primary care providers and specialists.
Diet, physical activity help, but weight regain common
Losing 5%-10% of body weight can lead to a more than 5–mm Hg reduction in systolic blood pressure and a 4–mm Hg reduction in diastolic blood pressure, the statement notes. Losing 10 kg may lower systolic blood pressure by 5-20 mm Hg.
To manage weight, control hypertension, and reduce the risk of cardiovascular disease, guidelines recommend the Mediterranean diet or the Dietary Approaches to Stop Hypertension (DASH) diet, which both emphasize fruits, vegetables, legumes, nuts, and seeds, with moderate intake of fish, seafood, poultry, and dairy, and low intake of red and processed meats and sweets. The Mediterranean diet also includes olive oil and moderate consumption of (mainly red) wine.
The effect of intermittent fasting on blood pressure control is not clear, the statement noted.
It added that typically 150-225 minutes and 225-420 minutes of physical activity per week can produce weight loss of 2-3 kg or 5-7.5 kg respectively, and 200-300 minutes of physical activity per week is needed to maintain this weight loss.
“Successful weight-loss maintenance over years therefore typically requires high levels of [physical activity] and limited sedentary time, frequent weight monitoring, and high levels of dietary restraint,” and weight regain is common, the authors summarize.
Other options to address obesity, hypertension
Weight-loss pharmacotherapies and metabolic surgery are other options to treat obesity and lower hypertension.
The statement reports that four drugs are approved by the Food and Drug Administration for long-term weight loss: Orlistat (Xenical, Alli), phentermine/topiramate extended release (Qsymia), naltrexone/bupropion (Contrave), and liraglutide 3.0 mg (Saxenda). On June 4, the FDA approved a fifth drug, semaglutide (Wegovy).
The long-term effects of antiobesity medications on blood pressure are mixed.
However, “prescription rates for these drugs remain low, likely because of limited insurance coverage and low levels of clinical proficiency with treating obesity,” Dr. Hall and colleagues write.
Metabolic surgery could be a weight loss option for certain patients, and it is associated with blood pressure lowering.
In the 100-patient Gastric Bypass to Treat Obese Patients With Steady Hypertension (GATEWAY) trial, published in Circulation in 2018, more patients in the Roux-en-Y gastric-bypass group than the control group (84% vs. 13%) met the primary outcome of a 30% or greater reduction in the number of blood pressure-lowering medications at 12 months while maintaining an office blood pressure less than 140/90 mm Hg.
Unanswered questions, future research directions
In 2015-2016, an estimated 18.5% of U.S. children and adolescents aged 2-19 years had obesity, the statement notes. Children with obesity have a twofold increased risk of incident hypertension, and those with severe obesity have an over fourfold increased risk of this outcome, compared with children who have a healthy weight.
Dr. Hall and colleagues emphasized that, “as the prevalence of obesity continues to increase, hypertension and associated cardiorenal diseases will also increase unless more effective strategies to prevent and treat obesity are developed.”
They identified 17 unanswered questions (knowledge gaps) that can guide the direction of future research. These include:
- What new strategies and science-based guidelines are needed to curb the growing evidence of childhood obesity?
- Does intentional weight loss with pharmacotherapy or metabolic surgery in childhood and early adulthood prevent hypertension and subsequent target organ damage in later life?
- What is the optimal amount of time that clinicians should allow before recommending more aggressive weight management strategies (that is, antiobesity medications or metabolic surgery) or hypertension strategies beyond lifestyle changes?
“To me,” Dr. Hall said, “addressing childhood obesity hypertension and determining optimal timing of antiobesity therapies are the most important [issues]. Certainly, these therapies (i.e., diets, medications, surgeries) have some risks, but we don’t have a clear understanding if their benefits outweigh these risks in younger obese people or whether initiating these therapies before the onset of target organ damage such as heart failure” outweigh the risks.
Dr. Hall has reported no relevant financial relationships. Disclosures for the other authors are listed with the article.
A version of this article first appeared on Medscape.com.
Whereas previous scientific statements from the American Heart Association have addressed how diet, physical activity, and weight control can help prevent and manage hypertension, a new AHA statement focuses on obesity-related hypertension.
The document, which was published online Sept. 20, 2021, in Hypertension, also identifies knowledge gaps and suggests future research directions.
“Given [that] obesity is a major risk factor for hypertension, and hypertension is one of the greatest (if not the greatest) attributable risk factors for most cardiovascular diseases, we thought it was important to focus on weight loss strategies and update what we know about the treatment options that are available to treat obesity hypertension,” writing group chair Michael E. Hall, MD, told this news organization.
“Medical and surgical strategies may help with long-term weight and blood pressure improvement, in addition to a heart-healthy diet and physical activity,” he noted in a press release from the AHA. “We often don’t consider medications or metabolic surgery until after there has been target organ damage, such as heart injury or having a stroke.”
However, by acting earlier, “we may be able to prevent these complications,” added Dr. Hall, associate division director for cardiovascular diseases at the University of Mississippi Medical Center in Jackson.
“This is not a call for greater use of one specific therapy,” he clarified. “However, we do know that more aggressive treatments including antiobesity medications or metabolic surgery are underutilized.”
According to Dr. Hall, “we treat the secondary problem [i.e., the hypertension or diabetes], but we are not treating the root cause [obesity] as aggressively.”
“Hopefully this statement will increase awareness that there are several [treatment] options [and] bring attention to this major health issue,” he said.
He added that the most important question, in his mind, is how best to tackle obesity among children and adolescents to lower their risk of hypertension and other associated complications.
The statement is aimed at both primary care providers and specialists.
Diet, physical activity help, but weight regain common
Losing 5%-10% of body weight can lead to a more than 5–mm Hg reduction in systolic blood pressure and a 4–mm Hg reduction in diastolic blood pressure, the statement notes. Losing 10 kg may lower systolic blood pressure by 5-20 mm Hg.
To manage weight, control hypertension, and reduce the risk of cardiovascular disease, guidelines recommend the Mediterranean diet or the Dietary Approaches to Stop Hypertension (DASH) diet, which both emphasize fruits, vegetables, legumes, nuts, and seeds, with moderate intake of fish, seafood, poultry, and dairy, and low intake of red and processed meats and sweets. The Mediterranean diet also includes olive oil and moderate consumption of (mainly red) wine.
The effect of intermittent fasting on blood pressure control is not clear, the statement noted.
It added that typically 150-225 minutes and 225-420 minutes of physical activity per week can produce weight loss of 2-3 kg or 5-7.5 kg respectively, and 200-300 minutes of physical activity per week is needed to maintain this weight loss.
“Successful weight-loss maintenance over years therefore typically requires high levels of [physical activity] and limited sedentary time, frequent weight monitoring, and high levels of dietary restraint,” and weight regain is common, the authors summarize.
Other options to address obesity, hypertension
Weight-loss pharmacotherapies and metabolic surgery are other options to treat obesity and lower hypertension.
The statement reports that four drugs are approved by the Food and Drug Administration for long-term weight loss: Orlistat (Xenical, Alli), phentermine/topiramate extended release (Qsymia), naltrexone/bupropion (Contrave), and liraglutide 3.0 mg (Saxenda). On June 4, the FDA approved a fifth drug, semaglutide (Wegovy).
The long-term effects of antiobesity medications on blood pressure are mixed.
However, “prescription rates for these drugs remain low, likely because of limited insurance coverage and low levels of clinical proficiency with treating obesity,” Dr. Hall and colleagues write.
Metabolic surgery could be a weight loss option for certain patients, and it is associated with blood pressure lowering.
In the 100-patient Gastric Bypass to Treat Obese Patients With Steady Hypertension (GATEWAY) trial, published in Circulation in 2018, more patients in the Roux-en-Y gastric-bypass group than the control group (84% vs. 13%) met the primary outcome of a 30% or greater reduction in the number of blood pressure-lowering medications at 12 months while maintaining an office blood pressure less than 140/90 mm Hg.
Unanswered questions, future research directions
In 2015-2016, an estimated 18.5% of U.S. children and adolescents aged 2-19 years had obesity, the statement notes. Children with obesity have a twofold increased risk of incident hypertension, and those with severe obesity have an over fourfold increased risk of this outcome, compared with children who have a healthy weight.
Dr. Hall and colleagues emphasized that, “as the prevalence of obesity continues to increase, hypertension and associated cardiorenal diseases will also increase unless more effective strategies to prevent and treat obesity are developed.”
They identified 17 unanswered questions (knowledge gaps) that can guide the direction of future research. These include:
- What new strategies and science-based guidelines are needed to curb the growing evidence of childhood obesity?
- Does intentional weight loss with pharmacotherapy or metabolic surgery in childhood and early adulthood prevent hypertension and subsequent target organ damage in later life?
- What is the optimal amount of time that clinicians should allow before recommending more aggressive weight management strategies (that is, antiobesity medications or metabolic surgery) or hypertension strategies beyond lifestyle changes?
“To me,” Dr. Hall said, “addressing childhood obesity hypertension and determining optimal timing of antiobesity therapies are the most important [issues]. Certainly, these therapies (i.e., diets, medications, surgeries) have some risks, but we don’t have a clear understanding if their benefits outweigh these risks in younger obese people or whether initiating these therapies before the onset of target organ damage such as heart failure” outweigh the risks.
Dr. Hall has reported no relevant financial relationships. Disclosures for the other authors are listed with the article.
A version of this article first appeared on Medscape.com.
Whereas previous scientific statements from the American Heart Association have addressed how diet, physical activity, and weight control can help prevent and manage hypertension, a new AHA statement focuses on obesity-related hypertension.
The document, which was published online Sept. 20, 2021, in Hypertension, also identifies knowledge gaps and suggests future research directions.
“Given [that] obesity is a major risk factor for hypertension, and hypertension is one of the greatest (if not the greatest) attributable risk factors for most cardiovascular diseases, we thought it was important to focus on weight loss strategies and update what we know about the treatment options that are available to treat obesity hypertension,” writing group chair Michael E. Hall, MD, told this news organization.
“Medical and surgical strategies may help with long-term weight and blood pressure improvement, in addition to a heart-healthy diet and physical activity,” he noted in a press release from the AHA. “We often don’t consider medications or metabolic surgery until after there has been target organ damage, such as heart injury or having a stroke.”
However, by acting earlier, “we may be able to prevent these complications,” added Dr. Hall, associate division director for cardiovascular diseases at the University of Mississippi Medical Center in Jackson.
“This is not a call for greater use of one specific therapy,” he clarified. “However, we do know that more aggressive treatments including antiobesity medications or metabolic surgery are underutilized.”
According to Dr. Hall, “we treat the secondary problem [i.e., the hypertension or diabetes], but we are not treating the root cause [obesity] as aggressively.”
“Hopefully this statement will increase awareness that there are several [treatment] options [and] bring attention to this major health issue,” he said.
He added that the most important question, in his mind, is how best to tackle obesity among children and adolescents to lower their risk of hypertension and other associated complications.
The statement is aimed at both primary care providers and specialists.
Diet, physical activity help, but weight regain common
Losing 5%-10% of body weight can lead to a more than 5–mm Hg reduction in systolic blood pressure and a 4–mm Hg reduction in diastolic blood pressure, the statement notes. Losing 10 kg may lower systolic blood pressure by 5-20 mm Hg.
To manage weight, control hypertension, and reduce the risk of cardiovascular disease, guidelines recommend the Mediterranean diet or the Dietary Approaches to Stop Hypertension (DASH) diet, which both emphasize fruits, vegetables, legumes, nuts, and seeds, with moderate intake of fish, seafood, poultry, and dairy, and low intake of red and processed meats and sweets. The Mediterranean diet also includes olive oil and moderate consumption of (mainly red) wine.
The effect of intermittent fasting on blood pressure control is not clear, the statement noted.
It added that typically 150-225 minutes and 225-420 minutes of physical activity per week can produce weight loss of 2-3 kg or 5-7.5 kg respectively, and 200-300 minutes of physical activity per week is needed to maintain this weight loss.
“Successful weight-loss maintenance over years therefore typically requires high levels of [physical activity] and limited sedentary time, frequent weight monitoring, and high levels of dietary restraint,” and weight regain is common, the authors summarize.
Other options to address obesity, hypertension
Weight-loss pharmacotherapies and metabolic surgery are other options to treat obesity and lower hypertension.
The statement reports that four drugs are approved by the Food and Drug Administration for long-term weight loss: Orlistat (Xenical, Alli), phentermine/topiramate extended release (Qsymia), naltrexone/bupropion (Contrave), and liraglutide 3.0 mg (Saxenda). On June 4, the FDA approved a fifth drug, semaglutide (Wegovy).
The long-term effects of antiobesity medications on blood pressure are mixed.
However, “prescription rates for these drugs remain low, likely because of limited insurance coverage and low levels of clinical proficiency with treating obesity,” Dr. Hall and colleagues write.
Metabolic surgery could be a weight loss option for certain patients, and it is associated with blood pressure lowering.
In the 100-patient Gastric Bypass to Treat Obese Patients With Steady Hypertension (GATEWAY) trial, published in Circulation in 2018, more patients in the Roux-en-Y gastric-bypass group than the control group (84% vs. 13%) met the primary outcome of a 30% or greater reduction in the number of blood pressure-lowering medications at 12 months while maintaining an office blood pressure less than 140/90 mm Hg.
Unanswered questions, future research directions
In 2015-2016, an estimated 18.5% of U.S. children and adolescents aged 2-19 years had obesity, the statement notes. Children with obesity have a twofold increased risk of incident hypertension, and those with severe obesity have an over fourfold increased risk of this outcome, compared with children who have a healthy weight.
Dr. Hall and colleagues emphasized that, “as the prevalence of obesity continues to increase, hypertension and associated cardiorenal diseases will also increase unless more effective strategies to prevent and treat obesity are developed.”
They identified 17 unanswered questions (knowledge gaps) that can guide the direction of future research. These include:
- What new strategies and science-based guidelines are needed to curb the growing evidence of childhood obesity?
- Does intentional weight loss with pharmacotherapy or metabolic surgery in childhood and early adulthood prevent hypertension and subsequent target organ damage in later life?
- What is the optimal amount of time that clinicians should allow before recommending more aggressive weight management strategies (that is, antiobesity medications or metabolic surgery) or hypertension strategies beyond lifestyle changes?
“To me,” Dr. Hall said, “addressing childhood obesity hypertension and determining optimal timing of antiobesity therapies are the most important [issues]. Certainly, these therapies (i.e., diets, medications, surgeries) have some risks, but we don’t have a clear understanding if their benefits outweigh these risks in younger obese people or whether initiating these therapies before the onset of target organ damage such as heart failure” outweigh the risks.
Dr. Hall has reported no relevant financial relationships. Disclosures for the other authors are listed with the article.
A version of this article first appeared on Medscape.com.
Moderate alcohol intake may curb subsequent diabetes after gestational diabetes
Among women with a history of gestational diabetes, alcohol intake of half a drink to one drink daily was associated with a 55% lower risk for subsequent type 2 diabetes, based on data from approximately 4,700 women in the Nurses’ Health Study II cohort.
However, the findings must be considered in the context of other risks and benefits of alcohol consumption before making statements or clinical recommendations, wrote Stefanie N. Hinkle, PhD, of the National Institutes of Health, Bethesda, Md., and colleagues.
Women with a history of gestational diabetes remain at increased risk for developing type 2 diabetes, so modifiable diet and lifestyle factors deserve further study, the researchers noted. Previous research has shown an association between light to moderate alcohol consumption and reduced risk of type 2 diabetes among women in the general population, but data on a similar risk reduction for women with a history of gestational diabetes are lacking, they added.
In a study published in JAMA Network Open, the researchers reviewed data from 4,740 women enrolled in the Nurses’ Health Study II who reported a history of gestational diabetes. These women were followed from Jan. 1, 1991, to Dec. 31, 2017, as part of the Diabetes & Women’s Health Study; dietary intake, including alcohol intake, was assessed every 4 years via validated food frequency questionnaires.
The average age at baseline was 38 years, and the median follow-up time was 24 years, yielding a total of 78,328 person-years of follow-up. Alcohol consumption was divided into four categories: none; 0.1 g/day to 4.9 g/day; 5.0 to 14.9 g/day, and 15.0 g/day or higher.
A total of 897 incident cases of type 2 diabetes were reported during the study period. After adjustment for multiple dietary and lifestyle variables, including diet and physical activity, only alcohol consumption of 5.0-14.9 g/day (approximately half a drink to one drink) was associated with a significantly decreased risk for incident type 2 diabetes (hazard ratio, 0.45) compared with women who reported no alcohol consumption.
On further adjustment for body mass index, women who reported alcohol consumption in the 5.0-14.9 g/day range had a 41% lower risk for developing incident type 2 diabetes (HR, 0.59); alcohol consumption in the other ranges remained unassociated with type 2 diabetes risk, although the researchers noted that these estimates were attenuated.
The median daily intake for women who consumed alcohol was 2.3 g/day, approximately one drink per week. Beer was the most frequently consumed type of alcohol.
When the researchers analyzed the data by alcohol type, notably, “only beer consumption of 1 or more servings a week was associated with a lower risk for type 2 diabetes,” although previous studies have suggested a stronger association in diabetes risk reduction with wine consumption vs. beer, the researchers noted.
The study findings were the potential for confounding factors not included in the adjustment, potential underreporting of alcohol intake, and potential screening bias toward women who were more health conscious, the researchers noted. Other limitations were lack of generalizability given that most of the study participants were white women, and a lack of data on binge drinking and whether alcohol was consumed with meals, they added. The study strengths included the prospective design, large size, long-term follow-up, and use of validated questionnaires, they said.
The researchers cautioned that the results should not be interpreted without considering other health outcomes. “Consistent with the 2020 Dietary Guidelines for Americans, which recommend that adults who do not consume alcohol do not initiate drinking, it may not be prudent for those with a history of gestational diabetes who do not consume alcohol to initiate drinking alcohol solely to reduce their risk for type 2 diabetes,” they emphasized.
Risk/benefit ratio for alcohol includes many factors
“There is a relative paucity of data regarding women’s long-term health as it may relate to pregnancy and pregnancy outcomes,” Angela Bianco, MD, of Mount Sinai Hospital, New York, said in an interview.
Dr. Bianco said she was surprised by some of the study findings.
“Generally speaking, I consider alcohol to be of little to no nutritional value, and to have a high sugar content/glycemic index,” she said. “However, a reduced incidence of adult-onset diabetes has been observed among moderate drinkers in other large prospective studies as well,” she noted. “In contrast, some studies have shown an increased risk of diabetes among a proportion of subjects in the top alcohol consumption category, while other studies have found no association. Possible inconsistencies may be due to differences in drinking patterns and the types of beverages consumed,” Dr. Bianco explained.
A key point for clinicians to keep in mind is that “the study may be flawed based on the different criteria used to make a diagnosis of history of gestational diabetes, the fact that they excluded patients that did not return the questionnaires, and the fact that respondents may not have answered correctly due to recall bias” or other reasons, Dr. Bianco said. “Additionally, those who responded obviously had access to health care, which in and of itself is a confounder,” she noted.
Another key point is that “the effect of alcohol being consumed with or without a meal was not examined,” said Dr. Bianco. “Alcohol concentration is reduced if consumed with meals. Alcohol can lead to hypoglycemia (from reduced gluconeogenesis) during fasting states, but after meals (postprandial states) it can result in lower glucose disposal and higher blood glucose levels,” she said. “The available literature suggests that alcohol may improve insulin sensitivity and reduce resistance, but there is likely a U-shaped association between alcohol consumption and the risk of diabetes,” Dr. Bianco noted. “There is likely a delicate balance between benefits and risks of alcohol intake. The inherent benefit/risk ratio must take into account with other potential comorbidities including BMI, activity level, stress, and preexisting conditions,” she said.
“Additional long-term studies engaging patients with diverse ethnic and socioeconomic backgrounds with detailed information regarding the role of nutrition, alcohol intake, tobacco and drug use, environmental exposures, and medical comorbidities need to be performed,” Dr. Bianco concluded.
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of General Medical Sciences, and the National Institute of Diabetes and Digestive and Kidney Diseases; the Nurses’ Health Study II was supported by the National Institutes of Health. Lead author Dr. Hinkle and coauthor Cuilin Zhang, MD, are employees of the U.S. federal government. The researchers and Dr. Bianco had no financial conflicts to disclose.
Among women with a history of gestational diabetes, alcohol intake of half a drink to one drink daily was associated with a 55% lower risk for subsequent type 2 diabetes, based on data from approximately 4,700 women in the Nurses’ Health Study II cohort.
However, the findings must be considered in the context of other risks and benefits of alcohol consumption before making statements or clinical recommendations, wrote Stefanie N. Hinkle, PhD, of the National Institutes of Health, Bethesda, Md., and colleagues.
Women with a history of gestational diabetes remain at increased risk for developing type 2 diabetes, so modifiable diet and lifestyle factors deserve further study, the researchers noted. Previous research has shown an association between light to moderate alcohol consumption and reduced risk of type 2 diabetes among women in the general population, but data on a similar risk reduction for women with a history of gestational diabetes are lacking, they added.
In a study published in JAMA Network Open, the researchers reviewed data from 4,740 women enrolled in the Nurses’ Health Study II who reported a history of gestational diabetes. These women were followed from Jan. 1, 1991, to Dec. 31, 2017, as part of the Diabetes & Women’s Health Study; dietary intake, including alcohol intake, was assessed every 4 years via validated food frequency questionnaires.
The average age at baseline was 38 years, and the median follow-up time was 24 years, yielding a total of 78,328 person-years of follow-up. Alcohol consumption was divided into four categories: none; 0.1 g/day to 4.9 g/day; 5.0 to 14.9 g/day, and 15.0 g/day or higher.
A total of 897 incident cases of type 2 diabetes were reported during the study period. After adjustment for multiple dietary and lifestyle variables, including diet and physical activity, only alcohol consumption of 5.0-14.9 g/day (approximately half a drink to one drink) was associated with a significantly decreased risk for incident type 2 diabetes (hazard ratio, 0.45) compared with women who reported no alcohol consumption.
On further adjustment for body mass index, women who reported alcohol consumption in the 5.0-14.9 g/day range had a 41% lower risk for developing incident type 2 diabetes (HR, 0.59); alcohol consumption in the other ranges remained unassociated with type 2 diabetes risk, although the researchers noted that these estimates were attenuated.
The median daily intake for women who consumed alcohol was 2.3 g/day, approximately one drink per week. Beer was the most frequently consumed type of alcohol.
When the researchers analyzed the data by alcohol type, notably, “only beer consumption of 1 or more servings a week was associated with a lower risk for type 2 diabetes,” although previous studies have suggested a stronger association in diabetes risk reduction with wine consumption vs. beer, the researchers noted.
The study findings were the potential for confounding factors not included in the adjustment, potential underreporting of alcohol intake, and potential screening bias toward women who were more health conscious, the researchers noted. Other limitations were lack of generalizability given that most of the study participants were white women, and a lack of data on binge drinking and whether alcohol was consumed with meals, they added. The study strengths included the prospective design, large size, long-term follow-up, and use of validated questionnaires, they said.
The researchers cautioned that the results should not be interpreted without considering other health outcomes. “Consistent with the 2020 Dietary Guidelines for Americans, which recommend that adults who do not consume alcohol do not initiate drinking, it may not be prudent for those with a history of gestational diabetes who do not consume alcohol to initiate drinking alcohol solely to reduce their risk for type 2 diabetes,” they emphasized.
Risk/benefit ratio for alcohol includes many factors
“There is a relative paucity of data regarding women’s long-term health as it may relate to pregnancy and pregnancy outcomes,” Angela Bianco, MD, of Mount Sinai Hospital, New York, said in an interview.
Dr. Bianco said she was surprised by some of the study findings.
“Generally speaking, I consider alcohol to be of little to no nutritional value, and to have a high sugar content/glycemic index,” she said. “However, a reduced incidence of adult-onset diabetes has been observed among moderate drinkers in other large prospective studies as well,” she noted. “In contrast, some studies have shown an increased risk of diabetes among a proportion of subjects in the top alcohol consumption category, while other studies have found no association. Possible inconsistencies may be due to differences in drinking patterns and the types of beverages consumed,” Dr. Bianco explained.
A key point for clinicians to keep in mind is that “the study may be flawed based on the different criteria used to make a diagnosis of history of gestational diabetes, the fact that they excluded patients that did not return the questionnaires, and the fact that respondents may not have answered correctly due to recall bias” or other reasons, Dr. Bianco said. “Additionally, those who responded obviously had access to health care, which in and of itself is a confounder,” she noted.
Another key point is that “the effect of alcohol being consumed with or without a meal was not examined,” said Dr. Bianco. “Alcohol concentration is reduced if consumed with meals. Alcohol can lead to hypoglycemia (from reduced gluconeogenesis) during fasting states, but after meals (postprandial states) it can result in lower glucose disposal and higher blood glucose levels,” she said. “The available literature suggests that alcohol may improve insulin sensitivity and reduce resistance, but there is likely a U-shaped association between alcohol consumption and the risk of diabetes,” Dr. Bianco noted. “There is likely a delicate balance between benefits and risks of alcohol intake. The inherent benefit/risk ratio must take into account with other potential comorbidities including BMI, activity level, stress, and preexisting conditions,” she said.
“Additional long-term studies engaging patients with diverse ethnic and socioeconomic backgrounds with detailed information regarding the role of nutrition, alcohol intake, tobacco and drug use, environmental exposures, and medical comorbidities need to be performed,” Dr. Bianco concluded.
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of General Medical Sciences, and the National Institute of Diabetes and Digestive and Kidney Diseases; the Nurses’ Health Study II was supported by the National Institutes of Health. Lead author Dr. Hinkle and coauthor Cuilin Zhang, MD, are employees of the U.S. federal government. The researchers and Dr. Bianco had no financial conflicts to disclose.
Among women with a history of gestational diabetes, alcohol intake of half a drink to one drink daily was associated with a 55% lower risk for subsequent type 2 diabetes, based on data from approximately 4,700 women in the Nurses’ Health Study II cohort.
However, the findings must be considered in the context of other risks and benefits of alcohol consumption before making statements or clinical recommendations, wrote Stefanie N. Hinkle, PhD, of the National Institutes of Health, Bethesda, Md., and colleagues.
Women with a history of gestational diabetes remain at increased risk for developing type 2 diabetes, so modifiable diet and lifestyle factors deserve further study, the researchers noted. Previous research has shown an association between light to moderate alcohol consumption and reduced risk of type 2 diabetes among women in the general population, but data on a similar risk reduction for women with a history of gestational diabetes are lacking, they added.
In a study published in JAMA Network Open, the researchers reviewed data from 4,740 women enrolled in the Nurses’ Health Study II who reported a history of gestational diabetes. These women were followed from Jan. 1, 1991, to Dec. 31, 2017, as part of the Diabetes & Women’s Health Study; dietary intake, including alcohol intake, was assessed every 4 years via validated food frequency questionnaires.
The average age at baseline was 38 years, and the median follow-up time was 24 years, yielding a total of 78,328 person-years of follow-up. Alcohol consumption was divided into four categories: none; 0.1 g/day to 4.9 g/day; 5.0 to 14.9 g/day, and 15.0 g/day or higher.
A total of 897 incident cases of type 2 diabetes were reported during the study period. After adjustment for multiple dietary and lifestyle variables, including diet and physical activity, only alcohol consumption of 5.0-14.9 g/day (approximately half a drink to one drink) was associated with a significantly decreased risk for incident type 2 diabetes (hazard ratio, 0.45) compared with women who reported no alcohol consumption.
On further adjustment for body mass index, women who reported alcohol consumption in the 5.0-14.9 g/day range had a 41% lower risk for developing incident type 2 diabetes (HR, 0.59); alcohol consumption in the other ranges remained unassociated with type 2 diabetes risk, although the researchers noted that these estimates were attenuated.
The median daily intake for women who consumed alcohol was 2.3 g/day, approximately one drink per week. Beer was the most frequently consumed type of alcohol.
When the researchers analyzed the data by alcohol type, notably, “only beer consumption of 1 or more servings a week was associated with a lower risk for type 2 diabetes,” although previous studies have suggested a stronger association in diabetes risk reduction with wine consumption vs. beer, the researchers noted.
The study findings were the potential for confounding factors not included in the adjustment, potential underreporting of alcohol intake, and potential screening bias toward women who were more health conscious, the researchers noted. Other limitations were lack of generalizability given that most of the study participants were white women, and a lack of data on binge drinking and whether alcohol was consumed with meals, they added. The study strengths included the prospective design, large size, long-term follow-up, and use of validated questionnaires, they said.
The researchers cautioned that the results should not be interpreted without considering other health outcomes. “Consistent with the 2020 Dietary Guidelines for Americans, which recommend that adults who do not consume alcohol do not initiate drinking, it may not be prudent for those with a history of gestational diabetes who do not consume alcohol to initiate drinking alcohol solely to reduce their risk for type 2 diabetes,” they emphasized.
Risk/benefit ratio for alcohol includes many factors
“There is a relative paucity of data regarding women’s long-term health as it may relate to pregnancy and pregnancy outcomes,” Angela Bianco, MD, of Mount Sinai Hospital, New York, said in an interview.
Dr. Bianco said she was surprised by some of the study findings.
“Generally speaking, I consider alcohol to be of little to no nutritional value, and to have a high sugar content/glycemic index,” she said. “However, a reduced incidence of adult-onset diabetes has been observed among moderate drinkers in other large prospective studies as well,” she noted. “In contrast, some studies have shown an increased risk of diabetes among a proportion of subjects in the top alcohol consumption category, while other studies have found no association. Possible inconsistencies may be due to differences in drinking patterns and the types of beverages consumed,” Dr. Bianco explained.
A key point for clinicians to keep in mind is that “the study may be flawed based on the different criteria used to make a diagnosis of history of gestational diabetes, the fact that they excluded patients that did not return the questionnaires, and the fact that respondents may not have answered correctly due to recall bias” or other reasons, Dr. Bianco said. “Additionally, those who responded obviously had access to health care, which in and of itself is a confounder,” she noted.
Another key point is that “the effect of alcohol being consumed with or without a meal was not examined,” said Dr. Bianco. “Alcohol concentration is reduced if consumed with meals. Alcohol can lead to hypoglycemia (from reduced gluconeogenesis) during fasting states, but after meals (postprandial states) it can result in lower glucose disposal and higher blood glucose levels,” she said. “The available literature suggests that alcohol may improve insulin sensitivity and reduce resistance, but there is likely a U-shaped association between alcohol consumption and the risk of diabetes,” Dr. Bianco noted. “There is likely a delicate balance between benefits and risks of alcohol intake. The inherent benefit/risk ratio must take into account with other potential comorbidities including BMI, activity level, stress, and preexisting conditions,” she said.
“Additional long-term studies engaging patients with diverse ethnic and socioeconomic backgrounds with detailed information regarding the role of nutrition, alcohol intake, tobacco and drug use, environmental exposures, and medical comorbidities need to be performed,” Dr. Bianco concluded.
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of General Medical Sciences, and the National Institute of Diabetes and Digestive and Kidney Diseases; the Nurses’ Health Study II was supported by the National Institutes of Health. Lead author Dr. Hinkle and coauthor Cuilin Zhang, MD, are employees of the U.S. federal government. The researchers and Dr. Bianco had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
EMPEROR-Preserved: Empagliflozin’s HFpEF efficacy catalyzes a heart failure redefinition
Groundbreaking results from the EMPEROR-Preserved trial did more than establish for the first time that a drug, empagliflozin, has clearly proven efficacy for treating patients with heart failure with preserved ejection fraction (HFpEF). The results also helped catalyze a paradigm shift in how heart failure thought leaders think about the role of ejection fraction for making important distinctions among patients with heart failure.
EMPEROR-Preserved may also be the final nail in the coffin for defining patients with heart failure as having HFpEF or heart failure with reduced ejection fraction (HFrEF).
This new consensus essentially throws out left ventricular ejection fraction (EF) as the key metric for matching patients to heart failure treatments. Experts have instead begun suggesting a more unified treatment approach for all heart failure patients regardless of their EF.
‘Forget about ejection fraction’
“We encourage you to forget about ejection fraction,” declared Milton Packer, MD, during discussion at a session of the annual scientific meeting of the Heart Failure Society of America. “We certainly encourage you to forget about an ejection fraction of less than 40%” as having special significance,” added Dr. Packer, a lead investigator for both the EMPEROR-Reduced and EMPEROR-Preserved trials (which researchers combined in a unified analysis with a total of 9,718 patients with heart failure called EMPEROR-Pooled), and a heart failure researcher at Baylor University Medical Center in Dallas.
“The 40% ejection fraction divide is artificial. It was created in 2003 as part of a trial design, but it has no physiological significance,” Dr. Packer explained. A much better way to distinguish systolic and diastolic heart failure is by strain assessment rather than by ejection fraction. “Strain is a measure of myocardial shortening, a measure of what the heart does. Ejection fraction is a measure of volume,” said Dr. Packer. “Sign me up to get rid of ejection fraction,” he added.
“Ejection fraction is not as valuable as we thought for distinguishing the therapeutic benefit” of heart failure drugs, agreed Marvin A. Konstam, MD, professor of medicine at Tufts University and chief physician executive of the CardioVascular Center of Tufts Medical Center, both in Boston, who spoke during a different session at the meeting.
“It would easier if we didn’t spend time parsing this number,” ejection fraction, commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern Medicine in Chicago. “Wouldn’t it be easier if we said that every patient with heart failure needs to receive one agent from each of the four [pillar] drug classes, and put them in a polypill” at reduced dosages, he proposed, envisioning one potential consequence of jettisoning ejection fraction.
The four pillar drug classes, recently identified as essential for patients with HFrEF but until now not endorsed for patients with HFpEF, are the sodium-glucose cotransporter 2 (SGLT2) inhibitors, such as empagliflozin (Jardiance); an angiotensin receptor blocker neprilysin inhibitor compound such as sacubitril/valsartan (Entresto); beta-blockers; and mineralocorticoid receptor antagonists such as spironolactone and eplerenone.
An opportunity for ‘simpler and easier’ treatments
“This is an opportunity to disrupt the way we’ve been doing things and think about something that is simpler and easier,” said Dr. Yancy, who chaired some of the panels serially formed by the American Heart Association and American College of Cardiology to write guidelines for treating heart failure. “An approach that would be easier to implement without worrying about staggering the start of each drug class and an incessant focus on titrating individual elements and taking 6 months to get to a certain place.”
Results from EMPEROR-Preserved and the combined EMPEROR-Pooled analysis triggered these paradigm-shifting sentiments by showing clear evidence that treatment with empagliflozin exerts consistent benefit – and is consistently safe – for patients with heart failure across a spectrum of EFs, from less than 25% to 64%, though its performance in patients with HFpEF and EFs of 65% or greater in the EMPEROR-Preserved trial remains unclear.
The consequence is that clinicians should feel comfortable prescribing empagliflozin to most patients with heart failure without regard to EF, even patients with EF values in the mid-60% range.
The EMPEROR-Preserved results showed a clear signal of attenuated benefit among patients with an EF of 65% or greater “on a population basis,” stressed Dr. Packer. “But on an individual basis, ejection fraction is not that reproducible, so measuring ejection fraction will not help you determine whom to treat or not treat. “
“There is significant variability” measuring EF using the most common modality, echocardiography, noted Javed Butler, MD, an EMPEROR coinvestigator who also spoke at the meeting session. A person with a measured EF of 65% could actually have a value that may be as low as 58% or as high as about 72%, noted Dr. Butler, who is professor and chair of medicine at the University of Mississippi, Jackson. The upshot is that any patient diagnosed with heart failure should receive an SGLT2 inhibitor “irrespective of their ejection fraction,” Dr. Butler advised.
“Ejection fraction is very crude, and probably not sufficient to identify a phenotype,” for treatment, said Dr. Yancy. “The real takeaway may be that we need to revisit what we call HFrEF, and then let that be the new standard for treatment.”
“Is [an EF of] 60% the new 40%?” asked Dr. Packer, implying that the answer was yes.
Results from several trials suggest redefining HFrEF
The idea that patients without traditionally defined HFrEF – an EF of 40% or less – could also benefit from other classes of heart failure drugs has been gestating for a while, and then rose to a new level with the August 2021 report of results from EMPEROR-Preserved. Two years ago, in September 2019, Dr. Butler, Dr. Packer, and a third colleague advanced the notion of redefining HFrEF by raising the ejection fraction ceiling in a published commentary.
They cited the experience with the angiotensin receptor blocker candesartan in a post hoc analysis of data collected in the CHARM-Preserved trial, which showed a strong signal of benefit in the subgroup of patients with EFs of 41%-49%, but not in those with an EF of 50% or higher. This finding prompted Dr. Konstam to express doubts about relying on EF to define heart failure subgroups in trials and guide management in a commentary published more than 3 years ago.
Another crack in the traditional EF framework came from analysis of results from the TOPCAT trial that tested spironolactone as a treatment for patients with HFpEF, according to the 2019 opinion published by Dr. Butler and Dr. Packer. Once again a post hoc analysis, this time using data from TOPCAT, suggested a benefit from the mineralocorticoid receptor antagonist spironolactone in patients with heart failure and an EF of 45%-49% (45% was the minimum EF for enrollment into the study).
Recently, data from a third trial that tested sacubitril/valsartan in patients with HFpEF, PARAGON-HF, showed benefit among patients with EFs below the study median of 57%. This finding led the Food and Drug Administration in February 2021 to amend its initial approval for sacubitril/valsartan by removing a specific EF ceiling from the drug’s indication and instead saying that patient’s receiving the drug should have a “below normal” EF.
Writing in a recent commentary, Dr. Yancy called the FDA’s action on sacubitril/valsartan “reasonable,” and that the subgroup assessment of data from the PARAGON-HF trial creates a “new, reasonably evidence-based therapy for HFpEF.” He also predicted that guideline-writing panels will “likely align with a permissive statement of indication” for sacubitril/valsartan in patients with HFpEF, especially those with EFs of less than 57%.
The idea of using an SGLT2 inhibitor like empagliflozin on all heart failure patients, and also adding agents like sacubitril/valsartan and spironolactone in patients with HFpEF and EFs in the mid-50% range or lower may take some time to catch on, but it already has one influential advocate.
“If a patient has HFpEF with an EF of less than 55%, use quadruple-class therapy,” summed up Dr. Butler during the HFSA session, while also suggesting prescribing an SGLT2 inhibitor to essentially all patients with heart failure regardless of their EF.
The EMPEROR-Preserved and EMPEROR-Reduced trials and the EMPEROR-Pooled analysis were sponsored by Boehringer Ingelheim and Lilly, the companies that jointly market empagliflozin (Jardiance). Dr. Packer has had financial relationships with BI and Lilly and numerous other companies. Dr. Konstam has served on data monitoring committees for trials funded by Boehringer Ingelheim and by Amgen, Luitpold, and Pfizer, and has been a consultant to Arena, LivaNova, Merck, SC Pharma, and Takeda. Dr. Yancy had no disclosures. Dr. Butler has had financial relationships with Boehringer Ingelheim and numerous other companies.
Groundbreaking results from the EMPEROR-Preserved trial did more than establish for the first time that a drug, empagliflozin, has clearly proven efficacy for treating patients with heart failure with preserved ejection fraction (HFpEF). The results also helped catalyze a paradigm shift in how heart failure thought leaders think about the role of ejection fraction for making important distinctions among patients with heart failure.
EMPEROR-Preserved may also be the final nail in the coffin for defining patients with heart failure as having HFpEF or heart failure with reduced ejection fraction (HFrEF).
This new consensus essentially throws out left ventricular ejection fraction (EF) as the key metric for matching patients to heart failure treatments. Experts have instead begun suggesting a more unified treatment approach for all heart failure patients regardless of their EF.
‘Forget about ejection fraction’
“We encourage you to forget about ejection fraction,” declared Milton Packer, MD, during discussion at a session of the annual scientific meeting of the Heart Failure Society of America. “We certainly encourage you to forget about an ejection fraction of less than 40%” as having special significance,” added Dr. Packer, a lead investigator for both the EMPEROR-Reduced and EMPEROR-Preserved trials (which researchers combined in a unified analysis with a total of 9,718 patients with heart failure called EMPEROR-Pooled), and a heart failure researcher at Baylor University Medical Center in Dallas.
“The 40% ejection fraction divide is artificial. It was created in 2003 as part of a trial design, but it has no physiological significance,” Dr. Packer explained. A much better way to distinguish systolic and diastolic heart failure is by strain assessment rather than by ejection fraction. “Strain is a measure of myocardial shortening, a measure of what the heart does. Ejection fraction is a measure of volume,” said Dr. Packer. “Sign me up to get rid of ejection fraction,” he added.
“Ejection fraction is not as valuable as we thought for distinguishing the therapeutic benefit” of heart failure drugs, agreed Marvin A. Konstam, MD, professor of medicine at Tufts University and chief physician executive of the CardioVascular Center of Tufts Medical Center, both in Boston, who spoke during a different session at the meeting.
“It would easier if we didn’t spend time parsing this number,” ejection fraction, commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern Medicine in Chicago. “Wouldn’t it be easier if we said that every patient with heart failure needs to receive one agent from each of the four [pillar] drug classes, and put them in a polypill” at reduced dosages, he proposed, envisioning one potential consequence of jettisoning ejection fraction.
The four pillar drug classes, recently identified as essential for patients with HFrEF but until now not endorsed for patients with HFpEF, are the sodium-glucose cotransporter 2 (SGLT2) inhibitors, such as empagliflozin (Jardiance); an angiotensin receptor blocker neprilysin inhibitor compound such as sacubitril/valsartan (Entresto); beta-blockers; and mineralocorticoid receptor antagonists such as spironolactone and eplerenone.
An opportunity for ‘simpler and easier’ treatments
“This is an opportunity to disrupt the way we’ve been doing things and think about something that is simpler and easier,” said Dr. Yancy, who chaired some of the panels serially formed by the American Heart Association and American College of Cardiology to write guidelines for treating heart failure. “An approach that would be easier to implement without worrying about staggering the start of each drug class and an incessant focus on titrating individual elements and taking 6 months to get to a certain place.”
Results from EMPEROR-Preserved and the combined EMPEROR-Pooled analysis triggered these paradigm-shifting sentiments by showing clear evidence that treatment with empagliflozin exerts consistent benefit – and is consistently safe – for patients with heart failure across a spectrum of EFs, from less than 25% to 64%, though its performance in patients with HFpEF and EFs of 65% or greater in the EMPEROR-Preserved trial remains unclear.
The consequence is that clinicians should feel comfortable prescribing empagliflozin to most patients with heart failure without regard to EF, even patients with EF values in the mid-60% range.
The EMPEROR-Preserved results showed a clear signal of attenuated benefit among patients with an EF of 65% or greater “on a population basis,” stressed Dr. Packer. “But on an individual basis, ejection fraction is not that reproducible, so measuring ejection fraction will not help you determine whom to treat or not treat. “
“There is significant variability” measuring EF using the most common modality, echocardiography, noted Javed Butler, MD, an EMPEROR coinvestigator who also spoke at the meeting session. A person with a measured EF of 65% could actually have a value that may be as low as 58% or as high as about 72%, noted Dr. Butler, who is professor and chair of medicine at the University of Mississippi, Jackson. The upshot is that any patient diagnosed with heart failure should receive an SGLT2 inhibitor “irrespective of their ejection fraction,” Dr. Butler advised.
“Ejection fraction is very crude, and probably not sufficient to identify a phenotype,” for treatment, said Dr. Yancy. “The real takeaway may be that we need to revisit what we call HFrEF, and then let that be the new standard for treatment.”
“Is [an EF of] 60% the new 40%?” asked Dr. Packer, implying that the answer was yes.
Results from several trials suggest redefining HFrEF
The idea that patients without traditionally defined HFrEF – an EF of 40% or less – could also benefit from other classes of heart failure drugs has been gestating for a while, and then rose to a new level with the August 2021 report of results from EMPEROR-Preserved. Two years ago, in September 2019, Dr. Butler, Dr. Packer, and a third colleague advanced the notion of redefining HFrEF by raising the ejection fraction ceiling in a published commentary.
They cited the experience with the angiotensin receptor blocker candesartan in a post hoc analysis of data collected in the CHARM-Preserved trial, which showed a strong signal of benefit in the subgroup of patients with EFs of 41%-49%, but not in those with an EF of 50% or higher. This finding prompted Dr. Konstam to express doubts about relying on EF to define heart failure subgroups in trials and guide management in a commentary published more than 3 years ago.
Another crack in the traditional EF framework came from analysis of results from the TOPCAT trial that tested spironolactone as a treatment for patients with HFpEF, according to the 2019 opinion published by Dr. Butler and Dr. Packer. Once again a post hoc analysis, this time using data from TOPCAT, suggested a benefit from the mineralocorticoid receptor antagonist spironolactone in patients with heart failure and an EF of 45%-49% (45% was the minimum EF for enrollment into the study).
Recently, data from a third trial that tested sacubitril/valsartan in patients with HFpEF, PARAGON-HF, showed benefit among patients with EFs below the study median of 57%. This finding led the Food and Drug Administration in February 2021 to amend its initial approval for sacubitril/valsartan by removing a specific EF ceiling from the drug’s indication and instead saying that patient’s receiving the drug should have a “below normal” EF.
Writing in a recent commentary, Dr. Yancy called the FDA’s action on sacubitril/valsartan “reasonable,” and that the subgroup assessment of data from the PARAGON-HF trial creates a “new, reasonably evidence-based therapy for HFpEF.” He also predicted that guideline-writing panels will “likely align with a permissive statement of indication” for sacubitril/valsartan in patients with HFpEF, especially those with EFs of less than 57%.
The idea of using an SGLT2 inhibitor like empagliflozin on all heart failure patients, and also adding agents like sacubitril/valsartan and spironolactone in patients with HFpEF and EFs in the mid-50% range or lower may take some time to catch on, but it already has one influential advocate.
“If a patient has HFpEF with an EF of less than 55%, use quadruple-class therapy,” summed up Dr. Butler during the HFSA session, while also suggesting prescribing an SGLT2 inhibitor to essentially all patients with heart failure regardless of their EF.
The EMPEROR-Preserved and EMPEROR-Reduced trials and the EMPEROR-Pooled analysis were sponsored by Boehringer Ingelheim and Lilly, the companies that jointly market empagliflozin (Jardiance). Dr. Packer has had financial relationships with BI and Lilly and numerous other companies. Dr. Konstam has served on data monitoring committees for trials funded by Boehringer Ingelheim and by Amgen, Luitpold, and Pfizer, and has been a consultant to Arena, LivaNova, Merck, SC Pharma, and Takeda. Dr. Yancy had no disclosures. Dr. Butler has had financial relationships with Boehringer Ingelheim and numerous other companies.
Groundbreaking results from the EMPEROR-Preserved trial did more than establish for the first time that a drug, empagliflozin, has clearly proven efficacy for treating patients with heart failure with preserved ejection fraction (HFpEF). The results also helped catalyze a paradigm shift in how heart failure thought leaders think about the role of ejection fraction for making important distinctions among patients with heart failure.
EMPEROR-Preserved may also be the final nail in the coffin for defining patients with heart failure as having HFpEF or heart failure with reduced ejection fraction (HFrEF).
This new consensus essentially throws out left ventricular ejection fraction (EF) as the key metric for matching patients to heart failure treatments. Experts have instead begun suggesting a more unified treatment approach for all heart failure patients regardless of their EF.
‘Forget about ejection fraction’
“We encourage you to forget about ejection fraction,” declared Milton Packer, MD, during discussion at a session of the annual scientific meeting of the Heart Failure Society of America. “We certainly encourage you to forget about an ejection fraction of less than 40%” as having special significance,” added Dr. Packer, a lead investigator for both the EMPEROR-Reduced and EMPEROR-Preserved trials (which researchers combined in a unified analysis with a total of 9,718 patients with heart failure called EMPEROR-Pooled), and a heart failure researcher at Baylor University Medical Center in Dallas.
“The 40% ejection fraction divide is artificial. It was created in 2003 as part of a trial design, but it has no physiological significance,” Dr. Packer explained. A much better way to distinguish systolic and diastolic heart failure is by strain assessment rather than by ejection fraction. “Strain is a measure of myocardial shortening, a measure of what the heart does. Ejection fraction is a measure of volume,” said Dr. Packer. “Sign me up to get rid of ejection fraction,” he added.
“Ejection fraction is not as valuable as we thought for distinguishing the therapeutic benefit” of heart failure drugs, agreed Marvin A. Konstam, MD, professor of medicine at Tufts University and chief physician executive of the CardioVascular Center of Tufts Medical Center, both in Boston, who spoke during a different session at the meeting.
“It would easier if we didn’t spend time parsing this number,” ejection fraction, commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern Medicine in Chicago. “Wouldn’t it be easier if we said that every patient with heart failure needs to receive one agent from each of the four [pillar] drug classes, and put them in a polypill” at reduced dosages, he proposed, envisioning one potential consequence of jettisoning ejection fraction.
The four pillar drug classes, recently identified as essential for patients with HFrEF but until now not endorsed for patients with HFpEF, are the sodium-glucose cotransporter 2 (SGLT2) inhibitors, such as empagliflozin (Jardiance); an angiotensin receptor blocker neprilysin inhibitor compound such as sacubitril/valsartan (Entresto); beta-blockers; and mineralocorticoid receptor antagonists such as spironolactone and eplerenone.
An opportunity for ‘simpler and easier’ treatments
“This is an opportunity to disrupt the way we’ve been doing things and think about something that is simpler and easier,” said Dr. Yancy, who chaired some of the panels serially formed by the American Heart Association and American College of Cardiology to write guidelines for treating heart failure. “An approach that would be easier to implement without worrying about staggering the start of each drug class and an incessant focus on titrating individual elements and taking 6 months to get to a certain place.”
Results from EMPEROR-Preserved and the combined EMPEROR-Pooled analysis triggered these paradigm-shifting sentiments by showing clear evidence that treatment with empagliflozin exerts consistent benefit – and is consistently safe – for patients with heart failure across a spectrum of EFs, from less than 25% to 64%, though its performance in patients with HFpEF and EFs of 65% or greater in the EMPEROR-Preserved trial remains unclear.
The consequence is that clinicians should feel comfortable prescribing empagliflozin to most patients with heart failure without regard to EF, even patients with EF values in the mid-60% range.
The EMPEROR-Preserved results showed a clear signal of attenuated benefit among patients with an EF of 65% or greater “on a population basis,” stressed Dr. Packer. “But on an individual basis, ejection fraction is not that reproducible, so measuring ejection fraction will not help you determine whom to treat or not treat. “
“There is significant variability” measuring EF using the most common modality, echocardiography, noted Javed Butler, MD, an EMPEROR coinvestigator who also spoke at the meeting session. A person with a measured EF of 65% could actually have a value that may be as low as 58% or as high as about 72%, noted Dr. Butler, who is professor and chair of medicine at the University of Mississippi, Jackson. The upshot is that any patient diagnosed with heart failure should receive an SGLT2 inhibitor “irrespective of their ejection fraction,” Dr. Butler advised.
“Ejection fraction is very crude, and probably not sufficient to identify a phenotype,” for treatment, said Dr. Yancy. “The real takeaway may be that we need to revisit what we call HFrEF, and then let that be the new standard for treatment.”
“Is [an EF of] 60% the new 40%?” asked Dr. Packer, implying that the answer was yes.
Results from several trials suggest redefining HFrEF
The idea that patients without traditionally defined HFrEF – an EF of 40% or less – could also benefit from other classes of heart failure drugs has been gestating for a while, and then rose to a new level with the August 2021 report of results from EMPEROR-Preserved. Two years ago, in September 2019, Dr. Butler, Dr. Packer, and a third colleague advanced the notion of redefining HFrEF by raising the ejection fraction ceiling in a published commentary.
They cited the experience with the angiotensin receptor blocker candesartan in a post hoc analysis of data collected in the CHARM-Preserved trial, which showed a strong signal of benefit in the subgroup of patients with EFs of 41%-49%, but not in those with an EF of 50% or higher. This finding prompted Dr. Konstam to express doubts about relying on EF to define heart failure subgroups in trials and guide management in a commentary published more than 3 years ago.
Another crack in the traditional EF framework came from analysis of results from the TOPCAT trial that tested spironolactone as a treatment for patients with HFpEF, according to the 2019 opinion published by Dr. Butler and Dr. Packer. Once again a post hoc analysis, this time using data from TOPCAT, suggested a benefit from the mineralocorticoid receptor antagonist spironolactone in patients with heart failure and an EF of 45%-49% (45% was the minimum EF for enrollment into the study).
Recently, data from a third trial that tested sacubitril/valsartan in patients with HFpEF, PARAGON-HF, showed benefit among patients with EFs below the study median of 57%. This finding led the Food and Drug Administration in February 2021 to amend its initial approval for sacubitril/valsartan by removing a specific EF ceiling from the drug’s indication and instead saying that patient’s receiving the drug should have a “below normal” EF.
Writing in a recent commentary, Dr. Yancy called the FDA’s action on sacubitril/valsartan “reasonable,” and that the subgroup assessment of data from the PARAGON-HF trial creates a “new, reasonably evidence-based therapy for HFpEF.” He also predicted that guideline-writing panels will “likely align with a permissive statement of indication” for sacubitril/valsartan in patients with HFpEF, especially those with EFs of less than 57%.
The idea of using an SGLT2 inhibitor like empagliflozin on all heart failure patients, and also adding agents like sacubitril/valsartan and spironolactone in patients with HFpEF and EFs in the mid-50% range or lower may take some time to catch on, but it already has one influential advocate.
“If a patient has HFpEF with an EF of less than 55%, use quadruple-class therapy,” summed up Dr. Butler during the HFSA session, while also suggesting prescribing an SGLT2 inhibitor to essentially all patients with heart failure regardless of their EF.
The EMPEROR-Preserved and EMPEROR-Reduced trials and the EMPEROR-Pooled analysis were sponsored by Boehringer Ingelheim and Lilly, the companies that jointly market empagliflozin (Jardiance). Dr. Packer has had financial relationships with BI and Lilly and numerous other companies. Dr. Konstam has served on data monitoring committees for trials funded by Boehringer Ingelheim and by Amgen, Luitpold, and Pfizer, and has been a consultant to Arena, LivaNova, Merck, SC Pharma, and Takeda. Dr. Yancy had no disclosures. Dr. Butler has had financial relationships with Boehringer Ingelheim and numerous other companies.
FROM HFSA 2021
A new weight loss threshold for T2d remission after bariatric surgery?
Patients with type 2 diabetes who underwent bariatric surgery commonly experienced remission, but there was little increase in rates of remission above a threshold of 20% total weight loss (TWL), according to a retrospective analysis of 5,928 patients with diabetes in an integrated health care system in Southern California.
The findings should reassure physicians and patients that surgery will be beneficial, according to lead author Karen Coleman, PhD, professor of health systems science at Kaiser Permanente Southern California.
Dr. Coleman has heard from many physicians saying they recommend against bariatric surgery because of concerns that patients gain weight back and therefore won’t get a long-term benefit, but this is not supported by the literature. “Hundreds of articles at this point show that this simply is not true. In addition, providers seem to think about bariatric surgery as an ‘all or none’ treatment. Gaining any weight back means that patients ‘fail.’ Weight regain is a normal part of massive weight loss; however, maintaining a certain amount of weight loss still provides benefits for patients, especially those with cardiovascular conditions like diabetes,” said Dr. Coleman.
Most patients lose 20%-30% of their body weight after bariatric surgery, but they don’t have to lose that much to see an improvement in type 2 diabetes (T2D). In addition, if patients lose that much or more, and then gain some weight back, it doesn’t eliminate benefit. “Although we did not measure weight regain, a corollary statement is that patients can regain some of the weight they lose, but if they stay around 20% of their total weight lost, then their diabetes still remits,” said Dr. Coleman.
In the past, some standards to treat severe weight loss and metabolic disease called for 50% or more TWL. More recent standards target a 30% threshold. “We want physicians to understand that they need to have more reasonable expectations of weight loss with surgery and that these reasonable expectations still result in profound improvements in cardiovascular risk, death, and quality of life. A 20% TWL threshold is easier for these patients to get to, and like other patients, they still get the benefit. So even if these patients may not have as much weight loss they can still benefit from the surgery for their diabetes,” Dr. Coleman added.
Physicians have long assumed that the effect of bariatric surgery on T2D remission is tied to weight loss, but this has been tested only recently. Previous studies found a link and suggested that 25% TWL may be the needed threshold, but more data are needed, especially for sleeve gastrectomy.
In the current study, published in Diabetes Care, 73% of patients were female. Mean age was 49.8 years, and mean body mass index was 43.8 kg/m2. Fifty-seven percent underwent Roux-en-Y gastric bypass (RYGB). Follow-up averaged 5.9 years. Overall, 71% of patients had an initial remission of their diabetes (72% RYGB, 70% sleeve). The average time to remission was 1.0 years. The researchers categorized participants by percentage TWL. Compared with the 0%-5% group, each 5% increase in TWL was linked with a greater likelihood of achieving remission: 5%-10%, hazard ratio 1.22 (P = .23); 10%-15%, HR 1.97 (95% confidence interval, 1.47-2.64); 15%-20%, HR 2.33 (95% CI, 1.74-3.11); 20%-25%, HR 2.81 (95% CI, 2.11-3.75); 25%-30%, HR 2.88 (95% CI, 2.16-3.83); >30%, HR, 2.92 (95% CI, 2.19-3.88). Categories above 25% TWL had remission rates similar to those of the 20%-25% group. Those in the over 20% TWL group who were taking insulin at the time of surgery had better odds of T2D remission than did those in the 0%-5% TWL group who were not taking insulin (HR, 2.18; 95% CI, 1.64-2.88).
The study is a useful addition to the literature on the topic, according to W. Timothy Garvey, MD, director of the diabetes research center at the University of Alabama at Birmingham. “This tends to quantify it a little bit more than people might have had before,” he said.
Dr. Garvey noted that there were wide error bars in the outcomes grouped by TWL, and suggested that individual results of surgery may vary widely. “There are plenty of individuals in each of those bins that will require more weight loss for remission or less weight loss. That’s just the average of people in that weight loss category. So if a clinician is going to use this information, they need to take it with a grain of salt and realize that, just because they reach that 20% weight loss threshold, it doesn’t mean that their patient is going to go into remission. As a loose guide, as something to shoot for, I think this is valuable,” he added.
Dr. Coleman recommended that physicians not wait too long to suggest bariatric surgery, since patients are likely to have better outcomes if they are healthier going in. “Bariatric surgery is by far the most effective long-term treatment we have for severe obesity and we should be treating it as a secondary prevention strategy, not a last resort to save people’s lives. Bariatric surgery cannot regrow the cells in the pancreas that make insulin. So if we wait until patients with type 2 diabetes are insulin dependent to offer bariatric surgery, we are compromising the great effect surgery can have for them,” said Dr. Coleman.
Patients with type 2 diabetes who underwent bariatric surgery commonly experienced remission, but there was little increase in rates of remission above a threshold of 20% total weight loss (TWL), according to a retrospective analysis of 5,928 patients with diabetes in an integrated health care system in Southern California.
The findings should reassure physicians and patients that surgery will be beneficial, according to lead author Karen Coleman, PhD, professor of health systems science at Kaiser Permanente Southern California.
Dr. Coleman has heard from many physicians saying they recommend against bariatric surgery because of concerns that patients gain weight back and therefore won’t get a long-term benefit, but this is not supported by the literature. “Hundreds of articles at this point show that this simply is not true. In addition, providers seem to think about bariatric surgery as an ‘all or none’ treatment. Gaining any weight back means that patients ‘fail.’ Weight regain is a normal part of massive weight loss; however, maintaining a certain amount of weight loss still provides benefits for patients, especially those with cardiovascular conditions like diabetes,” said Dr. Coleman.
Most patients lose 20%-30% of their body weight after bariatric surgery, but they don’t have to lose that much to see an improvement in type 2 diabetes (T2D). In addition, if patients lose that much or more, and then gain some weight back, it doesn’t eliminate benefit. “Although we did not measure weight regain, a corollary statement is that patients can regain some of the weight they lose, but if they stay around 20% of their total weight lost, then their diabetes still remits,” said Dr. Coleman.
In the past, some standards to treat severe weight loss and metabolic disease called for 50% or more TWL. More recent standards target a 30% threshold. “We want physicians to understand that they need to have more reasonable expectations of weight loss with surgery and that these reasonable expectations still result in profound improvements in cardiovascular risk, death, and quality of life. A 20% TWL threshold is easier for these patients to get to, and like other patients, they still get the benefit. So even if these patients may not have as much weight loss they can still benefit from the surgery for their diabetes,” Dr. Coleman added.
Physicians have long assumed that the effect of bariatric surgery on T2D remission is tied to weight loss, but this has been tested only recently. Previous studies found a link and suggested that 25% TWL may be the needed threshold, but more data are needed, especially for sleeve gastrectomy.
In the current study, published in Diabetes Care, 73% of patients were female. Mean age was 49.8 years, and mean body mass index was 43.8 kg/m2. Fifty-seven percent underwent Roux-en-Y gastric bypass (RYGB). Follow-up averaged 5.9 years. Overall, 71% of patients had an initial remission of their diabetes (72% RYGB, 70% sleeve). The average time to remission was 1.0 years. The researchers categorized participants by percentage TWL. Compared with the 0%-5% group, each 5% increase in TWL was linked with a greater likelihood of achieving remission: 5%-10%, hazard ratio 1.22 (P = .23); 10%-15%, HR 1.97 (95% confidence interval, 1.47-2.64); 15%-20%, HR 2.33 (95% CI, 1.74-3.11); 20%-25%, HR 2.81 (95% CI, 2.11-3.75); 25%-30%, HR 2.88 (95% CI, 2.16-3.83); >30%, HR, 2.92 (95% CI, 2.19-3.88). Categories above 25% TWL had remission rates similar to those of the 20%-25% group. Those in the over 20% TWL group who were taking insulin at the time of surgery had better odds of T2D remission than did those in the 0%-5% TWL group who were not taking insulin (HR, 2.18; 95% CI, 1.64-2.88).
The study is a useful addition to the literature on the topic, according to W. Timothy Garvey, MD, director of the diabetes research center at the University of Alabama at Birmingham. “This tends to quantify it a little bit more than people might have had before,” he said.
Dr. Garvey noted that there were wide error bars in the outcomes grouped by TWL, and suggested that individual results of surgery may vary widely. “There are plenty of individuals in each of those bins that will require more weight loss for remission or less weight loss. That’s just the average of people in that weight loss category. So if a clinician is going to use this information, they need to take it with a grain of salt and realize that, just because they reach that 20% weight loss threshold, it doesn’t mean that their patient is going to go into remission. As a loose guide, as something to shoot for, I think this is valuable,” he added.
Dr. Coleman recommended that physicians not wait too long to suggest bariatric surgery, since patients are likely to have better outcomes if they are healthier going in. “Bariatric surgery is by far the most effective long-term treatment we have for severe obesity and we should be treating it as a secondary prevention strategy, not a last resort to save people’s lives. Bariatric surgery cannot regrow the cells in the pancreas that make insulin. So if we wait until patients with type 2 diabetes are insulin dependent to offer bariatric surgery, we are compromising the great effect surgery can have for them,” said Dr. Coleman.
Patients with type 2 diabetes who underwent bariatric surgery commonly experienced remission, but there was little increase in rates of remission above a threshold of 20% total weight loss (TWL), according to a retrospective analysis of 5,928 patients with diabetes in an integrated health care system in Southern California.
The findings should reassure physicians and patients that surgery will be beneficial, according to lead author Karen Coleman, PhD, professor of health systems science at Kaiser Permanente Southern California.
Dr. Coleman has heard from many physicians saying they recommend against bariatric surgery because of concerns that patients gain weight back and therefore won’t get a long-term benefit, but this is not supported by the literature. “Hundreds of articles at this point show that this simply is not true. In addition, providers seem to think about bariatric surgery as an ‘all or none’ treatment. Gaining any weight back means that patients ‘fail.’ Weight regain is a normal part of massive weight loss; however, maintaining a certain amount of weight loss still provides benefits for patients, especially those with cardiovascular conditions like diabetes,” said Dr. Coleman.
Most patients lose 20%-30% of their body weight after bariatric surgery, but they don’t have to lose that much to see an improvement in type 2 diabetes (T2D). In addition, if patients lose that much or more, and then gain some weight back, it doesn’t eliminate benefit. “Although we did not measure weight regain, a corollary statement is that patients can regain some of the weight they lose, but if they stay around 20% of their total weight lost, then their diabetes still remits,” said Dr. Coleman.
In the past, some standards to treat severe weight loss and metabolic disease called for 50% or more TWL. More recent standards target a 30% threshold. “We want physicians to understand that they need to have more reasonable expectations of weight loss with surgery and that these reasonable expectations still result in profound improvements in cardiovascular risk, death, and quality of life. A 20% TWL threshold is easier for these patients to get to, and like other patients, they still get the benefit. So even if these patients may not have as much weight loss they can still benefit from the surgery for their diabetes,” Dr. Coleman added.
Physicians have long assumed that the effect of bariatric surgery on T2D remission is tied to weight loss, but this has been tested only recently. Previous studies found a link and suggested that 25% TWL may be the needed threshold, but more data are needed, especially for sleeve gastrectomy.
In the current study, published in Diabetes Care, 73% of patients were female. Mean age was 49.8 years, and mean body mass index was 43.8 kg/m2. Fifty-seven percent underwent Roux-en-Y gastric bypass (RYGB). Follow-up averaged 5.9 years. Overall, 71% of patients had an initial remission of their diabetes (72% RYGB, 70% sleeve). The average time to remission was 1.0 years. The researchers categorized participants by percentage TWL. Compared with the 0%-5% group, each 5% increase in TWL was linked with a greater likelihood of achieving remission: 5%-10%, hazard ratio 1.22 (P = .23); 10%-15%, HR 1.97 (95% confidence interval, 1.47-2.64); 15%-20%, HR 2.33 (95% CI, 1.74-3.11); 20%-25%, HR 2.81 (95% CI, 2.11-3.75); 25%-30%, HR 2.88 (95% CI, 2.16-3.83); >30%, HR, 2.92 (95% CI, 2.19-3.88). Categories above 25% TWL had remission rates similar to those of the 20%-25% group. Those in the over 20% TWL group who were taking insulin at the time of surgery had better odds of T2D remission than did those in the 0%-5% TWL group who were not taking insulin (HR, 2.18; 95% CI, 1.64-2.88).
The study is a useful addition to the literature on the topic, according to W. Timothy Garvey, MD, director of the diabetes research center at the University of Alabama at Birmingham. “This tends to quantify it a little bit more than people might have had before,” he said.
Dr. Garvey noted that there were wide error bars in the outcomes grouped by TWL, and suggested that individual results of surgery may vary widely. “There are plenty of individuals in each of those bins that will require more weight loss for remission or less weight loss. That’s just the average of people in that weight loss category. So if a clinician is going to use this information, they need to take it with a grain of salt and realize that, just because they reach that 20% weight loss threshold, it doesn’t mean that their patient is going to go into remission. As a loose guide, as something to shoot for, I think this is valuable,” he added.
Dr. Coleman recommended that physicians not wait too long to suggest bariatric surgery, since patients are likely to have better outcomes if they are healthier going in. “Bariatric surgery is by far the most effective long-term treatment we have for severe obesity and we should be treating it as a secondary prevention strategy, not a last resort to save people’s lives. Bariatric surgery cannot regrow the cells in the pancreas that make insulin. So if we wait until patients with type 2 diabetes are insulin dependent to offer bariatric surgery, we are compromising the great effect surgery can have for them,” said Dr. Coleman.
FROM DIABETES CARE
Nonopioid med promising for neuropathic pain
Top-line results from a phase 2 study suggest vixotrigine (BIIB074, Biogen), a nonopioid investigational oral pain medication, reduces chronic neuropathic pain caused by small fiber neuropathy (SFN) and is generally well tolerated.
“We are encouraged by the overall results of the CONVEY study, especially given the significant unmet medical need for additional agents to treat chronic painful neuropathy,” Katherine Dawson, MD, senior vice president and head of the therapeutics development unit at Biogen, said in a news release.
Vixotrigine (BIIB074) is a peripherally and centrally acting, orally administered, voltage- and use-dependent voltage-gated sodium channel blocker.
CONVEY was a phase 2, placebo-controlled, double-blind, randomized withdrawal study of 265 patients experiencing pain from confirmed idiopathic or diabetes-associated SFN.
Following a 4-week open-label run-in period, 123 responders to vixotrigine were randomly allocated to 200 mg or 350 mg vixotrigine or placebo twice daily for 12 weeks in the double-blind portion of the study.
At week 12, vixotrigine 200 mg twice daily met the primary endpoint of a statistically significant reduction from baseline in the mean average daily pain (ADP) score versus placebo (P = .0501).
A subgroup analysis showed a treatment effect in patients with diabetes-associated SFN but not in the smaller subgroup of patients with idiopathic SFN.
The 200-mg dose also led to a significant improvement over placebo in mean worst daily pain score at 12 weeks (P = .0455).
A numeric advantage of 200 mg vixotrigine over placebo was observed in additional secondary endpoints, including the proportion of patients with at least a 2-point improvement in ADP score and the proportion with at least a 30% reduction in ADP at week 12, but these failed to reach statistical significance.
Vixotrigine 350 mg twice daily did not meet the primary endpoint of mean change in ADP at 12 weeks.
However, treatment at the higher dose led to a significant increase in the proportion of patients who reported being “very much improved” or “much improved” over baseline (P = .0580), Biogen reported.
In addition, a numeric advantage of 350 mg over placebo was observed in the proportion of patients with a 2-point or greater improvement in ADP score and the proportion with at least a 30% reduction in ADP at 12 weeks, but these also did not reach statistical significance.
Both doses of vixotrigine were “generally well tolerated and the safety profile was consistent with previous studies of vixotrigine with no evidence of abuse potential,” the company said.
In the open-label period, common adverse events seen in at least 2.5% of patients were dizziness, headache, vertigo, and nausea; adverse events led 5.3% of patients to discontinue the open-label portion of the study. Across the entire study, most adverse events were mild or moderate in severity.
“The totality of data from the vixotrigine program will inform potential doses for study in future phase 3 clinical trials,” the company said.
A version of this article first appeared on Medscape.com.
Top-line results from a phase 2 study suggest vixotrigine (BIIB074, Biogen), a nonopioid investigational oral pain medication, reduces chronic neuropathic pain caused by small fiber neuropathy (SFN) and is generally well tolerated.
“We are encouraged by the overall results of the CONVEY study, especially given the significant unmet medical need for additional agents to treat chronic painful neuropathy,” Katherine Dawson, MD, senior vice president and head of the therapeutics development unit at Biogen, said in a news release.
Vixotrigine (BIIB074) is a peripherally and centrally acting, orally administered, voltage- and use-dependent voltage-gated sodium channel blocker.
CONVEY was a phase 2, placebo-controlled, double-blind, randomized withdrawal study of 265 patients experiencing pain from confirmed idiopathic or diabetes-associated SFN.
Following a 4-week open-label run-in period, 123 responders to vixotrigine were randomly allocated to 200 mg or 350 mg vixotrigine or placebo twice daily for 12 weeks in the double-blind portion of the study.
At week 12, vixotrigine 200 mg twice daily met the primary endpoint of a statistically significant reduction from baseline in the mean average daily pain (ADP) score versus placebo (P = .0501).
A subgroup analysis showed a treatment effect in patients with diabetes-associated SFN but not in the smaller subgroup of patients with idiopathic SFN.
The 200-mg dose also led to a significant improvement over placebo in mean worst daily pain score at 12 weeks (P = .0455).
A numeric advantage of 200 mg vixotrigine over placebo was observed in additional secondary endpoints, including the proportion of patients with at least a 2-point improvement in ADP score and the proportion with at least a 30% reduction in ADP at week 12, but these failed to reach statistical significance.
Vixotrigine 350 mg twice daily did not meet the primary endpoint of mean change in ADP at 12 weeks.
However, treatment at the higher dose led to a significant increase in the proportion of patients who reported being “very much improved” or “much improved” over baseline (P = .0580), Biogen reported.
In addition, a numeric advantage of 350 mg over placebo was observed in the proportion of patients with a 2-point or greater improvement in ADP score and the proportion with at least a 30% reduction in ADP at 12 weeks, but these also did not reach statistical significance.
Both doses of vixotrigine were “generally well tolerated and the safety profile was consistent with previous studies of vixotrigine with no evidence of abuse potential,” the company said.
In the open-label period, common adverse events seen in at least 2.5% of patients were dizziness, headache, vertigo, and nausea; adverse events led 5.3% of patients to discontinue the open-label portion of the study. Across the entire study, most adverse events were mild or moderate in severity.
“The totality of data from the vixotrigine program will inform potential doses for study in future phase 3 clinical trials,” the company said.
A version of this article first appeared on Medscape.com.
Top-line results from a phase 2 study suggest vixotrigine (BIIB074, Biogen), a nonopioid investigational oral pain medication, reduces chronic neuropathic pain caused by small fiber neuropathy (SFN) and is generally well tolerated.
“We are encouraged by the overall results of the CONVEY study, especially given the significant unmet medical need for additional agents to treat chronic painful neuropathy,” Katherine Dawson, MD, senior vice president and head of the therapeutics development unit at Biogen, said in a news release.
Vixotrigine (BIIB074) is a peripherally and centrally acting, orally administered, voltage- and use-dependent voltage-gated sodium channel blocker.
CONVEY was a phase 2, placebo-controlled, double-blind, randomized withdrawal study of 265 patients experiencing pain from confirmed idiopathic or diabetes-associated SFN.
Following a 4-week open-label run-in period, 123 responders to vixotrigine were randomly allocated to 200 mg or 350 mg vixotrigine or placebo twice daily for 12 weeks in the double-blind portion of the study.
At week 12, vixotrigine 200 mg twice daily met the primary endpoint of a statistically significant reduction from baseline in the mean average daily pain (ADP) score versus placebo (P = .0501).
A subgroup analysis showed a treatment effect in patients with diabetes-associated SFN but not in the smaller subgroup of patients with idiopathic SFN.
The 200-mg dose also led to a significant improvement over placebo in mean worst daily pain score at 12 weeks (P = .0455).
A numeric advantage of 200 mg vixotrigine over placebo was observed in additional secondary endpoints, including the proportion of patients with at least a 2-point improvement in ADP score and the proportion with at least a 30% reduction in ADP at week 12, but these failed to reach statistical significance.
Vixotrigine 350 mg twice daily did not meet the primary endpoint of mean change in ADP at 12 weeks.
However, treatment at the higher dose led to a significant increase in the proportion of patients who reported being “very much improved” or “much improved” over baseline (P = .0580), Biogen reported.
In addition, a numeric advantage of 350 mg over placebo was observed in the proportion of patients with a 2-point or greater improvement in ADP score and the proportion with at least a 30% reduction in ADP at 12 weeks, but these also did not reach statistical significance.
Both doses of vixotrigine were “generally well tolerated and the safety profile was consistent with previous studies of vixotrigine with no evidence of abuse potential,” the company said.
In the open-label period, common adverse events seen in at least 2.5% of patients were dizziness, headache, vertigo, and nausea; adverse events led 5.3% of patients to discontinue the open-label portion of the study. Across the entire study, most adverse events were mild or moderate in severity.
“The totality of data from the vixotrigine program will inform potential doses for study in future phase 3 clinical trials,” the company said.
A version of this article first appeared on Medscape.com.
Premature menopause a ‘warning sign’ for greater ASCVD risk
Premature menopause is well known to be linked to cardiovascular disease in women, but it may not carry as much weight as more traditional cardiovascular risk factors in determining a patient’s 10-year risk of having a heart attack or stroke in this population, a cohort study that evaluated the veracity of premature menopause found.
Premature menopause can serve as a “marker or warning sign” that cardiologists should pay closer attention to traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, lead study author Sadiya S. Khan, MD, MS, said in an interview. “When we looked at the addition of premature menopause into the risk-prediction equation, we did not see that it meaningfully improved the ability of the risk predictions of pooled cohort equations [PCEs] to identify who developed cardiovascular disease,” said Dr. Khan, a cardiologist at Northwestern University, Chicago.
The cohort study included 5,466 Black women and 10,584 White women from seven U.S. population-based cohorts, including the Women’s Health Initiative, of whom 951 and 1,039, respectively, self-reported early menopause. The cohort study researchers noted that the 2019 American College of Cardiology/American Heart Association guideline for prevention of CVD acknowledged premature menopause as risk-enhancing factor in the CVD assessment in women younger than 40.
The cohort study found that Black women had almost twice the rate of premature menopause than White women, 17.4% and 9.8%, respectively. And it found that premature menopause was significantly linked with ASCVD in both populations independent of traditional risk factors – a 24% greater risk for Black women and 28% greater risk for White women.
‘Surprising’ finding
However, when premature menopause was added to the pooled cohort equations per the 2013 ACC/AHA guideline, the researchers found no incremental benefit, a finding Dr. Khan called “really surprising to us.”
She added, “If we look at the differences in the characteristics of women who have premature menopause, compared with those who didn’t, there were slight differences in terms of higher blood pressure, higher body mass index, and slightly higher glucose. So maybe what we’re seeing – and this is more speculative – is that risk factors are developing after early menopause, and the focus should be earlier in the patient’s life course to try to prevent hypertension, diabetes, and obesity.”
Dr. Khan emphasized that the findings don’t obviate the value of premature menopause in assessing ASCVD risk in women. “We still know that this is an important marker for women and their risk for heart disease, and it should be a warning sign to pay close attention to those other risk factors and what other preventive measures can be taken,” she said.
Christie Ballantyne, MD, said it’s important to note that the study did not dismiss the relevance of premature menopause in shared decision-making for postmenopausal women. “It certainly doesn’t mean that premature menopause is not a risk,” Dr. Ballantyne said in an interview. “Premature menopause may cause a worsening of traditional CVD risk factors, so that’s one possible explanation for it. The other possible explanation is that women with worse ASCVD risk factors – who are more overweight, have higher blood pressure, and have more diabetes and insulin resistance – are more likely to have earlier menopause.” Dr. Ballantyne is chief of cardiology at Baylor College of Medicine and director of cardiovascular disease prevention at Methodist DeBakey Heart Center, both in Houston.
“You should still look very carefully at the patient’s risk factors, calculate the pooled cohort equations, and make sure you get a recommendation,” he said. “If their risks are up, give recommendations on how to improve diet and exercise. Consider if you need to treat lipids or treat blood pressure with more than diet and exercise because there’s nothing magical about 7.5%”, the threshold for lipid-lowering therapy in the ASCVD risk calculator.
Dr. Khan and coauthors disclosed receiving grants from the National Institutes of Health and the American Heart Association. One coauthor reported a financial relationship with HGM Biopharmaceuticals. Dr. Ballantyne is a lead investigator of the Atherosclerosis Risk in Communities study, one of the population-based cohorts used in the cohort study. He has no other relevant relationships to disclose.
Premature menopause is well known to be linked to cardiovascular disease in women, but it may not carry as much weight as more traditional cardiovascular risk factors in determining a patient’s 10-year risk of having a heart attack or stroke in this population, a cohort study that evaluated the veracity of premature menopause found.
Premature menopause can serve as a “marker or warning sign” that cardiologists should pay closer attention to traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, lead study author Sadiya S. Khan, MD, MS, said in an interview. “When we looked at the addition of premature menopause into the risk-prediction equation, we did not see that it meaningfully improved the ability of the risk predictions of pooled cohort equations [PCEs] to identify who developed cardiovascular disease,” said Dr. Khan, a cardiologist at Northwestern University, Chicago.
The cohort study included 5,466 Black women and 10,584 White women from seven U.S. population-based cohorts, including the Women’s Health Initiative, of whom 951 and 1,039, respectively, self-reported early menopause. The cohort study researchers noted that the 2019 American College of Cardiology/American Heart Association guideline for prevention of CVD acknowledged premature menopause as risk-enhancing factor in the CVD assessment in women younger than 40.
The cohort study found that Black women had almost twice the rate of premature menopause than White women, 17.4% and 9.8%, respectively. And it found that premature menopause was significantly linked with ASCVD in both populations independent of traditional risk factors – a 24% greater risk for Black women and 28% greater risk for White women.
‘Surprising’ finding
However, when premature menopause was added to the pooled cohort equations per the 2013 ACC/AHA guideline, the researchers found no incremental benefit, a finding Dr. Khan called “really surprising to us.”
She added, “If we look at the differences in the characteristics of women who have premature menopause, compared with those who didn’t, there were slight differences in terms of higher blood pressure, higher body mass index, and slightly higher glucose. So maybe what we’re seeing – and this is more speculative – is that risk factors are developing after early menopause, and the focus should be earlier in the patient’s life course to try to prevent hypertension, diabetes, and obesity.”
Dr. Khan emphasized that the findings don’t obviate the value of premature menopause in assessing ASCVD risk in women. “We still know that this is an important marker for women and their risk for heart disease, and it should be a warning sign to pay close attention to those other risk factors and what other preventive measures can be taken,” she said.
Christie Ballantyne, MD, said it’s important to note that the study did not dismiss the relevance of premature menopause in shared decision-making for postmenopausal women. “It certainly doesn’t mean that premature menopause is not a risk,” Dr. Ballantyne said in an interview. “Premature menopause may cause a worsening of traditional CVD risk factors, so that’s one possible explanation for it. The other possible explanation is that women with worse ASCVD risk factors – who are more overweight, have higher blood pressure, and have more diabetes and insulin resistance – are more likely to have earlier menopause.” Dr. Ballantyne is chief of cardiology at Baylor College of Medicine and director of cardiovascular disease prevention at Methodist DeBakey Heart Center, both in Houston.
“You should still look very carefully at the patient’s risk factors, calculate the pooled cohort equations, and make sure you get a recommendation,” he said. “If their risks are up, give recommendations on how to improve diet and exercise. Consider if you need to treat lipids or treat blood pressure with more than diet and exercise because there’s nothing magical about 7.5%”, the threshold for lipid-lowering therapy in the ASCVD risk calculator.
Dr. Khan and coauthors disclosed receiving grants from the National Institutes of Health and the American Heart Association. One coauthor reported a financial relationship with HGM Biopharmaceuticals. Dr. Ballantyne is a lead investigator of the Atherosclerosis Risk in Communities study, one of the population-based cohorts used in the cohort study. He has no other relevant relationships to disclose.
Premature menopause is well known to be linked to cardiovascular disease in women, but it may not carry as much weight as more traditional cardiovascular risk factors in determining a patient’s 10-year risk of having a heart attack or stroke in this population, a cohort study that evaluated the veracity of premature menopause found.
Premature menopause can serve as a “marker or warning sign” that cardiologists should pay closer attention to traditional atherosclerotic cardiovascular disease (ASCVD) risk factors, lead study author Sadiya S. Khan, MD, MS, said in an interview. “When we looked at the addition of premature menopause into the risk-prediction equation, we did not see that it meaningfully improved the ability of the risk predictions of pooled cohort equations [PCEs] to identify who developed cardiovascular disease,” said Dr. Khan, a cardiologist at Northwestern University, Chicago.
The cohort study included 5,466 Black women and 10,584 White women from seven U.S. population-based cohorts, including the Women’s Health Initiative, of whom 951 and 1,039, respectively, self-reported early menopause. The cohort study researchers noted that the 2019 American College of Cardiology/American Heart Association guideline for prevention of CVD acknowledged premature menopause as risk-enhancing factor in the CVD assessment in women younger than 40.
The cohort study found that Black women had almost twice the rate of premature menopause than White women, 17.4% and 9.8%, respectively. And it found that premature menopause was significantly linked with ASCVD in both populations independent of traditional risk factors – a 24% greater risk for Black women and 28% greater risk for White women.
‘Surprising’ finding
However, when premature menopause was added to the pooled cohort equations per the 2013 ACC/AHA guideline, the researchers found no incremental benefit, a finding Dr. Khan called “really surprising to us.”
She added, “If we look at the differences in the characteristics of women who have premature menopause, compared with those who didn’t, there were slight differences in terms of higher blood pressure, higher body mass index, and slightly higher glucose. So maybe what we’re seeing – and this is more speculative – is that risk factors are developing after early menopause, and the focus should be earlier in the patient’s life course to try to prevent hypertension, diabetes, and obesity.”
Dr. Khan emphasized that the findings don’t obviate the value of premature menopause in assessing ASCVD risk in women. “We still know that this is an important marker for women and their risk for heart disease, and it should be a warning sign to pay close attention to those other risk factors and what other preventive measures can be taken,” she said.
Christie Ballantyne, MD, said it’s important to note that the study did not dismiss the relevance of premature menopause in shared decision-making for postmenopausal women. “It certainly doesn’t mean that premature menopause is not a risk,” Dr. Ballantyne said in an interview. “Premature menopause may cause a worsening of traditional CVD risk factors, so that’s one possible explanation for it. The other possible explanation is that women with worse ASCVD risk factors – who are more overweight, have higher blood pressure, and have more diabetes and insulin resistance – are more likely to have earlier menopause.” Dr. Ballantyne is chief of cardiology at Baylor College of Medicine and director of cardiovascular disease prevention at Methodist DeBakey Heart Center, both in Houston.
“You should still look very carefully at the patient’s risk factors, calculate the pooled cohort equations, and make sure you get a recommendation,” he said. “If their risks are up, give recommendations on how to improve diet and exercise. Consider if you need to treat lipids or treat blood pressure with more than diet and exercise because there’s nothing magical about 7.5%”, the threshold for lipid-lowering therapy in the ASCVD risk calculator.
Dr. Khan and coauthors disclosed receiving grants from the National Institutes of Health and the American Heart Association. One coauthor reported a financial relationship with HGM Biopharmaceuticals. Dr. Ballantyne is a lead investigator of the Atherosclerosis Risk in Communities study, one of the population-based cohorts used in the cohort study. He has no other relevant relationships to disclose.
FROM JAMA CARDIOLOGY
Researchers warn young adults are at highest risk of obesity
Individuals aged 18-24 years are at the highest risk of weight gain and developing overweight or obesity over the next 10 years, compared with all other adults, and should be a target for obesity prevention policies, say U.K. researchers.
The research, published online Sept. 2, 2021, in The Lancet Diabetes and Endocrinology, showed that factors more traditionally associated with obesity – such as socioeconomic status and ethnicity – play less of a role than age.
“Our results show clearly that age is the most important sociodemographic factor for BMI [body mass index] change,” lead author Michail Katsoulis, PhD, Institute of Health Informatics, University College London, said in a press release.
Cosenior author Claudia Langenberg, PhD, agreed, adding young people “go through big life changes. They may start work, go to university, or leave home for the first time,” and the habits formed during these years “may stick through adulthood.”
Current obesity prevention guidelines are mainly directed at individuals who already have obesity, the researchers said in their article.
“As the evidence presented in our study suggests, the opportunity to modify weight gain is greatest in individuals who are young and do not yet have obesity,” they observed.
“If we are serious about preventing obesity, then we should develop interventions that can be targeted and are relevant for young adults,” added Dr. Langenberg, of the MRC Epidemiology Unit, University of Cambridge, (England), and Berlin Institute of Health.
Risks for higher BMI substantially greater in the youngest adults
The researchers gathered data on more than 2 million adults aged 18-74 years registered with general practitioners in England. Participants had BMI and weight measurements recorded between Jan. 1, 1998, and June 30, 2016, with at least 1 year of follow-up. Overall, 58% were women, 76% were White, 9% had prevalent cardiovascular disease, and 4% had prevalent cancer.
Changes in BMI were assessed at 1 year, 5 years, and 10 years.
At 10 years, adults aged 18-24 years had the highest risk of transitioning from normal weight to overweight or obesity, compared with adults aged 65-74 years, at a greatest absolute risk of 37% versus 24% (odds ratio, 4.22).
Moreover, the results showed that adults aged 18-24 years who were already overweight or obese had a greater risk of transitioning to a higher BMI category during follow-up versus the oldest participants.
They had an absolute risk of 42% versus 18% of transitioning from overweight to class 1 and 2 obesity (OR, 4.60), and an absolute risk of transitioning from class 1 and 2 obesity to class 3 obesity of 22% versus 5% (OR, 5.87).
Online risk calculator and YouTube video help explain findings
While factors other than age were associated with transitioning to a higher BMI category, the association was less pronounced.
For example, the OR of transitioning from normal weight to overweight or obesity in the most socially deprived versus the least deprived areas was 1.23 in men and 1.12 in women. The OR for making the same transition in Black versus White individuals was 1.13.
The findings allowed the researchers to develop a series of nomograms to determine an individual’s absolute risk of transitioning to a higher BMI category over 10 years based on their baseline BMI category, age, sex, and Index of Multiple Deprivation quintile.
“We show that, within each stratum, the risks for transitioning to higher BMI categories were substantially higher in the youngest adult age group than in older age groups,” the team writes.
From this, they developed an open-access online risk calculator to help individuals calculate their risk of weight change over the next 1, 5, and 10 years. The calculator takes into account current weight, height, age, sex, ethnicity, and socioeconomic-area characteristics.
They have also posted a video on YouTube to help explain their findings.
COVID and obesity pandemics collide
Cosenior author Harry Hemingway, MD, PhD, also of University College London, believes that focusing on this young age group is especially critical now because of the COVID-19 pandemic.
“Calculating personal risk of transitioning to a higher weight category is important” as COVID-19 “collides with the obesity pandemic,” he said, noting that “people are exercising less and finding it harder to eat healthy diets during lockdowns.
“Health systems like the NHS [National Health Service] need to identify new ways to prevent obesity and its consequences,” he continued. “This study demonstrates that NHS data collected over time in primary care holds an important key to unlocking new insights for public health action.”
The study was funded by the British Heart Foundation, Health Data Research UK, the UK Medical Research Council, and the National Institute for Health Research. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Individuals aged 18-24 years are at the highest risk of weight gain and developing overweight or obesity over the next 10 years, compared with all other adults, and should be a target for obesity prevention policies, say U.K. researchers.
The research, published online Sept. 2, 2021, in The Lancet Diabetes and Endocrinology, showed that factors more traditionally associated with obesity – such as socioeconomic status and ethnicity – play less of a role than age.
“Our results show clearly that age is the most important sociodemographic factor for BMI [body mass index] change,” lead author Michail Katsoulis, PhD, Institute of Health Informatics, University College London, said in a press release.
Cosenior author Claudia Langenberg, PhD, agreed, adding young people “go through big life changes. They may start work, go to university, or leave home for the first time,” and the habits formed during these years “may stick through adulthood.”
Current obesity prevention guidelines are mainly directed at individuals who already have obesity, the researchers said in their article.
“As the evidence presented in our study suggests, the opportunity to modify weight gain is greatest in individuals who are young and do not yet have obesity,” they observed.
“If we are serious about preventing obesity, then we should develop interventions that can be targeted and are relevant for young adults,” added Dr. Langenberg, of the MRC Epidemiology Unit, University of Cambridge, (England), and Berlin Institute of Health.
Risks for higher BMI substantially greater in the youngest adults
The researchers gathered data on more than 2 million adults aged 18-74 years registered with general practitioners in England. Participants had BMI and weight measurements recorded between Jan. 1, 1998, and June 30, 2016, with at least 1 year of follow-up. Overall, 58% were women, 76% were White, 9% had prevalent cardiovascular disease, and 4% had prevalent cancer.
Changes in BMI were assessed at 1 year, 5 years, and 10 years.
At 10 years, adults aged 18-24 years had the highest risk of transitioning from normal weight to overweight or obesity, compared with adults aged 65-74 years, at a greatest absolute risk of 37% versus 24% (odds ratio, 4.22).
Moreover, the results showed that adults aged 18-24 years who were already overweight or obese had a greater risk of transitioning to a higher BMI category during follow-up versus the oldest participants.
They had an absolute risk of 42% versus 18% of transitioning from overweight to class 1 and 2 obesity (OR, 4.60), and an absolute risk of transitioning from class 1 and 2 obesity to class 3 obesity of 22% versus 5% (OR, 5.87).
Online risk calculator and YouTube video help explain findings
While factors other than age were associated with transitioning to a higher BMI category, the association was less pronounced.
For example, the OR of transitioning from normal weight to overweight or obesity in the most socially deprived versus the least deprived areas was 1.23 in men and 1.12 in women. The OR for making the same transition in Black versus White individuals was 1.13.
The findings allowed the researchers to develop a series of nomograms to determine an individual’s absolute risk of transitioning to a higher BMI category over 10 years based on their baseline BMI category, age, sex, and Index of Multiple Deprivation quintile.
“We show that, within each stratum, the risks for transitioning to higher BMI categories were substantially higher in the youngest adult age group than in older age groups,” the team writes.
From this, they developed an open-access online risk calculator to help individuals calculate their risk of weight change over the next 1, 5, and 10 years. The calculator takes into account current weight, height, age, sex, ethnicity, and socioeconomic-area characteristics.
They have also posted a video on YouTube to help explain their findings.
COVID and obesity pandemics collide
Cosenior author Harry Hemingway, MD, PhD, also of University College London, believes that focusing on this young age group is especially critical now because of the COVID-19 pandemic.
“Calculating personal risk of transitioning to a higher weight category is important” as COVID-19 “collides with the obesity pandemic,” he said, noting that “people are exercising less and finding it harder to eat healthy diets during lockdowns.
“Health systems like the NHS [National Health Service] need to identify new ways to prevent obesity and its consequences,” he continued. “This study demonstrates that NHS data collected over time in primary care holds an important key to unlocking new insights for public health action.”
The study was funded by the British Heart Foundation, Health Data Research UK, the UK Medical Research Council, and the National Institute for Health Research. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Individuals aged 18-24 years are at the highest risk of weight gain and developing overweight or obesity over the next 10 years, compared with all other adults, and should be a target for obesity prevention policies, say U.K. researchers.
The research, published online Sept. 2, 2021, in The Lancet Diabetes and Endocrinology, showed that factors more traditionally associated with obesity – such as socioeconomic status and ethnicity – play less of a role than age.
“Our results show clearly that age is the most important sociodemographic factor for BMI [body mass index] change,” lead author Michail Katsoulis, PhD, Institute of Health Informatics, University College London, said in a press release.
Cosenior author Claudia Langenberg, PhD, agreed, adding young people “go through big life changes. They may start work, go to university, or leave home for the first time,” and the habits formed during these years “may stick through adulthood.”
Current obesity prevention guidelines are mainly directed at individuals who already have obesity, the researchers said in their article.
“As the evidence presented in our study suggests, the opportunity to modify weight gain is greatest in individuals who are young and do not yet have obesity,” they observed.
“If we are serious about preventing obesity, then we should develop interventions that can be targeted and are relevant for young adults,” added Dr. Langenberg, of the MRC Epidemiology Unit, University of Cambridge, (England), and Berlin Institute of Health.
Risks for higher BMI substantially greater in the youngest adults
The researchers gathered data on more than 2 million adults aged 18-74 years registered with general practitioners in England. Participants had BMI and weight measurements recorded between Jan. 1, 1998, and June 30, 2016, with at least 1 year of follow-up. Overall, 58% were women, 76% were White, 9% had prevalent cardiovascular disease, and 4% had prevalent cancer.
Changes in BMI were assessed at 1 year, 5 years, and 10 years.
At 10 years, adults aged 18-24 years had the highest risk of transitioning from normal weight to overweight or obesity, compared with adults aged 65-74 years, at a greatest absolute risk of 37% versus 24% (odds ratio, 4.22).
Moreover, the results showed that adults aged 18-24 years who were already overweight or obese had a greater risk of transitioning to a higher BMI category during follow-up versus the oldest participants.
They had an absolute risk of 42% versus 18% of transitioning from overweight to class 1 and 2 obesity (OR, 4.60), and an absolute risk of transitioning from class 1 and 2 obesity to class 3 obesity of 22% versus 5% (OR, 5.87).
Online risk calculator and YouTube video help explain findings
While factors other than age were associated with transitioning to a higher BMI category, the association was less pronounced.
For example, the OR of transitioning from normal weight to overweight or obesity in the most socially deprived versus the least deprived areas was 1.23 in men and 1.12 in women. The OR for making the same transition in Black versus White individuals was 1.13.
The findings allowed the researchers to develop a series of nomograms to determine an individual’s absolute risk of transitioning to a higher BMI category over 10 years based on their baseline BMI category, age, sex, and Index of Multiple Deprivation quintile.
“We show that, within each stratum, the risks for transitioning to higher BMI categories were substantially higher in the youngest adult age group than in older age groups,” the team writes.
From this, they developed an open-access online risk calculator to help individuals calculate their risk of weight change over the next 1, 5, and 10 years. The calculator takes into account current weight, height, age, sex, ethnicity, and socioeconomic-area characteristics.
They have also posted a video on YouTube to help explain their findings.
COVID and obesity pandemics collide
Cosenior author Harry Hemingway, MD, PhD, also of University College London, believes that focusing on this young age group is especially critical now because of the COVID-19 pandemic.
“Calculating personal risk of transitioning to a higher weight category is important” as COVID-19 “collides with the obesity pandemic,” he said, noting that “people are exercising less and finding it harder to eat healthy diets during lockdowns.
“Health systems like the NHS [National Health Service] need to identify new ways to prevent obesity and its consequences,” he continued. “This study demonstrates that NHS data collected over time in primary care holds an important key to unlocking new insights for public health action.”
The study was funded by the British Heart Foundation, Health Data Research UK, the UK Medical Research Council, and the National Institute for Health Research. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Texts boost activity, quality of life in patients with heart failure and diabetes
A 3-month lifestyle intervention that used a step counter and regular, personalized text messages to encourage increased mobility and adherence to medications led to a substantial rise in the quality of life in a randomized controlled study with 187 U.S. patients with heart failure and diabetes.
The TARGET-HF-DM study supplied a wrist-worn step counting device to adults with any type of heart failure and any type of diabetes at six U.S. sites and collected data on daily step counts and medication adherence through smartphone-based apps. Researchers randomized the patients to an intervention of thrice-weekly text messages that gave them personalized feedback on their recent activity and adherence and updated activity and adherence goals, or to a control group that only received a once-weekly generic message to wear the step counter.
After 3 months, patients in the intervention arm had an average incremental gain of 313 steps per day from baseline, compared with the controls, a significant difference for the study’s primary endpoint, G. Michael Felker, MD, reported at the annual scientific meeting of the Heart Failure Society of America.
A ‘quite large’ increase in quality of life.
Perhaps more importantly, a secondary analysis assessed quality of life with the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, which showed after 3 months a 5.5-point average increased improvement among patients in the intervention arm, compared with controls. Score increases of 5 of more points on the KCCQ represent clinically meaningful changes.
This average, incremental KCCQ score improvement was “quite large relative to what we typically see in placebo-controlled trials of effective drugs,” said Dr. Felker, professor of medicine at Duke University, Durham, N.C., and director of cardiovascular research at the Duke Clinical Research Institute. If a similar magnitude change in KCCQ was associated with a drug treatment “we would say it was an incredibly large signal in terms of quality of life, so I think the patients are telling us that [the intervention] is making a clinically important difference.”
But Dr. Felker cautioned that the study was not blinded, raising the possibility that the change in quality of life could have been partially explained by “patients feeling more engaged about doing something for their health.”
His report omitted data on the medication adherence facet of the study, which will come out in a subsequent report, raising the possibility that some of the quality of life benefit as well as the ability of patients to boost their step count was related to more consistent treatment with their prescribed medications, but Dr. Felker discounted this possibility.
“The adherence intervention was basically a digital tool that helped people better remember their medication regimen. While it is possible that this could have influenced the KCCQ data this seems quite unlikely to me,” he said in an interview.
‘Exercise is the new magic’
“Exercise is the new magic,” commented Mariann R. Piano, PhD, a professor at Vanderbilt University, Nashville, Tenn., and cochair of the session where Dr. Felker gave his report. “I love that the trial was pragmatic, randomized, and ran at six sites so the generalizability of the findings is really strong.” Dr. Piano also gave the study high marks for recruiting many African American patients, 47% of the study population, and its assessment of a patient-reported outcome, the KCCQ score.
Patients enrolled in TARGET-HF-DM averaged 59 years of age, about a third were women, and two-thirds had heart failure with a reduced ejection fraction of 40% or less. Eighty percent of participants had New York Heart Association class II functional limitations, and a third also had atrial fibrillation. Their average serum level of the N-terminal of the prohormone brain natriuretic peptide at baseline was 1,309 pg/mL. Most patients were on standard heart failure and diabetes medications, with 88% receiving an ACE inhibitor or angiotensin-receptor blocker (in some cases coupled with sacubitril), 90% were on a beta-blocker, 50% were on a mineralocorticoid receptor antagonist, 54% were on insulin, 47% were on a biguanidine, 25% were on a sulfonylurea, and 7% were on a sodium-glucose cotransporter inhibitor. About half the patients also had an implantable cardioverter defibrillator.
Dr. Felker acknowledged that the 313 average increment in steps per day among patients in the intervention group, compared with controls was modest, but it represented about a 10% increase from baseline among patients who in general had a very sedentary life. All patients had received at the start of the study guidelines from the American Heart Association on appropriate types and levels of physical activity for patients with heart failure and diabetes. The researcher previously published a description of the design and rationale of the study.
The study followed patients for an additional 3 months beyond the end of the intervention period, and the excess step count among people in the intervention arm persisted, although the between-group difference was no longer significant. The researchers also analyzed changes during the intervention phase in abnormal fatty acid metabolites among a subgroup of 110 patients and found that these levels tended to decline among those in the intervention group but not among the controls. These metabolites have been associated with disordered metabolism in patient with heart failure, so the observed reduced levels were consistent with the other outcomes. “The signals all went in the direction of reduced metabolic dysregulation,” said Dr. Felker.
Despite the positive outcomes of the intervention studied, Dr. Felker said that this type of approach needs further refinement and study before it’s ready for widespread use. “I think TARGET-HF-DM is another piece of the puzzle, but like all small trials it needs replication in larger trials before adoption into practice guidelines,” he added.
The study received no commercial funding. Dr. Felker has been a consultant to Amgen, Bristol-Myers Squibb, Cytokinetics, Medtronic, Novartis, Reprieve, and Sequana, and he has received research funding from several companies. Dr. Piano had no disclosures.
A 3-month lifestyle intervention that used a step counter and regular, personalized text messages to encourage increased mobility and adherence to medications led to a substantial rise in the quality of life in a randomized controlled study with 187 U.S. patients with heart failure and diabetes.
The TARGET-HF-DM study supplied a wrist-worn step counting device to adults with any type of heart failure and any type of diabetes at six U.S. sites and collected data on daily step counts and medication adherence through smartphone-based apps. Researchers randomized the patients to an intervention of thrice-weekly text messages that gave them personalized feedback on their recent activity and adherence and updated activity and adherence goals, or to a control group that only received a once-weekly generic message to wear the step counter.
After 3 months, patients in the intervention arm had an average incremental gain of 313 steps per day from baseline, compared with the controls, a significant difference for the study’s primary endpoint, G. Michael Felker, MD, reported at the annual scientific meeting of the Heart Failure Society of America.
A ‘quite large’ increase in quality of life.
Perhaps more importantly, a secondary analysis assessed quality of life with the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, which showed after 3 months a 5.5-point average increased improvement among patients in the intervention arm, compared with controls. Score increases of 5 of more points on the KCCQ represent clinically meaningful changes.
This average, incremental KCCQ score improvement was “quite large relative to what we typically see in placebo-controlled trials of effective drugs,” said Dr. Felker, professor of medicine at Duke University, Durham, N.C., and director of cardiovascular research at the Duke Clinical Research Institute. If a similar magnitude change in KCCQ was associated with a drug treatment “we would say it was an incredibly large signal in terms of quality of life, so I think the patients are telling us that [the intervention] is making a clinically important difference.”
But Dr. Felker cautioned that the study was not blinded, raising the possibility that the change in quality of life could have been partially explained by “patients feeling more engaged about doing something for their health.”
His report omitted data on the medication adherence facet of the study, which will come out in a subsequent report, raising the possibility that some of the quality of life benefit as well as the ability of patients to boost their step count was related to more consistent treatment with their prescribed medications, but Dr. Felker discounted this possibility.
“The adherence intervention was basically a digital tool that helped people better remember their medication regimen. While it is possible that this could have influenced the KCCQ data this seems quite unlikely to me,” he said in an interview.
‘Exercise is the new magic’
“Exercise is the new magic,” commented Mariann R. Piano, PhD, a professor at Vanderbilt University, Nashville, Tenn., and cochair of the session where Dr. Felker gave his report. “I love that the trial was pragmatic, randomized, and ran at six sites so the generalizability of the findings is really strong.” Dr. Piano also gave the study high marks for recruiting many African American patients, 47% of the study population, and its assessment of a patient-reported outcome, the KCCQ score.
Patients enrolled in TARGET-HF-DM averaged 59 years of age, about a third were women, and two-thirds had heart failure with a reduced ejection fraction of 40% or less. Eighty percent of participants had New York Heart Association class II functional limitations, and a third also had atrial fibrillation. Their average serum level of the N-terminal of the prohormone brain natriuretic peptide at baseline was 1,309 pg/mL. Most patients were on standard heart failure and diabetes medications, with 88% receiving an ACE inhibitor or angiotensin-receptor blocker (in some cases coupled with sacubitril), 90% were on a beta-blocker, 50% were on a mineralocorticoid receptor antagonist, 54% were on insulin, 47% were on a biguanidine, 25% were on a sulfonylurea, and 7% were on a sodium-glucose cotransporter inhibitor. About half the patients also had an implantable cardioverter defibrillator.
Dr. Felker acknowledged that the 313 average increment in steps per day among patients in the intervention group, compared with controls was modest, but it represented about a 10% increase from baseline among patients who in general had a very sedentary life. All patients had received at the start of the study guidelines from the American Heart Association on appropriate types and levels of physical activity for patients with heart failure and diabetes. The researcher previously published a description of the design and rationale of the study.
The study followed patients for an additional 3 months beyond the end of the intervention period, and the excess step count among people in the intervention arm persisted, although the between-group difference was no longer significant. The researchers also analyzed changes during the intervention phase in abnormal fatty acid metabolites among a subgroup of 110 patients and found that these levels tended to decline among those in the intervention group but not among the controls. These metabolites have been associated with disordered metabolism in patient with heart failure, so the observed reduced levels were consistent with the other outcomes. “The signals all went in the direction of reduced metabolic dysregulation,” said Dr. Felker.
Despite the positive outcomes of the intervention studied, Dr. Felker said that this type of approach needs further refinement and study before it’s ready for widespread use. “I think TARGET-HF-DM is another piece of the puzzle, but like all small trials it needs replication in larger trials before adoption into practice guidelines,” he added.
The study received no commercial funding. Dr. Felker has been a consultant to Amgen, Bristol-Myers Squibb, Cytokinetics, Medtronic, Novartis, Reprieve, and Sequana, and he has received research funding from several companies. Dr. Piano had no disclosures.
A 3-month lifestyle intervention that used a step counter and regular, personalized text messages to encourage increased mobility and adherence to medications led to a substantial rise in the quality of life in a randomized controlled study with 187 U.S. patients with heart failure and diabetes.
The TARGET-HF-DM study supplied a wrist-worn step counting device to adults with any type of heart failure and any type of diabetes at six U.S. sites and collected data on daily step counts and medication adherence through smartphone-based apps. Researchers randomized the patients to an intervention of thrice-weekly text messages that gave them personalized feedback on their recent activity and adherence and updated activity and adherence goals, or to a control group that only received a once-weekly generic message to wear the step counter.
After 3 months, patients in the intervention arm had an average incremental gain of 313 steps per day from baseline, compared with the controls, a significant difference for the study’s primary endpoint, G. Michael Felker, MD, reported at the annual scientific meeting of the Heart Failure Society of America.
A ‘quite large’ increase in quality of life.
Perhaps more importantly, a secondary analysis assessed quality of life with the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, which showed after 3 months a 5.5-point average increased improvement among patients in the intervention arm, compared with controls. Score increases of 5 of more points on the KCCQ represent clinically meaningful changes.
This average, incremental KCCQ score improvement was “quite large relative to what we typically see in placebo-controlled trials of effective drugs,” said Dr. Felker, professor of medicine at Duke University, Durham, N.C., and director of cardiovascular research at the Duke Clinical Research Institute. If a similar magnitude change in KCCQ was associated with a drug treatment “we would say it was an incredibly large signal in terms of quality of life, so I think the patients are telling us that [the intervention] is making a clinically important difference.”
But Dr. Felker cautioned that the study was not blinded, raising the possibility that the change in quality of life could have been partially explained by “patients feeling more engaged about doing something for their health.”
His report omitted data on the medication adherence facet of the study, which will come out in a subsequent report, raising the possibility that some of the quality of life benefit as well as the ability of patients to boost their step count was related to more consistent treatment with their prescribed medications, but Dr. Felker discounted this possibility.
“The adherence intervention was basically a digital tool that helped people better remember their medication regimen. While it is possible that this could have influenced the KCCQ data this seems quite unlikely to me,” he said in an interview.
‘Exercise is the new magic’
“Exercise is the new magic,” commented Mariann R. Piano, PhD, a professor at Vanderbilt University, Nashville, Tenn., and cochair of the session where Dr. Felker gave his report. “I love that the trial was pragmatic, randomized, and ran at six sites so the generalizability of the findings is really strong.” Dr. Piano also gave the study high marks for recruiting many African American patients, 47% of the study population, and its assessment of a patient-reported outcome, the KCCQ score.
Patients enrolled in TARGET-HF-DM averaged 59 years of age, about a third were women, and two-thirds had heart failure with a reduced ejection fraction of 40% or less. Eighty percent of participants had New York Heart Association class II functional limitations, and a third also had atrial fibrillation. Their average serum level of the N-terminal of the prohormone brain natriuretic peptide at baseline was 1,309 pg/mL. Most patients were on standard heart failure and diabetes medications, with 88% receiving an ACE inhibitor or angiotensin-receptor blocker (in some cases coupled with sacubitril), 90% were on a beta-blocker, 50% were on a mineralocorticoid receptor antagonist, 54% were on insulin, 47% were on a biguanidine, 25% were on a sulfonylurea, and 7% were on a sodium-glucose cotransporter inhibitor. About half the patients also had an implantable cardioverter defibrillator.
Dr. Felker acknowledged that the 313 average increment in steps per day among patients in the intervention group, compared with controls was modest, but it represented about a 10% increase from baseline among patients who in general had a very sedentary life. All patients had received at the start of the study guidelines from the American Heart Association on appropriate types and levels of physical activity for patients with heart failure and diabetes. The researcher previously published a description of the design and rationale of the study.
The study followed patients for an additional 3 months beyond the end of the intervention period, and the excess step count among people in the intervention arm persisted, although the between-group difference was no longer significant. The researchers also analyzed changes during the intervention phase in abnormal fatty acid metabolites among a subgroup of 110 patients and found that these levels tended to decline among those in the intervention group but not among the controls. These metabolites have been associated with disordered metabolism in patient with heart failure, so the observed reduced levels were consistent with the other outcomes. “The signals all went in the direction of reduced metabolic dysregulation,” said Dr. Felker.
Despite the positive outcomes of the intervention studied, Dr. Felker said that this type of approach needs further refinement and study before it’s ready for widespread use. “I think TARGET-HF-DM is another piece of the puzzle, but like all small trials it needs replication in larger trials before adoption into practice guidelines,” he added.
The study received no commercial funding. Dr. Felker has been a consultant to Amgen, Bristol-Myers Squibb, Cytokinetics, Medtronic, Novartis, Reprieve, and Sequana, and he has received research funding from several companies. Dr. Piano had no disclosures.
FROM HFSA 2021